Long Term Extracorporeal Oxygenating Device

描述（由申请人提供）：这项拟议的II期续期旨在完成一种新的和大大改进的长期体外膜氧合器（ECMO）的研究和开发，用于患有严重呼吸和/或心力衰竭的患者。II期工作结果表明，我们已经开发出一种显著改进的ECMO氧合器，优于目前使用的和过时的膜技术。在第二阶段，我们证明了我们专有的硅膜中空纤维与我们提出的氧合器设计相结合，能够开发出显着改进的ECMO氧合器，适用于新生儿，儿童和成人。目前在美国唯一批准并用于此目的的氧合器是在1963年开发的。MedArray的新型硅胶中空纤维和氧合器设计使其能够开发出一种紧凑的设备，该设备具有显着改善的气体传递，更小的启动体积，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，降低血液阻力和更低的成本。由于ECMO氧合器长期使用（超过1天），由于等离子体泄漏和膜疏松，膜不能微孔。因此，这些氧合器必须使用致密的膜，这种膜没有让等离子体泄漏的孔。硅胶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，因此用于ECMO氧合器。硅酮膜已经在商业上以片状结构生产，但是，它们还没有在更有效的中空纤维结构中生产。因此，目前的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已经开发出一种专利方法，以一种具有成本效益和商业可行性的方式制造硅膜中空纤维，从而开发出了一种久已改进的ECMO氧合器。拟议的第二阶段更新工作包括使用计算流体动力学、气体交换建模以及实验室和体内测试进一步改进设备。此外，我们打算完成一系列FDA要求的临床前和有效性研究，以寻求FDA的批准以启动临床阶段。

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II work indicate that we have developed a significantly improved ECMO oxygenator that outperforms currently used and outdated membrane technology.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