Improved Hollow Fiber Membranes for Artificial Lungs

描述(申请人提供)：ALung Technologies，Inc.正在开发一种呼吸导管(纳蒂尔导管)，用于治疗急性和急性-慢性呼吸衰竭，在美国有超过10万名成年人受到影响。 临床呼吸导管和其他正在开发的植入性人工肺的一个主要限制是商业中空纤维膜(HFM)仅在血液接触几个小时后就湿了。在润湿过程中，血浆填充纤维壁孔，纤维气体渗透率大大降低，导致气体交换不足。这造成了一个严重的问题，因为植入式人工肺装置的纤维不容易更换。因此，为了有效的临床使用，可植入的人工肺必须包含保持足够的气体交换特性的非湿润的HFM。 第一阶段目标-1)开发具有高气体透过率的非湿润性HFM。气体等离子体相聚合将用于产生超薄但连续的具有高气体渗透性的聚合物层，足以防止液体入侵，但足够薄，以满足所需的气体交换率；以及2)设计用于评估润湿阻力和气体渗透性的候选HFM的台架测试。在整个优化过程中，将在候选纤维样品的简单模块中进行测试。最佳候选纤维将被合并到Hattler导管中，并在工作台水和血气交换测试中进行评估。 第二阶段--专注于提高纤维涂层的抗血栓性能。第一阶段研究的聚合物通常比未涂覆的纤维具有更好的生物相容性，但为了最大限度地减少抗凝血的需要，有必要探索进一步改善生物相容性。从这个项目中产生的纤维将有望用于为肺衰竭患者开发的人工肺装置。

DESCRIPTION (provided by applicant): ALung Technologies, Inc. is developing a respiratory catheter (the Nattier Catheter) for treatment of acute and acute-on-chronic respiratory failure, which affects over 100,000 adults in the United States. A major limitation in clinical respiratory catheters and other implantable artificial lungs being developed is that commercial hollow fiber membranes (HFMs) wet after only a few hours of blood contact. In wetting, blood plasma fills the fiber wall pores and the fiber gas permeance decreases substantially causing insufficient gas exchange. This poses a serious problem because the fibers of implantable artificial lung devices cannot easily be replaced. Thus, for effective clinical use an implantable artificial lung must contain non-wetting HFMs that retain sufficient gas exchange characteristics. Phase I Goals -1) Develop non-wetting HFMs with high gas permeance. Gas-plasma phase polymerization will be used to create an ultra-thin but continuous layer of polymer with high gas permeability, sufficient to prevent liquid intrusion but thin enough to accommodate with negligible diminution the required gas exchange rates; and 2) Bench tests of candidate HFMs designed to evaluate wetting resistance and gas permeance. Tests will be performed in simple modules of candidate fiber samples throughout the optimization process. The best candidate fiber will be incorporated into the Hattler Catheter and evaluated in bench water and blood gas exchange tests. Phase II - Focuses on increased thromboresistance of fiber coatings. Polymers investigated in Phase I are generally more biocompatible than uncoated fibers, but the need for minimizing anticoagulation warrants exploring further improvements in the biocompatibility. The fibers emerging from this program will be of promise for artificial lung devices being developed for patients with lung failure.