Magnetic levitation motor for pediatric cardiac and cardiopulmonary therapies

摘要 这项第一阶段的应用促进了创新的、低成本的磁悬浮电机的开发 专为儿科体外心脏和心肺治疗而设计。磁悬浮 实现无接触叶轮运行，从而消除磨损和发热的关键区域，从而 会导致溶血和血栓形成。目前，体外儿科市场的服务对象是单一的 磁悬浮血泵(圣裘德医疗的儿科(前Thoratec))。与许多儿科医生一样 作为医疗产品，PediMag是先前成人设备的缩小版，最初是为后 心脏切开支持(CentriMag)。虽然PediMag已经成功地应用于心脏切开术后的一系列 支持应用程序，更广泛的使用因几个因素而变得复杂，包括缺乏辅助组件 专为泵系统(如儿科血液氧合器和热交换器)、复合体而设计 控制算法，以及高的一次性成本(每个一次性PediMag泵头大约8000美元)。至 针对这些不足，我们提出了一种基于磁滞回线的新型磁悬浮系统 电机概念，允许更小的整体配置，消除磁场安全担忧，减少 震动，并将昂贵的稀土磁性元素从一次性血液接触中重新定位 组件连接到可重复使用的电机定子。磁滞电机的设计也简化了控制。 增强健壮性和降低电力需求的算法增强了患者的运输能力， 机动性。所提议的磁滞电机的转子/叶轮部分将基于相同的叶轮 现有的PCAS泵-氧合器中目前使用的几何形状取代了现有的机械 轴承、转轴和血液接触密封。这一战略将降低总体开发成本，并 允许使用现有的全面的体外和体内测试数据，以便进行直接和有效的比较 与现有的基于血液密封的PCAS泵相比，新的磁悬浮原型的性能- 氧气机。在第一阶段，我们将进行两个急性动物研究和一个为期3天的慢性动物研究。这使我们能够 展示基本的可行性，同时将成本和第一阶段项目时间表降至最低。然而， 作为后续第二阶段工作的一部分，我们计划大幅扩大我们的慢性活体研究，以包括 至少30天的多次评估。 好了！

Abstract This Phase I STTR application proposes development of an innovative, low cost, magnetic levitation motor specifically designed for pediatric extracorporeal cardiac and cardiopulmonary therapies. Magnetic levitation enables contact-free impeller operation thereby eliminating critical areas of wear and heat generation that can contribute to hemolysis and thrombosis. The extracorporeal pediatric market is currently served by a single magnetically levitated blood pump (St. Jude Medical's PediMag (formerly Thoratec)). As with many pediatric medical products, the PediMag is a scaled-down version of a prior adult device originally designed for post- cardiotomy support (CentriMag). While PediMag has been used successfully in a range of post-cardiotomy support applications, broader usage is complicated by several factors including lack of ancillary componentry designed specifically for the pump system (e.g., pediatric blood oxygenator and heat exchanger), complex control algorithms, and a high disposable cost (approximately $8000 per disposable PediMag pump head). To address these shortcomings, we propose an innovative magnetic levitation system based on a hysteresis motor concept that permits a smaller overall configuration, eliminates magnetic field safety concerns, reduces vibration, and relocates the costly rare earth magnetic elements from the disposable blood-contacting component to the reusable motor stator. The hysteresis motor design also permits simplified control algorithms for enhanced robustness and reduced power requirements enhancing patient transport and mobility. The rotor/impeller portion of the proposed hysteresis motor will be based on the same impeller geometry as is currently used in the existing pCAS pump-oxygenator replacing the current mechanical bearings, rotating shaft, and blood contacting seal. This strategy will lower overall development costs and permit the use of existing comprehensive in vitro and in vivo test data to allow direct and efficient comparison of the performance of the new magnetically levitated prototype to the existing blood seal-based pCAS pump- oxygenator. In Phase I, we will perform two acute and one 3-day chronic animal study. This permits us to demonstrate basic feasibility while simultaneously minimizing costs and the Phase I project timeline. However, as part of a subsequent Phase II effort we plan to significantly expand our chronic in vivo studies to include multiple evaluations of at least 30 days. !