Antimicrobial indwelling voice prosthesis

• US 8,317,861 B2
• Filed: 03/29/2005
• Issued: 11/27/2012
• Est. Priority Date: 04/11/2001
• Status: Expired due to Term

• Current Assignee: Freudenberg Medical, LLC (Freudenberg & Company KG)
• Original Assignee: Helix Medical LLC (Freudenberg & Company KG)
• Inventors: Goldberg, Jeffrey L., Seder, Edmund V., Nelson, Jesse N., Madrigal, Juan M.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US11/093,351
• Publication Number:
  US 20050171602A1
• Time in Patent Office: 2,800 Days
• Field of Search: 623/9
• US Class Current: 623/9
• CPC Class Codes: A61F 2/203 comprising an air passage from trachea to oesophagus or to pharynx; Artificial epiglottis
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

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.

Claims

1. A voice prosthesis device that conducts air between a trachea and an esophagus of a patient, the voice prosthesis device comprising:

(a) a non-rigid tubular-shaped body portion formed from a first biocompatible elastomer material and defining a forward end comprising a front flange and a rear end comprising a rear flange, wherein said body portion has a first central lumen extending from said forward end to said rear end;

(b) a molded microbial-resistant valve seat component formed from a second biocompatible elastomer material comprising silver oxide at a concentration sufficient to retard microbial growth on a surface of said valve seat component, wherein said silver oxide is compounded with and substantially dispersed throughout said second biocompatible elastomer material, wherein said molded valve seat component is distinct from said body portion and non-releasably disposed within said central lumen of said body portion, wherein said valve seat component defines a second central lumen;

(c) a valve mounted on said valve seat component;

wherein said valve is operable to intermittently seal said second central lumen when said valve contacts a portion of said surface of said valve seat component and operable to open said second central lumen to permit gas to flow therethrough; and

(d) wherein the voice prosthesis device lacks any rigid cartridge or stiffening ring.

2. A voice prosthesis according to claim 1 wherein said first and said second biocompatible elastomers comprise silicone.

3. A voice prosthesis according to claim 1, further comprising silver oxide dispersed in said first biocompatible elastomer in a concentration sufficient to retard microbial growth on said first biocompatible elastomer.

4. A voice prosthesis according to claim 1, wherein the silver oxide in the valve seat component (b) is present therein at a concentration that is toxic to human tissue if in direct contact therewith.

5. A voice prosthesis device that conducts air between a trachea and an esophagus of a patient, the voice prosthesis device comprising:

(a) a non-rigid tubular-shaped body portion formed from a first biocompatible elastomer material and defining a forward end comprising a front flange and a rear end comprising a rear flange, wherein said body portion has a first central lumen extending from said forward end to said rear end and comprises a step defining a shoulder;

(b) a molded microbial-resistant valve seat component formed from a second biocompatible elastomer material comprising silver oxide at a concentration sufficient to retard microbial growth on a surface of said valve seat component, wherein said silver oxide is compounded with and substantially dispersed throughout said second biocompatible elastomer material, wherein said molded valve seat component is distinct from said body portion and non-releasably disposed within said central lumen and operably supported by said shoulder of said body portion, wherein said valve seat component defines a second central lumen;

(c) a valve mounted on said valve seat component;

wherein said valve is operable to intermittently seal said second central lumen when said valve contacts a portion of said surface of said valve seat component and operable to open said second central lumen to permit gas to flow therethrough; and

(d) wherein the voice prosthesis device lacks any rigid cartridge or stiffening ring.

6. A voice prosthesis according to claim 5 wherein said first and said second biocompatible elastomers comprise silicone.

7. A voice prosthesis according to claim 5 further comprising silver oxide dispersed in said first elastomer in a concentration sufficient to retard microbial growth on said first elastomer.

8. A voice prosthesis according to claim 5, wherein the silver oxide in the valve seat component (b) is present therein at a concentration that is toxic to human tissue if in direct contact therewith.