Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Amalienstr. 5, D-69126 Heidelberg, Germany.
Expert Rev Med Devices. 2011 May;8(3):307-12. doi: 10.1586/erd.11.10.
AeriSeal Emphysematous Lung Sealant is a novel endoscopic lung-volume reduction therapy designed to reduce hyperinflation and improve pulmonary function and quality of life in patients with advanced emphysema. The device is administered to the subsegmental bronchus via a catheter as a 20 ml volume of liquid-foam. It flows into the peripheral airways and alveoli where it polymerizes and functions as a tissue glue, forming a film of material on the lung surface that seals the target region to cause durable absorption atelectasis. The AeriSeal System received CE mark approval for the treatment of patients with advanced upper lobe predominant and homogeneous emphysema based upon favorable results from clinical studies, and is commercially available in Europe. Patient and treatment site selection algorithms have been developed to simplify product use and optimize outcomes. This manuscript summarizes how the device is used, its mechanism of action and clinical trial results supporting its safety and efficacy.
AeriSeal 气肿肺密封剂是一种新型的内镜下肺减容治疗方法,旨在减少过度充气,改善晚期肺气肿患者的肺功能和生活质量。该设备通过导管注入亚段支气管,体积为 20 毫升的液-泡沫。它流入外周气道和肺泡,在那里聚合并起到组织胶的作用,在肺表面形成一层材料膜,密封目标区域,导致持久的吸收性肺不张。基于临床研究的良好结果,AeriSeal 系统获得了 CE 标志批准,用于治疗晚期上叶为主和均匀性肺气肿的患者,并且在欧洲已商业化。已经开发了患者和治疗部位选择算法,以简化产品使用并优化结果。本文总结了该设备的使用方法、作用机制以及支持其安全性和有效性的临床试验结果。