EP0406374A1 - Storage and transfer bottle designed for storing a component of a medicamental substance. - Google Patents

Storage and transfer bottle designed for storing a component of a medicamental substance.

Info

Publication number
EP0406374A1
EP0406374A1 EP90900747A EP90900747A EP0406374A1 EP 0406374 A1 EP0406374 A1 EP 0406374A1 EP 90900747 A EP90900747 A EP 90900747A EP 90900747 A EP90900747 A EP 90900747A EP 0406374 A1 EP0406374 A1 EP 0406374A1
Authority
EP
European Patent Office
Prior art keywords
bottle
bottle according
end piece
substance
needle
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.)
Granted
Application number
EP90900747A
Other languages
German (de)
French (fr)
Other versions
EP0406374B1 (en
Inventor
Gabriel Meyer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson France SA
Original Assignee
Medicorp Holding SA
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 Medicorp Holding SA filed Critical Medicorp Holding SA
Priority to AT90900747T priority Critical patent/ATE93382T1/en
Publication of EP0406374A1 publication Critical patent/EP0406374A1/en
Application granted granted Critical
Publication of EP0406374B1 publication Critical patent/EP0406374B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093Containers having several compartments for products to be mixed
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D25/00Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/02Internal fittings
    • B65D25/04Partitions
    • B65D25/08Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents
    • B65D25/082Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents the partition being in the form of a plug or the like which is removed by increasing or decreasing the pressure within the container
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1475Inlet or outlet ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2031Separating means having openings brought into alignment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2051Connecting means having tap means, e.g. tap means activated by sliding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2058Connecting means having multiple connecting ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2058Connecting means having multiple connecting ports
    • A61J1/2062Connecting means having multiple connecting ports with directional valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068Venting means
    • A61J1/2075Venting means for external venting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J2205/00General identification or selection means
    • A61J2205/30Printed labels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0015Devices specially adapted for taking medicines
    • A61J7/0038Straws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0015Devices specially adapted for taking medicines
    • A61J7/0053Syringes, pipettes or oral dispensers

Definitions

  • the present invention relates to a single compartment storage and transfer bottle designed to store a component of a drug substance and to transfer it directly, or after having mixed it with another substance, in a device for use, this bottle comprising an open narrowed neck and a closure device engaged in this neck.
  • Medicinal substances whether directly usable or whether they constitute the components of a mixture, are usually stored in containers which can either be flame-sealed glass ampoules or vials sealed with a stopper. shutter.
  • a bottle of this type is for example described by US Patent No. 3,674,028 and comprises a body provided with a narrowed neck and a central constriction which defines two compartments respectively containing a lyophilisate and a solvent intended to be mixed.
  • the neck is closed by a special plug allowing the evacuation of the vapors during the lyophilization of the substance deposited in the lower compartment. After lyophilization, the plug is pushed back into the central zone of the body comprising the constriction and thus separates the two compartments in a leaktight manner.
  • a shutter is placed at the end of the neck to close the upper compartment after filling it.
  • This obturator comprises a central zone of lesser thickness, intended to be pierced by a needle for the purpose of withdrawing the mixture to be injected from a patient.
  • a liquid medicinal substance pose a significant problem during the transfer of their contents into a device for use such as a syringe.
  • the caregiver must, in all cases, use a needle to draw up the liquid from the ampoule.
  • the needle used to carry out the transfer is contaminated on its outer walls by the drug solution. This external contamination of the needle is responsible for pain, bruising or other tissue damage which should not in principle be in contact with the drug substance.
  • the transfer does not prevent bacterial and particulate contamination. Due to hygienic rules, the transfer needle is not to be reused and replaced with a new sterile needle, and this for each transfer operation.
  • Transfer set which has a double needle or a double trocar, and which is used to directly connect a vial closed by an elastomer stopper with a pocket or an infusion bottle.
  • the bottle may contain a liquid or dry drug substance.
  • the transfer device is however supplied independently of the bottle to which it is supposed to connect, and presented in sterile packaging. Therefore, nothing prevents its reuse on another bottle after a first use, even if the rules of hospital hygiene prohibit such reuse.
  • the only way to prevent both handling errors during the installation of a transfer device and its reuse, is to provide a bottle equipped with a non-removable transfer device.
  • the present invention proposes to overcome the above drawbacks by providing a storage bottle which can be connected to all kinds of receptacles or containers on the market, without any noticeable increase in the cost of manufacture and without technical complications,
  • the bottle according to the invention is characterized in that the closure device is designed to be moved between a first position, called storage, in which it constitutes a sealed shutter, and a second position, called use, in which it constitutes an open valve to allow the evacuation of said medicinal substance, and in that this device is integral with a device for connecting the vial with a container containing another component of the medicinal substance and / or with the device of use.
  • the closure device may comprise a flexible elastomeric closure member comprising a central cavity and a radial channel opening into the central cavity, it may be mounted on a capsule fitted to the neck of the bottle and axially movable between said storage position and said use position.
  • the capsule is provided with a conical connecting tip and a stiffening element engaged inside a cavity of the 'closure member.
  • connection end piece may be a "Luer” type end piece or may be a “Luer Lock” type end piece.
  • connection end piece is a male conical end piece or a female conical end piece.
  • connection endpiece carries a needle and the capsule is provided with a substantially cylindrical protective element whose length is at least approximately equal to that of the needle.
  • the bottle has connecting means for flexibly binding it to the device for use or to another container containing another component of the drug substance.
  • Said connecting means preferably comprise a lace, the ends of which are equipped with locking connecting elements.
  • the bottle comprises at least one filter mounted in the connection device or the closure device, in a zone of obligatory passage of the drug substance or of the mixture of this substance with another substance before its use.
  • this filter is of the membrane filter type.
  • the closure device When said device is in its first so-called storage position, the closure device can be linked to the bottle by a tamper-evident label.
  • the device comprises a needle arranged to perforate a closure plug of an empty or pre-filled container.
  • said needle has at least one lateral opening arranged to allow the evacuation of an overpressure generated inside the bottle and / or of another container connected to the bottle by means of said needle.
  • the closure device may include a vent and an elastic closure element arranged to close said vent in a first position and to release it in a second position.
  • said vent is formed in a wall of the capsule and the closure device carries a hydrophobic filter disposed over said vent.
  • this hydrophobic filter has an annular shape and has a central opening which ensures communication between the closure device and the connection device.
  • the closure device consists of two separate parts, a head and an annular seal.
  • the head and the annular seal are made of different materials.
  • FIGS. 1 to 5 illustrate the process of filling a flask containing a compound in the lyophilisate state
  • FIGS. 6 to 9 illustrate the process of filling a bottle containing a powder intended to be mixed with a liquid solvent
  • FIG. 10 shows another embodiment of a bottle according to the invention
  • FIGS. 11 and 12 illustrate a particular form of use of the bottle according to the invention
  • FIG. 13 represents a sectional view illustrating a method of coupling the bottle with an infusion bag
  • FIG. 14 illustrates a sectional view of a bottle whose cap is associated with a needle
  • FIG. 15 represents a perspective view of a closure member intended for a lyophilization bottle
  • FIG. 16 represents a perspective view of a closure member for a bottle intended to contain a powdery substance
  • FIG. 17 represents a bottle according to the invention coupled to a peristatic pump
  • FIG. 18 represents a bottle fitted with a mouthpiece
  • the ' Figure 19 shows a sectional view of a bottle according to the invention attached to a prefilled syringe
  • FIG. 20 represents a sectional view of a bottle coupled to a traditional syringe
  • FIG. 21 represents a sectional view of a bottle equipped with a needle and connected to an infusion bag
  • FIG. 22 shows a sectional view of a bottle according to the invention coupled to a flexible bottle
  • FIG. 23 represents a sectional view of a bottle according to the invention connected to a three-way valve
  • FIG. 24 represents a sectional view illustrating the storage position of a bottle according to the invention equipped with a needle
  • FIG. 25 represents a sectional view of a bottle according to the invention equipped with a connection device of the Luer-Lock type and protected by a cap
  • FIG. 26 represents a particular embodiment of a bottle intended to be coupled to an infusion bag
  • FIG. 27 represents a sectional view of another embodiment making it possible to release an overpressure inside the bottle and / or a pocket
  • FIG. 28 represents a sectional view illustrating the bottle of FIG. 27 in its use phase
  • FIG. 29 represents a variant of the embodiment of FIGS. 27 and 28, and
  • FIG. 30 represents an enlarged sectional view illustrating more specifically the hydrophobic filter mounted inside the obturation member.
  • a bottle 10 provided with a closed bottom 11 and an open neck 12 with a narrowed section relative to that of the body 13 of the bottle, is partially filled with a liquid substance 14 which is introduced at the interior of the bottle through a conduit 15.
  • the liquid 14 is in this case an aqueous solution of a medicinal substance intended to be lyophilized.
  • the freeze-drying phase is shown in fig. 2.
  • This operation is carried out inside a device essentially comprising an enclosure connected to a vacuum pump and cryogenic means.
  • the bottle 10 Before entering this enclosure, the bottle 10 is equipped a flexible closure member 16, made of elastomer, which comprises at its lower end a nozzle 17, integral with the upper part of this member and provided with at least one lateral opening 18 allowing the steam 19 to escape out of the bottle.
  • a flexible closure member 16 made of elastomer, which comprises at its lower end a nozzle 17, integral with the upper part of this member and provided with at least one lateral opening 18 allowing the steam 19 to escape out of the bottle.
  • the obturation member * is sterile at the time of its installation on the neck of the bottle and the enclosure. of lyophilization is a sterile enclosure.
  • FIG. 3 The next phase which consists in putting the obturation member in its storage position, is represented by FIG. 3.
  • a pusher 20 disposed inside the lyophilization enclosure.
  • the shutter member 16 is provided with a radial channel 21 which is closed by the wall of the neck of the bottle in the position represented by this figure.
  • this pusher is constituted by the ceiling of the freeze-drying enclosure. According to other embodiments, the ceiling of the freeze-drying enclosure is fixed and it is the floor supporting the bottles which moves upwards to cause the penetration of the closure member inside the neck .
  • the tip 17 is engaged inside the bottle and the upper part of the closure member is engaged inside the neck 12 so that a radial channel 21, formed in the upper part of the shutter member, or closed by the inner wall of the neck 12.
  • the closure member assumes one of its functions which is to ensure the tight closure of the bottle 10 during storage of the latter.
  • the vial containing the drug substance in the lyophilized state, and sealed in sealing form by the obturating member 16 is extracted from the lyophilization enclosure and is equipped with a capsule.
  • the capsule 22 which constitutes, with this closure member 16, a closure device for the bottle and serves as a support for a transfer device intended for connecting the bottle 10 with a device for use (not shown).
  • the capsule 22 comprises a connection end piece 23, the shape of which is conical, and which constitutes an end piece of the so-called "Luer” type.
  • This nozzle is extended towards the inside of the bottle by a stiffening element 24, of substantially cylindrical shape, which is engaged in an internal cavity 25 of the shutter member 16.
  • the capsule 22 comprises a peripheral flange 26 which is engaged over the rim 27 of the neck 12 of the bottle 10, and which has internal protuberances 28 which have the purpose of cooperating with the rim 27 to define, on the one hand the storage position, and on the other hand the position of use of the transfer device and consequently of the shutter member 16.
  • This transfer device proper is covered, during the storage phase, by a cap 29 which is adapted to the shape and dimensions of the various components of the capsule and in particular of the collar 26.
  • a cap 29 which is adapted to the shape and dimensions of the various components of the capsule and in particular of the collar 26.
  • the end piece connection is adapted to the shape and dimensions of the various components of the capsule and in particular of the collar 26.
  • the capsule 22 is extended on the side opposite to the bottle by a substantially cylindrical structure 32 whose length is approximately equal to that of the needle with its needle holder.
  • the cap 29 is enveloping at the level of the neck of the bottle and at the level of the flange of the capsule.
  • it comprises a first sector 29a of narrowed section which essentially envelops the structure 32 of the capsule, an intermediate sector 29b which bears against the external wall of the flange 26 and a flange 29c whose external diameter is substantially equal to the external diameter of the bottle 10.
  • This embodiment makes it possible to set up a tamper-evident label 33 which of course serves to identify the product but also to make the cap 29 and the bottle 10 integral.
  • the installation phase of this tamper-evident label is schematically represented by the arrows B.
  • the bottle described above and the filling and assembly phases illustrated in FIGS. 1 to 5 correspond to the use of a medicinal substance initially found in the form of a liquid solution and which is intended to be stored in the container. state of lyophilisate.
  • a medicinal substance initially found in the form of a liquid solution and which is intended to be stored in the container. state of lyophilisate.
  • the capsule is pressed onto the neck, which has the effect of * making the upper part of the closure member penetrate towards the inside of the bottle into a position where the lateral orifice 21 formed in the upper part of the closure member opens out inside the bottle and allows the needle and the interior space of the bottle to be placed in communication.
  • the connection with another sterile enclosure containing the solvent is made through the needle 30.
  • the sterile enclosure containing the solvent is a flexible bag or another suitable container.
  • the described bottle can be connected to all devices on the market equipped with the same type of standardized Luer or Luer Lock connection, corresponding to a cone connection equipped with a locking system, namely : an empty syringe, a pre-filled syringe, a tap to connect to another container or to a conduit, a tubing, a peristaltic pump, an inhaler, a flexible infusion bag, a collapsible flexible bottle for ocular application.
  • FIG. 6 represents a bottle 10 intended to allow the storage of a powder 40 introduced into this bottle through a supply tube 41.
  • the bottle 10 represented by FIG. 6 is in all points identical to the bottle 10 represented by FIGS. 1 and following.
  • the next phase consists in closing the bottle by means of a closure member 42 represented by FIG. 7.
  • This closure member differs from that represented by the Figures 2 to 5 in that it does not include the lower tip 17 whose function is strictly linked to the lyophilization phase.
  • this obturation member also comprises a radial duct 43 which makes it possible, during use, to ensure communication with the interior of the bottle 10.
  • FIG. 8 The phase represented by FIG. 8 and which corresponds to the installation of the obturation and transfer devices is in all points identical to that illustrated by FIG. 4, apart from the fact that, in one, of the cases , the content of the bottle is a powder, and in the other case it is a lyophilisate. For this reason, the reference numbers of the various constituent elements are the same in both cases.
  • FIG. 9 which illustrates the phase of fitting a tamper-evident label, is identical to FIG. 5 with the same difference as above. For this reason, the reference numbers of these two figures are identical.
  • the syringe needle which is mounted on the connection end of the connection device, allows a solvent arranged to dissolve the powder contained in the vial to enter.
  • FIG. 10 illustrates a variant of the connection device described above.
  • This device connection 50 is associated with a closure member 42 identical to that which is represented by FIGS. 6 to 9 in association with the bottle containing a powder.
  • the connection device 50 could also be associated with a sealing member 16 such as that shown in Figures 2 to 5 in combination with a bottle containing a lyophilisate.
  • This connection member comprises a capsule 51 provided with a collar 52 which passes over the rim 27 of the neck 12 of the bottle 10.
  • This collar which is shown in its position of use, has, as previously, internal protuberances 28 intended to cooperate with the rim 27 to define the storage and use positions.
  • This capsule is provided with the cylindrical end piece 24 (identical to that defined in FIG.
  • connection end piece 53 which is a conical female end piece with lock commonly called “Luer Lock”.
  • This end piece is closed by a cap 54 provided with an internal thread 55 which is screwed onto the connection end piece 53.
  • a filter 57 is placed inside the axial channel for passage of the liquid.
  • This filter can be mounted in all capsules of the ' embodiments shown in the previous figures. It will be noted that this filter is preferably of the membrane filter type.
  • connection with a male Luer or Luer Lock type connector is made after unscrewing the cap 54.
  • the link system must meet the following requirements:
  • the cap of the bottle 10 shown in Figures 11 and 12 is equipped with a passage 61 for a lace 60.
  • the pharmacist can pass a lace 60 in the passage 61 formed on the head of the protective cap of the bottle, then pass this lace through one of the passages 62 provided in the infusion bag 63 (for example in the passage provided for hanging the bag), then irreversibly tie the two ends 64 and 65 of the lace.
  • Such synthetic laces, equipped with an irreversible closure system are available on the market.
  • a special "lace" associated with a plate 66 intended to receive inscriptions such as patient name, bed number, date and other information may be provided in the packaging of the bottle.
  • the caregiver will be able to carry out a complete verification of the medication. Then it will separate the protective cap from the bottle. The protective cap will remain linked to the pocket by the lace. A part of the pasted label remaining attached to the cap will contain the "coded" information allowing the identification, by the nursing staff, of the medicament contained in the pocket.
  • the vial equipped with the needle is activated then its content is dissolved and transferred to the pocket. Then the caregiver removes the bottle and separates it from the pocket.
  • the two devices If the two devices are not used, they return to the pharmacy. It will be enough to cut the lace and reintroduce the material in store.
  • the bottle described above responds in all. -point -to the constraints imposed in terms of conservation and use of medicinal substances. It is inviolable. It has a blocking system which makes it inactivable during storage. It includes a transfer device secured to the actual bottle which is stable and does not fear pressure or radial stress. It guarantees the sterility of the contents and the interior space including the volumes of the transfer device which are placed in communication with the interior space in the bottle at the time of use.
  • the lock due to the tamper-evident label and the security system during storage is eliminated with a single gesture.
  • Activation of the bottle and its transfer device is carried out in a simple manner, without effort, and without piercing a closure cap. Activation is irreversible and there is no way to allow return to the storage position. This activation can be done without external equipment, next to the patient. The transfer takes place in a vacuum, without contact with the outside.
  • the coupling of the bottle and another container is carried out by means of standard members whose characteristics are perfectly known.
  • FIG. 13 illustrates a mode of coupling of a bottle 10 with an infusion bag 70 provided with a connection conduit 71 composed of a narrow section 71a and a wide section 71b.
  • the connection device of the bottle allows the coupling by screwing of a nozzle 72.
  • the connection pipe 71 contains a sealing plug 73 which, when it is in the narrow section 71a, closes this pipe and when it found in the wide section 71b household a peripheral passage 74 between it and the wall. of the conduit.
  • FIG. 14 illustrates a bottle 10 associated with a closure device and a connection device comprising a closure member 80, a capsule 81 and a needle 82, mounted on the neck 12 of this bottle.
  • the needle 82 is made in one piece with the capsule 81.
  • FIG. 15 represents a perspective view of the shutter member 16 which has been shown seen in section in Figure 2.
  • This closure member comprises an upper part 16a and a nozzle 17 which extends this upper part.
  • the end piece 17 includes, in the embodiment shown, four lateral recesses 18 which intervene during the lyophilization phase.
  • the upper part 16a comprises a radial duct 21 which communicates with the outside via a substantially circular opening formed in the central zone of this upper part 16a, between two beads 16b and 16c respectively.
  • FIG. 16 represents the closure member 42 which is used when the bottle 10 is intended to contain a powdery or liquid substance and not a lyophilisate.
  • This shutter member is shown in section in FIG. 7. It comprises an upper part 42a which is identical in all points to the upper part 16a of the shutter member 16. In particular it is provided with a radial channel 43 which opens into a central zone delimited by two beads 42b and 42c respectively.
  • a lower tip 42d of slightly frustoconical shape, extends the upper part of the shutter member. Note that this tip has no side opening.
  • FIG. 17 illustrates a particular use of the bottle 10 connected via a flexible pipe 90 to a peristaltic pump 91.
  • the capsule 92 is equipped with a connection end piece 93 which is coupled to a member for connection 94 to perform a Luer-Lock type coupling.
  • the capsule 100 is provided with a nozzle 101 comprising no connection member to another device but which is intended to be put in the mouth by the patient.
  • the bottle 10 is designed to contain a drug substance to be absorbed orally.
  • FIG. 19 illustrates another use of the vial 10, which in this case is coupled to a pre-filled syringe 110.
  • the capsule 111 of the closure device comprises an end piece 112 which is identical to the end piece 93 shown in FIG. 17.
  • the pre-filled syringe 110 is coupled to the tip 112 by a connecting member 113 fixed to said tip by locking means of the Luer-Lock type.
  • the connection member 113 includes an internal cavity 114 whose diameter is somewhat greater than the diameter of a closure plug 115 which closes the end of the syringe 110.
  • FIG. 20 represents a coupling of the vial 10 with a traditional syringe 120 which can be empty or pre-filled.
  • the coupling of these two components is of the Luer type.
  • the capsule 121 of the closure device comprises a conical female tip 122 intended to receive a frustoconical tip 123 which is in fact the needle-holder tip of the syringe 120.
  • the connection is made by means other than the needle intended to inject a substance into the patient, so that the needle is not contaminated during the transfer phase of the substances to be injected.
  • FIG. 21 illustrates another embodiment of the bottle as well as another mode of use of this bottle.
  • the bottle 10 is coupled to a transfusion bag 130 which comprises a connection tube 131 closed by a cap 132 made of a flexible elastomeric substance.
  • the bottle is equipped with a transfer device which includes a needle 133 mounted on a needle holder 134 which fits on a nozzle 135 integral with the capsule 136. All these elements are protected by a tubular member 137, substantially cylindrical, integral with the capsule 136.
  • the liquid substance contained inside the transfusion bag 130 can be transferred inside the said bottle then the mixture obtained can be transferred from the bottle to the bag 130.
  • FIG. 22 illustrates another form of use of the bottle 10 which is, in this case, coupled to a flexible bottle 140 by means of a device of the Luer-Lock type 141.
  • FIG. 23 illustrates a variant of the embodiment represented by FIG. 22.
  • the flexible bottle 140 is replaced by a three-way valve 150.
  • FIG. 24 represents the bottle 10 corresponding to the use illustrated by FIG. 21 in its storage position.
  • the capsule 136 is surrounded by a protective cap 138 and it is linked to the bottle by a tamper-evident label 139.
  • FIG. 25 represents the bottle 10 illustrated in particular by FIG. 22 and FIG. 23 in its position of storage.
  • the capsule 150 is completely covered by a protective cap 151 linked to the bottle by a tamper-evident label 152.
  • the closure member 153 engaged in the neck of the bottle 10 is made in two parts, a part 154, or head, which is in contact with the substance contained in the bottle and an annular seal 155 which will not be in contact with the drug substance or solution obtained after mixing with another substance, only for a short period of time. Therefore, the two parts can be made of different materials, the head is of course made of a material compatible with the substance contained in the bottle. This principle of realization can be applied to all the bottles.
  • FIG. 26 illustrates another embodiment particularly suitable for the use of medicaments containing bicarbonate and or citric acid or other chemical substances which, when dissolved, generate a significant release of carbon dioxide.
  • the pressure inside the entire system increases significantly. Since carbon dioxide dissolves relatively quickly in a solution, it would be possible to wait a few minutes before proceeding to infusion, nevertheless it is particularly advantageous to be able to remove this gas by a simple and effective means.
  • This means comprises at least one lateral opening made in the needle 161.
  • this needle has two openings 162 which are closed when it is sufficiently pressed inside the 'sealing plug 163 which closes the conduit 164 of the infusion bag 160 and which are released as shown in the figure, when it is somewhat set back from this plug.
  • Figures 27 and 28 illustrate another embodiment of a vial equipped with a transfer device to ensure rapid evacuation of the carbon dioxide released during the reconstitution of a drug solution from 'a solvent and a powder initially placed in the bottle.
  • Figure 27 shows an intermediate position between the storage position and the activated position of the bottle and Figure 28 shows the activated position of this bottle.
  • a protective cap completely covering the capsule was removed.
  • the capsule provides an opening which makes it possible to put the interior of the system in communication with the exterior.
  • the capsule 170 has an opening 171 which provides communication re in the cavity 172 formed inside the body 'shutter 173 and the outside.
  • a complementary element 174 which is engaged on the needle-holder endpiece 175 temporarily obtains the closure of this opening 171.
  • Figure 28 shows the device in working condition.
  • the operator presses as shown by the arrows M on the branches of the element 174 it releases the opening 171 and allows the evacuation of the gas under pressure inside the pocket and the bottle.
  • This achievement allows to evacuate the overpressure due to carbon dioxide which is released during the preparation of an antibiotic solution.
  • a simple push exerted for example by means of the thumb and the index on the elastic branches of the element 174 achieves the desired goal.
  • FIG. 29 illustrates a variant of the device represented by FIG. 28.
  • the modification consists in inserting a hydrophobic filter 180 inside the cavity 172, this filter being perforated in its center so as to allow a direct passage of the liquids between the bottle and pocket 181, but being arranged to cover the opening 171 which serves as a vent.
  • the role of the filter is to avoid the risk of release of aerosols of antibiotics or antimitotics which are very harmful to the nursing staff.
  • FIG. 30 represents an enlarged view of the zone which carries the filter 180.
  • the vent 171 is constituted by an axial perforation formed in the wall of the capsule 170.
  • the filter 180 is constituted by an annular part which is supported on two beads annular 182 formed on the wall of the capsule which comprises the opening 171. This opening which is unique in the embodiment shown could be replaced by several opening formed in the annular zone delimited by the two beads 182.
  • the advantage of the presence of the hydrophobic filter is that it makes it possible at all times to ensure the release of the overpressure without risking causing aerosols which, as mentioned above, are particularly harmful to the nursing staff.

Abstract

The bottle (10) comprises a stopper means (153) engaged in the neck and mounted on a capsule (150) situated above the neck. The capsule (150) is integral with a conical connecting tip allowing a Luer-Lock type connection to be made. The entire unit is protected by a cap (151). The stopper means ( 153) is made of two parts, a head (154) and an annular gasket (155) which may be of different materials. A tamper-proof label connects the bottle (10) to the cap (151).

Description

FLACON DE STOCKAGE ET DE TRANSFERT CONÇU POUR STOCKER UN COMPOSANT D'UNE SUBSTANCE MEDICAMENTEUSE STORAGE AND TRANSFER BOTTLE DESIGNED TO STORE A COMPONENT OF A DRUG SUBSTANCE
La présente invention concerne un flacon de stockage et de transfert à compartiment unique conçu pour stocker un composant d'une substance médicamenteuse et pour le transférer directement, ou après l'avoir mélangé à une autre substance, dans un dispositif d'utilisation, ce flacon comportant un col rétréci ouvert et un dispositif d'obturation engagé dans ce col.The present invention relates to a single compartment storage and transfer bottle designed to store a component of a drug substance and to transfer it directly, or after having mixed it with another substance, in a device for use, this bottle comprising an open narrowed neck and a closure device engaged in this neck.
Les substances médicamenteuses, qu'elles soient utilisables directement ou qu'elles constituent les composants d'un mélange, sont habituellement stockées dans des récipients qui peuvent être soit des ampoules en verre scellées à la flamme, soit des flacons obturés par un bouchon d'obturation.Medicinal substances, whether directly usable or whether they constitute the components of a mixture, are usually stored in containers which can either be flame-sealed glass ampoules or vials sealed with a stopper. shutter.
Un flacon de ce type est par exemple décrit par le brevet américain No. 3,674,028 et comporte un corps pourvu d'un col rétréci et d'un étranglement central qui définit deux compartiments contenant respectivement un lyophilisât et un solvant destinés à être mélangés. Le col est obturé par un bouchon spécial permettant l'évacuation des vapeurs lors de la lyophilisation de la substance déposée dans le compartiment inférieur. Après la lyophilisation le bouchon est repoussé dans la zone centrale du corps comportant l'étranglement et sépare ainsi de manière étanche les deux compartiments. Un obturateur est mis en place à l'extrémité du col pour fermer le compartiment supérieur après remplissage de ce dernier. Cet obturateur comporte une zone centrale de moindre épaisseur, destinée à être percée par une aiguille en vue du prélèvement du mélange à injecter à un patient. Ces flacons ainsi que ces ampoules connues qui contiennent une substance médicamenteuse liquide posent un problème important lors du transfert de leur contenu dans un dispositif d'utilisation tel qu'une seringue. En effet, le soignant doit, dans tous les cas, utiliser une aiguille pour aspirer le liquide de l'ampoule. Or, l'aiguille utilisée pour effectuer le transfert est contaminée sur ses parois extérieures par la solution médicamenteuse. Cette contamination externe de l'aiguille est responsable de douleurs, d'hématomes ou d'autres lésions des tissus qui ne doivent en principe pas être en contact avec la substance médicamenteuse. En outre, le transfert ne permet pas d'éviter une contamination bactérienne et particulaire. En raison des règles d'hygiène, on impose une non-réutilisation de l'aiguille de transfert et son remplacement par une aiguille neuve stérile, et cela pour chaque opération de transfert.A bottle of this type is for example described by US Patent No. 3,674,028 and comprises a body provided with a narrowed neck and a central constriction which defines two compartments respectively containing a lyophilisate and a solvent intended to be mixed. The neck is closed by a special plug allowing the evacuation of the vapors during the lyophilization of the substance deposited in the lower compartment. After lyophilization, the plug is pushed back into the central zone of the body comprising the constriction and thus separates the two compartments in a leaktight manner. A shutter is placed at the end of the neck to close the upper compartment after filling it. This obturator comprises a central zone of lesser thickness, intended to be pierced by a needle for the purpose of withdrawing the mixture to be injected from a patient. These bottles as well as these known ampoules which contain a liquid medicinal substance pose a significant problem during the transfer of their contents into a device for use such as a syringe. In fact, the caregiver must, in all cases, use a needle to draw up the liquid from the ampoule. However, the needle used to carry out the transfer is contaminated on its outer walls by the drug solution. This external contamination of the needle is responsible for pain, bruising or other tissue damage which should not in principle be in contact with the drug substance. In addition, the transfer does not prevent bacterial and particulate contamination. Due to hygienic rules, the transfer needle is not to be reused and replaced with a new sterile needle, and this for each transfer operation.
Cependant, rien ne garantit que le soignant respecte cette règle. Il existe de ce fait un véritable danger pour le patient, en particulier lorsque l'aiguille de transfert est également utilisée pour procéder à l'injection. La mise en contact des tissus avec la substance médicamenteuse et les contaminants, bactéries, et particules transportés par l'aiguille est alors inévitable.However, there is no guarantee that the caregiver respects this rule. There is therefore a real danger for the patient, especially when the transfer needle is also used for the injection. It is therefore inevitable that the tissues come into contact with the drug substance and the contaminants, bacteria and particles transported by the needle.
Le problème est sensiblement identique lorsque la substance est contenue dans un flacon, mais en plus s'ajoutent les inconvénients connus de la perforation de bouchons.The problem is substantially identical when the substance is contained in a bottle, but in addition there are the known drawbacks of puncturing plugs.
Parmi les systèmes qui sont actuellement commercialisés couramment, figure un dispositif appelé "Transfer set" qui comporte une double aiguille ou un double trocart, et qui est utilisé pour connecter directement un flacon obturé par un bouchon en élastomère avec une poche ou une bouteille à perfusion. Le flacon peut contenir une substance médicamenteuse liquide ou sèche. Le dispositif de transfert est toutefois fourni indépendamment du flacon auquel on est censé le raccorder, et présenté dans un emballage stérile. De ce fait, rien n'empêche sa réutilisation sur un autre flacon après une première utilisation, même si les règles d'hygiène hospitalière proscrivent un tel réemploi.Among the systems which are currently commercially available, is a device called "Transfer set" which has a double needle or a double trocar, and which is used to directly connect a vial closed by an elastomer stopper with a pocket or an infusion bottle. The bottle may contain a liquid or dry drug substance. The transfer device is however supplied independently of the bottle to which it is supposed to connect, and presented in sterile packaging. Therefore, nothing prevents its reuse on another bottle after a first use, even if the rules of hospital hygiene prohibit such reuse.
Le coût relativement élevé de ce système accentue la tendance à une réutilisation.The relatively high cost of this system accentuates the tendency to reuse.
Le seul moyen d'empêcher à la fois les erreurs de manipulation lors de la mise en place d'un dispositif de transfert et sa réutilisation, est de prévoir un flacon équipé d'un dispositif de transfert inamovible.The only way to prevent both handling errors during the installation of a transfer device and its reuse, is to provide a bottle equipped with a non-removable transfer device.
Pour qu'un système de transfert réponde à toutes les exigences en matière de sécurité il est indispensable qu'il soit inviolable, inactivable pendant le stockage, solidaire du flacon, résistant à une contrainte radiale, stérile et garantissant la stérilité de l'espace intérieur du flacon et de tous les canaux, cavités intérieures et orifices permettant de faire communiquer cet espace avec un autre espace délimité par un autre récipient pouvant contenir un autre composant destiné à être mélangé à la substance contenue dans le flacon.For a transfer system to meet all the security requirements, it is essential that it be tamper-proof, inactivable during storage, secured to the bottle, resistant to radial stress, sterile and guaranteeing the sterility of the interior space. of the bottle and of all the channels, internal cavities and orifices making it possible to communicate this space with another space delimited by another container which may contain another component intended to be mixed with the substance contained in the bottle.
La présente invention se propose de pallier les inconvénients ci-dessus en réalisant un flacon de stockage pouvant être connecté à toutes sortes de récipients ou conteneurs du marché, sans augmentation notoire du coût de fabrication et sans complications techniques, Dans ce but, le flacon selon l'invention est caractérisé en ce que le dispositif d'obturation est conçu pour être déplacé entre une première position, dite de stockage, dans laquelle il constitue un obturateur étanche, et une seconde position, dite d'utilisation, dans laquelle il constitue une vanne ouverte pour permettre l'évacuation de ladite substance médicamenteuse, et en ce que ce dispositif est solidaire d'un dispositif de raccordement du flacon avec un récipient contenant un autre composant de la substance médicamenteuse et/ou avec le dispositif d'utilisation.The present invention proposes to overcome the above drawbacks by providing a storage bottle which can be connected to all kinds of receptacles or containers on the market, without any noticeable increase in the cost of manufacture and without technical complications, For this purpose, the bottle according to the invention is characterized in that the closure device is designed to be moved between a first position, called storage, in which it constitutes a sealed shutter, and a second position, called use, in which it constitutes an open valve to allow the evacuation of said medicinal substance, and in that this device is integral with a device for connecting the vial with a container containing another component of the medicinal substance and / or with the device of use.
Selon une forme de réalisation préférée, le dispositif d'obturation peut comporter un organe d'obturation souple en élastomère comportant une cavité centrale et un canal radial débouchant dans la cavité centrale, il peut être monté sur une capsule ajustée sur le col du flacon et mobile axialement entre ladite position de stockage et ladite position d'utilisation.According to a preferred embodiment, the closure device may comprise a flexible elastomeric closure member comprising a central cavity and a radial channel opening into the central cavity, it may be mounted on a capsule fitted to the neck of the bottle and axially movable between said storage position and said use position.
De préférence, la capsule est pourvue d'un embout de raccordement conique et d'un élément raidisseur engagé à l'intérieur d'une cavité de' l'organe d'obturation.Preferably, the capsule is provided with a conical connecting tip and a stiffening element engaged inside a cavity of the 'closure member.
L'embout de raccordement peut être un embout du type "Luer" ou peut être un embout du type "Luer Lock".The connection end piece may be a "Luer" type end piece or may be a "Luer Lock" type end piece.
Selon les variantes, l'embout de raccordement est un embout conique mâle ou un embout conique femelle.According to the variants, the connection end piece is a male conical end piece or a female conical end piece.
Selon une forme de réalisation avantageuse, l'embout de raccordement porte une aiguille et la capsule est pourvue d'un élément de protection sensiblement cylindrique dont la longueur est au moins approximativement égale à celle de l'aiguille. Selon une variante, le flacon comporte des moyens de liaison pour le lier de façon souple au dispositif d'utilisation ou à un autre récipient contenant un autre composant de la substance médicamenteuse.According to an advantageous embodiment, the connection endpiece carries a needle and the capsule is provided with a substantially cylindrical protective element whose length is at least approximately equal to that of the needle. Alternatively, the bottle has connecting means for flexibly binding it to the device for use or to another container containing another component of the drug substance.
Lesdits moyens de liaison comprennent de préférence un lacet dont les extrémités sont équipées d'éléments de liaison à verrouillage.Said connecting means preferably comprise a lace, the ends of which are equipped with locking connecting elements.
D'une façon avantageuse, le flacon comporte au moins un filtre monté dans le dispositif de raccordement ou le dispositif d'obturation, dans une zone de passage obligatoire de la substance médicamenteuse ou du mélange de cette substance avec une autre substance avant son utilisation. De préférence, ce filtre est du type filtre à membrane.Advantageously, the bottle comprises at least one filter mounted in the connection device or the closure device, in a zone of obligatory passage of the drug substance or of the mixture of this substance with another substance before its use. Preferably, this filter is of the membrane filter type.
Lorsque ledit dispositif se trouve dans sa première position dite de stockage, le dispositif d'obturation peut être lié au flacon par une étiquette d'inviolabilité.When said device is in its first so-called storage position, the closure device can be linked to the bottle by a tamper-evident label.
Selon une forme de réalisation avantageuse, le dispositif comporte une aiguille agencée pour perforer un bouchon d'obturation d'un récipient vide ou prérempli.According to an advantageous embodiment, the device comprises a needle arranged to perforate a closure plug of an empty or pre-filled container.
De préférence, ladite aiguille comporte au moins une ouverture latérale agencée pour permettre l'évacuation d'une surpression engendrée à l'intérieur du flacon et/ou d'un autre conteneur connecté au flacon au moyen de ladite aiguille.Preferably, said needle has at least one lateral opening arranged to allow the evacuation of an overpressure generated inside the bottle and / or of another container connected to the bottle by means of said needle.
Le dispositif d'obturation peut comporter un évent et un élément d'obturation élastique agencé pour obturer ledit évent dans une première position et pour le libérer dans une deuxième position. D'une façon avantageuse, ledit évent est ménagé dans une paroi de la capsule et le dispositif d'obturation porte un filtre hydrophobe disposé par-dessus ledit évent.The closure device may include a vent and an elastic closure element arranged to close said vent in a first position and to release it in a second position. Advantageously, said vent is formed in a wall of the capsule and the closure device carries a hydrophobic filter disposed over said vent.
De préférence, ce filtre hydrophobe a une forme annulaire et comporte une ouverture centrale qui assure la communication entre le dispositif d'obturation et le dispositif de raccordement.Preferably, this hydrophobic filter has an annular shape and has a central opening which ensures communication between the closure device and the connection device.
Selon une forme de réalisation avantageuse, le dispositif d'obturation se compose de deux parties distinctes, une tête et un joint annulaire. De préférence, la tête et le joint annulaire sont réalisés en des matériaux différents.According to an advantageous embodiment, the closure device consists of two separate parts, a head and an annular seal. Preferably, the head and the annular seal are made of different materials.
'invention sera mieux comprise en référence à la description d'exemples de réalisation et du dessin annexé dans lequel :the invention will be better understood with reference to the description of exemplary embodiments and the appended drawing in which:
Les figures 1 à 5 illustrent le processus de remplissage d'un flacon contenant un composé à l'état de lyophilisât,FIGS. 1 to 5 illustrate the process of filling a flask containing a compound in the lyophilisate state,
les figures 6 a 9 illustrent le processus de remplissage d'un flacon contenant une poudre prévue pour être mélangée à un solvant liquide,FIGS. 6 to 9 illustrate the process of filling a bottle containing a powder intended to be mixed with a liquid solvent,
la figure 10 représente une autre forme de réalisation d'un flacon selon l'invention,FIG. 10 shows another embodiment of a bottle according to the invention,
les figures 11 et 12 illustrent une forme d'utilisation particulière du flacon selon l'invention,FIGS. 11 and 12 illustrate a particular form of use of the bottle according to the invention,
la figure 13 représente une vue en coupe illustrant un mode d'accouplement du flacon avec une poche à perfusion, la figure 14 illustre une vue en coupe d'un flacon dont la capsule est associée à une aiguille,FIG. 13 represents a sectional view illustrating a method of coupling the bottle with an infusion bag, FIG. 14 illustrates a sectional view of a bottle whose cap is associated with a needle,
la figure 15 représente une vue en perspective d'un organe d'obturation destiné à un flacon de lyophilisation,FIG. 15 represents a perspective view of a closure member intended for a lyophilization bottle,
la figure 16 représente une vue en perspective d'un organe d'obturation d'un flacon destiné à contenir une substance poudreuse,FIG. 16 represents a perspective view of a closure member for a bottle intended to contain a powdery substance,
la figure 17 représente un flacon selon l'invention couplé à une pompe péristatique,FIG. 17 represents a bottle according to the invention coupled to a peristatic pump,
la figure 18 représente un flacon équipé d'un embout buccal,FIG. 18 represents a bottle fitted with a mouthpiece,
la' figure 19 représente une vue en coupe d'un flacon selon l'invention raccordé à une seringue préremplie,the 'Figure 19 shows a sectional view of a bottle according to the invention attached to a prefilled syringe,
la figure 20 représente une vue en coupe d'un flacon couplé à une seringue traditionnelle,FIG. 20 represents a sectional view of a bottle coupled to a traditional syringe,
la figure 21 représente une vue en coupe d'un flacon équipé d'une aiguille et raccordé à une poche à perfusion,FIG. 21 represents a sectional view of a bottle equipped with a needle and connected to an infusion bag,
la figure 22 présente une vue en coupe d'un flacon selon l'invention accouplé à un flacon souple,FIG. 22 shows a sectional view of a bottle according to the invention coupled to a flexible bottle,
la figure 23 représente une vue en coupe d'un flacon selon l'invention connecté à une vanne à trois voies,FIG. 23 represents a sectional view of a bottle according to the invention connected to a three-way valve,
la figure 24 représente une vue en coupe illustrant la position de stockage d'un flacon selon l'invention équipé d'une aiguille, la figure 25 représente une vue en coupe d'un flacon selon l'invention équipé d'un dispositif de raccordement du type Luer-Lock et protégé par un capuchon,FIG. 24 represents a sectional view illustrating the storage position of a bottle according to the invention equipped with a needle, FIG. 25 represents a sectional view of a bottle according to the invention equipped with a connection device of the Luer-Lock type and protected by a cap,
la figure 26 représente une forme de réalisation particulière d'un flacon destiné à être accouplé à une poche à perfusion,FIG. 26 represents a particular embodiment of a bottle intended to be coupled to an infusion bag,
la figure 27 représente une vue en coupe d'une autre forme de réalisation permettant de libérer une surpression à l'intérieur du flacon et/ou d'une poche,FIG. 27 represents a sectional view of another embodiment making it possible to release an overpressure inside the bottle and / or a pocket,
la figure 28 représente une vue en coupe illustrant le flacon de la figure 27 dans sa phase d'utilisation,FIG. 28 represents a sectional view illustrating the bottle of FIG. 27 in its use phase,
la figure 29 représente une variante de la réalisation des figures 27 et 28, etFIG. 29 represents a variant of the embodiment of FIGS. 27 and 28, and
La figure 30 représente une vue en coupe agrandie illustrant de façon plus spécifique le filtre hydrophobe monté à l'intérieur de l'organe d'obturation.FIG. 30 represents an enlarged sectional view illustrating more specifically the hydrophobic filter mounted inside the obturation member.
En référence à la figure 1, un flacon 10 pourvu d'un fond 11 fermé et d'un col 12 ouvert de section rétrécie par rapport à celle du corps 13 du flacon, est partiellement rempli d'une substance liquide 14 qui est introduite à l'intérieur du flacon au travers d'un conduit 15. Le liquide 14 est dans ce cas une solution aqueuse d'une substance médicamenteuse destinée à être lyophilisée.With reference to FIG. 1, a bottle 10 provided with a closed bottom 11 and an open neck 12 with a narrowed section relative to that of the body 13 of the bottle, is partially filled with a liquid substance 14 which is introduced at the interior of the bottle through a conduit 15. The liquid 14 is in this case an aqueous solution of a medicinal substance intended to be lyophilized.
La phase de lyophilisation est représentée par la fig. 2. Cette opération se fait à l'intérieur d'un appareil comportant essentiellement une enceinte reliée à une pompe à vide et des moyens de cryogenation. Avant de pénétrer dans cette enceinte, le flacon 10 est équipé d'un organe d'obturation 16 souple, en élastomère, qui comporte à son extrémité inférieure un embout 17, solidaire de la partie supérieure de cet organe et pourvu d'au moins une ouverture latérale 18 permettant à la vapeur d'eau 19 de s'échapper hors du flacon. On notera que toute cette opération est faite dans des conditions stériles étant donné que le flacon est stérile au moment de son remplissage, l'organe d'obturation *est stérile au moment de sa mise en place sur le col du flacon et l'enceinte de lyophilisation est une enceinte stérile.The freeze-drying phase is shown in fig. 2. This operation is carried out inside a device essentially comprising an enclosure connected to a vacuum pump and cryogenic means. Before entering this enclosure, the bottle 10 is equipped a flexible closure member 16, made of elastomer, which comprises at its lower end a nozzle 17, integral with the upper part of this member and provided with at least one lateral opening 18 allowing the steam 19 to escape out of the bottle. It will be noted that this whole operation is carried out under sterile conditions since the bottle is sterile at the time of its filling, the obturation member * is sterile at the time of its installation on the neck of the bottle and the enclosure. of lyophilization is a sterile enclosure.
La phase suivante qui consiste à mettre en place l'organe d'obturation dans sa position de stockage, est représentée par la figure 3. Pour amener l'organe d'obturation 16 de sa position de lyophilisation représentée par la figure 2 à sa position de stockage représentée par la figure 3, on enfonce ledit organe comme le montrent les flèches A au moyen d'un poussoir 20 disposé à l'intérieur de l'enceinte de lyophilisation. L'organe d'obturation 16 est pourvu d'un canal radial 21 qui est obturé par la paroi du col du flacon dasn la position représentée par cette figure. Dans la pratique, ce poussoir est constitué par le plafond de l'enceinte de lyophilisation. Selon d'autres formes de réalisation, le plafond de l'enceinte de lyophilisation est fixe et c'est le plancher supportant les flacons qui se déplace vers le haut pour provoquer la pénétration de l'organe d'obturation à l'intérieur du col.The next phase which consists in putting the obturation member in its storage position, is represented by FIG. 3. To bring the obturation member 16 from its lyophilization position represented by FIG. 2 to its position storage shown in Figure 3, said member is pressed as shown by the arrows A by means of a pusher 20 disposed inside the lyophilization enclosure. The shutter member 16 is provided with a radial channel 21 which is closed by the wall of the neck of the bottle in the position represented by this figure. In practice, this pusher is constituted by the ceiling of the freeze-drying enclosure. According to other embodiments, the ceiling of the freeze-drying enclosure is fixed and it is the floor supporting the bottles which moves upwards to cause the penetration of the closure member inside the neck .
Comme le montre la figure 4, dans la position de stockage, l'embout 17 est engagé à l'intérieur du flacon et la partie supérieure de l'organe d'obturation est engagée à l'intérieur du col 12 de telle manière qu'un canal radial 21, ménagé dans la partie supérieure de l'organe d'obturation, soit fermé par la paroi intérieure du col 12. Dans cette position, l'organe d'obturation assume l'une de ses fonctions qui est d'assurer la fermeture étanche du flacon 10 pendant le stockage de ce dernier.As shown in Figure 4, in the storage position, the tip 17 is engaged inside the bottle and the upper part of the closure member is engaged inside the neck 12 so that a radial channel 21, formed in the upper part of the shutter member, or closed by the inner wall of the neck 12. In this position, the closure member assumes one of its functions which is to ensure the tight closure of the bottle 10 during storage of the latter.
Par la suite, le flacon contenant la substance médicamenteuse à l'état lyophilisé, et obturé de façon étanche par l'organe d'obturation 16, est extrait de l'enceinte de lyophilisation et est équipé d'une capsuleSubsequently, the vial containing the drug substance in the lyophilized state, and sealed in sealing form by the obturating member 16, is extracted from the lyophilization enclosure and is equipped with a capsule.
22 qui constitue, avec cet organe d'obturation 16, un dispositif d'obturation du flacon et sert de support à un dispositif de transfert destiné au raccordement du flacon 10 avec un dispositif d'utilisation (non représenté). La capsule 22 comporte un embout de raccordement 23, dont la forme est conique, et qui constitue un embout du type dit "Luer". Cet embout est prolongé vers l'intérieur du flacon par un élément raidisseur 24, de forme sensiblement cylindrique, qui est engagé dans une cavité intérieure 25 de l'organe d'obturation 16. Par ailleurs, la capsule 22 comporte une collerette périphérique 26 qui est engagée par-dessus le rebord 27 du col 12 du flacon 10, et qui comporte des protubérances intérieures 28 qui ont pour objet de coopérer avec le rebord 27 pour définir, d'une part la position de stockage, et d'autre part la position d'utilisation du dispositif de transfert et par conséquent de l'organe d'obturation 16.22 which constitutes, with this closure member 16, a closure device for the bottle and serves as a support for a transfer device intended for connecting the bottle 10 with a device for use (not shown). The capsule 22 comprises a connection end piece 23, the shape of which is conical, and which constitutes an end piece of the so-called "Luer" type. This nozzle is extended towards the inside of the bottle by a stiffening element 24, of substantially cylindrical shape, which is engaged in an internal cavity 25 of the shutter member 16. Furthermore, the capsule 22 comprises a peripheral flange 26 which is engaged over the rim 27 of the neck 12 of the bottle 10, and which has internal protuberances 28 which have the purpose of cooperating with the rim 27 to define, on the one hand the storage position, and on the other hand the position of use of the transfer device and consequently of the shutter member 16.
Ce dispositif de transfert proprement dit est recouvert, pendant la phase de stockage, par un capuchon 29 qui est adapté à la forme et aux dimensions des différents composants de la capsule et notamment de la collerette 26. Dans l'exemple représenté, l'embout de raccordementThis transfer device proper is covered, during the storage phase, by a cap 29 which is adapted to the shape and dimensions of the various components of the capsule and in particular of the collar 26. In the example shown, the end piece connection
23 est associé à une aiguille conventionnelle 30 soudée au collet d'une manière connue en soi à un embout porte- aiguille 31 qui est un embout femelle conique complémentaire au point de vue de la forme et des dimensions à l'embout de raccordement 23. Pour protéger cette aiguille, la capsule 22 se prolonge du côté opposé au flacon par une structure 32 sensiblement cylindrique dont la longueur est approximativement égale à celle de l'aiguille avec son porte-aiguille.23 is associated with a conventional needle 30 welded to the collar in a manner known per se with a needle holder tip 31 which is a complementary conical female tip from the point of view of shape and dimensions at the connecting piece 23. To protect this needle, the capsule 22 is extended on the side opposite to the bottle by a substantially cylindrical structure 32 whose length is approximately equal to that of the needle with its needle holder.
On constate que le capuchon 29 est enveloppant au niveau du col du flacon et au niveau de la collerette de la capsule. A cet effet, comme cela est représenté par la fig. 5 il comporte un premier secteur 29a de section rétrécie qui enveloppe essentiellement la structure 32 de la capsule, un secteur intermédiaire 29b qui est en appui contre la paroi extérieure de la collerette 26 et un rebord 29c dont le diamètre extérieur est sensiblement égal au diamètre extérieur du flacon 10. Cette réalisation permet de mettre en place une étiquette d'inviolabilité 33 qui sert bien entendu à identifier le produit mais également à rendre le capuchon 29 et le flacon 10 solidaire. La phase de mise en place de cette étiquette d'inviolabilité est schematiquement représentée par les flèches B.It can be seen that the cap 29 is enveloping at the level of the neck of the bottle and at the level of the flange of the capsule. To this end, as shown in FIG. 5 it comprises a first sector 29a of narrowed section which essentially envelops the structure 32 of the capsule, an intermediate sector 29b which bears against the external wall of the flange 26 and a flange 29c whose external diameter is substantially equal to the external diameter of the bottle 10. This embodiment makes it possible to set up a tamper-evident label 33 which of course serves to identify the product but also to make the cap 29 and the bottle 10 integral. The installation phase of this tamper-evident label is schematically represented by the arrows B.
Le flacon décrit précédemment et les phases de remplissage et d'assemblage illustrées par les figures 1 à 5, correspondent à l'utilisation d'une substance médicamenteuse se trouvant initialement à l'état de solution liquide et qui est destinée à être conservée à l'état de lyophilisât. Pour l'utilisation, on est obligé de réhydrater le lyophilisât pour le transformer en une solution pouvant être utilisée soit directement, soit après un mélange avec une autre substance. Avant une telle utilisation, il est nécessaire d'introduire un solvant liquide à l'intérieur du flacon, à travers le dispositif de transfert et plus exactement à travers l'aiguille de ce dispositif. A cet effet, on déchire l'étiquette d'inviolabilité, on enlève le capuchon de protection et on enfonce la capsule sur le col ce qui a pour effet de * faire pénétrer la partie supérieure de l'organe d'obturation vers l'intérieur du flacon jusque dans une position où l'orifice latéral 21 ménagé dans la partie supérieure de l'organe d'obturation débouche à l'intérieur du flacon et permet une mise en communication de l'aiguille et de l'espace intérieur du flacon. Le raccordement avec une autre enceinte stérile contenant le solvant se fait à travers l'aiguille 30. Selon une forme de réalisation avantageuse, l'enceinte stérile contenant le solvant est une poche souple ou un autre récipient approprié.The bottle described above and the filling and assembly phases illustrated in FIGS. 1 to 5 correspond to the use of a medicinal substance initially found in the form of a liquid solution and which is intended to be stored in the container. state of lyophilisate. For use, it is necessary to rehydrate the lyophilisate to transform it into a solution which can be used either directly or after mixing with another substance. Before such use, it is necessary to introduce a liquid solvent inside the bottle, through the transfer device and more precisely through the needle of this device. To this end, the tamper-evident label is torn, the cap is removed. protection and the capsule is pressed onto the neck, which has the effect of * making the upper part of the closure member penetrate towards the inside of the bottle into a position where the lateral orifice 21 formed in the upper part of the closure member opens out inside the bottle and allows the needle and the interior space of the bottle to be placed in communication. The connection with another sterile enclosure containing the solvent is made through the needle 30. According to an advantageous embodiment, the sterile enclosure containing the solvent is a flexible bag or another suitable container.
Grâce à ce type de connexion par cône Luer, le flacon décrit peut être connecté à tous les dispositifs du marché équipés du même type de connexion normalisée Luer ou Luer Lock, correspondant à une connexion par cône équipé d'un système de verrouillage, à savoir : une seringue vide, une seringue préremplie, un robinet de raccordement à un autre récipient ou à un conduit, une tubulure, une pompe péristaltique, un inhalateur, une poche à perfusion souple, un flacon souple collapsible pour application oculaire.Thanks to this type of Luer cone connection, the described bottle can be connected to all devices on the market equipped with the same type of standardized Luer or Luer Lock connection, corresponding to a cone connection equipped with a locking system, namely : an empty syringe, a pre-filled syringe, a tap to connect to another container or to a conduit, a tubing, a peristaltic pump, an inhaler, a flexible infusion bag, a collapsible flexible bottle for ocular application.
Pour certaines utilisations la substance médicamenteuse destinée à être stockée dans le flacon se trouve à l'état de poudre. A quelques modifications près, les démarches de remplissage de stockage et d'utilisation sont sensiblement les mêmes que celles décrites en référence aux figures 1 à 5. La figure 6 représente un flacon 10 destiné à permettre le stockage d'une poudre 40 introduite dans ce flacon à travers une tubulure d'amenée 41. On notera que le flacon 10 représenté par la figure 6 est en tout point identique au flacon 10 représenté par les figures 1 et suivantes. Lorsque la quantité de poudre requise a été introduite dans le flacon, la phase suivante consiste à obturer le flacon au moyen d'un organe d'obturation 42 représenté par la figure 7. Cet organe d'obturation diffère de celui qui est représenté par les figures 2 à 5 en ce qu'il ne comporte pas l'embout inférieur 17 dont la fonction est strictement liée à la phase de lyophilisation. En revanche, cet organe d'obturation comporte également un conduit radial 43 qui permet, en cours d'utilisation, d'assurer une communication avec l'intérieur du flacon 10.For certain uses, the medicinal substance intended to be stored in the bottle is in the form of a powder. With a few modifications, the storage and use filling procedures are substantially the same as those described with reference to FIGS. 1 to 5. FIG. 6 represents a bottle 10 intended to allow the storage of a powder 40 introduced into this bottle through a supply tube 41. It will be noted that the bottle 10 represented by FIG. 6 is in all points identical to the bottle 10 represented by FIGS. 1 and following. When the required quantity of powder has been introduced into the bottle, the next phase consists in closing the bottle by means of a closure member 42 represented by FIG. 7. This closure member differs from that represented by the Figures 2 to 5 in that it does not include the lower tip 17 whose function is strictly linked to the lyophilization phase. On the other hand, this obturation member also comprises a radial duct 43 which makes it possible, during use, to ensure communication with the interior of the bottle 10.
La phase représentée par la figure 8 et qui correspond à la mise en place des dispositifs d'obturation et de transfert est en tout point identique à celle illustrée par la figure 4, mis à part le fait que, dans l'un, des cas, le contenu du flacon est une poudre, et dans l'autre cas il s'agit d'un lyophilisât. Pour cette raison, les numéros de référence des différents éléments constitutifs sont les mêmes dans les deux cas.The phase represented by FIG. 8 and which corresponds to the installation of the obturation and transfer devices is in all points identical to that illustrated by FIG. 4, apart from the fact that, in one, of the cases , the content of the bottle is a powder, and in the other case it is a lyophilisate. For this reason, the reference numbers of the various constituent elements are the same in both cases.
La figure 9, qui illustre la phase de mise en place d'une étiquette d'inviolabilité, est identique à la figure 5 à la même différence près que précédemment. Pour cette raison, les numéros de référence de ces deux figures sont identiques.FIG. 9, which illustrates the phase of fitting a tamper-evident label, is identical to FIG. 5 with the same difference as above. For this reason, the reference numbers of these two figures are identical.
En ce qui concerne l'utilisation du flacon des figures 6 à 9, elle est sensiblement identique à celle du flacon précédent. L'aiguille de seringue, qui est montée sur l'embout de raccordement du dispositif de raccordement, permet de faire pénétrer un solvant agencé pour dissoudre la poudre contenue dans le flacon.Regarding the use of the bottle of Figures 6 to 9, it is substantially identical to that of the previous bottle. The syringe needle, which is mounted on the connection end of the connection device, allows a solvent arranged to dissolve the powder contained in the vial to enter.
La figure 10 illustre une variante du dispositif de raccordement décrit précédemment. Ce dispositif de raccordement 50 est associé à un organe d'obturation 42 identique à celui qui est représenté par les figures 6 à 9 en association avec le flacon contenant une poudre. On notera toutefois que le dispositif de raccordement 50 pourrait également être associé à un organe d'obturation 16 tel que celui représenté par les figures 2 à 5 en association avec un flacon contenant un lyophilisât. Cet organe de raccordement comporte une capsule 51 pourvue d'une collerette 52 qui passe par-dessus le rebord 27 du col 12 du flacon 10. Cette collerette, qui est représentée dans sa position d'utilisation, comporte, comme précédemment des protubérances intérieures 28 destinées à coopérer avec le rebord 27 pour définir les positions de stockage et d'utilisation. Cette capsule est pourvue de l'embout cylindrique 24 (identique à celui défini par la figure 4) qui est engagé à l'intérieur de l'organe d'obturation 42 et d'un embout de raccordement 53 qui est un embout femelle conique à verrouillage couramment appelé "Luer Lock". Cet embout est obturé par un capuchon 54 pourvu d'un filetage intérieur 55 qui se visse sur l'embout de raccordement 53. Dans l'exemple représenté, un filtre 57 est disposé à l'intérieur du canal axial de passage du liquide. Ce filtre peut être monté dans toutes les capsules des ' réalisations représentées par les figures précédentes. On notera que ce filtre est de préférence du type filtre à membrane.FIG. 10 illustrates a variant of the connection device described above. This device connection 50 is associated with a closure member 42 identical to that which is represented by FIGS. 6 to 9 in association with the bottle containing a powder. Note however that the connection device 50 could also be associated with a sealing member 16 such as that shown in Figures 2 to 5 in combination with a bottle containing a lyophilisate. This connection member comprises a capsule 51 provided with a collar 52 which passes over the rim 27 of the neck 12 of the bottle 10. This collar, which is shown in its position of use, has, as previously, internal protuberances 28 intended to cooperate with the rim 27 to define the storage and use positions. This capsule is provided with the cylindrical end piece 24 (identical to that defined in FIG. 4) which is engaged inside the shutter member 42 and with a connection end piece 53 which is a conical female end piece with lock commonly called "Luer Lock". This end piece is closed by a cap 54 provided with an internal thread 55 which is screwed onto the connection end piece 53. In the example shown, a filter 57 is placed inside the axial channel for passage of the liquid. This filter can be mounted in all capsules of the ' embodiments shown in the previous figures. It will be noted that this filter is preferably of the membrane filter type.
Au point de vue de l'utilisation, la connexion avec un embout du type Luer ou Luer Lock mâle s'effectue après dévissage du capuchon 54.From the point of view of use, the connection with a male Luer or Luer Lock type connector is made after unscrewing the cap 54.
La préparation des médicaments se faisant à la pharmacie, il faut offrir un moyen sûr et irréversible pour lier le flacon décrit avec la poche à perfusion contenant le solvant approprié. Il existe toutes sortes de poches standards contenant une grande variété de solvants ou solutions d'infusion. Une erreur dans le choix du solvant peut provoquer la précipitation du médicament, son altération, etc.The preparation of drugs being done at the pharmacy, it is necessary to offer a safe and irreversible means to bind the described bottle with the infusion bag containing the appropriate solvent. There are all kinds of standard bags containing a wide variety of solvents or infusion solutions. An error in the choice of solvent can cause precipitation of the drug, its alteration, etc.
Seule une personne compétente et autorisée peut donc décider du choix du solvant. Ce choix est généralement fait par le pharmacien et non par le personnel soignant.Only a competent and authorized person can therefore decide on the choice of solvent. This choice is generally made by the pharmacist and not by the nursing staff.
Le système de liaison doit répondre aux exigences suivantes :The link system must meet the following requirements:
1) il doit permettre la liaison de la poche et du flacon décrit sans imposer une activâtion du système;1) it must allow the connection of the bag and the bottle described without requiring activation of the system;
2) il doit permettre la reprise des deux dispositifs en magasin si le traitement n'a pas eu lieu (décès, interruption du traitement) ;2) it must allow the resumption of the two devices in store if the treatment has not taken place (death, interruption of treatment);
3) il doit garantir l'identification du médicament contenu dans la poche après reconstitution : a) en clair pour le personnel soignant; b) codée pour le patient, les autres patients, ainsi que pour les visiteurs afin de garantir la discrétion et le respect du patient (traitement anti-cancer, anti-sida, etc.) .3) it must guarantee the identification of the medication contained in the bag after reconstitution: a) in clear for the nursing staff; b) coded for the patient, other patients, as well as for visitors in order to guarantee the patient's discretion and respect (anti-cancer, anti-AIDS treatment, etc.).
Pour atteindre ce but, le capuchon du flacon 10 représenté par les figures 11 et 12 est équipé d'un passage 61 pour un lacet 60. Ainsi, le pharmacien pourra passer un lacet 60 dans le passage 61 ménagé sur la tête du capuchon protecteur du flacon, faire passer ensuite ce lacet dans un des passages 62 ménagés dans la poche à perfusion 63 (par exemple dans le passage prévu pour suspendre la poche) , puis lier irréversiblement les deux bouts 64 et 65 du lacet. De tels lacets en matière synthétique, équipés d'un système de fermeture irréversible sont disponibles sur le marché. Un "lacet" spécial associé à une plaquette 66 destinée à recevoir des inscriptions telles que nom du patient, numéro du lit, date et autres informations peut être prévu dans l'emballage du flacon.To achieve this goal, the cap of the bottle 10 shown in Figures 11 and 12 is equipped with a passage 61 for a lace 60. Thus, the pharmacist can pass a lace 60 in the passage 61 formed on the head of the protective cap of the bottle, then pass this lace through one of the passages 62 provided in the infusion bag 63 (for example in the passage provided for hanging the bag), then irreversibly tie the two ends 64 and 65 of the lace. Such synthetic laces, equipped with an irreversible closure system are available on the market. A special "lace" associated with a plate 66 intended to receive inscriptions such as patient name, bed number, date and other information may be provided in the packaging of the bottle.
Lors de la préparation, le soignant va pouvoir effectuer une vérification complète de la médication. Ensuite, il séparera le capuchon protecteur du flacon. Le capuchon protecteur restera lié à la poche par le lacet. Une partie de l'étiquette collée restant attachée sur le capuchon contiendra les informations "codées" permettant l'identification, par le personnel soignant, du médicament contenu dans la poche.During the preparation, the caregiver will be able to carry out a complete verification of the medication. Then it will separate the protective cap from the bottle. The protective cap will remain linked to the pocket by the lace. A part of the pasted label remaining attached to the cap will contain the "coded" information allowing the identification, by the nursing staff, of the medicament contained in the pocket.
Le flacon équipé de l'aiguille est activé puis son contenu est dissous et transféré dans la poche. Ensuite le soignant retire le flacon et le sépare de la poche.The vial equipped with the needle is activated then its content is dissolved and transferred to the pocket. Then the caregiver removes the bottle and separates it from the pocket.
En cas de non-utilisation des deux dispositifs, ceux-ci retournent à la pharmacie. Il suffira de couper le lacet et de réintroduire le matériel en magasin.If the two devices are not used, they return to the pharmacy. It will be enough to cut the lace and reintroduce the material in store.
Le flacon décrit ci-dessus répond en .tout. -point -aux contraintes imposées en matière de conservation et d'utilisation de substances médicamenteuses. Il est inviolable. Il dispose d'un système de blocage qui le rend inactivable pendant le stockage. Il comporte un dispositif de transfert solidaire du flacon proprement dit qui est stable et ne craint pas une pression ou contrainte radiale. Il garantit la stérilité du contenu et de l'espace intérieur y compris les volumes du dispositif de transfert qui sont mis en communication avec l'espace intérieur au flacon au moment de l'utilisation.The bottle described above responds in all. -point -to the constraints imposed in terms of conservation and use of medicinal substances. It is inviolable. It has a blocking system which makes it inactivable during storage. It includes a transfer device secured to the actual bottle which is stable and does not fear pressure or radial stress. It guarantees the sterility of the contents and the interior space including the volumes of the transfer device which are placed in communication with the interior space in the bottle at the time of use.
En outre, au moment de l'utilisation, le verrouillage dû à l'étiquette d'inviolabilité et au système de sécurité au stockage est éliminé d'un seul geste. L'activation du flacon et de son dispositif de transfert s'effectue de manière simple, sans effort, et sans percement d'un bouchon d'obturation. L'activation est irréversible et aucun moyen n'autorise le retour dans la position de stockage. Cette activation peut se faire sans appareillage extérieur, à côté du patient. Le transfert s'effectue en vase clos, sans contact avec l'extérieur. L'accouplement du flacon et d'un autre récipient s'effectue au moyen d'organes standards dont les caractéristiques sont parfaitement connues.In addition, at the time of use, the lock due to the tamper-evident label and the security system during storage is eliminated with a single gesture. Activation of the bottle and its transfer device is carried out in a simple manner, without effort, and without piercing a closure cap. Activation is irreversible and there is no way to allow return to the storage position. This activation can be done without external equipment, next to the patient. The transfer takes place in a vacuum, without contact with the outside. The coupling of the bottle and another container is carried out by means of standard members whose characteristics are perfectly known.
Un certain nombre de ces modes d'accouplement sont représentés par les figures suivantes et décrits ci- dessous.A number of these coupling modes are shown in the following figures and described below.
La figure 13 illustre un mode d'accouplement d'un flacon 10 avec une poche à perfusion 70 pourvue d'un conduit de raccordement 71 composé d'un tronçon étroit 71a et d'un tronçon large 71b. Le dispositif de raccordement du flacon permet le couplage par vissage d'un embout 72. Le conduit de raccordement 71 contient un bouchon d'obturation 73 gui, lorsqu'il se trouve dans le tronçon étroit 71a, obture ce conduit et lorsqu'il se trouve dans le tronçon large 71b ménage un passage périphérique 74 entre lui et la paroi.du conduit.FIG. 13 illustrates a mode of coupling of a bottle 10 with an infusion bag 70 provided with a connection conduit 71 composed of a narrow section 71a and a wide section 71b. The connection device of the bottle allows the coupling by screwing of a nozzle 72. The connection pipe 71 contains a sealing plug 73 which, when it is in the narrow section 71a, closes this pipe and when it found in the wide section 71b household a peripheral passage 74 between it and the wall. of the conduit.
La figure 14 illustre un flacon 10 associé à un dispositif d'obturation et un dispositif de raccordement comprenant un organe d'obturation 80, une capsule 81 et une aiguille 82, montés sur le col 12 de ce flacon. dans ce cas de réalisation, l'aiguille 82 est réalisée d'une pièce avec la capsule 81.FIG. 14 illustrates a bottle 10 associated with a closure device and a connection device comprising a closure member 80, a capsule 81 and a needle 82, mounted on the neck 12 of this bottle. in this embodiment, the needle 82 is made in one piece with the capsule 81.
La figure 15 représente une vue en perspective de l'organe d'obturation 16 qui a été représenté vu en coupe sur la figure 2. Cet organe d'obturation comprend une partie supérieure 16a et un embout 17 qui prolonge cette partie supérieure. L'embout 17, comprend dans la forme de réalisation représentée, quatre évidements latéraux 18 qui interviennent pendant la phase de lyophilisation. La partie supérieure 16a comporte un conduit radial 21 qui communique avec l'extérieur par une ouverture sensiblement circulaire ménagée dans la zone centrale de cette partie supérieure 16a, entre deux bourrelets respectivement 16b et 16c.FIG. 15 represents a perspective view of the shutter member 16 which has been shown seen in section in Figure 2. This closure member comprises an upper part 16a and a nozzle 17 which extends this upper part. The end piece 17 includes, in the embodiment shown, four lateral recesses 18 which intervene during the lyophilization phase. The upper part 16a comprises a radial duct 21 which communicates with the outside via a substantially circular opening formed in the central zone of this upper part 16a, between two beads 16b and 16c respectively.
La figure 16 représente l'organe d'obturation 42 qui est utilisé lorsque le flacon 10 est destiné à contenir une substance poudreuse ou liquide et non un lyophilisât. Cet organe d'obturation est représenté en coupe par la figure 7. Il comporte une partie supérieure 42a qui est en tout point identique à la partie supérieure 16a de l'organe d'obturation 16. En particulier il est pourvu d'un canal radial 43 qui débouche dans une zone centrale délimitée par deux bourrelets respectivement 42b et 42c. Un embout inférieur 42d, de forme légèrement tronconique, prolonge la partie supérieure de l'organe d'obturation. On notera que cet embout est dépourvu d'ouverture latérale.FIG. 16 represents the closure member 42 which is used when the bottle 10 is intended to contain a powdery or liquid substance and not a lyophilisate. This shutter member is shown in section in FIG. 7. It comprises an upper part 42a which is identical in all points to the upper part 16a of the shutter member 16. In particular it is provided with a radial channel 43 which opens into a central zone delimited by two beads 42b and 42c respectively. A lower tip 42d, of slightly frustoconical shape, extends the upper part of the shutter member. Note that this tip has no side opening.
La figure 17 illustre une utilisation particulière du flacon 10 connecté par l'intermédiaire d'un tuyau souple 90 à une pompe péristaltique 91. Dans cette réalisation, la capsule 92 est équipée d'un embout de raccordement 93 qui est couplé à un organe de raccordement 94 pour réaliser un couplage du type Luer-Lock.FIG. 17 illustrates a particular use of the bottle 10 connected via a flexible pipe 90 to a peristaltic pump 91. In this embodiment, the capsule 92 is equipped with a connection end piece 93 which is coupled to a member for connection 94 to perform a Luer-Lock type coupling.
La variante illustrée par la figure 18 correspond à une autre application du système. Dans ce cas, la capsule 100 est pourvue d'un embout 101 ne comprenant aucun organe de raccordement à un autre appareil mais qui est destiné à être mis en bouche par le patient. Dans ce cas, le flacon 10 est conçu pour contenir une substance médicamenteuse à absorber par voie buccale.The variant illustrated in FIG. 18 corresponds to another application of the system. In this case, the capsule 100 is provided with a nozzle 101 comprising no connection member to another device but which is intended to be put in the mouth by the patient. In this case, the bottle 10 is designed to contain a drug substance to be absorbed orally.
La figure 19 illustre une autre utilisation du flacon 10, qui est dans ce cas couplé à une seringue préremplie 110. La capsule 111 du dispositif d'obturation comporte un embout 112 qui est identique à l'embout 93 représenté par la figure 17. La seringue préremplie 110 est couplée à l'embout 112 par un organe de raccordement 113 fixé audit embout par des moyens de verrouillage du type Luer-Lock. L'organe de raccordement 113 comporte une cavité intérieure 114 dont le diamètre est quelque peu supérieur au diamètre d'un bouchon d'obturation 115 qui ferme l'extrémité de la seringue 110. Après activation du flacon 10, l'opérateur enfonce le piston 116 de la seringue 110 en direction du flacon 10, ce qui a pour effet de repousser le bouchon 115 dans la cavité 114. Le liquide 117 qui est initialement stocké entre le bouchon 115 et le piston 116 s'écoule vers l'intérieur du flacon. Après obtention du mélange souhaité, ce dernier peut être récupéré dans la seringue en vue d'une utilisation ultérieure. Etant donné que la seringue est raccordée directement au flacon autrement que par une aiguille destinée à l'injection, aucune contamination de cette aiguille n'a lieu pendant cette phase de transfert.FIG. 19 illustrates another use of the vial 10, which in this case is coupled to a pre-filled syringe 110. The capsule 111 of the closure device comprises an end piece 112 which is identical to the end piece 93 shown in FIG. 17. The pre-filled syringe 110 is coupled to the tip 112 by a connecting member 113 fixed to said tip by locking means of the Luer-Lock type. The connection member 113 includes an internal cavity 114 whose diameter is somewhat greater than the diameter of a closure plug 115 which closes the end of the syringe 110. After activation of the bottle 10, the operator depresses the piston 116 from the syringe 110 in the direction of the bottle 10, which has the effect of pushing the stopper 115 back into the cavity 114. The liquid 117 which is initially stored between the stopper 115 and the piston 116 flows towards the inside of the bottle . After obtaining the desired mixture, it can be collected in the syringe for later use. Since the syringe is connected directly to the vial other than by a needle intended for injection, no contamination of this needle takes place during this transfer phase.
La figure 20 représente un accouplement du flacon 10 avec une seringue traditionnelle 120 qui peut être vide ou préremplie. L'accouplement de ces deux composants est du type Luer. A cet effet, la capsule 121 du dispositif d'obturation comporte un embout femelle conique 122 destiné à recevoir un embout tronconique 123 qui est en fait l'embout porte-aiguille de la seringue 120. Là encore, le raccordement se fait par des moyens autres que l'aiguille destinée à injecter une substance au patient, de sorte que l'aiguille n'est pas contaminée pendant la phase de transfert des substances à injecter.FIG. 20 represents a coupling of the vial 10 with a traditional syringe 120 which can be empty or pre-filled. The coupling of these two components is of the Luer type. To this end, the capsule 121 of the closure device comprises a conical female tip 122 intended to receive a frustoconical tip 123 which is in fact the needle-holder tip of the syringe 120. Here again, the connection is made by means other than the needle intended to inject a substance into the patient, so that the needle is not contaminated during the transfer phase of the substances to be injected.
La figure 21 illustre une autre forme de réalisation du flacon ainsi qu'un autre mode d'utilisation de ce flacon. Le flacon 10 est couplé à une poche de transfusion 130 qui comporte un tube de raccordement 131 obturé par un capuchon 132 réalisé en une substance élastomère souple. Le flacon est équipé d'un dispositif de transfert qui comporte une aiguille 133 montée sur un porte-aiguille 134 qui s'adapte sur un embout 135 solidaire de la capsule 136. Tous ces éléments sont protégés par un organe tubulaire 137, sensiblement cylindrique, solidaire de la capsule 136. Après activation du flacon 10, la substance liquide contenue à l'intérieur de la poche de transfusion 130 peut être transférée à l'intérieur dudit flacon puis le mélange obtenu peut être transvasé du flacon dans la poche 130.FIG. 21 illustrates another embodiment of the bottle as well as another mode of use of this bottle. The bottle 10 is coupled to a transfusion bag 130 which comprises a connection tube 131 closed by a cap 132 made of a flexible elastomeric substance. The bottle is equipped with a transfer device which includes a needle 133 mounted on a needle holder 134 which fits on a nozzle 135 integral with the capsule 136. All these elements are protected by a tubular member 137, substantially cylindrical, integral with the capsule 136. After activation of the bottle 10, the liquid substance contained inside the transfusion bag 130 can be transferred inside the said bottle then the mixture obtained can be transferred from the bottle to the bag 130.
La figure 22 illustre une autre forme d'utilisation du flacon 10 qui est, dans ce cas, couplé à un flacon souple 140 au moyen d'un dispositif du type Luer-Lock 141.FIG. 22 illustrates another form of use of the bottle 10 which is, in this case, coupled to a flexible bottle 140 by means of a device of the Luer-Lock type 141.
La figure 23 illustre une variante de la forme de réalisation représentée par la figure 22. Dans ce cas, le flacon souple 140 est remplacé par une vanne à trois voies 150.FIG. 23 illustrates a variant of the embodiment represented by FIG. 22. In this case, the flexible bottle 140 is replaced by a three-way valve 150.
La figure 24 représente le flacon 10 correspondant à l'utilisation illustrée par la figure 21 dans sa position de stockage. Dans cette position, la capsule 136 est entourée d'un capuchon de protection 138 et elle est liée au flacon par une étiquette d'inviolabilité 139.FIG. 24 represents the bottle 10 corresponding to the use illustrated by FIG. 21 in its storage position. In this position, the capsule 136 is surrounded by a protective cap 138 and it is linked to the bottle by a tamper-evident label 139.
La figure 25 représente le flacon 10 illustré notamment par la figure 22 et la figure 23 dans sa position de stockage. Comme précédemment, la capsule 150 est complètement recouverte par un capuchon de protection 151 lié au flacon par une étiquette d'inviolabilité 152.FIG. 25 represents the bottle 10 illustrated in particular by FIG. 22 and FIG. 23 in its position of storage. As before, the capsule 150 is completely covered by a protective cap 151 linked to the bottle by a tamper-evident label 152.
On notera que l'organe d'obturation 153 engagé dans le col du flacon 10 est réalisé en deux parties, une partie 154, ou tête, qui est en contact avec la substance contenue dans le flacon et un joint annulaire 155 qui ne sera en contact, avec la substance médicamenteuse ou la solution obtenue après mélange avec une autre substance, que pendant un court laps de temps. De ce fait, les deux parties peuvent être réalisées en des matériaux différents, la tête étant bien entendu réalisée en un matériau compatible avec la substance contenue dans le flacon. Ce principe de réalisation peut s'appliquer à tous les flacons.Note that the closure member 153 engaged in the neck of the bottle 10 is made in two parts, a part 154, or head, which is in contact with the substance contained in the bottle and an annular seal 155 which will not be in contact with the drug substance or solution obtained after mixing with another substance, only for a short period of time. Therefore, the two parts can be made of different materials, the head is of course made of a material compatible with the substance contained in the bottle. This principle of realization can be applied to all the bottles.
La figure 26 illustre une autre forme de réalisation particulièrement adaptée à l'utilisation de médicaments contenant du bicarbonate et ou de l'acide citrique ou autres substances chimiques qui, lors de leur dissolution engendrent un important dégagement 'anhydride carbonique. Lors du transfert du solvant contenu dans une poche de perfusion 160, la pression à l'intérieur de tout le système augmente de façon importante. Etant donné que l'anhydride carbonique se dissout relativement rapidement dans une solution, il serait possible d'attendre quelques minutes avant de procéder à l'infusion, néanmoins il est particulièrement avantageux de pouvoir éliminer ce gaz par un moyen simple et efficace. Ce moyen comprend au moins une ouverture latérale ménagée dans l'aiguille 161. Dans la réalisation représentée, cette aiguille comporte deux ouvertures 162 qui sont obturées lorsqu'elle est suffisamment enfoncée à l'intérieur du 'bouchon d'obturation 163 qui ferme le conduit 164 de la poche de perfusion 160 et qui sont dégagés comme le montre la figure, lorsqu'elle est quelque peu en retrait par rapport à ce bouchon d'obturation.FIG. 26 illustrates another embodiment particularly suitable for the use of medicaments containing bicarbonate and or citric acid or other chemical substances which, when dissolved, generate a significant release of carbon dioxide. During the transfer of the solvent contained in an infusion bag 160, the pressure inside the entire system increases significantly. Since carbon dioxide dissolves relatively quickly in a solution, it would be possible to wait a few minutes before proceeding to infusion, nevertheless it is particularly advantageous to be able to remove this gas by a simple and effective means. This means comprises at least one lateral opening made in the needle 161. In the embodiment shown, this needle has two openings 162 which are closed when it is sufficiently pressed inside the 'sealing plug 163 which closes the conduit 164 of the infusion bag 160 and which are released as shown in the figure, when it is somewhat set back from this plug.
Les figures 27 et 28 illustrent une autre forme de réalisation d'un flacon équipé d'un dispositif de transfert permettant d'assurer une évacuation rapide de l'anhydride carbonique qui se dégage au moment de la reconstitution d'un solution médicamenteuse à partir d'un solvant et d'une poudre initialement disposée dans le flacon.Figures 27 and 28 illustrate another embodiment of a vial equipped with a transfer device to ensure rapid evacuation of the carbon dioxide released during the reconstitution of a drug solution from 'a solvent and a powder initially placed in the bottle.
La figure 27 représente une position intermédiaire entre la position de stockage et la position activée du flaconet la figure 28 représente la position activée de ce flacon. Entre la position de stockage et la position intermédiaire représentée par la figure 27, un capuchon de protection recouvrant intégralement la capsule a été retiré. Dans cette réalisation, la capsule prévoit une ouverture qui permet de mettre en communication l'intérieur du système avec l'extérieur. A cet effet, la capsule 170 comporte une ouverture 171 qui assure la communication en re la cavité 172 ménagée à l'intérieur de l'organe' d'obturation 173 et l'extérieur. Un élément complémentaire 174 qui est engagé sur l'embout porte- aiguille 175 assure momentanément l'obturation de cette ouverture 171.Figure 27 shows an intermediate position between the storage position and the activated position of the bottle and Figure 28 shows the activated position of this bottle. Between the storage position and the intermediate position shown in Figure 27, a protective cap completely covering the capsule was removed. In this embodiment, the capsule provides an opening which makes it possible to put the interior of the system in communication with the exterior. To this end, the capsule 170 has an opening 171 which provides communication re in the cavity 172 formed inside the body 'shutter 173 and the outside. A complementary element 174 which is engaged on the needle-holder endpiece 175 temporarily obtains the closure of this opening 171.
La figure 28 représente le dispositif en état de fonctionnement. Lorsque l'opérateur appuie comme le montre les flèches M sur les branches de l'élément 174, il libère l'ouverture 171 et permet l'évacuation du gaz en surpression à l'intérieur de la poche et du flacon. Cette réalisation permet d'évacuer la surpression due à l'anhydride carbonique qui se dégage lors de la préparation d'une solution d'antibiotique. Une simple poussée exercée par exemple au moyen du pouce et de l'index sur les branches élastiques de l'élément 174 permet d'atteindre le but recherché.Figure 28 shows the device in working condition. When the operator presses as shown by the arrows M on the branches of the element 174, it releases the opening 171 and allows the evacuation of the gas under pressure inside the pocket and the bottle. This achievement allows to evacuate the overpressure due to carbon dioxide which is released during the preparation of an antibiotic solution. A simple push exerted for example by means of the thumb and the index on the elastic branches of the element 174 achieves the desired goal.
La figure 29 illustre une variante du dispositif représenté par la figure 28. La modification consiste à insérer un filtre hydrophobe 180 à l'intérieur de la cavité 172, ce filtre étant perforé en son centre de manière à permettre un passage direct des liquides entre le flacon et la poche 181, mais étant agencé pour recouvrir l'ouverture 171 qui sert d'évent. Le rôle du filtre est d'éviter le risque de dégagement d'aérosols d'antibiotiques ou d'antimitotiques qui sont très nocifs pour le personnel soignant.FIG. 29 illustrates a variant of the device represented by FIG. 28. The modification consists in inserting a hydrophobic filter 180 inside the cavity 172, this filter being perforated in its center so as to allow a direct passage of the liquids between the bottle and pocket 181, but being arranged to cover the opening 171 which serves as a vent. The role of the filter is to avoid the risk of release of aerosols of antibiotics or antimitotics which are very harmful to the nursing staff.
La figure 30 représente une vue agrandie de la zone qui porte le filtre 180. L'évent 171 est constitué par une perforation axiale ménagée dans la paroi de la capsule 170. Le filtre 180 est constitué par une pièce annulaire qui prend appui sur deux bourrelets annulaires 182 ménagés sur la paroi de la capsule qui comporte l'ouverture 171. Cette ouverture qui est unique dans la forme de réalisation représentée pourrait être remplacée par plusieurs ouverture ménagées dans la zone annulaire délimitée par les deux bourrelets 182.FIG. 30 represents an enlarged view of the zone which carries the filter 180. The vent 171 is constituted by an axial perforation formed in the wall of the capsule 170. The filter 180 is constituted by an annular part which is supported on two beads annular 182 formed on the wall of the capsule which comprises the opening 171. This opening which is unique in the embodiment shown could be replaced by several opening formed in the annular zone delimited by the two beads 182.
L'avantage de la présence du filtre hydrophobe est qu'il permet à tout moment d'assurer le dégagement de la surpression sans risquer de provoquer des aérosols qui, comme mentionnés précédemment, sont particulièrement nocifs pour le personnel soignant. The advantage of the presence of the hydrophobic filter is that it makes it possible at all times to ensure the release of the overpressure without risking causing aerosols which, as mentioned above, are particularly harmful to the nursing staff.

Claims

REVENDICATIONS
1. Flacon de stockage et de transfert à compartiment unique conçu pour stocker un composant d'une substance médicamenteuse et pour le transférer directement, ou après l'avoir mélangé à une autre substance, dans un dispositif d'utilisation, ce flacon comportant un col rétréci ouvert et un dispositif d'obturation engagé dans ce col, caractérisé en ce que ce dispositif d'obturation est conçu pour être déplacé entre une première position, dite de stockage, dans laquelle il constitue un obturateur étanche et une seconde position, dite d'utilisation, dans laquelle il constitue une vanne ouverte pour permettre l'évacuation de ladite substance médicamenteuse, et en ce que ce dispositif est solidaire d'un dispositif de raccordement du flacon avec un récipient contenant un autre composant de la substance médicamenteuse et/ou avec le dispositif d'utilisation.1. Single compartment storage and transfer vial designed to store a component of a drug substance and to transfer it directly, or after having mixed it with another substance, in a device for use, this vial comprising a neck narrowed open and a closure device engaged in this neck, characterized in that this closure device is designed to be moved between a first position, called storage, in which it constitutes a sealed shutter and a second position, called d use, in which it constitutes an open valve to allow the evacuation of said medicinal substance, and in that this device is integral with a device for connecting the bottle with a container containing another component of the medicinal substance and / or with the operating device.
2. Flacon selon la revendication 1, caractérisé en ce que le dispositif d'obturation comporte un organe d'obturation souple en élastomère comportant une cavité centrale et un canal radial débouchant dans la cavité centrale, et en ce qu'il est monté sur une capsule ajustée sur le col du flacon et mobile axialement entre ladite position de stockage et ladite position d'utilisation.2. Bottle according to claim 1, characterized in that the closure device comprises a flexible elastomeric closure member comprising a central cavity and a radial channel opening into the central cavity, and in that it is mounted on a capsule adjusted on the neck of the bottle and movable axially between said storage position and said position of use.
3. Flacon selon la revendication 2, caractérisé en ce que la capsule est pourvue d'un embout de raccordement conique et d'un élément raidisseur engagé à l'intérieur d'une cavité de l'organe d'obturation.3. Bottle according to claim 2, characterized in that the capsule is provided with a conical connection end piece and with a stiffening element engaged inside a cavity of the closure member.
4. Flacon selon la revendication 3, caractérisé en ce que 1'embout de raccordement est un embout du type "Luer". 4. Bottle according to claim 3, characterized in that the connecting end piece is a "Luer" type end piece.
5. Flacon selon la revendication 3, caractérisé en ce que l'embout de raccordement est un embout du type "Luer Lock".5. Bottle according to claim 3, characterized in that the connection end piece is an end piece of the "Luer Lock" type.
6. Flacon selon la revendication 3, caractérisé en ce que l'embout de raccordement est un embout conique mâle.6. Bottle according to claim 3, characterized in that the connection end piece is a male conical end piece.
7. Flacon selon la revendication 3, caractérisé en ce que 1'embout de raccordement est un embout conique femelle.7. Bottle according to claim 3, characterized in that the connecting end piece is a female conical end piece.
8. Flacon selon la revendication 3, caractérisé en ce que l'embout de raccordement porte une aiguille et en ce que la capsule est pourvue d'un élément de protection sensiblement cylindrique dont la longueur est au moins approximativement égale à celle de l'aiguille.8. Bottle according to claim 3, characterized in that the connection endpiece carries a needle and in that the capsule is provided with a substantially cylindrical protective element whose length is at least approximately equal to that of the needle .
9. Flacon selon la revendication 1, caractérisé en ce qu'il comporte des moyens de liaison pour le lier de façon souple au dispositif d'utilisation ou à un autre récipient contenant un autre composant de la substance médicamenteuse.9. Bottle according to claim 1, characterized in that it comprises connecting means for flexibly binding it to the use device or to another container containing another component of the medicinal substance.
10. Flacon selon la revendication 9, caractérisé en ce que lesdits moyens de liaison comprennent un lacet dont les extrémités sont équipées d'éléments de liaison à verrouillage.10. Bottle according to claim 9, characterized in that said connecting means comprise a lace whose ends are equipped with locking connecting elements.
11. Flacon selon la revendication 1, caractérisé en ce qu'il comporte au moins un filtre monté dans le dispositif de raccordement ou le dispositif d'obturation, dans une zone de passage obligatoire de la substance médicamenteuse ou du mélange de cette substance avec une autre substance avant son utilisation.11. Bottle according to claim 1, characterized in that it comprises at least one filter mounted in the connection device or the closure device, in a compulsory passage zone for the drug substance or the mixture of this substance with a other substance before use.
12. Flacon selon la revendication 11, caractérisé en ce que le filtre est du type filtre à membrane. 12. Bottle according to claim 11, characterized in that the filter is of the membrane filter type.
13. Flacon selon la revendication 1, caractérisée en ce que le dispositif d'obturation est lié au flacon par une étiquette d'inviolabilité, lorsque ledit dispositif se trouve dans sa première position dite de stockage.13. Bottle according to claim 1, characterized in that the closure device is linked to the bottle by a tamper-evident label, when said device is in its first so-called storage position.
14. Flacon selon la revendication 1, caractérisé en ce que le dispositif comporte une aiguille agencée pour perforer un bouchon d'obturation d'un récipient vide ou prérempli.14. Bottle according to claim 1, characterized in that the device comprises a needle arranged to perforate a closure plug of an empty or pre-filled container.
15. Flacon selon la revendication 14, caractérisé en ce que ladite aiguille comporte au moins une ouverture latérale agencée pour permettre l'évacuation d'une surpression engendrée à l'intérieur du flacon et/ou d'un autre conteneur connecté au flacon au moyen de ladite aiguille.15. Bottle according to claim 14, characterized in that said needle has at least one lateral opening arranged to allow the evacuation of an overpressure generated inside the bottle and / or another container connected to the bottle by means of said needle.
16. Flacon selon la revendication 1, caractérisé en ce que le dispositif d'obturation comporte un évent et un élément d'obturation élastique agencé pour obturer ledit évent dans une première position et pour le libérer dans une deuxième position.16. Bottle according to claim 1, characterized in that the closure device comprises a vent and an elastic closure element arranged to close said vent in a first position and to release it in a second position.
17. Flacon selon la revendication 16, caractérisé en ce que ledit évent est ménagé dans une paroi de la capsule.17. Bottle according to claim 16, characterized in that said vent is formed in a wall of the capsule.
18. Flacon selon la revendication 16, caractérisé en ce que le dispositif d'obturation porte un filtre hydrophobe disposé par-dessus ledit évent.18. Bottle according to claim 16, characterized in that the closure device carries a hydrophobic filter disposed over said vent.
19. Flacon selon la revendication 18, caractérisé en ce que le filtre hydrophobe a une forme annulaire et comporte une ouverture centrale qui assure la communication entre le dispositif d'obturation et le dispositif de raccordement. 19. Bottle according to claim 18, characterized in that the hydrophobic filter has an annular shape and has a central opening which ensures communication between the closure device and the connection device.
20. Flacon selon la revendication 1, caractérisé en ce que le dispositif d'obturation se compose de deux parties distinctes, une tête et un joint annulaire.20. Bottle according to claim 1, characterized in that the closure device consists of two separate parts, a head and an annular seal.
21. Flacon selon la revendication 20, caractérisé en ce que la tête et le joint annulaire sont réalisés en des matériaux différents. 21. Bottle according to claim 20, characterized in that the head and the annular seal are made of different materials.
EP19900900747 1988-12-27 1989-12-27 Storage and transfer bottle designed for storing a component of a medicamental substance Expired - Lifetime EP0406374B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT90900747T ATE93382T1 (en) 1988-12-27 1989-12-27 STORAGE AND TRANSFER BOTTLE FOR STORING TWO COMPONENTS OF A HEALING SUBSTANCE.

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CH480588 1988-12-27
CH4805/88 1988-12-27
CH391989 1989-10-30
CH3919/89 1989-10-30

Publications (2)

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EP0406374A1 true EP0406374A1 (en) 1991-01-09
EP0406374B1 EP0406374B1 (en) 1993-08-25

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EP19900900747 Expired - Lifetime EP0406374B1 (en) 1988-12-27 1989-12-27 Storage and transfer bottle designed for storing a component of a medicamental substance

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US (1) US5487737A (en)
EP (1) EP0406374B1 (en)
JP (1) JPH0669474B2 (en)
AT (1) ATE93382T1 (en)
CA (1) CA2006584C (en)
DE (1) DE68908700T2 (en)
ES (1) ES2045897T3 (en)
WO (1) WO1990007318A1 (en)

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Also Published As

Publication number Publication date
DE68908700T2 (en) 1994-04-07
EP0406374B1 (en) 1993-08-25
JPH0669474B2 (en) 1994-09-07
CA2006584A1 (en) 1990-06-27
US5487737A (en) 1996-01-30
DE68908700D1 (en) 1993-09-30
ATE93382T1 (en) 1993-09-15
JPH03504568A (en) 1991-10-09
WO1990007318A1 (en) 1990-07-12
ES2045897T3 (en) 1994-01-16
CA2006584C (en) 1998-11-10

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