Process and apparatus for dry sterilization of medical devices and materials

• US 5,451,368 A
• Filed: 04/01/1994
• Issued: 09/19/1995
• Est. Priority Date: 02/25/1987
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Adir Jacob
• Inventors: Jacob, Adir
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/221,843
• Time in Patent Office: 536 Days
• Field of Search: 422/22, 422/23, 422/33, 422/37, 204/164, 250/455.1
• US Class Current: 422/23
• CPC Class Codes: A61L 2/12 Microwaves
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases

Abstract

Articles intended for dry sterilization are placed into a confined volume and are subjected to neutral species of an electrical plasma discharge while maintaining the volume glowless and substantially field free by interposing a barrier between the articles and the discharge, the barrier being transparent to neutral species and opaque to charged species emanating from the discharge.

Claims

1. Apparatus for sterilizing articles, comprising:

a gas-confining chamber constructed and arranged for containing an electrical discharge which includes substantially electrically neutral active species;

an article-containing zone positioned to receive substantially neutral active species from said electrical discharge; and

barrier means between said zone and said discharge, said barrier means being transparent to said substantially neutral active species and opaque to charged species;

said barrier means comprising a first electrode and said chamber comprising a second electrode, said first and second electrodes constituting means for initiating an electrical discharge within said chamber.

2. Apparatus according to claim 1, further including a source of gas associated with said chamber constructed and arranged to provide a stream of flowing gas to said chamber and an energy source associated with said first and second electrodes positioned to couple energy into said gas.

3. Apparatus according to claim 1, wherein said zone is defined by said barrier.

4. Apparatus according to claim 3, wherein the cross sectional configuration of said zone is similar to the cross sectional configuration of said chamber.

5. Apparatus according to claim 3, further including a source of gas associated with said chamber constructed and arranged to provide a stream of flowing gas to said chamber and an energy source associated with said first and second electrodes positioned to couple energy into said gas.

6. A method for sterilization of medical devices and materials comprising steps of:

placing said devices and materials within a gas-tight confining chamber wherein said chamber is formed at least in part from a metal wall and includes an internal perforated metallic element positioned within said 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 RF energy between said metal chamber wall and said internal perforated metallic element, creating a gas plasma; and

maintaining said gas plasma for a controlled period of time, said perforated metallic element creating a field free and glowless volume within said chamber, said devices and materials being placed within said field free and glowless volume.

7. A method in accordance with claim 6 and further including a second perforated metallic element, said first perforated element being positioned between said chamber wall and said second perforated metallic element, said second perforated element and said chamber wall being electrically connected together to a point of potential reference, said RF energy being applied between said first perforated metallic element and said point of potential reference.

8. A method in accordance with claim 6 including the steps of:

enclosing said medical devices and materials within pouches formed of gas permeable materials;

said pouches enclosing said medical devices and materials being placed within said field free and glowless volume.

9. A method in accordance with claim 6, wherein said gas is flowed through said chamber during said discharge.

10. A method for sterilization of medical devices and materials comprising the steps of:

placing said devices and materials within a gas-tight confining chamber wherein said chamber includes an internal perforated metallic element positioned within said 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, creating a gas plasma, wherein said discharge is powered by a microwave energy source; and

maintaining said gas plasma for a controlled period of time, said perforated metallic element creating a field free and .glowless volume within said chamber, said devices and materials being placed within said field free and glowless volume.

11. A method in accordance with claim 10, wherein said internal perforated metallic element is inserted within said chamber downstream and away from said microwave energy source thereby providing a substantially field-free and glowless volume within said chamber downstream of said microwave energy, and wherein said devices and materials are placed within said substantially field-free and glowless volume.

12. A method in accordance with claim 10, including the steps of:

enclosing said medical devices and materials within pouches formed of a gas permeable materials;

said pouches enclosing said medical devices and materials being placed within said field free and glowless volume.

13. A method in accordance with claim 10, wherein said gas is flowed through said chamber during said discharge.

14. Apparatus for sterilization of medical devices and materials in a gas plasma comprising:

a gas confining chamber;

a microwave energy source positioned to couple microwave energy into said chamber;

an internal metallic element positioned within said chamber such that it provides a portion of the internal volume of said chamber electrically shielded from said microwave energy but formed to allow electrically neutral gaseous species to flow into said portion, thereby providing a substantially field-free and glowless zone, and

means for holding said medical devices and materials to be sterilized within said internal shielded portion of said chamber volume.

15. Apparatus in accordance with claim 14, wherein said chamber is metallic except for a non-metallic portion of said chamber wherein the microwave energy is coupled into said chamber.