Title of Invention

A SYSTEM AND METHOD FOR VISUAL VERIFICATION OF VAPORIZED HYDROGEN PEROXIDE CONCENTRATION WITHIN A CHAMBER

Abstract

A method and apparatus for .sensing the concentration of a gaseous sterilant in a sealable enclosuie. An indicator is provided that has a chemistry such that the indicator changes color when exposed to vaporized hydrogen peroxide (VHP). The cnemistry is adapted to react when exposed to a specific minimum concentration of vaporized hydrogen peroxide for a specific minimum period of time. In this manner, it can be visually determined whether articles (e.g., medical instruments and like devices) located within the sealable enclosure have been exposed to a minimum threshold of vaporized hydrogen peroxide.

Full Text

FORM 2 THE PATENTS ACT, 1970 (39 of 1970) & THE PATENTS RULES, 2003 COMPLETE SPECIFICATION [See section 10, Rule 13] VISUAL DETECTOR FOR VAPORIZED HYDROGEN PEROXIDE; STERIS INC., A CORPORATION ORGANIZED AND EXISTING UNDER THE LAWS OF UNITED STATES OF AMERICA, WHOSE ADDRESS IS 43425 BUSINESS PARK DRIVE. TEMECULA, CA 92590, U.S.A. THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT iS TO BE PERFORMED. Field of the Invention The present invention relates generally to decontamination systems, and more particularly to a method and apparatus for sensing the concentration of a gaseous sterilant in a sealable enclosure. Background of the Invention Conventional, gaseous sterilization systems typically flow a vaporized sterilant through a sealable sterilization chamber. In such systems, it is important to maintain a desired concentration of the gaseous sterilant in the sterilization chamber during a sterilization cycle to effect deactivation of harmful biocontamination, such as viruses, bacteria and prions. When the sterilant of choice is vapor phase hydrogen peroxide, which is typically generated from an aqueous solution of liquid hydrogen peroxide, it is difficult to determine the concentration of vaporized hydrogen peroxide in the sterilization chamber. The present invention provides a method and apparatus for providing a visual indication of the presence of a sterilant in a sterilization chamber. Summary of the Invention In accordance with a preferred embodiment of the present invention, there is provided in an apparatus having a chamber for decontaminating articles by exposing said articles to vaporized hydrogen peroxide (VHP), a system for visually verifying a minimum concentration of vaporized hydrogen peroxide (VHP) in said 2 chamber, said system comprising: (a) a generally continuous web indicator that changes color when exposed to vaporized hydrogen peroxide (VHP), said web indicator having a specific reaction rate based upon a concentration of vaporized hydrogen peroxide (VHP) exposed thereto; and (b) a device for conveying said web indicator through said chamber during a decontamination cycle at a predetermined rate, wherein a portion of said web indicator is continuously exposed to vaporized hydrogen peroxide (VHP) in said chamber for a specific period of time, said rate and period of exposure being set to cause said web indicator to change color if a prede termined concentration of vaporized hydrogen peroxide (VHP) is present in said chamber. In accordance with another aspect of the present invention, there is provided in an apparatus having a chamber for decontaminating articles by exposing said articles to vaporized hydrogen peroxide (VHP), a system for visually verifying a minimum concentration of vaporized hydrogen peroxide (VHP) in said chamber, said system comprising: an indicator that changes color when exposed to vaporized hydrogen peroxide (VHP), said indicator having a specific reaction rate based upon a concentration of vaporized hydrogen peroxide (VHP) exposed thereto. In accordance with still another aspect of the present invention, there is provided in an apparatus having a chamber for decontaminating articles by exposing said articles to vaporized hydrogen peroxide (VHP), a method for visually verifying a minimum concentration of vaporized hydrogen peroxide (VHP) in said chamber, said method comprising the steps of: (a) advancing a generally continuous web indicator through said chamber, and (b) exposing said web indicator to a concentration of vaporized hydrogen peroxide, said web indicator changing color when .exposed to vaporized hydrogen peroxide (VHP), wherein said web indicator has a specific 3 reaction rate based upon the concentration of vaporized hydrogen peroxide (VHP) exposed thereto. In accordance with still another aspect of the present invention, there is provided in an apparatus having a chamber for decontaminating articles by exposing said articles to vaporized hydrogen peroxide (VHP), a system for visually verifying a minimum concentration of vaporized hydrogen peroxide (VHP) in said chamber, said system comprising: (a) introducing vaporized hydrogen peroxide into said chamber, and (b) exposing an indicator to a concentration of vaporized hydrogen peroxide, said indicator changing color when exposed to vaporized hydrogen peroxide (VHP), wherein said indicator has a specific reaction rate based upon the concentration of vaporized hydrogen peroxide (VHP) exposed thereto. An advantage of the present invention is the provision of a method and apparatus for testing a concentration level of vaporized hydrogen peroxide (VHP) in a decontamination chamber. Another advantage of the present invention is the provision of a method and apparatus that provides a visual record of the history of exposure of instruments to VHP in a decontamination system. Another advantage of the present invention is the provision of a method and apparatus that permits a visual determination of whether medical instruments and like devices have been exposed to a minimum threshold of VHP. These and other objects will become apparent from the following description of a prefsrred embodiment taken together with the accompanying drawings and the appended claims. 4 Brief Description of the Drawings The invention may take physical form in certain parts and arrangement of parts, a preferred embodiment of which will be described in detail in the specification and illustrated in the accompanying drawings which form a part hereof, and wherein: FIG. 1 is a partially-sectioned, elevational view of a decontamination system including a treatment chamber and a visual detector system, illustrating a first embodiment of the present invention; FIG. 2 is a partially-sectioned, elevational view of a decontamination system including a treatment chamber and a visual detector system, illustrating a second embodiment of the present invention; and FIG. 3 is a perspective view of a visual detector system comprised of an indicator having a plurality of indicator panels, illustrating still another embodiment of the present invention. Detailed Description of Preferred Embodiment Broadly stated, the present invention is comprised of an indicator having a chemistry such that the indicator changes color when exposed to vaporized hydrogen peroxide (VHP). In one embodiment of the present invention, the indicator is generally comprised of a continuous strip that may be continuously or intermittently conveyed through a treatment chamber during a decontammation (e.g., sterilization) cycle, wherein portions of the indicator are exposed to the atmosphere within the treatment chamber for a predetermined period of time during a decontamination cycle. In another embodiment of the present invention, the indicator may be formed as a 5 stationary strip disposed within a treatment chamber for exposure to the atmosphere within the treatment chamber during a decontamination cycle. The foregoing embodiments of the present invention are based upon the kinetics of the chemistry of the indicator, i.e., the rate at which (and the path by which) a chemical reaction occurs. In this respect, each embodiment of the indicator has a chemistry adapted to react when exposed to a specific minimum concentration of vaporized hydrogen peroxide (VHP) for a specific rninimum period of time. In this respect, the chemistry of an indicator is designed to produce a color change when a desired concentration exists for a set period of time. Such conditions drive a chemical reaction that provides a color change indicative that the minimum desired concentration existed for the desired time period. . When the sterilant of choice is vaporized hydrogen peroxide (VHP), which is commonly generated from an aqueous solution of liquid hydrogen peroxide, it is typically desired to maintain a minimum concentration of vaporized hydrogen peroxide (VHP) in a treatment chamber, as it is the vaporized hydrogen peroxide (VHP) that is the active agent in sterilizing articles (e.g., instruments) within the chamber. Typically, it is desirable to maintain a minimum vapor concentration of at least 500 to 1500 ppm through a decontamination cycle. The chemistry of an indicator is established to cause a color change if at least the minimum concentration of VHP is maintained for a desired period of time. The concentration of vaporized hydrogen peroxide (VHP) present in a treatment chamber is indicative of the number of VHP molecules available to drive a chemical reaction with the indicator. In other words, the higher the concentration of vaporized hydrogen peroxide (VHP), the larger the number of molecules available to interact with the chemistry of the indicator. 6 Referring now to a suitable chemistry for an indicator for exposure to vaporized hydrogen peroxide (VHP), an indicator includes chemistry having an iodide ion (I"), a thiosulfate (S2O32") ion and starch. When this chemistry is exposed to vaporized hydrogen peroxide (H2O2), the vapor phase hydrogen peroxide (H2O2) reacts with iodide ion (T) and hydronium ion (H’) to give a triodide ion (I3") and water. (1) H2O2 + 3I + 2H - I3' + 2H20 The thiosulfate (S2O32") reacts quantitatively with the triodide ion (I3*) and water according to the following: (2) I3- + 2S2O32" - 3I" + S4O62" This latter reaction occurs very rapidly relative to the foregoing reaction. Thus, so long as S2O32" is present on the indicator, the triodide ion (I3") produced by reaction (1) will be converted back to iodide ion (T) by reaction (2). Since reaction (2) occurs very rapidly relative to reaction (1), iodide ions (T) will continue to be produced and exist until the thiosulfate is gone. At that point, triodide ions I3) will accumulate and . immediately produce a blue color. Thus, with the foregoing chemistry, the amount of thiosulfate on the indicator will determine how much vapor phase hydrogen peroxide can react with the thiosulfate within a certain time interval before the color change-occurs;—By determining the desired concentration and the desired VHP exposure time, a concentration of thiosulfate for the indicator can be established, wherein the indicator will change color only when a mnimnm desired concentration of VHP is present for a minimum desired exposure time. Referring now to the drawings wherein the showings are for the purpose of illustrating the preferred embodiment of me invention only, and not for the purpose of limiting same, FIG. 1 shows a decontamination system 10 including a 7 treatment chamber 20 and a visual detector system 30, illustrating a first embodiment of the present invention. Treatment chamber 20 includes an inlet 32 and an outlet 34 for passing vaporized hydrogen peroxide there through. The vaporized hydrogen peroxide may be produced in a vaporization chamber (not shown) from an aqueous solution of liquid hydrogen peroxide. In the illustrated embodiment, articles 5 to be treated with vaporized hydrogen peroxide are located within chamber 20 on a support member 12. Visual detector system 30 is generally comprised of a media advancement means and an indicator 50. In the illustrated embodiment, indicator 50 takes the form of a continuous web arranged on a roll 52. Indicator 50 includes a media (including, but not limited to, paper, a polymer and the like) coated with the indicator chemistry discussed above. In the illustrated embodiment, the media advancement means is comprised of two pairs of rollers 40 driven by a motor 42. A control unit (not shown) controls the operation (i.e., rotation) of motor 42, and thus the advancement of indicator 50. Rollers 40 are located inside chamber 20, and advance indicator 50 through treatment chamber 20. As illustrated in FIG. 1, a portion of indicator 50 enters chamber 20 through a first slot 22A in a wall of chamber 20, is threaded-between the two pairs of rollers 40, and exits chamber 20 through a second slot 22B in a wall of chamber 20. In a preferred embodiment, the generally continuous indicator 50 is conveyed through treatment chamber 20 to allow only a section (i.e., length) of indicator 50 to be exposed to the vaporized hydrogen peroxide (VHP) in chamber 20, for only a portion of the total decontamination cycle time. The chemistry on indicator 50 is designed to change color when a section of indicator 50 within chamber 20 is exposed to the desired concentration of vaporized hydrogen peroxide (VHP). 8 For example, indicator 50 may be dimensioned to be conveyed such mat a given section of indicator 50 is within chamber 20 for only one-fifth (1/5) of the total decontamination cycle, and thus exposed to the vaporized hydrogen peroxide (VHP) within chamber 20 for only one-fifth (1/5) of the total decontamination cycle. If the section of indicator 50 within chamber 20 changes color, it is indicative of the vaporized hydrogen peroxide (VHP) within chamber 20 being at a desired concentration level, for that portion of the cycle time. In this manner, one can visually confirm that a minimum desired concentration level of vaporized hydrogen peroxide (VHP) has been maintained within chamber 20 for this portion of the exposure time. In other words, indicator 50 provides an indication that the vaporized hydrogen peroxide (VHP) concentration within chamber 20 for a given interval of the entire decontamination cycle is at a minium desired concentration level. It should be appreciated that indicator 50 may be conveyed through chamber 20 continuously (i.e., continuously advanced through chamber 20) or intermittently (i.e., periodically advanced through chamber 20). Referring now to FIG. 2, an alternative embodiment of me present invention will be described. Decontamination system 110 includes a treatment chamber 120 and a visual detector system 130, illustrating a second embodiment of the present invention. Treatment chamber 120 includes an inlet 132 and an outlet 134 for passing vaporized hydrogen peroxide mere through. The vaporized hydrogen peroxide may be produced in a vaporization chamber (not shown) from an aqueous solution of liquid hydrogen peroxide. In the illustrated embodiment, articles 5 to be treated with vaporized hydrogen peroxide are located within chamber 120 on a support " member 12. 9 Visual detector system 130 is generally comprised of an indicator 150 in the form of a strip. Indicator 150 includes a media (including, but not limited to, paper, a polymer, and the like) coated with the indicator chemistry discussed above. In a preferred embodiment, a hole 154 is formed in indicator 150 to suspend indicator 150 from the top wall of chamber YJ)t as shown in FIG. 2. The chemistry of indicator 150 is created to cause the strip to change color indicating that the strip has been exposed to a desired average concentration of vaporized hydrogen peroxide (VHP) throughout a decontamination cycle. For example, if indicator 150 is to be disposed within treatment chamber 120 for an entire decontamination cycle, the chemistry of indicator 150 is operable to change color if the strip ?"s exposed to a minimum average concentration of vaporized hydrogen peroxide (VHP) for the decontamination period. Still another embodiment of a visual detector system is shown in FIG. .3. Visual detector system 230 is generally comprised of an indicator 250 taking the form of a strip. The strip is formed of a support media 262 for supporting a plurality of individual indicator panels 270A-270F. By way of example, and not limitation, support media 262 may be formed of paper, a polymer and the like. In the illustrated embodiment, a hole 264 is formed in support media 262 of indicator 250 to facilitate suspension of indicator 250 from the top wall of chamber 120, in the same manner as indicator 150 is suspended in FIG. 2. In accordance with a preferred embodiment, indicator panels 270A-270F are comprised of a media (including, but not limited to,.paper, polymer and the like) coated with the indicator chemistry discussed above. Alternatively, indicator panels 270A-270F may Jake the form of regions of support media 262 coated with the abovementioned indicator chemistry. 10 Indicator panels 270A-270F form an incremental gradient indicator. In this regard, each indicator panel 270A-270F has a respective chemistry that causes each indicator panel 270A-270F to change color, after a different exposure time to a desired average concentration of vaporized hydrogen peroxide (VHP), throughout a decontamination cycle. The amount of thiosulfate on the indicator panel 270A-270F will determine how much vapor phase hydrogen peroxide can react with the thiosulfate within a certain time interval before the color change occurs. Accordingly, the less thiosulfate on the indicator panel, the faster a color change will be observed when the indicator panel is exposed to vapor phase hydrogen peroxide. For example, in the illustrated embodiment, indicator panel 270A has a respective chemistry that causes it to change color after At minutes of exposure to a desired average concentration of vaporized hydrogen peroxide. Likewise, indicator panels 270B, 270C, 270D, 270E, and 270F have respective chemistries that causes them to respectively change color after 2At, 3At, 4At, 5At, and 6At minutes of exposure to a desired average concentration of vaporized hydrogen peroxide. The foregoing description is a specific embodiment of the present invention. It should be appreciated that this embodiment is described for purposes of illustration only, and that numerous alterations and modifications may be practiced by those skilled in the art without departing from the spirit and scope of the invention. It is mended that all such modifications and alterations be included insofar as they come within the scope of the invention as claimed or the equivalents thereof. 11 WE CLAIM 1. In an apparatus having a chamber for decontaminating articles by exposing said articles to vaporized hydrogen peroxide (VHP), a system for visually verifying a minimum concentration of vaporized hydrogen peroxide (VHP) in said chamber, said system comprising: a generally continuous web indicator that changes color when exposed to vaporized hydrogen peroxide (VHP), said web indicator having a specific reaction rate based upon a concentration of vaporized hydrogen peroxide (VHP) exposed thereto; and a device for conveying said web indicator through said chamber during a decontamination cycle at a predetermined rate, wherein a portion of said web indicator is continuously exposed to vaporized hydrogen peroxide (VHP) in said chamber for a specific period of time, said rate and period of exposure being set to cause said web indicator to change color if a predetermined concentration of vaporized hydrogen peroxide (VHP) is present in said chamber. 2. A system according to claim 1, wherein said generally continuous web indicator is continuously advanced through said chamber. 3. A system according to claim 1, wherein said generally continuous web indicator is intermittently advanced through said chamber. 4. . A system according to claim 1, wherein said web indicator includes a chemistry that changes color when exposed to vaporized hydrogen peroxide. 12- 5. A system according to claim 4, wherein said chemistry includes an iodide ion (T), a thiosulfate (S2O32} ion and starch. 6. A system according to claim 5, wherein said chemistry is coated onto a media. 7. A system according to claim 6, wherein said media is selected from the group consisting of: paper and a polymer. 8. A system according to claim 5, wherein said color change is produced by an accumulation of triodide ions I3. 9. A system according to claim 1, wherein said rninimum concentration of the vaporized hydrogen peroxide is at Least 500 to 1500 ppm. 10. In an apparatus having a chamber for decontaminating articles by exposing said articles to vaporized hydrogen peroxide (VHP), a system for visually verifying a minimum concentration of vaporized hydrogen peroxide (VHP) in said chamber, said system comprising: an indicator that changes color when exposed to vaporized hydrogen peroxide (VHP), said indicator having a specific reaction rate based upon a concentration of vaporized hydrogen peroxide (VHP) exposed thereto. 11. • A system according to claim 10, wherein web indicator includes a chemistry that changes color when exposed to vaporized hydrogen peroxide. 13 12. A system according to claim 11, wherein said chemistry includes an iodide ion (T), a thiosulfate (S2O32) ion and starch. 13. A system according to claim :.l, wherein said chemistry is coated onto a media. 14. A system according to claim 13, wherein said media is selected from the group consisting of: paper and a polymer. 15. A system according to claim 10, wherein said color change is produced by an accumulation of triodide ions (I3"). 16. A system according to claim 10, wherein said minimum concentration of the vaporized hydrogen peroxide is at least 500 to 1500 ppm. 17. A system according to claim 10, wherein said indicator includes a plurality of indicator panels, each indicator panel having a respective chemistry that causes each indicator panel to change color after a different exposure time to said minimum concentration of vapor phase hydrogen peroxide. 18. A system according to claim 17, wherein said indicator has N indicator panels, each of said N indicator panels having a respective chemistry that causes a color change after an exposure time of N At minutes. 14 19. In an apparatus having a chamber for decontaminating articles by exposing said articles to vaporized hydrogen peroxide (VHP), a method for visually verifying a minimum concentration of vaporized hydrogen peroxide (VHP) in said chamber, said method comprising the steps of: advancing a generally continuous web indicator through said chamber, and exposing said web indicator to a concentration of vaporized hydrogen peroxide, said web indicator changing color when exposed to vaporized hydrogen peroxide (VHP), wherein said web indicator has a specific reaction rate based upon the concentration of vaporized hydrogen peroxide (VHP) exposed thereto. 20. A method according to claim 19, wherein said generally continuous web indicator is advanced continuously through said chamber. 21. A method according to claim 19, wherein said generally continuous web indicator is advanced intermittently through said chamber. 22. A method according to—claim 19, wherein said web indicator includes a chemistry that changes color when exposed to vaporized hydrogen peroxide. 23. A method according to claim 22, wherein said chemistry includes an iodide ion (T), athiosulfete (S2032") ion and starch. 24. A method according to claim 22, wherein said chemistry is coated onto a media. 15 25. A method according to claim 24, wherein said media is selected from the group consisting of: paper and a polymer. 26. A system according to claim 22, wherein said color change is produced by an accumulation of triodide ions (I3"). 27. A method according to claim 19 wherein said minimum concentration of the vaporized hydrogen peroxide is at least 500 to 1500 ppm. 28. In an apparatus having a chamber for decontaminating articles by exposing said articles to vaporized hydrogen peroxide (VHP), a system for visually verifying a minimum concentration of vaporized hydrogen peroxide (VHP) in said chamber, said system comprising: introducing vaporized hydrogen peroxide into said chamber; and exposing an indicator to a concentration of vaporized hydrogen peroxide, said indicator changing color when exposed to vaporized hydrogen peroxide (VHP), wherein said indicator has a specific reaction rate based upon the concentration of vaporized hydrogen peroxide (VHP) exposed thereto. 29. A method according to claim 28, wherein web indicator includes a chemistry that changes color when exposed to vaporized hydrogen peroxide. 30. A method according to claim 29, wherein said chemistry includes an iodide ion (T), a thiosulfate (S2O32") ion and starch. 16 '31. A method according to claim 29, wherein said chemistry is coated onto a media. 32. A method according to claim 31, wherein said media is selected from the group consisting of: paper and a polymer. 33. A method according to claim 28, wherein said color change is produced by an accumulation of triodide ions (I3). 34.. A method according to claim 28, wherein said minimum concentration of the vaporized hydrogen peroxide is at least 500 to 1500 ppm. 35. A method according to claim 28, wherein said indicator includes a plurality of indicator panels, each indicator panel having a respective chemistry that causes each indicator panel to change color after a different exposure time to said minimum concentration of vapor phase hydrogen peroxide. 36. A method according to claim 35, wherein said indicator has N indicator panels, each of said N indicator panels having a respective chemistry that causes a color change after an exposure time of N At minutes. Dated this 12th day of January, 2006. ABSTRACT i A method and apparatus for .sensing the concentration of a gaseous sterilant in a sealable enclosuie. An indicator is provided that has a chemistry such that the indicator changes color when exposed to vaporized hydrogen peroxide (VHP). The cnemistry is adapted to react when exposed to a specific minimum concentration of vaporized hydrogen peroxide for a specific minimum period of time. In this manner, it can be visually determined whether articles (e.g., medical instruments and like devices) located within the sealable enclosure have been exposed to a minimum threshold of vaporized hydrogen peroxide.

Documents:

46-mumnp-2006-abstract(20-7-2007).doc

46-mumnp-2006-abstract(20-7-2007).pdf

46-mumnp-2006-abstract.doc

46-mumnp-2006-abstract.pdf

46-mumnp-2006-assignment(15-5-2007).pdf

46-mumnp-2006-cancelled page(20-7-2007).pdf

46-mumnp-2006-claim(granted)-(20-7-2007).doc

46-mumnp-2006-claim(granted)-(20-7-2007).pdf

46-mumnp-2006-claims.doc

46-mumnp-2006-claims.pdf

46-mumnp-2006-correspondence(81-2-2008).pdf

46-mumnp-2006-correspondence(ipo)-(31-1-2008).pdf

46-mumnp-2006-correspondence-others.pdf

46-mumnp-2006-correspondence-received-ver-020206.pdf

46-mumnp-2006-correspondence-received-ver-060206.pdf

46-mumnp-2006-correspondence-received-ver-130106.pdf

46-mumnp-2006-correspondence-received-ver-220207.pdf

46-mumnp-2006-correspondence-received.pdf

46-mumnp-2006-correspondence-send.pdf

46-mumnp-2006-description (complete).pdf

46-mumnp-2006-drawings(20-7-2007).pdf

46-mumnp-2006-drawings.pdf

46-mumnp-2006-form 1(12-1-2006).pdf

46-mumnp-2006-form 1(2-2-2006).pdf

46-mumnp-2006-form 1(20-7-2007).pdf

46-mumnp-2006-form 13(12-1-2006).pdf

46-mumnp-2006-form 18(13-1-2006).pdf

46-mumnp-2006-form 2(granted)-(20-7-2007).doc

46-mumnp-2006-form 2(granted)-(20-7-2007).pdf

46-mumnp-2006-form 3(12-1-2006).pdf

46-mumnp-2006-form 5(12-1-2006).pdf

46-mumnp-2006-form 6(15-5-2007).pdf

46-mumnp-2006-form-1.pdf

46-mumnp-2006-form-18.pdf

46-mumnp-2006-form-2.doc

46-mumnp-2006-form-2.pdf

46-mumnp-2006-form-26.pdf

46-mumnp-2006-form-3.pdf

46-mumnp-2006-form-5.pdf

46-mumnp-2006-form-pct-ib-311.pdf

46-mumnp-2006-form-pct-isa-220.pdf

46-mumnp-2006-form-pct-isa-237.pdf

46-mumnp-2006-pct-search report.pdf

46-mumnp-2006-power of attorney(24-1-2006).pdf

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