Miniature MagLev VAD for Children & Adults

儿童微型磁悬浮 VAD

• 批准号: 6694375
• 负责人: KURT A DASSE
• 金额: $ 25.6万
• 依托单位: THORATEC, LLC
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-01 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6694375
• 关键词: auxiliary heart prosthesis; bioengineering /biomedical engineering; circulatory assist; cow; heart failure; heart ventricle; hemodynamics

DESCRIPTION (provided by applicant): The prevalence of congestive heart failure in the United States is nearly 5 million patients, with more than 500,000 new cases diagnosed per year. Of these patients, approximately 400,000 have a life expectancy of less than one year, and 200,000 die each year despite maximal medical therapy. To address the need for mechanical circulatory support in these patients, various left ventricular assist systems have been developed. Yet broad utilization of these devices has been limited by their size and cost. Our goal is to create a truly affordable left ventricular assist device, capable of meeting the needs of a broad range of patients with severe heart failure. The focus of this project will be to develop a miniature, low-cost, extracorporeal centrifugal left ventricular assist device, for use as a bridge-to-decision for durations ranging from days to months. Accordingly, the device will be designed to function as a bridge to recovery, transplant or an implantable device for patients in severe cardiac failure. The specific design will feature a novel magnetically levitated configuration, whose key features allow rapid acceleration and deceleration in response to prescribed motor input power cycles. The major advantages of the current design are its small and relatively simple extracorporeal design, its ability to efficiently regulate cardiac output over a large range of flow conditions, and its ease of production This program's overall goal will be to develop and optimize the design and construction of the magnetically levitated, centrifugal pump, and ascertain its physiological performance in vitro and in vivo. The specific aims of this proposal are to 1) Design and fabricate a long-term blood pump and pump controller. 2) Optimize pump design through a computational fluid dynamics model, which predicts system flow as a function of pump attributes. 3) Design and fabricate magnetically driven system controls and power supply integration. 4) Determine pressure-flow characteristics over a wide range of outputs. 5) Determine hemolysis levels over the expected range of cardiac outputs. 6) Perform preliminary in vitro endurance testing, 7) Conduct three acute in vivo experiments to demonstrate hemodynamic performance and biocompatibility. We believe that our technology, which provides effective left ventricular assistance with a small, disposable device, may provide needed benefits to the health of a broad range of patients, while not adding significantly to cost of caring for these patients. If we successfully meet the Phase I goals, we will propose in a Phase II program to refine the mechanical design with respect to manufacturing, optimize the ventricular assist control console (with appropriate safety and alarm systems), and expand the in vivo data to include longer-term animal experiments. This would provide a database to support the use of our device for long-term left ventricular support in clinical trials.

描述（由申请人提供）： 在美国，充血性心力衰竭的患病率接近 500 万患者，每年新诊断病例超过 50 万例。在这些患者中，大约有 400,000 人的预期寿命不足一年，尽管采取了最大程度的药物治疗，每年仍有 200,000 人死亡。为了满足这些患者对机械循环支持的需求，已经开发了各种左心室辅助系统。然而，这些设备的广泛使用受到其尺寸和成本的限制。我们的目标是创造一种真正负担得起的左心室辅助装置，能够满足广泛的严重心力衰竭患者的需求。该项目的重点是开发一种微型、低成本、体外离心左心室辅助装置，作为决策的桥梁，持续时间从几天到几个月不等。因此，该装置将被设计为严重心力衰竭患者康复、移植或植入装置的桥梁。具体设计将采用新颖的磁悬浮配置，其主要特点是能够根据规定的电机输入功率周期快速加速和减速。当前设计的主要优点是其小型且相对简单的体外设计，能够在大范围的血流条件下有效调节心输出量，并且易于生产。该项目的总体目标是开发和优化设计和构造磁悬浮离心泵的结构，并确定其体外和体内的生理性能。该提案的具体目标是 1) 设计和制造长期血泵和泵控制器。 2) 通过计算流体动力学模型优化泵设计，该模型根据泵属性预测系统流量。 3) 设计和制造磁驱动系统控制和电源集成。 4) 确定大范围输出的压力-流量特性。 5) 确定预期心输出量范围内的溶血水平。 6) 进行初步的体外耐力测试，7) 进行三个急性体内实验以证明血流动力学性能和生物相容性。我们相信，我们的技术通过小型一次性设备提供有效的左心室辅助，可以为广大患者的健康提供所需的好处，同时不会显着增加这些患者的护理成本。如果我们成功实现第一阶段目标，我们将在第二阶段计划中提出改进制造方面的机械设计，优化心室辅助控制台（配备适当的安全和报警系统），并扩展体内数据以包括更长期的动物实验。这将提供一个数据库来支持我们的设备在临床试验中用于长期左心室支持。