可吸收冠脉支架耐疲劳评价体系的研究  

Study on the Evaluation System of Absorbable Coronary Stents after Fatigue Test

作　　者：李崇崇 刘丽[1] 王硕[1] 王春仁[1] Li Chongchong;Liu Li;Wang Shuo;Wang Chunren(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2021年第1期79-83,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:建立可吸收支架耐疲劳测试的评价体系,为可吸收冠脉支架的安全性和有效性评价提供测试手段。方法:模拟人体血管内的受力、温度和腐蚀环境,在1.2 Hz频率下,对可吸收冠脉支架进行18662400次脉动的疲劳实验,相当于植入人体6个月。实验结束后对支架的整体情况和微观形态进行观测。结果:支架在疲劳实验后,未出现移位、弯曲、塌陷或裂缝等问题。支架药物涂层表面总体完整性较好,无分层、剥落、翘起、支架基体裸露等现象。结论:通过研究初步建立了可吸收冠脉支架耐疲劳性能的评价体系,评价方法对可吸收冠脉支架的安全性和有效性提供了合理的检测手段。Objective:To establish an evaluation system for the fatigue test of absorbable coronary stents to provide a means for the safety and efficacy tests of the absorbable coronary stent.Methods:By simulating the stress,temperature and corrosion environment in human blood vessels,the fatigue test was performed on absorbable coronary stents with 18662400 pulsations at a frequency of 1.2 Hz,which was equal to 6 months in vivo implantation.The whole situation and micro morphology of the absorbable stents were observed after the fatigue test.Results:After the fatigue test,no displacement,bending,collapse or cracks occurred in the absorbable coronary stents.The overall integrity of stent drug coating surface was good,without delaminating,peeling,warping,stent baring or other problems.Conclusion:The evaluation system of the fatigue performance of the absorbable coronary stent has been established preliminarily.The evaluation method provides a reasonable means for the safety and efficacy tests of the absorbable coronary stent.

关 键 词：聚乳酸 可吸收冠脉支架 体外耐疲劳测试 评价体系 

分 类 号：R955[医药卫生—药学] R318.11[医药卫生—生物医学工程]