Purpose

Mock circulatory loops (MCLs) can reproducibly generate physiologically relevant pressures and flows for cardiovascular device testing. These systems have been extensively used to characterize the performance of therapeutic cardiac devices, but historically MCLs have had limited use for assessing patient monitoring systems. Here, we adapted an MCL to include peripheral components and evaluated its utility for qualitative and quantitative benchtop testing of hemodynamic monitoring devices.

Methods

An MCL was designed to simulate three physiological hemodynamic states: normovolemia, cardiogenic shock, and hyperdynamic circulation. The system was assessed for stability in pressure and flow values over time, repeatability, waveform morphology, and systemic-peripheral pressure relationships.

Results

For each condition, cardiac output was controlled to the nearest 0.2 L/min, and flow rate and mean arterial pressure remained stable and repeatable over a 60-s period (n = 5, standard deviation of ± 0.1 L/min and ± 0.84 mmHg, respectively). Transfer function analyses showed that the systemic-peripheral relationships could be adequately manipulated. The results from this MCL were comparable to those from other published MCLs and computational simulations. However, resolving current limitations of the system would further improve its utility. Three pulse contour analysis algorithms were applied to the pressure and flow data from the MCL to demonstrate the potential role of MCLs in characterizing hemodynamic monitoring systems.

Conclusion

Overall, the development of robust analysis methods in conjunction with modified MCLs can expand device testing applications to hemodynamic monitoring systems. Properly validated MCLs can create a stable and reproducible environment for testing patient monitoring systems over their entire operating ranges prior to clinical use.

中文翻译：

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用模拟循环流回路模拟径向压力波形以表征血液动力学监测系统

目的

模拟循环回路 (MCL) 可以可重复地产生生理相关的压力和流量，用于心血管设备测试。这些系统已广泛用于表征治疗性心脏设备的性能，但从历史上看，MCL 在评估患者监测系统方面的用途有限。在这里，我们调整了 MCL 以包括外围组件，并评估了其在血液动力学监测设备的定性和定量台式测试中的效用。

方法

MCL 旨在模拟三种生理血流动力学状态：正常血容量、心源性休克和高动力循环。系统评估了压力和流量值随时间的稳定性、可重复性、波形形态和系统-外周压力关系。

结果

对于每种情况，心输出量控制在最接近的 0.2 L/min，并且流速和平均动脉压在 60 秒内保持稳定和可重复（n = 5，标准偏差为 ± 0.1 L/min 和 ± 0.84 mmHg ， 分别）。传递函数分析表明系统-外周关系可以被充分操纵。该 MCL 的结果与其他已发布的 MCL 和计算模拟的结果相当。然而，解决该系统当前的局限性将进一步提高其实用性。将三种脉冲轮廓分析算法应用于来自 MCL 的压力和流量数据，以证明 MCL 在表征血液动力学监测系统中的潜在作用。

结论

总的来说，结合改进的 MCL 开发稳健的分析方法可以将设备测试应用扩展到血液动力学监测系统。经过适当验证的 MCL 可以创建一个稳定且可重现的环境，用于在临床使用之前在整个操作范围内测试患者监护系统。