U.S. patent application number 11/395923 was filed with the patent office on 2007-07-05 for child resistant medicament package with built-in shield.
Invention is credited to David R. Barndt, Ronald R. JR. Bates, Victor JR. Gherdan.
Application Number | 20070151894 11/395923 |
Document ID | / |
Family ID | 46325354 |
Filed Date | 2007-07-05 |
United States Patent
Application |
20070151894 |
Kind Code |
A1 |
Gherdan; Victor JR. ; et
al. |
July 5, 2007 |
Child resistant medicament package with built-in shield
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; Victor JR.; (Cherry
Hill, NJ) ; Barndt; David R.; (Richlandtown, PA)
; Bates; Ronald R. JR.; (Norristown, PA) |
Correspondence
Address: |
CARDINAL HEALTH
7000 CARDINAL PLACE
LEGAL DEPARTMENT - INTELLECTUAL PROPERTY
DUBLIN
OH
43017
US
|
Family ID: |
46325354 |
Appl. No.: |
11/395923 |
Filed: |
March 31, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11325364 |
Jan 4, 2006 |
|
|
|
11395923 |
Mar 31, 2006 |
|
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Current U.S.
Class: |
206/531 ;
206/528 |
Current CPC
Class: |
B65D 73/0057 20130101;
B65D 2215/06 20130101; B65D 2215/00 20130101; B65D 83/0463
20130101 |
Class at
Publication: |
206/531 ;
206/528 |
International
Class: |
B65D 83/04 20060101
B65D083/04; B65D 85/42 20060101 B65D085/42 |
Claims
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
[0001] 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
[0002] 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
[0003] 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.
[0004] 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.
[0005] 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.
[0006] 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
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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
[0014] Without limiting the scope of the present invention as
claimed below and referring now to the drawings and figures:
[0015] FIG. 1 is a perspective exploded view of the child resistant
medicament package with built-in shield, not to scale;
[0016] FIG. 2 is a perspective view of the child resistant
medicament package with built-in shield, not to scale;
[0017] 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;
[0018] 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;
[0019] 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;
[0020] FIG. 6 is a perspective exploded view of the child resistant
medicament package with built-in shield with a backing substrate,
not to scale;
[0021] FIG. 7 is a perspective view of the child resistant
medicament package with built-in shield with a backing substrate,
not to scale;
[0022] 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;
[0023] 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;
[0024] 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;
[0025] 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
[0026] 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
[0027] 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.
[0028] 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.
[0029] 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.
[0030] 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).
[0031] 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.
[0032] 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.
[0033] 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.
[0034] 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).
[0035] 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).
[0036] 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.
[0037] 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).
[0038] 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).
[0039] 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.
[0040] 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.
[0041] 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).
[0042] 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).
[0043] 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.
[0044] 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.
[0045] 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).
[0046] 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).
[0047] 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.
[0048] 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.
[0049] 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.
[0050] 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
[0051] 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.
* * * * *