A widely recognized problem in pediatric cardiac surgery is the lack of suitable mechanical circulatory support devices. In this Phase I program, a consortium consisting of CardioPulmonary Technologies, Inc. (CPT), Nimbus, and the University of Pittsburgh (UOP) plan to utilize rotary pump technology for a blood pump system specifically intended for neonatal/pediatric (N/P) use. This device will be capable of generating pulsatile flow and operating in an uninterrupted fashion for durations consistent with N/P postcardiotomy applications (5-7 days on average). Phase I design activities will focus on the purged fluid seal for the pump, the motor/stator pair, and the features for a closed-loop, pulsatile flow controller. Sufficient pumps and controllers will be fabricated to support in vitro and in vivo testing. The key Phase I demonstration of feasibility of our N/P pump concept will be to successfully perform three in vivo lamb studies for seven-day durations in which the basic hemodynamic performance, biocompatibility and suitability of the pulsatile system for N/P applications is documented.
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