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

描述（由申请人提供）：目前，许多机械循环支持器械用于心切开术后、恢复桥、移植桥和目的地治疗。这些设备包括脉动流设备和连续流设备，并且世界各地正在开发许多连续流设备。宾州州立大学与ABI公司合作，开发了一种独特的和创新的特斯拉型血泵设计，解决了现有连续流动装置中遇到的缺点，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，具有大血流通道，不会产生溶血剪切应力，但可提供充分的表面清洗。将最新的计算流体动力学技术与经验证的体外和体内测试相结合，通过以下方式开发改进的LVAD系统：1）缩放先前ABI开发的心肺转流泵，同时保持流体动力学相似性，2）开发避免非生理压力的生理控制系统，3）体外溶血和液压测试，4）整合Arrow LionHeart和CorAide系统的现有电子设备; 5）体内系统性能评估。所有的研究和开发都将按照FDA质量体系法规进行。本建议经过认真修订，以解决前几次审查者提出的问题和意见。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.