Title:
Child resistant medicament package with built-in shield
Kind Code:
A1


Abstract:
A child resistant medicament package with built-in shield has base substrate and an integrally shielded blister layer. Accessing a medicament is easy for an adult to accomplish, yet the package resists children biting and picking at the integrally shielded blister layer. The integrally shielded blister layer contains an article receiving blister, a well, and a deflection plateau. The article receiving blister is designed for holding the medicament. The base substrate contains the medicament within the article receiving blister. The well and the deflection plateau are formed to protect the article receiving blister from lateral forces acting upon the article receiving blister sidewalls. To eject the medicament, application of a substantially orthogonal force to the article receiving blister is required.



Inventors:
Gherdan Jr., Victor (Cherry Hill, NJ, US)
Barndt, David R. (Richlandtown, PA, US)
Bates Jr., Ronald R. (Norristown, PA, US)
Application Number:
11/395923
Publication Date:
07/05/2007
Filing Date:
03/31/2006
Primary Class:
Other Classes:
206/528
International Classes:
B65D83/04; B65D85/42
View Patent Images:
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Primary Examiner:
STEPHENS III, JOSE S
Attorney, Agent or Firm:
Venable LLP (CATALENT) (New York, NY, US)
Claims:
We claim:

1. A child resistant medicament package with built-in shield (10) for housing a medicament (M) comprising: (a) a base substrate (100) having a base substrate interior surface (110), a base substrate exterior surface (120), and a base substrate perimeter (130); (b) a integrally shielded blister layer (200) having a blister layer front surface (210), a blister layer rear surface (220), a blister layer support bearing edge (230), and a blister layer perimeter edge (240), wherein the integrally shielded blister layer (200) is formed with a article receiving blister (250), a well (260), and a deflection plateau (270); wherein (i) the article receiving blister (250) has a sidewall (252), an end wall (254), a blister perimeter (256), and a blister height (258); (ii) the deflection plateau (270) has an internal sidewall (272), an external sidewall (273), a deflection surface (274), a deflection perimeter (276), and a deflection plateau height (278); (iii) the article receiving blister (250), the well (260), and the deflection plateau (270) are formed of a single substrate; and (iv) at least a portion of the base substrate interior surface (110) is joined to the blister layer rear surface (220) thereby sealing the medicament (M) in the article receiving blister (250); and (c) the well (260) and the deflection plateau (270) are formed to shield the article receiving blister (250) from the application of substantially lateral forces thereby preventing access to the medicament (M) via compromise of the article receiving blister (250) and requiring application of a substantially orthogonal force to the article receiving blister (250) to result in the medicament (M) breaking through the base substrate (100) for distribution.

2. The child resistant medicament package with built-in shield (10) of claim 1, further including a backing substrate (300) having a backing substrate interior surface (310), a backing substrate exterior surface (320), and a backing substrate perimeter (330) wherein the backing substrate (300) is formed with an article dispensing region (340) having an article dispensing region perimeter (342) wherein the article dispensing region (340) is configured to cooperate with the article receiving blister (250) and the backing substrate (300) is joined to the base substrate exterior surface (120) requiring application of a substantially orthogonal force to the article receiving blister (250) to result in the medicament (M) breaking through the base substrate (100) and passing out of the article dispensing region (340).

3. The child resistant medicament package with built-in shield (10) of claim 2, further including a cover substrate (400) having a cover substrate interior surface (410), a cover substrate exterior surface (420), and a cover substrate perimeter (430), wherein the cover substrate (400) is formed to have a cover substrate blister receiver (440) having a receiver perimeter (442) configured to cooperate with the integrally shielded blister layer (200) such that a portion of the integrally shielded blister layer (200) extends through the cover substrate (400) from the cover substrate interior surface (410) to the cover substrate exterior surface (420) and the integrally shielded blister layer (200) has a blister layer flange (280) positioned between the cover substrate (400) and the backing substrate (300).

4. The child resistant medicament package with built-in shield (10) of claim 3, wherein the backing substrate (300) and the cover substrate (400) are formed of a single substrate folded along a backing substrate dispensing fold line (350).

5. The child resistant medicament package with built-in shield (10) of claim 2, wherein the article dispensing region perimeter (342) defines a void formed in the backing substrate (300) sized to cooperate with the medicament (M) so that the medicament (M) may pass through the article dispensing region (340) for distribution.

6. The child resistant medicament package with built-in shield (10) of claim 2, wherein the article dispensing region (340) is an integral portion of the backing substrate (300) having a separation line (344) selectively reducing the strength of the backing substrate (300), thereby permitting the medicament (M) to break a portion of the article dispensing region (340) free of the backing substrate (300) along the separation line (344) when the medicament (M) is exposed to a substantially orthogonal force, thereby permitting the medicament (M) to pass through the article dispensing region (340) for distribution.

7. The child resistant medicament package with built-in shield (10) of claim 6, wherein the article dispensing region separation line (344) is located substantially on the article dispensing region perimeter (342).

8. The child resistant medicament package with built-in shield (10) of claim 7, wherein the separation line (344) comprises one or more of the group consisting of die cuts, perforations, indentations, score lines, and weakened fracture lines.

9. The child resistant medicament package with built-in shield (10) of claim 1, wherein the deflection plateau height (278) is between approximately 25% of the article receiving blister height (258) and approximately 250% of the article receiving blister height (258).

10. The child resistant medicament package with built-in shield (10) of claim 1, wherein the deflection plateau height (278) is between approximately 75% of the article receiving blister height (258) and approximately 125% of the article receiving blister height (258).

11. The child resistant medicament package with built-in shield (10) of claim 1, wherein the deflection plateau height (278) is substantially equal to the article receiving blister height (258).

12. The child resistant medicament package with built-in shield (10) of claim 1, wherein the integrally shielded blister layer (200) is comprised of a material and thickness that cannot be readily deformed by a human finger pushing adjacent to the article receiving blister (250) thereby preventing exposure of the article receiving blister (250) to the application of substantially lateral forces and thus preventing access to the medicament (M) via compromise of the article receiving blister (250).

13. The child resistant medicament package with built-in shield (10) of claim 1, wherein the article receiving blister (250), the well (260), and the deflection plateau (270) are formed to cooperate with the dimensions of a tip of a human finger.

14. A child resistant medicament package with built-in shield (10) for housing a medicament (M) comprising: (a) a base substrate (100) having a base substrate interior surface (110), a base substrate exterior surface (120), and a base substrate perimeter (130); (b) a integrally shielded blister layer (200) having a blister layer front surface (210), a blister layer rear surface (220), a blister layer support bearing edge (230), and a blister layer perimeter edge (240), wherein the integrally shielded blister layer (200) is formed with a article receiving blister (250), a well (260), and a deflection plateau (270); wherein (i) the article receiving blister (250) has a sidewall (252), an endwall (254), a blister perimeter (256), and a blister height (258); (ii) the deflection plateau (270) has an internal sidewall (272), an external sidewall (273), a deflection surface (274), a deflection perimeter (276), and a deflection plateau height (278), and wherein the deflection plateau height (278) is between approximately 75% of the article receiving blister height (258) and approximately 125% of the article receiving blister height (258); (iii) the article receiving blister (250), the well (260), and the deflection plateau (270) are formed of a single substrate and are sized to cooperate with the dimensions of a tip of a human finger; and (iv) at least a portion of the base substrate interior surface (110) is joined to the blister layer rear surface (220) thereby sealing the medicament (M) in the article receiving blister (250); and (c) the well (260) and the deflection plateau (270) are formed to shield the article receiving blister (250) from the application of substantially lateral forces thereby preventing access to the medicament (M) via compromise of the article receiving blister (250) and requiring application of a substantially orthogonal force to the article receiving blister (250) to result in the medicament (M) breaking through the base substrate (100) for distribution.

15. The child resistant medicament package with built-in shield (10) of claim 14, further including a backing substrate (300) having a backing substrate interior surface (310), a backing substrate exterior surface (320), and a backing substrate perimeter (330) wherein the backing substrate (300) is formed with an article dispensing region (340) having an article dispensing region perimeter (342) wherein the article dispensing region (340) is configured to cooperate with the article receiving blister (250) and the backing substrate (300) is joined to the base substrate exterior surface (120) requiring application of a substantially orthogonal force to the article receiving blister (250) to result in the medicament (M) breaking through the base substrate (100) and passing out of the article dispensing region (340).

16. The child resistant medicament package with built-in shield (10) of claim 15, further including a cover substrate (400) having a cover substrate interior surface (410), a cover substrate exterior surface (420), and a cover substrate perimeter (430), wherein the cover substrate (400) is formed to have a cover substrate blister receiver (440) having a receiver perimeter (442) configured to cooperate with the integrally shielded blister layer (200) such that a portion of the integrally shielded blister layer (200) extends through the cover substrate (400) from the cover substrate interior surface (410) to the cover substrate exterior surface (420) and the integrally shielded blister layer (200) has a blister layer flange (280) positioned between the cover substrate (400) and the backing substrate (300).

17. The child resistant medicament package with built-in shield (10) of claim 16, wherein the backing substrate (300) and the cover substrate (400) are formed of a single substrate folded along a backing substrate dispensing fold line (350).

18. The child resistant medicament package with built-in shield (10) of claim 15, wherein the article dispensing region perimeter (342) defines a void formed in the backing substrate (300) sized to cooperate with the medicament (M) so that the medicament (M) may pass through the article dispensing region (340) for distribution.

19. The child resistant medicament package with built-in shield (10) of claim 15, wherein the article dispensing region (340) is an integral portion of the backing substrate (300) having a separation line (344) selectively reducing the strength of the backing substrate (300), thereby permitting the medicament (M) to break a portion of the article dispensing region (340) free of the backing substrate (300) along the separation line (344) when the medicament (M) is exposed to a substantially orthogonal force, thereby permitting the medicament (M) to pass through the article dispensing region (340) for distribution.

20. The child resistant medicament package with built-in shield (10) of claim 19, wherein the article dispensing region separation line (344) is located substantially on the article dispensing region perimeter (342).

21. The child resistant medicament package with built-in shield (10) of claim 20, wherein the separation line (344) comprises one or more of the group consisting of die cuts, perforations, indentations, score lines, and weakened fracture lines.

22. The child resistant medicament package with built-in shield (10) of claim 14, wherein the deflection plateau height (278) is substantially equal to the article receiving blister height (258).

23. The child resistant medicament package with built-in shield (10) of claim 14, wherein the integrally shielded blister layer (200) is comprised of a material and thickness that cannot be readily deformed by a human finger pushing adjacent to the article receiving blister (250) thereby preventing exposure of the article receiving blister (250) to the application of substantially lateral forces and thus preventing access to the medicament (M) via compromise of the article receiving blister (250).

24. A child resistant medicament package with built-in shield (10) for housing a medicament (M) comprising: (a) a base substrate (100) having a base substrate interior surface (110), a base substrate exterior surface (120), and a base substrate perimeter (130); (b) a integrally shielded blister layer (200) having a blister layer front surface (210), a blister layer rear surface (220), a blister layer support bearing edge (230), and a blister layer perimeter edge (240), wherein the integrally shielded blister layer (200) is formed with a article receiving blister (250), a well (260), and a deflection plateau (270); wherein (i) the article receiving blister (250) has a sidewall (252), an endwall (254), a blister perimeter (256), and a blister height (258); (ii) the deflection plateau (270) has an internal sidewall (272), an external sidewall (273), a deflection surface (274), a deflection perimeter (276), and a deflection plateau height (278), and wherein the deflection plateau height (278) is substantially equal to the article receiving blister height (258); (iii) the article receiving blister (250), the well (260), and the deflection plateau (270) are formed of a single substrate and are sized to cooperate with the dimensions of a tip of a human finger; and (iv) at least a portion of the base substrate interior surface (110) is joined to the blister layer rear surface (220) thereby sealing the medicament (M) in the article receiving blister (250); (c) a backing substrate (300) having a backing substrate interior surface (310), a backing substrate exterior surface (320), and a backing substrate perimeter (330) wherein the backing substrate (300) is formed with an article dispensing region (340) having an article dispensing region perimeter (342) wherein the article dispensing region (340) is configured to cooperate with the article receiving blister (250) and the backing substrate (300) is joined to the base substrate exterior surface (120); (d) a cover substrate (400) having a cover substrate interior surface (410), a cover substrate exterior surface (420), and a cover substrate perimeter (430), wherein the cover substrate (400) is formed to have a cover substrate blister receiver (440) having a receiver perimeter (442) configured to cooperate with the integrally shielded blister layer (200) such that a portion of the integrally shielded blister layer (200) extends through the cover substrate (400) from the cover substrate interior surface (410) to the cover substrate exterior surface (420) and the integrally shielded blister layer (200) has a blister layer flange (280) positioned between the cover substrate (400) and the backing substrate (300); and (e) the well (260) and the deflection plateau (270) are formed to shield the article receiving blister (250) from the application of substantially lateral forces thereby preventing access to the medicament (M) via compromise of the article receiving blister (250) and requiring application of a substantially orthogonal force to the article receiving blister (250) to result in the medicament (M) breaking through the base substrate (100), and passing out of the article dispensing region (340).

25. The child resistant medicament package with built-in shield (10) of claim 24, wherein the backing substrate (300) and the cover substrate (400) are formed of a single substrate folded along a backing substrate dispensing fold line (350).

Description:

RELATED APPLICATION

This application is a continuation-in-part of U.S. application Ser. No. 11/325,364, filed Jan. 4, 2006, entitled: “Shielded Medicament Package”, still pending.

TECHNICAL FIELD

The present invention generally relates to medication packages and, more particularly, relates to child resistant medication packages that have an integrated protective shielding component to control distribution of medicaments.

BACKGROUND OF THE INVENTION

There is a continued need for medication packages that are child resistant and specifically resistant to children that bite or otherwise use their fingers to gain access to potentially harmful medication. In addition, there is also a desire to have medication packages that allow the average adult to see the medication contained in the package but retain an acceptable or aesthetic visual appearance after multiple medicaments have been removed from the package. Finally, there is also a need to make this type of package economical to manufacture.

Over the years, a wide variety of disposable medication 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, or by simply pushing on the blister until the medicament breaks through the backing layer. 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.

Child resistant medication packages that have blisters have been in use for some time, however, as is too often the case, “child resistant” simply means that many people who do not have sufficient motor skills, finger strength, or whose hands shake are not able to easily gain access to the medicament in such packages. Children, however, do not generally limit themselves to the use of their fingers to open containers or packages. Usually after failing to open an object, children readily resort to more destructive methods to overcome child resistant features. For smaller packages, or for features that are accessible, for example, a blister containing a pill, children will use their teeth to destroy the blister. This can be a problem especially when the protective, child-resistant features of the package are small enough to allow a child to place the blister in their mouth or grab it with their teeth.

There is a need for a medication package that is relatively easy to open for an adult, but still child resistant. Further, the package must remain visually appealing after several medicaments have been removed. Furthermore, the package must be easy to manufacture without having to introduce custom machinery, so that the package remains economical. The present invention has accomplished these needs by creating a medication package that does not require fine motor skill functions, such as pinching and peeling. The present invention is relatively easy to open by application of substantially orthogonal pressure on the medicament blister, retains its visual appeal after multiple uses, and yet will substantially fend off direct biting assaults made by children.

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 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 demonstrates such capabilities and overcomes many of the shortcomings of prior methods in new and novel ways.

The child resistant medicament package with built-in shield of the present invention is designed for housing a solid medicament regardless of form. The package includes two primary components which are a base substrate attached to an integrally shielded blister layer. The package may also include a backing substrate and a cover substrate. The arrangement of the two primary components is unique and requires application of a substantially orthogonal force on the integrally shielded blister layer to access the medicament. The integrally shielded blister layer prevents access to the medicament other than by a substantially orthogonal pressure applied to the integrally shielded blister layer in the proper location. Consequently, any attempts to pick at or bite the medicament from the side are thwarted by the integrally shielded blister layer. A child cannot readily bite or pinch the blister containing the medicament. The backing substrate may provide additional support to the integrally shielded blister layer. The cover substrate may provide an additional alignment mechanism that may be used to achieve the proper alignment of the components.

The base substrate is attached to the integrally shielded blister layer. The base substrate is designed for trapping the medicament inside the integrally shielded blister layer. Generally, a portion of the surface area of a base substrate interior surface is joined to a blister shield rear surface thereby sealing the medicament in the article receiving blister. The area of the integrally shielded blister layer that is formed into the article receiving blister is not joined to the base substrate.

The integrally shielded blister layer is formed with an article receiving blister, a well, and a deflection plateau. The well and the deflection plateau are generally formed to cooperate with the article receiving blister. The well and the deflection plateau are positioned to prevent access to the sides of the article receiving blister; however, the deflection plateau provides access to the top of the article receiving blister. Therefore, application of pressure to the top of the article receiving blister is required to remove the medicament.

The backing substrate is formed to have an article dispensing region. The article dispensing region is configured to cooperate with the integrally shielded blister layer. In other words, the article receiving blister and the article dispensing region must generally align such that when the medicament is ejected from the article receiving blister the medicament may pass through the article dispensing region.

The assembly and orientation of the various elements of the package imparts the desired functionality to achieve the child resistance, aesthetics, and operation necessary to open the package. Dispensing the medicament from the package requires application of a substantially orthogonal force to the exposed portion of the article receiving blister. Generally the force will be applied by a tip of a human digit, most likely the thumb. The force is applied from the integrally shielded blister layer side of the package. The shield prevents forces applied to areas other than the article receiving blister from substantially exposing the sides of the article receiving blister.

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.

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 exploded view of the child resistant medicament package with built-in shield, not to scale;

FIG. 2 is a perspective view of the child resistant medicament package with built-in shield, not to scale;

FIG. 3 is a cross-sectional view taken along section line 3-3 in FIG. 2 of the child resistant medicament package with built-in shield, not to scale;

FIG. 4 is a cross-sectional view taken along section line 3-3 in FIG. 2 of the child resistant medicament package with built-in shield with a deflection plateau height greater than a blister height, not to scale;

FIG. 5 is a cross-sectional view taken along section line 3-3 in FIG. 2 of the child resistant medicament package with built-in shield with a deflection plateau height less than a blister height, not to scale;

FIG. 6 is a perspective exploded view of the child resistant medicament package with built-in shield with a backing substrate, not to scale;

FIG. 7 is a perspective view of the child resistant medicament package with built-in shield with a backing substrate, not to scale;

FIG. 8 is a cross-sectional view taken along section line 8-8 in FIG. 7 of the child resistant medicament package with built-in shield, not to scale;

FIG. 9 is a perspective exploded view of the child resistant medicament package with built-in shield with a backing substrate and a cover substrate, not to scale;

FIG. 10 is a perspective view of the child resistant medicament package with built-in shield with a backing substrate and a cover substrate, not to scale;

FIG. 11 is a cross-sectional view taken along section line 11-11 in FIG. 10 of the child resistant medicament package with built-in shield, not to scale; and

FIG. 12 is a perspective exploded view of the child resistant medicament package with built-in shield with a backing substrate and a cover substrate formed of a unitary sheet, not to scale.

DETAILED DESCRIPTION OF THE INVENTION

The child resistant medicament package with built-in shield of the instant invention enables a significant advance in the state of the art. The preferred embodiments of the apparatus accomplish this by am arrangement 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 claims.

The child resistant medicament package with built-in shield (10) of the present invention is designed for housing a solid medicament (M) regardless of form, including, but not limited to, round pills, oval pills, oblong capsules, caplets, etc. As seen in FIG. 1, the package (10) includes a base substrate (100) and an integrally shielded blister layer (200). These two primary components are assembled in a unique way. Consequently, to access the medicament (M), application of a force substantially orthogonal to the integrally shielded blister layer (200) is required. In addition, the package (1O) prevents children from biting or picking off portions of the package (10) to gain access to the medicament (M). The characteristics of the two components will be briefly described so that the sequence of operation may be explained.

First, with reference to FIG. 1, the base substrate (100) has a base substrate interior surface (110), a base substrate exterior surface (120), and a base substrate perimeter (130). The base substrate (100) is designed for holding the medicament (M) in the integrally shielded blister layer (200). The base substrate (100) may be comprised of one or more separate layers of material, such as foil and polyester or other suitable “push through” materials. The base substrate (100) can be comprised of multiple layers, but it could be made of any material deemed child-resistant.

Second, with continued reference to FIG. 1, the integrally shielded blister layer (200) has a blister layer front surface (210), a blister layer rear surface (220), a blister layer perimeter (240), and is formed with an article receiving blister (250), a well (260), and a deflection plateau (270). The article receiving blister (250) is formed with a sidewall (252), an end wall (254), and a blister perimeter (256). A blister height (258), as seen in FIG. 3, is the distance from the well (260) to the end wall (254). Similarly, as seen in FIGS. 2 and 3, the deflection plateau (270) is formed with an internal sidewall (272) and an external sidewall (273) with a deflection surface (274) connecting the internal and external sidewalls (272, 273). A deflection perimeter (276) is defined by the transition of the internal sidewall (272) into the well (260), as shown in FIG. 2. A deflection plateau height (278) is the distance from the well (260) to the deflection surface (274).

The position and geometry of the well (260) and the deflection plateau (270) in cooperation with the article receiving blister (250) generally provides the child resistant features of the instant invention. The well (260) and the deflection plateau (270) are formed in a position relative to the article receiving blister (250) that allows substantially orthogonal access to the article receiving blister (250) with a human digit, most likely a thumb, but protects the article receiving blister side walls (252) from lateral forces (biting) acting upon these areas. Consequently, a substantially orthogonal force (F), seen in FIG. 3, must be applied to the article receiving blister end wall (254) in order to eject the medicament (M) from the article receiving blister (250). The functioning of the integrally shielded blister layer (200) will be described later in greater detail.

The integrally shielded 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. In one particular embodiment the integrally shielded blister layer (200) is comprised of a material and thickness that cannot be readily torn, ruptured, or otherwise compromised by a human finger pushing or human teeth scraping on the integrally shielded blister layer (200). The material may be paper, or other fiber product, plastic, foil, or composite. The integrally shielded blister layer (200) may be formed by a thermoforming process in which the integrally shielded blister layer (200) material is stretched into a cavity with a vacuum and/or pressure technique to form the article receiving blister (250), the well (260), and the deflection plateau (270). In a preferred embodiment, a sheet of suitable material for the integrally shielded blister layer (200) is exposed to heating elements for a predetermined time. This sheet is then trapped in a forming station where it is subjected to both vacuum and/or pressure. During this process, the material may also be mechanically assisted into each cavity via plug assist to form the article receiving blister (250) and the deflection plateau (270). In another embodiment, the integrally shielded blister layer (200) may be formed by using cold-formed foil and cold-form packaging processes.

A portion of the surface area of the base substrate interior surface (110) is joined to the blister layer rear surface (220) thereby sealing the medicament (M) in the article receiving blister (250). The integrally shielded blister layer (200) may be joined to the base substrate (100) by heat sealing, adhesive such as heat-activated adhesive that has been pre-applied to the base substrate (100) or solvent adhesive, radio frequency (RF) or sonic seal, or by other suitable means. The areas of the integrally shielded blister layer (200) that are formed into the article receiving blister (250) and the deflection plateau (270) are not joined to the base substrate (100). The blister layer perimeter (240) generally corresponds to the base substrate perimeter (130), shown in FIG. 2.

The integrally shielded blister layer (200) may be a sheet of material formed in any desired shape. By way of example and not limitation, and as one skilled in the art would appreciate, the integrally shielded blister layer (200) may have the deflection surface (274) formed as a flat surface that is disposed at a nearly perpendicular angle from the internal and external sidewalls (272, 273), as seen in FIG. 3. Of course, the deflection surface (274) may have a variety of other shapes and may be oriented at a multitude of angles from the deflection plateau internal and external sidewalls (272, 273). In addition, although the internal and external sidewalls (272, 273) are shown to be formed in a near perpendicular orientation from the well (260), the sidewalls (272, 273) may have other orientations. Furthermore, the internal sidewall (272) may be oriented differently than the external sidewall (273). Moreover, as seen in FIGS. 1 and 2, a multitude of deflection plateaus (270) are possible. Some of the plateaus (270) have both internal sidewalls (272) and external sidewalls (273) and others have only internal sidewalls (272). The plateaus (270) that have only internal sidewalls appear as islands surrounded by the well (260). The plateaus (270) having both internal and external sidewalls (272, 273) may form a continuous ring or encirclement along the perimeter of the integrally shielded blister layer (200), as shown. A complimentary formation of wells (260) separates the article receiving blister (250) from the plateaus (270).

In the present embodiment of the instant invention, the wells (260) are connected and form a continuous surface that surrounds each article receiving blister (250), though an individual, unconnected well (260) may also surround individual article receiving blister (250). A distance between the directly opposing internal side walls (272) with the article receiving blister (250) positioned between the side walls (272) is designed so that the tip of a human digit sized between approximately 0.25 inches (0.635 cm) and 1 inches (2.54 cm), most likely a thumb, will have sufficient space to apply enough orthogonal pressure to the article receiving end wall (254) to force the medicament (M) through the base substrate (100). At the same time, however, the distance between directly opposing internal side walls (272) with the article receiving blister (250) positioned between the side walls (272) prevents substantially lateral forces, such as a child's teeth, from contacting the article receiving blister side wall (252) with sufficient force to compromise the article receiving blister (250). By way of example and not limitation, the article receiving blister (250) maximum dimension is typically between approximately 0.1 inches (0.254 cm) and approximately 1.5 inches (3.81 cm) and the well (260) maximum dimension is typically between approximately 0.1 inches (0.254 cm) and approximately 0.5 inches (1.27 cm). At the same time, placing orthogonal pressure within the well (260) or adjacent to the article receiving blister (250) does not provide access to the medicament (M) within the article receiving blister (250). As one skilled in the art would appreciate, numerous arrangements of plateaus (270), both continuous and discrete islands, and complimentarily positioned wells (260) are possible. Additionally, various embodiments of the invention may have different blister heights (258) and deflection plateau heights (278).

The deflection plateau height (278) is generally from 25% to 250% of the blister height (258). However, in one embodiment, the deflection plateau height (278) may be from 75% to 125% of the height of the blister height (258) and in another embodiment the deflection plateau height (278) may be substantially the same as the blister height (258), as shown in FIG. 3. In the embodiment of the package (10) where the deflection plateau height (278) exceeds the blister height (258), as seen in FIG. 4, the integrally shielded blister layer (200) prevents substantially lateral forces from coming into contact with the article receiving blister (250). In another embodiment, shown in FIG. 3, the deflection plateau height (278) is substantially the same as the blister height (258). In this condition, substantially lateral forces may or may not contact the article receiving blister (250); however, the portion of the article receiving blister (250) exposed to side forces, if any, is insufficient so that the applied lateral force is not able to damage the article receiving blister (250). The remaining embodiment, with respect to the deflection plateau height (278) and the blister height (258), has the blister height (258) exceeding the deflection plateau height (278), as seen in FIG. 5. Lateral forces attacking the article receiving blister (250) are still unable to find sufficient surface area to compromise the article receiving blister (250) to the extent that the medicament (M) is accessible.

The assembly and orientation of the various elements of the package (10) imparts the desired functionality and child resistance of the child resistant medicament package. The base substrate (100) is brought into contact with the blister layer (200) thereby containing the medicament (M) inside. In the embodiment of FIGS. 1 and 2, the integrally shielded blister layer (200) has a rectangular shape with a blister layer proximal edge (242), a blister layer distal edge (244), a blister layer sinistral edge (246), and a blister layer dextral edge (248). In the rectangular shaped embodiment, the base substrate perimeter (130) consequently has a base substrate proximal edge (132), a base substrate distal edge (134), a base substrate sinistral edge (136), and a base substrate dextral edge (138). However, as one skilled in the art will recognize, the integrally shielded blister layer (200) can be circular, oval, or have any of a multitude of shapes having a complimentary number of edges. The deflection plateau (270) is formed in a position such that substantially all of each article receiving blister sidewall (252) is protected by the deflection plateau (270) from potential damage caused by substantially lateral forces contacting the article receiving blister sidewall (252).

In an embodiment of the invention shown in FIG. 1, the integrally shielded blister layer (200) is a sheet of material formed in a shape that protects the article receiving blister (250) from substantially lateral forces acting upon the article receiving blister sidewall (252). This result is achieved by designing the deflection plateau (270) and the well (260) positioned so that, in the event of a lateral force acting upon the integrally shielded blister layer (200), the lateral force contacts the deflection plateau (270) prior to contacting the article receiving blister (250), though the lateral force may not touch or rest upon the article receiving blister sidewall (252) at all. The deflection plateau (270) disrupts avenues of approach that would expose the sidewall (252) to lateral forces. For example, a child who desires to bite the article receiving blister (250) will not be able to do so. When the child presses their teeth against the integrally shielded blister layer (200) in an attempt to bite or chew out the medicament (M) housed in the article receiving blister (250), the deflection plateau (270) will not allow an adequate angle of attack. The child's teeth will not achieve a position on the article receiving blister sidewall (252) sufficient to damage the article receiving blister (250).

With reference to FIGS. 6 and 7, in an embodiment of the instant invention the package with built-in shield (10) includes a backing substrate (300) having a backing substrate interior surface (310), a backing substrate exterior surface (320), and a backing substrate perimeter (330). The backing substrate (300) is formed to have an article dispensing region (340). The article dispensing region (340) has an article dispensing region perimeter (342) and is configured to cooperate with the integrally shielded blister layer (200), as seen in FIG. 6. In other words, the article receiving blister (250) and the article dispensing region (340) must generally align such that when the medicament (M) is ejected from the article receiving blister (250), the medicament (M) may pass through the article dispensing region (340). In one embodiment, the article dispensing region (340) defines a void formed in the backing substrate (300) sized to cooperate with the medicament (M) so the medicament (M) may pass through the article dispensing region (340) for distribution, as shown below the right most medicament (M) in FIG. 8.

Alternatively, the article dispensing region (340) may be an integral portion of the backing substrate (300) having a separation line (344), seen below the leftmost medicament (M) in FIG. 8, selectively reducing the strength of the backing substrate (300), thereby permitting the medicament (M) to break a portion of the article dispensing region (340) free of the backing substrate (300) along the separation line (344) when the medicament (M) is exposed to an ejection force, thus permitting the medicament (M) to pass through the article dispensing region (340) for distribution. In a further embodiment the separation line (344) is located substantially on the article dispensing region perimeter (342). The separation line (344) need not be one continuous separation line (344) and may include one or more die cuts, perforations, indentations, score lines, and weakened fracture lines. As with the integrally shielded blister layer (200), in one particular embodiment the backing substrate (300) is comprised of a material and thickness that cannot be readily torn, ruptured, or otherwise compromised by a human finger picking at or human teeth biting or chewing the backing substrate (300). The material may be paper, or other fiber product, plastic, foil, or composite.

In yet another embodiment, as seen in FIGS. 6 and 7, the base substrate (100), the medicament (M), and the integrally shielded blister layer (200) are brought into proximity of the backing substrate (300) and placed so that the article receiving blisters (250) substantially align with the article dispensing regions (340). As seen in FIG. 7, with reference as indicated in FIG. 8, each article receiving blister (250) cooperates with each article dispensing region (340).

Another embodiment of the instant invention, seen in FIG. 9, includes a cover substrate (400) having a cover substrate interior surface (410), a cover substrate exterior surface (420), and a cover substrate perimeter (430). The cover substrate (400) is formed to have a cover substrate blister receiver (440) with a receiver perimeter (442). The cover substrate blister receiver (440) is sized to generally cooperate with the integrally shielded blister layer (200). The cover substrate blister receiver (440) is configured to cooperate with the integrally shielded blister layer (200) such that a portion of the article receiving blister (250) extends through the cover substrate (400) from the cover substrate interior surface (410) to the cover substrate exterior surface (420). This is illustrated best in FIG. 10 where the child resistant medicament package with built-in shield (10) is shown assembled with the cover substrate blister receiver (440). In an embodiment of the instant invention the cover substrate blister receiver (440) consists of a plurality of voids formed in the cover substrate (400) that align with the shielded blister layer (200).

In an embodiment of the instant invention, both the cover substrate (400) and the backing substrate (300) are rectangular in shape, as seen in FIG. 10. With this configuration, the cover substrate (400) has a proximal edge (432), a distal edge (434), a sinistral edge (436), and a dextral edge (438). Similarly, the backing substrate (300) has a proximal edge (332), and distal edge (334), a sinistral edge (336), and a dextral edge (338). As shown, the backing substrate perimeter (330) substantially aligns with the cover substrate perimeter (430). As one skilled in the art would appreciate, the cover substrate (400) and the backing substrate (300) need not be rectangular, nor do they need to be the same shape, in which case the individual substrate perimeters and edges may not align. Furthermore, the cover substrate (400) may have one of a multitude of shapes with an accompanying multitude of edges, and the backing substrate (300) may also have one of a multitude of shapes with a complimentary number of edges.

As with the backing substrate (300) and the integrally shielded blister layer (200), in one particular embodiment the cover substrate (400) is comprised of a material and thickness that cannot be readily torn, ruptured, or otherwise compromised by a human finger. The material may be paper, or other fiber product, plastic, foil, or composite.

In the embodiment of FIGS. 9 and 10, the integrally shielded blister layer (200) is formed with a blister layer flange (280). The blister layer flange (280) may be captured between the cover substrate interior surface (410) and the backing substrate interior surface (310). The cover substrate blister receiver (440) and the integrally shielded blister layer (200) cooperate to align the article dispensing blister (250) with the article dispensing region (340).

When the package (10) is assembled, as shown in FIG. 10, the article receiving blister (250) passes through the cover substrate (400) and cooperates with the article dispensing region (340). The cover substrate (400) retains the integrally shielded blister layer (200) against the backing substrate (300). A cross-sectional view of the embodiment shown in FIG. 10 is seen in FIG. 11. In this embodiment, the package (10) is a layered structure where each layer is aligned with respect to each preceding layer to position the medicament (M) for dispensing through the article dispensing region (340). Proper alignment of the integrally shielded blister layer (200) is achieved when the article receiving blister (250) cooperates with the article dispensing region (340). The package (10) is assembled by placing the integrally shielded blister layer (200), containing the medicament (M), onto the backing substrate (300). Once the article receiving blister (250) is in position relative to the article dispensing region (340), the cover substrate (400) is brought into alignment with the article receiving blister (250).

Now, dispensing the medicament (M) from the package (10) requires application of a substantially orthogonal force to the article receiving blister end wall (254) resulting in pressure being exerted to the medicament (M) so that the base substrate (100) first ruptures and medicament (M) then passes through the backing substrate dispensing region (340). Generally the substantially orthogonal force will be applied by a tip of a human digit, most likely the thumb.

The figures illustrate that each of these components may be separate and distinct elements that are joined together to create the child resistant medicament package with built-in shield (10). Alternatively, the continuous substrate embodiments illustrated in FIG. 12 may be preferred for their high-speed manufacturing and assembly characteristics. Such characteristics include having a predetermined fold location between the substrates (300, 400) so the article dispensing region (440) and the article receiving blisters (250) are consistently and precisely placed in relation with one another to cooperate to achieve the desired sequence of operation. For example, the embodiment seen in FIG. 12 that includes the cover substrate (400) and the backing substrate (300) may be formed from a unitary sheet of material. In this case, a backing substrate cover fold line (350) will be formed in the unitary sheet. The backing substrate cover fold line (350) may include one or more die cuts, perforations, indentations, score lines, and weakened fold lines to ease assembly.

It should be noted that although the figures of the present application illustrate embodiments of the package (10) having six article receiving blisters (250), and therefore six article dispensing regions (340), the present invention need only incorporate one of each of the previously listed elements, yet may incorporate hundreds of such elements.

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 claimed 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 medicament package with built-in shield answers a long felt need for a novel package that is resistant to children. In addition, there is a need for a package that retains its original aesthetic appeal after multiple medicaments have been removed from the package. The package is for use with small or large medicaments of various shapes. The present invention discloses a package that implements requiring the application of a substantially orthogonal force before the medicament can be dispensed, thereby avoiding some of the inherent problems of medication packages that require peeling of multiple layers to be opened. The package of the present invention is relatively easy for an adult to manipulate, but not easy for a child to access a medicament within the package.





 
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