Long Term Extracorporeal Oxygenating Device

长期体外氧合装置

• 批准号: 8056678
• 负责人: Jean Montoya
• 金额: $ 99.97万
• 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 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8056678
• 关键词: Adult; Amendment; Animals; Area; Blood; Blood flow; Carbon Dioxide; Cardiovascular system; Child; Clinical; Clinical Research; Clinical Trials; Clinical effectiveness; Coagulation Process; Coupled; Development; Devices; Environment; Evaluation; Extravasation; Fiber; Future; Gases; Goals; Government; Heart failure; Human Resources; Inflammatory Response; Legal patent; Light; Liquid substance; Marketing; Medical Device; Membrane; Membrane Oxygenators; Methods; Modeling; Newborn Infant; Outcome; Oxygen; Oxygenators; Patients; Performance; Permeability; Persons; Phase; Plasma; Process; Quality Control; Research; Research Project Grants; Resistance; Series; Silicones; Surface; System; Technology; Testing; Thrombus; Work; commercialization; cost; cost effective; design; good laboratory practice; improved; in vivo; older patient; pre-clinical; preclinical study; research and development; research clinical testing; respiratory; wound

DESCRIPTION (provided by applicant): This proposed Phase II Renewal is aimed at finalizing 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. Results from Phase II work indicate that we have developed a significantly improved ECMO oxygenator that outperforms currently used and outdated membrane technology. In Phase II 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, children, and adults. 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, 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 has enabled the development of a long due improved ECMO oxygenator. The proposed Phase II Renewal work includes further device improvements using computational fluid dynamics, modeling of gas exchange, and bench and in vivo testing. Moreover we intend to complete a series of FDA-required pre-clinical and effectiveness studies necessary to seek clearance from the FDA to initiate the clinical phase. PUBLIC HEALTH RELEVANCE: 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（由申请人提供）：该拟议的II期更新旨在最终确定患有严重呼吸和/或心脏衰竭的患者的新的且大大改善的长期体外膜氧合（ECMO）。第二阶段工作的结果表明，我们已经开发了一种显着改善的ECMO氧合，该氧合剂的表现优于当前使用和过时的膜技术。在第二阶段中，我们证明了我们的专有硅胶膜中空纤维以及我们提出的氧合设计，使得为新生婴儿，儿童和成人大小的ECMO氧合大大改善了Ecmo氧合。当前唯一在美国批准并用于此目的的氧化剂是在1963年开发的。Medarray的新硅酮空心纤维和氧化剂设计使得具有显着改善的气体转移，较低的启动量，较小的表面积，减少炎症反应，改善血液流动动力学，减少血液抵抗力和降低的成本和降低的成本和降低。 由于ECMO氧合剂长期使用（超过1天），因此由于血浆泄漏和膜雾而不能是微孔的。因此，这些氧合剂必须使用没有血浆孔泄漏的孔的致密膜。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。硅胶膜是在薄板配置中商业生产的，但并未以更有效的空心纤维构型生产。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，从而使长期适应的ECMO氧合能够开发长期。拟议的II期更新工作包括使用计算流体动力学，气体交换建模以及台式和体内测试的进一步改进。此外，我们打算完成一系列需要从FDA清除以启动临床阶段的FDA支出的临床和有效性研究。 公共卫生相关性：该研究项目的相关性是，它将为新生婴儿和患有严重呼吸道和/或心脏衰竭的老年患者带来显着改善的长期体外充氧剂。目前唯一在美国为此目的使用和批准的氧合剂是在1960年代初开发的，并且长期以来由于目前可用的改进。这项研究将使紧凑型充氧器的发展具有大大改善，较低的启动量，改善的流动动力学，较低的血液抵抗力和较低的成本。