Purpose

Despite the availability of first-generation extracorporeal mechanical circulatory support (MCS) systems that are widely used throughout the world, there is a need for the next generation of smaller, more portable devices (designed without cables and a minimal number of connectors) that can be used in all in-hospital and transport settings to support patients in heart failure. Moreover, a system that can be universally used for all indications for use including cardiopulmonary bypass (CPB), uni- or biventricular support (VAD), extracorporeal membrane oxygenation (ECMO) and respiratory assist that is suitable for use for adult, neonate, and pediatric patients is desirable. Providing a single, well designed, universal technology could reduce the incidence of human errors by limiting the need for training of hospital staff on a single system for a variety of indications throughout the hospital rather than having to train on multiple complex systems. The objective of this manuscript is to describe preliminary research to develop the first prototype pump for use as a ventricular assist device for pediatric patients with the Inspired Universal MCS technology. The Inspired VAD Universal System is an innovative extracorporeal blood pumping system utilizing novel MagLev technology in a single portable integrated motor/controller unit which can power a variety of different disposable pump modules intended for neonate, pediatric, and adult ventricular and respiratory assistance.

Methods

A prototype of the Inspired Pediatric VAD was constructed to determine the hemodynamic requirements for pediatric applications. The magnitude/range of hydraulic torque of the internal impeller was quantified. The hydrodynamic performance of the prototype pump was benchmarked using a static mock flow loop model containing a heated blood analogue solution to test the pump over a range of rotational speeds (500–6000 RPM), flow rates (0–3.5 L/min), and pressures (0 to ~ 420 mmHg). The device was initially powered by a shaft-driven DC motor in lieu of a full MagLev design, which was also used to calculate the fluid torque acting on the impeller.

Results

The pediatric VAD produced flows as high as 4.27 L/min against a pressure of 127 mmHg at 6000 RPM and the generated pressure and flow values fell within the desired design specifications.

Conclusions

The empirically determined performance and torque values establish the requirements for the magnetically levitated motor design to be used in the Inspired Universal MagLev System. This next step in our research and development is to fabricate a fully integrated and functional magnetically levitated pump, motor and controller system that meets the product requirement specifications and achieves a state of readiness for acute ovine animal studies to verify safety and performance of the system.

中文翻译：

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Inspired Therapeutics 儿科 VAD 的开发：用于 MagLev 电机设计的叶轮性能和扭矩的台式评估

目的

尽管第一代体外机械循环支持 (MCS) 系统已在全世界广泛使用，但仍需要下一代更小、更便携的设备（设计为无电缆和最少数量的连接器），可以用于所有住院和转运环境，以支持心力衰竭患者。此外，该系统可普遍用于所有适应症，包括体外循环 (CPB)、单心室或双心室支持 (VAD)、体外膜肺氧合 (ECMO) 和适用于成人、新生儿和儿童的呼吸辅助儿科患者是可取的。提供一个单一的，精心设计的，通用技术可以减少对医院工作人员在单一系统上针对整个医院的各种适应症进行培训的需要，而不必在多个复杂系统上进行培训，从而减少人为错误的发生率。本手稿的目的是描述初步研究，以开发第一个原型泵，用作使用 Inspired Universal MCS 技术的儿科患者的心室辅助装置。Inspired VAD Universal System 是一种创新的体外血液泵送系统，在单个便携式集成电机/控制器单元中采用新型 MagLev 技术，可为各种不同的一次性泵模块供电，用于新生儿、儿科和成人心室和呼吸辅助。

方法

构建了 Inspired Pediatric VAD 原型以确定儿科应用的血流动力学要求。量化了内部叶轮的液力扭矩的大小/范围。使用包含加热血液模拟溶液的静态模拟流动回路模型对原型泵的流体动力学性能进行基准测试，以测试泵在一定转速范围内（500–6000 RPM）、流速（0–3.5 L/min）、和压力（0 至 ~ 420 mmHg）。该设备最初由轴驱动直流电机提供动力，而不是完整的 MagLev 设计，它还用于计算作用在叶轮上的流体扭矩。

结果

儿科 VAD 在 127 mmHg 的压力下以 6000 RPM 产生高达 4.27 L/min 的流量，并且产生的压力和流量值符合所需的设计规格。

结论

凭经验确定的性能和扭矩值确定了用于 Inspired Universal MagLev 系统的磁悬浮电机设计要求。我们研发的下一步是制造一个完全集成且功能齐全的磁悬浮泵、电机和控制器系统，该系统符合产品要求规格，并为急性绵羊动物研究做好准备，以验证系统的安全性和性能。