AXIAL FLOW BLOOD PUMP WITH SIMPLIFIED BEARINGS--PHASE II

简化轴承轴流式血液泵--第二阶段

• 批准号: 2599875
• 负责人: KENNETH C BUTLER
• 金额: $ 35.62万
• 依托单位: NIMBUS, INC.
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-02-01 至 1998-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2599875
• 关键词: auxiliary heart prosthesis; biomedical equipment development; cow; implant; nonhuman therapy evaluation

This Phase II project involves development and pre-clinical qualification of a left ventricular assist system (LVAS) that features a miniature axial flow blood pump with simplified (e.g., blood-immersed) bearings. In Phase I convincing evidence was obtained demonstrating the feasibility of this new axial flow pump. In particular the results of several in vivo tests, including one of 2-months duration and one ongoing experiment approaching 5 months, indicate the pump's potential to operate in blood for periods of time consistent with clinical bridge-to-transplant (BTT) applications. Now in Phase II the goals are to complete development of this LVAS and conduct sufficient in vitro and animal testing to document its overall safety and performance, in anticipation of a clinical trial for BTT applications lasting up to 90 days. In addition to the pump, the LVAS consists of inflow/outflow cannulae and externally worn components, e.g., primary battery, back-up battery, and pump controller, which provide power and closed-loop speed control of the implanted pump. A small diameter percutaneous wire connects the implanted pump to the external controller. If ultimately successful, this new LVAS would be vastly simpler, smaller, and less costly than the products available today for clinical use. PROPOSED COMMERCIAL APPLICATION: The bridge-to-transplant application would only be the first use of this type of LVAS to treat heart failure patients. Beyond bridge-to-transplant applications, the LVAS would then be qualIfied for use as an alternative-to-transplant. This latter application has a very large commercial potential and is the most significant for this device.

该二期项目涉及开发和临床前鉴定 左心室辅助系统 (LVAS) 具有微型 带有简化（例如浸血）轴承的轴流血泵。在 第一阶段获得了令人信服的证据，证明了可行性 这种新型轴流泵。特别是一些体内实验的结果 测试，包括一项为期 2 个月的测试和一项正在进行的实验 接近 5 个月，表明泵在血液中运行的潜力 与临床移植桥 (BTT) 一致的时间段 应用程序。现在第二阶段的目标是完成 该 LVAS 并进行足够的体外和动物测试以记录 其整体安全性和性能，以期进行临床试验 适用于持续长达 90 天的 BTT 申请。 除泵外，LVAS 还包括流入/流出插管和 外部磨损组件，例如主电池、备用电池和 泵控制器，提供功率和闭环速度控制 植入泵。小直径经皮线连接植入物 泵至外部控制器。如果最终成功，这个新的LVAS 比产品更简单、更小、成本更低 今天可供临床使用。 拟议的商业应用：桥移植应用 这只是此类 LVAS 首次用于治疗心力衰竭 患者。除了桥梁移植应用之外，LVAS 还将 有资格用作移植的替代品。后者 应用具有非常大的商业潜力，是最 对于该设备来说意义重大。

项目成果

Progress on development of the Nimbus-University of Pittsburgh axial flow left ventricular assist system.

Nimbus-匹兹堡大学轴流左心室辅助系统的开发进展。

• DOI: 10.1097/00002480-199809000-00040
• 发表时间: 1998
• 期刊: ASAIO journal (American Society for Artificial Internal Organs : 1992)
• 作者: Thomas,DC;Butler,KC;Taylor,LP;LeBlanc,P;Rintoul,TC;Petersen,TV;Griffith,BP;Kormos,RL;Borovetz,HS;Litwak,P;Kameneva,MV;Choi,S;Burgreen,GW;Wu,Z;Antaki,JF
• 通讯作者: Antaki,JF