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In vitro characterization and performance testing of the ension pediatric cardiopulmonary assist system
George M Pantalos1, Tim Horrell, Tracey Merkley
1Department of Surgery, Division of Artificial Organs, Cardiovascular Innovation Institute, University of Louisville, Louisville, Kentucky 40202, USA. gmpant02@louisville.edu
Insights
A new pediatric cardiopulmonary assist system (pCAS) offers a smaller, integrated solution for infant heart failure. Tested on a mock circulation, the pCAS demonstrated sufficient flow rates for neonates under 5 kg.
Area of Science:
- Biomedical Engineering
- Pediatric Cardiology
- Medical Device Development
Background:
- Mechanical circulatory support (MCS) is established for adult end-stage heart failure.
- Limited cardiopulmonary support options exist for pediatric patients.
- Existing pediatric devices face limitations in size and complexity.
Purpose of the Study:
- To introduce the pediatric cardiopulmonary assist system (pCAS) developed by Ension Inc.
- To evaluate the performance of the pCAS prototype in a simulated infant circulation.
- To assess the pCAS's potential for treating heart failure in neonates.
Main Methods:
- The pCAS integrates an oxygenator and pump into a single, compact unit.
- Testing utilized a mock circulation simulating hemodynamic parameters of infants <5 kg.
- Specific cannulae (10-Fr. inflow, 8-Fr. outflow) were employed for testing.
Main Results:
- Revision 4 of the pCAS achieved a flow rate of 0.42 L/min at 6,500 RPM.
- Revision 5, with design improvements, reached a flow rate of 0.57 L/min at 5,000 RPM.
- The device demonstrated reduced priming volume and preparation time.
Conclusions:
- The pCAS is a promising, miniaturized cardiopulmonary support device for infants.
- The tested pump configurations provide adequate flow for patients weighing less than 5 kg.
- The integrated design addresses limitations of current pediatric extracorporeal support systems.
Abstract:
In the last 40 years, mechanical circulatory support devices have become an effective option for the treatment of end-stage heart failure in adults. Few possibilities, however, are available for pediatric cardiopulmonary support. Ension Inc. (Pittsburgh, PA) is developing a pediatric cardiopulmonary assist system (pCAS) intended to address the limitations of existing devices used for this patient population. The pCAS device is an integrated unit containing an oxygenator and pump within a single casing, significantly reducing the size and blood-contacting surface area in comparison to current devices. Prototype pCAS devices produce appropriate flows and pressures while minimizing priming volume and preparation time. The pCAS was tested on a mock circulation designed to approximate the hemodynamic parameters of a small infant using a 10-Fr. extracorporeal membrane oxygenation inflow cannula and an 8-Fr. extracorporeal membrane oxygenation outflow cannula. Revision 4 of the device provided a flow rate of 0.42 L/min at 6,500 RPM. Revision 5, featuring improved impeller and diffuser designs, provided a flow rate of 0.57 L/min at 5,000 RPM. The performance tests indicate that for this cannulae combination, the pCAS pump is capable of delivering sufficient flows for patients <5 kg.
