TUBULAR PEDIATRIC VENTRICULAR ASSIST DEVICE

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The use of dedicated pulsatile ventricular support devices (VAD) for circulatory support is becoming an accepted treatment modality for adult patients requiring support due to post-cardiotomy pump failure or post-AMI cardiogenic shock, and as bridge to transplant. Although temporary circulatory support in pediatric patients is being performed with ECMO or centrifugal pumps, no dedicated pulsatile VAD have been developed for pediatric application. The proposed pediatric VAD addresses this need with the goal of developing an inexpensive pulsatile device. The device is tubular in construction with integrally formed inflow valve, pump chamber, and outflow valve. The valves and pumps are actuated pneumatically. The designed stroke volume is under 10cc suitable for neonates and infants weighing up to 10kg. The device is designed to have minimal surface area and is small in size to minimize hemodilution, heat loss and bleeding complications. Phase I study will focus on in vitro and in vivo characterization of the device. The Phase II study will focus on system development leading to an easy to use device with no need for continuous attention by a perfusionist or an intensivist.