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，每年影响约150，000例患者，相关死亡率为30 - 40%。临床研究目前正在探索部分液体通气（PLV）的安全性和有效性，其中全氟化碳填充的肺是气体通气，在ARDS的设置。最近的数据表明，从生物物理和生理学角度来看，全液体通气（TLV）技术（其中使用液体通气装置对肺部进行全氟化碳通气）将更有效。在第一阶段，一个简化的全液体呼吸机的儿科患者高达30公斤的设计，建造，并在体外表征。还使用3小时油酸肺损伤绵羊模型在体内测试了液体呼吸机的临床优点。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I阶段试验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，该呼吸机将保持充分气体交换所需的潮气量、输注速率和全氟化碳清除率。将定义TLV的可制造性，并详细说明TLV的体内性能。将完成动物试验，以收集适用于全液体呼吸机临床使用的FDA申报资料的数据。在第二阶段结束时，MC3 Inc.将寻求一个合适的企业合作伙伴，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.