首页|血管支架疲劳性能的体外测试方法现状

血管支架疲劳性能的体外测试方法现状

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支架介入是血管疾病的重要治疗手段,血管支架在临床服役中会承受数亿次脉动循环的作用,耐疲劳性能直接关系到支架临床使用的安全性,成为该类医疗器械研发与注册中的关键性能考量指标.通过模拟体内血管环境建立体外等效试验已成为支架产品耐疲劳性能评价的主要手段,科学合理的体外疲劳测试方法对于评价支架产品的临床使用寿命具有重要意义.目前,国内外相关标准主要对体外疲劳测试中支架面临的径向脉动耐久性与轴向、弯曲和扭转三种非径向循环形变的耐久性测试方式提出了要求.一些文献报道了基于标准测试方法开发的体外疲劳测试平台,可以帮助评估支架产品临床预期的耐久性能,确定潜在的失效模式.但目前的测试平台仍有许多局限性,与真实体内环境还有一定差距.本文主要从支架疲劳测试方法和支架疲劳测试平台等方面,对国内外血管支架疲劳测试的研究现状进行归纳总结.
Current status of in vitro test methods for vascular stents fatigue performance
Stent implantation is an effective treatment of vascular surgery.In clinical,vascular stents are exposed to over 100 million cycles of pulsatile loading.Thus,during the development and registry of vascular stents,fatigue performance is one of the key factors of the safety evaluation.The establishment of an in vitro test by simulating the vascular environment in vivo has become the main means for assessing the fatigue durability performance of stents.In vitro fatigue test methods in a scientific and reasonable way are of great significance for assessing the clinical service life of stents.At present,domestic and foreign standards mainly propose requirements for the radial pulsation durability and the durability testing methods of axial,bending,and torsion non radial cyclic deformation faced by brackets in vitro fatigue testing.Some literature reports on an in vitro fatigue testing platform developed based on standard testing methods,which can help evaluate the clinical expected durability performance of stent products and determine potential failure modes.However,the current testing platform still has many limitations and there is still a certain gap compared to the real in vivo environment.In this review,the research status of fatigue tests on vascular stents at home and abroad is summarized from the perspective of fatigue test methods and fatigue test devices.

vascular stentsfatiguedurabilityin vitro test

陈奕文、黄秀玲、董双鹏、马金竹、焦永哲、华子恺

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国家药品监督管理局无源植入器械质量评价重点实验室 上海 200444

上海大学机电工程与自动化学院 上海 200444

国家药品监督管理局天津市医疗器械检测中心 天津 300384

血管支架 疲劳 耐久性 体外测试

2024

北京生物医学工程
北京市心肺血管疾病研究所

北京生物医学工程

CSTPCD
影响因子:0.474
ISSN:1002-3208
年,卷(期):2024.43(5)