EP3279110B1

EP3279110B1 - Cap for mixing a product with a main product contained in a vial, vial provided with such a cap and method for assembling the vial

Info

Publication number: EP3279110B1
Application number: EP16425084.7A
Authority: EP
Inventors: Angela FROSIO
Original assignee: Montefarmaco Otc SpA
Current assignee: Montefarmaco Otc SpA
Priority date: 2016-08-04
Filing date: 2016-08-04
Publication date: 2019-05-29
Anticipated expiration: 2036-08-04
Also published as: EP3279110A1; LT3279110T; HUE046007T2

Description

The present invention relates to a dispensing cap for dispensing a substance in a container and to a vial comprising such a dispensing cap.
In particular, the present invention relates to a cap suitable for being coupled to the mouth of a container and shaped for housing a capsule storing a first substance. The cap is also configured to deform under the action of a user, in order to break the capsule and to control the dispensing of the first substance in the container storing a second substance which, mixed with the first one, produces a desired solution.
Different types of vials, usually called single-dose, are now known and very popular on the market, and they consist of a container storing a first substance and a cap, or closure, storing a second substance. This arrangement keeps the two substances separate until the user mixes them. These types of vials are widespread in many fields of application, ranging from the purely pharmacological to food and sport. Generally, these vials are in fact usable whenever a predetermined mixture is needed in a short time while storing for a long time the separate components forming said mixture.
The two components should be mixed conveniently and rapidly just before their use and on site because the therapeutic properties of the mixed solution rapidly decay in time. Usually, the substance stored in the cap is housed in the capsule to be protected from external agents, e.g. humidity. Generally, the substance stored in the capsule arranged inside the cap is soluble, in the form of powder or tablet, whereas the substance stored in the container closed by the cap is usually liquid.
The dispensing caps are then provided with a base portion, usually sleeve-shaped, to be coupled to the neck of the container, and with an upper portion configured to be the housing of the capsule. In particular, the capsule, which is substantially dome-shaped, is fastened so that its flat base faces the mouth of the container and by breaking the lower membrane the dust enters by gravity in the container, while the dome is restrained between the walls and the roof of the cap.
The capsule is usually made of aluminium sheets with reinforcing layers of plastic material, and the flat base of the capsule, arranged on the mouth of the container, is suitably thinner than the rest of the capsule for its easy breaking.
The upper portion of the cap, namely the portion arranged over the neck of the container and housing the capsule, in turn comprises side walls and a roof.
By acting manually on the roof, usually pressing by means of one or both thumbs, the roof is lowered, thus causing the breaking of the capsule and the releasing of the substance in the container.
The breaking of the capsule can occur in various ways. According to one way, the side walls of the cap or the roof, possibly provided with a punch, break through the capsule piercing it from side to side. According to another way, the side walls penetrate in the cap, not piercing the capsule but squeezing it until causing the breaking of its bottom.
Both solutions presently in use are not entirely hygienically optimal. In fact, both cases show a kind of outside contamination of the internal environment of the cap, which was isolated until the breaking.
Specifically, in the first described embodiment, the outer walls of the cap, exposed to the external environment, come into direct contact with the substance to be dispensed, inevitably causing its contamination. In the second case the contamination is not direct, namely through the direct contact of the exposed walls with the substance to be dispensed, but indirect, since the walls, penetrating inside the cap, break only the bottom of the capsule, leaving the top undamaged.
The Applicant has studied this problem in the past and, as described in WO2015125123 , has developed a new and inventive solution providing for side walls of the cap which, starting from an outstretched configuration, fold back on themselves out of the cap thus creating, once the cap has been compressed, a substantially flower-shaped configuration, where each petal is a laterally folded side wall of the cap.
With the present invention, the Applicant carries out a further new and inventive step by making easily operable the cap described in WO2015125123 .
In fact, the analysis on the force required to break the dispensing capsule has showed two strength peaks requested to the user, wherein the first, with a larger absolute value, is the one for starting the folding phase of the side walls, while the second peak corresponds to the capsule breaking when, obviously, once opened the capsule, the powder comes out with no further resistance.
In particular, the first strength peak is necessary for weakening the side walls, which at rest have a substantially vertical continuous curved profile, at a junction point between the lower portion, connected to the cap base and substantially vertical, and the upper portion, connected to the cap roof and slightly inclined or curved towards the roof.
Starting from this prior art, an object of the present invention is to provide an easily operated cap dispensing a substance in a container.
In accordance with the present invention, it is provided a vial comprising:

a container provided with a mouth for storing a first substance;
a breakable capsule storing a second substance;
a cap coupled to the mouth of the container and housing the capsule.

The cap comprises a base coupled to the container, a roof moving between a raised rest position, where the capsule is intact inside the cap, and a lowered position, causing the opening of the capsule and the release of the second substance in the first substance, and side walls connecting the base and the roof.
The side walls are configured so that during the lowering of the roof they do not penetrate inside the cap but are outwardly and laterally folded on themselves.
The side walls include a lower portion connected to the base and an upper portion connected to the roof.
According to the present invention, starting from this vial structure, even when the roof is raised, the lower portion of the side walls is inclined to the outside of the cap.
In this way, the force required for the early cap lowering steps is minimal, in particular smaller than when the lower portion is substantially vertical, as in the prior art. In fact, the lowering resistance of an inclined lower portion is much smaller than when a vertical force acts on a vertical component to fold it laterally.
Preferably, the lower portion is inclined with respect to the axis of the vial, defined by the axis of the container and of the cap, of an angle α ranging between 2° and 45°. In particular, when the roof is raised, the upper portion of the side walls is inclined towards the inside of the cap so that the lower and upper portions, or their ideal continuations, form an angle β smaller than 180° facing the inside of the cap.
In this way, the force required for the early cap lowering steps is further reduced, since also the upper portion is inclined to be folded on the lower portion. The junction between the walls can be sharp-edged or curved.
In particular, the upper portion of the side walls is longer than the lower portion.
In this way, the lowering stroke of the cap roof is increased.
In particular, the cap is made of plastic material and the inclinations of the lower and upper portions of the side walls are obtained by preliminarily lowering the roof with a disassembled cap on the container and in the absence of any capsule.
As previously stated, characteristic inclinations of the walls are defined by a process aiming to achieve them, this being the best obtainable definition.
In this way, the cap can be manufactured by moulding, by providing inclinations of the non-undercut portions of the walls, to be then preliminarily compressed to reach the requested starting configuration of the walls where the undercut is evident at the junction between the base and the lower portion of the walls.
In fact, the inclination of the lower portion and the counter-inclination of the upper portion would make the cap not manufacturable by moulding.
Moreover, this first lowering not only allows an easy manufacture of the cap by moulding, but also weakens, at least in part, the walls at the junction of the lower and upper portions, further reducing the force required for the subsequent compression. There is thus a kind of hinge, which can easily collapse, between the upper and the lower portions of the side walls.
This weakening also involves the junction points of the lower and upper portions to the cap base and to the cap roof.
In particular, the junction point between the lower and upper portions of the side walls is thinner than the rest of the side walls.
In this way, the aforesaid ideal hinge has an even lower resistance during the folding of the side walls.
In particular, the junction point between the lower and the upper portions of the side walls has a V-shaped recess facing the inside of the cap.
In this way, the aforesaid ideal hinge has an even lower resistance during the folding of the side walls.
In particular, the junction point between the lower portions of the side walls and the base is thinner than the rest of the side walls.
In this way, the aforesaid ideal lower hinge has an even lower resistance during the folding of the side walls.
Up to this point, the cap has been described for convenience and clarity's sake together with the container and the capsule forming the vial according to the present invention. However, the cap is an autonomous part of the present invention, even when it is not coupled to the container and even in the absence of the capsule.
Further characteristics and advantages of the present invention will become clear from the following description of a non-limiting embodiment, with reference to the figures of the accompanying drawings, in which:

Figure 1 is a schematic side view of the vial according to the present invention before its use;
Figure 2 is a schematic section view of the vial of Figure 1;
Figure 3 is a schematic section view of the vial of Figure 1 after its use; and
Figure 4 is an enlarged view of the detail IV of Figure 1.

The figures indicate with the reference number 1 an embodiment of a dispensing cap according to the present invention and with 10 a vial comprising such a dispensing cap.
Figure 1 shows a side view of an embodiment of a vial 1, for example of the single-dose disposable type, comprising:

a container 2 in the form of a small vial provided with a mouth 3, said container storing a first liquid substance 4;
a breakable capsule 5, storing a second substance 6, soluble or miscible in the first substance 4, the second substance 6 being preferably in the form of powder or tablet;
a cap 7 connected to the mouth 3 of the container 2 and housing the capsule 5.

As shown in Figure 2, the capsule 5 is dome-shaped 15 with a flat base 16, and the cap 7 is configured to contain and protect the dome 15, leaving the flat base 16 facing and resting on the mouth 3 of the container 2.
In particular, as shown in the enlargement of Figure 4, where the flat base 16 rests on the mouth 3 of the container 2, the cap comprises a flange 17 that fits into a raised edge 18 of the capsule 5.
The capsule 5 is made with materials suitable for the prolonged maintenance of the second substance 4 and the flat base 16 is configured, in a known way, for breaking, while the dome portion 15 is only subjected to deformation. As described above, the cap 7 wraps the capsule 15 and keeps it steady, with the base 16 facing the mouth 3 of the container 2. In particular, the cap 7 comprises a base portion 8 in the form of a coupling sleeve with the neck of the container. In the attached figures, the coupling is threaded, but it can also be of another type, for example a snap coupling.
A series of side walls 10 of the cap 7 go from the sleeve or base 8 to the outside of the container 2, in particular, upwardly with respect to the mouth 3. They converge into the roof 9 arranged above the capsule 5 and aligned with the mouth 3 of the container 2 along its vertical axis A. In fact, both the container 2 and the roof 9 have a circular section and shape in order to localize the axis A passing through its centre.
Such roof 9 has a substantially flat shape or has a small depression to facilitate the user during the use of the vial.
As for known dispensing caps, during the use the user must lower the cap 9 so that a punch 19 arranged below the roof 9, or in the absence of the punch 19 the cap 7, compresses the capsule 5 until tearing its base 16 and then dispensing the powder 6 in the liquid 4 in the container. Figure 3 schematically shows the arrangement of the lowered roof 9. Therefore, the roof 9 is movable under the manual action of a user between a raised rest position, where it contacts without compression the capsule 5, or is slightly spaced as shown in Figure 2, and a lowered operating position, where it progressively compresses the capsule 5 to a collapsed configuration.
As shown in Figure 3, the side walls 10 are configured in a known manner so that during the compression of the roof 9 against the capsule 5, they do not penetrate inside the cap 7 but are laterally folded on themselves.
As shown in Figure 1, the side walls are mutually spaced by a series of openings or windows. Advantageously, these windows show the type of internal capsule 5, which can be of a different colour depending on the case, or give a more accessible and recognizable indication of the expiry date. As shown in Figure 2 and in detail in Figure 4, the side walls 10 of the cap 7 comprise a lower portion 11 connected to the base 8 and an upper portion 12 connected to the roof 9.
Figure 4 shows an enlarged section of the cap 7 with the roof 9 in the raised rest position. In this configuration, the lower portion 11 of the side walls 10 is inclined towards the outside of the cap. In other words, the lower portion 11 of the side walls 10 is externally inclined upwards, namely towards the roof 9, so that the junction point 14 with the base 8 is in the innermost position of the cap 7 with respect to the junction point 13 with its upper portion 12.
Ideally considering the upper portion 12 as a connecting rod, the junction point 14 to the base is the lower hinge, while the junction point 13 to the upper portion 12 acts as the middle hinge. Figure 4 shows the angle α that the first portion 11 forms with the vertical or parallel to the axis A.
Analogously, although with an opposite inclination, also the upper portion 12 of the side walls 10 is inclined towards the inside of the cap 7 until joining the roof 9 of the cap 7. Also the upper portion 12 forms a kind of connecting rod with the upper hinge 20 at the roof 9.
As shown in Figure 4, the middle hinge 13 is more external than the lower hinge 14 and the upper hinge 20. In this configuration, the side walls 10 form a kind of bellows structure, partially folded even before starting to press on the roof 9, where therefore the lower and upper portions 11 and 12, or their ideal continuations, form an angle β smaller than 180° facing the inside of the cap 7. This angle can be sharp-edged or can have a junction.
The aforesaid configuration of the particular inclinations of the upper and lower portions 12 and 11 of the side walls 10 is obtained thanks to the fact that a first compression of the roof 9, or at least a partial lowering of the roof 9, occurs with the cap 7 not assembled on the container 2 and in the absence of the capsule 5, starting from a configuration of the upper and lower portions 12 and 11 substantially vertical or, in any case, aligned in the absence of intermediate angles.
Since the cap is made by moulding of plastic material, the preliminarily deformed walls 10 to be folded on themselves maintain an already partially folded configuration that greatly reduces the force required to proceed then to the actual use of the vial 1.
Taking into account that this first preliminary lowering of the roof 9 with a disassembled cap 7 is automated during the final manufacturing steps of the cap 7, the final user obtains a cap 7 whose actuation is extremely facilitated. This preliminary compression not only partially folds the lower and the upper portions 11 and 12, thus facilitating the use of the vial, but also weakens the aforesaid hinges 13, 14, 20, with a consequent reduction of the effort required to carry out a new compression.
Finally, in the example of Figure 4, the point 13 joining the lower and upper portions 11 and 12, or middle hinge, is thinner than the rest of the wall 10 and has a V-shaped recess facing the inside of the cap 7 to facilitate any further folding.
Analogously, the lower hinge 14, or junction point of the lower portion 11 and of the base 8, and/or also the upper hinge 20, has a straight section with respect to the side walls 10, which helps in folding.
It is clear that the here described dispensing cap and relative single-dose vial may be modified and varied without departing from the scope of the appended claims.

Claims

A dispensing cap (7) configured to be coupled to the mouth (3) of a
container (2) storing a first substance (4) and configured to house a capsule (5) storing a second substance (6) ; the cap (7) comprising:
- a base (8) to be coupled to the container (2);

- a roof (9) movable between a raised rest position and a lowered dispensing position;

- side walls (10) connecting the base (8) and the roof (9), configured so that during the lowering of the roof (9) they do not penetrate inside the cap (7) but are laterally folded on themselves;
wherein the side walls (10) comprise a lower portion (11) connected to the base (8) and an upper portion (12) connected to the roof (9);
characterized in that
when the roof (9) is raised, the lower portion (11) of the side walls (10) is inclined (α) towards the outside of the cap (7) in a direction from the base (8) to the upper portion (12).
Cap according to claim 1, wherein when the roof (9) is raised, the upper portion (12) of the side walls (10) is inclined towards the inside of
the cap (7) in a direction from the lower portion (11) to the roof (9) so that the lower (11) and upper (12) portions, or their ideal continuations,
form an angle (β) smaller than 180° facing the inside of the cap (7).
Cap according to claim 2, wherein the lower portion (11) is shorter than the upper portion (12).
Cap according to any one of the preceding claims 1 to 3, wherein the junction point (13) of the lower (11) and upper (12) portions of the side walls is thinner than the rest of the side walls (10).
Cap according to any one of the preceding claims 1 to 4, wherein the junction point (13) of the lower (11) and upper (12) portions of the side walls (10) has a V-shaped recess facing the inside of the cap.
Cap according to any one of the preceding claims 1 to 5, wherein the junction point (14) of the lower portions (11) of the side walls (10) with the base (8) is thinner than the rest of the side walls (10).
A vial (1) comprising:
- a container (2) for storing a first substance (4) provided with a mouth (3);

- a breakable capsule (5) for storing a second substance(6);

- a cap (7) according to any one of the foregoing claims coupled to the mouth (3) of the container (2) and housing the capsule (5).
A method for assembly a vial (1), the method comprising the steps of:
a) providing a container (2) for storing a first substance (4) provided with a mouth (3);

b) providing a breakable capsule (5) for storing a second substance(6);

c) providing a cap (7) according to any one of the foregoing claims from 2 to 6;

d) preliminarily lowering the roof (9) of the cap (7), so as to obtain the inclinations of the lower portion (11) and the upper portion (12), the cap (7) being disassembled to the container (2) and in the absence of the capsule (5)

e) housing a capsule (5) in the cap (7)

f) coupling the cap (7) with the capsule (5) to the mouth (3) of a container (2).