Feasibility testing of the Inspired Therapeutics NeoMate mechanical circulatory support system for neonates and infants.
Feasibility testing of the Inspired Therapeutics NeoMate mechanical circulatory support system for neonates and infants.
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DOI：
10.1371/journal.pone.0266822
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发表时间：
2022
期刊：
影响因子：
3.7
通讯作者：
Dasse, Kurt A.
中科院分区：
文献类型：
--
作者：
Monreal, Gretel;Koenig, Steven C.;Slaughter, Mark S.;Morello, Gino F.;Prina, Steven R.;Tompkins, Landon H.;Huang, Jiapeng;Gellman, Barry N.;Dasse, Kurt A.
灵感疗法公司(佛罗里达州梅里特岛)正在开发一种机械循环支持(MCS)系统，该系统设计为单驱动器，带有可互换的体外磁悬浮泵。NeoMate系统设计的特点是集成了离心式旋转泵、电机和控制器，它们将安装在一个紧凑的单元中。从概念上讲，这项技术的主要创新将是将一次性低成本泵与一个单一、多功能、通用控制器结合使用，以支持多种儿科心肺指征。为了应对临床上可用的儿科设备的匮乏，灵感治疗公司首先专门针对服务不足的新生儿和婴儿心力衰竭(HF)患者群体。在本文中，我们介绍了用于儿童左心室辅助装置(LVAD)支持的原型Treateutics NeoMate系统的开发，以及在静态模拟流环(H-Q曲线)、动态模拟流环(血流动力学)和急性健康绵羊模型(血流动力学和临床适用性)中的可行性测试。由此产生的流体动力学和血流动力学数据表明，这一儿科LVAD原型和通用控制器能够在一定范围的旋转泵速度(500-6000RPM)下工作，提供高达2.6万L/分钟的泵流量，并在急性动物身上进行容量卸载。还提出了观察到的关键工程挑战和为下一次设计迭代提出的解决方案。
Inspired Therapeutics (Merritt Island, FL) is developing a mechanical circulatory support (MCS) system designed as a single driver with interchangeable, extracorporeal, magnetically levitated pumps. The NeoMate system design features an integrated centrifugal rotary pump, motor, and controller that will be housed in a single compact unit. Conceptually, the primary innovation of this technology will be the combination of disposable, low-cost pumps for use with a single, multi-functional, universal controller to support multiple pediatric cardiopulmonary indications. In response to the paucity of clinically available pediatric devices, Inspired Therapeutics is specifically targeting the underserved neonate and infant heart failure (HF) patient population first. In this article, we present the development of the prototype Inspired Therapeutics NeoMate System for pediatric left ventricular assist device (LVAD) support, and feasibility testing in static mock flow loops (H-Q curves), dynamic mock flow loops (hemodynamics), and in an acute healthy ovine model (hemodynamics and clinical applicability). The resultant hydrodynamic and hemodynamic data demonstrated the ability of this prototype pediatric LVAD and universal controller to function over a range of rotary pump speeds (500–6000 RPM), to provide pump flow rates of up to 2.6 L/min, and to volume unload the left ventricle in acute animals. Key engineering challenges observed and proposed solutions for the next design iteration are also presented.
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