A Mock Circulation System for in Vitro System Performance Test of Ventricular Assist Devices
CHEN Shi1, LI Shu2, CHEN Chen1,3, ZHI Mengzhu1, HUANG Penghui1, MA Yunshan3, CHEN Ziwen1, HSU Po-lin1
1.Artificial Organ Technology Laboratory, Biomanufacturing Centre, School of Mechanical and Electrical Engineering, Soochow
University, Suzhou Jiangsu 215000, China; 2.Institute for Medical Devices Control, National Institutes for Food and Drug Control,
Beijing 102629, China; 3.CH Biomedical, Inc., Suzhou Jiangsu 215000, China
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.
陈实1，李澍2，陈琛1,3，支梦竹1，黄鹏辉1，马云善3，陈紫文1，徐博翎1. 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.
CHEN Shi1, LI Shu2, CHEN Chen1,3, ZHI Mengzhu1, HUANG Penghui1, MA Yunshan3, CHEN Ziwen1, HSU Po-lin1. A Mock Circulation System for in Vitro System Performance Test of Ventricular Assist Devices. China Medical Devices, 2018, 33(9): 10-14.
