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的且大大改善的长期雌激素氧合氧合（ECMO），适用于患有严重呼吸道和/或心脏衰竭的新生婴儿。目前在美国目前用于此目的的唯一氧合剂是在1963年开发的。拟议的设计将使用Medarray新的专有硅酮空心纤维，这将使能够开发具有显着改善的气体转移，较低的引发量，较少的表面积的紧凑型氧化剂，以最小化炎症反应，改善血液流动动力学，较低的血液抵抗力，较低的血液抵抗力，并降低了血液的抵抗力。 由于ECMO氧合剂长时间使用（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，这些氧化剂必须使用没有血浆泄漏孔的致密膜。有机硅是一种致密的膜材料，对氧和二氧化碳的渗透性极高，因此用于ECMO氧合剂中。硅胶膜是商业生产的，但由于生产挑战和相关成本，而不是在更有效的空心纤维构型中。因此，当前的ECMO氧化剂使用螺旋伤硅薄膜，不如空心纤维膜高效和紧凑。 Medarray开发了一种专有（专利）的方法，用于以具有成本效益和商业上可行的方式制造有机硅膜中空纤维，从而能够开发长期的ECMO氧合。拟议的工作还包括使用计算流体动力学改进的设备设计，以及基准测试，将性能与当前的新生儿Ecmo氧合作用。在第二阶段，我们建议将这项工作扩展到儿科和成人大小的ECMO氧合，包括长期性能和血液表面相互作用研究。