EP0403626B1 - Aufbewahrungs- und umfüllflasche zum aufbewahren von zwei bestandteilen einer heilkräftigen substanz - Google Patents

Aufbewahrungs- und umfüllflasche zum aufbewahren von zwei bestandteilen einer heilkräftigen substanz Download PDF

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Publication number
EP0403626B1
EP0403626B1 EP19900900743 EP90900743A EP0403626B1 EP 0403626 B1 EP0403626 B1 EP 0403626B1 EP 19900900743 EP19900900743 EP 19900900743 EP 90900743 A EP90900743 A EP 90900743A EP 0403626 B1 EP0403626 B1 EP 0403626B1
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EP
European Patent Office
Prior art keywords
bottle
stopper
substance
bottle according
stopper means
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP19900900743
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English (en)
French (fr)
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EP0403626A1 (de
Inventor
Gabriel Meyer
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Becton Dickinson France SA
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Medicorp Holding SA
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Filing date
Publication date
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Priority to AT90900743T priority Critical patent/ATE94749T1/de
Publication of EP0403626A1 publication Critical patent/EP0403626A1/de
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/02—Internal fittings
    • B65D25/04—Partitions
    • B65D25/08—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents
    • B65D25/082—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents the partition being in the form of a plug or the like which is removed by increasing or decreasing the pressure within the container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2031—Separating means having openings brought into alignment
    • A—HUMAN NECESSITIES
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    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2037—Separating means having valve means
    • A—HUMAN NECESSITIES
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2041—Separating means having removable plugs
    • A—HUMAN NECESSITIES
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    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A61J1/2062—Connecting means having multiple connecting ports with directional valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0015—Devices specially adapted for taking medicines
    • A61J7/0053—Syringes, pipettes or oral dispensers

Definitions

  • the present invention relates to a sterile double-compartment storage and transfer vial, designed to store two components of a drug substance, namely a solid substance and a solvent, and to transfer this substance directly, or after having mixed it with another substance, in a device for use.
  • the medicinal substances whether they can be used directly or whether they constitute the components of a mixture, are usually stored in containers which can either be flame-sealed glass ampoules or bottles sealed with a stopper shutter.
  • Such a bottle is for example described by American patent US-A-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 bottle is made of a rigid material, preferably glass, to be able to be sealed in a sealed manner by means of a flexible stopper and to be able to withstand the thermal stresses of freeze-drying and sterilization in an autoclave.
  • the neck is closed by a special plug allowing the evacuation of vapors during the lyophilization of the substance deposited in the lower compartment.
  • 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.
  • disposable transfer devices have been developed to allow sterile transfer of a medicinal substance contained in a storage vial directly to a use device.
  • Transfer set which has a double needle or a double trocar, and which is used to directly connect a bottle closed by an elastomer stopper with a pocket or an infusion bottle.
  • the vial 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 re-use on another bottle after a first use, even if the rules of hospital hygiene prohibit such re-use.
  • 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 system which is the subject of American patent US-A-3,206,080 is one of these achievements. It comprises a rigid bottle which is associated with a transfer device defining a variable volume chamber, the walls of which are flexible, and which is located between the bottle itself and a trocar. This intermediate chamber acts as a pump and allows the evacuation of the solution contained in the bottle.
  • closure members are not intended to allow the bottle to be closed in a lyophilization enclosure. No measures are taken to prevent accidental activation during storage. The sterility of the device cannot be preserved during storage. The construction of the assembly is complicated and difficult to carry out.
  • the device described comprises an external bottle with flexible walls, provided with a neck in which an internal bottle with rigid cylindrical walls has been engaged which is intended to contain a substance to be mixed before use with another substance in the outer bottle.
  • the internal bottle has lateral openings which allow it, after activation of the assembly, to deliver the mixture of the two substances, through internal channels of a transfer device.
  • the seal between the outer bottle and the inner bottle is theoretically achieved at the neck. Since the outer bottle is made of flexible synthetic material and the inner bottle is made of rigid synthetic material, or made of glass, a seal preventing bacterial contamination during long-term storage cannot be guaranteed. This: the guarantee is only obtained with a seal using an elastomer plug.
  • the outer bottle is not suitable for lyophilization or sterilization in an oven, since it could not withstand thermal stresses. Even if this bottle was able to withstand the constraints imposed for the lyophilization of a substance that it should contain, it could not be closed in the lyophilization enclosure, since the closure is done by means of the inner bottle.
  • the sterility of the transfer device is not guaranteed during storage and nothing is provided to prevent accidental activation during this storage, or to guarantee inviolability.
  • 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 corresponds to the definition set out in claim 1.
  • said closure member is mounted on a capsule fitted to the neck of the bottle and axially movable between said storage position and said position of use.
  • the capsule is provided with a conical connection end piece and with a stiffening element engaged inside a cavity of the closure member.
  • the connection endpiece carries a needle
  • the capsule is provided with a substantially cylindrical protective element whose length is at least approximately equal to that of said 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 can include at least one filter mounted in the connection device or the obturation member, 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 member When said device is in its first so-called storage position, the closure member can be linked to the bottle by a tamper-evident label.
  • said needle advantageously comprises at least one lateral opening arranged to allow the evacuation of an overpressure generated inside the bottle and / or another container. connected to the vial by means of said needle.
  • the shutter member may include a vent and an elastic shutter 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 member 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 shutter member and the connection device.
  • the closure member consists of at least two parts, a head and an annular seal.
  • the head and the seal of this closure member are made of different materials.
  • a bottle 10 provided with a closed bottom 11 and an open neck 12, of section narrowed relative to that of the body of the bottle, has a central narrowing 13 which separates a first lower compartment 14 of a second upper compartment 15.
  • the lower compartment 14 is partially filled by means of an aqueous solution 16 which is introduced through a filling tube 17.
  • the freeze-drying phase is represented by 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 with a stopper 18, hereinafter called a movable intermediate stopper, which comprises at its lower end a nozzle 19 provided with at least one lateral opening 20 allowing the vapor to water 21 to escape from the bottle.
  • a stopper 18 hereinafter called a movable intermediate stopper, which comprises at its lower end a nozzle 19 provided with at least one lateral opening 20 allowing the vapor to water 21 to escape from the bottle.
  • the next phase consists in driving the movable intermediate plug 18 inside the neck 12 to ensure a tight closure of the bottle.
  • this plug is pushed in as shown by the arrows A by means of a pusher 22.
  • this pusher is made up of the ceiling of the lyophilization enclosure which is lowering.
  • 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 mobile intermediate stopper inside the neck. This procedure allows the aseptic and sealed closure of the bottle under a controlled atmosphere.
  • the position of the movable intermediate plug as shown in Figure 3 is transient. In fact, this stopper is intended for sealingly separating the lower compartment 14 from the upper compartment 15.
  • the phase which consists in bringing this stopper into its storage position is shown in FIG. 4.
  • the movable intermediate stopper 18 is pushed through the neck, then through the upper compartment 15 in the throttle 13 by a pusher 23 mounted at the end of a rod 24 axially movable.
  • This plug 18 is pressed in such a way that the end piece 19 comprising at least one lateral opening 20 is entirely located inside the lower compartment 14 and that the upper part ensures perfect sealing between the two compartments.
  • the upper compartment 15 is degassed by injecting, as shown by the arrows B, a gas 25 through the rod 24 of the pusher 23, this rod being provided with at least a radial opening 26 allowing the gas to invade the upper compartment 15.
  • This gas is a neutral gas having no reaction with the solvent intended to be subsequently introduced into the upper compartment.
  • Figure 5 shows the filling phase of the upper compartment 15 with a solvent 27 which is poured through a supply tube 28 engaged in the neck 12 of the bottle.
  • the bottle is equipped with a flexible closure member 29 which is engaged inside the neck 12 and which has a inner cavity 30 and at least one radial duct 31 whose role will be defined later.
  • FIG. 7 illustrates the complete installation of the closure device which consists of the closure member 29 and of a capsule 32 provided with a stiffening element 33, of substantially cylindrical shape, which engages the inside the cavity 30 of the shutter member 29 and of a connection end piece 34 intended to ensure the connection with a user device (not shown).
  • This connection end piece 34 is conical and, in the example shown in the figure, is an end piece of the female Luer type.
  • the capsule 32 also includes a peripheral flange 35 which is engaged over the rim 36 of the neck 12 of the bottle 10 and which carries internal protrusions 37 and 38 having the object of cooperating with the rim 36 to define, on the one hand the storage position and on the other hand the position of use defined above.
  • FIG. 8 illustrates the final phase of fitting a tamper-evident label 41 which extends above the support area of the free edge of the cap 39 on the outside wall of the bottle 10.
  • the cap 39 is first removed by tearing off the tamper-evident label 41.
  • the closure member 29 is then pushed inside the neck 12.
  • the radial channel 31 remains closed since its orifice remains in abutment against the inner wall of the neck 12.
  • This penetration also has the effect of generating a pressure which is transmitted, by means of the liquid contained in the upper compartment 15, to the movable intermediate plug 18 which is pushed back inside the lower compartment 14. This plug falls into this compartment which ensures communication between the two compartments and causes the liquid to flow into the lower compartment.
  • the solvent dissolves the lyophilisate and forms a ready-to-use liquid drug substance.
  • the capsule To activate the transfer device previously connected either to another container, or to any device of use known per se, equipped with a conical tip, for example of the Luer type, complementary to the conical tip 34, the capsule towards the inside of the bottle until the protuberance 38 exceeds the rim 36 of the neck 12. In this position, the closure member 29 is pressed enough towards the inside of the bottle for the radial conduit to open into the upper compartment. Communication with the user device is ensured through the transfer device.
  • a conical tip for example of the Luer type
  • FIGS. 9 and 10 show a bottle 10 identical to that of the preceding figures and the neck of which is closed by a closure member 50.
  • This closure member comprises a lower part 51 whose outside diameter is slightly greater than the inside diameter of the neck, so as to ensure closure of the bottle, and an upper part 52 whose diameter is narrower.
  • An inner cavity 53 is formed in this shutter member and is closed at its upper end by a wall 54 of relatively small thickness.
  • the upper part 52 of the closure member 50 is engaged in a central opening of a capsule 55 whose outer rim is mounted on the neck of the bottle.
  • a protective cap 56 is preferably placed over the capsule 55 and the closure member 50.
  • a tamper-evident label 57 is fixed so as to cover the junction line of the cap and from the bottle.
  • the bottle of FIG. 11 is original by the construction of the capsule 60 which covers the neck 12 of the bottle 10.
  • This capsule 60 is provided with a connection device constituted by a connection end piece 61 which defines an interior cavity 62 aux conical walls.
  • This interior cavity is dimensioned to be able to receive a needle-holder tip 63 of a conventional syringe 64.
  • the activation of the bottle is carried out in a manner identical to that which has been described with reference to FIGS. 7 and 8.
  • the solution contained inside the bottle after mixing the lyophilisate and the solvent, can be transferred to the inside the syringe 64 by simple aspiration by means of the piston 65 of this syringe.
  • the bottle of FIG. 12 comprises a capsule 70 which is extended by a tubular element 71 making it possible to protect a needle 72 secured to a needle holder element 73 mounted on a conical tip 74 secured to the capsule 70.
  • the needle 72 is intended to perforate a sealing plug 75 which ensures the tight closure of a flexible bag 76 which may contain a medicinal solution, a physiological liquid or distilled water etc., to which the caregiver must mix the solution obtained after activation of the bottle 10.
  • the transfer can be carried out alternately in both directions, that is to say from the bag to the bottle and from the bottle to the bag until the total quantity of the liquid contained in the bottle is transferred. in the pocket.
  • the closure member 76 may, in a conventional manner, include a radial channel for the flow of the liquid. However, in the embodiment shown, it consists of two parts, a head 77 made of a material compatible with the substances contained in the bottle, and a seal 78 which can be made of a material any elastomer since it is not constantly in contact with the solvent contained in the upper chamber of the bottle 10.
  • FIG. 13 illustrates a form of use of the bottle 10 in which there is a connection of this bottle with a three-way valve 80.
  • This connection is made by means of a connection device 81 of the Luer-Lock type, that is to say by means of a conical connection with locking.
  • This connection is made on a connection endpiece 82 which is integral with the capsule 83 mounted on the neck 12 of the bottle.
  • the capsule 100 is extended by a tubular element 101 which is intended for absorption by the oral route of the solution contained inside the bottle 10.
  • FIG. 16 illustrates a connection of the bottle 10 to a pump 110, for example to a peristaltic micropump, by means of a flexible conduit 111 which is connected by means of a connection member 112 of the Luer-Lock type to a tip 113 extending the capsule 114 mounted on the neck 12 of the bottle 10.
  • FIG. 17 illustrates a transfer device which consists of an end piece 120 extending the capsule 121, this end piece being capped by a closure element 122 based on the Luer-Lock principle.
  • a cap 123 covers this assembly and a tamper-evident label 124 covers the junction zone between the free end of the cap and the body of the bottle 10.
  • FIG. 18 illustrates a bottle 10 fitted with a capsule 130 which is extended by a tubular element 131 intended to protect a needle 132 mounted on a needle holder 133 which is engaged on the conical end piece 134 secured to the bottom of the capsule 130.
  • the neck of the bottle 10 is closed by a shutter member 136 made in two parts, the part 137 which constitutes the head of the shutter member and a seal 138 which constitutes its base.
  • the advantage of this construction lies in the fact that the two parts can be made of different materials.
  • the head 137 can be made of a material compatible with the drug substance, while the seal 138, which is in contact with this substance only for a very short period of time, can be made of a material which would not withstand the contact with this substance during a storage period which can be relatively long.
  • FIG. 19 illustrates a particular use of a bottle as described.
  • This bottle 10 is housed inside a box 140 which contains a vaporization or nebulization device which comprises an ultrasonic generator (not shown) intended to spray in the form of very fine droplets the drug substance initially contained in the bottle .
  • This substance is sucked through a conduit 141 by a micropump 142 and then discharged towards a mouthpiece 143.
  • the bottle 10 must be activated, that is to say that the movable intermediate plug 18 must be pushed back into the compartment furthest from the neck of the bottle and the flexible closure member 29 must be partially pushed back into the other compartment to clear the radial channel and allow the liquid to flow.
  • the bottle 10 is carried by a support 144 integral with the housing and which comprises a cylindrical cavity intended to receive a stopper 145 provided with an axial duct for the passage of a needle 146 allowing the passage of air inside the bottle and guaranteeing the operation of the micropump which sucks the liquid from the bottle , the volume withdrawn being replaced by an equivalent volume of air.
  • An elastic membrane 147 is disposed above the plug 145. It ensures the sealed closure of the liquid flow circuit, below the zone of connection to the conduit 141.
  • the needle 146 is carried by a nozzle 148 which is provided a sterilizing filter 149.
  • the support 144 is mounted on a door 150 pivoting about an axis 151 and making it possible to set up a bottle after activation and after having emptied an empty bottle.
  • the spraying of the liquid is controlled by a pusher 152.
  • Figure 20 shows a perspective view of a particular embodiment of the movable intermediate plug. It consists of an upper part 160 of cylindrical shape and a lower part 161 having a substantially elliptical section, the largest dimension being equal to the diameter of the cylindrical part 160.
  • the stopper is put in place. on the bottle so that the lower part 161 is partially engaged in the neck, which allows the evacuation of gases and vapors contained in the bottle. As soon as the upper part 160 is engaged in the neck, the bottle is sealed.
  • the bottle described above fully meets the constraints imposed in terms of storage 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 put in communication with the interior space in the bottle at the time of use.
  • the locking due to the tamper-evident label and to the storage security system 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 bottle and another container are coupled using standard members, the characteristics of which are well known.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (15)

  1. Keimfreie Aufbewahrungs- und Umfüllflasche (10) mit doppelter Kammer, ausgelegt für die Aufbewahrung von zwei Bestandteilen einer heilkräftigen Substanz, und zwar einem festen Stoff und einem Lösungsmittel, und zum Umfüllen dieser Substanz, unmittelbar oder nach deren Mischung mit einer anderen Substanz, in eine Verwendungsvorrichtung, wobei diese Flasche einen offenen engeren Hals (12), ein Verschlußorgan, das in den Hals eingeführt ist, wobei dieses Verschlußorgan (29,76) einen inneren Hohlraum (30) und mindestens einen radialen Kanal (31), der mit dem Hohlraum verbunden ist, enthält, und ferner eine Umfüllvorrichtung besitzt, die dazu dient, die Flasche mit einem Behälter, der eine andere heilkräftige Substanz enthält, und/oder mit der Verwendungsvorrichtung zu verbinden, wobei das Verschlußorgan (29) eingerichtet ist, um zwischen einer ersten Position für die Aufbewahrung, bei der es einen dichten Verschluß bildet, da der radiale Kanal durch die Wandung des engeren Halses (12) verschlossen ist, und einer zweiten Position für die Verwendung, bei der es einen geöffneten Schieber für den Abfluß der heilkräftigen Substanz zu der Umfüllvorrichtung bildet, verstellt zu werden, wobei der radiale Kanal (31) in das Innere der Flasche mündet, wobei diese Flasche aus einem Werkstoff hergestellt ist, der den thermischen Beanspruchungen bei einer Gefriertrocknung und/oder bei einer Sterilisierung standhalten kann, wobei die Umfüllvorrichtung, die mit dem Verschlußorgan (29) fest verbunden ist, sich mit dem Verschlußorgan zwischen seiner Position für die Aufbewahrung und seiner Position für die Verwendung verstellt, und einen mittleren Kanal enthält, der mit dem inneren Hohlraum (30) des Verschlußorganes (29) gekoppelt ist und durch das Verschlußorgan einen unmittelbaren Durchgang zwischen der Flasche und dem Behälter, der eine andere Substanz enthält, oder der Verwendungsvorrichtung herstellt, wenn das Verschlußorgan sich in der besagten Position für die Verwendung befindet.
  2. Flasche nach Anspruch 1,
    dadurch gekennzeichnet, daß das Verschlußorgan (29) auf einer Kapsel (32) aufgebaut ist, die dem Hals der Flasche angepaßt und zwischen der Position für die Aufbewahrung und der Position für die Verwendung axial beweglich ist.
  3. Flasche nach Anspruch 2,
    dadurch gekennzeichnet, daß die Kapsel (32) mit einem konischen Anschlußstück und mit einer Versteifung (33), die in das Innere des Hohlraumes (30) des Verschlußorganes (29) eingeführt ist, versehen ist.
  4. Flasche nach Anspruch 3,
    dadurch gekennzeichnet, daß das Anschlußstück (34) der Bauart "Luer" entspricht.
  5. Flasche nach Anspruch 3,
    dadurch gekennzeichnet, daß das Anschlußstück (82) der Bauart "Luer Lock" entspricht.
  6. Flasche nach Anspruch 3,
    dadurch gekennzeichnet, daß das Anschlußstück ein konisches Anschlußstück mit Außengewinde ist.
  7. Flasche nach Anspruch 3,
    dadurch gekennzeichnet, daß das Anschlußstück ein konisches Anschlußstück mit Innengewinde ist.
  8. Flasche nach Anspruch 1,
    dadurch gekennzeichnet, daß die beiden Kammern (14,15) durch einen Zwischenstopfen (18) getrennt sind, der zwischen einer Position für die Aufbewahrung, bei der er eine dichte Trennwand zwischen den beiden Kammern bildet, und einer Position für die Vorbereitung zu der Verwendung, bei der die beiden Kammern untereinander verbunden sind, damit das Auflösemittel den festen Bestandteil auflösen kann, beweglich ist.
  9. Flasche nach Anspruch 8,
    dadurch gekennzeichnet, daß die Position für die Vorbereitung zu der Verwendung des beweglichen Zwischenstopfens (18) eine Position für den Übergang zwischen der Position für die Aufbewahrung und der Position für die Verwendung der Verschlußvorrichtung ist.
  10. Flasche nach Anspruch 1,
    dadurch gekennzeichnet, daß sie mindestens einen Filter (135) enthält, der in der Anschlußvorrichtung oder in der Verschlußvorrichtung, in einem Bereich, der von der heilkräftigen Substanz oder von dem Gemisch dieser Substanz mit einer anderen Substanz, vor derer Verwendung zwangsläufig durchlaufen werden muß.
  11. Flasche nach Anspruch 10,
    dadurch gekennzeichnet, daß der Filter ein Filter mit Membran ist.
  12. Flasche nach Anspruch 1,
    dadurch gekennzeichnet, daß die Verschlußvorrichtung mit der Flasche mittels eines Siegels als Zeichen der Unversehrtheit (41) verbunden ist, wenn die Vorrichtung in ihrer ersten Position für die Aufbewahrung steht.
  13. Flasche nach Anspruch 1,
    dadurch gekennzeichnet, daß die Anschlußvorrichtung eine Nadel (72) enthält, die eingerichtet ist, um den Verschlußstopfen (75) eines leeren oder vorher gefüllten Behälter durchzustechen.
  14. Flasche nach Anspruch 1,
    dadurch gekennzeichnet, daß das Verschlußorgan (136) mindestens aus zwei Teilen, und zwar aus einem Kopfstück (137) und aus einer Ringdichtung (138), besteht.
  15. Flasche nach Anspruch 14,
    dadurch gekennzeichnet, daß das Kopfstück (137) und die Dichtung (138) zu dem Verschlußorgan (136) aus unterschiedlichen Werkstoffen hergestellt sind.
EP19900900743 1988-12-27 1989-12-27 Aufbewahrungs- und umfüllflasche zum aufbewahren von zwei bestandteilen einer heilkräftigen substanz Expired - Lifetime EP0403626B1 (de)

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AT90900743T ATE94749T1 (de) 1988-12-27 1989-12-27 Aufbewahrungs- und umfuellflasche zum aufbewahren von zwei bestandteilen einer heilkraeftigen substanz.

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CH480588 1988-12-27
CH4805/88 1988-12-27
CH392089 1989-10-30
CH3920/89 1989-10-30

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EP0403626A1 EP0403626A1 (de) 1990-12-27
EP0403626B1 true EP0403626B1 (de) 1993-09-22

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US (1) US5533994A (de)
EP (1) EP0403626B1 (de)
JP (1) JPH0669475B2 (de)
AT (1) ATE94749T1 (de)
CA (1) CA2006582A1 (de)
DE (1) DE68909402T2 (de)
ES (1) ES2044548T3 (de)
WO (1) WO1990007319A1 (de)

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Also Published As

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ATE94749T1 (de) 1993-10-15
ES2044548T3 (es) 1994-01-01
CA2006582A1 (fr) 1990-06-27
JPH03504569A (ja) 1991-10-09
DE68909402D1 (de) 1993-10-28
US5533994A (en) 1996-07-09
WO1990007319A1 (fr) 1990-07-12
JPH0669475B2 (ja) 1994-09-07
DE68909402T2 (de) 1994-03-31
EP0403626A1 (de) 1990-12-27

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