心室辅助装置溶血检测及关键问题研究  

Study on Testing and Key Problems of Hemolysis Evaluation in Ventricular Assist Device

作　　者：侯晓旭[1] 李澍[1] 王浩[1] 罗维娜[1] 王权[1] 任海萍[1] HOU Xiaoxu;LI Shu;WANG Hao;LUO Weina;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9期15-18,共4页China Medical Devices

基　　金：国家重点研发计划(2016YFC0103201)

摘　　要：目的溶血是评价心室辅助装置安全性的重要方面,以溶血指数作为评价对象。其物理意义是反映输出100 L压积标准化血液产生的血浆游离血红蛋白含量,是目前世界上公认的体外评价血泵溶血性能的标准。方法本文参照ASTM F1841-97标准规定的原则,对溶血试验进行了详细的设计,搭建了检测平台,进行了溶血指数测量,并针对标准中未进行详细说明的血液初始质量要求及游离血红蛋白检验方法进行研究和实现。结果成功设计并搭建了溶血试验检测平台,基于此检测平台成功对一台血泵的溶血指数进行了测试,表明了检测平台的有效性。结论采用ASTM F1841-97标准,搭建了检测平台,进行了溶血指数测量,明晰了实现方法和细节,希望供研发和评价人员借鉴。Objective The physical signifcance of the hemolytic index is to reflect the content of free hemoglobin in 100 L output hematocrit and to reflect the safety of the ventricular assist device content, which is recognized as the standard in the world to evaluate the hemolysis performance of the blood pump. Methods Based on the introduction of ASTM F1841-97, this paper focused on the refnement and discussion of the parts that not specifed in the standard. It included the initial blood quality requirement and the free hemoglobin test method. Results The detecting platform for hemolysis testing was successfully designed and built, and was used for the test of hemolysis performance of one blood pump, indicating the effectiveness of the platform. Conclusion Based on the introduction of ASTM F1841-97, we have established a detecting platform to realize the hemolysis testing for blood pump and explicate the test methods and details, which would provide some reference for the researcher and tester.

关 键 词：溶血指数 血泵 剪切力 心室辅助装置 

分 类 号：R318.11[医药卫生—生物医学工程]