钛镍形状记忆合金医疗器械评价方法研究进展

Research progress of assessment method for performance tests of NiTi shape memory alloy medical devices

近年来,随着血管支架等医疗器械结构设计方法不断进步,相关监管法规和标准不断完善,钛镍合金医疗器械应用取得显著进展。多种类型钛镍合金医疗器械取得注册证,包括心血管、脑血管和外周血管器械。其中,心血管器械包括支架、心脏瓣膜和封堵器等。然而,钛镍形状记忆合金医疗器械仍面临镍离子释放防护和关键原材料进口替代等问题,亟待开发高疲劳钛镍合金原材料,包括丝材、管材和棒材;亟待开发记忆合金表面改性技术和相关医疗器械结构设计、性能测试评价技术;亟待完善相关器械测试方法标准和相关器械评审技术指导原则。需要制定相关标准,规范有限元分析中血管、血液边界条件和参数个性化设置,以及弥补体外模拟验证中血管、血液材料选择、血管力学和血液环境模拟、支架和血管交互作用模拟等方面的标准缺少的问题。

In recent years,the structural design methods of Nickel-Titanium shape memory alloy medical devices have made continuous progress,and relevant regulations and standards of NiTi alloy medical devices are issued.Significant progress has been made in the application of NiTi SMA alloy medical devices,and various types of NiTi alloy medical devices have been registered,including cardiovascular devices,cerebrovascular devices and peripheral vascular devices,and the cardiovascular devices,such as stent,heart valves and occluders have been developed.However,the problems such as nickel ion release protection and import substitution of key raw materials of NiTi shape memory alloy medical devices exist.It is important to develop high fatigue NiTi alloy raw materials,including wire,pipe and rod,and it is important to develop surface modification technology of SMA,and the structural design and performance test evaluation technology of related medical instruments.And the standards of testing methods and the guidance for related device evaluation are imperative.Relevant standards should be formulated to standardize the individualized setting of vascular and blood boundary conditions and parameters in finite element analysis,as well as to make up for the lack of standards in in vitro simulation verification such as vascular,blood material selection,vascular mechanics and blood environment simulation,stent and vascular interaction simulation,etc.