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

摘要

本研究的目的是研制用于心室辅助装置(Ventricular Assist Device,VAD)标准化体外性能测试的体外模拟循环系统(Mock Circulation System,MCS).通过统计临床文献大数据,以涵盖文献中95%心力衰竭患者的生理参数的极值组合框定出MCS的测试条件矩阵.根据要求完成MCS元件设计,建立水力学回路,能够通过对生理参数的调节准确模拟不同的生理条件.同时集成传感仪器以及控制与数据采集模块,实现参数的实时运算和波形显示.最后将研制完成的MCS与待测VAD同步运行,模拟标称心衰状态下的VAD辅助性能实验.实验结果表明,MCS本身能够完全满足临床文献给出的测试条件,同时系统能够精准的模拟每一个生理参数的目标值.在VAD辅助性能实验中,待测VAD能够将系统流量和主动脉压恢复至健康生理范围.总而言之,本文研制的MCS能够满足ISO规定的VAD体外系统性能测试标准,提供科学有效的测试手段.同时,该MCS也能够提供VAD辅助下,循环系统的血流动力学变化的研究平台,具有重要的科学价值.%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.