冠脉支架的长期加速腐蚀疲劳测试.pdfVIP

第25卷 第2期 生物医学工程学杂志 VOI．25 N0．2 2008年 4月 Journal of Biomedical Engir ApriI 2Oo8 冠脉支架的长期加速腐蚀疲劳测试 王建宇 李佳戈△ 汤京龙 陆颂芳 奚廷斐 (中国药品生物制品检定所 医疗器械质量监督检验中心，北京 100050) 摘要 目前，在我国对血管内支架体外的腐蚀疲劳测试还没有开展，本文在符合相关标准下，设计了一套针对 冠脉支架的体外腐蚀疲劳的测试方法。测试条件近似模拟人体血管内环境：支架放置在乳胶管中，测试液体为 37℃的NaC1溶液，径向应变接近人体自身血管内情况。整个测试在60 Hz的频率下，进行了4X个循环的加速疲 劳试验，实验循环次数按70次／分的循环次数换算成人体时间相当于植入体内10年。并在此方法下，对12只不锈 钢制球囊扩张冠脉支架进行腐蚀疲劳测试，首先初步验证了方法，其次在疲劳试验前和试验后分别用扫描电镜对 支架的整体结构和表面特征进行检查，比较支架是否有因腐蚀疲劳试验而产生了结构损坏和表面损伤，从而展示 了不锈钢冠脉支架抗腐蚀疲劳的性能，并对疲劳后损伤产生的原因进行了初步分析，最后对血管内支架的发展提 出了一点建议。 关键词 冠脉支架 腐蚀疲劳 不锈钢 中图分类号 Q66 文献标识码 A 文章编号 1001—5515(2008}02—0398．04 A Long Term Accelerating Corrosion Fatigue Texting of Coronary Stents in Vitro WangJianyu Li Jiage TangJinglong Lu Songfang Xi Tingfei (National，mm“ formeControl ofPharmaceutical andBiologicalProducts，Beijing 100050，China) Abstract According tO the related standards，an in vitro COrlX)Sion fatigue testing of coronary stents was designed． The stents were fixed in the latex tubes，which were fuU of 0．9％saline solution。and radial stress was produced for simu— lating natural vesse1．The accelerated fatigue test was performed with 4×10 cycles at a frequency of 60 Hz。which was e— qual tO 10 years in vivo implantation．Twelve coronary stents made from stainless steel were adopted in the experiment． The bulk structure and surface morphology before and after testing were analysed by scanning electron microscopy．The structure damage and surface change caused by corrosion fatigue were identified and the probable reasons were pmp~ a． Key words Coronary stents Co rrosion fatigue Stainless steel 内支架体外的腐蚀疲劳测试还没有开展，本文参照 1 前 言 相关国际标准