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Magnetic levitation motor for pediatric cardiac and cardiopulmonary therapies

用于儿科心脏和心肺治疗的磁悬浮电机

基本信息

批准号：
9201563
负责人：
Mark Gartner
金额：
$ 35.7万
依托单位：
ENSION, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-08-15 至 2019-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9201563
关键词：
Acute Address Adult Algorithms Animals Area Blood Blood Cells Cardiac Cardiopulmonary Characteristics Childhood Chronic Complex Data Data Set Development Devices Elements Evaluation Extracorporeal Membrane Oxygenation Generations Geometry Goals Head Heating Hemolysis In Vitro Indium Life Magnetism Marketing Mechanics Medical Modeling Motor Oxygenators Patients Performance Phase Pump Safety Saint Jude Children&apos s Research Hospital Shapes Small Business Technology Transfer Research Steel Structure Support System Suspension substance Suspensions System Technology Testing Thrombosis Time TimeLine abstracting base blood oxygenator blood pump cell injury cost cost efficient design heat exchanger hemodynamics improved in vitro testing in vivo innovation magnetic field novel operation patient population pediatric patients prototype seal vibration

项目摘要

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. !

摘要第一阶段STTR应用提出了一种创新的、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。磁悬浮从而消除磨损和发热的关键区域，导致溶血和血栓形成。体外儿科市场目前由单一的磁悬浮血泵（St. Jude Medical的PediMag（前身为Thoratec））。与许多儿科 PediMag是先前成人设备的缩小版，最初设计用于术后，心切开术支持（CentriMag）。虽然PediMag已成功用于一系列心切开术后支持应用程序，但由于缺乏辅助组件等因素，专门设计用于泵系统（例如，儿科血液氧合器和热交换器），复合体控制算法和高的一次性成本（每个一次性PediMag泵头约8000美元）。到针对这些缺点，我们提出了一种创新的磁悬浮系统的基础上磁滞电动机概念允许更小的整体配置，消除了磁场安全问题，振动，并将昂贵的稀土磁性元件从一次性血液接触组件到可重复使用的电机定子。磁滞电动机的设计还允许简化控制用于增强鲁棒性和降低功率要求的算法，迁移率所提出的磁滞电机的转子/叶轮部分将基于相同的叶轮现有pCAS泵-氧合器中目前使用的几何形状，轴承、旋转轴和血液接触密封。这一战略将降低整体开发成本，允许使用现有的全面的体外和体内试验数据，以进行直接和有效的比较新磁悬浮原型与现有基于血液密封的pCAS泵的性能对比- 氧合器在第一阶段，我们将进行两项急性和一项为期3天的慢性动物研究。这使我们能够证明基本的可行性，同时最大限度地减少成本和第一阶段项目的时间轴。然而，在这方面，作为后续第二阶段工作的一部分，我们计划显著扩大我们的慢性体内研究，包括至少30天的多次评估。 !