Development of Suspended Telsa Pump Left Ventricular Assist Device (LVAD)

描述（申请人提供）：目前有许多机械循环支持装置用于心脏切开后、康复桥、移植桥和目的地治疗。这些装置包括脉动式和连续流装置，世界上有许多连续流装置正在开发中。宾夕法尼亚州立大学与ABI公司合作，开发了一种独特而创新的特斯拉型血泵设计，解决了现有连续血流设备遇到的缺点，如血栓和溶血。PSU/ABI LVAD系统采用独特的被动转子悬挂系统，具有大血流通道，不会产生溶血性剪切应力，但可提供足够的表面清洗。最新的计算流体动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出一种改进的LVAD系统：1)在保持流体动力学相似性的同时扩展ABI先前开发的体外循环泵；2)开发一种避免非生生性压力的生理控制系统；3)体外溶血和水力测试。4)整合来自Arrow LionHeart和CorAide系统的现有电子设备；5)评估系统在体内的性能。所有的研究和开发都将按照FDA质量体系的规定完成。该提案已经过仔细修订，以解决以前审稿人提出的问题和意见。它包含了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.