A three-plane medial malleolus partial osteotomy guiding device and its manufacturing method

Abstract

The present invention relates to the field of medical device technology, and specifically to a three-plane medial malleolus osteotomy guide device and a manufacturing method thereof, wherein the osteotomy guide device includes an osteotomy guide plate, which is a "door"-shaped structure. The osteotomy guide plate is attached to the medial malleolus and the anterior medial side of the lower tibia, and is fixed to the tibia by a plurality of fixing pins. The osteotomy guide plate is provided with three unequal osteotomy tracks, and an oscillating saw performs three-plane osteotomy on the target bone block through the osteotomy tracks. By providing an osteotomy guide plate, the present invention can guide the surgeon to perform precise osteotomy on the anterior malleolus of the lower tibia of the patient, retain the posterior medial malleolus, maintain the width of the medial malleolus, maintain the stability of the ankle hole, and achieve reasonable osteotomy selection, small osteotomy volume, and low bone damage. Moreover, when the osteotomy bone block is reduced and fixed, the three-dimensional space formed by the three osteotomy planes can improve the stability of the bone block fixation, have a better biomechanical fixation effect, reduce the risk of bone block displacement, and have significant clinical use value.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a three-plane medial malleolus partial osteotomy guiding device and a manufacturing method thereof. Background Art

[0002] The ankle joint is a key hub for mechanotransduction in the lower limb, and its biomechanical stability is primarily maintained by the talus-tibia-fibula complex. As the only tarsal bone without muscle attachment, the precise alignment of the talus dome with the distal tibial articular surface plays a crucial role in maintaining normal gait mechanotransduction.

[0003] When treating lesions of the talar dome or mid-body (such as osteochondral lesions, necrotic lesion removal, or fracture repair), conventional talar approaches often struggle to achieve adequate surgical exposure due to obstruction by bony structures of the medial and lateral malleolus. For surgical intervention of these deep lesions, the medial malleolus osteotomy approach is currently widely used clinically.

[0004] However, the following defects exist in the medial malleolus osteotomy approach technique: (1) The control of the angle and direction of the osteotomy mainly depends on the surgeon's empirical judgment and intraoperative fluoroscopic assistance, which is significantly operator-dependent; (2) The individualized analysis of the imaging anatomical parameters is insufficient, which can easily lead to the osteotomy surface deviating from the ideal anatomical plane, and multiple fluoroscopic verifications of the osteotomy path are required during the operation, which increases the operation time and difficulty, and poses a cumulative risk of radiation damage to medical staff and patients; (3) Improper osteotomy angle and direction may also damage the integrity of the attachment point of the medial malleolus triangular ligament; (4) Improper selection of the osteotomy plan may result in unsatisfactory fixation of the osteotomy bone fragment during reduction and fixation, and still have a high probability of displacement, which has a great impact on postoperative recovery and is prone to secondary injury; (5) In order to obtain a good field of view and surgical space, the main method is total medial malleolus osteotomy. Total medial malleolus osteotomy will cause large osteotomy damage, resulting in osteotomy surface displacement and malformation, which may induce traumatic ankle arthritis and damage the epiphysis. There are many osteotomy-related complications.

[0005] A domestic team from Jiangdong proposed a solution that uses the patient's CT scan to recreate the image before surgery, conducts a personalized osteotomy guide 3D design for the patient, and produces the personalized osteotomy guide through 3D printing. During surgery, after disinfection, the osteotomy guide is placed on the osteotomy part and matched to guide the osteotomy. However, the preparation period for this personalized osteotomy guide is too long, and the labor and material costs are high, making it difficult to promote and apply. In addition, the osteotomy guide uses a two-dimensional plane osteotomy. When the osteotomy bone fragment is returned to its place for restoration after surgery, the osteotomy bone fragment only has two planes of contact with the tibial osteotomy notch, achieving only two degrees of freedom of fixation. Therefore, there is a high probability of displacement, which can cause secondary damage after surgery. Summary of the Invention

[0006] In response to the technical problems existing in the prior art, the first purpose of the present invention is to provide a three-plane medial malleolus osteotomy guide device, which can guide the surgeon to perform precise osteotomy on the anterior malleolus of the lower tibia, retain the posterior medial malleolus, maintain the stability of the ankle hole, and have an excellent fixation effect when resetting and fixing the osteotomized bone fragments, thereby reducing the risk of bone fragment displacement.

[0007] The second purpose of the present invention is to provide a method for manufacturing a three-plane medial malleolus partial osteotomy guide device. Through this manufacturing method, medial malleolus partial osteotomy guide plates of different sizes and specifications that meet different anatomical sizes and curvatures of the medial malleolus can be generated, and a suitable osteotomy guide plate can be selected according to the size of the patient's ankle joint bones.

[0008] In order to achieve the above object, the present invention adopts the following technical solutions:

[0009] A three-plane medial malleolus partial osteotomy guide device includes an osteotomy guide plate. The osteotomy guide plate is a "door"-shaped structure. The osteotomy guide plate is attached to the medial malleolus and the anterior and medial side of the lower tibia and is fixed to the tibia by multiple fixing pins. The osteotomy guide plate is provided with three eccentric osteotomy tracks, and an oscillating saw performs three-plane osteotomy on the target bone block through the osteotomy tracks.

[0010] Furthermore, the osteotomy guide includes an osteotomy guide section A, an osteotomy guide section B and an osteotomy guide section C which are connected in sequence. The osteotomy guide section A is located on the front side of the lower tibia and is perpendicular to the lower tibial articular surface of the tibiotalar joint. The osteotomy guide section C is located on the inner side of the lower tibia and extends downward along the middle of the medial malleolus to the tip of the medial malleolus. The osteotomy guide section C is inclined to the lower tibial articular surface of the tibiotalar joint. The osteotomy guide section B is connected between the top of the osteotomy guide section A and the top of the osteotomy guide section C and is parallel to the lower tibial articular surface of the tibiotalar joint.

[0011] Furthermore, an osteotomy track A is provided in the middle of section A of the osteotomy guide plate, an osteotomy track B is provided in the middle of section B of the osteotomy guide plate, and an osteotomy track C is provided in the middle of section C of the osteotomy guide plate. Osteotomy track A, osteotomy track B and osteotomy track C are connected and connected in sequence. Osteotomy track A is perpendicular to the inferior tibial articular surface of the tibiotalar joint, osteotomy track B is parallel to the inferior tibial articular surface of the tibiotalar joint, and osteotomy track C is inclined to the inferior tibial articular surface of the tibiotalar joint.

[0012] Furthermore, a guide plate fixing hole A is provided on the outer side of the osteotomy guide section A, and the guide plate fixing hole A is parallel to the osteotomy track A. A guide plate fixing hole B is provided on the outer side of the osteotomy guide section B, and the guide plate fixing hole B is parallel to the osteotomy track B. A guide plate fixing hole C is provided on the outer side of the osteotomy guide section C, and the guide plate fixing hole C is parallel to the osteotomy track C. Three fixing pins pass through the guide plate fixing hole A, the guide plate fixing hole B and the guide plate fixing hole C respectively and penetrate the tibia to fix the osteotomy guide on the tibia.

[0013] Furthermore, a screw guide hole A is provided on the inner side of section A of the osteotomy guide plate, and the direction of the screw guide hole A is from the front side of the lower tibia to the back side of the lower tibia, and is parallel to the lower tibial articular surface of the tibiotalar joint. A screw guide hole B is provided on the inner side of section B of the osteotomy guide plate, and the direction of the screw guide hole B is from the inner side of the lower tibia to the outer side of the lower tibia, and is parallel to the lower tibial articular surface of the tibiotalar joint. A screw guide hole C is provided at the end of section C of the osteotomy guide plate, and the direction of the screw guide hole C is obliquely from the tip of the medial malleolus to the upper outer side of the tibia; the drill bit drills the target bone block through the screw guide hole A, screw guide hole B and screw guide hole C, and forms three screw pre-fixation holes on the target bone block, so that the cut target bone block can be repositioned and fixed by screws through the screw pre-fixation holes in the future.

[0014] Furthermore, the osteotomy guide device also includes two talar cartilage protection baffles, which are the upper surface protection baffle of the talus and the medial side protection baffle of the talus. The upper surface protection baffle of the talus is inserted into the gap of the tibiotalar joint to protect the upper surface cartilage of the talus from being injured by the swinging saw. The medial side protection baffle of the talus is inserted into the gap between the medial malleolus and the talus to protect the medial side cartilage of the talus from being injured by the swinging saw.

[0015] Furthermore, the osteotomy guide device also includes two retractors, each of which is L-shaped and includes a retractor head and a retractor handle. The retractor head is bent inward and the bent portion is arc-shaped.

[0016] Furthermore, the retractor head of one retractor is attached to the inner and posterior side of the lower tibia, and the retractor head of the other retractor is attached to the gap between the talus and the lateral malleolus, and the two retractors cooperate with each other to expose the ankle joint.

[0017] A method for manufacturing a three-plane medial malleolus osteotomy guide device comprises the following steps:

[0018] S1. Randomly collect CT thin-slice scan data of multiple normal adult ankle joints;

[0019] S2, importing the ankle joint CT thin-slice scan data acquired in step S1 into mimics software in DICOM format to generate a three-dimensional ankle joint model;

[0020] S3, importing the three-dimensional ankle joint model generated in step S2 into Geomagic software for smoothing the grid;

[0021] S4. Importing the smoothed grid three-dimensional ankle joint model from step S3 into SolidWorks software, measuring the anatomical features of the ankle joint, and selecting multiple models of different sizes based on the measurement results. The models are mirrored to generate left and right models, thereby obtaining multiple pairs of left and right three-dimensional ankle joint model data of different sizes.

[0022] S5. Perform three-dimensional design of osteotomy guides based on the data of multiple pairs of left and right three-dimensional ankle joint models of different sizes obtained in step S4, obtain multiple pairs of three-dimensional models of osteotomy guides of different sizes, and obtain multiple pairs of finished osteotomy guides of different sizes through metal 3D printing.

[0023] Furthermore, the method further includes the following steps:

[0024] S6. Performing three-dimensional design of the talar upper surface protection baffle and the talar medial side protection baffle based on the multiple pairs of left and right three-dimensional ankle joint model data of different sizes obtained in step S4, obtaining adapted three-dimensional models of the talar upper surface protection baffle and the talar medial side protection baffle, and obtaining finished products of the talar upper surface protection baffle and the talar medial side protection baffle by metal 3D printing;

[0025] S7. Perform three-dimensional design of the retractor based on the data of the multiple pairs of left and right three-dimensional ankle joint models of different sizes obtained in step S4 to obtain a three-dimensional model of an adapted retractor, and obtain the finished retractor by metal 3D printing.

[0026] In general, the present invention has the following advantages:

[0027] 1. The present invention, by providing an osteotomy guide, can guide the surgeon to perform precise osteotomy on the anterior malleolus of the patient's lower tibia, preserve the posterior part of the medial malleolus, maintain the width of the medial malleolus, maintain the stability of the ankle hole, and has reasonable osteotomy selection, small osteotomy volume, and low bone damage. In addition, when the osteotomy bone block is reduced and fixed, the three-dimensional space formed by the three osteotomy planes can improve the stability of the bone block fixation, have a better biomechanical fixation effect, reduce the risk of bone block displacement, and have significant clinical use value.

[0028] 2. The present invention adopts a three-plane osteotomy method. By opening three unequal osteotomy tracks on the osteotomy guide plate, the oscillating saw performs three-plane osteotomy on the target bone block through the osteotomy tracks, making the volume of the osteotomy bone block smaller. When the osteotomy bone block is reduced and fixed after the operation, the triangular prism-shaped medial malleolus notch limits the osteotomy bone block in three planes with multiple degrees of freedom, resulting in excellent fixation effect and reducing the risk of bone displacement.

[0029] 3. The osteotomy guide of the present invention is provided with three guide plate fixing holes, and three fixing pins pass through the three guide plate fixing holes and penetrate the tibia to fix the osteotomy guide on the tibia; the three fixing pins can not only fix the osteotomy guide, but two of them can also block and limit the oscillating saw to prevent the osteotomy depth from being too deep.

[0030] 4. The osteotomy guide plate of the present invention is provided with three screw guide holes, and the directions of the three screw guide holes are all different. The drill bit drills the target bone block through the three screw guide holes, forming three screw pre-fixing holes on the target bone block. When the target bone block needs to be repositioned and fixed after surgery, the three screws are respectively nailed into the osteotomy bone block from the three screw pre-fixing holes at different angles and directions, giving the osteotomy bone block a firm fixation from a three-dimensional plane, forming a stable biomechanical fixation of the bone block, further reducing the risk of bone block displacement, and improving the patient's postoperative recovery effect.

[0031] 5. The present invention provides a talus upper surface protection baffle and a talus medial side protection baffle. During osteotomy surgery, the talus upper surface protection baffle is pre-inserted into the gap of the tibiotalar joint to protect the talus upper surface cartilage from being injured by the swing saw. The talus medial side protection baffle is pre-inserted into the gap between the medial malleolus and the talus to protect the talus medial side cartilage from being injured by the swing saw.

[0032] 6. The present invention provides a retractor. During osteotomy, the medial retractor and the lateral retractor cooperate with each other to pull the tissue outwards, fully exposing the field of view at the ankle joint, giving the surgeon a better surgical field of view and improving surgical efficiency.

[0033] 7. The present invention is based on the 3D anatomical features of the normal adult ankle joint and generates medial malleolus osteotomy guides of different sizes and specifications that can meet the different anatomical sizes and curvatures of the medial malleolus. The appropriate osteotomy guide can be selected according to the size of the patient's ankle bones, thereby achieving standardization of the osteotomy guide. There is no need to design the osteotomy guide individually according to the patient. In addition, an adaptive talar upper surface protection baffle, talar medial side protection baffle and retractor are generated, which can be effectively used in osteotomy surgery, saving preoperative preparation work, improving efficiency and reducing costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a structural schematic diagram of the osteotomy guide plate of the present invention.

[0035] Figure 2 It is a structural schematic diagram of the osteotomy guide plate of the present invention attached to one side of the tibia.

[0036] Figure 3 It is a schematic structural diagram of the talus upper surface protection baffle of the present invention.

[0037] Figure 4 It is a structural schematic diagram of the talus medial side protection baffle of the present invention.

[0038] Figure 5 It is a structural schematic diagram of the talus medial side protection baffle from another perspective.

[0039] Figure 6It is a structural schematic diagram of the drag hook of the present invention.

[0040] Figure 7 It is a schematic diagram of the use of the drag hook of the present invention.

[0041] Figure 8 It is a schematic diagram of the use of the outer retractor of the present invention.

[0042] Figure 9 It is a schematic diagram of the use of the inner side retractor of the present invention.

[0043] Figure 10 It is a schematic diagram of fixing the osteotomy guide plate with a fixing pin of the present invention.

[0044] Figure 11 It is a schematic diagram of the use of the talus upper surface protection baffle of the present invention.

[0045] Figure 12 It is a schematic diagram of the use of the talus medial side protection baffle of the present invention.

[0046] Figure 13 It is a schematic diagram of the use of two talar cartilage protection baffles of the present invention.

[0047] Figure 14 This is a schematic diagram of the use of two talar cartilage protection baffles of the present invention from another perspective.

[0048] Figure 15 It is a schematic diagram of the screw fixation osteotomy bone block of the present invention.

[0049] Figure 16 It is a schematic diagram of another viewing angle of the screw fixation osteotomy bone block of the present invention.

[0050] Figure 17 It is a flow chart of the osteotomy guide design of the present invention.

[0051] (in, Figure 17 a is the CT thin-slice data of the ankle joint of a normal adult; Figure 17 b is the three-dimensional ankle joint model generated in mimics software; Figure 17 c is the smoothing grid of the 3D ankle joint model in Geomagic software; Figure 17 d is the design of the osteotomy guide based on the 3D ankle joint model in Soliworks software.

[0052] Figure 18 This is a schematic diagram of the operation of using a retractor to expose the ankle joint.

[0053] Figure 19 This is a schematic diagram of the operation of selecting an appropriately sized osteotomy guide to fit the lower tibia and using a Kirschner needle to fix the osteotomy guide.

[0054] Figure 20 This is a schematic diagram of the operation of using a drill bit to drill a target bone block through a screw guide hole.

[0055] Figure 21 This is a schematic diagram of the operation of inserting a protective baffle on the upper surface of the talus into the gap of the tibiotalar joint before performing the osteotomy operation.

[0056] Figure 22 This is a schematic diagram of the operation of inserting the medial side protection baffle of the talus into the gap between the medial malleolus and the talus before performing the osteotomy operation.

[0057] Figure 23 This is a schematic diagram of the operation of removing the Kirschner wire and dismantling the osteotomy guide after the osteotomy operation is completed.

[0058] Figure 24 This is a schematic diagram of the operation of using a thin piece to gently pry and remove the osteotomy bone block.

[0059] Figure 25 This is a schematic diagram of the operation to expose the talar body and talar dome.

[0060] Figure 26 This is a schematic diagram of the operation of repositioning the osteotomized bone fragment after completing the operation on the talus lesion.

[0061] Figure 27 This is a schematic diagram of the operation of using screws to perform three-dimensional fixation of osteotomy bone fragments from three angles and directions.

[0062] in:

[0063] 1 is the osteotomy guide, 1-1 is the osteotomy guide section A, 1-1-1 is the osteotomy track A, 1-1-2 is the guide fixation hole A, 1-1-3 is the screw guide hole A, 1-2 is the osteotomy guide section B, 1-2-1 is the osteotomy track B, 1-2-2 is the guide fixation hole B, 1-2-3 is the screw guide hole B, 1-3 is the osteotomy guide section C, 1-3-1 is the osteotomy track C, 1-3-2 is the guide fixation hole C, 1-3-3 is the screw guide hole C;

[0064] 2 is a fixed needle, 2-1 is fixed needle A, 2-2 is fixed needle B, and 2-3 is fixed needle C;

[0065] 3 is a screw, 3-1 is screw A, 3-2 is screw B, 3-3 is screw C;

[0066] 4 is the talar cartilage protection baffle, 4-1 is the talar upper surface protection baffle, 4-2 is the talar medial surface protection baffle;

[0067] 5 is a retractor, 5-1 is the retractor head, and 5-2 is the retractor handle;

[0068] 6 is the tibia, 6-1 is the medial malleolus;

[0069] 7 is the talus;

[0070] 8 is the calcaneus;

[0071] 9 is the fibula and 9-1 is the lateral malleolus. DETAILED DESCRIPTION

[0072] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0073] Example 1

[0074] like Figures 1-16 As shown, a three-plane medial malleolus partial osteotomy guiding device includes an osteotomy guide plate. The osteotomy guide plate is a "door"-shaped structure. The osteotomy guide plate is attached to the medial malleolus and the anterior and medial side of the lower tibia, and is fixed to the tibia by multiple fixing pins. Three eccentric osteotomy tracks are opened on the osteotomy guide plate, and an oscillating saw performs three-plane osteotomy on the target bone block through the osteotomy tracks.

[0075] This osteotomy guide can guide the surgeon to perform precise osteotomy on the anterior malleolus of the lower tibia, preserving the posterior part of the medial malleolus and maintaining the stability of the ankle hole. It also has an excellent fixation effect when repositioning and fixing the osteotomized bone fragments, reducing the risk of bone displacement.

[0076] like Figure 1 、 Figure 2 and Figures 7-16 As shown, specifically, the osteotomy guide includes an osteotomy guide segment A, an osteotomy guide segment B and an osteotomy guide segment C which are connected in sequence. The osteotomy guide segment A is located on the front side of the lower tibia and is perpendicular to the lower tibial articular surface of the tibiotalar joint. The osteotomy guide segment C is located on the inner side of the lower tibia and extends downward along the middle of the medial malleolus to the tip of the medial malleolus. The osteotomy guide segment C is inclined to the lower tibial articular surface of the tibiotalar joint. The osteotomy guide segment B is connected between the top of the osteotomy guide segment A and the top of the osteotomy guide segment C, and is parallel to the lower tibial articular surface of the tibiotalar joint.

[0077] like Figure 1 、 Figure 2 and Figure 7-Figure 16 As shown, specifically, the middle part of the osteotomy guide section A is provided with an osteotomy track A, the middle part of the osteotomy guide section B is provided with an osteotomy track B, and the middle part of the osteotomy guide section C is provided with an osteotomy track C. The osteotomy track A, osteotomy track B and osteotomy track C are connected and connected in sequence. The osteotomy track A is perpendicular to the inferior tibial articular surface of the tibiotalar joint, the osteotomy track B is parallel to the inferior tibial articular surface of the tibiotalar joint, and the osteotomy track C is inclined to the inferior tibial articular surface of the tibiotalar joint.

[0078] like Figure 24As shown, the oscillating saw performs three-plane osteotomy on the target bone block through osteotomy track A, osteotomy track B and osteotomy track C, so that the three cross-sections of the osteotomy bone block form a triangular prism structure, the volume of the osteotomy bone block is smaller, and when the osteotomy bone block is reduced and fixed after surgery, the triangular prism-shaped medial malleolus notch formed by the three osteotomy planes can limit the osteotomy bone block in three planes with multiple degrees of freedom, preventing the bone block from shifting along the plane direction, resulting in better fixation effect and conducive to postoperative recovery.

[0079] In this embodiment, the width of osteotomy track A, osteotomy track B, and osteotomy track C is 0.5 mm, and the thickness of the oscillating saw blade is 0.4 mm. The 0.4 mm thick oscillating saw blade is a thinner oscillating saw blade commonly used at present. It can swing smoothly in the 0.5 mm wide osteotomy track, and at the same time can reduce bone loss during the osteotomy process, and can also reduce bone displacement caused by bone loss during the reduction and fixation of the osteotomy bone fragment. Figure 26 As shown in the figure, after the osteotomy bone fragments are reduced, the bone joints are very thin, indicating that the bone loss is very low.

[0080] like Figure 1 、 Figure 2 and Figure 10 As shown, the outer side of the osteotomy guide section A is provided with a guide plate fixing hole A, which is parallel to the osteotomy track A. The outer side of the osteotomy guide section B is provided with a guide plate fixing hole B, which is parallel to the osteotomy track B. The outer side of the osteotomy guide section C is provided with a guide plate fixing hole C, which is parallel to the osteotomy track C. Three fixing pins pass through the guide plate fixing hole A, the guide plate fixing hole B and the guide plate fixing hole C respectively and penetrate the tibia to fix the osteotomy guide on the tibia.

[0081] In this embodiment, the diameters of the guide plate fixing hole A, the guide plate fixing hole B, and the guide plate fixing hole C are all 1.55 mm, and the fixing needle is a Kirschner wire with a diameter of 1.5 mm.

[0082] The three fixation pins not only secure the osteotomy guide, but the pins inserted through guide plate fixation hole A (fixation pin A) and guide plate fixation hole C (fixation pin C) also block and limit the oscillating saw, preventing excessive osteotomy depth. Without the support and limiter pins, over-cutting can easily occur as the saw blade continues to advance during osteotomy, resulting in unnecessary bone loss and harm to the patient. As the oscillating saw cuts the target bone fragment along osteotomy track A, fixation pins C block and limit the saw.

[0083] like Figure 1 、 Figure 2 、 Figure 15 and Figure 16 As shown, a screw guide hole A is provided on the inner side of section A of the osteotomy guide plate, and the direction of the screw guide hole A is from the front side of the lower tibia to the back side of the lower tibia, and is parallel to the lower tibial articular surface of the tibiotalar joint. A screw guide hole B is provided on the inner side of section B of the osteotomy guide plate, and the direction of the screw guide hole B is from the inner side of the lower tibia to the outer side of the lower tibia, and is parallel to the lower tibial articular surface of the tibiotalar joint. A screw guide hole C is provided at the end of section C of the osteotomy guide plate, and the direction of the screw guide hole C is obliquely from the tip of the medial malleolus to the upper outer side of the tibia; the drill bit drills the target bone block through the screw guide hole A, screw guide hole B and screw guide hole C, and forms three screw pre-fixation holes on the target bone block, so that the cut target bone block can be subsequently repositioned and fixed by screws through the screw pre-fixation holes.

[0084] In this embodiment, the diameters of the screw guide holes A, B, and C are 2.85 mm.

[0085] Screw guide holes A, B, and C have different orientations and angles, allowing the screws to reposition and secure the target bone fragment from various directions and angles. These three screws securely fix the osteotomized bone fragment in three dimensions. Their optimal placement and independent interaction ensure stable biomechanical fixation, preventing postoperative nonunion and displacement caused by bone resorption and screw loosening.

[0086] like Figure 3-Figure 5 and Figure 11-14 As shown, the osteotomy guide device also includes two talar cartilage protection baffles, which are the upper surface protection baffle of the talus and the medial side protection baffle of the talus. The upper surface protection baffle of the talus is inserted into the gap of the tibiotalar joint to protect the upper surface cartilage of the talus from being injured by the swing saw. The medial side protection baffle of the talus is inserted into the gap between the medial malleolus and the talus to protect the medial side cartilage of the talus from being injured by the swing saw.

[0087] In this embodiment, the upper surface protection baffle of the talus is adapted to the upper surface of the talus, and the medial side protection baffle of the talus is adapted to the medial side of the talus. When the oscillating saw performs osteotomy on the target bone block through the osteotomy track A, the upper surface protection baffle of the talus can protect the cartilage on the upper surface of the talus from being injured by the oscillating saw. When the oscillating saw performs osteotomy on the target bone block through the osteotomy track C, the medial side protection baffle of the talus can protect the cartilage on the medial side of the talus from being injured by the oscillating saw.

[0088] like Figure 6-Figure 9 As shown, the osteotomy guide device also includes two L-shaped retractors, each comprising a retractor head and a retractor handle. The retractor head is bent inward, and the bent portion is arc-shaped. Specifically, the retractor head of one retractor is attached to the inner and posterior side of the lower tibia, while the retractor head of the other retractor is attached to the gap between the talus and the lateral malleolus. The two retractors cooperate to expose the ankle joint.

[0089] When in use, insert the retractor head of one retractor (medial retractor) between the inner and posterior side of the lower tibia and other tissue layers, and insert the retractor head of the other retractor (lateral retractor) between the talus and the lateral malleolus. The retractors on both sides cooperate with each other to pull the tissue outwards, fully exposing the field of view at the ankle joint, giving the surgeon a better surgical field of view and improving surgical efficiency.

[0090] The application and operation process of the present invention are as follows:

[0091] (1) If Figure 18 As shown, the patient was placed in a supine position, and an incision of approximately 6.0 cm was made through the anterior ankle approach. The medial and lateral retractors were used to pull the tissues to both sides to expose the lower tibia including the medial malleolus and the anterior ankle joint. The joint capsule was incised to expose the anterior talus.

[0092] (2) If Figure 19 As shown, an appropriate osteotomy guide is selected according to the size of the patient's lower tibia, the osteotomy guide is fitted to the lower tibia, and the osteotomy track C is fitted to the center of the medial malleolus.

[0093] (3) If Figure 19 As shown, three Kirschner wires with a diameter of 1.5 mm are respectively passed through the guide plate fixing hole A, the guide plate fixing hole B and the guide plate fixing hole C and penetrate the tibia to fix the osteotomy guide on the tibia.

[0094] (4) If Figure 20 As shown, a drill bit with a diameter of 2.8 mm is selected to drill the target bone block through screw guide hole A, screw guide hole B and screw guide hole C respectively, forming three screw pre-fixation holes on the target bone block.

[0095] (5) Select a micro pendulum with a thickness of 0.4 mm and perform osteotomy on the target bone through osteotomy track A, osteotomy track B, and osteotomy track C respectively.

[0096] like Figure 21 As shown, when the oscillating saw is osteotomizing the target bone fragment through the osteotomy track A, a protective baffle on the upper surface of the talus is inserted into the gap of the tibiotalar joint in advance to protect the upper surface cartilage of the talus and the upper surface of the talar dome from being injured by the oscillating saw;

[0097] like Figure 22 As shown, when the oscillating saw is osteotomizing the target bone block through the osteotomy track C, the medial surface protection baffle of the talus is pre-inserted into the gap between the medial malleolus and the talus to protect the medial surface cartilage of the talus from being injured by the oscillating saw;

[0098] When the oscillating saw cuts the target bone through the osteotomy track A, the fixing pin C can block and limit the oscillating saw.

[0099] When the oscillating saw performs osteotomy on the target bone block through the osteotomy track C, the fixing pin A can block and limit the oscillating saw.

[0100] (6) If Figure 23-Figure 25 As shown, after the osteotomy operation is completed, the Kirschner wire is removed and the osteotomy guide is dismantled. A thin piece is used to gently pry the osteotomy bone fragments and separate them medially. The ankle joint is flexed and the position is maintained to fully expose the talar body and talar dome.

[0101] (7) If Figure 26 and Figure 27 As shown in the figure, after completing the operation on the talar lesion, the medial malleolus osteotomy fragment is reinserted in situ; the screw (screw A) is passed through the screw pre-fixation hole from the anterior side of the distal tibia to the posterior side of the distal tibia, the screw (screw B) is passed through the screw pre-fixation hole from the medial side of the distal tibia to the lateral side of the distal tibia, and the screw (screw C) is passed through the screw pre-fixation hole from the tip of the medial malleolus obliquely to the upper lateral side of the tibia. The target bone fragment is repositioned and fixed from three angles and directions to achieve three-plane fixation of the osteotomy fragment.

[0102] Example 2

[0103] A method for manufacturing a three-plane medial malleolus osteotomy guide device, such as Figure 17 As shown, the following steps are included:

[0104] S1. Randomly collect CT thin-slice scan data of multiple normal adult ankle joints;

[0105] In this embodiment, CT thin-slice scan data of ankle joints of 60 normal adults were randomly collected;

[0106] S2, importing the ankle joint CT thin-slice scan data acquired in step S1 into mimics software in DICOM format to generate a three-dimensional ankle joint model;

[0107] S3, importing the three-dimensional ankle joint model generated in step S2 into Geomagic software for smoothing the grid;

[0108] S4. Importing the smoothed grid three-dimensional ankle joint model from step S3 into SolidWorks software, measuring the anatomical features of the ankle joint, and selecting multiple models of different sizes based on the measurement results. The models are mirrored to generate left and right models, thereby obtaining multiple pairs of left and right three-dimensional ankle joint model data of different sizes.

[0109] In this embodiment, the ankle joint measurement data of 60 normal adults were divided into 6 groups according to size. The median of each group was taken to obtain 6 ankle joint models of different sizes. The left and right ankle joint models were then mirrored to generate 6 pairs of left and right 3D ankle joint model data of different sizes.

[0110] S5. Performing three-dimensional design of osteotomy guides based on the data of the multiple pairs of left and right three-dimensional ankle joint models of different sizes obtained in step S4, obtaining three-dimensional models of the multiple pairs of osteotomy guides of different sizes, and obtaining the multiple pairs of finished osteotomy guides of different sizes by metal 3D printing;

[0111] In this embodiment, based on the data of 6 pairs of left and right 3D ankle joint models of different sizes, 3D design of osteotomy guides was performed, 3D models of 6 pairs of osteotomy guides of different sizes were obtained, and 6 pairs of finished osteotomy guides of different sizes were obtained by metal 3D printing.

[0112] S6. Performing three-dimensional design of the talar upper surface protection baffle and the talar medial side protection baffle based on the multiple pairs of left and right three-dimensional ankle joint model data of different sizes obtained in step S4, obtaining adapted three-dimensional models of the talar upper surface protection baffle and the talar medial side protection baffle, and obtaining finished products of the talar upper surface protection baffle and the talar medial side protection baffle by metal 3D printing;

[0113] S7. Perform three-dimensional design of the retractor based on the data of the multiple pairs of left and right three-dimensional ankle joint models of different sizes obtained in step S4 to obtain a three-dimensional model of an adapted retractor, and obtain the finished retractor by metal 3D printing.

[0114] Based on the 3D anatomical features of the normal adult ankle joint, this invention generates medial malleolus osteotomy guides of varying sizes and specifications to accommodate the varying anatomical sizes and curvatures of the medial malleolus. Furthermore, it generates a matching talar upper surface protection baffle, a talar medial surface protection baffle, and a retractor, which can be effectively applied during osteotomy surgery. This invention adopts a standardized approach, designing osteotomy guides in a standardized manner. Multiple osteotomy guides of varying sizes and specifications are designed, allowing the appropriate osteotomy guide to be selected based on the patient's ankle bone size. This eliminates the need to reconstruct a 3D model of each patient's ankle joint and design a targeted osteotomy guide, saving preoperative preparation, improving efficiency, and reducing costs.

[0115] The above embodiments are preferred implementation modes of the present invention, but the implementation modes of the present invention are not limited to the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications that do not deviate from the spirit and principles of the present invention should be considered as equivalent replacement methods and are included in the scope of protection of the present invention.

Claims

1. A three-plane medial malleolus osteotomy guide device, characterized by: The osteotomy guide is a "door"-shaped structure that fits over the medial malleolus and the anterior medial side of the lower tibia and is fixed to the tibia via multiple fixation pins. The guide is provided with three eccentric osteotomy tracks, through which the oscillating saw performs three-plane osteotomy on the target bone. The osteotomy guide plate includes an osteotomy guide plate segment A, an osteotomy guide plate segment B, and an osteotomy guide plate segment C, which are connected in sequence. The osteotomy guide plate segment A is located on the front side of the lower tibia and is perpendicular to the lower tibial articular surface of the tibiotalar joint. The osteotomy guide plate segment C is located on the inner side of the lower tibia and extends downward along the middle of the medial malleolus to the tip of the medial malleolus. The osteotomy guide plate segment C is inclined to the lower tibial articular surface of the tibiotalar joint. The osteotomy guide plate segment B is connected between the top of the osteotomy guide plate segment A and the top of the osteotomy guide plate segment C and is parallel to the lower tibial articular surface of the tibiotalar joint. The middle part of the osteotomy guide plate A section is provided with an osteotomy track A, the middle part of the osteotomy guide plate B section is provided with an osteotomy track B, and the middle part of the osteotomy guide plate C section is provided with an osteotomy track C; The outer side of the osteotomy guide plate section A is provided with a guide plate fixing hole A, which is parallel to the osteotomy track A. The outer side of the osteotomy guide plate section B is provided with a guide plate fixing hole B, which is parallel to the osteotomy track B. The outer side of the osteotomy guide plate section C is provided with a guide plate fixing hole C, which is parallel to the osteotomy track C. Three fixing pins pass through the guide plate fixing hole A, the guide plate fixing hole B, and the guide plate fixing hole C respectively and penetrate the tibia to fix the osteotomy guide on the tibia. Three fixing pins are used to fix the osteotomy guide, two of which serve as a barrier and limit for the oscillating saw to prevent the osteotomy depth from being too deep.

2. The three-plane medial malleolus osteotomy guide device according to claim 1, characterized in that: Osteotomy track A, osteotomy track B and osteotomy track C are connected and connected in sequence. Osteotomy track A is perpendicular to the inferior tibial articular surface of the tibiotalar joint, osteotomy track B is parallel to the inferior tibial articular surface of the tibiotalar joint, and osteotomy track C is inclined to the inferior tibial articular surface of the tibiotalar joint.

3. The three-plane medial malleolus osteotomy guide device according to claim 1, characterized in that: A screw guide hole A is provided on the inner side of section A of the osteotomy guide plate, and the direction of the screw guide hole A is from the front side of the lower tibia to the back side of the lower tibia, and is parallel to the lower tibial articular surface of the tibiotalar joint. A screw guide hole B is provided on the inner side of section B of the osteotomy guide plate, and the direction of the screw guide hole B is from the inner side of the lower tibia to the outer side of the lower tibia, and is parallel to the lower tibial articular surface of the tibiotalar joint. A screw guide hole C is provided at the end of section C of the osteotomy guide plate, and the direction of the screw guide hole C is obliquely from the tip of the medial malleolus to the upper outer side of the tibia; the drill bit drills the target bone block through the screw guide hole A, screw guide hole B and screw guide hole C, and forms three screw pre-fixation holes on the target bone block, so that the cut target bone block can be repositioned and fixed by screws through the screw pre-fixation holes in the future.

4. The three-plane medial malleolus osteotomy guide device according to claim 1, characterized in that: The osteotomy guide device also includes two talar cartilage protection baffles, which are the upper surface protection baffle of the talus and the medial side protection baffle of the talus. The upper surface protection baffle of the talus is inserted into the gap of the tibiotalar joint to protect the upper surface cartilage of the talus from being injured by the swinging saw. The medial side protection baffle of the talus is inserted into the gap between the medial malleolus and the talus to protect the medial side cartilage of the talus from being injured by the swinging saw.

5. The three-plane medial malleolus osteotomy guide device according to claim 4, characterized in that: The osteotomy guiding device also includes two retractors, which are L-shaped and include a retractor head and a retractor handle. The retractor head is bent inward and the bent portion is arc-shaped.

6. The three-plane medial malleolus osteotomy guide device according to claim 5, characterized in that: The retractor head of one retractor is attached to the inner and posterior side of the lower tibia, and the retractor head of the other retractor is attached to the gap between the talus and the lateral malleolus. The two retractors cooperate with each other to expose the ankle joint.

7. A method for manufacturing a three-plane medial malleolus osteotomy guide device, for manufacturing the three-plane medial malleolus osteotomy guide device according to claim 5 or 6, characterized in that: The following steps are involved: S1. Randomly collect CT thin-slice scan data of multiple normal adult ankle joints; S2, importing the ankle joint CT thin-slice scan data acquired in step S1 into mimics software in DICOM format to generate a three-dimensional ankle joint model; S3, importing the three-dimensional ankle joint model generated in step S2 into Geomagic software for smoothing the grid; S4. Importing the smoothed grid three-dimensional ankle joint model from step S3 into SolidWorks software, measuring the anatomical features of the ankle joint, and selecting multiple models of different sizes based on the measurement results. The models are mirrored to generate left and right models, thereby obtaining multiple pairs of left and right three-dimensional ankle joint model data of different sizes. S5. Perform three-dimensional design of osteotomy guides based on the data of multiple pairs of left and right three-dimensional ankle joint models of different sizes obtained in step S4, obtain multiple pairs of three-dimensional models of osteotomy guides of different sizes, and obtain multiple pairs of finished osteotomy guides of different sizes through metal 3D printing.

8. The method for manufacturing a three-plane medial malleolus osteotomy guide device according to claim 7, characterized in that: The following steps are also included: S6. Performing three-dimensional design of the talar upper surface protection baffle and the talar medial side protection baffle based on the multiple pairs of left and right three-dimensional ankle joint model data of different sizes obtained in step S4, obtaining adapted three-dimensional models of the talar upper surface protection baffle and the talar medial side protection baffle, and obtaining finished products of the talar upper surface protection baffle and the talar medial side protection baffle by metal 3D printing; S7. Perform three-dimensional design of the retractor based on the data of the multiple pairs of left and right three-dimensional ankle joint models of different sizes obtained in step S4 to obtain a three-dimensional model of an adapted retractor, and obtain the finished retractor by metal 3D printing.

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