This proposed Phase II Renewal is aimed at finalizing the research and development of a new and greatly improved long term extracorporeal membrane oxygenator (ECMO) for patients afflicted with severe respiratory and/or cardiac failure. Results from Phase II work indicate that we have developed a significantly improved ECMO oxygenator that outperforms currently used and outdated membrane technology. In Phase II we demonstrated that our proprietary silicone membrane hollow fiber coupled with our proposed oxygenator design enabled the development of a significantly improved ECMO oxygenator sized for newborn babies, children, and adults. The only oxygenator currently approved and used for this purpose in the US was developed in 1963. MedArray's new silicone hollow fibers and oxygenator design have enabled the development of a compact device with significantly improved gas transfer, lower priming volume, less surface area to minimize inflammatory response, improved blood flow dynamics, reduced blood resistance, and lower cost. Since ECMO oxygenators are used for long term (more than 1 day), the membrane cannot be microporous because of plasma leakage and membrane fowling. Therefore these oxygenators must use dense membranes which have no pores for plasma to leak through. 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 configuration but, they have not been produced 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 has enabled the development of a long due improved ECMO oxygenator. The proposed Phase II Renewal work includes further device improvements using computational fluid dynamics, modeling of gas exchange, and bench and in vivo testing. Moreover we intend to complete a series of FDA-required pre-clinical and effectiveness studies necessary to seek clearance from the FDA to initiate the clinical phase.
The relevance of this research project is that it will result in a significantly improved long term extracorporeal oxygenator for newborn babies and older patients afflicted with severe respiratory and/or cardiac failure. The only oxygenator currently used and approved for this purpose in the US was developed in the early 1960s, and is long due for improvements currently available. This research will enable the development of a compact oxygenator with greatly improved gas transfer, lower priming volume, improved flow dynamics, lower blood resistance, and lower cost.