Process for dry sterilization of medical devices and materials

• US 4,976,920 A
• Filed: 03/31/1989
• Issued: 12/11/1990
• Est. Priority Date: 07/14/1987
• Status: Expired due to Fees

• Current Assignee: Adir Jacob
• Original Assignee: Adir Jacob
• Inventors: Jacob, Adir
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): ALEXANDER, LYLE
• Application Number:
  US07/331,438
• Time in Patent Office: 620 Days
• Field of Search: 422/21-23, 204/164, 250/424, 250/492
• US Class Current: 422/23
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases
• CPC Class Codes: Y10S 422/906 Plasma or ion generation means
• CPC Class Codes: Y10S 422/907 Corona or glow discharge means

Abstract

A process for dry sterilization of medical or dental devices and materials in which these materials are subjected to an electrical discharge in a gaseous atmosphere to produce an active low temperature plasma for surface sterilization and treatment of the devices and materials.

Claims

1. A method for sterilization and treatment of medical and dental devices and materials comprising the steps of,

placing said devices and materials within a first fluid cooled metallic perforated electrode, said electrode being positioned within, and spaced from a gas-tight confining chamber,

evacuating said chamber to a substantially low pressure and introducing a gas into said chamber,

initiating an electrical discharge in said gas within said chamber by application of an RF voltage between said internal perforated electrode and across the chamber wall, creating a gas plasma accompanied by a substantially field-free and glowless volume within the perforated electrode containing said devices and materials, whereby said devices and materials are contacted by a substantially electrically neutral active species at a temperature below that which would be detrimental to said devices and materials,

maintaining said gas plasma for a controlled period of time,

maintaining a flow of said gas through said chamber;

and

withdrawing said devices and materials from said chamber.

2. A method in accordance with claim 1 wherein said gas-tight confining chamber is fluid cooled.

3. A method in accordance with claim 1 wherein said gas tight chamber is formed of metal and is connected to a point of potential reference.

4. A method in accordance with claim 3 wherein said gas-tight confining chamber is fluid cooled.

8. A method in accordance with any one of claims 1, 3, 5, 6, and 7 wherein said devices and materials are enclosed within sealed pouches formed of gas-permeable material while said pouches containing said materials and devices are within said chamber.

9. A method in accordance, with any one of claims 1, 3, 5, 6, and 7 wherein said gas comprises one or more of the group of gases consisting of:

hydrogen;

oxygen;

nitrogen;

hydrogen-oxygen mixtures;

hydrogen-oxygen-inert gas mixtures;

oxygen-nitrogen mixtures;

oxygen-nitrogen-inert gas mixtures;

nitrogen-hydrogen mixtures;

nitrogen-hydrogen-inert gas mixtures;

oxygen-nitrogen-hydrogen mixtures;

oxygen-nitrogen-hydrogen-inert gas mixtures;

oxygen-helium mixtures;

nitrogen-helium mixtures;

hydrogen-helium mixtures;

oxygen-organohalogen mixtures;

oxygen-organohalogen-inert gas mixtures;

oxygen-organohalogen-nitrogen mixtures;

oxygen-inorganic halogen mixtures;

oxygen-inorganic halogen-inert gas mixtures;

oxygen-inorganic halogen-nitrogen mixtures;

oxygen-inorganic oxyhalogenated compound mixtures;

oxygen-inorganic oxyhalogenated compound-inert gas mixtures;

oxygen-inorganic oxyhalogenated compound-nitrogen mixtures, helium, argon, helium-argon mixtures.

10. A method in accordance with any one of claims 1, 3, 5, 6, and 7 and wherein said gas comprises water vapor in excess of 100 ppm as a constituent in a binary mixture with any one of the groups of gases consisting of oxygen, nitrogen, argon or a halogen.

5. A method for sterilization and treatment of medical and dental devices and materials comprising the steps of,

placing said devices and materials within a first fluid cooled metallic perforated electrode, said electrode being positioned within and spaced from a gas-tight confining chamber, said chamber enclosing a fluid cooled second perforated metallic electrode positioned between and spaced apart from said gas-tight chamber and said first perforated electrode,

evacuating said chamber to a substantially low pressure and introducing a gas into said chamber,

initiating an electrical discharge in said gas within said chamber by application of an RF voltage between said second perforated electrode are across said chamber wall, creating a gas plasma accompanied by a substantially field-free and glowless volume within said first perforated electrode containing said devices and materials, whereby said devices and materials are contacted by substantially electrically neutral active species at a temperature below that which would be detrimental to said devices and materials,

maintaining said gas plasma for a controlled period of time, and

maintaining a flow of said gas through said chamber;

withdrawing said devices and material from said first perforated electrode.

6. A method in accordance with claim 5 wherein said gas-tight confining chamber is fluid cooled.

7. A method in accordance with claim 5 wherein said gas-tight chamber is formed of metal and is connected to a point of potential reference.

11. A method for sterilization and treatment of medical and dental devices and materials comprising the steps of,

placing said devices and materials on a generally planar fluid cooled metallic electrode, said electrode being positioned within a gas-tight confining chamber, said chamber being made of metal and connected to a point of potential reference, the internal surface area of said chamber being substantially larger than the surface area of said planar electrode,

further including a perforated metallic enclosure within said chamber, said perforated enclosure being insulated from, but surrounding and containing said planar electrode and said devices and materials positioned thereon, said enclosure being connected to said point of potential reference, whereby said devices and materials are contacted by a substantially electrically neutral active species at a temperature that which could be detrimental to said devices and materials,

evacuating said chamber to a substantially low pressure and introducing a gas into said chamber,

initiating an electrical discharge in said gas within said chamber by application of an RF voltage between said planar electrode and said point of potential reference creating a gas plasma,

maintaining said gas plasma for a controlled period of time,

maintaining a flow of said gas through said chamber;

and

withdrawing said devices and materials from said chamber.

12. A method in accordance with claim 11 wherein said gas-tight confining chamber is fluid cooled.

13. A method in accordance with either of claims 11 or 12 wherein said gas comprises one or more of the groups of gases consisting of:

hydrogen;

oxygen;

nitrogen;

hydrogen-oxygen mixtures;

hydrogen-oxygen-inert gas mixtures;

oxygen-nitrogen mixtures;

oxygen-nitrogen-inert gas mixtures;

nitrogen-hydrogen mixtures;

nitrogen-hydrogen-inert gas mixtures;

oxygen-nitrogen-hydrogen mixtures;

oxygen-nitrogen-hydrogen-inert gas mixtures;

oxygen-helium mixtures;

nitrogen-helium mixtures;

hydrogen-helium mixtures;

oxygen-organohalogen mixtures;

oxygen-organohalogen-inert gas mixtures;

oxygen-organohalogen-nitrogen mixtures;

oxygen-inorganic halogen mixtures;

oxygen-inorganic halogen-inert gas mixtures;

oxygen-inorganic halogen-nitrogen mixtures;

oxygen-inorganic oxyhalogenated compound mixtures;

oxygen-inorganic oxyhalogenated compound-inert gas mixtures;

oxygen-inorganic oxyhalogenated compound-nitrogen mixtures, helium, argon, helium-argon mixtures.

14. A method in accordance with either claims 11 or 13 wherein said medical devices and materials are enclosed within pouches made of permeable material.

15. A method in accordance with either of claims 11 or 13 wherein said gas comprises water vapor in excess of 100 ppm in a binary mixture with any one of the groups of gases consisting of oxygen, nitrogen, argon or a halogen.

16. A method for sterilization and treatment of narrow bore, elongated and generally tubular devices comprising the steps of,

placing a said device within a generally cylindrical, narrow, elongated gas-tight confining chamber, said chamber having an inside diameter at least one and one half times that of the outer diameter of said elongated device, said chamber being plugged at both ends with gas permeable membranes, said membranes being impervious to microorganisms, said plugged chamber being removably connected through said membranes to a gas delivery system at one end thereof and to a gas exhaust system at the other end thereof,

evacuating said chamber through said gas exhaust system to a substantially low pressure and introducing a gas from said gas delivery system into said chamber,

initiating an electrical discharge in said gas within said chamber by application of a high frequency electromagnetic field in close proximity to said chamber, creating a gas plasma within said chamber, whereby said elongated device is contacted by plasma active species along its entire outer and inner surfaces at a temperature below that which would be detrimental to said device,

maintaining said gas plasma for a controlled period of time,

maintaining a flow of said gas through said chamber,

disconnecting said chamber from said gas delivery and exhaust systems, without removal of said membranes from said chamber and

withdrawing said chamber from said proximity of said electromagnetic field, and storing said device within said membrane-sealed chamber.

17. A method in accordance with claim 16 wherein said gas-tight confining chamber is fluid cooled.

18. A method in accordance with claim 16 wherein said gas comprises one or more of the group of gases consisting of:

hydrogen;

oxygen;

nitrogen;

hydrogen-oxygen mixtures;

hydrogen-oxygen-inert gas mixtures;

oxygen-nitrogen mixtures;

oxygen-nitrogen-inert gas mixtures;

nitrogen-hydrogen mixtures;

nitrogen-hydrogen-inert gas mixtures;

oxygen-nitrogen-hydrogen mixtures;

oxygen-nitrogen-hydrogen-inert gas mixtures;

oxygen-helium mixtures;

nitrogen-helium mixtures;

hydrogen-helium mixtures;

oxygen-organohalogen mixtures;

oxygen-organohalogen-inert gas mixtures;

oxygen-organohalogen-nitrogen mixtures;

oxygen-inorganic halogen mixtures;

oxygen-inorganic halogen-inert gas mixtures;

oxygen-inorganic halogen-nitrogen mixtures;

oxygen-inorganic oxyhalogenated compound mixtures;

oxygen-inorganic oxyhalogenated compound-inert gas mixtures;

oxygen-inorganic oxyhalogenated compound-nitrogen mixtures, helium, argon, helium-argon mixtures.

19. A method in accordance with claim 16, wherein said gas comprises a binary mixture of water vapor in excess of 100 ppm as a constituent and one of the group of gases consisting of oxygen, nitrogen, argon or a halogen.

20. A method in accordance with any one of claims 16, 18 or 19 wherein said devices are enclosed within gas-permeable sealed pouches during processing.