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US5451372A Expired / Lapsed US ⏱️ 0.0 years remaining

Device for monitoring sterilization process utilizing 100% ethylene oxide

Assignee: 3M Co
•
Filing: 1993-08-20
•
Granted: 1995-09-19
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Expires: 2013-08-20
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Abstract

Abstract A device is disclosed for monitoring an ethylene oxide sterilization process in which 100% ethylene oxide is utilized as the sterilant comprising a wick impregnated with an ethylene oxide responsive chemical compound, a quantifier and a pH sensitive dye; an ethylene oxide impervious backing strip upon which the wick is mounted; and a cover strip having an ethylene oxide impervious film. The backing and cover strip are adhered to one another, and in intimate contact with and sealed to the wick. At least one of the cover strip and backing strip having a centrally located perforation through which the ethylene oxide sterilant can access the wick.

Inventors

  • 👤 Raymond P. Larsson
  • 👤 Judith Nieves

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-09 15:38
CPC Classifications
A; A61; A61L; A61L2/00; A61L2/26; A61L2/28; A61L2/16; A61L2/20; A61L2/206; G; G01; G01N; G01N31/00; G01N31/22; G01N31/226

Claims Analysis

Total Claims: 20
Claim 1
Independent Claim 124 words
A device for monitoring an ethylene oxide sterilization process in which 100% ethylene oxide is utilized as the sterilant comprising: (a) a wick means, said wick means being impregnated with an ethylene oxide responsive chemical compound, a quantifier and a pH sensitive dye; (b) an ethylene oxide impervious backing strip upon which the wick means is mounted; and (c) a cover strip comprising an ethylene oxide impervious film; said backing and cover strip being adhered to one another, and in intimate contact with and sealed to the wicking means; at least one of said cover strip and backing strip having a centrally located perforation of about 0.3 to about 1.6 mm in diameter, through which the ethylene oxide sterilant can access the wick means.
Claim 2
Independent Claim 124 words
A device for monitoring an ethylene oxide sterilization process in which 100% ethylene oxide is utilized as the sterilant comprising: (a) a wick means, said wick means being impregnated with an ethylene oxide responsive chemical compound, a quantifier and a pH sensitive dye; (b) an ethylene oxide impervious backing strip upon which the wick means is mounted; and (c) a cover strip comprising an ethylene oxide impervious film; said backing and cover strip being adhered to one another, and in intimate contact with and sealed to the wicking means; at least one of said cover strip and backing strip having a centrally located perforation of about 0.3 to about 1.6 mm in diameter, through which the ethylene oxide sterilant can access the wick means.
Claim 3
Dependent Claim 19 words
The device according to claim 1 wherein the quantifier is tartaric acid, oxalic acid, citric acid or sodium bisulfate.
Claim 4
Dependent Claim 25 words
The device according to claim 1 wherein the ethylene oxide responsive chemical compound is MgCl 2 , FeCl 2 , ZnCl 2 or hydrates thereof.
Claim 5
Dependent Claim 19 words
The device according to claim 1 wherein the ethylene oxide responsive chemical compound is MgCl 2 .6H 2 O.
Claim 6
Dependent Claim 21 words
The device according to claim 1 wherein the backing strip and cover strip are adhered to one another by heat sealing.
Claim 7
Dependent Claim 22 words
The device according to claim 1 wherein the cover strip and backing strip are sealed to the wicking means by heat sealing.
Claim 8
Dependent Claim 22 words
The device according to claim 1 wherein the pH sensitive dye has at least one pK a value of less than 7.
Claim 9
Dependent Claim 23 words
The device according to claim 1 wherein the pH sensitive dye is bromphenol blue, thymol blue, xylenol blue or the sodium salt thereof.
Claim 10
Dependent Claim 24 words
The device according to claim 1 wherein the backing strip and cover strip comprise a laminate of ethylene glycol-terephthlate polyester and a polyethylene ionomer.
Claim 11
Dependent Claim 71 words
The device according to claim 1 wherein (a) the ethylene oxide responsive chemical compound is MgCl 2 .6H 2 O; (b the quantifier is tartaric acid; (c) the wick means comprises a paper strip on a carrier film; (d) the pH sensitive dye is bromphenol blue, sodium salt; and (e) the ethylene oxide impervious cover strip and backing strip are comprised of a laminate of ethylene glycol-terephthlate polyester and polyethylene ionomer.
Claim 12
Dependent Claim 37 words
The device according to claim 10 wherein the cover strip and backing strip are adhered to one another by heat sealing and the cover strip and backing strip are sealed to the wick means by heat sealing.
Claim 13
Dependent Claim 54 words
The device according to claim 1 wherein the wick means has been impregnated from a solution comprising about 110 to about 160 grams per liter of ethylene oxide responsive chemical compound, about 53 to about 82 grams per liter of quantifier and about 0.7 to about 1.1 grams per liter of pH sensitive dye.
Claim 14
Dependent Claim 54 words
The device according to claim 1 wherein the wick means has been impregnated from a solution comprising about 120 to about 155 grams per liter of ethylene oxide responsive chemical compound, about 58 to about 78 grams per liter of quantifier and about 0.8 to about 1.0 grams per liter of pH sensitive dye.
Claim 15
Dependent Claim 19 words
The device according to claim 1 wherein the perforation has a diameter of about 0.5 to about 0.9 mm.
Claim 16
Dependent Claim 18 words
The device according to claim 1 wherein the wick means dimensions are about 1 inch by four inches.
Claim 17
Dependent Claim 36 words
The device according to claim 1 wherein the perforation passes through the cover strip as well as the backing strip, and the perforation in the backing strip is sealed by a second ethylene oxide impervious layer.
Claim 18
Dependent Claim 19 words
The device according to claim 1 wherein the perforation has a diameter of about 0.4 to about 1.2 mm.
Claim 19
Dependent Claim 19 words
The device according to claim 1 wherein the perforation has a diameter of about 0.4 to about 1.2 mm.
Claim 20
Dependent Claim 28 words
The device according to claim 1 wherein the wick means is of a dimension of about 3 inches by 3/4 inches to about one inch by 4 inches.

References Cited (Backward Citations)

US4138216A Cited
US4138216B1 Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1998-09-18 1999-03-20 1999-09-19 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2002-09-18 2003-03-20 2003-09-19 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2006-09-18 2007-03-20 2007-09-19 $7700.00 Window Closed / Lapsed

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