Pediatric ECMO Oxygenator with Integrated Monitoring

摘要 体外膜肺氧合(ECMO)越来越多地被用于提供心肺支持 在患者中由于其通用性强、见效快、成本相对较低等优点。然而，仍然有 与止血并发症有关的显著发病率和死亡率，特别是在新生儿和儿童 人口。ECMO中使用了一些儿科氧合器；然而，所有这些装置的使用时间都很短 批准，目前在ECMO的标签外使用。此外，在ECMO中还需要各种监视器 电路，这增加了工作流程的复杂性，并引入了可能扰乱血液流动的访问站点 路径。目前，还没有这种氧合器被批准在儿科长期使用。 该项目的目标是开发一种儿科ECMO氧合器，具有集成的传感器，即 针对儿科ECMO的长期使用进行了优化。在第一阶段，MC3 Ped-ECMO氧合器(PedOxy)是 专门设计了优化的流动路径，通过避免高剪切区将凝血降至最低 作为停滞区。已经选择了一种非肝素涂层，Balance BioSurface，以防止血栓形成和 保护血小板功能。此外，还将简化的监测系统集成到一次性设备中 氧气机将提供实时诊断，最大限度地减少血液路径中断，并简化工作流程。这个 提出了创造独特流道的制造工艺。PedOxy的原型是 展示了与竞争对手的气体交换相匹配，同时显示了卓越的凝血性能 体外培养。 有了第二阶段的资金，MC3 PedOxy将达到设计冻结，验证/确认测试将 完成，设计将转移到内部的MC3制造。体内试验性研究将是 执行以准备GLP研究，该研究是提交ECMO途径监管报告所必需的 美国和CE标志符合新的欧洲医疗器械法规。我们已经组建了一支 由专家、临床医生、营销人员、制造商和工程师组成的团队，他们唯一有资格执行 建议的工作。

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.