EP2114345A1 - Closure cap for a container for receiving medical liquids, and container for receiving medical liquids - Google Patents

Closure cap for a container for receiving medical liquids, and container for receiving medical liquids

Info

Publication number
EP2114345A1
EP2114345A1 EP08707528A EP08707528A EP2114345A1 EP 2114345 A1 EP2114345 A1 EP 2114345A1 EP 08707528 A EP08707528 A EP 08707528A EP 08707528 A EP08707528 A EP 08707528A EP 2114345 A1 EP2114345 A1 EP 2114345A1
Authority
EP
European Patent Office
Prior art keywords
closure cap
closure
recess
cap according
membrane
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
EP08707528A
Other languages
German (de)
French (fr)
Other versions
EP2114345B1 (en
Inventor
Torsten Brandenburger
Gerhard Greier
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.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
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 Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of EP2114345A1 publication Critical patent/EP2114345A1/en
Application granted granted Critical
Publication of EP2114345B1 publication Critical patent/EP2114345B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61J1/2096—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
    • 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
    • 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
    • A61J1/1412—Containers with closing means, e.g. caps
    • 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
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1418—Threaded type
    • 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
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1431—Permanent type, e.g. welded or glued
    • 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
    • A61J1/18—Arrangements for indicating condition of container contents, e.g. sterile condition
    • 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
    • A61J1/2044—Separating means having slits
    • 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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means

Definitions

  • Cap for a container for holding medical fluids and container for receiving medical fluids
  • the invention relates to a closure cap for a container for holding medical fluids, in particular an infusion or transfusion container, which has a cover part and a peripheral part. Moreover, the invention relates to a container for receiving medical fluids, in particular a BFS container, with such a cap.
  • BFS method As a blow-fill-seal method (BFS method), a method is known in which containers, such as bottles of extruded PE or PP, in a single operation sterile and pyrogen-free blown into a desired shape and immediately after cooling with a sterile filling aseptically filled and hermetically sealed.
  • the containers, in particular bottles, produced according to the bubble-filling-sealing method are also referred to as BFS containers.
  • the containers When the known BFS containers are used for receiving sterile, medical liquids, for example infusion solutions, the containers require a closure cap system which allows a transfer of the infusion solution by means of an infusion device to the patient.
  • a closure cap system which allows a transfer of the infusion solution by means of an infusion device to the patient.
  • medication to the infusion solution should also be possible.
  • the dispensing part is for removing the infusion solution by means of a spike, while the injection part is used for supplying a drug by means of a syringe having a thin cannula (needle).
  • the injection part comprises a tubular connection part, which is closed by a protective cap designed as a break-off part.
  • a self-sealing membrane serum
  • a pierceable membrane in the connector prevents the septum from contacting the solution prior to use of the infusion bag.
  • the sampling part does not have a self-sealing septum.
  • the injection and withdrawal part known from WO 96/23545 is intended to be welded into an infusion bag.
  • the known Zuspritzmaschine have proven. From the use of an injection needle for injecting an active ingredient, however, there are disadvantages. First, there is a risk that the connection between the injection needle and the septum due to an unintentional pull on the syringe or an overpressure inside the bag dissolves. On the other hand, there is an increased risk of injury to the nursing staff through the injection needle. Also, the infusion bag, in which the injection part is welded, can be damaged by improper handling by the needle. The addition of a viscous drug is more difficult due to the small cross section of the needle beyond. Incidentally, the supply of a liquid agent due to the small cross section of the needle requires a relatively long time.
  • conical connections with a conical shank and a conical sleeve are known in medical technology whose conical surfaces are normalized.
  • the non-lockable conical connections with normalized conical surfaces are referred to as Luer connectors and the lockable conical connections as Luer-Lock connectors.
  • Tapered Luer or Luer-Lock connectors are referred to as male connectors and tapered sleeve connectors as female connectors.
  • the known connector has a connection part which has a channel-shaped recess in which a self-sealing membrane is arranged.
  • a break-off part which is connected to the connecting part, closes the channel-shaped recess.
  • the connecting part is designed as a connecting piece with an inner cone and an outer thread, wherein the membrane for sealingly receiving the Taper shank of a syringe is slotted.
  • the connector is composed of an upper and a lower section, between which the self-sealing membrane is clamped.
  • a cap for a BFS container which has a lid part and a peripheral part, wherein in the lid part a slotted membrane is used, which allows the imports of the spike of an infusion device.
  • the slotted membrane sits flush in the cover part of the cap.
  • the invention has for its object to provide a cap for a container for receiving medical fluids, in particular a BFS container, which allows the injection of a liquid without the use of an injection cannula. Moreover, it is an object of the invention to provide a container for receiving medical fluids, in particular a BFS container, which allows the injection of a liquid without the use of an injection cannula.
  • the closure cap according to the invention for a container for holding medical fluids in particular a BFS container for receiving an infusion solution, has a lid part and a rim part, wherein an injection part for injecting a medical fluid is arranged in the lid part.
  • the injection part has an outwardly pointing connection part with a conical recess for sealingly receiving the conical shaft of a needleless injection syringe and an inwardly pointing closure part which has a self-sealing membrane for closing the recess of the connection part.
  • the self-sealing membrane is slotted so that the cone shank of the syringe can be easily inserted. It is advantageous that the closure cap according to the invention with the exception of the self-sealing membrane is formed in one piece. As a result, the production of the cap in large quantities at low cost is possible.
  • the closure part of the injection part has a recess in which the self-sealing membrane is inserted by snap-fitting.
  • the self-sealing membrane is clamped by an inwardly projecting edge of the closure member in the recess.
  • the closure part can also have distributed circumferentially arranged hooks for clamping fixation of the self-sealing membrane.
  • the recess of the closure part has a first cylindrical portion adjoining the lid portion and a second cylindrical portion adjoining the first cylindrical portion, the first cylindrical portion having a smaller inner diameter than the second cylindrical portion Section has.
  • a preferred embodiment of the closure cap provides that the self-sealing membrane has an annular portion which is arranged in the second cylindrical portion of the recess with the larger inner diameter, and has a plate-shaped portion adjoining the annular portion via a central web, which in the first cylindrical portion having the smaller inner diameter is arranged.
  • the self-sealing membrane has a secure hold in the recess of the closure part.
  • the plate-shaped portion of the self-sealing membrane has a trough-shaped depression.
  • the trough-shaped depression ensures, on the one hand, that the cone shank of the syringe is securely guided and, on the other hand, ensures that the membrane seals securely after pulling out the conical shank. It has been shown in experiments that the special design of the membrane for the immediate Resealing is crucial, with increasing internal pressure in the package, the sealing of the membrane is still increased.
  • the closure part of the injection part is formed with the self-sealing membrane such that upon insertion of the conical shaft of the injection syringe, the membrane is compressed in the recess in the axial direction.
  • the membrane opens when inserting the conical shaft.
  • the self-sealing membrane is on the one hand sufficiently fixed in the recess of the closure part, but on the other hand so freely movable that the membrane can be compressed in the axial direction during insertion of the conical shaft.
  • the height of the membrane is reduced, i. the top of the diaphragm loses its contact with the contact surface of the recess of the closure part.
  • the closure part of the injection part can be designed for either a luer syringe or a luer lock syringe.
  • the connecting part of the injection part has an external thread, so that a Luer-lock connection with the syringe is possible.
  • connection part is preferably closed with a break-off part, which is connected to the upper end of the connection part via a ring-breaking zone. After breaking off the break-off part, the self-sealing membrane is exposed, so that the cone shank of the syringe can be inserted.
  • the break-off part preferably has a lateral grip tab which extends up to the edge part of the cover part of the closure cap.
  • the closure cap according to the invention can also have a removal part for removing a medical liquid with a spike.
  • the removal part preferably also has an outwardly facing fitting with a recess into which a spike is inserted and an inwardly facing closure part which is closed by a pierceable membrane.
  • the pierceable membrane is inserted snapping into a recess of the closure part of the removal part.
  • the membrane is clamped by an inwardly projecting edge of the closure part.
  • the connection part of the removal part is preferably closed with a break-off part, which is connected via a ring breaking zone to the upper end of the connecting part.
  • the break-off part of the removal part also has a lateral grip tab which extends up to the edge part of the cover part.
  • the container according to the invention in particular infusion or transfusion container, which is preferably designed as a bottle, is closed with the closure cap described above.
  • FIG. 1 shows an exemplary embodiment of the closure cap according to the invention
  • FIG. 4C is a detail of Figure 4 B in an enlarged view
  • FIG. 5 the closure cap of Fig. 1 in a sectional view
  • Fig. 6 shows an embodiment of a container according to the invention with the closure cap according to the invention.
  • FIGS. 1 and 2 show the closure cap according to the invention in side view, which has an injection part A and a removal part B.
  • the closure cap is a one-piece plastic part which can be produced inexpensively in large quantities.
  • the closure cap 1 has a lid part 2 and a rim part 3.
  • the lid member 2 has an outer portion 4 and an inner portion 5 projecting outwardly. From the inner outwardly projecting portion 5 has a connecting part 6 for inserting the conical shank of a needleless injection syringe to the outside (Fig. 3).
  • the connecting part 6 has a conical recess 7 for sealingly receiving the conical shaft of the syringe and an external thread 8.
  • the conical recess 7 and the external thread 8 are formed such that a commercially available Luer-lock syringe can be connected to the connecting part.
  • connection part 6 is closed by a break-off part 9, which is connected via a ring-breaking zone 10 to the upper end of the connection part.
  • the break-off part 9 has a round cap 11, to which a lateral tab 12 adjoins a narrow web 12, which extends down to the edge part of the cover part.
  • the grip tab 13 is designed such that it does not extend laterally beyond the closure cap.
  • a closure part 14 From the central portion 5 of the lid part 2, a closure part 14 has inwardly, which has a recess 15. In the recess 15 of the closure part 14, a self-sealing membrane 16 is inserted, which sits snapping into the recess.
  • the recess 15 of the closure part 14 has an upper cylindrical portion 17, which adjoins the central portion 5 of the lid part 2.
  • the upper cylindrical portion 17 is followed by a lower cylindrical portion 18 having a larger inner diameter than the upper cylindrical portion 17.
  • the Self-sealing membrane 16 has correspondingly a lower annular portion 19 with a larger outer diameter, which sits in the lower cylindrical portion 18 of the recess 15.
  • the closure part has an inwardly projecting edge 35, which fixes the membrane 16 in a clamping manner.
  • the dish-shaped portion 21 of the membrane 16 has a trough-shaped recess 22, which is provided with one or more slots 23, for example, is slotted crosswise.
  • the edge part 3 of the closure cap 1 has a lower bead-shaped edge 24, which has a circumferential groove 25 on the underside.
  • the cap can be placed on a bottle, wherein the upper edge of the bottle neck engages in the groove 25 of the bead-shaped edge 24 of the cap.
  • the break-off part 9 is first broken off from the connection part 6 by lateral pivoting of the handle bottle 13.
  • the self-sealing membrane 16 is exposed.
  • the conical taper shank 36 of a needleless injection syringe 26 is inserted into the conical recess 7 of the connection part 6.
  • the conical shaft 36 presses on the plate-shaped portion 22 of the self-sealing membrane 16, whereby the membrane is pressed together ( Figure 4C).
  • the middle web 20 of the membrane 16 presses inwards, wherein the plate-shaped portion 22 is opened in the region of the slots 23.
  • the drug can now be injected.
  • the closure cap In addition to the injection part A, the closure cap also has a removal part B.
  • the injection and removal part A, B are laterally the axis of the closure cap arranged side by side in the middle section 5 of the cover part 2 of the closure cap.
  • the Ent Spotifyteü B has the same structure as the Zuspritzteil A (Fig. 5).
  • the removal part B has a connecting part 27 which points outwards from the middle section 5 of the cover part 2 and has a recess 28 for insertion of the spike of a movement device.
  • the recess 28 of the connecting part 27 is closed by a break-off part 29, which is connected via a ring breaking zone 30 to the upper end of the connecting part.
  • the break-off member 30 again has a side handle bottle 31 which is formed like the Grifßlasche the break-off of Zuspritzteils.
  • From the central portion 5 of the cover part 2 has a closure member 32 down, in which a pierceable by a spike membrane 33 is fixed by clamping.
  • the membrane 33 is held by an inwardly projecting edge 34 of the closure member 32. After breaking off the break-off part 29, the membrane 33 free, which is pierced by the spike. With the spike, a liquid can be removed.
  • FIG. 6 shows the closure cap according to the invention together with a container according to the invention, which in the present exemplary embodiment is a BFS bottle
  • the cap 1 is firmly seated on the bottle neck 37 of the bottle 38, which is filled with, for example, an infusion solution. Since the neck of the bottle is not closed in the head area but is open, the liquid is in direct contact with the cap. Thus, it is possible to inject a drug with a needleless injection syringe.
  • the closure cap is preferably designed as a screw cap, which is screwed onto the bottle neck 37. But it is also possible to weld the cap with the bottleneck.

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Mechanical Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Closures For Containers (AREA)

Abstract

The invention relates to a closure cap for a container for receiving medical liquids, in particular a BFS vial which is produced by a blow-fill-seal process, and to a BFS container with such a closure cap. The closure cap (1) according to the invention has a cover part (2) and an edge part (3), with an injection part (A) arranged in the cover part. The injection part (A) has an outwardly directed connection part (6) with a conical recess (7) for receiving the cone stem of a needleless injection syringe in a seal-forming manner, and an inwardly directed closure part (14) which has a self-sealing membrane (16) for closing the recess (7) of the connection part. The self-sealing membrane (16) is slotted. The closure cap according to the invention allows a liquid to be injected without use of an injection needle.

Description

Verschlusskappe für ein Behältnis zur Aufnahme von medizinischen Flüssigkeiten und Behältnis zur Aufnahme von medizinischen Flüssigkeiten Cap for a container for holding medical fluids and container for receiving medical fluids
Die Erfindung bezieht sich auf eine Verschlusskappe für ein Behältnis zur Aufnahme von medizinischen Flüssigkeiten, insbesondere ein Infusions- oder Transfusionsbehältnis, die einen Deckelteil und einen Randteil aufweist. Darüber hinaus betrifft die Erfindung ein Behältnis zur Aufnahme von medizinischen Flüssigkeiten, insbesondere ein BFS- Behältnis, mit einer derartigen Verschlusskappe.The invention relates to a closure cap for a container for holding medical fluids, in particular an infusion or transfusion container, which has a cover part and a peripheral part. Moreover, the invention relates to a container for receiving medical fluids, in particular a BFS container, with such a cap.
Als Blow-Fill-Seal-Verfahren (BFS-Verfahren) ist ein Verfahren bekannt, bei dem Behältnisse, beispielsweise Flaschen aus extrudiertem PE oder PP, in einem Arbeitsgang steril und pyrogenfrei in eine gewünschte Form geblasen und unmittelbar nach der Abkühlung mit einem sterilen Füllgut aseptisch befüllt und hermetisch verschlossen werden. Die nach dem Blasen-Füllen-V erschließen- Verfahren hergestellten Behältnisse, insbesondere Flaschen, werden auch aus BFS-Behältnisse bezeichnet.As a blow-fill-seal method (BFS method), a method is known in which containers, such as bottles of extruded PE or PP, in a single operation sterile and pyrogen-free blown into a desired shape and immediately after cooling with a sterile filling aseptically filled and hermetically sealed. The containers, in particular bottles, produced according to the bubble-filling-sealing method are also referred to as BFS containers.
Wenn die bekannten BFS-Behältnisse zur Aufnahme von sterilen, medizinischen Flüssigkeiten, beispielsweise Infusionslösungen eingesetzt werden, benötigen die Behältnisse ein Verschlusskappensystem, das ein Überführen der Infusionslösung mittels eines Infüsionsgerätes zum Patienten erlaubt. Die Zugabe von Medikamenten in die Infusionslösung sollte ebenfalls möglich sein.When the known BFS containers are used for receiving sterile, medical liquids, for example infusion solutions, the containers require a closure cap system which allows a transfer of the infusion solution by means of an infusion device to the patient. The addition of medication to the infusion solution should also be possible.
Aus der WO 96/23545 ist ein Infusionsbeutel mit einem Zuspritzteil und einem Entnahmeteil bekannt. Der Entnahmeteil dient zur Entnahme der Infusionslösung mittels eines Spike, während der Zuspritzteil zum Zuführen eines Medikaments mittels einer Injektionsspritze dient, die über eine dünne Kanüle (Nadel) verfügt. Der Zuspritzteil urnfasst einen rohrförmigen Anschlussteil, der von einer als Abbrechteil ausgebildeten Schutzkappe verschlossen ist. In dem Anschlussteil sitzt eine selbstabdichtende Membran (Septum), die von der Kanüle der Injektionsspritze durchstochen wird. Eine durchstechbare Membran in dem Anschlussteil verhindert, dass das Septum vor dem Gebrauch des Infusionsbeutels mit der Lösung in Berührung kommt. Der Entnahmeteil weist ein selbstabdichtendes Septum nicht auf. Der aus der WO 96/23545 bekannte Zuspritz- und Entnahmeteil ist dafür bestimmt, in einen Infusionsbeutel eingeschweißt zu werden.From WO 96/23545 an infusion bag with an injection part and a removal part is known. The dispensing part is for removing the infusion solution by means of a spike, while the injection part is used for supplying a drug by means of a syringe having a thin cannula (needle). The injection part comprises a tubular connection part, which is closed by a protective cap designed as a break-off part. In the connection part sits a self-sealing membrane (septum), which is pierced by the cannula of the injection syringe. A pierceable membrane in the connector prevents the septum from contacting the solution prior to use of the infusion bag. The sampling part does not have a self-sealing septum. The injection and withdrawal part known from WO 96/23545 is intended to be welded into an infusion bag.
In der Praxis haben sich die bekannten Zuspritzteile bewährt. Aus der Verwendung einer Injektionsnadel zum Zuspritzen eines Wirkstoffs ergeben sich aber Nachteile. Zum einen besteht die Gefahr, dass sich die Verbindung zwischen Injektionsnadel und Septum infolge eines unbeabsichtigten Zugs an der Spritze oder eines Überdrucks im Beutelinneren löst. Zum anderen besteht eine erhöhte Verletzungsgefahr für das Pflegepersonal durch die Injektionsnadel. Auch der Infusionsbeutel, in den das Zuspritzteil eingeschweißt ist, kann bei unsachgemäßer Handhabung durch die Nadel beschädigt werden. Das Zuführen eines zähflüssigen Wirkstoffs ist darüber hinaus auf Grund des kleinen Querschnitts der Nadel erschwert. Im Übrigen erfordert auch das Zuführen eines dünnflüssigen Wirkstoffes auf Grund des kleinen Querschnitts der Nadel relativ viel Zeit.In practice, the known Zuspritzteile have proven. From the use of an injection needle for injecting an active ingredient, however, there are disadvantages. First, there is a risk that the connection between the injection needle and the septum due to an unintentional pull on the syringe or an overpressure inside the bag dissolves. On the other hand, there is an increased risk of injury to the nursing staff through the injection needle. Also, the infusion bag, in which the injection part is welded, can be damaged by improper handling by the needle. The addition of a viscous drug is more difficult due to the small cross section of the needle beyond. Incidentally, the supply of a liquid agent due to the small cross section of the needle requires a relatively long time.
Zum Anschluss medizinischer Geräte sind in der Medizintechnik Kegelverbindungen mit einem Kegelschaft und einer Kegelhülse bekannt, deren Kegelflächen normiert sind. Die nicht verriegelbaren Kegelverbindungen mit normierten Kegelflächen werden als Luer- Konnektoren und die verriegelbaren Kegelverbindungen als Luer-Lock-Konnektoren bezeichnet. Die Luer- oder Luer-Lock-Konnektoren mit Kegelschaft werden als männliche Konnektoren und die Konnektoren mit Kegelhülse als weibliche Konnektoren bezeichnet.For connection of medical devices, conical connections with a conical shank and a conical sleeve are known in medical technology whose conical surfaces are normalized. The non-lockable conical connections with normalized conical surfaces are referred to as Luer connectors and the lockable conical connections as Luer-Lock connectors. Tapered Luer or Luer-Lock connectors are referred to as male connectors and tapered sleeve connectors as female connectors.
Die DE 103 48 016 Al beschreibt einen in einen Infusionsbeutel einzuschweißenden Konnektor, der das Zuspritzen eines Wirkstoffes mittels einer konventionellen Luer-Lock- Spritze erlaubt, die nicht über eine Injektionskanüle (Nadel) verfügt. Der bekannte Konnektor verfügt über einen Anschlussteil, der eine kanalförmige Ausnehmung aufweist, in der eine selbstabdichtende Membran angeordnet ist. Ein Abbrechteil, der an den Anschlussteil angeschlossen ist, verschließt die kanalförmige Ausnehmung. Oberhalb der Membran ist der Anschlussteil als ein Anschlussstück mit einem Innenkonus und einem Außengewinde ausgebildet, wobei die Membran zur abdichtenden Aufnahme des Kegelschaftes einer Spritze geschlitzt ist. Der Konnektor ist aus einem oberen und einem unteren Teilstück zusammengesetzt, zwischen denen die selbstabdichtende Membran klemmend gehalten wird.DE 103 48 016 A1 describes a connector to be welded into an infusion bag, which allows the injection of an active substance by means of a conventional Luer-Lock syringe, which does not have an injection cannula (needle). The known connector has a connection part which has a channel-shaped recess in which a self-sealing membrane is arranged. A break-off part, which is connected to the connecting part, closes the channel-shaped recess. Above the membrane, the connecting part is designed as a connecting piece with an inner cone and an outer thread, wherein the membrane for sealingly receiving the Taper shank of a syringe is slotted. The connector is composed of an upper and a lower section, between which the self-sealing membrane is clamped.
Aus der DE 20 2004 003 267 Ul ist eine Verschlusskappe für ein BFS-Behältnis bekannt, die einen Deckelteil und einen Randteil aufweist, wobei in den Deckelteil eine geschlitzte Membran eingesetzt ist, die das Einfuhren des Spike eines Infusionsgerätes erlaubt. Die geschlitzte Membran sitzt bündig in dem Deckelteil der Verschlusskappe.From DE 20 2004 003 267 Ul a cap for a BFS container is known which has a lid part and a peripheral part, wherein in the lid part a slotted membrane is used, which allows the imports of the spike of an infusion device. The slotted membrane sits flush in the cover part of the cap.
Der Erfindung liegt die Aufgabe zugrunde, eine Verschlusskappe für ein Behältnis zur Aufnahme von medizinischen Flüssigkeiten, insbesondere ein BFS-Behältnis zu schaffen, die das Zuspritzen einer Flüssigkeit ohne die Verwendung einer Injektionskanüle erlaubt. Darüber hinaus ist eine Aufgabe der Erfindung, ein Behältnis zur Aufnahme von medizinischen Flüssigkeiten, insbesondere ein BFS-Behältnis bereitzustellen, das das Zuspritzen einer Flüssigkeit ohne die Verwendung einer Injektionskanüle ermöglicht.The invention has for its object to provide a cap for a container for receiving medical fluids, in particular a BFS container, which allows the injection of a liquid without the use of an injection cannula. Moreover, it is an object of the invention to provide a container for receiving medical fluids, in particular a BFS container, which allows the injection of a liquid without the use of an injection cannula.
Die Lösung dieser Aufgaben erfolgt erfindungsgemäß mit den in den Patentansprüchen 1 und 16 angegebenen Merkmalen. Bevorzugte Ausführungsformen der Erfindung sind Gegenstand der Unteransprüche.The solution of these objects is achieved according to the invention with the features specified in the claims 1 and 16. Preferred embodiments of the invention are subject of the dependent claims.
Die erfindungsgemäße Verschlusskappe für ein Behältnis zur Aufnahme von medizinischen Flüssigkeiten, insbesondere ein BFS-Behältnis zur Aufnahme einer Infusionslösung, weist einen Deckelteil und einen Randteil auf, wobei in dem Deckelteil ein Zuspritzteil zum Zuspritzen einer medizinischen Flüssigkeit angeordnet ist.The closure cap according to the invention for a container for holding medical fluids, in particular a BFS container for receiving an infusion solution, has a lid part and a rim part, wherein an injection part for injecting a medical fluid is arranged in the lid part.
Der Zuspritzteil weist einen nach außen weisenden Anschlussteil mit einer konischen Ausnehmung zur abdichtenden Aufnahme des Kegelschafts einer nadellosen Injektionsspritze und einen nach innen weisenden Verschlussteil auf, der eine selbstabdichtende Membran zum Verschließen der Ausnehmung des Anschlussteils aufweist. Die selbstabdichtende Membran ist geschlitzt, so dass der Kegelschaft der Injektionsspritze leicht eingeführt werden kann. Von Vorteil ist, dass die erfindungsgemäße Verschlusskappe mit Ausnahme der selbstabdichtenden Membran einteilig ausgebildet ist. Dadurch ist die Herstellung der Verschlusskappe in großen Stückzahlen mit geringen Kosten möglich.The injection part has an outwardly pointing connection part with a conical recess for sealingly receiving the conical shaft of a needleless injection syringe and an inwardly pointing closure part which has a self-sealing membrane for closing the recess of the connection part. The self-sealing membrane is slotted so that the cone shank of the syringe can be easily inserted. It is advantageous that the closure cap according to the invention with the exception of the self-sealing membrane is formed in one piece. As a result, the production of the cap in large quantities at low cost is possible.
Bei einer bevorzugten Ausfuhrungsform der Verschlusskappe weist der Verschlussteil des Zuspritzteils eine Ausnehmung auf, in der die selbstabdichtende Membran einschnappend eingesetzt ist. Vorzugsweise wird die selbstabdichtende Membran von einem nach innen vorspringenden Rand des Verschlussteils in der Ausnehmung klemmend fixiert. Anstelle eines nach innen vorspringenden Randes, der sich über den gesamten Umfang des Verschlussteils erstreckt, kann der Verschlussteil aber auch umfangsmäßig verteilt angeordnete Haken zur klemmenden Fixierung der selbstabdichtenden Membran aufweisen.In a preferred embodiment of the closure cap, the closure part of the injection part has a recess in which the self-sealing membrane is inserted by snap-fitting. Preferably, the self-sealing membrane is clamped by an inwardly projecting edge of the closure member in the recess. Instead of an inwardly projecting edge which extends over the entire circumference of the closure part, the closure part can also have distributed circumferentially arranged hooks for clamping fixation of the self-sealing membrane.
Bei einer weiteren bevorzugten Ausfuhrungsform der Erfindung weist die Ausnehmung des Verschlussteils einen ersten zylindrischen Abschnitt, der sich an den Deckelteil anschließt, und einen sich an den ersten zylindrischen Abschnitt anschließenden zweiten zylindrischen Abschnitt auf, wobei der erste zylindrische Abschnitt einen kleineren Innendurchmesser als der zweite zylindrische Abschnitt aufweist.In a further preferred embodiment of the invention, the recess of the closure part has a first cylindrical portion adjoining the lid portion and a second cylindrical portion adjoining the first cylindrical portion, the first cylindrical portion having a smaller inner diameter than the second cylindrical portion Section has.
Eine bevorzugte Ausführungsform der Verschlusskappe sieht vor, dass die selbstabdichtende Membran einen ringförmigen Abschnitt aufweist, der in dem zweiten zylindrischen Abschnitt der Ausnehmung mit dem größeren Innendurchmesser angeordnet ist, und einen sich über einen mittleren Steg an den ringförmigen Abschnitt anschließenden tellerförmigen Abschnitt aufweist, der in dem ersten zylindrischen Abschnitt mit dem kleineren Innendurchmesser angeordnet ist. Dadurch hat die selbstabdichtende Membran einen sicheren Halt in der Ausnehmung des Verschlussteils.A preferred embodiment of the closure cap provides that the self-sealing membrane has an annular portion which is arranged in the second cylindrical portion of the recess with the larger inner diameter, and has a plate-shaped portion adjoining the annular portion via a central web, which in the first cylindrical portion having the smaller inner diameter is arranged. As a result, the self-sealing membrane has a secure hold in the recess of the closure part.
Vorzugsweise weist der tellerförmige Abschnitt der selbstabdichtenden Membran eine muldenförmige Vertiefung auf. Die muldenförmige Vertiefung stellt zum einen sicher, dass der Kegelschaft der Spritze sicher geführt wird und gewährleistet zum anderen, dass die Membran nach dem Herausziehen des Kegelschaftes sicher abdichtet. Es hat sich in Versuchen gezeigt, dass die besondere Ausbildung der Membran für den sofortigen Wiederverschluss ausschlaggebend ist, wobei mit zunehmendem Innendruck in der Verpackung die Abdichtung der Membran noch erhöht wird.Preferably, the plate-shaped portion of the self-sealing membrane has a trough-shaped depression. The trough-shaped depression ensures, on the one hand, that the cone shank of the syringe is securely guided and, on the other hand, ensures that the membrane seals securely after pulling out the conical shank. It has been shown in experiments that the special design of the membrane for the immediate Resealing is crucial, with increasing internal pressure in the package, the sealing of the membrane is still increased.
Bei einer besonders bevorzugten Ausführungsform ist der Verschlussteil des Zuspritzteils mit der selbstabdichtenden Membran derart ausgebildet, dass beim Einführen des Kegelschafts der Injektionsspritze die Membran in der Ausnehmung in axialer Richtung zusammengedrückt wird. Dadurch öffnet sich die Membran beim Einführen des Kegelschafts. Die selbstabdichtende Membran ist einerseits in der Ausnehmung des Verschlussteils ausreichend fixiert, andererseits aber so frei beweglich, dass die Membran beim Einführen des Kegelschafts in axialer Richtung zusammengedrückt werden kann. Dabei wird die Höhe der Membran verringert, d.h. die Oberseite der Membran verliert ihren Kontakt zu der Anlagefläche der Ausnehmung des Verschlussteils.In a particularly preferred embodiment, the closure part of the injection part is formed with the self-sealing membrane such that upon insertion of the conical shaft of the injection syringe, the membrane is compressed in the recess in the axial direction. As a result, the membrane opens when inserting the conical shaft. The self-sealing membrane is on the one hand sufficiently fixed in the recess of the closure part, but on the other hand so freely movable that the membrane can be compressed in the axial direction during insertion of the conical shaft. The height of the membrane is reduced, i. the top of the diaphragm loses its contact with the contact surface of the recess of the closure part.
Der Verschlussteil des Zuspritzteils kann entweder für eine Luer-Spritze oder eine Luer- Lock-Spritze ausgelegt sein. Vorzugsweise weist der Anschlussteil des Zuspritzteils ein Außengewinde auf, so dass eine Luer-Lock-Verbindung mit der Spritze möglich ist.The closure part of the injection part can be designed for either a luer syringe or a luer lock syringe. Preferably, the connecting part of the injection part has an external thread, so that a Luer-lock connection with the syringe is possible.
Zum aseptischen Verschluss der selbstabdichtenden Membran ist der Anschlussteil vorzugsweise mit einem Abbrechteil verschlossen, der über eine Ringbruchzone an das obere Ende des Anschlussteils angeschlossen ist. Nach dem Abbrechen des Abbrechteils liegt die selbstabdichtende Membran frei, so dass der Kegelschaft der Spritze eingeführt werden kann.For the aseptic closure of the self-sealing membrane, the connection part is preferably closed with a break-off part, which is connected to the upper end of the connection part via a ring-breaking zone. After breaking off the break-off part, the self-sealing membrane is exposed, so that the cone shank of the syringe can be inserted.
Zur Verbesserung der Handhabung weist der Abbrechteil vorzugsweise eine seitliche Grifflasche auf, die sich bis zu dem Randteil des Deckelteils der Verschlusskappe erstreckt.In order to improve the handling, the break-off part preferably has a lateral grip tab which extends up to the edge part of the cover part of the closure cap.
Neben dem Zuspritzteil kann die erfindungsgemäße Verschlusskappe auch über einen Entnahmeteil zum Entnehmen einer medizinischen Flüssigkeit mit einem Spike verfügen. Der Entnahmeteil weist vorzugsweise ebenfalls einen nach außen weisenden Anschlussteil mit einer Ausnehmung auf, in die ein Spike eingeführt wird, und einen nach innen weisenden Verschlussteil auf, der von einer durchstechbaren Membran verschlossen wird. Die durchstechbare Membran ist in einer Ausnehmung des Verschlussteils des Entnahmeteils einschnappend eingesetzt. Vorzugsweise wird die Membran von einem nach innen vorspringenden Rand des Verschlussteils klemmend fixiert. Auch der Anschlussteil des Entnahmeteils ist vorzugsweise mit einem Abbrechteil verschlossen, der über eine Ringbruchzone an das obere Ende des Anschlussteils angeschlossen ist. Vorzugsweise weist auch der Abbrechteil des Entnahmeteils eine seitliche Grifflasche auf, die sich bis zu dem Randteil des Deckelteils erstreckt.In addition to the injection part, the closure cap according to the invention can also have a removal part for removing a medical liquid with a spike. The removal part preferably also has an outwardly facing fitting with a recess into which a spike is inserted and an inwardly facing closure part which is closed by a pierceable membrane. The pierceable membrane is inserted snapping into a recess of the closure part of the removal part. Preferably, the membrane is clamped by an inwardly projecting edge of the closure part. Also, the connection part of the removal part is preferably closed with a break-off part, which is connected via a ring breaking zone to the upper end of the connecting part. Preferably, the break-off part of the removal part also has a lateral grip tab which extends up to the edge part of the cover part.
Das erfindungsgemäße Behältnis, insbesondere Infusions- oder Transfusionsbehältnis, das vorzugsweise als Flasche ausgebildet ist, ist mit der oben beschriebenen Verschlusskappe verschlossen.The container according to the invention, in particular infusion or transfusion container, which is preferably designed as a bottle, is closed with the closure cap described above.
Im Folgenden wird ein Ausfuhrungsbeispiel der Erfindung unter Bezugnahme auf die Zeichnungen näher erläutert.In the following, an exemplary embodiment of the invention will be explained in more detail with reference to the drawings.
Es zeigen:Show it:
Fig. 1 ein Ausfuhrungsbeispiel der erfindungsgemäßen Verschlusskappe,1 shows an exemplary embodiment of the closure cap according to the invention,
Fig. 2 die Verschlusskappe von Figur 1 in der Seitenansicht,2 shows the closure cap of Figure 1 in side view,
Fig. 3 einen Schnitt durch die Verschlusskappe von Figur 1 entlang der3 shows a section through the closure cap of Figure 1 along the
Linie III-III in vergrößerter Darstellung,Line III-III in an enlarged view,
Fig. 4 A undFig. 4 A and
Fig. 4 B die Verschlusskappe vor und nach dem Einfuhren des Kegelschaftes einer Injektionsspritze,4 B, the cap before and after the import of the conical shank of a syringe,
Fig. 4C einen Ausschnitt von Figur 4 B in vergrößerter Darstellung,4C is a detail of Figure 4 B in an enlarged view,
Fig. 5 die Verschlusskappe von Fig. 1 in geschnittener Darstellung und Fig. 6 ein Ausführungsbeispiel eines erfindungsgemäßen Behältnisses mit der erfindungsgemäßen Verschlusskappe.Fig. 5, the closure cap of Fig. 1 in a sectional view and Fig. 6 shows an embodiment of a container according to the invention with the closure cap according to the invention.
Die Figuren 1 und 2 zeigen die erfindungsgemäße Verschlusskappe in der Seitenansicht die über einen Zuspritzteil A und einen Entnahmeteil B verfugt. Die Verschlusskappe ist mit Ausnahme der selbstabdichtenden bzw. durchstechbaren Membran ein einstückiges Kunststoffteil, das in großen Stückzahlen kostengünstig gefertigt werden kann.FIGS. 1 and 2 show the closure cap according to the invention in side view, which has an injection part A and a removal part B. With the exception of the self-sealing or puncturable membrane, the closure cap is a one-piece plastic part which can be produced inexpensively in large quantities.
Die Verschlusskappe 1 weist einen Deckelteil 2 und einen Randteil 3 auf. Der Deckelteil 2 hat einen äußeren Abschnitt 4 und einen inneren Abschnitt 5, der nach außen vorsteht. Von dem inneren nach außen vorstehenden Abschnitt 5 weist ein Anschlussteil 6 zum Einführen des Kegelschaftes einer nadellosen Injektionsspritze nach außen (Fig. 3). Der Anschlussteil 6 weist eine konische Ausnehmung 7 zur abdichtenden Aufnahme des Kegelschafts der Spritze und ein Außengewinde 8 auf. Die konische Ausnehmung 7 und das Außengewinde 8 sind derart ausgebildet, dass eine handelsübliche Luer-Lock-Spritze an dem Anschlussteil angeschlossen werden kann.The closure cap 1 has a lid part 2 and a rim part 3. The lid member 2 has an outer portion 4 and an inner portion 5 projecting outwardly. From the inner outwardly projecting portion 5 has a connecting part 6 for inserting the conical shank of a needleless injection syringe to the outside (Fig. 3). The connecting part 6 has a conical recess 7 for sealingly receiving the conical shaft of the syringe and an external thread 8. The conical recess 7 and the external thread 8 are formed such that a commercially available Luer-lock syringe can be connected to the connecting part.
Der Anschlussteil 6 ist mit einem Abbrechteil 9 verschlossen, der über eine Ringbruchzone 10 an das obere Ende des Anschlussteils angeschlossen ist. Der Abbrechteil 9 weist eine runde Kappe 11 auf, an die sich über einen schmalen Steg 12 eine seitliche Grifflasche 13 anschließt, die sich bis zu dem Randteil des Deckelteils nach unten erstreckt. Die Grifflasche 13 ist derart ausgebildet, dass sie sich seitlich nicht über die Verschlusskappe hinaus erstreckt.The connection part 6 is closed by a break-off part 9, which is connected via a ring-breaking zone 10 to the upper end of the connection part. The break-off part 9 has a round cap 11, to which a lateral tab 12 adjoins a narrow web 12, which extends down to the edge part of the cover part. The grip tab 13 is designed such that it does not extend laterally beyond the closure cap.
Von dem mittleren Abschnitt 5 des Deckelteils 2 weist ein Verschlussteil 14 nach innen, der eine Ausnehmung 15 aufweist. In der Ausnehmung 15 des Verschlussteils 14 ist eine selbstabdichtende Membran 16 eingesetzt, die einschnappend in der Ausnehmung sitzt.From the central portion 5 of the lid part 2, a closure part 14 has inwardly, which has a recess 15. In the recess 15 of the closure part 14, a self-sealing membrane 16 is inserted, which sits snapping into the recess.
Die Ausnehmung 15 des Verschlussteils 14 weist einen oberen zylindrischen Abschnitt 17 auf, der sich an den mittleren Abschnitt 5 des Deckelteils 2 anschließt. An den oberen zylindrischen Abschnitt 17 schließt sich ein unterer zylindrischer Abschnitt 18 an, der einen größeren Innendurchmesser als der obere zylindrische Abschnitt 17 hat. Die selbstabdichtende Membran 16 weist entsprechend einen unteren ringförmigen Abschnitt 19 mit einem größeren Außendurchmesser auf, der in dem unteren zylindrischen Abschnitt 18 der Ausnehmung 15 sitzt. An den ringförmigen Abschnitt 19 der Membran 16 schließt sich über eine mittleren Steg 20 ein oberer tellerförmiger Abschnitt 21 mit einem kleineren Außendurchmesser an, der passend in dem oberen zylindrischen Abschnitt 17 der Ausnehmung 15 sitzt. Der Verschlussteil weist einen nach innen vorspringenden Rand 35 auf, der die Membran 16 klemmend fixiert. Der tellerförmige Abschnitt 21 der Membran 16 hat eine muldenförmige Vertiefung 22, die mit einem oder mehreren Schlitzen 23 versehen ist, beispielsweise kreuzweise geschlitzt ist.The recess 15 of the closure part 14 has an upper cylindrical portion 17, which adjoins the central portion 5 of the lid part 2. The upper cylindrical portion 17 is followed by a lower cylindrical portion 18 having a larger inner diameter than the upper cylindrical portion 17. The Self-sealing membrane 16 has correspondingly a lower annular portion 19 with a larger outer diameter, which sits in the lower cylindrical portion 18 of the recess 15. Adjoining the annular section 19 of the membrane 16, via a central web 20, is an upper dish-shaped section 21 with a smaller outside diameter, which sits snugly in the upper cylindrical section 17 of the recess 15. The closure part has an inwardly projecting edge 35, which fixes the membrane 16 in a clamping manner. The dish-shaped portion 21 of the membrane 16 has a trough-shaped recess 22, which is provided with one or more slots 23, for example, is slotted crosswise.
Der Randteil 3 der Verschlusskappe 1 weist einen unteren wulstförmigen Rand 24 auf, der an der Unterseite eine umlaufende Nut 25 hat. Die Verschlusskappe kann auf eine Flasche aufgesetzt werden, wobei der obere Rand des Flaschenhalses in die Nut 25 des wulstförmigen Randes 24 der Verschlusskappe greift.The edge part 3 of the closure cap 1 has a lower bead-shaped edge 24, which has a circumferential groove 25 on the underside. The cap can be placed on a bottle, wherein the upper edge of the bottle neck engages in the groove 25 of the bead-shaped edge 24 of the cap.
Nachfolgend wird die Funktionsweise des Zuspritzteils A der Verschlusskappe unter Bezugnahme auf die Figuren 4 A, 4B und 4C beschrieben.Hereinafter, the operation of the injection part A of the cap will be described with reference to FIGS. 4A, 4B and 4C.
Zum Zuspritzen einer Flüssigkeit, beispielsweise eines Medikaments mit einer nadellosen Injektionsspritze wird zunächst der Abbrechteil 9 durch seitliches Schwenken der Griffflasche 13 von dem Anschlussteil 6 abgebrochen. Damit liegt die selbstabdichtende Membran 16 frei. Daraufhin wird der konische Kegelschaft 36 einer nadellosen Injektionsspritze 26 in die konische Ausnenmung 7 des Anschlussteils 6 eingeführt. Der Kegelschaft 36 drückt dabei auf den tellerförmigen Abschnitt 22 der selbstabdichtenden Membran 16, wodurch die Membran zusammengepresst wird (Figur 4C). Dadurch drückt sich der mittlere Steg 20 der Membran 16 nach innen, wobei der tellerförmige Abschnitt 22 im Bereich der Schlitze 23 geöffnet wird. Das Medikament kann nunmehr zugespritzt werden.For injecting a liquid, for example a medicament with a needleless injection syringe, the break-off part 9 is first broken off from the connection part 6 by lateral pivoting of the handle bottle 13. Thus, the self-sealing membrane 16 is exposed. Then the conical taper shank 36 of a needleless injection syringe 26 is inserted into the conical recess 7 of the connection part 6. The conical shaft 36 presses on the plate-shaped portion 22 of the self-sealing membrane 16, whereby the membrane is pressed together (Figure 4C). As a result, the middle web 20 of the membrane 16 presses inwards, wherein the plate-shaped portion 22 is opened in the region of the slots 23. The drug can now be injected.
Neben dem Zuspritzteil A verfügt die Verschlusskappe noch einen Entnahmeteil B. Zuspritz- und Entnahmeteil A, B sind seitlich der Achse der Verschlusskappe nebeneinanderliegend in dem mittleren Abschnitt 5 des Deckelteils 2 der Verschlusskappe angeordnet. Der Entnahmeteü B hat den gleichen Aufbau wie der Zuspritzteil A (Fig. 5).In addition to the injection part A, the closure cap also has a removal part B. The injection and removal part A, B are laterally the axis of the closure cap arranged side by side in the middle section 5 of the cover part 2 of the closure cap. The Entnahmeteü B has the same structure as the Zuspritzteil A (Fig. 5).
Der Entnahmeteil B weist einen von dem mittleren Abschnitt 5 des Deckelteils 2 nach außen weisenden Anschlussteil 27 auf, der eine Ausnehmung 28 zum Einführen, des Spike eines Musionsgerätes aufweist. Die Ausnehmung 28 des Anschlussteils 27 ist mit einem Abbrechteil 29 verschlossen, der über eine Ringbruchzone 30 an das obere Ende des Anschlussteils angeschlossen, ist. Der Abbrechteil 30 weist wieder eine seitliche Griffflasche 31 auf, die wie die Grifßlasche des Abbrechteils des Zuspritzteils ausgebildet ist. Von dem mittleren Abschnitt 5 des Deckelteils 2 weist ein Verschlussteil 32 nach unten, in dem eine von einem Spike durchstechbare Membran 33 klemmend fixiert ist. Die Membran 33 wird von einem nach innen vorspringenden Rand 34 des Verschlussteils 32 gehalten. Nach dem Abbrechen des Abbrechteils 29 Hegt die Membran 33 frei, die von dem Spike durchstochen wird. Mit dem Spike kann eine Flüssigkeit entnommen werden.The removal part B has a connecting part 27 which points outwards from the middle section 5 of the cover part 2 and has a recess 28 for insertion of the spike of a movement device. The recess 28 of the connecting part 27 is closed by a break-off part 29, which is connected via a ring breaking zone 30 to the upper end of the connecting part. The break-off member 30 again has a side handle bottle 31 which is formed like the Grifßlasche the break-off of Zuspritzteils. From the central portion 5 of the cover part 2 has a closure member 32 down, in which a pierceable by a spike membrane 33 is fixed by clamping. The membrane 33 is held by an inwardly projecting edge 34 of the closure member 32. After breaking off the break-off part 29, the membrane 33 free, which is pierced by the spike. With the spike, a liquid can be removed.
Figur 6 zeigt die erfindungsgemäße Verschlusskappe zusammen mit einem erfindungsgemäßen Behältnis, das im vorliegenden Ausfuhrungsbeispiel eine BFS-Flasche istFIG. 6 shows the closure cap according to the invention together with a container according to the invention, which in the present exemplary embodiment is a BFS bottle
Die Verschlusskappe 1 sitzt fest auf dem Flaschenhals 37 der Flasche 38, die beispielsweise mit einer Infusionslösung befüllt ist Da der Flaschenhals im Kopfbereich nicht verschlossen, sondern offen ist, steht die Flüssigkeit unmittelbar in Kontakt mit der Kappe. Somit besteht die Möglichkeit, mit einer nadellosen Injektionsspritze ein Medikament zuzuspritzen. Die Verschlusskappe ist vorzugsweise als Schraubkappe ausgebildet, die auf den Flaschenhals 37 aufgeschraubt wird. Es ist aber auch möglich, die Verschlusskappe mit dem Flaschenhals zu verschweißen.The cap 1 is firmly seated on the bottle neck 37 of the bottle 38, which is filled with, for example, an infusion solution. Since the neck of the bottle is not closed in the head area but is open, the liquid is in direct contact with the cap. Thus, it is possible to inject a drug with a needleless injection syringe. The closure cap is preferably designed as a screw cap, which is screwed onto the bottle neck 37. But it is also possible to weld the cap with the bottleneck.
BERICHTIGTES BLATT (REGEL 91) ISA/EP ADJUSTED SHEET (RULE 91) ISA / EP

Claims

Patentansprüche claims
1. Verschlusskappe für ein Behältnis zur Aufnahme von medizinischen Flüssigkeiten, insbesondere ein BFS-Behältnis, die einen Deckelteil (2) und einen Randteil (3) aufweist, dadurch gekennzeichnet, dass in dem Deckelteil (2) ein Zuspritzteil (A) zum Zuspritzen einer medizinischen Flüssigkeit angeordnet ist, der einen nach außen weisenden Anschlussteil (6) mit einer konischen Ausnehmung (7) zur abdichtenden Aufnahme des Kegelschafts einer nadellosen Injektionsspritze und einen nach innen weisenden Verschlussteil (14) aufweist, der eine selbstabdichtende Membran (16) zum Verschließen der Ausnehmung des Anschlussteils aufweist, die geschlitzt ist.1. cap for a container for receiving medical fluids, in particular a BFS container having a lid part (2) and an edge part (3), characterized in that in the cover part (2) an injection part (A) for injecting a medical liquid, which has an outwardly pointing connection part (6) with a conical recess (7) for sealingly receiving the conical shaft of a needleless injection syringe and an inwardly directed closure part (14) having a self-sealing membrane (16) for closing the Has recess of the connection part, which is slotted.
2. Verschlusskappe nach Anspruch 1, dadurch gekennzeichnet, dass der Verschlussteil (14) des Zuspritzteils (A) eine Ausnehmung (15) aufweist, in der die selbstabdichtende Membran (16) einschnappend eingesetzt ist.2. Closure cap according to claim 1, characterized in that the closure part (14) of the injection part (A) has a recess (15) in which the self-sealing membrane (16) is inserted snapping.
3. Verschlusskappe nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass der Verschlussteil (14) des Zuspritzteils (A) einen nach innen vorspringenden Rand (35) aufweist, der die selbstabdichtende Membran (16) in der Ausnehmung (15) klemmend fixiert.3. Closure cap according to claim 1 or 2, characterized in that the closure part (14) of the injection part (A) has an inwardly projecting edge (35) which fixes the self-sealing membrane (16) in the recess (15) by clamping.
4. Verschlusskappe nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass der Verschlussteil (13) des Zuspritzteils (A) mit der selbstabdichtenden Membran (16) derart ausgebildet ist, dass beim Einfuhren des Kegelschafts einer Injektionsspritze die Membran in der Ausnehmung (15) in axialer Richtung zusammengedrückt wird, so dass die Membran geöffnet wird.4. Closure cap according to one of claims 1 to 3, characterized in that the closure part (13) of the injection part (A) with the self-sealing membrane (16) is formed such that upon insertion of the conical shaft of a syringe, the membrane in the recess (15 ) is compressed in the axial direction, so that the membrane is opened.
5. Verschlusskappe nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass die Ausnehmung (15) des Verschlussteils (14) des Zuspritzteils (A) einen ersten zylindrischen Abschnitt (17) aufweist, der sich an den Deckteil (2) anschließt, und einen sich an den ersten zylindrischen Abschnitt anschließenden zweiten zylindrischen Abschnitt (18) aufweist, der einen größeren Innendurchmesser als der erste zylindrische Abschnitt hat.5. Closure cap according to one of claims 1 to 4, characterized in that the recess (15) of the closure part (14) of the injection part (A) has a first cylindrical portion (17) which adjoins the cover part (2), and a second cylindrical portion (18) adjoining the first cylindrical portion and having a larger inner diameter than the first cylindrical portion.
6. Verschlusskappe nach Anspruch 5, dadurch gekennzeichnet, dass die selbstabdichtende Membran (16) einen ringförmigen Abschnitt (19) aufweist, der in dem zweiten zylindrischen Abschnitt (18) der Ausnehmung (15) angeordnet ist, und einen sich über einen mittleren Steg (20) an den ringförmigen Abschnitt anschließenden tellerförmigen Abschnitt (21) aufweist, der in dem ersten zylindrischen Abschnitt (17) angeordnet ist.6. A closure cap according to claim 5, characterized in that the self-sealing membrane (16) has an annular portion (19) which is arranged in the second cylindrical portion (18) of the recess (15) and extends over a central web (16). 20) adjacent to the annular portion having plate-shaped portion (21) which is arranged in the first cylindrical portion (17).
7. Verschlusskappe nach Anspruch 6, dadurch gekennzeichnet, dass der tellerförmige Abschnitt (21) der selbstabdichtenden Membran (16) eine muldenförmige Vertiefung (22) aufweist.7. Closure cap according to claim 6, characterized in that the plate-shaped portion (21) of the self-sealing membrane (16) has a trough-shaped depression (22).
8. Verschlusskappe nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, dass der Anschlussteil (13) des Zuspritzteils (A) ein Außengewinde (8) aufweist.8. Closure cap according to one of claims 1 to 7, characterized in that the connection part (13) of the injection part (A) has an external thread (8).
9. Verschlusskappe nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, dass der Anschlussteil (14) mit einem Abrechtteil (9) verschlossen ist, der über eine Ringbruchzone (10) an das obere Ende des Anschlussteils angeschlossen ist.9. Closure cap according to one of claims 1 to 8, characterized in that the connecting part (14) with a Abrechtteil (9) is closed, which is connected via a ring breaking zone (10) to the upper end of the connecting part.
10. Verschlusskappe nach Anspruch 9, dadurch gekennzeichnet, dass der Abbrechteil (9) eine seitliche Grifflasche (13) aufweist, die sich bis zu dem Randteil (3) der Verschlusskappe erstreckt.10. Closure cap according to claim 9, characterized in that the break-off part (9) has a lateral grip tab (13) which extends up to the edge part (3) of the closure cap.
11. Verschlusskappe nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass in dem Deckelteil (2) ein Entnahmeteil (B) zum Entnehmen einer medizinischen Flüssigkeit mit einem Spike angeordnet ist, der einen nach außen weisenden Anschlussteil (27) mit einer Ausnehmung (28) zur Aufnahme eines Spike und einen nach innen weisenden Verschlussteil (32) aufweist, der eine durchstechbare Membran (33) zum Verschließen der Ausnehmung des Anschlussteils aufweist.11. Closure cap according to one of claims 1 to 10, characterized in that in the cover part (2) a removal part (B) for removing a medical fluid with a spike is arranged, which has an outwardly facing connection part (27) with a recess ( 28) for receiving a spike and an inwardly facing closure part (32) having a pierceable Membrane (33) for closing the recess of the connecting part.
12. Verschlusskappe nach Anspruch 11, dadurch gekennzeichnet, dass die durchstechbare Membran (33) des Entnahmeteils (B) einschnappend in die Ausnehmung (28) eingesetzt ist.12. A closure cap according to claim 11, characterized in that the pierceable membrane (33) of the removal part (B) is inserted into the recess (28) snapping.
13. Verschlusskappe nach Anspruch 12, dadurch gekennzeichnet, dass der Verschlussteil (32) des Entnahmeteils (B) einen nach innen vorspringenden Rand (34) aufweist, der die durchstechbare Membran (33) in der Ausnehmung (28) klemmend fixiert.13. Closure cap according to claim 12, characterized in that the closure part (32) of the removal part (B) has an inwardly projecting edge (34) which fixes the puncturable membrane (33) in the recess (28) by clamping.
14. Verschlusskappe nach einem der Ansprüche 11 bis 13, dadurch gekennzeichnet, dass der Anschlussteil (27) des Entnahmeteils (B) mit einem Abrechtteil (29) verschlossen ist, der über eine Ringbruchzone (30) an das obere Ende des Anschlussteils angeschlossen ist.14. Closure cap according to one of claims 11 to 13, characterized in that the connecting part (27) of the removal part (B) with a Abrechtteil (29) is closed, which is connected via a ring breaking zone (30) to the upper end of the connecting part.
15. Verschlusskappe nach Anspruch 14, dadurch gekennzeichnet, dass der Abbrechteil (29) des Entnahmeteils (B) eine seitliche Grifflasche (31) aufweist, die sich bis zu dem Randteil (3) der Verschlusskappe erstreckt.15. Closure cap according to claim 14, characterized in that the break-off part (29) of the removal part (B) has a lateral grip tab (31) which extends up to the edge part (3) of the closure cap.
16. Behältnis, insbesondere BFS-Flasche, mit einer Verschlusskappe (1) nach einem der Ansprüche 1 bis 15. 16. Container, in particular BFS bottle, with a closure cap (1) according to one of claims 1 to 15.
EP08707528.9A 2007-02-03 2008-02-04 Closure cap for a container for receiving medical liquids, and container for receiving medical liquids Active EP2114345B1 (en)

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DE200710005407 DE102007005407A1 (en) 2007-02-03 2007-02-03 Cap for a container for holding medical fluids and container for receiving medical fluids
PCT/EP2008/000851 WO2008095665A1 (en) 2007-02-03 2008-02-04 Closure cap for a container for receiving medical liquids, and container for receiving medical liquids

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EP2114345A1 true EP2114345A1 (en) 2009-11-11
EP2114345B1 EP2114345B1 (en) 2016-12-07

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JP (1) JP5563310B2 (en)
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Publication number Priority date Publication date Assignee Title
US9180070B2 (en) 2012-02-02 2015-11-10 Becton Dickinson Holdings Pte. Ltd. Adaptor for coupling to a medical container
US9549873B2 (en) 2012-02-02 2017-01-24 Becton Dickinson Holdings Pte. Ltd. Adaptor for coupling to a medical container
US9668939B2 (en) 2012-02-02 2017-06-06 Becton Dickinson Holdings Pte. Ltd. Adaptor for coupling with a medical container
US10532005B2 (en) 2012-02-02 2020-01-14 Becton Dickinson Holdings Pte. Ltd. Adaptor for coupling to a medical container
US10751252B2 (en) 2012-02-02 2020-08-25 Becton Dickinson Holdings Pte. Ltd. Adaptor for coupling with a medical container
US10966903B2 (en) 2012-02-02 2021-04-06 Becton Dickinson Holdings Pte. Ltd. Adaptor for coupling to a medical container
USD747650S1 (en) 2013-08-05 2016-01-19 Becton Dickinson France Blocking closure for container

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EP2114345B1 (en) 2016-12-07
US20100059474A1 (en) 2010-03-11
KR101462198B1 (en) 2014-11-17
DE102007005407A1 (en) 2008-08-07
BRPI0807070A2 (en) 2014-04-08
WO2008095665A1 (en) 2008-08-14
MX2009008272A (en) 2009-08-12
CA2677286C (en) 2015-04-07
ZA200904680B (en) 2010-04-28
AU2008213344B2 (en) 2013-08-29
AU2008213344A1 (en) 2008-08-14
CN101600411A (en) 2009-12-09
JP2010517607A (en) 2010-05-27
US9095500B2 (en) 2015-08-04
JP5563310B2 (en) 2014-07-30
KR20090113278A (en) 2009-10-29
BRPI0807070B1 (en) 2018-10-02
CA2677286A1 (en) 2008-08-14
CN101600411B (en) 2014-11-05
BRPI0807070B8 (en) 2021-06-22

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