Personalized 3D printing ankle joint bone fracture plate and matched navigation operation guide plate system thereof

Abstract

The invention discloses a personalized 3D printing ankle joint bone fracture plate and a navigation operation guide plate system matched with the personalized 3D printing ankle joint bone fracture plate, and relates to the technical field of orthopedic medical instruments, in particular to the personalized 3D printing ankle joint bone fracture plate and the navigation operation guide plate system matched with the personalized 3D printing ankle joint bone fracture plate. The main body plate is provided with a locking hole group, a pressurizing hole group, a supporting wing and an identification groove; the guide plate base plate is provided with guide columns and fixing nail holes corresponding to the hole positions of the main body plate. The inner side face of the main body plate is profiled according to the bone cortex of a patient and is provided with micron-sized concave textures, and the outer side face of the main body plate is a smooth plane and is provided with an operation driving groove. And the supporting wings are thin wings and form a structure adaptive to the included angle of the bone surface with the main body plate. Personalized customization of the bone fracture plate is achieved through the 3D printing technology, the bone fracture plate is matched with the guide plate base plate with the precise positioning guide columns, the operation precision is effectively improved, the attaching stability of the bone fracture plate and the bone surface is enhanced, and postoperative recovery is facilitated.

Description

Technical Field

[0001] This invention relates to the field of orthopedic medical device technology, specifically to a personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system. Background Technology

[0002] Ankle fractures are one of the most common types of trauma in clinical practice, accounting for approximately 10% of all fractures. Due to the complexity of the ankle joint's anatomy, involving multiple stress points such as the distal tibia and fibula, medial malleolus, lateral malleolus, and posterior malleolus, fractures in this area are often accompanied by severe soft tissue damage. Traditional surgical treatments mainly rely on standardized, mass-produced metal plate systems. However, in actual clinical application, this "one-size-fits-all" standardized product has revealed many insurmountable drawbacks.

[0003] First, poor anatomical fit limits the accuracy of reduction. Existing universal bone plates are designed based on averaged bone data and cannot perfectly fit the unique bone surface morphology of each patient. Especially in irregular joints like the ankle, standardized straight or shallowly curved plates struggle to achieve a zero-gap fit with the uneven cortical bone. This not only increases the difficulty of repeated reshaping during surgery and prolongs the operation time, but more importantly, the gap between the bone plate and the bone surface easily leads to stress shielding effects postoperatively, affecting normal healing of the fracture ends and even causing internal fixation failure or secondary fractures.

[0004] Secondly, intraoperative positioning is difficult and relies heavily on the surgeon's experience. In traditional open reduction and internal fixation (ORIF) surgery, the surgeon must align the screw holes of the bone plate with the pre-drilled holes in the bone using only touch and experience within a narrow field of vision. For the ankle joint, a deep area with dense blood vessels and nerves, repeated fluoroscopy and probing to find the holes significantly increases traction and dissection of soft tissues, thereby exacerbating local blood supply disruption and increasing the risk of postoperative infection, skin necrosis, and nonunion. Furthermore, to find the correct entry point, the surgeon often needs to enlarge the incision, which violates the basic principles of minimally invasive surgery.

[0005] Secondly, there is a lack of effective real-time intraoperative guidance mechanisms. Although medical imaging technology has entered the digital age, there is often a gap between traditional surgical instruments and digital planning. High-precision three-dimensional model data obtained through preoperative CT scans is difficult to effectively utilize during surgery. Surgeons cannot visually see the three-dimensional correspondence between the pre-planned screw channels and the actual bone structure during surgery, leading to deviations between the actual screw placement and the preoperative plan, affecting the controllability and precision of the surgical outcome.

[0006] Finally, the bone ingrowth environment is unfavorable. Traditionally machined bone plates typically have smooth surfaces with a low coefficient of friction with bone tissue, resulting in poor bioactivity. During the long postoperative healing period, micromovements easily occur between the bone plate and the bone surface, which is detrimental to osteoblast attachment and growth, thus slowing down the rate of bone integration.

[0007] In conclusion, designing a personalized surgical solution that can perfectly match the individual bone surface characteristics of patients, provide precise intraoperative guidance, and promote bone healing has become a technical challenge to be solved in the field of orthopedic trauma. Summary of the Invention

[0008] The purpose of this invention is to provide a personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system. By precisely aligning the guide posts of the guide plate substrate with the holes of the bone plate, accurate intraoperative positioning and fixation can be achieved. At the same time, the contour design of the inner side of the main plate and the micron-level texture enhance the bone surface fit, improve the fixation stability of the bone plate, reduce surgical trauma, and improve the treatment effect of ankle fractures.

[0009] To achieve the above objectives, the present invention provides the following technical solution: a personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system, comprising a main plate and a guide plate base plate. The end face of the main plate is provided with a plurality of locking hole groups and a plurality of pressure hole groups. Support wings are provided at both ends of the main plate, and a marking groove is provided at the end face of the main plate. The locking hole groups are used to implant locking screws with threaded structures to achieve pressure fixation of the fracture ends. The pressure hole groups are used to implant ordinary cortical bone screws to provide axial pressure. The support wings are used to increase the contact area between the bone plate and the bone to improve anti-torsion performance. The marking groove is used to accommodate radiopaque markers for intraoperative fluoroscopic positioning.

[0010] Furthermore, the end face of the guide plate substrate is provided with a locking hole guide post, a pressure hole guide post, and a fixing nail hole; the locking hole guide post and the locking hole group on the main body plate are coaxial in three-dimensional space to guide the drill bit to drill precisely into the predetermined trajectory; the pressure hole guide post and the pressure hole group on the main body plate are coaxial in three-dimensional space to assist in the precise insertion of the guide needle; the fixing nail hole is used to stably fix the guide plate substrate to the surface of the limb skin by means of Kirschner wires or skin nails.

[0011] Furthermore, the supporting wing is a thin wing-shaped structure extending outward from both ends of the main body plate. Its wing surface forms an angle with the main body plane of the main body plate to adapt to the bone surface protrusion, so as to enhance the adhesion stability of the bone plate to the bone surface. The size of the angle is set according to the local bone surface undulation data reconstructed by the preoperative CT scan, so that the supporting wing can conform to the anatomical shape of the distal fibula or the edge of the medial malleolus, thereby dispersing local stress and preventing the bone plate from lifting.

[0012] Furthermore, the locking hole guide posts are disposed on the end face of the guide plate substrate, and their number and arrangement position correspond completely with the number and arrangement position of the locking hole group of the main plate in the projection direction, forming a one-to-one guiding relationship; the internal channel diameter of each locking hole guide post matches the nominal diameter of the thread of the locking screw to be used, and the height of the guide post is sufficient to constrain the lateral displacement of the drill bit, ensuring that the drilling axis is perpendicular to the plane of the bone plate.

[0013] Furthermore, the pressure hole guide posts are disposed on the end face of the guide plate substrate, and their number and arrangement position correspond completely with the number and arrangement position of the pressure hole group of the main plate in the projection direction, forming a one-to-one guiding relationship; the pressure hole guide posts adopt a funnel-shaped inlet design to facilitate the rapid introduction of the guide needle, and after the guide needle passes through, it serves as a guide channel for reaming or tapping, ensuring that the pressure screw can pass smoothly through the bone plate and bite into the contralateral bone cortex.

[0014] Furthermore, the fixing pin hole is a blind hole structure that penetrates the end face of the guide plate substrate, and the direction of the hole is perpendicular to the surface of the guide plate substrate. This structure ensures sufficient holding force between the guide plate and the skin, while avoiding soft tissue irritation or guide plate slippage that may be caused by through holes, and a certain thickness of substrate material is retained at the bottom of the blind hole to maintain structural strength.

[0015] Furthermore, the marking groove extends along the length of the main plate in the region near the articular surface of the main plate, and the groove orientation is consistent with the long axis of the main plate. This design allows the overlapping image of the marking groove and the long axis of the bone plate to serve as an anatomical landmark for judging whether the anterior and posterior positions of the bone plate are correct under intraoperative C-arm X-ray fluoroscopy, preventing the bone plate from being placed too far forward or backward.

[0016] Furthermore, the fixing holes are located in the edge area of ​​the guide plate substrate, which is used to temporarily anchor the guide plate substrate to the skin and soft tissue surface of the affected limb during surgery; the distribution of the edge area follows the principle of mechanical balance to ensure that the guide plate will not rotate or translate during the surgical operation, thereby providing a stable reference platform for subsequent drilling operations.

[0017] Furthermore, the inner surface of the main plate is designed to mimic the surface morphology of the cortical bone at the patient's affected area, and micron-level concave textures are distributed on the bone contact surface. The mimicry design allows the bone plate to fit closely to the bone surface without extensive intraoperative shaping. The micron-level concave textures are used to generate a micro-mechanical interlocking effect, increasing the friction between the bone and the bone plate and reducing the risk of postoperative bone plate loosening.

[0018] Furthermore, the outer surface of the main plate is a smooth plane, and multiple operating drive grooves for screwing in the fixing screws are provided on the plane; the smooth plane design reduces the frictional resistance of the bone plate in the subcutaneous tissue, which facilitates postoperative incision suturing; the shape of the operating drive groove is adapted to the screwdriver head and is treated with anti-slip to ensure that the surgeon can smoothly complete the screw tightening or loosening operation in a narrow surgical field.

[0019] This invention provides a personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system, which has the following beneficial effects: 1. Significantly improves surgical precision and internal fixation stability. This system achieves a precise one-to-one projection correspondence between the guide posts on the guide plate substrate and the locking holes and pressure holes on the main body plate, effectively overcoming the risk of drilling misalignment caused by obstructed vision or operational errors in traditional surgery. This precise mechanical guidance ensures that the internal fixation screws are accurately implanted into the bone along a preset trajectory, significantly improving the fit of the bone plate and enhancing the holding force and overall stability of the internal fixation, thereby effectively reducing the risk of postoperative internal fixation failure and fracture displacement.

[0020] Optimizing biomechanical properties and accelerating bone healing, the inner surface of the main plate is highly contoured to the patient's cortical bone surface morphology, and features micron-level concave textures. This significantly increases the contact area and friction between the plate and the bone surface, effectively dispersing local stress concentration and avoiding the "stress shielding" effect. Simultaneously, the special angled design of the support wings better conforms to the bone's anatomical structure, providing three-dimensional support and enabling rapid healing of the fracture ends in a stable mechanical environment, thus shortening the patient's recovery period.

[0021] Enhancing intraoperative ease of operation and surgical efficiency. Fixing holes along the edge of the guide plate base allow the surgeon to temporarily anchor the guide plate to the skin surface of the affected limb, forming a stable operating platform and effectively preventing soft tissue interference and guide plate slippage. Furthermore, standardized operating drive grooves on the outer side of the main plate facilitate screw insertion using tools in confined spaces. These designs simplify complex surgical procedures, shorten surgical time, and reduce patient trauma and stress.

[0022] This system achieves truly personalized precision medicine. Based on the patient's imaging data, it is custom-designed to perfectly match the patient's bone morphology, both in terms of the main plate's outline and internal structural design. This personalized adaptation eliminates the drawbacks of universal steel plates that require repeated bending and shaping during surgery. It not only reduces iatrogenic bone injury but also maximizes the preservation of blood supply to the fracture site, providing patients with an optimized, customized treatment plan.

[0023] Enhanced postoperative management and safety assurance. The marking grooves on the main plate serve as crucial intraoperative positioning markers, helping surgeons quickly identify the proximal articular surface area, aiding in assessing reduction status and screw insertion depth, and preventing excessively long screws from accidentally entering the joint cavity. Simultaneously, the micron-level texture design improves initial stability without adding extra steps, reducing the incidence of postoperative complications and providing a solid safety foundation for postoperative rehabilitation and functional exercises. Attached Figure Description

[0024] To more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings in the following description are merely exemplary, and those skilled in the art can derive other embodiments based on the provided drawings without creative effort.

[0025] Figure 1 This is a schematic diagram of the overall structure of the present invention. Figure 1 ; Figure 2 This is a schematic diagram of the overall structure of the present invention. Figure 2 ; Figure 3 This is a schematic diagram of the overall structure of the present invention.

[0026] Part Name: Main body plate 1; Locking hole group 2; Pressurizing hole group 3; Support wing 4; Marking groove 5; Guide plate base plate 6; Locking hole guide post 7; Pressurizing hole guide post 8; Fixing nail hole 9. Detailed Implementation

[0027] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numerals in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this disclosure. Rather, they are merely examples of apparatuses consistent with some aspects of this disclosure as detailed in the appended claims.

[0028] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0029] How to use: 1. Preoperative preparation and treatment planning First, based on the patient's ankle CT or MRI images, a precise bone tissue model of the affected area is obtained using 3D reconstruction technology. According to the surface morphology of the bone cortex, a main plate 1 with a contoured structure and micron-level concave texture on its inner surface is designed and 3D printed. Simultaneously, a matching guide plate substrate 6 is designed and 3D printed. Locking hole groups 2 and pressure hole groups 3 are pre-set on the main plate 1, and marking grooves 5 are machined along the long axis in the region near the articular surface. Locking hole guide posts 7 and pressure hole guide posts 8, corresponding to the projections of locking hole groups 2 and pressure hole groups 3, are machined on the guide plate substrate 6, and fixing pin holes 9 are machined in the edge region.

[0030] Surgical incision and soft tissue exposure A standard ankle joint surgical approach is used, with the skin, subcutaneous tissue, and fascia incised layer by layer to fully expose the fracture ends and the area of ​​bone to be fixed. Hematoma and embedded soft tissue are cleared, and the fracture ends are reduced and temporarily fixed.

[0031] Temporary fixing of guide plate substrate Remove the guide plate base 6, which is adapted to the height of the patient's bone surface. Using the fixation pin holes 9 in the edge area of ​​the guide plate base 6, anchor it to the skin and soft tissue surface or periosteum surface of the affected limb with temporary fixation pins to ensure that the guide plate base 6 remains stable and does not shift during subsequent operations.

[0032] Drilling guidance and positioning The guide plate base 6 is precisely placed over the target fixation area. Since the locking hole guide post 7 and the locking hole group 2 of the main plate 1 are completely aligned in the projection direction, and the pressure hole guide post 8 and the pressure hole group 3 are completely aligned in the projection direction, the surgeon can use the guide post on the guide plate base 6 to drill through the skin, soft tissue and directly to the bone surface in sequence, thereby accurately creating a guide channel that is completely consistent with the hole position of the main plate 1.

[0033] Main panel placement and fixing Remove the guide plate substrate 6 and temporary fixation pins. Attach the pre-formed main body plate 1 to the bone surface. The inner surface of the main body plate 1 is designed to mimic the shape of the patient's bone surface, and the micron-level concave texture on the bone contact surface increases friction. Combined with the support wings 4 at both ends (whose wing surfaces form an angle with the main body plane to adapt to the bone surface protrusions), this significantly enhances the adhesion stability of the bone plate to the bone surface. Subsequently, pass the locking screws through the locking hole group 2 and the pressure hole group 3 of the main body plate 1 and screw them into the bone holes prepared in step 4 to complete the initial fixation of the bone plate.

[0034] Final confirmation and suturing Check that the main body plate 1 is flat and attached. Use the operating drive groove on the smooth surface of the outer side of the main body plate 1 to tighten all fixing screws to ensure a firm connection. Finally, suture the surgical incision to complete the operation.

[0035] Example: Example 1: Personalized application based on the anatomical morphology of the distal medial tibia This embodiment addresses a patient with a comminuted fracture of the distal medial tibia due to a fall from a height. Preoperatively, CT data of the patient's ankle joint was collected, with a focus on reconstructing the morphology of the distal medial tibia. When designing the main plate 1, a full-dimensional contouring was performed based on the cortical bone surface morphology of this area to ensure maximum fit between its medial surface and the patient's bone surface. To address local bone protrusions, support wings 4 were designed at both ends of the main plate 1, with their surfaces forming a specific angle with the main plate's plane. This allows the plate to conform to bone surface undulations during implantation, enhancing stability.

[0036] The end face of the main plate 1 is equipped with locking hole groups 2 and pressure hole groups 3 to meet the bone fixation requirements in different directions. In the region near the articular surface, a marking groove 5 is machined along the long axis of the main plate 1 to facilitate intraoperative identification of the proximal position. The accompanying navigation surgical guide system includes a guide plate base 6, on which locking hole guide posts 7 and pressure hole guide posts 8 are precisely positioned. The number and arrangement of these two posts correspond one-to-one with the hole groups on the main plate 1 in the projection direction. Furthermore, fixation pin holes 9 are pre-set in the edge region of the guide plate base 6.

[0037] During the surgery, the fractured bone fragments were first reduced. Then, the guide plate substrate 6 was placed over the bone surface, and temporary fixation screws were inserted using the fixation screw holes 9 on its edge to secure it to the soft tissue surface. Next, the surgeon used guide posts on the guide plate substrate 6 to drill holes, ensuring absolute precision in the drilling position. After removing the guide plate, the main plate 1 was implanted. Due to the micron-level concave texture on its inner surface increasing bone contact friction, and the adaptive filling of the support wings 4 to the bone surface protrusions, the main plate 1 was tightly adhered to the bone surface. Finally, screws were screwed in to complete the fixation, and the position of the marking groove 5 was checked. After confirmation, the incision was sutured.

[0038] Example 2: Application of multi-point compression fixation in complex comminuted fractures This embodiment is applied to a case of severe comminuted fracture around the ankle joint caused by a car accident. Due to the complexity of the fracture line and the involvement of multiple bone fragments, multi-point compression needs to be applied to the main plate 1 to enhance stability. The main plate 1 is designed with a long span layout. In addition to the conventional locking hole group 2, the end face is also equipped with a dense arrangement of compression hole groups 3 at key stress points to achieve concentrated stress compression on the dispersed bone fragments.

[0039] The inner surface of the main plate 1 adheres to a strict principle of personalized contouring, employing differentiated modeling to address the unevenness of the cortical bone in different areas. The support wings 4 at both ends are designed with an asymmetrical structure to accommodate the unique bony protrusion contour of the affected side. The guide plate base 6 in the navigation guide system is relatively complex to manufacture, featuring numerous and densely arranged pressure hole guide posts 8 on its end face. Each guide post corresponds precisely to the pressure hole group 3 of the main plate 1, ensuring that each pressure screw can accurately strike the predetermined position during surgery. The edge fixation screw holes 9 of the guide plate base 6 are evenly distributed, guaranteeing the torsional resistance of the guide plate when covering a large area.

[0040] During the surgical procedure, the large-area coverage of the guide plate 6 allows for the simultaneous drilling and guidance of multiple bone fragments. This "one plate, multiple guides" approach significantly improves surgical efficiency. After implantation of the main plate 1, pressure applied through the pressure hole group 3 re-aggregates the previously loose bone fragments. The smooth, flat design of the outer surface of the main plate 1 ensures a smooth operation for the surgeon when using a screwdriver to perform the final tightening operation through the drive groove, avoiding the risk of slippage. The entire fixation system, with its personalized design and the assistance of the navigation guide plate, achieves effective reduction and strong fixation for complex fractures.

[0041] Example 3: Application of micro-motion stabilization fixation in patients with osteoporosis This embodiment addresses an elderly patient with osteoporosis whose ankle fracture faces the risk of fixation failure. The design focuses on enhancing the holding force between the bone plate and the cancellous bone. The inner surface of the main plate 1, based on a contoured design, emphasizes the distribution density of micron-level concave textures, aiming to counteract the decrease in fixation strength caused by bone loss by increasing micro-mechanical interlocking force. While the main plate 1 is relatively thin, its left and right end support wings 4 are designed to be wider to increase the contact area with the bone surface and distribute compressive stress.

[0042] In terms of hole design, the main plate 1 primarily uses locking hole groups 2 to form an angularly stable structure, reducing micromovement. The guide plate base 6 in the navigation guide system is made extremely thin to minimize interference with soft tissues. The locking hole guide posts 7 on it are designed to be even thinner yet more rigid, ensuring a straight path of pins even on fragile bone surfaces. The fixation pin holes 9 on the edge of the guide plate base 6 are specially designed to allow the surgeon to control the depth during pin insertion, preventing penetration of the cortical bone.

[0043] During the surgery, the guide plate base 6 is gently fixed to the periosteum through the shallow fixation pin holes 9, serving as a guiding platform for minimally invasive procedures. The self-tapping screws, locked in place, are guided in using the guide post 7. Due to the high-precision guidance of the guide plate, the screws can perfectly penetrate the cancellous bone, forming a stable thread hold. After the main plate 1 is in place, its wide support wings 4 firmly support the bone surface, and combined with the texture of the inner surface, provide reliable initial stability even in cases of osteoporosis, effectively reducing the probability of postoperative internal fixation failure.

[0044] Example 4: Application of Precise Anatomical Reduction in Calcaneal Fractures This embodiment demonstrates the application of this system in calcaneal tuberosity fractures. The calcaneus has an irregular shape and is surrounded by abundant soft tissue, requiring extremely high conformity from the guide plate. The main plate 1 is custom-carved according to the three-dimensional morphology of the posterior articular surface of the calcaneus, with its inner surface perfectly conforming to the concave and convex surfaces of the calcaneus. The shape of the main plate 1 is not a traditional straight plate, but rather a curved design based on the physiological curvature of the calcaneus. The supporting wings 4 at both ends extend to the protrusions on the inner and outer walls of the calcaneus, respectively, providing lateral obstruction.

[0045] The locking holes 2 on the end face of the main plate 1 are arranged in a fan shape to accommodate the tilt angle of the calcaneus side. The guide plate base 6 in the navigation guide plate system is also designed using a flexible material concept, allowing it to conform to the tension of the soft tissue around the calcaneus. The layout of the locking hole guide posts 7 and the pressure hole guide posts 8 on the guide plate base 6 simulates the final shape of the main plate 1, providing three-dimensional spatial guidance. The fixation pin holes 9 on the edge of the guide plate base 6 are mainly used to temporarily fix the guide plate to the soft tissue next to the Achilles tendon or around the calcaneal tuberosity.

[0046] During the surgery, the posterior articular surface of the calcaneus is exposed through a small incision. The guide plate substrate 6 is attached to the soft tissue surface, and percutaneous drilling is performed using guide posts. This method greatly reduces damage to important soft tissues around the calcaneus (such as the sural nerve). After the main plate 1 is implanted, its contoured inner surface perfectly embeds into the calcaneal cavity, and the support wing 4 is secured at the edge of the bone cortex, acting as a "mortise and tenon"-like restraint. The operating drive groove on the outer surface allows the surgeon to easily tighten the screws in a confined space, ultimately achieving precise anatomical reduction and firm fixation of the calcaneal tuberosity.

[0047] Example 5: Application of osteotomy correction in malunion of old fractures This embodiment is applied to a case of malunion caused by an old ankle fracture, requiring osteotomy correction. The design of the main plate 1 not only considers fixation but also helps maintain the corrected bone position. The shape of the main plate 1 is topologically optimized based on the preoperatively planned osteotomy line and the expected correction angle. In addition to the conventional locking hole group 2 and pressure hole group 3, its end face also has a special arrangement of pressure hole group 3, used to apply continuous axial pressure to the osteotomy end to promote healing.

[0048] The inner surface of the main plate 1 features a precise cutout design to avoid the osteotomy area, while maintaining the structural integrity of the support wings 4 in the non-contact areas to provide overall mechanical support. In this case, the guide plate base 6 in the navigation guide plate system acts as an "osteotomy template." The guide posts on the guide plate base 6 not only guide the screw holes of the bone plate but also help mark the osteotomy boundaries. The fixing pin holes 9 on the edge of the guide plate base 6 are used to fix the guide plate to the bone surface before osteotomy, ensuring that the guide plate does not shift during the osteotomy process.

[0049] During the surgery, precise osteotomy was first performed using the guiding function of the guide plate substrate 6. Then, under the protection and guidance of the guide plate substrate 6, the pre-shaped main plate 1 was implanted. Since the main plate 1 was customized according to the corrected bone morphology, it acts like a "key," fitting perfectly into the bone surface. At this point, the support wings 4 are close to the bone cortex, and the locking hole guide post 7 ensures that the internal fixation device can be precisely inserted into the predetermined safe area. Postoperative examination showed that the main plate 1 perfectly maintained the anatomical alignment of the ankle joint, and the micron-level texture and support wings 4 together ensured the initial stability of the osteotomy site.

[0050] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system, comprising a main plate (1) and a guide plate substrate (6), characterized in that: The end face of the main body plate (1) is provided with a locking hole group (2), the end face of the main body plate (1) is provided with a pressure hole group (3), the left and right ends of the main body plate (1) are provided with support wings (4), and the end face of the main body plate (1) is provided with an identification groove (5).

2. The personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system according to claim 1, characterized in that: The end face of the guide plate substrate (6) is provided with a locking hole guide post (7), the end face of the guide plate substrate (6) is provided with a pressure hole guide post (8), and the end face of the guide plate substrate (6) is provided with a fixing nail hole (9).

3. The personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system according to claim 1, characterized in that: The supporting wing (4) is a thin wing-shaped structure extending outward from the left and right ends of the main body plate (1). Its wing surface forms an angle with the main body plane of the main body plate (1) to adapt to the bone surface protrusion, so as to enhance the adhesion stability of the bone plate to the bone surface.

4. The personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system according to claim 2, characterized in that: The locking hole guide post (7) is set on the end face of the guide plate substrate (6). Its number and arrangement position correspond completely with the number and arrangement position of the locking hole group (2) of the main plate (1) in the projection direction, forming a one-to-one guiding relationship.

5. The personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system according to claim 2, characterized in that: The pressure hole guide post (8) is set on the end face of the guide plate substrate (6), and its number and arrangement position are completely corresponding to the number and arrangement position of the pressure hole group (3) of the main plate (1) in the projection direction, forming a one-to-one guiding relationship.

6. The personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system according to claim 2, characterized in that: The fixing pin hole (9) is a blind hole structure that penetrates the end face of the guide plate substrate (6), and its hole direction is perpendicular to the plate surface of the guide plate substrate (6).

7. The personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system according to claim 1, characterized in that: The marking groove (5) extends along the length of the main plate (1) in the area near the joint surface of the main plate (1), and its groove orientation is consistent with the long axis of the main plate (1).

8. The personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system according to claim 2, characterized in that: The fixing pin hole (9) is located in the edge area of ​​the guide plate substrate (6) and is used to temporarily anchor the guide plate substrate (6) to the skin and soft tissue surface of the affected limb during surgery.

9. The personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system according to claim 1, characterized in that: The inner surface of the main plate (1) is designed to mimic the surface morphology of the cortical bone of the patient's affected area, and micron-level concave textures are distributed on the bone contact surface.

10. The personalized 3D-printed ankle joint bone plate and its matching navigation surgical guide system according to claim 1, characterized in that: The outer surface of the main plate (1) is a smooth plane, and multiple operating drive grooves for screwing in fixing screws are provided on the plane.

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