Adjustable bone-to-bone fixing device with main nail and implanting mechanism device

Abstract

The invention relates to the technical field of medical instruments, in particular to an adjustable bone-to-bone fixing device with a main nail and an implanting mechanism device.The adjustable bone-to-bone fixing device comprises the main nail, a fixing coil, a first auxiliary nail and a second auxiliary nail. Early load-bearing exercise of ankle joints of a patient is facilitated, ankle joint degeneration and traumatic arthritis are reduced, and the risk of fracture of an implant is greatly reduced; compared with elastic fixation, two fixing points are taken on the tibia, one fixing point is taken on the fibula, all the fixing points are connected through sutures, and the length of the sutures is adjustable, so that the tibia can bind the fibula in a surrounding mode through the sutures, compared with a single-strand suture transverse fixation mode, the fixation mode is closer to a native ligament, and fixation is more stable and reliable; and moreover, the micro-motion function between the tibia and the fibula is reserved while the bone removal amount is less.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a bone-to-bone fixation device with an adjustable main nail and an implantation mechanism 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 bone-to-bone fixation device with a main nail and an implant mechanism 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 reliable 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, the present invention provides an adjustable bone-to-bone fixation device with a main nail, comprising a main nail, a fixing coil, a first secondary nail and a second secondary nail, wherein the main nail, the first secondary nail and the second secondary nail are connected by the fixing coil, the fixing coil has a first coil, a second coil, a first traction end and a second traction end, the main nail has a first threading hole, a second threading hole and a third threading hole, the first secondary nail is connected to the first coil, the second secondary nail is connected to the second coil, the first traction end and the second traction end are cross-threaded into the first threading hole, and then enter the second threading hole from both sides respectively and pass out of the third threading hole to complete threading and realize suture-embracing binding of the fibula.

[0009] 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 overall length of the fixing device.

[0010] The main nail has a self-tapping locking screw that can be screwed into the bone, and the nail cap has a locking thread that matches the bone plate.

[0011] Wherein, the main nail has a nail cap structure with a locking thread that matches with the bone plate and passes through the fixing coil.

[0012] Wherein, the main nail is an anchor structure that needs to be implanted into the bone but does not need to be matched with the bone plate.

[0013] The main nail is a round button structure that does not need to be implanted into the bone or to be matched with a bone plate, but only needs to be placed on the bone surface.

[0014] Among them, a three-point embracing bone-to-bone fixation is adopted, the fixing point of the main nail is located at the fibula, the fixing points of the first and second auxiliary nails are located at the tibia, the main nail and the first and second auxiliary nails are connected by the fixing coil, and the fixing coil is shrunk and knotted at the main nail to achieve embracing fixation of the tibia and fibula.

[0015] The present invention also provides an implantation mechanism device, including a stainless steel rod and a handle, the stainless steel rod having a wire groove and a receiving groove, the receiving groove is used to receive the first secondary nail, the second secondary nail and the fixed coil, the handle is provided with a rubber ring groove, the rubber ring is bound to the rubber ring groove to fix the first secondary nail, the second secondary nail and the fixed coil to prevent the first secondary nail, the second secondary nail and the fixed coil from falling off.

[0016] The present invention discloses an adjustable bone-to-bone fixation device with a main nail and an implant mechanism device. The present invention 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 fracture of the implant. 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

[0017] 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.

[0018] Figure 1It is a structural schematic diagram of the first type of adjustable flexible bone-to-bone embracing fixation device of the present invention.

[0019] Figure 2 It is a structural schematic diagram of the second type of adjustable flexible bone-to-bone embracing fixation device of the present invention.

[0020] Figure 3 It is a structural schematic diagram of the third type of adjustable flexible bone-to-bone embracing fixation device of the present invention.

[0021] Figure 4 It is a structural schematic diagram of the fourth type of adjustable flexible bone-to-bone embracing fixation device of the present invention.

[0022] Figure 5 It is a schematic diagram of the threading structure of the first type of adjustable flexible bone-to-bone embracing fixation device of the present invention.

[0023] Figure 6 It is a schematic structural diagram of the first type of main nail of the present invention.

[0024] Figure 7 It is a schematic structural diagram of the second type of main nail of the present invention.

[0025] Figure 8 It is a schematic structural diagram of the third type of main nail of the present invention.

[0026] Fig. 9 It is a schematic structural diagram of the fourth type of main nail of the present invention.

[0027] Fig.10 It is a schematic structural diagram of the first pair of nails and the second pair of nails of the present invention.

[0028] Fig.11 It is a schematic diagram of the overall structure of the implant mechanism device of the present invention.

[0029] Fig.12 It is a schematic diagram of the implantation effect of the first type of adjustable flexible bone-to-bone embracing fixation device of the present invention.

[0030] In the figure: 1-main nail, 2-fixing coil, 3-first auxiliary nail, 4-second auxiliary nail, 6-elastic ring, 1A-first type main nail, 1B-second type main nail, 1C-third type main nail, 1D-fourth type main nail, 1A1-first type main nail thread hole 1, 1A2-first type main nail thread hole 2, 1A3-first type main nail thread hole 3, 1B1-second type main nail thread hole 1, 1B2-second type main nail thread hole 2, 1C1-third type main nail thread hole 1, 1C2-third type main nail thread hole 2, 1C3-third type main nail thread hole Wire hole three for nail, 1D1-wire hole one for fourth type main nail, 1D2-wire hole two for fourth type main nail, 11-wire hole one, 12-wire hole two, 13-wire hole three, 21-first coil, 22-second coil, 23-first traction end, 24-second traction end, 31-first threading hole, 32-second threading hole, 33-third threading hole, 41-fourth threading hole, 42-fifth threading hole, 43-sixth threading hole, 51-stainless steel rod, 52-wire groove, 53-storage groove, 54-rubber ring groove, 55-handle. DETAILED DESCRIPTION

[0031] 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.

[0032] First embodiment:

[0033] See also Figures 1 to 12 The present invention provides a bone-to-bone fixation device with an adjustable main nail, comprising a main nail 1, a fixing coil 2, a first auxiliary nail 3 and a second auxiliary nail 4.

[0034] 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.

[0035] Among them, taking the first type of main nail structure as an example, the main nail 1A, the first secondary nail 3 and the second secondary nail 4 are connected by the fixed coil 2, the fixed coil 2 has a first coil 21, a second coil 22, a first traction end 23 and a second traction end 24, the main nail 1A has a first threading hole 1A1, a second threading hole 1A2 and a third threading hole 1A3, the first secondary nail 3 is connected to the first coil 21, and the second secondary nail 4 is connected to the second coil 22, the first traction end 23 and the second traction end 24 are cross-pierced into the first threading hole 1A1, and then enter the second threading hole 1A2 from both sides respectively and pass out of the third threading hole 1A3 to complete threading, so as to realize the suture-embracing binding of the fibula, the first secondary nail 3 has a first threading hole 31, a second threading hole 32 and a third threading hole 33, the first traction end 23 completes the weaving of the first coil 21 by passing through and out of the wire hole 1A1, the wire hole 2A2, the wire hole 3A3, the first threading hole 31, the second threading hole 32 and the third threading hole 33, and realizes the connection of the first secondary nail 3 to the first coil 21. The second secondary nail 4 has a fourth threading hole 41, a fifth threading hole 42 and a sixth threading hole 43. The second traction end 24 passes through the wire hole 1A1, the wire hole 2A2, the wire hole 3A3, the fourth threading hole 41, the fifth threading hole 42 and the sixth threading hole 43 to complete the weaving of the second coil 22, and realizes the connection of the second secondary nail 4 to the second coil 22. The specifications of the main nail 1A can provide different lengths and different diameters according to corresponding needs.

[0036] Secondly, the first traction end 23 and the second traction end 24 are pulled to shrink the first coil 21 and the second coil 22, so as to adjust the overall length of the fixing device.

[0037] Again, the fixed coil 2 is woven from ultra-high molecular weight polyethylene yarn, polyethylene terephthalate or degradable material, and is a hollow circular cross-section suture with a length of 100 cm. The main nail 1, the first secondary nail 3 and the second secondary nail 4 are all made of titanium alloy, degradable polylactic acid, degradable metal, polyetheretherketone, polyethylene terephthalate or ultra-high molecular weight polyethylene.

[0038] At the same time, the main nail 1 has a self-tapping locking screw that can be screwed into the bone, and the nail cap has a locking thread that matches the bone plate, so that the main nail 1 can be implanted into the bone. It is a first-class main nail 1A, and the main nail 1A has thread holes 1A1, 1A2 and 1A3.

[0039] In addition, the main nail 1 has a nail cap structure with a locking thread that cooperates with the bone plate and passes through the fixing coil 2. The main nail 1 does not need to be implanted into the bone, but needs to cooperate with the bone plate. Therefore, this type of nail has no self-tapping screw, only a nail cap structure with a locking thread that cooperates with the bone plate and passes through the fixing coil 2. It is the second type of main nail 1B, and the main nail 1B has a wire hole 1B1 and a wire hole 1B2.

[0040] In addition, the main nail 1 is an anchor structure that needs to be implanted in the bone but does not need to be matched with the bone plate. It is a third type of main nail 1C. The main nail 1C has wire holes 1C1, 1C2 and a wire hole 1C3.

[0041] Finally, the main nail 1 is a circular button structure that does not need to be implanted into the bone or cooperate with the bone plate, but only needs to be placed on the bone surface. It is the fourth type of main nail 1D, and the main nail 1D has a wire hole 1D1 and a wire hole 1D2.

[0042] When using the bone-to-bone fixation device with an adjustable main nail of the present embodiment, an lateral approach is made to the ankle joint. After the fracture is basically fixed using a traumatic bone plate, a suitable locking hole position is selected at the distal end of the bone plate, a guide sleeve is used to locate and drill a low hole, and then the main nail 1 is implanted. After the main nail 1 is implanted, two suitable fixing points are selected on the tibia, a bottom hole is drilled, the corresponding first auxiliary nail 3 and the second auxiliary nail 4 are taken out, and the first auxiliary nail 3 and the second auxiliary nail 4 are knocked into the corresponding bone holes using a tool. After the implantation of the main nail and the auxiliary nail is completed, the first traction end 23 and the second traction end 24 of the fixing coil 2 are pulled so that the first coil 21 and the second coil 22 of the fixing coil 2 are contracted to tighten the tibia and fibula, thereby achieving relative fixation of the tibia and fibula, and achieving suture-embracing binding of the fibula, thereby achieving relative binding between the tibia and fibula. Afterwards, the suture is knotted and the excess suture is removed and cleaned up, and the tissue is sutured, thus completing the surgical treatment of tibiofibular joint ligament injury.

[0043] The specific threading process is as follows: the first traction end 23 of the fixed coil 2 is passed through the wire hole 11 of the main nail 1 and then folded back, entering from one side of the wire hole 2 12, and then passing through the wire hole 3 13, and then passing through the first threading hole 31 of the first secondary nail 3, and passing through the second threading hole 32, and then passing through the third threading hole 33, entering from the second threading hole 32, and passing through the first threading hole 31, and then, the first traction end 23 is passed through the wire hole 3 13 of the main nail 1 again, and passed through the same side hole as the wire hole 2 12, that is, the weaving of the first coil 21 is completed, so that the first secondary nail 3 is connected to the first coil 21 of the fixed coil 2.

[0044] Subsequently, the second traction end 24 of the fixed coil 2 enters through the wire hole 2 12 of the main nail 1 on the same side, and comes out through the wire hole 3 13, and then, passes through the fourth threading hole 41 of the second secondary nail 4, and comes out from the fifth threading hole 42, and then, let the second traction end 24 pass through the sixth threading hole 43, and then, let the second traction end 24 enter the fifth threading hole 42 on the same side, and come out from the fourth threading hole 41, and then, enter through the wire hole 3 13 of the main nail 1, and come out from the wire hole 2 12 on the same side when passing through the wire hole 2 12, thereby completing the weaving of the second coil 22, so that the second secondary nail 4 is connected to the second coil 22.

[0045] Then, the first traction end 23 and the second traction end 24 are cross-passed into the wire hole 11 of the main nail 1. Subsequently, the first traction end 23 and the second traction end 24 enter the wire hole 2 12 of the main nail 1 from both sides respectively, and pass out of the wire hole 3 13. After that, the first coil 21 and the second coil 22 are contracted by pulling the first traction end 23 and the second traction end 24 to adjust the length of the first traction end 23 and the second traction end 24, that is, the threading is completed, and the product threading production process is realized.

[0046] 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.

[0047] Second embodiment:

[0048] Based on the first embodiment, please refer to Fig.11 , Fig.11 Schematic diagram of the implantation mechanism of the present invention. The present invention further provides an implantation mechanism, including a stainless steel rod 51 and a handle 55.

[0049] In this embodiment, the main nail 1, the first secondary nail 3, the second secondary nail 4 and the fixed coil 2 are stored by an implantation mechanism, and when stored, the first secondary nail 3, the second secondary nail 4 and the fixed coil 2 are fixed to prevent the first secondary nail 3, the second secondary nail 4 and the fixed coil 2 from falling off.

[0050] Among them, the stainless steel rod 51 has a wire groove 52 and a storage groove 53, the storage groove 53 is used to store the first secondary nail 3, the second secondary nail 4 and the fixed coil 2, and the handle 55 is provided with a rubber ring groove 54, and the rubber ring 6 is bound to the rubber ring groove 54 to fix the first secondary nail 3, the second secondary nail 4 and the fixed coil 2 to prevent the first secondary nail 3, the second secondary nail 4 and the fixed coil 2 from falling off.

[0051] When using an implant mechanism device of the present embodiment, when the fixing coil 2 is used to connect the main nail 1, the first secondary nail 3 and the second secondary nail 4 to achieve relative binding between the tibia and fibula, there is a part of unused excess coils in the fixing coil 2. At this time, the first secondary nail 3, the second secondary nail 4 and the excess fixing coil 2 are placed in the receiving groove 53 to store the first secondary nail 3, the second secondary nail 4 and the excess fixing coil 2. When storing, the first secondary nail 3, the second secondary nail 4 and the excess fixing coil 2 are bound to the rubber ring groove 54 by using a rubber ring 6 to fix the first secondary nail 3, the second secondary nail 4 and the excess fixing coil 2 to prevent the first secondary nail 3, the second secondary nail 4 and the excess fixing coil 2 from falling off.

[0052] 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. A bone-to-bone fixation device with an adjustable main nail, characterized in that: It includes a main nail, a fixed coil, a first secondary nail and a second secondary nail, the main nail, the first secondary nail and the second secondary nail are connected by the fixed coil, the fixed coil has a first coil, a second coil, a first traction end and a second traction end, the main nail has a first wire hole, a second wire hole and a third wire hole, the first secondary nail is connected to the first coil, the second secondary nail is connected to the second coil, the first traction end and the second traction end are cross-passed into the first wire hole, and then enter the second wire hole from both sides respectively and pass out from the third wire hole, so that threading is completed.

2. The bone-to-bone fixation device with an adjustable main nail as claimed in 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 overall length of the fixing device.

3. The bone-to-bone fixation device with an adjustable main nail as claimed in claim 1, characterized in that: The main nail is provided with a self-tapping locking screw which can be screwed into the bone, and the nail cap is provided with a locking thread which matches with the bone plate.

4. The bone-to-bone fixation device with an adjustable main nail as claimed in claim 1, characterized in that: The main nail has a nail cap structure with locking threads that matches with the bone plate and passes through the fixing coil.

5. The bone-to-bone fixation device with an adjustable main nail as claimed in claim 1, characterized in that: The main nail is an anchor structure that needs to be implanted into the bone but does not need to be matched with the bone plate.

6. The bone-to-bone fixation device with an adjustable main nail as claimed in claim 1, characterized in that: The main nail is a round button structure that does not need to be implanted into the bone or to be matched with a bone plate, but only needs to be placed on the bone surface.

7. The bone-to-bone device with an adjustable main nail as claimed in claim 1, characterized in that: The three-point encircling fixation is used to fix the bone to the bone. The fixing point of the main nail is located at the fibula, and the fixing points of the first and second secondary nails are located at the tibia. The main nail is connected to the first and second secondary nails by the fixing coil, and the fixing coil is shrunk and knotted at the main nail to achieve circumferential fixation of the tibia and fibula.

8. An implant mechanism device, applied to the bone-to-bone fixation device with adjustable main nail as claimed in any one of claims 1 to 7, characterized in that: It includes a stainless steel rod and a handle. The stainless steel rod is provided with a wire groove and a storage groove. The storage groove is used to store the first pair of nails, the second pair of nails and the fixed coil. The handle is provided with a rubber ring groove. The rubber ring is bound to the rubber ring groove to fix the first pair of nails, the second pair of nails and the fixed coil to prevent the first pair of nails, the second pair of nails and the fixed coil from falling off.

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