Bone repair fixing and bundling device and application thereof, and application of magnesium wire as bone repair product

Abstract

The invention belongs to the technical field of medical auxiliary instruments, and particularly relates to a bone repair fixing and bundling device and application thereof and application of magnesium wires as bone repair products, the bone repair fixing and bundling device comprises a bundling belt and a fixing buckle, the bundling belt is formed by at least one magnesium wire, the fixing buckle and the magnesium wires are made of degradable pure magnesium, and the magnesium wires are made of degradable pure magnesium. The strapping tape surrounds a target bone, and the two ends of the strapping tape are tightened and fixed in the fixing buckles; the diameter of each magnesium wire ranges from 0.5 mm to 1.5 mm. The binding device is applied to internal fixation or auxiliary internal fixation of traumatic bone fractures and is combined with an external cortical bone bridge to be applied to bone tumor repair and fixation, and the degradation product in the magnesium degradation process is used for inhibiting tumor recurrence and promoting osteogenesis to promote formation of the external cortical bone bridge. Therefore, the magnesium wire has a great application prospect as a bone repair product.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical auxiliary equipment, and in particular relates to a bone repair fixing and bundling device and application thereof, and application of magnesium wire as a bone repair product. Background Art

[0002] Bone tumors are tumors that occur in bones or their accessory tissues (blood vessels, nerves, bone marrow, etc.). Malignant bone tumors develop rapidly, have poor prognosis, and high mortality. At present, limb-salvage surgery has become the main development direction of surgical treatment of malignant bone tumors. Clinical research results have shown that although there are many ways to repair tumor-induced bone defects, tumor-induced prosthesis replacement is still the most ideal choice in terms of function. Prosthesis replacement has the advantages of early weight bearing and ideal limb function recovery, but there are also complications such as infection, prosthesis fracture, and loosening. In recent years, loosening of prostheses after surgery has become a major complication. Kawai et al. followed up 40 patients with femoral tumor resection and artificial joint replacement for an average of 8 years. 11 patients required revision surgery due to loosening, and the 3-, 5-, and 10-year prosthesis survival rates were 85%, 67%, and 48%, respectively. Some scholars believe that tumor-induced prostheses will produce wear debris, leading to prosthesis loosening and surgical failure. Therefore, how to prevent postoperative loosening of tumor-induced prostheses has become the focus of further improving the success rate of limb-salvage surgery.

[0003] Biological fixation is an ideal way to fix tumor prostheses for a long time, so as to achieve long-term biological fixation. The concept of extracortical bone bridge has been proposed, and it is believed that bone cement can provide initial stability, and bone grafting of the prosthesis shoulder can form an extracortical bone bridge and bone ingrowth to achieve biological fixation. The extracortical bone bridge has two functions: ① sharing the stress between the bone and the prosthesis, reducing the stress of the prosthesis, bone cement, and bone interface; ② sealing the joint between the prosthesis and the bone to prevent the entry of wear particles. A 10-year follow-up study found that one-third of the patients had bone bridges exceeding 75% of the circumference of the entire porous coverage area, without translucent lines. Yu Xiuchun et al. reported that 57% of patients with tumor-type prosthesis replacement had bone bridges formed and surrounded the prosthesis and osteotomy ends, and another 28.6% of patients were concentrated on one side of the prosthesis. Kaste et al. reported 16 patients who underwent tumor resection and bone cement hinge porous coating prosthesis reconstruction due to tumors around the knee joint. All of them had the growth of extracortical bone bridges, and 14 of them had translucent lines under the extracortical bone bridges. Therefore, the quality of allogeneic bone promoting extracortical bone bridge is not high. Measures to promote the growth of extracortical bone bridge include the following aspects: implanting autologous bone in the shoulder and bone junction of the prosthesis, using periosteal sleeves and prostheses treated with diamond, pure titanium, etc. and porous coating prostheses. The above measures can promote the formation of extracortical bone bridge to a certain extent, but it is still not ideal. At present, there is a lack of simpler methods to promote extracortical bone bridge.

[0004] Since the 21st century, biodegradable medical metal materials represented by magnesium alloys have attracted people's attention and have been widely studied. This type of material not only inherits the good mechanical properties and processing properties of metal materials, but also has good biocompatibility and can be degraded and metabolized in the human body. Internationally, including the German HZG Materials and Coastal Research Center and the American Revolutionary Medical Metal Materials National Engineering Research Center (ERC-RMB) have carried out a lot of research work. In 2013, the German Syntellix company produced The magnesium alloy hollow compression screw obtained the European CE certification for the first time. It uses MgYREZr alloy (composition close to WE43), with a yield strength of >200MPa and an elongation of >10%. This product has been successfully used in tens of thousands of clinical surgeries. Although magnesium alloy hard tissue implant devices have been clinically applied abroad, only Dongguan Yian Technology Co., Ltd. in my country has developed high-purity magnesium screws for autologous bone transplantation fixation of femoral head necrosis and obtained the EU CE certification in 2021. my country's research on medical magnesium alloys is relatively advanced. Peking University, Shanghai Jiaotong University, Zhengzhou University, South China University of Technology and other institutions have also carried out a large number of related basic research and applied basic research, and developed a series of medical magnesium alloys and surface coating technology.

[0005] The above-mentioned magnesium alloys are mostly used in medical implants, but there is no report on the application of magnesium wire in orthopedics and how to use it. Summary of the invention

[0006] In response to the above technical problems, the first purpose of the present invention is to provide a bone repair fixation binding device with a simple structure. It only needs to use a binding belt to bind the target bone and tighten and fix the two ends. In addition, the binding device uses degradable magnesium to promote bone formation and inhibit the growth of bone tumor cells, and is used in bone repair.

[0007] The second purpose of the present invention is to provide an application of a bone repair fixation binding device, for example, in bone tumor repair, or in internal fixation or auxiliary internal fixation of traumatic fractures.

[0008] The third purpose of the present invention is to provide an application of magnesium wire as a bone repair product, utilizing the degradable property of metal magnesium in the body to assist in bone repair and exert its osteogenesis effect.

[0009] To achieve the above object, the technical solution of the present invention is:

[0010] A first aspect of the present invention provides a bone repair fixation binding device, comprising a binding belt formed of at least one magnesium wire and a fixing buckle, wherein the fixing buckle and the magnesium wire are made of degradable pure magnesium, the binding belt surrounds the target bone, and the two ends are tightened and fixed in the fixing buckle;

[0011] The binding device can generate hydrogen and magnesium ions during degradation, the magnesium ions promote osteogenesis and bone fusion, and the hydrogen and magnesium ions have anti-tumor effects;

[0012] The diameter of the magnesium wire is 0.5-1.5 mm. The magnesium wire within this diameter range can control the implantation amount of the degradable pure magnesium, thereby controlling the hydrogen and magnesium ions generated during the degradation of the degradable pure magnesium, fixing the target bone while promoting the repair of the target bone.

[0013] In a preferred embodiment of the first aspect of the present invention, the strapping belt is formed by twisting a plurality of magnesium wires into one strand.

[0014] In a preferred embodiment of the first aspect of the present invention, the fixing buckle comprises a fixing buckle body, a fixing groove is provided on the fixing buckle body, and two ends of the binding belt are embedded in the fixing groove.

[0015] In a preferred embodiment of the first aspect of the present invention, the fixing buckle comprises a fixing buckle body, the fixing buckle is provided with two axial through holes, and the binding belts at both ends cooperate with the two axial through holes in a one-to-one manner.

[0016] The second aspect of the present invention provides an application of the above-mentioned bone repair fixation binding device, such as application in bone repair of bone defects in bone tumor surgery or joint replacement surgery, wherein the binding device is used in combination with an artificial prosthesis;

[0017] The binding belt is wrapped around the outside of the artificial prosthesis, and the two ends are tightened and fixed in the fixing buckle.

[0018] Preferably, a plurality of bone grafts are arranged around the periphery of the artificial prosthesis, and the binding belt is wrapped around the outside of the plurality of bone grafts, with both ends tightened and fixed in the fixing buckle, so that the bone grafts are tightly bound around the periphery of the artificial prosthesis.

[0019] The third aspect of the present invention also provides another application of the bone repair fixation binding device, which is the application of the binding device in the preparation of an auxiliary internal fixation product for traumatic fractures.

[0020] The fourth aspect of the present invention further provides an application of magnesium wire as a bone repair product, using degradable pure magnesium wire as a basic material, and the diameter of the pure magnesium wire is 0.5-1.5 mm.

[0021] In a preferred embodiment of the fourth aspect of the present invention, the pure magnesium wire is configured to be filled into a residual nail channel after the fixing screw is removed.

[0022] In a preferred embodiment of the fourth aspect of the present invention, the repair product is a bundling device, which includes a bundling strap formed of at least one pure magnesium wire and a fixing buckle, the fixing buckle is made of degradable pure magnesium, the bundling strap surrounds the target bone, and both ends are tightened and fixed in the fixing buckle.

[0023] In a preferred embodiment of the fourth aspect of the present invention, the fixing buckle comprises a fixing buckle body, a fixing groove is provided on the fixing buckle body, and two ends of the binding belt are embedded in the fixing groove.

[0024] The fixing buckle comprises a fixing buckle main body, and two axial through holes are arranged on the fixing buckle. The binding belts at both ends match with the two axial through holes in a one-to-one manner.

[0025] A preferred embodiment of the fourth aspect of the present invention is the use of the strapping device in bone defect or joint replacement during bone tumor surgery: the strapping device is used in combination with an artificial prosthesis;

[0026] The binding belt is wrapped around the outside of the artificial prosthesis, and the two ends are tightened and fixed in the fixing buckle.

[0027] Preferably, a plurality of the artificial bone strips are arranged around the periphery of the artificial prosthesis, and the binding belt is wrapped around the outside of the bone graft, with both ends tightened and fixed in the fixing buckle, so that the bone graft is tightly bound around the periphery of the artificial prosthesis.

[0028] A preferred embodiment of the fourth aspect of the present invention is the application of the strapping device as an auxiliary internal fixation product for traumatic fractures. Magnesium, as a degradable metal material, promotes osteogenesis, bone fusion, and accelerates functional reconstruction in the body: from a material science perspective, magnesium metal is a typical light metal with a density close to that of human bones and an elastic modulus comparable to that of human bones. In orthopedic applications, it can effectively alleviate the stress shielding effect and promote functional reconstruction of bone tissue in the affected area; from a biological perspective, magnesium is an essential nutrient element for the human body and is involved in almost all physiological and biochemical reactions in the body. Magnesium is an essential element for bone growth metabolism. It promotes the adhesion and proliferation of osteoblasts by interacting with integrins on the surface of osteoblasts, thereby promoting bone growth.

[0029] Pure magnesium matrix degradation process and degradation products continue to prevent tumor recurrence:

[0030] (1) The degradation of magnesium or magnesium alloys can provide magnesium ions, which may inhibit the occurrence of tumors by stabilizing DNA structure and preventing damage caused by oxidative stress, and the former may be more important. Magnesium can also inhibit the growth of solid tumors by reducing the number of cells in the S phase of the cell cycle. (2) The degradation of magnesium or magnesium alloys will produce a local alkaline environment, which changes the acidic environment preferred by tumor growth and can inhibit the growth and proliferation of tumor cells. (3) Excess free radicals in the human body play an important role in the occurrence and development of many diseases, including tumors. During the degradation of magnesium, hydrogen is also produced. Hydrogen, as a selective antioxidant, can remove excess free radicals in the human body and therefore plays an important role in the prevention and treatment of tumors. (4) Immunosuppression and immune escape in the bone tumor microenvironment are important causes of tumor recurrence after surgery. Immunotherapy that restarts the "tumor-immune cycle" has shown strong anti-tumor activity in the treatment of various solid tumors. After the strapping device is implanted, the degradation process and degradation products in the human environment regulate the bone tumor immune microenvironment and inhibit the progression of bone tumors with the help of anti-tumor immune response.

[0031] Due to the adoption of the above technical solution, the present invention has the following advantages and positive effects compared with the prior art:

[0032] The bone repair fixation binding device provided by the present invention has a binding belt formed by magnesium wire that surrounds the target bone, and the two ends are tightened and fixed by a fixing buckle. For example, when applied to bone fractures or bone fractures, bone screws or steel plates are usually required to be driven in to fix the bone so that it can grow normally, and a removal operation is required later to remove the steel plate or bone screw. When the binding device is used to repair bone fractures or bone cracks or artificial joint replacement, the binding belt is wrapped around the peripheral side of the target bone, the two ends of the binding belt are tightened, and it is fixed with a fixing buckle, so that the binding device fixes the target bone. On the one hand, as the magnesium wire and the fixing buckle degrade, the repair of bone cracks, fractures or bone interfaces is promoted; on the other hand, the binding device uses a degradable pure magnesium substrate, which does not need to be removed later, avoiding secondary surgery; and the binding belt is tied around the peripheral side of the target lesion, with very little contact with the bone, and has little effect on the blood circulation at the target lesion bone.

[0033] The bundling device can also be used to prevent loosening of artificial prostheses after artificial prosthesis replacement after bone tumor surgery, as well as to prevent / inhibit local recurrence of tumors. Usually, after surgical resection of bone tumors, it is impossible to completely and effectively remove local micro-lesions and residual tumor cells immediately. The resection edge of the tumor bone is a site where the tumor is prone to recurrence. Moreover, large bone defects will be caused after bone tumor resection, which requires the use of artificial prostheses for repair and reconstruction. However, complications of artificial prosthesis loosening may occur after tumor prosthesis surgery. The bundling device is combined with an extracortical bone bridge to fix the junction between the artificial prosthesis and the bone. On the one hand, the fixing effect of the bundling device is used to bind the extracortical bone bridge to the junction between the artificial prosthesis and the bone to prevent loosening of the artificial prosthesis. On the other hand, the bundling device can be degraded and promote bone formation, promote the fusion of bone and artificial prosthesis, and prevent loosening of the artificial prosthesis. More importantly, the degradation process and degradation products of the bundling device continue to prevent recurrence at the resection edge of the bone tumor.

[0034] The present invention adopts a binding device for bone repair, which is easy to operate, reliable in fixation, low in production cost, and effectively reduces the surgical cost of patients.

[0035] Since the degradation process and degradation products of magnesium can promote bone formation and inhibit the growth of bone tumor cells, and magnesium wire with a diameter of 0.5-1.5mm has excellent mechanical strength, it can be used to prepare bone repair products.

[0036] In orthopedics, for example, fractures are usually fixed with metal nails. Usually, after the fracture is completely healed, the metal nails need to be removed from the body to prevent complications such as loosening or infection of the metal nails. Currently, after the metal nails are removed clinically, the residual nail channels are not treated or some osteogenic factors, such as hydroxyapatite, are injected into the residual nail channels. However, the residual nail channels are still empty, and the patients can only rely on their own abilities to repair the residual nail channels, which will have a long-term impact on the patients' lives after the removal of the metal nails. Applying magnesium wire in the repair scenario of residual nail channels and filling the residual nail channels with magnesium wire to play its degradable bone-promoting role can greatly reduce the repair time of the residual nail channels. After the residual nail channels are filled with magnesium wire with mechanical strength, the strength of the bones with residual nail channels can also be enhanced, which improves the comfort of patients to a certain extent. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 This is a schematic diagram of a binding belt of a bone repair fixation binding device according to Example 1 of the present invention;

[0038] Figure 2 Schematic diagram of the fixing buckle in the bone repair fixing and binding device of Example 1 of the present invention Figure 1 ;

[0039] Figure 3 Schematic diagram of the fixing buckle in the bone repair fixing and binding device of Example 1 of the present invention Figure 2 ;

[0040] Figure 4 This is a schematic diagram of the application of the bone repair fixation binding device of Example 2 of the present invention in bone tumor surgery or joint replacement surgery;

[0041] Figure 5 This is a schematic diagram of the bone repair fixation binding device according to Example 4 of the present invention in a traumatic fracture auxiliary fixation scenario;

[0042] Figure 6 This is a schematic diagram of the magnesium wire in the residual nail channel scene according to Example 5 of the present invention.

[0043] Explanation of the reference numerals: 1-binding device; 101-magnesium wire; 102-binding belt; 103-fixing buckle; 1031-fixing buckle body; 1032-fixing groove; 1033-axial through hole; 2-artificial prosthesis; 3-bone graft (artificial bone strip); 4-bone crack; 5-bone; 6-metal nail. DETAILED DESCRIPTION

[0044] The bone repair fixing and binding device and its application, and the application of magnesium wire in preparing bone repair products proposed by the present invention are further described in detail below in conjunction with the accompanying drawings and specific embodiments. The advantages and features of the present invention will become clearer according to the following description.

[0045] Example 1

[0046] A bone repair fixing and binding device, comprising a binding belt 102 formed by at least one magnesium wire 101 and a fixing buckle 103, wherein the fixing buckle 103 and the magnesium wire 101 are both made of degradable pure magnesium, the binding belt 102 surrounds the target bone, and the two ends are tightened and fixed in the fixing buckle 103;

[0047] The binding device can generate hydrogen and magnesium ions during the degradation process. Magnesium ions promote osteogenesis and bone fusion, and hydrogen and magnesium ions have anti-tumor effects.

[0048] The diameter of the magnesium wire 101 is 0.5-1.5 mm. The magnesium wire 101 within this diameter range can control the implantation amount of the degradable pure magnesium, thereby controlling the hydrogen and magnesium ions generated during the degradation of the degradable pure magnesium, thereby fixing the target bone and promoting the repair of the target bone.

[0049] The strapping device includes a strapping belt 102 and a fixing buckle 103. The strapping belt 102 surrounds the target bone and is tightened and fixed at both ends. It can be used in fracture and bone crack repair and fixation surgery, or in bone tumor surgery or joint replacement to fix artificial prostheses and autologous bones. After the operation, it is effectively guaranteed that there will be no displacement due to loosening, thereby improving the success rate of the operation. In addition, the strapping belt 102 has little contact with the target bone and has little effect on the blood circulation at this part of the backbone. The fixing buckle 103 is used to fix the strapping belt 102, which is easy to operate and reliable. The strapping device has a low production cost and effectively reduces the patient's surgical expenses.

[0050] Preferably, the strapping belt 102 is formed by twisting a plurality of magnesium wires 101 into a strand, which increases the mechanical strength of the strapping belt 102 and can effectively prevent the strapping belt 102 from breaking. Even if one magnesium wire 101 in the strapping belt 102 breaks, the other magnesium wires 101 can still achieve a fixing effect.

[0051] In one embodiment, if Figure 2 As shown, the fixing buckle 103 includes a fixing buckle body 1031, and two axial fixing grooves 1032 are arranged on the fixing buckle body 1031. The two ends of the strapping belt 102 are embedded in the fixing grooves 1032 after being tightened. In the actual implementation process, the two axial fixing grooves 1032 are very close to each other, and the two ends of the strapping belt 102 are respectively embedded in the two fixing grooves 1032 in a one-to-one correspondence, and then the fixing grooves 1032 are clamped to further fix the strapping belt 102. A clamping claw is further arranged in the fixing groove 1032. After the magnesium wire 101 is embedded in the fixing groove 1032, the clamping claw presses the two ends of the strapping belt 102 to achieve the magnesium wire 101 binding the target bone, or the fixing buckle body 1031 is clamped after the strapping belt 102 is tightened, so that the fixing groove 1032 is compressed, thereby fixing the strapping belt 102.

[0052] In other embodiments, Figure 3 As shown, the fixing buckle 103 includes a fixing buckle body 1031, and two axial through holes 1033 are provided on the fixing buckle 103. The strapping belt 102 at both ends cooperates with the two axial through holes 1033 in a one-to-one manner. Then, the strapping belt 102 can be fixed by tightening the two ends and clamping the fixing buckle 103 with pliers.

[0053] Example 2

[0054] The tying device is used to prevent loosening of artificial prosthesis after artificial prosthesis replacement after bone tumor surgery, and to prevent / inhibit local tumor recurrence. Usually, after surgical resection of bone tumors, it is impossible to completely and effectively remove local micro-lesions and residual tumor cells immediately, and the resection edge of the tumor bone is a site where the tumor is prone to recurrence; and after bone tumor resection, a large bone defect will be caused, which requires the use of artificial prosthesis for repair and reconstruction, but artificial prosthesis loosening complications may occur after tumor prosthesis surgery.

[0055] Because the magnesium wire 101 and the fixing buckle 103 of the entire binding device are all made of pure magnesium substrate, the degradation process and degradation products of the pure magnesium substrate continuously prevent tumor recurrence:

[0056] (1) The degradation of magnesium or magnesium alloys can provide magnesium ions, which may inhibit the occurrence of tumors by stabilizing DNA structure and preventing damage caused by oxidative stress, and the former may be more important. Magnesium can also inhibit the growth of solid tumors by reducing the number of cells in the S phase of the cell cycle. (2) The degradation of magnesium or magnesium alloys will produce a local alkaline environment, which changes the acidic environment preferred by tumor growth and can inhibit the growth and proliferation of tumor cells. (3) Excess free radicals in the human body play an important role in the occurrence and development of many diseases, including tumors. During the degradation of magnesium, hydrogen is also produced. Hydrogen, as a selective antioxidant, can remove excess free radicals in the human body and therefore plays an important role in the prevention and treatment of tumors. (4) Immunosuppression and immune escape in the bone tumor microenvironment are important causes of tumor recurrence after surgery. Immunotherapy that restarts the "tumor-immune cycle" has shown strong anti-tumor activity in the treatment of various solid tumors. After the strapping device is implanted, the degradation process and degradation products in the human environment regulate the bone tumor immune microenvironment and inhibit the progression of bone tumors with the help of anti-tumor immune response.

[0057] At the same time, magnesium, as a degradable metal material, promotes osteogenesis, bone fusion and accelerates functional reconstruction through its degradation products in the body: from a materials science perspective, magnesium is a typical light metal with a density close to that of human bones and an elastic modulus comparable to that of human bones. In orthopedic applications, it can effectively alleviate the stress shielding effect and promote functional reconstruction of bone tissue in the affected area; from a biological perspective, magnesium is an essential nutrient for the human body and is involved in almost all physiological and biochemical reactions in the body. Magnesium is an essential element for bone growth metabolism, and it promotes the adhesion and proliferation of osteoblasts by interacting with integrins on the surface of osteoblasts, thereby promoting bone growth.

[0058] like Figure 4As shown, when the binding device 1 is used as an auxiliary repair product for bone defects during bone tumor surgery: the binding device 1 fixes the interface between the artificial prosthesis 2 and the bone 5, and the binding belt 102 surrounds the outside of the artificial prosthesis 2, and the two ends are tightened and fixed in the fixing buckle 103. The magnesium ions released during the degradation process of the binding device 1 are used to inhibit the recurrence of tumor cells at the bone cutting edge, and the degradation products of the binding device 1 promote osteogenesis and promote the fusion of the artificial prosthesis 2 and the bone 5.

[0059] Furthermore, biological fixation of the extracortical bone bridge is currently the treatment method for long-term auxiliary fixation of tumor artificial prosthesis 2 in clinical practice. The basic concept of extracortical bone bridge fixation is: intramedullary bone cement fixation ensures the initial stability of the artificial prosthesis 2, cortical bone explantation is implemented at the junction of the bone 5 and the artificial prosthesis 2, and the bone and soft tissue grow into the micropores on the porous surface of the artificial prosthesis 2 to form a relatively firm embedded fixation, and heal with the adjacent extracortical bone to form a bone bridge.

[0060] However, the current clinical measures to promote the growth of extracortical bone bridges are not very effective. Using the binding device 1 in combination with an extracortical bone bridge can promote the formation of an extracortical bone bridge.

[0061] Therefore, this embodiment further combines the cortical bone bridge with the binding device 1, that is, a plurality of bone grafts 3 are arranged around the periphery of the junction area between the artificial prosthesis 2 and the bone 5, and the binding belt 102 is wrapped around the outside of the bone graft 3, and the two ends are tightened and fixed in the fixing buckle 103, so that the bone graft 3 is tightly bound around the periphery of the artificial prosthesis 2. The bone graft 3 can be an allogeneic or autologous bone graft 3, and in this embodiment, the bone graft 3 is an artificial bone strip.

[0062] The binding device binds the artificial bone strips at the junction of the bone 5 and the artificial prosthesis 2 to induce bone cells to accelerate their creeping growth. At the same time, magnesium ions are released during the degradation process of the binding device 1 to inhibit the recurrence of tumor cells at the bone cutting edge. The degradation products of the binding device 1 promote osteogenesis and promote the fusion of the prosthesis and the bone.

[0063] In order to make the artificial bone strip fit the surface of the artificial prosthesis 2, an artificial bone strip 3 with an arc surface matching the artificial prosthesis 2 can be used, or an artificial prosthesis 2 can be customized, and a plurality of grooves are provided on the surface of the end of the artificial prosthesis 2 that contacts the autologous bone 5, and the direction of the grooves is parallel to the axial direction of the artificial prosthesis 2. When the artificial bone strips 3 are tied with the binding belt 102, each artificial bone strip 3 will naturally fall into the grooves and be constrained by the direction of the grooves and neatly and evenly arranged around the junction of the bone and the artificial prosthesis 2. The binding device 1 is used to fix the junction area between the artificial prosthesis 2 and the bone 5. On the one hand, the fixing effect of the binding device 1 is used to prevent the loosening of the artificial prosthesis 2; on the other hand, the binding device 1 can degrade and promote the bone formation, promote the fusion of the bone 5 and the artificial prosthesis 2, and prevent the loosening of the artificial prosthesis 2; more importantly, the degradation process and degradation products of the binding device 1 continue to prevent the recurrence of the bone tumor resection margin.

[0064] Furthermore, the diameter of the magnesium wire is 0.5-1.5 mm. The magnesium wire within this diameter range can control the implantation amount of degradable pure magnesium, thereby controlling the hydrogen and magnesium ions generated during the degradation of the degradable pure magnesium, thereby fixing the target bone while promoting the repair of the target bone and producing an anti-tumor effect.

[0065] Example 3

[0066] The bundling device 1 can also be used for the repair and fixation of bone or bone joint prosthesis replacement in various parts caused by other reasons other than tumors. The same as Example 2 is that the bundling device 1 is used to fix the junction area between the artificial prosthesis 2 (bone joint prosthesis) and the bone 5 to fix the artificial prosthesis 2, and then the magnesium wire 101 and the fixing buckle 103 of the bundling device 1 are degraded to promote the fusion of the bone 5 and the artificial prosthesis 2. The diameter of the magnesium wire is 0.5-1.5mm. The magnesium wire within this diameter range can control the implantation amount of degradable pure magnesium, and then control the magnesium ions generated during the degradation of the degradable pure magnesium, thereby fixing the target bone and promoting the repair of the target bone.

[0067] Example 4

[0068] As a degradable metal material, magnesium promotes osteogenesis and bone fusion in vivo, accelerating functional reconstruction. Therefore, the strapping device can also be used for internal fixation or auxiliary internal fixation of traumatic fractures. For example, bone fractures or bone fractures usually require bone screws or steel plates to be inserted to allow the bone to grow normally, and later surgery is required to remove the steel plates or bone screws. The strapping device is used to repair fractures or bone cracks, such as Figure 5As shown in the bone crack schematic diagram, the strapping belt 102 is wrapped around the target bone 5, the two ends of the strapping belt 102 are tightened, and it is fixed by the fixing buckle 103, so that the strapping device 1 fixes the bone crack 4 on the target bone 5. On the one hand, as the magnesium wire 101 and the fixing buckle 103 degrade, the repair of the bone crack 4 and the fracture is promoted; on the other hand, the strapping device 1 adopts a degradable pure magnesium substrate, which does not need to be removed later, avoiding a secondary operation; and the magnesium wire 101 is tied around the target lesion, and the contact surface with the bone 5 is very small, which has little effect on the blood circulation at the target lesion bone.

[0069] Example 5

[0070] Since the current medical applications of magnesium alloys are mostly for implantable medical devices, there are no reports on the application of magnesium wire in orthopedics and how to use it.

[0071] Therefore, this embodiment provides an application of magnesium wire as an orthopedic repair product, using degradable pure magnesium wire as a basic material, and the diameter of the pure magnesium wire is 0.5-1.5 mm.

[0072] Pure magnesium wire in the range of 0.5-1.5mm has excellent mechanical strength and can be used to prepare bone repair products, such as repairing residual nail channels. Because of its excellent mechanical properties, after filling the residual nail channels, the relatively empty residual nail channels can enhance the strength of the bones, allowing it to be used in the residual nail channels; and because of its excellent mechanical properties, it can play a fixing role.

[0073] Specific as Figure 6 As shown, in orthopedics, for example, fractures are usually fixed with metal nails 6. Usually, after the fractures are completely healed, in order to prevent complications such as loosening or infection of the metal nails 6, the metal nails 6 need to be removed from the body. Currently, after the metal nails 6 are removed clinically, the remaining nail channels are not treated or some osteogenic factors, such as hydroxyapatite, are injected into the remaining nail channels. However, the remaining nail channels are still empty, and the patient can only rely on his or her own ability to repair the remaining nail channels, which will have a long-term impact on the patient's life after the removal of the metal nails.

[0074] Therefore, in a preferred embodiment, the pure magnesium wire 101 is configured to be filled into the residual screw channel after the fixing screw is removed to repair the bone growth of the residual screw channel.

[0075] Pure magnesium wire 101 is applied in the repair scenario of residual nail channels. Pure magnesium wire 101 is filled in the residual nail channels to exert its degradable bone-promoting effect, which can greatly reduce the repair time of the residual nail channels. After the residual nail channels are filled with mechanically strong filling magnesium wire 101, the strength of the bones with residual nail channels can also be enhanced, thereby improving the patient's living comfort after the removal of the bone screws to a certain extent.

[0076] In other preferred embodiments, the repair product is Figure 1-4 The strapping device 1 shown in the figure comprises a strapping belt 102 formed by at least one pure magnesium wire 101 and a fixing buckle 103. The fixing buckle 103 is made of degradable pure magnesium. The magnesium wire 101 surrounds the target bone, and the two ends are tightened and fixed in the fixing buckle 103. The strapping belt 102 is wrapped around the target bone body, and the two ends of the strapping belt 102 are fixed by the fixing buckle 103, so that the strapping device is firmly fixed to the target bone body.

[0077] Furthermore, the strapping strap 102 is formed by twisting a plurality of pure magnesium wires 101 into a strand, which increases the mechanical strength of the strapping strap 102 and can effectively prevent the strapping strap 102 from breaking. Even if one magnesium wire 101 in the strapping strap 102 breaks, the other pure magnesium wires 101 can still achieve a fixing effect.

[0078] Specifically, the structure of the fixing buckle 103 is as follows: Figure 2 As shown, the fixing buckle 103 includes a fixing buckle body 1031, and a fixing groove 1032 is arranged on the fixing buckle body 1031. The two ends of the strapping belt 102 are embedded in the fixing groove 1032, and claws are further arranged in the fixing groove 1032. After the strapping belt 102 is embedded in the fixing groove 1032, the two ends of the strapping belt 102 are tightened, and then the claws are used to press the two ends of the strapping belt 102, so that the fixing buckle 103 fixes the two ends of the strapping belt 102, and then the strapping belt 102 is tied to the target bone, or after the two ends of the strapping belt 102 are tightened, the fixing buckle 103 body is clamped to compress the fixing groove, thereby fixing the strapping belt 102.

[0079] or Figure 3 As shown, the fixing buckle 103 includes a fixing buckle body 1031, and two axial through holes 1033 are provided on the fixing buckle 103. The strapping belts 102 at both ends cooperate with the two axial through holes 1033 in a one-to-one manner. Then, the strapping belt 102 is tightened at both ends and the axial through holes 1033 on the fixing buckle 103 are clamped with pliers to fix the strapping belt 102.

[0080] In some embodiments, Figure 4 As shown, the application of the binding device 1 in bone defect or joint replacement during bone tumor surgery: the binding device binds the artificial bone strip 3 to the junction area of ​​the bone 5 and the artificial prosthesis 2 to induce bone cells to accelerate crawling growth, and at the same time releases magnesium ions during the degradation process of the binding device 1 to inhibit the recurrence of tumor cells at the bone cutting edge, and the degradation products of the binding device promote osteogenesis and promote the fusion of the prosthesis and the bone.

[0081] Furthermore, a plurality of the artificial bone strips 3 are arranged around the circumferential side of the junction area between the artificial prosthesis 2 and the bone 5, the binding belt 102 magnesium wire 101 is wrapped around the outside of the artificial bone strips 3, and the two ends are tightened and fixed in the fixing buckle 103, so that the bone graft 3 and the artificial bone strips 3 are tightly tied to the circumferential side of the artificial prosthesis 2.

[0082] The binding device 1 is used to fix the interface between the artificial prosthesis 2 and the bone 5. On the one hand, the fixing effect of the binding device 1 is used to prevent the loosening of the artificial prosthesis 2. On the other hand, the binding device 1 can be degraded and promote bone formation to promote the fusion of the bone 5 and the artificial prosthesis 2 and prevent the loosening of the artificial prosthesis 2. More importantly, when the binding device is used in bone defects during bone tumor surgery, the degradation process and degradation products of the binding device continue to prevent the recurrence of the bone tumor at the resection edge.

[0083] like Figure 5 As shown, the binding device 1 can also be used as an internal fixation or auxiliary internal fixation product for traumatic fractures, such as bone fractures or bone fractures. The binding device 1 is used to repair bone fractures or bone cracks 4. The magnesium wire 101 is wrapped around the target bone 5, and the two ends of the magnesium wire 101 are tightened and fixed with the fixing buckle 103, so that the binding device 1 fixes the bone crack 4 of the target bone 5. On the one hand, as the magnesium wire 101 and the fixing buckle 103 degrade, the repair of the bone crack 4 and the fracture is promoted; on the other hand, the binding device 1 uses a degradable pure magnesium substrate, which does not need to be removed later, avoiding secondary surgery; and the magnesium wire 101 is tied around the target lesion, with very little contact with the bone, which has little effect on the blood circulation at the target lesion bone.

[0084] The embodiments of the present invention are described in detail above in conjunction with the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they still fall within the protection scope of the present invention.

Claims

1. A bone repair fixation and binding device, characterized in that: It includes at least one strapping belt and a fixing buckle formed by a magnesium wire, wherein the fixing buckle and the magnesium wire are made of degradable pure magnesium, the strapping belt surrounds the target bone, and the two ends are tightened and fixed in the fixing buckle; The binding device can generate hydrogen and magnesium ions during degradation, the magnesium ions promote osteogenesis and bone fusion, and the hydrogen and magnesium ions have anti-tumor effects; The diameter of the magnesium wire is 0.5-1.5 mm. The magnesium wire within this diameter range can control the implantation amount of the degradable pure magnesium, thereby controlling the hydrogen and magnesium ions generated during the degradation process of the degradable pure magnesium, fixing the target bone while promoting the repair of the target bone.

2. The bone repair fixing and binding device according to claim 1, characterized in that: The strapping belt is formed by twisting a plurality of magnesium wires into one strand.

3. The bone repair fixing and binding device according to claim 1 or 2, characterized in that: The fixing buckle comprises a fixing buckle main body, a fixing groove is arranged on the fixing buckle main body, and two ends of the binding belt are embedded in the fixing groove.

4. The bone repair fixing and binding device according to claim 1 or 2, characterized in that: The fixing buckle comprises a fixing buckle main body, and two axial through holes are arranged on the fixing buckle. The binding belts at both ends match with the two axial through holes in a one-to-one manner.

5. The use of the bone repair fixing and binding device according to any one of claims 1 to 4, characterized in that: The strapping device is used in conjunction with an artificial prosthesis; The binding belt is wrapped around the outside of the artificial prosthesis, and the two ends are tightened and fixed in the fixing buckle.

6. The use of the bone repair fixation binding device according to claim 5, characterized in that: A plurality of bone grafts are arranged around the periphery of the artificial prosthesis, and the binding belt is wrapped around the outside of the plurality of bone grafts, with both ends tightened and fixed in the fixing buckle, so that the bone grafts are tightly bound around the periphery of the artificial prosthesis.

7. Use of the bone repair fixation and binding device according to any one of claims 1 to 4, characterized in that: The binding device is used in preparing auxiliary internal fixation products for traumatic fractures.

8. An application of magnesium wire as a bone repair product, characterized in that: The basic material is a degradable pure magnesium wire, the diameter of which is 0.5-1.5 mm.

9. The use of the magnesium wire as a bone repair product according to any one of claim 8, characterized in that: The pure magnesium wire is configured to fill into a residual nail channel after the fixing screw is removed.

10. The use of the magnesium wire as a bone repair product according to any one of claim 8, characterized in that: The repair product is a binding device, which includes a binding belt formed by at least one pure magnesium wire and a fixing buckle. The fixing buckle is made of degradable pure magnesium. The binding belt surrounds the target bone, and both ends are tightened and fixed in the fixing buckle.

11. The use of magnesium wire as a bone repair product according to claim 10, characterized in that: Application of the binding device in bone defect or joint replacement during bone tumor surgery: the binding device is used in combination with an artificial prosthesis; The binding belt is wrapped around the outside of the artificial prosthesis, and the two ends are tightened and fixed in the fixing buckle.

12. The use of pure silk as a bone repair product according to claim 11, characterized in that: A plurality of bone grafts are arranged around the periphery of the artificial prosthesis, and the binding belt is wrapped around the outside of the bone graft, with both ends tightened and fixed in the fixing buckle, so that the bone graft is tightly bound around the periphery of the artificial prosthesis.

13. The use of magnesium wire as a bone repair product according to claim 10, characterized in that: The binding device is used as an auxiliary internal fixation product for traumatic fractures.

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