Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Reexamination Certificate
1999-08-27
2001-02-13
Warden, Jill (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
C422S292000, C422S295000, C422S300000
Reexamination Certificate
active
06187265
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to the sterilization of articles such as medical instruments having long narrow lumens, and, more particularly, to an apparatus and method for delivering an antimicrobial fluid more effectively to contact surfaces within an instrument or between an instrument and the device which holds it during the sterilization process.
BACKGROUND OF THE INVENTION
Articles such as medical instruments should be sterilized before use. There are many methods of sterilization, including heat and chemical methods. Heat sterilization is normally done using steam. Some equipment cannot withstand either the heat or the moisture from steam treatment. As a result, chemical sterilization is now commonly used.
Chemical sterilization uses a sterilizing fluid such as hydrogen peroxide, ethylene oxide, chlorine dioxide, peracetic acid, or a combination thereof. A plasma may be induced to enhance the sterilization process. Although chemical sterilization is normally highly effective, it may not be as effective with medical devices containing long, narrow tubes, or lumens. Sterilization of these long lumens requires that the sterilizing agent penetrate the entire length of the long narrow tube. It is difficult for the sterilizing agent to completely penetrate these long narrow tubes. In order to enhance the penetration of the sterilizing agent down the entire length of the lumen, several forms of apparatus have been developed to flow sterilizing agent through the length of the lumen, thus enhancing the effectiveness of the sterilizing treatment.
For example, U.S. Pat. Nos. 4,410,492 and 4,337,223 describe a sterilization method in which the lumen is placed in a socket connected to a valve and a recirculating pump. The sterilizing gas is recirculated from the sterilization chamber through the lumen of the instrument. Although the method is effective at sterilizing the lumen, sterilization of endoscopes requires 2-3 hours using ethylene oxide as the sterilizing gas.
A method which delivers sterilizing agent down long, narrow lumens is described in U.S. Pat. No. 5,580,530. The lumen is inserted into an adaptor connected to a vessel containing hydrogen peroxide called the booster. The lumen, adaptor, and booster are all placed in the sterilization chamber. When the sterilization chamber is evacuated during the sterilization procedure, the hydrogen peroxide in the booster vaporizes and passes through the lumen, thereby sterilizing the interior of the lumen.
During use of the various sterilization methods, the lumen is held by a connecting device, a socket in the case of U.S. Pat. Nos. 4,410,492 and 4,337,223 or a truncated cone adaptor when using the method of U.S. Pat. No. 5,580,530. In all cases, there are areas of contact between the device and the lumen where the lumen attaches to the connecting device. It is difficult for the sterilizing agent to penetrate into these contact areas. There is a need for a method of enhancing the penetration of sterilizing gas into these contact areas more effectively to allay any potential concerns about incomplete sterilization.
SUMMARY OF THE INVENTION
An adaptor for delivering antimicrobial fluid to an article to be sterilized comprises an axially elongate body having an interior wall and an exterior wall, being open at a first end, an aperture in the body, where the article to be sterilized contacts the aperture at a contact area, and means for enhancing penetration of the antimicrobial fluid to the contact area. Preferably, the adaptor also comprises a truncated cone sealed to the interior wall of the body.
In accordance with one aspect of the invention, the means for enhancing penetration of the antimicrobial fluid to the contact area can comprise textured or uneven surfaces on the surface surrounding the aperture. Alternatively, the means for enhancing penetration of the antimicrobial fluid to the contact area can comprise a material, at least in the contact area, which is permeable to the antimicrobial fluid. In another embodiment, the adaptor can be formed from a material, at least in the contact area, which has minimal chemical and physical interaction with the antimicrobial fluid. The adaptor according to this invention can be formed using one or a combination of these means for enhancing penetration of the antimicrobial fluid to the contact area.
In accordance with another aspect of the invention, the material of construction of the adaptor, at least in the contact area, can be selected from the group consisting of: thermoplastic polyolefins, including thermoplastic elastomers; fluorovinylidene; chlorovinylidene; liquid crystal polymers, such as wholly aromatic polyester or polyester-amide; silicone rubber; and fluorinated silicone rubber.
In accordance with another aspect of this invention, the inside surface of the aperture is textured or uneven. In accordance with another aspect of the invention, the axially elongate body of the adaptor comprises a cylinder or an elongated body of any cross sectional configuration.
A method of sterilizing a device comprises: connecting the device to an adaptor through an aperture, where the device to be sterilized contacts the aperture at a contact area; placing the device and adaptor into a sterilization chamber; introducing an antimicrobial fluid through the adaptor and device; causing the antimicrobial fluid to penetrate the contact area; and sterilizing the device.
In accordance with another aspect of the invention, the aperture is located in a truncated cone sealed to an interior wall of an axially elongated body, and one end of the axially elongated body is open.
In accordance with another aspect of the invention, the surface of the adaptor surrounding the aperture can be textured or uneven. Alternatively, or in combination, the adaptor, at least in the contact area, can be constructed from a material which is permeable to the antimicrobial fluid. Alternatively, or in combination, the adaptor, at least in the contact area, can be made of a material which has minimal chemical/physical interaction with the antimicrobial fluid.
In accordance with another aspect of the invention, the material of construction of the adaptor, at least in the contact area, can be selected from the group consisting of: thermoplastic polyolefins, including thermoplastic elastomers; fluorovinylidene; chlorovinylidene; liquid crystal polymers, such as wholly aromatic polyester or polyester-amide; silicone rubber; and fluorinated silicone rubber.
In accordance with another aspect of the invention, the antimicrobial fluid is hydrogen peroxide. The device to be sterilized in accordance with one aspect of the invention comprises a lumen. In accordance with another aspect, the device comprises a rod. In accordance with another aspect of the invention, the antimicrobial fluid is additionally introduced into the sterilization chamber. Advantageously, a vessel containing the antimicrobial fluid may be attached to the open end of the axially elongated body of the adaptor.
In accordance with another aspect of this invention, a method for sterilizing a medical device having two or more parts, where there are one or more contact areas between the parts, comprises placing the medical device in a sterilization chamber, introducing an antimicrobial fluid and causing the antimicrobial fluid to penetrate the contact areas, and sterilizing the medical device.
Advantageously, at last one surface on at least one of the parts forming the medical device can have texturing or an uneven surface on the area forming the contact area. Alternatively, or in combination, at least one of the parts can be constructed from a material, at least in the contact area, which is permeable to the antimicrobial fluid. Alternatively, or in combination, at least one part can be made of a material, at least in the contact area, which has minimal chemical/physical interaction with the antimicrobial fluid.
Advantageously, the material of construction of at least one of the parts, at least in the contact area, can be selected from: thermoplastic polyo
Chu Nancy S.
Wu Su-Syin S.
Johnson & Johnson Medical Inc.
Knobbe Martens Olson & Bear LLP
Warden Jill
LandOfFree
Apparatus and method to deliver sterilants to articles... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Apparatus and method to deliver sterilants to articles..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Apparatus and method to deliver sterilants to articles... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2609228