Long Term Extracorporeal Oxygenating Device

长期体外氧合装置

• 批准号: 7282991
• 负责人: Jean Montoya
• 金额: $ 61.8万
• 依托单位: MEDARRAY, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-01 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7282991
• 关键词: Adult; Area; Blood; Blood flow; Carbon Dioxide; Childhood; Clinical; Coupled; Development; Device Designs; Devices; Evaluation; Extravasation; Fiber; Gases; Government; Heart failure; In Vitro; Inflammatory Response; Legal patent; Liquid substance; Marketing; Membrane; Membrane Oxygenators; Methods; Newborn Infant; Oxygen; Oxygenators; Patients; Performance; Permeability; Persons; Phase; Plasma; Production; Progress Reports; Property; Purpose; Research; Research Design; Research Personnel; Research Project Grants; Resistance; Silicones; Surface; Testing; Work; biomaterial compatibility; commercialization; cost; cost effective; day; design; hemodynamics; improved; in vivo; older patient; prototype; research and development; respiratory; size; wound

DESCRIPTION (provided by Investigator): This proposed Phase II work is aimed at continuing the research and development of a new and greatly improved long-term extracorporeal membrane oxygenator (ECMO) for patients afflicted with severe respiratory and/or cardiac failure. In Phase I we demonstrated that our proprietary silicone membrane hollow fiber coupled with our proposed oxygenator design enabled the development of a significantly improved ECMO oxygenator sized for newborn babies. The only oxygenator currently approved and used for this purpose in the US was developed in 1963. MedArray's new silicone hollow fibers and oxygenator design have enabled the development of a compact device with significantly improved gas transfer, lower priming volume, less surface area to minimize inflammatory response, improved blood flow dynamics, reduced blood resistance, and lower cost. Since ECMO oxygenators are used for long term (more than 1 day), the membrane cannot be microporous because of plasma leakage and membrane fowling. Therefore these oxygenators must use dense membranes which have no pores for plasma to leak through. Silicone is a dense membrane material with extremely high permeability to oxygen and CO2 and is therefore used in ECMO oxygenators. Silicone membranes have been commercially produced in sheet configuration but, because of production challenges and associated cost, they have not been produced in the more efficient hollow fiber configuration. Thus current ECMO oxygenators use spiral wound silicone sheet membranes which are not as efficient and compact as hollow fiber membranes. MedArray has developed a proprietary (patented) method for fabricating silicone membrane hollow fibers in a cost effective and commercially feasible way that will enable the development of a long due improved ECMO oxygenator. In Phase II we will expand our Phase I work to the pediatric and adult size ECMO oxygenators. The proposed work also includes improved device design using computational fluid dynamics, bench, and in-vivo testing to compare performance with the current ECMO oxygenators. The relevance of this research project is that it will result in a significantly improved long term extracorporeal oxygenator for newborn babies and older patients afflicted with severe respiratory and/or cardiac failure. The only oxygenator currently used and approved for this purpose in the US was developed in the early 1960s, and is long due for improvements currently available. This research will enable the development of a compact oxygenator with greatly improved gas transfer, lower priming volume, improved flow dynamics, lower blood resistance, and lower cost.

描述（由研究者提供）：这项拟议的II期工作旨在继续研究和开发一种新的和大大改进的长期体外膜氧合器（ECMO），用于严重呼吸和/或心力衰竭患者。在第一阶段，我们证明了我们专有的硅膜中空纤维与我们提出的氧合器设计相结合，能够显著改善新生儿ECMO氧合器的尺寸。目前在美国唯一批准并用于此目的的氧合器是在1963年开发的。MedArray的新型硅胶中空纤维和氧合器设计使其能够开发出一种紧凑的设备，该设备具有显着改善的气体传递，更小的启动体积，更小的表面积，以最大限度地减少炎症反应，改善血流动力学，降低血液阻力和更低的成本。由于ECMO氧合器长期使用（超过1天），由于等离子体泄漏和膜疏松，膜不能微孔。因此，这些氧合器必须使用致密的膜，这种膜没有让等离子体泄漏的孔。硅胶是一种致密的膜材料，对氧气和二氧化碳具有极高的渗透性，因此用于ECMO氧合器。硅酮膜已经以片状结构进行商业化生产，但由于生产挑战和相关成本，它们还没有以更高效的中空纤维结构生产。因此，目前的ECMO氧合器使用螺旋缠绕的硅胶片膜，其效率和紧凑性不如中空纤维膜。MedArray已经开发出一种专有的（专利）方法，以一种具有成本效益和商业可行性的方式制造硅膜中空纤维，这将有助于开发长期以来改进的ECMO氧合器。在第二阶段，我们将扩大我们的第一阶段工作到儿童和成人ECMO氧合器。建议的工作还包括改进设备设计，使用计算流体动力学，台架和体内测试来比较当前ECMO氧合器的性能。本研究项目的相关性在于，它将显著改善新生儿和患有严重呼吸和/或心力衰竭的老年患者的长期体外氧合器。在美国，目前唯一用于这一目的的氧合器是在20世纪60年代初开发的，目前已经得到了长期的改进。这项研究将使紧凑型氧合器的开发具有极大的改善气体传输，更小的启动体积，改善的流动动力学，更低的血液阻力和更低的成本。