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

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.

In the field of pharmaceutical products, single-use containers <NUM>' are known, shown for example in <FIG>, comprising a body <NUM> for containing a predetermined dose of product, provided with a neck <NUM> ending in a dispensing mouth <NUM>. Such dispensing mouth is closed by closing means <NUM> 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.

In order to allow the gripping and removal of the closing means, the single-use container is provided with a gripping key <NUM> 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.

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 <NUM> protruding laterally and provided with predefined breaking lines <NUM>.

The known single-use containers have some drawbacks.

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. <CIT>, describes a single-use container according to the preambles of claims <NUM> and <NUM>, with a child-proof cap whose end edge is interrupted by notches which generate a plurality of flaps.

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 <FIG>. 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. Example of prior art documents are <CIT> which discloses an hermetically sealed container with child safety overcap, and <CIT> which discloses a method for the manufacture of vials for fluid products, particularly for medical, pharmaceutical, cosmetic, food products or the like.

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.

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.

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

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.

This object is achieved by a single-use container for fluid pharmaceutical products according to claims <NUM> and <NUM>, and by a strip of said containers according to claims <NUM> and <NUM>. The dependent claims describe preferred embodiments of the invention.

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:.

With reference to the accompanying figures, the reference numeral <NUM> 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.

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.

The container <NUM> 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 <NUM> 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).

The container <NUM> according to the present invention is of the single-use type, that is, it may not be closed again.

The container <NUM> comprises a containment body <NUM>, hollow internally, adapted to house a predetermined dose of product.

Preferably, the containment body <NUM> is provided with a pair of flaps <NUM> adapted to facilitate the gripping of the container <NUM> by a user. The flaps <NUM> extend, diametrically opposite to each other, from the outer lateral surface of the containment body <NUM>.

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

The containment body <NUM>, of substantially tubular and elongated conformation, extends along a longitudinal axis X and has an end provided with a substantially cylindrical neck <NUM>, at the top of which a product dispensing mouth <NUM> is defined.

The containment body <NUM> comprises a shoulder <NUM>, substantially frusto-conical, which connects the neck <NUM> to a central portion <NUM>. The shoulder <NUM> has a greater diameter than the neck <NUM>. In particular, the shoulder <NUM> joins the diameter of the neck <NUM> to the diameter of the central portion <NUM> of the containment body <NUM>.

The opposite end of the containment body <NUM> is provided with an opening adapted to introduce the product, which is closed after filling (for example by welding) to form a bottom <NUM>.

The container <NUM> comprises a closing means <NUM> for the occlusion of the dispensing mouth <NUM>, removably associated with the containment body <NUM> at the neck <NUM>.

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

The closing means <NUM>, preferably cylindrical, comprises a lower portion <NUM> joined to the containment body <NUM> by means of the predetermined breaking line <NUM>, and an upper portion <NUM> which may be prismatically associated with an opening key <NUM> for removing the closing means <NUM> itself from the containment body <NUM>.

The container <NUM> comprises an opening key <NUM> which allows the gripping and rotation of the closing means <NUM> with respect to the containment body <NUM>, so as to tear the predetermined breaking zone <NUM>.

The opening key <NUM> comprises a gripping portion <NUM> and a portion <NUM> for the connection with the closing means <NUM>.

The gripping portion <NUM> is substantially plate-like to facilitate gripping and rotation thereof.

The connection portion <NUM>, preferably cylindrical, defines an inner seat <NUM>, also preferably cylindrical, in which the closing means <NUM> is completely inserted.

Advantageously, the connection portion <NUM> extends beyond the closing means <NUM>, beyond the predetermined breaking line <NUM>, until it at least partially covers the neck <NUM> of the containment body <NUM>.

Advantageously, a connection portion <NUM> which extends to cover the predetermined breaking line <NUM> 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.

Advantageously, a connection portion <NUM> which extends to cover the neck portion <NUM> which defines the dispensing mouth <NUM> 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.

Advantageously, a connection portion <NUM> which extends to at least partially cover the neck <NUM> of the containment body <NUM> helps to keep the opening key <NUM> in position in the initial configuration (<FIG>).

The opening key <NUM> is made separately from the containment body <NUM>, and in the initial configuration shown in <FIG>, <FIG> and <FIG>, it is already coupled to the closing means <NUM> by means of an axial constraint which allows the opening key <NUM> to rotate freely around the closing means <NUM> but to not be axially removed therefrom.

As shown in the detail of <FIG> and <FIG>, the closing means <NUM> comprises an axial stop <NUM>, for example a radial ring externally protruding between the lower portion <NUM> and the upper portion <NUM>. The opening key <NUM> comprises a corresponding axial stop <NUM>, for example a radial ring protruding inside the seat <NUM> of the lower portion <NUM>.

The opening key <NUM>, in the coupling configuration shown in <FIG>, <FIG>, <FIG> and <FIG>, is prismatically associated to the closing means <NUM> to lever it and tear it off from the containment body <NUM> and thus obtain the opening configuration of the container <NUM>.

The opening key <NUM> therefore comprises a prismatic coupling seat <NUM> and the closing means <NUM> has an upper portion <NUM> substantially shaped to mate with this seat <NUM>. The seat <NUM> of the opening key <NUM> is such as to constrain the closing means <NUM> in rotation around the axis X.

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

To open each container <NUM> it is therefore necessary to push the opening key <NUM> downwards so as to achieve the prismatic coupling between the closing means <NUM> and the opening key <NUM>. Only when the upper portion <NUM> of the closing means <NUM> is inserted matingly into the seat <NUM> of the opening key <NUM> the prismatic coupling is realized to constrain the closing means <NUM> to the opening key <NUM> in rotation around the axis X. Only in the coupling configuration, shown in <FIG>, the opening key <NUM> rotates the closing means <NUM> around the axis X to tear the predetermined breaking line <NUM>.

Advantageously, the single-dose container <NUM> according to the present invention is provided with anti-tampering means in the form of axial counterthrust means for the prismatic uncoupling between the opening key <NUM> and the closing means <NUM> in the absence of a downward pressure force, making the container <NUM> child-proof.

Preferably, the axial counterthrust means are a mechanical spring (as in the examples of <FIG>) or a pneumatic spring (as in the example of <FIG>).

In one embodiment, the axial counterthrust means for decoupling are a mechanical spring (<FIG>).

In this example, the axial counterthrust means are arranged between the connection portion <NUM> of the opening key <NUM> and the shoulder <NUM> of the containment body <NUM>.

In particular, in the initial configuration of the single-dose container <NUM> (<FIG>), the connection portion <NUM> extends up to the beginning of the shoulder <NUM>. As shown in <FIG>, therefore, the end edge <NUM> of the connection portion <NUM> is arranged at the beginning of the frusto-conical portion of the containment body <NUM>. By applying a downward pressure force, as occurs to activate the coupling configuration shown in <FIG>, the opening key <NUM> is pushed downwards and with it the connection portion <NUM> which advances along the containment body <NUM>. The end edge <NUM> of the connection portion <NUM>, meeting the shoulder <NUM> having a greater diameter than the neck <NUM>, is elastically deformed. Such deformation generates an upward thrust force in the direction of the prismatic decoupling between the opening key <NUM> and the closing means <NUM>. Therefore, the end edge <NUM> of the connection portion <NUM> engaging with the shoulder <NUM> forms the thrust means for the prismatic decoupling.

In the embodiment example of <FIG> and <FIG>, the end edge <NUM> of the connection portion <NUM> 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 <NUM> is deformed, with a flaring outwards, thus realizing the thrust means for the prismatic decoupling.

In the embodiment of <FIG> which is not part of the present invention, the end edge <NUM> of the connection portion <NUM> is interrupted by notches <NUM> which generate a plurality of flaps <NUM>. For example, the end edge <NUM> comprises from <NUM> to <NUM> flaps. This solution is well suited to more rigid materials such as polypropylene (PP). In this embodiment example, the flaps <NUM> are deformed, opening outwards, thus realizing the thrust means for the prismatic decoupling.

In one embodiment, the axial counterthrust means for decoupling are a pneumatic spring (<FIG>).

In this example, the axial counterthrust means are arranged inside the connection portion <NUM>, and are associated with the opening key <NUM> or with the containment body <NUM>.

In particular, in the initial configuration of the single-dose container <NUM> (<FIG>), the inner wall of the connection portion <NUM> of the opening key <NUM>, or the outer surface of the closing means <NUM> or of the neck <NUM> of the containment body <NUM>, is provided with a flexible sealing lip <NUM>, protruding radially. This lip <NUM>, in contact with the opposite surface (be it the inner wall of the connection portion <NUM> or the outer surface of the closing means <NUM> or of the neck <NUM>) forms an air chamber <NUM> inside the connection portion <NUM> of the opening key <NUM>. By applying a downward pressure force, as occurs to activate the coupling configuration shown in <FIG>, the opening key <NUM> is pushed downwards, thus compressing the air contained in the air chamber <NUM>. Such compression generates an upward thrust force in the direction of the prismatic decoupling between the opening key <NUM> and the closing means <NUM>. Therefore, the sealing lip <NUM> forms an air chamber <NUM> which forms the thrust means for the prismatic decoupling. The flexible sealing lip <NUM> 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 <NUM> is compressed to form the thrust means for the prismatic decoupling.

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 <NUM> around the longitudinal axis of the container <NUM> to tear the predetermined breaking zone <NUM>, obtaining the separation of the closing means <NUM> from the body <NUM>, 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".

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

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 <NUM>, as in <FIG>.

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

Claim 1:
A single-use container (<NUM>) for fluid products, comprising:
- a containment body (<NUM>) for a fluid product, provided with a neck (<NUM>) ending in a dispensing mouth (<NUM>), and with a shoulder (<NUM>) arranged below the neck (<NUM>) and having a greater diameter than said neck (<NUM>);
- a closing means (<NUM>) which in an initial configuration is joined to said containment body (<NUM>) along a predetermined breaking line (<NUM>) to close the dispensing mouth (<NUM>) and in an opening configuration, obtained by tearing said predetermined breaking line (<NUM>), is separated from said containment body (<NUM>) to open said dispensing mouth (<NUM>);
- an opening key (<NUM>) which in the initial configuration is slidingly fitted onto the closing means (<NUM>) and is rotationally disconnected therefrom and in a working configuration is prismatically rotationally engaged with said closing means (<NUM>) to put pressure thereon and remove the closing means (<NUM>) from said containment body (<NUM>) to obtain the opening configuration; said opening key (<NUM>) comprising a gripping portion (<NUM>) and a connection portion (<NUM>) having an end edge (<NUM>), wherein in the initial configuration the connection portion (<NUM>) extends up to the beginning of the shoulder (<NUM>), and wherein , when the end edge (<NUM>) meets the shoulder (<NUM>) of the containment body (<NUM>), due to an axial compression force acting on the opening key (<NUM>), it deforms elastically, thus generating an upward thrust force in the direction of the prismatic decoupling between the opening key (<NUM>) and the closing means (<NUM>);
- at least one axial counterthrust means for the prismatic decoupling between the opening key (<NUM>) and the closing means (<NUM>), activated by an axial compression force acting on the opening key (<NUM>), wherein the end edge (<NUM>) is the axial counterthrust means; characterized in that the end edge (<NUM>) of the connection portion (<NUM>) is cylindrical, uniform and free from interruptions.