生物可降解性血管内支架及药物释放支架的研制  

Fabrication of biodegradable and drug-eluting endovascular stent

作　　者：贾楠[1] 肖越勇[1] 张金山[1] 

机构地区：[1]解放军总医院放射诊断科,北京100853

出　　处：《中国医学影像技术》2007年第1期120-124,共5页Chinese Journal of Medical Imaging Technology

基　　金：国家自然科学基金项目资助(30370429)。

摘　　要：目的探讨采用溶液中加入药物的方法制作雷帕霉素释放BES的可行性及载药量准确性;明确裸BES、雷帕霉素释放BES及ASODN涂层BES与金属支架在力学性能方面的差异。方法应用高分子材料PLLA制作生物可降解血管内支架;采用溶液中加入药物的方法制作生物可降解雷帕霉素释放支架;采用表面涂层方法制作生物可降解反义寡核苷酸涂层支架。应用HPLC法对雷帕霉素释放BES的载药量进行检测。对三种支架进行径向支撑力测试并与金属支架比较。结果制作出BES基杆直径为0.5mm,扩张后直径为4.5或5.0mm,长度均为15mm。三种BES外观无明显区别;雷帕霉素释放BES平均载药量为181.4μg,与支架制作过程中的设计载药量基本一致;支撑力测试结果表明:三种PLLA支架径向支撑力略低于金属支架;裸BES与涂层BES径向支撑力相似,略高于雷帕霉素BES。结论生物可降解材料PL-LA制作的裸支架、载药支架及涂层支架的径向支撑力均略低于金属支架,载药支架径向支撑力略低于裸支架及表面涂层支架。溶液中加入雷帕霉素的方法含量可靠,可以代替支架表面多孔构型的加工工艺。Objective To investigate the feasibility and reliability of fabricating the sirolimus-incorporated biodegradable endovascular stent by means of adding drug into solution and to study the difference of mechanical performance among naed, ASODN-coated and sirolimus-incorporated BES. Methods Biodegradable endovascular stent was fabricated using macromolecular PLLA. Sirolimus-eluting BES was fabricated by means of adding drug into solution and its durg-loading capacity was measured by HPLC. ASODN-coated BES was fabricated by means of surface coating. Radial strength of three kinds of BES was measured and was compared with that of metal stent. Results The diameter of BES was 4.0 or 5.0 mm with strut diameter of 0. 5 mm and stent length of 15mm. There were on differences in appearance among three kinds of BES. The average loading-capacity of sirolimus-eluting BES was 181.4 μg, which was consistent with the design. Radial strength of three kinds of BES were inferior to that of matal stent. The naked BES showed similar radial strength to coated BES, both of which were slightly higher than that of sirolimus-eluting BES. Condesion Radial strength of naked BES, drug-incoperating BES and coating BES were lower than that of metal stent and radial strength of drug-incoperationg BES was slightly lower than that of naked BES and coating BES. The method of adding sirolimus into solution was reliable and can take the place of surface remodel technics.

关 键 词：生物可降解 聚乳酸 支架 新生内膜 再狭窄 

分 类 号：R815[医药卫生—放射医学]