Method and apparatus for an indwelling one-way valve prosthesis for hands-free tracheoesophageal speech

A method of implanting a system for hands-free tracheoesophageal speech in a patient who has undergone a laryngectomy, said method comprising the steps of

• (1) surgically creating a stoma in the anterior wall of the trachea of the patient, said stoma extending through the skin of the patient thereby permitting the passage of air inwardly through the stoma into the trachea,
• (2) surgically creating a supra stomal tracheal pocket above said stoma by preserving at least one tracheal ring above the stoma,
• (3) implanting said system in said stoma, said system comprising a one-way valve prosthesis adapted to be placed in said stoma, and supporting means attached to and extending laterally from the one-way valve prosthesis, said supporting means adapted to contact the anterior mucosa of the trachea around the circumference of the stoma and including an extension adapted to contact and conform to the surface of the tracheal mucosa above said stoma thereby to achieve an airtight seal between the one-way valve prosthesis and tracheal mucosa and to support the one-way valve prosthesis in place in the stoma;
• and
• (4) implanting a one-way tracheoesophageal prosthesis valve means between the trachea and pharynx, said prosthesis valve adapted to permit the passage of air from the trachea into the pharynx but to prevent the passage of food or liquid from the pharynx into the trachea, said prosthesis combination thereby permitting hands-free tracheoesophageal speech by preventing exhaled air from passing outwardly through the one-way valve and the stoma, and thus forcing said air into the pharynx through the one-way tracheoesophageal prosthesis valve means.

The method of implanting a system and creating a tracheopharyngeal shunt for hands-free tracheoesophageal speech in a patient who has undergone a near-total laryngectomy, said method comprising the steps of

• (1) surgically creating a stoma in the anterior wall of the trachea of the patient, said stoma extending through the skin of the patient thereby permitting the passage of air inwardly through the stoma into the trachea,
• (2) surgically creating a supra stomal tracheal pocket above said stoma by preserving at least one tracheal ring above the stoma,
• (3) implanting a system in said stoma, said system comprising a one-way valve prosthesis adapted to be placed in said stoma, and supporting means attached to and extending laterally from the one-way valve prosthesis, said supporting means adapted to contact the anterior mucosa of the trachea around the circumference of the stoma and further including an extension adapted to contact and conform to the surface of the tracheal mucosa above said stoma thereby to achieve an airtight seal between the one-way valve prosthesis and tracheal mucosa and to support the one-way valve prosthesis in place in the stoma;
• and
• (4) surgically creating a tracheopharyngeal shunt of the trachea above the stoma, said shunt including a mobile arytenoid that, through sphincteric action, thereby functioning as a one-way valve permitting exhaled air to pass through the shunt into the mouth while preventing solids and liquids from entering the trachea, said system and shunt thereby permitting hands-free tracheoesophageal speech.