Package making – Methods – Forming a cover adjunct or application of a cover adjunct to...
Reexamination Certificate
1999-12-29
2003-07-22
Gerrity, Stephen F. (Department: 3721)
Package making
Methods
Forming a cover adjunct or application of a cover adjunct to...
C053S425000, C053S433000, C053S434000
Reexamination Certificate
active
06594971
ABSTRACT:
FIELD
The present invention is directed to the field of coverings used to cover medical instruments during sterilization and in storage thereafter.
BACKGROUND
An endoscope typically comprises two flexible tubes connected to a body. One of the tubes is for insertion into a bodily orifice and the other typically connects to a light source. After a cleaning of an endoscope such as a sigmoidoscope or colonoscope, the endoscope is typically hung over a peg with the two flexible tubes hanging to opposite sides of the peg. This allows the flexible tubes to hang in a straight configuration. Due to the delicate nature of the fiber-optics in such tubes it is not recommended to coil them for storage.
A typical endoscope configuration comprises a small rigid control section connected to two flexible tubes. One tube comprises an insertion tube that contains a fiber-optic bundle and is usually covered with a sheath of polyurethane or other biocompatible material and contains a bending section that allows articulation or angulation of the insertion tube within human cavities. Connected to the control head, and hanging on the other side, is a universal cord that also contains a fiber-optic bundle and an air-water channel.
In a sterilization procedure, instruments are typically placed into a sterile barrier having a semi-permeable membrane. One popular form thereof comprises a pouch having at least one layer of a semi-permeable polymer such as TYVEK (registered trademark of E.I. duPont de Nemours Co., Inc.) brand polyethylene nonwoven fabric and a second layer which may comprise a layer of clear impermeable polymer or another layer of the same or a different semi-permeable polymer. The two layers are sealed together at their edges to enclose an instrument. Such pouches are typically rectangular in shape. Such a system allows sterilizing gases, such as hydrogen peroxide vapor, ethylene oxide or steam, to pass through the semi-permeable barrier to effect sterilization of the instrument therein but prevent microorganisms from entering the pouch after the sterilization process is complete thus allowing storage of the instrument in the packaging enclosure in a sterile manner. Those of skill in the art will recognize that many alternative package designs accomplish a similar function. For instance, such packages may comprise a layer of foam or other material which is rigid or semi-rigid and which may or may not be semi-permeable. The package may merely contain a small window or several small windows of semi-permeable material to allow sterilizing gases to enter.
Endoscopes such as sigmoidoscopes or colonoscopes have previously been only disinfected and the peg storage system was acceptable in such condition. Many users now demand that such instruments be sterilized, not merely subjected to a high level disinfection. The preferred barrier packaging enclosure for sterilization is a pouch, such as the aforementioned pouch, with heat or adhesive sealed boundaries that provides a sterile barrier with mechanical integrity, thereby preserving the sterility of the endoscope during storage of the endoscope after the sterilization procedure. However, such known pouches place the two flexible tubes of the endoscope together in a coiled pattern, and provide no method for storing a sterilized endoscope in an uncoiled or bent configuration. Some operators have even removed sterile endoscopes from rectangular pouches or other barrier systems to hang them on their old peg systems, thus compromising sterility.
SUMMARY OF THE INVENTION
The present invention overcomes these limitations to provide a sterile package which allows an endoscope to be sterilized therein and subsequently be stored in an uncoiled configuration by hanging over a peg while still in the package.
A packaging enclosure according to the present invention packages a flexible endoscope having first and second flexible tubes. The packaging enclosure comprises a wall forming an interior space impervious to microorganisms for receiving the endoscope. At least a portion of the wall is semi-permeable. A hanging means is provided for hanging the packaging enclosure, with the endoscope therein, over a hook.
Preferably, the packaging enclosure comprises a pouch having first and second films adhered to each other to form the interior space. The hanging means can comprise an aperture in the packaging enclosure. Alternatively, the hanging means can comprise the first flexible tube being receivable within one portion of the packaging enclosure and the second flexible tube being receivable within a second portion of the packaging enclosure and the packaging enclosure with the endoscope therein being drapable over the hook.
In one embodiment, the packaging enclosure comprises a thermoformed tray covered with a permeable lidstock.
Preferably, one side of the pouch or the entire lidstock of the tray is formed of a semi-permeable material pervious to sterilizing gases yet impervious to microorganisms. However, such pouch side or lidstock may merely have one or more semi-permeable ports.
A method according to the invention for sterilizing and storing an endoscope having first and second flexible tubes is also provided. The method comprises the steps of:
placing the endoscope within a packaging enclosure comprising a wall forming an interior space for receiving the endoscope, at least a portion of the wall being semi-permeable;
passing a sterilizing gas into the packaging enclosure; and
hanging the packaging enclosure with the sterile endoscope therein over a hook.
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Addy Tralance
Timm Debra
Wu Su Syin
Ethicon Inc.
Gerrity Stephen F.
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