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

The purpose of this research is to develop a Mock Circulation System (MCS) for the standardized in vitro performance testing of Ventricular Assist Devices (VAD). By statistically analyzing big data from clinical literature, the test condition matrix of the MCS is defined by the extreme value combination of physiological parameters covering 95% of heart failure patients in the literature. According to the requirements, the design of MCS components is completed and a hydraulic circuit is established, which can accurately simulate different physiological conditions by adjusting physiological parameters. At the same time, sensing instruments as well as control and data acquisition modules are integrated to realize the real-time calculation of parameters and waveform display. Finally, the developed MCS is operated synchronously with the VAD to be tested to simulate the VAD-assisted performance experiment under the nominal heart failure state. The experimental results show that the MCS itself can fully meet the test conditions given in the clinical literature, and the system can accurately simulate the target value of each physiological parameter. In the VAD-assisted performance experiment, the VAD to be tested can restore the system flow and aortic pressure to the healthy physiological range. In conclusion, the MCS developed in this paper can meet the VAD in vitro system performance testing standards stipulated by ISO and provide a scientific and effective testing means. At the same time, this MCS can also provide a research platform for the hemodynamic changes of the circulatory system under VAD assistance and has important scientific value.

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。