CENTRIFUGAL CIRCULATORY ASSIST DEVICE

离心循环辅助装置

• 批准号: 3508347
• 负责人: RICHARD K WAMPLER
• 金额: $ 21.87万
• 依托单位: NIMBUS, INC.
• 依托单位国家: 美国
• 财政年份: 1988
• 资助国家: 美国
• 起止时间: 1988-02-01 至 1990-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3508347
• 关键词: antithrombogenic surface; auxiliary heart prosthesis; cardiogenic shock; circulatory assist; clinical biomedical equipment; cow; hemolysis

The long-term objective of the proposed research is to develop, qualify for an IDE, conduct clinical trials, obtain PMA and market an implantable temporary ventricular assist system (VAS) which is superior to existing devices with respect to size, surgical complexity, ease of use and cost. The principal specific aim of the proposed program is to develop and demonstrate the continuous delivery VAS which is based on Phase I results and Nimbus sponsored developments. The device is targeted for the temporary ventricular assist market. The goals will be achieved by fabricating development devices, conducting performance, flow visualization and hemolysis tests and conducting acute and chronic in vivo tests. The in vivo tests will evaluate hemolysis and thrombogenicity characteristics, device-host interactions and demonstrate suitability of the device for moderate term use. Laboratory endurance testing of the device will also be accomplished. The technological innovation involves demonstration of a compact continuous delivery VAS which resolves shaft seal and thrombus problems characteristic of previous devices of this type and which retains required performance and hemolysis characteristics. The commercial potential lies in its superiority to currently available implantable devices with respect to size, complexity of surgical implantation, ease of use and cost.

拟议研究的长期目标是开发， 获得IDE资格，进行临床试验，获得PMA并上市 一种植入式临时心室辅助系统（VAS）， 在尺寸、外科手术方面上级于现有器械 复杂性、易用性和成本。 的主要具体目标 拟议的计划是开发和演示连续的 基于第一阶段结果和Nimbus赞助的交付VAS 发展理念 该器械用于暂时性心室 协助市场。 这些目标将通过制造开发设备来实现， 进行性能、流动可视化和溶血试验， 进行急性和慢性体内试验。 体内试验将 评价溶血和血栓形成特性，器械-宿主 相互作用，并证明器械适用于中度 术语使用。 还将对器械进行实验室耐久性测试。 完成了 技术创新包括展示一种紧凑的 解决轴封和血栓的连续输送VAS 这种类型的先前装置的特征问题， 保留所需的性能和溶血特性。 的 商业潜力在于其优于目前可用的 可植入器械的尺寸、手术复杂性 植入性、易用性和成本。