EP1226077B1 - Dispositif de connexion pret a l'emploi - Google Patents

Dispositif de connexion pret a l'emploi Download PDF

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Publication number
EP1226077B1
EP1226077B1 EP00974636A EP00974636A EP1226077B1 EP 1226077 B1 EP1226077 B1 EP 1226077B1 EP 00974636 A EP00974636 A EP 00974636A EP 00974636 A EP00974636 A EP 00974636A EP 1226077 B1 EP1226077 B1 EP 1226077B1
Authority
EP
European Patent Office
Prior art keywords
stopper
piston
base
bore
recipient
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
EP00974636A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP1226077A1 (fr
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
Original Assignee
Biodome SAS
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Biodome SAS filed Critical Biodome SAS
Publication of EP1226077A1 publication Critical patent/EP1226077A1/fr
Application granted granted Critical
Publication of EP1226077B1 publication Critical patent/EP1226077B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • 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
    • B65D51/18—Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
    • B65D51/20—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing
    • B65D51/22—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure
    • B65D51/221—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure a major part of the inner closure being left inside the container after the opening
    • B65D51/226—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure a major part of the inner closure being left inside the container after the opening the piercing or cutting means being non integral with, or not fixedly attached to, the outer closure
    • 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
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing 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
    • A61J1/20—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
    • 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
    • B65D2251/00—Details relating to container closures
    • B65D2251/0003—Two or more closures
    • B65D2251/0006—Upper closure
    • B65D2251/0015—Upper closure of the 41-type
    • 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
    • B65D2251/00—Details relating to container closures
    • B65D2251/0003—Two or more closures
    • B65D2251/0037—Intermediate closure(s)
    • B65D2251/0056—Intermediate closure(s) of the 47-type
    • 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
    • B65D2251/00—Details relating to container closures
    • B65D2251/0003—Two or more closures
    • B65D2251/0068—Lower closure
    • B65D2251/009—Lower closure of the 51-type

Definitions

  • the invention relates to a connection device between a closed container and a container.
  • the invention also relates to a ready-to-use assembly comprising, inter alia, a closed container and a connection device of the type supra.
  • a component of a pharmaceutical preparation such as for example its active ingredient
  • a container closed with a plug of relatively soft material for example made of elastomer.
  • a liquid can be introduced into this container after puncturing the cap to dissolve or suspend the component contained in the container, this in order to obtain a preparation, in particular a drug or a vaccine, in liquid form and ready to be administered to the patient.
  • connection devices comprising each a base adapted to cover the neck of a container and extending by a collar or socket forming a internal bore, while a piston is slidably mounted in this bore.
  • the piston is designed to be pushed towards a transfer position in which a hollow needle carried by this piston passes through the container cap.
  • These devices must incorporate means for maintaining the position of the piston in each of its two positions, that is to say in its position away from the plug and in the position of transfer.
  • connection device in which the piston is effectively guided in its translational movement between the above positions then that the cost price of the whole device can be significantly reduced compared to that of the devices known.
  • the invention relates to a device for connection between a closed container and a container, this container comprising a neck whose opening is closed by a plug while the connection device comprises a base, suitable for being mounted on the container and comprising a sleeve forming an internal bore, and a piston capable of slide in this bore, between a first position clear of this plug and a second position, called transfer, in which a hollow needle carried by or constituting the piston passes through this plug.
  • This device is characterized in that the piston and the base are formed of single piece and connected by at least one elastic tongue able to deform, essentially in one direction parallel to a central axis of the bore, to accompany the movement of the piston between the above positions.
  • the base and the piston can be molded in a single operation, which optimizes the manufacturing range of the device of the invention and lower the cost.
  • the elastic tab (s) determine the intensity of the effort that a user must apply to move the plunger and needle between the first and the second position, this effort can be relatively little important, which makes it easier for staff to use medical.
  • the piston is much easier to be moved only if it is connected to the base by one or more breakable legs whose rupture could request significant effort.
  • the tab (s) of device of the invention which essentially deform according to the direction of translation of the piston, do not deform not in a dimension that would allow rotation of the piston. This is why, these tongues also constitute means for translational guiding, without rotation, of the piston between these two positions.
  • the invention also relates to an assembly ready for use comprising a closed container containing a product, in particular a pharmaceutical preparation, this container being provided with a neck, the opening of which is closed by a plug, and a connection device as previously described mounted on the container.
  • a set allows to keep sterile component of a drug or vaccine, including its active ingredient, and to prepare it in good time by mixing with a liquid, while its piston is effectively held in position and guided during movement.
  • the device 1 has a double function. On the one hand it ensures the inviolability of a container 2, for example a glass bottle, containing a non- shown and previously closed or blocked.
  • This product can be a powder intended to form an oral vaccine. he can be any other type of pharmaceutical preparation, in particular particular of any type of medication.
  • the device 1 also makes it possible to ensure or establish a tight connection between the inside of the container 2 and the interior of another container, such as a syringe 3 containing a liquid intended to put in solution or in suspends the product in container 2.
  • container 3 could be formed by a flexible pouch, another glass bottle or any other container.
  • the bottle 2 has a neck 4, the opening 4a of which is sealed off by a plug 5 made of a relatively soft material, for example an elastomer, in particular rubber.
  • a capsule may be disposed around the cap 5 and an outer annular portion 4b of collar 4, the capsule being provided with a central opening through which it is possible to perforate the plug 5.
  • the plug 5 comprises a central part 5 a substantially cylindrical, suitable for a flexible and sealed fitting inside the opening 4 a , and a flat part 5 b , supported on the part 4 b and possibly covered by the capsule.
  • the device 1 is essentially formed of two parts made by injecting plastic, for example polyethylene and / or polypropylene, namely an element of base or base 10, intended to be mounted around the elements 4 and 5, and an outer envelope 40.
  • plastic for example polyethylene and / or polypropylene, namely an element of base or base 10, intended to be mounted around the elements 4 and 5, and an outer envelope 40.
  • the base 10 comprises a cylindrical part 11 intended to be centered on the axis XX 'of symmetry of the elements 2, 4 and 5.
  • This part 11 comprises a lower edge 11 a having in cross section a pointed profile intended to penetrate superficially in the upper or exposed surface 5 c of the plug 5.
  • the part 11 is extended by several elastic tabs 12 each equipped with a spout 13 capable of cooperating with the external surface of the neck 4 with a view to elastic snap-fitting of the base 10 on the collar.
  • the base 10 is provided with teeth 14 forming a device for blocking in rotation of the base 10 relative to the plug 5 with which the teeth 14 are engaged.
  • the base 10 Opposite the teeth 14 with respect to the zone 15 of junction between the legs 12 and the part 11, the base 10 has a second set of teeth 16.
  • the portion 11 is extended by an annular band 17 of junction with a sleeve 18 which forms an internal bore A storage and movement of a piston 19 consisting of a hollow needle.
  • the internal radial surface 20 of the sleeve 18 is generally cylindrical and centered on the axis XX 'which is thus the central axis of the bore A, while its external surface 21 is slightly frustoconical and that it carries two doubly chamfered ears 22 and 22 'allowing it to cooperate with a system for fixing the syringe 3 of the "LUER-LOCK" type by means of a nut 6 for mounting the syringe 3 on the base 10.
  • the connection between the syringe 3 and the nut 6 can be obtained by clipping or by the fact that the nut 6 is an integral part of the syringe 3.
  • the hollow needle 19 forms a central channel 23 and three openings 24, two of which appear in Figures 2 and 4, at near its tapered tip 25.
  • the sleeve 18 and the needle 19 are connected by three tabs elastic 26, so that elements 11 to 26 form a single integral piece constituting the base 10.
  • the tongues 26 have a width l , measured parallel to the surface 20 or to the external radial surface 27 of the needle 19, much greater than their thickness e which is measured perpendicular to the surfaces 20 and 27.
  • the tongues 26 can be deform in a direction parallel to the axis XX 'but have a relatively high rigidity in rotation about the axis XX'.
  • the width l is at least five times greater than the thickness e .
  • the edge 18 a of the sleeve 18 which is opposite the flange 2 has, like the edge 11 a , a pointed profile allowing it to penetrate superficially in the surface 5 c of the plug 5, a hollow volume 28 being defined between the part of the sleeve 18 closest to the plug 5 and the cylindrical part 11.
  • the envelope 40 is also monobloc and comprises a ring 41 serving as a hoop for the legs 12 when the spouts 13 are in place under the part 4 b of the neck 4.
  • the ring 41 is bordered by an internal collar 41 a locking under the spouts 13.
  • This ring 41 is extended by a second ring 42 of slightly smaller diameter and which more specifically surrounds part 11 of the base 10.
  • the envelope 40 is provided with teeth 44 intended to cooperate with the teeth 16 of the base 10 in order to allow immobilization in rotation of the envelope 40 relative to the base 10.
  • the ring 42 On its internal radial surface, the ring 42 carries three ribs 45, centered on the axis XX 'and perpendicular to this one, intended to create a tight assembly, without interposition of seal, between the base 10 and the casing 40.
  • the assembly between the base 10 and the envelope 40 is sealed provided that the ring 42 carries at least one rib of the type ribs 45.
  • the exact number of ribs which can be less than or more than three, depends on design choice.
  • Zone 47 can have a thickness between 0.5 and 1 tenth of a millimeter.
  • a device 1 is mounted on a container 2 in the configuration of Figures 2 and 3 for a relatively long period long, when storing the product contained in the container 2.
  • the cap 46 is removed by exerting on it a rotational movement R which has the effect of tearing the zone 47 since elements 10 to 45 are immobilized in rotation around the neck 4.
  • each tongue 26 has one end 29 secured to the piston 19 remote from a distance d relative to the surface 5 c while its end 30 secured to the surface 20 is remote from a distance d 'compared to the same surface 5 c .
  • the distance d is greater than the distance d 'in the configuration of FIGS. 2 and 3.
  • the distance d is less than the distance d ' which remains constant. In other words, the end 29 of each tongue 26 is approached to the plug 5 during the translation of the needle or piston 19 corresponding to the perforation of the plug 5.
  • the tongues 26 form two support zones 31 and 32, respectively against the surfaces 27 and 20, so that the progression of the needle 19 towards the interior volume of the container 2 is blocked in this configuration. So the tabs 26 can constitute a stop for the displacement of the needle 19 when the plug 5 is punctured.
  • the edge 18a of the sleeve 18 is permanently in firm abutment against the plug 5, which makes it possible to avoid any bulging effect of the plug due to a creep of its constituent material.
  • the surface penetration of the edge 18 a into the surface 5 c guarantees a seal between the volume 50, defined inside the sleeve 18 around the needle 19 and between the plug 5 and the end 3 a of the syringe 3, and the volume 28.
  • the dead volume 50 constitutes the volume in which part of the liquid could flow from the container 2 due to a leak between the needle 19 and the stopper 5.
  • the loss maximum active liquid is confined to this volume 50 which can be relatively small due to the small difference in diameter between the surfaces 20 and 27.
  • the elasticity of the tongues 26 can be chosen, so that their configuration shown in FIG. 4 is a stable configuration in the sense that the needle 19 does not tend to go up in the direction of the outlet of the sleeve 18 equipped with the flange 22, including after removal of the end 3 a .

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)
EP00974636A 1999-11-05 2000-11-02 Dispositif de connexion pret a l'emploi Expired - Lifetime EP1226077B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR9914197A FR2800713B1 (fr) 1999-11-05 1999-11-05 Dispositif de connexion entre un recipient et un contenant et ensemble pret a l'emploi comprenant un tel dispositif
FR9914197 1999-11-05
PCT/FR2000/003057 WO2001032524A1 (fr) 1999-11-05 2000-11-02 Dispositif de connexion pret a l'emploi

Publications (2)

Publication Number Publication Date
EP1226077A1 EP1226077A1 (fr) 2002-07-31
EP1226077B1 true EP1226077B1 (fr) 2003-07-23

Family

ID=9552020

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00974636A Expired - Lifetime EP1226077B1 (fr) 1999-11-05 2000-11-02 Dispositif de connexion pret a l'emploi

Country Status (23)

Country Link
EP (1) EP1226077B1 (es)
JP (2) JP4582983B2 (es)
KR (1) KR100726297B1 (es)
CN (1) CN1214955C (es)
AR (1) AR026357A1 (es)
AT (1) ATE245581T1 (es)
AU (1) AU761176B2 (es)
BR (1) BR0015268A (es)
CA (1) CA2386830C (es)
CO (1) CO5420204A1 (es)
DE (1) DE60004082T2 (es)
DK (1) DK1226077T3 (es)
ES (1) ES2202187T3 (es)
FR (1) FR2800713B1 (es)
HK (1) HK1048293A1 (es)
HU (1) HUP0203945A3 (es)
MX (1) MXPA02004526A (es)
PL (1) PL357270A1 (es)
PT (1) PT1226077E (es)
RU (1) RU2230693C2 (es)
TW (1) TW482670B (es)
WO (1) WO2001032524A1 (es)
ZA (1) ZA200202627B (es)

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JP4582983B2 (ja) 2010-11-17
ATE245581T1 (de) 2003-08-15
JP2010207610A (ja) 2010-09-24
DE60004082T2 (de) 2004-04-15
CN1214955C (zh) 2005-08-17
FR2800713B1 (fr) 2002-01-04
ZA200202627B (en) 2003-03-26
CA2386830C (en) 2009-09-29
KR100726297B1 (ko) 2007-06-12
EP1226077A1 (fr) 2002-07-31
WO2001032524A1 (fr) 2001-05-10
RU2230693C2 (ru) 2004-06-20
PL357270A1 (en) 2004-07-26
BR0015268A (pt) 2002-06-18
HUP0203945A2 (hu) 2003-03-28
CN1379724A (zh) 2002-11-13
AR026357A1 (es) 2003-02-05
JP2003523227A (ja) 2003-08-05
MXPA02004526A (es) 2002-09-02
DE60004082D1 (de) 2003-08-28
AU761176B2 (en) 2003-05-29
AU1286301A (en) 2001-05-14
KR20020050258A (ko) 2002-06-26
PT1226077E (pt) 2003-11-28
CA2386830A1 (fr) 2001-05-10
DK1226077T3 (da) 2003-10-27
TW482670B (en) 2002-04-11
FR2800713A1 (fr) 2001-05-11
ES2202187T3 (es) 2004-04-01
HUP0203945A3 (en) 2005-10-28
RU2002114693A (ru) 2004-03-20
HK1048293A1 (zh) 2003-03-28
CO5420204A1 (es) 2004-07-30

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