Extended dwell voice prosthesis
AssigneeHelix Medical, Inc.
InventorsDavid R. Suding, Edmund V. Seder
Life of this patent
Estimating the term…
Abstract
The position of the rear esophageal flange of a voice prosthesis disposed in a tracheoesophageal fistula is determined by forming a distinctive radiopaque pattern on the flange, preferably by insert molding a radiopaque ring along the perimeter of the flange and radiographically imaging the flange to determine the pattern of the ring. Pattern recognition of the ring is improved by forming the concentric flapper valve of radiopaque material.
Claims9
A method of forming a voice prosthesis that can be viewed when positioned in a tracheoesophageal wall of a patient, said voice prosthesis comprising a hollow, tubular annular body of flexible, medical grade resin, said prosthesis having a front tracheal flange, a rear esophageal flange which is substantially transparent to X-ray radiation and a flapper valve, comprising the steps of:
- forming an element containing sufficient pigment to be opaque when radiated by X-ray radiation, said element having a first distinctive image when the rear flange is fully seated on said wall and having a second distinctive image when the rear flange is not fully seated on said wall when said element is imaged by X-ray radiation;
- and
- adhering said element to said rear flange.
A method of forming a voice prosthesis that can be viewed when positioned in a tracheoesophageal fistula, said voice prosthesis comprising a tubular body of flexible, medical grade resin having a front tracheal flange, a rear esophageal flange in the form of an annular cylindrical disc and a flapper valve comprising the steps of forming a distinctive pattern of radiopaque material in the form of a preformed ring and adhering said preformed ring to said rear flange adjacent the periphery of said rear flange.
A method of determining whether the rear esophageal flange of a voice prosthesis having a distinct pattern of radiopaque material on or in the rear flange of the voice prosthesis is correctly seated on the esophageal wall surrounding a tracheoesophageal fistula of a patient comprising the steps of:
- applying X-rays to the tracheoesophageal fistula;
- imaging the radiopaque pattern on the rear flange;
- and
- comparing the pattern to a reference pattern to determine whether the rear flange is correctly positioned on the esophageal wall surrounding the fistula.
Dependencies are inferred from the claim text.