Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Reexamination Certificate
2000-02-07
2002-11-26
Thornton, Krisanne (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
C206S210000, C206S370000, C206S438000, C422S292000, C422S297000, C422S300000
Reexamination Certificate
active
06485684
ABSTRACT:
BACKGROUND OF THE INVENTION
The present application relates to the fluid handling arts. It finds particular application in conjunction with fluid sterilization and disinfection systems and will be described with reference thereto.
Fluid sterilization and disinfection systems are typically designed to cause microbes on the item to be removed or killed, i.e., microbially decontaminated, by a fluid anti-microbial agent. This is achieved in a variety of ways, including immersing the item in a bath of anti-microbial liquid, spraying the item with anti-microbial liquid, surrounding the item with anti-microbial vapor, and the like. While such systems work well for killing microbes on the exterior surface of the items to be decontaminated, internal lumens can be problematic. To be a viable commercial product, a sterilization or disinfection apparatus must provide assured contact between the anti-microbial agent and the microbes. On items with elongated lumens, such as endoscopes, it is desirable that the anti-microbial fluid assuredly contact all surfaces within the lumen. Typically, this is achieved by pumping or drawing the anti-microbial fluid through the lumen.
Often, endoscopes have a plurality of lumens which may have different cross-sections, length, internal obstructions, and the like. It is advantageous to supply the fluid to different lumens at different pressures. Further, some lumens have multiple openings. Typically, plugs are inserted into or over some of the openings to force the anti-microbial fluid to flow the entire length of the lumen. Often, endoscopes have a lumen which does not need to be sterilized and worse yet, can be damaged by contact with fluids. Further, the lumens have a variety of connector styles, such as screw threads, bayonet pipe connectors, and the like, as well as different diameters.
Typically, the sterilization technicians are given a variety of individual plugs and fittings from which they select the most appropriate plugs and fittings for a specific endoscope to be sterilized or disinfected. Being small parts, they are sometimes lost. The technicians, in many cases, improvise by using another part which appears to work. In other cases, the technicians merely make a mistake in selecting fittings or plugs or in making the connections between the fluid supply, fittings, and lumens. When improper plugs or fittings are used and when improper interconnections are made, the assurance that the anti-microbial agent is contacting all microbes within the lumens is lost.
The fittings and plugs typically connect securely with the structures at the lumen ports. At the surfaces of interconnection, microbes can become trapped between the fittings or plugs and the structures at the lumen port. When there is a good frictional fit, the frictional fit protects these microbes from the anti-microbial agent. This creates the possibility that at the end of the cycle there may be active microbes on the surfaces adjacent the lumen ports destroying the assurance of disinfection or sterility. One solution to the trapped microbe problem is shown in U.S. Pat. Nos. 5,552,115 and 5,833,935 of Malchesky in which the fittings and plugs are made of an open-celled plastic material. The porous fitting solution is effective, but does have some drawbacks. First, the porous plastic material is relatively soft. With repeated use, dimensions can change altering flow characteristics. Moreover, the plastic can be damaged or broken during use, again altering flow characteristics. After a disinfection or sterilization cycle, the fittings are typically wet with water from the final rinse. Wet, porous materials can become breeding grounds for airborne microbes if not handled properly. One use, disposable porous connectors and fittings can be costly and there is no assurance that the operator will use a new fitting in each cycle rather than reusing an old one.
The present invention provides a new and improved method and apparatus which overcomes the above-referenced problems and others.
SUMMARY OF THE INVENTION
In accordance with one aspect of the present invention, a fluid disinfection or sterilization system is provided. A chamber receives a lumened article to be microbially decontaminated. A plurality of fluid outlets in the chamber direct an anti-microbial fluid over exterior surfaces of the article. A plurality of fluid ports in the chamber discharge the anti-microbial fluid to supply it to interior lumens of the article. A tethered connection assembly provides for interconnection of the lumens of the article and the fluid ports. The tethered assembly includes a first tube assembly having fittings at its ends. One of the fittings is configured for interconnection with one of the fluid ports and the other fitting is configured for interconnection with a lumen of the article. The tethered connection assembly further includes at least one of (i) a second tube assembly with fittings and (ii) a plug configured for interconnection with a lumen of the article. A tether interconnects the tube assemblies and plugs.
In accordance with another aspect of the present invention, a tethered interconnection assembly is provided for interconnecting lumens of endoscopes with anti-microbial fluid discharge ports of a fluid disinfection or sterilization system. At least one tube assembly includes a tube, a fitting at one end configured for interconnection with an anti-microbial fluid discharge port, and a fitting at another end configured for interconnection with surfaces surrounding a lumen port on the endoscope. At least one plug is configured for interconnection with the surfaces surrounding one of the endoscope lumen ports. A tether is connected with the tube assemblies and the plug. At least one indicia is associated with the tether for indicating at least one of a model of endoscope and a family of endoscope models with which the tether assembly is to be used.
In accordance with another aspect of the present invention, a fluid disinfection or sterilization system is provided. A chamber receives a lumened article to be microbially decontaminated. A plurality of first fluid outlets in the chamber directs anti-microbial fluid over exterior surfaces of the article. At least one second fluid outlet discharges anti-microbial fluid and is configured for interconnection with a first fitting. A tube assembly interconnects the second fluid outlet with surfaces adjacent a port to a lumen in the article. The tube assembly includes a tube to which the first fitting is connected. A second fitting is connected with the tube and configured for loose interconnection with the surfaces adjacent the lumen port. The interconnection is in such a manner that (i) most of the anti-microbial fluid flows into the lumen and (ii) a fraction of the anti-microbial fluid flows between the fitting and the surfaces adjacent the lumen port. The interconnection is sufficiently loose that the fitting wobbles, changing momentary points of contact with the surfaces adjacent the lumen port.
One advantage of the present invention resides in the anti-microbial fluid's assured contact with the surfaces abutting the fittings and plugs.
Another advantage of the present invention is that it promotes the use of the proper fittings and plugs with each endoscope.
Another advantage of the present invention is that it is easy and convenient to use.
Another advantage of the present invention resides in consistent, repetitive operation.
Another advantage of the present invention is that it provides anti-microbial fluid flow through deadend passages.
Another advantage of the present invention is that it assures that the fittings and plugs are correctly matched to each type of endoscope.
Still further advantages and benefits of the present invention will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description of the preferred embodiments.
REFERENCES:
patent: 4281674 (1981-08-01), Tanaka et al.
patent: 4299244 (1981-11-01), Hirai
patent: 4552728 (1985-11-01), Taylor
patent: 4637378 (19
Jesurun David
Keselman Yury
Mapson Tara Denise
Schieman Richard A.
Selig Victor M.
Fay Sharpe Fagan Minnich & McKee LLP
Steris Inc.
Thornton Krisanne
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