Pediatric ECMO Oxygenator with Integrated Monitoring

带集成监控功能的儿科 ECMO 氧合器

• 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
• 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

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.

抽象的 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、直接效益和相对较低的成本，它仍然存在于患者中。 与止血并发症相关的显着发病率和死亡率，尤其是新生儿和儿童 少数儿童氧合器用于 ECMO；然而，所有这些设备的作用都是短期的。 已获得批准，目前已在 ECMO 中超标签使用。此外，ECMO 中还需要多种监视器。 电路，这增加了工作流程的复杂性并引入了可能扰乱血流的接入点 目前，尚无此类氧合器被批准用于儿科长期使用。 该项目的目标是开发一款带有集成传感器的儿科 ECMO 氧合器， 在第一阶段，MC3 Ped-ECMO 氧合器 (PedOxy) 已针对儿科 ECMO 的长期使用进行了优化。 经过专门设计，具有优化的流路，可避免高剪切区域，从而最大限度地减少凝血 选择非肝素涂层 Balance Biosurface 作为停滞区，以防止血栓形成和 此外，一次性设备中还集成了一个简化的监测系统。 氧合器将提供实时诊断、最大限度地减少血路中断并简化工作流程。 用于创建独特流路的 PedOxy 原型的制造工艺得到了改进。 匹配竞争对手的气体交换，同时显示出卓越的凝血性能 体外。 凭借第二阶段的资金，MC3 PedOxy 将达到设计冻结，验证/确认测试将在 完成，设计将转移到内部 MC3 制造中进行试点体内研究。 为 ECMO 途径监管提交所需的 GLP 研究做准备 我们根据新的欧洲医疗器械法规组装了美国和 CE 标志。 由专家、民兵、营销人员、制造商和工程师组成的团队，他们具有独特的资质来执行 拟议的工作。