Long Term Extracorporeal Oxygenating Device

长期体外氧合装置

基本信息

批准号：
7485028
负责人：
Jean Montoya
金额：
$ 32.53万
依托单位：
MEDARRAY, INC.
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-08-01 至 2010-04-30
项目状态：
已结题

项目摘要

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）：这项拟议的第二阶段工作旨在继续研究和开发一种新型且经过大幅改进的长期体外膜氧合器（ECMO），用于患有严重呼吸和/或心力衰竭的患者。在第一阶段，我们证明了我们专有的硅胶膜中空纤维与我们提出的氧合器设计相结合，能够开发出适合新生儿尺寸的显着改进的 ECMO 氧合器。目前美国唯一批准并用于此目的的氧合器于 1963 年开发。MedArray 的新型硅胶中空纤维和氧合器设计使得紧凑型设备的开发成为可能，该设备具有显着改善的气体传输、更低的启动量、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，降低血液阻力，并降低成本。由于ECMO氧合器是长期使用（超过1天），膜不能微孔，因为血浆泄漏和膜污染。因此，这些氧合器必须使用致密的膜，没有孔可供血浆泄漏。硅胶是一种致密膜材料，对氧气和二氧化碳具有极高的渗透性，因此用于 ECMO 氧合器。有机硅膜已以片材配置进行商业化生产，但由于生产挑战和相关成本，它们尚未以更有效的中空纤维配置生产。因此，当前的 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 开发了一种专有（专利）方法，以经济有效且商业上可行的方式制造有机硅膜中空纤维，这将有助于开发长期应有的改进型 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设备设计，以与当前的 ECMO 氧合器进行性能比较。该研究项目的相关性在于，它将为患有严重呼吸和/或心力衰竭的新生儿和老年患者带来显着改善的长期体外氧合器。美国目前使用和批准用于此目的的唯一充氧器是在 20 世纪 60 年代初开发的，并且很早就需要进行现有的改进。这项研究将有助于开发一种紧凑型氧合器，该氧合器具有大大改善的气体传输、更低的预充量、改善的流动动力学、更低的血液阻力和更低的成本。