SBIR-STTR Award

Extracorporeal 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.

Public Health Relevance Statement:
NARRATIVE There 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.

Project Terms:
Animals; Blood; Blood Reticuloendothelial System; Engineering; Extracorporeal Membrane Oxygenation; Extravasation; Leakage; Spillage; Gases; Goals; Grant; Hemolysis; erythrolysis; Hemorrhage; Bleeding; blood loss; Hemostatic Agents; Hemostatics; indexing; Lung; Lung Respiratory System; pulmonary; Morbidity - disease rate; Morbidity; mortality; United States National Institutes of Health; NIH; National Institutes of Health; Oxygenators; Patients; Pediatrics; Platelet Count measurement; Blood Platelet Count; Blood Platelet Number; Platelet Count; Platelet Number; research and development; Development and Research; R & D; R&D; Running; Temperature; Testing; Time; Work; Measures; Price; pricing; base; sensor; Site; Area; Surface; Clinical; Phase; Failure; pediatric; Childhood; Blood flow; Funding; fluid; liquid; Liquid substance; Diagnostic; Hour; System; Cardiopulmonary; Performance; Devices; Position; Positioning Attribute; Manufacturer; Manufacturer Name; Clotting; Coagulation; Coagulation Process; Address; Monitor; cost; designing; design; manufacturing process; manufacturing facility; Neonatal; Population; innovate; innovative; innovation; resistant; Resistance; prototype; risk mitigation; verification and validation; child patients; pediatric patients; neonatal patient; sensing technology; sensor technology; off-label application; off-label prescribing; off-label use

Extracorporeal membrane oxygenation (ECMO) is 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 add to the complexity of the workflow and introduce access sites that can disrupt the blood flow path. Currently, there is no such oxygenator approved for long term use 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. In Phase I, the MC3 Ped-ECMO Oxygenator (PedOxy) was designed specifically with an optimized flow path that minimizes clotting by avoiding areas of high shear as well as stagnant zones. A non-heparin coating, Balance Biosurface, has been selected to prevent thrombosis and preserve platelet function. In addition, a simplified monitoring system was integrated into the disposable oxygenator that will provide real-time diagnostics, minimize blood path disruptions and simplify workflows. The manufacturing processes for creating the unique flow path was advanced. Prototypes of the PedOxy were demonstrated to match competitors' gas exchange while showing superior clotting performance in vitro. With Phase II funding, the MC3 PedOxy will reach design freeze, verification/validation testing will be completed, and the design will be transferred to in-house MC3 manufacturing. Pilot in vivo studies will be performed to prepare for the GLP study that is required for regulatory submissions for the ECMO pathway in the US and CE Mark in accordance with the new European Medical Device Regulation. We have assembled a team of experts, clinicians, marketers, manufacturers and engineers who are uniquely qualified to carry out the proposed work.

Public Health Relevance Statement:
NARRATIVE There are approximately 4,000 neonatal and pediatric ECMO cases performed each year in the US. There are a few pediatric oxygenators used in ECMO, but all 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 and indicated for long term use in pediatric ECMO.

Project Terms:
Adhesions; Adult; 21+ years old; Adult Human; adulthood; Blood; Blood Reticuloendothelial System; Engineering; Equilibrium; balance; balance function; Extracorporeal Membrane Oxygenation; Freezing; Future; Gases; Goals; Hemolysis; erythrolysis; Hemorrhage; Bleeding; blood loss; Hemostatic Agents; Hemostatics; In Vitro; Lung; Lung Respiratory System; pulmonary; Medical Device; Morbidity - disease rate; Morbidity; mortality; United States National Institutes of Health; NIH; National Institutes of Health; Oxygenators; Patients; Pediatrics; Platelet Activation; research and development; Development and Research; R & D; R&D; Risk; Technology; Testing; Thrombosis; thrombotic disease; thrombotic disorder; Time; Work; Measures; Price; pricing; base; sensor; Site; Area; Clinical; Phase; Failure; Childhood; pediatric; Blood flow; European; Funding; Diagnostic; Hour; System; Cardiopulmonary; biocompatibility; biomaterial compatibility; experience; Performance; platelet preservation; success; novel; Devices; Position; Positioning Attribute; Regulation; Manufacturer; Manufacturer Name; preventing; prevent; Clotting; Coagulation; Coagulation Process; Address; in vivo; Monitor; Development; developmental; Pathway interactions; pathway; cost; design; designing; manufacturing process; Neonatal; Population; aged; innovation; innovate; innovative; Resistance; resistant; prototype; verification and validation; pediatric patients; child patients; neonatal patient; sensor technology; sensing technology; thrombogenesis; thrombogenicity; platelet function; off-label use; off-label application; off-label prescribing; thrombotic complications; thromboembolic complications; thrombosis complications