心室辅助装置机械振动骚扰评价方法及平台研究  

Evaluation Method and Platform for Mechanical Vibration Disturbance Test of Ventricular Assist Devices

作　　者：李澍[1] 王权[1] 任海萍[1] LI Shu;WANG Quan;REN Haiping(Institute for Medical Devices Control,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院医疗器械检定所,北京102629

出　　处：《中国医疗设备》2018年第10期64-66,78,共4页China Medical Devices

基　　金：国家重点研发计划(2016YFC0103202)

摘　　要：目的心室辅助装置在植入人体后会持续受到的来自人体的振动冲击,对于全磁悬浮和液磁悬浮类心室辅助装置,如果无法抵抗此类骚扰,会导致转子的碰壁和磨损,进而严重影响装置的泵血能力和可靠性,甚至造成血栓进而威胁到人体的生命安全。因此评价各类心室辅助装置在不同振动骚扰模式下的抗振能力是很有必要的。方法本文通过分析主动运动及受迫运动条件下人体对心室辅助装置的冲击作用,定义了三种振动骚扰模式:平动振动骚扰、转动振动骚扰和随机振动骚扰。结果确定了的三种振动模式的骚扰水平,分别为6 g、10 rad/s和0.1 g2/Hz(5~150 Hz)。按照骚扰水平的要求,搭建平动转动骚扰测试平台;使用商用随机振动平台完成了随机振动测试平台。结论并对上述测试平台进行了测试和验证,结果表明,相关试验平台能够完成振动骚扰测试。Objective The vibration shocks from the human body after implantation is associated with abrasion of rotor dangerous for both the magnetic levitation and liquid-magnetic levitation type ventricular assist devices, which will seriously affect the devices pump capacity and reliability, and even threaten the human life. Therefore, it is necessary to evaluate the anti-vibration ability of various ventricular assist devices under different modes of vibration and disturbance. Methods In this paper, by analyzing the influence of human body to the ventricular auxiliary equipment under the active and forced motion, three modes of vibration disturbance were determined, which were the line vibration disturbance, the rotational vibration disturbance and the random vibration disturbance. Results The disturbance levels of three kinds of vibration modes [6 g, 10 rad/s and 0.1 g2/Hz （5-150 Hz）] were determined, respectively. According to the requirements of the disturbance level, the line vibration disturbance platform was set up. Conclusion The platform is tested and verified, and the results show that the test platform can complete the vibration disturbance test.

关 键 词：平动振动骚扰 转动振动骚扰 随机振动骚扰 磁悬 液磁悬浮 

分 类 号：R318[医药卫生—生物医学工程]