TY - GEN
T1 - Improving hands-free speech rehabilitation in laryngectomized patients
T2 - 2021 Design of Medical Devices Conference, DMD 2021
AU - Leemans, Maartje
AU - Van Alphen, Maarten J.A.
AU - Dirven, Richard
AU - Verkerke, Gijsbertus J.
AU - Hekman, Edsko E.G.
AU - Van Den Brekel, Michiel W.M.
N1 - 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.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Automatic speaking valve
KW - Hands-free speech
KW - Intratracheal fixation
KW - Speech rehabilitation
KW - Total laryngectomy
KW - Tracheostoma valves
UR - http://www.scopus.com/inward/record.url?scp=85107212379&partnerID=8YFLogxK
U2 - https://doi.org/10.1115/DMD2021-1009
DO - https://doi.org/10.1115/DMD2021-1009
M3 - Conference contribution
T3 - Proceedings of the 2021 Design of Medical Devices Conference, DMD 2021
BT - Proceedings of the 2021 Design of Medical Devices Conference, DMD 2021
PB - American Society of Mechanical Engineers
Y2 - 12 April 2021 through 15 April 2021
ER -
