Tamper evident packaging

Special receptacle or package – For body treatment article or material – Bandage – drape or dressing

Reexamination Certificate

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Details

C206S807000

Reexamination Certificate

active

06349828

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to tamper-evident packaging for a product, such as, e.g., wound dressings.
2. Background
Tamper-evident packaging has been used for many years on a wide variety of consumable products. Examples of products that employ such packaging include food, drugs, and items that must be maintained in a sterile condition prior to use, such as medical products.
Wound dressings are exemplary of one such medical product that must be maintained in a sterile condition prior to use. One long-standing problem associated with packaged wound dressings, however, is assuring that a dressing which is to be applied onto a wound is in fact sterile prior to use. When wound dressings leave their point of manufacture, they are sterile and are packaged in a manner that ensures their sterility until use. However, at the hospital or other health care facility, a dressing is sometimes removed from its packaging, and pieces cut therefrom to fit the size of the wound. Any remaining unused dressing, with its sterility now compromised, is sometimes returned to the packaging and an effort made to reseal the packaging in order to allow the unused (and now non-sterile) portion of the dressing to be used at some future date. This practice, undertaken as a cost-saving measure, is contrary to the manufacturer's instructions and has the potential to introduce bacteria and other microorganisms into the wound situs, compromising the health of the patient.
Thus, a need exists for a means to enable a user to readily determine whether the packaging of a wound dressing has been previously opened, and the sterility of the wound dressing packaged therein compromised.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a packaging system which includes a tamper-evident feature so that a user of the packaged product can readily determine whether the package has previously been opened. This packaging system is advantageously used in connection with products that are required to be sterile prior to use, such as wound dressings and other medical products. Additional inventive features will be apparent from the description of the invention provided herein.
In accordance with the foregoing, one embodiment of the present invention provides tamper-evident packaging for a product comprising a top sheet and a bottom sheet. The top sheet is sealed to the bottom sheet about the product so as to seal the product between the top and bottom sheets. The portion of the top and bottom sheets that are sealed to each other define a sealing area with respect to each sheet. The top sheet includes at least one perforation in its sealing area so that when the sheets are separated from one another, the top sheet tears adjacent to the at least one perforation, thereby indicating that the package has been at least partially opened.
The foregoing and other features and advantages of the present invention will be more readily apparent upon reading the following description of a preferred exemplified embodiment of the invention and upon reference to the accompanying drawings wherein:


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