Device and method for correcting distal tibia deformity

Abstract

The invention discloses a device and a method for correcting distal tibia deformity. The device comprises a correction main body part and a correction auxiliary part, wherein the inner side surface of the correction main body piece is fitted and matched with the tibia surface of a patient; an osteotomy guide groove penetrating through the inner side surface and a plurality of kirschner wire grooves are formed in the outer side surface of the correction main body piece, and the side walls of the osteotomy guide groove and the kirschner wire grooves extend outwards from the inner side surface in the direction of a preset osteotomy angle and protrude out of the outer side surface; the kirschner wire groove is used for nailing a kirschner wire so as to fix the correction main body piece on the surface of the tibia, and the osteotomy guide groove is used for extending a saw blade so as to cut off the tibia; the correction auxiliary part comprises a wedge-shaped structure and a handle, the wedge-shaped structure is connected with the handle, and the wedge-shaped structure is used for correcting the relative spatial position of the near-end bone section and the far-end bone section. By means of the device, the osteotomy position and angle can be rapidly and accurately determined, the spatial position correction of the far-end bone section can be accurately indicated, and therefore accurate correction of the tibia far-end deformity is achieved.

Description

Technical Field

[0001] The present invention relates to the field of medical instruments, and in particular to a device and method for correcting distal tibia deformity. Background Art

[0002] Distal tibial deformity has a significant impact on human motor function, especially on the normal function of the tibiotalar joint surface. As one of the joints with the highest stress in the human body, the tibiotalar joint surface is used to channel the gravity transmitted from the trunk along the lower limbs, and at the same time provide a reaction force from the soles of the feet during the acceleration and elevation of the human body, thereby maintaining the body's flexible and precise posture adjustment and motor function. The distal tibia can produce various abnormal changes including angulation, displacement, rotation, etc. under various injuries, which can lead to significant differences in the anatomical axis and mechanical axis of the lower limb, not only resulting in the inability of the lower limb to provide normal mechanical support, but also causing inflammation and damage to the surrounding soft tissues under long-term abnormal force and activity, and then causing joint swelling and pain. In addition, the lower limb bones that have been in an abnormal force line state for a long time may also undergo abnormal bone remodeling under continuous and frequent stress loads of the human body, further aggravating the degree and range of bone deformity. Long-term abnormal joint movement of the lower limbs may also stimulate the autonomous compensation of the healthy limbs, thereby causing an overall change in the body posture and even leading to bone, muscle, and ligament lesions far away from the lesion site. It can be seen that the damage of distal tibial deformity is deep and wide, and has a profound impact on the patient's health and ability to live independently.

[0003] In terms of surgical techniques, supramalleolar osteotomy is the main treatment for correcting distal tibial deformity. The surgical method includes linear osteotomy (such as open wedge, closed oblique or neutral wedge) and circular dome osteotomy. Among them, open wedge linear osteotomy is widely used in clinical practice because of its intuitive and convenient surgical operation, definite clinical efficacy, and no loss of patient bone length. It is especially effective for angular deformity. Open wedge linear osteotomy can disconnect (truncate) the tibia at a predetermined position of the tibia, adjust the position and angle of the disconnected bone segment, and immediately give strong fixation, and use transplanted bone or artificial materials to fill the gap between the bone segments, thereby restoring the normal position, length and angle of the tibia bone. After reasonable comprehensive treatment and postoperative rehabilitation, the patient's tibial bone structure is expected to return to normal, the abnormally changed lower limb force line can be corrected, the soft tissue swelling and pain and limb motor function limitation are significantly improved, and the quality of life is significantly improved. However, in actual clinical practice, the large-scale promotion and application of this surgical method faces many limitations. The main reasons are:

[0004] (1) Difficulty in determining the osteotomy position and angle during surgery: Traditional supramalleolar osteotomy for distal tibial deformity correction surgery usually assesses the location and degree of the deformity based on the patient's physical examination and imaging data before surgery, and calculates the optimal position and angle for bone resection. However, in actual surgery, due to varying degrees of soft tissue coverage on the bone surface and limited surgical exposure field of view, the process of finding relevant bone anatomical landmarks to measure distances and angles and locate them will actually face considerable obstacles, making it difficult to confirm the osteotomy position and angle, which in turn leads to a decrease in the accuracy of osteotomy.

[0005] (2) It is difficult to correct the position and angle of the severed bone segment during surgery: After the tibia is severed at the predetermined osteotomy position and angle, it is necessary to perform spatial movement operations including rotation, bending, and stretching of the severed tibia segment according to the preoperative plan, and finally correct the deformed tibia by fixing the severed bone segment and filling the gap with new bone. However, the direction and degree of spatial position correction of the distal tibia are often very delicate and difficult to accurately grasp, especially for cases with very complex position and angle adjustments. During surgery, the surgeon usually relies on personal experience, combined with preoperative imaging and intraoperative observation, and uses limited tools to measure and adjust the position and angle of the severed bone segment in order to achieve the goal of preoperative planning. This process is complicated, time-consuming, and prone to errors. Sometimes, even if the initial osteotomy position and osteotomy angle are correct, the operation may fail due to improper subsequent adjustments.

[0006] In summary, the existing supramalleolar osteotomy correction surgery for distal tibial deformity has problems such as low osteotomy accuracy and difficulty in correcting tibia deformity. Summary of the invention

[0007] The purpose of the present invention is to provide a surgical device and method that can be customized according to the CT three-dimensional reconstruction structure of the patient's distal tibia and can guide precise supramalleolar osteotomy and correct adjustment of the spatial position of the deformed tibia.

[0008] In order to achieve the above object, the present invention provides a device for correcting distal tibial deformity, comprising:

[0009] A correction body, wherein the inner surface of the correction body is in the shape of a curved sheet, and fits and matches the patient's tibial surface; an outer surface of the correction body is provided with an osteotomy guide groove and a plurality of Kirschner wire grooves penetrating the inner surface, the side walls of the osteotomy guide groove and the Kirschner wire groove both extend outward from the inner surface in the direction of a preset osteotomy angle, and protrude from the outer surface, the Kirschner wire groove is used for Kirschner wires to be inserted to fix the correction body to the tibial surface, the osteotomy guide groove is used for a saw blade to be inserted to perform tibial segmentation, forming a proximal bone segment and a distal bone segment, and an osteotomy gap is provided between the proximal bone segment and the distal bone segment;

[0010] The correction auxiliary part includes a wedge-shaped structure and a handle, wherein the wedge-shaped structure is connected to the handle, and the wedge-shaped structure is used to fill the osteotomy gap so that the proximal bone segment and the distal bone segment are located at a set relative spatial position.

[0011] Furthermore, the wedge-shaped structure includes a first end surface and a second end surface, the first end surface matches the shape of the bone section of the proximal bone segment, and the second end surface matches the shape of the bone section of the distal bone segment.

[0012] Furthermore, the number of the Kirschner wire slots is 4 to 6.

[0013] Furthermore, the Kirschner wire grooves are symmetrically arranged on both sides of the osteotomy guide groove.

[0014] Furthermore, the inner diameter of the Kirschner wire groove is 3 mm to 4 mm, and the depth is 12 mm to 25 mm.

[0015] Furthermore, the width of the internal cross section of the osteotomy guide groove is 3 mm to 4 mm, the length of the internal cross section is 10 mm to 15 mm, and the depth of the osteotomy guide groove is 20 mm to 30 mm.

[0016] Furthermore, the correction main part and the correction auxiliary part are both made by 3D printing.

[0017] The present invention also provides a method for correcting distal tibial deformity, comprising:

[0018] Step S1, providing the above-mentioned device for correcting distal tibia deformity;

[0019] Step S2, after the inner surface of the correction main body is fitted into the tibia surface of the patient, a Kirschner wire is screwed into the Kirschner wire groove so that the correction main body is fixed to the tibia surface;

[0020] Step S3, extending the saw blade into the osteotomy guide groove along the inner wall of the osteotomy guide groove, cutting the tibia to form a proximal bone segment and a distal bone segment; an osteotomy gap is formed between the proximal bone segment and the distal bone segment;

[0021] Step S4, removing the correction main body component, filling the osteotomy gap with the wedge-shaped structure of the correction auxiliary component, adjusting the first end face of the wedge-shaped structure to fit the bone section of the proximal bone segment, and adjusting the position of the distal bone segment so that the bone section of the distal bone segment fits the second end face of the wedge-shaped structure, so that the proximal bone segment and the distal bone segment are located at a set relative spatial position;

[0022] Step S5, providing a fixing plate to maintain the relative spatial position of the proximal bone segment and the distal bone segment, fixing the two ends of the fixing plate to the side surfaces of the proximal bone segment and the distal bone segment respectively, removing the correction auxiliary component, and forming a bone implantation gap between the bone sections of the proximal bone segment and the distal bone segment;

[0023] Step S6, implanting bone material inside the bone implantation gap.

[0024] Furthermore, the fixing plate includes a plurality of Kirschner wire holes for inserting Kirschner wires to fix the two ends of the fixing plate to the side surfaces of the proximal bone segment and the distal bone segment respectively.

[0025] Furthermore, the bone material includes at least any one of transplanted bone and artificial bone.

[0026] Compared with the prior art, the beneficial effects of the present invention at least include:

[0027] The device of the present invention includes a correction main body and a correction auxiliary part. The correction main body and the correction auxiliary part are designed by software simulation based on the CT three-dimensional reconstruction structure of the patient's distal tibia to improve the efficiency and accuracy of the supramalleolar osteotomy correction surgery. The correction main body has a curved sheet-like inner surface that matches the patient's tibial surface, so that the device can be quickly and accurately positioned only by fitting with the tibial surface, without further expanding the surgical incision to determine the installation position of the device. At the same time, the osteotomy guide groove of the correction main body is designed according to the osteotomy position and osteotomy angle accurately calculated in the preoperative planning. After the correction main body is positioned, it can accurately guide the surgeon to perform osteotomy along the preset osteotomy position and osteotomy angle, thereby realizing the rapid execution of the osteotomy operation at the ideal position and angle.

[0028] Furthermore, the size and shape of the correction aid are customized according to the size and shape of the gap formed between the proximal bone segment and the distal bone segment after the spatial position correction, so that when the bone cross-sections of the proximal bone segment and the distal bone segment are fully in contact and fit with the correction aid, the spatial position correction of the bone structure of the deformed tibia can be achieved, further improving the accuracy and efficiency of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 It is a schematic structural diagram of the correction main body of the device for correcting distal tibial deformity of the present invention.

[0030] Figure 2 These are the side view, top view and front view of the correction main body of the device for correcting distal tibial deformity of the present invention; wherein A is the side view of the correction main body, B is the top view of the correction main body, and C is the front view of the correction main body.

[0031] Figure 3 It is a schematic diagram showing that the correction body of the device for correcting distal tibia deformity of the present invention is positioned and fixed on the distal tibia surface of the patient.

[0032] Figure 4 The present invention is a schematic structural diagram of a correction auxiliary component of a device for correcting distal tibial deformity.

[0033] Figure 5 The figures are the side view, top view and front view of the correction auxiliary component of the device for correcting distal tibial deformity of the present invention; wherein A is the side view of the correction auxiliary component, B is the top view of the correction auxiliary component, and C is the front view of the correction auxiliary component.

[0034] Figure 6 The present invention is a flow chart of the method for correcting distal tibia deformity; wherein A represents the disconnection and osteotomy after the installation of the correction main body, B represents the removal of the correction main body after the disconnection and osteotomy, and the preparation of filling the correction auxiliary parts between the bone sections of the proximal bone segment and the distal bone segment, C represents the filling of the correction auxiliary parts between the bone sections of the proximal bone segment and the distal bone segment to correct the relative spatial position of the proximal bone segment and the distal bone segment, and D represents the installation of the fixing plate on the side surface of the proximal bone segment and the distal bone segment after the relative spatial position correction of the proximal bone segment and the distal bone segment is completed.

[0035] Figure 7 It is a rendering of a clinical example of the present invention; wherein A represents the patient's preoperative tibia state, B represents the precise calculation of the device parameters required based on the CT three-dimensional reconstruction structure of the patient's distal tibia, C represents the correction main body and correction auxiliary parts designed based on the precise calculation results, D represents the use of the device of the present invention for surgical guidance, E represents the physical measurement of the bone implantation gap between the proximal bone segment and the distal bone segment, F represents the implantation of bone material in the bone implantation gap, and G represents that the patient's ankle (distal tibia) deformity is fully corrected as confirmed by imaging after the operation.

[0036] Description of the accompanying drawings:

[0037] Correction main body 10, Kirschner wire groove 11, osteotomy guide groove 12, Kirschner wire 13,

[0038] Correction aid 20, wedge-shaped structure 21, handle 22, first end surface 211, second end surface 212,

[0039] Proximal bone segment 31 , distal bone segment 32 , osteotomy gap 33 , bone implantation gap 34 . DETAILED DESCRIPTION

[0040] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0041] In the description of the present invention, it should be noted that the terms "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0042] The term "distal" as used herein refers to a direction close to a patient's foot, and the term "proximal" as used herein refers to a direction away from a patient's foot.

[0043] The "inner side" described herein refers to the side close to the patient's tibia, and the "outer side" described herein refers to the side away from the patient's tibia.

[0044] As described in the background technology, in the existing open wedge linear osteotomy, due to the limited surgical exposure field of view, the osteotomy position and angle of the distal tibial deformity are not accurate enough, and the position and angle of the severed bone segment are adjusted based on the surgeon's personal experience, which results in large errors and takes a long time, increasing the risk of surgical failure.

[0045] In order to solve the above problems, the present invention provides a device and method for correcting distal tibia deformity. According to the CT three-dimensional reconstruction structure of the distal tibia, the correction main body and correction auxiliary parts of the device are accurately designed before surgery, including the shape of the inner surface of the correction main body, the Kirschner wire groove on the outer surface, the position of the osteotomy guide groove and its extension angle, so that the surgeon can quickly and accurately locate the osteotomy position through the engagement of the inner surface of the correction main body with the tibia surface, and further guide the osteotomy angle and osteotomy position of the saw blade through the osteotomy guide groove to achieve a rapid osteotomy operation. Furthermore, the shape of the wedge-shaped structure of the correction auxiliary part is also accurately designed, so that after the wedge-shaped structure fills the osteotomy gap between the proximal bone segment and the distal bone segment, the proximal bone segment and the distal bone segment are adjusted so that the bone section and the surface of the wedge-shaped structure are in contact and fit, so that the proximal bone segment, the distal bone segment, and the wedge-shaped structure are restored to the normal tibial bone structure as a whole, thereby completing the spatial position correction of the distal tibia deformity.

[0046] The technical solution of the present invention is further described below in conjunction with the accompanying drawings.

[0047] A device for correcting distal tibial deformity of the present invention comprises a correction main body component 10 and a correction auxiliary component 20. Figures 1-2 The correction main body 10 of the device for correcting distal tibial deformity of the present invention is shown, wherein: Figure 2 A is a side view of the correction body 10, Figure 2 B is a top view of the correction body 10, Figure 2 C is a front view of the correction main body 10. The inner surface of the correction main body 10 is in the shape of a curved sheet. Before the operation, the shape of the inner surface of the correction main body 10 is designed according to the CT three-dimensional reconstruction structure of the patient's distal tibia to ensure that it accurately fits the tibial surface of the patient to be osteotomized, thereby ensuring that the tibial surface can clamp the inner surface of the correction main body 10 and guide the surgeon to quickly locate the osteotomy position. The outer surface of the correction main body 10 is provided with an osteotomy guide groove 12 and a plurality of Kirschner wire grooves 11 that pass through the inner surface. The side walls of the Kirschner wire groove 11 and the osteotomy guide groove 12 extend outward from the inner surface along the direction of the preset osteotomy angle and protrude from the outer surface. The position of the Kirschner wire groove 11 and the osteotomy guide groove 12 relative to the outer surface of the correction main body and the angle of outward extension can be obtained by precise calculation before the operation. Therefore, when the inner surface of the correction body 10 is engaged with the patient's tibial surface, the osteotomy position and osteotomy angle can be accurately guided by the osteotomy guide groove 12. The Kirschner wire groove 11 is used for the Kirschner wire 13 to be inserted to fix the correction body 10 to the tibial surface, see Figure 3 The osteotomy guide groove 12 is used for a saw blade to extend into to perform tibial segmentation to form a proximal bone segment and a distal bone segment, with an osteotomy gap between the proximal bone segment and the distal bone segment.

[0048] In some embodiments, the number of the Kirschner wire slots 11 is 4 to 6. When the surgical field of view is small, more Kirschner wire slots 11 are beneficial to provide the surgeon with more fixing point options, which is particularly important when some Kirschner wire slots 11 cannot be used due to soft tissue obstruction, avoiding the risk of unnecessary damage to the patient due to additional surgical incisions. As an example, in the present invention, four Kirschner wire slots 11 are provided on the outer surface of the correction body 10.

[0049] In some embodiments, see Figure 2 The Kirschner wire grooves 11 are symmetrically arranged on both sides of the osteotomy guide groove 12, thereby providing a more balanced fixing force for the osteotomy guide groove 12, helping to maintain the position stability of the osteotomy guide groove 12 and reducing the risk of displacement during surgery. As an example, the present invention sets two Kirschner wire grooves 11 on the upper side and the lower side of the osteotomy guide groove 12 respectively.

[0050] In some embodiments, the inner diameter of the Kirschner wire groove 11 is 3 mm to 4 mm, and the depth is 12 mm to 25 mm. The inner diameter and depth of the Kirschner wire groove 11 can be designed according to the size of the Kirschner wire required for the operation.

[0051] In some embodiments, see Figure 2 C, the width W of the internal cross section of the osteotomy guide groove 12 is 3mm to 4mm, the length L of the internal cross section is 10mm to 15mm, and the depth of the osteotomy guide groove 12 is 20mm to 30mm. The width W of the internal cross section of the osteotomy guide groove 12 is equivalent to the thickness of the saw blade to be used (W is slightly greater than or equal to the thickness of the saw blade), which helps to reduce the offset of the saw blade, thereby further improving the accuracy of osteotomy; the length L of the internal cross section is greater than the width of the saw blade, ensuring that the saw blade can smoothly extend into the interior of the osteotomy guide groove 12; the depth of the osteotomy guide groove 12 can be designed according to the length required for the operation to meet the requirement that the saw blade can perform reciprocating cutting motion to cut the tibia.

[0052] Figures 4-5 The corrective aid 20 of the device for correcting distal tibial deformity of the present invention is shown, wherein: Figure 5 A is a side view of the correction auxiliary member 20, Figure 5 B is a top view of the correction auxiliary member 20, Figure 5 C is a front view of the correction aid 20. The correction aid 20 includes a wedge-shaped structure 21 and a handle 22. The wedge-shaped structure 21 is connected to the handle 22. The wedge-shaped structure 21 is used to fill the osteotomy gap between the proximal bone segment and the distal bone segment, so that the proximal bone segment and the distal bone segment are located at a set relative spatial position. Before the operation, the wedge-shaped structure 21 is designed according to the CT three-dimensional reconstruction structure of the patient's distal tibia, so that the thickness of the wedge-shaped structure 21 and its inclination angle represent the size and shape of the gap formed after the proximal bone segment and the distal bone segment of the deformed tibia are corrected in space, ensuring that the thickness and inclination angle of the wedge-shaped structure 21 accurately match the gap state between the proximal bone segment and the distal bone segment of the patient's tibia, thereby achieving personalized and accurate osteotomy correction.

[0053] In some embodiments, the wedge-shaped structure 21 includes a first end face 211 and a second end face 212, the first end face 211 matches the shape of the bone cross-section of the proximal bone segment, and the second end face 212 matches the shape of the bone cross-section of the distal bone segment. When the bone cross-sections of the proximal bone segment and the distal bone segment are in contact with the first end face 211 and the second end face 212 respectively at the same time, the relative spatial positions of the proximal bone segment and the distal bone segment of the tibia conform to the normal spatial position relationship set in the preoperative planning, that is, at this time, the bone structure of the entire tibia has been fully restored and corrected according to the preoperative planning.

[0054] As an example, when the relative spatial positions of the proximal bone segment and the distal bone segment are in a misaligned relationship, the wedge-shaped structure 21 is filled in the gap between the proximal bone segment and the distal bone segment to expand the proximal bone segment and the distal bone segment, and the bone cross-sections of the proximal bone segment and the distal bone segment are respectively fitted and matched with the first end face 211 and the second end face 212 of the wedge-shaped structure 21, and then a fixing plate is installed on the side surfaces of the proximal bone segment and the distal bone segment to fix the positions of the proximal bone segment and the distal bone segment, and then the correction auxiliary component 20 is removed, so that the proximal bone segment and the distal bone segment are located at the set relative spatial positions, thereby realizing the correction of the relative spatial positions of the proximal bone segment and the distal bone segment.

[0055] In some embodiments, the correction main part 10 and the correction auxiliary part 20 are both made by 3D printing.

[0056] The present invention also provides a method for correcting distal tibial deformity using the above device, comprising the following steps:

[0057] Step S1, providing the above-mentioned device for correcting distal tibia deformity.

[0058] Preoperative planning is performed based on the CT three-dimensional reconstruction structure of the patient's distal tibia, and at least the following features are accurately calculated and designed: (1) the required morphology of the inner surface of the correction main body 10; (2) the required osteotomy position and osteotomy angle; (3) the size and shape of the gap required to be formed between the proximal bone segment 31 and the distal bone segment 32 with a normal spatial position relationship. According to the required gap size and shape, the wedge-shaped structure 21 of the correction auxiliary part 20 and the handle 22 that is convenient for the operator to hold are manufactured by 3D printing through software simulation design; according to the required morphology of the inner surface of the correction main body 10, the required osteotomy position and osteotomy angle, the inner surface of the correction main body 10, the osteotomy guide groove 12 and the Kirschner wire grooves 11 on both sides of the osteotomy guide groove 12 are manufactured by software simulation design.

[0059] Step S2, after the inner surface of the correction main body is embedded in the patient's tibial surface, the Kirschner wire is nailed into the Kirschner wire groove to fix the correction main body to the tibial surface.

[0060] See also Figure 6 A, the surgeon installs the inner surface of the correction main body 10 toward the patient's tibial surface through a surgical incision. When the inner surface of the correction main body 10 is completely engaged with the patient's tibial surface, it indicates that the osteotomy guide groove 12 of the correction main body 10 has reached the correct preoperative planned position, so that the saw blade can cut the tibia at the correct osteotomy position and osteotomy angle along the inner wall of the osteotomy guide groove 12.

[0061] When the patient's tibial surface is stuck to the inner surface of the correction body 10, the surgeon drives the Kirschner wire 13 into the Kirschner wire groove 11 exposed in the surgical field, and drives the distal end of the Kirschner wire 13 into the inside of the tibia, so that the correction body is fixed to the tibial surface.

[0062] Step S3, extending the saw blade into the osteotomy guide groove along the inner wall of the osteotomy guide groove, cutting the tibia to form a proximal bone segment and a distal bone segment; an osteotomy gap is provided between the proximal bone segment and the distal bone segment.

[0063] When a saw blade is used to perform reciprocating cutting of the tibia along the inner wall of the osteotomy guide groove 12, since the position and inclination angle of the osteotomy guide groove 12 relative to the outer surface of the correction main body 10 are accurately calculated and designed before the operation, the saw blade can perform the preoperatively planned cutting operation on the tibia along the preset osteotomy position and osteotomy angle, thereby improving the accuracy of the surgical operation. At the same time, there is no need for the surgeon to repeatedly observe and judge the osteotomy position and osteotomy angle, thereby improving the efficiency of the surgical operation.

[0064] See also Figure 6 B, after the tibia is cut off, the proximal end of the tibia is recorded as the proximal bone segment 31, and the distal end is recorded as the distal bone segment 32. There is an osteotomy gap 33 between the proximal bone segment 31 and the distal bone segment 32. At this time, the position and angle of the distal bone segment 32 can be finely adjusted relative to the proximal bone segment 31.

[0065] Step S4, removing the correction main body component, filling the osteotomy gap with the wedge-shaped structure of the correction auxiliary component, adjusting the first end face of the wedge-shaped structure to fit the bone section of the proximal bone segment, and adjusting the position of the distal bone segment so that the bone section of the distal bone segment fits with the second end face of the wedge-shaped structure, so that the proximal bone segment and the distal bone segment are located at a set relative spatial position.

[0066] See also Figure 6When the wedge-shaped structure 21 fills the osteotomy gap 33, since the size and shape of the wedge-shaped structure 21 are precisely calculated and designed before the operation, they can precisely match the size and shape of the gap that needs to be formed between the proximal bone segment 31 and the distal bone segment 32 of the deformed tibia after achieving the spatial position correction goal. By adjusting the position and angle of the wedge-shaped structure 21 relative to the proximal bone segment 31 and the distal bone segment 32 relative to the wedge-shaped structure 21, the two end surfaces of the wedge-shaped structure 21 are respectively in contact with and fit with the bone cross-sections of the proximal bone segment 31 and the distal bone segment 32, thereby achieving the consistency between the relative spatial position of the proximal bone segment 31 and the distal bone segment 32 of the tibia and the correct tibia position after correction planned before the operation, that is, achieving the preliminary restoration and correction of the tibial bone structure.

[0067] Step S5, providing a fixing plate to maintain the relative spatial position of the proximal bone segment and the distal bone segment, fixing the two ends of the fixing plate to the side surfaces of the proximal bone segment and the distal bone segment respectively, removing the correction auxiliary component, and forming a bone implantation gap between the bone sections of the proximal bone segment and the distal bone segment.

[0068] See also Figure 6 In some embodiments, the fixing plate 40 includes a plurality of Kirschner wire holes (not shown in the figure). The surgeon uses Kirschner wires (not shown in the figure) to nail into the Kirschner wire holes, so that the two ends of the fixing plate 40 are respectively fixed to the side surfaces of the proximal bone segment 31 and the distal bone segment 32, thereby fixing the relative spatial positions of the proximal bone segment 31 and the distal bone segment 32, ensuring that the proximal bone segment 31 and the distal bone segment 32 will not be displaced when the surgeon performs subsequent operations and the patient is in the subsequent rehabilitation stage, thereby maintaining the correct bone positions of the proximal bone segment 31 and the distal bone segment 32.

[0069] After the fixation of the fixation plate 40 is completed, the correction auxiliary component 20 is removed, and a bone implantation gap 34 is formed between the bone sections of the proximal bone segment 31 and the distal bone segment 32 .

[0070] Step S6, implanting bone material inside the bone implantation gap.

[0071] In some embodiments, the bone material includes but is not limited to transplanted bone and artificial bone. The bone material is filled into the bone implantation gap 34 between the bone sections of the proximal bone segment 31 and the distal bone segment 32, and then, through bone growth integration, the overall structure of the tibia will be completely restored and the distal tibia deformity will be fully corrected.

[0072] Clinical Examples

[0073] Figure 7 It is a rendering of a clinical example of the present invention. Figure 7A shows the patient's preoperative tibia condition. The dotted area L clearly shows the patient's left ankle joint is obviously deformed, the distal tibia is twisted, and the angle is abnormal. Figure 7 B shows that the surgeon performs personalized preoperative planning based on the patient's CT three-dimensional reconstruction structure of the distal tibia, including precise calculation of the morphology of the medial surface of the correction body, the osteotomy position, the osteotomy angle, and the size and shape of the gap formed between the proximal and distal bone segments after spatial position correction. Figure 7 C shows the correction main part and correction auxiliary part of the device designed by the surgeon according to the precise calculation results of the preoperative planning. It can be seen that the inner surface of the designed correction main part can be embedded with the distal surface of the patient's tibia, and the osteotomy line guided by the simulated osteotomy guide groove meets the preoperative planning requirements, proving that the osteotomy guide groove can correctly guide the osteotomy position and osteotomy angle; the designed correction auxiliary part can correct the relative spatial position relationship of the proximal bone segment and the distal bone segment of the tibia after completing the corresponding contact and fitting with the proximal bone segment and the distal bone segment of the tibia, and restore the normal tibial bone structure. Figure 7 D shows that the correction body of the device of the present invention is installed on the distal surface of the patient's tibia, and the device of the present invention is used for surgical guidance. Figure 7 E shows that after the spatial position of the tibia was corrected, the fixation plate was installed, and the correction aids were removed, the bone implant gap between the proximal bone segment and the distal bone segment measured physically met the preoperative planning requirements, thereby proving that the distal tibia structure has been restored to the correct state planned preoperatively. Figure 7 F shows the implantation of bone material into the bone implantation gap between the proximal bone segment and the distal bone segment. Figure 7 G shows that after the operation, the patient's ankle (distal tibia) deformity was fully corrected, the distal tibia twisting state disappeared, and the bone angle returned to normal, as confirmed by imaging.

[0074] In summary, the present invention provides a device and method for correcting distal tibial deformity, including a correction main part and correction auxiliary parts customized according to the patient's distal tibia CT three-dimensional reconstruction structure, aiming to improve the efficiency and accuracy of the operation. The curved sheet structure on the inner side of the correction main part matches the surface of the patient's tibia, achieving fast and accurate positioning without the need to expand the surgical incision. Its osteotomy guide groove can accurately restore the preoperatively planned osteotomy position and angle, making it easier for the surgeon to perform osteotomy. The correction auxiliary parts are customized according to the gap formed between the bone segments after the spatial position correction, ensuring that after the bone section is fitted with the indicator, the spatial position correction of the bone structure is achieved, further improving the accuracy and efficiency of the operation.

[0075] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0076] Although the content of the present invention has been described in detail through the above preferred embodiments, it should be appreciated that the above description should not be considered as a limitation of the present invention. After reading the above content, it will be apparent to those skilled in the art that various modifications and substitutions of the present invention will occur. Therefore, the protection scope of the present invention should be limited by the appended claims.

Claims

1. A device for correcting distal tibial deformity, characterized in that: include: A correction body, wherein the inner surface of the correction body is in the shape of a curved sheet, and fits and matches the patient's tibia surface; the outer surface of the correction body is provided with an osteotomy guide groove and a plurality of Kirschner wire grooves penetrating the inner surface, and the side walls of the osteotomy guide groove and the Kirschner wire groove both extend outward from the inner surface along the direction of a preset osteotomy angle and protrude from the outer surface; the Kirschner wire groove is used for inserting a Kirschner wire to fix the correction body to the tibia surface, and the osteotomy guide groove is used for inserting a saw blade to perform tibial amputation to form a proximal bone segment and a distal bone segment, and an osteotomy gap is provided between the proximal bone segment and the distal bone segment; The correction auxiliary part includes a wedge-shaped structure and a handle, wherein the wedge-shaped structure is connected to the handle, and the wedge-shaped structure is used to fill the osteotomy gap so that the proximal bone segment and the distal bone segment are located at a set relative spatial position.

2. The device for correcting distal tibial deformity according to claim 1, characterized in that: The wedge-shaped structure includes a first end surface and a second end surface. The first end surface matches the shape of the bone section of the proximal bone segment, and the second end surface matches the shape of the bone section of the distal bone segment.

3. The device for correcting distal tibial deformity according to claim 1, characterized in that: The number of the Kirschner wire slots is 4 to 6.

4. The device for correcting distal tibial deformity according to claim 1, characterized in that: The Kirschner wire grooves are symmetrically arranged on both sides of the osteotomy guide groove.

5. The device for correcting distal tibial deformity according to claim 1, characterized in that: The inner diameter of the Kirschner wire groove is 3mm to 4mm, and the depth is 12mm to 25mm.

6. The device for correcting distal tibial deformity according to claim 1, characterized in that: The width of the internal cross section of the osteotomy guide groove is 3 mm to 4 mm, the length of the internal cross section is 10 mm to 15 mm, and the depth of the osteotomy guide groove is 20 mm to 30 mm.

7. The device for correcting distal tibial deformity according to claim 1, characterized in that: The correction main part and the correction auxiliary part are both made by 3D printing.

8. A method for correcting distal tibial deformity, characterized in that: include: Step S1, providing a device for correcting distal tibial deformity as described in any one of claims 1 to 7; Step S2, after the inner surface of the correction main body is fitted into the tibia surface of the patient, a Kirschner wire is screwed into the Kirschner wire groove so that the correction main body is fixed to the tibia surface; Step S3, extending the saw blade into the osteotomy guide groove along the inner wall of the osteotomy guide groove, cutting the tibia to form a proximal bone segment and a distal bone segment; an osteotomy gap is formed between the proximal bone segment and the distal bone segment; Step S4, removing the correction main body component, filling the osteotomy gap with the wedge-shaped structure of the correction auxiliary component, adjusting the first end face of the wedge-shaped structure to fit the bone section of the proximal bone segment, and adjusting the position of the distal bone segment so that the bone section of the distal bone segment fits the second end face of the wedge-shaped structure, so that the proximal bone segment and the distal bone segment are located at a set relative spatial position; Step S5, providing a fixing plate to maintain the relative spatial position of the proximal bone segment and the distal bone segment, fixing the two ends of the fixing plate to the side surfaces of the proximal bone segment and the distal bone segment respectively, removing the correction auxiliary component, and forming a bone implantation gap between the bone sections of the proximal bone segment and the distal bone segment; Step S6, implanting bone material inside the bone implantation gap.

9. The method for correcting distal tibial deformity according to claim 8, characterized in that: The fixing plate comprises a plurality of Kirschner wire holes for inserting Kirschner wires to fix the two ends of the fixing plate to the side surfaces of the proximal bone segment and the distal bone segment respectively.

10. The method for correcting distal tibial deformity according to claim 8, characterized in that: The bone material includes at least any one of transplanted bone and artificial bone.

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