Medical devices having antimicrobial properties

• US 20050256573A1
• Filed: 11/15/2004
• Published: 11/17/2005
• Est. Priority Date: 04/11/2001
• Status: Active Grant

• Current Assignee: Freudenberg Medical, LLC (Freudenberg & Company KG)
• Original Assignee: Helix Medical LLC (Freudenberg & Company KG)
• Inventors: Nelson, Jesse N., Seder, Edmund V.
• Granted Patent: US 7,520,897 B2
• Time in Patent Office: Days
• 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 2300/104 Silver, e.g. silver sulfadiazine
• CPC Class Codes: A61L 2300/202 with halogen atoms, e.g. triclosan, povidone-iodine
• CPC Class Codes: A61L 2300/21 Acids
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

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.

Claims

1. A voice prosthesis device comprising in combination:

a first body portion having a first surface portion in direct contact with stoma tissue; and

a valve portion having a second surface in fluid contact with said tissue;

the material forming said body and valve comprising a medical grade silicone elastomer;

the first body portion comprises a tubular voice prosthesis having a central channel and the second body comprises a valve disposed within said channel and in which the outer surface of the tubular voice prosthesis is the first surface and the outer surface of the valve is the second surface, said valve containing a dispersion of antimicrobial agent.

2. A voice prosthesis device according to claim 1 in which the antimicrobial agent is selected from the group consisting of inorganic particles of metals having antimicrobial properties and oxides, salts and halides thereof and an organic antimicrobial material.

7. A voice prosthesis device in which the valve is mounted within a hard cartridge. A method of increasing the life of a valve having an outside surface not in contact with tissue mounted on a cartridge or a ring having an inside surface not in contact with tissue disposed in a channel through the body of a voice prosthesis, the outside surface of the body being in direct contact with tissue comprising the steps of:

providing antimicrobial activity in the valve by dispersing an inorganic or organic additive at a level that is effective to retard detrimental microbial growth; and

disposing the valve or cartridge within said channel.

9. A voice prosthesis for use in contact with tissue comprising in combination:

a tubular body having a central channel and an annular wall having an inside surface not in contact with tissue and an outside surface in contact with tissue;

a valve having an inside surface and an outside surface and being mounted to seal and intermittently open said channel, said outside surface of the valve being in contact with body fluids; and

the outside surface of the valve not being in direct contact with tissue and having a dispersion of agent throughout the valve at a level that would irritate or be toxic to that tissue.

3. A voice prosthesis device according to claim 5 in which the organic antimicrobial material is selected from unsaturated alihatic acid salts thereof, halogenated hydroxy aromatic acids, esters thereof and aromatic ethers.

4. A voice prosthesis device according to claim 9 or 10 in which the metal, salt or oxide thereof is present in an amount from 5 to 50 phr and the organic antimicrobial material is present in an amount from 0.2 to 5% by weight.

5. A prosthetic device according to claim 10 in which the organic antimicrobial material selected from the group consisting of butyl paraben and triclosan.

6. A prosthetic device according to claim 9 in which the inorganic particles comprise silver oxide.

10. A voice prosthesis according to claim 9 in which said body and said valve are formed of a silicone elastomer.

11. A voice prosthesis according to claim 10 in which the antimicrobial material is selected from metal salts, metal oxides and organic antimicrobial materials.

12. A voice prosthesis according to claim 11 in which the material is selected from silver oxide in an amount from 6 to at least 50 phr and butyl paraben or triclosan in an amount from 0.2 to 5% by weight dispersed in the resin forming the valve.

13. A voice prosthesis according to claim 10 in which the valve is mounted within a cartridge and further including a metal sleeve mounted on the cartridge surrounding the portion of the cartridge enclosing the valve.

14. A method of uniformly dispersion a silver oxide antimicrobial agent in a silicone valve for a voice prosthesis comprising the step of adding a polymerization inhibitor to the silicone resin material before curing the vavle.

8. A method according to claim 14 in which the microbial surface is provided by also dispersing an antimicrobial agents in at least one of the cartridge or ring.