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FATIGUE-TO-FRACTURE TESTING, FINITE ELEMENT ANALYSIS, AND METALLOGRAPHIC ANALYSIS TO ESTIMATE FATIGUE DURABILITY OF SUPERELASTIC NITINOL STENTS FOR MEDICAL DEVICE USE

机译:疲劳到断裂检测,有限元分析和金相分析,以估算软弹性镍钛合金支架耐用耐久性的医疗装置

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摘要

Superelastic medical devices (stents) allow for consistent radial force, flexibility, and wall apposition, thus providing effective treatments for patients. The aim of this study was to develop a methodology to statistically estimate superelastic stent fatigue strength by utilizing fatigue-to-fracture testing computer-aided engineering, and metallographic analysis techniques. To estimate fatigue strength, four load levels (S), based on finite element analysis (FEA) predictions, were chosen and applied. In accordance with ASTM F3211-17, load (represented as stent percent extension [R=0]) versus number of cycles at fracture (N) were determined. S-N data were used to estimate fatigue strength at the design life of the stent (e.g., 10 years of clinical use). Additionally, crack initiation and growth, as well as high-versus low-cycle fatigue characteristics, were examined using scanning electron microscopy (SEM). Results suggest correlations among fatigue-to-fracture data, FEA-predicted fracture location, and SEM evaluations.
机译:超弹性医疗器械(支架)允许一致的径向力,柔韧性和墙壁邻接,从而为患者提供有效的治疗方法。本研究的目的是通过利用疲劳 - 裂缝测试计算机辅助工程和金相分析技术来开发一种统计上估计超弹性支架疲劳强度的方法。为了估计疲劳强度,选择并施加基于有限元分析(FEA)预测的四个负载水平。根据ASTM F3211-17,测定载荷(表示为支架百分比[r = 0])与骨折(n)处的循环数。 S-N数据用于估计支架的设计寿命的疲劳强度(例如,10年的临床使用)。另外,使用扫描电子显微镜(SEM)检查裂纹引发和生长以及高与低循环疲劳特性。结果表明疲劳到骨折数据,FEA预测断裂位置和SEM评估之间的相关性。

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