van Geffen Geert-Jan, Markerink Hielke, van Barneveld Marc, Verhoeven Frank, Scheffer Gert Jan, Bruhn Jörgen
Department of Anesthesiology, Pain and Palliative Care, Radboud University Medical Centre (RUMC), Nijmegen, The Netherlands.
Medspray Anesthesia BV, Enschede, The Netherlands.
Med Devices (Auckl). 2021 Jan 22;14:9-14. doi: 10.2147/MDER.S292529. eCollection 2021.
Obtaining complete topical anaesthesia of the airway remains a clinical challenge. Particle size is one of the most important variables for the dose deposited and the distribution of aerosols in the airways. The mass median aerodynamic diameter of the particles should be in the range of 5-20 µm. We developed the "Trachospray" as a soft mist spray device for local anaesthetics. This in-vitro comparative test was designed to compare the performance of the new Trachospray device with two existing medical devices. The performance was determined by comparing the spray deposition patterns in the mouth, throat, trachea and lungs.
The human airway was simulated with an artificial idealized mouth and throat model, connected to a Next Generation Impactor. Four measurements were taken for each device (Trachospray, jet nebulizer and a spray pump) with 5.85% NaCl. A fifth measurement was carried out with 0.5% fluorescein solution for a visual inspection of the deposition patterns. The mass median aerodynamic diameter and geometric standard deviation of the droplets were measured.
The Trachospray produced an even coverage in the mouth, hypopharynx and vocal cords, with only a small lung fraction. The jet nebulizer produced a much thinner layer coverage of the tongue and surface around the vocal chords with a high lung deposition. The spray pump produced big droplets which deposited mainly at the hypopharynx.
The Trachospray device deposits local anaesthetics in the targeted areas for topical anaesthesia of the airway and has promising characteristics for providing effective airway anaesthesia.
实现气道的完全局部麻醉仍是一项临床挑战。颗粒大小是决定气道中药物沉积剂量和气溶胶分布的最重要变量之一。颗粒的质量中位空气动力学直径应在5 - 20微米范围内。我们开发了“Trachospray”作为一种用于局部麻醉剂的软雾喷雾装置。这项体外对比试验旨在比较新型Trachospray装置与两种现有医疗设备的性能。通过比较在口腔、咽喉、气管和肺部的喷雾沉积模式来确定性能。
使用连接到下一代撞击器的人工理想化口腔和咽喉模型模拟人体气道。对每个装置(Trachospray、喷射雾化器和喷雾泵)使用5.85%的氯化钠溶液进行四次测量。使用0.5%的荧光素溶液进行第五次测量,以目视检查沉积模式。测量液滴的质量中位空气动力学直径和几何标准差。
Trachospray在口腔、下咽和声带产生均匀覆盖,肺部沉积分数较小。喷射雾化器在舌头和声门周围表面产生的覆盖层薄得多,肺部沉积较高。喷雾泵产生大液滴,主要沉积在下咽。
Trachospray装置将局部麻醉剂沉积在气道局部麻醉的目标区域,具有提供有效气道麻醉的良好特性。