PERMANENT AORTIC BALLOON PUMP

第二阶段 SBIR 项目的目标是使 永久性主动脉球囊反搏器用于顽固性左侧动脉瘤的临床试验 心室衰竭（LVF）。 该系统提供了独特的 效益和低风险的平衡，因此在第三阶段，预计 在慢性充血性 LVF 治疗中赢得一席之地。 的 永久主动脉球囊系统支撑左心室 治疗有效水平，同时最大限度地提高患者安全。 它在左心室辅助系统中是独一无二的，因为它 连续泵送动作不是强制性的。 患者可以是 几个小时不受束缚。 在第一阶段，重新设计的血泵 已在 5 头犊牛身上进行了成功测试，间歇性吸奶无需 为期 6 周的抗凝治疗。 这些结果导致 第二阶段，我们的具体目标是： 1. 确认并定量血流动力学效应 小牛永久性主动脉球囊治疗导致急性心力衰竭 已被诱导。 2. 表征系统的性能极限。 3. 证明体外组件在两年内的可靠性 设计生活。 4. 测试并记录系统的可靠性和安全性 对 8 只动物进行长期（6 个月）测试。 5. 制定研究计划、方案和同意书 这将需要医院 IRB 和 FDA 批准进行试验 在人类受试者中。

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.