Process for dry sterilization of medical devices and materials

• US 5,741,460 A
• Filed: 06/07/1995
• Issued: 04/21/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Adir Jacob
• Inventors: Jacob, Adir, Wilder, Jonathan Allen
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/482,200
• Time in Patent Office: 1,049 Days
• Field of Search: 422/22, 422/23, 422/28, 250/455.11, 204/164
• US Class Current: 422/22
• CPC Class Codes: A61L 2/14 Plasma, i.e. ionised gases

Abstract

Articles which it is intended to sterilize are placed into a confined volume and are subjected to neutral species of an electrical 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. In a sterilization method wherein a load is exposed within a sterilization zone to active species of a plasma generated in a reaction zone operably associated with said sterilization zone;

the improvement which comprises;

introducing a biocidal fluid in vapor or gas state into said sterilization zone;

exposing said load to said biocidal fluid during a preconditioning phase;

inducing a plasma in said biocidal fluid within said chamber by application of electrical energy; and

contacting said plasma with a textured metal surface while contacting said load with said active species.

2. An improvement according to claim 1, wherein a barrier in the form of a perforated electrically conductive member is interposed between said reaction zone and said sterilization zone.

3. An improvement according to claim 1 wherein said plasma is generated within a gas-confining chamber containing said sterilization zone, said plasma being induced by the application of RF energy.

4. An improvement according to claim 3 wherein said chamber is defined by a surface of aluminum or stainless steel and said sterilization zone is defined by a perforated metallic shield constructed to be transparent to neutral plasma species and opaque to charged plasma species.

5. An improvement according to claim 1 wherein said plasma is generated within a reaction zone separated from said sterilization zone by a barrier constructed to be transparent to neutral plasma species and opaque to charged plasma species.

6. An improvement according to claim 5, wherein said reaction zone comprises an annular volume surrounding said sterilization zone.

7. An improvement according to claim 6, wherein said plasma is induced by the application of RF energy.

8. An improvement according to claim 5, wherein said plasma is induced by the application of microwave energy.

9. An improvement according to claim 5, wherein said load is exposed to a sterilant precursor within said sterilization zone during a preconditioning period, and thereafter energy is applied to said precursor to produce said plasma.

10. An improvement according to claim 9, wherein said precursor is selected from the group consisting essentially of hydrogen peroxide solutions and peracetic acid solutions.

11. An improvement according to claim 10, wherein said sterilization load is exposed to said sterilant precursor for a period of between about 10 minutes and about 8 hours prior to energizing that precursor to form a plasma.

12. An improvement according to claim 10 conducted within apparatus comprising:

a gas-confining chamber constructed and arranged for containing an electrical discharge;

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

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

a portion of said chamber having a textured surface which is rough compared to an unaltered mill surface finish of the material from which said portion is constructed.

13. An improvement according to claim 12, wherein said gas-confining chamber includes a plasma-reaction zone defined in part by an inner surface of said chamber, said inner surface being constructed of a metal selected from the group consisting essentially of stainless steel and aluminum alloys.

14. An improvement according to claim 12, wherein said portion is roughened by means equivalent to sand blasting with abrasive grit.

15. An improvement according to claim 14, wherein said portion is a stainless steel metal surface textured equivalent to being sand blasted with aluminum oxide grit having a grit size of between about 120 and about 300.

16. An improvement according to claim 1 comprising the steps of:

placing medical devices and/or materials within a gas-tight confining chamber wherein said chamber is formed at least in part from a metal wall;

evacuating said chamber to a substantially low pressure, and introducing a biocidal fluid in vapor or gas state into said chamber;

exposing said load to said biocidal fluid during a preconditioning phase;

inducing a plasma in said biocidal fluid within said chamber by application of electrical energy;

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

a portion of the inner surface of said chamber being provided with a textured surface capable of increasing the steady state concentration of active species contacting said load.

17. An improvement according to claim 16, wherein said plasma is initiated adjacent an inner surface of said chamber, and said inner surface has a texture which is rough compared to an unaltered mill surface finish of the material from which said surface is constructed.

18. An improvement according to claim 17, wherein said inner surface is constructed of a metal selected from the group consisting essentially of stainless steel and aluminum alloys.

19. An improvement according to claim 17, wherein said inner surface is roughened by means equivalent to sand blasting with abrasive grit.

20. An improvement according to claim 19, wherein said inner surface is a stainless steel metal surface textured equivalent to being sand blasted with aluminum oxide grit having a grit size of between about 120 and about 300.