Long term extracorporeal blood oxygenating device

描述(由申请人提供)：这项拟议的第一阶段工作旨在开发一种新的和大大改进的长期性交感膜氧合器(ECMO)，适用于患有严重呼吸和/或心力衰竭的新生儿。美国目前唯一用于这一目的的氧合器是在1963年开发出来的。拟议的设计将使用MedArray的新专利硅胶中空纤维，这将使紧凑型氧合器的开发具有显著改善的气体传输、更低的引爆量、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、改善血液阻力和降低成本。由于ECMO氧合器使用时间较长(超过1天)，膜不能微孔，因为它会导致血浆泄漏。因此，这些氧合器必须使用致密的膜，没有孔来进行等离子体泄漏。有机硅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，因此被用于ECMO氧合器。有机硅薄膜已经在商业上以片状形式生产，但由于生产挑战和相关成本，没有以更高效的中空纤维配置生产。因此，目前的ECMO氧合器使用的是螺旋缠绕的有机硅薄膜，其效率和致密性不如中空纤维薄膜。MedArray开发了一种专利(专利)方法，用于以具有成本效益和商业可行性的方式制造硅胶膜中空纤维，这将使早就应该改进的ECMO氧合器的开发成为可能。拟议的工作还包括使用计算流体动力学改进设备设计，以及进行台架测试以与当前新生儿ECMO氧合器的性能进行比较。在第二阶段，我们建议将这项工作扩展到儿童和成人大小的ECMO氧合器，并包括长期性能和血液表面相互作用研究。

DESCRIPTION (provided by applicant): This proposed Phase 1 work is aimed at developing a new and greatly improved long term estracorporeal membrane oxygenator (ECMO) sized for newborn babies afflicted with severe respiratory and/or cardiac failure. The only oxygenator currently used for this purpose in the US was developed in 1963. The proposed design will use MedArray's new proprietary silicone hollow fibers, which will enable the development of a compact oxygenator with significantly improved gas transfer, lower priming volume, less surface area to minimize inflammatory response, improved blood flow dynamics, improved blood resistance, and lower cost. Since ECMO oxygenators are used for long periods of time (more than 1 day), the membrane cannot be microporous as it can result in plasma leakage. Therefore these oxygenators must use dense membranes which have no pores for plasma leakage. 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 format but, because of production challenges and associated cost, not 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. The proposed work also includes improved device design using computational fluid dynamics, and bench testing to compare performance with the current neonatal ECMO oxygenator. In Phase II we propose to expand this work to the pediatric and adult size ECMO oxygenators, as well as include long term performance, and blood surface interaction studies.