Feasibility Testing of the RT Cardiac Systems Percutaneous Mechanical Circulatory Support Device.
Feasibility Testing of the RT Cardiac Systems Percutaneous Mechanical Circulatory Support Device.
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RT 心脏系统经皮机械循环支持装置的可行性测试。
DOI：
10.1097/mat.0000000000001887
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发表时间：
2023
期刊：
影响因子：
--
通讯作者：
Slaughter,MarkS
中科院分区：
文献类型：
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作者：
Monreal,Gretel;Koenig,StevenC;Taskin,MustafaErtan;ShambaughJr,Charles;LaRose,JeffreyA;Slaughter,MarkS
RT心脏系统公司(RTCS，Raleigh，NC)正在开发一种血管内经皮机械循环支持(PMCS)设备驱动系统，用于高风险经皮冠状动脉介入治疗和紧急心源性休克。专利的PMCS设备(美国专利10,780,206)由一个微型轴流泵和一个通过短而灵活的驱动系统连接的集成电机组成。这种新颖的柔性驱动系统创造了一种有利于经皮放置和符合解剖学的柔性泵。这种设计还具有不需要持续的外部润滑源的好处。在本文中，我们介绍了PMCS原型系统的工程开发和可行性测试。通过计算流体力学(CFD)模拟来评估候选叶片组设计(叶轮前缘和后缘、扩散器)，并预测流体动力性能和溶血风险。对候选唇形密封设计(径向干涉、硬度计和密封角度)进行了泄漏率的台架测试。然后制作了两个16Fr原型器件，并在静态模拟流动回路中进行了测试。实验结果表明，L流量为3 L/min，流量为110 mm Hg；L流量为4 mm/min，流量为80 mm Hg，与CFD预测的水动力性能相符。这些结果证明了工程设计的可行性和样机的性能。
RT Cardiac Systems (RTCS, Raleigh, NC) is developing an intravascular percutaneous mechanical circulatory support (pMCS) device drive system for use during high-risk percutaneous coronary intervention and emergent cardiogenic shock. The proprietary pMCS device (US patent 10,780,206) consists of a miniaturized axial flow pump with an integrated motor connected via a short flexible drive system. This novel flexible drive system creates a flexible pump that is advantageous for percutaneous placement and conforming to anatomy. This design also has the benefit of not requiring a continuous external lubrication source. In this article, we present engineering development and feasibility testing of the prototype pMCS system. Computational fluid dynamics (CFD) modeling was performed to evaluate candidate blade set designs (impeller leading and trailing edges, diffuser) and predict hydrodynamic performance and hemolysis risk. Bench testing of candidate lip seal designs (radial interference, durometer, and seal angle) was evaluated for leak rate. Two 16Fr prototype devices were then fabricated and tested in a static mock flow loop. Experimental testing demonstrated 3 L/min flow against 110 mmHg and 4 L/min flow against 80 mmHg, which matched the CFD-predicted hydrodynamic performance. These results demonstrate feasibility of the engineering design and performance of the prototype devices.