Long Term Extracorporeal Oxygenating Device

描述（由申请人提供）：本次拟定的II期更新旨在完成针对重度呼吸衰竭和/或心力衰竭患者的新型和大幅改进的长期体外膜式氧合器（ECMO）的研究和开发。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，其性能优于目前使用的过时膜技术。在第二阶段，我们证明了我们专有的硅胶膜中空纤维与我们提出的氧合器设计相结合，能够开发出适用于新生儿、儿童和成人的尺寸显著改进的ECMO氧合器。目前在美国批准并用于此目的的唯一氧合器是在1963年开发的。MedArray的新型硅胶中空纤维和氧合器设计使得能够开发出一种紧凑型器械，该器械具有显著改善的气体传输、更低的预充体积、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、降低血液阻力和降低成本。 由于ECMO氧合器长期使用（超过1天），由于血浆泄漏和膜破裂，膜不能是微孔的。因此，这些氧合器必须使用致密的膜，该膜没有用于血浆泄漏的孔。硅胶是一种致密的膜材料，对氧气和CO2具有极高的渗透性，因此用于ECMO氧合器。硅树脂膜已经以片状构造商业化生产，但是它们还没有以更有效的中空纤维构造生产。因此，目前的ECMO氧合器使用螺旋缠绕的硅胶片膜，其不如中空纤维膜有效和紧凑。MedArray已开发出一种专有（专利）方法，用于以具有成本效益和商业可行性的方式制造硅胶膜中空纤维，从而能够开发长期改进的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、气体交换建模以及台架和体内测试进一步改进器械。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批准启动临床阶段。 公共卫生相关性：本研究项目的相关性在于，它将为新生儿和患有严重呼吸和/或心力衰竭的老年患者提供一种显著改进的长期体外氧合器。目前在美国使用和批准用于此目的的唯一氧合器是在20世纪60年代早期开发的，并且目前可用的改进是长期的。这项研究将能够开发一种紧凑型氧合器，其具有大大改善的气体传输、较低的预充体积、改善的流动动力学、较低的血液阻力和较低的成本。

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II work indicate that we have developed a significantly improved ECMO oxygenator that outperforms currently used and outdated membrane technology.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