Long Term Extracorporeal Oxygenating Device

描述(由申请人提供)：这项拟议的第二阶段更新旨在完成一种新的、大大改进的长期体外膜氧合器(ECMO)的研究和开发，该氧合器适用于患有严重呼吸和/或心力衰竭的患者。第二阶段工作的结果表明，我们已经开发出一种显著改进的ECMO氧合器，其性能超过了目前使用的和过时的膜技术。在第二阶段，我们展示了我们专有的硅胶膜中空纤维与我们建议的氧合器设计相结合，使我们能够开发出适用于新生儿、儿童和成人的显著改进的ECMO氧合器。目前美国唯一被批准用于这一目的的氧合器是在1963年开发出来的。MedArray的新型硅酮中空纤维和氧合器设计使紧凑型设备的开发具有显著改善的气体传输、更低的引爆量、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、降低血液阻力和降低成本。由于ECMO氧合器使用时间较长(超过1天)，因此膜不能微孔，因为存在血浆泄漏和膜结垢。因此，这些氧合器必须使用致密的膜，这些膜没有供血浆渗漏的孔。有机硅是一种致密的膜材料，对氧气和二氧化碳具有极高的渗透性，因此被用于ECMO氧合器。硅氧烷薄膜已经在商业上以片状结构生产，但它们还没有以更有效的中空纤维结构生产。因此，目前的ECMO氧合器使用的是螺旋缠绕的有机硅薄膜，其效率和致密性不如中空纤维薄膜。MedArray开发了一种专利(专利)方法，用于以成本效益和商业可行的方式制造硅胶膜中空纤维，这使得早就应该改进的ECMO氧合器的开发成为可能。拟议的第二阶段更新工作包括使用计算流体力学、气体交换建模以及台架和体内测试来进一步改进设备。此外，我们打算完成FDA要求的一系列临床前和有效性研究，以寻求FDA的批准，启动临床阶段。 公共卫生相关性：这项研究项目的相关性在于，它将显著改善新生儿和患有严重呼吸和/或心力衰竭的老年患者的长期体外氧合器。目前在美国使用和批准用于这一目的的唯一氧合器是在20世纪60年代初开发出来的，目前已经很长时间没有改进了。这项研究将使紧凑型氧合器的开发成为可能，它大大改善了气体传递，降低了引射量，改善了流动动力学，降低了血液阻力，降低了成本。

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II work indicate that we have developed a significantly improved ECMO oxygenator that outperforms currently used and outdated membrane technology.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.