CN104873312B - Magnesium alloy cardiovascular stent - Google Patents
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- CN104873312B CN104873312B CN201510278853.6A CN201510278853A CN104873312B CN 104873312 B CN104873312 B CN 104873312B CN 201510278853 A CN201510278853 A CN 201510278853A CN 104873312 B CN104873312 B CN 104873312B
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- 229910000861 Mg alloy Inorganic materials 0.000 title claims abstract description 54
- 230000002526 effect on cardiovascular system Effects 0.000 title abstract description 15
- 229920000747 poly(lactic acid) Polymers 0.000 claims abstract description 53
- 239000004626 polylactic acid Substances 0.000 claims abstract description 53
- 239000002253 acid Substances 0.000 claims abstract 2
- 239000011241 protective layer Substances 0.000 claims description 25
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 16
- 102000008186 Collagen Human genes 0.000 claims description 16
- 108010035532 Collagen Proteins 0.000 claims description 16
- 229920001436 collagen Polymers 0.000 claims description 14
- 238000004108 freeze drying Methods 0.000 claims description 10
- 239000010410 layer Substances 0.000 claims description 6
- 239000011248 coating agent Substances 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 4
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims 2
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims 1
- 210000000481 breast Anatomy 0.000 claims 1
- 235000014655 lactic acid Nutrition 0.000 claims 1
- 239000004310 lactic acid Substances 0.000 claims 1
- 229910052749 magnesium Inorganic materials 0.000 claims 1
- 239000011777 magnesium Substances 0.000 claims 1
- 210000004204 blood vessel Anatomy 0.000 abstract description 11
- 238000000034 method Methods 0.000 abstract description 10
- 208000032594 Vascular Remodeling Diseases 0.000 abstract description 7
- 238000000354 decomposition reaction Methods 0.000 abstract description 4
- 239000000463 material Substances 0.000 abstract description 2
- 239000003814 drug Substances 0.000 description 8
- 229940079593 drug Drugs 0.000 description 8
- 238000004519 manufacturing process Methods 0.000 description 6
- 238000001816 cooling Methods 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 239000011148 porous material Substances 0.000 description 3
- 238000005507 spraying Methods 0.000 description 3
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 239000011247 coating layer Substances 0.000 description 2
- 238000009825 accumulation Methods 0.000 description 1
- 229910045601 alloy Inorganic materials 0.000 description 1
- 239000000956 alloy Substances 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 230000001028 anti-proliverative effect Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000002966 stenotic effect Effects 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
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Abstract
Description
技术领域technical field
本发明涉及一种心血管支架，尤其是一种镁合金心血管支架以及制作方法。The invention relates to a cardiovascular support, in particular to a magnesium alloy cardiovascular support and a manufacturing method.
背景技术Background technique
传统的血管支架是指在管腔球囊扩张成形的基础上，在病变段置入内支架以达到支撑狭窄闭塞段血管，减少血管弹性回缩及再塑形，保持管腔血流通畅的目的。经过无数专家学者的研究，现有的心血管支架已经发展到支架可自己展开，表面具有涂膜层或者覆膜层的可降解合金支架。The traditional vascular stent refers to the placement of an internal stent in the diseased segment on the basis of luminal balloon expansion to support the stenotic and occluded segment of the vessel, reduce the elastic retraction and reshaping of the vessel, and maintain the smooth blood flow in the lumen. . After the research of countless experts and scholars, the existing cardiovascular stents have been developed to a degradable alloy stent that can be deployed by itself and has a coating layer or a coating layer on the surface.
例如中国专利公开了一种心血管支架，申请号：201110179339.9，申请日：2011-06-29，本发明公开了一种心血管支架，包括镁合金支架体，在所述镁合金支架体表面附着有厚度为2-4μm的保护层，保护层外附着10-15μm药物层，所述保护层是将镁合金支架体浸入下述转化液中，在90℃温度下，浸泡10小时得到的，所述转化液的组成和体积比为：0.5-1％的磷酸：0.5-1％的磷酸氢二钠＝1:2-5，所述药物层是由药物和高分子聚合物组成，所述药物层中药物的含量，以质量分数计为20-40％。本发明的有益效果是：可以完全降解的镁合金药物释放支架，不仅具有金属支架强度高的特点，而且还能够逐渐降解，然后被生物体吸收，此外，该支架具有良好的生物相容性和抗组织增生性能。For example, a Chinese patent discloses a cardiovascular stent, application number: 201110179339.9, application date: 2011-06-29, and the present invention discloses a cardiovascular stent, which includes a magnesium alloy stent, attached to the surface of the magnesium alloy stent There is a protective layer with a thickness of 2-4 μm, and a 10-15 μm drug layer is attached to the protective layer. The protective layer is obtained by immersing the magnesium alloy stent in the following conversion solution at a temperature of 90° C. for 10 hours. The composition and volume ratio of the conversion solution are: 0.5-1% phosphoric acid: 0.5-1% disodium hydrogen phosphate=1:2-5, the drug layer is composed of drugs and high molecular polymers, and the drug The content of the drug in the layer is 20-40% by mass fraction. The beneficial effects of the present invention are: the fully degradable magnesium alloy drug-releasing stent not only has the characteristics of high metal stent strength, but also can be gradually degraded and then absorbed by organisms. In addition, the stent has good biocompatibility and Anti-proliferative properties.
该技术方案的不足之处在于所述的镁合金外侧设有保护层和药物层，保护层和药物层均具有成分复杂且制作工艺繁琐的特点。The disadvantage of this technical solution is that a protective layer and a drug layer are provided on the outside of the magnesium alloy, and both the protective layer and the drug layer have the characteristics of complex components and cumbersome manufacturing processes.
发明内容Contents of the invention
针对现有技术的不足，本发明提供一种制作方便且能完全被人体降解的心血管支Aiming at the deficiencies of the prior art, the present invention provides a cardiovascular support that is easy to manufacture and can be completely degraded by the human body.
架以及其制作方法。racks and methods of making them.
本发明的技术方案为：Technical scheme of the present invention is:
一种镁合金心血管支架，包括聚乳酸保护层和镁合金支架，其特征在于，所述的镁合金支架表面包覆一层聚乳酸保护层，其作用是保护镁合金支架在血管重塑过程中不会快速分解，所述的聚乳酸保护层上随机分布空隙，其作用是控制镁合金支架在血管中的分解速度，不会在血管中再次造成堵塞。A magnesium alloy cardiovascular stent, comprising a polylactic acid protective layer and a magnesium alloy stent, characterized in that the surface of the magnesium alloy stent is coated with a polylactic acid protective layer, and its function is to protect the magnesium alloy stent during the vascular remodeling process. The gaps are randomly distributed on the polylactic acid protective layer, and its function is to control the decomposition speed of the magnesium alloy stent in the blood vessel, so as not to cause blockage again in the blood vessel.
具体地，所述的镁合金支架为自展式支架，其作用是减少操作难度。Specifically, the magnesium alloy stent is a self-expanding stent, and its function is to reduce the difficulty of operation.
具体地，所述的聚乳酸保护层采用聚乳酸和胶原蛋白制成。Specifically, the polylactic acid protective layer is made of polylactic acid and collagen.
进一步地，所述的聚乳酸保护层其厚度为4μm-14μm且其镁合金支架各个部分的厚度 差小于6μm。Further, the polylactic acid protective layer has a thickness of 4 μm-14 μm and the thickness difference of each part of the magnesium alloy stent is less than 6 μm.
一种镁合金心血管支架的制作方法，其特征在于，其步骤包括：A kind of manufacture method of magnesium alloy cardiovascular stent, is characterized in that, its step comprises:
1)制备聚乳酸溶液；1) prepare polylactic acid solution;
2)将步骤1)制备的溶液通过涂膜机喷涂在镁合金支架表面；2) spraying the solution prepared in step 1) on the surface of the magnesium alloy stent by a coating machine;
3)冷冻干燥。3) Freeze drying.
具体地，所述的步骤1)制备聚乳酸溶液为：将胶原蛋白溶于浓度为0.05mol/L的丙酮溶液中制成胶原蛋白溶液；将聚乳酸溶于浓度为0.05mol/L的丙酮溶液中制成聚乳酸溶液；将胶原蛋白溶液和聚乳酸溶液按照重量比6:4的比例混合。Specifically, the step 1) to prepare the polylactic acid solution is: dissolving collagen in an acetone solution with a concentration of 0.05mol/L to make a collagen solution; dissolving polylactic acid in an acetone solution with a concentration of 0.05mol/L Prepare a polylactic acid solution; mix the collagen solution and the polylactic acid solution in a weight ratio of 6:4.
具体地，所述的步骤3)冷冻干燥为：将喷涂了聚乳酸的镁合金支架置于-80℃环境中冷冻且进行干燥至少15小时且降温速率至少为8℃/分钟。Specifically, the step 3) freeze-drying is: place the magnesium alloy stent sprayed with polylactic acid in a -80°C environment to freeze and dry for at least 15 hours with a cooling rate of at least 8°C/min.
本发明的有益效果为：本发明结构简单，通过聚乳酸保护层以及其独特的小孔隙结构，能有效保护镁合金支架本体不会过快崩解，同时由于小空隙结构使得在血管重塑后镁合金支架也刚好完成崩解并不会在血管内形成堆积。由于采用镁合金和聚乳酸为基本材料，本产品并不会损害人体身体健康。The beneficial effects of the present invention are as follows: the present invention has a simple structure, and the protective layer of polylactic acid and its unique small pore structure can effectively protect the body of the magnesium alloy stent from disintegrating too quickly, and at the same time, the small pore structure makes the blood vessel remodeled The magnesium alloy stent also just finished disintegrating and would not form accumulation in the blood vessel. Since magnesium alloy and polylactic acid are used as basic materials, this product will not harm human health.
具体实施方式detailed description
下面结合实施例对本发明的具体实施方式作进一步说明：The specific embodiment of the present invention will be further described below in conjunction with embodiment:
实施例1Example 1
一种镁合金心血管支架，包括聚乳酸保护层和镁合金支架，其特征在于，所述的镁合金支架表面包覆一层聚乳酸保护层，其作用是保护镁合金支架在血管重塑过程中不会快速分解，所述的聚乳酸保护层上随机分布空隙，其作用是控制镁合金支架在血管中的分解速度，不会在血管中再次造成堵塞。A magnesium alloy cardiovascular stent, comprising a polylactic acid protective layer and a magnesium alloy stent, characterized in that the surface of the magnesium alloy stent is coated with a polylactic acid protective layer, and its function is to protect the magnesium alloy stent during the vascular remodeling process. The gaps are randomly distributed on the polylactic acid protective layer, and its function is to control the decomposition speed of the magnesium alloy stent in the blood vessel, so as not to cause blockage again in the blood vessel.
具体地，所述的镁合金支架为自展式支架，其作用是减少操作难度。Specifically, the magnesium alloy stent is a self-expanding stent, and its function is to reduce the difficulty of operation.
具体地，所述的聚乳酸保护层采用聚乳酸和胶原蛋白制成。Specifically, the polylactic acid protective layer is made of polylactic acid and collagen.
所述的聚乳酸保护层其厚度为10μm。The polylactic acid protective layer has a thickness of 10 μm.
一种镁合金心血管支架的制作方法，其特征在于，其步骤包括：A kind of manufacture method of magnesium alloy cardiovascular stent, is characterized in that, its step comprises:
1)制备聚乳酸溶液；1) prepare polylactic acid solution;
2)将步骤1)制备的溶液通过涂膜机喷涂在镁合金支架表面；2) spraying the solution prepared in step 1) on the surface of the magnesium alloy stent by a coating machine;
3)冷冻干燥。3) Freeze drying.
具体地，所述的步骤1)制备聚乳酸溶液为：将胶原蛋白溶于浓度为0.05mol/L的丙酮溶液中制成胶原蛋白溶液；将聚乳酸溶于浓度为0.05mol/L的丙酮溶液中制成聚乳酸溶液；将胶原蛋白溶液和聚乳酸溶液按照重量比6:4的比例混合。Specifically, the step 1) to prepare the polylactic acid solution is: dissolving collagen in an acetone solution with a concentration of 0.05mol/L to make a collagen solution; dissolving polylactic acid in an acetone solution with a concentration of 0.05mol/L Prepare a polylactic acid solution; mix the collagen solution and the polylactic acid solution in a weight ratio of 6:4.
具体地，所述的步骤3)冷冻干燥为：将喷涂了聚乳酸的镁合金支架置于-80℃环境中冷冻且进行干燥15小时且降温速率9℃/分钟。Specifically, the step 3) freeze-drying is as follows: the magnesium alloy stent sprayed with polylactic acid is placed in a -80°C environment to freeze and dry for 15 hours at a cooling rate of 9°C/min.
实施例2Example 2
一种镁合金心血管支架，包括聚乳酸保护层和镁合金支架，其特征在于，所述的镁合金 支架表面包覆一层聚乳酸保护层，其作用是保护镁合金支架在血管重塑过程中不会快速分解，所述的聚乳酸保护层上随机分布空隙，其作用是控制镁合金支架在血管中的分解速度，不会在血管中再次造成堵塞。A magnesium alloy cardiovascular stent, comprising a polylactic acid protective layer and a magnesium alloy stent, characterized in that the surface of the magnesium alloy stent is coated with a polylactic acid protective layer, and its function is to protect the magnesium alloy stent during the vascular remodeling process. The gaps are randomly distributed on the polylactic acid protective layer, and its function is to control the decomposition speed of the magnesium alloy stent in the blood vessel, so as not to cause blockage again in the blood vessel.
具体地，所述的镁合金支架为自展式支架，其作用是减少操作难度。Specifically, the magnesium alloy stent is a self-expanding stent, and its function is to reduce the difficulty of operation.
具体地，所述的聚乳酸保护层采用聚乳酸和胶原蛋白制成。所述的聚乳酸保护层其厚度为10μm。Specifically, the polylactic acid protective layer is made of polylactic acid and collagen. The polylactic acid protective layer has a thickness of 10 μm.
一种镁合金心血管支架的制作方法，其特征在于，其步骤包括：A kind of manufacture method of magnesium alloy cardiovascular stent, is characterized in that, its step comprises:
1)制备聚乳酸溶液；1) prepare polylactic acid solution;
2)将步骤1)制备的溶液通过涂膜机喷涂在镁合金支架表面；2) spraying the solution prepared in step 1) on the surface of the magnesium alloy stent by a coating machine;
3)冷冻干燥。3) Freeze drying.
具体地，所述的步骤1)制备聚乳酸溶液为：将胶原蛋白溶于浓度为0.05mol/L的丙酮溶液中制成胶原蛋白溶液；将聚乳酸溶于浓度为0.05mol/L的丙酮溶液中制成聚乳酸溶液；将胶原蛋白溶液和聚乳酸溶液按照重量比6:4的比例混合。Specifically, the step 1) to prepare the polylactic acid solution is: dissolving collagen in an acetone solution with a concentration of 0.05mol/L to make a collagen solution; dissolving polylactic acid in an acetone solution with a concentration of 0.05mol/L Prepare a polylactic acid solution; mix the collagen solution and the polylactic acid solution in a weight ratio of 6:4.
具体地，所述的步骤3)冷冻干燥为：将喷涂了聚乳酸的镁合金支架置于-80℃环境中冷冻且进行干燥20小时且降温速率7℃/分钟。Specifically, the step 3) freeze-drying is as follows: the magnesium alloy stent sprayed with polylactic acid is placed in a -80°C environment to freeze and dry for 20 hours at a cooling rate of 7°C/min.
实施例1与实施例2的区别仅在于冷冻干燥的时间和降温速率。前者采用快速冷冻干燥，其作用是产生更加丰富的微小孔隙，这个方法适合制作预期血管重塑时间较短的产品；后者采用温和冷冻干燥，其作用是使得成膜光滑平整，适合用于制作预期血管重塑时间较长的产品。The difference between embodiment 1 and embodiment 2 only lies in the time and cooling rate of freeze-drying. The former adopts rapid freeze-drying, and its function is to produce more abundant micro-pores. This method is suitable for making products with a shorter expected vascular remodeling time; Products with longer expected vascular remodeling times.
上述实施例和说明书中描述的只是说明本发明的原理和最佳实施例，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。What described in above-mentioned embodiment and description just illustrate the principle of the present invention and preferred embodiment, under the premise of not departing from the spirit and scope of the present invention, the present invention also can have various changes and improvements, and these changes and improvements all fall into within the scope of the claimed invention.
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