Pediatric ECMO Oxygenator with Integrated Monitoring

摘要 体外膜肺氧合（ECMO）越来越多地用于提供心肺支持 由于其多功能性、即时效益和相对较低的成本，然而， 与止血并发症相关的显著发病率和死亡率，尤其是在新生儿和儿童中 人口ECMO中使用了一些儿科氧合器;然而，所有这些设备都只有短期的使用寿命。 已获得批准，目前在ECMO中超说明书使用。此外，ECMO中还需要各种监测器 回路，这增加了工作流程的复杂性，并引入了可能中断血流的入路部位 路径目前，还没有这种氧合器被批准长期用于儿科。 本项目的目标是开发一种集成传感器的儿科ECMO氧合器， 优化用于儿科ECMO的长期使用。在第一阶段，MC 3 Ped-ECMO氧合器（PedOxy） 专门设计了优化的流动路径，通过避免高剪切区域来最大限度地减少凝血 作为停滞区。选择了非肝素涂层Balance生物表面，以防止血栓形成， 保护血小板功能。此外，将简化的监测系统集成到一次性器械中， 氧合器将提供实时诊断，最大限度地减少血液路径中断并简化工作流程。的 改进了用于形成独特流动路径的制造工艺。PedOxy的原型是 证明与竞争对手的气体交换相匹配，同时显示出上级凝血性能， 体外 通过第二阶段的资助，MC 3 PedOxy将达到设计冻结，验证/确认测试将 完成，设计将转移到内部MC 3制造。将进行初步体内研究， 为准备GLP研究而进行，该研究是ECMO途径监管提交所需的， 美国和CE标志符合新的欧洲医疗器械法规。我们组建了一个 由专家、临床医生、营销人员、制造商和工程师组成的团队， 提议的工作。

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.