Long Term Extracorporeal Oxygenating Device

描述（由研究者提供）：这项拟定的II期工作旨在继续研究和开发一种新的、大大改进的长期体外膜式氧合器（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，能够开发出一种尺寸适合新生儿的显著改进的ECMO氧合器。目前在美国批准并用于此目的的唯一氧合器是在1963年开发的。MedArray的新型硅胶中空纤维和氧合器设计使得能够开发出一种紧凑型器械，该器械具有显著改善的气体传输、更低的预充体积、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、降低血液阻力和降低成本。由于ECMO氧合器长期使用（超过1天），由于血浆泄漏和膜堵塞，膜不能是微孔的。因此，这些氧合器必须使用致密的膜，该膜没有用于血浆泄漏的孔。硅胶是一种致密的膜材料，对氧气和CO2具有极高的渗透性，因此用于ECMO氧合器。有机硅膜已经以片材构造商业化生产，但是由于生产挑战和相关成本，它们还没有以更有效的中空纤维构造生产。因此，目前的ECMO氧合器使用螺旋缠绕的硅胶片膜，其不如中空纤维膜有效和紧凑。MedArray已开发出一种专有（专利）方法，用于以具有成本效益且商业上可行的方式制造硅胶膜中空纤维，从而能够开发长期改进的ECMO氧合器。在第二阶段，我们将把第一阶段的工作扩展到儿科和成人尺寸的ECMO氧合器。拟议的工作还包括使用计算流体动力学、台架和体内测试改进器械设计，以比较与当前ECMO氧合器的性能。本研究项目的相关性在于，它将为新生儿和患有严重呼吸和/或心力衰竭的老年患者提供一种显著改进的长期体外氧合器。目前在美国使用和批准用于此目的的唯一氧合器是在20世纪60年代早期开发的，并且目前可用的改进是长期的。这项研究将能够开发一种紧凑型氧合器，其具有大大改善的气体传输、较低的预充体积、改善的流动动力学、较低的血液阻力和较低的成本。

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.