Advancement of the Dragon Heart 7-Series for Pediatric Patients With Heart Failure

Background: Safe and effective pediatric blood pumps continue to lag far behind those developed for adults. To address this growing unmet clinical need, we are developing a hybrid, continuous-flow, magnetically levitated, pediatric total artificial heart (TAH). Our hybrid TAH design, the Dragon Heart (DH), integrates both an axial flow and centrifugal flow blood pump within a single, compact housing. The axial pump is embedded in the central hub region of the centrifugal pump, and both pumps rotate around a common central axis, while maintaining separate fluid domains.

Methods: In this work, we concentrated our design and development effort on the centrifugal blood pump by performing computational modeling. An iterative process was employed to improve the DH design. The pressure generation, scalar stress levels, and fluid forces exerted on the magnetically levitated impellers were computationally estimated. A shaft driven centrifugal prototype was also manufactured and tested using a hydraulic flow loop circulating a water-glycerol blood analog. Pressure and flow performance of the pump prototype was measured for a given rotational speed for comparison to computational predictions.

Results: Our design achieved the target pump pressures of 60-140 mm Hg for flow rates of 1-5 L/min, and strong agreement in pressure rise was demonstrated between the experimental data and simulation results (less than 10% deviation on average). Fluid stress levels were, however, found to exceed thresholds in the outflow region of the pump, and fluid residence times were less than 600 ms.

Conclusion: The findings of this work demonstrate that the more compact, next-gen DH's centrifugal pump design is able to achieve pressure-capacity requirements. Next steps will require a focused strategy to reduce hemolytic potential and to integrate magnetic suspension components for full rotor levitation.