Pediatric ECMO Oxygenator with Integrated Monitoring

带集成监控功能的儿科 ECMO 氧合器

基本信息

批准号：
10462756
负责人：
Scott I Merz
金额：
$ 77.17万
依托单位：
MC3, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-04-23 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10462756
关键词：
Acceleration Address Adhesions Adult Area Blood Blood flow Cardiopulmonary Childhood Clinical Coagulation Process Development Devices Diagnostic Engineering Equilibrium European Extracorporeal Membrane Oxygenation Failure Freezing Funding Future Gases Goals Hemolysis Hemorrhage Hemostatic Agents Hour In Vitro Lung Manufacturer Marketing Measures Medical Device Monitor Morbidity - disease rate Neonatal Oxygenators Pathway interactions Patients Pediatrics Performance Phase Platelet Activation Population Positioning Attribute Price Qualifying Regulation Risk Site Specific qualifier value System Technology Testing Thrombosis Time United States National Institutes of Health Work aged biomaterial compatibility clinic ready cost design expectation experience in vivo innovation manufacture manufacturing process mortality neonatal patient novel off-label use pediatric patients platelet function platelet preservation prevent prototype research and development sensor sensor technology success thrombogenesis thrombotic complications verification and validation

项目摘要

ABSTRACT 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.