SBIR-STTR Award

Intravascular membrane oxygenators represent a promising therapy for Acute Respiratory Distress Syndrome (ARDS), a serious medical condition that has a mortality rate of 50% due to hypoxemic respiratory failure. Intravascular oxygenators avoid the barotrauma and volutrauma associated with mechanical ventilation and have the potential to be effective, easy to use, portable, and economical. However, practical application of oxygenators has been hampered by limitations with the membranes employed, which wet after several hours of blood contact. When this occurs, gas exchange is reduced to insufficient levels and the device must be replaced. The goal of this program is to develop improved nonwetting hollow-fiber membranes that have high gas permeabilities for use in intravascular oxygenators. Specifically, we propose to develop composite membranes that consist of a thin, nonporous coating applied to a microporous hollow- fiber support. We will work with researchers from the University of Pittsburgh, developers of the Intravenous Membrane Oxygenator (IMO). Following demonstration in Phase I that membranes with acceptable mass- transfer characteristics and wetting resistance have been developed, Phase II work would be aimed at optimization of the membranes, testing with the IMO device, and animal studies, readying the membranes and device for commercialization with our potential Phase III sponsors.Proposed commercial application:Development of the improved hollow- fiber membranes should make possible the practical application of intravascular membrane oxygenators, extending the useful lifetime of the devices from less than 6 hours to up to 4 weeks. The membranes also promise to be useful for other commercial products, including extracorporeal oxygenators.National Institute of Heart, Lung, and Blood Institute (NHLBI)

Intravascular membrane oxygenators represent a promising therapy for Acute Respiratory Distress Syndrome (ARDS), a medical condition that has a mortality rate of 50% due to hypoxemic respiratory failure. Intra- vascular oxygenators avoid the barotrauma and volutrauma associated with mechanical ventilation and have the potential to be effective, easy to use, and economical. However, practical application of oxygenators has been hampered by limitations of current membranes, which wet after several hours of blood contract. When this occurs, gas exchange is reduced to insufficient levels and the device requires replacement. The goal of this program is to develop improved nonwetting, biocompatible hollow-fiber membranes that have high gas permeabilities for use in intravascular oxygenators. In Phase I, we demonstrated that a composite membrane (which consists of a thin, nonporous coating applied to a microporous hollow-fiber support) did not wet and maintains sufficient gas permeability to achieve target gas-exchange levels. We worked with the University of Pittsburgh, developers of the Intravenous Membrane Oxygenator (IMO). Phase II work is aimed at optimization of the membranes, particularly their long-term performance in contact with blood (e.g., bio- compatibility and in vivo testing of the IMO device), readying the membranes and device for commercialization with our potential Phase III sponsors. PROPOSED COMMERCIAL APPLICATION: Development of the improved hollow-fiber membranes should make possible the practical application of intravascular blood oxygenators, extending the useful lifetime of the devices from about 6 hours to up to 3 weeks. The membranes also promise to be useful for other commercial products, including extracorporeal oxygenators and processes based on membrane contractors.

Thesaurus Terms:
artificial membrane, artificial respiration, biomaterial development /preparation, biomaterial evaluation, blood oxygenator, membrane reconstitution /synthesis adult respiratory distress syndrome, biomaterial compatibility, hydropathy, membrane permeability, respiratory therapy