DEVELOPMENT OF INNOVATIVELY SUSPENDED TESLA PUMP LVAD

描述(申请人提供)：许多机械循环支持设备目前被用于心脏切开术后、通往康复的桥梁、通往移植的桥梁和目的地治疗。这些装置包括脉动和连续流动装置，世界各地有许多连续流动装置正在开发中。宾夕法尼亚州立大学与ABI公司合作，开发了一种独特的创新特斯拉血泵设计，解决了现有连续流动设备中遇到的缺陷，如血栓形成和溶血。PSU/ABI LVAD系统采用独特的无源转子悬挂系统，具有大的血液流动通道，不会产生溶血剪应力，但可提供足够的表面清洗。最新的计算流体力学技术与经过验证的体外和体内测试相结合，将通过以下方式开发改进的LVAD系统：1)在保持流体动力学相似性的同时对ABI以前开发的体外循环泵进行缩放，2)开发避免非生理性压力的生理控制系统，3)体外溶血和水力测试，4)整合Arrow LionHeart和CorAide系统的现有电子设备，以及5)体内系统性能评估。所有的研究和开发都将按照FDA的质量体系规定完成。本提案经过仔细修改，以解决以前审查员提出的问题和意见。它包含一个精致的设计系统，在保持系统性能的同时更小。

DESCRIPTION (provided by applicant): Numerous mechanical circulatory support devices are currently utilized for post cardiotomy, bridge to recovery, bridge to transplant and destination therapy. These devices include both pulsatile and continuous flow devices, and there are numerous continuous flow devices under development around the world. Penn State, in cooperation with ABI, Inc., has developed a unique and innovative Tesla type blood pump design that addresses shortcomings encountered in existing continuous flow devices such as thrombosis and hemolysis. The PSU/ABI LVAD system employs a unique passive rotor suspension system with large blood flow channels that do not create hemolytic shear stresses yet provide for adequate surface washing. The latest computational fluid dynamics techniques combined with proven in vitro and in vivo testing, will be combined to develop an improved LVAD system by, 1) scaling a previously ABI developed cardiopulmonary bypass pump while maintaining fluid dynamics similitude, 2) developing a physiologic control system that avoids unphysiologic pressures, 3) in vitro hemolysis and hydraulic testing, 4) integrating existing electronics from the Arrow LionHeart and CorAide systems and 5) evaluation of system performance in vivo. All research and development will be accomplished in compliance with the FDA Quality Systems regulations. This proposal has been carefully revised to address the questions and comments of previous reviewers. It contains a refined design system that is smaller while maintaining system performance.