PediaFlow Pediatric VAD

Over the past five years, LaunchPoint Technologies Inc. has participated in the development of a pediatric ventricular assist device (VAD) in collaboration with the University of Pittsburgh, Carnegie Mellon University, the University of Pittsburgh Medical Center, the Children's Hospital of Pittsburgh, and WorldHeart Corporation. Collectively known as the PediaFlow Consortium, the team has undertaken an ambitious program to develop a pediatric blood pump specifically designed to treat infants and toddlers with congenital and acquired heart diseases.

Originally funded in 2004 by the National Institutes of Health, the $5.1 million Pediatric Circulatory Support program culminated in the PediaFlow™ PF3 Pediatric VAD (Figures 1 & 2).

PediaFlow Design Evolution

The current VAD design arose from the comprehensive evaluation of three pump topologies incorporating a variety of magnetic suspension, motor, and fluid path arrangements. Each of the selected topologies utilized permanent magnet radial and moment bearings, an active axial thrust bearing, and a brushless DC motor (Figure 3). The team conducted rigorous computational fluid dynamics (CFD) analyses of the corresponding flow path geometries and selected the final PF3 configuration based on its preferred size for clinical implantation, shape, manufacturability, suspension robustness, and unique streamlined flow path that obviated recirculating flow or blood-filled clearances.

Believed to be the world’s smallest magnetically levitated (maglev) blood pump, the PF3 has the following outstanding features:

• Unparalleled biocompatibility, due to our maglev technology, streamlined single-flow-path design, and computer-optimized design process;

• Exceptionally small, due to our supercritical (above resonance frequency) rotordynamic technology;

• Valveless turbodynamic design with one moving part to minimize size;

• Computationally optimized using first principles of bioengineering and physics;

• Lightweight controller and battery designed for reliability and fail-safe operation

• Human factors design specifically for pediatric operation; and

• Cannulation designed to facilitate removal for bridge to recovery.

Development Status

The PF3 configuration is expected to meet the clinical design requirements for a fully implantable pediatric ventricular assist device based on its small size, flow capabilities, and the excellent hemodynamic compatibility observed in performance studies lasting as long as 70 days.

The clinical design requirements include:

• Fully implantable in children 3-15 kg;

• Flow rate of 0.3 L/min – 1.5 L/min;

• Capable of six months of circulatory support;

• Minimized risk of infection, bleeding, hemolysis, and thrombosis; and

• Cannulation providing optimal flow for this population.

Pending follow-on funding, the PediaFlow Consortium will continue developing the PF3, working towards a final validated model of the VAD as required by the FDA for clinical testing.

References

Noh, M.D., Antaki, J.F., Ricci, M., Gardiner, J., Paden, D., Wu, J., Prem, E., Borovetz, H.S. and Paden, B.E. Magnetic Design for the PediaFlow™ Ventricular Assist Device. ARTIFICIAL ORGANS 2008 32(2): 127-135.

Gardiner, J.M., Wu, J., Noh, M.D., Antaki, J.F., Snyder, T.A., Paden, D.B. and Paden, B.E. Thermal Analysis of the PediaFlow Pediatric Ventricular Assist Device. ASAIO Journal 2007; 53:65-73.

Borovetz, Harvey S., et. al., Towards the Development of a Pediatric Ventricular Assist Device. Cell Transplantation, Volume 15, Supplement 1, 2006, pp. 69-74(6).

Noh, M.D., Antaki, J.F., Ricci, M., Prem, E., Borovetz, H.S., and Paden, B.E. Magnetic Levitation Design for the PediaFlow™ Ventricular Assist Device. Proceedings of 2005 IEEE/ASME International Conference on Advanced Intelligent Mechatronics, 2005, pp. 1077–1082.