Simplified Total Liquid Ventilator

描述(由申请人提供)： 急性呼吸窘迫综合征(ARDS)是一种严重的、危及生命的疾病过程，每年影响大约15万名患者，相关死亡率为30%-40%。目前，临床研究正在探索部分液体通气(PLV)在ARDS中的安全性和有效性。在PLV中，充满全氟碳的肺被气体通风。最近的数据表明，从生物物理和生理学的角度来看，全液体通风(TLV)技术从生物物理和生理学的角度来看将更有效。在第一阶段，为一名体重达30公斤的儿科患者设计、建造了一种简化的全液体呼吸机，并对其进行了体外鉴定。液体呼吸机的临床优点也通过3小时的油酸型肺损伤绵羊模型进行了体内测试。第二阶段的目标是扩大液体呼吸机的开发，以适应成人和儿童患者。通过第一阶段测试获得的知识将与新技术的可用性相结合，以构建具有一次性部件的全液体呼吸机，以保持足够的气体交换所需的必要潮气量、输液率和全氟化碳的清除。将定义TLV的可制造性，并全面详细说明TLV的体内性能。动物测试将完成，以收集适合FDA提交的全液体呼吸机临床使用的数据。在第二阶段结束时，MC3公司将征集合适的企业合作伙伴来生产和销售全液体呼吸机。

DESCRIPTION (provided by applicant): The acute respiratory distress syndrome (ARDS) is a severe, life-threatening disease process that affects approximately 150,000 patients per year with an associated 30-40% mortality rate. Clinical studies are currently exploring the safety and effectiveness of Partial Liquid Ventilation (PLV), in which a perfluorocarbon-filled lung is gas-ventilated, in the setting of ARDS. Recent data has suggested that the technique of Total Liquid Ventilation (TLV), in which the lungs are ventilated with perfluorocarbon using a liquid ventilating device, will be more effective from a biophysical and physiologic perspective. In Phase I, a simplified total liquid ventilator for a pediatric patient up to 30 kg was designed, constructed, and characterized in-vitro. The clinical merits of the liquid ventilator were also tested in-vivo using a 3-hour, oleic acid lung injury sheep model. The objective of Phase II is to expand the development of the liquid ventilator to suit both adult and pediatric patients. The knowledge obtained through Phase I testing will be combined with the availability of new technology to construct a total liquid ventilator with disposable parts that will maintain the necessary tidal volumes, rates of infusion, and clearance of perfluorocarbon necessary for the adequate gas exchange. Manufacturability of the TLV will be defined and in vivo performance of the TLV will be fully detailed. Animal testing will completed to collect data appropriate for an FDA submission for the clinical use of the total liquid ventilator. At the conclusion of Phase II, MC3 Inc. will solicit an appropriate corporate partner to produce and market the total liquid ventilator.