EP0850178B1 - Connector for a closed container, preventing tampering therewith - Google Patents

Connector for a closed container, preventing tampering therewith Download PDF

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Publication number
EP0850178B1
EP0850178B1 EP19960931110 EP96931110A EP0850178B1 EP 0850178 B1 EP0850178 B1 EP 0850178B1 EP 19960931110 EP19960931110 EP 19960931110 EP 96931110 A EP96931110 A EP 96931110A EP 0850178 B1 EP0850178 B1 EP 0850178B1
Authority
EP
European Patent Office
Prior art keywords
cap
container
internal
capsule
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
EP19960931110
Other languages
German (de)
French (fr)
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EP0850178A1 (en
Inventor
Antoine Aneas
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.)
Biodome SAS
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Biodome SAS
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Filing date
Publication date
Application filed by Biodome SAS filed Critical Biodome SAS
Publication of EP0850178A1 publication Critical patent/EP0850178A1/en
Application granted granted Critical
Publication of EP0850178B1 publication Critical patent/EP0850178B1/en
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
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • 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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • 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
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • 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
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • 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
    • A61J1/2048—Connecting means
    • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding

Definitions

  • the present invention relates to the connection between a container and a closed container, comprising a neck whose opening is plugged by a plug made of a relatively soft material, for example made of elastomer, and provided with a bead outer annular, said rigid container being by glass example.
  • this connection is used to establish a communication between the aforementioned closed container on one side, and on the other side another closed container, comprising a mouthpiece, the opening of which is also blocked by a plug made of relatively soft and elastic material.
  • This definition relates to different applications at the forefront which includes therapy or administration of a medicine, in which case the closed container contains for example an active principle, in powder form, and the other container consists of a flexible pocket, containing a liquid medium capable of dissolving or suspension of the powder or active ingredient from the container, everything to get a drug preparation under liquid form, ready to be administered to the patient.
  • the closed container contains for example an active principle, in powder form
  • the other container consists of a flexible pocket, containing a liquid medium capable of dissolving or suspension of the powder or active ingredient from the container, everything to get a drug preparation under liquid form, ready to be administered to the patient.
  • connection device intended to be assembled tightly, on one side with a closed container as defined above, comprising tamper-evident, tearable or puncturable means, now the sterility of the cap, and on the other side with another container as defined above, also including means of inviolability tear or puncture, maintaining the sterility of the plug present in the mouthpiece opening, without remove the means of inviolability of the two containers to connect.
  • Such a device is not designed and adapted for ensure inviolability of the container with its cap, since this is obtained by other means already present on the container.
  • this device can be assembled and disassembled at will, relative to the clogged container.
  • this device only provides a seal temporary, at the time of connection, with each of the two containers, in direct contact with their own sealing.
  • connection device with a closed container, such as as defined above, and ensuring its closure, complete, but without inviolability, in the sense that it is not permanently placed on the container.
  • This device cooperates with a container particular, not standardized, distinguished from that defined above, by the presence of an annular rim circumscribing the external annular bead, and forming housing for an also annular flat part of the cap, in this case having a particular and specific form.
  • the capsule described above in one piece with the cap does not provide a tamper-evident function, at sense where these elements can be detached from the annular bead of the container on a voluntary basis or accidental and then replaced and glued for example on this same bead, in which case the user does not have no visible clue or sign of the violation of the connection device, and in particular breaking sterile conditions in the event that the connection is implemented in pharmacy or therapy.
  • the present invention relates to a device effectively tamper-proof connection, further ensuring effective and final sealing of the parts internal, both during storage and work of the container, and this in a simple way.
  • This sealing has in particular the objective of preserving, and the piercing end of the needle means connection, and the outer part of the plug included in the latter inside the capsule, of any external contamination, including breach of sterility of the container, whatever the conditions of use or storage of the connection device.
  • connection device including the volume between the piston of the connection means, the interior of the flange and the outer part of the cap delimited by this capsule, and this under conditions inviolability of the connection device.
  • This result is particularly obtained by simplifying the construction of the connection device, since it does not include not in particular axial or central elements, related to inside the inner capsule, protecting the piercing end of the needle.
  • Inviolability or “inviolability” means the characteristic or result that one cannot dismantle the connection device, and / or access inside the container, or to the product in it last, without leaving any sign or clue of this access, lasting, visible or detectable by the subsequent user of the container.
  • This sign or clue in this case consists of partial destruction or total integrity of the container and / or the device of connection.
  • connection device Being a container containing a medicine, for example, thanks to the invention, on the one hand sterility inside the connection device cannot be ruptured without violating the device and / or the container, and on the other hand, any relative movement between the different parts or components of the connection device is practically excluded, or in any case insufficient to break this tightness.
  • tightness means the absence passage of any liquid, especially contaminated or not sterile, from the outside to the inside of the connection, and / or plug contact, of course in the normal conditions of use, handling, or storage of the container.
  • a device 1 has a double function. On the one hand, it ensures the inviolability of a container 2, for example a glass vial, containing a product not shown, and previously closed or capped; it is for example a traditional bottle containing a powdered medication, closed or blocked, such as that it leaves a chain or conditioning equipment of the same drug. In use, it also allows ensure or establish a tight connection, between the inside of the container 2, on one side, and the inside of a other container (not shown) on the other side, by example a flexible bag containing a liquid intended for to put in solution or suspension the aforementioned drug. Consequently, the container 2 does not include means clean inviolability
  • This bottle 2 has a neck 3, the opening 3a is closed by a plug 4, in a leaktight manner.
  • This plug 4 is made of a relatively soft material, by example an elastomer such as rubber.
  • Pass 3 has around its opening 3a, a bead external annular 3b, serving as described below in mounting and fixing the connection device according to the invention.
  • the plug 4 has a central part cylindrical 4a, adapted to a flexible fitting and waterproof inside the neck 3, and an external part flattened 4b supported on the annular bead 3b.
  • the inner capsule 5 and the outer ring 10 are each made in one piece from a material plastic, or relatively hard material, compared to plug material 4, relatively soft.
  • the outer ring 10 is made of a plastic material having a relatively high modulus of elasticity, by example a technical plastic like a polyamide or high density polyethylene, while the capsule internal is made of a plastic material having a lower modulus of elasticity, for example a low density polyethylene.
  • the internal capsule 5 includes teeth hook 6, separated from each other, distributed angularly around the axis 7 of the capsule, which is the axis of the connection device 1, and forming together a cylindrical skirt.
  • Each tooth 6 has a outward radial elasticity, to come snap into place (see Fig. 3) under the annular bead 3b cervix 3.
  • the teeth hooking 6, and therefore the cylindrical skirt that they constitute therefore have a normal position, that is to say not stressed radially outwards, corresponding to direct contact with the neck 3 and under the annular bead 3b. But they have a outward radial elasticity, reminding them of centripetal towards the neck 3, and allowing them to cross the flattened outer part 4b of the plug 4 and the annular bead 3b of the plug 4, by pushing from above at the bottom of the internal capsule 5 on the neck 3 of the container.
  • Each hooking tooth 6 has a heel internal 6b of suitable shape to cooperate with the rim lower of the annular bead 3b.
  • the internal capsule 5 also includes, in one piece with the teeth attachment 6, a transverse wall, relatively rigid, of support 8 against the flat external part 4b of the relatively soft plug 4.
  • a central opening 8a is provided in the wall 8, in relation to the means 9 described below.
  • This central opening 8a cleaning with the rest of the internal capsule 5 a sidewall annular bearing against the flattened external part 4b of the plug 4.
  • This annular side has on the side of the plug 4 a rib 8b, circumferential and continuous, intended to at least partially penetrate the material relatively soft plug 4.
  • the outer ring 10 is adapted to slide coaxially against and outside the skirt formed by the attachment teeth 6 of the internal capsule 5.
  • This outer ring 10 has a ferrule 10a, circumferentially continuous, provided according to one of its borders, namely its free edge, of an internal ring 11, continuous or discontinuous, latching under the free edge 6a of the internal capsule 5, or more precisely, of its hooking teeth 6.
  • a times the outer ring 10 permanently mounted on the internal capsule 5, with internal ring 11 snapped under the attachment teeth 6, the latter are protected, and are no longer visible or accessible from the outside.
  • This ferrule 10a for example made of plastic, is sufficiently elastic radially to be fitted hard on the inner capsule 5, by tightening the latter, towards the snap-in position of the rod 11, but sufficiently resistant to be breakable, except to destroy definitely the outer ring 10, and therefore the ferrule 10a. Therefore, in the fitted position of the ring outer 10 on the inner capsule 5, the ferrule 10a tightens radially, centripetally, the attachment teeth, and the corresponding skirt, against the neck 3 of the container 2, itself resistant and rigid, since in glass for example.
  • the outer ring 10, and especially the ferrule 10a are made of a material having good mechanical properties, continuously and with no line or zone of weakness as far as the ferrule 10a, which gives the latter characteristics of indecency or indivisibility, except of course to permanently destroy the ferrule 10a, by example with a cutting tool or instrument.
  • the protective means or cap 12 is mounted on the outer ring 10, opposite the inner ring 11, by means of manual separation means 13 of the cap relative to the ring 10.
  • the cap 12 and the ring external 10 are constructed in one piece, plastic, with a perforated circumferential strip weakening separating them, and forming the means 13 of manual separation previously defined.
  • Way to protection or cap 12 is mounted in sealed contact with the outside and with the collar 14 described below, forming part of the connection means 9.
  • This contact waterproof, especially vis-à-vis any liquid, is obtained by any suitable means known per se, for example by thin circumferential strips, stepped, obtained directly by molding outside the flange 14, and engaged with the inner bearing of the cap 12.
  • Stop means 30 in translation are arranged between the outer ring 10 and the flange 14 of the capsule 5, in addition to the internal rod 11, in the fitted position of the outer ring 10 on the inner capsule 5.
  • These means consist of a rib circumferential protruding inside the ring external 10, and a corresponding circumferential groove formed on the outside of the collar 14. The whole allows with the internal ring 11 to lock permanently in translation of the outer ring 10 on the inner capsule 5.
  • Rotation stop means 31 are arranged between the outer ring 10 and the inner capsule 5, in the fitted position of the outer ring 10 on the capsule.
  • These means include for example internal longitudinal ribs on the outer ring 10, cooperating with external longitudinal grooves, corresponding and adapted, arranged on the collar 14.
  • These provisions allow the rotation to be blocked outer ring 10, in its fitted position on the inner capsule 5, which avoids digging or form a hollow mark in the cap 4, always detrimental to sealing, in correspondence with the rib 8b.
  • the internal capsule 5 comprises or defines a groove 24 adapted to receive the rod inner 11 of the outer ring 10, and allow a provisional and coaxial assembly of the capsule 5 and the ring 10.
  • connection means comprise, on one side a flange 14 extending in one piece and coaxially the internal capsule 5, and forming a bore internal 14a, and on the other side, a piston 15 mounted sliding way in the bore 14a, between a position disconnected, shown in Figures 3 and 4, in which the piston is opposite and at a distance from the plug 4, and a connected position, not shown, in which the piston 15 is placed on the side and against the plug 4, and its flattened outer part 4b.
  • a central needle or coaxial 16 passes through the piston 15, and has a end 16a of perforation of plug 4, and another connection end 16b, for example with another container, in particular a flexible bag of liquid by example.
  • This needle 16 is made of metal or plastic material, with one or two flow channels.
  • connection end 16a and / or 16b is optionally arranged to prevent the release of particles or fragments resulting from the perforation of the plug 4.
  • the cap 12 and the ring 10 are adapted relative to each other, to contain the connection means 9, in their disconnected position relative to the interior of container 2, i.e. with the piston 15 placed at a distance from the plug 4, without no penetration of the perforation end 16a of the needle 16 in said plug.
  • the piston 15 includes a transverse core 15a through which the needle passes 16, and an external sleeve 15b, opposite the plug 4, guiding any tip of another container, for example a liquid pocket, with which connects the inside of the container 2.
  • the container 2 is returned inviolable, since the internal capsule 5 cannot be detached from container 2 only by breaking, and therefore by destroying the shell 10a, with no possibility for the user to piece together the device shutter 1.
  • the inside of the collar 14 is permanently insulated tightly from the outside, in particular by compared to liquids, which allows in particular to preserve its sterility.
  • small displacements relative of the device 1 according to the invention, with respect to the container 2 are not able to break this sealing.
  • the capsule internal 5 directly covers the neck 3 of the container, glass contact, without interposition of any other means tamper-evident, such as a plastic collar or tearable metal. It is the same for the wall transverse 8 of the internal capsule 5 which is in support direct against the external part of the plug 4.
  • the container 2 When using for the first time, separating the cap 12 of ring 10, along the line of separation 13, in accordance with FIG. 4, the container 2 is ready for use, due to the accessibility of the connection means 9, which in particular can then be activated in its connected position, by pushing the piston 15 towards the plug 4, while inserting the end 16b, needle 16 in the tip of another container or pocket.

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Closures For Containers (AREA)
  • Cartons (AREA)
  • Dry Development In Electrophotography (AREA)
  • Connector Housings Or Holding Contact Members (AREA)
  • Supplying Of Containers To The Packaging Station (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

PCT No. PCT/FR96/01399 Sec. 371 Date May 12, 1997 Sec. 102(e) Date May 12, 1997 PCT Filed Sep. 11, 1996 PCT Pub. No. WO97/10156 PCT Pub. Date Mar. 20, 1997Device (1) for sealing a closed container (2) comprising a neck (3), the opening (3a) of which is plugged, and provided with an external annular lip (3b), the device firstly comprising an internal cap (5) for fitting coaxially over the neck (3) of the plugged container (2), comprising catching teeth (6) distributed angularly about the axis (7) of the cap, each teeth having a radially outwards elasticity starting from a position (FIG. 3) of snap-fastening under the annular lip (3b), secondly, means (9) of access, which are arranged on the cap (5), and thirdly, an external sleeve (10) for sliding coaxially against and on the outside of the catching teeth (6), including a circumferentially continuous band (10a) provided along one of its edges with an internal annular ridge which may be continuous or discontinuous, for snap-fastening under the rim (6a), when the said sleeve (10) is in the fitted position. The band is radially elastic so that it can be fitted onto the cap when the annular ridge (11) is in the snap-fastened position, but strong so as to be indivisible, unless the said sleeve (10) is permanently destroyed.

Description

La présente invention concerne la connexion entre un contenant et un récipient fermé, comprenant un col dont l'ouverture est bouchée par un bouchon en un matériau relativement mou, par exemple en élastomère, et pourvu d'un bourrelet annulaire externe, ledit récipient rigide étant par exemple en verre. De manière préférentielle mais non exclusive, cette connexion sert à établir une communication entre d'un côté le récipient fermé précité, et de l'autre côté un autre récipient fermé, comprenant un embout, dont l'ouverture est également bouchée par un bouchon en matériau relativement mou et élastique. Cette définition concerne différentes applications au rang desquelles figure la thérapeutique ou l'administration d'un médicament, auquel cas le récipient fermé contient par exemple un principe actif, sous forme de poudre, et l'autre récipient consiste en une poche souple, contenant un milieu liquide susceptible de dissoudre ou mettre en suspension la poudre ou principe actif du récipient, le tout pour obtenir une préparation médicamenteuse sous forme liquide, prête à être administrée au patient.The present invention relates to the connection between a container and a closed container, comprising a neck whose opening is plugged by a plug made of a relatively soft material, for example made of elastomer, and provided with a bead outer annular, said rigid container being by glass example. Preferably but not exclusive, this connection is used to establish a communication between the aforementioned closed container on one side, and on the other side another closed container, comprising a mouthpiece, the opening of which is also blocked by a plug made of relatively soft and elastic material. This definition relates to different applications at the forefront which includes therapy or administration of a medicine, in which case the closed container contains for example an active principle, in powder form, and the other container consists of a flexible pocket, containing a liquid medium capable of dissolving or suspension of the powder or active ingredient from the container, everything to get a drug preparation under liquid form, ready to be administered to the patient.

Conformément au document WO-9003536, on a décrit et proposé un dispositif de connexion, ou raccord, destiné à s'assembler de manière étanche, d'un côté avec un récipient fermé tel que défini précédemment, comprenant des moyens d'inviolabilité, déchirables ou perforables, maintenant la stérilité du bouchon, et de l'autre côté avec un autre récipient tel que défini précédemment, comprenant lui aussi des moyens d'inviolabilité déchirables ou perforables, maintenant la stérilité du bouchon présent dans l'ouverture de l'embout, et ce sans retirer les moyens d'inviolabilité des deux récipients à raccorder.In accordance with document WO-9003536, there has been described and proposed a connection device, or fitting, intended to be assembled tightly, on one side with a closed container as defined above, comprising tamper-evident, tearable or puncturable means, now the sterility of the cap, and on the other side with another container as defined above, also including means of inviolability tear or puncture, maintaining the sterility of the plug present in the mouthpiece opening, without remove the means of inviolability of the two containers to connect.

Ce dispositif de connexion comprend :

  • une capsule adaptée pour coiffer coaxialement le col du récipient bouché avec le bouchon, et revêtue également autour du bourrelet annulaire par les moyens d'inviolabilité recouvrant et étanchant la totalité de la partie externe du bouchon ; cette capsule est également adaptée pour se monter sur le col 3, et présente à cette fin une élasticité radiale vers l'extérieur pour s'encliqueter, au moyen d'un jonc interne, sous le bourrelet annulaire du col du récipient ; par ailleurs cette capsule comprend une collerette coaxiale la prolongeant et formant un alésage interne, dont il sera question ci-après,
  • un élément transversal, en matériau élastomère, souple et élastique, rapporté et disposé à l'intérieur de la capsule, comportant une paroi transversale agencée pour venir en contact avec la partie externe du bouchon ; cet élément transversal comprend un manchon ou embout axial emboíté de manière étanche sur l'extrémité de perforation de l'aiguille dont il sera question ci-après, ce manchon étant fermé et perforable à son extrémité obturant l'aiguille,
  • des moyens de connexion avec l'intérieur du récipient, au travers du bouchon, comprenant un piston monté de manière coulissante dans l'alésage de la collerette de la capsule, et une aiguille centrale traversant ledit piston, et comportant l'extrémité de perforation précitée, encapuchonnée dans le manchon ou embout de l'élément transversal en élastomère.
This connection device includes:
  • a capsule suitable for coaxially covering the neck of the stoppered container with the stopper, and also coated around the annular bead by the tamper-evident means covering and sealing all of the external part of the stopper; this capsule is also suitable for mounting on the neck 3, and has for this purpose a radial elasticity towards the outside to snap, by means of an internal ring, under the annular bead of the neck of the container; moreover, this capsule comprises a coaxial flange extending it and forming an internal bore, which will be discussed below,
  • a transverse element, made of elastomeric material, flexible and elastic, attached and disposed inside the capsule, comprising a transverse wall arranged to come into contact with the external part of the stopper; this transverse element comprises a sleeve or axial end fitting tightly fitted on the perforation end of the needle which will be discussed below, this sleeve being closed and perforable at its end closing the needle,
  • means for connection with the interior of the container, through the cap, comprising a piston slidably mounted in the bore of the flange of the capsule, and a central needle passing through said piston, and comprising the aforementioned perforation end , encased in the sleeve or end piece of the elastomeric cross member.

Un tel dispositif n'est pas agencé et adapté pour assurer une inviolabilité du récipient avec son bouchon, puisque celle-ci est obtenue par d'autres moyens déjà présents sur le récipient. En particulier, ce dispositif peut être monté et démonté à volonté, par rapport au récipient bouché.Such a device is not designed and adapted for ensure inviolability of the container with its cap, since this is obtained by other means already present on the container. In particular, this device can be assembled and disassembled at will, relative to the clogged container.

Et ce dispositif n'assure qu'une étanchéité provisoire, au moment de la connexion, avec chacun des deux récipients, au contact direct de leur propres moyens d'étanchéité.And this device only provides a seal temporary, at the time of connection, with each of the two containers, in direct contact with their own sealing.

Conformément au document US-C4624667, on a décrit un dispositif de connexion avec un récipient fermé, tel que défini précédemment, et assurant sa fermeture, complète, mais sans inviolabilité, au sens où il n'est pas mis en place définitivement sur le récipient.In accordance with document US-C4624667, there has been described a connection device with a closed container, such as as defined above, and ensuring its closure, complete, but without inviolability, in the sense that it is not permanently placed on the container.

Ce dispositif coopère avec un récipient particulier, non standardisé, se distinguant de celui défini précédemment, par la présence d'un rebord annulaire circonscrivant le bourrelet annulaire externe, et formant logement pour un méplat également annulaire du bouchon, ayant dans ce cas une forme particulière et spécifique.This device cooperates with a container particular, not standardized, distinguished from that defined above, by the presence of an annular rim circumscribing the external annular bead, and forming housing for an also annular flat part of the cap, in this case having a particular and specific form.

Le dispositif de connexion proprement dit comprend :

  • un manchon axial et extérieur monobloc avec le bouchon en matériau élastomère, formant à son extrémité borgne un opercule perforable par l'aiguille centrale
  • des moyens de connexion avec l'intérieur du récipient, constitués uniquement par une aiguille centrale ou axiale, maintenue dans le manchon précité par son extrémité de perforation,
  • une capsule tubulaire, scellée par un rebord sur le rebord annulaire du col du récipient,
  • un moyen de protection ou capuchon, prolongeant coaxialement la capsule par l'intermédiaire d'un moyen de séparation manuelle, telle qu'une ligne circonférencielle d'affaiblissement de matière plastique, le capuchon et la capsule étant ensemble agencés pour coiffer coaxialement l'aiguille des moyens de connexion, et en particulier son autre extrémité perforante.
The connection device itself includes:
  • a one-piece axial and external sleeve with the stopper made of elastomeric material, forming at its blind end a cover perforable by the central needle
  • means of connection with the interior of the container, constituted solely by a central or axial needle, held in the aforementioned sleeve by its perforation end,
  • a tubular capsule, sealed by a rim on the annular rim of the container neck,
  • a protective means or cap, coaxially extending the capsule by means of a manual separation means, such as a circumferential line of weakening of plastic material, the cap and the capsule being together arranged to cap the needle coaxially connection means, and in particular its other perforating end.

La capsule décrite précédemment, monobloc avec le capuchon n'assure pas une fonction d'inviolabilité, au sens où ces éléments peuvent être détachés par rapport au bourrelet annulaire du récipient de manière volontaire ou accidentelle, puis replacés et collés par exemple sur ce même bourrelet, auquel cas l'utilisateur ne dispose d'aucun indice ou signe, visible, de la violation du dispositif de connexion, et en particulier de la rupture des conditions stériles dans le cas où le dispositif de connexion est mis en oeuvre en pharmacie ou thérapeutique.The capsule described above, in one piece with the cap does not provide a tamper-evident function, at sense where these elements can be detached from the annular bead of the container on a voluntary basis or accidental and then replaced and glued for example on this same bead, in which case the user does not have no visible clue or sign of the violation of the connection device, and in particular breaking sterile conditions in the event that the connection is implemented in pharmacy or therapy.

La présente invention a pour objet un dispositif de connexion effectivement inviolable, assurant de plus une étanchéité effective et définitive des parties internes, aussi bien pendant le stockage que la mise en oeuvre du récipient, et ce de manière simple. Cette étanchéité a en particulier pour objectif de préserver, et l'extrémité de perforation de l'aiguille des moyens de connexion, et la partie extérieure du bouchon comprise dans ce dernier à l'intérieur de la capsule, de toute contamination externe, notamment rupture de stérilité du récipient, quelque soient les conditions d'utilisation ou stockage du dispositif de connexion.The present invention relates to a device effectively tamper-proof connection, further ensuring effective and final sealing of the parts internal, both during storage and work of the container, and this in a simple way. This sealing has in particular the objective of preserving, and the piercing end of the needle means connection, and the outer part of the plug included in the latter inside the capsule, of any external contamination, including breach of sterility of the container, whatever the conditions of use or storage of the connection device.

Conformément à l'invention, les moyens suivants coopèrent à cette fin :

  • la capsule est tout d'abord adaptée pour coiffer directement le col du récipient, et venir au contact de sa paroi,
  • la paroi transversale de la capsule est réalisée en un matériau relativement dur, pour venir directement en appui contre la partie externe du bouchon, et elle comporte une ouverture centrale, pour le passage de l'aiguille de sa position déconnectée à sa position connectée, avec perforation du bouchon,
  • il est prévu en outre une bague externe adaptée pour coulisser coaxialement entre et à l'extérieur de la capsule interne, comportant une virole circonférentiellement continue, pourvue selon l'une de ses bordures d'un jonc interne d'encliquetage sous le rebord libre de la capsule interne ; cette virole est suffisamment élastique radialement pour s'emmancher dur contre la capsule interne, et serrer cette dernière et s'encliqueter par le jonc sous le bord libre de la capsule interne, mais suffisamment résistante pour être insécable, sauf à vouloir la détruire.
  • il est prévu également un moyen de protection des moyens de connexion vis-à-vis de l'extérieur, en contact étanche avec la collerette de la capsule.
In accordance with the invention, the following means cooperate for this purpose:
  • the capsule is first of all suitable for directly styling the neck of the container, and coming into contact with its wall,
  • the transverse wall of the capsule is made of a relatively hard material, to come directly to bear against the external part of the stopper, and it has a central opening, for the passage of the needle from its disconnected position to its connected position, with perforation of the cap,
  • there is also provided an external ring adapted to slide coaxially between and outside the internal capsule, comprising a circumferentially continuous ferrule, provided along one of its edges with an internal snap ring under the free edge of the internal capsule; this ferrule is sufficiently radially elastic to be fitted hard against the internal capsule, and to tighten the latter and snap into place by the ring under the free edge of the internal capsule, but sufficiently resistant to be indivisible, unless it is desired to destroy it.
  • there is also provided a means of protecting the connection means from the outside, in sealed contact with the flange of the capsule.

Le tout aboutit à la mise sous étanchéité définitive, et à son maintien dans le temps, sauf à détruire le dispositif de connexion, du volume compris entre le piston des moyens de connexion, l'intérieur de la collerette et la partie extérieure du bouchon délimitée par cette capsule, et ce dans des conditions d'inviolabilité du dispositif de connexion. Ce résultat est en particulier obtenu en simplifiant la construction du dispositif de connexion, puisque celui-ci ne comporte pas en particulier d'éléments axial ou central, rapporté à l'intérieur de la capsule interne, de protection de l'extrémité de perforation de l'aiguille.All this leads to sealing definitive, and its maintenance over time, except destroy the connection device, including the volume between the piston of the connection means, the interior of the flange and the outer part of the cap delimited by this capsule, and this under conditions inviolability of the connection device. This result is particularly obtained by simplifying the construction of the connection device, since it does not include not in particular axial or central elements, related to inside the inner capsule, protecting the piercing end of the needle.

Par "inviolabilité" ou "inviolable", on entend la caractéristique ou le résultat selon lequel on ne peut démanteler le dispositif de connexion, et/ou accéder à l'intérieur du récipient, ou au produit contenu dans ce dernier, sans laisser subsister un signe ou un indice de cet accès, durable, visible ou détectable par l'utilisateur ultérieur du récipient. Ce signe ou indice consiste dans le cas présent dans la destruction partielle ou totale de l'intégrité du récipient et/ou du dispositif de connexion."Inviolability" or "inviolability" means the characteristic or result that one cannot dismantle the connection device, and / or access inside the container, or to the product in it last, without leaving any sign or clue of this access, lasting, visible or detectable by the subsequent user of the container. This sign or clue in this case consists of partial destruction or total integrity of the container and / or the device of connection.

S'agissant d'un récipient contenant un médicament, par exemple, grâce à l'invention, d'une part la stérilité à l'intérieur du dispositif de connexion ne peut être rompue sans violer le dispositif et/ou le récipient, et d'autre part, tout mouvement relatif entre les différentes parties ou composants du dispositif de connexion est pratiquement exclu, ou en tout cas insuffisant pour rompre cette étanchéité. Being a container containing a medicine, for example, thanks to the invention, on the one hand sterility inside the connection device cannot be ruptured without violating the device and / or the container, and on the other hand, any relative movement between the different parts or components of the connection device is practically excluded, or in any case insufficient to break this tightness.

Par "étanchéité" ou "étanche", on entend l'absence de passage de tout liquide, notamment contaminé ou non stérile, de l'extérieur vers l'intérieur du dispositif de connexion, et/ou contact du bouchon, bien entendu dans les conditions normales d'utilisation, manipulation, ou stockage du récipient.By "tightness" or "tightness" means the absence passage of any liquid, especially contaminated or not sterile, from the outside to the inside of the connection, and / or plug contact, of course in the normal conditions of use, handling, or storage of the container.

La coopération des caractéristiques techniques définies précédemment apporte par ailleurs d'autres avantages.

  • elle permet tout d'abord d'utiliser au maximum les caractéristiques propres, viscoélastiques, du bouchon, en terme d'étanchéité, aussi bien par rapport à l'extérieur que par rapport à l'intérieur du récipient.
  • les moyens de l'invention permettent aussi de s'affranchir des tolérances relativement importantes, et du bouchon en terme d'épaisseur, et du bourrelet annulaire du récipient, toujours en terme d'épaisseur, ce qui signifie qu'au maximum des tolérances précitées, l'intérieur du dispositif de connexion demeure étanche vis-à-vis de l'extérieur.
  • le dispositif de connexion demeure compatible avec tous les récipients standards, tels qu'utilisés en particulier en pharmacie, et conformes aux normes ISO4362-3 ou ISO8362-1,
  • l'utilisateur ne dispose d'aucun moyen visible ou externe, lui permettant facilement de forcer ou violer le dispositif de connexion, une fois celui-ci monté définitivement sur le récipient fermé,
  • et ce dispositif peut être facilement monté sur le récipient déjà fermé, sans modifier en particulier les chaínes ou équipements de conditionnement du produit contenu dans ledit récipient.
The cooperation of the technical characteristics defined above also brings other advantages.
  • firstly, it allows the maximum use of the specific, viscoelastic, characteristics of the stopper, in terms of sealing, both with respect to the exterior and with respect to the interior of the container.
  • the means of the invention also make it possible to overcome relatively large tolerances, and of the stopper in terms of thickness, and of the annular bead of the container, always in terms of thickness, which means that at the maximum of the above-mentioned tolerances , the interior of the connection device remains watertight vis-à-vis the exterior.
  • the connection device remains compatible with all standard containers, as used in particular in pharmacies, and complies with ISO4362-3 or ISO8362-1 standards,
  • the user has no visible or external means, allowing him easily to force or violate the connection device, once it is permanently mounted on the closed container,
  • and this device can be easily mounted on the already closed container, without modifying in particular the chains or equipment for packaging the product contained in said container.

La présente invention est maintenant décrite par référence au dessin annexé dans lequel :

  • la figure 1 représente, en vue éclatée, un dispositif de connexion conforme à l'invention, en relation avec le récipient bouché ou fermé, auquel il est destiné ;
  • la figure 2 représente, une étape du montage du dispositif de connexion selon figure 1, pendant laquelle la bague externe est montée provisoirement sur la capsule interne, cette dernière étant encliquetée sous le col du récipient ;
  • la figure 3 représente le dispositif de connexion selon figure 1, définitivement monté sur le récipient bouché ;
  • la figure 4 représente le récipient avec son dispositif de connexion duquel a été séparé un capuchon.
The present invention is now described with reference to the accompanying drawing in which:
  • Figure 1 shows, in exploded view, a connection device according to the invention, in relation to the stoppered or closed container, for which it is intended;
  • 2 shows a step in mounting the connection device according to Figure 1, during which the outer ring is temporarily mounted on the inner capsule, the latter being snapped under the neck of the container;
  • Figure 3 shows the connection device according to Figure 1, permanently mounted on the stoppered container;
  • Figure 4 shows the container with its connection device from which a cap has been separated.

Un dispositif 1 selon la présente invention a une double fonction. Il assure d'une part l'inviolabilité d'un récipient 2, par exemple un flacon en verre, contenant un produit non représenté, et préalablement fermé ou bouché ; il s'agit par exemple d'un flacon traditionnel contenant un médicament sous forme de poudre, fermé ou bouché, tel qu'il sort d'une chaíne ou équipement de conditionnement du même médicament. En utilisation, il permet d'autre part d'assurer ou établir une connexion étanche, entre l'intérieur du récipient 2, d'un côté, et l'intérieur d'un autre contenant (non représenté) de l'autre côté, par exemple une poche souple contenant un liquide destiné à mettre en solution ou suspension le médicament précité. Par conséquent, le récipient 2 ne comporte pas des moyens propres d'inviolabilitéA device 1 according to the present invention has a double function. On the one hand, it ensures the inviolability of a container 2, for example a glass vial, containing a product not shown, and previously closed or capped; it is for example a traditional bottle containing a powdered medication, closed or blocked, such as that it leaves a chain or conditioning equipment of the same drug. In use, it also allows ensure or establish a tight connection, between the inside of the container 2, on one side, and the inside of a other container (not shown) on the other side, by example a flexible bag containing a liquid intended for to put in solution or suspension the aforementioned drug. Consequently, the container 2 does not include means clean inviolability

Ce flacon 2 comporte un col 3, dont l'ouverture 3a est bouchée par un bouchon 4, de manière étanche. Ce bouchon 4 est réalisé en un matériau relativement mou, par exemple un élastomère comme du caoutchouc. Le col 3 comporte autour de son ouverture 3a, un bourrelet annulaire 3b externe, servant comme décrit ci-après au montage et à la fixation du dispositif de connexion selon l'invention. Le bouchon 4 comporte une partie centrale cylindrique 4a, adaptée à un emmanchement souple et étanche à l'intérieur du col 3, et une partie externe aplatie 4b épaulée sur le bourrelet annulaire 3b.This bottle 2 has a neck 3, the opening 3a is closed by a plug 4, in a leaktight manner. This plug 4 is made of a relatively soft material, by example an elastomer such as rubber. Pass 3 has around its opening 3a, a bead external annular 3b, serving as described below in mounting and fixing the connection device according to the invention. The plug 4 has a central part cylindrical 4a, adapted to a flexible fitting and waterproof inside the neck 3, and an external part flattened 4b supported on the annular bead 3b.

Pour l'essentiel, un dispositif de connexion selon l'invention comprend :

  • une capsule interne 5 adaptée pour coiffer coaxialement et se fixer sur le col 3 du récipient 2, bouché avec le bouchon 4,
  • des moyens de connexion 9 avec l'intérieur du récipient 2, au travers du bouchon 4, disposés et coopérant avec la capsule interne 5,
  • une bague externe 10 adaptée pour coulisser coaxialement contre et à l'extérieur de la capsule interne 5 , et se monter définitivement sur cette dernière, en serrant la capsule 5,
  • un moyen de protection ou capuchon 12, vis-à-vis du moyen de connexion 9, monté sur la bague externe 10.
Essentially, a connection device according to the invention comprises:
  • an internal capsule 5 suitable for styling coaxially and fixing on the neck 3 of the container 2, closed with the stopper 4,
  • connection means 9 with the interior of the container 2, through the plug 4, arranged and cooperating with the internal capsule 5,
  • an external ring 10 adapted to slide coaxially against and outside the internal capsule 5, and to be permanently mounted on the latter, by tightening the capsule 5,
  • a protection means or cap 12, opposite the connection means 9, mounted on the outer ring 10.

La capsule interne 5 et la bague externe 10 sont réalisées chacune de manière monobloc en une matière plastique, ou matériau relativement dur, par rapport au matériau du bouchon 4, relativement mou. En particulier, la bague externe 10 est réalisée en un matériau plastique ayant un module d'élasticité relativement important, par exemple une matière plastique technique comme un polyamide ou un polyéthylène haute densité, tandis que la capsule interne est réalisée en un matériau plastique ayant un module d'élasticité plus faible, par exemple un polyéthylène basse densité.The inner capsule 5 and the outer ring 10 are each made in one piece from a material plastic, or relatively hard material, compared to plug material 4, relatively soft. In particular, the outer ring 10 is made of a plastic material having a relatively high modulus of elasticity, by example a technical plastic like a polyamide or high density polyethylene, while the capsule internal is made of a plastic material having a lower modulus of elasticity, for example a low density polyethylene.

La capsule interne 5 comprend des dents d'accrochage 6, séparées les unes des autres, distribuées angulairement autour de l'axe 7 de la capsule, qui est l'axe du dispositif de connexion 1, et formant ensemble une jupe de forme cylindrique. Chaque dent 6 dispose d'une élasticité radiale vers l'extérieur, pour venir s'encliqueter (Cf. Fig.3) sous le bourrelet annulaire 3b du col 3. The internal capsule 5 includes teeth hook 6, separated from each other, distributed angularly around the axis 7 of the capsule, which is the axis of the connection device 1, and forming together a cylindrical skirt. Each tooth 6 has a outward radial elasticity, to come snap into place (see Fig. 3) under the annular bead 3b cervix 3.

Comme représenté à la figure 1, les dents d'accrochage 6, et par conséquent la jupe cylindrique qu'elles constituent, ont donc une position normale, c'est-à-dire non sollicitée radialement vers l'extérieur, correspondant à un contact direct avec le col 3 et sous le bourrelet annulaire 3b. Mais elles disposent d'une élasticité radiale vers l'extérieur, les rappelant de manière centripète vers le col 3, et leur permettant de franchir la partie externe aplatie 4b du bouchon 4 et le bourrelet annulaire 3b du bouchon 4, par poussée de haut en bas de la capsule interne 5 sur le col 3 du récipient.As shown in Figure 1, the teeth hooking 6, and therefore the cylindrical skirt that they constitute, therefore have a normal position, that is to say not stressed radially outwards, corresponding to direct contact with the neck 3 and under the annular bead 3b. But they have a outward radial elasticity, reminding them of centripetal towards the neck 3, and allowing them to cross the flattened outer part 4b of the plug 4 and the annular bead 3b of the plug 4, by pushing from above at the bottom of the internal capsule 5 on the neck 3 of the container.

Chaque dent d'accrochage 6 comporte un talon interne 6b de forme adaptée pour coopérer avec le rebord inférieur du bourrelet annulaire 3b. La capsule interne 5 comporte également, de manière monobloc avec les dents d'accrochage 6, une paroi transversale, relativement rigide, d'appui 8 contre la partie externe plane 4b du bouchon 4 relativement molle. Une ouverture centrale 8a est ménagée dans la paroi 8, en relation avec les moyens de connexion 9 décrits ci-après. Cette ouverture centrale 8a ménage avec le reste de la capsule interne 5 un flanc annulaire d'appui contre la partie externe aplatie 4b du bouchon 4. Ce flanc annulaire comporte du côté du bouchon 4 une nervure 8b, circonférencielle et continue, destinée à pénétrer au moins partiellement dans le matériau relativement mou du bouchon 4.Each hooking tooth 6 has a heel internal 6b of suitable shape to cooperate with the rim lower of the annular bead 3b. The internal capsule 5 also includes, in one piece with the teeth attachment 6, a transverse wall, relatively rigid, of support 8 against the flat external part 4b of the relatively soft plug 4. A central opening 8a is provided in the wall 8, in relation to the means 9 described below. This central opening 8a cleaning with the rest of the internal capsule 5 a sidewall annular bearing against the flattened external part 4b of the plug 4. This annular side has on the side of the plug 4 a rib 8b, circumferential and continuous, intended to at least partially penetrate the material relatively soft plug 4.

La bague externe 10 est adaptée pour coulisser coaxialement contre et à l'extérieur de la jupe formée par les dents d'accrochage 6 de la capsule interne 5. Cette bague externe 10 comporte une virole 10a, circonférentiellement continue, pourvue selon l'une de ses bordures à savoir son bord libre, d'un jonc interne 11, continu ou discontinu, d'encliquetage sous le rebord libre 6a de la capsule interne 5, ou plus précisément, de ses dents d'accrochage 6. Comme représenté à la figure 3, une fois la bague externe 10 montée définitivement sur la capsule interne 5, avec le jonc interne 11 encliqueté sous les dents d'accrochage 6, ces dernières sont protégées, et ne sont plus visibles ni accessibles par l'extérieur. Cette virole 10a, par exemple en matière plastique, est suffisamment élastique radialement pour être emmanchée dur sur la capsule interne 5, en serrant cette dernière, vers la position encliquetée du jonc 11, mais suffisamment résistante pour être insécable, sauf à détruire définitivement la bague externe 10, et donc la virole 10a. Par conséquent, dans la position emmanchée de la bague externe 10 sur la capsule interne 5, la virole 10a serre radialement, de manière centripète, les dents d'accroche, et la jupe correspondante, contre le col 3 du récipient 2, lui-même résistant et rigide, puisqu'en verre par exemple. Comme dit plus haut, la bague externe 10, et en particulier la virole 10a, sont réalisées en un matériau ayant de bonnes propriétés mécaniques, de manière continue et sans ligne ou zone d'affaiblissement en ce qui concerne la virole 10a, ce qui confère à cette dernière des caractéristiques d'indéchirabilité ou insécabilité, sauf bien entendu à détruire définitivement la virole 10a, par exemple avec un outil ou instrument coupant.The outer ring 10 is adapted to slide coaxially against and outside the skirt formed by the attachment teeth 6 of the internal capsule 5. This outer ring 10 has a ferrule 10a, circumferentially continuous, provided according to one of its borders, namely its free edge, of an internal ring 11, continuous or discontinuous, latching under the free edge 6a of the internal capsule 5, or more precisely, of its hooking teeth 6. As shown in FIG. 3, a times the outer ring 10 permanently mounted on the internal capsule 5, with internal ring 11 snapped under the attachment teeth 6, the latter are protected, and are no longer visible or accessible from the outside. This ferrule 10a, for example made of plastic, is sufficiently elastic radially to be fitted hard on the inner capsule 5, by tightening the latter, towards the snap-in position of the rod 11, but sufficiently resistant to be breakable, except to destroy definitely the outer ring 10, and therefore the ferrule 10a. Therefore, in the fitted position of the ring outer 10 on the inner capsule 5, the ferrule 10a tightens radially, centripetally, the attachment teeth, and the corresponding skirt, against the neck 3 of the container 2, itself resistant and rigid, since in glass for example. As said above, the outer ring 10, and especially the ferrule 10a, are made of a material having good mechanical properties, continuously and with no line or zone of weakness as far as the ferrule 10a, which gives the latter characteristics of indecency or indivisibility, except of course to permanently destroy the ferrule 10a, by example with a cutting tool or instrument.

Le moyen de protection ou capuchon 12 est monté sur la bague externe 10, à l'opposé du jonc interne 11, par l'intermédiaire d'un moyen 13 de séparation manuelle du capuchon par rapport à la bague 10. Préférentiellement, mais de manière non exclusive, le capuchon 12 et la bague externe 10 sont construits de manière monobloc, en matière plastique, avec une bande circonférentielle perforée d'affaiblissement les séparant, et formant le moyen 13 de séparation manuelle défini précédemment. Le moyen de protection ou capuchon 12 est monté en contact étanche à l'extérieur et avec la collerette 14 décrite ci-après, formant une partie des moyens de connexion 9. Ce contact étanche, notamment vis-à-vis de tout liquide, est obtenu selon tout moyen approprié et connu en soi, par exemple par de fines lamelles circonférencielles, étagées, obtenues directement par moulage à l'extérieur de la collerette 14, et engagées avec la portée intérieure du capuchon 12.The protective means or cap 12 is mounted on the outer ring 10, opposite the inner ring 11, by means of manual separation means 13 of the cap relative to the ring 10. Preferably, but not exclusively, the cap 12 and the ring external 10 are constructed in one piece, plastic, with a perforated circumferential strip weakening separating them, and forming the means 13 of manual separation previously defined. Way to protection or cap 12 is mounted in sealed contact with the outside and with the collar 14 described below, forming part of the connection means 9. This contact waterproof, especially vis-à-vis any liquid, is obtained by any suitable means known per se, for example by thin circumferential strips, stepped, obtained directly by molding outside the flange 14, and engaged with the inner bearing of the cap 12.

Des moyens d'arrêt 30 en translation sont agencés entre la bague externe 10 et la collerette 14 de la capsule 5, de manière complémentaire au jonc interne 11, dans la position emmanchée de la bague externe 10 sur la capsule interne 5. Ces moyens consistent en une nervure circonférentielle saillant à l'intérieur de la bague externe 10, et une gorge correspondante circonférentielle ménagée à l'extérieur de la collerette 14. Le tout permet avec le jonc interne 11 de bloquer définitivement en translation la bague externe 10 sur la capsule interne 5.Stop means 30 in translation are arranged between the outer ring 10 and the flange 14 of the capsule 5, in addition to the internal rod 11, in the fitted position of the outer ring 10 on the inner capsule 5. These means consist of a rib circumferential protruding inside the ring external 10, and a corresponding circumferential groove formed on the outside of the collar 14. The whole allows with the internal ring 11 to lock permanently in translation of the outer ring 10 on the inner capsule 5.

Des moyens 31 d'arrêt en rotation sont agencés entre la bague externe 10 et la capsule interne 5, dans la position emmanchée de la bague externe 10 sur la capsule. Ces moyens non représentés comportent par exemple des nervures longitudinales internes sur la bague externe 10, coopérant avec des gorges longitudinales externes, correspondantes et adaptées, ménagées sur la collerette 14. Ces dispositions permettent de bloquer en rotation la bague externe 10 , dans sa position emmanchée sur la capsule interne 5, ce qui permet d'éviter de creuser ou former dans le bouchon 4 une marque en creux, toujours nuisible à l'étanchéité, en correspondance avec la nervure 8b.Rotation stop means 31 are arranged between the outer ring 10 and the inner capsule 5, in the fitted position of the outer ring 10 on the capsule. These means, not shown, include for example internal longitudinal ribs on the outer ring 10, cooperating with external longitudinal grooves, corresponding and adapted, arranged on the collar 14. These provisions allow the rotation to be blocked outer ring 10, in its fitted position on the inner capsule 5, which avoids digging or form a hollow mark in the cap 4, always detrimental to sealing, in correspondence with the rib 8b.

Pour faciliter, par voie automatique, l'assemblage du dispositif de connexion, puis son montage définitif sur le récipient fermé, la capsule interne 5 comporte ou définit une rainure 24 adaptée pour recevoir le jonc interne 11 de la bague externe 10, et permettre un assemblage provisoire et coaxial de la capsule 5 et de la bague 10.To facilitate automatic assembly of the connection device, then its final mounting on the closed container, the internal capsule 5 comprises or defines a groove 24 adapted to receive the rod inner 11 of the outer ring 10, and allow a provisional and coaxial assembly of the capsule 5 and the ring 10.

Les moyens de connexion comprennent, d'un côté une collerette 14 prolongeant de manière monobloc et coaxialement la capsule interne 5, et formant un alésage interne 14a, et de l'autre côté, un piston 15 monté de manière coulissante dans l'alésage 14a, entre une position déconnectée, représentée aux figures 3 et 4, dans laquelle le piston se trouve à l'opposé et à distance du bouchon 4, et une position connectée, non représentée, dans laquelle le piston 15 est disposé du côté et contre le bouchon 4, et sa partie extérieure aplatie 4b. Une aiguille centrale ou coaxiale 16 traverse le piston 15, et comporte une extrémité 16a de perforation du bouchon 4, et une autre extrémité de connexion 16b, par exemple avec un autre récipient, notamment une poche souple d'un liquide par exemple. Cette aiguille 16 est réalisée en métal ou matière plastique, avec un ou deux canaux d'écoulement. L'extrémité de connexion 16a et/ou 16 b est éventuellement agencée pour éviter la libération de particules ou fragments résultant de la perforation du bouchon 4. Comme montré par les figures 2 et 3, le capuchon 12 et la bague 10 sont adaptés l'un par rapport à l'autre, pour contenir les moyens de connexion 9, dans leur position déconnectée par rapport à l'intérieur du récipient 2, c'est-à-dire avec le piston 15 disposé à distance du bouchon 4, sans aucune pénétration de l'extrémité 16a de perforation de l'aiguille 16 dans ledit bouchon.The connection means comprise, on one side a flange 14 extending in one piece and coaxially the internal capsule 5, and forming a bore internal 14a, and on the other side, a piston 15 mounted sliding way in the bore 14a, between a position disconnected, shown in Figures 3 and 4, in which the piston is opposite and at a distance from the plug 4, and a connected position, not shown, in which the piston 15 is placed on the side and against the plug 4, and its flattened outer part 4b. A central needle or coaxial 16 passes through the piston 15, and has a end 16a of perforation of plug 4, and another connection end 16b, for example with another container, in particular a flexible bag of liquid by example. This needle 16 is made of metal or plastic material, with one or two flow channels. The connection end 16a and / or 16b is optionally arranged to prevent the release of particles or fragments resulting from the perforation of the plug 4. As shown in Figures 2 and 3, the cap 12 and the ring 10 are adapted relative to each other, to contain the connection means 9, in their disconnected position relative to the interior of container 2, i.e. with the piston 15 placed at a distance from the plug 4, without no penetration of the perforation end 16a of the needle 16 in said plug.

Dans la configuration d'un dispositif selon la présente invention, représentée à la Figure 3, prête à l'emploi et inviolable, l'alésage interne 14a de la collerette 14, le piston 15 dans sa position à distance du bouchon 4, la face externe de ce dernier limitée par le flanc annulaire de la paroi transversale 8a de la capsule interne 5 délimitent ensemble une enceinte 32 dans laquelle est disposée, sans protection particulière, notamment embout souple perforable, l'extrémité 16a de l'aiguille 16. Cette extrémité 16a est donc directement en vis-à-vis du bouchon 4. L'étanchéité de cette enceinte 32 vis-à-vis des liquides externes est assurée, de part et d'autre de la collerette 14, par le capuchon 12 monté de manière étanche sur la collerette 14, et par l'appui dur/mou de la paroi transversale 8, et en particulier de la nervure 8b pénétrant partiellement dans le bouchon 4. Cette étanchéité permet d'assurer, pendant tout le stockage du récipient 2 avec le dispositif selon l'invention, le maintien des conditions stériles dans l'enceinte 32, et en particulier de la surface externe du bouchon 4 et de l'extrémité de perforation 16b, qui lors de l'activation des moyens 9 de connexion viendront au contact l'une de l'autre.In the configuration of a device according to the present invention, shown in Figure 3, ready to employment and tamper-proof, the internal bore 14a of the flange 14, the piston 15 in its position away from the plug 4, the outer face of the latter limited by the annular flank of the transverse wall 8a of the capsule internal 5 together delimit an enclosure 32 in which is arranged, without particular protection, in particular flexible perforable tip, the end 16a of the needle 16. This end 16a is therefore directly in opposite the plug 4. The tightness of this enclosure 32 vis-à-vis external liquids is ensured by both and on the other side of the flange 14, by the cap 12 mounted sealingly on the collar 14, and by the support hard / soft of the transverse wall 8, and in particular of the rib 8b partially penetrating the plug 4. This tightness ensures, throughout the storage of container 2 with the device according to the invention, maintaining sterile conditions in the enclosure 32, and in particular of the external surface of the plug 4 and the puncture end 16b, which during of the activation of the connection means 9 will come to the contact with each other.

Comme représenté aux figures, le piston 15 comprend une âme transversale 15a traversée par l'aiguille 16, et un manchon externe 15b, à l'opposé du bouchon 4, assurant le guidage de tout embout d'un autre récipient, par exemple d'une poche de liquide, avec laquelle on connecte l'intérieur du récipient 2.As shown in the figures, the piston 15 includes a transverse core 15a through which the needle passes 16, and an external sleeve 15b, opposite the plug 4, guiding any tip of another container, for example a liquid pocket, with which connects the inside of the container 2.

L'assemblage puis le montage du dispositif de connexion 1 précédemment décrit, sur le récipient 2 s'effectue, notamment par voie automatique, de la manière suivante :

  • le piston 15 avec l'aiguille 16 est disposé et monté en position haute dans l'alésage 14a de la collerette 14, monobloc avec la capsule interne 5 ;
  • la bague externe 10, monobloc avec le capuchon 12 est montée provisoirement sur la capsule interne 5 par l'intermédiaire du jonc 11 encliqueté dans la rainure 14 de la capsule interne 5 ;
  • le dispositif de connexion 1, ainsi provisoirement monté, est encliqueté sous le bourrelet annulaire 3b du récipient 2, par l'intermédiaire des dents d'accrochage 6 de la capsule 5 ;
  • en poursuivant la poussée axiale sur le capuchon 12, la virole 10a de la bague 10 s'emmanche définitivement, de manière serrée, sur et autour de la jupe formée par les parties externes des dents 6, avec encliquetage du jonc 11 sous le rebord 6a de la capsule 5 (cf figure 3).
The assembly and then the assembly of the connection device 1 described above on the container 2 is carried out, in particular automatically, in the following manner:
  • the piston 15 with the needle 16 is disposed and mounted in the high position in the bore 14a of the flange 14, integral with the internal capsule 5;
  • the outer ring 10, in one piece with the cap 12 is temporarily mounted on the inner capsule 5 by means of the ring 11 snapped into the groove 14 of the inner capsule 5;
  • the connection device 1, thus temporarily mounted, is snapped under the annular bead 3b of the container 2, by means of the attachment teeth 6 of the capsule 5;
  • continuing the axial thrust on the cap 12, the ferrule 10a of the ring 10 is permanently fitted, tightly, on and around the skirt formed by the external parts of the teeth 6, with snap-fastening of the ring 11 under the rim 6a of capsule 5 (see FIG. 3).

Dès ce moment, le récipient 2 est rendu inviolable, puisque la capsule interne 5 ne peut être désolidarisée du récipient 2 qu'en rompant, et donc en détruisant la virole 10a, sans possibilité pour l'utilisateur de reconstituer le dispositif d'obturation 1. Dans cette configuration définitive, l'intérieur de la collerette 14 est définitivement isolé de manière étanche de l'extérieur, en particulier par rapport aux liquides, ce qui permet notamment de préserver sa stérilité. En particulier, de faibles déplacements relatifs du dispositif 1 selon l'invention, par rapport au récipient 2, ne sont pas à même de rompre cette étanchéité.From this moment, the container 2 is returned inviolable, since the internal capsule 5 cannot be detached from container 2 only by breaking, and therefore by destroying the shell 10a, with no possibility for the user to piece together the device shutter 1. In this final configuration, the inside of the collar 14 is permanently insulated tightly from the outside, in particular by compared to liquids, which allows in particular to preserve its sterility. In particular, small displacements relative of the device 1 according to the invention, with respect to the container 2, are not able to break this sealing.

Dans cette configuration également, la capsule interne 5 coiffe directement le col 3 du récipient, au contact du verre, sans interposition de tout autre moyen d'inviolabilité, tel que collerette plastique ou métallique déchirable. Il en est de même pour la paroi transversale 8 de la capsule interne 5 qui est en appui direct contre la partie externe du bouchon 4.Also in this configuration, the capsule internal 5 directly covers the neck 3 of the container, glass contact, without interposition of any other means tamper-evident, such as a plastic collar or tearable metal. It is the same for the wall transverse 8 of the internal capsule 5 which is in support direct against the external part of the plug 4.

Lors de la première utilisation, en séparant le capuchon 12 de la bague 10, selon la ligne de séparation 13, conformément à la figure 4, le récipient 2 se trouve prêt à l'emploi, du fait de l'accessibilité du moyen de connexion 9, lequel en particulier peut alors être activé dans sa position connectée, en repoussant le piston 15 vers le bouchon 4, tout en insérant l'extrémité 16b, de l'aiguille 16 dans l'embout d'un autre récipient ou poche.When using for the first time, separating the cap 12 of ring 10, along the line of separation 13, in accordance with FIG. 4, the container 2 is ready for use, due to the accessibility of the connection means 9, which in particular can then be activated in its connected position, by pushing the piston 15 towards the plug 4, while inserting the end 16b, needle 16 in the tip of another container or pocket.

Différents essais effectués avec un dispositif de connexion selon l'invention, et tel que décrit précédemment, ont démontré que ce dispositif demeurait étanche, et constituait une barrière antimicrobienne effective vis-à-vis de toute contamination extérieure.Different tests carried out with a connection according to the invention, and as described previously demonstrated that this device remained waterproof, and constituted an antimicrobial barrier effective with respect to any external contamination.

Claims (10)

  1. Device (1) for connection between a receptacle and a closed container (2), the latter comprising a neck (3) the opening (3a) of which is plugged by a stopper (4) made of relatively soft material, and provided with an external annular lip (3b), the said connection device comprising:
    a cap (5) designed to fit coaxially over the neck (3) of the container (2) plugged with the said stopper (4), elastic radially outwards so that it can snap-fasten (Fig. 3) over the annular lip (3b) of the neck (3), the said cap comprising a coaxial collar (14) lengthening it and forming an internal bore (14a),
    a transverse wall (8) for coming into contact with the external part (4b) of the stopper (4),
    means (9) for connection with the inside of the container (2) through the said stopper (4), comprising a piston (15) mounted so that it can slide in the bore (14a) of the collar (14) of the cap (5), a central needle (16) passing through the said piston and having one end (16a) for perforating the said stopper,
    characterized in that, in combination, the cap (5) is designed to fit directly over the neck (3) of the container (2), the transverse wall (8) is made of a relatively hard material for coming directly to bear against the external part (4b) of the stopper (4), and includes a central opening (8a) for the passage of the central needle (16) of the connection means (9), and the said device furthermore includes, on the one hand, an external sleeve (10) designed to slide coaxially against and on the outside of the internal cap (5), including a circumferentially continuous band (10a) provided along one of its edges with an internal annular ridge (11) for snap-fastening under the free rim (6a) of the internal cap (5) which is radially elastic enough to fit tightly against the internal cap (5) and snap-fasten by means of the annular ridge (11) under the said free edge (6a) but is strong enough to be indivisible and, on the other hand, a means (12) for protecting the connection means (9) from the outside, in leaktight contact with the collar (14) of the cap (5).
  2. Device according to Claim 1, characterized in that the transverse wall (8) is constructed as a single piece, made of plastic, with the internal cap (5).
  3. Device according to Claim 1, characterized in that the transverse wall (8) comprises a continuous circumferential rib (8b) intended to penetrate, at least partially, the relatively soft material of the stopper (4).
  4. Device according to Claim 1, characterized in that means (30) for preventing translational movement are arranged between the external sleeve (10) and the collar (14) of the cap (5), so that they complement the internal annular ridge (11) in the position where the external sleeve (10) is fitted tightly on the internal cap (5).
  5. Device according to Claim 1, characterized in that means (31) for preventing rotational movement are arranged between the external sleeve (10) and the internal cap (5) in the position where the external sleeve (10) is fitted tightly on the internal cap (5).
  6. Device according to Claim 1, characterised in that the internal cap (5) comprises catching teeth (6) distributed angularly about the axis (7) of the cap, each tooth having elasticity radially outwards so that it can come into a position (Fig. 3) where it is snap-fastened under the annular lip (3b) of the neck (3).
  7. Device according to Claim 1, characterized in that the protection means (12) consists of a lid fitted over the external sleeve (10) by use of a means (13) for manually separating the said lid from the said sleeve.
  8. Device according to Claim 7, characterized in that the lid (12) and the external sleeve (10) are constructed as a single piece made of plastic, with a perforated circumferential ring (13) of weakness separating them, and forming the said means for manual separation.
  9. Device according to Claim 1, characterized in that the central needle (16) has another end (16b) for connecting, for example, with another container.
  10. Ready-for-use assembly comprising a closed container (2) containing a product, said container including a neck (3), the opening of which is plugged by a stopper (4) made of a relatively soft material and provided with an external annular lip (3b), and a connection device (1) according to any one of Claims 1 to 9, mounted permanently on the said container, by means of the external sleeve (10) being fitted tightly over the internal cap (5), itself snap-fastened under the annular lip (3b) of the container (2).
EP19960931110 1995-09-11 1996-09-11 Connector for a closed container, preventing tampering therewith Expired - Lifetime EP0850178B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR9510787A FR2738550B1 (en) 1995-09-11 1995-09-11 DEVICE FOR SEALING A CONTAINER ITSELF CLOSED, ASSEMBLY FOR PROVIDING A PRODUCT COMPRISING SUCH A CONTAINER AND SUCH A SEALING DEVICE
FR9510787 1995-09-11
PCT/FR1996/001399 WO1997010156A1 (en) 1995-09-11 1996-09-11 Connector for a closed container, preventing tampering therewith

Publications (2)

Publication Number Publication Date
EP0850178A1 EP0850178A1 (en) 1998-07-01
EP0850178B1 true EP0850178B1 (en) 1999-11-17

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Application Number Title Priority Date Filing Date
EP19960931110 Expired - Lifetime EP0850178B1 (en) 1995-09-11 1996-09-11 Connector for a closed container, preventing tampering therewith

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US (1) US5879345A (en)
EP (1) EP0850178B1 (en)
JP (1) JP3804982B2 (en)
CN (1) CN1061622C (en)
AT (1) ATE186701T1 (en)
AU (1) AU701353B2 (en)
BR (1) BR9610160A (en)
CA (1) CA2229989C (en)
DE (1) DE69605204T2 (en)
DK (1) DK0850178T3 (en)
ES (1) ES2138375T3 (en)
FR (1) FR2738550B1 (en)
GR (1) GR3031916T3 (en)
PT (1) PT850178E (en)
RU (1) RU2138432C1 (en)
WO (1) WO1997010156A1 (en)

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PT850178E (en) 2000-04-28
CN1061622C (en) 2001-02-07
US5879345A (en) 1999-03-09
CA2229989C (en) 2007-05-08
ATE186701T1 (en) 1999-12-15
ES2138375T3 (en) 2000-01-01
GR3031916T3 (en) 2000-03-31
DE69605204T2 (en) 2000-04-06
FR2738550B1 (en) 1997-11-07
WO1997010156A1 (en) 1997-03-20
AU6991896A (en) 1997-04-01
DK0850178T3 (en) 2000-03-13
FR2738550A1 (en) 1997-03-14
AU701353B2 (en) 1999-01-28
EP0850178A1 (en) 1998-07-01
BR9610160A (en) 1999-01-05
JP3804982B2 (en) 2006-08-02
CN1196023A (en) 1998-10-14
RU2138432C1 (en) 1999-09-27
DE69605204D1 (en) 1999-12-23
JPH11512309A (en) 1999-10-26

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