Paracorporeal Ambulatory Assist Lung

描述(申请人提供)：急性和慢性肺部疾病仍然是主要的医疗保健问题。每年有近35万美国人死于某种形式的肺部疾病。机械通气为这些患者提供了短期支持，但长期支持可能会导致气压伤、蜗牛伤和其他医源性损伤，进一步加剧呼吸功能不全。体外膜肺氧合(ECMO)可以提供较长时间的呼吸支持，但它复杂，严重限制了患者的行动能力。这个项目 将开发一种紧凑型呼吸辅助设备，即准心脏动态辅助肺(PAAL)，以取代ECMO，成为急慢性肺衰竭患者进行移植或康复的桥梁。Paal是一个完全集成的血泵和气体交换模块，专为外周插管(例如颈静脉到股骨)或中央插管(例如右 从心房到肺动脉，穿在皮套或背心上。Paal的设计将用于更长期的呼吸支持(在换药前1-3个月)，达到正常代谢需求的70%-100%，同时泵血速度从2升/分钟到3.5升/分钟。该项目的具体目标是1)优化Paal的设计和操作参数，以满足泵血、气体交换、预充量和外形因数的要求；2)沿着设计开发路线构建Paal原型，用于台式表征研究；3)通过探索新型分子两性离子涂层来提高Paal的血液相容性；4)在健康绵羊身上进行急慢性动物研究，以展示Paal设备的体内性能和血液相容性及其与心肺系统的相互作用。

DESCRIPTION (provided by applicant): Acute and chronic diseases of the lung remain major healthcare problems. Each year nearly 350,000 Americans die of some form of lung disease. Mechanical ventilation provides short-term support for these patients, but longer term support can lead to barotrauma, volutrauma, and other iatrogenic injuries, further exacerbating the respiratory insufficiency. Extracorporeal membrane oxygenation (ECMO) can provide longer term respiratory support but is complex and significantly limits a patient's mobility. This project will develop a compact respiratory assist device, the Paracorporeal Ambulatory Assist Lung (PAAL), to replace ECMO as a bridge to transplant or recovery in patients with acute and chronic lung failure. The PAAL is a fully integrated blood pump and gas exchange module and is designed for peripheral cannulation (e.g. jugular to femoral) or central cannulation (e.g. right atrium to pulmonary artery and worn on a holster or vest. The PAAL will be designed for longer-term respiratory support (1-3 months before change-out) at 70-100% of normal metabolic requirements, while pumping blood from 2 to 3.5 Liters/min. The specific aims of project are 1) To optimize the design and operational parameters of the PAAL to meet requirements for blood pumping, gas exchange, priming volume, and form factor; 2) To build PAAL prototypes along the design development pathway for bench characterization studies; 3) To improve hemocompatibility of the PAAL by exploring novel molecular Zwitterionic coatings; and 4) To perform acute and chronic animal studies in healthy sheep to demonstrate the in-vivo performance and hemocompatibility of the PAAL device and its interaction with the cardiopulmonary system.