Patent Application
20060249422
The present invention generally relates to medication packages and, more particularly, relates to child resistant blister packages.
There is a continued need for medication packages that are child resistant and tamper evident, yet allow the average adult to open the medication packages to get access to the medication therein, as well as the adult who, due to either age or medical infirmity, may have reduced motor skills. There is also a need to make this type of package economical to manufacture.
Over the years, a wide variety of disposable plastic packages have been suggested which are accessible through a variety of folding, stripping, rupturing, peeling and/or tearing procedures. These packages have typically been formed of transparent top layers which are sealed or otherwise bonded to backing layers in a manner which provides a cavity, pouch or “blister” in which the medicament is disposed. The top and backing layers may be formed of flexible packaging materials, rigid thermoformable plastic materials, foil, paper, laminates, or combinations thereof. Medicament cavities formed between such layers have been accessed by tearing into them from an edge of the package, which tearing may or may not be facilitated through the provision of a starting notch or slit. Alternatively, these cavities may be accessed by stripping a backing layer from the package to expose the cavity, or to expose a push-through underlayer. In other instances, the backing layer is made of foil that can be ruptured when the medication in the blister is pushed against the backing layer. Generally, these packages are tamper evident, but typically not child resistant. Other medication packages require some form of peeling of the bottom surface from the top surface to get access to the medication. Some examples of these types of medication packages that use peeling include U.S. Pat. No. Re 29,705 (Compere), U.S. Pat. No. 3,941,248 (Moser), U.S. Pat. No. 4,243,144 (Margulies), U.S. Pat. No. 4,988,004 (Intini), U.S. Pat. No. 5,046,618 (Wood), and U.S. Pat. No. 5,358,118 (Thompson).
Child resistant medication packages that use peeling have been in use for some time, however, many people who do not have sufficient motor skills or whose hands shake are not able to easily gain access to the medicament is such packages. This can be a problem especially when the medicament and the medication packages are small. Additionally, there have been a number of medication packages that are designed to be torn open to access the medication. Many medication packages that are designed to be torn suffer from the same problems as those designed for peeling, namely they are difficult to open for those with reduced motor skills or do not exhibit a high degree of child-resistance.
There is a need for a medication package that can be relatively easy to tear for an adult, but still be child resistant. The present invention has accomplished this by creating a blister package that is relatively easy to open when a user follows a sequence of steps to open the package, yet is extremely difficult to open in any other fashion, thereby avoiding some of the inherent problems of prior medication packages.
In its most general configuration, the present invention advances the state of the art with a variety of new capabilities and overcomes many of the shortcomings of prior art devices in new and novel ways. In its most general sense, the present invention overcomes the shortcomings and limitations of the prior art in any of a number of generally effective configurations. The instant invention includes a child-resistant blister package for housing a medicament having a base layer and a blister layer, in-part joined together. The base layer has a base layer tab creation separation line and the blister layer has a blister layer tab creation separation line. These separation lines allow a user to initiate a predetermined sequence of steps required to access the medicament. The blister layer is formed to include an article receiving blister having a sidewall and an endwall, wherein the article receiving blister is designed for holding the medicament, regardless of form, including, but not limited to, round pills, oval pills, oblong capsules, caplets, and the like.
Both of the tab creation separation lines are located interior to the perimeter of each associated layer. In other words, the separation lines do not extend to the perimeter of the associated layer, as is common in prior art blister packages. The tab creation separation lines selectively reduce the strength of the associated layer thereby allowing a user to “punch out,” or create a tab that is used in the steps of accessing the medicament. The tab creation separation lines may selectively reduce the strength of the associated layer in any number of ways, including, but not limited to, being formed as slits, die cuts, perforations, indentations, score lines, or weakened fracture lines.
In order to open the child-resistant blister package of the present invention, a user must complete a number of predetermined manipulations upon the package. These manipulations include (i) applying a force to a tab creation area to cause separation of the layers at the tab creation separation lines such that a tab is created, (ii) removing the tab from the blister package by pulling the tab away from the article receiving blister thereby tearing the layers to their perimeters, and creating a sinistral wing and a dextral wing, and (iii) rotating the sinistral wing and the dextral wing in opposite directions to cause a tear to propagate across a portion of the article receiving blister thereby allowing access to the medicament.
The shape and make-up of the separation lines need only facilitate the creation of the tab from application of a reasonable amount of force; however, the shape and make-up of the separation lines may be selected to create a tab of a predetermined shape and/or having a predetermined tendency to tear.
Various objects and advantages of the present invention will become apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which set forth certain embodiments of the invention.
Thus, there is disclosed a blister package for housing a medicament, comprising:
a base layer having a base layer perimeter with one or more exterior edges, a base layer exterior surface, a base layer interior surface, and a base layer tab creation separation line located interior to the base layer perimeter thereby selectively reducing the strength of the base layer at the base layer tab creation separation line and generally defining a base layer tab creation area;
a blister layer having a blister layer perimeter with one or more exterior edges, a blister layer exterior surface, a blister layer interior surface, and including an article receiving blister formed therein, wherein the article receiving blister is formed with a sidewall and an endwall and is designed for holding the medicament, the blister layer having a blister layer tab creation separation line located interior to the blister layer perimeter thereby selectively reducing the strength of the blister layer at the blister layer tab creation separation line and generally defining a blister layer tab creation area; wherein
at least twenty percent of the surface area of the base layer interior surface is joined to the blister layer interior surface such that the base layer tab creation separation line and the blister layer tab creation separation line substantially overlay one another and the base layer tab creation area and the blister layer tab creation area substantially overlay one another, and such that opening the blister package requires (i) application of a force to the base layer tab creation area and the blister layer tab creation area thereby causing separation of the base layer at the base layer tab creation separation line and the blister layer at the blister layer tab creation separation line such that a tab, having a base layer component and a blister layer component, is created, (ii) removal of the tab from the blister package by pulling the tab away from the article receiving blister thereby tearing the base layer and the blister layer to the base layer perimeter and the blister layer perimeter thereby creating a sinistral wing, having a base layer component and a blister layer component, and a dextral wing, having a base layer component and a blister layer component, and (iii) rotating the sinistral wing and the dextral wing in opposite directions causing a tear to propagate across a portion of the article receiving blister thereby allowing access to the medicament.
There is further disclosed a medication package having an array of separable blister packages for housing a medicament, each of the separable child-resistant blister packages comprising:
a base layer having a base layer perimeter with one or more exterior edges, a base layer exterior surface, a base layer interior surface, and a base layer tab creation separation line located interior to the base layer perimeter thereby selectively reducing the strength of the base layer at the base layer tab creation separation line and generally defining a base layer tab creation area;
a blister layer having a blister layer perimeter with one or more exterior edges, and including an article receiving blister formed therein, wherein the article receiving blister is formed with a sidewall and an endwall and is designed for holding the medicament, the blister layer having a blister layer tab creation separation line located interior to the blister layer perimeter thereby selectively reducing the strength of the blister layer at the blister layer tab creation separation line and generally defining a blister layer tab creation area; wherein
at least twenty percent of the surface area of the base layer interior surface is joined to the blister layer interior surface such that the base layer tab creation separation line and the blister layer tab creation separation line substantially overlay one another and the base layer tab creation area and the blister layer tab creation area substantially overlay one another, and such that opening the blister package requires (i) application of a force to the base layer tab creation area and the blister layer tab creation area thereby causing separation of the base layer at the base layer tab creation separation line and the blister layer at the blister layer tab creation separation line such that a tab, having a base layer component and a blister layer component, is created, (ii) removal of the tab from the blister package by pulling the tab away from the article receiving blister thereby tearing the base layer and the blister layer to the base layer perimeter and the blister layer perimeter thereby creating a sinistral wing, having a base layer component and a blister layer component, and a dextral wing, having a base layer component and a blister layer component, and (iii) rotating the sinistral wing and the dextral wing in opposite directions causing a tear to propagate across a portion of the article receiving blister thereby allowing access to the medicament.
Without limiting the scope of the present invention as claimed below and referring now to the drawings and figures:
The child-resistant blister package and associated medication package of the instant invention enables a significant advance in the state of the art. The preferred embodiments of the apparatus accomplish this by new and novel arrangements of elements that are configured in unique and novel ways and which demonstrate previously unavailable but preferred and desirable capabilities. The detailed description set forth below in connection with the drawings is intended merely as a description of the presently preferred embodiments of the invention, and is not intended to represent the only form in which the present invention may be constructed or utilized. The description sets forth the designs, functions, means, and methods of implementing the invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and features may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention.
Referring generally to
With reference to
The base layer tab creation separation line (140) is located interior to the base layer perimeter (110). Similarly, the blister layer tab creation separation line (240) is located interior to the blister layer perimeter (210). In other words, the base layer separation line (140) does not extend to the base layer perimeter (110), and likewise the blister layer separation line (240) does not extend to the blister layer perimeter (210). The tab creation separation lines (140, 240) thereby selectively reduce the strength of the associated base layer (100) or blister layer (200). The base layer tab creation separation line (140) generally defines a base layer tab creation area (150) and the blister layer tab creation separation line (240) generally defines a blister layer tab creation area (250), illustrated in
The base layer tab creation separation line (140) and the blister layer tab creation separation line (240) may selectively reduce the strength of their associated layers (100, 200) in any number of ways. For example, the separation lines (140, 240) may be formed as die cuts, perforations, indentations, score lines, or weakened fracture lines. In one particular embodiment, the base layer tab creation separation line (140) is a slit extending through the base layer (100) from the base layer exterior surface (120) to the base layer interior surface (130), and the blister layer tab creation separation line (240) is a slit extending through the blister layer (200) from the blister layer exterior surface (220) to the blister layer interior surface (230). Such an embodiment reduces the effort required to open the blister package (10), as is described in detail below.
Further, the shape and make-up of the separation lines (140, 240) is variable. The general method of opening the child-resistant blister package (10) must first be disclosed in order to explain the various embodiments of the separation lines (140, 240).
Generally, at least twenty percent of the surface area of the base layer interior surface (130) is joined to the blister layer interior surface (230). The blister layer (200) may be joined to the base layer (100) by heat sealing, adhesive such as heat-activated adhesive that has been pre-applied to the base layer (100) or solvent adhesive, radio frequency or sonic seal, or by other suitable means. The area of the blister layer (200) that is formed into the article receiving blister (260) is obviously not joined to the base layer (100). The layers (100, 200) are joined such that the base layer tab creation separation line (140) and the blister layer tab creation separation line (240) substantially overlay one another and the base layer tab creation area (150) and the blister layer tab creation area (250) substantially overlay one another. Therefore, to open the child-resistant blister package (10) a user must:
The tear (T) typically propagates from the tab retention projection (330). The tab retention projection (330) is shown in the Figures as semi-circular, however, any shape such as square, rectangular, oval and the like will work just as well. The tab retention projection (320) always points away from the blister (260) and is preferably square in shape with a ragged top.
One skilled in the art will also appreciate that the sinistral wing (400) and the dextral wing (500) can be pulled apart in place of rotating in opposite directions to create the tear propagation (T). In fact, almost any type of manipulation of the wings (400, 500) will create the tear (T) across the blister (260) to expose the medication (M).
The shape and make-up of the separation lines (140, 240) need only facilitate the creation of the tab (300) from application of a reasonable amount of force. The shape and make-up of the separation lines (140, 240) may be selected to create a tab (300) of a predetermined shape and/or having a predetermined tendency to tear. In the present invention, the child-resistant nature of the blister package (10) has to do with the fact that multiple steps must be performed to access the medicament (M). As such, the separation lines (140, 240) are configured to create the sinistral wing (400) and the dextral wing (500). Accordingly, in one embodiment the separation lines (140, 240) are a substantially concave shape that opens away from the article receiving blister (260), as seen in
Each of the separation lines (140, 240) may be composed of multiple sections. For example, the base layer tab creation separation line (140) may include a first base layer separation line section (142) and a second base layer separation line section (144), as seen in
In fact, it is often preferred to have at least one of the separation lines (140, 240) composed of multiple sections (142 and 144, 242 and 244) such that the multiple sections (142 and 144, 242 and 244) are separated by a separation line separation distance (146, 246). This is particularly true in embodiments wherein the separation lines (140, 240) are slits that cut all the way through the associated layer (100, 200) because the use of multiple sections (142 and 144, 242 and 244) creates a tab retention projection (330), illustrated in
In one particular embodiment, illustrated in
In yet another embodiment, the blister layer (200), and more particularly the blister layer exterior surface (220), within the blister layer tab creation area (250), projects away from the plane of the base layer (100) thereby providing a user an indication of the location upon which to exert the force necessary to create the tab (300), as illustrated best in
The blister layer (200) is preferably made of pharmaceutical grade PVC or other thermoplastic material, such as plastic, polypropylene, polyethylene, styrene, cold-formed foil, or other suitable materials for packaging. The article receiving blister (260) may be formed by a thermoforming process in which the blister layer material is stretched into a cavity with a vacuum technique to form the blister portion. In a preferred embodiment, a sheet of suitable material for the blister layer (200) is exposed to heating elements for a pre-determined time. This sheet is then trapped in a forming station where it is subjected to both vacuum and pressure. During this process, the material may also be mechanically assisted into the blister cavity via a matched metal plug to form the article receiving blister (260). In another embodiment, the article receiving blister (260) may be formed by using cold-formed foil and cold-form packaging processes. As used herein, “blister package” includes medication packages made with cold-formed foil and using cold-form packaging processes.
To increase the child-resistance of the blister package (10, the base layer (100) is comprised of a material and thickness that cannot be ruptured by a person pushing on the medicament (M) in the article receiving blister (260). The base layer (100) may be comprised of one or more separate layers of material, such as foil and polyester or other suitable child-resistant foils. The base layer (100) is typically comprised of multiple layers, but it could be made of any material deemed child-resistant. Additionally, the child-resistance is further increased by the fact that the previously disclosed method of joining the base layer (100) to the blister layer (200) ensures that peeling, or separation, of the layers (100, 200) from one another by human fingers is extremely difficult, if not impossible.
Another preferred embodiment of the present invention is a medication package (600), illustrated in
Numerous alterations, modifications, and variations of the preferred embodiments disclosed herein will be apparent to those skilled in the art and they are all anticipated and contemplated to be within the spirit and scope of the instant invention. For example, although specific embodiments have been described in detail, those with skill in the art will understand that the preceding embodiments and variations can be modified to incorporate various types of substitute and or additional or alternative materials, relative arrangement of elements, and dimensional configurations. Accordingly, even though only few variations of the present invention are described herein, it is to be understood that the practice of such additional modifications and variations and the equivalents thereof, are within the spirit and scope of the invention as defined in the following claims.
The child-resistant blister package of the present invention answers a number of long felt needs in the medical community. The present invention discloses the opening of a blister package that requires the performance of multiple steps before it can be torn open. The present invention also avoids some of the inherent problems of medication packages that use peeling to be opened. The blister package of the present invention can be relatively easy to open for an adult, but not easy for a child.
