CA2121695A1 - Container closure assemblies - Google Patents

Abstract

The present invention relates to double compartment closure assemblies in which materials are stored in at least two sepa-rate compartments until the compartments are opened for use. The multiple compartment container assembly includes at least two adjacent compartments (17, 19), each having a nozzle aligned at their discharge end (22, 23), and including a thin wall (25, 33) dispensing port for discharge of the contents from the compartments by use of a bellows arrangement (37, 39) formed from the compartments. A cap (11) is sized to moveably fit on the discharge end of the container and includes a puncture device (27.
31) positioned in alignment with the thin wall dispensing ports. The cap may be positioned at a first position to prevent inadvert ent movement of the cap, and to permit intentional movement of the cap to a second position to cause the puncture device to puncture the ports.

Description

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.

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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.
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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.

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.. ;-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~) -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.

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_, i WO93/08117PCT/~IS92/08953 212~
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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 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 ~.,.

.
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~

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,, 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.
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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 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!~`~

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.

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~

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 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

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.

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2 1 2 1 6 ~3 PCT/I'S9~/089~3 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 ~

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.

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WO93/08117 PCT/~'S97/0~953 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

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 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 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) 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~

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.

" ' ' , '.

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W093/OX117 PCTtU~2J089~3 ,--- 2~216~

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 ~ ~

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~

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~ ~

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 `

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 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~ ~

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".

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~ -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 ~

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.

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 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''-''' ,~' ~.'.

W043/08117 PCT/US92/08953 .-2~21~9~

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~

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.
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Claims

71 What is claimed is:
1. A multiple compartment container assembly, comprising;
a container having a discharge end and at least two adjacent compartments, said compartments each having a nozzle aligned at said discharge end and including a thin wall dispensing port for discharge of contents from said compartments;

a cap sized to movably fit on said discharge end of said container and having puncture means positioned in alignment with said thin wall dispensing ports, said cap and discharge end cooperatively including location means for positioning said cap at a first position on said end to prevent inadvertent movement of said cap and to permit intentional movement of said cap to a second position to.
thereby cause said puncture means to puncture said ports;
and bellows formed from said compartments for applying a discharge force upon squeezing said container to substantially uniformly discharge said contents from each compartment through the discharge end.

2. The assembly of claim 1 wherein said two compartments include a common wall and an axially aligned pivotal junction.

3. The assembly of claim 1 wherein each puncture means are differently sized to permit proportional discharge from each respective compartment.

4. The assembly of claim 3 wherein said proportional discharge is proportional to viscosity of the contents of each compartment.

5. The assembly of claim 3 wherein said discharge is proportional to the volume of contents in said compartments.

6. A dual compartment container assembly, comprising:
a container having two adjacent compartments defined by a common wall segment and a pair of outer arcuate walls, said container having a filling end which is sealed after contents are placed in said compartments;

said common wall segment having a first width prior to filling and a second longer width after said filling end is sealed to form a straight line seal at a point spaced from said filling end;

said outer arcuate walls and said common wall segment terminating axially at said filling end to provide a filling end seal region such that pressure forming a seal at said filling end joins the terminal ends of said outer arcuate walls to form a straight line seal including the terminal end of said common wall segment in said filling end seal region; and said outer arcuate walls extending arcuately from junctions with said common wall segment to form bellows in said compartments, said bellows terminating at a point axially spaced from said seal region such that none of the billows is included in the straight line seal.

7. The assembly of claim 6, wherein said arcuate walls are joined at each junction with said common wall segment to form axially aligned pivotal junctions.

8. The assembly of claim 7, wherein said arcuate walls and said common wall segment form bellows means by causing said compartments to taper outwardly from the axially inward most point of said straight line seal.

9. The assembly of claim 6, wherein said straight line seal is a heat seal.

10. The assembly of claim 6, wherein said common wall segment is curved to have a first width prior to filling and a second straightened longer width after said filling end is sealed to form a straight line seal at said filling end.

11. The assembly of claim 6, wherein said common wall has an "s" shaped curve in said first width.

18. A container and closure assembly, comprising:

a) a container having a neck portion terminating in a discharge opening, b) an elongated stem member comprising a stem connected at its inner end by frangible means to normally seal said discharge opening;

c) a cup shaped closure having an inwardly facing stem engaging socket member comprising a socket and axially moveable relative to the neck of the container between unarmed and armed limit positions;

d) first interengaging releasable locking means on the closure and neck normally positioning said closure in an unarmed position wherein said socket and stem are axially spaced so that the stem is prevented from being activated and: releasable to permit relative axial movement to engage the stem in the socket in an armed position;

e) second interengaging locking means comprising a radially directed rib on one of said members engaging in a complementary groove in the other of said members to thereby lock the stem in the socket in the armed position whereby the closure is rotated to fracture the frangible means and permit discharge of the contents through the discharge opening.

19. A container-closure assembly as claimed in Claim 18 wherein said closure is made of a transparent material so that the stem and frangible connection are visible to determine condition of seal.

20. A container-closure assembly as claimed in Claim 18 wherein said discharge opening is an elongated channel in one end of the neck of the container and the frangible diaphragm is disposed at the inner end of said channel.

21. A container-closure assembly as claimed in Claim 18 wherein said frangible connecting means comprises an annular thin wall portion between the stem and discharge opening and a plurality of radially extending circumferentially spaced bridges between the stem and side wall defining the discharge opening.

22. A container-closure assembly as claimed in Claim 18 wherein said socket opening is tapered and said stem is of a complementary taper of a dimension in relation to the socket opening to provide a press fit of the stem in the socket opening when the cap is actuated axially to the armed position whereby the cap can be rotated to break the frangible means connecting the stem over the discharge opening.

28. A tube assembly, comprising:
a tube having a nozzle portion including a discharge port having inner and outer ends, said nozzle portion having an axially aligned central bore with a thin wall sealing said central bore at the inner end of said discharge port;
pierce means mounted in said nozzle portion and sized to move axially in said central bore from a first ready position, axially inwardly of said thin wall, to a second discharge position puncturing said thin wall; and a cap mounted on the exterior of said nozzle portion having an axially centered support member sized to fit in said discharge port for abutment against said recessed thin wall.

29. The assembly of claim 28, wherein said piercer means includes a hollow piercer member sized to move axially in said central bore, said piercer means also including a piston member for mounting said hollow piercer member and sized to slideably fit in said nozzle portion and adapted to move said piercer member from said first position to said second position upon application of pressure to said tube.
30. A cap and tube assembly, comprising:
a tube having a nozzle portion at one end and a discharge port in said nozzle portion having inner and outer ends, said nozzle portion having an axially aligned central bore with a thin wall sealing said central bore at the inner end of said discharge port;
a cap mounted on the exterior of said nozzle portion, said cap having an axially centered support member sized to fit in said discharge port for abutment against said recessed thin wall, and piercer means mounted in said nozzle portion, said piercer means including a hollow piercer member sized to move axially in said central bore from a first ready position, axially inward of said thin wall, to a second discharge position puncturing said thin wall, said piercer means also including a piston member for mounting said hollow piercer member and sized to slideably fit in said nozzle portion and adapted to move said piercer member from said first position to said second position upon application of pressure to said tube.

32. A cap and tube assembly, comprising:
a tube having a nozzle portion at one end and a discharge port in said nozzle portion having inner and outer ends, said nozzle portion having an axially aligned central bore with a thin wall sealing said central bore at the inner end of said discharge port;
a cap mounted on the exterior of said nozzle portion, said cap having an axially centered support member sized to fit in said discharge port for abutment against said recessed thin wall; and piercer means mounted in said nozzle portion, said piercer means including a hollow piercer member sized to move axially in said central bore from a first ready position, axially inward of said thin wall, to a second discharge position puncturing said thin wall, said piercer means also including a piston member for mounting said hollow piercer member and sized to slidable fit in said nozzle portion and adapted to move said piercer member from said first position to said second position upon application of pressure to said tube, said piercer means being sized to be inserted inot said nozzle portion of said tube to prevent contents from opposing said piston member upon application of pressure to said tube.

33. A container for dispensing two substances simultaneously comprising:
a neck portion having two orifices therein;
a shoulder portion connected to said neck portion; and an elongated body portion, connected to said shoulder portion, comprising two adjacent chambers sharing a common wall, each said chamber in fluid communication with an orifice in said neck portion, wherein each said chamber includes an arcuate outer wall having a chord of a length greater than the width of said common wall, and connected to said common wall by two side walls which form hinges at the junctures of said outer and side walls.

34. A container as claimed in claim 33, wherein said two orifices have the same size and shape.

35. A container as claimed in claim 33, wherein said two orifices differ in size.

36. A container as claimed in claim 33, wherein said two chambers differ in volume.

37. A container as claimed in claim 33, wherein said container is formed from a material selected from the group consisting of polyethylene, polypropylene, polyvinyl chloride, polystyrene, and polyesters.

38. A container closure assembly as claimed in claim 18 wherein said second locking means comprises a radially outwardly directed, circumferentially extending rib on the stem which engages in a complementary groove in the socket opening to lock the stem in an axial direction in the socket opening in the armed position whereby upon axial movement of the cap away from the neck, the stem remains locked in the socket of the closure.

39. A container closure assembly as claimed in claim 18 including indicia on the side wall of the closure and the container which are circumferentially spaced apart a predetermined angular distance in the unarmed position of the closure.

40. A container closure assembly as claimed in claim 18 wherein said first interengaging locking means comprises a radially outwardly directed circumferentially extending rib on the neck of the container spraced downwardly from the discharge opeining an a complementary circumferentially extending groove in an internal wall of the skirt portion of the closure spaced upwardly from its lower terminal edge.

41. A dual compartment container assembly, comprising:
a container having adjacent compartments defined by a common wall segment and a pair of outer arcuate walls, said container including a discharge end operable to permit dispensing of the contents of said adjacent compartments and a filling end which is sealed after said contents are placed in said adjacent compartments;
said common wall segment being pleated to have a first width prior to filling said adjacent compartments and a second, straightened unpleated width after said sealing of said filling end, said second width being greater than said first width;
said outer arcuate walls and said common wall segment terminating axially at said filling end to provide a filling end seal region such that pressure forming a seal at said filling end joins the terminal ends of said outer arcuate walls to form a straight line seal, said filling end seal region includes the terminal end of said common wall segment, said straight line seal being greater in width than said second, straightened unpleated width of said common wall segment; and said outer arcuate walls extend arcuately from junctions with said common wall segment to form bellows in said adjacent compartments, said arcuate walls being joined at each said junction with said common wall segment to form axially aligned pivotal junctions to define said bellows by causing said adjacent compartments to taper outwardly from said straight line seal.

42. The apparatus of claim 41, wherein said bellows extend from said filling end seal region to said discharge end such that the terminal portion of said bellows is included in said straight line seal.

43. A dual compartment container assembly comprising:
a container having adjacent compartments defined by a common wall segment and a pair of outer arcuate walls, said container including a discharge end operable to permit dispensing of the contents of said adjacent compartments and a filling end which is sealed after said contents are placed in said adjacent compartments;
said common wall segment being pleated to have a first width prior to filling said adjacent compartments and a second, straightened unpleated width after said sealing of said filling end, said second width being greater than said first width;
said outer arcuate walls and said common wall segment terminating axially at said filling end to provide a filling end seal region such that pressure forming a seal at said filling end joins the terminal ends of said outer arcuate walls to form a straight line seal, said filling end seal region includes the terminal end of said common wall segment, said straight line seal being greater in width than said second, straightened unpleated width of said common wall segment; and said outer arcuate walls extend arcuately from junctions with said common wall segment to form bellows means in said adjacent compartments for exerting pressure on said adjacent compartments upon application of an external force and which is biased against said external force such that when said external force is withdrawn said bellows means tends to return said adjacent compartments to their position before application of said external force, said arcuate walls being joined at each said junction with said common wall segment to form axially aligned pivotal junctions to define said bellows means by causing said adjacent compartments to taper outwardly from said straight line seal.

44. The apparatus of claim 43, wherein said bellows means extend from said filling end seal region to said discharge end such that the terminal portion of said bellows means is included in said straight line seal.

45. The assembly of claim 44, wherein said straight line seal is a heat seal.

46. A dual compartment container assembly, comprising:
a container having adjacent compartments separated by a common wall segment, a discharge end on said container operable to permit dispensing of the contents of said container, and a filling end on said container which is sealed after contents are placed in said compartments;
wherein each said chamber includes an arcuate outer wall having a chord of a length greater than the width of said common wall, and connected to said common wall by two side walls which form hinges at the junctures of said outer and side walls; and said common wall segment being pleated to have a first length prior to filling and a second unpleated longer length after said filling end is sealed to form a straight line seal at said filling end, said second length of said common wall segment being less then the length of said filling end after sealing.

47. The assembly of claim 46, wherein said straight line seal is a heat seal.