心室辅助装置血流动力学关键参数可视化评价方法和平台研究  

Research on Visualization Evaluation Method and Platform for Hemodynamic Parameters of Ventricular Assistant Device

作　　者：李澍[1] 张琪 郝烨[1] 王权[1] LI Shu;ZHANG Qi;HAO Ye;WANG Quan(Institute for Medical Devices Control,National Institutes for Food and Drug Control,Beijing 102629,China;National Energy Conservation Center,Beijing 100045,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 [2]国家节能中心,北京100045

出　　处：《中国医疗设备》2020年第7期29-32,53,共5页China Medical Devices

基　　金：国家重点研发计划(2017YFC0111203)。

摘　　要：目的血流动力学特性对评价心室辅助装置的血液相容性和临床安全性至关重要。粒子图像测速(Particle Image Velocimetry,PIV)方法可以获得血流动力学特性,但结果准确性严重依赖PIV的实验参数。方法本文建立心室辅助装置关键血流动力学特性的PIV试验平台,从质量评价的角度,研究模型材料、加工工艺以及折射率对心室辅助装置血流动力学关键特征检测结果的影响,并确定相应的质量检测方法,提出检测规范。结果采用透光率高、强度高、化学性质稳定的高透明硅胶进行PIV模型的制作,并将工艺折射率保持在1.4,通过调节NaI的质量比消除PIV图像扭曲失真。结论通过对心室辅助装置开展PIV测试参数优化和确认,有利于科学有效地评价心室辅助装置血流动力学性能,有助于形成合理的心室辅助装置血流动力学质量评价规范。Objective Hemodynamic characteristics are important to evaluate the blood compatibility and clinical safety of ventricular assist devices.Particle image velocimetry(PIV)can obtain the hemodynamic characteristics,but the accuracy of the results depends heavily on the experimental parameters of PIV.Methods This study established a PIV platform for hemodynamic characteristics of ventricular assist devices.From the perspective of quality evaluation,the influence of model materials,processing technology and refractive index on the results of key hemodynamic characteristics of ventricular assist devices was studied,and the corresponding quality detection methods were determined and the detection specifications were proposed.Results PIV model was made by high transparent silica gel with high transmittance,high strength and stable chemical properties.The refractive index was kept at 1.4 by the process,and the distortion of PIV image was eliminated by adjusting the quality ratio of NaI.Conclusion The optimization and confirmation of PIV parameters for ventricular assist devices is conducive to the scientific and effective evaluation of the hemodynamic performance and the formation of a reasonable evaluation standard of hemodynamic quality for ventricular assist devices.

关 键 词：粒子图像测速 血流动力学 心室辅助装置 剪切力测试 

分 类 号：R318[医药卫生—生物医学工程]