Abstract: A catheter, voice prosthesis assembly, and delivery method include an elongated flexible body having a hollow voice prosthesis tubing disposed on a first end of the elongated flexible body. A voice prosthesis is received in the hollow voice prosthesis tubing. The voice prosthesis having an interior esophageal flange at a first end and an exterior tracheal flange at a second end, with the voice prosthesis being received in the hollow voice prosthesis tubing with the interior esophageal flange being folded within the hollow voice prosthesis tubing and the exterior tracheal flange being disposed exterior to the hollow voice prosthesis tubing.

Abstract: A therapy device is provided for trismus prevention and treatment, and includes a first arm hingedly connected to a second arm, and a spring device disposed therebetween to press the first and second arms apart. A pair of bite pads are provided at the ends of each of the first and second arms and are designed to be engaged by a user's teeth or gums in order to bite down on the device to exercise the user's jaw, and more specifically, the muscles of mastication.

Abstract: A trocar device and measurement assembly, includes a trocar having a sharply pointed shaft and a handle. An elongated sheath receives the shaft of the trocar therein, wherein the elongated sheath includes a plurality of measuring indicia thereon for measuring a length of a tracheoesophageal puncture formed by the trocar. A method of measuring the tracheoesophageal puncture is provided by inserting the elongated sheath into the puncture while observing the measuring indicia on the sheath to determine a length of the puncture.

Abstract: A catheter, voice prosthesis assembly, and delivery method include an elongated flexible body having a hollow voice prosthesis tubing disposed on a first end of the elongated flexible body. A voice prosthesis is received in the hollow voice prosthesis tubing. The voice prosthesis having an interior esophageal flange at a first end and an exterior tracheal flange at a second end, with the voice prosthesis being received in the hollow voice prosthesis tubing with the interior esophageal flange being folded within the hollow voice prosthesis tubing and the exterior tracheal flange being disposed exterior to the hollow voice prosthesis tubing.

Abstract: A trocar device and measurement assembly, includes a trocar having a sharply pointed shaft and a handle. An elongated sheath receives the shaft of the trocar therein, wherein the elongated sheath includes a plurality of measuring indicia thereon for measuring a length of a tracheoesophageal puncture formed by the trocar. A method of measuring the tracheoesophageal puncture is provided by inserting the elongated sheath into the puncture while observing the measuring indicia on the sheath to determine a length of the puncture.

Abstract: A voice prosthesis comprising a tubular body portion, a valve and a valve seat disposed within the body portion. The valve seat is further comprised of a medical grade elastomer containing a dispersion of an antimicrobial agent. This valve seat extends the life of the prosthesis by retarding the growth of microorganisms. The body portion of the prosthesis may also contain an antimicrobial agent at a concentration that is non-toxic to the tissue it contacts.

Abstract: A voice prosthesis device includes a barrel defining a passageway, a tracheal flange adjacent a tracheal end of the barrel and an esophageal flange adjacent an esophageal end of the barrel. The passageway includes a first stop extending inwardly from a sidewall of the passageway between the tracheal and esophageal ends and a plurality of second stops extending inwardly from the sidewall of the passageway between the first stop and the esophageal end of the passageway. A valve mechanism is located between the first and second stops and permits flow through the passageway from the tracheal end and impedes flow through the passageway from the esophageal end.

Abstract: A voice prosthesis device includes a barrel defining a passageway, a tracheal flange adjacent a tracheal end of the barrel and an esophageal flange adjacent an esophageal end of the barrel. The passageway includes a first stop extending inwardly from a sidewall of the passageway between the tracheal and esophageal ends and a plurality of second stops extending inwardly from the sidewall of the passageway between the first stop and the esophageal end of the passageway. A valve mechanism is located between the first and second stops and permits flow through the passageway from the tracheal end and impedes flow through the passageway from the esophageal end.

Abstract: A voice prosthesis dilator and sizer device is provided including an elongated member having a first end with a tip and a flange and a second end with a stop portion. The elongated member includes an intermediate portion with a measuring area disposed adjacent to the flange and including measuring indicia thereon and having a dilation area adjacent to the second end. The elongated member also includes a recessed region adjacent to the flange to receive the flange in a folded position upon insertion into the non-dilated fistula. The dilation area has a larger diameter than the measuring area.

Abstract: A gel cap is loaded on a folded flange of a voice prosthesis which is loaded on an end portion of an inserter, wherein a tip is pressed against a valve flap of the voice prosthesis. The voice prosthesis includes a strap that is stretched for engagement with an attachment portion on the inserter. The voice prosthesis, gel cap, and inserter are inserted into the tracheoesophageal puncture. The patient then swallows fluids to cause the gel cap to dissolve to allow the esophageal flange to deploy, whereby upon deployment of the esophageal flange, the tip of the end portion of the inserter presses the valve flap open, allowing the inserter to move axially relative to the voice prosthesis until a stop collar of the inserter engages the voice prosthesis providing external visual confirmation to the user that the gel cap has dissolved and the esophageal flange has deployed.

Abstract: A gel cap is loaded on a folded flange of a voice prosthesis which is loaded on an end portion of an inserter, wherein a tip of the end portion is pressed against a valve flap of the voice prosthesis. The voice prosthesis includes a strap that is stretched for engagement with an attachment portion on the inserter. The voice prosthesis, gel cap, and inserter are inserted into the tracheoesophageal puncture. The patient then swallows fluids to cause the gel cap to dissolve to allow the esophageal flange to deploy, whereby upon deployment of the esophageal flange, the tip of the end portion of the inserter presses the valve flap open, allowing the inserter to move axially relative to the voice prosthesis until a stop collar of the inserter engages the voice prosthesis providing external visual confirmation to the user that the gel cap has dissolved and the esophageal flange has deployed.

Abstract: A gel cap is loaded on a folded flange of a voice prosthesis which is loaded on an end portion of an inserter, wherein a tip of the end portion is pressed against a valve flap of the voice prosthesis. The voice prosthesis includes a strap that is stretched for engagement with an attachment portion on the inserter. The voice prosthesis, gel cap, and inserter are inserted into the tracheoesophageal puncture. The patient then swallows fluids to cause the gel cap to dissolve to allow the esophageal flange to deploy, whereby upon deployment of the esophageal flange, the tip of the end portion of the inserter presses the valve flap open, allowing the inserter to move axially relative to the voice prosthesis until a stop collar of the inserter engages the voice prosthesis providing external visual confirmation to the user that the gel cap has dissolved and the esophageal flange has deployed.

Abstract: A voice prosthesis dilator and sizer device is provided including an elongated member having a first end with a tip and a flange and a second end with a stop portion. The elongated member includes an intermediate portion with a measuring area disposed adjacent to the flange and including measuring indicia thereon and having a dilation area adjacent to the second end. The elongated member also includes a recessed region adjacent to the flange to receive the flange in a folded position upon insertion into the non-dilated fistula. The dilation area has a larger diameter than the measuring area.

Abstract: Microbial growth on the surface of a valve of a voice prosthesis and optionally the cartridge or ring supporting the valve, is inhibited by providing antimicrobial activity at a level sufficient to retard growth of a microbial film by dispersing an inorganic antimicrobial agent such as silver oxide or an organic antimicrobial agent such as triclosan or butyl paraben dispersed in a medical grade silicone elastomer. The valve, ring or cartridge is in contact with body fluids containing microorganisms and nutrients therefor. The antimicrobial surface can interfere with or inhibit the growth of a biofilm, bacterial layer or a yeast layer. The body of the prosthesis may also contain an antimicrobial surface as long as it is non-toxic to the tissue it contacts.

Abstract: A medical device, gel-cap loading tool. The loading tool facilitates the insertion of a component of a medical device, such as the esophageal flange of a voice prosthesis, within a dissolvable gel cap. The gel cap is disposed in a cavity with the component collapsed therein. A gel cap is disposed in the cavity and is axially aligned with the medical device. An engaging member engages with at least one of the gel cap and the medical device to cause relative movement between the gel cap and the medical device which causes the component to be inserted into the gel cap.

Abstract: A medical device, gel-cap loading tool. The loading tool facilitates the insertion of a component of a medical device, such as the esophageal flange of a voice prosthesis, within a dissolvable gel cap. The medical device is disposed in a cavity with the component collapsed therein. A gel cap is disposed in the cavity and is axially aligned with the medical device. An engaging member engages with at least one of the gel cap and the medical device to cause relative movement between the gel cap and the medical device which causes the component to be inserted into the gel cap.

Abstract: Microbial growth on the surface of a valve of a voice prosthesis and optionally the cartridge or ring supporting the valve, is inhibited by providing antimicrobial activity at a level sufficient to retard growth of a microbial film by dispersing an inorganic antimicrobial agent such as silver oxide or an organic antimicrobial agent such as triclosan or butyl paraben dispersed in a medical grade silicone elastomer. The valve, ring or cartridge is in contact with body fluids containing microorganisms and nutrients therefor. The antimicrobial surface can interfere with or inhibit the growth of a biofilm, bacterial layer or a yeast layer. The body of the prosthesis may also contain an antimicrobial surface as long as it is non-toxic to the tissue it contacts. Methods of making such antimicrobial components for voice prosthesis devices are also provided.

Abstract: A method for making an elastomeric material containing an antimicrobial composition such as a dispersion of silver oxide that is suitable for implantation within the body. The elastomer made in accordance with this method extends the amount of work-time available for processing the elastomer into an article as compared with the work-time available when using prior art compounding methods.