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A new voice for the voiceless; design of a voice-producing shunt prosthesis to improve voice quality after laryngectomy

For some patients, voice production after laryngectomy is
impossible.For others voice quality is unpredictable or poor
to enable high-quality voice production for those patients,
a voice-producing shunt prosthesis will be developed.

The larynx plays a crucial role in phonation, respiration and deglutition. For advanced laryngeal cancer a total laryngectomy is indicated consisting of the surgical removal of the larynx including vocal folds and epiglottis. The trachea is cut from the larynx and led outside to the neck where it is sutured to the skin forming a tracheostoma. The most disabling consequence of a laryngectomy is generally considered the loss of vocal function. Rehabilitation of speech is usually performed by placing a one-way shunt valve in a shunt that has been punctured in the tracheoesophageal wall. This shunt valve prevents food and liquid from entering the trachea. Closing the tracheostoma with a finger forces the air during expiration through the shunt valve into the oesophagus where soft tissues start to vibrate, creating a substitute voice, the pseudoglottis. A laryngectomy has drastic consequences for the patient. Most consequences are related to voice production. The rehabilitated voice produced by the pseudoglottis is, especially for women, low-pitched and often of poor quality. Food and fluid passing the shunt valve stimulate the formation of a biofilm on the shunt valve. This biofilm causes the shunt valve to malfunction, either by leakage or permanent valve closure, resulting in the necessity to replace the shunt valve frequently, on average every four months. Sometimes, leakage also occurs around the shunt valve due to fixation problems; this is often difficult to solve. The visible tracheostoma can form a mental problem, especially during speaking, when the patient has to point at his handicap. For some patients a tracheostoma valve is placed on the tracheostoma to allow hands-free speech. However, it cannot be used by all patients because fixation to the skin around the stoma is difficult. The inhaled air is not filtered, moisturised or heated up, which can irrate the lower airways. This leads to higher phlegm production and higher susceptibility to colds and even pneumonia. An HME filter that serves as an artificial nose could overcome these problems, but again, fixation of it to the skin around the stoma is difficult. To improve the plight of laryngectomees, this project aims to produce a voice-producing shunt prosthesis, consisting of an element that is able to produce a voice with sufficient loudness, adjustable fundamental frequency and natural intonation. The voice-producing element is integrated into a newly designed shunt value made of biofilm-resistant silicone rubber and fixed to soft tissue structures via a tissue connector; a ring that is partly implanted in the connective tissue around the shunt valve offering on the inner side, the possibility of connecting the shunt valve. By applying the same tissue connector principle, a tracheostoma valve with an HME filter can be fixed to the trachea, thus enabling hands-free control of the voice-producing prosthesis and prevention of trachea irritation. Keywords: voice production, laryngectomy, prosthesis.
Acronym: 
NEWVOICE
Project ID: 
2 614
Start date: 
01-02-2002
Project Duration: 
59months
Project costs: 
4 240 000.00€
Technological Area: 
Medical devices technology (instrumentation, medical imaging, radiology)
Market Area: 

Raising the productivity and competitiveness of European businesses through technology. Boosting national economies on the international market, and strengthening the basis for sustainable prosperity and employment.