Cushion block for proximal tibia high-position osteotomy

Abstract

The invention relates to a cushion block for tibia near-end high-position osteotomy. The cushion block comprises a first cushion block body, a second cushion block body and a plurality of screws. The bottom of the first cushion block and the top of the second cushion block are in wedge-shaped connection to form a C-shaped cushion block main body; a plurality of connecting holes are formed in the connecting position of the first cushion block and the second cushion block, and the screws penetrate through the connecting holes in a one-to-one correspondence mode. A plurality of special-shaped through holes penetrating through the top and the bottom of the first cushion block are formed in the first cushion block; a loading groove is formed in the second cushion block, and the multiple special-shaped through holes communicate with the loading groove. Bone induction medicine is arranged in the special-shaped through hole and the loading groove; the thickness of the first cushion block is 3-12 mm; the wedge-shaped cushion block has the advantages that the problems that a solid wedge-shaped cushion block is poor in attaching performance and compresses soft tissue and medullary cavities are solved, the pain points such as soft tissue compatibility unbalance, follow-up operation interference and poor parameter adaptability are improved, and the comprehensive curative effect of the wedge-opening type HTO operation is remarkably improved.

Description

Technical Field

[0001] This invention relates to the field of mining technology, and more particularly to a pad for high proximal tibial osteotomy. Background Technology

[0002] High proximal tibial osteotomy (HTO) is a classic surgical procedure for treating medial compartment osteoarthritis of the knee combined with varus deformity. Its core principle is to correct the force line of the proximal tibia, transferring the load from the diseased medial compartment to the relatively normal lateral compartment, thereby relieving pain and delaying joint degeneration. Among them, open wedge HTO (open wedge high tibial osteotomy) is widely used in clinical practice because it does not require the removal of tibial bone and preserves more bone volume. This procedure usually relies on a solid wedge pad or plate fixation system to maintain the height of the medial tibial osteotomy opening, and achieves lateral force line shift through precise wedge angle design to ensure postoperative knee joint biomechanical balance.

[0003] However, existing wedge-shaped HTO support and fixation schemes still have many clinical challenges: First, long-term osseointegration is insufficient. Traditional solid wedge-shaped pads are mostly dense structures, lacking effective connection channels with bone tissue, resulting in low bone ingrowth efficiency and easy pad loosening or nonunion. Second, initial stability and soft tissue tension balance are poor. The rigid fixation of the plate system can easily lead to stress concentration on the osteotomy surface, while simple wedge-shaped pads cannot balance fixation strength and soft tissue tension adjustment, which may cause excessive traction of the medial soft tissue or fixation failure after surgery. Third, there is a potential interference with subsequent total knee arthroplasty (TKA). Some pads are too large or poorly positioned, which may encroach on the installation space of the TKA prosthesis and increase the difficulty of secondary surgery. Fourth, the problem of parameter dispersion is prominent. The thickness and angle specifications of existing pads are uniform, making it difficult to adapt to the size of the osteotomy gap and the force line correction needs of different patients, thus limiting the personalized treatment effect. Summary of the Invention

[0004] (a) Technical problems to be solved

[0005] In view of the above-mentioned shortcomings and deficiencies of the prior art, the present invention provides a pad for high osteotomy of the proximal tibia, which solves the technical problems of poor fit and compression of soft tissue and medullary cavity of the existing wedge-shaped pad.

[0006] (II) Technical Solution

[0007] To achieve the above objectives, the main technical solutions adopted by the present invention include:

[0008] This invention provides a pad for high proximal tibial osteotomy, comprising a first pad, a second pad, and multiple screws; the bottom of the first pad and the top of the second pad are wedge-shapedly connected to form a C-shaped pad body; multiple connecting holes are provided at the connection between the first pad and the second pad, and multiple screws are correspondingly inserted into the multiple connecting holes; the first pad has multiple irregularly shaped through holes penetrating its top and bottom; the second pad has a loading groove inside, and the multiple irregularly shaped through holes connect to the loading groove; bone-inducing drugs are placed in the irregularly shaped through holes and the loading groove; the thickness of the first pad is 3~12mm; the acute angle of inclination between the mounting surface of the top of the second pad and the horizontal plane is 0~15°.

[0009] Optionally, the cross-sectional size of the irregularly shaped through hole gradually decreases from the first end near the tibial cortex to the second end connecting to the loading groove; when the thickness of the first pad is 3~6mm; the cross-sectional size of the first end of the irregularly shaped through hole is 400~550μm; the cross-sectional size of the second end of the irregularly shaped through hole is 150~300μm; the rate of change of the cross-sectional size from the first end to the second end is 40~60μm / mm; when the thickness of the first pad is 7~12mm; the cross-sectional size of the first end of the irregularly shaped through hole is 550~800μm; the cross-sectional size of the second end of the irregularly shaped through hole is 150~300μm; the rate of change of the cross-sectional size from the first end to the second end is 50~70μm / mm.

[0010] Optionally, the bone-inducing drug includes: an antibacterial drug disposed at the first end of the irregular through-hole, with a loading of 0.2~0.4 μg / mm. 2 BMP-2 is installed in the middle of the irregularly shaped through-hole; VEGF is installed at the second end of the irregularly shaped through-hole with a loading of 0.2~0.3μg / mm. 2 BMP-7 is installed in the loading slot.

[0011] Optionally, the irregular through hole is a non-circular irregular channel with a polygonal irregular cross-sectional shape; the inner wall of the irregular through hole is arranged with multiple irregularly shaped protrusions.

[0012] Optionally, the height of the protrusion is 20~50μm, and the spacing between adjacent protrusions is 50~100μm; the long axis of the protrusion is parallel to the extension direction of the irregular through hole.

[0013] Optionally, an elastic pad is provided between the first pad and the second pad; the thickness of the elastic pad is 0.2~1.1mm.

[0014] Optionally, the thickness of the elastic pad and the thickness of the first pad are related as follows: when the first pad is 3mm, the elastic pad is 0.2mm; for every 1mm increase in the thickness of the first pad, the elastic pad increases by 0.1mm.

[0015] Optionally, the inner radius R of the C-shaped pad body is related to the anatomical curvature R of the medial cortical bone of the proximal tibia.骨 Satisfying the adaptation relationship:

[0016] R=R 骨 ×(1±0.1).

[0017] Optionally, the opening angle α of the C-shaped pad body and the thickness h of the first pad satisfy the following:

[0018] α = 60° + (h - 3) × k1;

[0019] Where k1 is the variation coefficient, and the unit is ° / mm.

[0020] Optionally, the angle θ between the extension direction of the irregular through-hole and the long axis of the tibia satisfies:

[0021] θ = 10° + (h - 3) × k2;

[0022] Where k2 is the variation coefficient, and the unit is ° / mm.

[0023] (III) Beneficial Effects

[0024] The beneficial effects of this invention are:

[0025] This invention provides a pad for high proximal tibial osteotomy. The C-shaped pad body, formed by a wedge-shaped connection of a first and second pad, has its opening facing the medial side of the tibia. This allows for precise conformation to the anatomical curvature of the medial cortical bone of the proximal tibia. Utilizing the enveloping nature of the C-shaped structure, stable support is achieved solely through the tibial cortical bone, preventing invasion of the medullary cavity and interference with intramedullary blood supply. Simultaneously, the C-shaped opening provides ample space for the medial soft tissue, effectively reducing the risk of excessive postoperative soft tissue tension. Multiple screws pass through the connection holes at the junction of the first and second pads to fix the first and second pads together. With the mechanical transmission of the wedge-shaped connection surface, the height of the osteotomy opening after open wedge-type HTO can be reliably maintained, ensuring the stability of initial fixation. Multiple irregular through holes in the first pad penetrate the top and bottom and connect to the loading groove of the second pad. This provides a directional channel for callus growth to promote long-term bone integration and can also accelerate healing through the synergistic effect of bone-inducing drugs in the loading groove. The thickness of the first pad (3-12mm) and the tilt angle of the second pad (0-15°) can flexibly adapt to the osteotomy gap and force line correction needs of different patients, reducing parameter dispersion problems. Moreover, the lightweight design of the C-shaped pad body avoids spatial interference with subsequent possible total knee arthroplasty (TKA). Compared to existing technologies, this pad solves the problems of poor fit, compression of soft tissue and medullary cavity caused by solid wedge-shaped pads through the anatomical adaptability of the C-shaped structure. Combined with irregular through holes, drug loading and adjustable parameter design, it simultaneously improves the pain points such as long-term insufficient osseointegration, imbalance between initial stability and soft tissue compatibility, subsequent surgical interference and poor parameter adaptability, and significantly improves the overall efficacy of wedge-shaped HTO surgery. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of a pad for high proximal tibial osteotomy in Embodiment 1 of the present invention, which is disposed on the tibia;

[0027] Figure 2 This is a schematic diagram of a pad for high proximal tibial osteotomy in Embodiment 1 of the present invention, which is set at another angle on the tibia;

[0028] Figure 3 This is a schematic diagram of the structure of the C-shaped pad body disposed on the tibia in Embodiment 1 of the present invention;

[0029] Figure 4 This is a schematic diagram of the structure of the C-shaped pad body in Embodiment 1 of the present invention, which is set at another angle of the tibia;

[0030] Figure 5 This is a schematic diagram of the structure of the C-shaped pad body in Embodiment 1 of the present invention;

[0031] Figure 6 This is a structural schematic diagram of the C-shaped pad body from another angle in Embodiment 1 of the present invention;

[0032] Figure 7 This is a schematic diagram of the structure of the first pad at the first angle in Embodiment 1 of the present invention;

[0033] Figure 8 This is a schematic diagram of the structure of the first pad at the second angle in Embodiment 1 of the present invention;

[0034] Figure 9 This is a schematic diagram of the structure of the first pad at the third angle in Embodiment 1 of the present invention;

[0035] Figure 10 This is a schematic diagram of the structure of the first pad at the fourth angle in Embodiment 1 of the present invention;

[0036] Figure 11 This is a schematic diagram of the structure of the second pad block in Embodiment 1 of the present invention;

[0037] Figure 12 This is a front view schematic diagram of the second pad block in Embodiment 1 of the present invention;

[0038] Figure 13 This is a front view schematic diagram of a pad for high osteotomy of the proximal tibia in Embodiment 2 of the present invention.

[0039] [Explanation of Labels in the Attached Image]

[0040] 1: First pad; 11: Irregular through hole; 12: Protrusion; 2: Second pad; 21: Loading groove; 3: Screw; 4: Elastic pad. Detailed Implementation

[0041] To better understand the above technical solutions, exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that the present invention can be understood more clearly and thoroughly, and that the scope of the present invention can be fully conveyed to those skilled in the art.

[0042] Example 1:

[0043] like Figures 1-6 As shown, a specific embodiment of the present invention provides a pad for high proximal tibial osteotomy, including a first pad 1, a second pad 2, and a plurality of screws 3; the bottom of the first pad 1 and the top of the second pad 2 are wedge-shapedly connected to form a C-shaped pad body; a plurality of connecting holes are provided at the connection between the first pad 1 and the second pad 2, and the plurality of screws 3 are correspondingly inserted into the plurality of connecting holes to fix the first pad 1 and the second pad 2; the first pad 1 has a plurality of irregularly shaped through holes 11 penetrating its top and bottom; the second pad 2 has a loading groove 21, and the plurality of irregularly shaped through holes 11 connect to the loading groove 21; bone-inducing drugs are placed in the irregularly shaped through holes 11 and the loading groove 21; the thickness of the first pad 1 is 3~12mm; the acute angle of inclination between the mounting surface of the top of the second pad 2 and the horizontal plane is 0~15°. The thickness of the first pad 1 is increased in increments of 1 mm to form a series of specifications, including 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, and 12 mm; the acute angle of inclination between the top mounting surface of the second pad 2 and the horizontal plane is increased in increments of 1° to form a series of specifications, including 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 11°, 12°, 13°, 14°, and 15°.

[0044] Specifically, the C-shaped pad body formed by the wedge-shaped connection of the first pad 1 and the second pad 2 has its opening facing the medial side of the tibia. It can conform to the anatomical curvature of the medial cortical bone of the proximal tibia. Utilizing the embracing characteristic of the C-shaped structure, it relies solely on the tibial cortical bone for stable support, avoiding invasion into the medullary cavity and interference with intramedullary blood supply. At the same time, the C-shaped opening provides ample space for the medial soft tissue, which can effectively reduce the risk of excessive soft tissue tension after surgery. Multiple screws 3 pass through the connection holes at the junction of the first pad 1 and the second pad 2 to fix the first pad 1 and the second pad 2. With the mechanical transmission of the wedge-shaped connection surface, the height of the osteotomy opening after the open wedge HTO procedure can be reliably maintained, ensuring the stability of the initial fixation. Multiple irregular through holes 11 in the first pad 1 penetrate the top and bottom and connect to the loading groove 21 of the second pad 2. This provides a directional channel for callus growth to promote long-term bone integration and can also accelerate healing through the synergistic effect of the bone-inducing drugs in the loading groove 21. The thickness of the first pad 1 (3-12 mm) and the tilt angle of the second pad 2 (0-15°) can flexibly adapt to the osteotomy gap and force line correction needs of different patients, reducing parameter dispersion problems. Moreover, the lightweight design of the C-shaped pad body avoids spatial interference with subsequent possible total knee arthroplasty (TKA). Compared to existing technologies, this pad solves the problems of poor fit, compression of soft tissue and medullary cavity caused by solid wedge-shaped pads through the anatomical adaptability of the C-shaped structure. Combined with the irregular through-hole 11, drug loading and adjustable parameter design, it simultaneously improves the pain points such as long-term insufficient osseointegration, imbalance between initial stability and soft tissue compatibility, subsequent surgical interference and poor parameter adaptability, and significantly improves the overall efficacy of wedge-shaped HTO surgery.

[0045] Furthermore, the opening of the C-shaped pad faces the medial side of the tibia, with an opening angle of 60°~90°; the radius of the inner arc of the C-shape is 8mm~15mm, which matches the anatomical curvature of the medial cortex of the proximal tibia, and the radius of the outer arc is 15mm~25mm; the inner wall of the C-shaped pad (the side in contact with the tibia) has anatomical textures with a depth of 0.1mm~0.2mm, and the texture direction is consistent with the bone texture of the medial cortex of the tibia. The opening of the C-shaped pad faces the medial side of the tibia at an angle limited to 60°~90°. This not only adapts to the anatomical space of the proximal medial side of the tibia, reserving sufficient buffer area for medial soft tissues (such as the pes anserine and medial collateral ligament), avoiding postoperative soft tissue pressure that could cause pain or functional limitations, but also ensures circumferential support for the osteotomy surface through a reasonable opening range. The medial arc radius of 8mm~15mm precisely matches the natural anatomical curvature of the medial cortex of the proximal tibia, while the lateral arc radius of 15mm~25mm reduces volume redundancy while ensuring structural strength, avoiding excessive space occupation that could interfere with subsequent possible total knee replacement surgery. The anatomical texture of the medial wall, 0.1mm~0.2mm deep, is consistent with the bone texture of the medial cortex of the tibia. This micro-concave-convex structure increases the friction with the bone surface, improving the anti-slip performance of initial fixation, and guides callus growth along the texture direction, promoting the biological fusion of the pad and bone tissue, thus solving the problems of loosening or delayed osseointegration caused by poor adhesion of traditional pads. Through anatomically adaptable design, the overall structure achieves synergy between mechanical support, soft tissue compatibility, and bone integration guidance, significantly improving the stability and healing efficiency after wedge-shaped HTO surgery.

[0046] Furthermore, the opening angle α of the C-shaped pad body and the thickness h of the first pad 1 satisfy the following:

[0047] α = 60° + (h - 3) × k1;

[0048] Wherein, k1 is a variation coefficient, with units of ° / mm, and in this embodiment, k1 is 3° / mm. When the thickness of the first pad 1 is 3mm (corresponding to a smaller osteotomy gap), the opening angle is 60°, which can precisely fit the anatomical space of the medial side of the tibia for mild varus correction; as the thickness h increases (the osteotomy gap increases), the opening angle α increases at a rate of 3° / mm (maximum not exceeding 90°), which can simultaneously adapt to a larger range of osteotomy correction needs. This design avoids the problems of unstable support due to excessive angle of thin pads and compression of medial soft tissues (such as pes anserine) due to excessive angle of thick pads under a fixed angle. It also ensures that the C-shaped body always forms an effective circumferential support for the osteotomy surface through the linkage of angle and thickness, while reserving sufficient buffer space for soft tissues under different osteotomy ranges, thus balancing mechanical stability and soft tissue compatibility. Compared to the shortcomings of existing pads that cannot adapt to diverse osteotomy needs due to their single angle, this dynamic relationship significantly improves the pad's ability to be personalized to different patients' individual differences and different degrees of correction, reducing postoperative complications caused by angle mismatch.

[0049] Furthermore, the inner radius R of the C-shaped pad body is related to the anatomical curvature R of the medial cortical bone of the proximal tibia. 骨 Satisfying the fit relationship: R=R 骨 × (1±0.1). It can match the individualized anatomical morphology of the medial proximal tibia of different patients, ensuring that the medial wall of the pad forms a large area of ​​tight fit with the bone cortex, avoiding the problems of poor local fit or excessive compression caused by the mismatch between the traditional fixed radius design and the patient's anatomical curvature; the tight fit structure not only increases the mechanical transmission area, effectively disperses the supporting pressure of the osteotomy surface, and reduces bone damage caused by local stress concentration, but also improves the initial stability of the pad through anatomical adaptation, reducing the risk of postoperative loosening. At the same time, it reserves space for the medial soft tissue to fit the anatomical morphology, further reducing pain or functional limitation caused by soft tissue compression and traction, and significantly improving the anatomical compatibility and clinical application safety of the pad.

[0050] Furthermore, in this embodiment, the cross-sectional size of the irregular through hole 11 gradually decreases from the first end near the tibial cortex to the second end connecting the loading groove 21; when the thickness of the first pad 1 is 3~6mm; the cross-sectional size of the first end of the irregular through hole 11 is 400~550μm; the cross-sectional size of the second end of the irregular through hole 11 is 150~300μm; the rate of change of the cross-sectional size from the first end to the second end is 40~60μm / mm; when the thickness of the first pad 1 is 7~12mm; the cross-sectional size of the first end of the irregular through hole 11 is 550~800μm; the cross-sectional size of the second end of the irregular through hole 11 is 150~300μm; the rate of change of the cross-sectional size from the first end to the second end is 50~70μm / mm. For thin pads of 3-6 mm (corresponding to smaller osteotomy gaps), the size of the first end (400-550 μm) provides ample channel for the initial growth of callus on the tibial cortical side, while the contraction size of the second end (150-300 μm) guides the callus to focus its growth towards the loading groove 21. The change rate of 40-60 μm / mm adapts to the need for rapid callus penetration under small gaps, while avoiding excessively large through holes that weaken the pad's structural strength. For thick pads of 7-12 mm (corresponding to larger osteotomy gaps), the larger size of the first end (550-800 μm) provides more ample growth space for callus to cross wide gaps, while the higher change rate of 50-70 μm / mm ensures that the callus can gradually converge and effectively connect as it grows from both sides towards the middle, avoiding interruption of callus growth due to excessively large gaps. The second end, uniformly maintained at 150-300 μm, ensures precise connection with the drug release area of ​​the loading groove 21, enhancing the promoting effect of osteoinducing drugs on callus fusion. This dynamically adjusted dimensional gradient, which varies with the thickness of the pad, not only solves the problems of "insufficient strength" in thin pads or "insufficient bone ingrowth" in thick pads with fixed-size through holes, but also significantly improves the balance between bone integration efficiency and structural stability by matching the speed and path of callus growth under different gaps through the differentiated design of the rate of change.

[0051] Specifically, the rate of change of cross-sectional dimensions from the first end to the second end refers to the rate at which the cross-sectional dimensions of the irregular through-hole 11 decrease with the length of the through-hole (i.e., the thickness of the first pad 1 penetrated by the irregular through-hole 11, which is equal to the thickness of the first pad 1) from the first end near the tibial cortex to the second end connecting the loading groove 21. Specifically, it is the ratio of the "difference in cross-sectional dimensions between the first and second ends" to the "length of the irregular through-hole 11 (i.e., the thickness of the first pad)," expressed in μm / mm (micrometers per millimeter). This represents the number of micrometers by which the cross-sectional dimensions decrease for every 1 mm extension of the irregular through-hole 11. For example, for a first pad 1 with a thickness of 5 mm (5 mm in length of the irregular through-hole 11), if the cross-sectional dimensions of the first end of the irregular through-hole 11 are 500 μm and those of the second end are 200 μm, the difference in dimensions is 300 μm. Therefore, the rate of change is 300 μm ÷ 5 mm = 60 μm / mm, meaning that for every 1 mm extension of the irregular through-hole 11, the cross-sectional dimensions decrease by 60 μm.

[0052] Furthermore, in this embodiment, the bone-inducing drug includes an antibacterial drug disposed at the first end of the irregular through-hole 11, with a loading amount of 0.2~0.4 μg / mm. 2 BMP-2 is provided in the middle of the irregular through hole 11; VEGF is provided at the second end of the irregular through hole 11, with a loading of 0.2~0.3μg / mm. 2 The loading slot 21 contains BMP-7. The antibacterial drug at the first end of the irregular through-hole 11 acts directly on the osteotomy interface near the tibial cortex, and is rapidly released in the early postoperative period to inhibit local bacterial growth and specifically reduce the risk of infection in open osteotomy. The BMP-2 (bone morphogenetic protein-2) in the middle is in the core area of ​​callus growth and can efficiently induce osteoblast differentiation and proliferation, promoting the fusion of callus from both sides to the middle, matching the most active stage of bone growth in the middle of the through-hole. The VEGF (vascular endothelial growth factor) at the second end is close to the loading slot 21 and can promote the extension of new blood vessels into the depth of the through-hole, providing sufficient nutrition for callus growth and solving the problem of delayed healing caused by insufficient blood supply to bone tissue in the thick pad (large osteotomy gap). The BMP-7 in the loading slot 21 is continuously released through the communication structure with the irregular through-hole 11, forming a synergistic effect with BMP-2, strengthening the maturation and remodeling of callus, and ensuring long-term bone integration strength. This layered drug system of "anti-infection-bone induction-vascularization-long-term enhancement," combined with the gradient size and directional extension design of the pores, precisely covers all stages of bone healing. It avoids the problem of inefficiency caused by single drugs or disordered distribution, significantly improves the speed and quality of osteotomy healing, and reduces the risk of complications such as nonunion and infection.

[0053] It should be noted that the bone-inducing drug loading system has diverse adaptability and precise targeting. In addition to the core antibacterial drugs, BMP-2, VEGF, and BMP-7, the types of drugs can be flexibly replaced or supplemented according to clinical needs: For patients at high risk of infection, broad-spectrum antibacterial drugs such as gentamicin and vancomycin can be added to the first end of the irregular through-hole, and the loading amount can be adjusted to 0.3~0.5μg / mm² according to the infection risk level; For patients with osteoporosis, parathyroid hormone or bisphosphonates can be added to the loading tank to enhance callus mineralization and increase bone density; For patients with delayed healing, fibroblast growth factor can be supplemented to promote soft tissue repair and callus connection. Drug loading methods encompass various forms, including physical adsorption, encapsulation with biocompatible carriers (such as collagen and chitosan microspheres), and hydroxyapatite coating composites. Among these, carrier encapsulation technology enables controlled drug release cycles, avoiding rapid drug loss caused by physical adsorption alone, and ensuring a sustained and effective drug concentration at each stage of bone healing. Furthermore, all drugs have undergone biocompatibility verification to avoid triggering immune rejection or local tissue irritation, thus achieving diversified clinical adaptation goals.

[0054] Furthermore, such as Figures 7-12 As shown, the irregularly shaped through-hole 11 is a non-circular, irregular channel with a polygonal, irregular cross-sectional shape. Multiple irregularly shaped protrusions 12 are arranged on the inner wall of the irregularly shaped through-hole 11. The non-circular polygonal, irregular cross-sectional design of the irregularly shaped through-hole 11 significantly increases the contact area with bone tissue. The corners of its polygonal structure provide more attachment sites for osteoblasts, preventing callus slippage due to a smooth contact surface. The multiple irregularly shaped protrusions 12 arranged on the inner wall of the through-hole further expand the effective surface area of ​​the hole wall and form a micro-anchoring structure. During callus growth, these protrusions can interlock with each other, enhancing the mechanical interlocking effect of the bone-cushion interface and reducing the risk of postoperative cushion loosening. The combination of this polygonal irregular cross-section and irregular protrusions 12 on the inner wall creates a microenvironment conducive to bone tissue growth. It provides ample space for callus attachment and proliferation, and strengthens the mechanical connection through structural interlocking. This effectively solves the problems of small contact area and insufficient bone integration strength in traditional smooth circular channels, and significantly improves the biological integration efficiency and mechanical stability of the pad and bone tissue.

[0055] Specifically, the height of the protrusion 12 is 20-50 μm, and the spacing between adjacent protrusions 12 is 50-100 μm; the long axis of the protrusion 12 is parallel to the extension direction of the irregular through-hole 11. The parameter design of the protrusion 12 height of 20-50 μm and the adjacent spacing of 50-100 μm ensures the compactness of the microstructure of the pore wall, avoiding the protrusion 12 being too high or too dense and blocking the through-hole, thus affecting the callus penetration and nutrient transport. At the same time, it can form sufficient space for bone tissue attachment and growth through reasonable height difference and spacing, allowing osteoblasts to proliferate stably along the surface and gaps of the protrusion 12. The design that the long axis of the protrusion 12 is parallel to the extension direction of the irregular through-hole 11 can form a directional guiding trajectory, guiding the callus to grow in an orderly manner along the extension direction of the through-hole, avoiding growth disorder caused by disordered accumulation of bone tissue in the pore. This quantitative microstructure design not only strengthens the mechanical interlocking strength between the callus and the pore wall (the interlocking effect between the protrusion 12 and the callus enhances interface stability), but also optimizes the bone ingrowth path through directional guidance, further compensating for the defects of low bone integration efficiency and weak connection caused by traditional smooth channels or irregular protrusions 12, and significantly improving the biological integration quality and long-term stability of the pad and bone tissue.

[0056] Furthermore, the porous system constructed by the irregular through-holes 11 takes into account both macroscopic connectivity and microscopic biomimetic design. Besides the core size gradient and inner wall protrusions, the pore structure parameters can be dynamically optimized according to the size of the osteotomy gap and bone healing requirements: the porosity is controlled at 30%~60%. When the thickness of the first pad is 3~6mm, a porosity of 30%~40% is used to ensure structural strength; when the thickness of the first pad is 7~12mm, a porosity of 45%~60% is used to improve bone ingrowth efficiency. The irregular through-holes 11 are distributed in a uniform and locally denser pattern, with the irregular through-holes 11 appropriately denser in the stress-bearing core area of ​​the osteotomy surface (spacing 1~2). The non-core area maintains a spacing of 2-3 mm between the irregularly shaped through-holes 11, ensuring balanced mechanical support while enhancing bone integration in key areas. The cross-sectional shape of the irregularly shaped through-holes 11 can be adapted to polygonal irregularities, as well as triangular, trapezoidal, and other biomimetic structures, with rounded corners (radius 5-10 μm) to avoid stress concentration and bone tissue damage. In addition to irregular shapes, the inner wall protrusions can adopt spiral, longitudinal rib, and other directional structures to further guide callus growth along a predetermined path. Simultaneously, nanoscale grooves (50-100 nm wide) can be set on the protrusion surface to enhance osteoblast adhesion and proliferation. This porous system, through multi-dimensional parameter synergy, simulates the porous structure characteristics of natural bone, achieving functional integration of mechanical support, bone ingrowth channels, and drug sustained-release carrier.

[0057] Furthermore, the angle θ between the extension direction of the irregular through-hole 11 and the long axis of the tibia satisfies:

[0058] θ = 10° + (h - 3) × k2;

[0059] Wherein, k2 is a variation coefficient, with units of ° / mm, and in this embodiment, k2 is 1° / mm. When the thickness of the first pad 1, h, is 3mm (corresponding to a smaller osteotomy gap), θ = 10°. At this time, the direction of the through hole conforms to the initial growth path of the callus from the medial cortex of the tibia to the lateral side, guiding the early callus to extend steadily along a gentle angle. As h increases (the osteotomy gap widens), θ increases at a rate of 1° / mm, so that the direction of the through hole is adjusted synchronously with the increase of the gap, adapting to the natural growth angle when the callus needs to cross a larger distance. This design avoids the limitations of a fixed angle: if the angle is too small, the callus under the thick pad (large gap) may not be able to penetrate the entire osteotomy area due to the gentle path, resulting in interrupted healing; if the angle is too large, the callus under the thin pad (small gap) is prone to deviate from the normal growth trajectory and adhere to the surrounding soft tissue. The dynamic angle ensures that the irregularly shaped through-hole 11 always aligns with the physiological path of callus growth. Combined with the directional guidance of the protrusion 12 on the inner wall of the hole, this significantly improves the efficiency and precision of bone ingrowth, reduces the risk of nonunion, and ensures that the connection strength of the callus formed along the through-hole direction matches the size of the osteotomy gap, balancing the quality of bone healing under different thickness pads. Compared to the poor adaptability caused by the fixed through-hole angle in existing technologies, this design further enhances the advantage of "dynamic synergy between structure and bone growth," accelerating postoperative functional recovery.

[0060] Furthermore, the irregularly shaped through-holes 11 of the first pad 1, through their own through-hole characteristics and through-hole design with the loading groove 21, construct a "drug storage and bone guiding channel system" to achieve active guidance and bidirectional interaction in the bone healing process: these irregularly shaped through-holes 11 provide clear path guidance for callus growth, allowing bone healing precursor cells and blood vessels to migrate and proliferate in an orderly and directional manner from the host bone bed to the implant along the axis of the through-holes, rather than forming disordered encapsulation on the implant surface. This directional growth mode simulates the natural bone "creeping replacement" process, helping to form a bone-implant composite structure with better mechanical properties and higher bonding strength. The irregularly shaped through-holes 11 have multiple functions. They are drug release windows, with each non-circular, irregularly shaped through-hole being a local drug reservoir. Their complex shape and distribution can form a guiding channel network that guides callus growth into the implant from different directions and at different rates. They are also material exchange channels between bone and implant, ensuring nutrient delivery and metabolic waste removal. The irregular biomimetic perforated structure maximizes the specific surface area, creating a biomechanical microenvironment conducive to osteogenic formation and facilitating rapid and efficient osseointegration between the top of the first pad 1, the bottom of the second pad 2, and the bone bed. Simultaneously, it provides a complex adhesion and release pathway for drugs, forming an ideal sustained-release kinetic curve and avoiding potential drug release "short circuits" or blind spots that may occur with regular channels. The irregular edges of the irregular perforations 11 create micro-stress concentration zones, actively stimulating osteoblasts to aggregate and differentiate towards the perforation edges based on the principle of bone tissue adapting to mechanical stimulation, accelerating callus formation and anchoring. Furthermore, the pore size formed by the irregular perforations 11 and the loading groove 21 gradually changes from the bone bed side (first end) to the loading groove 21 side (second end), and the meandering channel structure effectively reduces tissue fluid erosion, allowing drugs to remain within the perforations for a longer period, forming a persistent "drug-rich area" at the bone-implant interface, significantly improving factor utilization efficiency. This micro-shaped through-hole 11 design works in perfect harmony with the macro-mechanical support of the C-shaped pad body. It not only ensures the overall stability after implantation through the C-shaped structure, but also enhances the micro-biointegration effect with the micro-shaped through-hole 11, further improving the quality of bone healing and long-term reliability.

[0061] Furthermore, in this embodiment, the first pad 1 and the second pad 2 are made of tantalum metal or Ti-6Al-4VELI titanium alloy; the first pad 1 and / or the second pad 2 are provided with 1 to 2 radiopaque markings, which are tungsten wires or tantalum wires. The first implant 1 and the second implant 2 are made of tantalum metal or Ti-6Al-4VELI titanium alloy. Both materials have excellent biocompatibility, which can reduce the risk of postoperative foreign body reaction and rejection. Their mechanical properties are highly compatible with human bone tissue, which can ensure the support strength to maintain the stability of the osteotomy gap, while avoiding stress concentration on the osteotomy surface due to excessive rigidity. The porous nature of tantalum metal can further promote bone ingrowth, while Ti-6Al-4VELI titanium alloy is both lightweight and corrosion resistant, suitable for long-term implantation. The 1-2 tungsten or tantalum wire radiopaque markers set in the first implant 1 and / or the second implant 2 can be clearly seen in postoperative X-ray and CT images, which can help doctors accurately confirm whether the implant position has deviated, the fit with bone tissue and the progress of osteotomy gap healing. No additional invasive examinations are required, simplifying the follow-up process. At the same time, it provides a clear positioning reference for possible secondary surgery, which significantly improves the safety of implantation, long-term stability and postoperative monitoring convenience.

[0062] It should be noted that the materials used for the first pad 1 and the second pad 2 cover a variety of high-performance biomedical metal materials. In addition to tantalum metal and Ti-6Al-4VELI titanium alloy, Ti-Nb-Zr-Ta (TNZT) β-type titanium alloy, cobalt-chromium-molybdenum (Co-Cr-Mo) alloy and medical stainless steel (such as 316LVM) can also be selected. TNZT alloy has an elastic modulus (40~60GPa) that is closer to that of human bone, which can minimize the stress shielding effect and is especially suitable for patients with osteoporosis. Co-Cr-Mo alloy has excellent mechanical strength and strong wear and corrosion resistance, and is suitable for osteotomy surface support in long-term weight-bearing scenarios. Medical stainless steel has controllable cost and excellent processing performance, which can meet the clinical needs of primary medical institutions. All materials undergo surface modification treatments, including micro-arc oxidation to form an oxide ceramic layer, hydroxyapatite coating deposition, and plasma nitriding. The hydroxyapatite coating thickness is controlled at 50-200 μm, forming a chemical bond with bone tissue and improving biocompatibility and bone integration rate. Micro-arc oxidation treatment forms a porous oxide film (pore size 1-5 μm) on the material surface, further enhancing drug loading capacity and cell adhesion. The diversified design of material selection and surface modification not only meets the differences in physical condition of different patients (e.g., patients with metal allergies can preferentially choose ceramic-coated modified materials) but also adapts to the performance requirements of different clinical scenarios, taking into account biosafety, mechanical reliability, and clinical economy.

[0063] The padding used for high proximal tibial osteotomy provided in this embodiment is used as follows: Preoperative preparation: High-resolution CT scan is used to obtain the patient's proximal tibial anatomical data. Three-dimensional reconstruction is performed using medical image processing software. The anatomical curvature Rbone of the medial cortical bone of the proximal tibial bone is measured according to the formula R=Rbone. 骨 ×(1±0.1) Determine the inner radius of the C-shaped pad body; at the same time, combine the preoperative force line analysis results to calculate the required osteotomy gap size, match the first pad 1 with the corresponding thickness (e.g., if the osteotomy gap is 4mm, select the first pad 1 with a thickness of 4mm), and check the loading amount of bone induction drugs in the irregular through hole 11 and loading groove 21 (ensure that the antibacterial drug is 0.2~0.4μg / mm² and VEGF is 0.2~0.3μg / mm²), and complete the pre-assembly and sterilization of the pad. Intraoperative procedure: After completing the wedge-shaped HTO osteotomy, first clean the residual bone and soft tissue on the osteotomy surface. Place the main opening of the C-shaped pad facing the medial side of the tibia, so that the anatomical texture of the medial wall 0.1~0.2mm deep is aligned with the texture of the medial cortical bone of the tibia. After confirming that the pad position is not offset and the force line correction is up to standard through intraoperative C-arm fluoroscopy, insert the screws 3 one by one into the connection hole, pre-tighten to fix the position, and then fully tighten to the specified torque (usually 8~10 N·m) to ensure that the wedge-shaped connection surface fits tightly and avoids gaps on the osteotomy surface. Postoperative monitoring: Within one week postoperatively, X-rays were used to observe the position of the radiopaque markers (tungsten / tantalum wire) to confirm that the padding was not loose or displaced; CT scans were performed at 4 and 12 weeks postoperatively to monitor the callus growth within the irregular through-hole 11 (focusing on whether the callus has advanced along the direction of the through-hole); during postoperative rehabilitation, patients were instructed to perform knee joint mobility training in stages to avoid excessive weight-bearing, and the progress of osseointegration was assessed based on imaging results until 6-12 months postoperatively when it was confirmed that the callus had completely penetrated the irregular through-hole 11 and the osteotomy surface had achieved stable healing, and then normal activities were gradually resumed.

[0064] Example 2:

[0065] This embodiment provides a pad for high proximal tibial osteotomy, including all the structures of the pad described in Embodiment 1.

[0066] In this embodiment, as Figure 13As shown, an elastic pad 4 is also provided between the first pad 1 and the second pad 2; the thickness of the elastic pad 4 is 0.2~1.1mm. Specifically, the thickness of the elastic pad 4 corresponds to the thickness of the first pad 1 as follows: when the first pad 1 is 3mm, the elastic pad 4 is 0.2mm; for every 1mm increase in the thickness of the first pad 1, the elastic pad 4 increases by 0.1mm. The elastic cushion 4 effectively buffers stress concentration on the osteotomy surface, avoiding abrupt mechanical transmission caused by the rigid connection between the first cushion 1 and the second cushion 2, and reducing postoperative osteotomy surface pain and bone damage risk. The linkage design between the thickness of the elastic cushion 4 and the thickness of the first cushion 1 (3mm cushion corresponds to 0.2mm liner, with a 0.1mm increase in liner thickness for every 1mm increase in cushion thickness) adapts to the mechanical needs of different osteotomy gaps—the smaller the osteotomy gap (the thinner the cushion), the thinner the elastic cushion 4 to ensure support stability and avoid force line shift caused by excessive buffering; the larger the osteotomy gap (the thicker the cushion), the thicker the elastic cushion 4 to enhance the buffering effect, balancing soft tissue tension and osteotomy surface stress under a larger gap, preventing excessive traction of medial soft tissue or bone tissue compression damage. Specifically, the thickness of the first cushion 1 directly corresponds to the filling amount of the osteotomy gap; a larger thickness means a larger separation distance of the osteotomy surface, and a higher risk of stress concentration in that area during postoperative load-bearing (especially in patients with osteoporosis, whose bone tissue has weak load-bearing capacity). Therefore, the thickness of the elastic pad 4 is designed with a linear relationship of "for every 1mm increase in the first pad 1, the elastic pad 4 increases by 0.1mm", to ensure that:

[0067] 3-5mm thin module (suitable for mild genu varum with small osteotomy gap): The elastic pad 4 is 0.2-0.4mm thick, providing basic cushioning (deformation range 0.1-0.2mm), avoiding excessive cushioning that could affect the stress stimulation of bone tissue (moderate stress can promote bone remodeling).

[0068] 6-9mm medium-thickness module (suitable for moderate genu varum): The elastic pad 4 is 0.5-0.8mm thick, improving cushioning capacity (deformation range 0.2-0.3mm), balancing stress concentration and bone stimulation needs.

[0069] 10-12mm thick module (suitable for severe genu varum or bone defects): The elastic pad 4 is 0.9-1.1mm thick, providing the strongest cushioning (deformation range 0.3-0.5mm), focusing on protecting fragile bone tissue (such as the medial cortical bone of the tibia) from overload damage.

[0070] This "elastic buffer and dynamic thickness adaptation" design solves the problem that traditional rigid connection or fixed thickness buffer structure cannot balance stability and soft tissue compatibility. It not only ensures the reliability of fixation in the early postoperative period, but also reduces the risk of complications such as fixation failure and soft tissue discomfort through stress dispersion and tension adjustment, thus improving the patient's postoperative recovery experience.

[0071] In the description of this invention, it should be understood that the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0072] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0073] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first and second features are in direct contact, or that they are in indirect contact through an intermediate medium. Furthermore, "above," "over," or "on top" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," or "beneath" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0074] In the description of this specification, the terms "one embodiment," "some embodiments," "embodiment," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0075] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make modifications, alterations, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A pad for high proximal tibial osteotomy, characterized in that, include: First pad (1), second pad (2) and multiple screws (3); The bottom of the first pad (1) and the top of the second pad (2) are connected in a wedge shape to form a C-shaped pad body; multiple connection holes are provided at the connection between the first pad (1) and the second pad (2), and multiple screws (3) are inserted into the multiple connection holes one by one; The first pad (1) has multiple irregular through holes (11) penetrating its top and bottom; the second pad (2) has a loading groove (21) inside, and the multiple irregular through holes (11) connect to the loading groove (21); bone-inducing drugs are placed in the irregular through holes (11) and the loading groove (21); The thickness of the first pad (1) is 3~12mm; the acute angle between the mounting surface of the top of the second pad (2) and the horizontal plane is 0~15°.

2. The pad for high proximal tibial osteotomy as described in claim 1, characterized in that, The cross-sectional dimensions of the irregular through hole (11) gradually decrease from the first end near the tibial cortex to the second end connecting the loading groove (21); When the thickness of the first pad (1) is 3~6mm; the cross-sectional dimension of the first end of the irregular through hole (11) is 400~550μm; the cross-sectional dimension of the second end of the irregular through hole (11) is 150~300μm; the cross-sectional dimension change rate from the first end to the second end is 40~60μm / mm; When the thickness of the first pad (1) is 7~12mm; the cross-sectional dimension of the first end of the irregular through hole (11) is 550~800μm; the cross-sectional dimension of the second end of the irregular through hole (11) is 150~300μm; the cross-sectional dimension change rate from the first end to the second end is 50~70μm / mm.

3. The pad for high proximal tibial osteotomy as described in claim 2, characterized in that, Bone-inducing drugs include: The antibacterial drug is placed at the first end of the irregular through-hole (11) with a loading capacity of 0.2~0.4μg / mm. 2 ; BMP-2 is provided in the middle of the irregular through hole (11); The VEGF loaded at the second end of the irregular through-hole (11) has a loading rate of 0.2~0.3μg / mm. 2 ; BMP-7 is installed in the loading slot (21).

4. The pad for high proximal tibial osteotomy as described in claim 1, characterized in that, The irregular through hole (11) is a non-circular irregular channel with a polygonal irregular cross-sectional shape; The inner wall of the irregular through hole (11) is arranged with multiple irregularly shaped protrusions (12).

5. The pad for high proximal tibial osteotomy as described in claim 4, characterized in that, The height of the protrusion (12) is 20~50μm, and the distance between adjacent protrusions (12) is 50~100μm; The long axis of the protrusion (12) is parallel to the extension direction of the irregular through hole (11).

6. The pad for high proximal tibial osteotomy as described in claim 1, characterized in that, An elastic pad (4) is also provided between the first pad (1) and the second pad (2); The thickness of the elastic pad (4) is 0.2~1.1mm.

7. The pad for high proximal tibial osteotomy as described in claim 1, characterized in that, The inner radius R of the C-shaped pad body is related to the anatomical curvature R of the medial cortical bone of the proximal tibia. 骨 Satisfying the adaptation relationship: R=R 骨 ×(1±0.1)。 8. The pad for high proximal tibial osteotomy as described in claim 1, characterized in that, The opening angle α of the C-shaped pad body and the thickness h of the first pad (1) satisfy: α = 60° + (h - 3) × k1; Where k1 is the variation coefficient, and the unit is ° / mm.

9. The pad for high proximal tibial osteotomy as described in claim 8, characterized in that, The angle θ between the extension direction of the irregular through-hole (11) and the long axis of the tibia satisfies: θ = 10° + (h - 3) × k2; Where k2 is the variation coefficient, and the unit is ° / mm.

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