LOW HEMOLYSIS BLOOD PUMP WITH INTEGRAL PRESSURE CONTROLS

在第I阶段构建并测试了一种新的体外血液泵设计。 该泵与标准滚子泵和离心泵进行了比较， 安全性、溶血性、有效性和 耐久性 新泵具有许多理想的性能， 在其他电流泵中发现，包括固有压力调节 (i.e.,不会过度加压或产生危险的负面影响 压力），相同输出的最低能耗，以及 优异的耐久性。 文丘里流量计的设计进行了测试的准确性 和溶血，结果表明，流量计是 非常精确，溶血率极低。 第二阶段的目标是研究泵系统的各个方面， 这对最终的商业应用很重要。 这项研究将 专注于材料，几何形状和制造技术， 泵室、泵硬件设计和所需控制。 泵将设计为具有适当的尺寸、压力和流量 纳入心脏专用系统的要求 手术、血液透析、泵血滤过和单采。 体外 并将完成性能、安全性 溶血和耐久性。 最后的设计将准备进行试点 生产和随后的FDA试验。

A new extracorporeal blood pump design was built an tested in Phase I. The pump was compared to the standard roller and centrifugal pumps under a variety of conditions for safety, hemolysis, efficiency, and durability. The new pump has many desirable properties which are not found in the other current pumps, including inherent pressure regulation (i.e., will not over pressurize or generate hazardous negative pressures), the lowest consumption of energy for the same output, and excellent durability. A venturi flowmeter design was tested for accuracy and hemolysis, and the results have demonstrated that the flowmeter is extremely accurate with very low hemolysis. The objective of Phase II is to research aspects of the pump system that will be important for eventual commercial application. The research will focus on materials, geometry, and manufacturing techniques used in the pump chambers, and the design of the pump hardware and required controls. Pumps will be designed with the appropriate size, pressure, and flow requirements to incorporate into application-specific systems for cardiac surgery, hemodialysis, pumped hemofiltration, and apheresis. In vitro and in vivo testing will be completed for performance, safety, hemolysis, and durability. The final designs will be ready for pilot manufacturing and subsequent FDA trials.