Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
WO 93~081 1 7PCI /U592/089~3 -:
~121~
-
CQNTAINER CLOSURE ASSEMBLIES
TEC~ICAL FIEI.D
5The present invention relates to double compartment
closure assemblies in ~hich materials are stored in at
least two separate compartments until the compartments
are opened for use. More particularly, the invention
relates ~o a construction of the closed or filling end of
such a dual chamber device in a manner which ~acilitates
~he discharge of materials therefrom at a later time whan
access to the contents of the chambers is desired
wi~hout any potential compromise to the end seal
integrity and also relates to a sterile cap and tube
assembly which i5 activated by further engagement of the
cap on the tube. Additionally, the invention relates to
: cap and tube assemblies in which a stem closing a
discharge end is removed by engagement of the stem ~ith a
: socket in the cap, followed by fracture or a frangible
: 20 support of ~he stem on the tube nozzle and removal of the
cap with the stem.
_
WQ93/OX117 PCT/US92/089~3
2 1 216g`'; 2
BAC~GROUND ART
There are a variety of applications in which two
lngredients ~re kept separate from one another in a
single container, such as in a dual chamber dispensing
package. At the appropriate time the multiple
components can be used for their intended purpose.
Prepackaging of specific doses or quantities is important
to save time during the application of medicine or
chemicals which need to be mixed prom~tly or in precise
quantities.
Multiple container closures are not new per se. In
my prior pa~entj U.S. Patent No. 4,884,703l a double
compartment closure and tube assembly is disclosed which
has certain features which have been found to be quite
acceptable in a number of markets. Specifically, the
patent discloses a container with two adjacent
compartments having a common surface at one end with a
thin wall portion at that end for each surface. The cap
slidably fits on the end of the container and includes
puncture means or piercers which are in alignment with
the walls so that the movement of the cap will cause the
piexcers to puncture the thin wall portion of each
compartment. The cap is placed in a first position on
the end of the container by cooperation between an
interference surface and a surface of resistance.
Typically, those surfaces are formed by a ring and groove
arrangement.
The double compartment closure of the above
referenced patent is admirably sui~ed for delivering
precise quantities of several reagents in a way where
monitoring and mixing takes place. However, under some
circumstan~es, the viscosities of two liquids are not
sufficien~ly similar that the rate of flow of the
contents will coincide. Other times, the viscosity of
WO93/~8117 PCTtUS92/089~3 j'.
2~2:~9~
, 3 .
the material con~ained in one or both compartments is so
high that an undesirably long period of time is necessary
for that component to be discharged when gravity is the
primary force on the material.
!-
Accordingly, it is important that a new and
improved container and closure a~sembly be developed
which is reliable and efficient for use with con~ents
having different viscosities from one another,
particularly, where one or both viscosities are
relatively high.
. ~
;~.
.. ..
!
WO93/0~117 PCT/US92/08953
~121~3.5
The f,eld of cap and tube assemblies which carry
medicines, vitamins and the like, have become cf major
importance and interest in the pharmaceutical industry.
There are many such devices, and recently interest has
focused on those applications in which two ingredients
are kept separate from one another in a single container,
such as in ~ dual chamber dispensing package. At the,
appropriate time, the multiple components can be used for
the intended purpose. Prepackaging of specific doses or
quantities is important to save time during the
application of medicine or chemicals which need to be
mixed promptly or in precise quantities.
,~
Often times, potent drugs which rapidly deteriorate
when mixed together are easily and safely maintained in
dual chambers to avoid premixing. Since these drugs are
often used by geriatric patients who may be Iimited in
their ability to mix in accurate proportions, it is
particularly advantageous for them to have the drugs kept
apart and mixed accurateIy just before use.
Multiple container closures are not new per se. In
my prior pa~ent, U.S. Patent No. 4,8S4,703, a double
compartment closure and tube assembly is disclosed which
has certain features which ha~e~been found to be quite
acceptable in a number of marke~s. Specifically, my
patent discloses a container with two adjacent
compartments having a common surface at one end with a
thin wall portion at that end for each surface. The cap
slideably fits on the end of the container and includes
puncture means or pier~ers which are in alignment with
the walls so that the mo~ement of the cap will cause the
piercers ~o puncture the thin wall portion of each
compartment. The ~ap is placed in a first position on
the end of the container by cooperation between an
interference surface and a surfac~ of resistance.
Typically, those surfaces are form~d by a ring and groove
WO93/08117 PCT/~'S92/08953 1 ~
2121~-3~ i
arrangement.
Another dual compartment container is described in
my co-pendir.g United States application titled DUAL
CHAMBER DISPENSING PA~KAGE, filed October 30, 1991, and
having Serial No. 07/784,964. In this application, a
multiple compartment chamber is disclosed which is
normally sealed at one end, such as by a crimp seal, and
has a discharge opening at the other end. At least two
adjacent compartments~ are provided for chemical
reac~an~s, medicines and the like. Each compartment is
aligned at the discharge end and has a thin wall
dispensing port for discharge of the contents once the
thin wall has been broken.
The devlce in my co-pending application
contemplates the use of~bellows; means which are formed
from the compartments for applying a discharge force to
the individual compartments upon squeezing the container.
In a preferred embodiment, there~ are two compartmen~s
sharing a common wall which are axially aligned and
pivotally joined. These two compartments form a hinge
point. Thus, particularly when high viscosity fluids are
employed, squeezing the walls of the containers causes
the bellows to force fluid out of the discharge ports at
a much faster rate than would be achieved by gravity
~alone.
: ~ -
In most cases when the contents are made from~`i 30 plastic or other quite ~lexible materials, designs of the
type described above are admirably suited for their
intended purposes. Medicines and the like are
effectively dispensed and the precise quantity of _ l
contents needed is placed at the point where it is most 1-
needed. This design is particularly effective in
providing precise proportions of two or more ingredients
at the point where it is dispensed while at the same time
.. ., .. .. . . . . ~, . .
WO93/08117 PCT/~IS92/089~3
2 1 2 1 ~ ` f - -
providing a positive force for dispensing the contents.
The bellows principle has been found to be particularly
helpful, especially with different quantities or
viscosities of the two or more fluids in the various
containers.
.
The only drawback to the general field of multiple
compartment containers is that sometimes the materials
from which the containers are manufactured is too stiff
10 or too inflexible. When small container chambers are -
needed, for example when eye drops, vitamins, or other
small dosage medicines and treating fluids are dispensed,
the material from which the containers are formed may
prevent ease of sealing. Specifically, when designs such
as described in my co-pending application and in my
a~orementioned U.S. Patent No . 4,884,703 and others are
employed, it is sometimes difficult to seal the end which
is us~d ~or filling~the containers. When bellows like
structures are used, particularly on small or stiff
compartments, the stress on the end which is to be sealed
is potentially too great to permit a complete and
effecti~e seal to be achieved.
~. .
Another dual compartment container is described in
my co-pending United States application titled DUA~
CHAMBER DISPENSING PACK~GE, filed January 31, 19~2, and
having SerLal No. 37/828,516. In this application, a
dual compartment container assembly has been provided
which includes two adjacent compartments which are
separated by a common wall segment. The container
includes a discharge end which is operable to permit
dispensing of the contents of said container, and a
filling end which is sealed after con~ents are placed in
said compartments. The two adjacent compartments have
outer arcuate walls which extend from the common wall
segment to form the compartments. The common wall
segment has a ~irst width prior to filling and a second
f~
WO93/08117 PCT/US92/08953 l-
212:169~
longer width after the filling end is sealed to form a
seal at the filling end. In a preferred embodiment, the
common wall segment is pleated to have a first length
prior to filling and a second straightened longer width
after the filling end is sealed.
This invention contemplates the use of bellows one
the opposed outer ends of both chambers so that effective
pressure can be applied to the insides of the chambers to
force the full dosage out of the chamber. While this is
effective, particularly in designs where the tube
material is ~lexible and where the size of the container
is sufficiently large, thexe is one drawback tO this
design when the container is small and relatively rigid.
Under some Cl rcumstances, the inclusion of the tWQ
outer wall, the center or common wal~, and the folded
overlap from the two bellows like portions of the outer
walls result.s in a configuration where 5 or more
thicknesses are being compressed at the filling end. It
is sometlmes di~ficult to achieve a complete seal that
has integrity and reliability that satisfies even the
most s~rict standards. Additionally, the pleated center
wall is formed with its own stresses due to the "memory~
of the plastic. These stresses form some kind of
resistance to a perfectly reliable seal at this îilling
end. This can place`an undue stress on the heat seal or
other closure and cause a problem in expelling all of the
contents of the ~o compartments of the container. More
important is the concern that the seal may not keep its
integrity for the useful life of the container. There is
the possibility that this undue stress may cause the
common wall to crack or separate, causing the contents to
mix at the wrong end of the container.
~ ccordingly, it is an object of this invention to
provide a simple and effective design for dual
W~93/~8~17 PCT/~IS92/~89~3
2i 21695
compartment containers which permits a safe and complete
seal o~ the filling end of the container.
.
Another object of this invention is to provide a
sealing system for dual compartment containers which are
small and relatively inflexible compared to larger
containers, and yet which permits all of the contents to
be expelled.
10Yet another object of this invention is to provide
: a seal design for use with dual compartment containers
which employ pressure dispensing features such as bellows
shaped containers and the llke in a manner which allows
for complete expulsion of the contents while maintaining
seal lntegrity.
.
.. ;-
WO93/~8l17 PCT/~;S92/08953
i` 2~21~9~ j
.... g
The field of cap and tube assemblies which carry
medicines, vitamins and the like, have become of major
importance and interest in the pharmaceutical industry.
There are many such devices, and recent interest ~as
focused on those applications in which two ingredients
are kept separate from one another in a single container,
such as in a dual chamber dispensing package. At the
appropriate time, the multiple components can ~e used for
the intended purpose. Prepackaging of specific doses or
quantities ls important to save time during the
application of medicine or chemicals which need to be
mixed promptly or ln precise quantities.
Often times, potent drugs which rapidly deteriorate
when mixed together are easily and safely maintained in
dual chambers to avoid premixing. Since these drugs are
often used by geriatric patients who may be limited in
their ability to mix in accurate proportions, it is
particularly advantageous for them to have the drugs kept
apart and mixed accurately jus~ before use.
Multiple container closures are not new per se. In
my prior patent, U.S. Patent No. 4,884,703, a double
compartment closure and tube assembly is disclosed which
has certain fea~ures which have been found to be quite
acceptable in a number of markets. Specifically, my
patent discloses a container with two ~djacent
compartments ha~ing a common surface at one end with a
thin wall portion at that end for each surface. The cap
slidable fits on the end of the container and includes
puncture means or piercers which are in alignment with
the walls so ~hat the movement of the cap will cause the
piercers ~o puncture the thin wall portion of each
compartment. The cap is placed in a first position on
the end of the container by cooperation between an
interference surface and a surface of resistance.
Typically, those surfaces are form~d by a ring and groove
WO 93/0811~ PCr/US91t/08953
212~69~
1 0 ' ' ~t
arrangement.
Another dual compartment cont~iner is described in
my co-pending United States application titled DUA~
CH~MBER DISPENSING PACKAGE, filed October 30, l991, and
ha~in~ Serial No. 07/784,964. In this application, a
multiple compartment chamber is disclosed which is
normally sealed at one end, such as by a crimp seal, and
has a discharge opening at the other end. At least two
adjacent compartments are provided for chemical
reactants, medicines and the like. Each compartment is
aligned at the discharge end and has a thin wall
dispensing port for discharge of the contents once the
thin wall has been broken.
The device further includes a cap which is sized to
movably fi~ on the discharge end of the container and
includes puncture means which are positioned in alignment
with the thin wall dispensing ports. The cap and
discharge end of the container cooperatively include
location means for positioning the cap at a first
position on the end of the container to prevent
inadvertent movement of the cap. The locating means also
permits intentional movement of the cap to a second
position to thereby cause the puncture means to puncture
the ports.
The device in my co-pending application
contemplates the use of bellows means which are formed
~rom ~he compartments for applying a discharge force to
the individual compartments upon squeezing the container.
In a preferred embodiment, there are two compartments
sharing a common wall which are axially aligned and
pivotally joined. These two compartments form a hinge
3S point. Thus, particularly when high viscosity fluids are
employed, squeeziny the walls of the containers causes
the bellows to force fluid out of the discharge ports at
WO93/0~11/ PCT/~'S9~/08953 j ~
212:~9~) -
11
a much faster rate than would be achieved by gravity
alone.
'.
In most cases when the compartments are made from
plastic or other quite flexible materials, designs of the
type described above are admirabl~ suited for their
intended purposes. Medlcines and the like are
effectively dispensed and the precise quantity of
contents needed is placed at the point where it is most
1~ needed. This deslgn is particularly effective in
providing precise proportions of two or more ingredients
at the point where it is dispensed while at the same time
providing a positive force for dispensing the contents.
The bellows principle has been found to be particularly
helpful, especially with different quantities or
viscosities of the two or more fluids in the various
containers.~
The only drawback to the general field of multiple
compartment containers is that sometimes the materials
from which the containers are manufactured is too stiff
or too inflexi~le. When small container chambers are
needed, for example when eye drops, vitamins, or other
small dosage medicines and treating fluids are dispensed,
the ma~erial from which the containers are formed may
prevent ease of sealing. Specifically, when designs such
as described in my co~pending application and in my
aforementioned U.S. Patent No. 4,884,703 and others are
employed, it is sometimes dif L icult to seal the end which
is~ used for filling the containers. When bellows like
structures are used, particularly on small or stiff
compartments, the stress on the end which is to be sealed
is potentially too great to permit a complete and
effective seal to be achieved.
Accordingly, it is an object of this invention to
provide a simple and effective design for dual
W093~X117 PCT/USg2/08953
2 1 2 ~ 12
compartment containers which permits a safe and complete
seal of the filling end of the container.
Another object of this invention is to provide a
sealing system for dual compartment containers which are
smalL and relatively inflexible compared to larger
containers.
: Yet another object of this invention is to provide
a seal design for use with dual compartment containers
which employ pressure dispensing features such as bellows
shaped containers and:the like.
,:~
-
. j , , , ~
_, i
WO93/08117PCT/~IS92/08953
212~
~ "
13
There are a variety of applications in which a
single dose of a medicine, reagent, or other material is ¦-
packaged in a disposable container under sealed
conditions. Often times, these packages include a method
for opening the assembly to provide access ~o the
contents of the container without resort to additional
tools or equipment.
One form of these containers may be generally
described as a container having the nozzle for discharge
of the contents, wherein the nozzle supports a stem like
element on a fransible diaphragm molded or otherwise
formed in the discharge opening. The cap is somehow
caused to interact with the stem, usually with the use of
a socket, whereby a fit between the stem and socket
ruptures the frangible diaphragm and causes removal of
the stem.
One example of this device is shown in the U. S.
.
patent No. 4,773,584. In this patent, a cap and tube are
combined such that~a frangible web supports a projection
which has knurling thereon. The cap is initially mounted
on the no~zle of the tube to protect the projection. The
cap has an end for acting as a cover with a reverse end
having a central~socket, and having axially extending
ribs. The ribs and the knurling frictionally engage and
interlock with each other. The obvious drawback of this
design is that the activation end of the cap is exposed
to the outside and can become contaminated. In addition,
thelcap must be taken off and turned over in order to
activa~e the system. This requires both hands at some
time during the removal of the stem or projec~ion. ~-
A design which avoids the sanitation problems of
the above identified patent is shown in U. S. Patent No.
4~134~5110 This patent describes a container with a neck
having an elongated solid projection on the tip. The
.................. .. . . .... . . .. . . . . ..
WO93/08117 PCT/~;Sg2/08953 ¦~
21216~33
14
projection is integrally connect~d to the tip by a
reduced wall portion forming a frangible annular link
whose rupture creates an outlet. The nec~ is closely
surrounded by a cap which firmly engages this removable
tip and cannot be de~ached until the tip has been broken
off. In other words, the tip is firmly mounted in the
cap.
As shown in U. S. Patent No. 4,134,511, the tip has
a smooth surface close to the neck but is polygonal over
the greater part of its length. A hexagonal shape is
preferred. This tip is then press f~it into a socket of
the same polygonal shape and both the tip and the socket
have a slight taper to limit the extent to which the neck
can be inserted into the cap.
The problems with this design are several. First r
there is no way to prevent the tip from being pushed in~o
the container when force is inadvertently applied ~o the
cap. Since the tip and cap are always in contac~, there
is a serious risk of inadvertent activation. Any time
there is a one s~ep activation, it is posslble for
children and others not authorized to have access to the
contents to inadvertently or intentionally open the
25 product. Another~drawback of this design is that axial
activation is possible e~en though the design is intende*
to have a rotatlonal movement to cause the fracture or
rupture of the frangible area holding th~ tip on the
nozzle. Finally, the tip is mounted to the nozzle at the
top of the nozzle. When the container is used for eye
drops, removal of the cap may provide a torn edge of the
frangible portion which may scrape or scratch the eye.
Similarly, when baby vitamins are dispensed from the
container, a quick movement by the child could cause a
cut or worse.
Accordingly, it is an object of the present
WO93/081l7 PCT/~'S92/~8953 ~.,.
212169J
.
invention to provide a safe and efficient method for
storing and dispensing materials in a container.
Another object of the present invention is to
provide a container of the type described which employs a
stem and socket in a manner which avoids the problems of
the prior art and which provides additional benef its and
safety features.
Specifically, it is an object of this invention to
provide a cap and tube assembly which normally exists in
a non-activated condition and which requires a multiple
step activation process prior to discharge of ~he
contents.
~ . ,
WO~3/08117 PCT/US92/~953
2121~ 3 16
The field of child resistan~ cap and tube
assemblies, which caxry medicines, vitamins and the like,
have become of major importance an~ interest in the
pharmaceutical industry. It is a growing need that
conta,ner ~ssemblies be diff~cult for children ~o open,
particularly accidentally. Also, increased interest is
beiI1g showr in cap and tube assemblies which cannot he
opened by happe~stance but wh..ch require a specific and
positive step ~o be taken in o.-der to have access to the
contents. This is particularly true when medicines,
vitamins and topical treatments such as eye drops are
contained in such tubes.
In prior art devices, desi~ns have been proposed
which include a three piece construction where a tube
body contains a plug attached to a portion of the main
~ody of the tube. The wall of the tube has been weakened
sufficiently ta permit the plug to be torn from the tube.
A cap portion lS designed so that one end might be fitted
over the tube having the plug, thereby protecting the
plug and the tube. The other end is then designat~d to
interact with the plug in a twisting manner to remove the
plug by rupturing the thin wall of the tube to which the
plug is attached. This design has not been effective,
however, because of the additional concern caused by the
existence of the plug and the need for safe and reliable
disposal of ~he plug.
In my prior U.S. Patent No. 4,867,326, I have
developed a child-resistant cap and tube assembly which
has a high reliability in pass/fail inspection
opportunities. This design permits easy inspection of
unit dose sterile medicaments which do not contain
preservatives in the product, to avoid use of spoiled or
3S contaminated products.
My prior device has a tube which has one end
WO93/08117 Pcr/~ 2/~
` 21216~
17
portion which terminates in an axially cen~ered first
opened surface at the outer perimeter of the end portion.
recessed bel~w the surface of the end portion is a thin
wall which seals the tube. The tube has a second
surface, called a surface of interference, which operates
to interfere with axial movement on the end portion The
cap has a resistance surface whic'n interengages the end
to locate the cap at a first position where a thin wall
porti.on on the tube is protec~éd. Movement overcoming
~he restraining efforts of the two surfaces causes a
puncture means to move to then puncture the thin wall and
provide access to the contents.
One of the difficulties with the prior device in my
U.S. Patent No. 4,867,326 is not that it is not
effecti~e. Ra~her, it has been highly effective in
keeping children and other from inadvertently opening the
container and causing loss or damage to the contents. It
is also suitable for pass/fail inspection step as the
thin wall is clearly visible when the cap is removed. If
it appears to have been punctured, the contents or the
condition of the thin wall will make that fact easily
determined.
One of the features of my prior U.S. Patent No.
4,867,326 is that the package 1ooks substantially the
same before and after activation. This is an appealing
appearance but is not suitable in those situations when
it is necessary to determine whether or not there has
been activation by the mere glance of the eye. In o~her
words, it is not possible to tell at a glance if the
child-resistant feature has been overcome in some manner.
Accordingly, it is an object of this invention to provide
a device which is capable of providing not only child-
resistance but also a quick visual warning or sign that
the device has in fact been opened.
;~ !
~ WO93/08~I7 PCT/US92/08953 ~-
,;, 1-
; 2 1 2 1 6 ~ 5 i-
,~! 18
As is true in any system where axial force is the
primary direction in which a system operates, there is
another way in which my system described in my U.S.
~' Paten-t No. 4,867,326 can be improved. In my prior
system, axial activation force was all that was needed to
overcome, abeit with substantial force, the
interengagement of the resistance surface and the surface
of interference. Once this takes place, for whatever
reason, the piercer moves to the second position as
described in that par.ent and the thin wall seai which has
been protecting the contents is pierced. That is
desirable only when the user makes that decision and not
l merely because the force has been overcome inadvertently.
I It is therefore another object of this invention to
provide a child-resistant tube and cap assembly tha~
requires more ~han axial force to provide access to the
contents. At ~he same time, it is an object of this
invention to provide a device which retains the simple
and very effective axial activation system of my U.S.
Patent No. 4,867,326. Thus it is an object of this
invention to have the best of my prior design while
adding additional features of value.
There is another concern that has become important
in the child-resistant container industry, and that is
the desire that a conscious mental step be needed in
order ~o move ~he cap and tube into alignment for
activation, and that they are somehow not capable of
activation without that conscious step. Stated another
` 30 way' it is an object of this invention to provide a
device which is sufficiently complex to prevent random
activity from putting the device in condition for being I-
activated. --
WO 93/0~1 1 7 PCr/VS92/08953 1';
2121 ~ ~
." 1,,
19
The field of cap and tube assemblies which carry
medicines, vitamins and the like, has become of major
importance and interest in the pharmaceutical industry.
It is a growing need that container assemblies be
difficult for children to open, particularly
accidentally. Also, increased interest is being shown in
cap and tube assemblies which cannot be opened by
happenstance but which require a specific and positive
step to be taken in order to have access to the
contents. This is particularly true when medicines,
vitamins and topical treatments such as eye drops are
contained in such tubes.
It is also important that it be easy and certain to
determine if there has been access to the contents. This
is normally referred to as a "tamper evident~ feature,
although in many cases the primary function is to provide
an inspection means which verifies the integrity of the
contents. Most concern is not for tampering, which can
be serious if not deadly but which is very rare in
actuaIity. At best, tamper evidence ~ans that the one
attemp~ing to tamper has not done that which is obvious,
such as breaking a visible seal or the like.
More common as a concern is the need to be sur~
that the contents are pure and have not been contaminated
by the environment. In many tube assemblies, the outside
environment can and does come in contact with the
discharge end o the tube and also with the part of the
3a t~be out of which the sterile contents will flow. No
matter how sterile the container, if it pours over
contaminated surfaces the contents will also be
contaminated.
_, ~
In prior art devices, tube assembly designs have
been proposed which include a three piece cons~ruction tC '
where a tube body contains a plug attached to a portion
, ~ .
i W~93/08117 PCT/US9~/08953 1~
` 212169~ - ,
i
of the main ~ody of the tube. The wall of the tube has
been weakened sufficiently to permit the plug to be torn
from the tube. A cap portion is designed so that one end
might be fitted over the tube having the plug, thereby
protecting the plug and tube. The other end is then
designed to interact with the plug in a twisting manner
to remove the plug ~y rupturing the thin wall of the tube
to which the plug is attached. This deslgn has not been
effective, however, because of the additional concern
caused by the existence of the plug and the need for safe
and reliable disposal of the plug.
.~
In U.S. Patent No. 4,867,326, a child-resistant cap
and tube assembiy is shown which has a high reliability
in pass/fail inspection opportunities. This design
permits easy inspection of unit dose sterile medicaments.
This prior device has a tube which has one end
portion terminating in an axially centered first opened
surface at the outer perimeter of the end portion.
Recessed below the surface of the end portion is a ~hin
wall which seals the tube. The tube has a second
surface, called a surface of interference, which operates
to interfere with axial movement on the end portion. The
cap has a resistance surface which engages the end to
locate the cap at a first position where the thin wall
portion on the tube is protected. Movement overcoming
~he restraining efforts of the two surfaces causes a
piercer to move to then puncture the thin wall and
provide access to the contents.
The prior de~ice in U.S. Patent No. 4,8D7, 326 has
been highly effective in keeping children and others from
inadvertently opening the container and causing loss or
damage to the contents. It is also suitable for a
pass/fail inspection step as the thin wall is clearly
visible when the cap is removed. The condition of the
` W093/08117 PCT/US92/08953
2 ~ 9 ~ i
;, I
' 21
, I
` thin wall is easily determined visually.
,` ' i'
In the prior system, axial activation force was all
that was needed to overcome the engagement between the
resistance surface and the surface of interference. Once
this is overcome for whatever reason, the piercer moves
to the second position as described in that patent and
he thin wall seal which has been prot~cting the contents
! is pierced. That is desirable only when the user makes
that decision and not merely because the force has been
overcome inad~ertently.
.
It is therefore an ob,ject of this invention to
provide a child-resistant tube and cap assembly that
requires more than axial force to provide access to the
contents.
In any system including those described above, when
the piercing agent enters the container from the outside,
there is always the potential that the piercer will bring
contamination with it. Even in the systems described
above, the sterile conditions are maintained nicely only
when the cap LS n~ver removed from the tube nozzle until
after it is intentionally activated. Under many
circumstances, this is fine, but when visual inspection
of the thin wall membrane is d~sixed, such as when there
is suspicion that the tube assembly has been in the hands
of children or other unauthorized persons, it is
comfoxting to inspect the thin wall visually. When ~he
cap is remo~ed to do this step, the possibility for
contamination exists.
,, Accor~ingly, i~ is an object of this invention to --
provide a device which is capable of providing not only
child-resistance but also a quick visual warning or sign
that ~he device has in fact been opened.
WO93/08117 PCT/~S92/08953 1'-
2 1 2 1 6 9~ 22
It is another object of this invention to provide
an activation system which permits visual inspection
without the possibility that the piercing member will be
contaminated.
:
It is a primary object of this invention to provide
a simple and effective design for permitting sanitary and
sterile access to the contents of a tube assembly without
the possibiiity of the piercing agent entering into the
I0 tube after assembly.
1 W~93/08~17 PCT/US~2/0~953 ,'",'5''
;` ` 2~2~ 3
23
A kno~!n means for dispensing two substances
~. simultaneously involves the use of dual chambers in a
.~ dispensing tube. As a typical example, Patent No.
4,528,180 to Schaeffer discloses a tube with two
~¦ 5 chambers, each chamber containing one of the substances
~I to be dispensed. As shown in Fig. 3~ of that patentj
3 each chamber i5 in communication with an orifice through
which the substances are dLspensed. The two chambers are
I separated by a divlder in the middle of the tube, which
10 is attached to the outside walls of the tube. Upon
squeezing the tube, ~he walls of the tube collapse,
¦ creating a pressure within each of the chambers and
', thereby causing the substances housed in the chambers and
thereby causing the substances housed in the chambers to
1 15 be dispensed simultaneously. Alternatively, as shown in
I Figures 1 and 2 of that patent, two separate tubes may be
secured together to dispense two substances.
Patent No. 4,964,539 to Meuller, while directed to
20 a closure, discloses~a tube with a plurality of chambers
for dispensing two or more substances simultaneously. As
in the Schaeffer patent, the chambers are separated by
dividers that attach to the outside walls of the tube.
Upon squeezing the tube, the flexible walls create a
25 pressure within the chambers, simultaneously dispensing
the substances in the~ chambers through orifices in
communication with the chambers.
Other such dispensing tubes are known wherein the
30 tubé contains two or more chambers, each housing a
substance to be dispensed through orifices in
communication with the chambers, by squeezing the tube.
In all of these known devices, however, the chambers are
separated by dividers that attach to the outside walls of
35 the tube. This construction creates fixed edges at the
intersections of the divider and the tube wall.
~ W093~08117 PCTtUS92/OB953 l~
21~,~6!~`~
24
As a result of the fixed edges, when the tube is
squeezedj the pressure increase within the chambers is
developed solely by the collapsing or flexing of the tube
wall itself between the fixed edges. In dual chamber.
~ubes, the amount of material dispensed from each chamber
: is dependent upon the decrease in volume o~ the chamber
oceasioned by the deformation of the walls of the
chamber. This deformation, and thus the amount of
material dispensed, depends upon several factors
including the viscosities of the substances to be
~ dispensed, the size and shape of the orifices through
which the substances are dispensed, the pressure applied
to the tube, and the configuration of the tube and
chambers.
15
As previously mentioned, in prior dual chamber
tubes, the inner walls are connected directly to ~he
outer walls of the chambers. In such tubes, upon the
application of force, the tu~e walls for each chamber
deform slightlyO Soon, however, upon continued
application of force, because of the fixed edges on
either end of the chamber, the deformation of the tube
wall becomes more difficult. Even upon constant force
application, deformation of the tube wall slows and may
even stop. However, upon application of slightly
increased force, another point is reached where the tube
wall undergoes rapid and se~ere deformation, as the outer
wall of the ~ube snaps inward toward the dividing wall,
causing a large amount of material to be dispensed from
that ch~mber. Noreover, this effect can happen to the
two different chambers with different amounts of force.
This causes the chamb~rs to dispense different amounts of
material, somewhat defeating the purpose of the dual
chamber dispensing device.
It is thus extremely difficult to dispense
substantially equal amounts of substance from the known
j WO93/08117
2121~
. .
dual chamber tubes as a result of the fixed edges at the
intersections of the dividers and the outside tube walls.
Because it is difficult to exert even pressure by
squeezing, it is difficult to apply even pressure to the
chambers of the known tubes, which is required of these
tubes for equal dispensation. Furthermore, with
resilient or resistive tube walls in the known devices,
even i equal force can be applied to the chambers, the
rate of deformation of the tube walls is variable and, as
a result of the sudden collapse observed, difficult ~o
control or regulate, making equal dispensation unlikely.
A dual chamber dispensing tube that facilitates
application of~ substantially equai pressure to both
chambers and thereby enables a constant, steady
deformation of the tube chambers and controlled
dispensing of the contents thereof is desirable.
Other objec~s will app~ar hereinafter.
WO93~0~117 PCT/~S92/08953
2 ~ 2 1 ~9~j 26
DISCLOSURE OF INVENTION
I~ has now been discovered that the above and other
objects of the present invention may ~e accomplished in
the following manner. Specifically, the invention
comprises a multiple compartment container. The
container is normally sealed at one end, such as by a
crimp seal and has a discharge opening at the other end.
At least two adjacent compartments are provided for
chemical reactants, medicines and the like. Each
compartment is aligned~at the discharge end having a thin
wall dispensing port for discharge of the contents once
the thin wall has been broken.
~;
The device further includes a cap which is sized to
movably fit on the discharge end of the container and
includes puncture means which are positioned in alignmen~
with the thin wall dispensing ports. The cap and
discharge end of the container cooperatively include
location means for positioning the cap at a first
position on the end of the container to prevent
!
nadvertent movement of the ~ap. The locating means also
permits intentional movement of the cap to a second
position to thereby cause the puncture means to puncture
the ports.
Finally, the invention contemplates the use of
bellows means which are formed from the compartments for
applying a discharge force to the individual compartments
upon squeezing the containex.
In a preferred embodiment, there are two
compartments sharing a common wall which are axially
aligned and pivotally joined. These two compartments
form a hinge point. Thus, particularly when high
viscosity fluids are employed, squeezing the walls of the
containers causes the bellows to force fluid out of the
WO93J08117 PCT/US92/089~3
2121~
27
discharge ports at a much faster rate than would be
achieved by gravity alone.
In some instances, when different viscosities are
employed in adjacent compartments, it has been found
effective in accordance with the present.invention to
provide different sized piercers in order to permit
proportionate discharge from the compartments.
Similarly, different sized piercers can be employed when
different volumes of fluids are being discharged, even
though the viscosities may be similar or the same. Thus,
the size of the piercers can be selected to accommodate
~ multiple properties of the contents being discharged.
~`
W093/~BII7 PCT/~'S92/OB953
2121695 28
Xt has now been discovered that the above and other
objects of present in~ention may be accomplished in the
following manner. Specifically, a dual compartment
container assembly has been discovered which includes two
S adjacent compartments which are separ~ted by a common
wall. The container includes an improved filling end
which is sealed in an improved manner after contents are
placed in said compartments.
1~ Th~ common wall has a first width prior to filling
and a longer width forming a straight line seal at a
point spa~ed from the filling end. Preferably the width
of the common wall is adjusted in this manner by forming
a gentle ~'s" curve in the wall, rather than sharp corners
such as are found in pl ats, so that as it is pulled at
both ends where it is joined to the outer walls, the
pleats will s~raighten and the width will increase
without adding resistance stress from the pleated
junctions~
The two outer walls terminate axially at the
filling end so that ~he end can be sealed. The preferred
method of sealing the filling end is to place the end in
a clamping device which applies pressure, and heat if
desired, to force the walls to seal. Since the material
from which these~ containers are fabricated is often a
thermoplastic material, heat sealing is relatively easy.
Of course, if the material in the compartments is heat
sensitive, pressure alone or pressure and an adhesive can
be employed.
r
The present invention also includes a common wall
which tenninates at the f illing end so as to provide a
filling end seal region with three commonly bonded wall.
This is important to prevent stress on the internal or
com~on wall.
WO 93~081 1 7 PCr/l~S92/089~3 .~,
2 1 2 ~
" 29
Pressure and heat if needed is used to form the
seal at the filling end`by joining the ends of the outer ¦-
walls. The seal ext~nds axially inward to include the ~, :
end of the common wall in only a portion of the seal. In i ~,'
S this manner, the two compartments are separated and the
contents dc not mix, but the alignr~ent of the
compartrnents and the common wall which has been stressed,
to make the seal still permits the contents to be ...
expelled easily and without undue effort. '
The outer walls are joined with the common wall to
form axially aligned pivotal junctions to define bellows. ~.
The bellows themselves terminate before the region where
the seal is to be 'formed, so that none of the bellows
15 thickness is imparted to the seal region. It is ~
preferred ehat the straight line seal 'is a heat seal. ~- `,
~.
WO93/08117 rCT/i'S92/089~3 ~:
2121~ 30
It has now been discovered that the above and other
objects of the present invention may be accomplished in
the following manner. Specifically, a dual compartment
container assembly has been discovered which includes two
adjacent compartments which are separated by a common
wall segment. The container includes a discharge end
which i5 operable to permit dispensing of the contents of
said container, and a filling end which is sealed after
contents are placed in said compartments.
The two adjacent compartments have outex arcuate
walls which extend from the common wall segment to form
the compartments. The common wall segment has a first
length prior to filling and a second longer length after
the filling end is sealed to form a seal at the fiLling
end. In a preferredlembodiment, the common wall segment
is pleated to ha~e a first length prior to filling and a
second unpleated longer length after the filling end is
sealed.
2~
The arcuate walls are joined to the common wall
segment at each junctio~ to form axially aligned pivotal
junctions which allow the compartments to function as
bellows means. The compartments and the common wall
segment define the ballows means by causing the
compartments to taper ou~wardly from the straigh~ line
seal to the discharge end of the container which is the
largest diameter that ~he container has. Thus, as
pressure is applied to the sides of the compartments, the
arcuate walls function as bellows to force the contents
out through the discharge end as desired.
L -` -
To maximize the discharge force of the bellows _
means, it is desirable to have the common wall segment
and the junction with the arcuate wall form a straight
line seal at the filling end. Preferably, the container
is made from a moldablP material such as plastic, and is
WO93J0~117 P~T/~'S92/08953 ~
21 ~ C~ iF
31
sealed using a heat seal. The container of the present f
invention is admirably suited for small capacity designs
because the common wall segment accommodates arcuate
walls of almost any small dimension without requiring
5 unreasonable or possibly damaging force when the seal is ,7
made.
:.
t
~I ~
.. ~., .
f ~
~
2 1 2 1 6 ~3 PCT/I'S9~/089~3
32
It has now been discovered that the above and other
objects of the present invention may be accomplished in
the following manner. Specifically, the invention
compxises an improved cap and tube assembly.
.
The tube includes a neck ending in a discharge end
having an outwardly extending stem. This stem is mounted
on the end of the tube neck with a frangible support a~ a
point recessed from the outer terminal end of the neck in
order to define an outlet when the stem is removed.
The assembly also includes a cap which is sized to
slidably fit the neck. The cap includes an inwardly
facing stem engaging socket for engaging the stem. The
stem and socket include a stem locking means for
positively locking the stem in the socket upon its
insertion into the socket to a predetermined position.
Additionally, the assembIy includes a location means
cooperatively positioned on the neck and cap to locate
the cap at a first position where the stem and socket are
spaced apart from one another and a second position which
is defined by the predetermined position of the s~em
locking means.
In a preferred embodiment, the stem is frangibly
supported on the discharge end by an annular thin wall
portion and by a plurality of axially extending bridges
which resist axial ~ovement of ~he stem and permit
engagement of the locking means at said predetermined
position. In one embvdiment, the engagement in the
predetermined position of the stem and the socket is
designed to provide a signal capable of being sensed by a
user This signal may be audible, such as by a click
from a ring and grove engaging one another.
Alternatively, it may just be tactile, as the user feels
a ring and groove engaging as they locate the stem in the
socket at the predetermined position.
.... ..
W0~3/08117 PCT/~S92/08953 ls
2 ~ 2 ~
33
In another embodiment, the stem and socket are
sized to have a friction fit at the predetermined
position in order to facilitate cooperative axial
rotation of the stem and rupture of the frangible
support.
,
In yet another embodiment of the present
invention, the assembly includes a first indicia
indicating a first condition prior to insertion of the
stem and socket to said predetermined position.
Normally, this will be a position where the stem and
socket are spaced from one another. One ~aria~ion of
this embodiment is to provide a clear cap so that the ~ ~-
15 relationship between the stem and the socket is clearly ~ -
visible. A further part of this embodiment includes a
second indicia indicating a second condition after
inser~ion of the~ stem and socket to said second or
predetermined positionj followed by axial rotation to
rupture said~rangible support.~ This indicia may be in
the form of markings around ~he cap.
: : ::~
~.
- - .
''- '' ~
:-:
,
i:
WO93/08117 PCT/~'S97/0~953
2121695
34
It has now been discovered that the above and other
objects of present invention may be accomplished in the
following manner. Specifically, a new child resistant
cap and tube assembly has been discovered. This assembly
includes a tube for containing a product, which tube has
an end portion with a recessed thin wall section which is
designed to be puncturable to provide a discharge opening
for the contents of the tube. There is also provided a
shoulder element or portion of the tube which serves to
limit axial movement of a cap on the end portion of the
tube.
The assembly also includes a cap having a central
axis for alignment with the tube. It is sized to
slidably engage the end portion of the tube. The cap
also has an axially centered puncture ~eans or piercer
which is positioned to be aligned with the thin wall
section o~ the tube. The piercer is normally spaced from
the thin wall section in a first position which is spaced
from the thin wall and where the thin wall is protected
from being punctured. The piercer is operable to
~puncture said thin wall upon movement of the cap to a
second position, after which is can be removed so that
the contents can be discharged for use.
~
The cap also has a shoulder engaging part which is
used to prevent axial movement of the cap from the first
position to said second position without intentional
manipulation of this shoulder engaging part to a shoulder
disengaging position. There are sevexal embodiments of
this portion of the assembly, each of which prevent
movement of the cap to the second position and engagement
of the piercer and the thin wall is protected and
prevented. Once the intentional manipulation is
performed, movement to the second position and puncture
of the ~hin wall is easy to accomplish.
W~93/0~117 PCT/VS92/~8953 1`
21216~ 1
In one embodiment, the shoulder is formed by the
terminal end of the tube on which the end portion is
placed. In this embodiment, the shoulder engaging m~ans
comprises a skirt which is detachably attached to the
S tube engaging end of the cap. The skirt thus engages the
shoulder to prevent movement of the cap to the second
position until the skirt is removed. One form of this
embodiment includes a skixt which is a tear-off skirt
that has been frangibly attached to the cap, such as by
scoring or the like. The tear~off skirt is adapted to be
removed by intentional manipulation, simply by tearing
the skirt from the assembly and placing the removed
portion in an appropriate disposal container.
Al~ernatively, the skirt may be a split skirt having a
frangible seam which is adapted to be split by said
intentional~manipulation, in this case simply by pushing
on the end of the cap.
, -.
A preferred embodiment includes the use of a ring
and groove, one of each being on the end portion and on
the one end of said cap to define the first position upon
engagement of the~groove and ring. The ring and groo~e
are sized to engage each other with sufficient force to
prevent accidental movement of the cap toward the thin
wall portion. In this embodiment, the axialIy centered
puncture means is preferably located on the other end of
said cap whereby the intentional manipulation includes
d~sengagement of the ring and groove and slidable
movement of the other end of the cap to the second
position. For sanitary reasons this embodiment includes
closure m~ans such as tear off tape for covering the end
of the cap having the axially centered puncture means.
Thus, the intentional manipulation also includes removal
o~ the tear-off tape or other closure means prior to
movement of the cap to the second position.
In yet another preferred embodiment, the shoulder
WO93/OBI~7 PCT/US92/08953 k
2 1 2 1 ~S
36
comprises a boss means located on the end portion of the
tube and the shoulder engaging mans comprises socket
means on the cap. The socket means is normally out of
alignment with the boss means and in this manner defines
the first position where the piercer is safely spaced
from the thin wall of the tube. The intentional
manipulation includes aligning the boss means and the
socket means to permit movement of the cap to the second
position. Once the boss and socket are aligned, there is
nothing preventing slidable movement of the piercer
through the thin wall of the tube. In this embodiment,
the socket should extend radially from the cap at one
location on the cap, both to indicate the location and to
provide purchase for the twisting movement of the cap on
the tube end which will be necessary to align the boss
and socket. Also to ~rovide visual location of the boss,
the boss extends below the cap when the cap is in the
first position.
In this way, the user is able to visually observe
the location of both the soc~et means and the boss means
so as to easily make the appropriate alig~men~ and to
recognize cap and tube assemblies which have been
acti~ated previously. In this manner, this embodiment
provldes as a tamper evident feature. Similarly, the
design which includes a detachable skirt very clearly
provides a tamper evident feature. Likewise, the ring
and groove embodiment has h tamper evident feature with
the remo~able tear-off tape or other closure, as well
with the cap having to be removed and the other end
attached to the tube.
_
WO ~3~8117 PCr/l,'S92/089~3
, 2 1 ~ ~L 6 9 ~:3 I ~
37 '
It has now been discovered that the abovs and other
objects of present invention may be accomplished in the
following manner. Specifically, a tube assembly has been
discovered which is admirably suited for containing
medicines and the like and which is designed for
dispensing the contents upon squeezing the tube.
~".
The assembly comprises a tube having a discharge
end with an axially aligned nozzle extending from the
tube to a discharge port. Typically, tubes of this type
are used for medicines, vitamins, eye drops, and the
like, but any tube can employ the present invention,
particularly those tubes which are to be sterile or at
the least very clean and free from contamination. The
present invention is also particularly useful when tamper
evident features are desired, as all of the operating
mechanisms are located inside the tube and any opening is
easily seen upon visual inspection.
The nozzle has an axially aligned central bore with
a thin wall sealing the central bore at a point recessed
rom the exposed end of the nozzle. Also included is a
piercer means which is mounted in the nozzle. The
piercer means is sized to slideably move axially in the
central bore from a ~first ready position axially inward
of the thin wall to a second discharge position Ln which
the piercer has completely puncturing the thin wall. It
is preferred that the piercer means is sized to be
inserted into the discharge port from the fillin~ end of
the tube prior to filling the tube.
In the first position, the piercer, which
preferably comprises a hollow needle~ e member, is
located in a first position which is a safe distance from
tha thin wall. The hollow needle-like member is sized to
move axially in the central bore and is mounted on a
piston which is sized to slideably fit in the discharge
WO93/08117 PCT/US92/089~3
21~i6~3 38 '~
port and n~ove the needle-like member from the first
position to the second position upon application of
pressure to the tube. Because the application of the
pressure is not axial, but rather comes from squeezing
the tube, the possibility of inadvertent axial force
causing an undesired puncture of the prGtective thin wall
is eliminated.
Most commonly, the assembly also includes a cap
0 mounted on the exterior of the nozzle. The cap provides
additional protection for the contents and specifically
keeps the discharge port free from contamination. It may
be desirable to include tamper evident features to the
manner in which the cap and tube are mounted on the
exterior of the nozzle portion.
. ~.
Of primary importance when a cap is employed is the
use of an axially centered support member which is sized
to fit in the discharge port. This axially centered
support plug is sized to fit in the discharge port for
ahutment against the recessed thin wall and prevent
inadvertent puncture of the thin wall. Thus, even if the
tube is squeezed, the internal pressure is not enough to
cause the piercer means to puncture the thin wall because
25 the thin wall is effectively made much thicker with the
support plug in mating contact with the wall via i~s
flat, axially transverse surface.
i.,
WO93/081l7 PCTIUS92/~8953 i~
I: 2121695
39
In accordance with this invention, there is
provided a container, for dispensing two substances
simultaneously, that includes a neck portion having two
oriices therein, a shoulder portion connected to the
S neck portion, and an elongated body portion connected to
the shoulder portion, the body portion including two
adjacent chambers sharing a common wall wherein each
chamber is in fluid communication with an orifice in the
neck portion, and wherein each chamber includes an
arcuate outer wall that has a chord of a length greater
than the width of the common wall and that is connected
to the common wall by two side walls which form hinges at
the junctures of the outer and side walls. The size and
shape of the orifices can be varied to adjust the rate of
dispensation of the substances to compensate for
vari~nces in viscosity ~etween the substances.
.
In the preferred embodiment, the container is a
tube made of resilient plastic and has t~o orifices in
20 the neck portion, the orifices having substantial equal ~--
areas.
L ~
_. ,
WO 93/0~ 1 7 PCI /~S92/08553
2121~3~3
4 0
E~RIEF DESCRIPTION OF THE DRAWINGS
. ;
These and other objects of the present invention
and the various features and details of the operation and
construction thereof are hereinafter more fully set forth
with reference to the accompanying drawings, wnere:
Fig. 1 is an isometric view of a dual chamber,
collapsible tube container with a bellows design.
Fig. 2 is an exploded, fragmentary, isometric view
of the dual chamber collapsible tube container shown in
Fi~. 1, with the closure members separated from the tube
body to show the dual dispensing ports and nozzle
15 design. '-5
Fig. 3 is a plan view of the nozzle and collapsible
tube body container taken along the line 3 - 3 of Fig. 2,
clearly showing the symmetrical design of the bellows.
~0 Fig. 4. is an enlarged, fragmentary, sectional,
elevational view taken along the line 4 - 4 of Fig. 1
showing details of construction.
Fig. 5 is a view similar to Fig. 4, showing the
closure membe~ activated to a full down position in which
the piercing points have cut through the thin wall
portions of the ports to provide openings for discharge
of the contents contained in the two compartments.
Fig. 6 is an enlarged, cross-sectional view taken
along the line 6,6 of Fig. 1.
.. ..
', ' '
WO93/08117 PCT/US92/08953 ~
2121~ 3 g
41 1 ::
Fig. lA is an exploded, isometric view of an ¦
unsealed, dual compartment, pierce point, b~llows tube, ! -
with the dual pierce point member shown separate from the
tube. i -
~ ~:
Fig. 2A is an isometric view of the unsealed dual
compartmen~ bellows tube shown in Fig lA in an inverted
position, with a portion broken away. `~-
:
Fig. 3A is an isometric :view similar to Fig. 2A,
but showing the dual compartment bellows tube in a sealed
configuration.
Fig. 4A is a greatly enlarged, fragmentary
15 sectional view taken on the line 4A,4A of Fig. 3A,
showing the heat sealed junction of the tubQ side walls
and the entrapped flattened and extended medial strip.
-: -
Fi~. 5A is an enlarged, sectional, elevational view
20 of the dual compartment bellows tube shown in Fig. 1~ and ~ -~
taken along the line 5A,5A of Fig. lA, shown with the
tube in an unsealed condition with the dot and dash lines
profiling the tube in a sealed configuration.
Fig. 6A is a sectional elevational view taken on
the line 6A,6A of Fi~. 5A. : :
Fig. 7A is a bottom plan view of Fig. 6A, taken
along the line ~A,7A of Fig. 6A.
Fig. 8A is a view similar to Fig. 7A and showing
the terminal ends of the outer arcuate side walls pressed
inwardly to form double thic3cness linear seal. _
. . '
WO93/0~117 PCT/US92/08953 ~;:
2 1 ~ 1 ~ ?J ~3 42
Fig. lB is an enlarged, isometric view of a molded
one-piece dual chamber tube for a package showing the 33.
discharge end of the tube covered by a closure membPr and
the opposite end of the tube having a line seal.
Fig. 2B is an exploded isometric view of the dual
chamber container assembly shown in Fig. 1~ with the
closure member removed to show details of the dual
discharge nozzle.
Fig. 3B is an enlarged plan view taken on the line
3B,3B of Fig. 2B, and showing the symm.etrical design of
the tube geometry.
lS Fig. 4B is an isometric view of the molded one
piece dual chamber container assembly of the invention in
an inverted or filling mode.
Fig. 5B is an enlarged, sectional, elevational view
20 of the molded container assembly taken along the line
5B/5B of Fig. 4B.
Fig. 6B is a sectional elevational view taken on
the line 5B,6B of Fig. SB.
Fig. 7B is an enlarged plan view of the open
sealing end of the one piece molded container assembly of
the invention taken along the line 7B,7B of Fig. 5B.
Fig. 8B is a view similar to Fig. 7B and showing ~-
the terminal ends of the outer arcu 3te side walls pressed
inwardly to form a straight line seal. ¦ -
!
``:.
212169.~ n~T/lJS9 2 / 0 8 9 5 3
~2A
1 PCT/P~ 2 5 OCT 199~
Figure lC is an isometric view of a dual compartmen~
container in which the contents must be discharged at
multiple rates. '-
Figure 2C is an enlarged, fragmentary, sect1onal, It
elevational view taken along the line 2C-2C of Figure lC,
showing details of the construction. - .
Figure 3C is an isometric view of the unsealed dual
compartment tube as shown in Figure lC. -
Figure 4C is a top plan view of the nozzle of the dual
compartment container along lines 4C-4C of Figure 3C,
clearly showing the design of the bellows and the cap for
regulating the different rates of discharge.
Figure 5C is an enlarged, sectional, elevational view of the
multi-rate dual co~partment tubes taken along linc 5C-5C of
Figure 3C.
Figure 6C is a sectional elevational view taken along line
6C-6C of Fi~ure SC.
Figure 7Cl through Figure 7Cc are top plan views of other .
embodiments show~ing multiple rate discharge tubes.
l.,
',':;
_
~5VBSTlTUTE SHEE~T
W~ ~f~ 7 PCT/US92/08953 ~
` 2121Ç~3r)
43
Fig. lG is a perspective view of a tamper evident
and child resistant collapsible tube container with a
multiple step activation enclosure in accordance with the
present invention. J
Fig. 2D is an enlarged frzgmentary, sectional,
elevational view taken along the line 2D,2D of Fig. lD.
Fig. 3D is a greatly enlarged fragmentary,
sectional, elevational view of the details contained
within the dot and dash circle of Fig. 2D and designated
Fig. 3D.
Fig. 4D is a fragmentary plan view taken along the
line 4D, 4D of Fig. 33, showing additional details of ~he
discharge end of the nozzle tip. ~
Fig. SD is a view similar to Fig. 2D, showing the ~ :
closure member in a frictionally engaged position.
~0
Fig. 6D is a greatly enlarged fragmentary,
sectional, ele~ational ViPW of ~he details co~tained with
the dot and dash circle shown in Fig. 5D and designed
Fig. 6D showing details of the closure member in an axmed -:
25 position. :--
Fig. 7D is a fragmentary sectional plan view taken -~
along the line 7D,7D of Fig. 6D.
''
Fig. 8D is an enlarged fragmentary elevational `:
view, with parts broken away and in sec~ion, showing theJ, ` .
closure being separated from the collapsible tube
nozzle.
' '-
Fig. 9D is a view similar to Fig. 8D, showing the
closure member and the retained nozzle stem, replaced on
the collapsible tube after use.
~,
l~cr/us !~ 2 / 0 8 9 ~ 3
212~ 343A f73 ~ p~/p,To 2 5 OCT 1993 '`
Figure lOD is an enlarged fragmentary, sectlonal,
elevational view of an alternate embodiment of the child , ~
resistant collapsible tube container with a multiple-step ! ~ -
activation enclosure.
Figure llD is a view similar to Figure lOD, showing the
closure in a frictionally engaged position
Figure 12D is a top plan view of the alternate embodiment as
shown in Figure lOD.
S~,S~ ~H~~
~ Ai~ ~ P~T/~iS92/089~3
2121~
44
Fig. 1~ is an isometric view of a child resistant
and tamper evident pierce-pak container, all in
accurdance with the invention. ~-
Figs. 2E-4E are sequential isometric views
illustrating the method of use of the present invention
in order to release the medicament contained within the
sealed tube.
Fig. 5E is an enlarged, fragmentary, sectional
elevational ~iew taken along the line 5E,SE of Fig. lE,
illustrating details of construction and asse~bly.
Fig~ 6E is fragmentary, sectional elevational view
taken on the line 6E,6E of Fig. 5E, illustrating
additional details of ~he ~ear-off skirt.
Fig. 7E is an enlarged, fragmentary, sectional --~
elevational Yiew taken along the line 7E r 7E of Fig. 3E.
Fig. 8E is an enlarged, fragmentary, elevational -
view with a portion broken away and in section, showing -
another e~bodiment of the invention. ~ -
....
Fig. 9E is a fra~mentary, sectional, plan view -
taken on the line 9E,9E of Fig. 8E. -~
.'.'.
Fig. lOE is a fragmentary, ele~ational view of the
embodiment of Fig. 8E, with a portion broken away and in
30 section. --~
~ ,` ,
Fig. llE i5 an enlarged, fragmentary, sectional ~- -
elevational view of another embodiment which is different
from the embodiment shown in Fig. lE again illustrating
details of construc~ion and assembly.
Fig. 12E is a plan view taken on the line 12E,12E -~
:"
WO93/08117 PCT/US92/08953 ~ ~
212~5~S 45
of Fig. llE.
Fig. 13E is an enlarged, fragmentary, sectional
elevational view of the embodiment shown in Fig. llE,~in
5 an activation mode. ¦
Figs. 14E-16E are sequential isometric views
illustrating the method of use of another embodiment of ~-
the invention shown in Fig. lE, showing the steps needed
in order to release the medicament contained within the
sealed tube.
FLg. 17E ls :an~enlarged, fragmentary, sectional
elevational view taken along line 17E,17E of Fig. 14E .
illustrating details of cons~ruction and assembly.
Fig. 18E is an enlarged, sectional, plan view taken
on the line 18E,18E of Fig. 17E.
Fig. l9E is an enlarged, fragmentary, sectional -~
elevational view of the embodiment shown in Fig. 17E, in
an activation mode.
Fig. 20E is a section, plan view taken on the line
20E,20E of Fig. l9E. :
'' ~ '
i:
. .
W093/08117 PCI/I'S92/08953
21~169~ 46
Fig. lF is an enlarged, fragmentary elevational
view at the upper or discharge portion of a molded
plastic tube having an internally actuated pierce point
device.
Fig. 2F is a view similar to Fig. lF, showing the
internally actuated pierce point having pierced the ~hin
wall `for~ing a nozzle diaphragm under hand discharge
pressure.
" ' ' , '.
- ,,.
.-: .,
- .
'; ',,
,
,,~,...
W093/OX117 PCTtU~2J089~3 ,--
- 2~216~
47
Fig. lGi is a side view of a container of the
present invention.
,~
Fig. 2G is a cross-sectional view, in the plane 2G- I
5 2G of Fig. lG, of the container shown in Fig. lG. ~.
Fig. 3G is a cross-sectional view, in the plane 2G-
2G of Fig. 2G, of the conta_ner shown in Figs. lG and 2G.
Fig. 4G is a cxoss-sectional view of an alternate
embodiment of the pres~nt invention.
Fig. 5G is a cross-sectional view of an alternate ::
embodiment of the present invention.
, .,
WO93/08117 PCT/US92/08953 .:;
212 L6~5 48
MODES FOR CARRYING OUT THE INVENTION
AND_INDUSTRIAL APPLICABILITY
As shown in Fig. l, the assembly generally include
a cap ll and tube 13. Tube 13 is crimped at the bottom
15 or closed end of the tube. The tube 13 includes a
first compartment 17 and a second compartment l9 which,
as will be shown below, are separated from one another
and separately contain contents which are to be
discharged from the conta~ner.
As shown in Fig. 2, removal of the cap ll exposes
the nozzle end 21 of the tube 13. Nozæle 21 includes a
first nozzle port 22 and a second nozzle port 23, each of
which is connected separately to a compartment such as
first compartment l7 and second compartment l~
respectively.
Turning now to Fig. 4, it can be seen that nozzle
22 includes a first thin wall 25 which is aligned and
facing piercer 27 which in turn is attached to thP tOp
wall 29 of cap ll. Similarly, piercer 31 is aligned with
thin wall 33 of nozzle port 23.
The two noz~les 22 and 23 and the associated
containers 17 and l9 are separated from one another by a
divider wall 35. A bellows is formed from a first facing
bellows wall 37 on tube 17 and a second bellows wall 39
on tube l9 for expulsion of the materials contained in
tubes 17 and 19 as will be described below. First, cap
ll is moved from a first position with the piercers 27
and 31 separated from the thin walls 25 and 33. Pressure
in the direction of arrow 41 causes cap ll to move to a
point where piercer 27 tears or ruptures wall 25.
Similarly, piercer 31 causes a similar opening in wall
33. Removal of the cap then permits access ~o the
conten~s of both containers 17 and 19.
WO93~08117 PCT/US92/089~3
2121S9 ~ ~
49
Bellows walls 37 and 39 join together at a center
hinge point 45. Hinge point 45 can be made wider or
narrower during the construction of the device of the
present invention to adjust the amount of flex between
bellows walls 37 and 39. This ~ill enccurag2 or restrain
movement of walls 37 and 39 during squeezing. Pressure
by squeezing the container in the direction of arrows o
47 and 49 will cause the contents to be discharged from
the containers 17 and 19.
: In a preferred embodiment of present invention, one
of the piercers 27 or 31 can be made larger or smaller to
. accommodate higher or lower viscosi~y fluids which might
be contained in one compartment, such as compartment 17,
relative to the viscosity; of the fl~id contained in the
other compartment 19. Alternatively, if more fluid is to
be removed from compartment 17 than compartment 19, again
piercer 27 can be larger than piercer 31 so as to provide
a larger outlet and maintain the desired proportional
discharge from the two compartments-17 and 19.
Cap 11 is normally located in a first position on
end 21 to pre~ent inad~ertent movement of the cap and to
permit intentional movement of the cap to a second
position to thereby cause p~ncture of the recessed walls
25 and 33. Cap lI is held in the first position by ring
51 and groove 53 into which the cap 11 snaps. Shown in
Fig. 4 is the ring 51 and groove 53 maintaining the cap
in a safe position with the piercers 27 and 31 spaced
from thin walls 25 and 33 respectively. The ring 51 and
groove 53 permit intentional movement of the cap 11 in
the direction of arrow 41 when access to the contents of
containers 17 and 19 is desirèd. As previously
describsd, movement of cap ll in the direction of arrow
41 causes piercers 27 and 31 to puncture walls ~5 and 33.
The force applied to the end 29 of cap 11 in the
WO~3/08117 PCT/US92/08953
21~169~
direction of arrow 41 is sufficient to dislodge the
groove 53 from ring 51. Cap ll is typically made from a l `~
plastic material which possesses some degree of , ~-
elasticity.
. :
: .
The present invention is admirably suited for `::
, ::
permitting the evacuation of two chambers at the same
rate in spite of viscosity differences. The bellows can
be varied through hinge:point 45 and the walls 37 and 39,
to encourage or resis~ movement of both walls 37 and 39,
as well as other parts of the containers 17 and l9, so
that when tube 13 is squeezed a desired discharged rate
from both nozzles will take place.~
~, -..,
In another embodiment, the piercers 27 and 31 can
be of different sizes, so as to provide different hole
sizes 25A and 33A, to accommodate differ viscosities or
situations where it is desired to maintain a proportional
dlscharge from two containers of different volumes.
~0
It is also noted that the present in~ention
includes an addi~ional safety feature. Both the first
recessed wall 25 and second recessed wall 33 are recessed
from the end of the nozzle 21. There is actual evidence
of instances where children have bitten ends of tu~es and
caused the contents to be discharged ccidentally.
Recessed diaphragms of this type prevent such accidsn~s
from occurring. .
:
,.
i-,
.. , :
W093/08l17 PCT/US92/08953 -.
212~
51
As is shown in the drawings, the assembly of this
invention is shown generally by the reference number 210.
The container assembly includes a cap 211 which fits on
tube ~13 at ~he discharge end 215 as described in my
previously identified U.S. Patent No. 4,884,703 and my
co-pending United States application titled D~AL CHAMBER
DISPENSING PACKAGE filed October 30, l991r and having
Serial No. 07/784,964. Both the patent and the
application show dual compartment container assemblies
which are suitable for use with the present invention.
The filling end 217 of tube 213 is provided with
the improved seal of the present invention as is
described herein. As shown in Fig. 2A, the filLing end
gF
217 is formed by the terminal ends of arcuate walls 219
and 221, which are joined to each other and to a common
wall 223. Common wall 223 has a first width before
filling which is shorter than the width after filling.
Common wall 223 is shown with a gentle ~s~ curve 225,
which allow the width to expand when the end 217 is
sealed with a seal 227, usually by pressure and heat
without. Seal end 227 is a straight line seal, in that
all of the walls 219, 221 and 223 form a straight line
which is perpendicular to the axis of the container 213.
The thickness is three layers thick, which can easily be
accommodated by conventional seal~ng devices.
Fig. 4A shows the seal region 227 after sealing
pressure has been applied. It is important tha~ the
terminal ends of walls 219, 221 and 223 form the
relationship show~ in Fig. 4A, which relationship
includes the seal region 227 and an additional region of
seal 229. The terminal ends of arcuate walls 219 and 221
are sealed at their end against each other to form a
straight line seal and to insure that the seal is
effec~i~e to preserve the integrity of the contents.
Those terminal ends of arcuate walls 219 and 221 are also
WO93/~117 PCT/US92/08953
'-','.''
21216~S 52
sealed to the terminal end of common wall 223 to seal and
separate the contents of the two compartments and to 1 -
present a geometric alignment of the walls 219, 221 and -
223 which allows for most efficient expulsion of the
5 contents at ~he time they are to be used. By including ' ;~
the straight portion of the common wall 223 in the seal
region 227, distortion is eliminated and the end, :~
particularly in small scale versions, will no longer - ~-
twist. -~
' ,~'.".
It has been discovered that it is important to -
eliminate a four layer seal, which is otherwise formed -~
from walls 219 and 221 and from wall 223 when pleats in
walls 219 and 221 are folded on to each other. A wall
~3, . -
thickness o~ only walls 219, 221 and 2~3 provides a much
superior seal.
The arcuate walls 219 and~221 form a pair of
bellows 231 as the walls 219 and 221 are fixedly joined
to common wall 223 at both ends of the arcuate walls 219
and 221. The portion of the wall junctions which forms
bellows 231 extends axially from the cap end of tube 213
to a terminating point 233 at the beginning of seal
region 227. Bellows 231 also pivot about pivot point
~5 237, which is the junction point between walls 219 or 221
and in this manner,~ the bellows 231 may be collapsed
completely to totally expel the contents from tube 213.
If terminating point 233 extends into the seal region
227, it will be impossible to expel viscous liquids and
gels which need to be pressed out. The above mentioned
five layer seal will not have reliability and integrity
that is expected. This particular advantage of the
present invention is important when the contents are
expensive, or when a single unit dose is contained
therein and the entire dose is needed for treatment or
application.
WO93~08117 PCT/US92/089~3
2121~9~ ~
53
It is an important feature of the present invention
to preserve the regular expectations of users of single
compartment tubes while also giving a superior seal.
When the tube is used, the tapered sides of the two walls
219 and 221 form bellows 231, in which the bellows pivot
about pivotal junctions 237, as shown in Fig6. lA and 5A,
and allow squeezing pressure to force all of the contents
out the discharge ports.
Figs. 7A and 8A show the effect of pressure (and
heat if needed) to form the seal as pleats ~25 are
straightened and the lower terminal ends of arcua~e walls
219, 221, and 223 are brought together to form a safe and
sanitary closure once the contents have been added to the
two compartments. As sh~wn in Fig. 4A, there is
sufficient length at the terminal end of common wall 223
to insure that leakage between ~he two chambers is also
prevented.
!
WO93/08117 PCT/US92/08953 ~`
2121~i~5 `
54
As is noted in Figs. lB-8B, inclusive, the assembly
of this invention is shown generally by the reference
number 310. The container assembly includes a cap 311
which fits on tube 313 at the discharge end 315 as
described in my previously identified U.S. Patent ~Jo.
4,884,703 and my co-pending United States application
titled DUAL CHAMBER DISPENSING PACKAG~, filed October 30,
1991, and having Serial No. 07/784,964. Both the patent
and the application show dual compartment container
assemblies which are suitable for use with the present
invention.
The present invention differs from the above
referenced inventions because it deals with the filling
end 317 of the container assemblies. The contents of
these container assemblies are removed when needed
through discharge ports 319 and 321 on discharge end 315
as described in my paten~ and my application.
` The container assembly of the present invention
includes two adjacent compartments 323 and 325 which
contain the contents after filling has been completed and
before ~he assembly is used. Compartments 323 and 325
extend from a sealed end 327 to a full or top portion 329
of each compar~ment 323 and 325. Compartmen~ 323
includes an arcuate outer wall 331 and compartment 325
includes a similar arcuate outer wall 333. In the
embodiment shown in the drawings, the compartments 323
and 325 and the arcuate outer walls 331 and 333,
respectively, are~ the same size and the assembly is
symmetrical. This is preferred for simplicity of
manufacture, but it is recognized that the two
compartments 323 and 325 could be of different sizes
,
without departing from the spirit and scope of the ~-
present invention.
Turning now to Fig. 4B, the filling end 317 is
WO93/08117 PCT/US~/08953
21216~ :
shown open and ready to receive the contents. Normally,
the filling operation ia automated and con~ents are
measured and dispersed into the containers 323 and 325
au~omatically, followed immediately by a sealing s~ep in
S order to preserve the integrity of the contents. The
container assemblies of the present inventlon are
normally manufactured from plastics which are
thermoplastic rather than thermoset in nature.
Manufacturing may be by any conventional process such as
by injection molding. The filling end 317 is therefore
suitable for heat sealing as will be described. Heat and
pressure are normally all that is needed to seal
container assemblies of this construction.
The two arcuate outer walls 331 and 333 are
separated by a common wall se~m nt 335 as shown in Figs.
4B-8B. The wall segment 335 is constructed to have a
first length prior to filling and a second longer length
ater the filling end 317 is sealed. In the preferred
embodiment shown in Fig. 4B, common w ll segment 335 is
pleated to de~ine the first length. The outer arcuate
walls 331 and 333 are joined at each end or junction to
the common wall segment 335. These junctions for axially
aligned junctions which are pi~otal in operation. As
shown in Fig. 7B particularly, junctions 332 and 334 are
formed where the two ends of arcuate outer walls 331 and
333 join to the common wall seqment 335.
In Figs. 5B and 6B, it is clear to see that the
common wall s~gment 335 extends from the filling end 317
completely between containers 323 and 3~5 up into the
discharge end 315, shown as wall segment 337. Thus the
contents of ~he two compartments 323 and 325 do not
contact one another until af~er the contents have been
discharged.
Once the contents have been placed in compartments
'
WO93/08117 PCT/US92/~953 ' -
2 t 2 1 fi ~.'3 '`'j ,
56 -~
~23 and 325, the filling end 317 is sealed by forcing the
outer arcuate walls 331 and 333 together at the filling
end 317 in the direction of arrows 339 and 341, shown~in
Fig. 8B. The force of bringing outer arcuate walls 331
and 333 together as shown causes a straight line seal
327. This straight line seal 327 is formed from the end
343 of wall 333, the end 345 of common wall segment 335
and the end 347 of wall 331. With pressure and heat, the
seal is compl.eted and the container assembly takes the
ready to use form shown in Figs. lB and 2B, for example.
In prior art designs where two adjacent
compartments are separated by a common wall, there is a
great deal of pressure on the common wall as the side
walls are forced together to make the seal. ~hen the two
compartments are relatively large and flexible, this is
not a serious pro~lem, although the seal is not always
skraight and appealing to the consumer. When the
compartments are not as large, the force on a straight
wall segment is so great that either the container
assembly cannot be closed and sealed safely and
effectivel~ or the straight wall segment is ruptured or
destroyed. -
Efforts to overcome this problem with different
shapes for the two compartments have not met with success -~
since ~he compartments need to have a certain size in -~
order to contain ~he appropriate quantities of medicines
and the like. Some shapes actually prevent the effective ~ ~-
and efficient squeezing discharge which users of single
compartment tube assemblies hava come to know and expect. ¦
1'-"`
The present invPntion is the only design which --
..
preserves the common expectations of users of single
compartment tubes while also giving a sup~rior seal.
~hen the tube is used, the tapered sides of the two
compartments 323 and 325 form bellows means, whereby the
WOg3/08117 PCT/US92/0~953
2:121693
57
pi~otal juncLions 332 and 334 allow squeezing pressure to
force all of the contents out the discharge ports 319 and
321.
,
.
~,,,
WO93/08117 ~CT/US92/089~3
212~69~ ~
58
Shown in Figure lD is a perspective view of the
preferred embodiment of the present invention, shown
generally as 510. The device includes a cap 511 and a
tube 513. Tube 513 is collapsible and may contain
5 medicaments, ointments, eye drops and other products, ~-
either in a single dose quantity or in more than one
dose. The present invention is admirably suited to both
single dose treatments and multiple dose portions. The
contents are placed in the tube and end 515 is closed, -
such as by crimping.
As will become clear during the description of the
operation of ~he present;invention, cap 511 includes a
first indicia in the form of an arrow 517. Arrow 517
indicates an appropriate location of the cap 511 on tube
513 prior to any use. Similarly, tube 513 includes a ~~
second indicia arrow 5~19 which is to be lined up with
arxow 517 after the closure has been opened.
20Turning first to the cap 511, ridges or grooves 521
cover a portion of the cap 511 to permit gripping and
facilitate t~isting of the cap 511. Cap 511 includes a .~r~,
terminal end 523 which has an annular ring defining a
socket 525 on the inside of end 523 and facing tube 513.
25Socket 525 is axiaLly aligned with a stem 527. Stem 527
is part of the nozzle of tube 513. Cap 511 is fixed in a
first position where the stem 527 and socket 525 are
spaced from one another.~ This first position is defined
by groove 529 in cap 511 and ring 531 in tube neck 533 of
30tu~e 513. Groove 529 and ring 531 serve to locate the
cap 511 on tube neck 533. As sho~n in Figure 3D, stem
527 is spaced from socket 525 prior to use of the cap and
~ube assembly. _
:'
35Stem 527 is mounted on tube neck 533 by a thin wall
535 drawn by the molding operation. Thin wall 535 is
easily frangible and can easi~y be ruptured by pressure
WO93/08117 PCT/~S92/~89~3 ~
~1216~
5~
on stem 527. One unique feature of the present invention
is the inclu~ion of a plurality of bridges 537 which are
attached to stem 527 at one end and to the tube neck 533
and thin wall membrane 535 as shown in Figures 3D and 4D.
Bridges 537 serve to strengthen the junction of stem 527
on tube neck 533 in the axial direction. Thus, when the
device is ac~ivated as hereinafter described, stem 527
resists axial movement into the tube 513 so that stem 527
seats properly in socket S25.
To assist in the seating of stem 527 in socket 525l
a groo~e 539 is formed in the interior of socket 525 to
cooperate with a ring 541 on stem 527. This ring and
groove, 541 and 539, comprise a stem locking means for
positively locating the stem 527 in the socket 525 at a
predetermined position. The interior of socket 525 and
the exterior of stem 527 may also be tapered in order to
prov.ide a frictional fit as well.
In Figure 5D, pressure is exerted on the end 523 of
cap 511 in the direction shown by arrow 545. This causes
ring 531 to escape groove 529 and stem 527 moves into
socket 525. When stem 527 has moved to the posi~ion
shown in Figure 6D, ring 541 and groove 539 function to
lock the stem in the socket at a predetermined position.
Bridges 537 resist axial movement of the stem 527 and
permit engagement of the locking means as described.
This first movement of the stem 527 into socket 525
normally takes place when the assembly is in the position
shown in Figure lD, and indicia arrow 517 is not aligned
with indicia arrow 519. After stem 527 is locked in
place in socket 525, arrow 517 is turned by twisting the
cap 511 so that indicia arrows 517 and 519 are aligned
with each o~her. This 90 degree rotation in the
direction shown by arrow 547 of Figure 5D causes the thin
wall membrane 535 to rupture. Bridges 537 are only
WO93/08117 . PCT/US92/089~3 ;:-
2~21~
slightly contacting tube neck 533 and offer no
substantial resistance to radial movement in the
direction shown by arrow 547. As a result, stem 527 is
broken free from tube neck 533.
It is then easy to remove cap 511 from tube neck :
533, shown by movement in the direction of arrow 549 in
Figure 8D. ~ecause the thin wall is recessed back from
the terminal end of tube neck 533, fragments ~nd torn
portions of the membrane are not exposed and will not
present a dan~er when the tube assembly is used to -~ dispense the contents. After dispensing the contents,
the cap 511 can be replaced on tube end 533 as shown in .
Figure 9D, for future use or disposal. ~ .
~.
' :'
WO93~0~117 PCT/US92/08953
21~16~3 g-
1".
61
As is noted in Figs. lE-20E, inclusive, the
assembly of this invention is shown generally by the
reference number 610. The assembly includes a tube 613
and cap 615 which is positioned on the discharge or
terminal end portion 617 of tube 613. Movement of the
cap 615 in the direction of the arrow 619, -as shown in
Fig. 3E, engages a part of the device, described herein
below, which provides access to the contents of the ~ube
613. Movement of cap 615 in the direction of arrow 621
in Fig. 4E removes the cap 615 and allows the contents of
the tube to be dispensed. Typically, vitamins, eye
drops, and unit dose medicaments are contained in tube
and cap assemblies of this type.
Access to the contents in the tube of the present
inventioTI is restricted by the assembly of the presen~
invention, requiring an intentional manipulation of a
portion of the assembly before access to the contents can
be obtained. In Fig. lE, a skirt 623 having a pull tab
625 is located on the tube engaging end of cap 615. This
skirt 623 rests on shoulder 627 of tube 613 so that
further movement of the cap, such as in the direction of
arrow 619 is not~possible as long as skirt 623 is still
on the cap. Intentional manipulation to remove the skir~
623 by pulling pull tab 625, as illustrated in Fig. 2E,
places the assembIy in a ready to use condi~ion.
Turning now to F~ gs . 5E, 6E and 7E, the internal
working of the assembly can be seen. In Fig. 5E, the
30 device is as shown in Fig. lE and the skirt 623 abuts
shoulder 627 to prevent movement of the cap 615 in the
tube engaging direction. The edge 625a of pull tab 625
is accessible and the pull tab 625 can be removed easily.
This intentional manipula~ion is necessary for use of the
tube. Piercer 6 2 9 is mounted on the inside of end wall
631 of cap 615, and is held in a first position as
illustrated in Fig. 5E. As long as skirt 623 is present,
WO93/081l7 PCT/US92/089~3
212169~ -
62
piercer 629 cannot contact thin wall section 633 of tip
635 of tube end portion 617.
Also shown on the assembly illustrated in Fig. SE
is a ring 637 and groove 639 which serves as a secondary . -
restraint to prevent unintentional movement of the cap
toward the tube. As shown in Fig. 7E, the puncture ~-~
means, or piercer 629 t is able to penetrate thin wall
section 633, allowing for access to the contents after ~-
the cap 615 is removed from the tube end portion 617.
.. .
A similar assembly is shown in Figs. 8E, 9E and
10E, in which a modification of the s~irt praviously
described is shown. Split skirt 641 restrains movement
lS of cap 615~ toward tube 613 because it cannot move past
shoulder 627. In this embodiment, intentional
manipulation of the assem~ly to open the tube requires
that the cap 615'- be pushed axially toward the tube 613
so that split s~irt 641 impinges on shoulder 627 in the
direction of arr:ow :643. If sufficient pressure is
applied, split skirt 641 splits~ along a frangible
portion, such as produced by score lines, and breaks into
two portions 641a and 641b. Once the skirt 641 has
split, cap 615' can be mo~ed to cause piercer 629 to
puncture thin wall section 633 as previously described.
Turning now to Figs. llE, 12E and 13E, another
assembly according to the present invention is shown.
This assembly includes a modifiad cap 645 which has a
first end 645a and a second end 545b separated by
dividing wall 647. Piercer 629 is mounted on dividing
wall 647 and is facing away from thin wall section 633 of
end 635 of ~ube end portion 617. Piercer 62~ is
sterilized and kept sanitary by a closure member, shown
in Fig. llE in ~he form of tear-off tape 649. Tear-off
tape 649 seals the end 645b of cap 645 and can be removed
when needed by pulling tab 651 on tear-off tape ~49.
WO93/0~1l7 PCT/~S92/08953 '~-
212169S ~
63
The cap 645, which has been held in place by ring
637 and groove 639, is removed from tube end portion 617,
the cap 645 is inverted, the tear-off tape 649 is removed
by pulling tab 651, and the end 645b of cap 645 is placed
in a second position, shown in Fig. 13E, where piercer
629 once again punctures thin wall section 633 to provide
access to the tube contents.
A preferred embodiment is shown in Figs. 14E-20E.
In this embodimentj the cap 653 is prevented from moving
toward tube 655 by a boss 657 which is part of tube end
portion 659. The lower terminal end 653a of cap 653 can
not move past boss 657, and thus the cap 653 is
maintained in its first position, where access to the
contents is prevented. Intentlonal manipulation of cap
653 to bring so~ket 661 into alignment with boss 657, as
illustrated in Fig. I5E, allows the cap 653 to slide on
the tube end portion 659 to a second position shown in
20 Fig. l9E.
When the lower terminal end 653a of cap 653 is in
contact with boss 657, as shown in Fig. 17E, the cap 653
i~ held in a first position ~here piercer 629 is spaced
from thin wall section 633. Rotation of cap 653 to align
boss 657 and socket 661, as shown in Figs. l9E and 20E,
allows cap 653 ~o be pushed in the direction of arrow 663
to provide access to the tube contents~ Without the
intentional manipula~ion of ~he cap 653 from the safe
position o~ Fig. 17E to the ready position of Fig. l9E,
the assembly is at least child resistant. Casual playing
is not likely to cause the needed alignment. When such
alignment is desired, pressure on boss 657 and the
ou~side of socket 661 allows the two components to be
rotated with respect to each other to achieve a ready to
use condition.
W O 93/08117 PCT/US92/08953
64
In ea~h of the embodiments shown herein, it is
necessary to move the cap from a first position with a
puncture means spaced from the thin wall section of the
end portion of the tube to a second position to permit
puncture of the thin wall section. This required or
necessaxy mo~ement of the cap with respect to the tube
must be made using intentional manipulation of the
assembly. This substant~ially reduces accidental access
to the tube and greatly increases the safety and security
of the product being sold.
'
, -
;,
.. 1,'
WO 93/08117 PCr/US92J089;3
~ 21~16~~3
As shown in Figs. lF and 2F, the drawings, the tube
assembly of the present invention is shown generally by
the reference numeral 710. The assembly includes a tube
711 having a filling end of conventional design ~at the
5 bottom of tube 711. Tube 711 also includes a discharge
end 715. The filling end allows for the piercing
mechanism of the present invention to be inserted into
tube 711 prior to placing the contents into the assembly.
As has been noted, any product such as medicines,
10 vitamins, eye drops or other products are suitable for
use with the present invention. The filling end is
sealed in a conventional manner, often by heat seal,
' after the contents have been placed in the tube.
' ~
lS A nozzle portion 717 is mounted on the discharge
end 715 of tube 711 and incIudes a discharge port 718
which has a central bore 719. A thin wall 721 or
diaphragm is located in central bore 719 at a
predetermined point which is recessed from the exposed
20 end 723 of dlscharge poxt 718.
In a~preferred embodiment, the invention includes a
cap 725 which is shown in friction fit on nozzle portion
717 of the discharge end ?15 of tube 711. Cap 725 is
25 preferably fit on the nozzle portion 717 using a friction
fit for economy of manufacture, but it is also possible
~o use thxeaded fittings, ring and groove means for
fastening caps and tubes, or other such mechanisms which
hold the cap 725 on the nozzle 717. Located on the
30 inside of cap 725 is an axially centered support member
727 which is shown in the shape of a plug having an
axially transverse, flat face 728.
lt is of primary importance to hold the plug 727 in
35 place as the plllg 727 is sized to present flat, axially
transverse surface 728 across the entire external face of
the ~hin wall 721. In this embodiment, the plug 7~7 is
W093/08117 PCT/U~92/08953
2 1 2 1 6 9~ 6~
normally in contact with the thin wall 721 when the cap
725 is mounted on the exterior of the nozzle portion 717.
Located inside the tube 711 is a piercer means 729
S which is in the form of a hollow piercer 729 sized to
move axially in central bore 719. Piercer 729 is hollow,
having an axially ~centered bore 731 through which the
contents ~ill be passing when the device is activated.
The piercer means 729 also includes a piston member 733
which functions to mount the hollow piercer member 729.
Piston member 733 is sized to slideably fit in the
central bore 71ga of discharge port 718 and is adapte~ to
move the piercer 729 from a first position shown in Fig.
lF to a second position shown in Fig. 2F after cap 72S
has been removed and there has been application of
pressure to tube 711.
When piston 733 and piercer 729 are inserted into
tube 711, such as through filling end 713, the piercer
729 is aligned with and moved into central bore 713. The
diameter of piston 733 is the same as the inside diameter
of nozzle portion 717 where the piston 733 thus will
function as a piston. The piston 733 and piercer 729 are
molded in one piece and can be easily inserted using
automatic filling e~uipment.
~.
The contents are added to tube 711 after this step
so ~hat no contents are present in space 735 which exists
on the discharge side of piston 733 when piston 733 is in
the posi~ion shown in Fig. lF. Piston 733 is positioned
in this first position which can be described as a ready
to use position. Plug 727 has plug face 728 acxoss the
entire surface of thin wall 721 and prevents piercer 729
from puncturing thin wall 721. During normal filling
opera~ions th~ force of filling is not sufficient to
cause piercer 729 to damage thin wall 721.
W093S08117 PCT~US92/08953 -s
''' 2121~ig5
67
When cap 725 is removed, as shown in Fig. 2F, the
restraining force of plug face 728 is also removed.
Application of pressure to tube 711 by squeezing in the
direction of arrows 737 causes the contents to move in
the direction of arrow 739 up against the tapered inside
surface 741 OL piston 733. This movement of contents
forces piston 733 to compress the same amount of air
trapped in space 735 as the piston 733 and piercer 729
move in the direction of arrow 739 along central bore 719
and puncture thin wall 721. The hydraulic forces on
piston 733 are sufficient to cause the piston to move to
that position shown in Fig. 2F and the contPnts can be
used as intended.
The cap 725 shown in Fig. lF is press fit or
friction fit on nozzle portion 717 and can easily be
removed to allow visual inspection of thin wall 721. The
cap 725 can then be replaced until it is time to use the
tube. Alternatively, cap 725 could be attached to nozzle
portion 717 by a tamper evident band 743. Band 743 can
function to alert the user that the cap 725 has been
removed and band ?43 can also provide additional
protection against inadvertent removal of cap 725 as well
as insuring that plug 727 remains in position against
thin wall 721.
i''-''' ,~'
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W043/08117 PCT/US92/08953 .-
2~21~9~
68
According to the present invention, a dual chamber
dispensing container comprises side walls cor,nected to a
common inner wall shared by the dual chambers and to the
arcuate outer walls of the chambers. These side walls
form hinges where they meet the ou~er walls. These
hinges allow the chambers to act as bellows when squeezed
toward one another, thereby allowing a substantially
equal pressure to be applied to both chambers in an even
and steady manner. If the two substances to be dispensed
have substantially the same viscosities, they will be
dispensed in substantially equal quantities.
As seen in the exemplification of this invention
shown in Figs. lG, 2G, and 3G, the duzl chamber
dispensing container 801 i~ comprised of a neck portion
802, a shoulder portion 815, and an elongated body
portion 803. The elongated body portion 803 comprises
two chambers 811 and 812, as shown in Figs. 2G and 3G.
Fig. 2G shows orifices 813 and 814, which are in fluid
communication with chambers 811 and 812, respectively.
As shown in Fig. 3G, chambers 811 and 812 are separated
by a shared common wall 804. Chambers 811 and 81? have
arcuate outer walls 805 and 806, respectively. Arcuate
outer wall 805 of chamber 811 is connected to common
wall 804 by side wa~ls 809 and 810. The intersections of
arcuate wall 805 and side wal~s 807 and 808 form hinges
~2Q and 821, respectively. Similarly, the intersections
of arcuate outer wall 806 and side walls 809 and 810 form
hinges 822 and 823, respectively. A chord (not shown) or
arcuate outer wall 805 extending betw~en hinges 820 and
821 ~s greater in length than the width of the common
wall. A chord of outer wall 806 extending from hinge 822
to hinge 823 is also greater in length than the width of
the common wall.
When chambers 811 and 812 are squeezed toward one
ano~her by the application of force to the arcuate out~r
W~93/~8117 PCT/US9~/08953
21216~
69
walls 805 and 806, respectively, hinges 820 and 821, and
822 and 823, flex, the angle formed by each intersection
decreasing. All four hinges flex simultaneously, caus ng
the chambers to act as bellows. As a result of this
bellows action, the two chambers 811 and 812 are exposed
- to substan~ially equal pressure and steady deformation
from the squeezing. This occurs because the four hinges
820, 821, 822 and 823 all flex evenly. A force exerted
on arcuate o~tter walls 805 and 806 for example, causes
hinges 822 and 823 and hinges 820 and 821 to flex,
thereby pressurizing chambers 811 and 812 and dispensing
the two substances disposed therein. Thus, squeezing the
tube creates equal pressure in the two chambers.
15In addi~ion, as a result of the bellows action,
chambers 811 and 812 undergo predictable deformation when
constructed of a resilient material, such as
polyethylene, polypropylene, polyvinyl chloride,
polystyrene, polyester, or other known resiliently
flexible materials. Upon application of a constant
force, predictable chamber deformation occurs. The
present invention thus allows substantially equal
dispensing of two materials by enabling a steady and
equal pressure application upon the two chambers.
Fig. 4G shows an alternative embodiment of the
present invention. In this embodiment, the two chambers
811a and 812a have unequal ~olumes (chamber 811a has a
greater Yolume than chamber 812a). Therefore arcuate
outer wall 805a which forms part of chamber 811a is
longer than arcuate outer wall 806a which forms part of
chamber 812a. A chord (not shown) of arcuate outer wall
806a ( the smaller of the two outer walls ) extending
between hinges 822a and 823a is greater in length than
the width of the common wall 804a. Similarly, a chord of
outer wall 805a extending from hinge 820a to hinge 821a
is also greater in length than the width of the common
WO93/08117 PCT/US92/08953 ~
212169~ - ---
wall 804a.
The container of the present invention can also be
arranged to dispense similar materials in the two
chambers in different amounts, in constant predetermined
propor~ions when configured as shown in figure 5G. This
can be accomplished by varying th sizes and shapes of
orifices 824 and 825. If one orifice 824 is larger than
the other orifice 825, the material contained in the
chamber communicating with the larger orifice 824 will be
dispensed in a greater amount than the material in the
chamber communicating with the smaller orifice 825.
Similarly, a round orifice will allow more material to be
dispensed than a rectangular orifice having the same
15 cross-sectional area. Dif~ering orifice sizes and ~ --~
shapes can also be utilized to allow for even dispensing v-
of two materials of substantially differing viscosities
by introducing thelma~erial having a greater viscosity
into the chamber communicating with the larger orifice.
While this invention has been described with
reference to specific embodiments, it is not necessarily
limited thereto. Accordingly, the appended claims should
be construed to encompass not only those forms and
embodiments of the invention specifically described
above, but to such other forms and embodiments as may be
:devised by those ~skilled in the art without departing
from its true spirit and scope.
:
