Simplified Total Liquid Ventilator

DESCRIPTION (provided by applicant): The acute respiratory distress syndrome (ARDS) is a severe, life-threatening disease process that affects approximately 150,000 patients per year with an associated 30-40% mortality rate. Clinical studies are currently exploring the safety and effectiveness of Partial Liquid Ventilation (PLV), in which a perfluorocarbon-filled lung is gas-ventilated, in the setting of ARDS. Recent data has suggested that the technique of Total Liquid Ventilation (TLV), in which the lungs are ventilated with perfluorocarbon using a liquid ventilating device, will be more effective from a biophysical and physiologic perspective. In Phase I, a simplified total liquid ventilator for a pediatric patient up to 30 kg was designed, constructed, and characterized in-vitro. The clinical merits of the liquid ventilator were also tested in-vivo using a 3-hour, oleic acid lung injury sheep model. The objective of Phase II is to expand the development of the liquid ventilator to suit both adult and pediatric patients. The knowledge obtained through Phase I testing will be combined with the availability of new technology to construct a total liquid ventilator with disposable parts that will maintain the necessary tidal volumes, rates of infusion, and clearance of perfluorocarbon necessary for the adequate gas exchange. Manufacturability of the TLV will be defined and in vivo performance of the TLV will be fully detailed. Animal testing will completed to collect data appropriate for an FDA submission for the clinical use of the total liquid ventilator. At the conclusion of Phase II, MC3 Inc. will solicit an appropriate corporate partner to produce and market the total liquid ventilator.