Variable-cross-section high-strength degradable bar and manufacturing method thereof
阅读说明：本技术 一种变截面高强度可降解棒材及其制造方法 (Variable-cross-section high-strength degradable bar and manufacturing method thereof ) 是由 邵惠锋 贺永 傅建中 龚友平 刘海强 陈慧鹏 李文欣 陈国金 于 2019-11-26 设计创作，主要内容包括：本发明公开了一种变截面高强度可降解棒材及其制造方法,所述棒材采用钙镁硅酸盐经生物墨水制备、冷冻干燥定型、高温烧结而成,棒材笔直,由圆柱段和过渡段组成,圆柱段笔直,截面均匀,过渡段为圆台。棒材有高的力学强度和良好的生物活性,棒材在体内可持续吸收,且吸收降解过程有磷酸盐层生成,有利于骨传导。本发明高强度可降解棒材的变截面设计,大大减轻了棒材的重量,减少了材料成本。(The invention discloses a variable cross-section high-strength degradable bar and a manufacturing method thereof, wherein the bar is prepared by adopting calcium magnesium silicate through biological ink preparation, freeze drying and shaping and high-temperature sintering, the bar is straight and consists of a cylindrical section and a transition section, the cylindrical section is straight, the cross section is uniform, and the transition section is a circular truncated cone. The bar has high mechanical strength and good biological activity, can be continuously absorbed in vivo, and is beneficial to bone conduction because a phosphate layer is generated in the absorption and degradation process. The variable cross-section design of the high-strength degradable bar greatly reduces the weight of the bar and reduces the material cost.)
1. The variable cross-section high-strength degradable bar is characterized in that the bar is straight and consists of two parts, namely a cylindrical section and a transition section; the cylindrical section is straight, the cross section is uniform, the transition section is a circular truncated cone and is made of a bioactive material, the bioactive material is calcium magnesium silicate, and the mass percentage of magnesium in the calcium magnesium silicate is 0.22-3.2%.
2. The variable cross-section high-strength degradable bar according to claim 1, wherein the cylindrical sections have two or more different diameters.
3. The variable cross-section high-strength degradable bar material of claim 1, wherein the axial length of the transition section is 0.5-4mm, and the diameter of the round table is 1/4-7/8 of the diameter of the large circle.
4. A method of manufacturing the variable cross-section high strength degradable rod of claim 1, comprising the steps of:
1) uniformly mixing the biological material with polyvinyl alcohol, polyacrylic acid, Surfynol and deionized water to obtain uniformly dispersed biological ink;
2) calculating the size of each part of the blank bar according to the shrinkage rate of the material, customizing corresponding outer contours, and combining the outer contours together to form an outer die;
3) slowly injecting the biological ink in the step 1) into an outer mold, and then freezing for 2-24 hours;
4) freezing and drying the frozen sample, and demolding to obtain a bar blank;
5) and (3) placing the bar blank into a high-temperature furnace for high-temperature calcination, and cooling to obtain the variable-section high-strength degradable bar.
5. The method for manufacturing a variable cross-section high-strength degradable bar according to claim 4, wherein the outer profiles are combined with each other as required, the inner portion is hollow, and the inner wall is smooth; after the sample is frozen and dried, the outer contour can be separated from the biological ink.
6. The method according to claim 4, wherein the outer profile is a glass tube or a quartz tube.
7. The method according to claim 4, wherein the thickness of the outer wall is 1-3 mm.
8. The method for manufacturing the variable cross-section high-strength degradable bar according to claim 4, wherein the freezing is quick freezing, and the quick freezing temperature is 60 ℃ below zerooC-80oC。
9. The method for manufacturing the variable cross-section high-strength degradable bar according to claim 4, wherein the calcination temperature is 1100 ℃oC-1200oC, the temperature rising speed is 1 to 3oCMin, and the heat preservation time is 2-6 hours.
Technical Field
The invention relates to an apparatus in the technical field of medical apparatus and instruments and a manufacturing method thereof, in particular to a variable-section high-strength degradable bar and a manufacturing method thereof.
Background
Currently, intramedullary nails are a good method of treating straight fractures and fractures with slight curvature. The intramedullary nail in current clinical application is mainly made of stainless steel and titanium alloy, and the mechanical strength of the alloy is not matched with human bones, so that a stress shielding effect can be generated, and the fracture healing treatment effect is poor or even fails. Meanwhile, after being implanted into the body, the intramedullary nail can slowly release toxic ions or particles to cause chronic inflammation, so that the intramedullary nail is difficult to cure and has poor bioactivity. In addition, such intramedullary nails do not degrade in the body, requiring a secondary operation to remove them, which can cause complications and increase the economic burden and pain to the patient. The absorbable intramedullary nail can solve the problems, but the existing clinical absorbable instruments are basically made of polymer materials, such as polylactic acid, polyvinyl alcohol, chitosan and the like, the strength and the height are high, the mechanical property is difficult to meet the requirements, and acidic substances generated in the absorption process can cause rejection reaction. Moreover, the currently manufactured intramedullary nails have single structures and the same section sizes, but the stress analysis shows that the forces at all the positions of the intramedullary nails are different when the intramedullary nails are in the human body, so if the corresponding intramedullary nails can be manufactured according to the stress condition, the weight of the intramedullary nails can be greatly reduced, and meanwhile, the mechanical requirements can be met.
Therefore, there is a need to produce a biodegradable, bioactive intramedullary nail implant with a variable cross-section, high strength, which gradually degrades in vivo as the bone heals, is non-toxic, has good bioactivity, can promote bone healing, and is lightweight.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides a variable-section high-strength degradable bar and a manufacturing method thereof.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
the utility model provides a variable cross section high strength degradable rod, the rod is straight, comprises 2 parts, for cylinder section and changeover portion, the cylinder section is straight, and the cross-section is even, the changeover portion is the round platform, adopts bioactive material to make. The bioactive material is calcium magnesium silicate, and the mass percentage of magnesium in the calcium magnesium silicate is 0.22-3.2%. When calcium silicate powder is prepared by a chemical precipitation method, a certain amount of magnesium ion aqueous solution is added in proportion, and magnesium is used for replacing calcium, so that calcium-magnesium silicate is finally obtained.
Preferably, the cylindrical section can be 2 or more, and the cylindrical section can be 2 or more different diameters.
Preferably, the axial length of the transition section is 0.5-4mm, and the diameter of the small circle of the circular truncated cone is 1/4-7/8 of the diameter of the large circle.
Preferably, the present invention relates to a method for manufacturing the variable cross-section high-strength degradable bar, comprising the steps of:
1) uniformly mixing the biological material with polyvinyl alcohol, polyacrylic acid, Surfynol and deionized water to obtain uniformly dispersed biological ink.
2) Calculating the size of each part of the blank bar according to the shrinkage rate of the material, customizing corresponding outer contours, and combining the outer contours together to form an outer die.
3) Slowly injecting the bio-ink in the step 1) into an outer mould, and then freezing for 2-24 hours.
4) And (5) freezing and drying the frozen sample, and demolding to obtain a bar blank.
5) And (3) placing the bar blank into a high-temperature furnace for high-temperature calcination, and cooling to obtain the variable-section high-strength degradable bar.
Preferably, the concentration of the polyvinyl alcohol is 4-18%, the mass percentage of all materials in the biological ink is 45-63% of biological materials, 1-4% of polyvinyl alcohol, 0.4-1% of polyacrylic acid, 0.4-1% of Surfynol, and the balance of deionized water.
Preferably, the outer contours can be combined freely according to requirements, the inner parts of the outer contours are hollow, the inner walls of the outer contours are smooth, the outer contours can be separated from the biological ink after the sample is freeze-dried, and the outer contours can be glass tubes, quartz tubes and the like.
Furthermore, the wall thickness of the outer contour is 1-3 mm.
Furthermore, the diameter of the bar blank can be directly changed by changing the inner diameter of the outer contour, so that the size of the final bar is influenced, and the size of the outer contour is easy to change, so that the bar with any size can be easily manufactured.
Preferably, the freezing process is quick freezing, and the quick freezing temperature is 60 ℃ below zerooC-80oC。
Preferably, the calcination temperature is 1100 DEGoC-1200oC, the temperature rising speed is 1 to 3oC/min, and the heat preservation time is 2-6 hours.
Compared with the prior art, the invention has the following advantages:
the invention can manufacture high-strength bioactive degradable bars, makes up the defects of degradable polymer materials and has good straightness.
Through the design of variable cross section, under the prerequisite that satisfies rod mechanical strength, can alleviate the weight of rod, reduce the input of raw and other materials, have fine economic benefits and practicality.
And thirdly, the method for manufacturing the variable cross-section high-strength degradable bar is convenient to operate and low in manufacturing cost.
Fourthly, the variable cross-section high-strength degradable bar material manufactured by the invention can be continuously absorbed in vivo, and a phosphate layer is generated in the absorption and degradation process, thereby being beneficial to bone conduction.
Drawings
FIG. 1 is a schematic structural diagram of a 2-segment type variable cross-section high-strength degradable bar material of the invention;
FIG. 2 is a schematic structural view of an outer mold for manufacturing a 2-segment type variable cross-section high-strength degradable bar of the invention;
FIG. 3 is a schematic view of the 2-stage variable cross-section high-strength degradable bar material pouring process of the present invention;
FIG. 4 is a schematic structural diagram of a 3-segment variable cross-section high-strength degradable bar of the invention;
FIG. 5 is a schematic structural view of an outer mold for manufacturing a 3-segment type variable cross-section high-strength degradable bar according to the present invention;
FIG. 6 is a schematic view of the 3-stage variable cross-section high-strength degradable bar material pouring process of the present invention;
FIG. 7 is a schematic flow chart of the manufacturing method of the variable cross-section high-strength degradable bar material of the invention;
wherein: 1 is a cylindrical section, and 2 is a transition section.
Detailed Description
The following embodiments of the present invention are described in detail, and the embodiments are implemented on the premise of the technical solution of the present invention, and the detailed embodiments and the specific operation procedures are given, but the scope of the present invention is not limited to the following embodiments, and those skilled in the art to which the present invention pertains may also make changes and modifications to the following embodiments, and therefore, some changes and modifications of the present invention should also fall within the scope of the claims of the present invention.
As shown in fig. 1 and 4, the variable cross-section high-strength degradable bar material of the invention is straight, is composed of 2 parts, and comprises a
The cylindrical sections may be 2 or more, and the cylindrical sections may be 2 or more different diameters.
The axial length of the transition section is 0.5-4mm, and the diameter of the small circle of the circular truncated cone is 1/4-7/8 of the diameter of the large circle.
Fig. 7 is a schematic flow chart of a manufacturing method of the variable cross-section high-strength degradable bar of the invention, which comprises the following steps:
1) uniformly mixing the biological material with polyvinyl alcohol, polyacrylic acid, Surfynol and deionized water to obtain uniformly dispersed biological ink.
2) Calculating the size of each part of the blank bar according to the shrinkage rate of the material, customizing corresponding outer contours, and combining the outer contours together to form an outer die.
3) Slowly injecting the bio-ink in the step 1) into an outer mould, and then freezing for 2-24 hours.
4) And (5) freezing and drying the frozen sample, and demolding to obtain a bar blank.
5) And (3) placing the bar blank into a high-temperature furnace for high-temperature calcination, and cooling to obtain the variable-section high-strength degradable bar.
The concentration of the polyvinyl alcohol is 4% -18%, the mass percentage of all materials in the biological ink is 45% -63% of biological materials, 1% -4% of polyvinyl alcohol, 0.4% -1% of polyacrylic acid, 0.4% -1% of Surfynol, and the balance is deionized water.
The outer contours can be combined randomly according to requirements, the inner part is hollow, the inner wall is smooth, and after the sample is freeze-dried, the outer contours can be separated from the biological ink, and the outer contours can be glass tubes, quartz tubes and the like.
Furthermore, the wall thickness of the outer contour is 1-3 mm.
Furthermore, the diameter of the bar blank can be directly changed by changing the inner diameter of the outer contour, so that the size of the final bar is influenced, and the size of the outer contour is easy to change, so that the bar with any size can be easily manufactured.
The freezing process is quick freezing at-60 deg.CoC-80oC。
The calcination temperature was 1100 deg.CoC-1200oC, the temperature rising speed is 1 to 3oC/min, and the heat preservation time is 2-6 hours.
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