Metal total ankle joint prosthesis for bone trabecula

Abstract

The invention provides a bone trabecula metal total ankle joint prosthesis, and belongs to the technical field of ankle joint prostheses. Comprising a talus connecting frame, a joint device is fixedly installed at the top of the talus connecting frame, and a tibia connecting part is fixedly installed at the top of the joint device. The joint device is characterized in that the joint device and the hinge ball can freely rotate in the hinge groove of the fixed seat, the device can adapt to the ankle joint of the human body, the rotation angle can be adjusted in a self-adaptive mode, the wear-resistant ceramic gasket is attached to the hinge ball, the friction resistance is greatly improved, and lubricating balls arranged at the outer end of the hinge ball at equal intervals provide self-lubrication; the elastic bag body is matched with the one-way valve, when the hinge ball rotates, the fixing base extrudes the elastic bag body, tissue lubricating liquid is sucked in from the outside through the piston pumping function, then the tissue lubricating liquid is evenly conveyed to the surfaces of the hinge ball and the abrasion-resistant ceramic gasket through the linear micropores, the lubricating performance is comprehensively improved, abrasion is reduced, and smooth operation of joints is guaranteed.

Description

Technical Field

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

[0002] In the field of the treatment of ankle joint diseases or injuries, ankle joint replacement surgery is one of the important means, and trabecular all-metal ankle joint prostheses play a key role. Such prostheses are generally made of metal materials such as titanium alloy and cobalt-chromium-molybdenum, simulating the shape, structure and function of the human ankle joint, and are composed of a tibial prosthesis, a talus prosthesis and an intermediate part connecting the two. The purpose is to replace a severely damaged ankle joint, help the patient relieve pain and restore joint function. The internal trabecular structure promotes bone growth and improves the stability of the combination of the prosthesis and the human bone;

[0003] In the prior art, for example, the ankle joint prosthesis with the publication number CN214632512U has certain innovations in design. A large number of ceramic gaskets are evenly fixed in the movable groove at the bottom of the supporting part of the tibial prosthesis to form a smooth curved surface, and the upper half of the movable ball of the talus prosthesis is slidably connected thereto. At the same time, the honeycomb layer structure promotes the ingrowth of bone tissue to avoid prosthesis loosening, converts the metal-polymer friction into ceramic-metal friction to reduce the friction coefficient and reduce the precipitation of metal ions, and enhances the stability by using the support plate to fix the talus screw through the fixing plate and the limiting plate;

[0004] However, this existing solution still has obvious defects. Its ceramic gaskets are located in the inner gap between the movable groove and the movable ball and are in large-area contact with the movable ball. During the joint linkage process, the rotation angle of the movable ball is limited, mostly only able to rotate 30-40 degrees. Due to the limited rotation angle and the large contact area between the gasket and the sphere, when the joint moves, it is difficult for the tissue lubricating fluid to evenly contact the movable ball and cannot evenly penetrate into all contact areas, and dry grinding is very likely to occur, which in turn leads to severe friction of the ceramic gaskets. This not only affects the service life of the prosthesis, but also may 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 joint prosthesis to overcome the above technical bottlenecks and improve the overall performance and clinical application effect of the ankle joint prosthesis. Summary of the Invention

[0005] Aiming at the problem of poor lubrication ability in the prior art, the purpose of the present invention is to provide a trabecular metal total ankle joint prosthesis.

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

[0007] A trabecular metal total ankle joint prosthesis, comprising a talus connecting frame, a joint device is fixedly installed at the top of the talus connecting frame, and a tibial connecting part is fixedly installed at the top of the joint device;

[0008] The joint device includes a fixed seat. An articulated groove is formed inside the fixed seat. An articulated ball is movably installed inside the articulated groove. The bottom of the articulated ball is connected to the top of the talus connecting frame. A wear-resistant ceramic gasket is fixedly connected inside the articulated groove. The inner side of the wear-resistant ceramic gasket is connected to the outer surface of the articulated ball. Self-lubricating mechanisms are equidistantly arranged on the outer surface of the articulated ball. Linear guide holes are equidistantly formed inside the articulated ball. The inner ends of the linear guide holes are all communicated with the inside of the self-lubricating mechanisms.

[0009] Optionally, lubricating balls are rotatably connected to the upper end of the outer surface of the articulated ball at equal intervals. The outer sides of the lubricating balls are in fit connection with the inner wall of the wear-resistant ceramic gasket. The wear-resistant ceramic gasket is made of wear-resistant zirconia ceramic material.

[0010] Optionally, the self-lubricating mechanism includes an elastic capsule body. The elastic capsule bodies are arranged in an equidistant annular array and fixedly connected to the lower end of the outer surface of the articulated ball. One-way valves are fixedly connected to both the outer bottom and the inner bottom of the elastic capsule body. The output end of the one-way valve located on the outer side is communicated with the inside of the elastic capsule body. The output end of the one-way valve located at the inner end is communicated with the input end of the linear guide hole. The elastic capsule body is made of polycarbonate-type polyurethane material.

[0011] Optionally, the tibia connecting part includes a connecting main pipe. A tibia 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 fixed seat. Outer layer large holes are equidistantly formed on the outer surface of the connecting main pipe.

[0012] Optionally, inner layer micro holes are equidistantly arranged on the inner wall of the connecting main pipe around the outer layer large holes. The aperture of the outer layer large holes is larger than that of the inner layer micro holes.

[0013] Optionally, microspheres are arranged inside the inner layer micro holes. Bone morphogenetic protein and vascular endothelial growth factor are carried inside the microspheres.

[0014] Optionally, mounting frames are fixedly connected to both sides of the bottom of the talus connecting frame. Mounting holes are formed at the lower ends of the mounting frames.

[0015] Optionally, antibacterial composite coatings are provided on the outer surfaces of the connecting main pipe, the tibia connecting frame, the articulated ball and the talus connecting frame. The antibacterial composite coating is a coating in which silver nanoparticles or quaternary ammonium salt compounds are doped in the HA coating.

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

[0017] In the above solution, the core of this ankle joint prosthesis lies in the joint device. The articulated ball can rotate freely within the articulated groove of the fixed seat, enabling the device to adapt to the human ankle joint and adjust the rotation angle adaptively. The wear-resistant ceramic gasket fits the articulated ball, greatly enhancing the friction resistance performance. Lubricating balls are evenly arranged at the outer end of the articulated ball to provide self-lubrication. Particularly, the elastic bladder cooperates with the one-way valve. When the articulated ball rotates, the fixed seat squeezes the elastic bladder, enabling it to suck in tissue lubricating fluid from the outside through the piston pumping function and then evenly deliver it to the surface of the articulated ball and the wear-resistant ceramic gasket through linear micropores, comprehensively enhancing the lubrication performance, reducing wear, and ensuring the smooth operation of the joint.

[0018] In the application of the ankle joint prosthesis, the tibial connection part plays a crucial role. The tibial connection frame at the top of the connecting main pipe ensures a firm connection with the tibia. The connecting main pipe is fixed to the top of the fixed seat to strengthen the overall structural stability. The outer layer of macropores with a size of 500 - 800 μm on the outer surface of the connecting main pipe is conducive to the growth of bone tissue and enhances the prosthesis anchoring effect. The inner layer of micropores with a size of 100 - 200 μm inside increases the surface area, adsorbs growth factors to support vascularization. PLGA microspheres loaded with BMP-2 and VEGF in the micropores continuously release growth factors by controlling the degradation rate of the microspheres, directionally activating the differentiation of osteoblasts and angiogenesis, forming a "bone-vascular synchronous growth" synergistic effect, greatly accelerating bone healing, and strengthening the integration of the prosthesis and the tibia.

[0019] The mounting brackets and the lower mounting holes on both sides at the bottom of the talus connection frame are conveniently and firmly connected to the talus, ensuring the coherence of the structure and function of the entire ankle joint prosthesis. The antibacterial composite coating applied on the outer surfaces of the connecting main pipe, tibial connection frame, articulated ball, and talus connection frame, whether it is an HA coating doped with 0.5 - 1 wt% silver nanoparticles or a quaternary ammonium salt compound, has strong antibacterial properties, can effectively inhibit the growth of bacteria, and greatly reduces the risk of postoperative infection, providing a solid guarantee for the long-term stable operation of the prosthesis after implantation and the physical health of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The drawings incorporated herein and constituting a part of the specification illustrate embodiments of the present invention and, together with the specification, are further used to explain the principles of the present invention and enable those skilled in the relevant art to implement and use the present invention.

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

[0022] Figure 2 is a front view structural schematic diagram of the separated state of the present invention;

[0023] Figure 3 is a bottom view structural schematic diagram of the separated state of the present invention;

[0024] Figure 4Schematic diagram of the tibia connection part of the present invention;

[0025] Figure 5 Schematic diagram of the talus connection frame and hinge ball structure of the present invention;

[0026] Figure 6 Schematic diagram of the internal structure of the hinge ball of the present invention;

[0027] Figure 7 Schematic diagram of the cross-sectional state structure of the outer large pores, inner micro-pores and microspheres of the present invention;

[0028] Figure 8 For the present invention Figure 4 Enlarged structure schematic diagram at position A;

[0029] Figure 9 For the present invention Figure 6 Enlarged structure schematic diagram at position B;

[0030] Figure 10 For the present invention Figure 7 Enlarged structure schematic diagram at position C.

[0031] [Reference numerals]

[0032] 1. Talus connection frame;

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

[0034] 26. Self-lubricating mechanism; 261. Elastic capsule; 262. Check valve;

[0035] 27. Lubricating ball;

[0036] 3. Tibia connection part; 31. Connection main pipe; 32. Tibia connection frame; 33. Outer large pores; 34. Inner micro-pores; 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 embodiments of the present invention, specific structures and devices are marked in the figure, but this is only for schematic needs and is not intended to limit the present invention to this specific structure, device and environment. Those of ordinary skill in the art can adjust or modify these devices and environments according to specific needs. Detailed implementation manners

[0039] The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. At the same time, it should be noted here that in order to make the embodiments more detailed, the following embodiments are the best and preferred embodiments. For some well-known technologies, those skilled in the art can also adopt other alternative methods for implementation; moreover, the accompanying drawings are only for more specifically describing the embodiments and are not intended to specifically limit the present invention.

[0040] It should be noted that in the specification, references to "an embodiment", "embodiment", "exemplary embodiment", "some embodiments", etc. indicate that the described embodiments may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes that particular feature, structure, or characteristic. Additionally, when combining embodiments to describe a particular feature, structure, or characteristic, implementing such feature, structure, or characteristic in combination with other embodiments (whether explicitly described or not) should be within the knowledge of those skilled in the relevant art.

[0041] Generally, 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 a singular sense, or can be used to describe a combination of features, structures, or characteristics in a plural sense. Additionally, the term "based on" can be understood to not necessarily convey a set of exclusive factors, but rather, at least in part depending on the context, to allow for the existence of other factors that may not be explicitly described.

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

[0043] In addition, spatial relative terms such as "under...", "below...", "lower", "above...", "upper", etc. may be used herein for convenience of description to describe the relationship of one element or feature to another or other elements or features, as shown in the drawings. The spatial relative terms are intended to cover different orientations in the use or operation of the device in addition to the orientation depicted in the drawings. The device may be oriented in other ways, and the spatial relative descriptive terms used herein may be interpreted correspondingly.

[0044] As Figures 1 to 10As shown in the figure, an embodiment of the present invention provides a trabecular metal total ankle joint prosthesis, which includes a talus connecting frame 1. A joint device 2 is fixedly installed on the top of the talus connecting frame 1, and a tibia connecting part 3 is fixedly installed on the top of the joint device 2. The joint device 2 includes a fixed seat 21. An articulated groove 22 is formed inside the fixed seat 21. An articulated ball 23 is movably installed inside the articulated groove 22. The bottom of the articulated ball 23 is connected to the top of the talus connecting frame 1. A wear-resistant ceramic gasket 24 is fixedly connected inside the articulated groove 22. The inner side of the wear-resistant ceramic gasket 24 is connected to the outer surface of the articulated ball 23. Self-lubricating mechanisms 26 are equidistantly arranged around the outer surface of the articulated ball 23. Linear guide holes 25 are equidistantly formed inside the articulated ball 23. The inner ends of the linear guide holes 25 are all communicated with the inside of the self-lubricating mechanisms 26. When the trabecular metal total ankle joint prosthesis works, the talus connecting frame 1 is responsible for connecting with the talus, playing a role of support and connection. The articulated ball 23 in the articulated groove 22 inside the fixed seat 21 of the joint device 2 can move flexibly and is connected to the top of the talus connecting frame 1. It can rotate at multiple angles inside the articulated groove 22 according to the movement needs of the human body to realize various activities of the ankle joint. The wear-resistant ceramic gasket 24 fixed in the articulated groove 22 closely fits the outer surface of the articulated ball 23. When the joint moves, it effectively reduces the frictional loss between the articulated ball 23 and the articulated groove 22, improving the durability of the prosthesis. The self-lubricating mechanisms 26 equidistantly arranged on the outer surface of the articulated ball 23 are communicated with the inside of the articulated ball 23 through the linear guide holes 25. During the movement of the joint, the self-lubricating mechanisms 26 are activated to convey lubricating substances into the linear guide holes 25, and then evenly guide the lubricating substances to the contact part between the articulated ball 23 and the wear-resistant ceramic gasket 24 through the linear guide holes 25 to achieve continuous and uniform lubrication, ensuring the stable and smooth operation of the joint device 2. Furthermore, the tibia connecting part 3 can cooperate with the tibia stably as the joint device 2 moves, completing the functions of the entire ankle joint prosthesis.

[0045] Please refer to Figures 1 - 6, lubricating balls 27 are rotatably connected at equal intervals to the upper end of the outer surface of the articulated ball 23. The outer side of the lubricating ball 27 is in fit connection with the inner wall of the wear-resistant ceramic gasket 24. The wear-resistant ceramic gasket 24 is made of wear-resistant zirconia ceramic material. When the trabecular metal total ankle joint prosthesis operates, the talus connecting frame 1 is connected to the talus to provide support for the entire device. In the joint device 2, the articulated ball 23 in the articulated groove 22 of the fixed seat 21 can rotate flexibly, driving the entire joint to simulate the activities of the human ankle joint. The lubricating balls 27 rotatably connected at equal intervals to the upper end of the outer surface of the articulated ball 23 have their outer sides in fit 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 balls 27 roll accordingly. On the one hand, the lubricating balls 27 can reduce the direct friction between the articulated ball 23 and the wear-resistant ceramic gasket 24, playing a preliminary lubricating and buffering role; on the other hand, in cooperation 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 material has good wear resistance, can effectively resist the friction generated by the articulated ball 23 and the lubricating balls 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, enable the tibia connecting part 3 to cooperate well with the tibia, and complete various functions of the ankle joint.

[0046] Please refer to Figures 1 - 7 and Figure 9 , the self-lubricating mechanism 26 includes an elastic capsule 261. The elastic capsules 261 are arranged in an annular shape at equal intervals and fixedly connected to the lower end of the outer surface of the articulated ball 23. One-way valves 262 are fixedly connected to both the outer bottom and the inner bottom of the elastic capsule 261. The output end of the one-way valve 262 located on the outer side is communicated with the inside of the elastic capsule 261, and the output end of the one-way valve 262 located at the inner end is communicated with 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 this trabecular metal total ankle joint prosthesis, the elastic capsules 261 made of polycarbonate polyurethane material are arranged in an annular shape at equal intervals and fixed to the lower end of the outer surface of the articulated 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 compressed, the elastic capsule 261 shrinks, 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, it prevents the air from flowing out. When the pressure on the elastic capsule 261 is released due to the rotation of the articulated ball 23, the elastic capsule 261 quickly resets, generating a negative pressure. At this time, the outer one-way valve 262 opens. When compressed again, the elastic capsule 261 squeezes the internal lubricating liquid 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 a continuous and efficient self-lubricating function and ensuring the stable and smooth operation of the joint.

[0047] Please refer to Figures 1 - 4 andFigures 7 - 10 The tibial connecting part 3 includes a connecting main pipe 31. A tibial connecting frame 32 is fixedly installed at the top of the connecting main pipe 31. The connecting main pipe 31 is fixedly connected to the top of the fixed seat 21. Outer large holes 33 are equidistantly formed on the outer surface of the connecting main pipe 31 in a circumferential manner. Inner micro-holes 34 are arranged in a ring shape equidistantly on the inner wall of the connecting main pipe 31 and around the outer large holes 33. The aperture of the outer large holes 33 is larger than that of the inner micro-holes 34. The aperture of the outer large holes 33 is 500 - 800 μm, and the aperture of the inner micro-holes 34 is 100 - 200 μm. Microspheres 35 are arranged inside the inner micro-holes 34. Bone morphogenetic protein and vascular endothelial growth factor are carried inside the microspheres 35. Mounting frames 4 are fixedly connected to both sides of the bottom of the talar connecting frame 1. Mounting holes are formed at the lower ends of the mounting frames 4. Antibacterial composite coatings 5 are arranged on the outer surfaces of the connecting main pipe 31, the tibial connecting frame 32, the articulated ball 23, and the talar connecting frame 1. The antibacterial composite coating 5 is a coating in which silver nanoparticles (0.5 - 1 wt%) or quaternary ammonium salt compounds are doped in the HA coating. In the tibial connecting part 3, the tibial connecting frame 32 fixedly installed at 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 fixed seat 21, ensuring the stability of the connection between the joint device 2 and the tibia. Outer large holes 33 with an aperture of 500 - 800 μm are arranged on the outer surface of the connecting main pipe 31, providing a spacious channel for bone tissue ingrowth and promoting the initial combination of the prosthesis and the surrounding bones. Inner micro-holes 34 with an inner aperture of 100 - 200 μm greatly increase the surface area. Mounting frames 4 with mounting holes on both sides of the bottom of the talar connecting frame 1 facilitate the connection with the talus, ensuring the overall coherence of the ankle joint prosthesis. The antibacterial composite coatings 5 on the outer surfaces of the connecting main pipe 31, the tibial connecting frame 32, the articulated ball 23, and the talar connecting frame 1, whether it is the HA coating doped with 0.5 - 1 wt% silver nanoparticles or the quaternary ammonium salt compound coating, can effectively inhibit bacterial growth with their strong antibacterial properties, reduce the risk of postoperative infection, ensure the long-term stable operation of the prosthesis, and provide protection for the health of patients.

[0048] The specific working process of the technical solution provided by 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 this joint device 2 lies in the delicate cooperation between the articulated ball 23 and the fixed seat 21. The articulated ball 23 can rotate flexibly in the articulated groove 22 on the fixed seat 21. This design enables the ankle joint frame to adaptively adjust the rotation angle according to the human movement requirements when adapting to the human ankle joint, effectively simulating the movement range of the natural ankle joint and improving the movement comfort and flexibility of patients.

[0050] During the operation of the joint, the wear-resistant ceramic gasket 24 closely fits the articulated ball 23. With its excellent wear resistance, it greatly reduces the frictional loss generated during the rotation of the articulated ball 23 and significantly extends the service life of the ankle joint frame. In addition, 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 squeezing force to the elastic capsule 261. During the squeezing stage, the elastic capsule 261 is compressed under the action of 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 inhales the surrounding tissue lubricating fluid through the outer one-way valve 262. Due to the one-way flow characteristic of the one-way valve 262, the tissue lubricating fluid can only enter the elastic capsule 261 unidirectionally. When the articulated ball 23 rotates again to squeeze the elastic capsule 261, because the outer one-way valve 262 prevents the liquid from flowing out in the reverse direction, while the inner one-way valve 262 allows the liquid to flow from the inside to the outside, the tissue lubricating fluid inside the elastic capsule 261 is under the action of the squeezing force and is transported to the top of the articulated ball 23 through the inner one-way valve 262 and the linear micropores 25. The linear micropores 25 are evenly distributed around the articulated ball 23 and can evenly infiltrate the tissue lubricating fluid onto the surfaces of the articulated ball 23 and the wear-resistant ceramic gasket 24, comprehensively improving the lubrication performance during the rotation of the joint, effectively reducing wear, and ensuring the smooth operation of the joint.

[0051] The tibial connection part 3 of this device plays a key role in promoting bone growth and rapidly achieving bone integration in the application of ankle joint prostheses. The tibial connection frame 32 fixedly installed at the top of the connection main pipe 31 is made of a material with high strength and good biocompatibility, ensuring a firm and reliable connection with the tibia. The connection main pipe 31 is fixed to the top of the fixed seat 21, further strengthening the stability of the overall structure, effectively dispersing the stress generated during joint movement, and improving the mechanical properties of the prosthesis in the body. The outer large holes 33 evenly arranged on the outer surface of the connection main pipe 31 have an aperture precisely controlled within 500 - 800 μm, providing an ideal channel for the ingrowth of bone tissue, greatly promoting the close combination of the prosthesis and the surrounding bones, and significantly enhancing the anchoring effect of the prosthesis at the tibial part. The inner micro-holes 34 are arranged in a ring at equal intervals on the inner wall of the connection main pipe 31 and around the outer large holes 33, with an aperture of 100 - 200 μm. These micro-holes greatly increase the surface area, can efficiently adsorb growth factors, and provide strong support for vascularization. The microspheres 35 loaded with bone morphogenetic protein and vascular endothelial growth factor are arranged in the micro-holes. The bone morphogenetic protein and vascular endothelial growth factor can be recombinant human bone morphogenetic protein-2 or recombinant human vascular endothelial growth factor-165, and can be released when applied to the human bone joint to promote bone growth, greatly accelerating the bone healing process and significantly enhancing the integration degree of the prosthesis and the tibia; the mounting frames 4 fixedly connected to both sides of the bottom of the talar connection frame 1 are scientifically and reasonably designed. 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 coherence and integrity of the entire ankle joint prosthesis in terms of structure and function. The outer surfaces of the connection main pipe 31, the tibial connection frame 32, the articulated ball 23, and the talar connection frame 1 are all coated with an antibacterial composite coating 5. The coating material is selected as HA coating doped with 0.5 - 1 wt% silver nanoparticles or quaternary ammonium salt 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 a solid and reliable guarantee for the long-term stable operation of the prosthesis after implantation and the physical health of patients.

[0052] This ankle joint prosthesis adopts a precision spherical matching structure, and works in coordination with the fixed seat 21 through the articulated ball 23 that rotates with ±30° freedom, and combines with the medical-grade silicone rubber elastic capsule 261 to build an intelligent lubrication system. The system drives the elastic capsule 261 through the cam effect to realize piston-type liquid circulation: when the joint movement produces periodic displacement, the elastic capsule 261 absorbs synovial fluid at a rate of 2-5μL / time through the outer one-way valve 262 (aperture 0.1-0.3mm), and generates an internal pressure of 20-50kPa when the articulated ball 23 rotates to the extreme position, forcing the synovial fluid to enter the high-density microporous network (50-80 pores / cm²) through the inner one-way valve 262 (aperture 0.05-0.1mm). The linear micropores adopt a bionic synovial villus structure, and a uniform lubricating film (thickness 5-10μm) is formed at the interface between the ceramic gasket and the articulated ball 23 through the surface tension gradient design, so that the friction coefficient is reduced to 0.015-0.02, significantly improving the smoothness of joint movement.

[0053] The tibial connection part 3 adopts a three-dimensional collaborative design, which promotes bone integration through the triple mechanisms of gradient pore structure, growth factor sustained release system and dynamic stress stimulation. The outer layer of 500-800μm titanium alloy grid and the inner layer of 100-200μm honeycomb micropores form graded bone ingrowth channels, and cooperate with PLGA microspheres 35 prepared by microfluidics to achieve biphasic release of BMP-2 (24-hour burst release of 30% + 60-day sustained release of >80%). The integrated 0.2mm thick piezoelectric ceramic sheet generates a 10-50μA pulse current when subjected to a load of >150N, and activates osteoblast differentiation and angiogenesis by regulating the current density of 0.1-1.0mA / cm², forming a "bone-vascular synchronous growth" synergistic effect.

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

[0055] This device adopts multidisciplinary manufacturing technology, including five-axis CNC machining of cobalt-chromium-molybdenum alloy hinged balls 23 (Ra≤0.4μm), SLM preparation of titanium alloy porous scaffolds (porosity control ±2%), and intelligent upgrade solutions including integrated micro pressure sensors (accuracy ±0.5%FS) to achieve real-time load monitoring, surface grafting of PEGDA hydrogel (swelling rate 300%) and introduction of bionic microvilli structure (height 50-100μm), which improve lubrication efficiency while maintaining biocompatibility.

[0056] The present invention encompasses any alternatives, modifications, equivalent methods, and solutions made to the essence and scope of the present invention. For the public to have a thorough understanding of the present invention, specific details are described in detail in the following preferred embodiments of the present invention. However, those skilled in the art can fully understand the present invention without the description of these details. Additionally, well-known methods, processes, procedures, components, and circuits, etc. are not described in detail to avoid unnecessary confusion to the essence of the present invention.

[0057] The above description is only a preferred embodiment of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A trabecular metal total ankle prosthesis, comprising a talus connecting frame, characterized in that, The top of the talus connecting frame is fixedly installed with a joint device, and the top of the joint device is fixedly installed with a tibia connecting part; The joint device includes a fixed seat. An articulated groove is formed inside the fixed seat. An articulated ball is movably installed inside the articulated groove. The bottom of the articulated ball is connected to the top of the talus connecting frame. A wear-resistant ceramic gasket is fixedly connected inside the articulated groove. The inner side of the wear-resistant ceramic gasket is connected to the outer surface of the articulated ball. Self-lubricating mechanisms are equidistantly arranged on the outer surface of the articulated ball. Linear guide holes are equidistantly formed inside the articulated ball. The inner ends of the linear guide holes are all communicated with the inside of the self-lubricating mechanisms.

2. The trabecular metal total ankle joint prosthesis according to claim 1, characterized in that, Lubricating balls are rotatably connected to the upper end of the outer surface of the articulated ball at equal intervals. The outer sides of the lubricating balls are in fit connection with the inner wall of the wear-resistant ceramic gasket.

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

4. The trabecular metal total ankle joint prosthesis according to claim 1, characterized in that, The self-lubricating mechanism includes elastic capsules. The elastic capsules are fixedly connected to the lower end of the outer surface of the articulated ball in an equidistant annular arrangement. One-way valves are fixedly connected to both the outer bottom and the inner bottom of the elastic capsules. The output end of the one-way valve located on the outer side is communicated with the inside of the elastic capsule. The output end of the one-way valve located at the inner end is communicated with the input end of the linear guide hole.

5. The trabecular metal total ankle joint prosthesis according to claim 4, characterized in that, The elastic capsule is made of polycarbonate polyurethane material.

6. The trabecular metal total ankle joint prosthesis according to claim 1, wherein The tibia connecting part includes a connecting main pipe. A tibia 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 fixed seat. Outer layer large holes are equidistantly formed on the outer surface of the connecting main pipe.

7. The trabecular metal total ankle prosthesis according to claim 6, characterized in that, Inner layer micro holes are equidistantly arranged inside the connecting main pipe and on the inner wall of the ring-shaped outer layer large holes. The aperture of the outer layer large hole is larger than that of the inner layer micro hole.

8. The trabecular metal total ankle joint prosthesis according to claim 7, characterized in that Microspheres are arranged inside the inner layer micro holes. Bone morphogenetic protein and vascular endothelial growth factor are carried inside the microspheres.

9. The trabecular metal total ankle joint prosthesis according to claim 8, characterized in that, Mounting frames are fixedly connected to both sides of the bottom of the talus connecting frame. Mounting holes are formed at the lower ends of the mounting frames.

10. The trabecular metal total ankle joint prosthesis according to claim 9, characterized in that, Antibacterial composite coatings are provided on the outer surfaces of the connecting main pipe, the tibia connecting frame, the articulated ball and the talus connecting frame. The antibacterial composite coating is a coating in which silver nanoparticles or quaternary ammonium salt compounds are doped in the HA coating.

Images