Voice Prothesis Automatic Flange Deployment Confirmation Method

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.

1 . A method of inserting a voice prosthesis into a tracheoesophageal puncture of a speech restoration patient, comprising:
 loading a gel cap on a forward folded esophageal flange of the voice prosthesis;   loading the voice prosthesis on an end portion of an inserter, wherein the end portion has a length greater than a length of the voice prosthesis and a tip of the end portion is pressed against a valve flap of the voice prosthesis, said inserter including a stop collar, said forward folded esophageal flange engaging said valve flap in a closed position and obstructing said valve flap from opening such that said stop collar is spaced from said voice prosthesis, said voice prosthesis being biased toward said stop collar;   inserting the voice prosthesis, gel cap and inserter into the tracheoesophageal puncture;   having the speech restoration patient swallow fluids to thereby cause said gel cap to dissolve to allow the esophageal flange to deploy, whereby upon deployment of said esophageal flange, said tip of the end portion of the inserter presses the valve flap open from the closed position and allows the inserter to move relative to the voice prosthesis under the biasing force until the stop collar engages the voice prosthesis providing visible, external confirmation to the user that the gel cap has dissolved and the internally located, not visible esophageal flange has deployed.