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:
- 金额:$ 77.17万
- 依托单位:
- 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:
- 关键词:AccelerationAddressAdhesionsAdultAreaBloodBlood flowCardiopulmonaryChildhoodClinicalCoagulation ProcessDevelopmentDevicesDiagnosticEngineeringEquilibriumEuropeanExtracorporeal Membrane OxygenationFailureFreezingFundingFutureGasesGoalsHemolysisHemorrhageHemostatic AgentsHourIn VitroLungManufacturerMarketingMeasuresMedical DeviceMonitorMorbidity - disease rateNeonatalOxygenatorsPathway interactionsPatientsPediatricsPerformancePhasePlatelet ActivationPopulationPositioning AttributePriceQualifyingRegulationRiskSiteSpecific qualifier valueSystemTechnologyTestingThrombosisTimeUnited States National Institutes of HealthWorkagedbiomaterial compatibilityclinic readycostdesignexpectationexperiencein vivoinnovationmanufacturemanufacturing processmortalityneonatal patientnoveloff-label usepediatric patientsplatelet functionplatelet preservationpreventprototyperesearch and developmentsensorsensor technologysuccessthrombogenesisthrombotic complicationsverification 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.
摘要
项目成果
期刊论文数量(0)
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{{ truncateString('Scott I Merz', 18)}}的其他基金
Pediatric ECMO Oxygenator with Integrated Monitoring
带集成监控功能的儿科 ECMO 氧合机
- 批准号:
10320808 - 财政年份:2020
- 资助金额:
$ 77.17万 - 项目类别:
Nonthrombogenic, Antiseptic Nitric Oxide Releasing Catheters
非血栓形成、抗菌一氧化氮释放导管
- 批准号:
8902256 - 财政年份:2012
- 资助金额:
$ 77.17万 - 项目类别:
Nonthrombogenic, Antiseptic Nitric Oxide Releasing Catheters
非血栓形成、抗菌一氧化氮释放导管
- 批准号:
8311942 - 财政年份:2012
- 资助金额:
$ 77.17万 - 项目类别:
Nonthrombogenic, Antiseptic Nitric Oxide Releasing Catheters
非血栓形成、抗菌一氧化氮释放导管
- 批准号:
8778830 - 财政年份:2012
- 资助金额:
$ 77.17万 - 项目类别:
Novel, Long-Term Percutaneous Access Device for Chronic Therapy
用于慢性治疗的新型长期经皮接入装置
- 批准号:
8726459 - 财政年份:2011
- 资助金额:
$ 77.17万 - 项目类别:
Novel, Long-Term Percutaneous Access Device for Chronic Therapy
用于慢性治疗的新型长期经皮接入装置
- 批准号:
8591332 - 财政年份:2011
- 资助金额:
$ 77.17万 - 项目类别:
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