U.S. patent application number 12/554198 was filed with the patent office on 2011-03-10 for pharmaceutical container having non-child-resistant closure.
This patent application is currently assigned to PACIFIC MANAGEMENT HOLDING, LLC. Invention is credited to Sean M. Brennan.
Application Number | 20110056948 12/554198 |
Document ID | / |
Family ID | 43646899 |
Filed Date | 2011-03-10 |
United States Patent
Application |
20110056948 |
Kind Code |
A1 |
Brennan; Sean M. |
March 10, 2011 |
Pharmaceutical Container Having Non-Child-Resistant Closure
Abstract
A non-child-resistant closure and container system for a
pharmaceuticals comprises a cap configured to cooperate with a2
container. The container has at least one bayonet structure that
includes a leading taper, a recess, and a backstop. The cap has an
outer shell that includes a skirt and at least one lug formed
thereon. The lug is configured to cooperate with the bayonet
structure such that one of an audible signal and a tactile
sensation is produced upon closing the cap onto the container. The
cap is closed onto the container by rotating the cap until a
portion of the lug enters the recess. The lug is further configured
to be released from the recess by reverse rotation of the cap
causing the lug to move axially relative to the recess.
Inventors: |
Brennan; Sean M.; (Grafton,
OH) |
Assignee: |
PACIFIC MANAGEMENT HOLDING,
LLC
Elyria
OH
|
Family ID: |
43646899 |
Appl. No.: |
12/554198 |
Filed: |
September 4, 2009 |
Current U.S.
Class: |
220/301 |
Current CPC
Class: |
B65D 51/18 20130101;
B65D 2251/0075 20130101; B65D 2251/0015 20130101; B65D 41/06
20130101 |
Class at
Publication: |
220/301 |
International
Class: |
B65D 41/06 20060101
B65D041/06 |
Claims
1. A non-child-resistant closure and container system for a
pharmaceutical comprising: a container having at least one bayonet
structure that includes a leading taper, a recess, and a backstop;
and a cap configured to cooperate with the container and having an
outer shell that includes a skirt and at least one lug formed
thereon, the lug configured to cooperate with the bayonet structure
such that one of an audible signal and a tactile sensation is
produced upon closing the cap onto the container and rotating the
cap until a portion of the lug enters the recess, and the lug being
further configured to be released from the recess by reverse
rotation of the cap causing the lug to move axially relative to the
recess.
2. The non-child-resistant closure and container system of claim 1
wherein the cap includes a resilient portion having a spring rate
and the resilient portion being configured to engage the portion of
the lug into the recess when the cap is moved to a closed
position.
3. The non-child-resistant closure and container system of claim 1
wherein the rotation of the cap from a closed and latched position
to an unlatched position causes the lug to move axially out of
engagement with the recess in response to compression of a
resilient inner seal that is disposed between the container and the
outer shell.
4. The non-child-resistant closure and container system of claim 3
wherein the resilient inner seal provides a fluid tight engagement
with the container.
5. A non-child-resistant closure and container system for a
pharmaceutical comprising: a container having at least one bayonet
structure that includes a leading taper, a recess, and a backstop;
and a cap having at least one lug configured to cooperate with the
bayonet structure, the lug having a primary profile that engages
the recess and a secondary profile that controls the amount of
engagement of the lug into the recess.
6. The non-child-resistant closure and container system of claim 5
wherein the primary and secondary lug profiles are primary and
secondary lug upper surface profiles.
7. The non-child-resistant closure and container system of claim 5
wherein the primary and secondary lug profiles cooperate with the
bayonet structure to provide at least one of an audible signal and
a tactile sensation when the cap engages the container in a closed
and axially retained position.
8. The non-child-resistant closure and container system of claim 5
wherein the primary profile is a step.
9. The non-child-resistant closure and container system of claim 5
wherein the primary profile is one of a bump, a ramp, and a
pin.
10. The non-child-resistant closure and container system of claim 5
wherein the cap includes a separate resilient inner seal.
11. The non-child-resistant closure and container system of claim 5
wherein the cap includes an integral inner seal.
12. The non-child-resistant closure and container system of claim 5
wherein the primary profile is a pin and the pin contacts a portion
of the backstop in the closed position.
13. The non-child-resistant closure and container system of claim
12 wherein the pin is positioned on the lug in a manner that will
result in contact with the leading taper of the bayonet structure
as the cap is moved to a closed position.
14. The non-child-resistant closure and container system of claim 9
wherein the cap includes a resilient inner seal.
15. The non-child-resistant closure and container system of claim
14 wherein the resilient inner seal is compressed between the outer
shell and the container, the inner seal having a spring rate such
that compression of the inner seal causes the primary profile to
engage the recess and the secondary profile to engage another
portion of the bayonet structure.
16. The non-child-resistant closure and container system of claim 7
wherein the cap includes a resilient inner seal that is compressed
as the lug engages the leading taper of the bayonet structure, the
at least one of the audible signal and the tactile sensation being
produced in response to the compression of the resilient inner
seal.
17. A non-child-resistant closure and container system for a
pharmaceutical comprising: a container having at least one bayonet
structure that includes a leading taper, a recess, and a backstop;
and a cap having an outer shell, a resilient inner seal having a
spring force characteristic, and at least one lug formed onto a
portion of the outer shell and further configured to cooperate with
the bayonet structure, the lug having a profile that controls
compression of the resilient inner seal such that the spring force
characteristic permits the lug to be released from the recess by
rotation of the cap causing the lug to move axially relative to the
recess.
18. The non-child-resistant closure and container system of claim
17 wherein the spring force characteristic is an inversely
proportional function of a spring rate of the resilient inner seal
and a depth of engagement between a primary profile of the lug and
the recess.
19. The non-child-resistant closure and container system of claim
18 wherein a secondary profile of the lug is configured to engage
another portion of the bayonet structure and thus limit the depth
of engagement of the primary profile.
20. The non-child-resistant closure and container system of claim
19 wherein the primary and secondary lug profiles cooperate with
the bayonet structure to provide at least one of an audible signal
and a tactile sensation when the cap engages the container in a
closed and axially retained position.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates in general to pharmaceutical
containers. In particular, this invention relates to
non-child-resistant closures for pharmaceutical containers.
[0002] Pharmaceutical containers are used to dispense drugs and
other medicines from a pharmacist to patients. Because of the
potential for children to gain access to these medicines with
potentially dangerous effects, closure devices have been provided
with various mechanisms to prevent or deter small children from
gaining access to the contents. One popular type of child-resistant
(CR) closure and container system is a push and turn type system
that includes a cap having an outer shell and an inner seal. While
this closure configuration has the intended result of hampering or
preventing small children from gaining unauthorized access to
medicines, it also has the unintended result of hampering access to
medicines by the elderly or physically challenged patients. The
difficulty lies in certain users having a lack of manual dexterity
and strength to both compress and twist the cap. For this reason,
non-child-resistant caps are still in substantial use.
[0003] Previous non-child-resistant closures, such as traditional
snap caps, are easy to open but may not provide adequate sealing to
contain liquids or may be inadvertently opened, such as when
carried in a purse or pocket. Other non-child-resistant cap
configurations may include external threads that engage threads
formed on the inner diameter of the container. However, forming
threads on containers, particularly on the inner diameter of the
containers, increases the cost of manufacture. Other
non-child-resistant closure configurations do not provide any
indication that they are truly in a closed position. Thus, it would
be desirable to provide an improved non-child-resistant closure for
pharmaceutical containers.
SUMMARY OF THE INVENTION
[0004] This invention relates to a non-child-resistant closure and
container system for a pharmaceuticals. The system comprises a
container and a cap configured to cooperate with the container. The
container has at least one bayonet structure that includes a
leading taper, a recess, and a backstop. The cap has an outer shell
that includes a skirt and at least one lug formed thereon. The lug
is configured to cooperate with the bayonet structure such that one
of an audible signal and a tactile sensation is produced upon
closing the cap onto the container. The cap is closed onto the
container by rotating the cap until a portion of the lug enters the
recess. The lug is further configured to be released from the
recess by reverse rotation of the cap causing the lug to move
axially relative to the recess.
[0005] The lug of the cap includes a primary profile and a
secondary profile. The primary profile engages the recess and the
secondary profile controls the amount of engagement of the lug into
the recess. The secondary profile further controls the compression
of a resilient inner seal having a spring force characteristic and
a spring rate. The amount of engagement of the primary profile into
the recess compresses the resilient inner seal. Compression of the
resilient inner seal is such that the lug is permitted to be
released from the recess by rotation of the cap. Rotation of the
cap causes the lug to move axially relative to the recess.
[0006] Various aspects of this invention will become apparent to
those skilled in the art from the following detailed description of
the preferred embodiment, when read in light of the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 is an exploded, perspective view of a closure and
container system for pharmaceuticals.
[0008] FIG. 2 is an enlarged view, in partial cross-section, of the
closure and container system of FIG. 1.
[0009] FIG. 3 is an exploded view of an embodiment of a cap of the
closure and container system of FIG. 1.
[0010] FIG. 4A is an enlarged view, in cross-section, of the
closure and container system of FIG. 1 shown in a closed and
unlocked orientation.
[0011] FIG. 4B is the closure and container system of FIG. 4A shown
in a closed and locked orientation.
[0012] FIG. 4C is an enlarged view, in cross-section, of an
embodiment of a closure positioned on the container of FIG. 1 shown
in a closed and locked orientation.
[0013] FIG. 5A is a first embodiment of a bayonet and lug closure
structure.
[0014] FIG. 5B is a second embodiment of a bayonet and lug closure
structure.
[0015] FIG. 5C is a third embodiment of a bayonet and lug closure
structure.
[0016] FIG. 5D is a fourth embodiment of a bayonet and lug closure
structure.
[0017] FIG. 5E is a fifth embodiment of a bayonet and lug closure
structure.
[0018] FIG. 6 is a prior art child-resistant bayonet and lug
closure structure.
[0019] FIG. 7 is a prior art non-child-resistant bayonet and lug
closure structure.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0020] Referring now to the drawings, there is illustrated in FIGS.
1 and 2 a closure and container system, shown generally at 10, that
includes a non-child-resistant cap 12 and a container 14. The
container 14 includes a plurality of bayonets 16 spaced around an
open end 18 of the container 14 and may be suitable for both
child-resistant and non-child resistant closures. The bayonets 16
include a leading taper 20, a recess 22, and a backstop 24. The
bayonets 16 are configured to cooperate with a lug 26 that is part
of the cap 12. As shown in FIG. 3, the cap 12 includes an outer
shell 28 having a skirt 30 that extends from a back portion 32 of
the outer shell 28. The lugs 26, the skirt 30, and the back portion
32 are integrally molded to form the outer shell 28. The lugs 26
are shown spaced around an inner surface of the skirt 30. The cap
12 further includes a resilient inner seal, shown generally at 34.
Though illustrated as a separate member, the inner seal 34, or any
portions of the inner seal 34, may be integrally formed with the
outer shell 28.
[0021] Referring now to FIGS. 4A and 4B, the inner seal 34 is
illustrated having a sealing bead 36 and an edge seal 38, though
any resilient sealing geometry may be used. The resilient
characteristic of the inner seal 34 applies a spring force between
the outer shell 28 and the container 14 that causes the two
structures to separate. The sealing bead 36 is shown in the form of
a general "U" or "V" shape, though such a geometry is not required.
The sealing bead 36 extends into the opening 18 and seals against
the leading edge of the container 14 and may produce a fluid tight
seal arrangement. The edge seal 38 may be shaped in a in a "U" or
"V" geometry or any other contacting shape such as flat, rounded,
"C"-shaped, or any other suitable sealing geometry. The sealing
bead 36 and the edge seal 38 may produce the spring force as they
are compressed between the outer shell 28 and the container 14, as
shown in FIG. 4B. Either structure, alone or in cooperation, may
generate the separating spring force between the outer shell 28 and
the container 14. In order to generate a spring force, the
resilient inner seal 34 is made from an elastomeric material such
as, for example, synthetic rubber, urethane, poly vinyl chloride,
polyethylene, and the like.
[0022] Referring now to FIG. 4C, there is illustrated another
embodiment of a closure, shown generally at 12a, which is similar
to the closure 12 described previously. Similar reference numbers
will be used to describe features of closure 12a that are similar
to closure 12. The closure 12a includes an outer shell 28a having a
skirt 30a that extends from a back portion 32a of the outer shell
28a. A plurality of lugs 26a, similar to lugs 26 or any other lug
embodiment described herein, are formed on the inner surface of the
skirt 30a. The lugs 26a, the skirt 30a, and the back portion 32a
are integrally molded to form the outer shell 28a. The outer shell
28a includes an inner seal 34a that is also formed integrally with
the back portion 32a. The inner seal 34a is shown having a tapered
outer surface 36a which may also be applied as a taper on the inner
surface, though such is not required. The tapered outer surface 36a
includes an edge seal portion 38a that seals against the container
14. The edge seal portion 38a may have either a smooth surface
finish or a matte or satin textured finish in order to adjust the
coefficient of friction between portions of the container 14 and
the closure 12.
[0023] The integral inner seal 34a includes an anchor section 37a
that is formed integrally with the outer shell 28a. The anchor
section 37a extends from an inner surface of the back portion 32a
of the outer shell 28a. In the illustrated embodiment, the anchor
section 37a is thicker than the edge seal 38a. The tapered surface
36a may extend from the anchor portion 37a and provide the inner
seal 34a with a gradually decreasing cross section. The gradually
decreasing cross section of the inner seal 34a has a spring rate
that applies a sealing force against the container 14 as the
closure 12a is moved to the closed position of FIG. 4C. The inner
seal 34a may be deflected at the edge seal portion 38a to create a
fluid tight seal.
[0024] Referring now to FIG. 5A, in a first embodiment, the lug 26
includes a primary profile 40 and a secondary profile 42. The
primary profile 40 engages the recess 22 of the bayonet 16. The
secondary profile 42 contacts another portion of the bayonet 16
such as the leading taper 20, near the intersection with the recess
22 shown in FIG. 5A. Referring again to FIGS. 4A and 4B, the cap 12
is moved from an unclosed position shown in FIG. 4A to a closed and
secured position of FIG. 4B by twisting the cap 12 relative to the
container 14. As the outer shell 28 is twisted, the lug 26 makes
contact with the leading taper 20 of the bayonet 16. The lug 26
moves along the leading taper 20 which draws the outer shell 28
onto the container 14. As the outer shell 28 is rotated and drawn
onto the container 14, the inner seal 34 is compressed between the
back portion 32 of the outer shell 28 and a portion of the
container 14, such as the rim. As the outer shell 28 is twisted
further, the primary profile 40 of the lug 26 enters the recess 22
of the bayonet 16. The depth of engagement between the primary
profile 40 and the recess 22 is controlled by contact between the
secondary profile 42 and a portion of the bayonet 16. As shown in
FIGS. 4B and 5A, the end of the leading taper 20 contacts the
secondary profile 42. Upon closing, the contact of the secondary
profile 42 with the bayonet 16 produces at least one of an audible
signal or a tactile sensation that indicates the cap 12 is engaged
in a closed and secure condition with the container 14. The audible
signal may sound like a "click" and a corresponding "tap" or
impulse input to the cap may be felt by the user's finger tips or
palm.
[0025] To open the cap 12 from the container 14, the outer shell 28
is twisted relative to the container 14 in the opposite direction
of the closing movement. The depth of engagement between the
primary profile 40 and the recess 22 is controlled by the secondary
profile 42 such that added compression of the inner seal 34
required to disengage the primary profile 40 from the recess 22 can
be achieved without requiring the application of a secondary axial
force to the outer shell 28. In other words, the secondary profile
42 limits the spring force generated by the inner seal 34 so that
when the cap is unscrewed, the lug 26 disengages from the recess
22. The lug 26 disengages from the recess 22 without an additional
axial force being applied by the user to urge the lug 26 away from
engagement with the recess 22. As shown in FIG. 6, such a secondary
axial force and deflection, A, is required to disengage a lug 526
of a conventional child-resistant cap from the recess 22 of the
container 14, as will be explained in detail below. Only after the
lug 526 of the child-resistant cap of FIG. 6 is disengaged from the
recess 22 by the axial deflection "A" can the lug 526 be rotated to
permit removal of the child-resistant closure from the container.
In contrast, rotating the non-child-resistant cap 12 provides a
sufficient axial compression of the inner seal 34 to permit the lug
26 to disengage the recess 22 without requiring the application of
a secondary axial force.
[0026] The primary profile 40 is offset or spaced apart from the
secondary profile such that a depth of engagement "B", as shown in
FIG. 5A, of the lug 26 with the recess 22 is limited. The depth of
engagement of the lug 26 with the recess 22 is a function of the
stiffness of the resilient inner seal 34. As the spring rate
(measured, for example, in pounds per inch) of the inner seal 34
becomes higher (i.e., stiffer), the depth of engagement is smaller.
This inverse proportion of stiffness to depth of engagement
provides a force to compress the seal, with the force being
achievable by rotation alone of the outer shell 28. In one
embodiment, the primary profile is offset to permit the lug 22 to
project approximately 0.005 inch into the recess 22. The offset
however may be any depth such as within the range of 0.003 to 0.060
inches if desired.
[0027] Referring now to FIGS. 5B-5E, there are illustrated various
alternative embodiments of lugs where the primary and secondary
profiles are engaged with the recess 22 of the bayonet 16. As shown
in FIG. 5B, a lug 126 has a primary profile 140 that may be a
projection extending into the recess 22, such as a rounded bump.
Such a projection may permit a stiffer inner seal member to be used
with a greater depth of engagement "B" by providing a less abrupt
transition between the primary profile 140 and a secondary profile
142. FIG. 5C shows an alternative primary profile 240 that is a
double sided ramp having a lead-in surface 240a with a longer
length and shallow inclination angle and a retaining surface 240b
having a steep inclination angle. Such a primary profile may allow
for a wider range of seal spring rates to be used while still
permitting the cap to be removed by the user only rotating the
outer shell.
[0028] FIGS. 5D and 5E illustrate alternative embodiments of
secondary profiles. As shown in FIG. 5D, a secondary profile 342
that extends from a lug 326 adjacent to the leading taper 20 of the
bayonet 16. A primary profile 340 abuts the bayonet 16 in a similar
manner as the lug 26 of FIG. 5A. FIG. 5E shows another embodiment
of a lug 426 having a secondary profile 442 that engages a portion
of the backstop 24. A primary profile 440 abuts the bayonet 16 in a
similar manner as depicted in FIG. 5A. Alternatively, the secondary
profile 442 may be combined with any primary profile shape
desired.
[0029] Referring now to FIG. 6 there is illustrated a cooperating
bayonet 16 and lug 526 of a conventional push and turn type
child-resistant (CR) closure and container system that includes a
cap having an outer shell and an inner seal. The outer shell
includes a skirt having lugs formed thereon, similar to the outer
shell described above. The lugs 526 are adapted to cooperate with
the bayonet structure 16 formed on an outer surface of the
container. The bayonet structure includes a leading edge taper or
cam surface, a back stop portion, and a recess 22 as previously
described above.
[0030] The cap is aligned on the container so that the lugs may
pass vertically between adjacent bayonet structures. Rotating the
cap on the container causes the lugs to contact the leading taper
of the bayonet structure. As the cap continues to be rotated, the
lugs 526 move along the leading taper which draws the outer shell
toward the container. The outer shell compresses the inner seal
into the opening of the container. The lugs 526 are rotated beyond
the taper toward the back stop portion. The lugs 526 are then drawn
into the recess 22 by the spring force of the compressed inner seal
to lock the cap onto the container. If the cap is rotated relative
to the container, without a secondary axial force applied to the
cap, the seating of the lug 526 into the recess 22 provides both of
an audible signal and a tactile sensation to indicate the lid has
been properly secured. The seating of the lug into the recess may
also provide one of the audible and tactile indicators to the user
in certain instances. Rotating the cap without compressing the cap
against the container provides an added confirmation that the cap
is properly closed. The inner seal maintains a residual compression
to provide a liquid and/or air tight seal.
[0031] To release the child-resistant cap from the container, a
downward force is applied to the cap causing the inner seal to be
further compressed from the closed seal state. The lugs 526 are
then axially disengaged from the recesses 22 of the bayonet
structure 16. A rotational force is required to slide the lugs
around the cam surface on the bayonets and back to the spaces
between adjacent bayonets. The torque to rotate the container lid
increases with the amount of axial force applied to compress the
seal. The axial force is high enough to prevent or frustrate a
child's attempts to open the container. By way of the coefficient
of friction between the inner seal and one of the outer shell of
the child-resistant cap or the container 14, the torque to rotate
the cap to a removable position also increases while compressing
the inner seal. As previously mentioned, certain of the elderly or
physically challenged patients may be hampered or even prevented
from accessing their medications with these child-resistant closure
systems. The difficulty lies in certain users having a lack of
manual dexterity and strength to both compress and twist the cap.
Depending upon the materials selected for the container and the
inner seal and outer shell of the cap, the different coefficients
of friction of the contacting materials may add to the difficulties
in opening these pharmaceutical containers.
[0032] Referring now to FIG. 7, there is illustrated a cooperating
lug 626 and bayonet structure 16 of a prior art non-child-resistant
closure and container system. The closure is similar to the CR cap
described above and shown in FIG. 6. The main difference is that
the lug 626 is sized to be larger than the recess 22 to prevent
engagement therewith. The lug 626 engages and is moved along the
leading taper or cam of the bayonet 16 as described above. However,
the lug 626 completely spans the recess 22 when the edge of the lug
626 contacts the back stop. While these closures are more easily
twisted to remove, they do not provide any indication that they are
completely seated. As such, they may be more susceptible to
inadvertent opening in a purse or pocket. Additionally, because of
a lack of confidence in closing these containers, users may twist
the closure so hard that the lugs 626 are permanently deformed and
the cap is no longer operable or fluid tight.
[0033] The principle and mode of operation of this invention have
been explained and illustrated in its preferred embodiment.
However, it must be understood that this invention may be practiced
otherwise than as specifically explained and illustrated without
departing from its spirit or scope.
* * * * *