An adjustable flexible embracing bone-to-bone fixation device
By adopting an adjustable flexible enclosing bone-to-bone fixation device in tibial and fibula injury surgery, the problems of fixation instability and loss of micromotor function in the prior art are solved, and stable and reliable retention of bone-to-bone fixation and micromotor function is achieved.
Patent Information
- Application Number
- CN202411812405.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-10
- Publication Date
- 2025-04-04
AI Technical Summary
The existing semi-rigid fixation method is unstable and reliable in the surgical treatment of tibial and fibula combined ligament injury, and cannot retain the micromotor function between the tibia and the fibula.
An adjustable flexible enclosing bone-to-bone fixation device is adopted. By taking two fixing points on the tibia and one fixing point on the fibula, each fixing point is used to connect sutures, and the suture length can be adjusted to achieve relative binding between the tibia and fibula.
More stable and reliable bone-to-bone fixation is achieved, while reducing bone removal, retaining the micromotor function between the tibia and fibula, and reducing the risk of internal implant breakage.
Smart Images
Figure CN119745491A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of medical devices, and in particular to an adjustable flexible embracing bone-to-bone fixing device. Background Art
[0002] The tibia and fibula are a common combination of support and connection in the human body, and the tibiofibular syndesmosis is composed of the distal tibiofibular joint and the tibiofibular ligament complex. In short, it is composed of two bones and four ligaments. The tibiofibular syndesmosis is a micro-motion elastic joint. In the physiological state, it can move accordingly with the movement of the ankle joint. The movement pattern is a conforming movement of rotation and translation, which plays an extremely important role in stabilizing the ankle joint.
[0003] Syndesmotic injury is a common injury in clinical practice, accounting for 5%-10% of ankle sprains and 23% of ankle fractures. Syndesmotic injury can occur alone, but in most cases it is accompanied by other ankle injuries. Due to its complexity, if it is missed or improperly diagnosed and treated, it can easily cause complications such as ankle instability, long-term chronic pain, and traumatic osteoarthritis. In recent years, research on syndesmotic injury has continued to deepen, and its anatomy, function, and diagnostic methods have been gradually improved, and treatment concepts have been continuously updated. Clinically, for syndesmotic injury type II and III, tibia and fibula need to be fixed.
[0004] For a long time, the surgical treatment method for syndesmotic ligament injury is usually to stabilize the fibula and tibia in an appropriate position so that the ligament can gradually recover. The current stabilization methods are mostly to pass one or more cortical screws through the fibula and nail them into the tibia to obtain a relatively stable rigid fixation method; or to place a titanium plate with loops on the outside of the fibula and the inside of the tibia respectively, and use sutures as a flexible fixation method before the syndesmotic ligament is restored; there is also a semi-rigid fixation method that combines the two, that is, a titanium plate with loops and a metal screw. A titanium plate with loops (which can be matched with a bone plate) is placed on the outside of the fibula, a metal screw is driven into the outside of the tibia, and the titanium plate and the metal screw are connected with sutures.
[0005] All three methods provide a stable environment for the recovery of the tibiofibular ligament. However, the rigid fixation method using cortical bone screws prevents the shear movement and rotation of the fibula relative to the tibia, and the position of the screw is not easy to control during actual surgery. There is a high risk of screw fatigue fracture after surgery. Usually, after the ligament recovers, the doctor will perform a second operation to remove the screw, which has the risk of secondary damage and infection. Although the fixation method using two titanium plates with loops solves most of the problems of rigid fixation, it needs to penetrate the tibia and fibula, which increases the amount of bone removed. Although the semi-rigid fixation combining titanium plates with loops and metal screws has achieved better performance in all aspects than the first two fixation methods, and is widely used in the surgical treatment of tibiofibular ligament injuries, this semi-rigid fixation method usually uses a single suture to connect the titanium plate and the metal screw, resulting in unstable and unreliable fixation between the titanium plate and the metal screw, and cannot retain the micro-motion function between the tibia and fibula.
[0006] The present invention takes two fixing points on the tibia and one fixing point on the fibula, and the fixing points are connected by sutures. The suture length is adjustable, and the relative binding between the tibia and fibula can be achieved by tightening the sutures. The tibia is bound to the fibula in an embracing manner through sutures. Compared with single-strand suture fixation of bones, the embracing fixation provides a more stable and reliable fixing method, and while achieving a reliable fixation method with less bone removal, it also retains the micro-motion function between the tibia and the fibula. Summary of the invention
[0007] The purpose of the present invention is to provide an adjustable flexible embracing bone-to-bone fixation device, which solves the technical problems that the existing semi-rigid fixation method usually uses a single suture to connect the titanium plate and the metal screw, resulting in unstable and unreliable fixation between the titanium plate and the metal screw, and cannot retain the micro-motion function between the tibia and the fibula.
[0008] To achieve the above-mentioned purpose, in a first aspect, the present invention provides an adjustable flexible embracing bone-to-bone fixation device, comprising a fixing coil, a first fixing nail and a second fixing nail, wherein the fixing coil has a first coil, a second coil, a first traction end, a second traction end, a first wire entry hole, a first wire exit hole, a second wire entry hole and a second wire exit hole, the first fixing nail has a first wire threading hole, a second wire threading hole and a third wire threading hole, and the second fixing nail has a fourth wire threading hole, a fifth wire threading hole and a sixth wire threading hole;
[0009] The first traction end passes through the first threading hole, the second threading hole and the third threading hole to complete the weaving of the first coil, and the first fixing nail is connected to the first coil. The second traction end passes through the fourth threading hole, the fifth threading hole and the sixth threading hole to complete the weaving of the second coil, and the second fixing nail is connected to the second coil. The length of the fixed coil is adjusted to complete the threading.
[0010] The first coil and the second coil are contracted by pulling the first traction end and the second traction end, so as to adjust the length of the fixed coil.
[0011] The specific method of weaving the first coil is as follows:
[0012] The first traction end is passed through the first threading hole, comes out from the second threading hole, then passes through the third threading hole, and then passes through the second threading hole and comes out from the first threading hole. Subsequently, it is passed through the first wire entry hole and comes out from the first wire exit hole, thus completing the weaving of the first coil and connecting the first fixing nail to the first coil.
[0013] The specific method of weaving the second coil is as follows:
[0014] The second traction end is passed through the fourth threading hole, comes out from the fifth threading hole, then passes through the sixth threading hole, and then enters the fifth threading hole on the same side, comes out from the fourth threading hole, then passes through the second wire entry hole, and comes out from the second wire exit hole, thus completing the weaving of the second coil and connecting the second fixing nail to the second coil.
[0015] Wherein, the fixed coil is woven from ultra-high molecular weight polyethylene yarn, polyethylene terephthalate or degradable material.
[0016] Wherein, the first fixing nail and the second fixing nail are both made of titanium alloy, polyetheretherketone, ultra-high molecular weight polyethylene, polyethylene terephthalate or degradable material.
[0017] The present invention discloses an adjustable flexible embracing bone-to-bone fixation device, which combines the advantages of rigid fixation and elastic fixation. Compared with screw fixation, the present invention retains the micro-motion function of the joint, is beneficial to the early weight-bearing exercise of the patient's ankle joint, reduces ankle joint degeneration and traumatic arthritis, and greatly reduces the risk of implant fracture. Compared with elastic fixation such as button titanium plates, two fixing points are taken on the tibia and one fixing point is taken on the fibula. Sutures are used to connect the fixing points, and the length of the sutures can be adjusted. Relative binding between the tibia and fibula can be achieved by tightening the sutures, that is, the tibia is bound to the fibula in an embracing manner through sutures. Compared with the transverse fixation of bones to bones by single-strand sutures, the fixation method is closer to the native ligament, the fixation is more stable and reliable, and less bone removal is achieved while retaining the micro-motion function between the tibia and fibula. BRIEF DESCRIPTION OF THE DRAWINGS
[0018] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art are briefly introduced below.
[0019] Figure 1 It is a schematic diagram of the overall structure of an adjustable flexible embracing bone-to-bone fixation device according to the first embodiment of the present invention.
[0020] Figure 2 It is a schematic structural diagram of the first fixing nail and the second fixing nail of the first embodiment of the present invention.
[0021] Figure 3 Schematic diagram of a fixed coil according to the first embodiment of the present invention.
[0022] Figure 4 It is a schematic diagram of the implantation effect of the adjustable flexible embracing bone-to-bone fixation device according to the first embodiment of the present invention.
[0023] In the figure: 1-fixed coil, 2-first fixed nail, 3-second fixed nail, 11-first coil, 12-second coil, 13-first traction end, 14-second traction end, 15-first wire entry hole, 16-first wire exit hole, 17-second wire entry hole, 18-second wire exit hole, 21-first threading hole, 22-second threading hole, 23-third threading hole, 31-fourth threading hole, 32-fifth threading hole, 33-sixth threading hole. DETAILED DESCRIPTION
[0024] Embodiments of the present invention are described in detail below. Examples of the embodiments are shown in the accompanying drawings. The embodiments described below with reference to the accompanying drawings are exemplary and are intended to be used to explain the present invention, but should not be construed as limiting the present invention.
[0025] First embodiment:
[0026] See also Figures 1 to 4,in, Figure 1 1 is a schematic diagram of the overall structure of an adjustable flexible embracing bone-to-bone fixation device according to a first embodiment of the present invention. Figure 2 is a schematic structural diagram of the first fixing nail 2 and the second fixing nail 3 of the first embodiment of the present invention, Figure 3 is a schematic diagram of a fixed coil 1 of the present invention, Figure 4 It is a schematic diagram of the implantation effect of an adjustable flexible encircling bone-to-bone fixation device according to the first embodiment of the present invention. The present invention provides an adjustable flexible encircling bone-to-bone fixation device, comprising a fixing coil 1, a first fixing nail 2 and a second fixing nail 3. The fixing coil 1 has a first coil 11, a second coil 12, a first traction end 13, a second traction end 14, a first wire entry hole 15, a first wire exit hole 16, a second wire entry hole 17 and a second wire exit hole 18. The first fixing nail 2 has a first wire threading hole 21, a second wire threading hole 22 and a third wire threading hole 23. The second fixing nail 3 has a fourth wire threading hole 31, a fifth wire threading hole 32 and a sixth wire threading hole 33.
[0027] In this embodiment, the present invention combines the advantages of rigid fixation and elastic fixation. Compared with screw fixation, the micro-motion function of the joint is retained, which is beneficial to the patient's early weight-bearing exercise of the ankle joint, reduces ankle joint degeneration and traumatic arthritis, and greatly reduces the risk of implant fracture; compared with elastic fixation such as button titanium plates, two fixing points are taken on the tibia and one fixing point is taken on the fibula, and sutures are used to connect the fixing points. The length of the sutures can be adjusted, and the relative binding between the tibia and fibula can be achieved by tightening the sutures, that is, the tibia is bound to the fibula in an embracing manner through sutures. Compared with the horizontal fixation of bones to bones by single-strand sutures, it is a fixation method that is closer to the original ligament, the fixation is more stable and reliable, and less bone removal is achieved while retaining the micro-motion function between the tibia and fibula.
[0028] Among them, the first traction end 13 passes through the first threading hole 21, the second threading hole 22 and the third threading hole 23 to complete the weaving of the first coil 11, and the first fixing nail 2 is connected to the first coil 11. The second traction end 14 passes through the fourth threading hole 31, the fifth threading hole 32 and the sixth threading hole 33 to complete the weaving of the second coil 12, and the second fixing nail 3 is connected to the second coil 12. Then, the length of the fixed coil 1 is adjusted to complete the threading.
[0029] Secondly, the first traction end 13 and the second traction end 14 are pulled to shrink the first coil 11 and the second coil 12 , so as to adjust the length of the fixed coil 1 .
[0030] Again, the specific method of weaving the first coil 11 is:
[0031] The first traction end 13 is inserted through the first threading hole 21 and comes out from the second threading hole 22, then passes through the third threading hole 23, and then enters from the second threading hole 22 and comes out from the first threading hole 21, then enters from the first wire entry hole 15 and comes out from the first wire exit hole 16, thus completing the weaving of the first coil 11 and connecting the first fixing nail 2 to the first coil 11.
[0032] Meanwhile, the specific method of weaving the second coil 12 is as follows:
[0033] The second traction end 14 is passed through the fourth threading hole 31, comes out from the fifth threading hole 32, then passes through the sixth threading hole 33, enters the fifth threading hole 32 on the same side, and comes out from the fourth threading hole 31. Subsequently, it is passed through the second wire entry hole 17 and comes out from the second wire exit hole 18, thereby completing the weaving of the second coil 12 and connecting the second fixing nail 3 to the second coil 12.
[0034] In addition, the fixing coil 1 is woven from ultra-high molecular weight polyethylene yarn, polyethylene terephthalate or a degradable material, and the fixing coil 1 is a hollow circular cross-section suture with a length of 100 cm.
[0035] Finally, the first fixing nail 2 and the second fixing nail 3 are both made of titanium alloy, polyetheretherketone, ultra-high molecular weight polyethylene, polyethylene terephthalate or degradable materials.
[0036] When using the adjustable flexible embracing bone-to-bone fixation device of the present embodiment, an lateral approach is made to the ankle joint, two suitable fixing points are selected on the lateral side of the tibia, bottom holes are drilled, the corresponding first fixing nails 2 and second fixing nails 3 are taken out, and the first fixing nails 2 and second fixing nails 3 are knocked into the corresponding bone holes using tools, and the first traction end 13 and the second traction end 14 are pulled to shrink the fixing coil 1, and the fibula is bound in a suitable position. After the binding is completed, a surgical knot is tied to fix it, and the excess sutures are removed and the tissues are sutured to complete the implantation.
[0037] The specific threading process is as follows: first, the first traction end 13 is inserted through the first threading hole 21 and comes out from the second threading hole 22, then passes through the third threading hole 23, then enters through the second threading hole 22, and comes out from the first threading hole 21, then enters through the first wire entry hole 15 and comes out from the first wire exit hole 16, thus completing the weaving of the first coil 11 and connecting the first fixing nail 2 to the first coil 11, then, the second traction end 14 is inserted through the fourth threading hole 31 and comes out from the fifth threading hole 32. The threading device 10 passes through the thread hole 32, then passes through the sixth threading hole 33, enters the fifth threading hole 32 on the same side, passes through the fourth threading hole 31, and then passes through the second thread entry hole 17 and passes through the second thread exit hole 18, thus completing the weaving of the second coil 12 and connecting the second fixing nail 3 to the second coil 12. The first coil 11 and the second coil 12 are contracted by pulling the first traction end 13 and the second traction end 14, so that the overall length of the fixing device can be adjusted to complete the entire threading process.
[0038] In summary, the present invention combines the advantages of rigid fixation and elastic fixation. Compared with screw fixation, it retains the micro-motion function of the joint, is beneficial to the patient's early weight-bearing exercise of the ankle joint, reduces ankle joint degeneration and traumatic arthritis, and greatly reduces the risk of implant fracture; compared with elastic fixation such as button titanium plates, by taking two fixing points on the tibia and one fixing point on the fibula, each fixing point is connected by sutures, the suture length is adjustable, and the relative binding between the tibia and fibula can be achieved by tightening the sutures, that is, the tibia is bound to the fibula in an embracing manner through sutures. Compared with the transverse fixation of bones to bones by single-strand sutures, it is a fixation method that is closer to the native ligament, the fixation is more stable and reliable, and less bone removal is achieved while retaining the micro-motion function between the tibia and fibula.
[0039] What is disclosed above is only one or more preferred embodiments of the present application, and cannot be used to limit the scope of rights of the present application. Ordinary technicians in this field can understand that all or part of the processes of implementing the above embodiments and equivalent changes made according to the claims of the present application are still within the scope covered by the present application.
Claims
1. An adjustable flexible embracing bone-to-bone fixation device, characterized in that: It includes a fixed coil, a first fixed nail and a second fixed nail, the fixed coil has a first coil, a second coil, a first traction end, a second traction end, a first wire entry hole, a first wire exit hole, a second wire entry hole and a second wire exit hole, the first fixed nail has a first wire threading hole, a second wire threading hole and a third wire threading hole, and the second fixed nail has a fourth wire threading hole, a fifth wire threading hole and a sixth wire threading hole; The first traction end passes through the first threading hole, the second threading hole and the third threading hole to complete the weaving of the first coil, and the first fixing nail is connected to the first coil. The second traction end passes through the fourth threading hole, the fifth threading hole and the sixth threading hole to complete the weaving of the second coil, and the second fixing nail is connected to the second coil. The length of the fixed coil is adjusted to complete the threading.
2. The adjustable flexible embracing bone-to-bone fixation device according to claim 1, characterized in that: The first coil and the second coil are contracted by pulling the first traction end and the second traction end, so as to adjust the length of the fixed coil.
3. The adjustable flexible embracing bone-to-bone fixation device according to claim 1, characterized in that: The specific method of weaving the first coil is: The first traction end is passed through the first threading hole, comes out from the second threading hole, then passes through the third threading hole, and then passes through the second threading hole and comes out from the first threading hole. Subsequently, it is passed through the first wire entry hole and comes out from the first wire exit hole, thus completing the weaving of the first coil and connecting the first fixing nail to the first coil.
4. The adjustable flexible embracing bone-to-bone fixation device according to claim 3, characterized in that: The specific method of weaving the second coil is: The second traction end is passed through the fourth threading hole, comes out from the fifth threading hole, then passes through the sixth threading hole, and then enters the fifth threading hole on the same side, comes out from the fourth threading hole, then passes through the second wire entry hole, and comes out from the second wire exit hole, thus completing the weaving of the second coil and connecting the second fixing nail to the second coil.
5. The adjustable flexible embracing bone-to-bone fixation device according to claim 1, characterized in that: The fixed coil is woven from ultra-high molecular weight polyethylene yarn, polyethylene terephthalate or a degradable material.
6. The adjustable flexible embracing bone-to-bone fixation device according to claim 1, characterized in that: The first fixing nail and the second fixing nail are both made of titanium alloy, polyetheretherketone, ultra-high molecular weight polyethylene, polyethylene terephthalate or a degradable material.