EP0898951B1 - Zugangsvorrichtung für eine Flüssigkeit und Verfahren um eine Spritze mit einer flüssigen Arznei zu füllen - Google Patents

Zugangsvorrichtung für eine Flüssigkeit und Verfahren um eine Spritze mit einer flüssigen Arznei zu füllen Download PDF

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Publication number
EP0898951B1
EP0898951B1 EP19980115546 EP98115546A EP0898951B1 EP 0898951 B1 EP0898951 B1 EP 0898951B1 EP 19980115546 EP19980115546 EP 19980115546 EP 98115546 A EP98115546 A EP 98115546A EP 0898951 B1 EP0898951 B1 EP 0898951B1
Authority
EP
European Patent Office
Prior art keywords
ampoule
cannula
vial
adapter
syringe
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
EP19980115546
Other languages
English (en)
French (fr)
Other versions
EP0898951A2 (de
EP0898951A3 (de
Inventor
Fredy Zinger
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.)
Medimop Medical Projects Ltd
Original Assignee
Medimop Medical Projects Ltd
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 Medimop Medical Projects Ltd filed Critical Medimop Medical Projects Ltd
Publication of EP0898951A2 publication Critical patent/EP0898951A2/de
Publication of EP0898951A3 publication Critical patent/EP0898951A3/de
Application granted granted Critical
Publication of EP0898951B1 publication Critical patent/EP0898951B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules
    • 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
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end

Definitions

  • the present invention relates to a fluid access assembly as defined in the preamble of claim 1 and a method for preparing a liquid drug.
  • a fluid access assembly (10) having a vial access pin (12) and an ampoule access tube (14) for enabling access to a liquid drug contained either in a vial or an ampoule, respectively.
  • the vial access pin (12) has a mounting hub (20) constituted by a female Luer connector, a flange (30) and a cannula (36) with a piercing end and on which the ampoule access tube (14) is sealingly and detachably mounted for aspiration of an ampoule's contents.
  • the fluid access assembly does not facilitate neither the handling nor the discarding of a spent vessel and particularly an ampoule. In particular, it is relatively difficult to slide an opened ampoule's opened end which is of a small cross section area onto the ampoule access tube whilst its attendant exposed sharp edge when opened further militates against convenient use and its discarding when spent.
  • a fluid access assembly for use with a syringe in accordance with claim 1.
  • the ampoule adapter of the present invention affords easier handling of an ampoule by virtue of its gripping members which facilitates sliding an ampoule onto its cannula. Additionally, the body portion of the ampoule adapter precludes injury from an opened ampoule's exposed sharp edge during handling and also provides for safer discarding of a spent ampoule together therewith.
  • the fluid access assembly of the present invention can be employed as a universal adapter for use with either an ampoule or a vial and can be employed for mixing liquid drugs in a convenient manner.
  • the method of the present invention provides for a convenient preparation of a liquid drug mixed from at least two components by the fluid access assembly of the present invention thereby affording safer and easier handling of spent parts and in particular a spent ampoule.
  • a fluid access assembly 1 includes a vial adapter 2 and an ampoule adapter 3 for preparing a syringe 4 with a liquid drug mixed from a first component stored in a vial 6 having a mouth portion 7 housing a rubber stopper 8 and a second component stored in an ampoule 9 having a frangible end 10 and a sealed end 11.
  • the vial 6 contains a dry powder, however, it can equally contain a liquid component.
  • the ampoule adapter 3 has a tubular shroud 18 constituting a body portion and attached to a second cannula 19 having a proximal portion 19A and a distal portion 19B terminating in a V-shaped tip 21, the shroud 18 having a flange 22 with a downward depending rim 23 substantially co-directional with the second cannula 19.
  • Two pairs of oppositely disposed gripping members 24 downwardly depend from the rim 23 and are co-directional with the second cannula 19.
  • the ampoule adapter 3 is longitudinally dimensioned to receive substantially the entire opened ampoule 6 when fully inserted therein i.e. when further insertion is prevented by the cannula tip 21 abutting against the ampoule's sealed end 11. On such insertion, the ampoule's opened end is received in the shroud 18 and the gripping members 24 friction fit grip substantially its entire periphery (see Figure 3).
  • the ampoule adapter 3 is detachably mounted on the vial adapter 2 by means of its second cannula's proximal portion 19A being initially sealingly and detachably mounted on the puncturing member 14.
  • the use of the fluid access assembly 1 for preparing an initially empty syringe with a reconstituted drug is now described with reference to Figures 5A-5F.
  • the syringe 4 is inserted into the ampoule adapter's female Luer ® connector 13 (see Figure 5A).
  • the ampoule 9 is broken open and fully slided up the second cannula 19 until the cannula's tip 21 abuts against its sealed end 11 whereby its opened end 10 is contained within the ampoule adapter's shroud 18 and its lower portion is gripped by the gripping members 24 (see Figure 5A).
  • the ampoule's contents are aspirated into the syringe 4 (see Figure 5B).
  • Figures 9A-9D shows an ampoule adapter 37 with gripping members 38 each having a flange portion 38A substantially co-extensive therewith and resiliently foldable from a normally inwardly radially disposed state for gripping the small diameter ampoule 34 (see Figures 9A and 9B) to a flexed circumferentially disposed state for gripping the large diameter ampoule 36 (see Figures 9C and 9D).
  • the syringe can initially contain a liquid drug component whilst the ampoule can contain a dry powder.
  • the spent vial can be removed whereby the vial adapter can then be inserted into another vial or a Y-site fitting of an intravenous set

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (12)

  1. Flüssigkeits-Zugriffseinheit (1) zur Verwendung mit einer Spritze (4) für ein Fläschchen (6) mit einem Verschluss (8) oder eine Ampulle (9, 28, 34, 36) mit einem abbrechbaren Ende (10) und einem abgedichteten Ende (11), wobei die Einheit umfasst:
    einen Fläschchenadapter (2) mit einer Kanüle (12) mit einem naheliegenden Bereich (13) zum abdichtenden Aufnehmen der Spritze und einem entfernten Bereich (14) zum Einstechen in den Verschluss des Fläschchens; und
    einen Ampullenadapter (3, 26, 29, 32, 37), der eine zweite Kanüle (19, 27, 31) mit einem naheliegenden Bereich (19A), der unmittelbar abdichtend und entfembar um den entfernten Bereich der ersten Kanüle montiert ist, wobei die zweite Kanüle so dimensioniert ist, dass sie an das abgedichtete Ende der vorher geöffneten Ampulle anstößt, wenn die Ampulle auf die zweite Kanüle aufgleitet, wodurch ein Ansaugen ihrer Inhaltsstoffe in die Spritze möglich wird, dadurch gekennzeichnet, dass der Ampullenadapter (3) einen Körperbereich (18) mit mindestens einem Paar gegenüberliegend angeordneter Greifelemente (24, 33, 38) aufweist, die sich mit der zweiten Kanüle co-erstrecken, um jeweils das geöffnete Ende der Ampulle aufzunehmen und gegenüberliegende Seiten von mindestens dem unteren Bereich der Ampulle in Richtung auf das abgedichtete Ende während des Gleitens ergreifen.
  2. Einheit nach Anspruch 1, wobei der Körperbereich rohrförmig ist und einen sich nach unten erstreckenden Steg (23) aufweist, der sich in gleicher Richtung wie die zweite Kanüle zum Aufnehmen des geöffneten Endes der Ampulle erstreckt.
  3. Einheit nach Anspruch 1 oder 2, wobei der Ampullenadapter eine Vielzahl von Greifteilen zum Ergreifen im Wesentlichen des gesamten Umfangs einer Ampulle aufweist.
  4. Einheit nach einem der Ansprüche 1 bis 3, wobei die zweite Kanüle (27, 29) teleskopisch ausgebildet ist.
  5. Einheit nach Anspruch 4, wobei der Ampullenadapter (26) die zweite Kanüle (27) umfasst, wobei ein naher Bereich (27A) fest mit dem rohrförmigen Körperbereich und ein entfernter Bereich (27B) gleitend auf dem nahen Bereich montiert ist, wobei der entfernte Bereich zunächst verlängerbar an dem nahen Bereich montiert ist, wobei der entfernte Bereich in Richtung auf den nahen Bereich beim Gleiten einer kurzen Ampulle gedrückt wird.
  6. Einheit nach Anspruch 4, wobei die zweite Kanüle (29) einen anfänglich verlängerten, zusammendrückbaren, faltenbalgähnlichen Bereich (29a) enthält, der mindestens teilweise beim Gleiten einer kurzen Ampulle zusammengedrückt wird.
  7. Einheit nach einem der Ansprüche 1 bis 6, wobei ein Greifteil (33) einen unteren Bereich (33a) entfernt vom Körperbereich aufweist, der von einem normalerweise innenliegenden, radial angeordneten Zustand zum Ergreifen einer Ampulle (34) mit kleinem Durchmesser nach außen in einen nach außen gebogenen, radial angeordneten Zustand zum Ergreifen einer Ampulle (36) mit großem Durchmesser drückbar ist.
  8. Einheit nach einem der Ansprüche 1 bis 6, wobei ein Greifteil (38) einen Flanschbereich (38A) aufweist, die sich in die gleiche Richtung erstrecken, und flexibel faltbar ist von einem normalerweise innenliegenden, radial angeordneten Zustand zum Ergreifen einer Ampulle (34) mit kleinem Durchmesser in einen gebogenen, in Umfangsrichtung angeordneten Zustand zum Ergreifen einer Ampulle (36) mit großem Durchmesser.
  9. Verfahren zum Vorbereiten einer Spritze (4) mit einem flüssigen Arzneimittel aus einer ersten Komponente, die in einem Fläschchen (2) enthalten ist, das einen Verschluss (8) umfasst, und einer zweiten Komponente, die in einer Ampulle (9, 28, 34, 36) mit einem abbrechbaren Ende (10) und einem abgedichteten Ende (11) enthalten ist, wobei das Verfahren die folgenden Schritte umfasst:
    (a) Vorbereiten eines Fläschchenadapters (2) mit einer ersten Kanüle (12) mit einem nahen Bereich (13) zum abdichtenden Aufnehmen der Spritze und einem entfernten Bereich (14) zum Punktieren des Verschlusses des Fläschchens, und einen Ampullenadapter (3, 26, 28, 32, 37) mit einer zweiten Kanüle (19, 27, 31) mit einem nahen Bereich (19a), der anfänglich abdichtend und entfernbar am entfernten Bereich der ersten Kanüle montiert ist; wobei der Ampullenadapter mindestens ein Paar gegenüberliegend angeordneter Greifteile (24, 33, 38) aufweist, die sich in die gleiche Richtung wie die zweite Kanüle erstrecken zum Erleichtem des Einsetzens der zweiten Kanüle in die Ampulle und zum Ergreifen gegenüberliegender Seiten von mindestens dem unteren Bereich der Ampulle in Richtung auf ihr abgedichtetes Ende;
    (b) Schieben einer vorher geöffneten Ampulle auf die zweite Kanüle;
    (c) Verbinden der Spritze mit dem nahen Bereich der ersten Kanüle;
    (d) Ansaugen des Inhalts der Ampulle in die Spritze;
    (e) Abnehmen des Ampullenadapters vom Fläschchenadapter;
    (f) Einsetzen des Fläschchens in den Fläschchenadapter, so dass sein Verschluss punktiert wird;
    (g) Einspritzen des Inhalts der Spritze in das Fläschchen;
    (h) Mischen der Inhaltsstoffe der Spritze mit den Inhaltsstoffen des Fläschchens; und
    (i) Ansaugen der Inhaltsstoffe des Fläschchens in die Spritze.
  10. Verfahren nach Anspruch 9, wobei die zweite Kanüle so bemessen ist, dass sie an dem abgedichteten Ende der vorab geöffneten Ampulle beim Einsetzen der Ampulle anstößt.
  11. Verfahren nach einem der Ansprüche 9 oder 10, wobei der Ampullenadapter einen Körperbereich (18) zum Aufnehmen mindestens des geöffneten Endes der Ampulle aufweist.
  12. Verfahren nach einem der Ansprüche 9 bis 11, wobei der Fläschchenadapter (2) federnd flexible Greifteile (17) für einen Schnappsitz unter dem Maulbereich des Fläschchens aufweist nachdem das Fläschchen positiv in den Fläschchenadapter eingesetzt wurde.
EP19980115546 1997-08-22 1998-08-18 Zugangsvorrichtung für eine Flüssigkeit und Verfahren um eine Spritze mit einer flüssigen Arznei zu füllen Expired - Lifetime EP0898951B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL12160597 1997-08-22
IL12160597A IL121605A (en) 1997-08-22 1997-08-22 Fluid access assembly and a method for preparing a liquid drug

Publications (3)

Publication Number Publication Date
EP0898951A2 EP0898951A2 (de) 1999-03-03
EP0898951A3 EP0898951A3 (de) 1999-11-10
EP0898951B1 true EP0898951B1 (de) 2002-11-13

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EP (1) EP0898951B1 (de)
DE (1) DE69809352T2 (de)
IL (1) IL121605A (de)

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WO2012150587A1 (en) * 2011-05-03 2012-11-08 Sabiedriba Ar Ierobezotu Atbildibu "Sdmd" Vial adaptor
WO2015002646A1 (en) * 2013-07-02 2015-01-08 Hoftman Mike Moshe Device for safe withdrawal and administration of liquids by syringe
US9522098B2 (en) 2006-05-25 2016-12-20 Bayer Healthcare, Llc Reconstitution device

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Cited By (3)

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Publication number Priority date Publication date Assignee Title
US9522098B2 (en) 2006-05-25 2016-12-20 Bayer Healthcare, Llc Reconstitution device
WO2012150587A1 (en) * 2011-05-03 2012-11-08 Sabiedriba Ar Ierobezotu Atbildibu "Sdmd" Vial adaptor
WO2015002646A1 (en) * 2013-07-02 2015-01-08 Hoftman Mike Moshe Device for safe withdrawal and administration of liquids by syringe

Also Published As

Publication number Publication date
EP0898951A2 (de) 1999-03-03
IL121605A0 (en) 1998-02-08
DE69809352T2 (de) 2003-03-20
EP0898951A3 (de) 1999-11-10
DE69809352D1 (de) 2002-12-19
IL121605A (en) 2001-03-19

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