Improving hands-free speech rehabilitation in laryngectomized patients: Preliminary results of a novel intratracheal fixation device

Maartje Leemans, Maarten J.A. Van Alphen, Richard Dirven, Gijsbertus J. Verkerke, Edsko E.G. Hekman, Michiel W.M. Van Den Brekel

Research output: Chapter in Book / Report / Conference proceedingConference contributionAcademicpeer-review

Abstract

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.

Original languageEnglish
Title of host publicationProceedings of the 2021 Design of Medical Devices Conference, DMD 2021
PublisherAmerican Society of Mechanical Engineers
ISBN (Electronic)9780791884812
DOIs
Publication statusPublished - 2021
Event2021 Design of Medical Devices Conference, DMD 2021 - Virtual, Online
Duration: 12 Apr 202115 Apr 2021

Conference

Conference2021 Design of Medical Devices Conference, DMD 2021
CityVirtual, Online
Period12/04/2115/04/21

Bibliographical note

Funding Information:
The Netherlands Cancer Institute's Department of Head and Neck Oncology and Surgery receives a research grant from Atos Medical AB (Malmo, Sweden), which contributes to the existing infrastructure for quality of life research of the Department of Head and Neck Oncology and Surgery

Funding Information:
The Netherlands Cancer Institute’s Department of Head and Neck Oncology and Surgery receives a research grant from Atos Medical AB (Malmö, Sweden), which contributes to the existing infrastructure for quality of life research of the Department of Head and Neck Oncology and Surgery.

Publisher Copyright:
© 2021 by ASME.

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