可吸收冠脉支架耐疲劳评价体系的研究

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...

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

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.