Long term extracorporeal blood oxygenating device

DESCRIPTION (provided by applicant): This proposed Phase 1 work is aimed at developing a new and greatly improved long term estracorporeal membrane oxygenator (ECMO) sized for newborn babies afflicted with severe respiratory and/or cardiac failure. The only oxygenator currently used for this purpose in the US was developed in 1963. The proposed design will use MedArray's new proprietary silicone hollow fibers, which will enable the development of a compact oxygenator with significantly improved gas transfer, lower priming volume, less surface area to minimize inflammatory response, improved blood flow dynamics, improved blood resistance, and lower cost. Since ECMO oxygenators are used for long periods of time (more than 1 day), the membrane cannot be microporous as it can result in plasma leakage. Therefore these oxygenators must use dense membranes which have no pores for plasma leakage. Silicone is a dense membrane material with extremely high permeability to oxygen and CO2 and is therefore used in ECMO oxygenators. Silicone membranes have been commercially produced in sheet format but, because of production challenges and associated cost, not in the more efficient hollow fiber configuration. Thus current ECMO oxygenators use spiral wound silicone sheet membranes which are not as efficient and compact as hollow fiber membranes. MedArray has developed a proprietary (patented) method for fabricating silicone membrane hollow fibers in a cost effective and commercially feasible way that will enable the development of a long due improved ECMO oxygenator. The proposed work also includes improved device design using computational fluid dynamics, and bench testing to compare performance with the current neonatal ECMO oxygenator. In Phase II we propose to expand this work to the pediatric and adult size ECMO oxygenators, as well as include long term performance, and blood surface interaction studies.