EP0462255B1 - Two-compartment storage and transfer flask - Google Patents

Abstract

PCT No. PCT/EP90/02332 Sec. 371 Date Aug. 28, 1991 Sec. 102(e) Date Aug. 28, 1991 PCT Filed Dec. 30, 1990 PCT Pub. No. WO91/10417 PCT Pub. Date Jul. 25, 1991.Bottle (10) for storage and transfer with dual compartments (11 and 12) separated during storage by a movable intermediate seal (13). The bottle (10) also has a narrow neck (15) in which a sealing device engages comprising an elastomeric sealing member (61) and a capsule (17) attached to said member. The capsule extends toward the outside into a tip (18) in which there is a closing valve (63) urged by a spring (62) which supports a disc (60b) of a rigid element (60) attached to the inside of the sealing member (61).

Description

The present invention relates to a storage and transfer bottle with a double compartment, designed to store two components of a medicinal substance of which at least one is in a liquid state, and to transfer this substance directly or after having mixed it with a another substance, towards a device for use, this bottle comprising, on the one hand an open narrowed neck and a closure device engaged in this neck and, on the other hand, a narrowed section zone closed in the storage phase by a movable intermediate plug arranged to separate the two compartments and isolate the two components from each other, this closure device comprising an elastomeric closure member engaged in the narrowed neck and designed to be moved between a first position, called storage, during a storage phase in which it constitutes a sealed shutter, and a second position, called use, in a phase of use in which it allows the evacuation of said medicinal substance, and a rigid capsule partially engaged inside the narrowed neck and fixed to said obturation member, in which the elastomer obturation member has a section d '' seal whose outer diameter is substantially equal to the inner diameter of the neck narrowed to seal the bottle at the neck during the storage phase, and an extension that extends the sealing section through the upper compartment delimited by sealing section and the movable intermediate plug to ensure mechanical coupling between the capsule and this plug.

Various bottles of this type are already known in which the passage from the storage position to the use position requires the ejection of the movable intermediate stopper towards the lower compartment to allow the mixing of the components which are respectively stored in the upper compartment and in the lower compartment during the storage phase. In this type of bottle, the upper compartment is completely filled with a substance in the liquid state and the pressure exerted on the closure member to move it from its closure position to its storage position is fully transmitted. to the movable intermediate plug by this liquid substance. For certain applications, this construction is too complicated and too costly or unsuitable since the filling of the upper compartment may be more or less complete, or filled with a powder. To this end, provision has been made in certain embodiments for rigid members to activate the bottle, that is to say to push back the movable intermediate plug. The presence of these rigid members generally constitutes a drawback because they are in contact with the component contained in the upper compartment, hence significant problems of compatibility between the medicament and the synthetic material from which the rigid members are made.

There is in particular known a mixing bottle intended for cosmetic preparations described by the French patent application published under the number FR-A-2239390, which comprises a first compartment closed by a movable stopper and a second compartment formed in a capsule and closed by a stopper engaged in an opening in the bottom of the capsule. The movable plug is equipped with an extension extending to the plug of the second compartment, to push the latter back when the movable plug is moved. This device lends itself to use for cosmetic products but does not lend itself to medical use.

The present invention proposes to solve this problem by providing a bottle which can be produced in a simple and economical manner and which can be used for the storage and application of any medicinal substances without the problem of compatibility of the substances being posed. contained in the bottle with the components of this bottle.

For this purpose, the bottle according to the invention is characterized in that said extension comprises a rigid element integral with the capsule and integrally housed inside said closure member essentially consisting of a thin envelope of elastomer stiffened in its section sealing by the capsule and in its extension by said rigid element.

According to a preferred embodiment, the rigid element consists of a central rod produced in one piece with the capsule, or may be an independent piece pinched between the capsule and the extension of the shutter member.

According to this embodiment of the bottle, the sealing section of the closure member comprises at least one radial opening closed by the inner wall of the neck narrowed during the storage phase and open to the interior of the upper compartment during the use phase.

Advantageously, when the capsule comprises an end piece of tubular shape, this end piece contains a closing valve urged by a spring.

Preferably, this spring is in abutment against the rigid element, said rigid element being associated with a disc bearing against the bottom of the capsule and serving as a support for said spring.

Said disc may include at least one opening which communicates the upper compartment with the tip of the capsule.

In an advantageous embodiment, the capsule has a bottom and this bottom has at least one opening serving as a vent which may include a filter.

Said filter can be mounted outside or inside the bottom of the capsule.

According to another embodiment, the closure member comprises a zone of reduced thickness arranged to be pierced by the needle of a syringe.

• la fig. 1 illustre une première forme de réalisation du flacon selon l'invention en position de stockage,
• la fig. 2 représente la construction de la fig. 1 en position d'utilisation et couplée à une seringue,
• la fig. 3 représente une autre réalisation du flacon selon l'invention,
• les fig. 4 et 5 illustrent deux autres formes de réalisation du flacon selon l'invention, équipé d'un filtre-évent,
• les fig. 6 et 7 sont des vues partielles d'une variante du flacon selon l'invention, respectivement en position de stockage et en position activée,
• les fig. 8 et 9 représentent la forme de réalisation préférée du flacon selon l'invention respectivement au stockage et en utilisation, et
• les fig. 10 à 14 représentent plusieurs variantes de réalisation du flacon selon l'invention.

The present invention will be better understood with reference to the description of several embodiments and to the accompanying drawing in which:

• fig. 1 illustrates a first embodiment of the bottle according to the invention in the storage position,
• fig. 2 shows the construction of FIG. 1 in the position of use and coupled to a syringe,
• fig. 3 shows another embodiment of the bottle according to the invention,
• fig. 4 and 5 illustrate two other embodiments of the bottle according to the invention, equipped with a vent filter,
• fig. 6 and 7 are partial views of a variant of the bottle according to the invention, respectively in the storage position and in the activated position,
• fig. 8 and 9 represent the preferred embodiment of the bottle according to the invention respectively during storage and in use, and
• fig. 10 to 14 represent several alternative embodiments of the bottle according to the invention.

With reference to fig. 1 and 2, the storage bottle 10, which can be made of a synthetic material such as for example polyethylene, glass or any other suitable material, has two compartments 11 and 12 respectively, separated by a movable intermediate stopper 13 which is engaged in a central zone 14 of narrowed section whose diameter is calculated so as to allow complete sealing by this plug.

At its upper end provided with a narrowed neck 15 whose section is substantially equal to that of the central zone 14, the bottle 10 is equipped with a closure device 16 comprising, on the one hand a capsule 17 made of synthetic material closed by a plug 18 screwed onto a threaded end 19 formed at the outer end of the capsule 17 and, on the other hand, a sealing member 21 made of elastomer. In the construction described and illustrated by these figures, the capsule 17 is extended by a rigid element 20 which stiffens said closure member. It will be noted that this shutter member 21 is composed a sealing section 21a whose diameter is substantially equal to the inside diameter of the narrowed neck to seal the bottle at the neck during the storage phase, and an extension 21b which extends the sealing section 21a through the upper compartment delimited by said sealing section and the movable intermediate plug to ensure mechanical coupling between the capsule and this plug. The shutter member and rigid element assembly is supported on the intermediate plug 13 and constitutes in a way a mechanical coupling between the shutter device and the movable intermediate plug. Due to the existence of this coupling, the displacement of the capsule 17, in the direction indicated by the arrow A, which is due to the engagement of this capsule towards the inside of the neck 15, makes it possible to repel the intermediate plug. movable inside the compartment 12 and consequently to free the passage between the two compartments at the level of the central zone 14 of narrowed section.

It will be noted that the shutter member 21 has at least one lateral opening 22 which coincides with at least one lateral opening 23 of the capsule 17. The purpose of these openings is to allow communication between the two compartments when the bottle is in the storage position shown in fig. 2.

In this embodiment, the rigid element 20 is independent of the capsule 17. On the other hand, the shutter member 21 is integral with this capsule. To this end, this member has a peripheral bead 24 which engages in a groove 25 formed at the periphery of a cylindrical internal extension 26 of the capsule. It will also be noted that, in this embodiment, the rigid element 20 is taken between the shutter member and the end of said extension 26 and held in place by the elasticity of the shutter member. In this variant, the rigid element 20 can be made in one piece with the capsule 17, that is to say attached to the cylindrical inner extension of this capsule.

In the storage position, the capsule 17 and in particular the endpiece 19 are hidden by a protective cap 27 which is linked to the bottle 10 by a tamper-evident label 28.

Fig. 2 represents the bottle of FIG. 1 in its position of use. The tamper-evident label 28 has been cut and the capsule 17 has been pushed back towards the inside of the neck 15. The closure member 21 which provided the seal at the neck has been pushed back partially inside the first compartment 11 and the lateral openings 22 and 23 allow the flow of the substance contained in the bottle towards the nozzle 19 with female Luer cone in which is engaged a syringe 29 with male Luer cone. The fact of pushing the capsule towards the inside of the neck exerted a push on the movable intermediate stopper 13 which fell inside the second compartment 12 (before inversion of the bottle). This thrust was transmitted from the capsule to the stopper by the rigid element 20 and the shutter member 21 which covers this element.

This embodiment is particularly advantageous because, during storage, the medicinal substances are only in contact with the bottle and the elastomer components such as the intermediate stopper 13 and the closure member 21. Problems of drug compatibility synthetic material are therefore completely resolved.

Fig. 3 illustrates another embodiment which is in fact a variant of the previous embodiment shown in FIGS. 1 and 2. The rigid element 20 of the previous embodiment is replaced in this case by a rigid element 30 integral with the capsule 17. The function of this part is strictly identical to that of the element 20. It is presented in the form of a solid rod arranged axially. The shape of the member 31, to which the rigid element 30 serves as a support, is somewhat different in its lower part. The upper part, whose function is to ensure the tightness of the neck has a shape identical to that illustrated in FIGS. 1 and 2.

Figs. 4 and 5 illustrate two variants from the embodiment shown in FIG. 3. These constructions differ from the previous one on the one hand by the shape of the shutter member 41 carried by the rigid element 40 which is substantially identical to the rigid element 30 and, on the other hand, by the presence of a vent formed in the wall of the capsule 17. In the example of FIG. 4, the capsule 17 has openings 42 formed in its bottom 43. A filter 44 of annular shape is fixed on this bottom to hide these openings. This filter can have two functions, a first function which consists in letting escape gases such as carbon dioxide which can be released in relatively large quantity during the mixing of the two components initially contained in the two compartments, or such as air which is in suspension when the closure member is pressed into the neck, and a second function which consists in letting in filtered air when the mixture of components is aspirated by means of a syringe.

In the embodiment of FIG. 5, the filter 44 is located outside the bottom 43 of the capsule. The functions of the filter are the same in the two examples.

Figs. 6 and 7 show another embodiment which, however, incorporates the main features of the previous examples. The capsule 17 is made in one piece with the rigid element 50 which is in the form of a central rod fixed to the bottom of the capsule and extending axially through the first compartment 11. The shutter member 51 surrounds this rigid element and folds around the cylindrical inner extension 26 of the capsule, to which it is attached by a peripheral bead, so as to seal the neck.

After activation of the system, that is to say when the movable intermediate stopper has been pushed back, the medicinal mixture is withdrawn using a syringe (not shown). The area 52 of the thinner member is punctured by means of the needle of this syringe.

Figs. 8 and 9 show a particularly interesting embodiment in which the bottle remains sealed even after its activation thanks to the presence of a valve. The capsule 17 is substantially identical to that shown in FIG. 4, and the shutter member 61 is identical to the shutter member 41 of FIG. 4. The rigid element 60 comprises a central rod 60a which ends in a disc 60b which is housed in a circular recess formed in the bottom of the capsule. This disc has an opening 60c for ensuring communication between the interior of the bottle and the tip 19 of the capsule. The disc 60b serves as a support for a spring 62 which carries a valve 63 which ensures the closure of the end piece. To this end, the end piece 19 has a narrowing 64 and the valve 63 has a frustoconical part 65 which cooperate to seal this closure. The rod 60a, the disc 60b, the spring 62 and the valve 63 are made in one piece by injection of a synthetic material compatible with the medicament of the bottle.

After activation of the bottle, the seal is preserved at the tip. When a syringe 29 is connected to this nozzle, the needle-holder cone of this syringe pushes the valve 63 and compresses the spring 62. The medicament from the vial can pass (after inversion of the vial) through the openings 22, 23, 60c and enter the syringe 29.

Another advantage of this system is the multidose use. Indeed, as soon as the syringe 29 is withdrawn, the valve closes and sealingly seals the end of the capsule.

A vent with filter 44, identical to that of FIGS. 4 and 5, equips capsule 17.

Figs. 10 and 11 roughly repeat the construction of FIGS. 4 and 8. However, in the example of FIG. 10, the end piece 19 is closed by a plug 79 made of elastomer, called a septum. The liquid is withdrawn from the inside of the bottle by a syringe, the needle of which must first perforate the septum. In the example of fig. 11, the end piece 19 consists of a wide area 19a and a narrowed area 19b. A sealing plug 83 is initially engaged in the narrowed area 19b and seals the bottle at this nozzle. After activation, if you want to remove the liquid from the bottle, you insert a syringe into the nozzle 19. The Luer-type cone of this syringe pushes the cap back into the wide area 19a, which allows the passage of the liquid . The other components are respectively identical to those of the embodiments of FIGS. 4 and 8.

Fig. 12 shows a variant of the embodiment according to FIG. 11. The closure plug 83 has been removed and the closure plug 18 screwed onto this end piece comprises, on the one hand a central opening 98 and, on the other hand, a filter 99 constituting a vent whose role is identical to that of the filter-vents described above.

The embodiment according to fig. 13 differs from the previous constructions in that the capsule 17 is provided with a valve 102 formed in the bottom of the capsule 17. This valve is activated by a push-button 103 when a syringe is put in place (not shown). ) in the nozzle 19. A vent filter 104 is disposed near the bottom of the capsule. The rigid element 100 comprises a central rod 100a and a disc 100b whose diameter corresponds substantially the inside diameter of the capsule and which has an opening 100c for the passage of the liquid.

The construction illustrated in fig. 14 is a variant of that of FIG. 13. The nozzle 19 represents the shape of a Luer cone and the bottom of the capsule is equipped with a filter 104 serving as a vent.

The present invention is not limited to the embodiments described but can undergo different modifications and come in various variants obvious to those skilled in the art. In particular, the shape of the rigid element can be modified. As has been shown in the various embodiments above, this rigid element can be linked either to the closure device engaged in the neck of the bottle, or to the movable intermediate stopper, or to these two components. The longitudinal dimension is determined by the stroke of the closure device in the neck of the bottle. This stroke must be sufficient to allow the displacement of the movable intermediate stopper inside the compartment 12 of the bottle and, in the cases where the closure device comprises a closure member provided with a radial opening, the release of the radial opening to allow the passage of the drug substance towards the evacuation end of the capsule. The actual bottle can be made of glass or synthetic material. The top compartment can contain any liquid or solid substance and, in the case of a liquid, the filling can be any.

Claims (13)

1. Dual compartment (11, 12) storage and transfer bottle (10) designed to store two components of a medicinal substance, at least one of which is in liquid state, and to transfer this substance directly or after mixture with another substance into an utility device, said bottle comprising at one end a narrow open neck (15) and a sealing device (16) engaged in said neck, and at the other end, a narrow region sealed during the storage phase by a movable intermediate seal (13) designed to separate the two compartments and isolate the two components from each other, said sealing device comprising an elastomeric sealing member engaged in the narrow neck and designed to be displaceable between a first position, known as the storage position, during a storage phase in which it constitutes a tight seal, and a second position known as the utility position, in an utility phase in which it allows said medicinal substance to be evacuated, and a rigid capsule (17) partially engaged inside the narrow neck and attached to said sealing member, in which said elastomeric sealing member (21, 31, 41, 51, 61) comprises a sealing section with an outside diameter essentially equal to the inside diameter of the narrow neck to ensure sealing of the bottle at neck level during the storage phase, and an extension which prolongs the sealing section through the upper compartment (11) defined by the sealing section and the movable intermediate seal (13) to form a mechanical connection between the capsule (17) and said seal, characterized in that said extension comprises a rigid element (20, 30, 40, 50, 60, 100) integral with the capsule (17) and completely located inside said sealing member (21), essentially consisting of an elastomeric thin wrapping, made rigid in its sealing section by the capsule (17) and in its extension by said rigid element.
2. Bottle according to claim 1, characterized in that the rigid element (30, 40, 50) consists of a central shaft made as one piece with the capsule.
3. Bottle according to claim 1, characterized in that the rigid element (20) is an independent piece positioned between the capsule (17) and the extension (21b) of the sealing member (21).
4. Bottle according to claim 1, characterized in that the sealing section (21a) of the sealing member (21) comprises at least one radial opening (22) sealed by the interior wall of the narrow neck (15) during the storage phase and open toward the interior of the upper compartment (11) during the utility phase.
5. Bottle according to claim 1, in which the capsule (17) comprises a tube shaped end tip (18), characterized in that said tip contains a closing valve (63) urged by a spring (62).
6. Bottle according to claim 5, characterized in that the spring (62) is in contact with the rigid element (60).
7. Bottle according to claim 6, characterized in that the rigid element (60) is associated with a disc (60b) supporting the capsule base (17) and supporting said spring (62).
8. Bottle according to claim 7, characterized in that the disc (60b) has at least one opening (60c) allowing the upper compartment (11) to communicate with the tip of the capsule (17).
9. Bottle according to claim 1, characterized in that the capsule (17) has a base and in that said base has at least one opening (42) serving as a vent hole.
10. Bottle according to claim 9, characterized in that said vent hole comprises a filter (44).
11. Bottle according to claim 10, characterized in that said filter is attached to the outside of the base of the capsule (17).
12. Bottle according to claim 10, characterized in that said filter is attached to the inside of the base of the capsule (17).
13. Bottle according to claim 1, characterized in that the sealing member comprises one thinner region (52) designed to be punctured by a syringe needle.

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