WO2000019961A1 - Receptacle pour medicaments injectables constitues de deux phases - Google Patents

Receptacle pour medicaments injectables constitues de deux phases Download PDF

Info

Publication number
WO2000019961A1
WO2000019961A1 PCT/EP1999/007336 EP9907336W WO0019961A1 WO 2000019961 A1 WO2000019961 A1 WO 2000019961A1 EP 9907336 W EP9907336 W EP 9907336W WO 0019961 A1 WO0019961 A1 WO 0019961A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
container
ampoule
syringe
injectable drugs
Prior art date
Application number
PCT/EP1999/007336
Other languages
English (en)
Inventor
Giuseppe Santoro
Original Assignee
Giuseppe Santoro
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 Giuseppe Santoro filed Critical Giuseppe Santoro
Publication of WO2000019961A1 publication Critical patent/WO2000019961A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing

Definitions

  • the present invention relates to a container used to carry and prepare injectable drugs consisting in two phases to be mixed, such as, but not exclusively, a liquid phase of physiological solution and a solid phase of lyophilized active composition.
  • the invention relates to a container that allows to isolate the used needle after the injection of the drug.
  • Injectable drugs consisting in two phases to be mixed, are usually provided in two distinct ampoules that contain respectively a liquid phase of physiological solution and a solid phase of a lyophilized active composition.
  • the preparation of an injectable drug can then be outlined in a plurality of successive steps: - opening the first ampoule, which contains the physiological solution;
  • an ampoule with an opening for the introduction of a syringe - a first phase of a drug put into the ampoule
  • the internal means may comprise a cup element in the ampoule, the first phase of drug being arranged between the cup and the bottom of the ampoule.
  • the cup has a bottom with a weakened line suitable for being broken by the movement of introduction of the syringe.
  • the means for allowing the introduction of the needle and for breaking the weakened line preferably comprise an open tubular piston slidably engaging in the cup and having a sharpened end, the piston housing the needle and its length being such that contact is avoided between the needle and the cup.
  • the piston may have a recess suitable for engaging with the support of the needle or with the body of the syringe, whereby the recess blocks the syringe same in axial direction so that the syringe when pushed can break the weakened line.
  • the piston has advantageously a flanged upper edge having diameter equal to the inner diameter of the cup.
  • the piston can be equipped with axial stiffening and guiding ridges.
  • the bottom of the cup may have tapered bottom walls converging towards the weakened portion, whereas its upper edge is flanged for engaging with the rim of the ampoule.
  • the piston preferably has a lower sharp end with asymmetrical shape comprising two points of different length, capable of breaking the weakened line, the points of different length having the function of protecting the needle of the syringe .
  • the piston has two points of equal length, for positioning the needle of the syringe at the right distance from the bottom of the ampoule.
  • the piston has a lower end linked directly to the basis of the cup by a weakened line, which has the function of keeping the two phases separate form each other.
  • the flanged upper edge of the piston has advantageously holes for allowing the passage of air for sucking the drug.
  • the piston has side apertures located for making easier the flow of the phase present in the cup towards the bottom of the ampoule and in order to make easier the sucking of the drug.
  • the ampoule has a concave bottom for making easier the sucking of all the drug with the needle of the syringe .
  • the closure member means of the ampoule comprises an apertured plate, a pierceable disc and a plastics ring, the ring being engageable in the apertured plate and has internal diameter slightly less than the support of the needle of a syringe, whereby after an injection, the ring can be forced in the plate and the needle can be forced in the ampoule, allowing a withdrawal of the syringe without needle .
  • the means for allowing the introduction of the needle and for breaking the weakened line comprises an open tubular piston integral to he needle of the syringe, suitable for being slidably inserted into the cup after breaking the closure member of the ampoule, and having a sharpened end, the piston being suitable for receiving the needle and its length being such that the contact of the needle with the cup is avoided.
  • - figure 1 shows an exploded view of a first embodiment of the container, according to the present invention
  • - figure 2 shows a cross sectional view of the container of figure 1 assembled and ready for use
  • FIG. 4 shows an exploded view of a second embodiment of the container, according to the present invention.
  • FIG. 5A and 5B show a cross sectional view of a third embodiment of the container, according to the present invention and of a special syringe to it associated, respectively withdrawn from and introduced in the container.
  • a container has an ampoule 1, comprising: an upper opening 2 stopped by a closure member 3, a wall 4 for keeping separate a first phase 26 from a second phase 27 of the drug, and an element 5 for guiding the introduction of the needle 30 of a syringe 29 (fig. 3A- 3C) .
  • Wall 4 is arranged in ampoule 1 and has the shape of a cup 6, containing the second phase 27 of the drug, having an upper opening 10 and having at the bottom a septum 7 with a weakened line 8 that can be broken at the moment of use .
  • the side bottom walls 9 of cup 6 are tapered towards septum 7 whereas the edge of upper opening 10 is flanged.
  • Guiding element 5 comprises a tubular hollow piston 11 slidably engaging in cup 6 and having a lower end 14 suitable for breaking in use septum 7, as well as a recess 13 for the introduction of needle 30 of syringe 29 (fig. 3A-3C) and of support 30a to which needle 30 is connected. At the bottom of this recess 13 a hole 36 is made through which needle 30 of syringe 29 passes.
  • lower end 12 of tubular piston 11 is sharp and of asymmetric shape, comprising two points 14 of different length that have the function of preventing needle 30 of the syringe from hitting septum 7 which, once broken at weakened line 8, folds under push of piston 11 and then hangs from cup 6.
  • Piston 5 may have a flanged upper edge 15 having diameter equal to the inner diameter of cup 6 for slidably guiding the piston in cup 6.
  • piston 5 may have guiding and stiffening ridges 25.
  • Edge 15 provides through holes 16 that allow the passage of air from the outer environment into cup 6 that contains second phase 27 of the drug, and then to the space below that contains first phase 26 of the drug, through apertures 17.
  • Ampoule 1 has a variation of cross section at 18 so that that the level reached by the drug 26+27 (fig. 3B) in this zone is contained in the lower portion of the ampoule same. Furthermore, ampoule 1 has a bottom 19 with a concave shape in order to make easier the sucking of all drug 26+27 with needle 30 of syringe 29.
  • Closure member 3 is a metal element 20 with central hole 31, a pierceable disc 21 and a plastics disc 22 with central hole 38.
  • Pierceable disc 21 comprises a central portion 23 that can be torn by means of a tongue 24; this portion 23, as known, is made of a material capable of assuring sterility of the drug inside the ampoule.
  • the apertured plate 20 keeps together the assembly comprising ampoule 1, wall 4 and pierceable disc 21, that separates the inside of the container from the environment.
  • liquid phase 27 is contained by cup 6 and solid phase 26 is at the bottom of ampoule 1.
  • FIG. 3A the container according to the invention has been opened tearing tongue 24 (fig. 1) and removing the central portion 23 of pierceable disc 21, thus creating an opening 28 wherein syringe 29 has been introduced.
  • Support 30a of needle 30 is forced into recess 13 so that the sharp end of needle 30 is not damaged at the bottom of cup 6.
  • syringe 29 a pressure is applied sufficient to break septum 7.
  • the force applied on syringe 29 is transferred to the lower end 12 of tubular piston 11 which breaks septum 7 owing to the longer of the two asymmetrical points 14; the shorter point 14 protects needle 30 from the accidental contact with the broken septum 7.
  • septum 7 creates a hole 32 through which tubular piston 11 passes bringing lower point 14 onto bottom 19 of ampoule 1 so that needle 30 is very close to this bottom 19 but it does not touch it.
  • liquid phase 27 (shown in figure 2) contained in cup 6 falls down into ampoule 1 through aperture 17 and reaches first phase 26 of the drug (fig. 2) ; ampoule 1 can be then stirred for mixing the solution 26+27.
  • FIG 3C is shown the container according to the invention that is used for disposing of and isolating needle 30 of syringe 29 after the injection.
  • Disc 22 which is in the kit of the container according to the invention, is forced into opening 31 of the metal apertured plate 20, by snap fit engagement. Then support 30a of needle 30 can be forced in the inner hole 38 of disc 22, whose diameter is slightly less than support 30a.
  • Disc 22 can have of radial cuts not shown for increasing the flexibility of the edges of inner hole 38.
  • support 30a is introduced in the empty container, and by withdrawing syringe body 29 it remains in recess 13 and can be disposed of together with the used container.
  • FIG 4 is shown an exploded view of a second embodiment of the container, which is different from the first since the weakened line 8 is directly formed on the piston 11.
  • the latter has longitudinal ridges 40 that protrude from piston 11 for enlarging hole 32 indicated in figure 3A. Furthermore, the ridges 40 have function of stiffening and guiding piston 11.
  • the space of cup 6 is always in communication with the ampoule, since the aperture 17 allows flow of air and of drug.
  • the piston 11 can be supplied along with the cap of the syringe needle, instead of being provided in the container. In this case, points 14 first pierce portion 23 of the closure member 3, and then carry out the steps described hereinabove for the first embodiment of figures 1, 2 and 3A-3C.

Abstract

L'invention porte sur un réceptacle pour médicaments injectables constitués de deux phases. Ce réceptacle comprend une ampoule (1) contenant une première phase d'un médicament (26) et pourvue d'un orifice (2) supérieur fermé par un élément (20) de fermeture, un dispositif (4) interne placé dans l'ampoule et permettant de conserver les deux phases séparées, un dispositif (5) pour permettre l'introduction de l'aiguille (30) d'une seringue (29). Le dispositif (4) interne comporte un godet (6) contenant la seconde phase du médicament (27) et pourvu d'un orifice (10) supérieur et, au fond, d'un septum (7) doté d'une ligne (8) de faiblesse qui peut être cassée au moment de l'utilisation. Le dispositif (5) permettant l'introduction de l'aiguille (30) comprend un piston (11) creux tubulaire, s'engageant de manière coulissante dans le godet (6) et dont l'extrémité (12) inférieure se casse lors de l'utilisation du septum (7), et un évidement (13) dans lequel s'engage le support (30a) de l'aiguille (30). Le piston (11) casse le septum (7), ce qui provoque le mélange des deux phases (26 et 27) et l'entraînement de l'aiguille (30) vers le fond (29) de l'ampoule où le médicament obtenu par le mélange des deux phases (26 + 27) peut être aspiré directement. Le dispositif d'obturation est constitué d'une plaque (20) métallique à trous, d'un disque (21) pouvant être percé et d'une bague (22) en plastique qui peut être utilisée après l'injection de façon à maintenir l'aiguille dans le réceptacle et jeter ensuite l'ensemble.
PCT/EP1999/007336 1998-10-02 1999-10-04 Receptacle pour medicaments injectables constitues de deux phases WO2000019961A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITPI98A000072 1998-10-02
IT98PI000072 IT1304543B1 (it) 1998-10-02 1998-10-02 Contenitore per farmaci iniettabili composti da due fasi

Publications (1)

Publication Number Publication Date
WO2000019961A1 true WO2000019961A1 (fr) 2000-04-13

Family

ID=11394326

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1999/007336 WO2000019961A1 (fr) 1998-10-02 1999-10-04 Receptacle pour medicaments injectables constitues de deux phases

Country Status (2)

Country Link
IT (1) IT1304543B1 (fr)
WO (1) WO2000019961A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8678224B2 (en) 2009-04-08 2014-03-25 Fresenius Medical Care Deutschland Gmbh Insert for receptacle containing solid products to be dissolved
WO2017036605A1 (fr) * 2015-09-03 2017-03-09 Boehringer Ingelheim International Gmbh Adaptateur doté d'un réservoir pour contenant
EP3452002A4 (fr) * 2016-05-02 2019-12-11 Sun Pharmaceutical Industries Limited Emballage à deux chambres pour compositions pharmaceutiques
GB2544951B (en) * 2014-09-08 2021-08-04 Eulysis Uk Ltd Container and closure

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2661742A (en) * 1949-08-13 1953-12-08 Hauduroy Paul Multiple container
US3066671A (en) * 1959-10-27 1962-12-04 Milton J Cohen Disposable additive container
EP0577200A1 (fr) * 1992-07-02 1994-01-05 Laboratorios Cusi, S.A. Récipient pour produits pharmaceutiques à deux composants séparés, comprenant un dispositif de mélange, et de distribution dosée
EP0778221A1 (fr) * 1995-12-04 1997-06-11 Laboratorios Cusi, S.A. Récipient pour produits pharmaceutiques comprenant deux composants séparés et dispositif de mélange, ainsi que la distribution dosée et procédé d'assemblage de ce récipient

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2661742A (en) * 1949-08-13 1953-12-08 Hauduroy Paul Multiple container
US3066671A (en) * 1959-10-27 1962-12-04 Milton J Cohen Disposable additive container
EP0577200A1 (fr) * 1992-07-02 1994-01-05 Laboratorios Cusi, S.A. Récipient pour produits pharmaceutiques à deux composants séparés, comprenant un dispositif de mélange, et de distribution dosée
EP0778221A1 (fr) * 1995-12-04 1997-06-11 Laboratorios Cusi, S.A. Récipient pour produits pharmaceutiques comprenant deux composants séparés et dispositif de mélange, ainsi que la distribution dosée et procédé d'assemblage de ce récipient

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8678224B2 (en) 2009-04-08 2014-03-25 Fresenius Medical Care Deutschland Gmbh Insert for receptacle containing solid products to be dissolved
GB2544951B (en) * 2014-09-08 2021-08-04 Eulysis Uk Ltd Container and closure
WO2017036605A1 (fr) * 2015-09-03 2017-03-09 Boehringer Ingelheim International Gmbh Adaptateur doté d'un réservoir pour contenant
EP3452002A4 (fr) * 2016-05-02 2019-12-11 Sun Pharmaceutical Industries Limited Emballage à deux chambres pour compositions pharmaceutiques

Also Published As

Publication number Publication date
ITPI980072A1 (it) 2000-04-02
ITPI980072A0 (it) 1998-10-02
IT1304543B1 (it) 2001-03-19

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