WINDMILL CARDIOVASCULAR — Department of Health and Human Services SBIR Phase II: NHLBI

Description

DESCRIPTION provided by applicant The goal of this project is to develop a miniaturized pediatric version of the TORVADTM a unique ventricular assist system that delivers low shear synchronous pulsatile flow using controlled piston motion within a toroidal chamber Low shear is achieved by the relatively low piston speed in conjunction with localized hydrodynamic bearings that maintain bulk piston torus gap at a fixed distance The TORVAD synchronizes with the heart to preserve aortic valve flow and maintains autoregulation of cardiac output by the Frank Starling mechanism The design of the TORVAD also allows for inherent determination of differential pump pressure without additional sensors which can be used to manage patientandapos s medications and flow rates These advantages have been confirmed in preliminary studies with an adult TORVAD In vitro tests have demonstrated that the low shear design preserves high molecular weight von Willebrand factor and results in significantly reduced hemolysis as compared to a continuous flow device In addition hemodynamic compatibility has been demonstrated using acute and chronic animal models The TORVADandapos s hematological results are unmatched by any other ventricular assist device These preliminary findings demonstrate that the TORVAD has the potential to reduce bleeding thrombus formation and strokes that are associated with the use of other ventricular assist devices The goal of this project is to develop a pediatric version of the TORVAD to be used in patients with body surface area BSA between and m The feasibility of a pediatric TORVAD has been demonstrated through the development and testing of the adult version where computational models for hemodynamics heat transfer motor design fluid dynamics and magnetostatics were used to design fabricate and verify performance with the assembled pump For this work we will Use the established computational design methodology to miniaturize the device for pediatric patients with a BSA between and m Fabricate five devices and perform design verification Conduct in vitro experiments to assess hemolysis high molecular weight von Willebrand factor preservation and platelet activation and Perform three acute animal experiments to assess implantability hemodynamic performance and synchronization PUBLIC HEALTH RELEVANCE Hundreds of children die each year waiting for a donor heart Options for mechanical circulatory support in pediatrics are limited and the development of new devices is in progress to address this unmet clinical need The pediatric TORVAD tm shows promise to address challenges associated with ventricular assist devices including the incidence of bleeding neurological dysfunction and strokes its success will provide beneficial patient outcomes and allow for more widespread use of ventricular assist devices in pediatric patients