Single-ankle-joint clinical operation surface replacement system

Abstract

The invention provides a single-ankle-joint clinical operation surface replacement system, and belongs to the field of medical instruments. Comprising a lateral tibia tray, a middle liner and a lateral talus top, the middle liner is arranged at the top of the lateral tibia tray, the lateral talus top is arranged on the side, away from the lateral tibia tray, of the middle liner, the outer wall of the side, close to the lateral talus top, of the middle liner is a concave face, and connecting grooves are formed in the two sides of the surface of the lateral tibia tray correspondingly; connecting strips are connected to the end, close to the side tibia tray, of the middle liner in an arrayed mode, the connecting strips are matched with the connecting grooves, the connecting strips are embedded in the connecting grooves, limiting grooves are formed in the edges of the inner walls of the connecting grooves in an arrayed mode, and first shape memory polymers are embedded in the limiting grooves. After the side tibia tray and the middle liner are fixedly connected, the first shape memory polymer expands to fill the gap between the connecting strip and the connecting groove to form rigid connection, and therefore the stability of connection is improved.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and more particularly to a single ankle joint clinical surgical surface replacement system. Background Art

[0002] Currently, ankle fusion and total ankle arthroplasty are the mainstream surgical procedures for treating end-stage ankle joint diseases such as traumatic arthritis, osteoarthritis, and rheumatoid arthritis. However, patients who undergo ankle fusion often experience poor joint function after surgery. Therefore, total ankle arthroplasty has become a more popular treatment option and its application is gradually increasing. Currently, all artificial ankle joints used in clinical practice are total ankle arthroplasties, which replace the entire articular surface of the distal tibia and proximal talus. However, many patients experience ankle degeneration, cartilage defects or damage, and pain primarily due to damage to some of the articular surfaces of the ankle joint, such as the medial and lateral articular surfaces, or localized articular surfaces of talar necrosis. Replacing relatively normal articular surfaces is highly destructive. Furthermore, total ankle arthroplasties are subject to numerous problems, including prosthetic loosening, limited service life, and dislocation of the active spacer. Revision of failed total ankle arthroplasties also presents issues such as bone loss and reconstruction difficulties. Based on the above technical problems, the existing technology has also provided some solutions. For example, the Chinese patent with the authorization announcement number CN109620483A discloses a single ankle joint surface replacement system, which consists of a tibial side, a rotation core, and a talar side, wherein the tibial side and the talar side are made of metal or alloy materials, and the rotation core is a polyethylene friction-resistant material. The above structure can be used to achieve single ankle joint surface replacement. The front part of the tibial side is connected to the sagittal plane of the body at an angle, the top of the tibial side is a rough sprayed surface or a non-polished metal surface; the bottom of the tibial side is a polished smooth surface. There are double fin-shaped keels in the middle of the body. The left and right diameters and the anterior-posterior diameters of the rotation core are smaller than the tibial side; the top of the rotation core is a convex surface in both the sagittal and coronal planes, and the bottom of the rotation core is a horizontal smooth plane. The top of the talar side is a polished horizontal smooth surface, the bottom is a non-polished metal surface, and there are double fin-shaped keels in the middle of the bottom. It has a simple structure and is easy to use. It can obtain good ankle joint function, effectively preserve bone volume, effectively improve initial stability, and reduce revision rate.

[0003] However, in actual production operations, the existing single ankle replacement system is prone to dislocation of the gasket when the middle pad layer and the lateral tibial tray are slidably connected. The fixed connection is often fixed by a simple locking structure or bolts. During long-term exercise, the bolts are easily loosened, resulting in an unstable connection. Summary of the Invention

[0004] In view of the problem that the blanking device in the prior art cannot be adjusted according to the blanking needs of steel bars of different length specifications and can only blank steel bars of fixed length, the purpose of the present invention is to provide a single ankle joint clinical surgical surface replacement system.

[0005] In order to solve the above problems, the present invention adopts the following technical solutions:

[0006] A single ankle joint clinical surgical surface replacement system comprises a lateral tibial tray, an intermediate pad and a lateral talar top; the top of the lateral tibial tray is provided with an intermediate pad, and the side of the intermediate pad away from the lateral tibial tray is provided with a lateral talar top;

[0007] The outer wall of the side of the middle pad close to the lateral talar top is a concave surface, the side of the lateral talar top close to the middle pad is slidably connected to the concave surface, the side of the lateral talar top close to the middle pad is a smooth surface, and the side of the lateral talar top away from the middle pad is a rough surface;

[0008] It also includes connecting grooves arranged on both sides of the surface of the lateral tibial tray, and the middle pad is connected to one end of the lateral tibial tray with a connecting strip, the connecting strip matches the connecting groove, and the connecting strip is embedded in the connecting groove. The inner wall edge of the connecting groove is arranged with a limiting groove, and the interior of the limiting groove is embedded with a No. 1 shape memory polymer.

[0009] Optionally, a connecting assembly is provided in the middle part of the lateral tibial tray, and the connecting assembly includes a connecting groove, a push rod, a push block, a slope block, and a fixing hole. The connecting groove is connected to the connecting grooves on both sides, and the inner walls on both sides of the connecting groove are slidably connected with push rods, and the ends of the two groups of push rods that are away from each other are connected to push blocks, and the ends of the two groups of push rods that are opposite to each other are connected to slope blocks, and the two groups of slope blocks are abutted against each other, and a fixing hole is provided on the outer wall of one side of the top block.

[0010] Optionally, a threaded groove is provided in the middle of the two groups of connecting grooves, the ends of the threaded groove are connected to the connecting groove, and the inner wall of the middle part of the threaded groove is threadedly connected with a fastening bolt.

[0011] Optionally, a card slot is provided on one side outer wall of the two groups of connecting strips, and the two groups of top blocks match the card slots on both sides. A No. 2 shape memory polymer is embedded on one side inner wall of the card slot, and the No. 2 shape memory polymer matches the fixing hole.

[0012] Optionally, oblique locking nail holes are provided at the four ends of the lateral talar top, the oblique locking nail holes are threaded, and the direction of the nail holes is at an angle of 40° to the horizontal plane. The rough surface of the lateral talar top is generated by laser cladding technology to form a gradient porous titanium structure, the porosity gradually changes from 80% to 30% from the surface to the inside, and the pore diameter is 50-500μm.

[0013] Optionally, a piezoelectric sensor is embedded in the center of the middle liner, an RFID sensor is provided on one side of the piezoelectric sensor, and outer walls of the piezoelectric sensor and the RFID sensor are wrapped with a silicone pad.

[0014] Optionally, the middle liner is made of vitamin E-doped highly cross-linked polyethylene, and the lateral tibial tray and the lateral talar top are both made of titanium alloy.

[0015] Optionally, a mounting connection hole is provided at the center of the lateral tibial tray, positioning columns are provided at four ends of the outer wall of the lateral tibial tray away from the middle pad, and micro holes are arranged on the outer wall of the lateral tibial tray close to the positioning columns.

[0016] Optionally, the materials of the No. 1 shape memory polymer and the No. 2 shape memory polymer are both polyurethane-based shape memory polymers.

[0017] Optionally, the bone contact surfaces of the lateral tibial tray and the lateral talar crest are coated with a gradient bioactive coating, and the gradient bioactive coating is sequentially as follows from the inside to the outside:

[0018] Inner layer: hydroxyapatite, content 80wt%, the balance is titanium alloy base material, thickness 50μm;

[0019] Middle layer: strontium-doped hydroxyapatite, content 50wt%, the balance is titanium alloy base material, thickness 30μm;

[0020] Outer layer: mesoporous silica nanoparticle layer loaded with bone morphogenetic protein-2, with a thickness of 20 μm.

[0021] Compared with the prior art, the technical solution provided by the present invention has at least the following beneficial effects:

[0022] In the above scheme, after the lateral tibial tray and the middle pad are fixedly connected, the No. 1 shape memory polymer expands at 37°C to fill the gap between the connecting strip and the connecting groove to form a rigid connection, thereby improving the stability of the connection. At the same time, the No. 2 shape memory polymer expands at 37°C to fill the fixing hole, thereby achieving fixed positioning of the top block. The top block is snap-fitted with the No. 1 shape memory polymer to achieve a dual firm connection between the connecting strip and the connecting groove, thereby avoiding loose connection under long-term wear. At the same time, the No. 2 shape memory polymer can fill the fixing hole to achieve fixed positioning of the connected top block, thereby avoiding loose bolts that cause the top block to separate from the card slot, thereby improving the stability of the connection between the contralateral tibial tray and the middle pad, and even if the bolts are loose, it will not affect its rigid connection.

[0023] The pressure signal is converted into a charge signal through a piezoelectric sensor, and stored or transmitted after analog-to-digital conversion by an RFID chip. The model of the RFID sensor is ST25TV02KC. ​​The internal integrated piezoresistive sensor monitors the thickness change of the middle liner 2 and monitors the wear rate of the liner in real time. If the threshold is exceeded, the doctor is prompted to adjust the rehabilitation plan or intervene in advance.

[0024] The bone contact surfaces of the lateral tibial tray and the lateral talar top are coated with a gradient bioactive coating. The outer layer of BMP-2 induces the aggregation of osteoprogenitor cells to form callus, the middle layer of Sr-HA promotes mineralization, and the inner layer of HA guides osteogenesis to achieve complete integration of the bone interface and mechanical strength reaching physiological levels. The gradient coating is designed through the three-in-one regulation of bone induction, bone conduction and bone metabolism. It can accurately regulate the bone regeneration process at different stages after surgery, while solving the core clinical problems of infection, loosening and stress shielding, and improving the bone integration efficiency and long-term stability of ankle prostheses. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] 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.

[0026] Figure 1 It is a schematic diagram of the three-dimensional structure of the present invention;

[0027] Figure 2 For the present invention Figure 1 Schematic diagram of the decomposition structure;

[0028] Figure 3 This is a schematic diagram of the installation and connection structure of the system of the present invention;

[0029] Figure 4 This is a schematic diagram of the top view of the tibial tray of the present invention;

[0030] Figure 5 This is a schematic diagram of the connection structure between the lateral tibial tray and the middle liner of the present invention;

[0031] Figure 6 This is a schematic diagram of the connection assembly structure of the present invention;

[0032] Figure 7 This is a schematic diagram of the connection structure between the top block and the card slot of the present invention;

[0033] Figure 8 It is a front view structural schematic diagram of the present invention.

[0034] [Reference Signs]

[0035] 1. Lateral tibial tray; 2. Middle liner; 3. Lateral talar top;

[0036] 201, concave;

[0037] 4. Connecting groove; 401. Limiting groove; 402. Shape memory polymer No. 1;

[0038] 5. Connecting strip;

[0039] 6. Connecting assembly; 601. Connecting groove; 602. Ejector rod; 603. Ejector block; 604. Inclined block; 605. Fixing hole;

[0040] 7. Thread groove; 8. Fastening bolt; 9. Slot; 901, No. 2 shape memory polymer;

[0041] 6. Unpowered blanking mechanism; 61. No. 2 motor; 62. Limit slot; 63. Rotating shaft; 64. Mounting cylinder; 65. Lower limit rod; 66. Upper limit rod; 67. Co-rotating block; 68. Telescopic slot; 69. Telescopic sleeve;

[0042] 10. Oblique locking nail hole;

[0043] 11. Piezoelectric sensor; 12. RFID sensor; 13. Silicone pad;

[0044] 14. Mounting connection hole; 15. Positioning column; 16. Micro hole; 17. Gradient bioactive coating.

[0045] 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

[0046] 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.

[0047] 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).

[0048] 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.

[0049] 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.

[0050] 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.

[0051] like Figures 1 to 8 As shown, an embodiment of the present invention provides a single ankle joint clinical surgical surface replacement system, including a lateral tibial tray 1, an intermediate pad 2 and a lateral talar top 3; the top of the lateral tibial tray 1 is provided with an intermediate pad 2, and the side of the intermediate pad 2 away from the lateral tibial tray 1 is provided with a lateral talar top 3.

[0052] The outer wall of the side of the middle pad 2 close to the lateral talar top 3 is a concave surface 201, and the side of the lateral talar top 3 close to the middle pad 2 is slidingly connected to the concave surface 201. The side of the lateral talar top 3 close to the middle pad 2 is a smooth surface, and the side of the lateral talar top 3 away from the middle pad 2 is a rough surface.

[0053] It also includes connecting grooves 4 arranged on both sides of the surface of the lateral tibial tray 1, and the middle pad 2 is connected to one end of the lateral tibial tray 1 with a connecting strip 5, which matches the connecting groove 4. The connecting strip 5 is embedded in the connecting groove 4, and the inner wall edge of the connecting groove 4 is arranged with a limiting groove 401, and the interior of the limiting groove 401 is embedded with a No. 1 shape memory polymer 402.

[0054] The lateral tibial tray 1 serves as a fixed base for the tibial end of the prosthesis, plays a role in fixing the tibial joint and connecting with the middle liner 2. The lateral tibial tray 1 and the lateral talar top 3 are temporarily fixed to the joint through absorbable calcium phosphate bone cement. Through the cooperation of the split lateral tibial tray 1, the middle liner 2 and the lateral talar top 3, a minimally invasive incision of 3-4 cm is supported for implantation, and the amount of osteotomy is reduced by 30%, thereby improving the convenience and safety of the operation. The rough surface increases the contact area between the bone and the lateral talar top 3 and the mechanical locking effect, thereby improving the speed of bone integration. The sagittal plane is formed between one side of the lateral talar top 3 and the concave surface 201. The angled sliding connection simulates the progressive rolling and sliding mechanism of the natural ankle joint, reduces stress concentration at the edge of the joint surface, reduces peak stress by 30%, and significantly extends the life of the polyethylene pad. The cooperation between the connecting groove 4 and the connecting strip 5 provides rapid positioning during surgery, reduces surgery time, and allows non-destructive adjustments during surgery. It can also replace the intermediate pads 2 of different thicknesses during surgery. During the connection process, when the connecting strip 5 is embedded in the connecting groove 4 and the buckle is locked, the shape memory polymer 402 is stimulated, and expands at 37°C to fill the gap between the connecting strip 5 and the connecting groove 4 to form a rigid connection.

[0055] A connecting component 6 is provided in the middle of the lateral tibial tray 1, and the connecting component 6 includes a connecting groove 601, a top rod 602, a top block 603, a bevel block 604, and a fixing hole 605. The connecting groove 601 is connected to the connecting grooves 4 on both sides, and the inner walls on both sides of the connecting groove 601 are slidably connected with the top rod 602. The ends of the two groups of top rods 602 that are away from each other are connected with the top block 603, and the opposite ends of the two groups of top rods 602 are connected with the bevel block 604. The two groups of bevel blocks 604 are abutted against each other, and a fixing hole 605 is provided on one side outer wall of the top block 603. A threaded groove 7 is provided in the middle of the two groups of connecting grooves 4, and the end of the threaded groove 7 is connected to The connecting grooves 601 are connected, and the connecting grooves 4 on the surfaces of the contralateral tibial tray 1 and the connecting strips 5 at the bottom of the middle pad 2 can be connected and fixed to each other through the connecting assembly 6. When the connecting strips 5 are embedded in the connecting grooves 4, the two groups of top blocks 603 are matched with the clamping grooves 9 on both sides. By screwing the fastening bolts 8 into the threaded grooves 7, the fastening bolts 8 are screwed inwards and the ends squeeze the inclined blocks 604 on both sides, thereby driving the inclined blocks 604 on both sides to translate along the connecting grooves 601 toward the push rod 602. The middle inner wall of the threaded groove 7 is threadedly connected with the fastening bolts 8. The outer walls of one side of the two groups of connecting strips 5 are provided with clamping grooves 9. The two groups of top blocks The blocks 603 are matched with the slots 9 on both sides. The inner wall of one side of the slot 9 is embedded with a No. 2 shape memory polymer 901, and the No. 2 shape memory polymer 901 is matched with the fixing hole 605. The inclined block 604 moves to push the top rod 602 to perform synchronous translation movement. The top rod 602 moves to drive the top block 603 to move out of the connecting groove 601 and then embeds it into the slot 9 to engage and fix the connecting strip 5, thereby realizing a fixed connection between the lateral tibial tray 1 and the middle pad 2. At the same time, after the connection, the No. 1 shape memory polymer 402 expands at 37°C to fill the gap between the connecting strip 5 and the connecting groove 4 to form a rigid connection, thereby improving the stability of the connection. At the same time, the No. 2 The shape memory polymer 901 expands at 37°C to fill the fixing hole 605, thereby fixing and limiting the top block 603. The top block 603 is snap-fitted with the No. 1 shape memory polymer 402 to achieve a dual firm connection between the connecting strip 5 and the connecting groove 4, thereby avoiding loose connection due to long-term wear. At the same time, the No. 2 shape memory polymer 901 expands at 37°C to fill the fixing hole 605, thereby fixing and limiting the connected top block 603, thereby avoiding loose bolts that cause the top block 603 to separate from the slot 9, thereby improving the stability of the connection between the contralateral tibial tray 1 and the middle pad 2, and even if the bolts are loose, it will not affect its rigid connection.

[0056] The four ends of the lateral talar top 3 are all provided with oblique locking nail holes 10, the holes of the oblique locking nail holes 10 are threaded, and the direction of the nail holes is at an angle of 40° to the horizontal plane. The rough surface of the lateral talar top 3 is generated by laser cladding technology to form a gradient porous titanium structure, the porosity gradually changes from 80% to 30% from the surface to the inside, the pore size is 50-500μm, and the design of the nail hole direction at an angle of 40° to the horizontal plane is in line with the shear force transmission direction when the ankle joint is stressed, which can effectively disperse the stress at the bone and screw interface and reduce the loosening or breakage of the screw caused by stress concentration. Risk, the high porosity of 80% on the surface promotes rapid ingrowth of bone cells, the bone ingrowth rate is >50% 6 weeks after surgery, the internal porosity decreases to 30% to match the elastic modulus transition of 1-15GPa from cancellous bone to cortical bone, avoiding stress-shielding bone absorption, the large pore size is 300-500μm in the pore size classification, the area is conducive to vascularization and bone tissue ingrowth, the small pore size is 50-200μm, the area enhances mechanical strength, and the titanium alloy powder is melted layer by layer by high-energy laser beam to achieve integrated molding of the pore structure and the substrate to avoid the risk of coating peeling.

[0057] A piezoelectric sensor 11 is embedded in the center of the middle liner 2 , an RFID sensor 12 is provided on one side of the piezoelectric sensor 11 , and the outer walls of the piezoelectric sensor 11 and the RFID sensor 12 are both wrapped with a silicone pad 13 .

[0058] The silicone pad 13 is a layer of medical silicone. The surface of the piezoelectric sensor 11 and the RFID sensor 12 is covered with the silicone pad 13 to ensure biocompatibility and compatibility with human tissue. The sensor is activated by radio frequency energy emitted by an external reader and does not require a built-in battery, avoiding the risk of power supply in the body. The pressure signal is converted into a charge signal through the piezoelectric sensor 11, and is stored or transmitted after analog-to-digital conversion by the RFID chip. The model of the RFID sensor 12 is ST25TV02KC, and the internal integrated piezoresistive sensor monitors the thickness changes of the middle liner 2 and monitors the wear rate of the liner in real time. If the threshold is exceeded, the doctor is prompted to adjust the rehabilitation plan or intervene in advance.

[0059] The material of the middle liner 2 is vitamin E-doped highly cross-linked polyethylene, and the lateral tibial tray 1 and the lateral talar top 3 are both made of titanium alloy.

[0060] Vitamin E doping significantly reduces the inflammatory response of wear particles, reduces the macrophage activation rate by 40%, and inhibits bone resorption around the prosthesis. Titanium alloy provides rigid support, and polyethylene absorbs impact loads. The elastic modulus gradient of the two is matched to achieve physiological stress transmission.

[0061] A mounting connection hole 14 is provided at the center of the lateral tibial tray 1, positioning columns 15 are provided at the four ends of the outer wall of the lateral tibial tray 1 away from the middle pad 2, and micro holes 16 are arranged on the outer wall of the lateral tibial tray 1 close to the positioning columns 15.

[0062] A magnesium alloy biodegradable screw can be screwed in through the connecting hole 14 to connect and fix it to the tibial joint. The positioning column 15 plays a positioning role to avoid displacement during the installation process. After the bone tissue grows into the micro hole 16, an anchoring structure is formed, which improves the shear strength and significantly reduces the risk of loosening.

[0063] The materials of the No. 1 shape memory polymer 402 and the No. 2 shape memory polymer 901 are both polyurethane-based shape memory polymers. By adjusting the ratio of hard segments to soft segments, the glass transition temperature is accurately set to 36-37°C.

[0064] After implantation, the body temperature triggers the expansion of the shape memory polymer No. 1 402 and the shape memory polymer No. 2 901, filling the 0.2mm micro-motion gap. The interface shear strength is increased from the temporary 5MPa to 20MPa, thereby improving the stability of the connection and preventing loosening.

[0065] The bone contact surfaces of the lateral tibial tray 1 and the lateral talar top 3 are coated with a gradient bioactive coating 17. The gradient bioactive coating 17 is sequentially:

[0066] Inner layer: hydroxyapatite, content 80wt%, the balance is titanium alloy base material, thickness 50μm;

[0067] Middle layer: strontium-doped hydroxyapatite, content 50wt%, the balance is titanium alloy base material, thickness 30μm;

[0068] Outer layer: mesoporous silica nanoparticle layer loaded with bone morphogenetic protein-2, with a thickness of 20 μm.

[0069] The outer layer contains bone morphogenetic protein-2 (BMP-2) to induce the aggregation of osteoprogenitor cells and form callus, the middle layer does strontium hydroxyapatite (Sr-HA) to promote mineralization, and the inner layer of hydroxyapatite (HA) guides osteogenesis, achieving complete integration of the bone interface and mechanical strength reaching physiological levels. The gradient coating is designed through a three-in-one mechanism of bone induction, bone conduction and bone metabolism regulation. It can accurately regulate the bone regeneration process at different stages after surgery, while solving the core clinical problems of infection, loosening and stress shielding, and improving the bone integration efficiency and long-term stability of ankle prostheses.

[0070] The working process of the technical solution provided by the present invention is as follows:

[0071] When the present invention is used, first, a minimally invasive incision of 3 cm is made during the operation, the diseased cartilage is removed under positioning, a lateral tibial tray 1 is implanted in one side of the tibial joint, and a lateral talar top 3 is implanted in one side of the talar joint, which are temporarily fixed by bone cement, and a magnesium alloy degradable screw is screwed in the oblique locking nail hole 10 and the installation connection hole 14 to connect and fix them, and a sample pad is installed on the top of the lateral tibial tray 1, and different angles are adjusted to determine the size of the middle pad 2, and then the sample pad is taken out to install the middle pad 2, and after the connecting strip 5 is embedded in the connecting groove 4, the two groups of the top blocks 603 are matched with the card slots 9 on both sides, and the screws are screwed into the threaded groove 7. The bolt is screwed inwardly and fixed while the ends squeeze the inclined blocks 604 on both sides, thereby driving the inclined blocks 604 on both sides to move in translation along the connecting groove 601 toward the top rod 602. The movement of the inclined blocks 604 pushes the top rod 602 to move in synchronization. The movement of the top rod 602 drives the top block 603 to move out of the connecting groove 601 and then embeds it into the card slot 9 to engage and fix the connecting strip 5, thereby realizing the fixed connection between the lateral tibial tray 1 and the middle pad 2. At the same time, after the connection, the No. 1 shape memory polymer 402 expands at 37°C to fill the gap between the connecting strip 5 and the connecting groove 4 to form a rigid connection, thereby improving the stability of the connection. At the same time, the No. 2 shape memory polymer 901 expands and fills the fixing hole 605 at 37°C, thereby fixing and limiting the top block 603. The top block 603 is snap-fitted with the No. 1 shape memory polymer 402 to achieve a dual firm connection between the connecting strip 5 and the connecting slot 4, thereby avoiding loosening of the connection under long-term wear. At the same time, the No. 2 shape memory polymer 901 expands and fills the fixing hole 605 at 37°C, thereby fixing and limiting the top block 603 after connection, thereby avoiding loosening of the bolts and separating the top block 603 from the card slot 9, thereby improving the stability of the connection between the contralateral tibial tray 1 and the middle pad 2, even in the face of screw Loosening of the bolt will not affect its rigid connection. Body temperature triggers the expansion of SMP to achieve a stable fixation effect for the installation. The outer layer contains bone morphogenetic protein-2 (BMP-2) to induce the aggregation of osteoprogenitor cells and form callus. The middle layer does with strontium hydroxyapatite (Sr-HA) to promote mineralization. The inner layer of hydroxyapatite (HA) guides osteogenesis to achieve complete integration of the bone interface and mechanical strength reaches physiological levels. The gradient coating is designed through the three-in-one regulation of bone induction, bone conduction and bone metabolism. It can accurately regulate the bone regeneration process at different stages after surgery, while solving the core clinical problems of infection, loosening and stress shielding, and improving the bone integration efficiency and long-term stability of the ankle prosthesis.

[0072] 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.

[0073] 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 single ankle joint clinical surgical surface replacement system, comprising a lateral tibial tray, an intermediate liner and a lateral talar top; characterized in that: A middle pad is provided on the top of the lateral tibial tray, and a side of the middle pad away from the lateral tibial tray is provided with a lateral talus top; The outer wall of the side of the middle pad close to the lateral talar top is a concave surface, the side of the lateral talar top close to the middle pad is slidably connected to the concave surface, the side of the lateral talar top close to the middle pad is a smooth surface, and the side of the lateral talar top away from the middle pad is a rough surface; It also includes connecting grooves arranged on both sides of the surface of the lateral tibial tray, and the middle pad is connected to one end of the lateral tibial tray with a connecting strip, the connecting strip matches the connecting groove, and the connecting strip is embedded in the connecting groove. The inner wall edge of the connecting groove is arranged with a limiting groove, and the interior of the limiting groove is embedded with a No. 1 shape memory polymer.

2. The single ankle joint clinical surgical surface replacement system according to claim 1, characterized in that: A connecting assembly is provided in the middle part of the lateral tibial tray, and the connecting assembly includes a connecting groove, a push rod, a push block, a slope block, and a fixing hole. The connecting groove is connected to the connecting grooves on both sides, and the inner walls on both sides of the connecting groove are slidably connected with push rods, and the ends of the two groups of push rods that are away from each other are connected to the push blocks, and the ends of the two groups of push rods that are opposite to each other are connected to the slope blocks. The two groups of slope blocks are abutted against each other, and a fixing hole is provided on one side outer wall of the top block.

3. The single ankle joint clinical surgical surface replacement system according to claim 2, characterized in that: A thread groove is provided in the middle of the two groups of connecting grooves, the ends of the thread groove are connected with the connecting groove, and the inner wall of the middle part of the thread groove is threadedly connected with a fastening bolt.

4. The single ankle joint clinical surgical surface replacement system according to claim 2, characterized in that: One side outer wall of the two groups of connecting strips is provided with a card slot, and the two groups of top blocks are matched with the card slots on both sides. One side inner wall of the card slot is embedded with a No. 2 shape memory polymer, and the No. 2 shape memory polymer matches the fixing hole.

5. The single ankle joint clinical surgical surface replacement system according to claim 1, characterized in that: The four ends of the lateral talar top are all provided with oblique locking nail holes, the oblique locking nail holes are threaded, and the direction of the nail holes is at an angle of 40° to the horizontal plane. The rough surface of the lateral talar top is generated by laser cladding technology to form a gradient porous titanium structure, the porosity gradually changes from 80% to 30% from the surface to the inside, and the pore diameter is 50-500μm.

6. The single ankle joint clinical surgical surface replacement system according to claim 1, characterized in that: A piezoelectric sensor is embedded in the center of the middle liner, an RFID sensor is arranged on one side of the piezoelectric sensor, and the outer walls of the piezoelectric sensor and the RFID sensor are both wrapped with a silicone pad.

7. The single ankle joint clinical surgical surface replacement system according to claim 6, characterized in that: The material of the middle liner is vitamin E-doped highly cross-linked polyethylene, and the lateral tibial tray and the lateral talar top are both made of titanium alloy.

8. The single ankle joint clinical surgical surface replacement system according to claim 7, characterized in that: A mounting connection hole is provided at the center of the lateral tibial tray, positioning columns are provided at four ends of the outer wall of the lateral tibial tray away from the middle pad, and micro holes are arranged on the outer wall of the lateral tibial tray close to the positioning columns.

9. The single ankle joint clinical surgical surface replacement system according to claim 4, characterized in that: The materials of the No. 1 shape memory polymer and the No. 2 shape memory polymer are both polyurethane-based shape memory polymers.

10. The single ankle joint clinical surgical surface replacement system according to claim 8, characterized in that: The bone contact surfaces of the lateral tibial tray and the lateral talar top are coated with a gradient bioactive coating, and the gradient bioactive coating is sequentially as follows from the inside to the outside: Inner layer: hydroxyapatite, content 80wt%, the balance is titanium alloy base material, thickness 50μm; Middle layer: strontium-doped hydroxyapatite, content 50wt%, the balance is titanium alloy substrate material thickness 30μm; Outer layer: mesoporous silica nanoparticle layer loaded with bone morphogenetic protein-2, with a thickness of 20 μm.

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