Abstract：In recent years, the structural design methods of Nickel-Titanium shape memory alloy medical devices, such as finite element analysis and in vitro simulation and verification technology, 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. With the relevant standards to be formulated, it can make up for the lack of standards in setting blood vessels and blood boundary conditions and personalized parameters in finite element analysis, and to make up for the lack of standards in in vitro simulation verification of blood vessels and blood material selection, vascular mechanics and blood environment simulation, stent and vascular interaction simulation, etc.
2020, Vol. 27 