Method and apparatus for rapid sterilization of material

• US 5,019,359 A
• Filed: 11/22/1989
• Issued: 05/28/1991
• Est. Priority Date: 04/21/1988
• Status: Expired due to Fees

• Current Assignee: Flexiclave, Inc.
• Original Assignee: Flexiclave, Inc.
• Inventors: Latowicki, Daniel A., Kutner, Barry S.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): McMahon, Timothy M.
• Application Number:
  US07/440,793
• Time in Patent Office: 552 Days
• Field of Search: 219/10.55 E, 422/21, 422/22, 422/28, 422/32, 422/33, 422/294, 422/288, 422/299, 422/305, 250/455.1, 426/107, 426/243, 426/234
• US Class Current: 422/294
• CPC Class Codes: A45C 11/005 Contact lens cases A45C11/046 takes precedence
• CPC Class Codes: A61L 2/20 Gaseous substances, e.g. vapours
• CPC Class Codes: B65D 2581/3489 Microwave reflector, i.e. microwave shield B65D2581/3487 takes precedence
• CPC Class Codes: B65D 2585/545 Contact lenses
• CPC Class Codes: B65D 81/3461 Flexible containers, e.g. bags, pouches, envelopes

Abstract

Method and apparatus for rapidly sterilizing material including articles such as dental handpieces include introducing the article and liquid sterilant solution into a collapsible pouch formed of vapor-impermeable sheet material, sealing the collapsible pouch to form a gas-tight assembly, and vaporizing the liquid sterilant solution by heating it to produce an atmosphere of hot sterilant vapor. The liquid sterilant is introduced into the pouch in a quantity sufficient to create an overpressure when vaporized which is indicated by the collapsible pouch expanding to a distended condition. In one embodiment, the liquid sterilant solution is vaporized by irradiating the gas-tight assembly with microwave radiation in which case the material is sterilized under the combined effects of chemical vapor and microwave irradiation. In other embodiments particularly suited for sterilizing material comprising a plurality of articles, the at least one article is surrounded by shielding, which may be separate from or integrated with the pouch, and which may be provided on or in, i.e. as part of, the sheet material forming the pouch, which presents a barrier to the transmission of microwave radiation. The pouch containing the shielded article or articles and liquid sterilant is sealed and the gas-tight assembly is irradiated with microwave radiation to vaporize the sterilant whereupon the article or articles are sterilized under the effect of chemical vapor.

Claims

1. An assembly for use in sterilizing at least one object by vapor under pressure, including:

a collapsible pouch comprising flexible vapor-impermeable sheet material forming an interior and a sealable opening into said interior through which said at least one object can be introduced into said interior, said sheet material including a first wall portion comprising microwave electromagnetic radiation shield material substantially surrounding and defining a first interior portion of said collapsible pouch which is adapted to receive said at least one object and which is maintained substantially free from microwave electromagnetic radiation during irradiation of said pouch by microwave irradiating means, and a second wall portion comprising microwave electromagnetic radiation transparent material substantially surrounding and defining a second interior portion of said collapsible pouch which is exposed to microwave electromagnetic radiation during irradiation of said pouch by microwave irradiating means; and

means for positioning said pouch such that said first shielded interior portion of said collapsible pouch that is substantially free of radiation during irradiation is elevated to a position that is higher than said second unshielded interior portion of said collapsible pouch which is exposed to said radiation.

2. An assembly as recited in claim 1, wherein said microwave radiation shield material of said first wall portion of said pouch extends continuously from a first end region of said pouch to a central region thereof, and said microwave electromagnetic radiation transparent material of said second wall portion extends from a second end of said pouch opposite from said first end to said central region thereof.

3. An assembly as recited in claim 1 wherein said first and second interior portions of said pouch together comprise the entire interior of said pouch.

4. An assembly as recited in claim 1 wherein said vapor-impermeable sheet material forming said pouch comprises plastic sheet material, and wherein said microwave electromagnetic radiation shield material is applied on said plastic sheet material to form said first wall portion.

5. An assembly as recited in claim 1 wherein said pouch positioning means comprise and elongate platform having leg means at an end region thereof for orienting said platform in an inclined position, said pouch adapted to be supported on said inclined platform with said first shielded interior portion elevated to a position higher than said second unshielded interior portion.

6. Apparatus for sterilizing at least one object by vapor under pressure, comprising:

a collapsible pouch formed of flexible vapor-impermeable sheet material;

said flexible sheet material including a first wall portion comprising microwave electromagnetic radiation shield means substantially surrounding a first interior portion of said collapsible pouch which is thereby shielded from microwave electromagnetic radiation, said sheet material of said pouch including a second wall portion comprising material transparent to microwave radiation substantially surrounding a second non-shielded interior portion of said collapsible pouch;

said first shielded interior portion of said collapsible pouch adapted to receive said at least one object;

said second non-shielded interior portion of said collapsible pouch adapted to receive a quantity of liquid;

said collapsible pouch being sealable after receiving said at least one object and said liquid to form a gas-tight assembly;

said liquid contained within said pouch being of a quantity sufficient to create an overpressure within said gas-tight assembly when vaporized, indicated by said collapsible pouch expanding to a distended condition;

means for irradiating said gas-tight assembly with microwave electromagnetic radiation to vaporize said liquid to produce an atmosphere of hot vapor under pressure in said gas-tight assembly with said shield means presenting a barrier to transmission of substantial microwave electromagnetic radiation to said at least on object thereby preventing arcing or sparking and;

means for positioning said gas-tight assembly during irradiation such that said first shielded interior portion of said collapsible pouch that is substantially free of said radiation is elevated to a position that is higher than said second unshielded interior portion of said collapsible pouch which is exposed to said radiation,

whereby upon irradiating said gas-tight assembly with microwave electromagnetic radiation, said at least one object situated in said first interior portion of said pouch is substantially entirely shielded from said radiation, and said liquid situated in said second interior portion is exposed to said radiation whereupon it is heated and then vaporized thereby, whereupon the vapor moves into said first shielded interior portion of said pouch in which some of said vapor may condense whereupon the condensate then flows downwardly under gravity into said second unshielded interior portion of said pouch in which it is revaporized, whereupon said at least one object is sterilized under the effect of vapor under pressure.

7. Apparatus as recited in claim 6 wherein said shield means comprise a coating of metallic material provided on said first wall portion of said sheet material of said collapsible pouch.

8. Apparatus as recited in claim 6 wherein said collapsible pouch includes means for separating said first and second interior portions of said collapsible pouch, and means for fluidly communicating said first and second interior portions of said collapsible pouch.

9. Apparatus as recited in claim 6 wherein said gas-tight assembly positioning means comprise an elongate platform having leg means at an end region thereof for orienting said platform in an inclined position, said pouch adapted to be supported on said inclined platform with said first shielded interior portion elevated to a position higher than said second unshielded interior portion.

10. Apparatus for sterilizing at least one object by vapor under pressure, comprising:

a gas-tight collapsible pouch formed of flexible vapor-impermeable sheet material at least partially transparent to microwave electromagnetic radiation, said pouch having a sealable opening through which said at least one object can be introduced into the interior thereof;

liquid receivable within said pouch in a quantity sufficient such that when said pouch opening is sealed and said liquid is vaporized, an overpressure is created within said gas-tight pouch which causes said pouch to expand to a visually-apparent distended condition;

means for irradiating said gas-tight pouch with microwave electromagnetic radiation to vaporize said liquid to produce an atmosphere of hot vapor under pressure in said gas-tight pouch which expands said collapsible pouch to a visually-apparent distended condition;

shielding means associated with said collapsible pouch for dividing the interior of said pouch into a first shielded interior portion which is substantially free of said microwave electromagnetic radiation during irradiation of said gas-tight pouch by said irradiating means and a second unshielded interior portion which is exposed to said microwave electromagnetic radiation during irradiation of said gas-tight pouch by said irradiating means, said first interior portion being receivable of said at least one object to be sterilized and said second interior portion being receivable of said liquid, and

means for positioning said gas-tight pouch during irradiation such that said first shielded interior portion of said collapsible pouch that is substantially free of said radiation is elevated to a position higher than said second unshielded interior portion of said collapsible pouch which is exposed to said radiation;

whereby upon irradiating said gas-tight pouch with microwave electromagnetic radiation, said at least one object situated in said first interior portion of said pouch is substantially entirely shielded from said radiation, and said liquid situated in said second interior portion is exposed to said radiation whereupon it is heated and then vaporized thereby, whereupon the vapor moves into said first shielded interior portion of said pouch in which some of said vapor may condense whereupon the condensate then flows downwardly under gravity into said second unshielded interior portion of said pouch in which it is revaporized, whereupon said at least one object is sterilized under the effect of vapor under pressure.

11. Apparatus as recited in claim 10 wherein said pouch positioning means comprise an elongate platform having leg means at an end region thereof for orienting said platform in an inclined position, said pouch adapted to be supported on said inclined platform with said first shielded interior portion elevated to a position higher than said second unshielded interior portion.

12. Apparatus as recited in claim 10, wherein said shielding means and said collapsible pouch comprise an integrated unit.

13. Apparatus as recited in claim 12 wherein said flexible vapor-impermeable sheet material which forms said collapsible pouch includes a first wall portion comprising microwave electromagnetic radiation shield material substantially surrounding and defining said first shielded interior portion of said collapsible pouch which is thereby maintained substantially free from microwave electromagnetic radiation during irradiation of said pouch by said irradiating means, and a second wall portion comprising microwave electromagnetic radiation transparent material substantially surrounding and defining said second unshielded interior portion of said collapsible pouch which is thereby exposed to microwave electromagnetic radiation during irradiation of said pouch by said irradiating means.

14. Apparatus as recited in claim 13 wherein said microwave radiation shield material of said first wall portion of said pouch extends continously from a first end of said pouch to a central region thereof, and said microwave electromagnetic radiation transparent material of said second wall portion of said pouch extends continuously from a second end of said pouch opposite from said first end to said central region thereof.

15. Apparatus as recited in claim 14 wherein said vapor-impermeable sheet material comprises flexible plastic sheet material, and wherein said shield material comprises a coating of metallic material provided on said plastic sheet material comprising said first wall portion of said collapsible pouch.

16. Apparatus as recited in claim 12 wherein said integrated unit comprises said shielding means situated within and fixed to said collapsible pouch.

17. Apparatus as recited in claim 16 wherein said shielding means include a holder member fixed within said collapsible pouch, said holder member defining an interior in fluid communication with the ambient atmosphere and adapted to receive said at least one object.

18. Apparatus as recited in claim 17 wherein said holder member includes a receptacle adapted to receive said at least one object, said receptacle having an insertion opening situated proximate to said pouch opening.

19. Apparatus as recited in claim 18 wherein said receptacle comprises a sheath formed of microwave electromagnetic radiation shield material.

20. Apparatus as recited in claim 10, wherein said shielding means include a holder member defining an interior in fluid communication with the ambient atmosphere and adapted to receive said at least one object.

21. Apparatus as recited in claim 20 wherein said holder member is formed of microwave electromagnetic radiation shield material.

22. Apparatus as recited in claim 21 wherein said holder member comprises a sheath formed of microwave electromagnetic radiation shield material.

23. Apparatus as recited in claim 21 wherein said microwave electromagnetic radiation shield material comprises metallic wire-mesh material.

24. Apparatus as recited in claim 21 wherein said microwave electromagnetic radiation shield material comprises metallic sheet material.

25. Apparatus as recited in claim 21 wherein said microwave electromagnetic radiation shield material comprises metallic foil material.

26. Apparatus as recited in claim 21 wherein said microwave electromagnetic radiation shield material comprises non-metallic sheet material having a metallic coating.

27. Apparatus as recited in claim 20 wherein said holder member includes a receptacle adapted to receive said at least one object and having at least one wall defining said interior, said wall having inner and outer surfaces, and wherein said shielding means further includes microwave electromagnetic radiation shield material surrounding said interior of said receptacle.

28. Apparatus as recited in claim 27 wherein said shield material is situated over said outer surface of said at least one receptacle wall.

29. Apparatus as recited in claim 27 wherein said shield material is situated over said inner surface of said at least one receptacle wall.

30. Apparatus as recited in claim 27 wherein said shield material is embedded within said at least one receptacle wall.

31. Apparatus as recited in claim 27 wherein said receptacle comprises a tubular member.

32. Apparatus as recited in claim 27 wherein said receptacle comprises a rigid box-like member.

33. Apparatus as recited in claim 27 wherein said receptacle includes means for positioning said at least one object within said interior thereof.

34. Apparatus as recited in claim 27 wherein said microwave electromagnetic radiation shield material comprises metallic wire-mesh material.

35. Apparatus as recited in claim 27 wherein said microwave electromagnetic radiation shield material comprises a metallic coating applied on at least one of said inner and outer surfaces of said at least one receptacle wall.