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用于心室辅助装置系统性能测试的标准化体外模拟循环系统研究

陈实 李澍 陈琛 支梦竹 黄鹏辉 马云善 陈紫文 徐博翎

中国医疗设备2018,Vol.33Issue(9):10-14,18,6.
中国医疗设备2018,Vol.33Issue(9):10-14,18,6.DOI:10.3969/j.issn.1674-1633.2018.09.003

用于心室辅助装置系统性能测试的标准化体外模拟循环系统研究

A Mock Circulation System for in Vitro System Performance Test of Ventricular Assist Devices

陈实 1李澍 2陈琛 1支梦竹 3黄鹏辉 1马云善 1陈紫文 3徐博翎1

作者信息

  • 1. 苏州大学 机电工程学院/生物制造中心 人工器官研究所,江苏 苏州 215000
  • 2. 中国食品药品检定研究院,北京 102629
  • 3. 苏州同心医疗器械有限公司,江苏 苏州 215000
  • 折叠

摘要

Abstract

The aim of this research is to develop a mock circulation system (MCS) for comprehensive ventricular assist device (VAD) in vitro performance evaluation. According to the statistical data available in clinical literature, the test condition matrix of the MCS was determined covering the physiological conditions of 95% of heart failure patients. According to the requirements, we completed the design of all components to establish a hydraulic circuit, which could accurately represent different physiological conditions through adjusting design parameters. Meanwhile, the integration of sensors and control and data acquisition module allowed for realizing real-time data processing and waveform display. Finally, a VAD was incorporated with the MCS to simulate the assisted heart failure condition and evaluate the effect of assistance with the VAD under test. The results showed that the MCS was able to simulate the entire test condition matrix given in the clinical literature with satisfactory accuracy for each physiological parameter. In the assisted heart failure condition, the VAD under test was able to restore the systemic flow and aortic pressure to the healthy level. In conclusion, the MCS developed in this study is capable of providing a scientific and effective testing method per ISO standards for the VAD in vitro system performance tests. At the same time, this MCS can also serve as a valuable platform for hemodynamics research and physiological interaction between a VAD and the human circulatory system.

关键词

左心室辅助装置/体外模拟循环系统/生理条件/标准化/系统性能测试

Key words

mock circulation system/ventricular assist device/physiological condition/standard/system performance evaluation

分类

医药卫生

引用本文复制引用

陈实,李澍,陈琛,支梦竹,黄鹏辉,马云善,陈紫文,徐博翎..用于心室辅助装置系统性能测试的标准化体外模拟循环系统研究[J].中国医疗设备,2018,33(9):10-14,18,6.

基金项目

国家自然科学基金面上项目(81471754) (81471754)

国家重点研发计划(2016YFC0103201). (2016YFC0103201)

中国医疗设备

OACSTPCD

1674-1633

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