Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Reexamination Certificate
1998-12-23
2001-12-04
Warden, Sr., Robert J. (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
Reexamination Certificate
active
06325968
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to the decontamination arts. It finds particular application in conjunction with powdered reagents which are reacted in situ to form a liquid sterilant solution for sterilizing or disinfecting medical instruments and equipment and will be described with particular reference thereto. It should be appreciated, however, that the invention is also applicable to a wide variety of technologies in which at least two components or reagents are kept separate until time of use and then combined through dissolution in a common solvent.
Disinfection connotes the absence of pathogenic life forms. Sterilization connotes the absence of all life forms, whether pathogenic or not. The term decontamination is used herein to connote sterilization, disinfection or other antimicrobial treatments.
Heretofore, medical equipment and instruments have often been decontaminated in a steam autoclave. Autoclaves kill life forms with a combination of high temperature and pressure. However, steam autoclaves have several drawbacks. The high temperature pressure vessels tend to be bulky and heavy. The high temperature and pressure tends to curtail the useful life of endoscopes, rubber and plastic devices, lenses, and portions of devices made of polymeric materials and the like. Moreover, a typical autoclave decontaminating and cool down cycle is sufficiently long that multiple sets of the medical instruments are commonly required.
Instruments which cannot withstand the pressure or temperature of the oven autoclave are often decontaminated with ethylene oxide gas, particularly in larger medical facilities or hospitals. However, the ethylene oxide decontamination technique also has several drawbacks. First, the ethylene oxide decontamination cycle tends to be even longer than the steam autoclave cycle. Another drawback is that ethylene oxide decontamination is sufficiently sophisticated that trained technicians are commonly required, making it unsuitable for physician and dental offices and for other smaller medical facilities. Moreover, some medical equipment can not be decontaminated with ethylene oxide gas.
Liquid decontamination systems have also been utilized for equipment which could not withstand the high temperatures of steam decontamination. Commonly, a technician mixes a liquid disinfectant composition immediately prior to use and manually immerses the items to be decontaminated. The high degree of manual labor introduces numerous uncontrolled and unreported variables into the process. There are quality assurance problems with the weakening of the decontaminant chemicals due to aging on the shelf, and technician errors in the mixing of decontaminant, control of immersion times, rinsing of residue, exposure to the ambient atmosphere after the rinsing step, and the like. On occasion, powdered reagents are carried away from the mixing region and deposited in undesired locations before they dissolve or react. When systems are used for decontaminating medical instruments, undissolved reagent particles remaining on the medical instruments after a decontamination cycle are considered undesirable.
U.S. Pat. No. 5,662,866 to Siegel, et al. discloses a two-compartment cup for powdered sterilant reagent components. An outer cup holds a first reagent while an inner cup, disposed within the outer cup, holds a second reagent. Peripheral walls of inner and outer cups are affixed together at their open ends at flanges. A permeable sheet is affixed to the inner cup portion flange for ventedly sealing both cups. The outer cup is closed at its base by a first detachable base and the inner cup similarly closed by a second detachable base. In use, the two bases are opened to allow mixing of the two reagents. The two-compartment cup ensures sterilization or disinfection with a reproducible, pre-measured dose of reagents, while also facilitating handling and shipping of the reagents.
The present invention provides for a new and improved two compartment package which does not require detachment of first and second compartment bases and which is ideal for storing powdered reagents which are retained separately until time of use and are released in solution when a solvent is passed through both compartments.
SUMMARY OF THE INVENTION
In accordance with one aspect of the present invention, a multi-compartment package for holding powdered reagents which interact with water to form an anti-microbial solution is provided. The package includes:
a) an outer, first container portion including a first peripheral wall which defines a base extending to a continuous side with an opening at an end, and
b) an inner, second container portion including a second peripheral wall which defines a base extending to a continuous side with an opening at an end.
The first and second container portions are configured such that the second peripheral wall abuts and is connected to the outer first container portion adjacent the end of the first peripheral wall. A top cover covers the openings in the first and second container portions. The first and second peripheral walls are configured such that a first powdered reagent receiving chamber is defined in the first container portion for receiving a first reagent and a second powdered reagent receiving chamber is defined in the second container portion for receiving a second reagent. The first peripheral wall includes a region which is formed from a first material which is impermeable to the first reagent but is permeable to water and to solutions containing dissolved reagents. The second peripheral wall includes a region which is formed from a second material which is impermeable to the first and second reagents but is permeable to water and to solutions containing dissolved reagents.
In accordance with another aspect of the present invention, a flow-through reagent cartridge for holding powdered reagents which interact with a solvent to form an anti-microbial solution is provided. The cartridge includes:
a) a first reagent receiving compartment which receives a first particulate reagent and is sealed against escape of the first particulate reagent received therein and which selectively releases dissolved reagent and
b) a second reagent receiving compartment which receives and is sealed against escape of a second particulate reagent received therein and which selectively releases dissolved reagent.
The cartridge is configured for selectively holding the first and second powdered reagents separately within the cartridge and for permitting dissolved first and second reagents to pass out of the cartridge.
In accordance with yet another aspect of the present invention, a multi compartment package for separately holding a first reagent and a second reagent which react in water to form an anti-microbial solution is provided. The package includes:
a) a first container which holds the first reagent, the first container defining an inlet region through which water is received and an outlet region through which water and dissolved first reagent are discharged,
b) a second container which holds the second reagent, the second container defining an inlet region through which water is received and an outlet region through which water and at least dissolved second reagent are discharged, and
c) a porous medium which permits the passage of water, the anti-microbial solution, and water with dissolved first and second reagents, and which blocks the passage of undissolved first and second reagents, the porous medium being disposed at the first container inlet region and at the second container outlet region.
In accordance with a still further aspect of the present invention a method is provided. The method includesmetering a preselected volume of a first powdered reagent into a first container, the first container including a region of a first porous material which is impermeable to the first reagent but is permeable to water and to aqueous solutions containing dissolved reagents. The method further includes inserting a second container into the first container, the s
Christopher Todd A.
Fricker Christopher M.
Jusek Michael F.
Minerovic David E.
Schindly Brian E.
Chorbaji Monzer R.
Steris Corporation
Warden, Sr. Robert J.
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