PERMANENT AORTIC BALLOON PUMP

永久性主动脉球囊泵

• 批准号: 3508431
• 负责人: ADRIAN KANTROWITZ
• 金额: $ 13.15万
• 依托单位: VIADERM, LLC
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-09-21 至 1990-09-20
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3508431
• 关键词: aortic balloon pump; auxiliary heart prosthesis; biomedical equipment resource; biomedical equipment safety; clinical biomedical equipment; cow; heart failure; hemodynamics

The objective of this Phase II SBIR project is to qualify the permanent aortic balloon pump for clinical trial in intractable left ventricular failure (LVF). The system provides a distinctive balance of benefits and low risk so that in Phase III, it is expected to earn a niche among therapies for chronic congestive LVF. The permanent aortic balloon system supports the left ventricle at therapeutically effective levels while maximizing patient safety. It is unique among left ventricular assist systems in that its continuous pumping action is nonobligatory. The patient can be untethered for hours. During Phase I, the redesigned blood pump was successfully tested in 5 calves pumped intermittently without anticoagulant therapy over a 6 week period. These results lead to Phase II in which our specific aims are: 1. To confirm and quantitate hemodynamic effects of the permanent aortic balloon in calves in which acute heart failure has been induced. 2. To characterize the performance limits of the system. 3. To demonstrate in vitro component reliability over a 2-year design life. 4. To test and document the reliability and safety of the system in long-term (6 month) test in each of 8 animals. 5. To develop an investigational plan, protocols and consent form that will warrant approval by the hospital IRB and FDA for trial in human subjects.

该SBIR第二阶段项目的目标是使 永久性主动脉球囊反搏治疗顽固性左冠状动脉病变的临床研究 心力衰竭(LVF)。该系统提供了一种独特的 平衡利益和低风险，因此在第三阶段，预计 在慢性充血性左心室流出道的治疗中赢得一席之地。这个 永久性主动脉球囊系统支持左心室 治疗有效水平，同时最大限度地提高患者的安全性。 它在左心室辅助系统中的独特之处在于它的 连续的抽水动作是非强制性的。病人可能是 一连几个小时都不受束缚。在第一阶段，重新设计的血泵 在5头小牛身上成功地进行了间歇泵血，没有 抗凝治疗超过6周。这些结果导致了 第二阶段我们的具体目标是： 1.确认和量化血液动力学效应。 急性心力衰竭的小牛永久性主动脉球囊 已经被诱导了。 2.确定系统的性能极限。 3.在两年内证明体外组件的可靠性 设计生活。 4.测试和记录系统的可靠性和安全性 在长期(6个月)试验中，每只动物8只。 5.制定调查计划、方案和同意书 这将需要得到医院IRB和FDA的批准进行试验 在人类实验对象中。

项目成果

A mechanical auxiliary ventricle. Histologic responses to long-term, intermittent pumping in calves.

机械辅助心室。

• 发表时间: 1995
• 期刊: ASAIO journal (American Society for Artificial Internal Organs : 1992)
• 作者: Kantrowitz,A;Freed,PS;Zhou,Y;Mandell,G;DeDecker,P;Riddle,J;Wilson,D;Mullaney,TP
• 通讯作者: Mullaney,TP