Abstract: An externally worn tracheal valve has a valve assembly supporting a flexible, resilient lightweight diaphragm centrally thereof. The diaphragm is folded towards the trachea so that air expelled from the trachea will tend to unfold the diaphragm to an extended position to close the valve. During normal breathing the diaphragm remains at least partially folded and the valve remains open. During voice exhalation, the diaphragm extends to close the valve. During high pressure coughing exhalation, the diaphragm may evert, opening the valve to release excessive pressure.

Abstract: A tracheostoma valve includes a tubular housing with an inner aperture at an inner end, and a smaller outer aperture at an outer end. The inner end of the valve is for being attached to a stoma of a patient. A shaft is positioned axially within the housing, and a rigid piston is slidable along the shaft. The piston has a smaller diameter than the interior diameter of the tubular housing, so that air can flow around it. The piston is movable between an open position intermediate of the inner and outer apertures, and a closed position against the outer aperture. The piston is biased by a spring to the open position when the air pressure is relatively low, such as during relaxed respiration, so that air may flow through the valve in either direction. At a high enough expiratory air pressure, such as that used for producing speech, the spring is collapsed and the piston is moved against the outer aperture.

Abstract: A surgical implant for use in voice restoration comprises a length of coiled spring. The length of coiled spring has a first end adapted for positioning adjacent the anterior wall of the esophagus of the wearer of the surgical implant and a second end adapted for positioning adjacent the posterior wall of the trachea. A voice prosthesis device for use with the surgical implant comprises a right circular cylinder, the outside diameter of which is substantially equal to the inside diameter of the length of coiled spring. This permits insertion of the voice prosthetic device from the tracheal end of the implant thereinto, as well as removal of the voice prosthetic device for cleaning, repair, or replacement. The voice prosthetic device contains a one-way valve permitting air flow from the tracheal end thereof to the esophageal end thereof, to provide the wearer with esophageal speech.

Abstract: A low pressure prosthesis device includes a housing having a proximal end with one or more retainers extending outwardly from the proximal end, a distal end and a port operatively cooperating with a tracheostoma in the neck of a patient. The housing further includes a one-way valve structure comprising a valve seat positioned in the housing between the port and the distal end and a valve membrane hingedly mounted within the housing to cooperate with the valve seat to provide the one-way valve structure. A second retainer in the form of an annular collar extends outwardly from the housing and is positioned to abut against the esophagus tissue when the device has been positioned within a fistula connecting the esophagus to the tracheostoma. The valve membrane is movable from the closed to the opened position when air passes through the port from the tracheostoma to the esophagus to produce alaryngeal speech and sounds in the patient.

Abstract: A method for simulating speech in a tracheotomized individual includes providing a source of compressed air, regulating the air pressure, and controlling the flow of air from the source between a condition in which airflow is stopped and a condition in which airflow is allowed in response to actuation by the individual. The air flow is supplied to a reed to vibrate it, and the resulting vibration-modulated air flow is introduced into the pharynx of the individual, permitting the individual to articulate audibly comprehensible speech. Apparatus for carrying out this method is also described.

Abstract: A low pressure prosthesis device includes a cylindrical housing having a proximal end with strap elements extending outwardly from the proximal end, a distal end and a port operatively cooperating with a tracheostoma in the neck of a patient. The cylindrical housing further includes a one-way valve structure comprised of an annular sealing rim positioned perpendicularly in the housing adjacent the distal end and a valve membrane hingedly mounted within the housing to cooperate with the annular sealing rim to provide the one-way valve structure. An annular collar flange extends outwardly from the housing and is positioned to abut against the esophagus tissue when the device has been positioned within a fistula connecting the esophagus to the tracheostoma. The valve membrane is movable from the closed to the opened position when air passes through the port from the tracheostoma to the esophagus to produce alaryngeal speech and sounds in the patient.