EP0462255B1 - Aufbewahrungs- und umfüllflasche mit doppelter kammer - Google Patents

Aufbewahrungs- und umfüllflasche mit doppelter kammer Download PDF

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Publication number
EP0462255B1
EP0462255B1 EP19910902154 EP91902154A EP0462255B1 EP 0462255 B1 EP0462255 B1 EP 0462255B1 EP 19910902154 EP19910902154 EP 19910902154 EP 91902154 A EP91902154 A EP 91902154A EP 0462255 B1 EP0462255 B1 EP 0462255B1
Authority
EP
European Patent Office
Prior art keywords
capsule
bottle
bottle according
rigid element
neck
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP19910902154
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English (en)
French (fr)
Other versions
EP0462255A1 (de
Inventor
Gabriel Meyer
Joseph Meyer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson France SA
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Becton Dickinson France SA
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Filing date
Publication date
Application filed by Becton Dickinson France SA filed Critical Becton Dickinson France SA
Publication of EP0462255A1 publication Critical patent/EP0462255A1/de
Application granted granted Critical
Publication of EP0462255B1 publication Critical patent/EP0462255B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/02—Internal fittings
    • B65D25/04—Partitions
    • B65D25/08—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents
    • B65D25/085—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents the partition being in the form of a plug or the like which is dislodged by means of a plunger rod or the like pushing the plug down
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1418—Threaded type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2041—Separating means having removable plugs

Definitions

  • 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 ''
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • this end piece contains a closing valve urged by a spring.
  • 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.
  • 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.
  • the closure member comprises a zone of reduced thickness arranged to be pierced by the needle of a syringe.
  • 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.
  • 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.
  • 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.
  • the capsule 17 is extended by a rigid element 20 which stiffens said closure member.
  • 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.
  • 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.
  • the rigid element 20 is independent of the capsule 17.
  • the shutter member 21 is integral with this capsule.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • second function which consists in letting in filtered air when the mixture of components is aspirated by means of a syringe.
  • 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.
  • 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.
  • 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.
  • the seal is preserved at the tip.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. Aufbewahrungs- und Umfüllflasche (10) mit einer doppelten Kammer (11, 12), für die Aufbewahrung von zwei Bestandteilen einer heilkräftigen Substanz, von denen mindestens eine im flüssigen Zustand ist, und für die Umfüllung dieser Substanz zusammen mit einer anderen Substanz in eine Verwendungseinrichtung, wobei die Flasche einerseits einen offenen engeren Hals (15) und eine Verschlußeinrichtung (16) aufweist, die in den Hals eingeführt ist, und andererseits einen Bereich mit einem engeren Querschnitt enthält, der in der Phase der Aufbewahrung durch einen beweglichen Zwischenstopfen (13) verschlossen und dazu vorgesehen ist, die beiden Kammern zu trennen und die beiden Bestandteile voneinander zu isolieren, wobei die Verschlußvorrichtung ein Verschlußorgan aus einem Elastomer ist, das in den engeren Hals eingeführt und dazu vorgesehen ist, zwischen einer ersten Position während der Phase der Aufbewahrung, bei der es einen dichten Verschluß bildet, und einer zweiten Position für die Verwendung, bei der es das Auslaufen der heilkräftigen Substanz ermöglicht, verstellt zu werden, und eine starre Kapsel (17) enthält, die teilweise in den engeren Hals eingeführt und an dem Verschlußorgan befestigt ist, wobei das Verschlußorgan (21,31,41,51,61) aus dem Elastomer einen Dichtungsquerschnitt aufweist, dessen Aussendurchmesser im wesentlichen dem Innendurchmesser des engeren Halses entspricht, um im Bereich des Halses während der Phase der Aufbewahrung die Dichtheit der Flasche sicherzustellen, und eine Ausdehnung aufweist, die den Dichtungsquerschnitt durch die obere Kammer (11) verlängert, welche durch den Dichtungsquerschnitt und den beweglichen Zwischenstopfen (13) abgegrenzt ist, um die mechanische Verbindung zwischen der Kapsel (17) und dem Zwischenstopfen (13) sicherzustellen,
    dadurch gekennzeichnet, daß die Ausdehnung einen starren Bestandteil (20,30, 40,50,60,100) enthält, der mit der Kapsel (17) fest verbunden und voll in dem Inneren des Verschlußorgans (21) eingebaut ist, das im wesentlichen aus einer dünnen Umhüllung aus einem Elastomer besteht, die in ihrem Dichtungsquerschnitt durch die Kapsel (17) und in ihrer Ausdehnung durch den starren Bestandteil gebildet ist.
  2. Flasche nach Anspruch 1,
    dadurch gekennzeichnet, daß der starre Bestandteil (30,40,50) aus einer mittleren Spindel gebildet ist, die mit der Kapsel einteilig ausgeführt ist.
  3. Flasche nach Anspruch 1,
    dadurch gekennzeichnet, daß der starre Bestandteil (20) ein unabhängiger Teil ist, der zwischen der Kapsel (17) und der Ausdehnung (21b) des Verschlußorgans (21) geklemmt ist.
  4. Flasche nach Anspruch 1,
    dadurch gekennzeichnet, daß der Dichtungsquerschnitt (21a) des Verschlußorgans (21) mindestens eine radiale Öffnung (22) enthält, die durch die innere Wandung des engeren Halses (15) während der Phase der Aufbewahrung verschlossen und zu dem Inneren der oberen Kammer (11) während der Phase der Verwendung geöffnet ist.
  5. Flasche nach Anspruch 1, bei dem die Kapsel (17) ein rohrförmiges Endstück (18) aufweist,
    dadurch gekennzeichnet, daß das Endstück eine Verschlußklappe (63) enthält, die von einer Feder (62) vorgespannt ist.
  6. Flasche nach Anspruch 5,
    dadurch gekennzeichnet, daß die Feder (62) an dem starren Bestandteil (60) anliegt.
  7. Flasche nach Anspruch 6,
    dadurch gekennzeichnet, daß der starre Bestandteil (60) mit einer Scheibe (60b) verbunden ist, die an dem Boden der Kapsel (17) aufliegt und als Auflage für die Feder (62) dient.
  8. Flasche nach Anspruch 7,
    dadurch gekennzeichnet, daß die Scheibe (60b) mindestens eine Öffnung (60c) aufweist, die die obere Kammer (11) mit dem Endstück der Kapsel (17) verbindet.
  9. Flasche nach Anspruch 1,
    dadurch gekennzeichnet, daß die Kapsel (17) einen Boden aufweist und daß der Boden mindestens eine Öffnung (42) enthält, die als Entlüftung dient.
  10. Flasche nach Anspruch 9,
    dadurch gekennzeichnet, daß die Entlüftung einen Filter (44) aufweist.
  11. Flasche nach Anspruch 10,
    dadurch gekennzeichnet, daß der Filter an der Außenseite des Bodens der Kapsel (17) angebracht ist.
  12. Flasche nach Anspruch 10,
    dadurch gekennzeichnet, daß der Filter an der Innenseite des Bodens der Kapsel (17) angebracht ist.
  13. Flasche nach Anspruch 1,
    dadurch gekennzeichnet, daß die Verschlußeinrichtung einen Bereich (52) mit einer geringeren Wandstärke aufweist, der von einer Nadel einer Spritze durchstechbar ist.
EP19910902154 1990-01-08 1990-12-30 Aufbewahrungs- und umfüllflasche mit doppelter kammer Expired - Lifetime EP0462255B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CH4590 1990-01-08
CH45/90 1990-01-08
PCT/EP1990/002332 WO1991010417A1 (fr) 1990-01-08 1990-12-30 Flacon de stockage et de transfert a double compartiment

Publications (2)

Publication Number Publication Date
EP0462255A1 EP0462255A1 (de) 1991-12-27
EP0462255B1 true EP0462255B1 (de) 1994-09-21

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EP19910902154 Expired - Lifetime EP0462255B1 (de) 1990-01-08 1990-12-30 Aufbewahrungs- und umfüllflasche mit doppelter kammer

Country Status (9)

Country Link
US (1) US5348548A (de)
EP (1) EP0462255B1 (de)
JP (1) JPH04504817A (de)
AT (1) ATE111725T1 (de)
CA (1) CA2048601A1 (de)
DE (1) DE69012803T2 (de)
DK (1) DK0462255T3 (de)
ES (1) ES2064990T3 (de)
WO (1) WO1991010417A1 (de)

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WO1991010417A1 (fr) 1991-07-25
ES2064990T3 (es) 1995-02-01
US5348548A (en) 1994-09-20
ATE111725T1 (de) 1994-10-15
DE69012803D1 (de) 1994-10-27
DK0462255T3 (da) 1994-11-21
EP0462255A1 (de) 1991-12-27
DE69012803T2 (de) 1995-04-06
CA2048601A1 (fr) 1991-07-09
JPH04504817A (ja) 1992-08-27
JPH0560945B2 (de) 1993-09-03

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