This application claims priority to British Application No. GB 0601018.5 filed on Jan. 18, 2006, the entire disclosure of which is hereby incorporated by reference.
The present invention relates to inserts for multiple component containers, which contain two or more different substances or components which are stored separately but are mixed together at the time the container is opened.
There are many fields in which multiple component, particularly binary component, containers are used or are desirable. Thus, there are certain pharmaceutical compositions which are administered in the form of a mixture but which are unstable in the long term in the form of a mixture. The components of such a composition are therefore stored separately and only mixed shortly before administration. In this case, both components are generally in liquid form but it is also possible for one of the components to be in solid or powder form. Such containers may also find application in the foodstuff market, particularly for beverages. Thus it is desirable, for instance in connection with canned or bottled lager and lime, only to mix the lime into the lager shortly before consumption of the beverage.
It is the object of the invention to provide an insert for a multiple component container which is simple and cheap and which enables one component in the container to be reliably automatically mixed with a second component in the container as the container is opened.
According to the present invention, an insert for a multiple component container includes a diaphragm and a sealing element which together define a reservoir, the diaphragm including a stationary portion and a movable portion, the movable portion being connected to the stationary portion by at least two spaced annular fold lines of opposite sense, a discharge opening being formed in the movable portion within the annular fold lines, a gas leakage path being provided in the diaphragm, a valve member connected to the stationary portion and cooperating with the discharge opening and substantially sealing it, whereby the application of a greater gas pressure to the interior of the reservoir than to its exterior results in rotational movement about the fold lines and thus in movement of the movable portion relative to the stationary portion and thus in the valve member moving out of sealing contact with the flow opening.
In use, the insert will be partially filled with one component, preferably in liquid form, of a multiple component system and will be placed inside a container including a further component of the multiple component system. Once the container has been sealed by means of a lid or other closure, which may be separate from the insert or may be connected to it, the interior of the container, that is to say the head space above the component situated within it, is pressurised. If the component with the container is a carbonated beverage, this pressurisation will occur automatically by virtue of the progressive release of carbon dioxide from it. If, however, the component within the container is not carbonated and is e.g. a pharmaceutical preparation, this pressurisation of the head space of the container may be conveniently effected by adding a few drops of e.g. liquid nitrogen into the container immediately before it is sealed. Vaporisation of the nitrogen will commence immediately and the initial vaporisation will result in the atmospheric air in the head space being replaced by the nitrogen. Subsequent vaporisation of the nitrogen after application of the sealing lid will result in pressurisation of the head space. The gas leakage path in the diaphragm will progressively admit pressurised gas into the interior of the reservoir, whereby the pressure within the reservoir will reach a value substantially the same as that in the pressurised head space of the container. When the container lid is removed, the head space of the container will be instantly depressurised. However, the leakage path in the diaphragm is sufficiently small that instant depressurisation of the interior of the reservoir is not possible, whereby a substantial pressure differential across the diaphragm will be created. This will act on the movable portion of the diaphragm and will result in relative rotation of the annular portions of the diaphragm on each side of each fold line. This relative rotation will result in movement of the movable portion away from the stationary portion and thus in movement of the discharge opening away from the valve member. This movement is sufficient to move the discharge opening out of cooperation with the valve member, whereby the discharge opening is now open. The gas pressure prevailing within the reservoir will then expel the component within the reservoir through the discharge opening and into the body of the container, where it will mix with the other components present therein. The container now contains a two-component mixture which may then be administered to a patient or otherwise used.
The valve member may take various forms but in a simple preferred embodiment, it constitutes a spigot or the like which is integrally connected to the diaphragm. This spigot will normally cooperate with the discharge opening, e.g. extend into it and form a seal with it, so as to close the discharge opening and prevent premature discharge of the component within the reservoir into the container. It is convenient for manufacturing reasons for the valve member to be integral with the peripheral edge of the diaphragm and this will necessitate the spigot being connected to the edge of the diaphragm by means of a link or connector of some sort. This link will inherently be relatively long and in order to ensure that it is retained in the desired position, it is preferred that the insert includes a support member integral with the stationary portion which is engaged by the link and stabilises it.
The gas leakage path in the diaphragm may be constituted simply by a very small hole in it. It is, however, convenient if the valve member and discharge opening together define the gas leakage path because this will obviate the necessity of forming a separate leakage path. It is preferred that the valve member and discharge opening together constitute a one-way valve defining the gas leakage path through which gas may flow into the reservoir but not out of it.
The insert may be used with two-component containers and in this event one component will of course be stored in the body of the container and the other in the insert. The invention is, however, applicable to containers for three or more component systems and thus the reservoir may include one or more partitions dividing it into two or more compartments, each of which communicates with a respective flow opening cooperating with a respective valve member. In use, each compartment will of course be filled with a different component of the multi-component system. In this event, it is preferred that each flow opening is associated with a respective set of at least two spaced annular fold lines.
The insert will of course need to be sealed prior to use to prevent leakage or contamination of its contents and the sealing element may be a sheet of plastic material or of metal or a composite thereof sealingly connected to the peripheral edge of the diaphragm.
The insert may be applied to a container in the form of a discrete component and the lid or other closure subsequently applied to the container. It is, however, convenient if the insert and closure constitute a composite unit, whereby they are then applied simultaneously to the container. Such a closure will include a closure plate which, in use, extends across a dispensing opening in the container and it is therefore possible for the sealing sheet of plastic material or the like to be omitted and for the closure plate of the closure to constitute the sealing element of the insert.
Further features and details of the invention will be apparent from the following description of certain specific embodiments which is given by way of example only with reference to the accompanying drawings.
The insert illustrated in the accompanying drawings constitutes a one-piece moulding of polypropylene or the like. It could, however, also be made from metallic foil or from a composite comprising metal and plastics material which is stamped or pressed into shape. When the insert is ejected from the mould, it has the configuration shown in
The insert is now brought into the operative configuration by applying an upward force to the lower end of the pocket 6. This results in the annular wall of the pocket 4 corrugating, that is to say folding about the annular lines of weakness, adjacent folds being of opposite sense. The pocket 4 is moved upwardly until it is generally at the same level as the remainder of the base of the cup-shaped portion 2. Prior or subsequent to this, the link 12 is rotated through 180□ in the anticlockwise direction, as seen in
The insert is then partially filled with the desired substance, in liquid or powder form, and in the present case it will be assumed that this substance is one component of a two-component pharmaceutical composition which is administered in the form of a mixture but is unstable in the long term in the form of a mixture. The insert is then sealed by connecting to the upper surface of its upper peripheral flange 10 a sealing film 20, preferably of metalized plastic material because such composite materials are impermeable to both liquids and vapours. The insert is now ready for use.
The insert may be used in a variety of ways but in its simplest form it is placed within the neck of a binary component container, which already contains the other component of the two-component pharmaceutical composition referred to above, with its peripheral flange 10 resting on the rim of the container. Before positioning the insert on the rim of the container, a few drops of liquid nitrogen are inserted into the container and an outer sealing lid is then rapidly applied before all the nitrogen has vaporised. The initial vaporisation of the liquid nitrogen will fill the head space of the container with nitrogen and displace all atmospheric air and any bacteria contained therein. The subsequent vaporisation of the nitrogen, which occurs after application of the lid, will increase the pressure in the head space of the container to a super-atmospheric level. As this pressure increases, the lip 8 will yield outwardly to open up a small gas leakage path into the interior of the insert. The pressure in the interior of the insert will therefore over time reach a value substantially equal to that in the head space of the container.
When it is desired to administer the two-component pharmaceutical composition, the container lid is removed. This will result in instant depressurisation of the head space of the container. However, the valve constituted by the engagement of the lip 8 with the spigot 14 is a one-way valve, by virtue of the orientation of the lip 8. The interior of the insert is thus not instantly depressurised and there is therefore a substantial pressure differential across the wall of the pocket 4. This results in instantaneous movement of the pocket downwardly accompanied by simultaneous unfolding of the various folds in its annular wall, this unfolding being in opposite senses in adjacent folds. As the lower portion of the pocket moves downwardly, the rim 8 of the flow opening 6 will move out of contact with the spigot 14, which is stationary. The flow opening 6 is now unobstructed and the super-atmospheric pressure prevailing in the interior of the insert above the pharmaceutical component within it now acts to expel the pharmaceutical component rapidly through the opening 6 into the container, where it will mix with the pharmaceutical component already in the container with the aid of the mixing action produced by the high speed jet through the opening 6. The pocket may be so dimensioned and the container may be filled to such a level that the opening 6 is situated below the level of the liquid in the container, though this is not essential. The insert will now be in the configuration shown in
As described above, the insert in accordance with the invention and the closure or lid are applied to the container separately. It may, however, be more convenient to integrate the insert with the lid and such a construction is shown in
It will be appreciated that the insert and lid described above are for use with a binary component container, that is to say a container which contains one component in the body of the container and a second component to be mixed with it in the insert. However, the insert and lid in accordance with the invention can also be used for containers to contain three or more different components to be mixed shortly before use or administration. Thus in a modified embodiment, which is not illustrated, the insert is for use with a container to contain three different components. The base of the cup-shaped member 2 is formed with two sets of annular, preferably concentric, fold lines of opposite sets, a respective discharge opening being situated within each set of fold lines. The interior of the reservoir defined by the insert is divided into two compartments by a partition which is integral with the wall and base of the insert and extends between the two sets of fold lines, whereby each of the compartments communicates with a respective flow opening. Also integrally formed with the cup-shaped member are two spigots and links, substantially the same as that illustrated in the figures, cooperating with respective flow openings. It will be appreciate that, in use, the two compartments will be filled with different components and that operation of the insert is essentially the same as that described above, the only difference being that when the container is opened both flow openings will move downwardly and thus move out of contact with the associated spigots, whereby the two flow openings will be opened substantially simultaneously and the contents of the two compartments will be expelled into the body of the container substantially simultaneously and will be mixed with the third component already present in the body of the container.
Number | Date | Country | Kind |
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0601018.5 | Jan 2006 | GB | national |