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）：这项拟议的第一阶段工作旨在开发一种新型且经过大幅改进的长期体外膜肺氧合器（ECMO），其尺寸适合患有严重呼吸和/或心力衰竭的新生儿。美国目前唯一用于此目的的氧合器于 1963 年开发。拟议的设计将使用 MedArray 的新型专有硅树脂中空纤维，这将有助于开发紧凑型氧合器，该氧合器具有显着改善的气体传输、更低的启动体积和更小的表面积最大限度地减少炎症反应，改善血流动力学，提高血液抵抗力并降低成本。 由于ECMO氧合器使用时间较长（超过1天），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致密的膜，不存在用于血浆泄漏的孔。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。有机硅膜已以片材形式进行商业化生产，但由于生产挑战和相关成本，并未采用更有效的中空纤维配置。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。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。在第二阶段，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。