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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. !

抽象的 STTR 第一阶段的应用建议开发一种创新的低成本磁悬浮电机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有助于溶血和血栓形成。体外儿科市场目前由单一的磁悬浮血泵（St. Jude Medical 的 PediMag（以前称为 Thoratec））。和许多儿科一样医疗产品中，PediMag 是先前成人设备的缩小版本，最初设计用于术后康复。心脏切开术支持 (CentriMag)。 PediMag 已成功应用于一系列心脏切开术后支持应用程序，但由于缺乏辅助组件等多种因素，更广泛的使用变得复杂专为泵系统（例如儿科血液氧合器和热交换器）而设计，复杂控制算法，以及高昂的一次性成本（每个一次性 PediMag 泵头大约 8000 美元）。到为了解决这些缺点，我们提出了一种基于磁滞的创新磁悬浮系统电机概念允许更小的整体配置，消除磁场安全问题，减少振动，并将昂贵的稀土磁性元件从一次性血液接触器中重新定位可重复使用的电机定子的组件。磁滞电机设计还可以简化控制增强稳健性和降低功耗的算法，增强患者运输和流动性。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 泵氧合器当前使用的几何结构取代了当前的机械结构轴承、旋转轴和血液接触密封件。该策略将降低总体开发成本允许使用现有的综合体外和体内测试数据进行直接有效的比较新型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动物研究和一项为期 3 天的慢性动物研究。这使我们能够展示基本的可行性，同时最大限度地降低成本和第一阶段项目时间表。然而，作为后续第二阶段工作的一部分，我们计划显着扩大我们的慢性体内研究，包括至少30天的多次评估。！