PEDIATRIC BLOOD PUMP DEVELOPMENT

心脏外科医生面临的一个问题是缺乏合适的设备， 为新生儿和老年儿童提供临时心脏支持 患者 临床使用的现有器械（ECMO和离心泵） 相对于患者的体型来说太大了。 的具体目标 该计划的重点是演示一种新的旋转泵， 为这些特殊的年轻患者。 Nimbus的最新发明是一种非常小的，廉价的离心血液 用于成人心肺转流手术的泵。 广泛的体外 试验证实该泵在流量性能方面是等效的， 现有离心装置产生溶血。 初步 构成第一阶段建议基础的研究表明， Nimbus泵可轻松适应新生儿/儿科版本。 关键 创新之处在于所得到的泵尺寸（15 cc灌注体积）为1/5 是现有离心泵的1/3。 本I期研究将通过体外试验评估该泵概念 流动性能、溶血生成和轴密封试验 完整 体内试验，将在大学进行 匹兹堡，旨在证明血流动力学性能， 该泵的生物相容性和一般适用性 新生儿/儿科应用。 第二阶段研究将涉及更长的时间， 泵的体内试验和开发及其作为临床应用的控制 产品

One problem facing cardiac surgeons is lack of suitable devices to provide temporary cardiac support to neonates and pediatric aged patients. Existing devices used clinically (ECMO and centrifugal pumps) are too large relative to the size of the patient. The specific aims of this program focus on demonstration of a new rotary pump intended solely for these special young patients. Nimbus' latest creation is a very small, inexpensive centrifugal blood pump for adult cardiopulmonary bypass procedures. Extensive in vitro testing verifies that this pump is equivalent in flow performance and hemolysis generation to existing centrifugal devices. Preliminary studies which form the basis of this Phase I proposal show that the Nimbus pump adapts readily to a neonatal/pediatric version. The key innovation is that the resulting pump size (15 cc priming volume) is 1/5 to 1/3 that of existing centrifugal pumps. This Phase I study will evaluate this pump concept through in vitro testing of flow performance, hemolysis generation, and shaft seal integrity. In vivo tests, to be performed at the University of Pittsburgh, are intended to demonstrate the hemodynamic performance, biocompatibility and general suitability of this pump for neonatal/pediatric applications. A Phase II study would involve longer in vivo trials and development of the pump and its control as a clinical product.