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Title:
CONTAINER CLOSURE ASSEMBLIES
Document Type and Number:
WIPO Patent Application WO/1993/008117
Kind Code:
A1
Abstract:
The present invention relates to double compartment closure assemblies in which materials are stored in at least two separate 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 inadvertent 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.

Inventors:
O'MEARA JOHN R (US)
GALLAGHER JOHN A (US)
CISTONE DAVID R (US)
Application Number:
PCT/US1992/008953
Publication Date:
April 29, 1993
Filing Date:
October 20, 1992
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
CP PACKAGING INC (US)
International Classes:
B65D35/22; B65D51/20; B65D51/22; B65D81/32; (IPC1-7): B67D5/00
Foreign References:
US4884703A1989-12-05
US1894115A1933-01-10
US2160705A1939-05-30
US1952840A1934-03-27
US3581940A1971-06-01
US3727803A1973-04-17
US4307821A1981-12-29
US4678098A1987-07-07
US4692151A1987-09-08
US4867326A1989-09-19
US5052589A1991-10-01
DE2921528A11980-12-04
EP0228751A21987-07-15
Attorney, Agent or Firm:
Renz Jr., Eugene E. (P.O. Box 2056 Media, PA, US)
Download PDF:
Claims:
CLAIMS
1. What is claimed is: 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 moveably 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 means formed from said compartments for applying a discharge force upon squeezing said container.
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 said cap includes at least two different sized piercers to permit proportional discharge from said compartments.
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 means in said compartments, said bellows means terminating at a point axially spaced from said seal region such that none of the bellows 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.
12. 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; said adjacent compartments having outer arcuate walls extending from said common wall segment to form said compartments; and said common wall segment having a first length prior to filling and a second longer length after said filling end is sealed to form a seal at said filling end.
13. The assembly of claim 12, wherein said arcuate walls are joined at each junction with said common wall segment to form axially aligned pivotal junctions.
14. The assembly of claim 12, wherein said arcuate walls and said common wall segment form bellows means.
15. The assembly of claim 14, wherein common wall segment is 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.
16. The assembly of claim 15, wherein said compartments and said common wall segment define said bellows means by causing said compartments to taper outwardly from said straight line seal to said discharge end of said container.
17. The assembly of claim 16, wherein said straight line seal is a heat seal.
18. A container and closure assembly, comprising: a) a container having a neck portion terminating in a discharge opening; b) an elongated stem connected at' its inner end by frangible means to normally seal said discharge opening; c) a closure of cuplike form having an inwardly facing stem engaging socket and axially moveable relative to the neck of the container between unarmed and armed limit positions; d) first interengaging releas ble 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 cannot be activated and releasable to permit relative axial movement to engage the stem in the socket in an armed position; e) second interengaging locking means locking the stem in the socket in the armed position whereby the closure may be rotated to fracture the frangible means and permit discharge of the contents through the discharge opening.
19. A containerclosure 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 containerclosure assembly as claimed in Claim 18 wherein said discharge opening is an elongated channel in the one end of the neck of the container and the frangible diaphragm is disposed at the inner end of said channel.
21. A containerclosure 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 the side wall defining the discharge opening.
22. A containerclosure 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.
23. A child resistant cap and tube assembly, comprising: a tube for containing a product and having an end portion with a recessed thin wall section puncturable to provide a discharge opening and a shoulder means for limiting axial movement on said end portion; a cap having a central axis for alignment with said tube and sized to slidably engage said end portion; an axially centered puncture means positioned to be aligned with said thin wall section and normally spaced from said thin wall section in a first position and operable to puncture said thin wall upon movement of said cap to a second position for opening said discharge opening; said cap further including shoulder engaging means for preventing axial movement of said cap from said first position to said second position without intentional manipulation of said shoulder engaging means to a shoulder disengaging position.
24. The assembly of claim 23, wherein said shoulder means comprises the terminal end of said tube on which said end portion is placed.
25. The assembly of claim 24, wherein said shoulder engaging means comprises a skirt detachably attached to the tube engaging end of said cap, said skirt engaging said shoulder to prevent movement of said cap to said second position until said skirt is removed.
26. The assembly of claim 25, wherein said skirt is a tear off skirt fragibly attached to said cap and adapted to be removed by said intentional manipulation.
27. The assembly of claim 25, wherein said skirt is a split skirt having a frangible seam adapted to be split by said intentional manipulation.
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.
31. The assembly of claim 30, wherein said piercer means is sized to be inserted into said nozzle portion from the filling end of said tube prior to filling 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 and sized to be inserted into said nozzle portion of said tube to prevent contents from opposing said piston member upon application of pressure to said tube, 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.
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.
Description:
CONTAINER CLOSURE ASSEMBLIES

TECHNICAL FIELD

The present invention relates to double compartment closure assemblies in which materials are ■ stored in at least two separate compartments until the compartments are opened for use. More particularly, the invention relates to a construction of the closed or filling end of such a dual chamber device in a manner which facilitates the discharge of materials therefrom at a later time when access to the contents of the chambers is desired without any potential compromise to the end seal integrity and also relates to a sterile cap and tube assembly which is 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 with a socket in the cap, followed by fracture of a frangible support of the stem on the tube nozzle and removal of the cap with the stem.

BACKGROUND ART

There are a variety of 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 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 promptly or in precise quantities.

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 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 piercers 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 suited for delivering precise quantities of several reagents in a way where monitoring and mixing takes place. However, under some circumstances, the viscosities of two liquids are not sufficiently similar that the rate of flow of the contents will coincide. Other times, the viscosity of

the material contained 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 assembly be developed which is reliable and efficient for use with contents having different viscosities from one another, particularly, where one or both viscosities are relatively high.

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 recently interest has 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 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 limited in their ability to mix in accurate proportions, it is particularly advantageous for them to have the drugs kept apart and mixed accurately just 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 features which have been found to be quite acceptable in a number of markets. 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 piercers which are in alignment with the walls so that the movement of the cap will cause the piercers 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.

Another dual compartment container is described in my co-pending United States application titled DUAL CHAMBER DISPENSING PACKAGE, 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 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 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 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 discharge ports at a much faster rate than would be achieved by gravity alone.

In most cases when the contents are made from plastic or other quite flexible 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 contents needed is placed at the point where it is most 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

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 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 aforementioned U.S. Patent No. 4,884,703 and others are employed, it is sometimes difficult 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.

Another dual compartment container is described in my co-pending United States application titled DUAL CHAMBER DISPENSING PACKAGE, filed January 31, 1992, and having Serial No. 07/828,516. 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 contents 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 first width prior to filling and a second

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 flexible and where the size of the container is sufficiently large, there is one drawback to this design when the container is small and relatively rigid.

Under some circumstances, the inclusion of the two outer wall, the center or common wall, and the folded overlap from the two bellows like portions of the outer walls results in a configuration where 5 or more thicknesses are being compressed at the filling end. It is sometimes difficult to achieve a complete seal that has integrity and reliability that satisfies even the most strict 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 filling 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 two 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.

Accordingly, it is an object of this invention to provide a simple and effective design for dual

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, and yet which permits all of the contents to be expelled.

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 in a manner which allows for complete expulsion of the contents while maintaining seal integrity.

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 has 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 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 limited in their ability to mix in accurate proportions, it is particularly advantageous for them to have the drugs kept apart and mixed accurately just 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 features which have been found to be quite acceptable in a number of markets. 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 slidable 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 piercers 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.

Another dual compartment container is described in my co-pending United States application titled DUAL CHAMBER DISPENSING PACKAGE, 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 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 fit 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 from the 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 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 compartments are made from plastic or other quite flexible 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 contents needed is placed at the point where it is most 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 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 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 aforementioned U.S. Patent No. 4,884,703 and others are employed, it is sometimes difficult 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

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.

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 to 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 frangible 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 nozzle 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, the cap must be taken off and turned over in order to activate the system. This requires both hands at some time during the removal of the stem or projection.

A design which avoids the sanitation problems of the above identified patent is shown in U. S. Patent No.

4,134,511. This patent describes a container with a neck having an elongated solid projection on the tip. The

projection is integrally connected to the tip by a reduced wall portion forming a frangible annular link whose rupture creates an outlet. The neck is closely surrounded by a cap which firmly engages this removable tip and cannot be detached 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 fit 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, there is no way to prevent the tip from being pushed into the container when force is inadvertently applied to the cap. Since the tip and cap are always in contact, there is a serious risk of inadvertent activation. Any time there is a one step activation, it is possible for children and others not authorized to have access to the contents to inadvertently or intentionally open the product. Another drawback of this design is that axial activation is possible even though the design is intended to have a rotational movement to cause the fracture or rupture of the frangible area holding the 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

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 benefits and sa ety 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 the contents.

The field of child resistant cap and tube assemblies, which carry medicines, vitamins and the like, have 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.

In prior art devices, designs have been proposed which include a three piece construction where a tube body contains a plug attached to e, portion of the main body 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 the tube. The other end is then designated 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 the 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 contaminated products.

My prior device has a tube which has one end

portion which terminates 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 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 which interengages the end to locate the cap at a first position where a thin wall portion on the tube is protected. Movement overcoming the 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 effective. Rather, 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 looks 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 other 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.

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. Patent 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 patent and the thin wall seal which has been protecting the contents is pierced. That is desirable only when the user makes that decision and not merely because the force has been overcome inadvertently. It is therefore another object of this invention to provide a child-resistant tube and cap assembly that requires more than axial force to provide access to the contents. At the 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 to move the cap and tube into alignment for activation, and that they are somehow not capable of activation without that conscious step. Stated another 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 activated.

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 actuality. At best, tamper evidence mans that the one attempting 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 tp be sure 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 of the tube and also with the part of the tube 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 construction where a tube body contains a plug attached to a portion

of the main body 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 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 the plug.

In U.S. Patent No. 4,867,326, a child-resistant cap and tube assembly 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 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 which engages the end to locate the cap at a first position where the thin wall portion on the tube is protected. Movement overcoming the 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 device in U.S. Patent No. 4,867,326 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

thin wall is easily determined visually.

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 the thin wall seal which has been protecting the contents is pierced. That is desirable only when the user makes that decision and not merely because the force has been overcome inadvertently.

It is therefore an object 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 is never 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 desired, such as when there is suspicion that the tube assembly has been in the hands of children or other unauthorized persons, it is comforting to inspect the thin wall visually. When the cap is removed to do this step, the possibility for contamination exists.

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.

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 possibility of the piercing agent entering into the tube after assembly.

A known 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 chambers, each chamber containing one of the substances to be dispensed. As shown in Fig. 3A of • that patent, each chamber is in communication with an orifice through which the substances are dispensed. The two chambers are separated by a divider in the middle of the tube, which is attached to the outside walls of the tube. Upon squeezing the tube, the 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 be dispensed simultaneously. Alternatively, as shown in 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 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 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 tube 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 the tube. This construction creates fixed edges at the intersections of the divider and the tube wall.

As a result of the fixed edges, when the tube is squeezed, 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 tubes, the amount of material dispensed from each chamber is dependent upon the decrease in volume of the chamber occasioned by the deformation of the walls of the chamber. This deformation, and thus the amount of material dispensed, depends upon several actors 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 the outer walls of the chambers. In such tubes, upon the application of force, the tube walls for each chamber deform slightly. 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 severe deformation, as the outer wall of the tube snaps inward toward the dividing wall, causing a large amount of material to be dispensed from that chamber. Moreover, this effect can happen to the two different chambers with different amounts of force. This causes the chambers 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

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 if 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 to control or regulate, making equal dispensation unlikely.

A dual chamber dispensing tube that facilitates application of substantially equal 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 objects will appear hereinafter.

DISCLOSURE OF INVENTION

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 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 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.

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 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 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 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.

It has now been discovered that the above and other objects of 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. The container includes an improved filling end which is sealed in an improved manner after contents are placed in said compartments.

The common wall has a first width prior to filling and a longer width forming a straight line seal at a point spaced 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 pleats, so that as it is pulled at both ends where it is joined to the outer walls, the pleats will straighten 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 the 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.

The present invention also includes a common wall which terminates at the filling 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 common wall.

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 extends axially inward to include the end of the common wall in only a portion of the seal. In this manner, the two compartments are separated and the contents do not mix, but the alignment of the compartments 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 thickness is imparted to the seal region. It is preferred that the straight line seal is a heat seal.

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 is 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 outer 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 preferred embodiment, the common wall segment is pleated to have a first length prior to filling and a second unpleated longer length after the filling end is sealed.

The arcuate walls are joined to the common wall segment at each junction to form axially aligned pivotal junctions which allow the compartments to function as bellows means. The compartments and the common wall segment define the bellows means by causing the compartments to taper outwardly from the straight line seal to the discharge end of the container which is the largest diameter that the 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.

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 moldable material such as plastic, and is

sealed using a heat seal. The container of the present invention is admirably suited for small capacity designs because the common wall segment accommodates arcuate walls of almost any small dimension without requiring unreasonable or possibly damaging force when the seal is made.

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 comprises 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 at 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 assembly 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 stem 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 movement of the stem and permit engagement of the locking means at said predetermined position. In one embodiment, 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.

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 variation of this embodiment is to provide a clear cap so that the 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 insertion of the stem and socket to said second or predetermined position, followed by axial rotation to rupture said frangible support. This indicia may be in the form of markings around the cap.

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 means or piercer which is positioned to be aligned with the thin wall section of 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 several 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 thin wall is easy to accomplish.

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 means comprises a skirt which is detachably attached to the 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 skirt 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. Alternatively, 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 groove 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 axially centered puncture means is preferably located on the other end of said cap whereby the intentional manipulation includes disengagement 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 means 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 of 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

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 provide 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 visuallyObserve the location of both the socket means and the boss means so as to easily make the appropriate alignment and to recognize cap and tube assemblies which have been activated previously. In this manner, this embodiment provides 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 a tamper evident feature with the removable tear-off tape or other closure, as well with the cap having to be removed and the other end attached to the tube.

It has now been discovered that the above 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 from 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 in 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 filling end of the tube prior to filling the tube.

In the first position, the piercer, which preferably comprises a hollow needle-like member, is located in a first position which is a safe distance from the 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

port and move 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 protective thin wall is eliminated.

Most commonly, the assembly also includes a cap 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 abutment 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 the thin wall is effectively made much thicker with the support plug in mating contact with the wall via its flat, axially transverse surface.

In accordance with this invention, there is provided a container, for dispensing two substances simultaneously, that includes a neck portion having two orifices therein, a shoulder portion connected to the 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 variances in viscosity between the substances.

In the preferred embodiment, the container is a tube made of resilient plastic and has two orifices in the neck portion, the orifices having substantial equal areas.

BRIEF 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,- where:

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

Fig. 1, with the closure members separated from the tube body to show the dual dispensing ports and nozzle design.

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.

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 member 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.

Fig. 1A is an exploded, isometric view of an unsealed, dual compartment, pierce point, bellows tube, with the dual pierce point member shown separate from the tube.

Fig. 2A is an isometric view of the unsealed dual compartment bellows tube shown in Fig 1A 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 sectional view taken on the line 4A,4A of Fig. 3A, showing the heat sealed junction of the tube side walls and the entrapped flattened and extended medial strip.

Fig. 5A is an enlarged, sectional, elevational view of the dual compartment bellows tube shown in Fig. 1A and taken along the line 5A,5A of Fig. 1A, 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 Fig. 5A.

Fig. 7A is a bottom plan view of Fig. 6A, taken along the line 7A,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 thickness linear seal.

Fig. IB is an enlarged, isometric view of a molded one-piece dual chamber tube for a package showing the discharge end of the tube covered by a closure member 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. IB 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 symmetrical design of the tube geometry.

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 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 6B,6B of Fig. 5B.

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 arcuate side walls pressed inwardly to form a straight line seal.

Fig. ID 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.

Fig. 2D is an enlarged fragmentary, sectional, elevational view taken along the line 2D,2D of Fig. ID.

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. 3D, showing additional details of the discharge end of the nozzle tip.

Fig. 5D is a view similar to Fig. 2D, showing the closure member in a frictionally engaged position.

Fig. 6D is a greatly enlarged fragmentary, sectional, elevational view of the details contained with the dot and dash circle shown in Fig. 5D and designed

Fig. 6D showing details of the closure member in an armed 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 section, showing the 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.

Fig. IE is an isometric view of a child resistant and tamper evident pierce-pak container, all in accordance 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 view taken along the line 5E,5E of Fig. IE, illustrating details of construction and assembly.

Fig. 6E is fragmentary, sectional elevational view taken on the line 6E,6E of Fig. 5E, illustrating additional details of the tear-off skirt.

Fig. 7E is an enlarged, fragmentary, sectional elevational view taken along the line 7E,7E of Fig. 3E.

Fig. 8E is an enlarged, fragmentary, elevational view with a portion broken away and in section, showing another embodiment of the invention.

Fig. 9E is a fragmentary, sectional, plan view taken on the line 9E,9E of Fig. 8E.

Fig. 10E is a fragmentary, elevational view of the embodiment of Fig. 8E, with a portion broken away and in section.

Fig. HE is an enlarged, fragmentary, sectional elevational view of another embodiment which is different from the embodiment shown in Fig. IE again illustrating details of construction and assembly.

Fig. 12E is a plan view taken on the line 12E,12E

of Fig . HE .

Fig. 13E is an enlarged, fragmentary, sectional elevational view of the embodiment shown in Fig. HE, in an activation mode.

Figs. 14E-16E are sequential isometric views illustrating the method of use of another embodiment of the invention shown in Fig. IE, showing the steps needed in order to release the medicament contained within the sealed tube.

Fig. 17E is an enlarged, fragmentary, sectional elevational view taken along line 17E,17E of Fig. 14E illustrating details of construction and assembly.

Fig. 18E is an enlarged, sectional, plan view taken on the line 18E,18E of Fig. 17E.

Fig. 19E 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. 19E.

Fig. IF 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. IF, showing the internally actuated pierce point having pierced the thin wall forming a nozzle diaphragm under hand discharge pressure.

Fig. IG is a side view of a container of the present invention.

Fig. 2G is a cross-sectional view, in the plane 2G- 2G of Fig. IG, of the container shown in Fig. IG.

Fig. 3G is a cross-sectional view, in the plane 2G- 2G of Fig. 2G, of the container shown in Figs. IG and 2G.

Fig. 4G is a cross-sectional view of an alternate embodiment of the present invention.

Fig. 5G is a cross-sectional view of an alternate embodiment of the present invention.

MODES FOR CARRYING OUT THE INVENTION AND INDUSTRIAL APPLICABILITY

As shown in Fig. 1, the assembly generally include a cap 11 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 19 which, as will be shown below, are separated from one another and separately contain contents which are to be discharged from the container.

As shown in Fig. 2, removal of the cap 11 exposes the nozzle end 21 of the tube 13. Nozzle 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 17 and second compartment 19 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 the top wall 29 of cap 11. Similarly, piercer 31 is aligned with thin wall 33 of nozzle port 23.

The two nozzles 22 and 23 and the associated containers 17 and 19 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 19 for expulsion of the materials contained in tubes 17 and 19 as will be described below. First, cap 11 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 11 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 to the contents of both containers 17 and 19.

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 will encourage or restrain movement of walls 37 and 39 during squeezing. Pressure by squeezing the container in the direction of arrows of 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 viscosity fluids which might be contained in one compartment, such as compartment 17, relative to the viscosity of the fluid 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 prevent inadvertent movement of the cap and to permit intentional movement of the cap to a second position to thereby cause puncture of the recessed walls 25 and 33. Cap 11 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 desired. As previously described, movement of cap 11 in the direction of arrow 41 causes piercers 27 and 31 to puncture walls 25 and 33. The force applied to the end 29 of cap 11 in the

direction of arrow 41 is sufficient to dislodge the groove 53 from ring 51. Cap 11 is typically made from a 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 resist movement of both walls 37 and 39, as well as other parts of the containers 17 and 19, 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 discharge from two containers of different volumes.

It is also noted that the present invention includes an additional 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 tubes and caused the contents to be discharged accidentally. Recessed diaphragms of this type prevent such accidents from occurring.

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 213 at the discharge end 215 as described in my previously identified U.S. Patent No. 4,884,703 and my co-pending United States application titled DUAL CHAMBER DISPENSING PACKAGE 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 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 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 sealing devices.

Fig. 4A shows the seal region 227 after sealing pressure has been applied. It is important that the terminal ends of walls 219, 221 and 223 form the relationship shown* 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 effective to preserve the integrity of the contents. Those terminal ends of arcuate walls 219 and 221 are also

sealed to the terminal end of common wall 223 to seal and separate the contents of the two compartments and to present a geometric alignment of the walls 219, 221 and 223 which allows for most efficient expulsion of the contents at the 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 thickness of only walls 219, 221 and 223 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 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.

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 Figs. 1A 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 225 are straightened and the lower terminal ends of arcuate 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 shown in Fig. 4A, there is sufficient length at the terminal end of common wall 223 to insure that leakage between the two chambers is also prevented.

As is noted in Figs. 1B-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 No. 4,884,703 and my co-pending United States application titled DUAL CHAMBER DISPENSING PACKAGE, 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 patent 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 the assembly is used. Compartments 323 and 325 extend from a sealed end 327 to a full or top portion 329 of each compartment 323 and 325. Compartment 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

shown open and ready to receive the contents. Normally, the filling operation ia automated and contents are measured and dispersed into the containers 323 and 325 automatically, followed immediately by a sealing step in order to preserve the integrity of the contents. The container assemblies of the present invention are normally manufactured from plastics which are thermoplastic rather than ther oset 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 segment 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 after the filling end 317 is sealed. In the preferred embodiment shown in Fig. 4B, common wall segment 335 is pleated to define 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 pivotal 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 segment 335.

In Figs. 5B and 6B, it is clear to see that the common wall segment 335 extends from the filling end 317 completely between containers 323 and 325 up into the discharge end 315, shown as wall segment 337. Thus the contents of the two compartments 323 and 325 do not contact one another until after the contents have been discharged.

Once the contents have been placed in compartments

323 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 completed and the container assembly takes the ready to use form shown in Figs. IB 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. When the two compartments are relatively large and flexible, this is not a serious problem, although the seal is not always straight 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 effectively 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 the compartments need to have a certain size in order to contain the appropriate quantities of medicines and the like. Some shapes actually prevent the effective and efficient squeezing discharge which users of single compartment tube assemblies have come to know and expect.

The present invention is the only design which preserves the common expectations of users of single compartment tubes while also giving a superior seal.

When the tube is used, the tapered sides of the two compartments 323 and 325 form bellows means, whereby the

pivotal junctions 332 and 334 allow squeezing pressure to force all of the contents out the discharge ports 319 and 321.

Shown in Figure ID 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 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 the 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 519 which is to be lined up with arrow 517 after the closure has been opened.

Turning first to the cap 511, ridges or grooves 521 cover a portion of the cap 511 to permit gripping and facilitate twisting of the cap 511. Cap 511 includes a terminal end 523 which has an annular ring defining a socket 525 on the inside of end 523 and facing tube 513. Socket 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 tube 513. Groove 529 and ring 531 serve to locate the cap 511 on tube neck 533. As shown in Figure 3D, stem 527 is spaced from socket 525 prior to use of the cap and tube assembly.

Stem 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 easily be ruptured by pressure

on stem 527. One unique feature of the present invention is the inclusion 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 activated as hereinafter described, stem 527 resists axial movement into the tube 513 so that stem 527 seats properly in socket 525.

To assist in the seating of stem 527 in socket 525, a groove 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 provide 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 position 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 ID, 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 other. 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

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. Because the thin wall is recessed back from the terminal end of tube neck 533, fragments and torn portions of the membrane are not exposed and will not present a danger 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.

As is noted in Figs. 1E-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 tube 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 invention is restricted by the assembly of the present invention, requiring an intentional manipulation of a portion of the assembly before access to the contents can be obtained. In Fig. IE, 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 skirt 623 by pulling pull tab 625, as illustrated in Fig. 2E, places the assembly in a ready to use condition.

Turning now to Figs. 5E, 6E and 7E, the internal working of the assembly can be seen. In Fig. 5E, the device is as shown in Fig. IE 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 manipulation is necessary for use of the tube. Piercer 629 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,

piercer 629 cannot contact thin wall section 633 of tip 635 of tube end portion 617.

Also shown on the assembly illustrated in Fig. 5E 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, 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 skirt previously described is shown. Split skirt 641 restrains movement of cap 615' toward tube 613 because it cannot move past shoulder 627. In this embodiment, intentional manipulation of the assembly to open the tube requires that the cap 615 l be pushed axially toward the tube 613 so that split skirt 641 impinges on shoulder 627 in the direction of arrow 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 moved to cause piercer 629 to puncture thin wall section 633 as previously described.

Turning now to Figs. HE, 12E and 13E, another assembly according to the present invention is shown. This assembly includes a modified cap 645 which has a first end 645a and a second end 645b 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 tube end portion 617. Piercer 629 is sterilized and kept sanitary by a closure member, shown in Fig. HE in the 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 649.

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 embodiment, 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. Intentional manipulation of cap 653 to bring socket 661 into alignment with boss 657, as illustrated in Fig. 15E, allows the cap 653 to slide on the tube end portion 659 to a second position shown in Fig. 19E.

When the lower terminal end 653a of cap 653 is in contact with boss 657, as shown in Fig. 17E, the cap 653 is held in a first position where piercer 629 is spaced from thin wall section 633. Rotation of cap 653 to align boss 657 and socket 661, as shown in Figs. 19E and 20E, allows cap 653 to be pushed in the direction of arrow 663 to provide access to the tube contents. Without the intentional manipulation of the cap 653 from the safe position of Fig. 17E to the ready position of Fig. 19E, 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 outside of socket 661 allows the two components to be rotated with respect to each other to achieve a ready to use condition.

In each 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 necessary movement of the cap with respect to the tube must be made using intentional manipulation of the assembly. This substantially reduces accidental access to the tube and greatly increases the safety and security of the product being sold.

As shown in Figs. IF 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 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, 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.

A nozzle portion 717 is mounted on the discharge end 715 of tube 711 and includes 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 end 723 of discharge port 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 715 of tube 711. Cap 725 is preferably fit on the nozzle portion 717 using a friction fit for economy of manufacture, but it is also possible to use threaded 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 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.

It is of primary importance to hold the plug 727 in place as the plug 727 is sized to present flat, axially transverse surface 728 across the entire external face of the thin wall 721. In this embodiment, the plug 727 is

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 which is in the form of a hollow piercer 729 sized to move axially in central bore 719. Piercer 7-29 is hollow, having an axially centered bore 731 through which the contents will 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 719a of discharge port 718 and is adapted to move the piercer 729 from a first position shown in Fig. IF to a second position shown in Fig. 2F after cap 725 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 719. 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 equipment.

The contents are added to tube 711 after this step so that no contents are present in space 735 which exists on the discharge side of piston 733 when piston 733 is in the position shown in Fig. IF. Piston 733 is positioned in this first position which can be described as a ready to use position. Plug 727 has plug face 728 across the entire surface of thin wall 721 and prevents piercer 729 from puncturing thin wall 721. During normal filling operations the force of filling is not sufficient to cause piercer 729 to damage thin wall 721.

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 of 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 contents can be used as intended.

The cap 725 shown in Fig. IF 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 743 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.

According to the present invention, a dual chamber dispensing container comprises side walls connected 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 outer 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. IG, 2G, and 3G, the dual chamber dispensing container 801 is 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 812 have arcuate outer walls 805 and 806, respectively. Arcuate outer wall 805 of chamber 811 is connected to common wall 804 by side walls 809 and 810. The intersections of arcuate wall 805 and side walls 807 and 808 form hinges

820 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 between hinges 820 and

821 is 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 another by the application of force to the arcuate outer

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, causing the chambers to act as bellows. As a result of this bellows action, the two chambers 811 and 812 are exposed to substantially 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 outer 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.

In addition, 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 volumes (chamber 811a has a greater volume 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

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 proportions when configured as shown in figure 5G. This can be accomplished by varying the 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 cross-sectional area. Differing orifice sizes and shapes can also be utilized to allow for even dispensing of two materials of substantially differing viscosities by introducing the material 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.

ADDENDUM SHEET TO BOX 3C OF THE PCT INTERNATIONAL APPLICATION TRANSMITTAL LETTER

3C (continued)

The PCT Application filed concurrently herewith is a combination of six previ filed United States Applications by one inventor, John R. O'Meara, as noted below:

Title S/N Filed Inventor Figs Claim

Sterile Pull Push Closure 07/785,438 10/24/91 John R. O'Meara 1D-9D 18-22

Dual Chamber Dispensing Package 07/784,964 10/30/91 John R. O'Meara 1-6 1-5

Dual Chamber Medicament Dispenser 07/828,516 01/31/92 John R. O ' Meara 1B-8B 12-17

Child Resistant Medicament Dispenser 07/830,308 01/31/92 John R. O ' Meara 1E-20E 23-27

Dual Chamber Medicament Dispenser 07/931,989 08/19/92 John R. O ' Meara 1A-8A 6-11

plus two disclosures not yet filed by the inventor, John R. O'Meara;

Title Inventor Figs

6. Dual Compartment

Container With Screw Cap John R. O'Meara 1C-7C

7. Sterile Pull Push Closure John R. O'Meara 10D-12D

plus another previously filed United States Application by another inventor, John A. Gallagher:

Title S/N Filed Inventor Figs Claims

8. Internal Pierce

Point Container 07/828,517 01/31/92 John A. Gallagher 1F-2F 28-32

plus one additional Application by yet another inventor, David R. Cistone:

Title Inventor Figs Claims

9. Dual Chamber Dispensing Tube David R. Cistone 1G-5G 33-37

The PCT Application filed concurrently herewith contains subject matter that is substantially identical to the sum of the above-identified Applications and prior Applications.