Stent for repairing oral maxillofacial bone defects

Abstract

The invention belongs to the technical field of biomedical tissue engineering, and aims to solve the problems that an existing oral maxillofacial bone defect repair stent is not provided with a corresponding fixing assembly, the stability of the stent is not enough in the early stage of bone recovery, and the stent is likely to deviate and misplace due to the movement of a patient in the recovery process, so that the repair efficiency is poor. The stent for repairing the oral maxillofacial bone defect comprises a stent body, the stent body is arranged at the defect part of the oral maxillofacial bone, and the stent body and the defect part are used in a matched mode; the support body and the defect part of the oral maxillofacial bone are fixed through a fixing mechanism. Through the design of the fixing mechanism, the filling unit and the oral maxillofacial bone can be fixed, so that the stability of the filling unit can be improved.

Description

Technical Field

[0001] The invention belongs to the technical field of biomedical tissue engineering, and in particular relates to a bracket for repairing oral and maxillofacial bone defects. Background Art

[0002] The restoration of oral and maxillofacial bone defects caused by cleft lip and palate, congenital malformations, tooth extraction, tumor resection, or trauma is often affected by local and systemic pathological conditions. For example, periodontitis is a chronic inflammatory disease that can lead to inflammatory bone resorption, change the alveolar bone structure, damage tooth-supporting tissues, and cause severe periodontitis infection, delayed bone healing at the extraction site, and its alveolar ridge healing pattern is more complex and unpredictable than that of healthy teeth. Diabetes is characterized by chronic hyperglycemia caused by insufficient insulin secretion or utilization, which can lead to delayed healing of extraction sockets and impaired implant osseointegration. These pathological conditions often lead to the failure of oral and maxillofacial bone defects to heal, causing chewing difficulties, aesthetic problems, and speech disorders. Therefore, how to effectively restore oral and maxillofacial bone defects in a fully functional and aesthetic manner is essential to maintain the physical and mental health of patients, which remains a challenge for oral surgeons. Traditional bone repair usually uses autologous bone grafts, however, the limited availability of donor tissue, inevitable additional surgery, and variable bone graft survival limit its practical application in clinical practice.

[0003] In recent decades, the rise of tissue engineering technology has provided a potential alternative method for the repair of oral and maxillofacial bone defects. Tissue engineering bone constructed by tissue engineering technology includes factors such as seed cells, scaffold materials and osteoinductive factors. Although tissue engineering bone has made great progress, this field still faces many challenges, such as selecting appropriate seed cells, growth factors, scaffolds, and retention of tissue engineering bone to ensure high implantation rate and long-term durability of engineered tissue. The division ability and undisputed potential differentiation ability of seed cells play a vital role in this tissue engineering. Insulin is a hormone that mainly affects glucose homeostasis. It is essential for a variety of biological functions (such as normal energy storage, cell growth, proliferation and differentiation) through direct reception and signal transduction of the insulin pathway. There is increasing evidence that insulin is a growth regulator both in vitro and in vivo, stimulating the growth and proliferation of a series of cells, such as somatic cells, osteoblasts, osteoblast lineage and stem cells. In addition, it is increasingly recognized that insulin is an osteogenic inducer. In vivo, insulin treatment improves skeletal abnormalities in type 1 diabetic rodents and promotes the healing of fractures and the healing of extraction sockets in diabetic rabbits. In vitro, insulin enhances the activity of alkaline phosphatase (ALP), type I collagen (COL-1) secretion, osteocalcin (OCN) gene expression and mineralized nodule formation of MG-63 cells, and promotes the osteogenic differentiation of MC3T3-E1 cells under high glucose conditions. Oral and maxillofacial bone marrow-derived mesenchymal stem cells play an important role in the healing and regeneration of oral and maxillofacial bones. Previous studies have confirmed that insulin can promote the proliferation and osteogenic differentiation of alveolar bone marrow mesenchymal stem cells (ABM-MSCs) cultured in vitro, and promote the osteogenesis and angiogenesis of ABM-MSCs in vivo. Insulin-induced osteogenic differentiation of ABM-MSCs depends on insulin / mTOR signaling, which indicates that insulin has a direct anabolic effect on oral and maxillofacial bone marrow-derived mesenchymal stem cells, which is beneficial to the repair of oral and maxillofacial bone defects.

[0004] The function of tissues and organs depends on the behavior of cells. Scaffolds play a vital role in maintaining high cell density and supporting cell proliferation and differentiation to simulate physiological conditions. They also play a vital role in providing the nutrient factors necessary for repairing bone defects. The scaffold material determines the shape of the reconstructed tissue, which is of great significance for the repair of maxillofacial bone defects with high requirements for appearance and function. Autologous bone transplants cannot be tailored to the patient's condition and are difficult to process into a shape suitable for bone defects, which is also an important problem in the maxillofacial region.

[0005] At present, the commonly used tissue engineering bone scaffold materials are mainly divided into two categories, namely, degradable natural materials and degradable synthetic materials. Degradable natural polymer materials (collagen, chitosan, etc.) have poor strength and processing properties, and the degradation rate cannot be adjusted; degradable natural inorganic materials (coral, etc.) are hard, lack flexibility and are difficult to shape; the degradation products of degradable synthetic polymer materials (polylactic acid, polyglycolic acid, etc.) are prone to cause local aseptic inflammation; degradable synthetic inorganic materials [calcium carbonate cement, tricalcium phosphate (TCP)), hydroxyapatite (HA), bioactive ceramics, etc.] are relatively fragile and lack biomechanical strength; degradable synthetic composite materials (TCP / HA, HA / coral, nanohydroxyapatite / collagen, etc.) are often used as ideal bone repair materials because their absorption and bone formation speeds are more matched, their biomechanical properties are closer to bone tissue, and their auxiliary bone formation effect is significantly improved compared to single materials. Nano-hydroxyapatite / Collagen (nHAC) is a ceramic / polymer composite material used to simulate the nano- to micro-scale hierarchical structure of natural cancellous bone. Due to its low inflammatory response, good cell compatibility, biodegradability, and ability to regulate cell growth and differentiation, nHAC is considered an ideal tissue engineering bone scaffold, and personalized scaffold materials can be constructed by digital reconstruction and rapid prototyping technology according to the size of the bone defect. Studies have shown that the constructed personalized nHAC was used to repair skull defects in 13 children with skull defects, and the postoperative follow-up repair effect was good. Previous studies of the present invention also confirmed that dental stem cells can effectively adhere, proliferate and differentiate on nHAC scaffolds, promoting the repair of rabbit jaw defects.

[0006] The scaffold material is transplanted to the bone defect site. The stability of the scaffold is particularly important in the early stage of bone recovery. If the scaffold is not stably fixed and easily shifted and dislocated, it will not only affect the quality of bone regeneration, but also the function and appearance of the bone after formation.

[0007] The utility model patent with publication number CN206342720U discloses a degradable stent for repairing oral and maxillofacial bone defects. Although the patent sets the material of the stent body as a magnesium alloy stent material, which can release magnesium ions during the degradation process, and magnesium ions can promote the proliferation and differentiation of osteoblasts after entering the human body, which is beneficial to the formation and mineralization of new bones and the healing of maxillofacial bone defects, the degradable stent for repairing oral and maxillofacial bone defects still has defects during use. The stent is not provided with a corresponding fixing component. In the early stage of bone recovery, the stability of the stent is insufficient. During the recovery process, the stent may be offset and dislocated due to the patient's movement, thereby affecting the subsequent recovery quality. Over time, it may also have a negative impact on the temporomandibular joint, causing pain, bite problems or other temporomandibular joint disorders.

[0008] The invention patent with publication number CN118078501A discloses a degradable stent for repairing oral and maxillofacial bone defects, comprising: oral and maxillofacial bones, the oral and maxillofacial bones include a defect site, a vertical positioning shallow hole is opened at the bottom of the defect site, and a horizontal positioning shallow hole is opened on the side of the defect site; a filling structure, the filling structure is located inside the defect site, and the filling structure and the defect site are used in conjunction with each other; a stabilizing structure, the stabilizing structure is fixedly installed on the oral and maxillofacial bones, and the stabilizing structure limits the filling structure. Although the above technical solution can fill the defect site by setting the filling structure, and the filling structure is limited by the stabilizing structure, the stability of the filling structure can be improved. However, the vertical outer bonding plate and the vertical inner bonding plate in the above technical solution can only limit the middle part of the filling structure, so that the two sides of the filling structure may not be able to achieve a better fit with the defective part, and it is necessary to use screws to horizontally penetrate the oral and maxillofacial bones and then fix the vertical outer bonding plate and the vertical inner bonding plate in the middle, which increases the pain of the patient; at the same time, in the above technical solution, it is necessary to make the end of the horizontal positioning shallow column away from the limiting baffle pass through the connecting through hole and be inserted into the inside of the corresponding horizontal positioning shallow hole, and then the extrusion block needs to be inserted into the inside of the accommodating cavity to achieve the fixation of the filling structure and the oral and maxillofacial bones. Not only is the operation cumbersome, but also because people need to manually perform the above operations, the difficulty of operation is increased. Summary of the invention

[0009] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a bracket for repairing oral and maxillofacial bone defects.

[0010] To achieve the above object, the technical solution adopted by the present invention is: A bracket for repairing oral and maxillofacial bone defects, comprising a bracket body, the bracket body is arranged at the defective part of the oral and maxillofacial bone, and the bracket body and the defective part are used in cooperation with each other; The bracket body and the defective part of the oral and maxillofacial bones are fixed by a fixing mechanism.

[0011] Preferably, the bracket body includes a filling unit adapted to the defective part, a first mounting groove is opened in the middle of the top of the filling unit, a mounting film is arranged on the top of the first mounting groove, two second mounting grooves are symmetrically opened on both sides of the filling unit, the bottom of the first mounting groove is connected with the two second mounting grooves, a fixing column is arranged in the middle of the bottom of the filling unit, the fixing column is plugged into the third mounting groove opened on the bottom of the defective part, movable rods are respectively placed in the two second mounting grooves, two fourth mounting grooves are symmetrically opened on the two side walls of the defective part, and each movable rod is respectively plugged into the fourth mounting groove on the same side.

[0012] Preferably, the fixing mechanism includes an arc-shaped fitting plate and two limiting units. The arc-shaped fitting plate is arranged on the top of the filling unit. A first through hole is opened in the middle of the arc-shaped fitting plate. An extrusion rod is arranged in the first through hole. The bottom of the extrusion rod passes through the mounting film and is connected to the first mounting groove. The two limiting units are symmetrically arranged on the left and rear sides of the arc-shaped fitting plate, and each limiting unit is respectively abutted against the oral and maxillofacial bones and the filling unit.

[0013] Preferably, each limiting unit comprises a vertical outer bonding plate and a vertical inner bonding plate, which are vertically symmetrically arranged on the front and rear sides of the arc-shaped bonding plate, respectively, and the vertical outer bonding plate is located on the outside of the oral and maxillofacial bones and the filling unit, the vertical inner bonding plate is located on the inside of the oral and maxillofacial bones and the filling unit, and the bottom of the arc-shaped bonding plate is connected to the top of the oral and maxillofacial bones and the filling unit.

[0014] Preferably, two second through holes are symmetrically provided on both sides of the top of the arc-shaped bonding plate, and two boss through holes are symmetrically provided on both sides of the bottom of the arc-shaped bonding plate, each boss through hole is connected to the corresponding second through hole above, and two fifth mounting grooves are provided on the top of the oral and maxillofacial bone, and the two fifth mounting grooves are respectively located on both sides of the defective part, and the arc-shaped bonding plate is fixed to the fifth mounting groove on the oral and maxillofacial bone by screws passing through the second through holes and the boss through holes in sequence.

[0015] Preferably, a first position limiting fitting mechanism and a second position limiting fitting mechanism are respectively arranged between the two vertical outer bonding plates and between the two vertical inner bonding plates. The first position limiting fitting mechanism and the second position limiting fitting mechanism have the same structure, and the first position limiting fitting mechanism is connected to the two vertical outer bonding plates, and the second position limiting fitting mechanism is connected to the two vertical inner bonding plates.

[0016] Preferably, the first limit fitting mechanism includes an arc-shaped limit fixing plate, two sliding grooves, two sliding plates, two third through holes, two fixing screws and two threaded holes, the two sliding grooves are symmetrically arranged on the adjacent side surfaces of the two vertical outer fitting plates, the two sliding plates are symmetrically arranged on the two ends of the arc-shaped limit fixing plate, the two sliding plates are slidably connected to the corresponding sliding grooves, the two third through holes are symmetrically arranged on both sides of the top of the arc-shaped fitting plate, the two threaded holes are respectively arranged on the two sliding plates, and each threaded hole is respectively located directly below the third through hole on the same side, and each fixing screw passes through the corresponding third through hole and threaded hole to fix the arc-shaped limit fixing plate and the arc-shaped fitting plate.

[0017] The present invention also provides a method for installing the above-mentioned bracket for repairing oral and maxillofacial bone defects, comprising the following steps: S1. Place the filling unit at the defective part of the oral and maxillofacial bone, so that the fixing column is plugged into the third installation groove opened on the bottom of the defective part, and the two movable rods are completely located in the corresponding second installation grooves, and the filling unit is in contact with the two side surfaces and the lower surface of the defective part, and the filling unit is flush with the top plane of the oral and maxillofacial bone; S2, moving the two vertical outer laminating plates and the two vertical inner laminating plates downward along the outer side and the inner side of the filling unit and the oral and maxillofacial bones respectively, until the bottom of the arc-shaped laminating plate abuts against the oral and maxillofacial bones and the top of the filling unit, and limiting the filling unit by the arc-shaped laminating plate, the vertical outer laminating plate and the vertical inner laminating plate, so as to achieve preliminary fixation of the filling unit and the oral and maxillofacial bones; S3, push the extrusion rod downward, the extrusion rod passes through the first through hole, penetrates the mounting film, and enters the first mounting groove. As the extrusion rod continues to move downward, the two movable rods are pushed out of the second mounting groove respectively by the air pressure pushing downward in the first mounting groove, and inserted into the corresponding fourth mounting groove. When the extrusion rod completely enters the first through hole, the end of the movable rod conflicts with the bottom of the fourth mounting groove, so as to achieve the limiting of the filling unit and the oral and maxillofacial bones; S4, screwing the screw downward, the screw gradually penetrates the fifth installation slot along the boss through hole and the fifth installation slot and enters the oral and maxillofacial bone, and then the lower end of the screw penetrates the movable rod to fix the movable rod, thereby achieving installation and fixation of the filling unit and the oral and maxillofacial bone; S5. Simultaneously rotate the two fixing screws on the first limiting fitting mechanism. As the fixing screws rotate, the arc-shaped limiting fixing plate moves downward along the sliding groove through the sliding plate. When the arc-shaped limiting fixing plate moves to the outer side of the oral and maxillofacial bone at the lower half, stop rotating the fixing screws, and use the arc-shaped limiting fixing plate to limit and fix the bottom of the outer side of the filling unit and the outer side of the oral and maxillofacial bone; then simultaneously rotate the two fixing screws on the second limiting fitting mechanism. As the fixing screws rotate, the arc-shaped limiting fixing plate moves downward along the sliding groove through the sliding plate. When the arc-shaped limiting fixing plate moves to the inner side of the oral and maxillofacial bone at the lower half, stop rotating the fixing screws, and use the arc-shaped limiting fixing plate to limit and fix the bottom of the inner side of the filling unit and the inner side of the oral and maxillofacial bone.

[0018] Compared with the prior art, the present invention has the following beneficial effects: (1) The present invention can fill the defective part by providing a stent body made of a degradable material, and the filling unit is not easy to fall off after filling, thereby greatly improving the filling quality; (2) The present invention can use the arc-shaped bonding plate, the vertical outer bonding plate and the vertical inner bonding plate to limit the filling unit in all directions by placing the arc-shaped bonding plate, the vertical outer bonding plate and the vertical inner bonding plate on the top, the outer side and the inner side of the oral and maxillofacial bones respectively; (3) The present invention can fix the two sides of the filling unit to the oral and maxillofacial bones respectively through the design of two limiting units, and better limit the filling unit, so that the filling unit can achieve better fit with the defect part, which is beneficial to the later defect repair, and solves the technical problem that the existing bracket only limits the middle part of the filling unit, so that the two sides of the filling unit 4 cannot achieve better fit with the defect part; and the present invention can directly clamp the filling unit and the oral and maxillofacial bones at the same time by arranging the limiting units on both sides, so that there is no need to use screws to pass through the oral and maxillofacial bones horizontally and then limit the limiting units in the middle, which reduces the pain of patients; (4) The present invention can achieve fixation of the filling unit and the oral and maxillofacial bones through the design of the extrusion rod, the connecting rod, the fixing column and the screw, thereby improving the stability of the filling unit; (5) The present invention adopts the combined design of the extrusion rod, the mounting film, and the second mounting groove and the fourth mounting groove. The two sides of the filling unit can be fixed to the oral and maxillofacial bones by only one step of pushing the extrusion rod downward and utilizing the air pressure of the downward push. The operation is simple and convenient. It simplifies the operation of the existing bracket, which requires that the end of the horizontal positioning shallow column away from the limit baffle pass through the connecting through hole and be inserted into the corresponding horizontal positioning shallow hole, and then the extrusion block needs to be inserted into the interior of the accommodating cavity, thereby avoiding cumbersome operation. In addition, the present invention only needs to push the extrusion rod, and does not need to manually move the horizontal positioning shallow column to insert it into the horizontal positioning shallow hole, and then manually insert the extrusion block into the interior of the accommodating cavity, thereby reducing the difficulty of operation and facilitating clinical operation and use. (6) The present invention can limit and fix the bottom of the outer side surface and the bottom of the inner side surface of the filling unit respectively through the design of the first limiting fitting mechanism and the second limiting fitting mechanism, thereby improving the fixing stability of the filling unit. In addition, the present invention can use the arc-shaped limiting fixing plate to move downward on the filling unit only by rotating the fixing screw, so that the filling unit can be better fitted with the defective part, thereby improving the repair effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 A schematic diagram of the structure of a stent for repairing oral and maxillofacial bone defects provided in Example 1 of the present invention; Figure 2 An exploded view of a stent for repairing oral and maxillofacial bone defects provided in Example 1 of the present invention; Figure 3 A schematic diagram of the structure of the stent for repairing oral and maxillofacial bone defects provided in Example 1 of the present invention with the screws removed; Figure 4A schematic diagram of the structure of the stent for repairing oral and maxillofacial bone defects provided in Example 1 of the present invention with the fixing mechanism removed; Figure 5 This is a schematic diagram of the structure of the oral and maxillofacial bones and defect parts in Example 1 of the present invention; Figure 6 This is a schematic diagram of the structure of the filling unit in Example 1 of the present invention; Figure 7 is a schematic structural diagram of a fixing mechanism in Embodiment 1 of the present invention; Figure 8 This is a schematic diagram of the connection structure between the fixing mechanism and the filling unit in Example 1 of the present invention; Fig. 9 It is a schematic diagram of the connection structure between the fixing mechanism and the movable rod in Example 1 of the present invention; Fig.10 A schematic diagram of the structure of a stent for repairing oral and maxillofacial bone defects provided in Example 2 of the present invention; Fig.11 It is a schematic diagram of the connection structure of the fixing mechanism, the first position limiting and fitting mechanism, the second position limiting and fitting mechanism and the movable rod in Example 2 of the present invention; Fig.12 Schematic diagram of the structure of the first position limiting and laminating mechanism in Embodiment 2 of the present invention; In the figure: 1. oral and maxillofacial bones; 2. defect site; 3. fixing mechanism; 4. filling unit; 5. first mounting slot; 6. mounting film; 7. second mounting slot; 8. fixing column; 9. third mounting slot; 10. movable rod; 11. fourth mounting slot; 12. arc-shaped laminating plate; 13. limiting unit; 14. first through hole; 15. extrusion rod; 16. vertical outer laminating plate; 17. vertical inner laminating plate; 18. second through hole; 19. boss through hole; 20. fifth mounting slot; 21. screw; 22. arc-shaped limiting fixing plate; 23. sliding slot; 24. sliding plate; 25. third through hole; 26. fixing screw; 27. threaded hole. DETAILED DESCRIPTION

[0020] The following is a description of the embodiments of the present invention. Figures 1 to 12 , the technical solutions in the embodiments of the present invention are clearly and completely described. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Example 1

[0021] like Figures 1 to 9As shown, the embodiment of the present invention provides a stent for repairing oral and maxillofacial bone defects, wherein the stent body is arranged at the defect site 2 of the oral and maxillofacial bone 1, and the stent body and the defect site 2 are used in cooperation with each other; the stent body and the defect site 2 are fixed by a fixing mechanism 3. In the embodiment of the present invention, all components in the fixing mechanism 3 are made of magnesium alloy, and the fixing column 8 and the movable rod 10 in the filling unit 4 are also made of magnesium alloy; the magnesium alloy has certain strength and stability, and through the setting of this material, it can not only play a certain fixing and protective role on the filling unit 4 in the initial recovery process, thereby ensuring the quality of bone recovery, but also in the process of bone recovery, as the fixing mechanism, the fixing column 8 and the movable rod 10 degrade, the magnesium ions decomposed therefrom can be absorbed by bone cells, promoting bone growth, and at the same time, the bone expands under the interaction between the stent body and the bone induction factor loaded therein and the bone defect microenvironment, thereby gradually replacing the stent body, and finally completing bone recovery; the degradation rate of the stent body can be adjusted according to the needs of the patient and the progress of bone healing, thereby ensuring the matching of degradation and recovery. The degradable stent body and the fixing mechanism 3 made of magnesium alloy do not need a second operation to be removed, which reduces the pain of the patient and effectively prevents the occurrence of secondary injuries caused by the operation.

[0022] In the embodiment of the present invention, the bracket body includes a filling unit 4 adapted to the defective part 2, a first mounting groove 5 is provided in the middle of the top of the filling unit 4, a mounting film 6 is provided on the top of the first mounting groove 5, and the mounting film 6 is used to close the first mounting groove 5, two second mounting grooves 7 are symmetrically provided on both sides of the filling unit 4, and the bottom of the first mounting groove 5 is connected with the two second mounting grooves 7. The design of the first mounting groove 5 and the two second mounting grooves 7 being connected facilitates the extrusion rod 15 to move downward in the first mounting groove 5, and facilitates the air pressure in the first mounting groove 5 to the two second mounting grooves 7. The filling unit 4 flows in the direction of the installation groove 7; thereby facilitating the two movable rods 10 to be pushed out from their respective second installation grooves 7; a fixed column 8 is provided in the middle of the bottom of the filling unit 4, and the fixed column 8 is plugged into the third installation groove 9 opened on the bottom of the defective part 2. Through the design of the fixed column 8 and the third installation groove 9, the filling unit 4 can be limited to achieve preliminary positioning with the defective part 2; movable rods 10 are respectively placed in the two second installation grooves 7, and two fourth installation grooves 11 are symmetrically opened on the two side walls of the defective part 2, and each movable rod 10 is respectively plugged into the fourth installation groove 11 on the same side. In the specific design, a certain volume of inert gas can be filled into the first installation groove 5. After the filling is completed, the notch of the first installation groove 5 is immediately closed by the installation film 6, so that there is a certain air pressure between the first installation groove 5 and the two second installation grooves 7, so that when the extrusion rod 15 passes through the installation film 6 and enters the first installation groove 5 downward, the two movable rods 10 are pushed out of the second installation groove 7 respectively by the air pressure in the first installation groove 5, and inserted into the corresponding fourth installation groove 11 on the same side, so as to further fix the two sides of the filling unit 4 to the oral and maxillofacial bones 1. When the extrusion rod 15 completely enters the first through hole 14 (that is, the upper surface of the extrusion rod 15 is flush with the upper surface of the arc-shaped bonding plate 12), the end of the movable rod 10 conflicts with the bottom of the fourth installation groove 11. That is, the present invention can fix the two sides of the filling unit 4 to the oral and maxillofacial bones 1 by only pushing the extrusion rod 15 downward and using the air pressure of the downward push, and the operation is simple.

[0023] In an embodiment of the present invention, the fixing mechanism 3 includes an arc-shaped bonding plate 12 and two limiting units 13. The arc-shaped bonding plate 12 is arranged on the top of the filling unit 4. A first through hole 14 is opened in the middle of the arc-shaped bonding plate 12. An extrusion rod 15 is arranged in the first through hole 14. The extrusion rod 15 is connected to the first through hole 14 by friction. The bottom of the extrusion rod 14 can pass through the mounting film 6 and be connected to the first mounting groove 5. The two limiting units 13 are symmetrically arranged on the left and rear sides of the arc-shaped bonding plate 12, and each limiting unit 13 is respectively abutted against the oral and maxillofacial bone 1 and the filling unit 4.

[0024] In the embodiment of the present invention, each limiting unit 13 includes a vertical outer bonding plate 16 and a vertical inner bonding plate 17, and the vertical outer bonding plate 16 and the vertical inner bonding plate 17 are respectively arranged vertically and symmetrically on the front side and the rear side of the arc-shaped bonding plate 12, and the vertical outer bonding plate 16 is located on the outer side of the oral and maxillofacial bone 1 and the filling unit 4, and the vertical inner bonding plate 17 is located on the inner side of the oral and maxillofacial bone 1 and the filling unit 4, and the bottom of the arc-shaped bonding plate 12 is connected to the top of the oral and maxillofacial bone 1 and the filling unit 4. In the embodiment of the present invention, the vertical outer bonding plate 16 and the vertical inner bonding plate are both strip plates with a certain curvature that can fit the oral and maxillofacial bone 1 and the filling unit 4; through the joint design of the vertical outer bonding plate 16 and the vertical inner bonding plate 17, the vertical outer bonding plate 16 and the vertical inner bonding plate 17 can be used to perform lateral two-way limiting on the filling unit 4, thereby improving the stability of the fixing of the filling unit 4. Furthermore, the present invention uses two limiting units 13 to clamp and limit the two sides of the filling unit 4 and the oral and maxillofacial bones 1 at the same time, which can not only achieve the initial limiting fixation of the filling unit 4 and the oral and maxillofacial bones 1, but also enable it to maintain a good fit with the defective part, thereby facilitating the subsequent smooth fixation.

[0025] In the embodiment of the present invention, two second through holes 18 are symmetrically provided on both sides of the top of the arc-shaped bonding plate 12, and two boss through holes 19 are symmetrically provided on both sides of the bottom of the arc-shaped bonding plate 12, each boss through hole 19 is respectively connected to the corresponding second through hole 18 above, and each boss through hole 19 can be inserted into the corresponding fifth mounting groove 20. Through the design of the boss through hole 19 and the fifth mounting groove 20, the screw 21 can be guided, so that when the screw 21 is screwed downward, the screw 21 can gradually penetrate the fifth mounting groove 20 along the boss through hole 19 and the fifth mounting groove 20 and enter the oral and maxillofacial bone 1, and the lower end of the screw 21 can penetrate the movable rod 10, thereby fixing the movable rod 10, and then firmly fixing the filling unit 4 and the oral and maxillofacial bone 1. Two fifth mounting grooves 20 are provided on the top of the oral and maxillofacial bone 1, and the two fifth mounting grooves 20 are respectively located on both sides of the defective part 2, and the arc-shaped fitting plate 12 is fixed to the movable rod 10 and the oral and maxillofacial bone 1 by screws 21 that pass through the second through hole 18, the boss through hole 19, the fifth mounting groove 20 in sequence. Example 2

[0026] like Figures 10 to 12As shown, the structure of the bracket for repairing oral and maxillofacial bone defects provided by the embodiment of the present invention is the same as the structure of the bracket for repairing oral and maxillofacial bone defects provided by the embodiment, and the only difference is that a first limiting fitting mechanism and a second limiting fitting mechanism are respectively provided between the two vertical outer laminating plates 16 and between the two vertical inner laminating plates 17 in the embodiment of the present invention, and the first limiting fitting mechanism and the second limiting fitting mechanism have the same structure, and the first limiting fitting mechanism is connected to the two vertical outer laminating plates 16, and the second limiting fitting mechanism is connected to the two vertical inner laminating plates 17. In order to enable the filling unit 4 to be better fitted with the defective part 2, the present invention further designs a first limiting fitting mechanism and a second limiting fitting mechanism to limit and fix the filling unit 4, so that the filling unit 4 can be limited in all directions. At the same time, the tops of the two vertical outer laminating plates 16 and the two vertical inner laminating plates 17 are respectively connected into a whole by connecting plates, and the tops of the outer side and inner side of the filling unit 4 are limited and fixed by the design of the connecting plates.

[0027] In the embodiment of the present invention, the first position limiting and fitting mechanism comprises an arc-shaped position limiting and fixing plate 22, two sliding grooves 23, two sliding plates 24, two third through holes 25, two fixing screws 26 and two threaded holes 27. The two sliding grooves 23 are symmetrically arranged on the adjacent side surfaces of the two vertical outer fitting plates 16, and the two sliding plates 24 are symmetrically arranged on the two ends of the arc-shaped position limiting and fixing plate 22. The two sliding plates 24 are slidably connected with the corresponding sliding grooves 23, and the two third through holes 25 are symmetrically arranged on the two sides of the top of the arc-shaped fitting plate 12, and the two threaded holes 27 are respectively arranged on the two sliding plates 24, and each threaded hole 27 is respectively located directly below the third through hole 25 on the same side, and each fixing screw 26 passes through the corresponding third through hole 25 and threaded hole 27 to fix the arc-shaped position limiting and fixing plate 22 and the arc-shaped fitting plate 12. The two sliding grooves 23 on the second position limiting and fitting mechanism are symmetrically arranged on the adjacent side surfaces of the two vertical inner fitting plates 17.

[0028] In the specific design, in the initial state, after each fixing screw passes through the corresponding third through hole 25, it is threadedly connected with the threaded hole below, and the top of the arc-shaped limit fixing plate 22 contacts the bottom of the connecting plate. When the filling unit 4 is limited and fixed by the arc-shaped bonding plate 12, the vertical outer bonding plate 16 and the vertical inner bonding plate 17, the two arc-shaped limit fixing plates 22 are respectively located on the outside and inside of the oral and maxillofacial bone 1, and then the two fixing screws 26 on the first limiting bonding mechanism are rotated at the same time. As the fixing screws 26 rotate, the arc-shaped limit fixing plate 22 moves downward along the sliding groove 23 through the sliding plate 24. When the arc-shaped limit fixing plate 22 moves to the lower half on the outer side of the oral and maxillofacial bone 1, the fixing screws 26 are stopped from rotating, and the arc-shaped limit fixing plate 22 is used to align the bottom of the outer side of the filling unit 4 with the outer side of the oral and maxillofacial bone 1. Perform limit fixing; then simultaneously rotate the two fixing screws 26 on the second limit fitting mechanism. As the fixing screws 26 rotate, the arc-shaped limit fixing plate 22 moves downward along the sliding groove 23 through the sliding plate 24. When the arc-shaped limit fixing plate 22 moves to the lower half on the inner side of the oral and maxillofacial bone 1, stop rotating the fixing screws 26, and use the arc-shaped limit fixing plate 22 to limit and fix the bottom of the inner side of the filling unit 4 and the inner side of the oral and maxillofacial bone 1. During the rotation process, keep the rotation speed of each fixing screw 26 the same to ensure that the arc-shaped limit fixing plate 22 can move from top to bottom along the filling unit 4 until the outer side and the bottom of the inner side of the filling unit 4 are fixed, thereby achieving full-surrounding limit of the filling unit 4, so that the filling unit 4 can better fit the defective part 2, thereby improving the repair effect.

[0029] The filling unit in the bracket for repairing oral and maxillofacial bone defects provided by the embodiment of the present invention is designed by the following method: When it is necessary to repair the defective part 2 on the oral and maxillofacial bone 1, the doctor first performs a CT scan of the defective part of the oral and maxillofacial bone with more than 16 spiral CT rows, imports the obtained oral and maxillofacial bone image data into the medical reverse software, sets the upper and lower thresholds to select the oral and maxillofacial bone and exclude the surrounding soft tissue, and excludes the bone tissue not connected to the main oral and maxillofacial bone through the regional growth operation, so as to obtain a three-dimensional model of the oral and maxillofacial bone; then the three-dimensional model of the oral and maxillofacial bone is imported into the reverse engineering software, and a surface model of the internal repair surface and the external repair surface matching the defective part of the oral and maxillofacial bone is created; furthermore, the obtained surface model is imported into the digital model engraving software for detail processing; then, the surface model after detail processing is imported into the reverse engineering software, the internal repair surface and the external repair surface are sutured into a closed entity to form a restoration model, and the restoration model is subjected to Boolean operation with the three-dimensional model of the oral and maxillofacial bone to make the edge of the restoration model coincide with the defective bone edge; finally, the restoration model is subjected to a mold turning operation to obtain an upper mold and a lower mold processing for tool path programming Data, then a 3D solid mold is processed by a five-axis CNC machining center; a nano-hydroxyapatite collagen nHAC solution containing 10-20 mg / ml insulin is configured according to the size of the defect, and it is injected into the processed 3D printed mold, and the mold together with the mixed suspension infused therein is placed in an environment of minus 20°C for pre-freezing, and the upper mold is removed after the mixed suspension is frozen into a solid, and then placed in a freeze dryer for freeze drying until the weight no longer changes, and the mold is removed to obtain a filling unit 4. After the filling unit 4 is made, a first installation groove 5 is opened in the middle of the top of the filling unit 4, and a certain volume of inert gas is filled in the first installation groove 5. After the inflation is completed, the notch of the first installation groove 5 is immediately closed by setting a mounting film 6 on the top of the first installation groove 5, and two second installation grooves 7 are symmetrically opened on both sides of the filling unit 4, and the bottom of the first installation groove 5 is connected to the two second installation grooves 7, and then a fixing column 8 is set in the middle of the bottom of the filling unit 4, and then a movable rod 10 is placed in the two second installation grooves 7 respectively, to complete the final preparation of the filling unit 4.

[0030] The working method of the stent for repairing oral and maxillofacial bone defects provided by the embodiment of the present invention is as follows: The prepared filling unit 4 is placed at the defective part 2, and the fixing column 8 is plugged into the third mounting groove 9 opened on the bottom of the defective part 2. At this time, the two movable rods 10 are completely located in the corresponding second mounting grooves 7, and the filling unit 4 is fitted with the two side surfaces and the lower surface of the defective part 2, and the filling unit 4 is flush with the top plane of the oral and maxillofacial bone 1. Then, the two vertical outer bonding plates 16 and the two vertical inner bonding plates 17 are moved downward along the outer side and the inner side of the filling unit 4 and the oral and maxillofacial bone 1 respectively, until the bottom of the arc-shaped bonding plate 12 abuts against the oral and maxillofacial bone 1 and the top of the filling unit 4, and the arc-shaped bonding plate 12 is used to bond the filling unit 4 to the outer side and the inner side of the filling unit 4. The clamping plate 12, the vertical outer laminating plate 16 and the vertical inner laminating plate 17 limit the filling unit 4 to achieve preliminary fixation of the filling unit 4 and the oral and maxillofacial bone 1; then the extrusion rod 14 is pushed downward, the extrusion rod 15 passes through the first through hole 14, and penetrates the mounting film 6, and enters the interior of the first mounting groove 5. As the extrusion rod 15 continues to move downward, the two movable rods 10 are pushed out of the second mounting groove 7 respectively by the downward air pressure in the first mounting groove 5, and inserted into the corresponding fourth mounting groove 11. When the extrusion rod 15 completely enters the first through hole 14, the end of the movable rod 10 conflicts with the bottom of the fourth mounting groove 11. The filling unit 4 and the oral and maxillofacial bone 1 are limited, and then the screw 21 is screwed downward. The screw 21 gradually penetrates the fifth mounting groove 20 along the boss through hole 19 and the fifth mounting groove 20 and enters the oral and maxillofacial bone 1. Then the lower end of the screw 21 penetrates the movable rod 10 to fix the movable rod 10, thereby achieving a stable fixation of the filling unit 4 and the oral and maxillofacial bone 1; then the two fixing screws 26 on the first limiting fitting mechanism are rotated at the same time. As the fixing screws 26 rotate, the arc-shaped limiting fixing plate 22 moves downward along the sliding groove 23 through the sliding plate 24. When the arc-shaped limiting fixing plate 22 moves to the lower half in the oral and maxillofacial position, the fixing screws 26 rotate. When the arc-shaped limiting fixing plate 22 is on the outer side of the facial bone 1, stop rotating the fixing screw 26, and use the arc-shaped limiting fixing plate 22 to limit and fix the bottom of the outer side of the filling unit 4 and the outer side of the oral and maxillofacial bone 1; then simultaneously rotate the two fixing screws 26 on the second limiting fitting mechanism. As the fixing screws 26 rotate, the arc-shaped limiting fixing plate 22 moves downward along the sliding groove 23 through the sliding plate 24. When the arc-shaped limiting fixing plate 22 moves to the lower half of the inner side of the oral and maxillofacial bone 1, stop rotating the fixing screw 26, and use the arc-shaped limiting fixing plate 22 to limit and fix the bottom of the inner side of the filling unit 4 and the inner side of the oral and maxillofacial bone 1.

[0031] Although the embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the claims and their equivalents.

Claims

1. A stent for repairing oral and maxillofacial bone defects, characterized in that: The support body is arranged at the defective part (2) of the oral and maxillofacial bones (1), and the support body and the defective part (2) are used in cooperation with each other; The stent body and the defective part (2) are fixed via a fixing mechanism (3).

2. The stent for repairing oral and maxillofacial bone defects according to claim 1, characterized in that: The support body comprises a filling unit (4) adapted to the defective part (2), a first mounting groove (5) is provided in the middle of the top of the filling unit (4), a mounting film (6) is provided on the top of the first mounting groove (5), two second mounting grooves (7) are symmetrically provided on both sides of the filling unit (4), the bottom of the first mounting groove (5) is connected to the two second mounting grooves (7), a fixing column (8) is provided in the middle of the bottom of the filling unit (4), the fixing column (8) is plugged into a third mounting groove (9) provided on the bottom of the defective part (2), movable rods (10) are respectively placed in the two second mounting grooves (7), two fourth mounting grooves (11) are symmetrically provided on the two side walls of the defective part (2), and each movable rod (10) is respectively plugged into the fourth mounting groove (11) on the same side.

3. The stent for repairing oral and maxillofacial bone defects according to claim 2, characterized in that: The fixing mechanism (3) comprises an arc-shaped laminating plate (12) and two limiting units (13); the arc-shaped laminating plate (12) is arranged on the top of the filling unit (4); a first through hole (14) is opened in the middle of the arc-shaped laminating plate (12); an extrusion rod (15) is arranged in the first through hole (14); the bottom of the extrusion rod (14) passes through the mounting film (6) and is connected to the first mounting groove (5); the two limiting units (13) are symmetrically arranged on the left side and the rear side of the arc-shaped laminating plate (12), respectively, and each limiting unit (13) is respectively in contact with the oral and maxillofacial bone (1) and the filling unit (4).

4. The stent for repairing oral and maxillofacial bone defects according to claim 3, characterized in that: Each limiting unit (13) comprises a vertical outer bonding plate (16) and a vertical inner bonding plate (17), the vertical outer bonding plate (16) and the vertical inner bonding plate (17) being respectively arranged vertically symmetrically on the front side and the rear side of the arc-shaped bonding plate (12), and the vertical outer bonding plate (16) is located on the outer side of the oral and maxillofacial bones (1) and the filling unit (4), and the vertical inner bonding plate (17) is located on the inner side of the oral and maxillofacial bones (1) and the filling unit (4), and the bottom of the arc-shaped bonding plate (12) is connected to the top of the oral and maxillofacial bones (1) and the filling unit (4).

5. The stent for repairing oral and maxillofacial bone defects according to claim 3, characterized in that: Two second through holes (18) are symmetrically formed on both sides of the top of the arc-shaped bonding plate (12), and two boss through holes (19) are symmetrically formed on both sides of the bottom of the arc-shaped bonding plate (12), and each boss through hole (19) is connected to the corresponding second through hole (18) above. Two fifth mounting grooves (20) are formed on the top of the oral and maxillofacial bone (1), and the two fifth mounting grooves (20) are respectively located on both sides of the defective part (2). The arc-shaped bonding plate (12) is fixed to the fifth mounting groove (20) on the oral and maxillofacial bone (1) by screws (21) passing through the second through holes (18) and the boss through holes (19) in sequence.

6. The stent for repairing oral and maxillofacial bone defects according to claim 4, characterized in that: A first position-limiting fitting mechanism and a second position-limiting fitting mechanism are respectively arranged between the two vertical outer fitting plates (16) and between the two vertical inner fitting plates (17); the first position-limiting fitting mechanism and the second position-limiting fitting mechanism have the same structure; the first position-limiting fitting mechanism is connected to the two vertical outer fitting plates (16), and the second position-limiting fitting mechanism is connected to the two vertical inner fitting plates (17).

7. The stent for repairing oral and maxillofacial bone defects according to claim 6, characterized in that: The first position limiting laminating mechanism comprises an arc-shaped position limiting fixing plate (22), two sliding grooves (23), two sliding plates (24), two third through holes (25), two fixing screws (26) and two threaded holes (27). The two sliding grooves (23) are symmetrically arranged on adjacent side surfaces of two vertical outer laminating plates (16), the two sliding plates (24) are symmetrically arranged on both ends of the arc-shaped position limiting fixing plate (22), the two sliding plates (24) are slidably connected to the corresponding sliding grooves (23), the two third through holes (25) are symmetrically arranged on both sides of the top of the arc-shaped laminating plate (12), the two threaded holes (27) are respectively arranged on the two sliding plates (24), and each threaded hole (27) is respectively located directly below the third through hole (25) on the same side, and each fixing screw (26) passes through the corresponding third through hole (25) and the threaded hole (27) to fix the arc-shaped position limiting fixing plate (22) and the arc-shaped laminating plate (12).

8. A method for installing a bracket for repairing oral and maxillofacial bone defects according to any one of claims 1 to 7, characterized in that: The following steps are involved: S1. Place the filling unit (4) at the defective part (2) of the oral and maxillofacial bone (1), so that the fixing column (8) is plugged into the third mounting groove (9) opened at the bottom of the defective part (2), and the two movable rods (10) are completely located inside the corresponding second mounting grooves (7), and the filling unit (4) is in contact with the two side surfaces and the lower surface of the defective part (2), and the filling unit (4) is flush with the top plane of the oral and maxillofacial bone (1); S2, moving the two vertical outer bonding plates (16) and the two vertical inner bonding plates (17) downward along the outer side and the inner side of the filling unit (4) and the oral and maxillofacial bone (41) respectively, until the bottom of the arc-shaped bonding plate (12) abuts against the top of the oral and maxillofacial bone (1) and the filling unit (4), and limiting the filling unit (4) by the arc-shaped bonding plate (12), the vertical outer bonding plate (16) and the vertical inner bonding plate (17), so as to achieve preliminary fixation of the filling unit (4) and the oral and maxillofacial bone (1); S3, pushing the extrusion rod (15) downward, the extrusion rod (15) passes through the first through hole (14), penetrates the mounting film (6), and enters the first mounting groove (5). As the extrusion rod (15) continues to move downward, the two movable rods (10) are respectively pushed out from the second mounting groove (7) by the air pressure pushing downward in the first mounting groove (5), and inserted into the corresponding fourth mounting groove (11). When the extrusion rod (15) completely enters the first through hole (14), the end of the movable rod (10) contacts the bottom of the fourth mounting groove (11), thereby achieving the limiting of the filling unit (4) and the oral and maxillofacial bone (1); S4, the screw (21) is screwed downward, and the screw (21) gradually penetrates the fifth installation groove (20) along the boss through hole (19) and the fifth installation groove (20) and enters the oral and maxillofacial bone (1), and then the lower end of the screw (21) penetrates the movable rod (10) to fix the movable rod (10), thereby achieving installation and fixation of the filling unit (4) and the oral and maxillofacial bone (1); S5. The two fixing screws (26) on the first limiting fitting mechanism are rotated simultaneously. As the fixing screws (26) rotate, the arc-shaped limiting fixing plate (22) moves downward along the sliding groove (23) through the sliding plate (24). When the arc-shaped limiting fixing plate (22) moves to the point where the lower half is on the outer side of the oral and maxillofacial bone (1), the fixing screws (26) are stopped from rotating. The arc-shaped limiting fixing plate (22) is used to limit and fix the bottom of the outer side of the filling unit (4) to the outer side of the oral and maxillofacial bone (1). Then, the two fixing screws (26) on the second limiting fitting mechanism are rotated simultaneously. As the fixing screws (26) rotate, the arc-shaped limiting fixing plate (22) moves downward along the sliding groove (23) through the sliding plate (24). When the arc-shaped limiting fixing plate (22) moves to the point where the lower half is on the inner side of the oral and maxillofacial bone (1), the fixing screws (26) are stopped from rotating, and the arc-shaped limiting fixing plate (22) is used to limit and fix the bottom of the inner side of the filling unit (4) and the inner side of the oral and maxillofacial bone (1).

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