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WO2006121621A2 - Child-resistant blister package with tear tab - Google Patents

Child-resistant blister package with tear tab Download PDF

Info

Publication number
WO2006121621A2
WO2006121621A2 PCT/US2006/015873 US2006015873W WO2006121621A2 WO 2006121621 A2 WO2006121621 A2 WO 2006121621A2 US 2006015873 W US2006015873 W US 2006015873W WO 2006121621 A2 WO2006121621 A2 WO 2006121621A2
Authority
WO
WIPO (PCT)
Prior art keywords
blister
layer
base layer
separation line
tab
Prior art date
Application number
PCT/US2006/015873
Other languages
French (fr)
Other versions
WO2006121621A3 (en
Inventor
Ronald R. Bates, Jr.
Original Assignee
R.P. Scherer Technologies, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by R.P. Scherer Technologies, Inc. filed Critical R.P. Scherer Technologies, Inc.
Priority to JP2008510056A priority Critical patent/JP2008540265A/en
Priority to EP06751541A priority patent/EP1877324A2/en
Publication of WO2006121621A2 publication Critical patent/WO2006121621A2/en
Publication of WO2006121621A3 publication Critical patent/WO2006121621A3/en

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/36—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
    • B65D75/367—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed and forming several compartments
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/52—Details
    • B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
    • B65D75/5827—Tear-lines provided in a wall portion
    • B65D75/5833—Tear-lines provided in a wall portion for tearing out a portion of the wall
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2215/00—Child-proof means
    • B65D2215/04—Child-proof means requiring the combination of different actions in succession
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2575/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D2575/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by association or interconnecting two or more sheets or blanks
    • B65D2575/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D2575/36—One sheet or blank being recessed and the other formed or relatively stiff flat sheet material, e.g. blister packages
    • B65D2575/361—Details
    • B65D2575/362—Details with special means for gaining access to the contents

Definitions

  • the present invention generally relates to medication packages and, more particularly, relates to child resistant blister packages.
  • 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.
  • these cavities may be accessed by stripping a backing layer from the package to expose the cavity, or to expose a push-through underlayer.
  • the backing layer is made of foil that can be ruptured when the medication in the blister is pushed against the backing layer.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a user 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.
  • 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
  • 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
  • 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
  • FIG. 1 is a perspective view of an embodiment of the child-resistant blister package in accordance with the present invention.
  • FIG. 2 is a top plan view of an embodiment of the child-resistant blister package in accordance with the present invention.
  • FIG. 3 is a bottom plan view of an embodiment of the child-resistant blister package in accordance with the present invention.
  • FIG. 4 is a cross-sectional view, taken along section line 4-4 in FIG. 2, of an embodiment of the child-resistant blister package in accordance with the present invention
  • FIG. 5 is a perspective view of an unassembled embodiment of the child- resistant blister package in accordance with the present invention.
  • FIG. 6 is a right side elevation view of an embodiment of the child- resistant blister package in accordance with the present invention
  • FIG. 7 is an end elevation view of an embodiment of the child-resistant blister package in accordance with the present invention
  • FIG. 8 is a right side elevation view of an embodiment of the child- resistant blister package as a user may grip it in accordance with the present invention
  • FIG. 9 is a right side elevation view of an embodiment of the child- resistant blister package as a user may grip and manipulate it to expose the tab, in accordance with the present invention.
  • FIG. 10 is a top plan view of an embodiment of the child-resistant blister package having the tab bent in a plane orthogonal to the base layer, in accordance with the present invention
  • FIG. 11 is a right side elevation view of an embodiment of the child- resistant blister package as a user may grip and manipulate it to remove the tab, in accordance with the present invention
  • FIG. 12 is a top plan view of an embodiment of the child-resistant blister package having the tab removed thereby exposing the sinistral wing and the dextral wing, in accordance with the present invention
  • FIG. 13 is a perspective view of an embodiment of the child-resistant blister package with the tab removed thereby exposing the sinistral wing and the dextral wing and an indication of one means of manipulating the wings, in accordance with the present invention
  • FIG. 14 is a perspective view of an embodiment of the child-resistant blister package illustrating one method of manipulation of the sinistral wing and the dextral wing, in accordance with the present invention
  • FIG. 15 is a perspective view of an embodiment of the child-resistant blister package illustrating one method of manipulation of the sinistral wing and the dextral wing along with the initiation of a tear, in accordance with the present invention
  • FIG. 16 is a perspective view of an embodiment of the child-resistant blister package illustrating one method of manipulation of the sinistral wing and the dextral wing along with the propagation of a tear, in accordance with the present invention
  • FIG. 17 is a perspective view of an embodiment of the child-resistant blister package illustrating one method of manipulation of the sinistral wing and the dextral wing along with the propagation and separation of a tear thereby exposing the medicament, in accordance with the present invention
  • FIG. 18 is a perspective view of an unassembled embodiment of the child-resistant blister package in accordance with the present invention
  • FIG. 19 is a perspective view of an unassembled embodiment of the child-resistant blister package in accordance with the present invention.
  • FIG. 20 is a perspective view of an embodiment of the medication package in accordance with the present invention.
  • FIG. 21 is a perspective view of an embodiment of the child-resistant blister package in accordance with the present invention.
  • FIG. 22 is a top plan view of an embodiment of the child-resistant blister package in accordance with the present invention
  • FIG. 23 is a top plan view of an embodiment of the child-resistant blister package in accordance with the present invention.
  • FIG. 24 is a top plan view of an embodiment of the child-resistant blister package in accordance with the present invention.
  • FIG. 25 is a top plan view of an embodiment of the child-resistant blister package in accordance with the present invention.
  • 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 FIGS.
  • the instant invention includes a child-resistant blister package (10) for housing a medicament (M).
  • the blister package (10) includes a base layer (100) and a blister layer (200), in-part joined together.
  • the base layer (100) has a base layer perimeter (110) with one or more exterior edges (112), abase layer exterior surface (120), a base layer interior surface (130), and a base layer tab creation separation line (140).
  • the blister layer (200) has a blister layer perimeter (210) with one or more exterior edges (212), a blister layer exterior surface (220), a blister layer interior surface (230), and a blister layer tab creation separation line (240).
  • the blister layer (200) is formed to include an article receiving blister (260) having a sidewall (262) and an endwall (264), wherein the article receiving blister (260) is designed for holding the medicament (M), regardless of form, including, but not limited to, round pills, oval pills, oblong capsules, caplets, and the like.
  • 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 FIG. 5.
  • 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.
  • the separation lines (140, 240) may be formed as die cuts, perforations, indentations, score lines, or weakened fracture lines.
  • 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)
  • 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).
  • 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).
  • 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: (i) apply a force to the base layer tab creation area (150) and the blister layer tab creation area (250) to cause separation of the base layer (100) at the base layer tab creation separation line (140) and the blister layer (200) at the blister layer tab creation separation line (240) such that a tab (300), having a base layer component (310) and a blister layer component (320), is created, as seen in FIGS. 9 and 11,
  • 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.
  • 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.
  • 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).
  • the separation lines (140, 240) are configured to create the sinistral wing (400) and the dextral wing (500).
  • the separation lines (140, 240) are a substantially concave shape that opens away from the article receiving blister (260), as seen in FIGS.
  • Such a configuration cooperates with the natural tendency of a user to grip the blister package (10) between the thumb and forefinger from the end opposite the location of the medicament, or article receiving blister (260), as seen in FIG. 8. Gripping the blister package (10) in this fashion permits the user to simply roll the thumb, or forefinger, into either tab creation area (150, 250), while exerting a force on the area (150, 250), such that the separation lines (140, 240) allow the release of the tab (300) for subsequent manipulation.
  • 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 FIG. 19.
  • the blister layer tab creation separation line (240) may include a first blister layer separation line section (242) and a second blister layer separation line section (244), as seen in FIG. 18.
  • simply because one of the separation lines (140, 240) is composed of multiple sections does not mean that the other separation line (140, 240) must be composed of multiple sections.
  • 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).
  • 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 FIGS. 10, 18, and 19, that prevents the unintentional creation of a tab (300).
  • the tab retention projection (330) acts to connect the tab creation area (150, 250) with the remaining body of the layer (100, 200).
  • the tab (300) could be created by the application of a minimal amount of force to either tab creation area (150, 250), and potentially by accident.
  • the tab retention projection (330) prevents such tab (300) formation and permits the blister package (10) manufacturer to determine the amount of force necessary to allow for the creation of the tab (300).
  • One such way of setting the amount of force necessary to create the tab (300) is by altering the magnitude of the separation line separation distance (146, 246).
  • the magnitude of the separation line separation distance (146, 246) is generally between 1/128 of an inch (0.198mm) and 1/8 of an inch (3.175mm), depending on the desired level of child-resistance.
  • the child-resistant blister package (10) may incorporate multiple tab retention projections (330), as seen in FIG. 23.
  • FIG. 23 illustrates that the separation lines (140, 240) may be composed of even more than two individual sections.
  • the base layer tab creation separation line (140) includes a first base layer separation line section (142) and a second base layer separation line section (144), and the blister layer tab creation separation line (240) includes a first blister layer separation line section (242) and a second blister layer separation line section (244).
  • the first base layer separation line section (142) and the second base layer separation line section (144) cooperate to form a substantially concave shape that opens away from the article receiving blister (260) and the first blister layer separation line section (242) and the second blister layer separation line section (244) cooperate to form a substantially concave shape that opens away from the article receiving blister (260).
  • a further variation of this embodiment is one in which 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), 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), and further including a tab retention projection (330) connecting the base layer tab creation area (150) and the blister layer tab creation area (250) to the main body of the blister package (10) thereby preventing the tab (300) from unintentionally leaving the plane of the base layer (100).
  • 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 FIGS. 4, 6, and 7.
  • Such a projection allows a user to quickly identify, both visually and tactilely, the area upon which to apply a force to reveal the tab (300).
  • the projection of the blister layer exterior surface (220) also provides additional rigidity to the blister layer tab creation area (250) and provides an improved gripping surface for the tab (300).
  • 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.
  • 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).
  • the article receiving blister (260) may be formed by using cold-formed foil and cold-form packaging processes.
  • "blister package” includes medication packages made with cold-formed foil and using cold-form packaging processes.
  • 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 lingers is extremely difficult, if not impossible.
  • FIG. 20 Another preferred embodiment of the present invention is a medication package (600), illustrated in FIG. 20, comprising a plurality of separable blister packages (10) like those described above.
  • These separable blister packages (10) have their base layer (100) and/or blister layer (200) formed from one integral base layer (100) and one integral blister layer (200) with tear lines (610) on the base layer (100) and the blister layer (200) to enable the separation of the individual blister packages (10) from each other.
  • tear lines (610) may be perforations, score lines, slits, indentations, and/or weakened fracture lines.
  • 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.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

A blister package (10) for housing a medicament (M) having a base layer (100) and a blister layer (200), joined together in-part. Each layer has a tab creation separation line (140, 240) allowing a user to initiate a predetermined sequence of steps required to access the medicament. The tab creation separation lines are located interior to the perimeter (110, 210) of each associated layer. The tab creation separation lines selectively reduce the strength of the associated layer thereby allowing a user to ' 'punch out,' ' or create, a tab (300) for use in accessing the medicament. A number of predetermined manipulations must be completed to access the medicament. These manipulations include applying a force to create a tab, removing the tab thereby creating a sinistral wing (400) and a dextral wing (500) , and rotating the sinistral wing and the dextral wing in opposite directions to cause a tear (T) that exposes the medicament.

Description

CHILD-RESISTANT BLISTER PACKAGE WITH TEAR TAB
Inventors: Ronald R. Bates
TECHNICAL FIELD
The present invention generally relates to medication packages and, more particularly, relates to child resistant blister packages.
BACKGROUND OF THE INVENTION
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. Nos. Re 29,705 (Compere), 3,941,248 (Moser), 4,243,144 (Margulies), 4,988,004 (Intini), 5,046,618 (Wood), and 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.
SUMMARY OF THE INVENTION
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.
BRIEF DESCRIPTION OF THE DRAWINGS Without limiting the scope of the present invention as claimed below and referring now to the drawings and figures:
FIG. 1 is a perspective view of an embodiment of the child-resistant blister package in accordance with the present invention;
FIG. 2 is a top plan view of an embodiment of the child-resistant blister package in accordance with the present invention;
FIG. 3 is a bottom plan view of an embodiment of the child-resistant blister package in accordance with the present invention;
FIG. 4 is a cross-sectional view, taken along section line 4-4 in FIG. 2, of an embodiment of the child-resistant blister package in accordance with the present invention;
FIG. 5 is a perspective view of an unassembled embodiment of the child- resistant blister package in accordance with the present invention;
FIG. 6 is a right side elevation view of an embodiment of the child- resistant blister package in accordance with the present invention; FIG. 7 is an end elevation view of an embodiment of the child-resistant blister package in accordance with the present invention; FIG. 8 is a right side elevation view of an embodiment of the child- resistant blister package as a user may grip it in accordance with the present invention;
FIG. 9 is a right side elevation view of an embodiment of the child- resistant blister package as a user may grip and manipulate it to expose the tab, in accordance with the present invention;
FIG. 10 is a top plan view of an embodiment of the child-resistant blister package having the tab bent in a plane orthogonal to the base layer, in accordance with the present invention; FIG. 11 is a right side elevation view of an embodiment of the child- resistant blister package as a user may grip and manipulate it to remove the tab, in accordance with the present invention;
FIG. 12 is a top plan view of an embodiment of the child-resistant blister package having the tab removed thereby exposing the sinistral wing and the dextral wing, in accordance with the present invention;
FIG. 13 is a perspective view of an embodiment of the child-resistant blister package with the tab removed thereby exposing the sinistral wing and the dextral wing and an indication of one means of manipulating the wings, in accordance with the present invention; FIG. 14 is a perspective view of an embodiment of the child-resistant blister package illustrating one method of manipulation of the sinistral wing and the dextral wing, in accordance with the present invention; FIG. 15 is a perspective view of an embodiment of the child-resistant blister package illustrating one method of manipulation of the sinistral wing and the dextral wing along with the initiation of a tear, in accordance with the present invention; FIG. 16 is a perspective view of an embodiment of the child-resistant blister package illustrating one method of manipulation of the sinistral wing and the dextral wing along with the propagation of a tear, in accordance with the present invention;
FIG. 17 is a perspective view of an embodiment of the child-resistant blister package illustrating one method of manipulation of the sinistral wing and the dextral wing along with the propagation and separation of a tear thereby exposing the medicament, in accordance with the present invention;
FIG. 18 is a perspective view of an unassembled embodiment of the child-resistant blister package in accordance with the present invention; FIG. 19 is a perspective view of an unassembled embodiment of the child-resistant blister package in accordance with the present invention;
FIG. 20 is a perspective view of an embodiment of the medication package in accordance with the present invention;
FIG. 21 is a perspective view of an embodiment of the child-resistant blister package in accordance with the present invention;
FIG. 22 is a top plan view of an embodiment of the child-resistant blister package in accordance with the present invention; FIG. 23 is a top plan view of an embodiment of the child-resistant blister package in accordance with the present invention;
FIG. 24 is a top plan view of an embodiment of the child-resistant blister package in accordance with the present invention; and FIG. 25 is a top plan view of an embodiment of the child-resistant blister package in accordance with the present invention.
DETAILED DESCRIPTION OF THE INVENTION
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 FIGS. 1 through 25, the instant invention includes a child-resistant blister package (10) for housing a medicament (M). The blister package (10) includes a base layer (100) and a blister layer (200), in-part joined together. With reference to FIGS. 1-5, the base layer (100) has a base layer perimeter (110) with one or more exterior edges (112), abase layer exterior surface (120), a base layer interior surface (130), and a base layer tab creation separation line (140). Similarly, the blister layer (200) has a blister layer perimeter (210) with one or more exterior edges (212), a blister layer exterior surface (220), a blister layer interior surface (230), and a blister layer tab creation separation line (240). Additionally, the blister layer (200) is formed to include an article receiving blister (260) having a sidewall (262) and an endwall (264), wherein the article receiving blister (260) is designed for holding the medicament (M), regardless of form, including, but not limited to, round pills, oval pills, oblong capsules, caplets, and the like.
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 FIG. 5. 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: (i) apply a force to the base layer tab creation area (150) and the blister layer tab creation area (250) to cause separation of the base layer (100) at the base layer tab creation separation line (140) and the blister layer (200) at the blister layer tab creation separation line (240) such that a tab (300), having a base layer component (310) and a blister layer component (320), is created, as seen in FIGS. 9 and 11,
(ii) remove the tab (300) from the blister package (10) by pulling the tab (300) away from the article receiving blister (260), as seen in FIG. 11, thereby tearing the base layer (100) and the blister layer (200) to the base layer perimeter (110) and the blister layer perimeter (210) and thereby creating a sinistral wing (400), having a base layer component
(410) and a blister layer component (420), and a dextral wing (500), having a base layer component (510) and a blister layer component (520), as seen in FIGS. 12 and 13, and,
(iii) rotate the sinistral wing (400) and the dextral wing (500) in opposite directions, as seen in FIG. 14, to cause a tear to propagate (T) across a portion of the article receiving blister (260) thereby allowing access to the medicament (M), as seen in FIGS. 15, 16, and 17. 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 FIGS. 2 and 3. Such a configuration cooperates with the natural tendency of a user to grip the blister package (10) between the thumb and forefinger from the end opposite the location of the medicament, or article receiving blister (260), as seen in FIG. 8. Gripping the blister package (10) in this fashion permits the user to simply roll the thumb, or forefinger, into either tab creation area (150, 250), while exerting a force on the area (150, 250), such that the separation lines (140, 240) allow the release of the tab (300) for subsequent manipulation. While the figures illustrate the tab (300) being created such that it bends downward, or away from the blister layer (200), the invention works equally as well if the tab (300) is created from the bottom and bends away from the base layer (100), or in a direction opposite that shown in FIG. 9. Further, one with skill in the art will appreciate the numerous other configurations of separation lines (140, 240) that may be incorporated into the present invention to create the sinistral wing (400) and the dextral wing (500), some of which are illustrated in FIGS. 21-25. 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 FIG. 19. Similarly, the blister layer tab creation separation line (240) may include a first blister layer separation line section (242) and a second blister layer separation line section (244), as seen in FIG. 18. Further, as seen in FIGS. 18 and 19, simply because one of the separation lines (140, 240) is composed of multiple sections does not mean that the other separation line (140, 240) must be composed of multiple sections.
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 FIGS. 10, 18, and 19, that prevents the unintentional creation of a tab (300). The tab retention projection (330) acts to connect the tab creation area (150, 250) with the remaining body of the layer (100, 200). As one can imagine, if both the base layer tab creation separation line (140) and the blister layer tab creation separation line (240) were continuous slits all the way through the associated layer (100, 200) then the tab (300) could be created by the application of a minimal amount of force to either tab creation area (150, 250), and potentially by accident. The tab retention projection (330) prevents such tab (300) formation and permits the blister package (10) manufacturer to determine the amount of force necessary to allow for the creation of the tab (300). One such way of setting the amount of force necessary to create the tab (300) is by altering the magnitude of the separation line separation distance (146, 246). The greater the magnitude of the separation line separation distance (146, 246), the greater the amount of force that must be applied to the tab creation area (150, 250) by the finger, as seen in FIG. 9, to break the tab retention projection (330) and thus permit the tab (300) to rotate out of the plane of the base layer (100). The magnitude of the separation line separation distance (146, 246) is generally between 1/128 of an inch (0.198mm) and 1/8 of an inch (3.175mm), depending on the desired level of child-resistance. Additionally, the child-resistant blister package (10) may incorporate multiple tab retention projections (330), as seen in FIG. 23. Additionally, FIG. 23 illustrates that the separation lines (140, 240) may be composed of even more than two individual sections.
In one particular embodiment, illustrated in FIG. 5, the base layer tab creation separation line (140) includes a first base layer separation line section (142) and a second base layer separation line section (144), and the blister layer tab creation separation line (240) includes a first blister layer separation line section (242) and a second blister layer separation line section (244). In this embodiment the first base layer separation line section (142) and the second base layer separation line section (144) cooperate to form a substantially concave shape that opens away from the article receiving blister (260) and the first blister layer separation line section (242) and the second blister layer separation line section (244) cooperate to form a substantially concave shape that opens away from the article receiving blister (260). A further variation of this embodiment is one in which 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), 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), and further including a tab retention projection (330) connecting the base layer tab creation area (150) and the blister layer tab creation area (250) to the main body of the blister package (10) thereby preventing the tab (300) from unintentionally leaving the plane of the base layer (100).
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 FIGS. 4, 6, and 7. Such a projection allows a user to quickly identify, both visually and tactilely, the area upon which to apply a force to reveal the tab (300). The projection of the blister layer exterior surface (220) also provides additional rigidity to the blister layer tab creation area (250) and provides an improved gripping surface for the tab (300). 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 lingers is extremely difficult, if not impossible.
Another preferred embodiment of the present invention is a medication package (600), illustrated in FIG. 20, comprising a plurality of separable blister packages (10) like those described above. These separable blister packages (10) have their base layer (100) and/or blister layer (200) formed from one integral base layer (100) and one integral blister layer (200) with tear lines (610) on the base layer (100) and the blister layer (200) to enable the separation of the individual blister packages (10) from each other. These tear lines (610) may be perforations, score lines, slits, indentations, and/or weakened fracture lines. 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. INDUSTRIAL APPLICABILITY
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.

Claims

I CLAIM:
1. A blister package (10) for housing a medicament (M), comprising: a base layer (100) having a base layer perimeter (110) with one or more exterior edges (112), a base layer exterior surface (120), a base layer interior surface (130), and a base layer tab creation separation line (140) located interior to the base layer perimeter (110) thereby selectively reducing the strength of the base layer (100) at the base layer tab creation separation line (140) and generally defining a base layer tab creation area (150); a blister layer (200) having a blister layer perimeter (210) with one or more exterior edges (212), a blister layer exterior surface (220), a blister layer interior surface (230), and including an article receiving blister (260) formed therein, wherein the article receiving blister (260) is formed with a sidewall (262) and an endwall (264) and is designed for holding the medicament (M), the blister layer (200) having a blister layer tab creation separation line (240) located interior to the blister layer perimeter (210) thereby selectively reducing the strength of the blister layer (200) at the blister layer tab creation separation line (240) and generally defining a blister layer tab creation area (250); wherein at least twenty percent of the surface area of the base layer interior surface (130) is joined to the blister layer interior surface (230) such that the base layer tab creation separation line (240) 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, and such that opening the blister package (10) requires (i) application of a force to the base layer tab creation area (150) and the blister layer tab creation area (250) thereby causing separation of the base layer (100) at the base layer tab creation separation line (140) and the blister layer (200) at the blister layer tab creation separation line (240) such that a tab (300), having a base layer component (310) and a blister layer component (320), is created, (ii) removal of the tab (300) from the blister package (10) by pulling the tab (300) away from the article receiving blister (260) thereby tearing the base layer (100) and the blister layer (200) to the base layer perimeter (110) and the blister layer perimeter (210) thereby creating a sinistral wing (400), having a base layer component (410) and a blister layer component (420), and a dextral wing (500), having a base layer component (510) and a blister layer component (520), and (iii) rotating the sinistral wing (400) and the dextral wing (500) in opposite directions causing a tear to propagate across a portion of the article receiving blister (260) thereby allowing access to the medicament (M).
2. The blister package (10) of claim 1, wherein 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).
3. The blister package (10) of claim 1 , wherein 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).
4. The blister package (10) of claim 1, wherein the base layer tab creation separation line (140) includes a first base layer separation line section (142) and a second base layer separation line section (144).
5. The blister package (10) of claim 1, wherein the blister layer tab creation separation line (240) includes a first blister layer separation line section (242) and a second blister layer separation line section (244).
6. The blister package (10) of claim 1, wherein the base layer tab creation separation line (140) includes a first base layer separation line section (142) and a second base layer separation line section (144), and the blister layer tab creation separation line (240) includes a first blister layer separation line section (242) and a second blister layer separation line section (244), such that the first base layer separation line section (142) and the second base layer separation line section (144) cooperate to form a substantially concave shape that opens away from the article receiving blister (260) and the first blister layer separation line section (242) and the second blister layer separation line section (244) cooperate to form a substantially concave shape that opens away from the article receiving blister (260).
7. The blister package (10) of claim 1, wherein 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), 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), and further including a tab retention projection (330) connecting the base layer tab creation area (150) and the blister layer tab creation area (250) preventing the tab (300) from unintentionally leaving the plane of the base layer (100).
8. The blister package (10) of claim 1, wherein the base layer tab creation separation line (140) is substantially concave in shape and opens away from the article receiving blister (260) and the blister layer tab creation separation line (240) is substantially concave in shape and opens away from the article receiving blister (260).
9. The blister package (10) of claim 1, wherein the base layer (100) is comprised of a material and thickness that cannot be readily ruptured by a human finger pushing on the medicament in the article receiving blister (260).
10. The blister package (10) of claim 1, wherein the blister layer (200) 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).
11. The blister package (10) of claim 1, wherein the blister layer (200) is formed of a thermoplastic or cold-form material.
12. The blister package (10) of claim 1, wherein the article receiving blister (260) are thermoformed or cold-formed in the blister layer (200).
13. The blister package (10) of claim 1, wherein the portions of the base layer (100) and the blister layer (200) that are joined together cannot be readily torn from the base layer perimeter (110) or the blister layer perimeter (210).
>
14. The blister package (10) of claim 1, wherein the base layer tab creation separation line (140) and the blister layer tab creation separation line (240) comprise one or more of the group consisting of die cuts, perforations, indentations, score lines, and weakened fracture lines.
15. A medication package (600) having an array of separable blister packages (10) for housing a medicament (M), each of the separable blister packages comprising: a base layer (100) having a base layer perimeter (110) with one or more exterior edges (112), a base layer exterior surface (120), a base layer interior surface (130), and a base layer tab creation separation line (140) located interior to the base layer perimeter (110) thereby selectively reducing the strength of the base layer (100) at the base layer tab creation separation line (140) and generally defining a base layer tab creation area (150); a blister layer (200) having a blister layer perimeter (210) with one or more exterior edges (212), and including an article receiving blister (260) formed therein, wherein the article receiving blister (260) is formed with a sidewall (262) and an endwall (264) and is designed for holding the medicament (M), the blister layer (200) having a blister layer tab creation separation line (240) located interior to the blister layer perimeter (210) thereby selectively reducing the strength of the blister layer (200) at the blister layer tab creation separation line (240) and generally defining a blister layer tab creation area (250); wherein at least a portion of the surface area of the base layer interior surface (130) is joined to the blister layer interior surface (230) such that the base layer tab creation separation line (240) 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, and such that opening the blister package (10) requires (i) application of a force to the base layer tab creation area (150) and the blister layer tab creation area (250) thereby causing separation of the base layer (100) at the base layer tab creation separation line (140) and the blister layer (200) at the blister layer tab creation separation line (240) such that a tab (300), having a base layer component (310) and a blister layer component (320), is created, (ii) removal of the tab (300) from the blister package (10) by pulling the tab (300) away from the article receiving blister (260) thereby tearing the base layer (100) and the blister layer (200) to the base layer perimeter (110) and the blister layer perimeter (210) thereby creating a sinistral wing (400), having a base layer component (410) and a blister layer component (420), and a dextral wing (500), having a base layer component (510) and a blister layer component (520), and (iii) rotating the sinistral wing (400) and the dextral wing (500) in opposite directions causing a tear to propagate across a portion of the article receiving blister (260) thereby allowing access to the medicament (M).
16. The medication package (600) of claim 15, wherein the array of separable blister packages (10) with the base layer (100) and the blister layer (200) are formed from one integral base layer and one integral blister layer with tear lines (610) in the base layer (100) and the blister layer (200), wherein the tear lines (610) enable the separation of the individual blister packages (10) from each other.
17. The medication package (600) of claim 16, wherein the tear lines (610) , comprise one or more of the group consisting of die cuts, perforations, indentations, score lines, and weakened fracture lines.
18. A child-resistant blister package (10) for housing a medicament (M), comprising: a base layer (100) having a base layer perimeter (110) with one or more exterior edges (112), a base layer exterior surface (120), a base layer interior surface (130), and a base layer tab creation separation line (140) comprising a slit extending through the base layer (100) from the base layer exterior surface (120) to the base layer interior surface (130) and being located interior to the base layer perimeter (110) thereby selectively reducing the strength of the base layer (100) at the base layer tab creation separation line (140) and generally defining a base layer tab creation area (150), wherein the base layer (100) is comprised of a material and thickness that cannot be readily ruptured by a human finger pushing on the medicament (M); a blister layer (200) having a blister layer perimeter (210) with one or more exterior edges (212), a blister layer exterior surface (220), a blister layer interior surface (230), and including an article receiving blister (260) formed therein, wherein the article receiving blister (260) is formed with a sidewall (262) and an endwall (264) and is designed for holding the medicament (M), the blister layer (200) having a blister layer tab creation separation line (240) comprising is a slit extending through the blister layer (200) from the blister layer exterior surface (220) to the blister layer interior surface (230) and being located interior to the blister layer perimeter (210) thereby selectively reducing the strength of the blister layer (200) at the blister layer tab creation separation line (240) and generally defining a blister layer tab creation area (250); wherein at least twenty percent of the surface area of the base layer interior surface (130) is joined to the blister layer interior surface (230) such the portions of the base layer (100) and the blister layer (200) that are joined together cannot be readily torn from the base layer perimeter (110) or the blister layer perimeter (210), and the base layer tab creation separation line (240) 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, and such that opening the blister package (10) requires (i) application of a force to the base layer tab creation area (150) and the blister layer tab creation area (250) thereby causing separation of the base layer (100) at the base layer tab creation separation line (140) and the blister layer (200) at the blister layer tab creation separation line (240) such that a tab (300), having a base layer component (310) and a blister layer component (320), is created, (ii) removal of the tab (300) from the blister package (10) by pulling the tab (300) away from the article receiving blister (260) thereby tearing the base layer (100) and the blister layer (200) to the base layer perimeter (110) and the blister layer perimeter (210) thereby creating a sinistral wing (400), having a base layer component (410) and a blister layer component (420), and a dextral wing (500), having a base layer component (510) and a blister layer component (520), and (iii) rotating the sinistral wing (400) and the dextral wing (500) in opposite directions causing a tear to propagate across a portion of the article receiving blister (260) thereby allowing access to the medicament (M).
19. The child-resistant blister package (10) of claim 18, wherein the base layer tab creation separation line (140) includes a first base layer separation line section (142) and a second base layer separation line section (144).
20. The child-resistant blister package (10) of claim 18, wherein the blister layer tab creation separation line (240) includes a first blister layer separation line section (242) and a second blister layer separation line section (244).
21. The child-resistant blister package (10) of claim 18, wherein the base layer tab creation separation line (140) includes a first base layer separation line section (142) and a second base layer separation line section (144), and the blister layer tab creation separation line (240) includes a first blister layer separation line section (242) and a second blister layer separation line section (244), such that the first base layer separation line section (142) and the second base layer separation line section (144) cooperate to form a substantially concave shape that opens away from the article receiving blister (260) and the first blister layer separation line section (242) and the second blister layer separation line section (244) cooperate to form a substantially concave shape that opens away from the article receiving blister (260).
22. The child-resistant blister package (10) of claim 18, wherein 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), 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), and further including a tab retention projection (330) connecting the base layer tab creation area (150) and the blister layer tab creation area (250) preventing the tab (300) from unintentionally leaving the plane of the base layer (100).
23. The child-resistant blister package (10) of claim 18, wherein the base layer tab creation separation line (140) is substantially concave in shape and opens away from the article receiving blister (260) and the blister layer tab creation separation line (240) is substantially concave in shape and opens away from the article receiving blister (260).
24. The child-resistant blister package (10) of claim 18, wherein the blister layer (200) 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).
25. The child-resistant blister package (10) of claim 18, wherein the blister layer (200) is formed of a thermoplastic or cold-form material.
26. The child-resistant blister package (10) of claim 18, wherein the article receiving blister (260) are thermoformed or cold-formed in the blister layer (200).
27. The child-resistant blister package (10) of claim 18, wherein the base layer tab creation separation line (140) and the blister layer tab creation separation line (240) comprise one or more of the group consisting of die cuts, perforations, indentations, score lines, and weakened fracture lines.
PCT/US2006/015873 2005-05-05 2006-04-27 Child-resistant blister package with tear tab WO2006121621A2 (en)

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JP2008510056A JP2008540265A (en) 2005-05-05 2006-04-27 Blister package with child lock function with tear tab
EP06751541A EP1877324A2 (en) 2005-05-05 2006-04-27 Child-resistant blister package with tear tab

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US11/122,829 US20060249422A1 (en) 2005-05-05 2005-05-05 Child-resistant blister package with tear tab
US11/122,829 2005-05-05

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US20060249422A1 (en) 2006-11-09
EP1877324A2 (en) 2008-01-16
JP2008540265A (en) 2008-11-20

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