AN EXTRACORPOREAL PULSATILE ASSIST DEVICE (EPAD)

THE OBJECTIVE OF THIS PROGRAM IS THE DEVELOPMENT OF AN EXTRACORPOREAL PULSATILE ASSIST DEVICE (EPAD), A VALVELESS DIASTOLIC AUGMENTATION PUMP WITH VARIABLE STROKE VOLUMES UP TO 80 ML PER BEAT. THE EPAD IS DESIGNED AS A LOW-COST, DISPOSABLE DEVICE WHOSE INITIAL APPLICATION WILL BE AS A TEMPORARY RIGHT VENTRICULAR ASSIST DEVICE IN CONJUNCTION WITH THE USE OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD) FOR PATIENTS IN REVERSIBLE BIVENTRICULAR FAILURE. THE EPAD WILLALSO BE USABLE ULTIMATELY AS A TEMPORARY LEFT HEART ASSIST DEVICE WHICH, IN CONTRAST TO THE INTRA-AORTIC BALLOON PUMP (IAPB), PROVIDES ANY DESIRED STROKE VOLUME AND DELIVERS ITS OUTPUT INTO THE ASCENDING AORTA FOR MAXIMAL EFFECTIVENESS. THE EPAD DESIGN PERMITS RAPID OPEN-CHEST CANNULATION OF EITHER THE PULMONARY ARTERY OR AORTA WITHOUT THE NEED FOR ANEND-TO-SIDE ANASTOMOSIS OF A VASCULAR GRAFT FOR BLOOD ACCESS. BECAUSE THE DEVICE IS READILY MANUFACTURABLE AND USES SIMPLE MOLDED COMPONENTS, IT IS LIKELY TO BE COST- COMPETITIVE WITH THE IAPB WHEN PRODUCED IN QUANTITY. PHASE I DEVELOPMENT WILL CONSIST OF PROTOTYPE FABRICATION AND IN VITRO CHARACTERIZATION, FOLLOWED BY A SERIES OF ACUTE IN VIVO STUDIES USING THE EPAD AS A RIGHT HEART ASSIST DEVICE WITH A MODEL OF INDUCED RIGHT VENTRICULAR FAILURE.