Miniature MagLev VAD for Children & Adults

描述（由申请人提供）：我们的目标是创造一种负担得起的心室辅助装置，能够满足广泛的严重心力衰竭患者的需求。该项目的重点将是开发一种小型，低成本，心室辅助装置，适合用于单心室或双心室支持，作为恢复，移植或长期植入式装置的桥梁。具体的设计将采用一种新颖的磁悬浮配置，其主要特点是允许快速加速和减速，以响应规定的电机输入功率周期。目前设计的主要优点是体积小，设计相对简单，能够在大范围的流量条件下有效调节泵的输出，并且易于生产。该项目的总体目标是开发和优化磁悬浮离心泵的设计和结构，并确定其在体外和体内的生理性能。在这个项目的第一阶段，我们与德克萨斯心脏研究所合作，通过一系列的体外和体内实验，证明了这项技术在成人和儿童应用中的合理性。在第二阶段，我们打算完成产品的设计和验证，并在预期的临床试验中启动设备准备测试。本二期方案的具体目标是：1)设计和优化泵系统的关键功能属性，以满足心脏支持要求。2)改进心室辅助装置插管。3)完善控制器的设计，使其能够在广泛的儿童和成人操作条件下运行，并结合系统报警以实现故障安全操作。4)对控制器、电机和泵进行可靠性测试，建立系统置信度。5)在动物模型中证明所建议的长期VAD的血流动力学性能和生物相容性。我们相信，我们的技术可以通过一个小的一次性装置提供有效的心室辅助，可以为广大患者的健康提供所需的好处，同时不会显著增加照顾这些患者的成本。实现该II期项目中提出的目标将验证该设备的安全性和适用性，以便在IDE临床试验中进行评估，该临床试验将在III期项目中进行。我们预计，在项目的第三阶段，我们将满足管理IDE的监管要求，制造经过验证和验证的硬件，建立可靠性，并进行指示性临床试验。

DESCRIPTION (provided by applicant): Our goal is to create an affordable 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, ventricular assist device, suitable for use for univentricular or biventricular support, for use as a bridge to recovery, transplant or a longer term implantable device. 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 design, its ability to efficiently regulate pump 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. During Phase I of this project, in collaboration with the Texas Heart Institute, we demonstrated the soundness of this technology for both the adult and pediatric applications through a series of in vitro and in vivo experiments. In Phase II we intend to complete the design and validation of the product, and to launch device readiness testing in anticipation of clinical trials. The specific aims of this Phase II proposal are to: 1) Design and optimize the critical functional attributes of the pump system to meet cardiac support requirements. 2) Develop improved cannulae for ventricular assist device insertion. 3) Refine the design of the controller to operate over a broad range of pediatric and adult operating conditions, and to incorporate system alarms for fail-safe operation. 4) Conduct reliability testing of the controllers, motors and pumps to establish system confidence levels. 5) Demonstrate hemodynamic performance and biocompatibility for the proposed long-term VAD in an animal model. We believe that our technology, which provides effective 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 the cost of caring for these patients. Achieving the aims proposed in this Phase II program will validate the safety and suitability of this device for evaluation under an IDE clinical trial, which will be carried out in a Phase III program. We project that in Phase III of the project we will meet the regulatory requirements governing an IDE, fabricate verified and validated hardware, establish reliability, and conduct indicated clinical trials.