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

Telsa 悬吊泵左心室辅助装置 (LVAD) 的开发

• 批准号: 7416778
• 负责人: GERSON ROSENBERG
• 金额: $ 67.31万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7416778
• 关键词: Address; Adverse event; Australia; Biological; Blood flow; Blood typing procedure; Cardiac; Cardiac Output; Cardiopulmonary Bypass; Custom; Destinations; Development; Devices; Electronics; Ensure; Evaluation; Goals; Heart Diseases; Heart-Lung Machine; Hemolysis; Implant; In Vitro; Incidence; Infection; Left; Liquid substance; Manuals; Mechanics; Modeling; Motor; Patients; Performance; Physiological; Population; Published Comment; Pump; Recovery; Regulation; Research; Running; Staging; Support System; Surface; Suspension substance; Suspensions; System; Techniques; Technology; Testing; Tetradecanoylphorbol Acetate; Thromboembolism; Thrombosis; Thrombus; Transplantation; United States Food and Drug Administration; blood pump; cost; design; improved; in vivo; indexing; innovation; pressure; prototype; research and development; response; shear stress; size; ventricular assist device

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.

描述（由申请人提供）：目前，许多机械循环支撑装置用于心脏切开术，恢复桥梁，移植桥和目的地治疗。这些设备既包括脉动和连续的流动设备，并且在世界各地开发了许多连续的流动设备。宾夕法尼亚州立大学（Penn State）与ABI，Inc。合作开发了一种独特而创新的特斯拉型血泵设计，该设计解决了在现有的连续流动设备（例如血栓形成和溶血）中遇到的缺点。 PSU/ABI LVAD系统采用了独特的无源转子悬架系统，其血流通道较大，不会产生溶血剪切应力，但可以提供足够的表面洗涤。 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箭头Lionheart和Coraide系统以及5）体内系统性能的评估。所有研发将根据FDA质量系统法规来完成。该提案已经过仔细修订，以解决以前的审稿人的问题和评论。它包含一个精致的设计系统，该系统在保持系统性能的同时较小。