Novel Fabrication of Long Term Blood Oxygenators

描述（由申请人提供）： 长期血液氧合器（BO）治疗需要无孔涂层，以限制BO浸湿。紧凑型膜系统（CMS）已经确定了新的材料，可以最大限度地减少湿出，同时保持所需的气体的气液输送。 为了使这些新材料具有显著的商业价值，它们必须能够容易地集成到现有的商业BO操作中。目前这些新型材料的制造能力受到很大限制。由于纤维-纤维桥接，原位引入无孔涂层目前是不可接受的。在模块制造之前涂覆单个纤维虽然具有一定的潜力，但具有许多下游问题，并且不容易集成到现有的BO生产线中。 与该领域专家的讨论已经确定了许多可以利用该新产品的血液氧合应用。这些应用包括ARDS（急性呼吸窘迫综合征）、ECMO（体外膜氧合器）心脏和呼吸系统患者以及高风险心脏外科手术。 CMS已经确定了新的程序，可以轻松地将其新材料集成到现有的BO制造系统中。在第一阶段，CMS将展示其新的程序使用CMS的高气体通量无孔非润湿膜。第I阶段将包括体外和体内测试，这些测试表明CMS工艺为BO提供了所需的抗润湿性，同时保持了血液内外的气体交换，同样重要的是，它易于集成到商业BO操作中。生物相容性试验将在第I阶段完成。第一阶段定量地定义了项目目标和备选战略（如有必要）。体内测试将证明与I期资金一致的可行性证明，并增强我们针对II期项目的能力。临床前测试和关键合作伙伴将增强我们快速进入临床测试的能力。

DESCRIPTION (provided by applicant): Long-term blood oxygenator (BO) therapy requires non-porous coatings to limit BO wet out. Compact Membrane Systems (CMS) has identified novel materials that can minimize wet out while simultaneously maintaining needed gas-liquid transport of gases. In order for these novel materials to be of significant commercial value they must be able to easily integrate into existing commercial BO operations. Present fabrication capabilities with these novel materials are significantly limited. In-situ introduction of non-porous coatings is presently unacceptable due to fiber-fiber bridging. Coating of individual fibers prior to module fabrication while having some potential has many downstream problems and is not easily integrated into existing BO manufacturing lines. Discussions with experts in the field have identified a number of blood oxygenation applications that can take advantage of the novel product. These applications include ARDS (Acute Respiratory Distress Syndrome), ECMO (Extracorporeal Membrane Oxygenators) cardiac and respiratory patients and high risk cardiac surgical procedures. CMS has identified novel procedure to easily integrate their novel material into existing BO fabrication systems. In Phase I CMS will demonstrate its novel procedure using CMS's high gas flux non-porous non-wetting membrane. Phase I will include in-vitro and in-vivo tests which show CMS process provides BO with needed wet out resistance while maintaining gas exchange into and out of blood and equally as important is easily integrated into commercial BO operations. Bio-compatibility testing will be completed in Phase I. Phase I quantitatively defines program objectives and alternative strategies if needed. In-vivo testing will demonstrate proof of feasibility consistent with Phase I funds, and enhance our ability for a targeted Phase II program. Pre-clinical testing and key partners will enhance our ability to rapidly move to clinical testing.