A tibial osteotomy guide, osteotomy system and spatial position determination method

Abstract

The application discloses a tibial osteotomy guide plate, an osteotomy system and a spatial position determination method, and relates to the technical field of medical instruments. The tibial osteotomy guide plate comprises a guide plate body, a plurality of groups of positioning needle nail channels and a first force line verification interface. The guide plate body is provided with a bone contact surface, the shape of the bone contact surface is adapted to the proximal end anatomical morphology of a tibia of a patient, the plurality of groups of positioning needle nail channels penetrate through the guide plate body, and the perpendicular distances from the axes of the groups of positioning needle nail channels to the osteotomy reference plane of the guide plate body are different. The first force line verification interface is arranged on the guide plate body and is configured to be accessible to a force line verification instrument. Based on the technical scheme disclosed by the application, the cumbersome and potential errors of intraoperative multi-hole alignment selection are avoided, the adjustment is more intuitive, accurate and efficient, the final accuracy of force line recovery can be maximally guaranteed, the surgical risk can be reduced, and the consumable cost of a single surgery can be greatly reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a tibial osteotomy guide plate, an osteotomy system, and a method for determining spatial position. Background Technology

[0002] Currently, total knee arthroplasty is an effective treatment for end-stage arthritis and other diseases. Precise osteotomy of the tibial plateau is crucial for surgical success and restoring normal lower limb alignment. Traditional methods rely heavily on the surgeon's experience using general-purpose extramedullary positioning instruments, which suffers from a long learning curve, complex operation, and inaccurate force line control.

[0003] In recent years, 3D printing of personalized surgical guides based on medical images has been applied, which can improve the initial positioning accuracy by matching the guide with the patient's bones in a personalized manner. However, the relevant technology still has obvious limitations.

[0004] For example, some solutions integrate osteotomy guidance function with personalized guide plate design, resulting in each guide plate being a costly, one-time custom part, and the resin material may pose a risk when bearing osteotomy load.

[0005] For example, some alternative approaches separate the personalized guide plate from the metal osteotomy device. However, the adjustment of the osteotomy amount relies on multiple sets of positioning holes machined on the metal osteotomy device itself, which are then aligned with large-sized "matching holes" on the guide plate. This adjustment method is relatively cumbersome, and the alignment of the positioning holes during surgery may introduce secondary errors. Furthermore, it usually lacks a systematic force line verification process that runs through key surgical nodes, making it difficult to ensure controllable precision throughout the entire process from planning to execution.

[0006] Therefore, it is of great significance to develop a total knee tibial osteotomy solution that can overcome the above-mentioned defects. Summary of the Invention

[0007] The purpose of this invention is to overcome the above-mentioned technical deficiencies and propose a tibial osteotomy guide plate, osteotomy system and spatial position determination method to solve the technical problems of cumbersome operation, insufficient precision, high cost and lack of force line verification process in the existing total knee tibial osteotomy surgery.

[0008] To achieve the above-mentioned technical objectives, the present invention adopts the following technical solution: In a first aspect, the present invention provides a tibial osteotomy guide plate, comprising: The guide plate body has a bone contact surface, the shape of which is adapted to the anatomical morphology of the proximal tibia of the patient. Multiple sets of positioning pin tracks are disposed on the guide plate body and penetrate the guide plate body, and the vertical distance from the axis of each set of positioning pin tracks to the osteotomy reference plane of the guide plate body is different; and The first force line verification interface is located on the guide plate body and is configured to allow the force line verification device to be connected for lower limb force line verification.

[0009] In some embodiments, the number of positioning pin tracks is four sets; the four sets of positioning pin tracks are parallel to each other, and the height difference between any two adjacent sets of positioning pin tracks is a preset value, so that the osteotomy amount covered by the four sets of positioning pin tracks is at least 6 mm.

[0010] In some embodiments, the preset value is 2mm; the four sets of positioning pin tracks correspond to any four of the five osteotomy adjustment options: standard osteotomy amount, standard osteotomy amount plus 2mm, standard osteotomy amount minus 2mm, standard osteotomy amount minus 4mm, and standard osteotomy amount plus 4mm.

[0011] In some embodiments, the tibial osteotomy guide plate is configured as a guide plate for the left leg or a guide plate for the right leg, depending on the applicable scenario. The guide plate for the left leg and the guide plate for the right leg are designed and molded separately according to the anatomical morphology of the proximal tibia on the left and right sides of the patient, respectively. The guide plate body is made of medical-grade polymer material by 3D printing.

[0012] Secondly, the present invention also provides an osteotomy system, comprising: Tibial osteotomy guide plate as described in the first aspect; An osteotomy plate having an osteotomy groove and at least one positioning hole, and the osteotomy plate being configured as a standardized reusable instrument; A matching connector, configured to connect to the osteotomy plate, and further provided with a second force line verification interface; and The positioning pin can be inserted into the bone through any set of positioning pin channels on the tibial osteotomy guide plate and is configured as the positioning reference of the osteotomy plate. The positioning hole is configured to cooperate with the positioning pin of the implanted bone to reproduce the spatial position of the tibial osteotomy guide plate during the operation.

[0013] In some embodiments, the position of the positioning hole is configured to be coaxially aligned with the position of the selected target positioning pin path on the tibial osteotomy guide in the design state; the axial position of the second force line verification interface is consistent with the axial position of the first force line verification interface in the spatial mapping relationship.

[0014] In some embodiments, a capped pin is also included, which is configured to pass through the osteotomy plate and be implanted into the bone; after implantation into the bone, the capped pin is positioned at an angle to the axis of the positioning pin, and the capped pin's head abuts against the osteotomy plate to assist in fixing the osteotomy plate.

[0015] Thirdly, the present invention also provides a method for determining the spatial position of an osteotomy system, applied to the osteotomy system as described in the second aspect, comprising the following steps: S1. Guide plate preparation: Design and prepare the corresponding tibial osteotomy guide plate based on the patient's proximal tibial imaging data; S2. Guide plate matching and benchmark preset: The bone contact surface of the guide plate is negatively matched with the anatomical shape of the proximal tibia; according to the preoperative planned osteotomy volume, a target positioning pin channel is selected from multiple groups of positioning pin channels, and the spatial position of the target positioning pin channel corresponds to the planned ideal osteotomy plane position. S3. Initial force line data acquisition: Connect the force line verification device to the first force line verification interface set on the guide plate, acquire the first force line measurement data, and verify whether the preset osteotomy reference plane of the guide plate in the current matching state meets the lower limb force line planning requirements. S4. Spatial reference transfer: If the first force line measurement data meets the planning requirements, the axis passing through the target positioning pin track is established as the spatial reference axis; the guide plate is removed, and the positioning hole of the osteotomy plate is fitted into the positioning entity set along the spatial reference axis, so that the osteotomy plate reproduces the spatial posture of the guide plate; S5. Secondary force line data verification: Connect the matching connector to the osteotomy plate, and connect the force line verification instrument to the second force line verification interface on the matching connector to obtain the second force line measurement data; S6. Osteotomy posture confirmation: Compare the second force line measurement data with the planned threshold. If the comparison is consistent, confirm that the osteotomy groove on the osteotomy plate is in the final spatial posture in which osteotomy can be performed, and output a confirmation signal to guide the subsequent osteotomy process.

[0016] In some embodiments, in step S2, the number of the plurality of positioning pin tracks is four; the height difference between any two adjacent groups of positioning pin tracks is 2 mm, so that the selected target positioning pin track can provide an osteotomy adjustment option of at least 6 mm based on the standard osteotomy amount.

[0017] In some embodiments, after step S4 and before step S5, an auxiliary fixing step is also included: using capped pins to lock the position of the osteotomy plate, thereby improving the spatial orientation stability of the osteotomy plate.

[0018] Compared with the prior art, the present invention provides a tibial osteotomy guide plate, osteotomy system and spatial position determination method, which directly integrates the osteotomy amount adjustment variable into the form of different height pin channels on a disposable guide plate, avoiding the cumbersome and potential error of multi-hole alignment selection on metal instruments during operation, making the adjustment more intuitive, precise and efficient.

[0019] Meanwhile, the first and second force line verification interfaces can be used to achieve dual verification. Checkpoints are set at two key nodes, namely the initial positioning stage and the final osteotomy stage, to form a closed-loop quality control. This helps to detect and correct deviations as early as possible, maximize the final accuracy of force line restoration, and reduce surgical risks.

[0020] In addition, only the guide plate needs to be customized and manufactured quickly, so the cost can be controlled; the osteotomy plate, which undertakes the main osteotomy function and requires high strength and wear resistance, can be a standardized and reusable instrument. This realizes the combination mode of "personalized disposable parts + standardized reusable instruments", which can significantly reduce the consumable cost of a single operation while ensuring the performance of the instruments. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the overall structure of the tibial osteotomy guide plate in one embodiment of the present invention; Figure 2 This is a front view of the guide plate conforming to the proximal tibia in one embodiment of the present invention; Figure 3 This is a side view of the guide plate conforming to the proximal tibia in one embodiment of the present invention; Figure 4 This is a top view of the guide plate conforming to the proximal tibia in one embodiment of the present invention; Figure 5 This is a schematic diagram of a guide plate connected to a force line verification device in one embodiment of the present invention; Figure 6 This is a schematic diagram of the overall structure of the osteotomy system in one embodiment of the present invention; Figure 7 This is a schematic diagram of the positioning pin structure in one embodiment of the present invention; Figure 8 This is a schematic diagram of the osteotomy plate in one embodiment of the present invention; Figure 9 This is a schematic diagram of the structure of the osteotomy plate and the matching connector in one embodiment of the present invention; Figure 10 This is a schematic diagram of the structure of the matching connector in one embodiment of the present invention; Figure 11 This is a front view of the osteotomy plate adhering to the proximal end of the tibia in one embodiment of the present invention; Figure 12 This is a top view of the osteotomy plate adhering to the proximal end of the tibia in one embodiment of the present invention; Figure 13 This is a flowchart illustrating a method for determining the spatial position of an osteotomy system according to one embodiment of the present invention; Figure 14 This is a flowchart illustrating a clinical application scenario of the osteotomy system and its spatial position determination method according to one embodiment of the present invention.

[0022] Explanation of reference numerals in the attached drawings: 100, Tibia; 110, Tibial plateau; 10, Guide plate; 11, Guide plate body; 12, Bone contact surface; 121, First bone contact surface; 122, Second bone contact surface; 13, Positioning pin track; 131, First pin track; 132, Second pin track; 133, Third pin track; 134, Fourth pin track; 14, Extension; 15, Protrusion; 151, First force line verification interface; 16, Guide groove; 161, Osteotomy reference plane; 20, Force line verification instrument; 30, Osteotomy plate; 31, Osteotomy groove; 32, Positioning hole; 33, Connecting part; 331, Connecting hole; 34, Auxiliary positioning hole; 40, Matching connector; 41, Fitting part; 42, Positioning pin; 43, Functional part; 431, Second force line verification interface; 50, Positioning pin; 51, Quick-release interface; 60, Fitting arc surface; 70, Capped pin. Detailed Implementation

[0023] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0024] To address the aforementioned technical problems, this invention provides a tibial osteotomy guide plate, an osteotomy system, and a method for determining spatial position. This avoids the tediousness and potential errors associated with multi-hole alignment selection during surgery, making adjustments more intuitive, precise, and efficient. It also maximizes the final accuracy of force line restoration, reduces surgical risks, and significantly lowers the cost of consumables per surgery.

[0025] Please see Figure 1-2 This invention provides a tibial osteotomy guide plate, which includes a guide plate body 11 and a bone contact surface 12 on the guide plate body 11. The shape of the bone contact surface 12 is adapted to the anatomical shape of the proximal end of the patient's tibia 100. At the same time, the guide plate body 11 is also provided with multiple sets of positioning pin channels 13.

[0026] In practical applications, the guide plate body 11 can be attached to the proximal end of the tibia 100 through the bone contact surface 12, and any set of positioning pin channels 13 can be used with the positioning pins 50 to fix the guide plate body 11 to the tibia 100.

[0027] In this embodiment, the guide plate body 11 can be 3D printed using medical-grade polymer materials, such as medical-grade PEEK, nylon, or other polymer materials, but no specific limitation is made. Thus, the guide plate body 11 possesses good biocompatibility and structural strength, making it suitable for sterile surgical environments.

[0028] At this point, the aforementioned bone contact surface 12 can be reverse-engineered based on the three-dimensional model of the proximal tibia 100 reconstructed from the patient's preoperative CT / MRI images, so that it negatively matches the anatomical morphology of a specific region of the patient's bone.

[0029] In one embodiment, please refer to Figure 3 On the guide plate body 11, the bone contact surface 12 may include a first bone contact surface 121 and a second bone contact surface 122. The first bone contact surface 121 is formed on one side of the guide plate body 11, and its shape can be adapted to the medial surface of the medial condyle of the tibia 100. That is, the first bone contact surface 121 can perfectly fit the medial surface of the medial condyle of the tibia 100 to prevent the guide plate body 11 from shifting or rotating in the proximal end of the tibia 100.

[0030] Based on this, an extension 14 is connected to the top of the guide plate body 11. The extension 14 extends toward the location of the tibial plateau 110, and the aforementioned second bone contact surface 122 is formed on the bottom surface of the extension 14 away from the guide plate body 11. At this time, when the first bone contact surface 121 is in contact with the medial surface of the medial condyle of the tibia 100, the second bone contact surface 122 can be in contact with the surface of the tibial plateau 110 to prevent the guide plate 10 from sliding back and forth as a whole.

[0031] Understandably, by reverse-engineering the three-dimensional model of the proximal tibia 100 reconstructed from the patient's preoperative CT / MRI images, a negative curved surface (i.e., the aforementioned bone contact surface 12) that is completely complementary to the anatomical morphology of the anterior edge and medial and lateral condyles of the patient's tibial plateau 110 can be formed. This achieves full fit between the guide plate 10 and the proximal tibia 100 of the patient, and the guide plate 10 can only be placed in one correct posture, thus eliminating the possibility of misalignment from a physical structure perspective.

[0032] In one embodiment, please refer to Figure 1 The front side of the guide plate body 11 (i.e. the side opposite to the first bone contact surface 121) is formed with a protrusion 15, and the guide plate body 11 is also formed with a guide groove 16 that runs through the guide plate body 11 from front to back. The guide groove 16 can be used to define the osteotomy reference plane 161 of the guide plate 10.

[0033] Based on this, the aforementioned positioning pin channels 13 can be configured into four groups. Taking any one group of positioning pin channels 13 as an example, each group of positioning pin channels 13 includes two positioning pin channels 13 of the same height. Both positioning pin channels 13 penetrate the guide plate body 11 from front to back, and these two positioning pin channels 13 can be respectively located on both sides of the protrusion 15. In this way, the four groups of positioning pin channels 13 are parallel to each other and can be distributed at different height positions on the guide plate body 11. That is, the vertical distance of the axis of each group of positioning pin channels 13 from the osteotomy reference plane 161 of the guide plate body 11 is different, so as to provide multiple osteotomy amount adjustment options.

[0034] It should be noted that the height position of each of the four sets of positioning pin tracks 13 on the guide plate body 11 can be flexibly set as needed.

[0035] For example, in some embodiments, the height difference between any two adjacent sets of positioning pin tracks 13 is the same preset value, which can be set to 2mm. In this case, the four sets of positioning pin tracks 13 can be respectively referred to as the first track 131, the second track 132, the third track 133, and the fourth track 134. The first track 131, the second track 132, the third track 133, and the fourth track 134 can correspond to any four of the five osteotomy adjustment options: standard osteotomy amount, standard osteotomy amount plus 2mm, standard osteotomy amount minus 2mm, standard osteotomy amount minus 4mm, and standard osteotomy amount plus 4mm.

[0036] For example, such as Figure 1 As shown, taking the standard osteotomy amount corresponding to the first pin track 131 as a reference, the second pin track 132 can correspond to the standard osteotomy amount plus 2mm, the third pin track 133 can correspond to the standard osteotomy amount minus 2mm, and the fourth pin track 134 can correspond to the standard osteotomy amount plus 4mm. At this time, the four sets of positioning pin tracks 13 can cover a 6mm osteotomy amount adjustment range.

[0037] Of course, in some other embodiments, based on the above-mentioned rule form, the four sets of positioning pin tracks 13 can provide a maximum osteotomy amount adjustment range of 8mm. For example, with the first pin track 131 corresponding to the standard osteotomy amount as the benchmark, the second pin track 132 can correspond to the standard osteotomy amount plus 4mm, the third pin track 133 can correspond to the standard osteotomy amount minus 2mm, and the fourth pin track 134 can correspond to the standard osteotomy amount minus 4mm.

[0038] Understandably, according to the preoperative plan, the specific setting of the above four sets of positioning pin channels 13 can be designed specifically before the preparation of the guide plate 10. Based on experience, the maximum osteotomy volume adjustment range of 8mm can cover most situations in total knee arthroplasty and can comprehensively meet the clinical fine-tuning needs.

[0039] In one embodiment, please refer to Figure 1 The guide plate body 11 can also be provided with a standardized first force line verification interface 151, which can be connected to the force line verification device 20 to realize the initial force line verification.

[0040] Specifically, such as Figure 4-5As shown, the first force line verification interface 151 can penetrate the protrusion 15 vertically. It can adopt a standardized interface structure, and its geometry can be designed as a hexagon or a keyway circle to ensure that the force line verification instrument 20 does not shake or deflect after being connected, and that the interface axis maintains a fixed geometric relationship with the osteotomy reference plane 161, thereby ensuring that the force line parameters of the current osteotomy plane can be accurately reflected after the instrument is connected, and quantitative verification can be achieved.

[0041] It should be noted that, in this embodiment, the guide plate 10 can be configured as a guide plate 10 for the left leg or a guide plate 10 for the right leg, depending on the applicable scenario. The guide plate 10 for the left leg and the guide plate 10 for the right leg can be designed and formed separately according to the anatomical morphology of the proximal end of the left and right tibias 100 of the patient, respectively, which will not be elaborated here.

[0042] Please see Figure 6 The present invention also provides an osteotomy system, which includes the guide plate 10 in any of the above embodiments, and also includes an osteotomy plate 30, a matching connector 40 and a positioning pin 50, and can form a complete closed-loop system.

[0043] For details, please refer to Figure 7 The positioning pin 50 can be made of medical-grade stainless steel to ensure sufficient rigidity. Simultaneously, the diameter of the positioning pin 50 should be compatible with the diameter of the positioning pin channels 13 on the guide plate body 11, allowing the positioning pin 50 to pass through any of the positioning pin channels 13 for implantation into the bone, and ensuring that the positioning pin 50 remains fixed in its position within the corresponding positioning pin channel 13 after implantation. Furthermore, to facilitate quick implantation and removal of the positioning pin 50, a quick-release interface 51 can be provided at the end of the positioning pin 50 (i.e., the end furthest from the tibia 100).

[0044] The osteotomy plate 30 mentioned above can be made of metal, such as medical titanium alloy or stainless steel, and can be set as a standardized reusable instrument to reduce the cost of surgical consumables.

[0045] Based on this, please refer to Figure 8 The osteotomy plate 30 is provided with an osteotomy groove 31 and at least one positioning hole 32. The osteotomy groove 31 can be used to guide the saw blade to complete the osteotomy operation, while the positioning hole 32 is used to cooperate with the positioning pin 50 to reproduce the spatial position of the guide plate 10 during the operation.

[0046] It should be noted that in actual operation, once the initial force line verification (achieved through the first force line verification interface 151) is passed, the guide plate 10 fixed on the tibia 100 can be removed, while the positioning pin 50 remains implanted in the bone. With the help of the positioning hole 32 on the osteotomy plate 30, the osteotomy plate 30 can be positioned on the same side of the bone (i.e., the position where the guide plate 10 was before removal).

[0047] At this time, one side of the osteotomy plate 30 can abut against the bone, while the side away from the tibia 100 can form the operating side for the operator. For ease of description, the two sides of the osteotomy plate 30 that are away from and close to the tibia 100 can be defined as the front and back sides of the osteotomy plate 30, respectively.

[0048] Based on this, the osteotomy groove 31 can penetrate the osteotomy plate 30 from front to back, and its position on the osteotomy plate 30 can correspond to the position of the osteotomy reference plane 161 on the guide plate body 11 (i.e., the position of the guide groove 16). At the same time, the groove size of the osteotomy groove 31 can be adapted to a standard osteotomy saw blade (not shown in the figure).

[0049] At the same time, the aforementioned positioning hole 32 also penetrates the osteotomy plate 30 from front to back, and its position on the osteotomy plate 30 corresponds to the position of the positioning pin track 13 on the guide plate body 11.

[0050] Specifically, the number of positioning holes 32 can be determined according to the number of positioning pin tracks 13 on the guide plate body 11. For example, when four sets of positioning pin tracks 13 are set on the guide plate body 11, four sets of positioning holes 32 can be set on the osteotomy plate 30. Each positioning hole 32 can correspond to one positioning pin track 13 on the guide plate body 11, so that each positioning hole 32 can be coaxially aligned with the corresponding positioning pin track 13 on the guide plate body 11, and the size can be kept consistent.

[0051] Thus, once the target positioning pin path is determined on the guide plate 10, the corresponding positioning hole 32 can be determined based on the target positioning pin path. After the guide plate 10 is removed, the osteotomy plate 30 can be fitted with the positioning pin 50 of the implanted bone through the determined positioning hole 32. The positioning pin 50, in conjunction with the determined positioning hole 32, can reproduce the spatial position and orientation of the guide plate 10 during the operation. In this process, the positioning pin 50 of the implanted bone can constitute the positioning reference of the osteotomy plate 30.

[0052] In one embodiment, please refer to Figure 8 The osteotomy plate 30 is provided with a connecting part 33. The connecting part 33 can be provided on the left and right sides of the osteotomy plate 30 (determined according to the front and back direction mentioned above), and each connecting part 33 is provided with a connecting hole 331. Both connecting holes 331 penetrate the osteotomy plate 30 from front to back.

[0053] Correspondingly, such as Figure 9-10As shown, the aforementioned matching connector 40 is provided with two mating parts 41. The two mating parts 41 can form a U-shaped structure on the matching connector 40, and the two mating parts 41 can respectively fit into the two connecting parts 33. On this basis, a positioning pin 42 can be fixed on the side of each mating part 41 near the corresponding connecting part 33, so that the mating part 41 can be inserted and mated with the connecting hole 331 on the corresponding connecting part 33 through the positioning pin 42. By controlling the relative size of the positioning pin 42 and the corresponding connecting hole 331 (for example, the two can be in an interference fit), the mating part 41 and the corresponding connecting part 33 can be kept stably connected.

[0054] Meanwhile, in order to further improve the stability of the connection between the matching connector 40 and the osteotomy plate 30, the mating surface between the connecting part 33 and the mating part 41 can be set as a mating arc surface 60. The mating arc surface 60 can further limit the matching connector 40, thereby improving stability.

[0055] In one embodiment, please refer to Figure 10 The matching connector 40 is provided with a functional part 43 on the side away from the mating part 41. The functional part 43 is provided with a standardized second force line verification interface 431. The second force line verification interface 431 can be connected to the force line verification device 20 to realize secondary force line verification.

[0056] Specifically, the second force line verification interface 431 can run vertically through the functional part 43. It can adopt a standardized interface structure, and its geometry and spatial position can be completely consistent with the first force line verification interface 151 mentioned above. This allows the first force line verification interface 151 and the second force line verification interface 431 to be adapted to the same force line verification device 20, so as to ensure that the spatial reference of the two measurement data is consistent.

[0057] Of course, in some other embodiments, multiple standardized second force line verification interfaces 431 can be provided on the functional part 43 at the same time. Each second force line verification interface 431 can adopt a different geometry, so that the standardized osteotomy plate 30 can be adapted to different guide plates 10 or force line verification instruments 20.

[0058] In one embodiment, please refer to Figure 8 The osteotomy plate 30 is also provided with an auxiliary positioning hole 34, and the osteotomy system also includes a capped screw 70 for engaging with the auxiliary positioning hole 34. Specifically, the auxiliary positioning hole 34 extends through the osteotomy plate 30 from front to back, and the capped screw 70 can pass through the osteotomy plate 30 through the auxiliary positioning hole 34 and be implanted into the bone.

[0059] Based on this, such as Figure 11-12As shown, by controlling the relative angle between the auxiliary positioning hole 34 and the positioning pin track 13, the axial direction of the capped pin 70 can be set at an angle to the axial direction of the positioning pin 50 after implantation into the bone. The angle between the two can be flexibly set as needed, for example, the angle can be set to 15-60 degrees, and there is no specific limitation on this.

[0060] Understandably, after the capped screw 70 is implanted into the bone, because the capped screw 70 and the positioning pin 50 are set at an angle, the capped screw 70, the osteotomy plate 30, and the positioning pin 50 can form a triangular fixation structure, thereby improving the stability of the osteotomy plate 30. At the same time, the head of the capped screw 70 can press against the side of the osteotomy plate 30 away from the bone, thus playing a role in assisting in fixing the osteotomy plate 30 and preventing micromovement of the osteotomy plate 30.

[0061] Please see Figure 13 This invention also provides a method for determining the spatial position of an osteotomy system, applicable to the aforementioned osteotomy system, comprising the following steps: S1. Guide plate preparation: Based on the patient's 100mm proximal tibial imaging data, a corresponding guide plate 10 was designed and prepared.

[0062] S2. Guide plate matching and benchmark preset: The bone contact surface 12 of the guide plate 10 is negatively matched with the proximal anatomical shape of the target tibia 100; according to the preoperative planned osteotomy volume, a target positioning pin channel is selected from multiple groups of positioning pin channels 13, and the spatial position of the target positioning pin channel corresponds to the planned ideal osteotomy plane position.

[0063] S3. Initial force line data acquisition: Connect the force line verification device 20 to the first force line verification interface 151 provided on the guide plate 10 to acquire the first force line measurement data and verify whether the preset osteotomy reference plane 161 of the guide plate 10 in the current matching state meets the lower limb force line planning requirements.

[0064] S4. Spatial reference transfer: If the first force line measurement data meets the planning requirements, the axis passing through the target positioning pin track is established as the spatial reference axis; the guide plate 10 is removed, and the positioning hole 32 of the osteotomy plate 30 is fitted into the positioning entity set along the spatial reference axis, so that the osteotomy plate 30 reproduces the spatial posture of the guide plate 10.

[0065] S5. Secondary force line data verification: Connect the matching connector 40 to the osteotomy plate 30, and connect the force line verification instrument 20 to the second force line verification interface 431 on the matching connector 40 to obtain the second force line measurement data.

[0066] S6. Osteotomy posture confirmation: Compare the second force line measurement data with the planned threshold. If the comparison is consistent, confirm that the osteotomy groove 31 on the osteotomy plate 30 is in the final spatial posture in which osteotomy can be performed, and output a confirmation signal to guide the subsequent osteotomy process.

[0067] In one embodiment, during step S1, high-resolution CT or MRI images of the patient's knee joint can be acquired to reconstruct a three-dimensional digital model of the proximal tibia 100. Then, in conjunction with preoperative planning, the osteotomy plane, osteotomy amount and force line target can be determined. Based on the planning data, the structure of the guide plate 10 and the position of the pin channel can be designed, and the solid guide plate 10 can be fabricated by 3D printing. The entire operation is performed outside the body.

[0068] It should be noted that during the preparation of the guide plate 10, multiple sets of positioning pin tracks 13 can be preset on the guide plate 10. The vertical distance between the axis of each set of positioning pin tracks 13 and the osteotomy reference plane 161 on the guide plate 10 is different, so as to correspond to different tibial osteotomy amounts and provide doctors with multiple osteotomy amount adjustment options.

[0069] In one embodiment, during step S2, the number of positioning pin channels 13 can be four groups; the height difference between any two adjacent groups of positioning pin channels 13 can be set to 2 mm, so that the selected target positioning pin channel can provide an osteotomy adjustment option of at least 6 mm based on the standard osteotomy amount. As for how to achieve the required osteotomy adjustment, please refer to the description of the specific setting of the positioning pin channels 13 on the guide plate body 11 above, which will not be repeated here.

[0070] In one embodiment, in step S4, the positioning entity used to position the osteotomy plate 30 can be the aforementioned positioning pin 50. In actual operation, after the guide plate 10 is removed from the bone, the positioning pin 50 is left on the bone. By using the cooperation between the positioning pin 50 and the positioning hole 32, the position of the osteotomy plate 30 can be positioned so that the osteotomy plate 30 can reproduce the spatial orientation of the guide plate 10.

[0071] Meanwhile, after step S4 and before step S5, the spatial position determination method also includes an auxiliary fixing step: using a capped nail 70 to lock the position of the osteotomy plate 30, thereby improving the spatial posture stability of the osteotomy plate 30.

[0072] It should be noted that in this embodiment, the first force line verification aims to find the target positioning pin path that meets the force line planning requirements. Therefore, in the actual first force line verification process, situations that do not meet the planning requirements can be left unrecorded. Instead, the situation that meets the force line planning requirements will be used as the standard to further determine the target positioning pin path.

[0073] Furthermore, step S6 above aims to confirm that the osteotomy plate 30 is in a suitable spatial position for subsequent operations. Once confirmed, the procedure is complete. Subsequent osteotomy operations are performed independently by the physician based on the confirmed position and are not covered by this method.

[0074] It should be noted that the embodiments of the present invention actually provide a spatial position determination logic for an osteotomy system. This spatial position determination logic can be used by doctors in total knee replacement surgery. However, the spatial position determination method described in the embodiments of the present invention is limited to spatial positioning for non-therapeutic purposes, and does not include surgical steps that directly act on the human body for treatment, nor does it include the diagnosis and treatment process of diseases.

[0075] Based on this, please refer to Figure 14 To facilitate understanding of how the spatial location determination method provided in this embodiment of the invention is specifically applied in a clinical environment, this embodiment of the invention also provides the following clinical application scenario examples, which may include the following steps: First, the guide plate 10 is designed and prepared based on the patient's proximal tibial imaging data. The guide plate 10 has multiple sets of positioning pin channels 13. The vertical distance between the axis of each set of positioning pin channels 13 and the osteotomy reference plane 161 on the guide plate 10 is different, so as to correspond to different tibial osteotomy amounts.

[0076] Then, the guide plate 10 is attached to the proximal end of the patient's tibia 100. According to the preoperative planning results, one set of target positioning pin channels is selected, and the positioning pin 50 is inserted into the tibia 100 through the target positioning pin channel to fix the guide plate 10. The force line verification device 20 is connected to the first force line verification interface 151 provided on the guide plate 10 to perform the initial lower limb force line verification.

[0077] If the initial force line verification is successful, the force line verification device 20 and guide plate 10 can be removed, leaving the positioning pin 50 within the tibia 100; if it fails, the bone contact surface 12 can be cleaned, the position of the guide plate 10 adjusted, or the positioning pin track 13 replaced, and the verification can be repeated until it is successful.

[0078] Subsequently, the positioning pin 50 retained in the tibia 100 can be inserted into the osteotomy plate 30 through the positioning hole 32 on it, and the matching connector 40 can be installed on the osteotomy plate 30; the force line verification device 20 can be connected to the second force line verification interface 431 on the matching connector 40 for secondary force line verification.

[0079] During the secondary force line verification process, the force line data read from the secondary force line verification can be compared with the data from the initial verification. If the data are consistent, it proves that the spatial attitude conversion from guide plate 10 to osteotomy plate 30 is successful. If there is a deviation, osteotomy plate 30 can be removed for cleaning, reinstalled and verified until the data from the secondary force line verification is qualified.

[0080] After the second review is passed, capped screws 70 can be selectively driven into the osteotomy plate 30 to reinforce the osteotomy plate 30. After confirming that the osteotomy groove 31 is in the final spatial position where the osteotomy operation can be performed, the tibia osteotomy can be performed along the osteotomy groove 31 on the osteotomy plate 30.

[0081] The specific embodiments of the present invention described above do not constitute a limitation on the scope of protection of the present invention. Any other corresponding changes and modifications made in accordance with the technical concept of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A tibial osteotomy guide plate, characterized in that, include: The guide plate body has a bone contact surface, the shape of which is adapted to the anatomical morphology of the proximal tibia of the patient. Multiple sets of positioning pin tracks are disposed on the guide plate body and penetrate the guide plate body, and the vertical distance from the axis of each set of positioning pin tracks to the osteotomy reference plane of the guide plate body is different; and The first force line verification interface is located on the guide plate body and is configured to allow the force line verification device to be connected for lower limb force line verification.

2. The tibial osteotomy guide plate according to claim 1, characterized in that, The number of positioning pin tracks is four sets; the four sets of positioning pin tracks are parallel to each other, and the height difference between any two adjacent sets of positioning pin tracks is a preset value, so that the osteotomy amount covered by the four sets of positioning pin tracks is at least 6mm.

3. The tibial osteotomy guide plate according to claim 2, characterized in that, The preset value is 2mm; the four sets of positioning pin tracks correspond to any four of the five osteotomy adjustment options: standard osteotomy amount, standard osteotomy amount plus 2mm, standard osteotomy amount minus 2mm, standard osteotomy amount minus 4mm, and standard osteotomy amount plus 4mm.

4. The tibial osteotomy guide plate according to claim 1, characterized in that, The tibial osteotomy guide plate is configured as a guide plate for the left leg or a guide plate for the right leg, depending on the applicable scenario. The guide plate for the left leg and the guide plate for the right leg are designed and molded separately according to the anatomical morphology of the proximal tibia on the left and right sides of the patient, respectively. The guide plate body is made of medical-grade polymer material through 3D printing.

5. An osteotomy system, characterized in that, include: Tibial osteotomy guide plate as described in any one of claims 1-4; An osteotomy plate having an osteotomy groove and at least one positioning hole, and the osteotomy plate being configured as a standardized reusable instrument; A matching connector is configured to connect to the osteotomy plate and is also provided with a second force line verification interface. as well as The positioning pin can be inserted into the bone through any set of positioning pin channels on the tibial osteotomy guide plate and is configured as the positioning reference of the osteotomy plate. The positioning hole is configured to cooperate with the positioning pin of the implanted bone to reproduce the spatial position of the tibial osteotomy guide plate during the operation.

6. The osteotomy system according to claim 5, characterized in that, The position of the positioning hole is configured to be coaxially aligned with the position of the selected target positioning pin path on the tibial osteotomy guide in the design state; the axial position of the second force line verification interface is consistent with the axial position of the first force line verification interface in the spatial mapping relationship.

7. The osteotomy system according to claim 5, characterized in that, It also includes capped pins configured to pass through the osteotomy plate and be implanted into the bone; after implantation into the bone, the axial direction of the capped pin is set at an angle to the axial direction of the positioning pin, and the capped pin head abuts against the osteotomy plate to assist in fixing the osteotomy plate.

8. A method for determining the spatial position of an osteotomy system, characterized in that, The osteotomy system applied to any one of claims 5-7 comprises the following steps: S1. Guide plate preparation: Design and prepare the corresponding tibial osteotomy guide plate based on the patient's proximal tibial imaging data; S2. Guide plate matching and benchmark preset: The bone contact surface of the guide plate is negatively matched with the anatomical shape of the proximal tibia; according to the preoperative planned osteotomy volume, a target positioning pin channel is selected from multiple groups of positioning pin channels, and the spatial position of the target positioning pin channel corresponds to the planned ideal osteotomy plane position. S3. Initial force line data acquisition: Connect the force line verification device to the first force line verification interface set on the guide plate, acquire the first force line measurement data, and verify whether the preset osteotomy reference plane of the guide plate in the current matching state meets the lower limb force line planning requirements. S4. Spatial reference transfer: If the first force line measurement data meets the planning requirements, the axis passing through the target positioning pin track is established as the spatial reference axis; the guide plate is removed, and the positioning hole of the osteotomy plate is fitted into the positioning entity set along the spatial reference axis, so that the osteotomy plate reproduces the spatial posture of the guide plate; S5. Secondary force line data verification: Connect the matching connector to the osteotomy plate, and connect the force line verification instrument to the second force line verification interface on the matching connector to obtain the second force line measurement data; S6. Osteotomy posture confirmation: Compare the second force line measurement data with the planned threshold. If the comparison is consistent, confirm that the osteotomy groove on the osteotomy plate is in the final spatial posture in which osteotomy can be performed, and output a confirmation signal to guide the subsequent osteotomy process.

9. The spatial location determination method according to claim 8, characterized in that, In step S2, the number of the multiple sets of positioning pin tracks is four; the height difference between any two adjacent sets of positioning pin tracks is 2mm, so that the selected target positioning pin track can provide an osteotomy adjustment option of at least 6mm based on the standard osteotomy amount.

10. The spatial location determination method according to claim 8, characterized in that, After step S4 and before step S5, an auxiliary fixing step is also included: The osteotomy plate is positioned by using capped pins to improve its spatial orientation stability.

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