Permanent hands-free speech with the use of an automatic speaking valve (ASV) is regarded as the optimal voice rehabilitation after total laryngectomy. Due to fixation problems, regular ASV use in laryngectomized patients is limited. We have developed a novel intratracheal fixation device (ITFD), composed of an intratracheal button augmented by a hydrophilic PVA foam exterior around its shaft. The aim of this study was to evaluate the ITFD’s feasibility in vitro, defined as an effective ASV fixation without causing mucosal tissue traumatization.
We found that when the expanded PVA foam is compressed less than 60% of its original thickness, it can potentially provide both a safe and effective ASV fixation in a range of tracheostoma morphologies; enough fixation to withstand pressures related to loud speech (approximately 6 kPa) without exerting excessive pressure (>32 mmHg) which could lead to ischemic damage to the tracheal tissue.
This study demonstrates the feasibility of the ITFD in vitro that might improve stomal attachment of ASVs. The ITFD’s deformable foam exterior may provide an effective fixation in most laryngectomized patients, compared to commercially available fixation methods, without the need for a user-specific customization. The results of a clinical feasibility study in laryngectomized patients are pending.