An adjustable flexible bone-to-bone fixation device and implantation mechanism

Abstract

The present application relates to the technical field of medical devices, in particular to an adjustable flexible bone-to-bone fixation device and an implanting mechanism, the adjustable flexible bone-to-bone fixation device comprising a first suture and a flexible fixation assembly, the first suture having a first traction end, a second traction end, a first wire inlet hole and a second wire outlet hole, the flexible fixation assembly comprising a second suture and a titanium alloy button; in use, the fibula and the tibia are adjusted to a suitable position, a drill bit is used to drill through the fibula, a drill bit is used to create a bone channel on the tibia through the fibula bone channel created by the drill bit, the second suture is passed through the fibula bone channel and knocked into the tibia bone channel, the titanium alloy button is arranged on the surface of the lateral cortical bone of the fibula, the first traction end and the second traction end are pulled, and the second suture is contracted into a mass in the bone channel to extrude the bone channel and achieve flexible fixation, so that reliable fixation can be achieved with a smaller amount of bone removal.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an adjustable flexible bone-to-bone fixation device and implantation mechanism. Background Technology

[0002] The tibia and fibula, along with the radius and ulna, are common supporting and connecting structures in the human body. For example, the tibia and fibula: the distal tibiofibular syndesmosis is formed by the distal tibiofibular joint and the distal tibiofibular ligament complex. Surgical treatment for tibiofibular syndesmosis ligament injury often involves stabilizing the fibula and tibia in a suitable position to allow the ligament to gradually recover. Currently, the commonly used method is to use one or more cortical screws to penetrate the fibula and insert them into the tibia to achieve a relatively stable rigid fixation. However, using cortical bone screws for rigid fixation prevents the fibula from shearing and rotating relative to the tibia, and the placement of the screws during actual surgery is difficult to control, resulting in a high risk of postoperative screw fatigue fracture.

[0003] The existing technology discloses a device that uses a looped titanium plate placed on the lateral side of the fibula and the medial side of the tibia as a flexible fixation method, with sutures as fixation before the tibiofibular syndesmosis ligament is restored.

[0004] However, while the above method of using two looped titanium plates to fix the bone solves most of the problems of rigid fixation, it requires penetrating the tibia and fibula, which increases the amount of bone removed. Summary of the Invention

[0005] The purpose of this invention is to provide an adjustable flexible bone-to-bone fixation device and implantation mechanism, which aims to solve the problem of large bone removal caused by the existing method of fixing the fibula and tibia with two looped titanium plates.

[0006] To achieve the above objectives, in a first aspect, the present invention provides an adjustable flexible bone-to-bone fixation device, comprising a first suture and a flexible fixation component, wherein the first suture has a first traction end, a second traction end, a first inlet hole and a first outlet hole, and the flexible fixation component comprises a second suture and a titanium alloy button.

[0007] The second suture is sleeved on the side of the first suture. The second suture has a second inlet hole, a second outlet hole, and multiple openings. The second inlet hole and the second outlet hole are located at both ends of the second suture, and the multiple openings are respectively located on the side of the second suture. The titanium alloy button is located on one side of the second suture. The titanium alloy button has a first thread guide hole, a second thread guide hole, a third thread guide hole, a fourth thread guide hole, a fifth thread guide hole, and a sixth thread guide hole. The first thread guide hole is located on one side of the titanium alloy button, and the second thread guide hole is located on one side of the first thread guide hole. The third thread guide hole and the... The fourth wire-passing hole is located between the first wire-passing hole and the second wire-passing hole, and the fifth wire-passing hole and the sixth wire-passing hole are located between the first wire-passing hole and the second wire-passing hole; the second traction end passes through the second inlet hole, the plurality of openings, the second outlet hole, the fifth wire-passing hole, the sixth wire-passing hole, the first inlet hole, the first outlet hole, and the second wire-passing hole in sequence to form a second closed loop; the first traction end passes through the third wire-passing hole, the fourth wire-passing hole, the first outlet hole, the first inlet hole, and the first wire-passing hole in sequence to form a first closed loop.

[0008] The number of openings is eight.

[0009] The eight openings are evenly distributed on the side of the second suture.

[0010] Secondly, the present invention also provides an adjustable flexible bone-to-bone implantation mechanism, including an adjustable flexible bone-to-bone implantation mechanism and an implantation component; the implantation component is disposed on the side of the titanium alloy button.

[0011] The implanted component includes a handle and a stainless steel rod; the handle is located on the side of the titanium alloy button, and the handle has a first wire guide groove, a second wire guide groove, a third wire guide groove, and a button groove; the stainless steel rod is fixedly connected to the handle and is located on the side of the handle, and the stainless steel rod has a steel rod wire guide groove.

[0012] The implantation component also includes a rubber ring; the rubber ring is fitted onto the side of the third wire channel.

[0013] This invention discloses an adjustable flexible bone-to-bone fixation device and implantation mechanism. The first suture is woven from ultra-high molecular weight polyethylene yarn, with a hollow circular cross-section and a length of 1000 mm. The second suture, which can be made of ultra-high molecular weight polyethylene yarn or polyethylene terephthalate, is sleeved in the center of the first suture and has a length of 40-50 mm. To achieve the desired function, the fibula and tibia must first be adjusted to the appropriate position. A 3.5 mm drill bit is used to drill through the fibula (avoiding contact with the tibial surface). Then, a 3.0 mm drill bit is used to create a bone tunnel of approximately 30 mm depth on the tibia through the fibular tunnel created with the 3.5 mm drill bit. The second suture is then passed through the fibular tunnel and tapped into the tibial tunnel. The titanium alloy button is placed on the lateral cortical bone surface of the fibula. The first traction end and the second traction end are pulled, causing the second suture to contract and clump within the bone tunnel, thus achieving flexible fixation. Once the fixation is confirmed, the exposed excess thread of the first suture is cut off without tying a knot. This application combines the advantages of rigid and flexible fixation. Compared to screw fixation, it preserves the joint's micro-movement function, which is beneficial for patients' early weight-bearing exercises of the ankle joint, reducing ankle degeneration and traumatic arthritis, and significantly lowering the risk of implant breakage. Compared to elastic fixation methods such as button titanium plates, this application only passes through the lateral cortical bone at the tibial end, removing less bone and reducing friction between sutures and bone, thus reducing local inflammatory reactions. It also solves the problems of osteolysis or sinking of the internal fixation device associated with button titanium plates. The surgical approach of this application only requires a lateral incision, making the operation simple, convenient, and quick, with a short learning curve. By using a flexible fixation method at the tibial end with only three layers of cortical bone, this application solves the problem of titanium alloy screws being prone to inflammation due to rejection after implantation, causing osteolysis at the implantation site and leading to screw loosening. It also achieves less bone removal and a reliable fixation method. Attached Figure Description

[0014] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below.

[0015] Figure 1 This is a schematic diagram of the overall structure of an adjustable flexible bone-to-bone fixation device according to the present invention.

[0016] Figure 2 This is a schematic diagram of the structure of the first suture of the present invention.

[0017] Figure 3 This is a schematic diagram of the structure of the second suture of the present invention.

[0018] Figure 4 This is a schematic diagram of the structure of the titanium alloy button of the present invention.

[0019] Figure 5 This is a schematic diagram of the structure of an adjustable flexible bone-to-bone fixation device and implantation mechanism according to the present invention.

[0020] Figure 6 This is a schematic diagram of the handle and stainless steel rod of the present invention.

[0021] Figure 7 This is a schematic diagram of the structure of the rubber ring of the present invention.

[0022] Figure 8 This is a diagram showing the usage state of an adjustable flexible bone-to-bone fixation device according to the present invention.

[0023] 1-First suture, 2-Flexible fixation component, 3-Second suture, 4-Titanium alloy button, 5-Implant component, 6-Handle, 7-Stainless steel rod, 8-Rubber ring, 11-First traction end, 12-Second traction end, 13-First inlet hole, 14-First outlet hole, 15-First closed loop, 16-Second closed loop, 31-Second inlet hole, 32-Second outlet hole, 33-Opening, 41-First thread passage hole, 42-Second thread passage hole, 43-Third thread passage hole, 44-Fourth thread passage hole, 45-Fifth thread passage hole, 46-Sixth thread passage hole, 61-First thread passage groove, 62-Second thread passage groove, 63-Third thread passage groove, 64-Button groove, 70-Steel rod thread passage groove. Detailed Implementation

[0024] In a first aspect, the present invention provides an adjustable flexible bone-to-bone fixation device, see [link to relevant documentation]. Figures 1-4 , Figure 8 ,in, Figure 1 This is a schematic diagram of the overall structure of an adjustable flexible bone-to-bone fixation device according to the present invention. Figure 2 This is a schematic diagram of the structure of the first suture of the present invention. Figure 3 This is a schematic diagram of the structure of the second suture of the present invention. Figure 4 This is a schematic diagram of the structure of the titanium alloy button of the present invention. Figure 8 This is a diagram illustrating the usage state of an adjustable flexible bone-to-bone fixation device according to the present invention. The present invention provides an adjustable flexible bone-to-bone fixation device, including a first suture 1 and a flexible fixation component 2. The first suture 1 has a first traction end 11, a second traction end 12, a first inlet hole 13, and a first outlet hole 14. The flexible fixation component 2 includes a second suture 3 and a titanium alloy button 4. The second suture 3 has a second inlet hole 31, a second outlet hole 32, and multiple openings 33. The titanium alloy button 4 has a first thread through hole 41, a second thread through hole 42, a third thread through hole 43, a fourth thread through hole 44, a fifth thread through hole 45, and a sixth thread through hole 46.

[0025] In this specific embodiment, the first suture 1 has a first traction end 11, a second traction end 12, a first inlet hole 13, and a second outlet hole 32. The second suture 3 is sleeved on the side of the first suture 1. The second inlet hole 31 and the second outlet hole 32 are located at both ends of the second suture 3. A plurality of openings 33 are respectively located on the side of the second suture 3. The titanium alloy button 4 is located on one side of the second suture 3. The first thread guide hole 41 is located on one side of the titanium alloy button 4. The second thread guide hole 42 is located on one side of the first thread guide hole 41. The third thread guide hole 43 and the fourth thread guide hole 44 are located on the side of the first thread guide hole 41 and the second thread guide hole 42. Between the second wire passage hole 42, the fifth wire passage hole 45 and the sixth wire passage hole 46 are located between the first wire passage hole 41 and the second wire passage hole 42; the second traction end 12 passes through the second inlet hole 31, the plurality of openings 33, the second outlet hole 32, the fifth wire passage hole 45, the sixth wire passage hole 46, the first inlet hole 13, the first outlet hole 14, and the second wire passage hole 42 in sequence to form a second closed loop 16; the first traction end 11 passes through the third wire passage hole 43, the fourth wire passage hole 44, the first outlet hole 14, the first inlet hole 13, and the first wire passage hole 41 in sequence to form a first closed loop 15.

[0026] The titanium alloy button 4 is made of TC4 titanium alloy, the first stitch 1 is made of ultra-high molecular weight polyethylene yarn, and the second stitch 3 is made of ultra-high molecular weight polyethylene or polyethylene terephthalate material; the second stitch 3 can slide axially relative to the first stitch 1 to produce shrinkage deformation. The second traction end 12 of the first suture 1 is inserted through the second inlet hole 31 of the second suture 3, then passes through multiple openings 33 in sequence and exits through the second outlet hole 32. Then the first traction end 11 passes through the third suture hole 43 and the fourth suture hole 44 of the titanium alloy button 4, then enters through the first outlet hole 14, exits through the first inlet hole 13, and finally passes through the first suture hole 41 of the titanium alloy button 4 to form the first closed loop 15. The second traction end 12 of the first suture 1 passes through the fifth suture hole 45 and the sixth suture hole 46 of the titanium alloy button 4, then enters through the first inlet hole 13, exits through the first outlet hole 14, and finally passes through the second suture hole 42 of the titanium alloy button 4 to form the second closed loop 16. Since the first suture 1 can slide relative to each other through multiple openings, when the first traction end 11 of the first suture 1 is pulled, the first suture 1 slides axially relative to the second suture 3, causing the second suture 3 to contract into a ball and compress the bone tunnel to achieve fixation. The first closed loop 15 and the second closed loop 16 can slide axially relative to the threading section. The length of the first closed loop 15 and the second closed loop 16 can be adjusted by pulling the first traction end 11. Since the force-bearing object does not include the first traction end 11 and the second traction end 12, it is not necessary to tie the first traction end 11 and the second traction end 12 into a knot for fixation, so knotless fixation can be achieved.

[0027] Specific usage process: The first suture 1 is woven from ultra-high molecular weight polyethylene yarn, with a hollow circular cross-section and a length of 1000mm; the second suture 3 can be made of ultra-high molecular weight polyethylene yarn or polyethylene terephthalate material, and is sleeved in the center of the first suture 1, with a length of 30-50mm; to achieve the function, the fibula and tibia need to be adjusted to a suitable position first, and a 3.5mm drill bit is used to drill through the fibula (note that it should not touch the surface of the tibia), and then a 3.0mm drill bit is used to create a bone tunnel of about 30mm depth on the tibia through the fibular bone tunnel created by the 3.5mm drill bit. The second suture 3 is passed through the fibular bone tunnel and knocked into the tibial bone tunnel. The titanium alloy button 4 is placed on the lateral cortical bone surface of the fibula. The first traction end 11 and the second traction end 12 are pulled, and the second suture 3 shrinks into a ball in the bone tunnel to squeeze the bone tunnel to achieve flexible fixation. After confirming that the fixation is correct, the exposed excess thread of the first suture 1 can be cut off without knotting. This application combines the advantages of rigid and flexible fixation. Compared to screw fixation, it preserves the micro-movement function of the joint, which is beneficial for patients' early weight-bearing exercises of the ankle joint, reduces ankle degeneration and traumatic arthritis, and greatly reduces the risk of implant breakage. Compared to elastic fixation such as the Button 4 titanium plate, this application only passes through the lateral cortical bone at the tibial end, removing less bone and reducing friction between sutures and bone, thus reducing local inflammatory reactions. It also solves the problems of osteolysis or sinking of the internal fixation device associated with the Button 4 titanium plate. The surgical approach of this application only requires a lateral incision, making the operation simple, convenient, and quick, with a short learning curve. By using a flexible fixation method at the tibial end with only three layers of cortical bone, this application solves the problem of titanium alloy screws being prone to inflammation due to rejection after implantation, causing osteolysis at the implantation site and leading to screw loosening. It also achieves less bone removal and a reliable fixation method.

[0028] The number of openings 33 is eight. By providing eight openings 33, the system becomes more stable when pulling the first traction end 11.

[0029] Secondly, the eight openings 33 are evenly distributed on the side of the second suture 3. By evenly distributing the eight openings 33 on the side of the second suture 3, the system becomes more stable when the first traction end 11 is pulled.

[0030] An adjustable flexible bone-to-bone fixation device of the present invention, wherein the second traction end 12 of the first suture 1 is inserted through the second inlet hole 31 of the second suture 3, then passes through eight openings 33 in sequence and exits through the second outlet hole 32, then the first traction end 11 passes through the third suture hole 43 and the fourth suture hole 44 of the titanium alloy button 4, then enters through the first outlet hole 14, exits through the first inlet hole 13, and finally passes through the first suture hole 41 of the titanium alloy button 4 to form the first closed loop 15; the second traction end 12 of the first suture 1 passes through the fifth suture hole 45 and the sixth suture hole 46 of the titanium alloy button 4, then enters through the first inlet hole 13, exits through the first outlet hole 14, and finally passes through the second suture hole 42 of the titanium alloy button 4 to form the second closed loop 16; due to the first A suture 1 can slide relative to each other through multiple openings. Therefore, when the first traction end 11 of the first suture 1 is pulled, the first suture 1 slides axially relative to the second suture 3, causing the second suture 3 to contract into a ball and compress the bone tunnel to achieve fixation. In use, first adjust the fibula and tibia to a suitable position, use a 3.5 drill bit to drill through the fibula (note that it should not touch the surface of the tibia), and then use a 3.0 drill bit to create a bone tunnel of about 30mm depth on the tibia by passing through the fibula bone tunnel created by the 3.5 drill bit. Pass the second suture 3 through the fibula bone tunnel and knock it into the tibia bone tunnel. Place the titanium alloy button 4 on the lateral cortical bone surface of the fibula, pull the first traction end 11 and the second traction end 12, and the second suture 3 will contract into a ball in the bone tunnel to compress the bone tunnel to achieve flexible fixation. After confirming that the fixation is correct, cut off the exposed excess thread of the first suture 1.

[0031] Secondly, the present invention also provides an adjustable flexible bone-to-bone implantation mechanism, please refer to [link to relevant documentation]. Figures 5-7 ,in, Figure 5 This is a schematic diagram of the structure of an adjustable flexible bone-to-bone fixation device and implantation mechanism according to the present invention. Figure 6 This is a schematic diagram of the handle and stainless steel rod of the present invention. Figure 7 This is a schematic diagram of the structure of the rubber ring of the present invention. The adjustable flexible bone-to-bone implantation mechanism provided by the present invention includes an adjustable flexible bone-to-bone fixation device and an implantation component 5; the implantation component 5 includes a handle 6, a stainless steel rod 7 and a rubber ring 8; the handle 6 has a first wire groove 61, a second wire groove 62, a third wire groove 63 and a button groove 64; the stainless steel rod 7 has a steel rod wire groove 70.

[0032] In this specific embodiment, the implant component 5 is disposed on the side of the titanium alloy button 4. The implant component 5 can accommodate and fix the titanium alloy button 4.

[0033] The handle 6 is located on the side of the titanium alloy button 4, and the stainless steel rod 7 is fixedly connected to the handle 6 and located on the side of the handle 6. The steel rod groove 70 on the stainless steel rod 7 can fix the relative position of the second thread 3, and the first thread groove 61, the second thread groove 62, the third thread groove 63 and the button groove 64 on the handle 6 can accommodate the titanium alloy button 4 and excess thread.

[0034] Secondly, the rubber ring 8 is fitted onto the side of the third thread guide groove 63. By fitting the rubber ring 8 onto the third thread guide groove 63, the stitching and the titanium alloy button 4 are protected from falling off.

[0035] The present invention discloses an adjustable flexible bone-to-bone implantation mechanism. The suture groove 70 on the stainless steel rod 7 can fix the relative position of the second suture 3. The first suture groove 61, the second suture groove 62, the third suture groove 63, and the button groove 64 on the handle 6 can accommodate the titanium alloy button 4 and excess suture. The rubber ring 8 is fitted onto the third suture groove 63 to protect the suture and the titanium alloy button 4 from falling off.

[0036] The above-disclosed embodiments are merely one or more preferred embodiments of this application and should not be construed as limiting the scope of this application. Those skilled in the art can understand that all or part of the processes for implementing the above embodiments and equivalent changes made in accordance with the claims of this application still fall within the scope of this application.

Claims

1. An adjustable flexible bone-to-bone fixation device, comprising a first suture, the first suture having a first traction end, a second traction end, a first inlet hole, and a first outlet hole, characterized in that, It also includes flexible fixing components; The flexible fixing component includes a second suture and a titanium alloy button; The second suture is sleeved on the side of the first suture. The second suture has a second inlet hole, a second outlet hole and a plurality of openings. The second inlet hole and the second outlet hole are located at both ends of the second suture, and the plurality of openings are respectively located on the side of the second suture. The titanium alloy button is located on one side of the second seam. The titanium alloy button has a first thread guide hole, a second thread guide hole, a third thread guide hole, a fourth thread guide hole, a fifth thread guide hole, and a sixth thread guide hole. The first thread guide hole is located on one side of the titanium alloy button, the second thread guide hole is located on one side of the first thread guide hole, the third and fourth thread guide holes are located between the first and second thread guide holes, and the fifth and sixth thread guide holes are located between the first and second thread guide holes. The second traction end passes through the second inlet hole, the plurality of openings, the second outlet hole, the fifth thread guide hole, the sixth thread guide hole, the first inlet hole, the first outlet hole, and the second thread guide hole in sequence to form a second closed loop. The first traction end passes through the third thread guide hole, the fourth thread guide hole, the first outlet hole, the first inlet hole, and the first thread guide hole in sequence to form a first closed loop.

2. The adjustable flexible bone-to-bone fixation device as described in claim 1, characterized in that, The number of openings is eight.

3. The adjustable flexible bone-to-bone fixation device as described in claim 2, characterized in that, The eight openings are evenly distributed on the side of the second suture.

4. An adjustable flexible bone-to-bone implantation mechanism, comprising an adjustable flexible bone-to-bone fixation device as described in any one of claims 1-3, characterized in that, It also includes implantable components; The implanted component is located on the side of the titanium alloy button.

5. The adjustable flexible bone-to-bone fixation device as described in claim 4, characterized in that, The implanted component includes a handle and a stainless steel rod; the handle is located on the side of the titanium alloy button, and the handle has a first wire guide groove, a second wire guide groove, a third wire guide groove, and a button groove; the stainless steel rod is fixedly connected to the handle and is located on the side of the handle, and the stainless steel rod has a steel rod wire guide groove.

6. The adjustable flexible bone-to-bone fixation device as described in claim 5, characterized in that, The implantation component also includes a rubber ring; the rubber ring is fitted onto the side of the third wire channel.

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