WO2009144553A1

WO2009144553A1 - Bottle for containing injectable fluids, particularly medical, pharmaceutical, cosmetic products or the like

Info

Publication number: WO2009144553A1
Application number: PCT/IB2009/005634
Authority: WO
Inventors: Antonio Fontana
Original assignee: Lameplast SRL
Current assignee: Lameplast SRL
Priority date: 2008-05-27
Filing date: 2009-05-18
Publication date: 2009-12-03
Anticipated expiration: 2010-11-27
Also published as: ITMO20080160A1; EP2303716A1; EP2303716B1; ES2391068T3

Abstract

The bottle for containing injectable fluids, particularly medical, pharmaceutical, cosmetic products or the like, comprises a containment container (2) of an injectable fluid (3) having an access mouth (7), a closing element (8) that is at least partially inserted in the access mouth (7) and which has an area in penetrable material suitable for being crossed by an extracting element for the injectable fluid, and a protection plug (10) for protecting the closing element (8), which plug (10) comprises a cap (11) that can be placed to at least partially cover the closing element (8) and which has an opening for accessing the area in penetrable material, and a cover (16) that is associated with the cap (11) by interposition of rotation means (17) around a swinging axis and which supports a shutter element (18) that can be fitted sealed in the opening.

Description

BOTTLE FOR CONTAINING INJECTABLE FLUIDS, PARTICULARLY MEDICAL, PHARMACEUTICAL, COSMETIC PRODUCTS OR THE LIKE

Technical Field The present invention relates to a bottle for containing injectable fluids, particularly medical, pharmaceutical, cosmetic products or the like.

Background Art

It is known that in the medical field, the use of sterile fluids is often required such as medicines, drugs, saline solutions and so on, to be injected with intravenous injection into patients.

These sterile fluids are normally supplied in bottles made of glass or plastic, which are chemically inert materials and suitable for safeguarding the sterility of the fluids which they contain.

The bottles are usually closed by means of a closing element called "stopper", which is fitted in the access mouth of the bottle.

The closing element is made of rubber to allow its penetration by a pointed extraction element, such as e.g. the needles of hypodermic syringes and infusion line spikes, and thus allow the extraction and exit of the sterile fluid.

Furthermore, for the purpose of preventing the portion of the stopper intended for penetration being contaminated with polluting substances and dirt, this is generally covered with a protection cap that can be screwed around the bottle neck.

The cap comprises a tear-off removable portion, that can be removed to gain access to the stopper from the outside. For such purpose, the removable portion has a grip eyelet, a tab or other similar systems that permit gripping the removable portion and tearing it fully away from the rest of the protection cap, which remains stably fastened to the bottle neck.

Bottles of this type are described in EP 0 819 617 and EP 1 044 135. These bottles, nevertheless, have a number of drawbacks among which must be mentioned the fact that to remove the removable portion it is absolutely necessary to use both hands, one to hold the bottle firm and the other to tightly grip and tear away the grip eyelet/tab.

This results in a considerable loss of time and practical use for the user, who before opening the bottle must necessarily free himself/herself of everything he/she has in his/her hands and, after the removal of the removable portion, must recover the extraction element (needle, spike or the like) to fit it in the rubber stopper.

It must also be underlined that the tear-away removal of the removable portion of the cap means splitting the cap into two distinct pieces, which therefore need to be disposed of at different times and in different ways. The removable portion in fact must be thrown away once removed, i.e., when the bottle is opened and at the start of its use; the rest of the bottle, on the other hand, becomes a waste to be thrown away only once it has been emptied of its contents, i.e., after it has been used. This means a further loss of time and practical use for the user who, in fact, once the bottle has been opened, is forced to find a litter bin to dispose of the removable portion after this has been removed from the cap. In this respect, it must be underlined that, in situations critical for the health of the patients, the opening of the bottles and the administering of the fluids contained in them must be done with the utmost possible speed and rapidity and the minimum delay can produce even serious consequences for the patients.

Furthermore, taking into account the small dimensions of the removable portions, it sometimes occurs that these are thrown directly on the ground, thus dirtying the surrounding environment and representing a waste which, inconveniently, has to be picked up later on. Object of the invention

The main aim of the present invention is to provide a bottle for containing injectable fluids, particularly medical, pharmaceutical, cosmetic products or the like, that is practical, easy and functional to use, can be opened quickly using just one hand, freeing the user from the need of having to use both hands, and at the same time permits considerably reducing waste materials, facilitating waste disposal operations. Another object of the present invention is to provide a bottle for containing injectable fluids, particularly medical, pharmaceutical, cosmetic products or the like, that allows overcoming the mentioned drawbacks of the background art in the ambit of a simple, rational, easy, effective to use and low cost solution. The above objects are achieved by the present bottle for containing injectable fluids, particularly medical, pharmaceutical, cosmetic products or the like, comprising at least a container for containing an injectable fluid having at least an access mouth, at least a closing element that is at least partially inserted in said access mouth and which has at least an area in penetrable material suitable for being crossed by an extracting element for extracting said injectable fluid, and at least a protection plug for protecting said closing element, characterized in that said plug comprises at least a cap that can be placed to at least partially cover said closing element and which has at least an opening for accessing said area, and at least a cover that is associated with said cap by interposition of rotation means around a swinging axis and which supports at least a shutter element that can be fitted sealed in said opening. Brief Description of the Drawings

Other characteristics and advantages of the present invention will become more evident from the description of some forms of preferred, but not sole, embodiments, of a bottle for containing injectable fluids, particularly medical, pharmaceutical, cosmetic products or the like, illustrated purely as an example but not limited to the annexed drawings in which: figure 1 is an axonometric view of a preferred form of embodiment of the bottle according to the invention in a closing configuration; figure 2 is a longitudinal section view of the bottle of figure 1; figure 3 is an axonometric view of the plug fitted on the bottle of figure 1, arranged in the initial opening configuration; figure 4 is an axonometric view of the plug of figure 3, arranged in the final opening configuration; figure 5 is an axonometric view of the plug of an alternative form of embodiment according to the invention, arranged in the initial opening configuration; figure 6 is an axonometric view of the plug of figure 5, arranged in the final B2009/005634

4 opening configuration.

Embodiments of the Invention

With particular reference to the form of embodiment of the figures from 1 to 4, a bottle for containing injectable fluids, particularly medical, pharmaceutical, cosmetic products or the like, has been globally indicated by 1.

The bottle 1 comprises a container 2 for containing an injectable fluid 3 to be administered to a patient by means of a syringe, an infusion line or the like.

The container 2 has a bottom 4, at which is associable a hanger 5, and a threaded neck 6, which is arranged in the opposite direction to the bottom 4 and which terminates with an access mouth 7.

In the access mouth 7, a closing element 8, of the type of a rubber stopper, is at least in part insertable by interlock.

The closing element 8 has a thinned area 9, in penetrable material, which is suitable for being crossed by an extraction element for the extraction and the exit of the inj ectable fluid 3.

The extraction element is not shown in detail in the illustrations and, e.g., consists of a syringe needle, an infusion line spike or similar devices.

At the top of the collar 6 is associable a plug 10 for the protection of the closing element 8. Both the container 2 and the plug 10 are advantageously made of plastic, e.g., in polypropylene.

The plug 10, in particular, comprises a cap 11 that is placeable to cover the closing element 8 and which has an opening 12 for accessing the area 9.

The cap 11 has a substantially round section cylindrical shape and is composed, e.g., of a cylindrical side body 13, inside which is obtained an inner thread 14 engageable by screwing on the neck 6 of the container 2, and of an annular wall

15, which is associated at the top of the cylindrical side body 13.

The opening 12 is obtained on the annular wall 15 in such a position that, when the cap 11 is fitted on the neck 6, the opening 12 is arranged at the area 9. Furthermore, the plug 10 comprises a cover 16 that is associated with the cap 11 by interposition of the rotation means 17 around a swinging axis.

In the particular embodiment of the invention shown in the figures from 1 to 4, B2009/005634

5 the rotation means 17 are arranged on the periphery of the cap 11, i.e., on the edge of the annular wall 15, and tangent with this, and are composed of a first folding line with weakened section.

For this purpose, the cap 11 and the cover 16 are made in a single body by means of injection moulding and remain joined together at the first folding line 17, the weakened section of which permits turning the cap 11 and the cover 16, the one with respect to the other, between a closing configuration, in which the cover 16 is up against the annular wall 15, and an opening configuration, in which on the other hand the cover 16 is turned with respect to the annular wall 15.

Alternative embodiments of the present invention cannot however be ruled out in which the cap 11 and the cover 16 are made in two or more pieces which may be assembled together. Usefully, the cover 16 supports a shutter element 18 which in the closing configuration of the plug 10 can be fitted sealed in the opening 12.

For this purpose, the shutter element 18 is defined by a cylindrical body with shape substantially complementary to that of the opening 12. Between the cap 11 and the cover 16 are interposed first anti-tampering seal means 19, 20, 21 suitable for evidencing whether or not the plug 10 has been previously opened.

The first anti-tampering seal means 19, 20, 21 consist, e.g., of a protruding element 19, of the type of a tooth or the like, that is associated with the cover 16 by interposition of first tearable support means 20, and of a retention seat 21, that is obtained on the cap 11 and in which the protruding element 19 can be slotted in the closing configuration of the plug 10.

More in detail, the tooth 19 is defined on a flap 22 that is arranged on the diametrically opposite side of the cover 16 with respect to the first folding line 17 and which is associated with the rest of the cover 16 along a second folding line 23 with weakened section, substantially parallel with the first folding line 17, that enables the flap 22 to fold with respect to the rest of the cover 16.

Through the flap 22 is defined a through slot 24 on the inner edge of which are arranged the first tearable support means 20 made up, e.g., of a series of preset fracture connecting bridges suitable for breaking once the tooth 19 is fitted in the retention seat 21.

Usefully, the retention seat 21 is obtained on the annular wall 15 of the cap 11 on the diametrically opposite side with respect to the first folding line 17 so that in closing configuration of the plug 10 the tooth 19 fits exactly in the retention seat 21.

Furthermore, the plug 10 comprises second anti-tampering seal means 25, 26 placed between the cover 16 and the shutter element 18. In particular, it is pointed out that the shutter element 18 is associated with the cover 16 by means of the second anti-tampering seal means 25, 26.

These second anti-tampering seal means comprise second tearable support means 25, of the type of a series of preset fracture connecting bridges, and a supporting edge 26 suitable for keeping the cover 16 and the shutter element 18 joined together upon breakage of the second tearable support means 25. The supporting edge 26, in detail, is obtained on the cover 16 on the part arranged at and near the first folding line 17.

This arrangement of the supporting edge 26, together with the particular sizing of the section of the second tearable support means 25, causes, when the cover 16 is opened starting from the closing configuration, the shutter element 18 to remain temporarily blocked inside the opening 12 so as to allow the breakage of the second tearable support means 25 while, once out of the opening 12, the shutter element 18 remains attached to the cover 16 by means of the supporting edge 26. Advantageously, placed between the cap 11 and the container 2 are third anti- tampering seal means 27, 28, 29.

The third anti-tampering seal means 27, 28, 29 comprise a seal ring 27 which is associated with the base of the cap 11 by interposition of third tearable support means 28 and can be coupled by slotting in with a retention edge 29 obtained on the neck 6 of the container 2. In particular, the seal ring 27 is obtained in a single body with the cap 11 and the third tearable support means 28 are composed of a series of preset fracture connecting bridges. B2009/005634

7

During the screwing up of the plug 10 on the container 2, the seal ring 27 and the retention edge 29 are shaped so the cap 11 can be fitted on the neck 6 without causing the breakage of the third tearable support means 28 while, on the contrary, when we try to unscrew the plug 10, the retention edge 29 opposes resistance to the moving away of the seal ring 27 determining the fracture of the third tearable support means 28.

The operation of the embodiment of the present invention shown in the figures from 1 to 4 is the following. Immediately after forming, the plug 10 is arranged in an initial opening configuration (figure 3) in which the first, the second and the third tearable support means 20, 25 and 28 are integral, the tooth 19 is fitted on the flap 22, the shutter element 18 is fitted on the cover 16 and the seal ring 27 is fitted on the base of the cap 11. At this point, the plug 10 is screwed onto the container 2 and the cover 16 is closed.

In the closing configuration, the tooth 19 slots stably into the inside of the retention seat 21 and the shutter element 18 is seal fitted and partially slotted into the opening 12, as seen in figure 2. At the time of first opening 12 of the plug 10, the user levers on the flap 22 and pushes the cover 16 to turn around the first folding line 17 placing the plug in the final opening configuration shown in the figure 4.

Such operation is particularly simple and can also be performed by the user with just one hand, enabling him/her to keep the other hand free or use it to grip the extraction element and prepare it for its subsequent fitting in the closing element 8.

When the plug 10 is opened, the tooth 19 remains blocked in the retention seat 21, tearing the first tearable support means 20 and acting as clear evidence that the cover 16 has been opened. Furthermore, when the cover 16 is opened, starting from the closing configuration, the shutter element 18 remains temporarily blocked in the opening 12, the second tearable support means 25 break and the shutter element 18 remains attached to the cover 16 only by means of the supporting edge 26, IB2009/005634

8 this too acting as evidence that the cover 16 has been opened. The fact is also underlined that even if an attempt is made to tamper with the bottle 1, removing the plug 10 by unscrewing it from the container 2, then the third anti-tampering seal means 27, 28, 29 allow evidencing the tampering by means of the breakage of the third tearable support means 28.

With reference to the embodiment of the invention shown in the figures 5 and 6, the fact is underlined that the bottle 1 has a container 2 that is completely identical to that of the previous embodiment; consequently, in these illustrations, the container 2 has not been shown, but only the plug 10. The plug 10 of this embodiment is altogether similar to that shown in the figures from 1 to 4 and comprises a cap 11₅ a cover 16, a shutter element 18, first anti- tampering seal means 19, 20, 21 and third anti-tampering seal means 27, 28, 29 identical to those previously described and which, therefore, will not be the subject of further detailed explanation, it remaining understood that for these reference is best made to the above description.

The only substantial difference compared to the previous embodiment concerns the fact that the plug 10 of the figures 5 and 6 does not have second anti- tampering seal means 25, 26 but, also, the cover 16 and the shutter element 18 are rigidly and stably associated together along an immovable connection edge 30.

This means that when the cover 16 is opened starting from the closing configuration, the shutter element 18 comes immediately out of the opening 12, being dragged by the cover 16 in turn pushed by the flap 22 on which the user levers. In the final opening configuration (figure 6) as well therefore, the shutter element 18 is integrally and rigidly joined to the cover 16 and to prove that the cover 16 has been opened remains the tooth 19 slotted into the retention seat 21. It has in point of fact been ascertained how the described invention achieves the proposed objects. In this respect, the fact is underlined that the bottle according to the invention can be opened in a practical, easy and functional way, and above all quickly and using just one hand, thus allowing the user to prepare the other hand for inserting a needle, a spike or the like in the rubber closing element. Furthermore, the particular solution of envisaging a tooth that remains fitted in the retention seat and a shutter element which remains attached to the cover even in the final opening configuration avoids the inconvenient splitting of the bottle into several pieces and allows a faster and simpler management of waste materials compared to bottles of known type.

The invention thus conceived is susceptible to numerous modifications and variations, all of which falling within the scope of the inventive concept. Furthermore all the details can be replaced with others that are technically equivalent.

In practice, the materials used, as well as the contingent shapes and dimensions, may be any according to requirements without because of this moving outside the protection scope of the following claims.

Claims

5634

10 CLAIMS

1) Bottle for containing injectable fluids, particularly medical, pharmaceutical, cosmetic products or the like, comprising at least a container for containing an injectable fluid having at least an access mouth, at least a closing element that is at least partially inserted in said access mouth and which has at least an area in penetrable material suitable for being crossed by an extracting element for extracting said injectable fluid, and at least a protection plug for protecting said closing element, characterized in that said plug comprises at least a cap that can be placed to at least partially cover said closing element and which has at least an opening for accessing said area, and at least a cover that is associated with said cap by interposition of rotation means around a swinging axis and which supports at least a shutter element that can be fitted sealed in said opening.

2) Bottle according to claim I₅ characterized in that said rotation means are arranged substantially on the periphery of said cap. 3) Bottle according to one or more of the preceding claims, characterized in that said rotation means comprise at least a first folding line with weakened section.

4) Bottle according to one or more of the preceding claims, characterized in that said shutter element comprises at least a body with shape substantially complementary to said opening.

5) Bottle according to one or more of the preceding claims, characterized in that said plug comprises first anti-tampering seal means interposed between said cover and said cap.

6) Bottle according to one or more of the preceding claims, characterized in that said first anti-tampering seal means comprise at least a protruding element that is associated with one between said cover and said cap by interposition of first tearable support means, and at least a retention seat, that is obtained on the other between said cap and said cover and in which said protruding element can be slotted in. 7) Bottle according to one or more of the preceding claims, characterized in that said protruding element is associated with a flap of said cover. 8) Bottle according to one or more of the preceding claims, characterized in that said flap is associated with the rest of said cover along a second folding line with weakened section.

9) Bottle according to one or more of the preceding claims, characterized in that said first tearable support means comprise at least a preset fracture connecting bridge.

10) Bottle according to one or more of the preceding claims, characterized in that said plug comprises second anti-tampering seal means interposed between said cover and said shutter element.

11) Bottle according to one or more of the preceding claims, characterized in that said second anti-tampering seal means comprise second tearable support means interposed between said cover and said shutter element.

12) Bottle according to one or more of the preceding claims, characterized in that said second tearable support means comprise at least a preset fracture connecting bridge. 13) Bottle according to one or more of the preceding claims, characterized in that said second anti-tampering seal means comprise at least a supporting edge interposed between said cover and said shutter element and suitable for keeping said cover and said shutter element joined together upon breakage of said second tearable support means. 14) Bottle according to one or more of the preceding claims, characterized in that said cap comprises at least an inner thread engageable by screwing on said container at said access mouth.

15) Bottle according to one or more of the preceding claims, characterized in that it comprises third anti-tampering seal means interposed between said plug and said container.

16) Bottle according to one or more of the preceding claims, characterized in that said third anti-tampering seal means comprise at least a seal ring associated with the base of said cap by interposition of third tearable support means and couplable by slotting in with a retention edge obtained on said container. 17) Bottle according to one or more of the preceding claims, characterized in that said third tearable support means comprise at least a preset fracture connecting bridge. 18) Bottle according to one or more of the preceding claims, characterized in that said shutter element and said cover are rigidly and stably associated together.

19) Bottle according to one or more of the preceding claims, characterized in that at least one between said container and said plug is made of plastic.

20) Bottle according to one or more of the preceding claims, characterized in that said closing element is made of rubber.