Simplified Pump Oxygenator for Pediatric Use

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DESCRIPTION (Verbatim from the Applicant's Abstract): Cardiopulmonary Technologies, Inc. (CPT) has developed very efficient Active Mixing Membrane Oxygenator (AMMO) with an inherent ability to pump blood as it transfers gases. Currently, this device consists of 0.18 M2 of membrane surface area and pumps 3.0 Lpm of blood. CPT is proposing to alter its current AMMO design to meet the needs of newborn and infant sized patients (less than 5 kg body weight). Experimental evidence supports the feasibility of our design criteria for a pediatric device that would include: membrane surface area of 0.1 M2, rated gas transfer of 50ml/min., pumping capability of 1.0 Lpm, and priming volume of 25 ml. Another advantage of this device will be the incorporation of efficient cooling elements within the oxygenator unit, thus taking further advantage of the active mixing concept and eliminating the need for a separate heater/cooler manifold. This Phase I program is designed to demonstrate the feasibility of our concept. The aims of this program are to modify our current design to meet the needs of the smallest patients, fabricate pediatric-sized AMMO units, and perform sufficient in vitro and in vivo trials to evaluate system performance and suitability for the intended use. If successful, we believe that this CPT product would gain acceptance by pediatric perfusionists throughout the medical community. PROPOSED COMMERCIAL APPLICATION: Pediatric patients represent a substantial number of open heart operations each year. Current oxygenators are miniaturized versions of adult sized devices that have not been optimized for these patients. This device is especially designed to meet the needs of small patients and as the first oxygenator designed specifically for this population, coupled with its increased efficiency, should become the dominant device in this market.