Antimicrobial gas-releasing ear drainage tubes

• US 8,043,246 B2
• Filed: 09/19/2008
• Issued: 10/25/2011
• Est. Priority Date: 09/21/2007
• Status: Active Grant

• Current Assignee: Enox Biopharma Inc.
• Original Assignee: Enox Biopharma Inc.
• Inventors: Av-Gay, Yossef, Greenberg, David
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Patel; Pritesh
• Application Number:
  US12/234,599
• Publication Number:
  US 20090131883A1
• Time in Patent Office: 1,131 Days
• Field of Search: None
• US Class Current: 604/7
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61L 2300/114 Nitric oxide, i.e. NO
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2430/14 for ear reconstruction or ear implants, e.g. implantable hearing aids
• CPC Class Codes: A61L 31/04 Macromolecular materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/06 for tuberculosis

Abstract

A nitric oxide gas-releasing conduit configured for surgical implantation through a patient'"'"'s tympanic membrane. The nitric oxide gas-releasing conduit comprises a gas-permeable cured resin material configured for releasably sequestering therein gas. The gas-permeable cured resin material is charged with nitric oxide gas. The nitric oxide gas-releasing conduit may be optionally coated with an antimicrobial gas-releasing composition. The gas-releasing coating composition may be configured to release nitric oxide.

Claims

1. A process for producing an antimicrobial gas-releasing conduit suitable for surgical implantation through a patient'"'"'s tympanic membrane, the process comprising:

placing into a sealable chamber, a plurality of selected conduits comprising a gas-permeable cured resin material, said gas-permeable cured resin material configured for releasably sequestering therein permeating antimicrobial gases;

sealing and then controllably saturating said chamber with a selected antimicrobial gas whereby the antimicrobial gas permeates into and is releasably sequestered therein the gas-permeable cured resin material;

controllably evacuating unsequestered antimicrobial gas from said sealed chamber and then unsealing the chamber; and

individually sealing each antimicrobial gas-saturated conduit within a gas-impermeable packaging.

2. A process according to claim 1, wherein said gas-impermeable cured resin comprises a hydrophobic resin material.

3. A process according to claim 1, wherein said gas-impermeable cured resin is selected from the group consisting of curable silicones, polyvinyl acetates, thermoplastic elastomers, acrylonitrile-butadiene-styrene copolymer rubber, polyurethanes and selected combinations thereof.

4. A process according to claim 1, wherein the antimicrobial gas is nitric oxide.

5. The process according to claim 1, wherein said gas-releasing conduit is a tympanostomy tube.

6. The process according to claim 1, wherein said gas-releasing conduit is a myringotomy tube.

7. The process according to claim 1, wherein said gas-permeable cured resin material sequestering therein a permeating antimicrobial gas, is coated with an antimicrobial gas-releasing composition prior to sealing said antimicrobial gas-saturated conduit within a gas-impermeable packaging.

8. The process according to claim 7, wherein said antimicrobial gas-releasing composition is configured to release nitric oxide gas.

9. The process according to claim 7, wherein said antimicrobial gas-releasing composition is selected from the group consisting of nitric oxide gas-releasing intramolecular salts, S-nitrosothiols, compounds provided with N₂O₂⁻

functional groups, and combinations thereof.

10. A process for producing a nitric oxide gas-releasing conduit suitable for surgical implantation through a patient'"'"'s tympanic membrane, the process comprising:

commingling and intermixing a nitric-acid-saturated nitric-acid-chelating compound with a polymeric resin material capable of forming a gas-permeable cured resin;

producing and curing a plurality of nitric oxide gas-releasing conduits from said polymeric resin material intermixed with said nitric-acid-saturated nitric-acid-chelating compound; and

individually packaging and sealing said plurality of nitric oxide gas-releasing conduits into gas-impermeable containers.

11. A process according to claim 10, wherein the nitric-acid chelating compound is selected from the group comprising sodium nitrite, nitrosothiols, dipyridoxyl chelating agents, L-arginine, organic nitrates, organic nitrites, thionitrates, thionitrites, N-oxo-N-nitrosamines, N-nitrosamines, sydnonimines, 2-hydroxyimino-5-nitro-alkenamides, diazenium diolates, oxatriazolium compounds, oximes, syndomines, molsidomine and derivatives thereof, pirsidomine, furoxanes, nitrosonium salts, and combinations thereof.

12. A process according to claim 10, wherein the polymeric resin material is selected from the group consisting of curable silicones, polyvinyl acetates, thermoplastic elastomers, acrylonitrile-butadiene-styrene copolymer rubber, polyurethanes and combinations thereof.

13. The process according to claim 10, wherein said gas-permeable cured resin material sequestering therein nitric oxide gas, is coated with an antimicrobial gas-releasing composition prior to sealing said nitric oxide gas-releasing conduit within a gas-impermeable packaging.

14. The process according to claim 10, wherein said antimicrobial gas-releasing composition is configured to release nitric oxide gas.

15. The process according to claim 10, wherein said antimicrobial gas-releasing composition is selected from the group consisting of nitric oxide gas-releasing intramolecular salts, S-nitrosothiols, compounds provided with N₂O₂⁻

functional groups, and combinations thereof.

16. The process according to claim 10, wherein said conduit-is a tympanostomy tube.

17. The process according to claim 10, wherein said conduit-is a myringotomy tube.