CN115245599B - 一种抗凝润滑支架的制备以及应用 - Google Patents
一种抗凝润滑支架的制备以及应用 Download PDFInfo
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- CN115245599B CN115245599B CN202210569683.7A CN202210569683A CN115245599B CN 115245599 B CN115245599 B CN 115245599B CN 202210569683 A CN202210569683 A CN 202210569683A CN 115245599 B CN115245599 B CN 115245599B
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Abstract
本发明属于A61K技术领域，更具体的涉及一种抗凝润滑支架的制备以及应用。一种抗凝润滑支架的制备，包括如下步骤：1)采用激光雕刻或者编织方法制成的管状支架，用钝化液完成表面钝化后行清洁处理；2)将步骤1)处理后的支架进行表面活化处理；3)将步骤2)处理后的支架放到处理液中0.5h～96h，温度控制在4℃～80℃，pH调节为7.5～14；4)将步骤3)处理的支架放入含有磷酸胆碱基团的聚合物水溶液中浸泡5min～48h，温度控制在4℃～80℃；5)将步骤4)处理后的支架进行后处理，即得抗凝润滑支架。经本发明制备得到的抗凝润滑支架具有亲水性能，在后续使用过程中可以减少血小板的粘附、激活和聚集，避免血栓的形成。
Description
技术领域
本发明属于A61K技术领域，更具体的涉及一种抗凝润滑支架的制备以及应用。
背景技术
颅内动脉瘤是脑动脉壁上的异常突起，其瘤壁较为纤薄，容易自发破裂，而颅内动脉瘤一旦发生破裂往往导致灾难性的后果。随着神经介入材料的革新与技术的进步，研究人员逐渐意识到动脉瘤病变的基础是载瘤动脉，对瘤颈部病变血管的重建修复是治疗颅内动脉瘤的关键。血管内支架可以将血流沿着管腔长轴方向引流，降低流入及流出瘤腔的血流量，减少甚至避免动脉瘤复发及破裂出血，然而血管内支架作为外来物移植于体内，容易引起血小板的粘附、激活和聚集，最终导致血栓的形成。
贻贝仿生粘附是近年发展起来的一种水相涂层技术，其通过贻贝中的关键粘附单元多巴胺和/或类多巴胺结构之间的共价键、静电相互作用、π-π共轭等协同作用，几乎实现所有基材表面的粘附，具有广谱性粘附优势。而且，多巴胺和/或类多巴胺不仅具有良好的生物相容性，其结构上具有反应活性的氨基、醛基、羟基，有利于后续的接枝改性。因此，多巴胺和/或类多巴胺结构在表面改性技术领域具有良好的应用前景。
中国发明专利CN105073070公开了一种被涂覆的医疗装置及其制造和使用方法，该专利通过浸涂和刮涂工艺在医疗装置表面制备的涂层属于物理涂覆范畴，所制备的涂层厚度通常在微米级别，而涂层越厚越容易从基材表面脱落造成血管堵塞等严重后果。另外，为了避免涂层在医疗装置的网孔中结网，该专利需要使用空气刮刀持续对支架进行刮涂，工序较为复杂。
中国发明专利CN10578068.8公开了一种抗凝血的密网支架及其制备。该专利通过采用柠檬酸等有机小分子酸在密网支架基底表面形成涂层从而达到抗凝功效。然而，柠檬酸等有机小分子酸通过络合血液中的钙离子达到阻止血栓形成的功效，其多用于体外抗凝剂使用，尚未广泛推荐体内使用。
中国发明专利CN105744965公开了一种抗血栓产生的医疗装置和方法。该专利利用硅烷偶联剂固定磷酸胆碱聚合物，从而形成抗血栓表面。然而大多数硅烷偶联剂都是非水溶性的硅烷，在接枝硅烷偶联剂以及去除多余的硅烷偶联剂过程中，需要大量使用有机溶剂，不仅增加了生产成本而且具有潜在的生物毒性。
面对目前出现的问题，研制一款亲水抗凝血的血管内支架具有重大的临床意义。
发明内容
为了解决上述技术问题，本发明的第一方面提供了一种抗凝润滑支架的制备，包括如下步骤：
1)采用激光雕刻或者编织方法制成的管状支架，用钝化液完成表面钝化后行清洁处理；
2)将步骤1)处理后的支架进行表面活化处理；
3)将步骤2)处理后的支架放到处理液中0.5h～96h，温度控制在4℃～80℃，pH调节为7.5～14；
4)将步骤3)处理的支架放入含有磷酸胆碱基团的聚合物水溶液中浸泡5min～48h，温度控制在4℃～80℃；
5)将步骤4)处理后的支架进行后处理，即得抗凝润滑支架。
在一些优选的实施方式中，所述的钝化液为硝酸水溶液与氢氟酸水溶液的混合溶液。更优选的，所述的硝酸水溶液的质量分数为65％，氢氟酸水溶液的质量分数为35％。
在一些优选的实施方式中，所述的硝酸水溶液与氢氟酸水溶液的体积比为(10-90)：(90-10)。
更优选的，所述的硝酸水溶液与氢氟酸水溶液的体积比为65：35。
在一些优选的实施方式中，步骤2)所述的活化处理通过活化溶液进行；所述的活化溶液选自氧等离子体溶液、氮等离子体溶液、氢氧化钠溶液、硝酸溶液、硫酸溶液、盐酸溶液、氢氧化铵溶液、氢氧化钠溶液、过氧化氢溶液、高锰酸钾溶液、氢氟酸溶液、食人鱼溶液、重铬酸钾溶液、高氯酸溶液中的一种或几种组合。
进一步优选的，所述的活化溶液为氢氧化钠溶液。
在一些优选的实施方式中，所述的活化溶液的质量浓度为1-100％。
进一步优选的，所述的活化溶液的质量浓度为20％。
在一些优选的实施方式中，所述的活化处理的时间为5min～96h；所述的活化处理的温度为20-100℃。
更优选的，所述的氢氧化钠溶液为质量浓度为20％的氢氧化钠水溶液。
经过申请人大量的创造性实验探究，在本体系中，使用质量浓度为20％的氢氧化钠水溶液对支架表面进行处理后，可以保证在经过钝化处理后的支架表面存在一定量的带电电荷，并且经过上述处理后将钝化处理后的支架表面可能存在的油脂等物质可以进一步清除，在保证质量浓度为20％的氢氧化钠水溶液时，即可避免在对支架表面处理时造成对钝化处理后支架表面的破坏，也进一步保证了在后续对支架表面进行功能化处理时，保证其形成的涂层可以稳定的在支架表面，进一步保证支架在颅内动脉瘤治疗过程中的使用效果。
在一些优选的实施方式中，步骤3)所述的处理液为多巴胺水溶液和/或类多巴胺水溶液。
在一些优选的实施方式中，所述的类多巴胺水溶液选自表儿茶素水溶液、表没食子儿茶素水溶液、儿茶素没食子酸酯水溶液、单宁酸水溶液、原儿茶醛水溶液、去甲肾上腺素水溶液、阿魏酸水溶液、2,3-二羟基苯甲醛中的一种或多种。
进一步优选的，所述的类多巴胺水溶液为原儿茶醛水溶液。
在一些优选的实施方式中，所述的处理液的质量浓度为0.05mg/mL～20mg/mL。
进一步优选的，所述的处理液的质量浓度为2mg/mL。
经过申请人大量的创造性实验探究发现，在本体系中通过对处理液的选择和处理条件的确定，可以对活化处理后的支架表面进行进一步的修饰，在支架表面进行多巴胺或者类多巴胺的修饰，对于后续步骤中进行聚合物的接枝提供了基础，经过申请人的精心设计，申请人发现，在本体系中，温度为70℃，pH为8.5时，经过24h的处理后，可以使支架表面被类多巴胺水溶液(原儿茶醛水溶液)进行进一步修饰，并且可以保证原儿茶醛水溶液在支架表面进行粘附，通过分子间强相互作用可以在活化后的支架表面发生贻贝仿生粘附，为后续对在其表面进行接枝改性提供基础。
另外，申请人发现，在本体系中，经过步骤3)的处理温度对贻贝仿生粘附有较大的影响，当处理温度低于4℃时，会造成原儿茶醛水溶液在支架表面的粘附效果下降，但是当温度高于80℃时，由于分子间的运动频率加快，会造成活性基团之间的碰撞频率大大增加，进而造成粘附涂层过厚，造成后续在进行接枝改性时接枝后的聚合物容易从支架表面脱落，造成支架的应用受到限制。
在一些优选的实施方式中，步骤4)所述的含有磷酸胆碱基团的聚合物的结构式为其中R1和R2为H，CH3，C2H5中的一种；A为O或N；B为含2～5个-CH2-的碳链单元；m和n为单体的个数，m：n＝1：99～99：1。
在一些优选的实施方式中，所述的含有磷酸胆碱基团的聚合物的重均分子量为2000-2000000；所述的含有磷酸胆碱基团的聚合物水溶液的质量浓度为0.05％～50％。
本申请中所述的含有磷酸胆碱基团的聚合物的来源无特殊要求，可以自制或者购买。
所述的含有磷酸胆碱基团的聚合物若为自制，其制备方法如下：
(1)将含磷脂基团以及丙烯酸酯类单体溶于反应溶剂中，得单体混合液；(2)将引发剂按比例混合至反应溶剂中，得引发剂溶液；(3)将上述两种混合液按照比例混合，酸液调整pH为3.5，之后除水除氧，在惰性气体保护下，控制温度反应24小时，纯化即得。
丙烯酸酯类单体为2-氨乙基甲基丙烯酸盐酸盐；含磷脂基团为2-甲基丙烯酰氧乙基磷酸胆碱。
反应溶剂为甲醇；引发剂为过氧化苯甲酰；酸液为磷酸的甲醇溶液。
所述的含有磷酸胆碱基团的聚合物若为购买，可购于日油公司。
更优选的，所述的含有磷酸胆碱基团的聚合物水溶液的质量浓度为1％～20％。
更优选的，所述的含有磷酸胆碱基团的聚合物水溶液的质量浓度为5％。
在一些优选的实施方式中，步骤5)所述的后处理包括控干和灭菌消毒。
进一步优选的，所述的控干操作控制温度为20-180℃，时间为5min-96h。
进一步优选的，所述的灭菌消毒不限于环氧乙烷灭菌、Co-60辐射灭菌，X射线灭菌消毒。
另外，需要说明，在具体制备抗凝润滑支架的过程中，步骤3)经过处理液处理后的支架需要经过冲洗去除多余的处理液。
本发明的第二方面提供了一种抗凝润滑支架的制备的应用，在制备医疗器械材料中的应用。
有益效果：经本发明提供的抗凝润滑支架的制备相比现有技术具有如下优势：
1.经本发明制备得到的抗凝润滑支架具有亲水性能，在后续使用过程中可以减少血小板的粘附、激活和聚剂，避免血栓的形成；
2.经本发明制备得到的抗凝润滑支架经过严格的钝化处理、活化处理、多巴胺或者类多巴胺处理、含有磷酸胆碱基团的聚合物处理后，可以保证在支架表面形成稳固的涂层，并且由于含有的磷酸胆碱结构和羟基等活性官能团，进一步建立共价-非共价的相互作用，保证了其在血管中使用的时候极佳的亲水性、生物相容性，即实现了非有机成分的改性，也保证了支架表面涂层的稳定性。
3.经本发明制备得到的抗凝润滑支架其在制备过程中，对活化条件和多巴胺或者类多巴胺的处理条件进行了大量的尝试，探究发现在温度为70℃，pH为8.5时，经过24h的处理后，可以使支架表面被类多巴胺水溶液原儿茶醛水溶液进行进一步修饰，并且可以保证原儿茶醛水溶液在支架表面进行粘附，通过分子间强相互作用可以在活化后的支架表面发生贻贝仿生粘附，为后续对在其表面进行接枝改性提供基础。
附图说明
图1为空白支架(对比例1)血小板粘附情况(a)和本申请实施例1制备得到的抗凝润滑支架血小板粘附情况(b)SEM图；
图2为空白支架(对比例1)抗纤维蛋白粘附能力(c)和本申请实施例1制备得到的抗凝润滑支架抗纤维蛋白粘附能力(d)SEM图；
具体实施方式
实施例
实施例1
一种抗凝润滑支架的制备，包括如下步骤：
1)采用激光雕刻方法制成的管状支架，用钝化液完成表面钝化后行清洁处理；
2)将步骤1)处理后的支架进行表面活化处理：使用质量浓度为20％氢氧化钠水溶液，活化处理的时间为24；所述的活化处理的温度为30℃；
3)将步骤2)处理后的支架放到处理液中24h，温度控制在70℃，pH调节为8.5；
4)将步骤3)处理的支架放入含有磷酸胆碱基团的聚合物水溶液中浸泡24h，温度控制在30℃；
5)将步骤4)处理后的支架进行控干和灭菌消毒，控干温度为80℃，时间为1h，即得抗凝润滑支架。
步骤1)所述的钝化液为硝酸水溶液与氢氟酸水溶液的混合溶液。硝酸水溶液的质量分数为65％，氢氟酸水溶液的质量分数为35％，其中硝酸水溶液与氢氟酸水溶液的体积比为：65：35；
步骤3)所述的处理液为原儿茶醛水溶液；
所述的处理液的质量浓度为2mg/mL；
所述的含有磷酸胆碱基团的聚合物的重均分子量为：
其中R1和R2为CH3；A为N；B为含3个碳链单元(-CH2-)；m和n为单体的个数，m:n＝75：25
含有磷酸胆碱基团的聚合物的质量浓度为5％；购于日油公司。
对比例1
对比例1为未经过处理的采用激光雕刻方法制成的管状支架，其具体的制备实施方式与实施例1的步骤1)完全相同，唯一不同的点在于不经过后续所有步骤的处理。
Claims (7)
1.一种抗凝润滑支架的制备方法，其特征在于，包括如下步骤：
1）采用激光雕刻或者编织方法制成的管状支架，用钝化液完成表面钝化后行清洁处理；
2）将步骤1）处理后的支架进行表面活化处理；
3）将步骤2）处理后的支架放到处理液中24 h，温度控制在70℃，pH调节为8.5；
4）将步骤3）处理的支架放入含有磷酸胆碱基团的聚合物水溶液中浸泡5min~48h，温度控制在4℃~80℃；
5）将步骤4）处理后的支架进行后处理，即得抗凝润滑支架；
所述活化溶液为氢氧化钠溶液，所述的氢氧化钠溶液为质量浓度为20%的氢氧化钠水溶液；
所述步骤3）所述的处理液为多巴胺水溶液和/或类多巴胺水溶液。
2.根据权利要求1所述的抗凝润滑支架的制备方法，其特征在于，所述的活化处理的时间为5min~96h；所述的活化处理的温度为20-100℃。
3.根据权利要求2所述的抗凝润滑支架的制备方法，其特征在于，所述的类多巴胺水溶液选自表儿茶素水溶液、表没食子儿茶素水溶液、儿茶素没食子酸酯水溶液、单宁酸水溶液、原儿茶醛水溶液、去甲肾上腺素水溶液、阿魏酸水溶液、2,3-二羟基苯甲醛中的一种或多种。
4.根据权利要求1所述的抗凝润滑支架的制备方法，其特征在于，所述的处理液的质量浓度为0.05 mg/mL~20 mg/mL。
5.根据权利要求1所述的抗凝润滑支架的制备方法，其特征在于，步骤4）所述的含有磷酸胆碱基团的聚合物的结构式为，其中R1和R2为H，CH3，C2H5中的一种；A为O或N；B为含2～5个-CH2-的碳链单元；m和n为单体的个数，m：n=1：99~99：1。
6.根据权利要求1所述的抗凝润滑支架的制备方法，其特征在于，所述的含有磷酸胆碱基团的聚合物的重均分子量为2000-2000000；所述的含有磷酸胆碱基团的聚合物水溶液的质量浓度为0.05%~50%。
7.一种根据权利要求1-6任一项所述的抗凝润滑支架的制备方法的应用，其特征在于，在制备医疗器械材料中的应用。
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| CN1568166A (zh) * | 2001-10-15 | 2005-01-19 | 荷姆泰克股份有限公司 | 预防再狭窄的涂层支架 |
| CN101264346A (zh) * | 2007-11-27 | 2008-09-17 | 天津百畅医疗器械科技有限公司 | 含有抗凝血磷酸胆碱成份的可降解聚合物血管支架药物涂层 |
| CN107670121A (zh) * | 2017-11-09 | 2018-02-09 | 北京赛铂医药科技有限公司 | 一种可吸收血管支架及其制备方法 |
| CN113797398A (zh) * | 2021-09-26 | 2021-12-17 | 苏州纽创医疗科技有限公司 | 一种具有抗凝血涂层的钛合金支架的制备方法及支架 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1568166A (zh) * | 2001-10-15 | 2005-01-19 | 荷姆泰克股份有限公司 | 预防再狭窄的涂层支架 |
| CN101264346A (zh) * | 2007-11-27 | 2008-09-17 | 天津百畅医疗器械科技有限公司 | 含有抗凝血磷酸胆碱成份的可降解聚合物血管支架药物涂层 |
| CN107670121A (zh) * | 2017-11-09 | 2018-02-09 | 北京赛铂医药科技有限公司 | 一种可吸收血管支架及其制备方法 |
| CN113797398A (zh) * | 2021-09-26 | 2021-12-17 | 苏州纽创医疗科技有限公司 | 一种具有抗凝血涂层的钛合金支架的制备方法及支架 |
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