Long-term blood oxygenator (BO) therapy requires non-porous coatings to limit BO wet out. Compact Membrane Systems (CMS) has identified novel materials that can minimize wet out while simultaneously maintaining needed gas-liquid transport of gases. In order for these novel materials to be of significant commercial value they must be able to easily integrate into existing commercial BO operations. Present fabrication capabilities with these novel materials are significantly limited. In-situ introduction of non-porous coatings is presently unacceptable due to fiber-fiber bridging. Coating of individual fibers prior to module fabrication while having some potential has many downstream problems and is not easily integrated into existing BO manufacturing lines. Discussions with experts in the field have identified a number of blood oxygenation applications that can take advantage of the novel product. These applications include ARDS (Acute Respiratory Distress Syndrome), ECMO (Extracorporeal Membrane Oxygenators) cardiac and respiratory patients and high risk cardiac surgical procedures. CMS has identified novel procedure to easily integrate their novel material into existing BO fabrication systems. In Phase I CMS will demonstrate its novel procedure using CMS's high gas flux non-porous non-wetting membrane. Phase I will include in-vitro and in-vivo tests which show CMS process provides BO with needed wet out resistance while maintaining gas exchange into and out of blood and equally as important is easily integrated into commercial BO operations. Bio-compatibility testing will be completed in Phase I. Phase I quantitatively defines program objectives and alternative strategies if needed. In-vivo testing will demonstrate proof of feasibility consistent with Phase I funds, and enhance our ability for a targeted Phase II program. Pre-clinical testing and key partners will enhance our ability to rapidly move to clinical testing.
