Patent ID: 7909868
Filing Date: 2011-03-22
Classification: A61F,Y10S

Abstract:
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 voice prosthesis including a strap that is stretched into engagement with an attachment portion of the inserter, 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 from the closed position when the gel cap is in a non-dissolved state such that said stop collar is spaced from said voice prosthesis when said strap is stretched into engagement with the attachment portion, wherein said valve flap being obstructed from opening maintains said voice prosthesis spaced apart from said stop collar when said strap is stretched into engagement with the attachment portion of said inserter thereby applying a biasing force to said voice prosthesis toward said stop collar; inserting the voice prosthesis, gel cap and inserter into the tracheoesophageal puncture; and 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, the biasing force applied to said voice prosthesis toward said stop collar by the stretched strap causes the inserter to move relative to the voice prosthesis and into engagement with the stop collar upon dissolving of the gel cap and deployment of said esophageal flange, which allows the inserter tip of the end portion of the inserter to press open the valve flap from the closed position and allows the inserter to move relative to the voice prosthesis until the stop collar engages the voice prosthesis providing visible, external confirmation that the gel cap has dissolved and the internally located, not visible esophageal flange has deployed.