Biodegradable magnesium-based oral membrane device for assisting in bone increment and preparation method of biodegradable magnesium-based oral membrane device

Abstract

The invention relates to the field of medical instruments, in particular to a biodegradable magnesium-based oral membrane device for assisting bone increment and a preparation method of the biodegradable magnesium-based oral membrane device. The magnesium-based fixing nail is fixed on the coating modified biodegradable magnesium-based oral membrane, so that the operation steps are simplified, the operation time is saved, and the infection risk of a patient is reduced. And meanwhile, the coating of the magnesium-based oral membrane can avoid too high degradation speed in the initial stage, and is beneficial to osteogenesis.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a biodegradable magnesium-based oral membrane device for assisting bone augmentation and a preparation method thereof. Background Art

[0002] The oral and maxillofacial region has a complex anatomical structure and multiple tissue types. It is an important part of the human body and is difficult to repair once damaged. Currently, severe oral and maxillofacial bone deficiency caused by congenital bone dysplasia or deformity, tumors, inflammation, traumatic necrosis, etc. is very common in clinical practice, and its repair is still a challenge in the treatment of plastic surgery and oral and maxillofacial surgery.

[0003] With the development of technology, guided bone regeneration and guided tissue regeneration technologies are often used for bone augmentation. Common oral barrier membranes in this technology are divided into two categories: non-degradable and degradable. Non-degradable membranes are mainly polytetrafluoroethylene and titanium membranes, which have good biocompatibility and can provide a good space for bone defects. However, these membranes are non-degradable and lack antibacterial ability. After bone repair, secondary surgery is required to remove them, which will increase the patient's pain and the risk of bacterial infection. At the same time, the regenerated alveolar crest bone tissue may also be resorbed due to flap opening. Resorbable membranes are mainly animal collagen membranes and synthetic polymer membranes. Degradable membranes are mainly animal collagen membranes and synthetic polymer membranes. Animal collagen membranes have good biocompatibility and tissue adhesion. Although these membranes do not require secondary surgery to remove them, they lack mechanical properties and lack sufficient strength to maintain space in the bone regeneration area. Although synthetic polymer membranes have sufficient mechanical strength, the degradation of these membranes will produce a local acidic environment and foreign bodies, causing significant tissue inflammation and immune response.

[0004] Biodegradable metals, especially magnesium and its alloys, have good biocompatibility and mechanical properties, are degradable in the human body, and have certain antibacterial capabilities, making them ideal materials for oral membranes. The current degradation rate of magnesium and its alloys is relatively fast, but researchers have used their characteristics or modified them to design and develop oral membranes that can solve the above-mentioned common oral barrier membrane problems and achieve other beneficial functions. Patent CN115671378A provides a magnesium alloy guided bone regeneration implant with controllable degradation rate to meet the specific requirements of different implant sites for alloy degradation performance; Patent CN113648467A provides a double-sided heterogeneous degradable metal film and its preparation method, which can simultaneously meet the two functional requirements of antibacterial and promoting bone cell regeneration.

[0005] However, when metal oral membranes are implanted, they usually need to be fixed with additional membrane pins. Before fixing the oral membrane, the membrane pins must be grasped with a nail grabber or holes must be made in the maxillary bone. This requires many steps, which reduces surgical efficiency and increases the risk of infection, as well as the pain of the patient. Therefore, it is of great significance to develop a biodegradable magnesium-based oral membrane device with membrane pins for auxiliary bone augmentation. Summary of the invention

[0006] The purpose of this application is to provide a biodegradable magnesium-based oral membrane device for assisting bone augmentation and a preparation method thereof, aiming to solve the problem of the numerous steps in the use of the above-mentioned common oral barrier membranes and metal oral membranes. To achieve the above-mentioned purpose, the present invention adopts the following technical solutions:

[0007] The present invention provides a method for preparing a biodegradable magnesium-based oral membrane device for assisting bone augmentation, comprising the following steps:

[0008] (1) Preparation of biodegradable magnesium-based oral film

[0009] The degradable magnesium-based metal ingot is subjected to homogenization heat treatment, and then the outer skin is turned and cut into magnesium-based metal blocks of 90mm×60mm×20mm, and then rolled into magnesium-based metal sheets. The magnesium-based metal sheets are flattened and cut to obtain oral membrane sheets; the oral membrane contour and holes are cut out on the oral membrane sheet by laser cutting to obtain a magnesium-based oral membrane blank; the magnesium-based oral membrane blank is polished, cleaned, and dried, and then immersed in hydrofluoric acid with a concentration of 40% for a certain period of time, and then washed and dried after completion to obtain an oral membrane modified by magnesium fluoride; a calcium nitrate solution of a certain concentration is heated to a certain temperature, and the oral membrane modified by magnesium fluoride is immersed therein while stirring at a certain speed, and a diammonium phosphate solution of a certain concentration is added thereto, and after a certain reaction time, a biodegradable magnesium-based oral membrane is obtained;

[0010] (2) Preparation of biodegradable magnesium-based fixation nails

[0011] Processing the degradable magnesium-based metal ingot into a magnesium-based metal rod after homogenization heat treatment, processing it into a magnesium-based fixing nail blank by using a Swiss-type lathe, polishing, cleaning and drying it to obtain a biodegradable magnesium-based fixing nail;

[0012] (3) Preparation of biodegradable magnesium-based oral membrane device for assisting bone augmentation

[0013] Place the biodegradable magnesium-based fixing nail on the nailing workpiece with the nail body facing upward and the nail cap facing downward, then align the retention hole of the biodegradable magnesium-based oral membrane with the nail body of the biodegradable magnesium-based fixing nail, press down until the retention hole passes through the first step of the nail body of the biodegradable magnesium-based fixing nail and the nail cap, and repeat the above steps until all retention holes are assembled with biodegradable magnesium-based fixing nails.

[0014] The degradable magnesium-based metal is selected from pure magnesium, magnesium-zinc system, magnesium-zinc-silver system, magnesium-zinc-calcium system binary or multi-element alloys.

[0015] The thickness of the oral membrane sheet is 0.15-0.3 mm;

[0016] In the laser cutting method, the energy is 30%-100%, the laser frequency is 500-1000 Hz, and the laser pulse width is 100-200 μs;

[0017] The hydrofluoric acid soaking time is 1-48h;

[0018] The concentration of the calcium nitrate solution is 0.05-0.20 mol / L, and the heating temperature is 80-90° C.;

[0019] The concentration of the diammonium phosphate solution is 0.02-0.12 mol / L;

[0020] The reaction time is 30-60min;

[0021] The magnesium-based oral membrane has a positioning hole, a small hole and a retention hole, the positioning hole has a diameter of Φ2.5-3.0 mm, the small hole has a diameter of Φ0.6-1.0 mm, the retention hole is a plum blossom-shaped hole, the circumscribed circle diameter of the plum blossom-shaped hole is Φ1.0-2.5 mm, and the inscribed circle diameter of the plum blossom-shaped hole is Φ0.5-0.9 mm;

[0022] The magnesium-based oral membrane has a length of 15-30 mm and a width of 9-20 mm;

[0023] The diameter of the magnesium-based metal rod is Φ5-8mm;

[0024] The length of the magnesium-based fixing nail is 3-5 mm;

[0025] The diameter of the nail cap of the magnesium-based fixing nail is Φ2.5-4mm, and the height is 0.7-1.0mm;

[0026] The nail cap of the magnesium-based fixing nail is in the shape of a circle, a hexagon or a plum blossom, and the bottom of the nail cap is a plane;

[0027] The diameter of the magnesium-based fixing nail is Φ0.5-0.9mm;

[0028] The angle of the nail head of the magnesium-based fixing nail is 40-50°;

[0029] The magnesium-based fixing nail has two steps, the first step is a step close to the nail cap, and the distance between the bottom end of the first step and the top end of the nail cap is 0.3-0.45mm; the second step is a step far from the nail cap, and the distance between the top end of the second step and the nail head is 1.0-1.2mm;

[0030] The second step is conducive to close integration with the cortical bone;

[0031] The magnesium-based fixing pins in the biodegradable magnesium-based oral membrane device are fixed on the magnesium-based oral membrane;

[0032] The diameter of the hole of the nailing workpiece is Φ2.6-4.1mm, and the hole depth is 0.5-0.8mm.

[0033] In summary, the present application includes at least one of the following beneficial technical effects:

[0034] (1) A degradable magnesium-based oral membrane structure was designed, which can be bent and cut according to actual conditions and can be degraded in vivo;

[0035] (2) The degradable magnesium-based oral membrane was modified to facilitate matching its service time with the needs of relevant parts in the body and to promote osteogenesis;

[0036] (3) A positioning hole is designed on the degradable magnesium-based oral membrane, and the degradable magnesium-based oral membrane can be positioned through the positioning hole;

[0037] (4) The degradable magnesium-based oral membrane is designed with plum blossom-shaped retention holes, through which the degradable magnesium-based fixing pins can be fixed;

[0038] (5) The magnesium-based fixation nail is directly fixed on the degradable magnesium-based oral membrane, which is beneficial to improve the efficiency of surgery and reduce the risk of infection for patients;

[0039] (6) The nail cap of the magnesium-based fixing nail is in the shape of a circle, a hexagon, or a plum blossom, and the bottom is set to be flat, which is convenient for the alignment of the magnesium-based fixing nail during fixation. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 This is a schematic diagram of the degradable magnesium-based oral film in Example 1 of the present application.

[0041] Figure 2 This is a schematic diagram of the magnesium-based fixing nail in Example 1 of the present application.

[0042] Figure 3 This is a schematic diagram of the stapling workpiece in Example 1 of the present application.

[0043] Figure 4 It is a top view of the biodegradable magnesium-based oral membrane device in Example 1 of the present application.

[0044] Figure 5 It is a stereoscopic diagram of the biodegradable magnesium-based oral membrane device in Example 1 of the present application.

[0045] Figure 6 It is a left view of the biodegradable magnesium-based oral membrane device in Example 1 of the present application.

[0046] Figure 7 This is a schematic diagram of the degradable magnesium-based oral film in Example 2 of the present application.

[0047] Figure 8 This is a schematic diagram of the magnesium-based fixing nail in Example 2 of the present application.

[0048] Fig. 9 It is a top view of the biodegradable magnesium-based oral membrane device in Example 2 of the present application.

[0049] Fig.10 It is a stereoscopic diagram of the biodegradable magnesium-based oral membrane device in Example 2 of the present application.

[0050] Fig.11 It is a left view of the biodegradable magnesium-based oral membrane device in Example 2 of the present application.

[0051] Fig.12 This is a schematic diagram of the degradable magnesium-based oral film in Example 3 of the present application.

[0052] Fig.13 This is a schematic diagram of the magnesium-based fixing nail in Example 3 of the present application.

[0053] Fig.14 It is a top view of the biodegradable magnesium-based oral membrane device in Example 3 of the present application.

[0054] Fig.15 It is a stereoscopic diagram of the biodegradable magnesium-based oral membrane device in Example 3 of the present application.

[0055] Fig.16 It is a left view of the biodegradable magnesium-based oral membrane device in Example 3 of the present application.

[0056] Fig.17 This is a schematic diagram of the degradable magnesium-based oral film in Example 4 of the present application.

[0057] Fig.18 This is a schematic diagram of the magnesium-based fixing nail in Example 4 of the present application.

[0058] Fig.19 It is a top view of the biodegradable magnesium-based oral membrane device in Example 4 of the present application.

[0059] Fig. 20 It is a stereoscopic diagram of the biodegradable magnesium-based oral membrane device in Example 4 of the present application.

[0060] Fig.21 It is a left view of the biodegradable magnesium-based oral membrane device in Example 4 of the present application.

[0061] Among them, 101 is the positioning hole of the degradable magnesium-based oral membrane, 102 is the small hole of the degradable magnesium-based oral membrane, 103 is the retention hole of the degradable magnesium-based oral membrane; 201 is the nail cap of the magnesium-based fixing nail, 202 is the first step of the magnesium-based fixing nail, 203 is the second step of the magnesium-based fixing nail, 204 is the nail body of the magnesium-based fixing nail; 301 is the nailing hole for nailing the workpiece. DETAILED DESCRIPTION

[0062] Reference Figure 1-21 The present application will be further described in detail below with reference to the embodiments.

[0063] Example 1

[0064] The present application provides a biodegradable magnesium-based oral membrane device for assisting bone augmentation and a preparation method thereof, which adopts the following technical solutions:

[0065] (1) Preparation of biodegradable pure magnesium oral film

[0066] The biodegradable pure magnesium metal ingot was subjected to homogenization heat treatment, and then the outer skin was turned and cut into pure magnesium metal blocks of 90mm×60mm×20mm, which were then rolled into pure magnesium metal sheets with a thickness of 0.15mm. The pure magnesium metal sheets were flattened and cut to obtain oral membrane sheets. Laser cutting was adopted with the parameters set as energy 30%, laser frequency 1000Hz, and laser pulse width 100μs. Figure 1 Cut out the outline and holes of the oral membrane to obtain a pure magnesium oral membrane blank; polish, clean and dry the pure magnesium oral membrane blank, immerse it in 5mL of hydrofluoric acid with a concentration of 40% for 1h, wash it with water and dry it after completion to obtain a magnesium fluoride modified oral membrane; heat 25mL of a calcium nitrate solution with a concentration of 0.05mol / L to 80°C, stir it at 300rpm, immerse the magnesium fluoride modified oral membrane therein, drop 38mL of ammonium dihydrogen phosphate solution with a concentration of 0.02mol / L therein, react for 30min to obtain a biodegradable pure magnesium oral membrane; the obtained pure magnesium oral membrane has a positioning hole, a small hole and a retention hole, the positioning hole has a diameter of Φ3mm, the small hole has a diameter of Φ0.6mm, the retention hole is a plum blossom-shaped hole, the circumscribed circle diameter of the plum blossom-shaped hole is Φ1.3mm, and the inscribed circle diameter of the plum blossom-shaped hole is Φ0.7mm; the obtained pure magnesium oral membrane has a length of 28mm and a width of 10mm.

[0067] (2) Preparation of biodegradable pure magnesium fixation nails

[0068] The biodegradable pure magnesium metal ingot is processed into Φ8mm pure magnesium metal rod after homogenization heat treatment, and then processed into the following Figure 2A pure magnesium fixing nail blank is polished, cleaned and dried to obtain a biodegradable pure magnesium fixing nail; the obtained pure magnesium fixing nail has a length of 3 mm, a nail cap diameter of Φ3 mm, a height of 1.0 mm, a round nail cap shape, a flat bottom of the nail cap, a nail body diameter of Φ0.6 mm, and a nail body head angle of 40°; the obtained pure magnesium fixing nail has two steps, the first step is a step close to the nail cap, and the distance between the lowest end of the first step and the highest end of the nail cap is 0.2 mm; the second step is a step far from the nail cap, and the distance between the highest end of the second step and the nail head is 1.2 mm; the second step is conducive to close combination with cortical bone.

[0069] (3) Preparation of biodegradable magnesium-based oral membrane device for assisting bone augmentation

[0070] Place the biodegradable pure magnesium fixing nail with the nail body facing up and the nail cap facing down. Figure 3 On the nailing workpiece, the diameter of the hole of the nailing workpiece is Φ3.1mm and the depth of the hole is 0.8mm; then align the retention hole of the pure magnesium oral membrane with the pure magnesium-based fixing nail body, press down until the retention hole passes through the first step of the pure magnesium fixing nail body and the nail cap, repeat the above steps until all the retention holes are assembled with pure magnesium fixing nails, such as Figure 4-6 .

[0071] Example 2

[0072] (1) Preparation of biodegradable magnesium-zinc oral film

[0073] The degradable magnesium-zinc metal ingot was subjected to homogenization heat treatment, and then the outer skin was turned and cut into magnesium-zinc metal blocks of 90 mm×60 mm×20 mm, and then rolled into magnesium-zinc metal sheets with a thickness of 0.2 mm. The magnesium-zinc metal sheets were flattened and cut to obtain oral membrane sheets. Laser cutting was adopted with the parameters set as energy 35%, laser frequency 500 Hz, and laser pulse width 200 μs. Figure 7 Cut out the outline and holes of the oral membrane to obtain a magnesium-2-zinc oral membrane blank; polish, clean and dry the magnesium-2-zinc oral membrane blank, immerse it in 5 mL of 40% hydrofluoric acid for 6 hours, wash it with water and dry it after completion to obtain a magnesium fluoride-modified oral membrane; heat 25 mL of a 0.1 mol / L calcium nitrate solution to 85°C, stir it at 350 rpm, immerse the magnesium fluoride-modified oral membrane therein, drop 30 mL of a 0.05 mol / L ammonium dihydrogen phosphate solution therein, react for 60 minutes, and obtain a biodegradable magnesium-2-zinc oral membrane; the obtained magnesium-2-zinc oral membrane has a positioning hole, a small hole and a retention hole, the positioning hole has a diameter of Φ2.5 mm, the small hole has a diameter of Φ0.8 mm, the retention hole is a plum blossom-shaped hole, the circumscribed circle diameter of the plum blossom-shaped hole is Φ1 mm, and the inscribed circle diameter of the plum blossom-shaped hole is Φ0.5 mm; the obtained magnesium-2-zinc oral membrane has a length of 30 mm and a width of 20 mm;

[0074] (2) Preparation of biodegradable pure magnesium fixation nails

[0075] The biodegradable pure magnesium metal ingot was processed into Φ7mm pure magnesium metal rod after homogenization heat treatment. Figure 8 The pure magnesium fixing nail blank is processed, polished, cleaned and dried to obtain a biodegradable pure magnesium fixing nail; the obtained pure magnesium fixing nail has a length of 3 mm, a diameter of a nail cap circumscribed circle of Φ2.5 mm, a height of 0.9 mm, a hexagonal shape, a flat bottom of the nail cap, a nail body diameter of Φ0.5 mm, and a nail body head angle of 45°; the obtained pure magnesium fixing nail has two steps, the first step is a step close to the nail cap, and the distance between the bottom end of the first step and the top end of the nail cap is 0.35 mm; the second step is a step far from the nail cap, and the distance between the top end of the second step and the nail head is 1.1 mm; the second step is conducive to close bonding with cortical bone;

[0076] (3) Preparation of biodegradable magnesium-based oral membrane device for assisting bone augmentation

[0077] Place the biodegradable magnesium-based fixing nail with the nail body facing up and the nail cap facing down. Figure 3 On the nailing workpiece, the diameter of the hole of the nailing workpiece is Φ2.6mm and the depth of the hole is 0.7mm; then the retention hole of the biodegradable magnesium-based oral membrane is aligned with the body of the biodegradable magnesium-based fixing nail, and pressed down until the retention hole passes through the first step of the body of the biodegradable magnesium-based fixing nail and the nail cap, and the above steps are repeated until all the retention holes are assembled with the biodegradable magnesium-based fixing nails, such as Figure 9-11 .

[0078] Example 3

[0079] (1) Preparation of biodegradable magnesium-based oral film

[0080] The degradable magnesium-zinc-silver metal ingot was subjected to homogenization heat treatment, and then the outer skin was turned and cut into magnesium-zinc-silver metal blocks of 90 mm×60 mm×20 mm, and then rolled into magnesium-zinc-silver metal sheets with a thickness of 0.25 mm. The magnesium-zinc-silver metal sheets were flattened and cut to obtain oral membrane sheets. Laser cutting was adopted with the parameters set as energy 40%, laser frequency 800 Hz, and laser pulse width 150 μs, and the oral membrane sheets were cut according to the following steps: Fig.12Cut out the outline and holes of the oral membrane to obtain a magnesium-zinc-silver oral membrane blank; polish, clean and dry the magnesium-zinc-silver oral membrane blank, immerse it in 10mL of 40% hydrofluoric acid for 24 hours, and then wash and dry it to obtain a magnesium fluoride-modified oral membrane; heat 30mL of 0.15mol / L calcium nitrate solution to 90°C, stir at 400rpm, immerse the magnesium fluoride-modified oral membrane therein, and drop 27mL of 0.15mol / L calcium nitrate solution therein. The invention relates to a 0.1 mol / L ammonium dihydrogen phosphate solution, and after reacting for 45 minutes, a biodegradable magnesium-zinc-silver oral membrane is obtained; the obtained magnesium-zinc-silver oral membrane has a positioning hole, a small hole and a retention hole, the positioning hole has a diameter of Φ2.5, the small hole has a diameter of Φ1.0 mm, the retention hole is a plum blossom-shaped hole, the circumscribed circle diameter of the plum blossom-shaped hole is Φ2 mm, and the inscribed circle diameter of the plum blossom-shaped hole is Φ0.8 mm; the obtained magnesium-zinc-silver oral membrane has a length of 17 mm and a width of 12 mm;

[0081] (2) Preparation of biodegradable magnesium-based fixation nails

[0082] The biodegradable pure magnesium metal ingot was processed into Φ5mm pure magnesium metal rod after homogenization heat treatment. Fig.13 Processing into a pure magnesium fixing nail blank, polishing, cleaning and drying it, to obtain a biodegradable pure magnesium fixing nail; the obtained pure magnesium fixing nail has a length of 3mm, a diameter of a nail cap circumscribed circle of Φ4mm, a height of 0.8mm, a shape of a nail cap of plum blossom shape, a flat bottom of the nail cap, a nail body diameter of Φ0.8mm, and a nail body head angle of 50°; the obtained pure magnesium fixing nail has two steps, the first step is a step close to the nail cap, and the distance between the lowest end of the first step and the highest end of the nail cap is 0.4mm; the second step is a step far from the nail cap, and the distance between the highest end of the second step and the nail head is 1.0mm; the second step is conducive to close bonding with cortical bone;

[0083] (3) Preparation of biodegradable magnesium-based oral membrane device for assisting bone augmentation

[0084] Place the biodegradable magnesium-based fixing nail with the nail body facing up and the nail cap facing down. Figure 3 On the nailing workpiece, the diameter of the hole of the nailing workpiece is Φ4.1mm and the depth of the hole is 0.5mm; then the retention hole of the biodegradable magnesium-based oral membrane is aligned with the body of the biodegradable magnesium-based fixing nail, and pressed down until the retention hole passes through the first step of the body of the biodegradable magnesium-based fixing nail and the nail cap, and the above steps are repeated until all the retention holes are assembled with the biodegradable magnesium-based fixing nails, such as Figure 14-16 .

[0085] Example 4

[0086] (1) Preparation of biodegradable magnesium-based oral film

[0087] The degradable magnesium-zinc-calcium metal ingot was subjected to homogenization heat treatment, and then the outer skin was turned and cut into magnesium-zinc-calcium metal blocks of 90 mm×60 mm×20 mm, and then rolled into magnesium-zinc-calcium metal sheets with a thickness of 0.3 mm. The magnesium-zinc-calcium metal sheets were flattened and cut to obtain oral membrane sheets. Laser cutting was adopted with the parameters set as 100% energy, 500 Hz laser frequency, and 200 μs laser pulse width. Fig.17 Cut out the outline and holes of the oral membrane to obtain a magnesium-zinc-calcium oral membrane blank; polish, clean and dry the magnesium-zinc-calcium oral membrane blank, immerse it in 10 mL of 40% hydrofluoric acid for 48 hours, and then wash and dry it to obtain a magnesium fluoride-modified oral membrane; heat 25 mL of 0.2 mol / L calcium nitrate solution to 85° C., stir at 350 rpm, immerse the magnesium fluoride-modified oral membrane therein, and drop 25 mL of 0.2 mol / L calcium nitrate solution therein. The invention relates to a 0.12 mol / L ammonium dihydrogen phosphate solution, and after reacting for 45 minutes, a biodegradable magnesium-zinc-calcium oral membrane is obtained; the obtained magnesium-zinc-calcium oral membrane has a positioning hole, a small hole and a retention hole, the positioning hole has a diameter of Φ2.5, the small hole has a diameter of Φ0.6 mm, the retention hole is a plum blossom-shaped hole, the circumscribed circle diameter of the plum blossom-shaped hole is Φ1.5 mm, and the inscribed circle diameter of the plum blossom-shaped hole is Φ0.8 mm; the obtained magnesium-based oral membrane has a length of 15 mm and a width of 9 mm;

[0088] (2) Preparation of biodegradable magnesium-based fixation nails

[0089] The biodegradable pure magnesium metal ingot is processed into Φ8mm pure magnesium metal rod after homogenization heat treatment. Fig.18 The pure magnesium fixing nail blank is processed, polished, cleaned and dried to obtain a biodegradable pure magnesium fixing nail; the obtained pure magnesium fixing nail has a length of 5 mm, a nail cap diameter of Φ4 mm, a height of 0.9 mm, a round nail cap shape, a flat bottom of the nail cap, a nail body diameter of Φ0.8 mm, and a nail body head angle of 43°; the obtained pure magnesium fixing nail has two steps, the first step is a step close to the nail cap, and the distance between the bottom end of the first step and the top end of the nail cap is 0.45 mm; the second step is a step far from the nail cap, and the distance between the top end of the second step and the nail head is 1.0 mm; the second step is conducive to close bonding with the cortical bone;

[0090] (3) Preparation of biodegradable magnesium-based oral membrane device for assisting bone augmentation

[0091] Place the biodegradable magnesium-based fixing nail with the nail body facing up and the nail cap facing down. Figure 3On the nailing workpiece, the diameter of the hole of the nailing workpiece is Φ4.1mm and the depth of the hole is 0.6mm; then the retention hole of the biodegradable magnesium-based oral membrane is aligned with the body of the biodegradable magnesium-based fixing nail, and pressed down until the retention hole passes through the first step of the body of the biodegradable magnesium-based fixing nail and the nail cap, and the above steps are repeated until all the retention holes are assembled with the biodegradable magnesium-based fixing nails, such as Figure 19-21 .

[0092] The above are all preferred embodiments of the present application, and the protection scope of the present application is not limited thereto. Therefore, any equivalent changes made according to the structure, shape, and principle of the present application should be included in the protection scope of the present application.

Claims

1. A biodegradable magnesium-based oral membrane device for assisting bone augmentation and a preparation method thereof, characterized in that: The method comprises the following steps: Place the biodegradable magnesium-based fixing nail on the nailing workpiece with the nail body facing upward and the nail cap facing downward, then align the retention hole of the biodegradable magnesium-based oral membrane with the nail body of the biodegradable magnesium-based fixing nail, press down until the retention hole passes through the first step of the nail body of the biodegradable magnesium-based fixing nail and the nail cap, and repeat the above steps until all retention holes are assembled with biodegradable magnesium-based fixing nails.

2. The method for preparing the biodegradable magnesium-based oral membrane device for assisting bone augmentation according to claim 1, characterized in that: The magnesium-based fixing pins in the biodegradable magnesium-based oral membrane device are fixed on the magnesium-based oral membrane.

3. The biodegradable magnesium-based oral film according to claims 1-2, characterized in that: The magnesium-based oral membrane has a positioning hole, a small hole and a retention hole. The positioning hole has a diameter of Φ2.5-Φ3.0 mm, the small hole has a diameter of Φ0.6-Φ1.0 mm, the retention hole is a plum blossom-shaped hole, the circumscribed circle diameter of the plum blossom-shaped hole is Φ1.0-Φ2.5 mm, and the inscribed circle diameter of the plum blossom-shaped hole is Φ0.5-Φ0.9 mm.

4. The biodegradable magnesium-based oral film according to claims 1-3, characterized in that: The biodegradable magnesium-based oral film has a length of 15-30 mm and a width of 9-20 mm.

5. The method for preparing the biodegradable magnesium-based oral film according to claims 1-4, characterized in that: The degradable magnesium-based metal ingot is subjected to homogenization heat treatment, and then the outer skin is turned and cut into magnesium-based metal blocks of 90mm×60mm×20mm, which are then rolled into magnesium-based metal sheets. The magnesium-based metal sheets are flattened and cut to obtain oral membrane sheets; the oral membrane contour and holes are cut out on the oral membrane sheet by laser cutting to obtain a magnesium-based oral membrane blank; the magnesium-based oral membrane blank is polished, cleaned, and dried, and then immersed in hydrofluoric acid with a concentration of 40% for a certain period of time, and then washed and dried to obtain an oral membrane modified by magnesium fluoride; a calcium nitrate solution of a certain concentration is heated to a certain temperature, and the oral membrane modified by magnesium fluoride is immersed therein while stirring at a certain speed, and a diammonium phosphate solution of a certain concentration is dripped therein to react for a certain period of time.

6. The method for preparing the biodegradable magnesium-based oral film according to claims 1-5, characterized in that: The degradable magnesium-based metal is characterized by being selected from pure magnesium, magnesium-zinc system, magnesium-zinc-silver system, magnesium-zinc-calcium system binary or multi-element alloys.

7. The method for preparing the biodegradable magnesium-based oral film according to claims 1-6, characterized in that: The thickness of the oral membrane sheet is 0.15-0.3 mm.

8. The method for preparing the biodegradable magnesium-based oral film according to claims 1-7, characterized in that: In the laser cutting method, the energy is 30%-100%, the laser frequency is 500-1000 Hz, and the laser pulse width is 100-200 μs, preferably the energy is 35%, the laser frequency is 950 Hz, and the laser pulse width is 100 μs.

9. The method for preparing the biodegradable magnesium-based oral film according to claims 1-8, characterized in that: The hydrofluoric acid soaking time is 1-48 hours, preferably 24 hours.

10. The method for preparing the biodegradable magnesium-based oral film according to claims 1-9, characterized in that: The concentration of the calcium nitrate solution is 0.05-0.20 mol / L, preferably 0.1 mol / L.

11. The method for preparing the biodegradable magnesium-based oral film according to claims 1-10, characterized in that: The heating temperature is 80-90°C, preferably 90°C.

12. The method for preparing the biodegradable magnesium-based oral film according to claims 1-11, characterized in that: The concentration of the diammonium phosphate solution is 0.02-0.12 mol / L, preferably 0.05 mol / L.

13. The method for preparing the biodegradable magnesium-based oral film according to claims 1-12, characterized in that: The reaction time is 30-60 min, preferably 50 min.

14. The biodegradable magnesium-based fixing nail according to claim 1, characterized in that: The magnesium-based fixing nail has two steps. The first step is a step close to the nail cap, and the distance between the lower end of the first step and the upper end of the nail cap is 0.2-0.4mm; the second step is a step far from the nail cap, and the distance between the upper end of the second step and the nail head is 1.0-1.2mm.

15. The method for preparing the biodegradable magnesium-based fixing nail according to claim 14, characterized in that: The biodegradable magnesium-based metal ingot is processed into a magnesium-based metal rod after homogenization heat treatment, and then processed into a magnesium-based fixing nail blank by a Swiss machine, which is polished, cleaned and dried to obtain a biodegradable magnesium-based fixing nail.

16. The method for preparing the biodegradable magnesium-based fixing nail according to claims 14-15, characterized in that: The degradable magnesium-based metal is selected from pure magnesium.

17. The method for preparing the biodegradable magnesium-based fixing nail according to claims 14-16, characterized in that: The diameter of the magnesium-based metal rod is Φ5-Φ8mm.

18. The method for preparing the biodegradable magnesium-based fixing nail according to claims 14-17, characterized in that: The length of the magnesium-based fixing nail is 3-5 mm.

19. The method for preparing the biodegradable magnesium-based fixing nail according to claims 14-18, characterized in that: The diameter of the nail cap of the magnesium-based fixing nail is Φ2.5-Φ4mm, and the height is 0.7-1.0mm.

20. The method for preparing the biodegradable magnesium-based fixing nail according to claims 14-19, characterized in that: The nail cap of the magnesium-based fixing nail is in the shape of a circle, a hexagon or a plum blossom, and the bottom of the nail cap is a plane.

21. The method for preparing the biodegradable magnesium-based fixing nail according to claims 14-20, characterized in that: The diameter of the magnesium-based fixing nail is Φ0.5-Φ0.9 mm, preferably Φ0.8 mm.

22. The method for preparing the biodegradable magnesium-based fixing nail according to claims 14-21, characterized in that: The angle of the nail head of the magnesium-based fixing nail is 40-50°, preferably 45°.

23. The method for preparing the biodegradable magnesium-based oral membrane device for assisting bone augmentation according to claim 1, characterized in that: The diameter of the hole for nailing the workpiece is Φ2.6-4.1mm, and the hole depth is 0.5-0.8mm.

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