外科植入式人工生物心脏瓣膜支架疲劳性能的研究方法

Research Method of Fatigue Performance of Surgically Implanted Heart Valve Stent

对一种国产外科植入式人工生物心脏瓣膜支架(SIHVS)的体外疲劳耐久性能进行了初步评估。试验中以国产SIHVS为试验样品,参考检验标准GB 12279-2008和ISO 5840-2:2015,制定了该试验的测试方案,采用动态疲劳试验机在SIHVS端部施加0.365 mm的径向位移,经过4亿次加速疲劳试验后观察SIHVS表面。结果显示,SIHVS结构完整,未出现断裂、明显磨损、丝材与套管松脱、结构扭曲变形、裂纹和明显的凹坑现象。这说明,SIHVS结构达到了植入物预期的疲劳性能要求。

The aim of this study was to evaluate the fatigue property in vitro of a domestic surgically implanted heart valve stent(SIHVS).The domestic SIHVS was used as a testing sample,and a protocol was developed according to the standards GB 12279-2008 and ISO 5840-2:2015.A dynamic fatigue testing machine was used to apply for a 0.365 mm cyclic radial displacement at the end of the SIHVS.The SIHVS were observed after 400 million cycles by a scanning electron microscope.The observed results show that the structure of SIHVS is intact.There are no fracture,no obvious wear,and no loosening of the wire and casing.In the tested stents,no structural distortion,no cracks and obvious pits were observed.This study demonstrated that SIHVS structure meets the expected fatigue performance requirements.