Knee external fixation orthopedic apparatus for distraction osteogenesis

Abstract

This application discloses a distraction osteotomy knee joint external fixation orthopedic device, comprising: a first fixation nail and a first fixation structure; the first fixation nail is constrained by the first fixation structure on a first plane, which is parallel to the plane of the proximal tibia in the wedge osteotomy state; a second fixation nail and a second fixation structure; the second fixation nail is constrained by the second fixation structure on a second plane, which is arranged along the longitudinal axis of the tibia in the use state; both the first and second fixation structures are provided with rod mounting parts, and multiple symmetrically arranged intelligent support rods are also included. These intelligent support rods are positioned between the first and second fixation structures, increasing the distance between them, thereby gradually increasing the angle of the wedge osteotomy until it returns to the un-osteotomized state. This method allows for highly controllable and uniform slow elongation of the wedge osteotomy, enabling the angle of the medial open wedge osteotomy to be adjusted according to the rate of bone growth.

Description

Technical Field

[0001] This invention relates to the field of external fixation devices for fractures, and more particularly to the field of knee joint devices. Specifically, this invention also relates to a distraction osteogenesis external fixation orthotic device for the knee joint. Background Technology

[0002] Knee osteoarthritis is often accompanied by varus deformity of the knee, resulting in altered weight-bearing stress distribution within the joint, leading to an imbalance in weight-bearing between the medial and lateral condyles. This, in turn, accelerates the progression of knee osteoarthritis, and symptoms gradually worsen. Clinically, surgical treatment options include total knee replacement, unicompartmental knee replacement, fibular osteotomy, and high tibial osteotomy. High tibial osteotomy, because it preserves the original bone tissue, ligaments, and soft tissues, is often used for early to mid-stage knee osteoarthritis, postponing or avoiding knee replacement surgery.

[0003] High tibial body osteotomy involves cutting the proximal tibial body to shift the lower limb alignment from the inflamed and worn medial compartment of the knee joint to the relatively normal lateral compartment, thereby relieving joint inflammation. High tibial body osteotomy is divided into lateral closed wedge osteotomy and medial open wedge osteotomy. Lateral closed wedge osteotomy results in lower limb shortening with limited correction, requiring additional procedures such as fibular osteotomy, and is therefore less commonly used clinically. Medial open wedge osteotomy combined with internal fixation can more precisely correct lower limb alignment with a relatively larger correction angle. However, medial osteotomy ends have a longer healing time, and excessive bone sutures may require bone grafting. Bone grafts are often allografts, which have poor healing outcomes and place greater demands on the surgeon; clinical results are highly dependent on surgical technique.

[0004] Existing technologies CN111202571B - An External Fixation Infrakal Orthotome and CN113693674B - A Fixation Bracket, respectively, involve fixing bone pins, namely bone pin one and bone pin two, on both sides of an open wedge osteotomy on the medial side. Bone pin one is fixed to the proximal tibia, and bone pin two is fixed to the distal tibia. Fixation structures for bone pin one and bone pin two are then set on the external bone pins, and an adjustment structure is provided to control the distance between the two fixation structures. By adjusting the distance between the two fixation structures, the distal tibia slowly rotates around the proximal tibia at the junction with the distal tibia, controlling the rotation speed to match the rate of bone growth. Another external fixation infrakal orthotome uses a triangular structure composed of a fixation structure and an adjustment structure. Slow rotation is achieved by adjusting one side of the triangle. The fixation bracket uses an adjustment track as the second adjustment structure, allowing one fixation structure to be fixed on the track while the other moves along the track, thus achieving slow rotation. However, both of the above methods are manual adjustments and locks, and the overall control is intermittent. It is easy to make too little or too much adjustment. Too little adjustment can make it difficult to readjust after bone formation, while too much adjustment can easily lead to bone nonunion. Summary of the Invention

[0005] The treatment involves a medial open wedge osteotomy to slowly increase the angle between the proximal and distal tibias at the rate of bone growth, until the appropriate tibial alignment is achieved, at which point adjustments are made. Because it utilizes autologous bone growth, this approach is relatively safe. However, achieving effective, uniform, and slow angle adjustments is crucial for ensuring the success of autologous bone growth. Current techniques rely on manual and intermittent adjustments with uneven force application. This results in varying bone growth at different osteotomy surfaces at different distances from the rotation axis, ultimately causing alignment deviation and impacting treatment outcomes.

[0006] To address the aforementioned technical problems, this application addresses these issues by using 2-3 first fixation screws positioned on a first plane in the proximal tibia, which are then confined to an upper fixation structure with a limiting hole on the first plane. In use, the first plane containing the first fixation screws is parallel to the osteotomy surface of the proximal tibia corresponding to the wedge-shaped osteotomy. A second fixation structure further addresses this by using 2-3 second fixation screws positioned on a second plane in the distal tibia, which are then confined to the second plane. Under the constraint of the second fixation structure, the second fixation screws are positioned along the longitudinal axis of the tibia to the distal tibia. A rod mounting portion 1 is provided on the first fixation structure, and a rod mounting portion 2 is provided on the second fixation structure. Two to three support rods are symmetrically positioned between the rod mounting portions 1 and 2, and the support rods are electrically controlled to extend evenly and slowly, allowing the angle of the medial open wedge osteotomy to be adjusted according to the rate of bone growth.

[0007] The specific technical solution is as follows: This application discloses a distraction osteogenesis knee joint external fixation orthopedic device, which includes a fixation structure one, a fixation structure two, and a support rod.

[0008] Fixation pin 1, 2-5 pieces, used to set the upper tibia.

[0009] The fixing structure 1 includes a nail body setting part 1 with multiple limiting holes 1, and 2-5 fixing nails 1 are limited to a first plane after passing through the limiting holes 1; the fixing structure 1 also includes a rod body setting part 1.

[0010] Fixation pins, 2-5 in total, are used to install on the lower segment of the tibia.

[0011] The second fixation structure includes a nail body setting part 2 with multiple limiting holes 2, and the fixation nail 2 is defined on a second plane after passing through the limiting holes 2; the second fixation structure also includes a rod body setting part 2; the rod body setting part 2 and the nail body setting part 2 are rod-shaped structures arranged intersecting each other, so that the nail body setting part 2 has limiting holes 2 arranged along the longitudinal axis of the lower segment of the tibia.

[0012] Support rods, 2-5 in total. The first end of the support rod is connected to the first rod body mounting part, and the second end of the support rod is connected to the second rod body mounting part. Multiple support rods are symmetrically arranged on the first and second fixed structures.

[0013] The first plane and the second plane are at an angle of 80-100 degrees, so that the first plane where the first fixation nail is located can be parallel to the osteotomy surface of the upper tibia corresponding to the wedge osteotomy in the use state; the second fixation nail is set to the lower tibia along the longitudinal axis of the tibia under the constraint of the second fixation structure; the electric control support rod extends evenly and slowly, so that the angle of the medial open wedge osteotomy is adjusted according to the bone growth rate.

[0014] Furthermore, the first nail body setting part is a rod-shaped structure with multiple limiting holes, the multiple limiting holes being arranged along the central axis of the rod-shaped structure; the second nail body setting part is a rod-shaped structure with multiple limiting holes, the multiple limiting holes being arranged along the central axis of the rod-shaped structure, and the cross-sectional shape of the rod-shaped structure is rectangular.

[0015] Furthermore, a rod connecting hole 1 is provided on the rod body setting part 1, which is perpendicular to the limiting hole 1; the vertical setting makes the setting of the support rod more stable, and the support rod is inserted into the rod connecting hole 1 by insertion.

[0016] Furthermore, the second rod mounting section is a rod-shaped structure three, with multiple rod connecting holes two arranged along the longitudinal axis of the second rod mounting section. The second nail mounting section is arranged in a cross-combination with the second rod mounting section. The first rod connecting hole and the second rod connecting hole are arranged opposite each other to ensure that the support rod can be effectively inserted between the first fixed structure and the second fixed structure.

[0017] Furthermore, rod-shaped structure one is an arc-shaped rod, while rod-shaped structures two and three are straight rods. This arrangement allows for a larger horizontal spatial interval between fixation pins one, while the arrangement of rod-shaped structures two and three, considering the smaller size of the lower tibia, ensures that fixation pin two is positioned along the longitudinal axis of the tibia, and also allows for the placement of three support rods within a limited space. This ensures the symmetry of the support rod placement, resulting in more uniform bone growth.

[0018] Furthermore, the rod-shaped structure 2 of the rod body setting part 2 and the nail body setting part 2 are cross-locked by fasteners, which ensures that the two do not shift relative to each other during dynamic tension. Before use, the fasteners can be loosened to adjust the angle, so that the limiting hole 2 of the nail body setting part can be effectively set along the longitudinal axis of the tibia according to the patient's needs. In addition, by adjusting the direction, the setting conflict between the fixation nail 2 and the support rod can be avoided.

[0019] Furthermore, to avoid spatial interference between the fixing pin two and the support rod, the positions of the arbitrary rod connection holes two on the rod-shaped structure three are staggered with the fastener mounting holes to ensure that the two maintain a safe distance in three-dimensional space.

[0020] Furthermore, the support rod can be a manual support rod or an intelligent support rod. The intelligent support rod includes a hollow sleeve, a tension / compression sensor, a motor structure, a planetary reducer, a telescopic structure, a first universal joint with a first connecting rod, and a second universal joint with a second connecting rod. From the first end to the second end of the hollow sleeve, a portion of the first universal joint, the tension / compression sensor, the motor structure, the planetary reducer, and a portion of the telescopic structure are arranged sequentially, and the longitudinal axis of all structures within the hollow sleeve is consistent. When the telescopic structure is fully extended, the length of the telescopic section extending beyond the second end of the hollow sleeve is greater than or equal to the length of the threaded pipe. The motor structure drives the planetary reducer to rotate, and the planetary reducer then drives the telescopic structure to rotate, thereby extending and retracting the telescopic structure.

[0021] Furthermore, it includes a control structure that receives the pressure values ​​from the tension and compression sensors of each smart support rod and can simultaneously control the smart support rods to undergo elongation movements, thereby ensuring stable support and dimensional extension of each support rod for the wedge osteotomy and ensuring uniform bone formation.

[0022] Furthermore, the first connecting rod is combined with the first connecting hole of the rod body, and the second connecting rod is combined with the second connecting hole of the rod body to realize the combination of the intelligent support rod with the first and second fixed structures. Furthermore, a movable groove is provided inside the hollow sleeve, and a protruding slider extending into the movable groove is provided on the outside of the telescopic section, so that the telescopic section moves smoothly along the axial direction of the hollow sleeve without radial swaying; ensuring that the telescopic section does not rotate with the rotating section.

[0023] Furthermore, the first end of the hollow sleeve is provided with an outlet smaller than the inner diameter of the hollow sleeve body. The first universal joint includes a cylindrical section confined within the inner cavity of the first end of the hollow sleeve. The cylindrical section extends into a joint section one, which extends out from the outlet. This arrangement can confine the various structures within the hollow sleeve and prevent them from detaching from the first end.

[0024] Technical effect Fixation structure one confines fixation nail one on a first plane, which is parallel to the osteotomy surface of the proximal tibia corresponding to the wedge osteotomy. Fixation structure two confines fixation nail two on a second plane, which is set along the longitudinal axis of the tibia. Multiple intelligent support rods symmetrically arranged between fixation structure one and fixation structure two are used to control the increase of the distance between fixation structure one and fixation structure two, so that the angle of the medial open wedge osteotomy is adjusted according to the bone growth rate. This method allows for controllable growth according to the bone growth rate. The symmetrical arrangement of intelligent support rods and the control structure ensure that the bone growth rate is uniform at each position. Finally, the resectioned bone segment is restored through the continuous growth of autologous bone, without rejection.

[0025] By setting the first plane and the second plane at an angle of 80-100 degrees, it is possible to ensure that the first fixation screw is positioned in the upper segment of the tibia and that the second fixation screw is positioned in the lower segment of the tibia along the longitudinal axis of the tibia.

[0026] By setting the second nail body setting part as a linear rod structure and the second rod body setting part as a linear rod structure in a cross arrangement, it is possible to ensure that the setting direction of the second fixing nail is different from the setting direction of the intelligent support rod, thus ensuring the setting of the structure and avoiding mutual interference.

[0027] By setting up intelligent support rods, the pressure sensors can be monitored to understand how to maintain a stable and balanced force between fixed structure one and fixed structure two, thus avoiding uneven recovery caused by different forces on one end. Attached Figure Description

[0028] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings: Figure 1 This is a schematic diagram of the overall structure of the external fixation orthotic device for the knee joint of the present invention.

[0029] Figure 2 This is a schematic diagram of the combined structure of the fixation structure 1 and the fixation pin 1 of the external fixation orthopedic device for the knee joint of the present invention. Figure 3 This is a schematic diagram of the combined structure of the second fixation structure and the second fixation nail of the knee joint external fixation orthotic device of the present invention; Figure 4 A schematic diagram of the overall structure of an intelligent support rod with a universal joint-type universal joint for universal adjustment; Figure 5 A schematic diagram of a universal joint with a cross-shaped universal joint structure, excluding the hollow sleeve; Figure 6 This is a schematic diagram of the longitudinal cross-sectional structure of a single intelligent support rod of the present invention; Figure 7 For the present invention Figure 6 A magnified schematic diagram of a portion of the structure in the middle circle A; Figure 8 For the present invention Figure 6 A magnified schematic diagram of a portion of the middle circle, B. Figure 9 For the present invention Figure 6 A magnified schematic diagram of a portion of the central circle C section; Figure 10 For the present invention Figure 6 A magnified schematic diagram of a portion of the central circle, D section; Figure 11 This is a partially enlarged schematic diagram of the connection point between the motor structure and the planetary reducer of the present invention.

[0030] Label Explanation 1. Intelligent support rod; 11. Hollow sleeve; 111. Moving groove; 12. Motor structure; 13. Planetary reducer; 14. Telescopic structure; 141. Telescopic section; 1411. Threaded pipe; 1412. Protruding slider; 142. Rotating section; 1421. Threaded section; 143. Locking nut; 15. Tension / compression sensor; 161. First connecting rod; 162. Second connecting rod; 163. Limiting ring; 171. First universal joint; 1711. Cylindrical section; 1712. Joint section one; 172. Second universal joint; 181. Rotary mating section; 182. Boss; 191. Longitudinal protrusion; 192. Longitudinal groove; 193. Limiting protrusion; 194. Axial limiting groove; 21. Fixing pin one; 221. Pin body setting part one; 2211. Limiting hole one; 222. Rod body setting part one; 2221. Rod body connecting hole one; 23. Fixing pin two; 241. Pin body setting part two; 2411. Limiting hole two; 242. Rod body setting part two; 2421. Rod body connecting hole two; Detailed Implementation To make the objectives, technical solutions, and advantages of this application clearer, the technical solutions of this application will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0031] In this document, “illustrative” means “serving as an example, illustration or description”, and any illustration or implementation described herein as “illustrative” should not be construed as a more preferred or advantageous technical solution.

[0032] To keep the drawings concise, only the parts relevant to this application are shown schematically in each drawing, and they do not represent the actual structure of the product. In addition, to make the drawings concise and easy to understand, in some drawings, only one of the components with the same structure or function is shown schematically, or only one of them is labeled.

[0033] In this document, unless otherwise expressly specified and limited, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance; unless otherwise specified or stated, the term "multiple" refers to two or more; the terms "connected," "fixed," etc., should be interpreted broadly. For example, "connected" can be a fixed connection, a detachable connection, an integral connection, or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0034] Example 1: A distraction osteogenesis external fixation orthotic device for the knee joint refer to Figure 1-3 A distraction-induced osteotomy knee joint external fixation orthopedic device includes a first fixation structure, a second fixation structure, and a support rod 1. Two to five fixation nails 21 are provided for placement on the proximal tibia. The first fixation structure includes a nail body placement portion 221 with multiple limiting holes 2211, through which the fixation nails 21 are defined on a first plane. The first fixation structure also includes a rod body placement portion 222. Two to five fixation nails 23 are provided for placement on the distal tibia. The second fixation structure includes a nail body placement portion 241 with multiple limiting holes 2411, through which the fixation nails 23 are defined on a second plane. The second fixation structure also includes a rod body placement portion 242. The rod body placement portion 242 and the nail body placement portion 241 are intersecting rod-shaped structures, such that the nail body placement portion 241 has limiting holes 2411 arranged along the longitudinal axis of the distal tibia. There are 12-5 support rods. The first end of the support rod 1 is connected to the rod body setting part 222. The second end of the support rod 1 is connected to the rod body setting part 242. Multiple support rods 1 are symmetrically arranged on the fixed structure 1 and the fixed structure 2.

[0035] refer to Figure 1 The first plane and the second plane are at an angle of 80-100 degrees, so that the first plane where the first fixation nail is located can be parallel to the osteotomy surface of the upper tibia corresponding to the wedge osteotomy in the use state; the second fixation nail is set to the lower tibia along the longitudinal axis of the tibia under the constraint of the second fixation structure; the electric control support rod 1 extends evenly and slowly, so that the angle of the medial open wedge osteotomy is adjusted according to the bone growth rate.

[0036] Both fixing pin 1 21 and fixing pin 2 23 are threaded pins, and both limiting hole 1 2211 and limiting hole 2 2411 are threaded holes. This arrangement can ensure that the position is stable after assembly and there will be no adjustment deviation.

[0037] refer to Figure 2The first fixing structure has a first nail mounting part 221, which is a rod-shaped structure with multiple limiting holes 2211 arranged along its central axis. The second fixing structure has a second nail mounting part 241, which is a rod-shaped structure with multiple limiting holes 2411 arranged along its central axis. The cross-sectional shape of the rod-shaped structure is rectangular. This arrangement ensures that the first fixing structure limits the first limiting holes 2211, and the second fixing structure limits the second limiting holes 2411. The rod-shaped structure also ensures the safe and effective installation of each structure. A rod-body mounting portion 222 is provided with a rod-body connecting hole 2221 perpendicular to the limiting hole 2211; preferably, the limiting hole 2211 extends from the outer side to the side, while the rod-body connecting holes are provided on multiple rod-body mounting portions 222 on the bottom surface of the rod-shaped structure, or the rod-body mounting portions 222 extend outward toward the nail mounting portion 221, with the rod-body connecting holes 2221 provided from top to bottom. The vertical arrangement makes the support rod 1 more stable. Providing the fixing nail 21 and support rod 1 in two directions maximizes their usability. Furthermore, the vertical arrangement makes the support rod 1 more stable, and the support rod 1 is inserted into the rod-body connecting hole 2221 by insertion.

[0038] More specifically, see reference Figure 3 The second rod mounting section 242 is a rod-shaped structure 3, with multiple rod connecting holes 2421 arranged along its longitudinal axis. The nail mounting section 241 and the rod mounting section 242 are arranged in a cross-shaped combination. The first rod connecting hole 2221 and the second rod connecting hole 2421 are arranged opposite to each other to ensure that the support rod 1 can be effectively inserted between the first fixed structure and the second fixed structure.

[0039] More specifically, rod-shaped structure one is an arc-shaped rod with an arc range of 90-110 degrees, while rod-shaped structures two and three are straight rods. This arrangement allows for a larger horizontal spatial interval for fixing nail 21, while the arrangement of rod-shaped structures two and three, considering the smaller size of the lower tibia, ensures that fixing nail 23 is positioned along the longitudinal axis of the tibia, and allows for the placement of three support rods 1 within a limited space, ensuring the symmetry of the support rod 1 placement, thereby promoting more uniform bone growth. The rod-shaped structure two of the rod body setting part two 242 and the nail body setting part two 241 are cross-locked by fasteners, ensuring that there is no relative displacement between the two during dynamic tension. Before use, the fasteners can be loosened to adjust the angle, allowing the limiting hole two 2411 of the nail body setting part to be effectively positioned along the longitudinal axis of the tibia according to the patient's needs. In addition, adjusting the direction can avoid the conflict between the placement of fixing nail 23 and support rod 1.

[0040] More specifically, in order to avoid spatial interference between the fixing nail 23 and the support rod 1, the positions of the arbitrary rod connection holes 2421 on the rod structure 3 are staggered with the fastener mounting holes to ensure that the two maintain a safe distance in three-dimensional space.

[0041] Smart support rods can be either manual or intelligent. Alternatively, refer to... Figure 4-6 The support rod is an intelligent support rod 1, which includes a hollow sleeve 11, a motor structure 12, a planetary reducer 13, a telescopic structure 14, universal joints at both ends, and connecting rods.

[0042] refer to Figure 6-7 The telescopic structure 14 utilizes its telescopic movement to adjust the overall length of the support rod, comprising a telescopic section 141 and a rotating section 142. The rotation of the rotating section 142 drives the telescopic section 141 to extend or retract. The telescopic section 141 has a threaded tube 1411, and the rotating section 142 has a threaded section 1421. The threaded section 1421 engages with the threaded tube 1411, and its rotation causes the threaded tube 1411 to extend or retract along the longitudinal axis of the telescopic structure 14. The pitch of the rotating section 142 of the telescopic structure 14 is 1mm; for every revolution of the rotating section 142, the telescopic section 141 moves 1mm. Thus, by controlling the rotating section 142 to rotate 1-2 revolutions repeatedly via the motor structure 12, a telescopic vibration of 1-2mm can be achieved, making the entire control process simple and controllable.

[0043] Motor structure 12 is used to provide rotational power to the rotating section 142. The motor type is a 12mm diameter micro motor with a rated power of 1-3W.

[0044] Planetary reducer 13 is used to control the rotation of rotating section 142 while reducing the power of motor structure 12. The first end of planetary reducer 13 is connected to the shaft of motor structure 12, and the second end is connected to rotating section 142. Motor structure 12 drives planetary reducer 13 to rotate, which in turn drives rotating section 142. The reduction ratio of the planetary reducer is 256:1.

[0045] The tension / compression sensor 15 is used to monitor the tension or compression force borne by the support rod. The range of the tension / compression sensor 15 is 0 to 80 kg, with a resolution of 0.1 kg.

[0046] refer to Figure 4-6 The support rod has a first connecting rod 161 and a second connecting rod 162 at both ends for fixing the support rod to the external fixing frame. The first connecting rod 161 is connected to the first universal joint 171, and the second connecting rod 162 is connected to the second universal joint 172. This ensures that when the length of the telescopic rod is adjusted, the support rod is stably maintained on the external fixing frame by changing the angle. The second end of the telescopic section 141 includes part or all of the second universal joint 172.

[0047] refer to Figure 4 and Figure 6 The hollow sleeve 11 includes, from its first end to its second end, a partial first universal joint 171, a tension / compression sensor 15, a motor structure 12, a planetary reducer 13, a rotating section 142, and a partial telescopic section 141, all arranged sequentially. All structures within the hollow sleeve 11 have the same longitudinal axis. When the telescopic section 141 is fully extended, the length of the portion of the telescopic section 141 extending beyond the second end of the hollow sleeve 11 is greater than or equal to the length of the threaded pipe 1411.

[0048] When implementing, refer to Figure 4-6 Both the hollow sleeve 11 and the telescopic section 14 have a threaded section on their outer sides, and a locking nut 143 is provided on the corresponding outer side. The inner thread of the first end of the locking nut 143 corresponds to the thread on the outer side of the telescopic section 14, and the inner thread of the second end of the locking nut 143 corresponds to the thread on the outer side of the hollow sleeve 11. The locking nut 143 locks the positional relationship between the hollow sleeve and the telescopic section before use. During use, rotating the locking nut separates the inner thread of the locking nut from the threads of the hollow sleeve and the telescopic section, releasing the locking effect and allowing the entire intelligent support rod to effectively perform its supporting function.

[0049] The fixation frame also includes a control structure. This control structure receives pressure values ​​from the tension / compression sensors 15 of each intelligent support rod 1. Based on these pressure values, it individually controls each intelligent support rod 1 or simultaneously controls several intelligent support rods 1 to extend and retract, ensuring adjustment of one or more intelligent support rods 1 in case of stress blockage; or it controls the extension and retraction of all six intelligent support rods 1 at a certain frequency, with each rod extending or retracting by 1-2 mm at a time, achieving micro-motion mechanical stimulation of the fracture site through the micro-motion of the Taylor frame. By receiving the pressure values ​​from the tension / compression sensors 15, the control structure automatically adjusts the extension and retraction of each intelligent support rod 1, ensuring that each intelligent support rod 1 is in a normal state, thereby monitoring the treatment process and ensuring treatment effectiveness. This solves the problem of traditional Taylor frames being unable to be adjusted or having very cumbersome adjustments after fixation. Compared to existing technologies that involve continuous rotation of the Hooke hinge, this method avoids negative interference with the patient. In addition, the rotation of the Hooke hinge can easily cause entanglement of objects around the patient, thus affecting the rotation. Therefore, the existing Hooke hinge method cannot achieve continuous micro-movements and extensions at different frequencies. In contrast, the intelligent support rod 1 in the Taylor frame has a built-in motor, and the entire extension and retraction adjustment can only be observed through the extension and retraction of the extension structure 14. Therefore, continuous small-amplitude adjustments will not affect the patient or their family.

[0050] By incorporating the planetary reducer 13, a small motor mechanism coaxial with the planetary reducer 13 is housed within the hollow sleeve. The planetary reducer 13 connects to the rotating section 142 of the telescopic structure 14, enabling a low-power motor to control the extension and retraction of the telescopic rod. This confines all structures to a single longitudinal axis. During operation, the motor's rotation and all structural elements are confined within a narrow hollow sleeve. In use, patients and their families can only observe a single wire and a support rod. Controlling the extension and retraction is also only visible through the movement of the telescopic section 141 relative to the hollow sleeve 11, ensuring no disruption to the patient's experience. The entire support rod is a single, integrated unit, featuring a simple design that facilitates easy handling and transportation.

[0051] More specifically, see reference Figure 7 A movable groove 111 is provided inside the hollow sleeve 11, and a protruding slider 1412 extending into the movable groove 111 is provided on the outside of the telescopic section 141, so that the telescopic section 141 can move smoothly along the axial direction of the hollow sleeve 11 without radial shaking, ensuring that the telescopic section 141 does not rotate with the rotating section 142.

[0052] A more preferred embodiment is, referring to Figure 6 The first end of the hollow sleeve 11 has an outlet smaller than the inner diameter of the main body of the hollow sleeve 11. The first universal joint 171 includes a cylindrical section 1711 confined within the inner cavity of the first end of the hollow sleeve 11. The cylindrical section 1711 extends to form a joint section 1712, which extends from the outlet. This arrangement confines each structure within the hollow sleeve 11, preventing it from detaching from the first end.

[0053] More specifically: Reference Figure 6Both the first universal joint 171 and the second universal joint 172 include a ball-and-socket structure and a ball-and-head structure. The ball-and-socket of the first universal joint 171 is located on joint segment 1712, and the first connecting rod 161 is integrally connected to the ball-and-head structure. The telescopic segment 141 includes joint segment 2, and the ball-and-socket of the second universal joint 172 is located on joint segment 2. The second connecting rod 162 is integrally connected to the ball-and-head structure. The ball-and-head structure is embedded in the corresponding ball-and-socket, forming a spherical pair that can rotate freely around any axis. Through the above configuration, it is possible to combine the support rod with various types of external fixation frames to form a certain support angle. The ends of the first connecting rod 161 and the second connecting rod 162 are provided with threaded sections 1421, and both the first connecting rod 161 and the second connecting rod 162 are provided with limiting rings 163 to prevent the universal joint from contacting the combination hole of the external fixation frame, thus affecting the degree of freedom of the universal joint during initial setup. The above configuration ensures that after the nut is tightened, the limiting ring 163 and the surface of the outer fixing bracket form a reliable limit, guaranteeing the full degree of freedom adjustment space of the universal joint during initial installation and suppressing loosening of the connection during subsequent micro-movements. Alternatively, other forms of universal adjustment structures can be used, such as a cross-shaft universal joint.

[0054] A more preferred embodiment is, referring to Figure 6 The cylindrical segment 1711 is fixed to the first end of the hollow sleeve 11 by gluing, and the tension / compression sensor 15 is fixedly connected to the cylindrical segment 1711. The motor structure 12, the planetary reducer 13 and the telescopic structure 14 each include a matching segment with an outer diameter that matches the inner diameter of the hollow sleeve 11. The outer wall of the matching segment is in smooth contact with the inner wall of the hollow sleeve 11 segment, and the matching segment of each structure moves relative to the longitudinal axis of the hollow sleeve 11. The second end of the motor structure 12 is combined with the tension / compression sensor 15, so that the tension and pressure can be transmitted to the tension / compression sensor 15 through the motor structure 12. The above configuration ensures the positional relationship between the cylindrical section 1711, the tension / compression sensor 15, and the hollow sleeve 11. The variable relative positions of the motor structure 12, the planetary reducer 13, and the telescopic structure 14 to the longitudinal axis of the hollow sleeve 11 ensures that the force applied to the longitudinal axis of the support rod in a static state is effectively applied to the tension / compression sensor 15 through the motor structure 12, and ensures the accuracy of force transmission, unaffected by the contact between the mating section and the hollow sleeve 11.

[0055] A more preferred embodiment is described in reference. Figure 6 and Figure 8The motor structure 12 is combined with the planetary reducer 13, and their relative positional relationship along the longitudinal axis is fixed after the combination; the planetary reducer 13 is combined with the rotating section 142, and their relative positional relationship along the longitudinal axis is fixed after the combination; the motor structure 12, the planetary reducer 13, and the telescopic structure 14 are constructed as a whole with a fixed relative positional relationship along the longitudinal axis, and only rotational transmission occurs between the structures, without relative axial displacement. (Reference) Figure 11 Specifically, a rotating shaft extends from the motor structure 12, and a connecting pipe extends from below the planetary reducer 13. Multiple longitudinal protrusions 191 and longitudinal grooves 192 are provided on the connecting pipe and rotating shaft to ensure the two sets of engagement. After assembly, the assembly relationship is fixed by gluing. The planetary reducer 13 and the rotating section 142 also adopt the above-mentioned assembly and fixing method. This arrangement ensures that the torque output by the motor is transmitted to the rotating section 142 only through the planetary reducer 13, and then converted into a precise linear displacement along the longitudinal axis via the telescopic structure 14. This linear displacement is coupled to the external fixator via the second universal joint 172, ultimately generating a periodic micromotion stimulation with controllable amplitude (1–2 mm) and stable direction at the fracture site. By constructing the motor structure 12, planetary reducer 13 and telescopic structure 14 into a structure with a fixed longitudinal axis position, the stability of the support rod structure can be guaranteed, avoiding the risk of separation of the various structures during use. In conjunction with the protruding slider 1412 of the telescopic section 141 and the moving groove 111 of the hollow sleeve 11, the various structures can be stably confined within the hollow sleeve 11, avoiding the risk of structural separation.

[0056] A more preferred embodiment is described in reference. Figure 9 To prevent excessive movement of the integrated structure of motor structure 12, planetary reducer 13, and telescopic structure 14, which could affect the measurement of tension / compression sensor 15, an axial limiting protrusion is provided on the housing of motor structure 12 or planetary reducer 13. Correspondingly, an axial limiting groove 194 is provided on the inner wall of hollow sleeve 11 to mate with the limiting protrusion. The length of the axial limiting groove 194 is 1–3 mm to limit the maximum displacement of the entire structure along the longitudinal axis, ensuring that the tension / compression sensor 15 remains within its calibrated operating range and avoiding measurement inaccuracies or structural interference due to overtravel. Alternatively, refer to... Figure 10The inner diameter of the portion of the hollow sleeve 11 that encloses the rotating section 142 and the telescopic section 141 is smaller than that of other positions. However, the rotating section 142 includes a rotating mating section 181 whose size matches that of the larger portion of the hollow sleeve 11, forming a boss 182 at the two dimensional change positions. In the vertically placed state, the distance between the mating section on the rotating section 142 and the bottom of the boss 182 is controlled within the range of 1 to 3 mm. The above setting can ensure the stability of the moving groove 111. In addition, through this dimensional change, when all structures are set in the hollow sleeve 11, this dimensional change can form a natural barrier, which can confine the motor structure 12, the planetary reducer 13 and the telescopic structure 14 within the hollow sleeve 11, preventing the risk of any structure coming off the hollow sleeve 11. In addition, it also ensures that the structure under the boss 182 has a certain amount of room to move, so as to ensure that the tension and compression sensor 15 is pulled within a safe range.

[0057] In a more preferred embodiment, the hollow sleeve 11 has an outer diameter ranging from 10 to 15 mm, a wall thickness ranging from 1.5 to 2.5 mm, and an inner diameter ranging from 8.5 to 12.5 mm; this size satisfies the overall structural strength and clinical installation space constraints. This results in a structure with sufficient strength yet a relatively simple overall design, eliminating any negative impact on patient observation during use.

[0058] In a more preferred embodiment, the hollow sleeve 11 is symmetrically assembled from two identical halves, and the joint is protected by both airtightness and structural rigidity through laser welding or micron-level interference fit. This arrangement effectively confines each structure within the hollow sleeve 11 before assembly, ensuring convenient assembly.

[0059] In a more preferred embodiment, a miniature battery is installed inside the hollow sleeve 11 to power the tension / compression sensor 15. This battery allows for real-time display of the current force value of the tension / compression sensor 15 before the motor power is switched on, ensuring that preoperative calibration and intraoperative monitoring are performed simultaneously. The mechanical sensitivity of the tension / compression sensor 15 is 0.1 kg, ensuring the accuracy of monitoring. (See attached figures.)

[0060] Each motor structure 12 extends a wire. When a single external fixing frame requires multiple support rods, the wires of each motor structure 12 are connected in parallel to the power supply, and a control structure is set up to control the rotation direction, rotation speed, and rotation duration of the motor structure 12 to ensure that the support rods are set on the external fixing frame.

[0061] A method for setting up and using a distraction osteogenic external fixation orthotic device for the knee joint.

[0062] First, locate the position and orientation of the three fixation screws 21, pre-create the screw holes, and then place the three fixation screws 21 into the limiting hole 2211 of the fixation structure 1. Fix the fixation screws 21 into the proximal tibia according to the pre-prepared screw holes. At this time, the rod-shaped structure 1 of the fixation structure 1 is set around the periphery of the proximal tibia. Next, locate the position and orientation of the three fixation screws 23, create the screw holes, and then place the three fixation screws 23 into the limiting hole 2411 of the fixation structure 2. Fix the fixation screws 23 into the distal tibia according to the pre-prepared screw holes. Adjust the angle between the rod-shaped structure 2 and the rod-shaped structure 3 of the fixation structure 2 so that the rod connecting hole 1 on the rod-shaped structure 3 is aligned with the support rod setting hole 2 on the rod-shaped structure 1. Then, control the length of the support rod to be as short as possible so that it can be effectively set between the fixation structure 1 and the fixation structure 2. First, set one end into the support rod setting hole, and then gradually adjust the other end into the support rod setting hole 2 by controlling the structure to ensure that both ends are coaxially stressed. Then the motor structure 12 is activated, and the extension and retraction speed of the intelligent support rod 1 is adjusted according to the bone growth rate. Because the intelligent support rod 1 is symmetrically arranged and has a tension and compression sensor 15 that provides real-time feedback on stress distribution, it ensures that the support force on both sides is uniform and there will be no problem of uneven growth.

[0063] The above description is merely a specific embodiment of this application. Under the guidance of the above teachings, those skilled in the art can make other improvements or modifications based on the above embodiments. Those skilled in the art should understand that the above specific description is only to better explain the purpose of this application, and the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A distraction osteotomy external fixation orthotic device for the knee joint, characterized in that, It includes, One set of 2-5 fixation pins, used to be installed on the upper tibia; The fixing structure 1 includes a nail body setting part 1 with multiple limiting holes 1, and 2-5 fixing nails 1 are constrained to a first plane after passing through the limiting holes 1; the fixing structure 1 also includes a rod body setting part 1; Fixation pin 2, 2-5 pieces, used to be installed on the lower segment of the tibia; The second fixation structure includes a nail body setting part 2 with multiple limiting holes 2, and the second fixation nail is defined on a second plane after passing through the limiting holes 2; the second fixation structure also includes a rod body setting part 2; the rod body setting part 2 and the nail body setting part 2 are rod-shaped structures that are intersected with each other, so that the nail body setting part 2 has limiting holes 2 arranged along the longitudinal axis of the lower segment of the tibia; Support rods, 2-5 in total; the first end of the support rod is connected to the first rod body mounting part; the second end of the support rod is connected to the second rod body mounting part; multiple intelligent support rods are symmetrically arranged on the first fixed structure and the second fixed structure. The first plane and the second plane are at an angle of 80-100 degrees, so that the first plane where the first fixation nail is located can be parallel to the osteotomy surface of the upper tibia corresponding to the wedge osteotomy in the use state; the second fixation nail is set to the lower tibia along the longitudinal axis of the tibia under the constraint of the second fixation structure; the electrically controlled intelligent support rod extends evenly and slowly, so that the angle of the medial open wedge osteotomy is adjusted according to the bone growth rate.

2. The knee joint external fixation orthotic device according to claim 1, characterized in that, The first nail mounting part is a rod-shaped structure with multiple limiting holes, the multiple limiting holes being arranged along the central axis of the rod-shaped structure; the second nail mounting part is a rod-shaped structure with multiple limiting holes, the multiple limiting holes being arranged along the central axis of the rod-shaped structure, and the cross-sectional shape of the rod-shaped structure is rectangular.

3. The knee joint external fixation orthotic device according to claim 2, characterized in that, A rod connection hole is provided on the rod body setting part 1, which is perpendicular to the limiting hole 1.

4. The knee joint external fixation orthotic device according to claim 2, characterized in that, The second rod setting part is a rod-shaped structure three, with multiple rod connecting holes two arranged along the longitudinal axis of the second rod setting part. The second nail setting part and the second rod setting part are arranged in a cross combination. The first rod connecting hole and the second rod connecting hole are arranged opposite to each other.

5. The knee joint external fixation orthotic device according to claim 2, characterized in that, The first rod structure is an arc-shaped rod, while the second and third rod structures are straight rods.

6. The knee joint external fixation orthotic device according to claim 2, characterized in that, The rod-shaped structure of the second rod body setting part and the second nail body setting part are locked together by fasteners.

7. The knee joint external fixation orthotic device according to claim 2, characterized in that, The rod-shaped structure three is also provided with fastener mounting holes, and the positions of any rod connection hole two on the rod-shaped structure three are staggered with the fastener mounting holes.

8. The knee joint external fixation orthotic device according to claim 2, characterized in that, The support rod can be an intelligent support rod or a manually telescopic support rod; The intelligent support rod includes a hollow sleeve, a tension / compression sensor, a motor structure, a planetary reducer, a telescopic structure, a first universal joint with a first connecting rod, and a second universal joint with a second connecting rod. From the first end to the second end of the hollow sleeve, a portion of the first universal joint, the tension / compression sensor, the motor structure, the planetary reducer, and a portion of the telescopic structure are sequentially arranged, with all structures within the hollow sleeve having the same longitudinal axis. When the telescopic structure is fully extended, the length of the telescopic section extending beyond the second end of the hollow sleeve is greater than or equal to the length of the threaded pipe. The motor structure drives the planetary reducer to rotate, which in turn drives the telescopic structure to rotate, thus extending and retracting the telescopic structure. Preferably, the intelligent support rod also includes a control structure. The control structure receives the pressure value from the tension and compression sensors of each intelligent support rod and can simultaneously control the intelligent support rod to undergo elongation movement, so as to ensure stable support and dimensional extension of each support rod for the wedge osteotomy and ensure uniform bone formation.

9. The knee joint external fixation orthotic device according to claim 8, characterized in that, The first connecting rod is combined with the first connecting hole of the rod body, and the second connecting rod is combined with the second connecting hole of the rod body to realize the combination of the intelligent support rod with the first fixed structure and the second fixed structure. Preferably, a movable groove is provided inside the hollow sleeve, and a protruding slider extending into the movable groove is provided on the outside of the telescopic section, so that the telescopic section moves smoothly along the axial direction of the hollow sleeve without radial swaying; ensuring that the telescopic section does not rotate with the rotating section.

10. The knee joint external fixation orthotic device according to claim 8, characterized in that, The first end of the hollow sleeve is provided with an extension opening smaller than the inner diameter of the hollow sleeve body. The first universal joint includes a cylindrical section limited in the inner cavity of the first end of the hollow sleeve. The cylindrical section extends into a joint section one, which extends out from the extension opening. Preferably, the cylindrical segment is fixed to the first end of the hollow sleeve by gluing, and the force sensor is fixedly connected to the cylindrical segment; the motor structure, planetary reducer and telescopic structure all include a matching segment with an outer diameter consistent with the inner diameter of the hollow sleeve; the outer wall of the matching segment is smooth with the inner wall of the hollow sleeve segment, and the matching segment of each structure moves relative to the longitudinal axis of the hollow sleeve; the second end of the motor structure is combined with the tension and compression sensor, so that the tension and compression can be transmitted to the tension and compression sensor through the motor structure; Preferably, the motor structure is combined with the planetary reducer, and the relative positional relationship between the two along the longitudinal axis is fixed after the combination; the planetary reducer is combined with the rotating section, and the relative positional relationship between the two along the longitudinal axis is fixed after the combination; the motor structure, the planetary reducer and the telescopic structure are constructed as a whole with a fixed relative positional relationship along the longitudinal axis, and only rotational transmission occurs between the structures, without relative axial displacement.

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