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. !

抽象的此阶段I STTR应用提出了创新，低成本，磁性电动机的开发专为儿科体外心脏和心肺疗法设计。磁悬浮启用无联系的叶轮操作，从而消除了可以有助于溶血和血栓形成。体外儿科市场目前由一个单一服务磁悬浮的血泵（St. Jude Medical's Pedimag（以前为Thoratec））。与许多小儿一样医疗产品，PEDIMAG是最初设计用于邮政的成人设备的缩放版本心脏切开术（Centrimag）。虽然PEDIMAG已成功地用于一系列心脏切开术支持应用程序，更广泛的使用使几个因素复杂化，包括缺乏辅助组件专为泵系统设计（例如，小儿血氧和热交换器），复杂控制算法和高一次性成本（每个一次性pedimag泵头约8000美元）。到解决这些缺点，我们提出了基于磁滞的创新磁悬浮系统允许较小整体配置，消除磁场安全问题的运动概念，减少了振动，并从一次性血液接触中重新定位了昂贵的稀土磁性元素可重复使用的电机定子的组件。磁滞运动设计还允许简化控制增强鲁棒性和功率要求降低的算法，增强了患者运输和机动性。拟议的滞后电动机的转子/叶轮部分将基于同一叶轮几何形状与现有的PCAS泵氧化剂中当前使用的几何形状取代了当前的机械轴承，旋转轴和血接触密封。该策略将降低整体发展成本，并允许使用现有的全面体外和体内测试数据，以进行直接有效的比较现有的磁性悬浮原型的性能氧合剂。在第一阶段，我们将进行两次急性和3天的慢性动物研究。这允许我们展示基本的可行性，同时最大程度地减少成本和I期项目时间表。然而，作为随后的第二阶段努力的一部分，我们计划显着扩展我们的慢性体内研究，以包括多次评估至少为30天。呢