Tibia osteotomy guide plate

Abstract

The utility model belongs to the field of medical instruments, and provides a tibia osteotomy guide plate which comprises a tibia osteotomy guide part, a tibia first attaching part and a tibia second attaching part, and the tibia osteotomy guide part is provided with a tibia osteotomy groove; the tibia first attaching part is connected with the tibia osteotomy guide part, and the tibia first attaching part is provided with a tibia first attaching face used for being attached to a tibia articular face; the second tibia attaching part is connected with the tibia osteotomy guiding part, the second tibia attaching part is provided with a second tibia attaching face used for being attached to the side face of the near end of the tibia, and the second tibia attaching part is provided with a tibia positioning hole; wherein a tibia side anti-skid structure is formed on the tibia first binding surface and / or the tibia second binding surface. The tibia osteotomy guide plate can be stably and accurately attached to the proximal end of the tibia.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medical devices, and more particularly relates to a tibial bone osteotomy guide plate. BACKGROUND

[0002] Total knee arthroplasty (TKA) is a surgical procedure in which the knee joint of a patient suffering from severe degenerative joint disease or inflammatory joint disease is resected, and then an artificial joint prosthesis is used to replace the damaged joint structure. The main purpose of the surgery is to relieve knee pain, restore joint function, and improve the quality of life of the patient.

[0003] To improve the success rate of total knee arthroplasty, a corresponding guide plate is generally used to assist in surgical operation. The fitting surface of the existing guide plate is usually designed to fit the bone surface. If there is cartilage, unstripped periosteum or other soft tissue on the bone surface, it will affect the fitting stability of the guide plate, resulting in poor positioning accuracy. In addition, if there is cartilage on the bone surface of the fitting area, the cartilage is stripped when the guide plate is used in the operation. For the bone tissue that needs to be resected from the patient, the cartilage stripping only increases the operation time of the doctor, but for the bone tissue that does not need to be resected from the patient, stripping the surface cartilage not only increases the operation time of the doctor, but also causes harm to the patient. SUMMARY

[0004] The purpose of the embodiments of the present application is to provide a tibial bone osteotomy guide plate to solve the technical problem of difficulty in ensuring the positioning accuracy of the guide plate for total knee arthroplasty in the prior art.

[0005] To achieve the above-mentioned purpose, the first aspect of the present application provides a tibial bone osteotomy guide plate, comprising:

[0006] a tibial bone osteotomy guide portion, the tibial bone osteotomy guide portion being provided with a tibial bone osteotomy groove;

[0007] a tibial bone first fitting portion, the tibial bone first fitting portion being connected with the tibial bone osteotomy guide portion, the tibial bone first fitting portion having a tibial bone first fitting surface for fitting with a tibial bone articular surface; and

[0008] a tibial bone second fitting portion, the tibial bone second fitting portion being connected with the tibial bone osteotomy guide portion, the tibial bone second fitting portion having a tibial bone second fitting surface for fitting with a proximal side surface of the tibial bone, the tibial bone second fitting portion being provided with a tibial bone positioning hole;

[0009] wherein the tibial bone first fitting surface and / or the tibial bone second fitting surface is / are formed with a tibial bone side anti-skid structure.

[0010] Optionally, the tibial bone side anti-skid structure comprises a plurality of anti-skid protrusions.

[0011] Optionally, the tibial second fitting part is sequentially provided with a plurality of tibial positioning hole groups along the tibial force line direction, and the axes of the tibial positioning holes in different tibial positioning hole groups are parallel to each other.

[0012] Optionally, the tibial second fitting part is further provided with a tibial fixing hole, and the axis of the tibial fixing hole is obliquely arranged relative to the axis of the tibial positioning hole.

[0013] Optionally, the tibial first fitting part is formed with a weakened area near the tibial osteotomy guiding part.

[0014] Optionally, the weakened area is provided with a hollow hole.

[0015] Optionally, the tibial osteotomy guiding plate further comprises a force line rod mounting member, the force line rod mounting member is detachably connected with the tibial osteotomy guiding part, and the force line rod mounting member is provided with a channel for inserting a force line rod.

[0016] Optionally, either of the force line rod mounting member and the tibial osteotomy guiding part is provided with a socket for inserting the other.

[0017] Optionally, the tibial osteotomy guiding plate comprises two tibial first fitting parts, and the tibial first fitting surfaces of the two tibial first fitting parts are respectively used for fitting with the medial tibial articular surface and the lateral tibial articular surface.

[0018] Optionally, the tibial osteotomy guiding plate comprises two tibial first fitting parts, and the tibial first fitting surfaces of the two tibial first fitting parts are respectively used for fitting with the medial tibial articular surface and the lateral tibial articular surface.

[0019] The beneficial effects of the tibial osteotomy guide plate provided in this application are as follows: Compared with the prior art, when using the tibial osteotomy guide plate of this application, the first tibial contact surface of the first contact portion of the tibia is contacted with the tibial articular surface, and the second tibial contact surface of the second contact portion of the tibia is contacted with the proximal lateral side of the tibia. The tibial lateral positioning pin is inserted into the tibial positioning hole and fixedly connected to the proximal tibia, so that the tibial osteotomy guide plate is positioned on the proximal tibia. The osteotomy knife performs osteotomy on the proximal tibia by inserting the tibial osteotomy groove. When the first tibial contact surface is contacted with the tibial articular surface, the anti-slip structure of the tibial lateral side of the first tibial contact surface can increase the size of the first tibial contact surface. The friction between the tibial articular surface and the tibial articular surface is increased when the second tibial contact surface is in contact with the proximal tibial side. This friction is amplified by the anti-slip structure on the tibial side of the second tibial contact surface. This anti-slip structure ensures a tight fit between the tibial osteotomy guide plate and the proximal tibial bone surface, effectively preventing slippage after contact. This improves the stability and positioning accuracy of the tibial osteotomy guide plate, thus enhancing surgical safety and success rate. Furthermore, it eliminates the need for cartilage stripping, reducing surgical difficulty and time, and minimizing harm to the patient. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 The usage state of the tibial osteotomy guide plate provided in the embodiments of this application. Figure 1 ;

[0022] Figure 2 A three-dimensional structural schematic diagram of the tibial osteotomy guide plate provided in an embodiment of this application;

[0023] Figure 3 This is a schematic diagram of the front view of the tibial osteotomy guide plate provided in an embodiment of this application;

[0024] Figure 4 A top view of the tibial osteotomy guide plate provided in the embodiments of this application. Figure 1 ;

[0025] Figure 5 A top view of the tibial osteotomy guide plate provided in the embodiments of this application. Figure 2 ;

[0026] Figure 6 A top view of the tibial osteotomy guide plate provided in the embodiments of this application.Figure 3 ;

[0027] Figure 7 The use state of the tibial osteotomy guide plate provided by the embodiment of the present application Figure 2 ;

[0028] Figure 8 The use state of the tibial osteotomy guide plate provided by the embodiment of the present application Figure 3 ;

[0029] Figure 9 The three-dimensional structural schematic diagram of the force line rod mounting provided by the embodiment of the present application;

[0030] Figure 10 The three-dimensional structural schematic diagram of the proximal tibia provided by the embodiment of the present application;

[0031] Figure 11 The use state diagram of the femoral osteotomy guide plate provided by the embodiment of the present application;

[0032] Figure 12 The three-dimensional structural schematic diagram of the femoral osteotomy guide plate provided by the embodiment of the present application;

[0033] Figure 13 The front view structural schematic diagram of the femoral osteotomy guide plate provided by the embodiment of the present application;

[0034] Figure 14 The top view structural schematic diagram of the femoral osteotomy guide plate provided by the embodiment of the present application;

[0035] Figure 15 The three-dimensional structural schematic diagram of the distal femur provided by the embodiment of the present application.

[0036] In the drawings, various reference signs represent:

[0037] 100, tibial osteotomy guide plate;

[0038] 10, tibial osteotomy guide part; 11, tibial osteotomy groove; 12, limiting part; 13, tibial pressing part;

[0039] 20, tibial first fitting part; 21, tibial first fitting surface; 22, tibial side anti-skid structure; 23, weakened area; 24, hollow hole;

[0040] 30, tibial second fitting part; 31, tibial second fitting surface; 32, first tibial positioning hole group; 33, second tibial positioning hole group; 34, third tibial positioning hole group; 35, tibial positioning hole; 36, tibial fixing hole; 37, tibial side positioning nail; 38, tibial side fixing nail;

[0041] 40, force line rod mounting; 41, channel; 42, insertion hole;

[0042] 50, force line rod;

[0043] 200, proximal tibia; 201, tibial articular surface; 202, proximal tibial side surface; 203, tibial intercondylar eminence inner surface; 204, tibial intercondylar eminence outer surface;

[0044] 300, femoral osteotomy guide plate;

[0045] 60, femoral osteotomy guide; 61, femoral osteotomy slot; 62, femoral pressing part;

[0046] 70, first femoral fitting part; 71, first femoral fitting surface; 72, anti-skid structure;

[0047] 80, second femoral fitting part; 81, second femoral fitting surface; 82, first femoral positioning hole group; 83, second femoral positioning hole group; 84, third femoral positioning hole group; 85, femoral positioning hole; 86, femoral fixing hole; 87, femoral side positioning pin; 88, femoral side fixing pin;

[0048] 90, calibration rod;

[0049] 400, distal femur; 401, femoral articular surface; 402, femoral condyle anterior side surface; 403, femoral intercondylar eminence inner surface; 404, femoral intercondylar eminence outer surface. DETAILED DESCRIPTION

[0050] In order to make the technical problems to be solved, technical solutions and beneficial effects of the present application more clearly understood, the present application will be further described in detail below in conjunction with the drawings and embodiments. It should be understood that the specific embodiments described herein are only intended to explain the present application, and not to limit the present application.

[0051] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element.

[0052] It should be understood that the terms "length", "width", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0053] In addition, the terms "first", "second", etc. are used only for descriptive purposes and should not be construed as implying or suggesting relative importance or an ordered ranking such that one feature is inherently more important than another feature. Thus, features defined with "first", "second", etc. can explicitly or implicitly include one or more of the features. In the description of the present application, the meaning of "a plurality" is two or more, unless otherwise explicitly and specifically limited.

[0054] Please refer to Figures 1 to 10 The tibial osteotomy guide 100 provided by the embodiments of the present application will be described. The tibial osteotomy guide 100 is applied to total knee arthroplasty surgery and is used to guide the osteotomy of the proximal end of the tibia 200, wherein the proximal end of the tibia 200 refers to the end of the tibia close to the femur.

[0055] Please refer to Figure 1 and Figure 2 The tibial osteotomy guide 100 includes a tibial osteotomy guide portion 10, a tibial first fitting portion 20, and a tibial second fitting portion 30. The tibial osteotomy guide portion 10 is provided with a tibial osteotomy groove 11. The tibial first fitting portion 20 is connected to the tibial osteotomy guide portion 10, and the tibial first fitting portion 20 has a tibial first fitting surface 21 for fitting with the articular surface 201 of the tibia. The tibial second fitting portion 30 is connected to the tibial osteotomy guide portion 10, and the tibial second fitting portion 30 has a tibial second fitting surface 31 for fitting with the proximal end side surface 202 of the tibia. The tibial second fitting portion 30 is provided with a tibial positioning hole 35. The tibial first fitting surface 21 and / or the tibial second fitting surface 31 form a tibial side anti-slip structure 22.

[0056] The tibial osteotomy groove 11 penetrates the inner surface and the outer surface of the tibial osteotomy guide portion 10. The inner surface of the tibial osteotomy guide portion 10 refers to the surface of the tibial osteotomy guide portion 10 facing the proximal end of the tibia 200 when the tibial osteotomy guide 100 is fixed to the proximal end of the tibia 200. The outer surface of the tibial osteotomy guide portion 10 refers to the surface of the tibial osteotomy guide portion 10 away from the proximal end of the tibia 200 when the tibial osteotomy guide 100 is fixed to the proximal end of the tibia 200. When the tibial osteotomy guide 100 is fixed to the predetermined position of the proximal end of the tibia 200, the tibial osteotomy groove 11 is aligned with the osteotomy position of the proximal end of the tibia 200, and the osteotomy knife performs the osteotomy operation on the proximal end of the tibia 200 by inserting the tibial osteotomy groove 11. The osteotomy knife can be a swing saw.

[0057] Compared with the prior art, the tibial osteotomy guide plate 100 is used, the tibial first fitting surface 21 of the tibial first fitting part 20 is fitted with the tibial articular surface 201, the tibial second fitting surface 31 of the tibial second fitting part 30 is fitted with the tibial proximal side surface 202, the tibial side positioning pin 37 is inserted into the tibial positioning hole 35 and is fixedly connected with the tibial proximal end 200, positioning connection is realized, the tibial osteotomy guide plate 100 is positioned on the tibial proximal end 200, the osteotomy cutter is inserted into the tibial osteotomy groove 11 to perform osteotomy operation on the tibial proximal end 200, if there is cartilage in the area where the tibial articular surface 201 is fitted with the tibial first fitting surface 21, a spacing capable of compensating for the thickness of the cartilage is reserved between the tibial first fitting surface 21 and the tibial articular surface 201, and when the tibial first fitting surface 21 is fitted with the tibial articular surface 201, the tibial side anti-skid structure 22 of the tibial first fitting surface 21 can increase the friction between the tibial first fitting surface 21 and the tibial articular surface 201, when the tibial second fitting surface 31 is fitted with the tibial proximal side surface 202, the tibial side anti-skid structure 22 of the tibial second fitting surface 31 can increase the friction between the tibial second fitting surface 31 and the tibial articular surface 201, and if there is unstripped periosteum or other soft tissue in the area where the tibial proximal side surface 202 is fitted with the tibial first fitting surface 21, the tibial side anti-skid structure 22 of the tibial second fitting surface 31 can be embedded in the periosteum or other soft tissue of the tibial proximal side surface 202, further increasing the friction between the tibial second fitting surface 31 and the tibial proximal side surface 202. In this way, the arrangement of the tibial side anti-skid structure 22 can make the tibial osteotomy guide plate 100 closely fit the bone surface of the tibial proximal end 200, effectively avoiding slipping after fitting, and is conducive to improving the fitting stability and positioning accuracy of the tibial osteotomy guide plate 100, thereby being conducive to improving the safety and success rate of the operation, and without stripping the cartilage, which is conducive to reducing the difficulty of the operation and saving the operation time, and at the same time reducing the harm to the patient.

[0058] Further, the tibial second fitting surface 31 is used to fit with the medial surface of the tibial proximal end.

[0059] Optionally, the material of the tibial osteotomy guide plate 100 can be medical resin or medical metal, wherein the medical resin can be but is not limited to polyethylene, polyether ether ketone, polyacetic acid, etc., and the medical metal can be but is not limited to metal titanium, titanium alloy, stainless steel, etc. When the material of the tibial osteotomy guide plate 100 is medical resin, the tibial osteotomy guide plate 100 can be made by additive manufacturing processing technology, wherein the additive manufacturing processing technology is also called 3D printing technology.

[0060] In an embodiment of the present application, please refer to Figure 1 and Figure 2, the tibial first fitting surface 21 and the tibial second fitting surface 31 are substantially L-shaped, so that the tibial first fitting surface 21 is fitted with the tibial articular surface 201 and the tibial second fitting surface 31 is fitted with the tibial proximal surface 202, and the tibial osteotomy guide 100 is in contact with the tibial proximal surface 202 in two spatial directions close to vertical, thereby improving the stability of the tibial osteotomy guide 100.

[0061] In some embodiments of the present application, referring to Figure 2 , the tibial anti-skid structure 22 includes a plurality of anti-skid protrusions. The anti-skid protrusions on the tibial first fitting surface 21 are uniformly distributed in a dot shape, so that when the tibial first fitting surface 21 is fitted with the tibial articular surface 201, the anti-skid protrusions on the tibial first fitting surface 21 are in multi-point contact with the tibial articular surface 201, thereby increasing the friction between the tibial first fitting surface 21 and the tibial articular surface 201, and improving the stability of the tibial first fitting surface 21. The anti-skid protrusions on the tibial second fitting surface 31 are also uniformly distributed in a dot shape, so that when the tibial second fitting surface 31 is fitted with the tibial proximal surface 202, the anti-skid protrusions on the tibial second fitting surface 31 are in multi-point contact with the tibial proximal surface 202, and the anti-skid protrusions on the tibial second fitting surface 31 can be embedded in the periosteum or other soft tissues of the tibial proximal surface 202, the gaps between the anti-skid protrusions can accommodate the periosteum or other soft tissues, thereby increasing the friction between the tibial second fitting surface 31 and the tibial proximal surface 202, and improving the stability of the tibial second fitting surface 31.

[0062] Optionally, the anti-skid protrusions are formed with a pointed portion, for example, the anti-skid protrusions can be in a conical structure or a frustum structure, and the pointed portion facilitates the anti-skid protrusions to pass through the cartilage, the periosteum or other soft tissues.

[0063] In another embodiment of the present application, the tibial anti-skid structure 22 includes a plurality of anti-skid lines, and the anti-skid lines have the same effect as the anti-skid protrusions. Understandably, the anti-skid lines on the tibial first fitting surface 21 can increase the friction between the tibial first fitting surface 21 and the tibial articular surface 201, and the anti-skid lines on the tibial second fitting surface 31 can increase the friction between the tibial second fitting surface 31 and the tibial proximal surface 202. In other embodiments of the present application, the tibial anti-skid structure 22 can include both a plurality of anti-skid protrusions and a plurality of anti-skid lines.

[0064] In some embodiments of the present application, referring to Figure 3 , the tibial second fitting portion 30 is sequentially provided with a plurality of tibial positioning hole groups along the tibial force line direction, and the axes of the tibial positioning holes 35 in different tibial positioning hole groups are parallel to each other.

[0065] The technical scheme above, by distributing multiple tibial positioning hole groups along the tibial force line direction of the tibial second fitting part 30, enabling the tibial side positioning nail 37 to pass through the positioning holes of different tibial positioning hole groups, can increase or decrease the bone cutting thickness, so that the tibial bone cutting thickness can be adjusted in actual operation, more bone cutting methods can be met, and the practicability of the tibial bone cutting guide plate 100 is improved. The axes of the tibial positioning holes 35 between different tibial positioning hole groups are parallel to each other, so that the tibial positioning holes 35 of different tibial positioning hole groups can be inserted with the tibial side positioning nail 37 at the same position of the tibia, so that when the tibial bone cutting thickness is adjusted, the tibial side positioning nail 37 does not need to be pulled out, only the different tibial positioning hole groups on the bone cutting plate need to be adjusted to cooperate with the tibial side positioning nail 37, and the tibial bone cutting guide plate 100 does not need to be repositioned, so that the up-down position adjustment of the tibial bone cutting guide plate can be realized, the operation is simplified, the efficiency is improved, the number of tibial side positioning nails 37 is reduced, and the harm to the patient is reduced.

[0066] Optionally, the spacing between each tibial positioning hole group in the tibial force line direction is equal.

[0067] Optionally, each tibial positioning hole group includes one or more tibial positioning holes 35. When each tibial positioning hole group includes multiple tibial positioning holes 35, the multiple tibial positioning holes 35 of each tibial positioning hole group are located at the same horizontal height, and the multiple tibial positioning holes 35 of each tibial positioning hole group are parallel to each other. By providing multiple first tibial positioning holes 35 in each tibial positioning hole group, the positioning stability and positioning accuracy of the tibial bone cutting guide plate 100 are improved.

[0068] Further, when each tibial positioning hole group includes multiple tibial positioning holes 35, the horizontal spacing between the tibial positioning holes 35 of each tibial positioning hole group is equal.

[0069] In this embodiment, please refer to Figure 3The second tibia fitting part 30 is sequentially provided with three tibia positioning hole groups in the tibia force line direction, which are the second tibia positioning hole group 33, the first tibia positioning hole group 32 and the third tibia positioning hole group 34. The position height corresponding to the tibia positioning hole 35 of the first tibia positioning hole group 32 is the initial positioning height. The second tibia positioning hole group 33 is located above the first tibia positioning hole group 32 in the tibia force line direction. When the tibia side positioning pin 37 is inserted into the tibia positioning hole 35 of the second tibia positioning hole group 33 to position the tibia osteotomy guide plate 100, the osteotomy knife can increase the tibia osteotomy thickness when performing osteotomy on the proximal tibia 200 through the tibia osteotomy groove 11. The third tibia positioning hole group 34 is located below the first tibia positioning hole group 32 in the tibia force line direction. When the tibia side positioning pin 37 is inserted into the tibia positioning hole 35 of the third tibia positioning hole group 34 to position the tibia osteotomy guide plate 100, the osteotomy knife can reduce the tibia osteotomy thickness when performing osteotomy on the proximal tibia 200 through the tibia osteotomy groove 11.

[0070] Optionally, in the tibia force line direction, the interval between the first tibia positioning hole group 32 and the second tibia positioning hole group 33 is equal to the interval between the first tibia positioning hole group 32 and the third tibia positioning hole group 34. In the embodiment, the interval between the first tibia positioning hole group 32 and the second tibia positioning hole group 33 is greater than or equal to 2mm in the tibia force line direction, and the interval between the first tibia positioning hole group 32 and the third tibia positioning hole group 34 is greater than or equal to 2mm.

[0071] Optionally, the first tibia positioning hole group 32, the second tibia positioning hole group 33 and the third tibia positioning hole group 34 each include two tibia positioning holes 35, and the two tibia positioning holes 35 of the first tibia positioning hole group 32 are located at the same height, the two tibia positioning holes 35 of the second tibia positioning hole group 33 are located at the same height, and the two tibia positioning holes 35 of the third tibia positioning hole group 34 are located at the same height.

[0072] Further, the horizontal interval between the two tibia positioning holes 35 of the second tibia positioning hole group 33 is equal to the horizontal interval between the two tibia positioning holes 35 of the first tibia positioning hole group 32, and the horizontal interval between the two tibia positioning holes 35 of the third tibia positioning hole group 34 is equal to the horizontal interval between the two tibia positioning holes 35 of the first tibia positioning hole group 32.

[0073] In some embodiments of the present application, please refer to Figures 1 to 3 The second tibia fitting part 30 is further provided with a tibia fixing hole 36, and the axis of the tibia fixing hole 36 is obliquely arranged relative to the axis of the tibia positioning hole 35.

[0074] It can be understood that the axis of the tibial fixation hole 36 is not parallel to the axis of the tibial positioning hole 35, and the tibial fixation hole 36 is provided for the tibial side fixation nail 38 to be inserted, specifically, the tibial side fixation nail 38 is inserted into the tibial fixation hole 36 and is fixedly connected with the proximal tibia 200. By cooperating the tibial positioning hole 35 and the tibial fixation hole 36 which are not parallel, the tibial osteotomy guide plate 100 is fixed, which effectively prevents the tibial osteotomy guide plate 100 from moving along the axis direction of the tibial positioning hole 35, and is beneficial to improve the stability of the fixation of the tibial osteotomy guide plate 100.

[0075] Optionally, the number of tibial fixation holes 36 is two.

[0076] It should be noted that the tibial side positioning nail 37 inserted into the tibial positioning hole 35 will not interfere with the tibial side fixation nail 38 inserted into the tibial fixation hole 36, and will not affect the osteotomy operation by the osteotomy cutter through the tibial osteotomy groove 11.

[0077] In some embodiments of the present application, please refer to Figure 4 , the tibial first fitting part 20 is formed with a weakened area 23 near the position of the tibial osteotomy guide part 10. In the process of adjusting the osteotomy thickness of the proximal tibia 200, if the tibial first fitting part 20 is reversed with the tibial articular surface 201, which causes the tibial osteotomy guide plate 100 to be unable to move, a cutting tool can be used to cut the tibial first fitting part 20 from the weakened area 23, so that the tibial osteotomy guide plate 100 can move. The cutting tool can be a rongeur or a saw blade.

[0078] Optionally, the weakened area 23 is provided with a hollow hole 24, and the hollow hole 24 is arranged in the weakened area 23 to reduce the strength of the weakened area 23, so that the weakened area 23 is easy to be cut. Of course, other ways can also be used to weaken the structural strength of the weakened area 23, for example, the weakened area 23 can be designed as a groove structure, a V-shaped structure, an arc-shaped structure or an inclined structure, so that the thickness of the tibial first fitting part 20 corresponding to the weakened area 23 is thinner than the thickness of other regions of the tibial first fitting part 20, thereby reducing the structural strength of the weakened area 23, so that the weakened area 23 is easy to be cut.

[0079] In some embodiments of the present application, please refer to Figure 5 and Figure 6 The tibial osteotomy guide plate 100 further comprises a force line rod mounting piece 40, the force line rod mounting piece 40 is detachably connected with the tibial osteotomy guide part 10, and the force line rod mounting piece 40 is provided with a channel 41 for the force line rod 50 to be inserted.

[0080] The force line rod 50 is used to verify whether the tibial osteotomy guide plate 100 is positioned accurately. Specifically, please refer to Figure 7 and Figure 8In the process of installing the tibial osteotomy guide plate 100, when the tibial first fitting surface 21 of the tibial first fitting part 20 is fitted with the tibial articular surface 201 and the tibial second fitting surface 31 of the tibial second fitting part 30 is fitted with the tibial proximal surface 202, the force line rod 50 is inserted into the channel 41 of the force line rod mounting part 40, and whether the force line rod 50 is correctly directed to the tibial force line direction, i.e. whether the axis direction of the force line rod 50 is consistent with the tibial force line direction, is observed. If the force line rod 50 is correctly directed to the tibial force line direction, it indicates that the tibial osteotomy guide plate 100 is positioned accurately; if the force line rod 50 is not correctly directed to the tibial force line direction, it indicates that the tibial osteotomy guide plate 100 is not positioned accurately, and the fitting position of the tibial osteotomy guide plate 100 needs to be adjusted until the force line rod 50 is correctly directed to the tibial force line direction.

[0081] The above technical solution, in the process of installing the tibial osteotomy guide plate 100, verifies whether the tibial osteotomy guide plate 100 is positioned accurately by inserting the force line rod 50 into the channel 41 of the force line rod 50, effectively ensuring the positioning accuracy of the tibial osteotomy guide plate 100. And by detachably connecting the force line rod mounting part 40 and the tibial osteotomy guide part 10, after the verification is completed, the force line rod mounting part 40 can be detached from the tibial osteotomy guide part 10, effectively avoiding the interference of the force line rod mounting part 40 and the force line rod 50 to the installation operation, at the same time, it is beneficial to reduce the weight of the tibial osteotomy guide plate 100, facilitate the operation, and at the same time, it is beneficial to improve the positioning stability and accuracy of the tibial osteotomy guide plate 100.

[0082] In some embodiments of the present application, referring to Figure 6 and Figure 9 , either of the force line rod mounting part 40 and the tibial osteotomy guide part 10 is provided with a socket 42 for the other to be inserted, so that the force line rod mounting part 40 and the tibial osteotomy guide part 10 are inserted and connected, thereby realizing the detachable connection of the force line rod mounting part 40 and the tibial osteotomy guide part 10. By inserting and connecting the force line rod mounting part 40 and the tibial osteotomy guide part 10, the detachable connection of the force line rod mounting part 40 and the tibial osteotomy guide part 10 is realized, and the connection method is simple and convenient to operate.

[0083] Specifically in the present embodiment, the socket 42 is provided on the force line rod mounting part 40, and the outer side end of the tibial osteotomy guide part 10 is inserted into the socket 42 on the force line rod mounting part 40, so that the force line rod mounting part 40 and the tibial osteotomy guide part 10 are inserted and connected, and then the force line rod mounting part 40 is installed on the outer side of the tibial osteotomy guide part 10, which is convenient for doctors to operate and observe the force line rod 50, and there is no need to make great improvement on the tibial osteotomy guide part 10 for installing the force line rod mounting part 40, which is beneficial to reduce the production cost.

[0084] Optionally, referring to Figure 5 and Figure 6, a limiting portion 12 is arranged on the lateral end of the tibial osteotomy guide 10, and the limiting portion 12 is used to limit the depth of the lateral end of the tibial osteotomy guide 10 inserted into the insertion hole 42 of the force line rod mounting member 40. It can be understood that, during the process of the lateral end of the tibial osteotomy guide 10 inserted into the insertion hole 42 of the force line rod mounting member 40, when the force line rod mounting member 40 abuts against the limiting portion 12, it indicates that the force line rod mounting member 40 is installed in place.

[0085] In another embodiment of the present application, the insertion hole 42 is arranged on the tibial osteotomy guide 10, and the force line rod mounting member 40 is inserted into the insertion hole 42, so that the force line rod mounting member 40 is connected with the tibial osteotomy guide 10.

[0086] Of course, in other embodiments of the present application, other ways can also be used to achieve the detachable connection between the force line rod mounting member 40 and the tibial osteotomy guide 10, for example, a spring clip is arranged on the force line rod mounting member 40, and the lateral end of the tibial osteotomy guide 10 is clamped by the spring clip on the force line rod mounting member 40, so as to achieve the detachable connection between the force line rod mounting member 40 and the tibial osteotomy guide 10.

[0087] In some embodiments of the present application, please refer to Figure 1 and Figure 3 , the tibial osteotomy guide plate 100 further comprises a tibial pressing portion 13, and the tibial pressing portion 13 is connected with the tibial osteotomy guide 10. During the positioning of the tibial osteotomy guide plate 100, the doctor can press the tibial pressing portion 13 to make the tibial osteotomy guide plate 100 closely adhere to the proximal tibia 200, so as to facilitate the operation of the doctor.

[0088] In some embodiments of the present application, please refer to Figure 1 and Figure 2 , the tibial osteotomy guide plate 100 comprises two tibial first adhering portions 20, and the two tibial first adhering portions 20 are spaced apart along the length direction of the tibial osteotomy guide 10. The tibial first adhering surface 21 of one of the two tibial first adhering portions 20 is used to adhere to the medial tibial articular surface, and the tibial first adhering surface 21 of the other tibial first adhering portion 20 is used to adhere to the lateral tibial articular surface.

[0089] The above technical solution makes the tibial osteotomy guide plate 100 have a larger adhering area with the tibial articular surface 201 by the two tibial first adhering portions 20 adhering to the medial tibial articular surface and the lateral tibial articular surface respectively, and forms a stable adhering positioning by the cooperation of the two tibial first adhering portions 20 and the tibial second adhering portion 30, thereby effectively improving the positioning accuracy of the tibial osteotomy guide plate 100.

[0090] In this embodiment, please refer to Figure 10The tibial first abutting surface 21 of the two tibial first abutting portions 20 is used to abut with the medial intercondylar ridge surface 203 and the lateral intercondylar ridge surface 204 respectively.

[0091] The specific use and operation of the tibial osteotomy guide plate 100 provided by the embodiments of the present application are described by the following exemplary description:

[0092] Step 1, detachably connecting the force line rod mounting piece 40 with the tibial osteotomy guide portion 10.

[0093] Step 2, abutting the tibial first abutting surface 21 of the tibial first abutting portion 20 with the tibial articular surface 201, and abutting the tibial second abutting surface 31 of the tibial second abutting portion 30 with the tibial proximal surface 202.

[0094] Step 3, inserting the force line rod 50 into the channel 41 of the force line rod mounting piece 40, and observing whether the force line rod 50 is correctly directed to the tibial force line direction, if the force line rod 50 is not correctly directed to the tibial force line direction, returning to step 2 to adjust the abutting position of the tibial osteotomy guide plate 100, if the force line rod 50 is correctly directed to the tibial force line direction, then performing step 4.

[0095] Step 4, inserting the two tibial side positioning nails 37 into the two tibial positioning holes 35 of the first tibial positioning hole group 32 respectively, and fixedly connecting with the tibial proximal end 200, and inserting the tibial side fixing nail 38 into the tibial fixing hole 36, and fixedly connecting with the tibial proximal end 200, so as to fix the tibial osteotomy guide plate 100 on the tibial proximal end 200.

[0096] Step 5, detaching the force line rod mounting piece 40 from the tibial osteotomy guide portion 10.

[0097] Step 6, before osteotomy, the traditional instrument dart is used to pass through the osteotomy slot to evaluate the osteotomy thickness of the proximal tibia 200. If the osteotomy thickness needs to be reduced, for example, 2mm needs to be removed, the tibial fixation nail 38 inserted into the tibial fixation hole 36 is removed, the two tibial positioning nails 37 remain connected with the proximal tibia 200, the tibial osteotomy guide plate 100 is translated outward along the axis direction of the tibial positioning nail 37 to remove the tibial osteotomy guide plate 100 from the proximal tibia 200, and then the tibial osteotomy guide plate 100 is moved upward and outward of the proximal tibia 200. If the tibial osteotomy guide plate 100 cannot be moved due to the first tibial fitting part 20 being inverted with the tibial articular surface 201, the bone rongeur can be used to cut the first tibial fitting part 20 from the weakened area 23, so that the tibial osteotomy guide plate 100 can be moved, the tibial osteotomy guide plate 100 is moved upward as a whole, and the tibial positioning holes 35 of the third tibial positioning hole group 34 are respectively aligned with the two tibial positioning nails 37 remaining on the proximal tibia 200. The tibial osteotomy guide plate 100 is translated inward along the axis direction of the tibial positioning nail 37, so that the two tibial positioning nails 37 respectively pass through the two tibial positioning holes 35 of the third tibial positioning hole group 34, the tibial fixation nail 38 is inserted into the tibial fixation hole 36 and fixedly connected with the proximal tibia 200, and the tibial osteotomy guide plate 100 is fixed on the proximal tibia 200 again.

[0098] It should be noted that, during the movement of the tibial osteotomy guide plate 100, the two tibial positioning nails 37 remain connected with the proximal tibia, serving as positioning marks, so that after the position of the tibial osteotomy guide plate 100 is adjusted, the tibial osteotomy guide plate 100 is repositioned by the tibial positioning nails 37 connected with the proximal tibia 200, which can ensure that the tibial osteotomy slot 11 is aligned with the osteotomy position of the proximal tibia 200, so that the tibial osteotomy guide plate 100 does not need to be completely fitted with the proximal tibia 200.

[0099] Step 7, the osteotomy knife is inserted into the tibial osteotomy slot 11 and osteotomizes the proximal tibia 200 along the side inner surface of the tibial osteotomy slot 11 having the indicating arrow.

[0100] Step 8, when step 6 is performed, if two tibial side positioning nails 37 are inserted into two tibial positioning holes 35 of the first tibial positioning hole group 32 respectively, so that after osteotomy, if the thickness of the osteotomy needs to be increased, for example, 2mm needs to be removed, the tibial side fixation nail 38 inserted into the tibial fixation hole 36 is removed, the two tibial side positioning nails 37 remain connected with the proximal tibia 200, the tibial osteotomy guide plate 100 is translated outward along the axis direction of the tibial side positioning nail 37, the tibial osteotomy guide plate 100 is removed from the proximal tibia 200, then the tibial osteotomy guide plate 100 is moved downward and outward of the tibia, the tibial osteotomy guide plate 100 is moved downward as a whole, and the two tibial positioning holes 35 of the second tibial positioning hole group 33 are aligned with the two tibial side positioning nails 37 remaining on the proximal tibia 200 respectively, the tibial osteotomy guide plate 100 is translated inward along the axis direction of the tibial side positioning nail 37, the two tibial side positioning nails 37 pass through the two tibial positioning holes 35 of the second tibial positioning hole group 33 respectively, the tibial side fixation nail 38 is inserted into the tibial fixation hole 36 and fixedly connected with the proximal tibia 200, and the tibial osteotomy guide plate 100 is fixed on the proximal tibia 200 again. Similarly, since the two tibial side positioning nails 37 remain connected with the proximal tibia during the movement of the tibial osteotomy guide plate 100, they serve as positioning marks, so that the tibial osteotomy guide plate 100 does not need to be completely attached to the proximal tibia 200. The osteotomy cutter is inserted into the tibial osteotomy groove 11 again, and osteotomy is performed on the proximal tibia 200 by abutting against the inner surface of the side of the tibial osteotomy groove 11 having the indicating arrow.

[0101] Step 9, after the osteotomy operation is completed, the tibial side positioning nail 37 and the tibial side fixation nail 38 are removed, and then the tibial osteotomy guide plate 100 is removed from the proximal tibia 200.

[0102] The tibial osteotomy guide plate 100 provided in the application can effectively assist the doctor to perform the proximal tibial osteotomy surgery, which is beneficial to reduce the dependence of the osteotomy surgery on the experience of the doctor, and at the same time reduces the amount of use of traditional osteotomy instruments, which is beneficial to reduce the difficulty of the surgery, save the surgery time and reduce the amount of bleeding of the patient during the surgery, and is beneficial to improve the surgery effect, and the specific effects are as follows:

[0103] 1. The tibial osteotomy guide plate 100 of the application can be designed individually for the part of the tibia that needs to be osteotomied, so that the tibial osteotomy guide plate 100 can be matched and attached to the proximal tibia 200 of the patient, and through the cooperation of the tibial first attachment surface 21, the tibial second attachment surface 31, the tibial positioning hole 35 and the tibial fixation hole 36, the positioning accuracy of the tibial osteotomy guide plate 100 is high, which is beneficial to quickly attach and fix the tibial osteotomy guide plate 100 during the surgery.

[0104] 2. By forming the tibial side anti-skid structure 22 on the tibial first fitting surface 21, the friction between the tibial first fitting surface 21 and the tibial articular surface 201 can be increased when the tibial first fitting surface 21 is fitted with the tibial articular surface 201; by forming the tibial side anti-skid structure 22 on the tibial second fitting surface 31, the friction between the tibial second fitting surface 31 and the tibial articular surface 201 can be increased when the tibial second fitting surface 31 is fitted with the tibial proximal side surface 202; and if there is unstripped periosteum or other soft tissue in the area where the tibial proximal side surface 202 is fitted with the tibial first fitting surface 21, the tibial side anti-skid structure 22 of the tibial second fitting surface 31 can be embedded in the periosteum or other soft tissue of the tibial proximal side surface 202, further increasing the friction between the tibial second fitting surface 31 and the tibial proximal side surface 202. In this way, the arrangement of the tibial side anti-skid structure 22 can make the guide plate tightly fitted with the bone surface of the tibial proximal end 200, avoid slipping after the tibial osteotomy guide plate 100 is fitted, and thus affect the stability of the tibial osteotomy guide plate 100, which is conducive to improving the positioning accuracy of the tibial osteotomy guide plate 100.

[0105] 3. In the process of installing the tibial osteotomy guide plate 100, the positioning accuracy of the tibial osteotomy guide plate 100 is verified by using the force line rod 50, which can effectively avoid the situation that the installation position of the tibial osteotomy guide plate 100 does not match the expected planning, thereby affecting the positioning accuracy of the tibial osteotomy guide plate 100, and is conducive to improving the accuracy and success rate of the osteotomy surgery.

[0106] 4. By distributing a plurality of tibial positioning hole groups in the tibial force line direction on the tibial second fitting portion 30, the thickness of the osteotomy can be temporarily adjusted during the surgery, which is convenient for the doctor to deal with complex clinical situations during the surgery, and is conducive to improving the success rate of the osteotomy surgery.

[0107] It should be noted that the design of the tibial osteotomy guide plate 100 depends on the preoperative planning scheme, but whether the tibial osteotomy guide plate 100 can reproduce the preoperative planning scheme during the surgery to obtain the expected result depends on the positioning accuracy of the tibial osteotomy guide plate 100, that is, whether the tibial osteotomy guide plate 100 can be fitted to the preset position of the tibial proximal end 200, and the main factor affecting the positioning accuracy of the tibial osteotomy guide plate 100 is whether the fitting surface of the tibial osteotomy guide plate 100 is matched with the tibial proximal end 200, and whether there is a verification structure for verifying the positioning accuracy of the tibial osteotomy guide plate 100. The present application forms the tibial side anti-skid structure 22 on the tibial first fitting surface 21 and / or the tibial second fitting surface 31, which is conducive to improving the fitting stability of the tibial osteotomy guide plate 100, and the positioning accuracy of the tibial osteotomy guide plate 100 is effectively guaranteed by verifying whether the tibial osteotomy guide plate 100 is positioned accurately by using the force line rod 50.

[0108] The embodiment of the present application also provides a design method of a tibial osteotomy guide plate, which comprises the following steps:

[0109] Step S10: preoperative planning, constructing a tibial three-dimensional model of the target tibia.

[0110] The target tibia refers to the tibial part of the patient in need of osteotomy.

[0111] Step S20: determining the cartilage thickness value of the target tibia fitting area.

[0112] Specifically, if the nuclear magnetic scanning image data of the target tibia can be obtained, the tibial three-dimensional model of the target tibia is reconstructed according to the image data, and the cartilage thickness value of the tibial articular surface fitting area, such as the cartilage thickness value of the intercondylar eminence fitting area, is measured on the reconstructed tibial three-dimensional model. If the nuclear magnetic scanning image data of the target tibia cannot be obtained, the cartilage thickness value of the target tibial articular surface fitting area marked by the doctor can be recorded through doctor-engineer interaction. By determining the cartilage thickness value of the target tibia, when the first three-dimensional model of the guide plate is constructed, a gap with the cartilage thickness value needs to be reserved between the first three-dimensional model of the guide plate and the target tibial fitting area with cartilage.

[0113] It should be noted that if the doctor is used to stripping the cartilage of the target tibial fitting area, the cartilage thickness value of the target tibial fitting area is 0.

[0114] Step S30: constructing the first three-dimensional model of the guide plate according to the tibial three-dimensional model and the cartilage thickness value.

[0115] Step S40: interference check, confirming whether the first three-dimensional model of the guide plate needs to be adjusted, and obtaining the second three-dimensional model of the guide plate.

[0116] The spatial positions of the tibial positioning pin after passing through the tibial positioning hole on the first three-dimensional model of the guide plate, the tibial fixation pin after passing through the tibial fixation hole on the first three-dimensional model of the guide plate, and the osteotomy knife after passing through the tibial osteotomy slot on the first three-dimensional model of the guide plate are checked, and it is confirmed whether the tibial positioning pin and the tibial fixation pin, the tibial positioning pin and the osteotomy knife, and the tibial fixation pin and the osteotomy knife will intersect to cause interference between each other. If the intersection phenomenon occurs, the directions and positions of the tibial positioning hole and the tibial fixation hole of the first three-dimensional model of the guide plate need to be adjusted, and then the second three-dimensional model of the guide plate is obtained. Of course, if the intersection phenomenon does not occur, the first three-dimensional model of the guide plate does not need to be adjusted, so the first three-dimensional model of the guide plate is the second three-dimensional model of the guide plate.

[0117] Step S50: doctor-engineer interaction, confirming whether the second three-dimensional model of the guide plate needs to be adjusted, and obtaining the preset three-dimensional model of the guide plate.

[0118] The structure of the second three-dimensional model of the guide plate is confirmed by the doctor, and is adjusted according to the needs of the doctor, and then a preset three-dimensional model of the guide plate is obtained. Of course, if the structure of the second three-dimensional model of the guide plate is confirmed by the doctor and does not need to be adjusted, the second three-dimensional model of the guide plate is the preset three-dimensional model of the guide plate.

[0119] Step S60: manufacturing the tibial osteotomy guide plate according to the preset three-dimensional model of the guide plate.

[0120] Optionally, the preset three-dimensional model of the guide plate is imported into an additive manufacturing processing equipment, and the additive manufacturing processing equipment is used to manufacture the tibial osteotomy guide plate by using an additive manufacturing processing technology.

[0121] The design method of the tibial osteotomy guide plate provided in the application improves the accuracy of the design of the tibial osteotomy guide plate by enabling the doctor to interact with the tibial osteotomy guide plate during the design of the tibial osteotomy guide plate, and enabling the tibial osteotomy guide plate to be designed according to the preoperative planning scheme confirmed by the doctor, so that the tibial osteotomy guide plate can complete the osteotomy scheme that meets the personalized customization needs of the doctor, that is, when the proximal tibia is osteotomied, the doctor can control the osteotomy direction and the osteotomy thickness more accurately with the assistance of the tibial osteotomy guide plate.

[0122] Optionally, step S30: constructing the first three-dimensional model of the guide plate according to the three-dimensional model of the tibia and the cartilage thickness value specifically includes the following steps:

[0123] Step S31: constructing the first three-dimensional model of the tibia and the second three-dimensional model of the tibia according to the three-dimensional model of the tibia and the cartilage thickness value.

[0124] Step S32: constructing the three-dimensional model of the tibial osteotomy guide part according to the three-dimensional model of the tibia.

[0125] Step S33: constructing the three-dimensional model of the positioning guide part according to the three-dimensional model of the tibia.

[0126] Step S34: constructing the three-dimensional model of the force line mounting part according to the three-dimensional model of the tibia.

[0127] Step S35: constructing the first three-dimensional model of the guide plate according to the first three-dimensional model of the tibia, the second three-dimensional model of the tibia, the three-dimensional model of the tibial osteotomy guide part, the three-dimensional model of the positioning guide part, and the three-dimensional model of the force line mounting part.

[0128] The above technical solution can improve the design efficiency of the tibial osteotomy guide plate by separately designing the three-dimensional models of the parts of the tibial osteotomy guide plate and then constructing the first three-dimensional model of the guide plate according to the three-dimensional models of the parts.

[0129] In some embodiments of the application, step S31 specifically includes the following steps:

[0130] Step S311: Based on the three-dimensional model of the tibia, determine the tibial soft tissue incision and the tibial exposure area of ​​the target tibia.

[0131] Step S312: Based on the exposed area of ​​the tibia, extract the tibial articular surface fitting area and the proximal lateral surface fitting area of ​​the target tibia.

[0132] Step S313: At the position where the cartilage thickness value is maintained in the contact area with the tibial articular surface, the cartilage is stretched outward at equal intervals to generate a preliminary three-dimensional model of the first contact part of the tibia. At the same time, the cartilage is stretched outward at equal intervals in the contact area on the proximal side of the tibia to generate a preliminary three-dimensional model of the second contact part of the tibia.

[0133] Step S313: Generate a tibial side anti-slip structure on the preliminary three-dimensional model of the first tibial fitting part to obtain a three-dimensional model of the first tibial fitting part. Generate a tibial side anti-slip structure on the preliminary three-dimensional model of the second tibial fitting part to obtain a three-dimensional model of the second tibial fitting part.

[0134] Optionally, a portion of the preliminary 3D model of the first tibial contact area that can contact the contact area of ​​the tibial articular surface is extracted, and this portion of the entity is designed as multiple anti-slip protrusions. These anti-slip protrusions are then combined with the remaining portions of the preliminary 3D model of the first tibial contact area to obtain the 3D model of the first tibial contact area. Similarly, a portion of the preliminary 3D model of the second tibial contact area that can contact the contact area of ​​the proximal lateral aspect of the tibia is extracted, and this portion of the entity is designed as multiple anti-slip protrusions. These anti-slip protrusions are then combined with the remaining portions of the preliminary 3D model of the second tibial contact area to obtain the 3D model of the second tibial contact area.

[0135] In some embodiments of this application, step S32 specifically includes the following steps:

[0136] Step S321: Determine the osteotomy location and direction of the target tibia based on the three-dimensional model of the tibia.

[0137] Step S322: Call the basic 3D model of the tibial osteotomy guide in the model database, and stretch the basic 3D model of the tibial osteotomy guide according to the osteotomy position and direction of the target tibia to generate the 3D model of the tibial osteotomy guide.

[0138] The above technical solution generates a three-dimensional model of the tibial osteotomy guide by directly stretching the basic three-dimensional model of the tibial osteotomy guide according to the osteotomy position and direction of the target tibia, which makes the construction efficiency of the three-dimensional model of the tibial osteotomy guide high.

[0139] In some embodiments of this application, step S33 specifically includes the following steps:

[0140] Step S331: determining the insertion direction and insertion position of the fixing device according to the tibial exposure area of the tibial three-dimensional model.

[0141] The fixing device comprises a tibial positioning pin and a tibial fixing pin.

[0142] Step S331: calling the positioning guide base three-dimensional model in the database, and stretching the positioning guide base three-dimensional model according to the insertion direction and insertion position of the fixing device to generate the positioning guide three-dimensional model.

[0143] The above technical solution directly generates the positioning guide three-dimensional model according to the insertion direction and insertion position of the fixing device based on the positioning guide base three-dimensional model, so that the positioning guide three-dimensional model has high construction efficiency.

[0144] In some embodiments of the present application, step S34 specifically comprises the following steps:

[0145] Step S341: extracting the tibial force line direction of the target tibia according to the tibial three-dimensional model.

[0146] Step S342: generating a circular ring three-dimensional model at a preset position in front of the tibial three-dimensional model, and stretching the circular ring three-dimensional model along the tibial force line direction to generate a cylindrical ring three-dimensional model.

[0147] Step S343: stretching the side part of the cylindrical ring three-dimensional model towards the tibial osteotomy guide three-dimensional model to generate an extension three-dimensional model, and stretching a connecting body three-dimensional model for assembling with the tibial osteotomy guide three-dimensional model from the extension three-dimensional model, thereby obtaining a force line mounting piece three-dimensional model.

[0148] In some embodiments of the present application, step S35 specifically comprises the following steps:

[0149] Step S351: synthesizing the tibial first fitting part three-dimensional model, the tibial second fitting part three-dimensional model, the tibial osteotomy guide three-dimensional model, the positioning guide three-dimensional model, and the force line mounting piece three-dimensional model.

[0150] Step S352: generating a tibial osteotomy groove in the tibial osteotomy guide three-dimensional model, and generating a tibial positioning hole and a tibial fixing hole in the positioning guide three-dimensional model, thereby obtaining a first guide plate three-dimensional model.

[0151] Optionally, the number of tibial positioning holes is six, the axes of the six tibial positioning holes are parallel to each other, and the six tibial positioning holes are divided into three groups, i.e., a first tibial positioning hole group, a second tibial positioning hole group, and a third tibial positioning hole group, and the second tibial positioning hole group, the first tibial positioning hole group, and the third tibial positioning hole group are sequentially distributed along the tibial force line direction.

[0152] Each tibial positioning hole group includes two tibial positioning holes, the two tibial positioning holes of the first tibial positioning hole group are located at the same height, the two tibial positioning holes of the second tibial positioning hole group are located at the same height, and the two tibial positioning holes of the third tibial positioning hole group are located at the same height. The distance between the two tibial positioning holes of the second tibial positioning hole group is equal to the distance between the two tibial positioning holes of the first tibial positioning hole group, and the distance between the two tibial positioning holes of the third tibial positioning hole group is equal to the distance between the two tibial positioning holes of the first tibial positioning hole group. The height of the position corresponding to the first tibial positioning hole group is the initial positioning height, the second tibial positioning hole group is located above the first tibial positioning hole group along the tibial force line direction, and the positioning is realized by switching the tibial positioning holes of the second tibial positioning hole group to increase the bone cutting thickness. The third tibial positioning hole group is located below the first tibial positioning hole group along the tibial force line direction, and the positioning is realized by switching the tibial positioning holes of the third tibial positioning hole group to reduce the bone cutting thickness.

[0153] Optionally, in the tibial force line direction, the distance between the first tibial positioning hole group and the second tibial positioning hole group is equal to the distance between the first tibial positioning hole group and the third tibial positioning hole group. In the embodiment, the distance between the first tibial positioning hole group and the second tibial positioning hole group is greater than or equal to 2mm in the tibial force line direction, and the distance between the first tibial positioning hole group and the third tibial positioning hole group is greater than or equal to 2mm.

[0154] The number of tibial fixation holes is two, and the axes of the two tibial fixation holes are not parallel to the axis of the tibial positioning hole.

[0155] Please refer to Figures 11 to 15 , now the femoral bone cutting guide plate 300 provided by the embodiment of the application will be described. The femoral bone cutting guide plate 300 is applied to total knee arthroplasty surgery and is used for guiding the cutting of the distal end of the femur 400, wherein the distal end of the femur 400 refers to the end of the femur close to the tibia.

[0156] Please refer to Figure 11 and Figure 12 The femoral bone cutting guide plate 300 includes a femoral bone cutting guide part 60, a femoral first fitting part 70, and a femoral second fitting part 80. The femoral bone cutting guide part 60 is provided with a femoral bone cutting groove 61. The femoral first fitting part 70 is connected with the femoral bone cutting guide part 60, and the femoral first fitting part 70 has a femoral first fitting surface 71 for fitting with the articular surface 401 of the femur. The femoral second fitting part 80 is connected with the femoral bone cutting guide part 60, and the femoral second fitting part 80 has a femoral second fitting surface 81 for fitting with the front condyle surface 402 of the femur. The femoral second fitting part 80 is provided with a femoral positioning hole 85. The femoral first fitting surface 71 and / or the femoral second fitting surface 81 form a femoral side anti-skid structure 72.

[0157] The femur osteotomy groove 61 penetrates the inner surface and the outer surface of the femur osteotomy guide part 60. The inner surface of the femur osteotomy guide part 60 refers to the surface of the femur osteotomy guide part 60 facing the femur distal end 400 when the femur osteotomy guide plate 300 is fixed to the femur distal end 400. The outer surface of the femur osteotomy guide part 60 refers to the surface of the femur osteotomy guide part 60 away from the femur distal end 400 when the femur osteotomy guide plate 300 is fixed to the femur distal end 400. When the femur osteotomy guide plate 300 is fixed to the preset position of the femur distal end 400, the femur osteotomy groove 61 is aligned with the osteotomy position of the femur distal end 400, and the osteotomy knife performs osteotomy operation on the femur distal end 400 by inserting the femur osteotomy groove 61. The osteotomy knife can be a swing saw.

[0158] The femur osteotomy guide plate 300 provided by the present application has the following advantages compared with the prior art. When used, the femur first fitting surface 71 of the femur first fitting part 70 is fitted with the femur articular surface 401, the femur second fitting surface 81 of the femur second fitting part 80 is fitted with the femur condyle anterior surface 402, the femur side positioning pin 87 is inserted into the femur positioning hole 85 and fixedly connected with the femur distal end 400, realizing positioning connection, so that the femur osteotomy guide plate 300 is positioned on the femur distal end 400. The osteotomy knife performs osteotomy operation on the femur distal end 400 by inserting the femur osteotomy groove 61. If there is cartilage in the area where the femur articular surface 401 is fitted with the femur first fitting surface 71, a spacing capable of compensating for the thickness of the cartilage is reserved between the femur first fitting surface 71 and the femur articular surface 401. When the femur first fitting surface 71 is fitted with the femur articular surface 401, the tibial side anti-skid structure 22 of the femur first fitting surface 71 can increase the friction between the femur first fitting surface 71 and the femur articular surface 401. When the femur second fitting surface 81 is fitted with the femur condyle anterior surface 402, the tibial side anti-skid structure 22 of the femur second fitting surface 81 can increase the friction between the femur second fitting surface 81 and the femur condyle anterior surface 402. If there is unstripped periosteum or other soft tissue in the area where the femur condyle anterior surface 402 is fitted with the femur second fitting surface 81, the femur side anti-skid structure 72 of the femur second fitting surface 81 can be embedded in the periosteum or other soft tissue, further increasing the friction between the femur first fitting surface 71 and the femur articular surface 401. In this way, the arrangement of the femur side anti-skid structure 72 can make the femur osteotomy guide plate 300 tightly fitted with the bone surface of the femur distal end 400, effectively preventing the femur osteotomy guide plate 300 from slipping after fitting, and is conducive to improving the fitting stability and positioning accuracy of the femur osteotomy guide plate 300, thereby being conducive to improving the safety and success rate of the surgery, without the need to strip the cartilage, which is conducive to reducing the difficulty of the surgery and saving the surgery time, while reducing the harm to the patient.

[0159] Optionally, the femoral osteotomy guide plate 300 can be made of medical-grade resin or medical-grade metal. The medical-grade resin can be, but is not limited to, polyethylene, polyetheretherketone, polyacetic acid, etc., and the medical-grade metal can be, but is not limited to, titanium, titanium alloy, stainless steel, etc. When the femoral osteotomy guide plate 300 is made of medical-grade resin, it can be manufactured using additive manufacturing technology, also known as 3D printing technology.

[0160] In one embodiment of this application, please refer to Figure 11 and Figure 12 The first femoral fitting portion 70 and the second femoral fitting portion 80 are roughly L-shaped. When the first femoral fitting surface 71 fits against the femoral articular surface 401 and the second femoral fitting surface 81 fits against the anterior surface of the femoral condyle 402, the femoral osteotomy guide plate 300 contacts and fits against the distal femoral bone surface 400 in two nearly perpendicular spatial directions, thereby improving the stability of the femoral osteotomy guide plate 300 fitting.

[0161] In some embodiments of this application, please refer to Figure 12 The femoral side anti-slip structure 72 includes multiple anti-slip protrusions. The anti-slip protrusions on the first femoral contact surface 71 are evenly distributed in a dotted pattern, so that when the first femoral contact surface 71 is in contact with the femoral articular surface 401, the multiple anti-slip protrusions on the first femoral contact surface 71 make multiple points of contact with the femoral articular surface 401, increasing the friction between the first femoral contact surface 71 and the femoral articular surface 401, thereby helping to improve the stability of the fit between the first femoral contact surface 71 and the femoral articular surface 401. The anti-slip protrusions on the second femoral contact surface 81 are also evenly distributed in a dotted pattern. When the second femoral contact surface 81 is in contact with the anterior surface of the femoral condyle 402, multiple anti-slip protrusions on the second femoral contact surface 81 make multi-point contact with the anterior surface of the femoral condyle 402. The anti-slip protrusions on the second femoral contact surface 81 can embed into the periosteum or other soft tissues of the anterior surface of the femoral condyle 402 and make contact with the bone points of the anterior surface of the femoral condyle 402. The gaps between the anti-slip protrusions can accommodate the periosteum or other soft tissues, which increases the friction between the second femoral contact surface 81 and the anterior surface of the femoral condyle 402, thereby improving the stability of the fit between the second femoral contact surface 81 and the anterior surface of the femoral condyle 402.

[0162] Optionally, the anti-slip protrusions are formed with pointed ends. For example, the anti-slip protrusions can be conical or frustum-shaped structures. The pointed ends facilitate the anti-slip protrusions passing through cartilage, periosteum, or other soft tissues.

[0163] In another embodiment of this application, the femoral side anti-slip structure 72 includes multiple anti-slip patterns. The anti-slip patterns serve the same function as the anti-slip protrusions. It can be understood that the anti-slip patterns on the first femoral contact surface 71 can increase the friction between the first femoral contact surface 71 and the femoral articular surface 401, and the anti-slip patterns on the second femoral contact surface 81 can increase the friction between the second femoral contact surface 81 and the anterior surface 402 of the femoral condyle. In other embodiments of this application, the femoral side anti-slip structure 72 may also include both multiple anti-slip protrusions and multiple anti-slip patterns.

[0164] In some embodiments of this application, please refer to Figure 13 The second femoral fitting portion 80 has multiple femoral positioning hole groups distributed sequentially along the height direction of the second femoral fitting portion 80, and the axes of the femoral positioning holes 85 between different femoral positioning hole groups are parallel to each other.

[0165] The above-mentioned technical solution, by distributing multiple femoral positioning hole groups along the height direction of the second femoral fitting portion 80, allows the femoral lateral positioning nail 87 to pass through the positioning holes of different femoral positioning hole groups, thereby increasing or decreasing the osteotomy thickness. This enables adjustment of the femoral osteotomy thickness in actual operation, accommodating more osteotomy methods and improving the practicality of the femoral osteotomy guide plate 300. Furthermore, the axes of the femoral positioning holes 85 between different femoral positioning hole groups are parallel to each other, allowing the femoral positioning holes 85 of different femoral positioning hole groups to accommodate the insertion of femoral lateral positioning nails 87 at the same position on the femur. Therefore, when adjusting the femoral osteotomy thickness, it is not necessary to remove the femoral lateral positioning nail 87; only the alignment of different femoral positioning hole groups on the osteotomy plate with the femoral lateral positioning nail 87 needs to be adjusted. Repositioning of the femoral osteotomy guide plate 300 is not required, simplifying the operation, improving efficiency, and reducing the number of times the femoral lateral positioning nail 87 needs to be inserted, thus reducing harm to the patient.

[0166] Optionally, the spacing between each femoral positioning hole group is equal in the height direction of the second femoral fitting portion 80.

[0167] Optionally, each femoral positioning hole group includes one or more femoral positioning holes 85. When each femoral positioning hole group includes multiple femoral positioning holes 85, the multiple femoral positioning holes 85 in each femoral positioning hole group are located at the same horizontal level. By setting multiple first femoral positioning holes 85 in each femoral positioning hole group, it is beneficial to improve the positioning stability and positioning accuracy of the femoral osteotomy guide plate 300.

[0168] Furthermore, when each femoral positioning hole group includes multiple femoral positioning holes 85, the horizontal spacing between the femoral positioning holes 85 in each femoral positioning hole group is equal.

[0169] Specifically, in this embodiment, please refer to Figure 13The second femoral fitting portion 80 has three sets of femoral positioning holes distributed sequentially along its height direction: a second femoral positioning hole set 83, a first femoral positioning hole set 82, and a third femoral positioning hole set 84. The position height corresponding to the femoral positioning hole 85 in the first femoral positioning hole set 82 is the initial positioning height. The second femoral positioning hole set 83 is located below the first femoral positioning hole set 82 along the height direction of the second femoral fitting portion 80. When the femoral lateral positioning nail 87 is inserted through the femoral positioning hole 85 of the second femoral positioning hole set 83 to operate the femoral osteotomy guide plate 300, the osteotomy blade, through the insertion of the femoral osteotomy groove 61, can increase the femoral osteotomy thickness when performing osteotomy on the distal femur 400. The third femoral positioning hole group 84 is located above the first femoral positioning hole group 82 along the height direction of the second femoral fitting part 80. When the femoral side positioning nail 87 is inserted through the femoral positioning hole 85 of the third femoral positioning hole group 84 to perform femoral osteotomy guide plate 300, the osteotomy knife can reduce the femoral osteotomy thickness by inserting the femoral osteotomy groove 61 to perform osteotomy on the distal femoral 400.

[0170] Optionally, in the height direction of the second femoral fitting portion 80, the distance between the first femoral positioning hole group 82 and the second femoral positioning hole group 83 is equal to the distance between the first femoral positioning hole group 82 and the third femoral positioning hole group 84. Specifically, in this embodiment, in the direction along the tibial force line, the distance between the first tibial positioning hole group 32 and the second tibial positioning hole group 33 is greater than or equal to 2 mm, and the distance between the first tibial positioning hole group 32 and the third femoral positioning hole group 84 is greater than or equal to 2 mm.

[0171] Optionally, the first femoral positioning hole group 82, the second femoral positioning hole group 83, and the third femoral positioning hole group 84 each include two femoral positioning holes 85, and the two femoral positioning holes 85 of the first femoral positioning hole group 82 are located at the same horizontal level, the two femoral positioning holes 85 of the second femoral positioning hole group 83 are located at the same horizontal level, and the two femoral positioning holes 85 of the third femoral positioning hole group 84 are located at the same horizontal level.

[0172] Furthermore, the horizontal distance between the two femoral positioning holes 85 in the second femoral positioning hole group 83 is equal to the horizontal distance between the two femoral positioning holes 85 in the first femoral positioning hole group 82, and the horizontal distance between the two femoral positioning holes 85 in the third femoral positioning hole group 84 is equal to the horizontal distance between the two femoral positioning holes 85 in the first tibial positioning hole group 32.

[0173] In some embodiments of this application, please refer to Figures 11 to 13 The second femoral fitting part 80 also has a femoral fixation hole 86, and the axis of the femoral fixation hole 86 is inclined relative to the axis of the femoral positioning hole 85.

[0174] Understandably, the axis of the femoral fixation hole 86 is not parallel to the axis of the femoral positioning hole 85. The femoral fixation hole 86 is for inserting the femoral lateral fixation screw 88. Specifically, the femoral lateral fixation screw 88 is inserted into the femoral fixation hole 86 and fixedly connected to the distal femur 400. By cooperating with the non-parallel femoral positioning hole 85 and the femoral fixation hole 86, the femoral osteotomy guide plate 300 is fixed, effectively preventing the femoral osteotomy guide plate 300 from moving along the axial direction of the femoral positioning hole 85, which helps to improve the stability of the fixation of the femoral osteotomy guide plate 300.

[0175] Optionally, the number of femoral fixation holes 86 is two.

[0176] It should be noted that the femoral lateral positioning nail 87 inserted into the femoral positioning hole 85 and the femoral lateral fixation nail 88 inserted into the femoral fixation hole 86 will not interfere with each other, nor will they affect the osteotomy operation performed by inserting the osteotomy groove 61 through the osteotomy knife.

[0177] In some embodiments of this application, please refer to Figure 11 , Figure 12 and Figure 14 The femoral osteotomy guide plate 300 also includes a verification rod 90, which verifies whether the femoral osteotomy guide plate 300 is accurately positioned by checking whether the verification rod 90 points in the direction of the femoral condyle line.

[0178] Specifically, during the installation of the femoral osteotomy guide plate 300, after the first femoral contact surface 71 of the first femoral contact portion 70 is in contact with the femoral articular surface 401, and the second femoral contact surface 81 of the second femoral contact portion 80 is in contact with the anterior surface 402 of the femoral condyle, the verification rod 90 is observed from the distal side of the femur to see if it points in the direction of the femoral condyle line, that is, whether the axial direction of the verification rod 90 is consistent with the direction of the femoral condyle line. If the calibration rod 90 points towards the femoral condyle line, that is, the axis of the calibration rod 90 is parallel to the femoral condyle line, it indicates that the femoral osteotomy guide plate 300 is accurately positioned. If the calibration rod 90 does not point towards the femoral condyle line, that is, the axis of the calibration rod 90 is not parallel to the femoral condyle line, it indicates that the femoral osteotomy guide plate 300 is not accurately positioned, and the fit of the femoral osteotomy guide plate 300 needs to be adjusted until the calibration rod 90 points towards the femoral condyle line.

[0179] The above technical solution verifies the accurate positioning of the femoral osteotomy guide plate 300 by checking whether the verification rod 90 points in the direction of the femoral condyle line during the installation process, thus effectively ensuring the positioning accuracy of the femoral osteotomy guide plate 300.

[0180] Optionally, the verification rod 90 is connected to the first femoral contact portion 70. By connecting the verification rod 90 to the first femoral contact portion 70, after the femoral osteotomy guide plate 300 is installed on the distal femur 400, the verification rod 90 is closer to the femoral condyle line, which is easier for doctors to observe and helps improve the accuracy of the verification by the verification rod 90.

[0181] In some embodiments of this application, please refer to Figure 11 and Figure 13 The femoral osteotomy guide plate 300 also includes a femoral pressing part 62, which is connected to the femoral osteotomy guide part 60. During the positioning of the femoral osteotomy guide plate 300, the doctor can press the femoral pressing part 62 to make the femoral osteotomy guide plate 300 fit tightly against the distal femur 400, which facilitates the doctor's operation.

[0182] In some embodiments of this application, please refer to Figure 11 , Figure 12 and Figure 14 The femoral osteotomy guide plate 300 includes two femoral first contact portions 70, which are spaced apart along the length of the femoral osteotomy guide portion 60. One femoral first contact surface 71 of the first contact portion 70 is used to contact the medial femoral articular surface, and the other femoral first contact surface 71 is used to contact the lateral femoral articular surface. This technical solution, by having the two femoral first contact portions 70 contact with the medial and lateral femoral articular surfaces respectively, provides a large contact area between the femoral osteotomy guide plate 300 and the femoral articular surface 401. Furthermore, the two femoral first contact portions 70, in conjunction with the femoral second contact portion 80, form a stable contact and positioning, effectively improving the positioning accuracy of the femoral osteotomy guide plate 300.

[0183] Specifically, in this embodiment, please refer to Figure 14 and Figure 15 The first femoral contact surfaces 71 of the two first femoral contact portions 70 are used to contact the medial femoral condyle 403 and the lateral femoral surface 404 respectively.

[0184] Please see Figure 11 , Figure 12 and Figure 14 The verification rod 90 is connected between the two femoral first conning portions 70. Specifically, one end of the verification rod 90 is connected to one of the first conning portions 70, and the other end of the verification rod 90 is connected to the first conning portion 70. By connecting the verification rod 90 between the two femoral first conning portions 70, it is easier for doctors to quickly determine whether the verification rod 90 points in the direction of the femoral condyle line, and it also helps to strengthen the structural strength of the femoral first conning portions 70.

[0185] The specific operation of the femoral osteotomy guide plate 300 provided in this application embodiment is illustrated by the following examples:

[0186] Step 1: Fit the first femoral fitting surface 71 of the first femoral fitting part 70 with the femoral articular surface 401, and fit the second femoral fitting surface 81 of the second femoral fitting part 80 with the anterior surface of the femoral condyle 402.

[0187] Step 2: Observe from the distal side of the femur whether the verification rod 90 points in the direction of the femoral condyle line. If the verification rod 90 does not point in the direction of the femoral condyle line, return to Step 2 and adjust the fitting position of the femoral osteotomy guide plate 300. If the verification rod 90 points in the direction of the femoral condyle line, proceed to Step 3.

[0188] Step 3: Insert two femoral lateral positioning nails 87 into the two femoral positioning holes 85 of the first femoral positioning hole group 82 respectively, and fix them to the distal femur 400. Insert the femoral lateral fixation nail 88 into the femoral fixation hole 86 and fix it to the distal femur 400 to fix the femoral osteotomy guide plate 300 on the distal femur 400.

[0189] Step 4: Before osteotomy, use a conventional instrument, such as a dart, to pass through the osteotomy groove to assess the osteotomy thickness at the distal femur 400. If you want to reduce the osteotomy thickness, for example, to remove 2mm less, remove the femoral lateral fixation screws 88 inserted into the femoral fixation hole 86. Keep the two femoral lateral positioning screws 87 connected to the distal femur 400. Translate the femoral osteotomy guide plate 300 outward along the axis of the femoral lateral positioning screws 87 to remove the femoral osteotomy guide plate 300 from the distal femur 400. Then move the femoral osteotomy guide plate 300 downward and laterally to the distal femur 400, so that the femur... The osteotomy guide plate 300 is moved upward as a whole, and the femoral positioning holes 85 of the third femoral positioning hole group 84 are respectively aligned with the two femoral lateral positioning nails 87 retained on the distal femur 400. The femoral osteotomy guide plate 300 is translated inward along the axial direction of the femoral lateral positioning nails 87, so that the two femoral lateral positioning nails 87 pass through the two femoral positioning holes 85 of the third femoral positioning hole group 84 respectively. The femoral lateral fixation nail 88 is inserted into the femoral fixation hole 86 and fixedly connected to the distal femur 400, thereby fixing the femoral osteotomy guide plate 300 to the distal femur 400 again.

[0190] It should be noted that, during the movement of the femoral osteotomy guide plate 300, the two femoral lateral positioning screws 87 remain connected to the distal femur 400, serving as positioning markers. Thus, after adjusting the position of the femoral osteotomy guide plate 300, the femoral lateral positioning screws 87, which remain connected to the distal femur 400, are used to reposition the femoral osteotomy guide plate 300, ensuring that the osteotomy groove 61 and the osteotomy position of the distal femur 400 are aligned. Therefore, it is not required that the femoral osteotomy guide plate 300 and the distal femur 400 be completely fitted together.

[0191] Step 5: Insert the osteotomy knife into the femoral osteotomy groove 61 and perform osteotomy on the distal femur 400 along the inner surface of the femoral osteotomy groove 61 with the indicator arrow.

[0192] Step 6: If, during step 5, the two femoral lateral positioning screws 87 are respectively inserted into the two femoral positioning holes 85 of the first femoral positioning hole group 82, and after osteotomy, if it is necessary to increase the osteotomy thickness, for example, to remove an additional 2mm, remove the femoral lateral fixation screws 88 inserted into the femoral fixation holes 86. Keep the two femoral lateral positioning screws 87 connected to the distal femur 400. Move the femoral osteotomy guide plate 300 outward along the axial direction of the femoral lateral positioning screws 87 to remove the femoral osteotomy guide plate 300 from the distal femur 400. Then move the femoral osteotomy guide plate upward and laterally along the femur. The femoral osteotomy guide plate 300 is moved upwards as a whole, and the two femoral positioning holes 85 of the second femoral positioning hole group 83 are aligned with the two femoral lateral positioning nails 87 retained on the distal femur 400. The femoral osteotomy guide plate 300 is then translated inwards along the axis of the femoral lateral positioning nails 87, so that the two femoral lateral positioning nails 87 pass through the two femoral positioning holes 85 of the second femoral positioning hole group 83. The femoral lateral fixation nail 88 is inserted into the femoral fixation hole 86 and fixedly connected to the distal femur 400, thus fixing the femoral osteotomy guide plate 300 to the distal femur 400 again. Similarly, since the two femoral lateral positioning nails 87 remain connected to the distal femur 400 during the movement of the femoral osteotomy guide plate 300, serving as positioning markers, it is not required that the femoral osteotomy guide plate 300 be completely fitted to the distal femur 400. The osteotomy knife is inserted back into the femoral osteotomy groove 61, and the distal femur 400 is osteotomized along the inner surface of the side of the femoral osteotomy groove 61 with the indicator arrow.

[0193] Step 7: After the osteotomy is completed, first remove the femoral side positioning nail 87 and the femoral side fixation nail 88, and then remove the femoral osteotomy guide plate 300 from the distal femur 400.

[0194] The femoral osteotomy guide plate 300 provided in this application can effectively assist doctors in performing distal femoral osteotomy at a distance of 400 degrees. It helps to reduce the reliance on the surgeon's experience in osteotomy surgery, while also reducing the use of traditional osteotomy instruments. This helps to reduce the difficulty of the surgery, save surgical time, reduce intraoperative bleeding, and improve surgical outcomes, as detailed below:

[0195] 1. The femoral osteotomy guide plate 300 of this application can be customized for the femoral portion that needs to be osteotomized by the patient, so that the femoral osteotomy guide plate 300 can match and fit with the distal femur 400 of the patient. Through the cooperation of the first femoral fitting surface 71, the second femoral fitting surface 81, the femoral positioning hole 85 and the femoral fixation hole 86, the femoral osteotomy guide plate 300 has high positioning accuracy, which facilitates rapid fitting and fixation of the femoral osteotomy guide plate 300 during the operation.

[0196] 2. By forming a femoral-side anti-slip structure 72 on the first femoral contact surface 71, when the first femoral contact surface 71 is in contact with the femoral articular surface 401, the tibial-side anti-slip structure 22 on the first femoral contact surface 71 can increase the frictional force between the first femoral contact surface 71 and the femoral articular surface 401; by forming a femoral-side anti-slip structure 72 on the second femoral contact surface 81, when the second femoral contact surface 81 is in contact with the anterior surface of the femoral condyle 402, the frictional force between the first femoral contact surface 71 and the femoral articular surface 401 can be increased. The tibial anti-slip structure 22 on the femoral second contact surface 81 increases the friction between the femoral second contact surface 81 and the anterior surface 402 of the femoral condyle. Furthermore, if there is incompletely removed periosteum or other soft tissue in the area where the anterior surface 402 of the femoral condyle is in contact with the femoral second contact surface 81, the femoral side anti-slip structure 72 on the femoral second contact surface 81 can embed into the periosteum or other soft tissue, further increasing the friction between the femoral first contact surface 71 and the femoral articular surface 401. Thus, the femoral side anti-slip structure 72 ensures close contact between the guide plate and the bone surface of the distal femur 400, preventing slippage after the femoral osteotomy guide plate 300 is attached, thereby affecting the stability of the femoral osteotomy guide plate 300 and improving the positioning accuracy of the femoral osteotomy guide plate 300.

[0197] 3. During the installation of the femoral osteotomy guide plate 300, the accuracy of the positioning of the femoral osteotomy guide plate 300 is verified by using the calibration rod 90. This effectively avoids the installation position of the femoral osteotomy guide plate 300 not conforming to the expected plan, which would affect the positioning accuracy of the femoral osteotomy guide plate 300 and help improve the accuracy and success rate of osteotomy surgery.

[0198] 4. By distributing multiple femoral positioning holes along the height direction of the second femoral contraption 80, the osteotomy thickness can be temporarily adjusted during the operation, which makes it easier for doctors to deal with complex clinical situations during the operation and helps to improve the success rate of osteotomy surgery.

[0199] It should be noted that the design of the femoral osteotomy guide 300 depends on the preoperative planning scheme. However, whether the femoral osteotomy guide 300 can reproduce the preoperative planning scheme and achieve the expected results during surgery depends on the positioning accuracy of the femoral osteotomy guide 300, that is, whether the femoral osteotomy guide 300 can be fitted to the preset position of the distal femur 400. The main factors affecting the positioning accuracy of the femoral osteotomy guide 300 are whether the contact surface of the femoral osteotomy guide 300 matches the distal femur 400, and whether there is a verification structure to verify the positioning accuracy of the femoral osteotomy guide 300. This application improves the fit stability of the femoral osteotomy guide 300 by forming a femoral side anti-slip structure 72 on the first contact surface 71 and / or the second contact surface 81 of the femur, and effectively ensures the positioning accuracy of the femoral osteotomy guide 300 by using a verification rod 90 to verify whether the femoral osteotomy guide 300 is positioned accurately.

[0200] This application also provides a method for designing a femoral osteotomy guide plate, the method comprising the following steps:

[0201] Step S10: Preoperative planning, constructing a three-dimensional model of the target femur.

[0202] The target femur refers to the part of the femur where the patient needs to undergo osteotomy.

[0203] Step S20: Determine the cartilage thickness value of the target femoral apposition area.

[0204] Specifically, if MRI scan data of the target femur can be obtained, a three-dimensional model of the target femur is reconstructed based on this data. The cartilage thickness in the articular surface contact area of ​​the femur is then measured on the reconstructed three-dimensional model, such as the cartilage thickness in the distal region of the medial femoral condyle and the distal region of the lateral femoral condyle. If MRI scan data of the target femur cannot be obtained, the cartilage thickness in the articular surface contact area of ​​the target femur, as defined by the physician, can be recorded through medical-engineering interaction. By determining the cartilage thickness of the target femur, a gap for the cartilage thickness needs to be reserved between the first three-dimensional model of the femoral guide and the cartilage-containing contact area of ​​the target femur when constructing the first three-dimensional model of the femoral guide.

[0205] It should be noted that if the doctor is accustomed to dissecting the cartilage in the target femoral apposition area, then the cartilage thickness value in the target femoral apposition area is determined to be 0.

[0206] Step S30: Construct the first three-dimensional model of the femoral guide plate based on the three-dimensional model of the femur and the cartilage thickness value.

[0207] Step S40: Interference check to confirm whether the first three-dimensional model of the femoral guide plate needs to be adjusted, and to obtain the second three-dimensional model of the femoral guide plate.

[0208] The spatial positions of the femoral lateral positioning screw, the femoral lateral fixation screw, and the osteotomy blade after passing through the femoral osteotomy groove on the first three-dimensional model of the femoral guide plate are examined. It is confirmed whether there will be any intersections between the femoral lateral positioning screw and the femoral lateral fixation screw, between the femoral lateral positioning screw and the osteotomy blade, or between the femoral lateral fixation screw and the osteotomy blade, causing interference. If intersections occur, the direction and position of the femoral positioning and fixation holes in the first three-dimensional model of the femoral guide plate need to be adjusted to obtain the second three-dimensional model of the femoral guide plate. Of course, if no intersections occur, no adjustment is needed to the first three-dimensional model of the femoral guide plate; thus, the first three-dimensional model of the femoral guide plate is the second three-dimensional model of the femoral guide plate.

[0209] Step S50: Medical-engineering interaction, confirm whether the second three-dimensional model of the femoral guide plate needs to be adjusted, and obtain the preset three-dimensional model of the femoral guide plate.

[0210] The structure of the second 3D model of the femoral guide plate is confirmed by the doctor and adjusted according to the doctor's needs, thus obtaining the preset 3D model of the femoral guide plate. Of course, if the structure of the second 3D model of the femoral guide plate is confirmed by the doctor and no adjustments are needed, then the second 3D model of the femoral guide plate is the preset 3D model of the femoral guide plate.

[0211] Step S60: Fabricate the femoral osteotomy guide plate based on the preset three-dimensional model of the femoral guide plate.

[0212] Optionally, a pre-set three-dimensional model of the femoral guide plate is imported into an additive manufacturing processing equipment, and the femoral osteotomy guide plate is fabricated using additive manufacturing technology.

[0213] The femoral osteotomy guide plate design method provided in this application, through medical-engineering interaction, enables the femoral osteotomy guide plate to be designed according to the preoperative planning scheme confirmed by the doctor, thereby improving the accuracy of the femoral osteotomy guide plate design. In turn, the femoral osteotomy guide plate can complete the osteotomy plan that meets the doctor's personalized customization needs. That is, when performing osteotomy on the distal femur, the doctor can more accurately control the osteotomy direction and osteotomy thickness with the assistance of the femoral osteotomy guide plate.

[0214] Optionally, step S30: Constructing the first three-dimensional model of the femoral guide plate based on the three-dimensional model of the femur and the cartilage thickness value specifically includes the following steps:

[0215] Step S31: Based on the three-dimensional model of the femur and the cartilage thickness value, construct the three-dimensional model of the first femoral apposition and the three-dimensional model of the second femoral apposition.

[0216] Step S32: Construct a three-dimensional model of the femoral osteotomy guide based on the three-dimensional model of the femur.

[0217] Step S33: Construct a three-dimensional model of the femoral positioning guide based on the three-dimensional model of the femur.

[0218] Step S34: Construct a three-dimensional model of the verification rod based on the three-dimensional model of the femur.

[0219] Step S35: Based on the three-dimensional models of the first femoral patency part, the second femoral patency part, the femoral osteotomy guide part, the femoral positioning guide part, and the calibration rod, construct the first three-dimensional model of the femoral guide plate.

[0220] The above-mentioned technical solution can improve the design efficiency of the femoral osteotomy guide by designing three-dimensional models of each part of the femoral osteotomy guide separately, based on the doctors' habits and the characteristics of total knee replacement surgery.

[0221] In some embodiments of this application, step S31 specifically includes the following steps:

[0222] Step S311: Based on the three-dimensional model of the femur, determine the femoral soft tissue incision and the femoral exposure area of ​​the target femur.

[0223] Step S312: Based on the exposed area of ​​the femur, extract the femoral articular surface fitting area and the anterior surface 402 fitting area of ​​the femoral condyle of the target femur respectively.

[0224] Step S313: At the position where the cartilage thickness value is maintained in the contact area with the femoral articular surface, the cartilage is stretched outward at equal intervals to generate a preliminary three-dimensional model of the first contact part of the femur. At the contact area 402 on the anterior side of the femoral condyle, the cartilage is stretched outward at equal intervals to generate a preliminary three-dimensional model of the second contact part of the femur.

[0225] Step S313: Generate an anti-slip structure on the preliminary three-dimensional model of the first femoral apposition to obtain the three-dimensional model of the first femoral apposition. Generate an anti-slip structure on the preliminary three-dimensional model of the second femoral apposition to obtain the three-dimensional model of the second femoral apposition.

[0226] Optionally, a portion of the preliminary 3D model of the first femoral condyle that can contact the area of ​​the femoral articular surface is extracted, and this portion of the entity is designed as multiple anti-slip protrusions. These anti-slip protrusions are then combined with the remaining portions of the preliminary 3D model of the first femoral condyle to obtain the 3D model of the first femoral condyle. Similarly, a portion of the preliminary 3D model of the second femoral condyle that can contact the area of ​​the anterior surface of the femoral condyle is extracted, and this portion of the entity is designed as multiple anti-slip protrusions. These anti-slip protrusions are then combined with the remaining portions of the preliminary 3D model of the second femoral condyle to obtain the 3D model of the second femoral condyle.

[0227] In some embodiments of this application, step S32 specifically includes the following steps:

[0228] Step S321: Determine the osteotomy location and direction of the target femur based on the three-dimensional model of the femur.

[0229] Step S322: Call the basic 3D model of the femoral osteotomy guide in the model database, and stretch the basic 3D model of the femoral osteotomy guide according to the osteotomy position and direction of the target femur to generate the 3D model of the femoral osteotomy guide.

[0230] The above technical solution generates a three-dimensional model of the femoral osteotomy guide part by directly stretching the basic three-dimensional model of the femoral osteotomy guide part according to the osteotomy position and direction of the target femur, which makes the construction efficiency of the three-dimensional model of the femoral osteotomy guide part high.

[0231] In some embodiments of this application, step S33 specifically includes the following steps:

[0232] Step S331: Determine the insertion direction and position of the fixation device based on the femoral exposure area of ​​the three-dimensional femoral model.

[0233] The fixing device includes positioning pins and fixing pins.

[0234] Step S331: Call the basic three-dimensional model of the femoral positioning guide in the database, and stretch the basic three-dimensional model of the femoral positioning guide according to the insertion direction and position of the fixation device to generate the three-dimensional model of the positioning guide.

[0235] The above technical solution generates a three-dimensional model of the femoral positioning guide by directly building the three-dimensional model of the femoral positioning guide based on the insertion direction and position of the fixation device, which makes the construction of the three-dimensional model of the femoral positioning guide highly efficient.

[0236] In some embodiments of this application, step S34 specifically includes the following steps:

[0237] Step S341: Based on the three-dimensional model of the femur, extract the direction of the femoral condyle line of the target femur.

[0238] Step S342: Generate a circular three-dimensional model at a preset position directly below the femoral three-dimensional model, and stretch it along the femoral condyle line to generate a cylindrical three-dimensional model.

[0239] Step S343: Stretch the two ends of the cylindrical 3D model toward the two femoral second fitting parts 3D models to extend the connecting entity, so as to connect with the two femoral second fitting parts 3D models, thereby obtaining the verification rod 3D model.

[0240] In some embodiments of this application, step S35 specifically includes the following steps:

[0241] Step S351: Combine the three-dimensional models of the first femoral apposition part, the second femoral apposition part, the femoral osteotomy guide part, the femoral positioning guide part, and the calibration rod.

[0242] Step S352: Generate a femoral osteotomy groove in the three-dimensional model of the femoral osteotomy guide, and generate femoral positioning holes and femoral fixation holes in the three-dimensional model of the femoral positioning guide, thereby obtaining the first three-dimensional model of the femoral guide plate.

[0243] Optionally, the number of femoral positioning holes is six, the axes of the six femoral positioning holes are parallel to each other, and the six femoral positioning holes are divided into three groups, namely the first femoral positioning hole group, the second femoral positioning hole group and the third femoral positioning hole group, which are distributed sequentially along the height direction of the second femoral apposition.

[0244] Each femoral positioning hole group includes two femoral positioning holes. The two femoral positioning holes in the first group are at the same horizontal height, as are those in the second and third groups. The height corresponding to the first group is the initial positioning height. The second group is located below the first group along the height of the second femoral contraption; therefore, switching the femoral positioning holes in the second group increases the osteotomy thickness. The third group is located above the first group along the height of the second femoral contraption; therefore, switching the femoral positioning holes in the third group decreases the osteotomy thickness.

[0245] Optionally, along the height direction of the second femoral contact portion, the distance between the first femoral positioning hole group and the second femoral positioning hole group is equal to the distance between the first femoral positioning hole group and the third femoral positioning hole group. Specifically, in this embodiment, along the height direction of the second femoral contact portion, the distance between the first femoral positioning hole group and the second femoral positioning hole group is greater than or equal to 2 mm, and the distance between the first femoral positioning hole group and the third femoral positioning hole group is greater than or equal to 2 mm.

[0246] There are two femoral fixation holes, and the axes of the two femoral fixation holes are not parallel to the axis of the femoral positioning holes.

[0247] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A tibial osteotomy guide plate (100), characterized in that, include: Tibial osteotomy guide (10), wherein the tibial osteotomy guide (10) is provided with a tibial osteotomy groove (11); Tibial first fitting portion (20), the tibial first fitting portion (20) is connected to the tibial osteotomy guide portion (10), the tibial first fitting portion (20) has a tibial first fitting surface (21) for fitting with the tibial articular surface (201); as well as Tibial second fitting part (30), the tibial second fitting part (30) is connected to the tibial osteotomy guide part (10), the tibial second fitting part (30) has a tibial second fitting surface (31) for fitting with the proximal side surface (202) of the tibia, and the tibial second fitting part (30) is provided with a tibial positioning hole (35); The first tibial contact surface (21) and / or the second tibial contact surface (31) are provided with a tibial side anti-slip structure (22).

2. The tibial osteotomy guide plate (100) as described in claim 1, characterized in that: The tibial anti-slip structure (22) includes multiple anti-slip protrusions.

3. The tibial osteotomy guide plate (100) as described in claim 1, characterized in that: The second tibial fitting portion (30) has multiple tibial positioning hole groups distributed sequentially along the tibial force line direction, and the axes of the tibial positioning holes (35) between different tibial positioning hole groups are parallel to each other.

4. The tibial osteotomy guide plate (100) as described in claim 1, characterized in that: The second tibial fitting part (30) is also provided with a tibial fixation hole (36), and the axis of the tibial fixation hole (36) is inclined relative to the axis of the tibial positioning hole (35).

5. The tibial osteotomy guide plate (100) as described in any one of claims 1-4, characterized in that: A weakened region (23) is formed at the position of the first tibial fitting portion (20) near the tibial osteotomy guide portion (10).

6. The tibial osteotomy guide plate (100) as described in claim 5, characterized in that: The weakened area (23) is provided with a perforated hole (24).

7. The tibial osteotomy guide plate (100) as described in any one of claims 1-4, characterized in that: The tibial osteotomy guide plate (100) also includes a force line rod mounting component (40), which is detachably connected to the tibial osteotomy guide portion (10), and the force line rod mounting component (40) is provided with a channel (41) for inserting the force line rod (50).

8. The tibial osteotomy guide plate (100) as described in claim 7, characterized in that: Either the force line rod mounting part (40) or the tibial osteotomy guide part (10) is provided with a socket (42) for the other to be inserted.

9. The tibial osteotomy guide plate (100) as described in any one of claims 1-4, characterized in that: The tibial osteotomy guide plate (100) includes two tibial first contact portions (20), and the tibial first contact surfaces (21) of the two tibial first contact portions (20) are respectively used to contact the medial articular surface and the lateral articular surface of the tibia.

10. The tibial osteotomy guide plate (100) as described in any one of claims 1-4, characterized in that: The tibial osteotomy guide plate (100) includes two tibial first contact portions (20), and the tibial first contact surfaces (21) of the two tibial first contact portions (20) are respectively used to contact the medial articular surface and the lateral articular surface of the tibia.

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