Implantation instrument

Abstract

The invention belongs to the technical field of medical surgical materials, and particularly relates to an implantation instrument. Common metal fracture internal fixation instruments generate artifacts during Micro-CT scanning, and the fracture healing process cannot be observed. The invention provides an implantation instrument which is used for fixing a bone and comprises a supporting part, the supporting part is a carbon fiber rod, and the implantation instrument can dynamically observe the bone mass and the bone microstructure at different time points. The experimental workload is reduced, the number of animals is reduced, working efficiency is improved, and cost is reduced.

Description

Technical Field

[0001] This application belongs to the technical field of medical surgical materials, and particularly relates to an implant device. Background Art

[0002] Animal fracture models are often used to study the effectiveness and mechanism of action of drugs for promoting fracture healing. The fracture healing process is divided into the following stages: inflammatory phase, anabolic phase, catabolic phase, endochondral ossification phase, and coupling and remodeling phase. It is crucial to study the effects of drugs on fracture healing at different time points. Micro-CT in vivo scanning can obtain three-dimensional structure diagrams of the fracture site and can quantitatively calculate bone mass and bone microstructure, enabling a comprehensive evaluation of fracture healing. The internal fixation of existing fracture models usually uses stainless steel metal materials such as intramedullary needles, intramedullary nails, and syringe needles, which produce metal artifacts during Micro-CT scanning. To study the whole process of fracture healing events, multiple time points need to be set, and a group of animals is set at each time point. After sacrificing and obtaining samples, the metal implants are removed for Micro-CT scanning, which greatly increases the workload of the experiment and the number of animals, and the healing law of the fracture site of the same animal cannot be reproduced. Carbon fiber is a material with a fibrous structure composed of carbon elements, with characteristics such as light weight, high strength, high stiffness, and corrosion resistance, and is widely used in clinical research such as spinal, trauma, arthroplasty, and oncology.

[0003] Existing technologies usually use metal fixation materials. Although there are patents involving the use of carbon fiber materials as external fracture fixation materials or internal fixation or bone repair materials, such as fixation brackets or bone plates and intramedullary needles, the function of fixing both ends of the fracture and preventing dislocation when using carbon fiber materials for internal fixation is not mentioned. Summary of the Invention

[0004] 1. Technical Problems to be Solved

[0005] Based on the fact that common metal fracture internal fixation devices produce artifacts during Micro-CT scanning and the whole process of fracture healing cannot be observed, this application provides an implant device.

[0006] 2. Technical Solutions

[0007] To achieve the above purpose, this application provides an implant device for fixing bones, including a support part, and the support part is a carbon fiber rod. The implant device can achieve dynamic observation of bone mass and bone microstructure at different time points.

[0008] Another implementation provided by this application is that an anti-displacement part is provided on the support part, and the anti-displacement part is a carbon fiber plate.

[0009] Another embodiment provided by the present application is that the length of the supporting part is 150% - 180% of the length of the bone to be fixed, and the width of the supporting part is 30% - 50% of the long-axis diameter of the medullary cavity of the femur to be fixed.

[0010] Another embodiment provided by the present application is that the shape of the carbon fiber rod is a cylinder, a cuboid, a cube or a triangular pyramid, and the carbon fiber rod is made of carbon fiber material.

[0011] Another embodiment provided by the present application is that the width of the carbon fiber plate is 50% - 80% of the long-axis diameter of the femur to be fixed and is greater than the short-axis diameter. The thickness of the carbon fiber plate is 30% - 45% of the short-axis length of the femur to be fixed, and the height of the carbon fiber plate is 10% - 20% of the length of the femur to be fixed. The carbon fiber plate is made of carbon fiber material.

[0012] Another embodiment provided by the present application is that the carbon fiber plate is a solid structure, a hollow structure or a porous structure.

[0013] Another embodiment provided by the present application is that the carbon fiber material includes carbon fiber and epoxy reinforced composite material, carbon fiber CF / PAEK thermoplastic composite material, carbon fiber CFR / PAEK thermoplastic composite material or carbon fiber and polyetheretherketone composite material, carbon fiber and methyl methacrylate reinforced composite material, carbon fiber reinforced hydroxyapatite modified polyetheretherketone, or a combination of several of the above materials.

[0014] Another embodiment provided by the present application is that the supporting part and the anti-displacement part are integrally formed or spliced.

[0015] Another embodiment provided by the present application is that the implant device is used for fracture fixation.

[0016] Another embodiment provided by the present application is that the implant device can be manually made, automatically made or compression molded.

[0017] 3. Beneficial effects

[0018] Compared with the prior art, the beneficial effects of the implant device provided by the present application are as follows:

[0019] The implant device provided by the present application is an implant device that can be used for internal fixation of fractures; a fracture internal fixation implant device is prepared using carbon fiber material. This implant device can prevent displacement of the fracture ends, has no artifacts during Micro-CT scanning, and can observe the fracture healing progress of the same batch of animals at different time points.

[0020] The implant device provided by the present application reduces the experimental workload, reduces the number of animals, improves work efficiency, and reduces costs. Description of the drawings

[0021] Figure 1 is a schematic structural view of the implant device of the present application;

[0022] Figure 2 is a schematic application view of the implant device of the present application;

[0023] Figure 3 is a schematic view of the Micro-CT scan image of the present application;

[0024] Figure 4 is a schematic internal structure view of the implant device mold of the present application. Detailed implementation manners

[0025] In the following, specific embodiments of the present application will be described in detail with reference to the accompanying drawings. According to these detailed descriptions, those skilled in the art can clearly understand the present application and can implement the present application. Without departing from the principle of the present application, the features in different embodiments can be combined to obtain new implementation manners, or some features in certain embodiments can be replaced to obtain other preferred implementation manners.

[0026] See Figures 1 to 4 , the present application provides an implant device for fixing bones, including a support portion 1, the support portion 1 being a carbon fiber rod, and the implant device being capable of dynamically observing bone mass and bone microstructure at different time points.

[0027] Further, an anti-displacement portion 2 is provided on the support portion 1, and the anti-displacement portion 2 is a carbon fiber plate.

[0028] Further, the length of the support portion 1 is 150% - 180% of the length of the bone to be fixed, and the width of the support portion 1 is 30% - 50% of the long axis diameter of the medullary cavity of the bone to be fixed. Further, the shape of the carbon fiber rod is a cylinder, a cuboid, a cube or a triangular pyramid, and the carbon fiber rod is made of carbon fiber material.

[0029] Further, the width of the carbon fiber plate is 50% - 80% of the long axis diameter of the femur to be fixed and is greater than the short axis diameter, the thickness of the carbon fiber plate is 30% - 45% of the short axis length of the femur to be fixed, the height of the carbon fiber plate is 10% - 20% of the length of the femur to be fixed, and the carbon fiber plate is made of carbon fiber material.

[0030] Further, the carbon fiber plate is a solid structure, a hollow structure or a porous structure.

[0031] Further, the carbon fiber material includes carbon fiber and epoxy reinforced composite material, carbon fiber CF / PAEK thermoplastic composite material, carbon fiber CFR / PAEK thermoplastic composite material or carbon fiber and polyether ether ketone composite material, carbon fiber and methyl methacrylate reinforced composite material, carbon fiber reinforced hydroxyapatite modified polyether ether ketone, or a combination of several of the above materials.

[0032] Further, the support part 1 and the anti-displacement part 2 are integrally formed or spliced.

[0033] Further, the implant device is used for fracture fixation. The implant device includes, but is not limited to, the application of other models of fracture or non-fracture.

[0034] Technical solution for fracture fixation using an implant device (the objects of use of the implant device include, but are not limited to, mice, rats, rabbits, monkeys or humans)

[0035] Taking 10-week-old male C57 mice as an example, in the present invention, the middle segment of the femur is sawn off using a carborundum saw, the proximal and distal ends of the femur are drilled through using a syringe needle with a diameter of 0.5 mm, and a carbon fiber device with a diameter of 0.6 mm, a carbon fiber plate width of 1.1 mm, and a height of 1.5 mm is drilled into the distal and proximal ends of the femur to fix the fracture site ( Figure 2 ).

[0036] The detailed steps and the flowchart of the key steps are as follows:

[0037] ① Induce anesthesia in the mice using 2% - 2.5% isoflurane and maintain anesthesia with a concentration of 1.5% - 2%. After anesthesia, prepare the skin, disinfect and drape the lower limbs and part of the abdomen and back.

[0038] ② Make a 1 - 1.5 cm incision on the anterolateral skin of the middle and lower part of the mouse femur, bluntly separate and enter along the lateral muscle space between the vastus lateralis and the biceps femoris, expose the middle segment of the femur, and place a small curved forceps under the middle segment of the femur (key step 1).

[0039] ③ Use a small round carborundum saw to saw off the middle segment of the femur, and drip saline during the sawing process to cool down and reduce friction (key step 2).

[0040] ④ Use a 0.5 mm needle to drill through the proximal end and the distal end of the femur respectively (key step 3).

[0041] ⑤ Insert a 0.6 mm carbon fiber rod from the femoral cross-section towards the proximal end of the femur, piercing through the skin (key step 4).

[0042] ⑥ Adjust the direction of the distal end of the femur to avoid internal and external dislocation with the proximal end of the femur, and at the same time make the long axis of the fracture section parallel to the width of the carbon fiber plate.

[0043] ⑦Then insert the other end of the carbon fiber rod into the distal femur, align the fracture port, cut off the excess carbon fiber rod, and complete the fixation (key step 5).

[0044] ⑧Suture the muscle and skin, and inject tolfenamic acid for analgesia.

[0045] The implantation method of the implant device includes, but is not limited to, using a diamond saw blade to saw off the middle segment of the femur, using a syringe needle or drill bit to drill through the distal and proximal cortices of the cortical bone, using an electric drill to drill the two ends of the device into the proximal or distal femur, fixing the carbon fiber plate corresponding to the long axis of the femur to prevent dislocation, etc.

[0046] Figure 3 It is the Micro-CT scan image. A. There is no loosening of the carbon fiber implant device on the fracture side. B. Metal fixation produces artifacts, while the carbon fiber rod does not produce artifacts. C. Micro-CT 2D images of the same mouse at different time points.

[0047] One week after the operation, the operated legs can all walk normally. Ten weeks after the operation, samples are taken. In 90% of the experimental animals, there is no loosening of the carbon fiber implant device on the fracture side, and the fracture sites have all healed well ( Figure 3 A). Animals in the same batch of surgeries are subjected to Micro-CT scans at 0, 2, 4, 6, 8, and 10 weeks respectively. No artifacts are produced, and clear images of the bone and bone microstructure can be obtained. Observe the bone healing situation at different time points, and conduct quantitative analysis and comparison.

[0048] Furthermore, the implant device can be manufactured by hand, automated manufacturing, or compression molding.

[0049] Among them, the manual manufacturing method: According to Figure 1 the schematic diagram of the device structure, customize the corresponding mold; lay the carbon fiber cloth on the mold, then apply epoxy resin, and compact it with hands or a scraper and dry it; after drying, take out the mold to obtain the carbon fiber implant device as Figure 1 shown.

[0050] The automated manufacturing method: Apply epoxy resin on the carbon fiber cloth, compact it, and dry it; after drying, fix it in a numerical control machine tool; use the numerical control machine tool to program according to Figure 1 the device structure; start the numerical control machine tool to cut and obtain the carbon fiber implant device as Figure 1 shown.

[0051] The compression molding method: According to Figure 1 the schematic diagram of the device structure, customize the corresponding mold; lay the carbon fiber cloth on the mold, then apply epoxy resin, and compact it with a compressor and dry it; after drying, take out the mold to obtain the carbon fiber implant device as Figure 1 shown.

[0052] As Figure 4As shown, the manufacturing mold of the implant device can be an integrated mold or composed of two upper and lower parts. Its interior consists of two parts: a cylindrical groove and a rectangular parallelepiped groove. The radius of the cylinder is the same as that of the carbon fiber rod. The total depth of the two grooves on both sides is the thickness H of the fiber board, and the width is (fiber board width W - carbon fiber rod diameter D) / 2.

[0053] Embodiment

[0054] The implant device is characterized by a cylindrical carbon fiber material. The middle section of the carbon fiber material is a rectangular parallelepiped carbon fiber board. The length of the cylindrical carbon fiber material is 150% - 180% of the length of the bone to be fixed, the diameter is 30% - 50% of the long-axis diameter of the medullary cavity of the femur to be fixed, the width of the carbon fiber board is 50% - 80% of the long-axis diameter of the femur to be fixed and is greater than the short-axis diameter, the thickness of the carbon fiber board is 30% - 45% of the short-axis length of the femur to be fixed, and the height of the carbon fiber board is 10% - 20% of the length of the femur to be fixed. The structure of the carbon fiber board includes, but is not limited to, solid, hollow or porous structures.

[0055] Both ends of the carbon fiber material of the implant device are drilled into the proximal and distal ends of the femur through the fracture site respectively. During the drilling process, the transverse direction of the carbon fiber board is aligned with the long axis of the two fracture surfaces respectively to prevent misalignment of the connections at both ends of the fracture.

[0056] Preliminary experiments showed that after the carbon fiber material was implanted into the femur, it could effectively support the fracture site, the fracture healing process was normal, and at the same time, artifacts during Micro-CT scanning were avoided, enabling dynamic observation of bone mass and bone microstructure at different time points.

[0057] A bone implant device for internal fixation in a fracture model was designed using carbon fiber material. This device is applicable to diaphyseal fractures. It can not only fix the fracture site and ensure no misalignment when connecting both ends of the fracture, but also be used for Micro-CT scanning to obtain dynamic images of the same animal at multiple time points and acquire data on the entire process of fracture healing, which can be used to study the law of drug promotion of fracture healing.

[0058] Although the present application has been described above with reference to specific embodiments, those skilled in the art should understand that many modifications can be made to the configurations and details disclosed in the present application within the principles and scope of the present application. The protection scope of the present application is determined by the appended claims, and the claims are intended to cover all modifications included in the literal meaning or scope of the equivalents of the technical features in the claims.

Claims

1. An implant device, characterized in that: for fixing bones, including a support part, the support part is a carbon fiber rod, and the implant device can dynamically observe bone mass and bone microstructure at different time points.

2. The implant device according to claim 1, characterized in that: an anti-displacement part is arranged on the support part, and the anti-displacement part is a carbon fiber plate.

3. The implant device according to claim 1 or 2, characterized in that: the length of the support part is 150% - 180% of the length of the bone to be fixed, and the width of the support part is 30% - 50% of the long-axis diameter of the medullary cavity of the bone to be fixed.

4. The implant device according to claim 3, characterized in that: the shape of the carbon fiber rod is a cylinder, a cuboid, a cube or a triangular pyramid, and the carbon fiber rod is made of carbon fiber material.

5. The implant device according to claim 4, characterized in that: the width of the carbon fiber plate is 50% - 80% of the long-axis diameter of the femur to be fixed, the thickness of the carbon fiber plate is 30% - 45% of the short-axis length of the femur to be fixed, the height of the carbon fiber plate is 10% - 20% of the length of the femur to be fixed, and the carbon fiber plate is made of carbon fiber material.

6. The implant device according to claim 5, characterized in that: the carbon fiber plate is a solid structure, a hollow structure or a porous structure.

7. The implant device according to claim 6, characterized in that: the carbon fiber material includes carbon fiber and epoxy reinforced composite material, carbon fiber CF / PAEK thermoplastic composite material, carbon fiber CFR / PAEK thermoplastic composite material or carbon fiber and polyetheretherketone composite material, carbon fiber and methyl methacrylate reinforced composite material, carbon fiber reinforced hydroxyapatite modified polyetheretherketone, or a combination of several of the above materials.

8. The implant device according to claim 2, characterized in that: the support part and the anti-displacement part are integrally formed or spliced.

9. The implant device according to claim 8, characterized in that: the implant device is used for fracture fixation.

10. The implant device according to claim 9, characterized in that: the implant device can be manually made, automatically made or compression molded.

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