Pediatric ECMO Oxygenator with Integrated Monitoring

ABSTRACTExtracorporeal membrane oxygenation (ECMO) is becoming increasingly utilized to provide cardiopulmonary support in patients due to its versatility, immediate benefit, and relatively low cost. However, there continues to be significant morbidity and mortality related to hemostatic complications, especially in the neonatal and pediatric population. A few pediatric oxygenators are used in ECMO; however, all of these devices only have short term approval and are currently used off label in ECMO. In addition, a variety of monitors are needed in an ECMO circuit, which can add to the complexity of the work flow, as well as introducing access sites that can disrupt the blood flow path. Currently, there is no such oxygenator approved for this indication in pediatrics.The goal of this project is to develop a pediatric ECMO oxygenator with integrated sensors that is optimized for long term use in pediatric ECMO. The proposed MC3 Ped-ECMO Oxygenator (PedOxy) will be designed specifically with a flow path that minimizes clotting by avoiding areas of high shear as well as stagnant zone. In addition, a simplified monitoring system will be integrated into the disposable oxygenator that will provide real-time diagnostics, minimize blood path disruptions and simplify workflows. Phase I will include optimizing the blood flow path and integrated sensor module. The manufacturing processes for creating the unique flow path will be advanced. Feasibility will be established by evaluating performance of the PedOxy against specific criteria unique to usage in the pediatric application. Phase II funding, if granted, will be sufficient to complete verification/validation testing, transfer to manufacture, and FDA and CE mark submissions. We have assembled a synergistic team of experts, clinicians, marketers, manufacturers and engineers who are uniquely qualified to carry out the proposed work.NARRATIVEThere are approximately 3,000 neonatal and pediatric ECMO cases performed each year in the US. There are a few pediatric oxygenators used in ECMO, but only have short term (6 hour approval). The goal of this project is to develop a pediatric ECMO oxygenator with integrated monitoring that is optimized for long term use in pediatric ECMO.