Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Affecting structure – article – etc. – submerged in marine...
Reexamination Certificate
2002-04-11
2004-09-21
Jastrzab, Krisanne (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Affecting structure, article, etc., submerged in marine...
C206S309000, C206S361000, C206S439000, C422S028000, C422S040000, C422S294000, C422S297000, C422S300000
Reexamination Certificate
active
06793882
ABSTRACT:
The present invention relates to a container for use in sterilizing an object and to a method for sterilizing an object. The apparatus and method of the present invention are particularly suitable for use in sterilizing medical and surgical equipment.
Surgical operations must be carried out under strict conditions of sterility to minimize infection risk in the patient. To this end, a sterile field is set up in the operating theatre around the patient. Any theatre staff, such as surgeons or nurses, who have to touch the patient during surgery must rigorously scrub and wear sterile surgical gloves. All instruments and equipment used in the surgery must also be sterile.
Surgical equipment is frequently supplied inside sterile packaging which ensures that the equipment inside the packaging is sterile and remains so whilst the packaging remains unopened. However, storage, handling and distribution of the packaging causes the outer surface of the packaging to become non-sterile. To account for this whilst maintaining the sterile field in the operating theatre, surgical teams include a non-sterile nurse who opens the packaging of pieces of surgical equipment and exposes the sterile equipment to a nurse within the sterile field. The nurse within the sterile field then removes the sterile equipment from the packaging. Provided that the non-sterile nurse does not touch the equipment, sterility of the sterile field is not compromised.
A number of pieces of medical and surgical equipment are re-usable. In order to re-use such equipment, it is necessary to sterilize the equipment before use in the next operation. Sterilization of medical and surgical equipment is commonly carried out in an autoclave in which steam at elevated pressure and a temperature of around 134° C. sterilizes the equipment.
Although autoclaving is an effective sterilizing method, difficulties can arise when it is desired to sterilize delicate medical and surgical equipment. In particular a number of pieces of equipment are typically loaded into the autoclave at a time, which can lead to breakage of delicate equipment. Moreover, it can be difficult to maintain sterility of the equipment when it is removed from the autoclave and stored for use in the next operation.
Other methods of sterilisation that are frequently used include exposing the medical apparatus to a sterilising gas, such as ethylene oxide or STERAD, or soaking in a cold sterilizing liquid.
Endoscopic or laparoscopic surgery, also commonly known as key-hole surgery, is become more wide spread. Endoscopic and laparoscopic techniques are low invasive techniques that can dramatically reduce the duration of stays in hospitals by patients. Endoscopic and laparoscopic techniques require the use of telescopes (hereinafter called “endoscopic telescopes” for convenience) to enable the surgeon to see the site of the surgery on a monitor. Endoscopic telescopes comprise an elongated body in the form of a thin tube having an enlarged housing at one end thereof, which housing contains optical components and allows coupling to a camera or video feed. The other end of the endoscopic telescope is inserted into the patient via an incision made in the patient's skin. The endoscopic telescope projects into the sterile field and hence the endoscopic telescope must be sterilized.
BRIEF DESCRIPTION OF THE INVENTION
It is an object of the present invention to provide a method for and an apparatus for use in sterilizing an object such as a piece of medical or surgical equipment.
In one aspect, the present invention provides a method for sterilizing an object comprising placing the object into a container, the container having an opening through which the object is inserted, the container having at least a portion which is adapted to be collapsed or deformed, closing the opening with a vapour permeable closure and placing the container in a sterilizing environment for sufficient time to sterilize the object.
Preferably, the vapour permeable membrane is a water vapour permeable membrane.
Preferably, the vapour permeable membrane is also permeable to liquid water.
Preferably, the vapour permeable membrane is permeable to other liquids, such as sterilizing liquids.
Preferably the step of placing the container in a sterilizing environment includes the step of placing the container in an autoclave and operating the autoclave for sufficient time to sterilize the object. Although autoclaving is the preferred sterilizing method, other sterilizing methods may be used. Such methods may include placing the container in a sterilizing fluid. In such cases, the closure should also be permeable to the sterilizing fluid.
The step of closing the opening of the container preferably comprises the step of affixing a vapour-permeable closure to a rim of the opening. The closure may be affixed to the rim of the opening by an adhesive. The closure may comprise any suitable vapour permeable material. Preferably, the material is also permeable to other fluids, such as gases. However, it is preferred that the closure material does not allow the passage of bacteria therethrough.
In another embodiment, the step of closing the opening comprises placing a lid or cover on or over the opening, which lid or cover includes at least a portion which is permeable to vapour. The lid or cover is preferably a tamper-evident lid or cover that can only be removed from the container in a tamper-evident manner. Such tamper-evident lids or covers are well known and will not be described further.
The closure material may comprise a microporous membrane. More preferably, the closure material comprises a paper or paper-based material. It will be appreciated that the closure material should be resistant to failure under the sterilizing conditions used. For example, a thermoplastic material that melts at a temperature below the temperature used in an autoclave is unsuitable for use in the present invention if autoclaving is to be used to obtain sterilization. A suitable membrane material could be TYVEK, a proprietary material manufactured by DuPont. This would be suitable for use in the STERAD system. Other materials could also be used.
By placing the object in a container and closing the opening in the container, the object is protected from damage by contact with other objects during sterilization by virtue of the object being protected by the container. The closure confines the object within the container and prevents the entry of bacteria into the container after sterilization is complete. Thus, the container also provides a convenient storage container that can maintain sterility of the object.
In another aspect, the present invention provides a container for use in. sterilizing an object, the container being adapted to receive the object, the container having a first end having an opening to allow positioning of the object in the container, a second end located generally opposite the first end and wherein at least a portion of the container is adapted to be collapsed or deformed whereby the first end and the second end are moved relatively towards each other.
Preferably, at least a portion of the container near the first end is collapsible or deformable whereby collapsing or deforming of the collapsible or deformable portion causes the first end to move relatively closer to the second end.
Preferably, the container includes an elongated portion for receiving an elongate object.
Preferably, the container is relatively enlarged at the open end. This allows easier insertion of the object into the container. It also enables the container to hold objects having a relatively enlarged part, for example, such as an endoscopic telescope. Preferably, the container is adapted to contain a piece of medical or surgical equipment, more preferably an elongated medical apparatus, most preferably an endoscopic telescopic.
Preferably, the opening in the first end of the container is sealable by a vapour-permeable closure. The vapour-permeable closure may be affixed to the rim of the opening in the first end to thereby close the opening.
Andrus Sceales Starke & Sawall LLP
Fairmont Medical Products PTY LTD
Jastrzab Krisanne
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