Long term extracorporeal blood oxygenating device

长期体外血液氧合装置

• 批准号: 6993169
• 负责人: Jean Montoya
• 金额: $ 15.79万
• 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 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6993169
• 关键词: biomaterial compatibility; biomedical equipment development; blood oxygenator; cost effectiveness; extended care; extracorporeal circulation; laboratory rabbit; newborn human (0-6 weeks); organosilicon compound; surgery material /equipment

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.

描述（由申请人提供）：这项拟议的第1阶段工作旨在开发一种新的和大大改进的长期雌激素膜式氧合器（ECMO），其尺寸适用于患有严重呼吸和/或心力衰竭的新生儿。目前在美国用于此目的的唯一氧合器是在1963年开发的。拟议的设计将使用MedArray的新型专有硅胶中空纤维，这将使开发一种紧凑型氧合器成为可能，该氧合器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、改善的血流动力学、改善的血液阻力和更低的成本。 由于ECMO氧合器使用时间较长（超过1天），因此膜不能是微孔的，因为它可能导致血浆泄漏。因此，这些氧合器必须使用没有用于血浆泄漏的孔的致密膜。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。硅树脂膜已经以片材形式商业化生产，但是由于生产挑战和相关成本，而不是以更有效的中空纤维配置。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。拟议的工作还包括使用计算流体动力学改进设备设计，以及与当前新生儿ECMO氧合器进行性能比较的台架测试。在第II阶段，我们建议将这项工作扩展到儿科和成人尺寸的ECMO氧合器，并包括长期性能和血液表面相互作用研究。