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
  • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
• • 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

Definitions

• CONNECTION DEVICE BETWEEN A CONTAINER AND A CONTAINER AND READY-TO-USE ASSEMBLY COMPRISING SUCH A DEVICE
• 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 aforementioned type.
• a component of a pharmaceutical preparation such as, for example, its active principle
• a stopper made of relatively soft material, for example elastomer.
• a liquid can be introduced into this container after puncturing the stopper to dissolve or suspend the component contained in the container, this in order to obtain a preparation, in particular a medicament or a vaccine, in liquid form and ready to be administered to the patient .
• WO-A-97/10 156 discloses a connection device which comprises a base adapted to cover the neck of a container and which is extended by a flange or sleeve forming an internal bore, while a piston is slidably mounted in this bore.
• the piston carries a needle intended to pass through the stopper of the container in a so-called transfer position.
• This device also includes a cap enabling the base and the piston to be isolated from the ambient atmosphere before the piston is pushed towards the plug.
• connection device After operation of the connection device, and in particular after injection of a liquid and / or removal of part of the preparation that it contains, the cap of this known device can be replaced on it, so that it is not immediately apparent that the connection device has already been activated and brought into contact with the ambient atmosphere. This could lead to handling errors, in particular on the part of nurses having to work under sometimes severe stress conditions.
• the invention relates to a connection device between a closed container and a container, this closed container comprising a neck, the opening of which is closed by a plug, while this connection device comprises: - a base suitable for being mounted on the container, comprising a sleeve forming an internal bore and capable of being snapped onto the neck;
• a piston capable of sliding in this bore between a first position released relative to the plug and a second position, called transfer, in which a hollow needle moved or formed by the piston passes through this plug;
• This device is characterized in that the cap is provided with at least one relief capable of being engaged in the internal volume of the skirt, this relief extending radially relative to a central axis of the cap over a distance greater than the minimum distance between this axis and an edge of an access opening to the internal volume of the skirt, while the relief is connected to the main part of the cap, so that it remains integral with the latter when the cap is removed from the device, before its first use.
• the cap remains trapped in the skirt inside which it is locked by its relief which comes to bear and locks against the edge of the opening.
• the connection device In this first position, the connection device has not yet been used. To use the connection device, you must separate the cap from the cap, which requires extracting the relief from the internal volume of the skirt. This operation is not reversible, so that the user immediately notices when such an extraction has taken place.
• the device incorporates one or more of the following characteristics:
• the geometry of the relief of the cap and the geometry of the edge of the opening of the skirt are compatible with a movement of the relief in a direction parallel to the axis of the sliding of the piston in a direction of extraction of the relief relative to the internal volume of the skirt through the aforementioned opening, while these geometries are incompatible with movement through this opening in the opposite direction.
• the geometry of the relief and of the edge makes it possible to extract the cap from the internal volume of the skirt but is opposed to a posterior introduction of the cap into the skirt, which avoids a new fitting of the cap. on the base and around the piston after activation of the device, ie after displacement of the piston from its released position towards its transfer position.
• the relief of the cap is a radial flange extending at the periphery of the cap, with a radius greater than the inside radius of the edge ' of the opening of the skirt which is generally circular.
• the flange may have a frustoconical external radial surface which converges towards the bottom of the cap, while the edge of the opening of the skirt is frustoconical and converges opposite the latching means of the device on the collar. Thanks to this aspect of the invention, the flange and the edge form two frustoconical surfaces capable of coming into abutment against each other, which allows an effective force transmission when the relief is pressed.
• the aforementioned force transmission also makes it possible to envisage a radial expansion of the edge of the opening under the effect of a force transmitted by the flange during the removal of the cap.
• the skirt is elastically deformable, to the point of allowing extraction of the .relief relative to its internal volume by an essentially radial deformation of its edge.
• the seal is advantageously made of injectable elastomer, for example Santoprene (brand deposited), such a material retaining, for the most part, its elasticity properties after a terminal sterilization treatment.
• injectable elastomer for example Santoprene (brand deposited)
• plastic materials conventionally used to make a base or a cap, such as polypropylene or polyethylene, while styrene-based compounds are capable of melting at the sterilization temperatures used.
• the cap is provided with a thread capable of cooperating with at least one relief formed on the external surface of the sleeve for positioning the cap along the sliding axis of the piston.
• This internal thread and this relief make it possible to decouple the force exerted by a user on the cap and transmitted to the edge of the opening, which makes it possible to exert a sufficient effort of radial expansion of this edge.
• This relief and this tapping also make it possible to exert a compression force on the injectable elastomer seal, when such a seal is provided.
• the cap and the skirt are in one piece and made in the form of a single piece of plastic, breakable bridges being provided to connect this cap and this skirt.
• the fact of making the cap and the skirt in one piece guarantees their relative positioning at the start of assembly and facilitates assembly of the device.
• the invention also relates to a ready-to-use assembly which comprises a closed container containing a product, in particular a pharmaceutical preparation, this container being provided with a neck whose opening is closed by a plug, and a connection device such as previously described mounted on this container.
• a container makes it possible to sterile store a component of a drug or a vaccine, in particular its principle active, while a user can immediately see if such a set has already been activated or not.
• FIG. 1 is an exploded side view of a ready-to-use assembly according to the invention. and a syringe provided to cooperate with this assembly;
• FIG. 2 is an axial section of the connection device of the assembly of Figure 1, during the establishment of this device on the container of this assembly;
• Figure 3 is a section similar to Figure 2, when the device is in the storage configuration of the assembly of Figure 1;
• Figure 4 is a section similar to Figure 2, when removing the cap from the connection device;
• FIG. 5 is a section similar to Figure 2, when the device is used to transfer a liquid from the syringe to the container or vice versa;
• FIG. 6 is a section similar to Figure
• Figure 7 is a section similar to Figure
• Figure 8 is a section similar to Figure
• FIG. 9 is a section similar to Figure 6 for the device of Figures 7 and 8.
• the 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 previously closed or capped. This product can be a powder containing an active principle of a drug or a vaccine.
• the device 1 also makes it possible to ensure or establish a sealed connection between the interior of the container 2 and the interior of another container, such as a syringe 3 containing a liquid intended to dissolve or the product in container 2 is suspended.
• the container could be formed by a flexible bag or another glass vial.
• 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 made of elastomer, preferably rubber.
• a capsule can be arranged around the plug 5 and an external annular part 4b of the neck 4.
• the device 1 comprises a base 10, produced by injection of polyethylene and / or polypropylene, which • comprises a cylindrical part 11 intended to be centered on the axis of symmetry XX ′ of the elements 2, 4 and 5.
• the part 11 is extended by several elastic tabs 12 each equipped with a spout 13 and capable of cooperating with the external surface of the neck 4 for the purpose of elastic snap-fitting of the base 10 on the neck.
• the part 11 Opposite a lower edge 11a intended to penetrate superficially into the upper surface of the plug 5, the part 11 is extended by an annular strip 14 of junction with a sleeve 15 which forms an internal bore A for storage and movement d 'a piston 16 consisting mainly of a hollow needle.
• the radial surface internal 17 of sleeve 15 is cylindrical with circular base and centered on axis XX 'which is thus the central axis of bore A.
• the sleeve 15 also carries four “ears” 18 ⁇ , 18 2 , 18 3 and 18 4 allowing it to cooperate with a nut 6 associated with the syringe 3.
• a tip 3a of the “LU ⁇ R LOCK” type is provided on the syringe and is intended to be introduced into the sleeve 15, as shown in FIG. 5.
• the lower edge 15a of the sleeve 15 is intended to penetrate superficially into the plug 5.
• the hollow needle 16 forms a central channel 19 and is connected to the sleeve 15 by three elastic tabs, two of which are shown in the figures with the reference 1.6a, so that the elements 11 to 19 form a single piece, in accordance with the technical teaching of WO-A-01/32524.
• piston shapes can be envisaged with the present invention, in particular as known from WO-A-97/10156, WO-A-98/13006, OA-00/16730 or WO-A- 00 / 47159.
• a skirt or ring 20 is mounted around the base 10 and comprises two internal beads 21 and 22 intended to be selectively engaged in an external radial groove 10a of the base 10.
• the passage of the ring 20 from the position of the FIG. 2 to that of FIGS. 3 to 6 makes it possible to immobilize the tabs 12 in position around the neck 4, in accordance with the technical teaching of OA-97/10 156.
• the skirt 20 is provided, opposite the bead 21 with an internal radial flange 23 which forms the edge of an opening O for access to the internal volume V of the skirt 20, when the latter is in place around the base 10.
• the internal radial face 23a of the flange 23 is frustoconical, centered on the axis XX 'and converging opposite the bead 21.
• a cap 30 is provided around the sleeve 15 and is, for the most part, in place in the volume V in the configuration of FIG. 2 while it is, for the most part, disposed outside this volume, when the ring 20 is in the position of FIG. 3 to 5.
• This cap 30 comprises a main part 31a in the form of a cap which is generally symmetrical around the axis XX ′ and provided with external ribs 31b facilitating its handling.
• the cap also includes a bottom 31c.
• the cap 30 defines an opening O 'through which the sleeve 15 can be introduced into this cap.
• An internal thread 32 forms a thread inside the cap 30.
• the collar 33 comprises a radial surface 33a centered on the axis of symmetry of the cap 30, which coincides with the axis XX ′, and converging towards the bottom 31c.
• the maximum radius R 33 of the surface 33a is greater than the minimum radius R 23 of the surface 23a.
• angles at the respective apex ⁇ 23 and ⁇ 33 of the surfaces 23a and 33a are substantially equal, so that a surface support of the surfaces 23a and 33a can be obtained in the configuration of FIG. 3.
• the flange 23 contributes to keeping the cap 30 in position in the configuration of FIG. 3.
• the cap 30 is also provided with teeth 34 intended to penetrate superficially into the strip 14, this making it possible to create a sealed connection between the cap 30 and the base 10 and to isolate the sleeve 15 and the piston 16 relative to the ambient atmosphere.
• the thread 32 can cooperate with the ears 18 and 18 ′ so that, thanks to a screwing force represented by the rotation arrow R in FIG. 3, the teeth 34 are firmly engaged in the band 14.
• the nut 6 of the syringe 3 can be screwed onto the sleeve 15, which induces a displacement of the needle-piston 16 towards the internal volume of the vial 2. This displacement allows the needle to cross the plug 5 to pour into the container 2 a liquid whose flow is represented by the arrow E in FIG. 5.
• the flange 33 is opposed to an introduction of the cap 30 through the opening O, the cap 30 then resting on the upper surface 23b of the collar . 23, the total height of the device 1 then being different from that of this same device in the configuration of FIG. 3.
• the respective values of the radii R 23 and R 3 3 are incompatible with an introduction of the cap 30 into the volume V through the opening O.
• the device 101 of this embodiment comprises a base 110 provided with lugs 112 provided with spouts 113 for hooking onto the neck 104 of a bottle 102.
• the base 110 forms a sleeve 115 which defines a bore A for sliding a piston-needle 116.
• the base 110 is identical to the base 10 of the first embodiment.
• a skirt 120 is provided for locking the tabs 112 around the neck 104, while a cap 130 is provided for isolating the base 110 from the ambient atmosphere.
• a cap 130 is provided for isolating the base 110 from the ambient atmosphere.
• 131a, 131b and 131c the main part, the grip ribs and the bottom of the cap 130.
• the elements 120 and 130 are produced in the form of a single integral piece and connected, at the level of external ribs 135 of the cap 130, by breakable bridges 136, the skirt 120 being able to pass from the configuration of FIG. 7 to that of FIG. 8 by rupture of these bridges 136.
• the skirt 120 is provided with a collar 123 defining an opening O for access to the internal volume V of the skirt 120 and the radius of which R 123 and 123a can be noted on the internal radial face.
• a flange 133 is provided near the opening 0 'of the cap 130 and 133a denotes its external radial surface and R 133 its maximum radius.
• the radius R ⁇ 33 is greater than the radius R123 / which prohibits a re-introduction of the cap 130 into the volume V through the opening 0, from the configuration of FIG. 9.
• An O-ring 140 made of Santoprene (registered trademark) is interposed between the cap 130 and the base 110. In practice, this seal is embedded in a groove 137 of the cap 130 and adjoins the opening O 'of this cap. This Santoprene seal makes it possible to effectively isolate the internal volume of the cap 130 from the ambient atmosphere regardless of the use of teeth such as the teeth 34 of the first embodiment.
• This seal is particularly suitable for the case where the product contained in the vial 2 is a vaccine or contains a molecule in liquid form which must be subjected to terminal sterilization in an autoclave, at a temperature of approximately 120 ° and for a period of twenty minutes. about.
• the polyethylene or polypropylene parts, such as the cap or the base are slightly deformed by a terminal sterilization step. Indeed, the rise in temperature necessary during this sterilization induces a relaxation of the internal tensions of the material and a reduction in the pressure force generated at the level of reliefs, such as the teeth 34 of the first embodiment. The effectiveness of these teeth cannot therefore be guaranteed.
• An elastomer seal therefore makes it possible to fulfill the sealing function, while it is compatible with a sterilization step under the conditions mentioned above.
• an injectable elastomer such as
• the piston of the device of the invention can be equipped with a valve for controlling the flow of a fluid from or to the internal volume of the container.
• the collar 33 or 133 of the cap can be replaced by one or more reliefs extending over only part of the circumference of the opening O '.
• the flange 23 or 123 can be interrupted on one or more parts of the circumference of the opening O.

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• 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)
• Closures For Containers (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Insertion Pins And Rivets (AREA)

Applications Claiming Priority (3)

Publications (1)

Family

ID=27636343

Family Applications (1)

Country Status (9)

Families Citing this family (73)

Family Cites Families (74)

• 2002
  • 2002-02-20 FR FR0202149A patent/FR2836129B1/fr not_active Expired - Fee Related
• 2003
  • 2003-01-29 TW TW92101982A patent/TWI277410B/zh not_active IP Right Cessation
  • 2003-02-19 JP JP2003569107A patent/JP4300116B2/ja not_active Expired - Fee Related
  • 2003-02-19 AU AU2003222936A patent/AU2003222936A1/en not_active Abandoned
  • 2003-02-19 AR ARP030100540 patent/AR038840A1/es unknown
  • 2003-02-19 EP EP03718901A patent/EP1476117A2/fr not_active Withdrawn
  • 2003-02-19 US US10/504,837 patent/US7628779B2/en not_active Expired - Fee Related
  • 2003-02-19 WO PCT/FR2003/000555 patent/WO2003070147A2/fr active Application Filing
  • 2003-02-19 CA CA 2476659 patent/CA2476659A1/en not_active Abandoned

Non-Patent Citations (1)

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