WO2022118124A1

WO2022118124A1 - Disposable container for fluid products with childproof tamper-evident means

Info

Publication number: WO2022118124A1
Application number: PCT/IB2021/060607
Authority: WO
Inventors: Bruno Rossi
Original assignee: Bisio Progetti S.P.A.
Priority date: 2020-12-01
Filing date: 2021-11-16
Publication date: 2022-06-09
Also published as: IT202000029300A1; US20230415966A1; EP4255816A1

Abstract

A single-use container (1) for fluid products, particularly pharmaceutical, cosmetic, medical or similar products, according to the present invention comprises a containment body (10) closed by a closing means (20) removable along a predetermined breaking line (22), and an opening key (30) slidingly fitted onto the closing means (20) and prismatically rotationally engageable therewith to remove it from the containment body (10). The container (1) is characterized in that it comprises child-proof anti-tampering means in the form of axial counterthrust means. When an axial compression force acts on the opening key (30), said means are activated, thus generating an axial counterthrust upwards in the direction of the prismatic decoupling between the opening key (30) and the closing means (20).

Description

DESCRIPTION

DISPOSABLECONTAINER FOR FLUID PRODUCTSWITH CHILDPROOFTAMPER-EVIDENT MEANS

[0001]The present invention relates to a single-use container for fluid products, such as for example pharmaceutical, medicinal or cosmetic products, usually made by injection molding of polymeric material.

[0002]In particular, the present invention relates to a single-use container provided with anti-tampering means against accidental opening, even "child-proof".

[0003]There are known containers in the field that are used to package one or more doses of fluid products in paste, gel, or liquid form; depending on the number of doses, they may be single-use or multiple-use containers, and therefore reclosable.

[0004]In the field of pharmaceutical products, single-use containers 1' are known, shown for example in Figure 1, comprising a body 10 for containing a predetermined dose of product, provided with a neck 11 ending in a dispensing mouth 12. Such dispensing mouth is closed by closing means 20 which may be removed by the user at the time of use. In single-use containers, the closing means is made in one piece with the containment body in the molding step, connected to it by means of a predetermined breaking zone. In other words, the containment body and the closing means are made in a single monolithic piece so that the dispensing mouth of the container is initially closed and may be opened by tear-off removal of the closing means from the containment body.

[0005]In order to allow the gripping and removal of the closing means, the single-use container is provided with a gripping key 30 of various shapes, which allows the rotation of the closing means with respect to the containment body so as to tear the predetermined breaking zone.

[0006]These containers may be produced in single units or be associated with each other in series (strips); in the latter case, the containment bodies of two containers side by side are temporarily associated by means of flaps 14 protruding laterally and provided with predefined breaking lines 15.

[0007]The known single-use containers have some drawbacks.

[0008]It should be noted that in the absence of a medical prescription, the intake of certain products (for example medicinal or pharmaceutical products) may be dangerous and therefore the need has arisen to design single-use containers provided with anti-tampering, even child-proof means. In fact, it is evident that in known containers even a child, after a few attempts, is able to tear off the closing means by acting on the gripping key and access the contents. US 2005/045579 Al describes a single-use container with child-proof cap whose end edge is interrupted by notches which generate a plurality of flaps.

[0009]Furthermore, known single-use containers do not always guarantee the sterility of the product in the dispensing step since the gripping key does not guarantee complete coverage of the annular edge of the neck which defines the dispensing mouth, as shown in Figure 1. It should be noted that this annular edge is an essential element in order to be able to deliver calibrated drops of product. However, during dispensing, the drop of product comes into contact with the outer surface of the container, precisely at the annular edge of the neck. During use, the user opens the container using the gripping key, which is located immediately above the dispensing mouth. In carrying out this operation, the user's fingers inevitably end up coming into contact with the annular edge of the container neck, thus risking contaminating it. Consequently, even the calibrated drops of product risk being contaminated by microbes and bacteria.

[0010]The sector therefore feels the need to have a single-use container, particularly for pharmaceutical products, which is tamper-proof even for a child, and which limits the contamination of the product during the use step.

[0011]The object of the present invention is to provide a single-use container for pharmaceutical products which solves the problems of the prior art taking into account the needs of the field.

[0012]In particular, the object of the present invention is to provide a single-use container for fluid pharmaceutical products which is provided with antitampering, even child-proof means, as well as anticontamination means for the product during the use step.

[0013]Furthermore, the object of the present invention is to provide a single-dose container for fluid pharmaceutical products which may be used in a practical, easy and functional manner, which has particularly compact and limited overall dimensions.

[0014]This object is achieved by a single-use container for fluid pharmaceutical products according to claim 1, and by a strip of containers according to claim 11. The dependent claims describe preferred embodiments of the invention.

[0015]The features and advantages of the container according to the present invention will appear more clearly from the following description, made by way of an indicative and non-limiting example with reference to the accompanying figures, in which:

[0016]- Figure 1 shows a front view of a series of singleuse containers of the prior art;

[0017]- Figure 2A shows a sectional view of a container according to an embodiment variant of the present invention, in a safety configuration of the child-proof lever;

[0018]- Figure 2B shows an enlargement of a detail of Figure 2A;

[0019]- Figure 3A shows a sectional view of the container of Figure 2A, in a configuration for operating the lever for opening the container;

[0020]- Figure 3B shows an enlargement of a detail of Figure 3A;

[0021]- Figure 4A shows an axonometric view of a container according to a further embodiment variant of the present invention, in a safety configuration of the child-proof lever;

[0022]- Figure 4B shows an axonometric view of the container of Figure 4A, in a configuration for operating the lever for opening the container;

[0023]- Figure 5A shows a sectional view of a container according to an even further embodiment variant of the present invention, in a safety configuration of the child-proof lever; [0024]- Figure 5B shows an enlargement of a detail of

Figure 5A;

[0025]- Figure 6A shows a sectional view of the container of Figure 5A, in a configuration for operating the lever for opening the container;

[0026]- Figure 6B shows an enlargement of a detail of Figure 6A;

[0027]- Figure 7A shows a sectional view of the container according to the present invention, in a prismatic coupling configuration of the opening lever on the containment body;

[0028]- Figure 7B shows an enlargement of a detail of Figure 7A.

[0029]With reference to the accompanying figures, the reference numeral 1 shows a single-dose container for packaging one or more doses of fluid, liquid or paste products, particularly for medical, pharmaceutical, cosmetic, food or similar products.

[0030]The term "fluid products" does not mean only liquid products but also viscous products, for example in the paste and gel state, and powdered products, in particular very fine powders with great flowability.

[0031]The container 1 is made of polymeric material, for example of polyethylene or polypropylene by means of forming techniques such as injection molding. In a different example, the container 1 is made using the blowing technique which allows multilayer walls to be obtained in polymeric materials (of the type of polyethylene and/or polypropylene) and/or barrier materials (LDPE, HDPE, LLDPE, EVOH).

[0032]The container 1 according to the present invention is of the single-use type, that is, it may not be closed again.

[0033]The container 1 comprises a containment body 10, hollow internally, adapted to house a predetermined dose of product.

[0034]Preferably, the containment body 10 is provided with a pair of flaps 14 adapted to facilitate the gripping of the container 1 by a user. The flaps 14 extend, diametrically opposite to each other, from the outer lateral surface of the containment body 10.

[0035]It should be noted that the container 1 may be produced in single units or in series to form a strip. In the latter case, each flap 14 is removably associated, by means of a weakened zone 15, to a flap 14 of one or more adjacent containers, so as to form a monolithic strip, i.e. in a single piece. The weakened zones 15 may be easily torn by the user to separate one container from the other.

[0036]The containment body 10, of substantially tubular and elongated conformation, extends along a longitudinal axis X and has an end provided with a substantially cylindrical neck 11, at the top of which a product dispensing mouth 12 is defined.

[0037]The containment body 10 comprises a shoulder 111, substantially frusto-conical, which connects the neck 11 to a central portion 112. The shoulder 111 has a greater diameter than the neck 11. In particular, the shoulder 111 joins the diameter of the neck 11 to the diameter of the central portion 112 of the containment body 10.

[0038]The opposite end of the containment body 10 is provided with an opening adapted to introduce the product, which is closed after filling (for example by welding) to form a bottom 13.

[0039]The container 1 comprises a closing means 20 for the occlusion of the dispensing mouth 12, removably associated with the containment body 10 at the neck 11.

[0040]The closing means 20 is made in a monolithic body together with the containment body 10 and, in an initial configuration, is joined thereto along a predetermined breaking line 22. In other words, the containment body 10 and the closing means 20 are made in a single monolithic piece so that the dispensing mouth 12 of the container 1 is initially closed and may be opened by tear-off removal of the closing means 20. The closing means 20 may be separated from the containment body 10 in an opening configuration in which the dispensing mouth 12 through which the fluid product may be dispensed is formed on the body 10, at the predetermined breaking line 22.

[0041]The closing means 20, preferably cylindrical, comprises a lower portion 21 joined to the containment body 10 by means of the predetermined breaking line 22, and an upper portion 23 which may be prismatically associated with an opening key 30 for removing the closing means 20 itself from the containment body 10.

[0042]The container 1 comprises an opening key 30 which allows the gripping and rotation of the closing means 20 with respect to the containment body 10, so as to tear the predetermined breaking zone 22.

[0043]The opening key 30 comprises a gripping portion 31 and a portion 32 for the connection with the closing means 20.

[0044]The gripping portion 31 is substantially plate-like to facilitate gripping and rotation thereof.

[0045]The connection portion 32, preferably cylindrical, defines an inner seat 33, also preferably cylindrical, in which the closing means 20 is completely inserted.

[0046]Advantageously, the connection portion 32 extends beyond the closing means 20, beyond the predetermined breaking line 22, until it at least partially covers the neck 11 of the containment body 10.

[0047]Advantageously, a connection portion 32 which extends to cover the predetermined breaking line 22 avoids involuntary and unwanted tearing of this zone before the effective use of the fluid product even in the event of accidental and involuntary collisions, thus improving the integrity of the product.

[0048]Advantageously, a connection portion 32 which extends to cover the neck portion 11 which defines the dispensing mouth 12 prevents the user's fingers from coming into contact with the zone dedicated to the formation of the calibrated drop of product, thus limiting any risk of contamination of the drop itself in the dispensing step.

[0049]Advantageously, a connection portion 32 which extends to at least partially cover the neck 11 of the containment body 10 helps to keep the opening key 30 in position in the initial configuration (Figure 2A).

[0050]The opening key 30 is made separately from the containment body 10, and in the initial configuration shown in Figure 2A, 4A and 5A, it is already coupled to the closing means 20 by means of an axial constraint which allows the opening key 30 to rotate freely around the closing means 20 but to not be axially removed therefrom . [0051]As shown in the detail of Figures 2B and 5B, the closing means 20 comprises an axial stop 24, for example a radial ring externally protruding between the lower portion 21 and the upper portion 23. The opening key 30 comprises a corresponding axial stop 35, for example a radial ring protruding inside the seat 33 of the lower portion 33.

[0052]The opening key 30, in the coupling configuration shown in Figure 3A, 4B, 6A and 7A, is prismatically associated to the closing means 20 to lever it and tear it off from the containment body 10 and thus obtain the opening configuration of the container 1.

[0053]The opening key 30 therefore comprises a prismatic coupling seat 33 and the closing means 20 has an upper portion 23 substantially shaped to mate with this seat 33. The seat 33 of the opening key 30 is such as to constrain the closing means 20 in rotation around the axis X.

[0054]As stated above, the opening key 30, in the initial configuration, is already connected to the closing means 20 by means of an axial constraint which allows the opening key 30 to rotate freely around the closing means 20 (without prismatic coupling) but to not be axially removed therefrom.

[0055]To open each container 1 it is therefore necessary to push the opening key 30 downwards so as to achieve the prismatic coupling between the closing means 20 and the opening key 30. Only when the upper portion 23 of the closing means 20 is inserted matingly into the seat 33 of the opening key 30 the prismatic coupling is realized to constrain the closing means 20 to the opening key 30 in rotation around the axis X. Only in the coupling configuration, shown in Figure 7B, the opening key 30 rotates the locking means 20 around the axis X to tear the predetermined breaking line 22.

[0056]Advantageously, the single-dose container 1 according to the present invention is provided with antitampering means in the form of axial counterthrust means for the prismatic uncoupling between the opening key 30 and the closing means 20 in the absence of a downward pressure force, making the container 1 child-proof.

[0057]Preferably, the axial counterthrust means are a mechanical spring (as in the examples of Figures 2A to 4B) or a pneumatic spring (as in the example of Figures 5A to 6B).

[0058]In one embodiment, the axial counterthrust means for decoupling are a mechanical spring (Figures 2A to 4B) [0059]In this example, the axial counterthrust means are arranged between the connection portion 32 of the opening key 30 and the shoulder 111 of the containment body 10. [0060]In particular, in the initial configuration of the single-dose container 1 (Figures 2A and 4A), the connection portion 32 extends up to the beginning of the shoulder 111. As shown in Figure 2B, therefore, the end edge 321 of the connection portion 32 is arranged at the beginning of the frusto-conical portion of the containment body 1. By applying a downward pressure force, as occurs to activate the coupling configuration shown in Figure 3A, the opening key 30 is pushed downwards and with it the connection portion 32 which advances along the containment body 10. The end edge 321 of the connection portion 32, meeting the shoulder 111 having a greater diameter than the neck 11, is elastically deformed. Such deformation generates an upward thrust force in the direction of the prismatic decoupling between the opening key 30 and the closing means 20. Therefore, the end edge 321 of the connection portion 32 engaging with the shoulder 111 forms the thrust means for the prismatic decoupling.

[0061]In the embodiment example of Figures 2A and 3A, the end edge 321 of the connection portion 32 is cylindrical, uniform and free from interruptions. This solution is well suited to flexible materials such as polyethylene (PE). In this embodiment example, the entire end edge 321 is deformed, with a flaring outwards, thus realizing the thrust means for the prismatic decoupling.

[0062]In the embodiment of Figure 4A, the end edge 321 of the connection portion 32 is interrupted by notches 322 which generate a plurality of flaps 323. For example, the end edge 321 comprises from 4 to 8 flaps. This solution is well suited to more rigid materials such as polypropylene (PP). In this embodiment example, the flaps 323 are deformed, opening outwards, thus realizing the thrust means for the prismatic decoupling.

[0063]In one embodiment, the axial counterthrust means for decoupling are a pneumatic spring (Figures 5A to 6B).

[0064]In this example, the axial counterthrust means are arranged inside the connection portion 32, and are associated with the opening key 30 or with the containment body 10.

[0065]In particular, in the initial configuration of the single-dose container 1 (Figure 5A), the inner wall of the connection portion 32 of the opening key 30, or the outer surface of the closing means 20 or of the neck 11 of the containment body 10, is provided with a flexible sealing lip 324, protruding radially. This lip 324, in contact with the opposite surface (be it the inner wall of the connection portion 32 or the outer surface of the closing means 20 or of the neck 11) forms an air chamber 325 inside the connection portion 32 of the opening key 30. By applying a downward pressure force, as occurs to activate the coupling configuration shown in Figure 6A, the opening key 30 is pushed downwards, thus compressing the air contained in the air chamber 325. Such compression generates an upward thrust force in the direction of the prismatic decoupling between the opening key 30 and the closing means 20. Therefore, the sealing lip 324 forms an air chamber 325 which forms the thrust means for the prismatic decoupling. The flexible sealing lip 324 is annular, uniform and free from interruptions. This solution is well suited to flexible materials such as polyethylene (PE). In this embodiment example, the air chamber 325 is compressed to form the thrust means for the prismatic decoupling.

[0066]Advantageously, by virtue of the presence of the anti-tampering means described above, it is necessary to maintain a downward pressure force and at the same time rotate the opening key 30 around the longitudinal axis of the container 1 to tear the predetermined breaking zone 22, obtaining the separation of the closing means 20 from the body 10, allowing the fluid product to escape. Therefore, a combined action (pushing plus rotation) is required to obtain the opening of the container. This need configures the container as "child-resistant".

[0067]The object of the present invention is therefore a container 1 for fluid products, particularly pharmaceutical, cosmetic, medical or similar products, comprising the anti-tampering means described above.

[0068]The object of the present invention is also a monolithic strip of containers for fluid products, particularly pharmaceutical, cosmetic, medical or similar products, comprising the anti-tampering means described above. In one example, the strip comprises five containers 1, as in Figure 1.

[0069]Innovatively, a container according to the present invention has a child-proof opening system.

[0070]Advantageously, a container according to the present invention allows the drawbacks of known containers to be overcome in a simple, rational, easy and effective manner and at a low cost.

[0071]It is understood that a person skilled in the art could make modifications to the product described above, all of which are contained within the scope of protection as defined by the following claims.

Claims

1. A single-use container (1) for fluid products, comprising :

- a containment body (10) for a fluid product, provided with a neck (11) ending in a dispensing mouth (12), and with a shoulder (111) arranged below the neck (11) and having a greater diameter than said neck (11);

- a closing means (20) which in an initial configuration is joined to said containment body (10) along a predetermined breaking line (22) to close the dispensing mouth (12) and in an opening configuration, obtained by tearing said predetermined breaking line (22), is separated from said containment body (10) to open said dispensing mouth (12);

- an opening key (30) which in the initial configuration is slidingly fitted onto the closing means (20) and is rotationally released therefrom and in a working configuration is prismatically rotationally engaged with said closing means (20) to put pressure thereon and remove it from said containment body (10) to obtain the opening configuration; said opening key (30) comprising a gripping portion (31) and a portion (32) for the connection with an end edge (321), wherein in the initial configuration the connection portion (32) extends up to the beginning of the shoulder (111); - at least one axial counterthrust means for the prismatic decoupling between the opening key (30) and the closing means (20), activated by an axial compression force acting on the opening key (30); characterized in that the end edge (321) of the connection portion (32) is cylindrical, uniform and free from interruptions, and is the axial counterthrust means which, when it meets the shoulder (111) of the containment body (10), due to an axial compression force acting on the opening key (30), it deforms elastically, thus generating an upward thrust force in the direction of the prismatic decoupling between the opening key (30) and the closing means (20).

2. A single-use container (1) according to any one of the preceding claims, wherein in the initial configuration the connection portion (32) of the opening key (30) completely covers the locking means (20) and the predetermined breaking line (22).

3. A single-use container (1) according to any one of the preceding claims, provided with a pair of flaps (14) protruding from the outer lateral surface of the containment body (10).

4. A monolithic strip of containers for fluid products, comprising a plurality of single-use containers (1) according to claim 3, wherein each flap (14) is removably associated, by means of a weakened zone (15), with a flap (14) of one or more adjacent vials.

5. A single-use container (1) for fluid products, comprising :

- a containment body (10) for a fluid product, provided with a neck (11) ending in a mouth (12) for dispensing said product;

- an opening key (30) which in the initial configuration is slidingly fitted onto the closing means (20) and is rotationally released therefrom and in a working configuration is prismatically rotationally engaged with said closing means (20) to put pressure thereon and remove it from the containment body (10) to obtain the opening configuration; said opening key (30) comprising a gripping portion (31) and a connection portion (32);

- at least one axial counterthrust means for the prismatic decoupling between the opening key (30) and the closing means (20), activated by an axial compression force acting on the opening key (30); characterized in that said axial counterthrust means is a flexible lip (324), arranged on an inner wall of the connection portion (32) of the opening key (30), or on an outer surface of the closing means (20) or of the neck (11) of the containment body (10), said flexible lip

(324), in contact with an opposite surface, defines an air chamber (325) inside the connection portion (32) of the opening key (30) and, due to an axial compression force acting on the opening key (30), said air chamber

(325) is compressed, thus generating an upward thrust force in the direction of the prismatic decoupling between the opening key (30) and the closing means (20).

6. A single-use container (1) according to claim 5, wherein in the initial configuration the connection portion (32) of the opening key (30) completely covers the locking means (20) and the predetermined breaking line (22).

7. A single-use container (1) according to claim 5 or 6, provided with a pair of flaps (14) protruding from the outer lateral surface of the containment body (10).

8. A monolithic strip of containers for fluid products, comprising a plurality of single-use containers (1) according to claim 7, wherein each flap (14) is removably associated, by means of a weakened zone (15), with a flap (14) of one or more adjacent vials.