Ankle joint replacement joint fixing device based on 3D printing

Abstract

The invention provides an ankle joint replacement joint fixing device based on 3D printing, and belongs to the technical field of medical instruments. The device comprises a bottom plate, an adjusting assembly, a foot fixing groove and a tibia fixing assembly, and a core structural part is integrally formed through 3D printing; during use, the foot is placed in the foot groove, the tibia is placed between the tibia fixing blocks, then the adjusting assembly drives the sliding block to move, the angle of the foot fixing groove is adjusted between-30 degrees and 52 degrees, then the first fixing piece is used for fixing the foot dorsum to prevent horizontal displacement, the second fixing piece and the third fixing piece are used for limiting the inner and outer ankles to prevent transverse displacement, and finally the rotating wheel is rotated to drive the lead screw. And the tibia is clamped and locked by the tibia fixing assembly within the range of 0-86mm. The problems that a traditional device is single in angle, unstable in fixation and long in manufacturing period are solved, the adaptability and operation accuracy of the device are improved, meanwhile, the production cost is reduced, and the production period is shortened.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a 3D-printed ankle joint replacement fixation device. Background Technology

[0002] As a core weight-bearing joint in the human body, the ankle joint has a complex anatomical structure and plays a vital supporting role in daily activities such as walking and standing. This makes ankle replacement surgery require far higher standards of instrument compatibility and fixation precision than other joint replacement surgeries. In current clinical practice, traditional ankle replacement joint fixation devices have several shortcomings that fail to meet the surgical requirements. Specific problems are as follows:

[0003] First, the angle adjustment adaptability is poor. Traditional fixation devices mostly adopt standardized designs, with a single and fixed range of foot tilt angle adjustment. They cannot be flexibly adjusted according to the individual differences in the patient's skeletal morphology (such as the thickness of the tibia and the height of the arch) or the body position required for surgical operation (such as the exposure angle corresponding to different lesion types). This results in low adaptability between the device and the patient's anatomical structure, affecting the exposure of the surgical field and the accuracy of the operation.

[0004] Secondly, the stability of fixation is insufficient. Traditional devices have a relatively simple fixation method for the foot and tibia, which is only achieved through simple clamping or limiting structures. During the operation, they are easily affected by external forces such as instrument collisions and vibrations, which can cause displacement of the foot or tibia, thereby affecting the accuracy of the prosthesis placement and increasing the risk of surgery and postoperative complications.

[0005] Third, the manufacturing process is inefficient and costly. The core structural components of traditional devices (such as the load-bearing base plate, adjustment components, and fixing tanks) need to be manufactured through multiple machining processes (such as milling, drilling, and grinding). This not only results in a long production cycle and difficulty in quickly responding to clinical needs, but also leads to significant material waste during the machining process. At the same time, special molds need to be customized for complex components with different structures, which further increases the production and manufacturing costs and is not conducive to the clinical promotion and application of the device.

[0006] The shortcomings of traditional fixation devices have become key factors restricting the improvement of ankle replacement surgery efficiency and quality. Therefore, there is an urgent need to develop an ankle replacement joint fixation device that is highly adaptable, provides stable fixation, is highly efficient to manufacture, and has controllable costs, in order to address the pain points of existing technologies. Summary of the Invention

[0007] In view of this, embodiments of the present invention provide a 3D-printed ankle replacement joint fixation device, which at least partially solves the problems in the prior art.

[0008] This invention provides a 3D-printed ankle joint replacement fixation device, including a base plate (1), an adjustment component (2), a foot fixation groove (3), and a tibial fixation component (4).

[0009] The base plate (1) is a basic load-bearing structure. A rectangular protrusion (13) is provided on the upper surface of its left end, and a pair of positioning blocks (11) and a pair of connecting blocks (12) are provided on its right end.

[0010] The adjustment component (2) is assembled in the groove (13) of the base plate (1);

[0011] The foot fixing groove (3) is connected to the adjustment component (2);

[0012] The tibial fixation assembly (4) is fixedly connected to the base plate (1) via a positioning block (11) and a connecting block (12).

[0013] The ankle joint replacement joint fixation device based on 3D printing described in this embodiment of the invention includes an adjustment component (2) comprising a stop (21), a slider (22), a connecting guide bar (23), a guide block (24), an adjustment screw (25), and an adjustment nut (26).

[0014] The stop block (21) is fixed to the left end of the groove (13) of the base plate (1). The stop block (21) is provided with a threaded through hole (211), and the thread is implanted into the 3D printed stop block (21) by the hot welding process of the insert nut.

[0015] The slider (22) is located at the right end of the stop (21) and is adapted to the groove (13) of the base plate (1). The slider (22) includes a base structure (221) and an inclined structure (222). The base structure (221) is in the shape of a "U" and has a spherical hole (223) at the left end. The inclined structure (222) extends upward from the right end of the base structure (221) and has inclined through holes (224) at the front and rear ends.

[0016] The connecting guide strip (23) is a pair of long strip-shaped components, which are symmetrically distributed along the front and back direction of the inclined structure (222) of the slider (22). The front and back sides of its left end are connected and fixed to the inclined through hole (224) by a pin, and the upper and lower surfaces are fastened to the foot fixing groove (3) by screws.

[0017] The guide blocks (24) are a pair, symmetrically fixed in the middle of the front and rear sides of the upper surface of the base plate (1), and the side is provided with guide holes (241). The right end of the connecting guide strip (23) is inserted into the guide hole (241) through a pin to form a fit.

[0018] The first end of the adjusting screw (25) is fastened to the adjusting nut (26), and after passing through the through hole (211) of the stop block (21), the end is assembled into the spherical hole (223) of the slider (22) base structure (221) through a steel ball with internal thread;

[0019] The adjusting screw (25) and the adjusting nut (26) are wing screws.

[0020] The ankle joint replacement joint fixation device based on 3D printing described in this embodiment of the invention includes a foot fixation groove (3) comprising a foot groove (31) adapted to the shape of the foot, a first fixation member (32), a second fixation member (33) and a third fixation member (34).

[0021] The foot groove (31) is an arc-shaped groove adapted to the shape of the foot sole. The left end of the foot groove (31) is provided with a threaded hole, and the inner and outer threaded holes are respectively provided at the inner and outer ankle positions.

[0022] The first fixing member (32) includes a first fixing screw (321), a first fixing curved surface (322) and a first fixing nut (323). The first fixing screw (321) passes through the threaded hole at the left end of the foot groove (31), one end of which is engaged with the first fixing nut (323), and the other end is connected to the first fixing curved surface (322) of the arc-shaped soft pad adapted to the curvature of the back of the foot through a steel ball with internal threads.

[0023] The second fixing member (33) includes a second fixing screw (331), a second fixing surface (332), and a second fixing nut (333). The second fixing screw (331) passes through the threaded hole inside the foot groove (31), one end of which is engaged with the second fixing nut (333), and the other end is connected to the second fixing surface (332) of the arc-shaped soft pad adapted to the curvature of the ankle through a steel ball with internal threads.

[0024] The third fixing member (34) includes a third fixing screw (341), a third fixing curved surface (342) and a third fixing nut (343). The third fixing screw (341) passes through the threaded hole on the outside of the foot groove (31), one end of which is engaged with the third fixing nut (343), and the other end is connected to the third fixing curved surface (342) of the arc-shaped soft pad adapted to the curvature of the ankle through a steel ball with internal threads.

[0025] The first fixing screw (321), the first fixing nut (323), the second fixing screw (331), the second fixing nut (333), the third fixing screw (341), and the third fixing nut (343) are all wing screws.

[0026] The ankle joint replacement joint fixation device based on 3D printing described in this embodiment of the invention includes a tibial fixation component (4) comprising a screw box (41), a screw assembly (42), a first tibial fixation block (43), and a second tibial fixation block (44).

[0027] The main body of the screw box (41) is a box structure without a cover. The left side is fixedly connected to the base plate (1) through the positioning block (11) and the connecting block (12). The screw box (41) is equipped with a screw assembly (42) in its cavity. A first tibial fixation block (43) is fixed on the inner side edge. A second tibial fixation block (44) is assembled on the screw assembly (42).

[0028] The lead screw assembly (42) consists of a lead screw (421), a BF support base (422), a BK fixing base (423), a lead screw nut (424), a limit locking mechanism (425), and a rotating wheel (426);

[0029] One end of the lead screw (421) is fixed to the inner wall of the lead screw box (41) through the BF support seat (422) and is located in front of the first tibial fixation block (43). The other end passes through the BK fixation seat (423) and is connected to the outer wheel (426).

[0030] The BK mounting bracket (423) is fixed to the outer wall of the screw box (41);

[0031] A screw nut (424) is fitted onto the screw rod (421), and the second tibial fixation block (44) is fixed onto the screw nut (424);

[0032] The BK fixing seat (423) is provided with a limiting locking mechanism (425) that is compatible with the lead screw (421) on the inner side.

[0033] According to the 3D printing-based ankle joint replacement fixation device of the present invention, the foot fixation groove (3) can be driven to adjust the tilt angle within the range of -30° to 52° by adjusting the component (2);

[0034] When the slider (22) is pushed 90mm along the protrusion (13), the foot fixing groove (3) tilts at an angle of -30°.

[0035] When the slider (22) is pushed 25mm along the protrusion (13), the foot fixing groove (3) tilts at an angle of 52°.

[0036] According to the 3D-printed ankle replacement joint fixation device of the present invention, the tibial fixation component (4) has an adjustment range of 0-86mm;

[0037] The rotating wheel (426) drives the lead screw (421) to rotate, which in turn drives the lead screw nut (424) and the second tibial fixation block (44) to move back and forth along the lead screw axis;

[0038] The maximum range of motion is 86mm to accommodate tibias of different thicknesses.

[0039] According to the embodiments of the present invention, the ankle joint replacement joint fixation device based on 3D printing, except for conventional standard parts, the base plate (1), adjustment component (2), foot groove (31), screw box (41), first tibial fixation block (43) and second tibial fixation block (44) are all integrally manufactured by 3D printing technology.

[0040] The present invention has the following beneficial effects:

[0041] This invention enables the foot fixation groove to be adjusted within a wide range of angles from -30° to 52° by adjusting the components. Specifically, the angle is controlled by the linear displacement of the slider along the bottom plate groove. This allows for precise adaptation to the individual bone morphology differences and surgical positions required for different types of lesions in different patients during ankle replacement surgery. It effectively solves the problems of single angle and poor adaptability of traditional fixation devices, providing more flexible positional support for surgical operations.

[0042] This invention employs a dual fixation structure to ensure surgical fixation stability. Using the heel as a fulcrum, the first fixation component achieves a tight longitudinal fit and fixation of the dorsum of the foot, preventing horizontal displacement of the foot. The second and third fixation components then provide lateral limiting and clamping for the medial and lateral malleoli of the ankle joint, preventing the foot from shifting due to external force collisions or operational vibrations during surgery. This significantly improves the stability and reliability of foot fixation, ensuring surgical precision.

[0043] The tibial fixation component of this invention has an ultra-large adjustment range of 0-86mm. It drives the second tibial fixation block to move back and forth with the help of a screw drive structure. The maximum movement distance can reach 86mm. It can accurately adapt to the differences in the thickness of the tibia of patients of different ages and body types. There is no need to customize special fixation components for different patients. It greatly improves the versatility and clinical applicability of the device and reduces the cost of clinical use and management difficulty.

[0044] The core structural components of this invention (base plate, adjustment components, foot groove, screw box and tibial fixation block, etc.) are manufactured using a 3D printing one-time molding process. Compared with traditional machining, complex and adaptable structures can be directly replicated without multiple processes and special molds. This ensures the accuracy of the parts structure, reduces material waste and production cycle, significantly improves manufacturing efficiency and reduces production costs, and is more conducive to the large-scale production and clinical promotion of the device. Attached Figure Description

[0045] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0046] Figure 1 This is a schematic diagram of the overall structure of a 3D-printed ankle joint replacement fixation device.

[0047] Figure 2 This is a schematic diagram of the base plate structure;

[0048] Figure 3 This is a schematic diagram of the disassembled structure of the adjustment components;

[0049] Figure 4 This is a schematic diagram of a partial structure of the foot fixing groove;

[0050] Figure 5 This is a detailed structural diagram of each fixing component in the foot fixing groove;

[0051] Figure 6 This is a schematic diagram of the connection structure between the tibial fixation component and the base plate;

[0052] Figure 7 This is a detailed structural diagram of the tibial fixation assembly and the lead screw assembly;

[0053] Figure 8 This is a schematic diagram showing the foot fixing groove tilted at an angle of -30°.

[0054] Figure 9 This is a schematic diagram showing the foot fixing groove tilted at an angle of -52°.

[0055] Figure 10 This is a schematic diagram of the foot in a dual fixed state, both horizontally and laterally.

[0056] Figure 11 This is a schematic diagram showing the tibial fixation component with an adjustment range of 86mm. Detailed Implementation

[0057] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0058] See Figure 1-11 The present invention provides a 3D-printed ankle joint replacement fixation device. The joint fixation device for ankle joint replacement includes: a base plate (1), an adjustment component (2), a foot fixation groove (3), and a tibial fixation component (4). The components work together to achieve foot positioning and angle adjustment functions.

[0059] 1. Base plate

[0060] The base plate (1) serves as the basic load-bearing structure of the device and is used to connect the adjustment component (2) and the tibial fixation component (4): the adjustment component (2) is mounted on its upper left side, and the tibial fixation component (4) is set on its right end. The adjustment component (2) carries the foot fixation groove (3), which can drive the foot fixation groove (3) to adjust the angle and direction, so as to achieve precise fixation of the foot during ankle replacement surgery.

[0061] The base plate (1) is long and narrow, with the main body being a cuboid. A pair of positioning blocks (11) and a pair of connecting blocks (12) are provided on the right end for positioning, installation and secure connection of the tibial fixation component (4); a rectangular groove (13) is provided on the upper surface of the left end to provide a sliding track for the adjustment component (2) and ensure its accurate movement trajectory.

[0062] 2. Adjustment components

[0063] The adjustment component (2) includes a stop (21), a slider (22), a connecting guide bar (23), a guide block (24), an adjustment screw (25), and an adjustment nut (26). The components work together to adjust the position and angle of the foot fixing groove (3).

[0064] Preferably, the adjusting screw (25) and the adjusting nut (26) are wing screws, which are convenient for manual adjustment.

[0065] The stop block (21) is fixed to the left end of the groove (13) of the base plate (1) and is used to limit the leftward movement of the slider (22) in the groove (13). The stop block (21) is provided with a threaded through hole (221). The thread is implanted into the 3D printed stop block (21) by insert nut hot welding process. After being tightened with the wing screw, the position of the adjusting screw (25) along the axial direction can be locked.

[0066] The slider (22) is located at the right end of the stop (21) and fits into the groove (13) of the base plate (1). Its overall shape is irregular, comprising a base structure (221) and an inclined surface structure (222).

[0067] The base structure (221) is in the shape of a concave "U" and forms a concave-convex fit with the groove (13) of the base plate (1) to ensure that the slider (22) slides smoothly along the groove (13); a spherical hole (223) is provided at the left end to accommodate the end of the screw (25) and adapt to its movement trajectory.

[0068] The inclined structure (222) extends upward from the right end of the base structure (221) and has inclined through holes (224) on the front and rear ends as installation points for connecting guide strips (23).

[0069] The adjusting screw (25) and adjusting nut (26) are connected at the head end of the adjusting screw (25) and the adjusting nut (26). After passing through the through hole (211) of the stop block (21), its end is assembled into the spherical hole (223) of the base structure (221) of the slider (22) through a steel ball with internal threads. The steel ball can adapt to any rotation angle of the adjusting screw (25), and its contact surface with the slider (22) can uniformly transmit thrust. By tightening or loosening the adjusting nut (26), the slider (22) can be driven to move left and right along the groove (13).

[0070] The connecting guide strip (23) is a pair of long strip-shaped components, symmetrically distributed along the front and back direction of the inclined structure (222) of the slider (22), serving to transmit the slider's power and adjust the angle of the foot fixing groove (3): the front and back sides of the left end are connected and fixed to the inclined through hole (224) by a pin, realizing synchronous movement with the slider (22); the upper and lower surfaces are fastened to the foot fixing groove (3) by screws, transmitting the slider's power to the foot fixing groove (3); the right end is inserted into the guide hole (241) of the guide block (24) by a pin to form a fit, and can slide smoothly along the hole (241). When the slider (22) moves left and right, the connecting guide strip (23) moves synchronously under the guidance and limitation of the guide block (24), thereby driving the foot fixing groove (3) to realize angle adjustment.

[0071] The guide blocks (24) are a pair, symmetrically fixed in the middle of the front and rear sides of the upper surface of the base plate (1). Their core function is to guide and limit the movement of the connecting guide strip (23). They are provided with guide holes (241) on their sides, which cooperate with the right end pin of the connecting guide strip (23) to ensure accurate movement trajectory.

[0072] 3. Foot fixing groove

[0073] The bottom right end of the foot fixation groove (3) is fastened to the upper surface of the connecting guide strip (23) by screws. The foot fixation groove (3) includes a foot groove (31) adapted to the shape of the foot, a first fixation member (32), a second fixation member (33) and a third fixation member (34), which are used to accurately position and fix the foot in ankle replacement surgery.

[0074] The foot groove (31) is an arc-shaped groove that adapts to the shape of the sole of the foot, used for foot support and initial positioning: the sole of the foot can be completely pressed against the bottom of the foot groove (31), the heel is stably engaged with the right end limiting structure of the foot groove (31), and the toes are naturally placed on the left end of the foot groove (31), forming a basic fixation of the foot in the front and back direction.

[0075] The first fixing component (32) includes a first fixing screw (321), a first fixing curved surface (322), and a first fixing nut (323). The first fixing screw (321) passes through a threaded hole at the left end of the foot groove (31), one end of which engages with the first fixing nut (323), and the other end is connected to the first fixing curved surface (322), which is an arc-shaped soft pad adapted to the curvature of the back of the foot, through a steel ball with internal threads. The steel ball can adapt to any rotation angle of the screw, and its contact surface with the first fixing curved surface (322) can uniformly transmit thrust. When the nut is turned, the steel ball at the end of the wing screw pushes the first fixing curved surface (322) to move along the screw axis until it is tightly attached to the back of the foot to complete the longitudinal fixation.

[0076] The second fixing component (33) includes a second fixing screw (331), a second fixing curved surface (332), and a second fixing nut (333); the third fixing component (34) includes a third fixing screw (341), a third fixing curved surface (342), and a third fixing nut (343). The second fixing screw (331) and the third fixing screw (341) are respectively provided with inner and outer threaded holes in the foot groove (31) corresponding to the medial and lateral malleoli. One end is engaged with the corresponding nut, and the other end is connected to the second fixing curved surface (332) and the third fixing curved surface (332) of the arc-shaped soft pad adapted to the curvature of the ankle through a steel ball with internal threads. The steel ball can adapt to any rotation angle of the screw, and its contact surface with the curved surface can uniformly transmit the thrust. When the nut is turned, the steel ball at the end pushes the two fixing curved surfaces closer or further away from each other along the screw axis until they respectively fit the medial and lateral malleoli of the ankle joint, thereby realizing the lateral limiting and fixing of the ankle joint.

[0077] Preferably, the first fixing screw (321), the first fixing nut (323), the second fixing screw (331), the second fixing nut (333), the third fixing screw (341), and the third fixing nut (343) are all wing screws, which facilitates quick manual adjustment during the operation.

[0078] 4. Tibial fixation components

[0079] The left side of the tibial fixation component (4) is fixedly connected to the base plate (1) via the positioning block (11) and connecting block (12). It includes a screw box (41), a screw assembly (42), a first tibial fixation block (43), and a second tibial fixation block (44), which are used to adjust, position, and fix the tibia of the lower leg in ankle replacement surgery.

[0080] The main body of the screw box (41) is a lidless box structure. Its left side is fixedly connected to the base plate (1) through the positioning block (11) and connecting block (12). The screw box (41) is equipped with a screw assembly (42) in its cavity. A first tibial fixation block (43) is fixed on the inner edge, while a second tibial fixation block (44) is assembled on the screw assembly (42). The screw assembly (42) can be driven to move in the front and back directions.

[0081] The lead screw assembly (42) consists of a lead screw (421), a BF support base (422), a BK fixing base (423), a lead screw nut (424), a limit locking mechanism (425), and a rotating wheel (426). The assembly and function of each component are as follows:

[0082] Screw positioning: One end of the screw (421) is fixed to the inner wall of the screw box (41) through the BF support seat (422) and is located in front of the first tibial fixation block (43); the other end passes through the BK fixation seat (423) and is connected to the outer wheel (426). The BK fixation seat (423) is fixed to the outer wall of the screw box (41). Through the cooperation of the BF support seat (422) and the BK fixation seat (423), the screw (421) is horizontally positioned in the screw box (41).

[0083] Transmission and fixation: A screw nut (424) is fitted on the screw (421), and the second tibial fixation block (44) is fixed on the screw nut (424). Through the cooperation of the two, the tibia of the lower leg can be clamped between the first tibial fixation block (43) and the second tibial fixation block (44).

[0084] Adjustment and locking: The inner side of the BK fixing seat (423) is provided with a limiting locking mechanism (425) adapted to the lead screw (421). When the rotating wheel (426) is rotated, the lead screw (421) rotates synchronously, driving the lead screw nut (424) and the second tibial fixing block (44) to move back and forth along the lead screw axis, thereby clamping or releasing the tibia of the lower leg; when adjusted to the required clamping position, turning the limiting locking mechanism (425) can lock the lead screw (421), thereby fixing the position of the lead screw nut (424) and the second tibial fixing block (44) to ensure stable clamping.

[0085] 5. Ankle replacement joint fixation methods

[0086] 1) Initial foot positioning: Gently place the patient's foot into the foot groove (31), so that the sole of the foot is completely in contact with the bottom of the groove, the heel is precisely engaged with the limiting structure at the right end of the foot groove (31), and the toes are naturally extended and placed at the left end of the foot groove (31) to complete the initial support and positioning of the foot.

[0087] 2) Initial placement of the tibia: Rotate the wheel (426) of the tibia fixation assembly (4) to drive the lead screw (421) to rotate, causing the lead screw nut (424) and the second tibia fixation block (44) to move backward along the lead screw axis, widening the gap between the first tibia fixation block (43) and the second tibia fixation block (44) to be greater than the diameter of the patient's tibia. Place the patient's tibia between the two blocks to ensure that the tibia position is aligned with the initial position required for ankle replacement surgery.

[0088] 3) Precise adjustment of the foot fixation groove angle: According to the required position angle of the ankle joint during surgery, by tightening or loosening the adjusting nut (26) of the adjusting component (2), the adjusting screw (25) is driven to push the slider (22) to move left and right along the protrusion (13) of the base plate (1). At this time, the connecting guide bar (23) moves synchronously under the guidance and limiting action of the guide block (24), thereby driving the foot fixation groove (3) to adjust the tilt angle. The preset parameters can be referenced according to the surgical requirements (such as the slider advancing 90mm corresponding to -30°, advancing 25mm corresponding to 52°) until the foot fixation groove (3) reaches the target angle and remains stable.

[0089] 3) Dual fixation of the foot, both horizontally and laterally.

[0090] Horizontal fixation: Using the heel as the fulcrum, tighten the first fixing nut (323) of the first fixing member (32), drive the first fixing surface (322) to move along the screw axis (slanted down and left and right direction) until the arc-shaped soft pad structure fits tightly against the back of the foot, so as to achieve longitudinal stability fixation of the back of the foot and avoid displacement of the foot in the horizontal direction.

[0091] Lateral fixation: Tighten the corresponding nuts of the second fixing member (33) and the third fixing member (34) respectively, so that the second fixing surface (332) and the third fixing surface (342) are relatively close to each other along the screw axis (front and back direction) until they are closely attached to the medial and lateral malleoli of the ankle joint respectively, forming a lateral limiting fixation to ensure the stability of the ankle joint position during the replacement process.

[0092] 4) Tibial clamping and locking fixation: Rotate the wheel (426) of the tibia fixation assembly (4) clockwise. Through the threaded transmission of the screw (421) and screw nut (424), the second tibia fixation block (44) moves forward along the screw axis, gradually approaching the first tibia fixation block (43), until both clamp the tibia together and the patient has no obvious discomfort. At this time, turn the limiting locking mechanism (425) on the inside of the BK fixation seat (423) to lock the screw (421), fix the position of the screw nut (424) and the second tibia fixation block (44), ensure that the tibia is clamped firmly, and prevent the position from shifting due to external force interference during the operation.

[0093] II. The foot fixing groove tilt angle is adjustable from -30° to 52°.

[0094] When the slider (22) moves left and right along the groove (13), the connecting guide bar (23) will move synchronously under the precise guidance and stable limiting effect of the guide block (24). This synchronous movement then drives the foot fixing groove (3), enabling it to achieve angle adjustment.

[0095] Specifically, when the slider (22) advances 90mm into the groove (13), the foot fixation groove (3) will have a tilt angle of -30°; while when the slider (22) advances 25mm into the groove (13), the foot fixation groove (3) will have a tilt angle of 52°. By advancing at these different distances, the foot fixation groove (3) can be precisely controlled to reach the required tilt angle to meet the different angle requirements during ankle replacement.

[0096] III. Fixation of the horizontal and lateral directions of the foot

[0097] Using the heel as a fulcrum, by tightening or loosening the first fixing nut (323), the first fixing curved surface (322) can be driven to move along the screw axis (slanted down and left and right direction) until it fits tightly against the instep, thereby achieving longitudinal stability of the instep and ensuring the stability of the foot position in the horizontal direction.

[0098] For the second fixed surface (332) and the third fixed surface (342), by tightening or loosening the corresponding fixing nuts, the two can be made to move closer or further apart along the screw axis (front and back direction) until they are closely fitted with the medial and lateral malleoli of the ankle joint, respectively, forming a lateral limiting fixation of the ankle joint, effectively ensuring that the ankle joint maintains a stable position during the replacement process.

[0099] IV. The tibial fixation component has an adjustment range of 0-86mm, which can adapt to tibias of different thicknesses in the lower leg.

[0100] During the specific adjustment process, when the rotating wheel (426) is rotated clockwise or counterclockwise, the lead screw (421) will rotate synchronously. Through the thread transmission principle, the lead screw nut (424) sleeved on the lead screw and the second tibial fixation block (44) fixed on the nut will move smoothly in the front and back direction along the axis of the lead screw. The maximum movement distance can reach 86mm, thereby achieving precise clamping or flexible release of tibias of different diameters. When adjusted to a suitable clamping position, and the first tibial fixation block (43) and the second tibial fixation block (44) together form a stable clamping state, the lead screw (421) can be firmly locked by turning the limiting locking mechanism (425) on the inner side of the BK fixation seat (423), thereby fixing the position of the lead screw nut (424) and the second tibial fixation block (44), effectively avoiding position displacement caused by external force collision or vibration during the operation, and ensuring that the clamping of the tibia of the lower leg remains stable and reliable.

[0101] V. Material 3D printing for one-time molding

[0102] In addition to standard parts, the core structural components of the ankle joint fixation device—the base plate (1), adjustment assembly (2), foot groove (31), screw box (41), first tibial fixation block (43), and second tibial fixation block (44)—are all manufactured using 3D printing technology in one piece.

[0103] This process allows for the precise replication of complex structures directly from the design model, eliminating the need for multiple milling and drilling steps required in traditional machining. This significantly shortens the parts production cycle and dramatically improves the overall device manufacturing efficiency. Furthermore, 3D printing reduces material waste during cutting and eliminates the need for numerous custom-made molds, effectively lowering the cost of single-piece production and small-batch manufacturing, thus balancing structural accuracy with economic efficiency.

[0104] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A 3D-printed ankle joint replacement fixation device, characterized in that, It includes a base plate (1), an adjustment assembly (2), a foot fixation groove (3), and a tibial fixation assembly (4); The base plate (1) is a basic load-bearing structure. A rectangular protrusion (13) is provided on the upper surface of its left end, and a pair of positioning blocks (11) and a pair of connecting blocks (12) are provided on its right end. The adjustment component (2) is assembled in the groove (13) of the base plate (1); The foot fixing groove (3) is connected to the adjustment component (2); The tibial fixation assembly (4) is fixedly connected to the base plate (1) via a positioning block (11) and a connecting block (12).

2. The ankle joint replacement fixation device based on 3D printing according to claim 1, characterized in that, The adjustment assembly (2) includes a stop (21), a slider (22), a connecting guide bar (23), a guide block (24), an adjustment screw (25), and an adjustment nut (26); The stop block (21) is fixed to the left end of the groove (13) of the base plate (1). The stop block (21) is provided with a threaded through hole (211), and the thread is implanted into the 3D printed stop block (21) by the hot welding process of the insert nut. The slider (22) is located at the right end of the stop (21) and is adapted to the groove (13) of the base plate (1). The slider (22) includes a base structure (221) and an inclined structure (222). The base structure (221) is in the shape of a "U" and has a spherical hole (223) at the left end. The inclined structure (222) extends upward from the right end of the base structure (221) and has inclined through holes (224) at the front and rear ends. The connecting guide strip (23) is a pair of long strip-shaped components, which are symmetrically distributed along the front and back direction of the inclined structure (222) of the slider (22). The front and back sides of its left end are connected and fixed to the inclined through hole (224) by a pin, and the upper and lower surfaces are fastened to the foot fixing groove (3) by screws. The guide blocks (24) are a pair, symmetrically fixed in the middle of the front and rear sides of the upper surface of the base plate (1), and the side is provided with guide holes (241). The right end of the connecting guide strip (23) is inserted into the guide hole (241) through a pin to form a fit. The first end of the adjusting screw (25) is fastened to the adjusting nut (26), and after passing through the through hole (211) of the stop block (21), the end is assembled into the spherical hole (223) of the slider (22) base structure (221) through a steel ball with internal thread; The adjusting screw (25) and the adjusting nut (26) are wing screws.

3. The ankle joint replacement fixation device based on 3D printing according to claim 1, characterized in that, The foot fixing groove (3) includes a foot groove (31) adapted to the shape of the foot, a first fixing member (32), a second fixing member (33) and a third fixing member (34); The foot groove (31) is an arc-shaped groove adapted to the shape of the foot sole. The left end of the foot groove (31) is provided with a threaded hole, and the inner and outer threaded holes are respectively provided at the inner and outer ankle positions. The first fixing member (32) includes a first fixing screw (321), a first fixing curved surface (322) and a first fixing nut (323). The first fixing screw (321) passes through the threaded hole at the left end of the foot groove (31), one end of which is engaged with the first fixing nut (323), and the other end is connected to the first fixing curved surface (322) of the arc-shaped soft pad adapted to the curvature of the back of the foot through a steel ball with internal threads. The second fixing member (33) includes a second fixing screw (331), a second fixing surface (332), and a second fixing nut (333). The second fixing screw (331) passes through the threaded hole inside the foot groove (31), one end of which is engaged with the second fixing nut (333), and the other end is connected to the second fixing surface (332) of the arc-shaped soft pad adapted to the curvature of the ankle through a steel ball with internal threads. The third fixing member (34) includes a third fixing screw (341), a third fixing curved surface (342) and a third fixing nut (343). The third fixing screw (341) passes through the threaded hole on the outside of the foot groove (31), one end of which is engaged with the third fixing nut (343), and the other end is connected to the third fixing curved surface (342) of the arc-shaped soft pad adapted to the curvature of the ankle through a steel ball with internal threads. The first fixing screw (321), the first fixing nut (323), the second fixing screw (331), the second fixing nut (333), the third fixing screw (341), and the third fixing nut (343) are all wing screws.

4. The ankle joint replacement fixation device based on 3D printing according to claim 1, characterized in that, The tibial fixation assembly (4) includes a screw box (41), a screw assembly (42), a first tibial fixation block (43), and a second tibial fixation block (44). The main body of the screw box (41) is a box structure without a cover. The left side is fixedly connected to the base plate (1) through the positioning block (11) and the connecting block (12). The screw box (41) is equipped with a screw assembly (42) in its cavity. A first tibial fixation block (43) is fixed on the inner side edge. A second tibial fixation block (44) is assembled on the screw assembly (42). The lead screw assembly (42) consists of a lead screw (421), a BF support base (422), a BK fixing base (423), a lead screw nut (424), a limit locking mechanism (425), and a rotating wheel (426); One end of the lead screw (421) is fixed to the inner wall of the lead screw box (41) through the BF support seat (422) and is located in front of the first tibial fixation block (43). The other end passes through the BK fixation seat (423) and is connected to the outer wheel (426). The BK mounting bracket (423) is fixed to the outer wall of the screw box (41); A screw nut (424) is fitted onto the screw rod (421), and the second tibial fixation block (44) is fixed onto the screw nut (424); The BK fixing seat (423) is provided with a limiting locking mechanism (425) that is compatible with the lead screw (421) on the inner side.

5. The 3D-printed ankle joint replacement fixation device according to any one of claims 1-4, characterized in that, The foot fixing groove (3) can be driven by adjusting component (2) to achieve tilt angle adjustment within the range of -30° to 52°; When the slider (22) is pushed 90mm along the protrusion (13), the foot fixing groove (3) tilts at an angle of -30°. When the slider (22) is pushed 25mm along the protrusion (13), the foot fixing groove (3) tilts at an angle of 52°.

6. The 3D-printed ankle joint replacement fixation device according to any one of claims 1-4, characterized in that, The adjustment range of the tibial fixation component (4) is 0-86 mm; The rotating wheel (426) drives the lead screw (421) to rotate, which in turn drives the lead screw nut (424) and the second tibial fixation block (44) to move back and forth along the lead screw axis; The maximum range of motion is 86mm to accommodate tibias of different thicknesses.

7. The 3D-printed ankle joint replacement fixation device according to any one of claims 1-4, characterized in that, The base plate (1), adjustment component (2), foot groove (31), screw box (41), first tibial fixation block (43) and second tibial fixation block (44) are all manufactured by 3D printing technology in one piece.

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