New Magnetically Suspended LEV-VAD

新型磁悬浮 LEV-VAD

• 批准号: 6942894
• 负责人: Don B. Olsen
• 金额: $ 119.05万
• 依托单位: UTAH ARTIFICIAL HEART INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-22 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6942894
• 关键词: auxiliary heart prosthesis; biomedical equipment development; cow; heart circulation; heart failure; implant; magnetic field; medical implant science; auxiliary heart prosthesis; biomedical equipment development; cow; heart circulation; heart failure; implant; magnetic field; medical implant science

DESCRIPTION (provided by applicant): The primary goal and objective of this project is to develop and validate the LEV-VAD with sufficient results and documentation to submit an Investigational Device Exemption application to the FDA to obtain approval for clinical trials. We propose to begin testing and validating our present designed and manufactured device through in vitro characterization in a series of well planned and executed steps. These steps include utilizing several computer programs selected to optimize the design components and these functions and performance simulation studies. The LEV-VAD will then have performance curves and well characterized in mock circulations where both the motor and electromagnetic bearing controllers will be optimized to operate the pump within the anticipated ranges in vivo. After preliminary results of verification the device will be implanted into a series of healthy calves for up to six hours to assure the anatomic fit and assess function in the in fully instrumented calves. In a later series of instrumented calves living up to two months, the cardiovascular system will be perturbed with drugs and removing and/or adding volumes and rapid heart rate. Implants will be done for longer durations in both instrumented and noninstrumented experiments. After the design and well-characterized prototype II are verified, the design will be frozen. Ten of these devices will be placed on an FDA-approved test circuit and test protocols for one year to demonstrate reliability of the pump and its controller. A major effort will be to develop a responsive physiologic controller utilizing first monitoring the axial forces on the impeller (power to the electronic bearings), in combination with the power delivered to the motor. Preliminary studies demonstrated that the readily available power for the levitation bearing and motor power can be used for a very sensitive controller. If a robust responsive controller cannot be developed with these two basic parameters the heart rate and/or the signal from the transonic flow meter will be incorporated into the algorithm. There are a large number of congestive heart failure patients unlikely to receive a donor heart. The existing VADs have a high rate of mechanical failure and thromboemboli. Our design targets destination therapy for recipients with a device that could provide a 20-year life extension. We have a high level of confidence that at the completion of these proposed studies we will know the application and limitations of the LEV-VAD as a destination therapy device.

描述（由申请人提供）：该项目的主要目标和目标是开发和验证LEV-VAD，并提供足够的结果和文件，以向FDA提交研究设备的豁免申请，以获得临床试验的批准。我们建议通过一系列精心计划和执行的步骤开始测试和验证当前​​设计和制造的设备。这些步骤包括利用选择的几个计算机程序来优化设计组件以及这些功能和性能模拟研究。然后，LEV-VAD将具有性能曲线，并在模拟循环中表征良好，在该模拟循环中，电动机和电磁轴承控制器都将被优化以在体内预期的范围内操作泵。验证初步结果后，该设备将被植入一系列健康的犊牛中，以确保在完全仪器的犊牛中的解剖拟合和评估功能。在后来的一系列仪器犊牛中，寿命长达两个月，心血管系统将受到药物的干扰，去除和/或增加体积和快速心率。在仪器和未录制的实验中，植入物将在更长的时间内进行更长的持续时间。在设计和特征良好的原型II验证后，设计将被冷冻。这些设备中的十个将放置在FDA批准的测试电路和测试协议上一年，以证明泵及其控制器的可靠性。主要的努力是开发一个响应式生理控制器，该控制器首先监测叶轮上的轴向力（电子轴承的功率），并结合传递到电动机的功率。初步研究表明，悬浮轴承和运动功率的随时可用功率可用于非常敏感的控制器。如果无法使用这两个基本参数开发出强大的响应控制器，则将跨气流计的心率和/或信号纳入算法中。有大量充血性心力衰竭患者不太可能接受供体心脏。现有的VAD具有很高的机械故障和血栓栓塞率。我们的设计针对接收者的目的地治疗，该设备可以提供20年的寿命。我们有很高的信心，即在完成这些拟议的研究时，我们将知道LEV-VAD作为目的地治疗设备的应用和局限性。