Special receptacle or package – For ampule – capsule – pellet – or granule – Single unit container
Reexamination Certificate
2001-06-04
2003-02-11
Bui, Luan K. (Department: 3728)
Special receptacle or package
For ampule, capsule, pellet, or granule
Single unit container
C206S539000
Reexamination Certificate
active
06516949
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a safety blister package for enclosing medication or pills.
As disclosed in U.S. Pat. No. 3,809,211, one of the problems facing today's parents is keeping medication or pills beyond the reach of their children. Children do not have the ability to recognize the risk involved in consuming non-prescription medication. Because of this fact there is an urgent need for a package from which pills are readily accessible to the adult, but not accessible to the child.
Press-through packs or “blister” packs are commonly used today to package units of medication or pills for oral ingestion. The press-through package is made up of a blister sheet, typically a clear, preformed polyvinyl chloride or polystyrene with flexible bubbles which form separate compartments or blisters for one or more pills; and a second rupturable backing sheet, like an aluminum foil or paper sheet, which has been attached to the blister sheet. The metal foil is attached by heat-sealing, solvent welding, gluing, or otherwise adhering the foil sheet to the blister sheet. A tablet is removed from a blister by pressing on the flexible blister which in turn forces the tablet against the foil, rupturing the foil, and ejecting the tablet.
It is sometimes desirable in making such a press-through package to include between the blister and backing sheets a rigid tray in which there are holes which coincide with the blisters in said blister sheet. The rigid tray is used to protect the pills from contamination and mechanical damage and may contain printed instructions as to the type of pill or the time a particular dosage is to be taken and with an indication of the dosage that has already been taken.
The recent trend in the packaging of medication has been to provide packages which will be safe, even if found by children. Most developments in the “child-resistant” line have been directed to the improvement in pill bottles. In this regard, safety caps have been devised which require a certain series of pushes and turns in order to open the bottle. However, there has been little development in the area of “child-resistant” press-type blister packages with which this invention is concerned.
Packages which have used more than one backing sheet on a press-through blister-type package have not used a layer of backing material which cannot be ruptured. The prior layers which have been used to cover the rupturable layer, have been made from paper or foil and may have been scored or weakened so that all backing layers can be ruptured to press a pill through the package. These additional prior art backing layers have been used for the purposes of providing printed information on the back of the pill package and for additional sealing engagement to protect the pills from the environment. For example, see the following U.S. Pat. Nos.: Nagy, U.S. Pat. No. 3,503,493; Osborn, U.S. Pat. No. 3,621,992; Sorensen, U.S. Pat. No. 2,317,860; and Heller, U.S. Pat. No. 3,387,699. In each of these patents the multiple backing layers used on the blister or press-through type pill package can be easily ruptured or peeled away and are not strong enough to provide “child-resistance.”
One attempt at providing a “resistant” blister-type pill package, can be seen in the Helstrom U.S. Pat. No. 3,472,368. In this patent, there is no second backing member which is peeled away to expose the rupturable layer as will be disclosed in describing the present invention. This package is supposedly “child-resistant” simply by providing a rupturable sheet which is ruptured with difficulty. The Helstrom patent, therefore, relies on the child's weakness as the necessary element to prevent him from opening the package.
Compere, U.S. Pat. No. 3,921,805, discloses a pill package which requires knowledge of the package opening procedure rather than a minimum amount of strength for opening said package. A person likely to be taking pills is not generally very strong. Quite often, the strength of a child is greater than the strength of an adult who is ill. Because of this fact, this invention was developed to provide a pill package which can be opened by an instructed adult who may have no more strength than the average child. The child who is uninstructed on the opening of the disclosed package will not be able to reach the package contents. The present invention, therefore, relies on the superior knowledge of the adult rather than his superior strength.
SUMMARY OF THE INVENTION
A primary object of the present invention is to provide a “child-resistant” pill package which can be easily opened by one who has been given instructions on how to do so, but cannot be opened by the uninstructed child.
Another object of the present invention is to provide a pill package which, when opened, makes only one dosage of pills accessible to the user, which dosage, of course, is less than a harmful dosage.
Another object of the present invention is to provide a pill package in which any desired number of pills can be made accessible upon opening.
Another object of the present invention is to provide a pill package in which one pill or one dosage of pills can be removed from the package while the remaining pills can be maintained in an air-tight enclosure.
Another object of the present invention is to provide a pill package in which the use of-cumbersome bottles is not required.
Another object of the present invention is to provide a pill package in which each individual pill can be separately packaged so that the desired dosage can be carried by the user without the necessity of carrying excess pills.
Another object of the present invention is to provide a pill package which requires an additional opening step to remove each additional pill.
Another object of the present invention is to provide a safety pill package which children, on average, cannot open without the aid of tools.
Yet another object of the present invention is to provide a pill package in which opening of the package makes accessible fewer than a dangerous number of units of medication. The number of units exposed upon each opening of the package can be varied depending upon the toxicity of the packaged medication.
The present invention provides a blister package which is similar to the common blister package, but which has a strong flexible backing sheet which encloses each blister. The strong flexible backing sheet is secured to the back of the blister sheet in such a manner that when secured, the backing sheet is not pushed away from the blister sheet when pressure is put on the blister-side of the package in an attempt to push the pill through the package. For a user to be able to remove a pill from the package, the strong backing sheet must first be peeled away. So long as the required adherence is obtained, the strong backing sheet can be secured to the blister sheet by heat sealing, solvent welding, gluing or otherwise adhering the two sheets together. A preferred method is by heat-sealing.
There are hundreds of heat-sealed coating formulations which can be used to provide heat-sealability between the layers of the package laminate of the present invention. These heat-seal formulations are commonly used in making foil/paper and resin sheet/resin sheet laminates for soap wraps, carton overwraps, cereal liners, cookie wraps, and other uses. The heat-seal formulations are typically a water dispersion of a vinyl resin or a vinyl resin containing wax for providing lower heat-sealing temperatures. The vinyl resin can be ion-linked and acid-modified ethylene interpolymers known as ionomer resins. Wax and other modifiers further extend the range of performance properties.
The preferred heat-seal formulations are water dispersions of ethylene interpolymers, for example ethylene/vinyl acetate interpolymers. The vinyl resin formulations combine broad adhesion properties with moderate hot tack. Modifiers such as pigments, waxes or other resins can be used.
It is preferred to apply the heat-seal coatings in an amount of about 7 grams/meter
2
. The coatings can
Fuller Kenneth E.
Sowden Harry S.
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