CN115671378B - Degradation rate controllable magnesium alloy guided bone regeneration implant - Google Patents
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Abstract
The invention relates to a heterogeneous magnesium alloy guided bone regeneration implant with controllable degradation rate and fitting with a tissue to be contacted at an implantation site, belonging to the technical field of medical appliances. Aiming at the problems that the degradation rates of the existing pure magnesium and magnesium alloy implants at different parts in the body are different, the contacted different tissues are different in regeneration characteristics, the reaction conditions of different tissues to the degradation rates of the magnesium alloy are different, and the like, the degradation of the magnesium alloy implants and the growth suitability of the tissues at the implantation parts are poor, the degradation rates of the magnesium alloy guided bone regeneration implants of different types (including oral cavity barrier films, bone nails, bone plates and the like) are controllable by utilizing the matching of different alloy element proportions, extrusion ratios and structural coupling, so that the specific requirements of implantation at different parts on degradation performance are met.
Description
Technical Field
The invention relates to the technical field of medical appliances, in particular to a magnesium alloy guided bone regeneration implant with controllable degradation rate.
Background
With the rapid development of medical science and technology, metal materials such as Stainless Steel (SS), titanium alloy and cobalt-chromium alloy have been widely applied to the orthopedics repair fields such as oral implantation, fracture fixation repair and the like due to good mechanical strength and biocompatibility.
At present, the problems of insufficient bone mass and peripheral bone mass of an implant in clinical restoration of stomatology such as oral implantation and the like are urgently needed to be solved, and bone conduction regeneration (Guided bone regeneration, GBR) is becoming more and more widely accepted in clinic as a novel means. GBR is reported to provide optimal and most predictable results when filling periodontal bone defects with new bone clinically. The basic principle of GBR technology is to add a mechanical barrier membrane to isolate bone defects from surrounding connective tissue. Five design requirements are therefore placed on the barrier film: good biocompatibility, sufficient osteogenic space maintenance, selective isolation of cells, tissue integration, clinical operability, and the like. Barrier membranes currently used in clinic can be largely divided into non-absorbable membranes (including polytetrafluoroethylene and titanium mesh) and absorbable membranes (commonly including collagen membranes, polylactic acid (PLA) membranes, and polypropylene lactic acid (PLGA) membranes). The non-absorbable membrane has good biocompatibility and higher mechanical strength, can maintain an osteogenic space, but needs to be taken out by a secondary operation, and has potential risks. Although the absorbable membrane avoids secondary operation, the absorption degree is unpredictable, the strength maintenance time after implantation is short, and the acidic environment caused by the degradation of most organic materials is easy to induce inflammatory reaction, so that the bone reconstruction is finally failed.
Bone nails and bone plate materials used clinically for fracture repair can be classified into absorbable materials and non-absorbable materials. The absorbable bone nail and the bone plate are mainly made of polylactic acid, the polylactic acid has no osteoinductive property, the bone defect repairing speed is low, and the mechanical strength is low and is not enough to be used as a fracture internal fixation material of a bearing part; the non-absorbable bone nail and the bone plate are mainly made of titanium, titanium alloy or stainless steel, the Young modulus of the bone nail and the bone plate is far higher than that of bones, the stress shielding effect is generated to cause a high risk of re-fracture of a fracture patient suffering from osteoporosis, the bone nail and the bone plate are non-degradable, the bone nail and the bone plate need to be taken out by an operation after the fracture repair is finished, and secondary injury is caused to the patient.
The magnesium alloy has wide application prospect in the aspect of medical instrument implantation due to good mechanical strength and degradability, but has poor material performance and tissue regeneration suitability due to uncontrollable degradation performance of the magnesium alloy material in a complex in-vivo environment and lack of adaptability to implantation environment, so that the repair effect is directly influenced, and the clinical application is limited. How to realize the programmed degradation regulation of the magnesium alloy material so as to adapt to the regeneration time sequence of different tissues in the body is a key problem of poor suitability of the current magnesium alloy in the regeneration and repair process of the hard tissues.
The invention provides the concept that the performance of the magnesium alloy implantation instrument in the whole life cycle is matched with the tissue regeneration time sequence, and aims to clearly define the performance requirement on the three-dimensional space position of the implantation instrument according to the characteristics of the tissue in the body which is expected to be contacted with the implantation site, and adopts different alloy element proportions, deformation (extrusion ratio) and structural coupling of the implantation body to realize the accurate regulation and control of the material performance in a program multi-dimensional manner so as to be matched with the tissue regeneration time sequence in the body. The magnesium alloy procedural microstructure regulation technology established by the invention provides a new idea for the clinical personalized design and application of the magnesium alloy implantation instrument.
The invention relates to a magnesium alloy guided bone regeneration implant with controllable degradation rate, which adopts magnesium alloy, the mechanical property and degradation performance of the magnesium alloy guided bone regeneration implant can be realized by controlling the content of different alloy elements and extrusion ratio (deformation), and the requirements of different implantation positions on the stress and degradation process of the implant can be met by matching with the structural design of the implant. The magnesium element released by degradation can promote osteogenesis and accelerate the bone healing process.
Disclosure of Invention
Aiming at the situation that the existing implant material degradation and implant part tissue growth suitability are poor, the invention utilizes different alloy element contents, extrusion ratios and structural coupling matching to realize controllable degradation rate of magnesium alloy guided bone regeneration implants of different types (including oral cavity barrier films, bone nails, bone plates and the like) so as to meet the specific requirements of different implant parts on alloy degradation performance.
In order to achieve the above object, the present invention can be achieved by the following technical solutions.
The magnesium alloy guided bone regeneration implant with the controllable degradation rate is characterized by mainly comprising an oral cavity barrier film, bone nails, bone plates and the like, wherein the oral cavity barrier film can block soft tissues and provide stable space environment for bone growth, and according to different parts of the barrier film, the corrosion resistance of different parts of the barrier film is regulated and controlled by controlling the alloy element proportion and alloy sectional extrusion according to different stress distribution of the different parts of the barrier film, so that the barrier film is uniformly and controllably degraded in the bone tissue healing process; the bone nail can fix the oral cavity barrier membrane or the bone plate with bone, can also be singly used for fracture reduction, and can realize segmented and controllable degradation of the bone nail by controlling alloy element proportion and alloy segmented extrusion and regulating and controlling corrosion resistance of different parts of the bone nail according to different growth rates of cortical bone and cancellous bone tissues at the fixed part and different stress distribution of the bone nail; the bone plate is mainly used for maintaining the stability of a broken end of a bone, and according to the healing time of the bone tissue, the degradation process of the bone plate is matched with the healing process of the bone tissue by controlling the proportion of alloy elements and the extrusion ratio of alloy, so that the bone plate is uniformly and controllably degraded in the healing process of the bone tissue.
The length of the oral cavity barrier film is 10.0-35.0mm, the width is 6.0-20.0mm, the thickness is 0.10-0.30mm, the barrier film is provided with a retention through hole with the diameter of 0.5-3.0mm matched with the nail body of the bone nail, and according to the degradation rate requirements of different parts of the barrier film, the through holes with the aperture size of 0.1-0.6mm are uniformly distributed in the range of 2.0-5.0mm from the bottom, 3.0-7.0mm from the top and 4.0-10.0mm from the upper and lower parts of the waist line of the barrier film; the extrusion ratio of the alloy material is 10-100 within the range of 4.0-10.0mm from the upper and lower parts of the waist line of the barrier film, and the extrusion ratio of the alloy material at the other parts is 0-10; the barrier film structure profile and the through-holes can be prepared using a laser marking apparatus.
The diameter of the bone screw body is 0.7-3.0mm, the length of the screw body is 5.5-15.5mm, the diameter of the screw cap is 1.5-4.0mm, the height of the screw cap is 0.5-3.0mm, and the screw body is threaded; according to the requirements on the degradation rates of different parts of the talar nail, the extrusion ratio of the alloy at the parts within 1.5-4.5mm of the bottom of the talar nail and within 4.5-6.5mm of the top of the talar nail is 10-100, and the extrusion ratio of the alloy at the bottom of the talar nail within the range of 1.5-4.4mm to 3.0-13.0mm is 0-10; the bone screw may be rotated into place using a special screwdriver or other rotation tool.
The length of the bone plate is 10.5-25.5mm, the width is 2.5-10.5mm, the thickness is 0.5-3.5mm, the bone plate is provided with a through hole matched with the diameter of the bone screw body, a sinking base table matched with the height of the bone screw cap is arranged above the through hole, the bone plate alloy is extruded with the same extrusion ratio of 0-10 according to the requirement of uniform degradation of the bone plate.
When the implant is used, the oral cavity barrier membrane and the bone plate are matched with the bone nails for use, and the bone nails can be used independently.
The surfaces of the oral barrier membrane, bone nails, and bone plates may be modified by a variety of methods to enhance their biocompatibility and degradability.
Compared with the existing magnesium alloy guided bone regeneration implant, the invention has the following advantages:
1. the magnesium matrix is added with a proper amount of alloy elements, so that the effects of solid solution strengthening, fine grain strengthening and the like can be achieved, the mechanical property of the material can be improved, the degradation rate of the material can be influenced by different alloy element contents, and part of alloy elements (such as Ag, zn and the like) have certain antibacterial property, so that the biocompatibility of the material can be improved.
2. According to the implantation requirements of different parts, the implant body is extruded by different extrusion ratios in sections, so that the accurate regulation and control of tissues are realized, and further the mechanical properties and degradation characteristics of the implant body are realized.
Drawings
FIG. 1 is a graph of macroscopic morphology of alloys of different extrusion ratios in example 1.
FIG. 2 shows the microstructure of the pure Mg and Mg-3Ag alloy samples with different extrusion ratios observed by a scanning electron microscope in example 1.
FIG. 3 shows tensile test results of pure Mg and Mg-3Ag alloy samples with different extrusion ratios in example 1.
FIG. 4 shows electrochemical corrosion test results of pure Mg and Mg-3Ag alloy samples with different extrusion ratios in example 1.
FIG. 5 shows the macroscopic surface morphology of samples of the pure Mg and Mg-3Ag alloys of different extrusion ratios of example 1 after in vitro corrosion.
FIG. 6 shows XPS test results after in vitro corrosion of samples of pure Mg and Mg-3Ag alloys of different extrusion ratios in example 1.
FIG. 7 shows the results of micro-CT analysis of samples of Mg-3Ag alloy of example 1 at different extrusion ratios after 1 month of in-vivo implantation.
FIG. 8 is a schematic illustration of an oral barrier film design and application;
a is a front view of an oral barrier membrane design, wherein the barrier membrane uses Mg-3Ag alloy, and b is a schematic view of implantation and fixation of the oral barrier membrane.
FIG. 9 shows microstructures of Mg-3Ag and Mg-6Ag alloy samples of different extrusion ratios in example 2.
FIG. 10 is a tensile test result of Mg-3Ag and Mg-6Ag alloy samples with different extrusion ratios in example 2.
FIG. 11 shows electrochemical corrosion test results of samples of Mg-3Ag and Mg-6Ag alloys with different extrusion ratios in example 2.
FIG. 12 shows the macroscopic morphology of the surface of samples of Mg-3Ag and Mg-6Ag alloys with different extrusion ratios after in vitro corrosion in example 2.
FIG. 13 shows XPS test results of samples of Mg-3Ag and Mg-6Ag alloys of different extrusion ratios in example 2 after in vitro corrosion.
FIG. 14 shows the results of micro-CT analysis of samples of Mg-3Ag and Mg-6Ag alloy at different extrusion ratios of example 2 after 1 month of in-vivo implantation.
FIG. 15 is a schematic view of a bone screw and bone plate design and application;
a is a bone screw design drawing, b is a bone plate design drawing, a bone plate is made of Mg-3Ag alloy, c is a bone screw fixing small-range joint or avulsion fracture schematic drawing, and d is a bone screw fracture schematic drawing of the bone screw matched with the bone plate.
FIG. 16 is a graph showing degradation of an oral barrier membrane made of as-cast MgZnYNd alloy after one month implantation in a beagle bone defect region.
1: a retention through hole mated with the screw; 2: a through hole; 3: waist line; 4: the extrusion ratio of the materials at the positions of 2.0-4.0mm above and below the waist line is 72.2;5: the extrusion ratio of the materials at the two ends of the barrier film is 7.1;6: an oral barrier membrane; 7: bone nails; 8: alveolar bone; 9: bone meal; 10: a nail cap; 11: nailing the body; 12: the extrusion ratio of the lower part of the bone nail is 72.2;13: the extrusion ratio of the middle part of the bone nail is 7.1;14: the extrusion ratio of the upper part of the bone nail is 72.2;15: a bone plate; 16: a through hole; 17: sinking the base station; 18: the extrusion ratio of the bone plate material is 7.1;19: loosening bones; 20: cortical bone; 21: bone marrow cavity.
Detailed Description
The following describes the technical scheme of the present invention in detail with reference to specific examples, but the scope of the present invention is not limited thereto.
Example 1
This example is the preparation of oral barrier films and barrier film applications.
The barrier film material used was a Mg-3Ag alloy with a diameter Φ85mm, a silver mass percentage of 3% (where Fe <0.0022%, cu <0.001%, ni < 0.001%), and the alloy was extruded in stages (extrusion ratios 7.1, 72.2 and 7.1 respectively) as follows:
and continuously extruding the alloy ingot in a segmented manner along the length direction. Heating the ingot to 300 ℃, carrying out hot extrusion processing at a stamping advancing speed of 5-10m/min at the temperature of a container and a steel die of 300 ℃, and extruding the first section to phi 32mm (extrusion ratio is about 7.1) and the length is 7mm; the second section was extruded to Φ10mm (extrusion ratio about 72.2), 10mm in length; the third section was extruded to Φ32mm (extrusion ratio about 7.1), 7mm long. The three sections are a group, and the extrusion processes of the first section to the third section are continuously repeated, so that a plurality of groups of segmented extrusion magnesium-silver alloy can be obtained.
FIG. 1 shows the macro morphology of magnesium-silver alloy with different extrusion ratios. The diameter of the as-cast alloy ingot is 85mm, the diameter of the alloy rod with the extrusion ratio of 7.1 is 32mm, and the diameter of the alloy rod with the extrusion ratio of 72.2 is 10mm.
FIG. 2 shows the microstructure of the sample after being extruded to different degrees by scanning electron microscope. As the extrusion ratio increases, the grain size of pure magnesium decreases first and then increases slightly, and the second phase content increases first and then decreases; after adding 3% silver, the grain size decreases and the second phase content increases as the extrusion ratio of the alloy increases.
FIG. 3 shows the tensile test results of samples of pure magnesium and Mg-3Ag alloy after various degrees of extrusion. The yield strength of the pure magnesium group after extrusion is increased by more than 35%, and the plasticity is reduced by half; the yield strength of the alloy added with 3% Ag is increased by more than 50% compared with pure magnesium after extrusion, and the plastic change is not obvious.
FIG. 4 shows electrochemical corrosion test results of samples of pure magnesium and Mg-3Ag alloys after various degrees of extrusion. Compared with pure magnesium, the self-corrosion current of the alloy is increased after 3 percent of silver is added, which proves that Ag can accelerate corrosion to form a second phase, and the second phase and a matrix form a micro battery. However, as the extrusion ratio of the alloy increases, the self-etching current decreases and the etching rate decreases.
FIG. 5 shows the macroscopic morphology of the in vitro etched surface of the sample after extrusion of pure magnesium and Mg-3Ag alloy to different degrees. The white material is corrosion product. Mg-3Ag alloys have localized corrosion phenomena due to the creation of second phases in the grains.
FIG. 6 shows XPS test results of in vitro corrosion of samples of pure magnesium and Mg-3Ag alloys after various degrees of extrusion. The surface deposition elements after corrosion are mainly C, N, O, na, P, S, cl and Ca.
FIG. 7 shows micro-CT analysis results of samples implanted in a body after various degrees of extrusion of Mg-3Ag alloy. The alloy with the extrusion ratio of 72.2 has lower degradation degree than the alloy with the extrusion ratio of 7.1, and the alloy with the extrusion ratio of 72.2 has higher bone formation amount in the implanted bone defect area.
The magnesium-silver alloy oral barrier film with 3% silver content and segmented extrusion (extrusion ratios of 7.1, 72.2 and 7.1 respectively) was prepared as follows:
(1) And (3) extruding the magnesium-silver alloy by a group of sections, and cutting the magnesium-silver alloy on an alloy rod parallel to the axial direction by using a diamond wire cutting machine. The diameter of the diamond cutting line is 0.14mm, the cutting speed is 0.15mm/min, the cutting span is 0.3mm, the cutting depth is 24mm, and finally a plurality of magnesium-silver alloy sheets with the thickness of 0.6mm and the length of 24mm are obtained.
(2) An oral barrier film was prepared on the cut magnesium-silver alloy sheet using a laser labeler. The laser wavelength is 355nm, the laser power is 5W, the frequency is 20KHz, the pulse width is 10us, and the processing speed is 100mm/s.
Fig. 8 is a schematic illustration of an oral barrier film design and application.
Fig. 8a is a front view of the oral barrier membrane, and fig. 8b is a schematic view of the implantation and fixation of the oral barrier membrane. The barrier membrane is covered in the bone defect area, the upper end and the lower end are fixed by bone nails, and bone powder is filled in the bone defect area at the lower side of the barrier membrane. When the barrier film is used, the bending degree of the waist line and the nearby area materials is high, and the tensile stress and the fatigue load generated in the chewing process are more easily degraded, so that the materials are treated by an extrusion process with the extrusion ratio of 72.2 to improve the corrosion resistance; the tensile stress and fatigue load of the materials at the upper end and the lower end of the barrier film have small influence, and the extrusion process with the extrusion ratio of 7.1 is selected for treatment. The stress corrosion influence on each part of the oral cavity barrier film is different, and different extrusion processes are selected to regulate and control the material structure, so that the degradation rate is regulated and controlled, and the uniform and controllable degradation of the oral cavity barrier film in the use process is realized.
Example 2
This example is for the preparation of bone nails, bone plates and their use in fracture repair.
The bone screw uses Mg-3Ag alloy cast ingot with diameter phi 85mm and silver mass percentage of 3% (wherein Fe <0.0022%, cu <0.001% and Ni < 0.001%), and the alloy cast ingot is extruded continuously and sectionally along the length direction. Heating the ingot to 300 ℃, carrying out hot extrusion processing at a stamping advancing speed of 5-10m/min at the temperature of a container and a steel die of 300 ℃, and extruding the first section to phi 32mm (extrusion ratio is about 7.1) and the length is 4.5mm; the second section was extruded to Φ10mm (extrusion ratio about 72.2), 8.5mm in length; the third section was extruded to Φ32mm (extrusion ratio about 7.1) and 6.5mm long. The three sections are a group, and the extrusion processes of the first section to the third section are continuously repeated, so that a plurality of groups of segmented extrusion magnesium-silver alloy can be obtained. The bone plate used a Mg-6Ag alloy with a diameter Φ85mm and a silver mass fraction of 6% (where Fe <0.0022%, cu <0.001%, ni < 0.001%) and the bone plate was integrally extruded with the alloy to Φ32mm (extrusion ratio about 7.1).
FIG. 9 shows the microstructure of the sample scanning electron microscope after the Mg-3Ag and Mg-6Ag alloys are extruded to different degrees. As the extrusion ratio and silver content increase, the grain size of the alloy decreases and the second phase content increases.
FIG. 10 shows the tensile test results of the samples after various degrees of extrusion of Mg-3Ag and Mg-6Ag alloys. After extrusion, the yield strength of the material added with 6% of Ag magnesium alloy is improved relative to that of the material added with 3% of Ag magnesium alloy, and the plastic change is not obvious.
FIG. 11 shows electrochemical corrosion test results of samples of Mg-3Ag and Mg-6Ag alloys after various degrees of extrusion. Compared with Mg-3Ag, the self-corrosion current of the Mg-6Ag alloy is slightly increased, and the corrosion resistance is reduced.
FIG. 12 shows the macroscopic morphology of the in vitro etched surface of the samples extruded to different degrees from Mg-3Ag and Mg-6Ag alloys. The local corrosion phenomenon of the Mg-6Ag alloy is more obvious.
FIG. 13 shows the results of XPS test of in vitro corrosion of samples of Mg-3Ag and Mg-6Ag alloys after various degrees of extrusion. The surface deposition elements after corrosion are mainly C, N, O, na, P, S, cl and Ca.
FIG. 14 shows micro-CT analysis results of samples implanted in a body after being extruded to different degrees by Mg-3Ag and Mg-6Ag alloys for 1 month. At an extrusion ratio of 7.1, the Mg-6Ag alloy corroded to a lower degree in vivo than the 3% silver alloy, but had a lower osteogenic mass.
The bone nail is formed by cutting, thread rolling and other processes according to the design drawing, and the bone plate is formed by cutting, polishing and other processes according to the design drawing.
Fig. 15 is a schematic view of a bone screw, bone plate design and application.
Fig. 15a is a design of a bone screw using a magnesium silver alloy with a silver content of 3%.
Fig. 15b is a design of a bone plate using a magnesium silver alloy with a silver content of 6%.
Fig. 15c is a schematic view of a bone screw fixation small range joint or avulsion fracture. The bone nail penetrates through the fracture part after being implanted, the front end and the rear end of the nail body are contacted with the cortical bone, the middle part of the nail body is contacted with the cancellous bone, the part of the bone nail contacted with the cortical bone bears most of load, the influence of stress corrosion is larger, and the cortical bone heals slower than the cancellous bone. Therefore, the contact part of the bone nail and the cortical bone adopts an extrusion process with the extrusion ratio of 72.2, so that the bone nail has higher corrosion resistance, the degradation rate is reduced, and the bone nail is prevented from being corroded and broken too quickly in the bone healing process; the contact part of the bone nail and the cancellous bone is treated by adopting an extrusion process with the extrusion ratio of 7.1, so that the partial material can bear a small amount of load in the bone healing process and can be degraded more quickly after the bone healing. The aim of adapting the program degradation regulation and control of the magnesium-silver alloy to the regeneration time sequence of different tissues in the body can be realized through the technical treatment.
Fig. 15d is a schematic view of a bone screw used in conjunction with a bone plate to fix a wide range of fractures. After the bone nail and the bone plate are implanted, the front end and the rear end of the nail body are contacted with cortical bone, the middle part of the nail body is positioned in a bone marrow cavity, the contact part of the bone nail and the cortical bone bears most of load, the stress concentration of the contact part of the bone nail and the bone plate is obvious, and the materials at the parts are greatly influenced by stress corrosion, so that the contact part of the bone nail and the cortical bone adopts an extrusion process with the extrusion ratio of 72.2, the bone nail has higher corrosion resistance, the degradation rate is reduced, and the osteogenesis promoting capability is strong; the bone nail is positioned at the bone marrow cavity and is processed by adopting an extrusion process with the extrusion ratio of 7.1; the whole bone plate uses Mg-6A alloy with extrusion ratio of 7.1, and has good mechanical property and higher corrosion resistance.
Comparative example 1
The oral cavity barrier film was prepared from mgznync alloy having an extrusion ratio of 17.4 (the mass% of each element in the alloy is respectively Zn1%, Y0.23%, nd 0.5%, and the balance Mg). The preparation method comprises the following steps:
(1) And (3) taking the MgZnYNd alloy, and cutting the MgZnYNd alloy on an alloy rod parallel to the axial direction by using a diamond wire cutting machine. The diameter of the diamond cutting line is 0.14mm, the cutting speed is 0.15mm/min, the cutting span is 0.3mm, the cutting depth is 24mm, and finally a plurality of MgZnYNd alloy sheets with the thickness of 0.6mm are obtained.
(2) An oral barrier film was prepared on the mgznync alloy sheet cut as described above using a laser marker. The laser wavelength is 355nm, the laser power is 5W, the frequency is 20KHz, the pulse width is 10us, and the processing speed is 100mm/s.
The prepared barrier membrane is ultrasonically cleaned by alcohol for 5min, then the barrier membrane is implanted into the defect area of the alveolar bone of the beagle, and after 1 month, the degradation condition of the barrier membrane is observed, as shown in fig. 16, the bending part of the barrier membrane is corroded and broken, more complete materials remain at the two ends, and the reconstruction of new bones at the defect area of the bone is not completed yet, which indicates that after MgZnYNd alloy is uniformly extruded, the corrosion resistance of the bending part of the barrier membrane is not high enough, and the barrier membrane can not be uniformly degraded to meet the requirement of repairing the defect of the bone.
Claims (6)
1. A preparation method of a degradation rate controllable magnesium-silver alloy guided bone regeneration implant oral cavity barrier film, wherein the barrier film material uses Mg-3Ag alloy with the diameter phi of 85mm and the silver mass percentage of 3%, wherein Fe is less than 0.0022%, cu is less than 0.001%, ni is less than 0.001%, the magnesium-silver alloy uses segmented extrusion, and the extrusion ratio is respectively 7.1, 72.2 and 7.1, and the preparation method comprises the following steps: continuously extruding the alloy cast ingot in sections along the length direction, heating the cast ingot to 300 ℃, heating the container and the steel mould to 300 ℃, and carrying out hot extrusion processing at a punching advancing speed of 5-10m/min, wherein the extrusion ratio of the first section is 7.1 and the extrusion length is 7mm; the second section is extruded to phi 10mm, the extrusion ratio is 72.2, and the length is 10mm; the third section is extruded to phi 32mm, the extrusion ratio is 7.1, and the length is 7mm; the three sections are a group, and the extrusion flow of the first section to the third section is continuously repeated, so that the magnesium-silver alloy is obtained;
the preparation method of the oral cavity barrier film comprises the following steps:
(1) Cutting the magnesium-silver alloy on an alloy rod in parallel to the axial direction by using a diamond wire cutting machine, wherein the diameter of a diamond cutting wire is 0.14mm, the cutting speed is 0.15mm/min, the cutting span is 0.3mm, the cutting depth is 24mm, and finally a plurality of magnesium-silver alloy sheets with the thickness of 0.6mm and the length of 24mm are obtained;
(2) An oral cavity barrier film is prepared on the magnesium-silver alloy sheet by a laser marking machine, wherein the laser wavelength is 355nm, the laser power is 5W, the frequency is 20KHz, the pulse width is 10us, and the processing speed is 100mm/s.
2. A magnesium silver alloy guided bone regeneration implant oral barrier membrane with a controllable degradation rate obtained by the preparation method of claim 1.
3. Use of the oral barrier membrane of claim 2 in the manufacture of a product for promoting bone tissue healing.
4. A degradation rate controllable magnesium-silver alloy guided bone regeneration implant bone nail and a bone plate preparation method, wherein the bone nail uses Mg-3Ag alloy cast ingots with the diameter phi of 85mm and the silver mass percentage of 3%, wherein Fe is less than 0.0022%, cu is less than 0.001%, ni is less than 0.001%, the alloy cast ingots are continuously extruded in a segmented manner along the length direction, the cast ingots are heated to 300 ℃, the temperature of a container and a steel mould is 300 ℃, hot extrusion processing is carried out at the punching advance speed of 5-10m/min, the extrusion ratio of the first section is 7.1 and the extrusion length is 4.5mm, and the diameter phi of the first section is 32 mm; the second section is extruded to phi 10mm, the extrusion ratio is 72.2, and the length is 8.5mm; extruding the third section to phi 32mm, wherein the extrusion ratio is 7.1, the length is 6.5mm, the three sections are a group, and continuously repeating the extrusion processes of the first section to the third section to obtain the magnesium-silver alloy;
the bone plate uses Mg-6Ag alloy with diameter phi 85mm and silver mass fraction of 6%, wherein Fe is less than 0.0022%, cu is less than 0.001%, ni is less than 0.001%, and the whole bone plate is extruded to phi 32mm by the alloy, and the extrusion ratio is 7.1.
5. A magnesium-silver alloy guided bone regeneration implant bone nail and bone plate with controllable degradation rate obtained by the preparation method of claim 4.
6. Use of the bone screw and bone plate of claim 5 in the manufacture of a product for promoting fracture repair.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20110054629A1 (en) * | 2008-03-18 | 2011-03-03 | U&I Corporation | Composite implant having porous structure filled with biodegradable alloy and method of magnesium-based manufacturing the same |
| CN107164673A (en) * | 2017-03-30 | 2017-09-15 | 北京大学口腔医学院 | A kind of Absorbale magnesium alloy repair system for oral cavity guiding bone/regeneration |
| CN109252117A (en) * | 2018-11-20 | 2019-01-22 | 北京工业大学 | A kind of degradable bone implant magnesium alloy and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20110054629A1 (en) * | 2008-03-18 | 2011-03-03 | U&I Corporation | Composite implant having porous structure filled with biodegradable alloy and method of magnesium-based manufacturing the same |
| CN107164673A (en) * | 2017-03-30 | 2017-09-15 | 北京大学口腔医学院 | A kind of Absorbale magnesium alloy repair system for oral cavity guiding bone/regeneration |
| CN109252117A (en) * | 2018-11-20 | 2019-01-22 | 北京工业大学 | A kind of degradable bone implant magnesium alloy and preparation method thereof |
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