Paracorporeal Ambulatory Assist Lung

描述（由申请人提供）：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病。机械通气为这些患者提供短期支持，但长期支持可能导致气压伤、体积伤和其他医源性损伤，进一步加剧呼吸功能不全。体外膜氧合（ECMO）可以提供更长期的呼吸支持，但是是复杂的并且显著地限制了患者的移动性。这个项目 该公司将开发一种紧凑的呼吸辅助设备，即Paracetamilatory Ambulatory Assist Lung（PAAL），以取代ECMO，作为急性和慢性肺衰竭患者移植或恢复的桥梁。PAAL是一种完全集成的血泵和气体交换模块，设计用于外周插管（例如颈静脉至股静脉）或中心插管（例如右 心房到肺动脉，并戴在枪套或背心上。PAAL将设计用于长期呼吸支持（更换前1-3个月）在70-100%的正常代谢要求，同时泵血从2升/分钟到3.5升/分钟。项目的具体目标是1）优化PAAL的设计和操作参数，以满足血液泵送、气体交换、预充量和形状因子的要求; 2）按照实验室表征研究的设计开发途径构建PAAL原型沿着; 3）通过探索新型分子两性离子涂层改善PAAL的血液相容性;以及4）在健康绵羊中进行急性和慢性动物研究，以证明PAAL器械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.