EP1010635A2 - Capuchon de fermeture d'un récipient pour médicaments avec un goulot façonné fermé - Google Patents

Capuchon de fermeture d'un récipient pour médicaments avec un goulot façonné fermé Download PDF

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Publication number
EP1010635A2
EP1010635A2 EP99124158A EP99124158A EP1010635A2 EP 1010635 A2 EP1010635 A2 EP 1010635A2 EP 99124158 A EP99124158 A EP 99124158A EP 99124158 A EP99124158 A EP 99124158A EP 1010635 A2 EP1010635 A2 EP 1010635A2
Authority
EP
European Patent Office
Prior art keywords
closure cap
seal
container
container neck
cap according
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
EP99124158A
Other languages
German (de)
English (en)
Other versions
EP1010635A3 (fr
EP1010635B2 (fr
EP1010635B1 (fr
Inventor
Albert Louis Victor Josef Claessens
Serge Leon Guy Marie Ghislain De Schaetzen
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.)
Helvoet Pharma NV
Datwyler Pharma Packaging Belgium NV
Original Assignee
Helvoet Pharma NV
Helvoet Pharma Belgium NV
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=7891733&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP1010635(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Helvoet Pharma NV, Helvoet Pharma Belgium NV filed Critical Helvoet Pharma NV
Publication of EP1010635A2 publication Critical patent/EP1010635A2/fr
Publication of EP1010635A3 publication Critical patent/EP1010635A3/fr
Application granted granted Critical
Publication of EP1010635B1 publication Critical patent/EP1010635B1/fr
Publication of EP1010635B2 publication Critical patent/EP1010635B2/fr
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
    • A61J1/1406—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
    • A61J1/1412—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
    • A61J1/1475—Inlet or outlet ports
    • 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

  • the invention relates to a cup-shaped closure cap with a lid and a jacket area for a medicament, in particular an infusion container, the put on the closed container neck and firmly connected to it is, with at least one piercing opening in the lid region of the closure cap is provided with a seal made of an elastic material and on a Medicament, in particular infusion containers with an attached Sealing cap.
  • Such known medication or infusion containers increasingly solve the earlier only used and made of glass infusion bottles. Usually still have these made of a soft plastic material infusion container bottle shape, but are also increasingly being produced in bag form.
  • the medication or Drug is filled with infusion containers after it has been filled into the container and after hermetically sealing it absolutely protected and it only comes up again with the planned removal of the drug from the container the problem to be able to do this cleanly and sterile, because the medication or The infusion container must be opened.
  • the medication or infusion containers are on your Provide the container neck with the known cap described above, which consists of a firmer or harder plastic material is made and that between themselves and includes a seal on the neck of the medication or infusion container, through which the cannula or hollow mandrel of an infusion set is pushed, the hollow mandrel is held by this seal against slipping out when the Infusion bottle is held upside down.
  • the known cap described above which consists of a firmer or harder plastic material is made and that between themselves and includes a seal on the neck of the medication or infusion container, through which the cannula or hollow mandrel of an infusion set is pushed, the hollow mandrel is held by this seal against slipping out when the Infusion bottle is held upside down.
  • a closure cap is known from EP 0 364 783 B1, which is on the closed Container neck of a medication or medical device made of soft plastic material Infusion container is placed. This made of harder plastic material manufactured cap overlaps with its cylindrical jacket part cylindrical outer wall of the container neck, the cap with its The lid area is arranged at a distance from the lid surface of the container neck, so that there is a cavity of a certain volume between the two for the Arrangement of a seal is provided.
  • the lid area of the cap has at least one piercing opening, which is closed from the outside with a film.
  • the in the between the cap on the one hand and the container neck or Cover surface of the container neck on the other hand contained existing cavity Seal is made of a soft sealant, the seal in the Piercing opening protrudes and this sealant with the cap, so with the inner surfaces of the sealing cap completely in the area of the cavity is welded
  • This seal which is formed in the sealing cap and is usually injected, requires relatively much sealing material, since they have the cap in their upper Area completely filled, i.e. taking into account the large number in which such Caps have to be produced, these numbers are in hundreds or Thousands of millions of dollars results in an enormous amount of material because of that its special sealing qualification is cost-intensive, is definitely more expensive than the one used for the medication container or the cap Plastic material. It is therefore an object of the present invention to control the amount of special sealing material to reduce significantly and thus the cost of To minimize the manufacture of such caps.
  • the Form the closure cap in its lid area so that it can be torn out Cover part is provided, wherein a tab is integrally formed on this cover part is by means of which the pull-out part are torn out of the closure cap can, so that an opening is formed in the lid region of the closure cap.
  • a perforated disc is provided below this opening, which is connected to the underside of the Cover area of the cap is firmly connected by welding.
  • the Perforated disk has several holes that have different diameters can and through which the cannulas or hollow mandrels can be passed.
  • a sealing washer is provided below this perforated washer Top of the lid surface of the container closure rests and that when piercing a cannula or a hollow mandrel through the holes of the perforated disc in the container into it the sealing function.
  • the sealing washer is designed that it fills the cap completely in diameter and therefore relatively a lot of material has to be used.
  • the invention therefore has on the one hand the task of a closure cap to improve the type described at the outset with regard to its sterile properties, ie in particular the sealing effect between the existing in the cap
  • This above-described embodiment of the closure cap according to the invention forms by the arrangement of the chamber in the lid area a firm fit for the inside used seal, which ensures that the seal during the Puncture does not suffer excessive deformation, which can occur when arranged a second puncture opening on the underlying area of the same seal transmits. Especially when there is more than one puncture opening in the cap are provided, is guaranteed by this embodiment according to the invention, that the seal associated with the respective puncture opening is not of the adjacent seal with respect to deformations etc. is affected.
  • the chamber in contrast to its cover region having the piercing opening, is designed as a cylinder section which is almost completely open towards the top of the container neck.
  • This configuration of the chambering ensures that the seal arranged in it with its sealing surface directed towards the top of the container neck comes almost completely to rest on the top of the container neck and thus seals the opening in the container neck which arises during the piercing process.
  • the cylindrical section advantageously has a circumferential groove in its axial inner wall, into which the disk-shaped seal having a round cross section protrudes with a circumferential projection formed on its axial outer wall.
  • This form of tongue and groove connection form of the seal on the one hand with the chambering on the other hand ensures that the seals, which are made of a softer and thus more easily deformable material, can be easily inserted into the chambering made of a stronger and less deformable harder plastic , on the other hand, are kept dimensionally stable by this chambering, for example, if they are pierced by the hollow mandrel of an infusion set.
  • the seal although it could easily be inserted into the chamber, cannot be pushed out of it, because it is held in the chamber by the top of the neck of the container, on which the closure cap is placed, and nestles just when the piercing process takes place particularly close to the top of the container neck, which further increases its sealing effect.
  • the projection advantageously has an interruption at at least one point.
  • This interruption of which several, for example evenly over the Distributed circumference of the circumferential projection can be provided, this facilitates for example inserting the seals to be carried out by an assembly machine into the chambers by the fact that air that is in the closed Chamber area of the cap is located by these interruptions can escape, so not a cushion of compressed air between them Forms seal on the one hand and the chambering on the other hand, which could cause the seal is pushed out of the chamber after insertion.
  • the seal is in in its central area their thickness is thinner, for example by specifying indentations in at least one of their radial sealing surfaces.
  • the piercing opening provided on the outside of the chamber has a tearable closure which is formed in one piece with the lid region of the closure cap.
  • a closure which is formed in one piece with the lid region, guarantees an absolute tightness of the puncture region to the outside in the closed state, in particular such a tearable closure can be produced at the same time as the closure cap is being produced; no subsequent application of a film or other closure means is necessary.
  • the tearable closure has a tear lever.
  • This tear-open lever can also be molded in one production process, it can be gripped with a finger and pulled up, so that the piercing opening underneath is opened without touching it and the hollow mandrel of an infusion set can be inserted.
  • the tear lever is on the outside via a hinge attached to the chambering, so that the tear lever does not open after the Piercing hole is lost, rather together with the cap or the entire, empty medication container can be disposed of.
  • the tear lever on the one hand and the outside of the Chambering each has parts of a locking device that are complementary trained to each other and assigned to each other so that they are open Tear lever form the locking device.
  • Two piercing openings are advantageously provided in the lid area of the closure cap. These can be used independently of one another, in particular opened, whereby they show the advantage that their respective seals are completely independent of one another and thus do not influence one another when the hollow dome is inserted.
  • the seal used in the chambers can be made of rubber, but also on the other hand be made of a plastic, depending on the requirements of the Properties of the seal.
  • the invention further relates to a medicament, in particular infusion, container with a closure cap according to one of claims 1 to 11, which is made of a plastic and in which the closure cap also made of plastic and with its jacket area placed on the neck of the container with the Container neck is welded.
  • a medicament, in particular infusion, container with a closure cap according to one of claims 1 to 11, which is made of a plastic and in which the closure cap also made of plastic and with its jacket area placed on the neck of the container with the Container neck is welded.
  • the top of the container neck is advantageously welded to the bottom of the chamber. This avoids the fact that when the seal is pierced and thus by the pressure exerted on the cover surface of the container neck, the seal bends excessively into the interior of the container. This measure ensures that the sealing surface of the seal facing the upper side of the cover surface of the container neck also bears against the upper side of the cover surface of the container neck after it has been pierced.
  • the top of the container neck is also welded to the sealing surface of the seals. This additional measure ensures a particularly good seal between these individual parts of the medication container and the closure cap.
  • the closure cap 1 shown in the figures is essentially pot-shaped formed, i.e. it has a lid area 2 and a jacket area 3, with which they, as shown in Fig. 6, the closed container neck 4th a medicament container 5, for example an infusion container.
  • the closure cap 1 can be a one not described here in particular have trained jacket edge 6, for example, on a circular flange 7 of the container neck 4 of the medication container 5 attached, for example screwed or welded.
  • the cap 1 with the inside 8 of its jacket 3 with the outer surface of the container neck 4 is glued or welded.
  • closures 10 and 10 ' are also formed in one piece with Tear-open levers 11 and 11 ', respectively, under which fingers are gripped can, then with appropriate force, the closures 10 and 10 ' to tear out the lid area 2 of the closure cap 1 and thus the To give piercing openings 9 or 9 '.
  • This tear lever 11 or 11 ' or the closures 10 and 10 ' are on hinges 12 and 12' attached to the lid portion 2 so that it does not detach from the Cap 1 fall off and can be disposed of together with this.
  • Locking device which the tear lever 11 or 11 'in the torn Hold the position as shown in Fig. 8.
  • the locking device consists of a part 26, which is provided on the tearing levers 11 and 11 ', and one second part 27, which is formed on the outside of the chamber eyes 13 and 13 ' and when the tear lever 11 or 11 'is torn open Supplement locking device, such as a hook-and-eye connection or, more similar to a lower and an upper hook.
  • the lid area 2 of the closure cap 1 is in the area of the piercing openings 9 or 9 'in a special shape, there it namely has each piercing opening a chamber 13 or 13 'on the outside 14 of the Cover area 2 protrude so far that the top 15 of the Container neck 4 directed sealing surfaces 16 and 16 'of in the chambers 13th or 13 'used seals 17 or 17' only slightly over the inside 18 of the lid area 2 protrude.
  • This Holding devices are, as can be seen in particular from FIGS. 5 to 7, designed in the manner of tongue and groove, which between chambers 13 and 13 ' and seals 17 and 17 'are formed.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)
EP19990124158 1998-12-18 1999-12-02 Capuchon de fermeture d'un récipient pour médicaments avec un goulot façonné fermé Expired - Lifetime EP1010635B2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE1998158715 DE19858715B4 (de) 1998-12-18 1998-12-18 Entnahmevorrichtung zur festen Anordnung auf dem geschlossen ausgebildeten Behälterhals eines Medikamenten-, insbesondere Infusionsbehälters
DE19858715 1998-12-18

Publications (4)

Publication Number Publication Date
EP1010635A2 true EP1010635A2 (fr) 2000-06-21
EP1010635A3 EP1010635A3 (fr) 2001-05-02
EP1010635B1 EP1010635B1 (fr) 2004-03-03
EP1010635B2 EP1010635B2 (fr) 2007-10-24

Family

ID=7891733

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19990124158 Expired - Lifetime EP1010635B2 (fr) 1998-12-18 1999-12-02 Capuchon de fermeture d'un récipient pour médicaments avec un goulot façonné fermé

Country Status (2)

Country Link
EP (1) EP1010635B2 (fr)
DE (3) DE29824812U1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006042579A1 (fr) * 2004-10-20 2006-04-27 Fresenius Kabi Deutschland Gmbh Bouchon de fermeture pour recipients remplis de liquides medicaux
ITBO20080475A1 (it) * 2008-07-30 2010-01-31 Brev Angela Srl Inserto perforabile per contenitore.
WO2013068636A1 (fr) 2011-10-28 2013-05-16 Thermo Fisher Scientific Oy Flacon à réactif, système, procédé et appareil de manipulation de bouchons de fermeture et similaires
WO2015166134A1 (fr) 2014-04-28 2015-11-05 Thermo Fisher Scientific Oy Bouchon de flacon de réactif, système, procédé et appareil pour manipuler des bouchons de fermeture et similaire
DE102016003253A1 (de) 2016-03-16 2017-09-21 Braunform Gmbh Modulierbare und adaptierbare Verschlusskappe für Behältnisse.
WO2017209250A1 (fr) * 2016-06-02 2017-12-07 大塚テクノ株式会社 Capuchon
US20180055734A1 (en) * 2015-03-27 2018-03-01 Fresenius Kabi Deutschland Gmbh Sealing cap for a container for holding a medical liquid
CN110420120A (zh) * 2019-08-13 2019-11-08 永嘉企达知识产权咨询有限公司 一种塑料药瓶

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10311154A1 (de) * 2003-03-14 2004-09-23 Helvoet Pharma Belgium N.V. Für pharmazeutische Verwendung dienende Überkappe mit Verschlussstopfen
DE102004042290A1 (de) * 2004-09-01 2006-03-02 Helvoet Pharma Belgium N.V. Medizinischer Verpackungsbehälter
DE202005015861U1 (de) * 2005-10-13 2007-02-15 Pharmaplan International Gmbh Verschlusskappe für mit medizinischen Flüssigkeiten gefüllte Behältnisse
FI118678B (fi) 2006-10-23 2008-02-15 Thermo Fisher Scientific Oy Reagenssisulku

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1325077A (fr) * 1962-03-16 1963-04-26 Bouchon, en particulier pour flacon de perfusion sanguine
DE2844206C2 (de) * 1978-10-11 1984-11-08 Matthias Faensen Kleinmetallwarenfabrikation, 5190 Stolberg Schutzkappe
DE3835720A1 (de) * 1988-10-20 1990-05-03 Wimmer Pharma Gummi Gmbh Verschluss fuer eine medikamentenflasche und verfahren zur herstellung dieses verschlusses
DE4231750C1 (de) * 1992-09-23 1994-03-10 Pohl Gmbh & Co Kg Infusionsflasche aus Kunststoff
DE4327845C2 (de) * 1993-08-19 1995-06-29 Matthias Faensen Gmbh & Co Kg Verschluß für einen Behälter
DE4425433C1 (de) * 1994-07-19 1996-02-29 Fresenius Ag Behältnis zur Aufnahme medizinischer Flüssigkeit
DE19500460A1 (de) * 1995-01-10 1996-07-11 Pohl Gmbh & Co Kg Anordnung an Infusionsflaschen oder dergleichen
DE19539897A1 (de) * 1995-09-13 1997-03-20 Pohl Gmbh Kappenverschluß für einen Behälter

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA009498B1 (ru) * 2004-10-20 2008-02-28 Фрезениус Каби Дойчланд Гмбх Колпачок для заполненных медицинскими жидкостями емкостей
JP2008516707A (ja) * 2004-10-20 2008-05-22 フレセニウス カビ ドイチュランド ゲーエムベーハー 医療液体で充填された容器の密閉蓋
US8211081B2 (en) 2004-10-20 2012-07-03 Fresenius Kabi Deutschland Gmbh Closing cap for containers filled with medical liquids
WO2006042579A1 (fr) * 2004-10-20 2006-04-27 Fresenius Kabi Deutschland Gmbh Bouchon de fermeture pour recipients remplis de liquides medicaux
ITBO20080475A1 (it) * 2008-07-30 2010-01-31 Brev Angela Srl Inserto perforabile per contenitore.
US10335792B2 (en) 2011-10-28 2019-07-02 Thermo Fisher Scientific Oy Reagent bottle cap, system, method and apparatus for handling closure caps and like
WO2013068636A1 (fr) 2011-10-28 2013-05-16 Thermo Fisher Scientific Oy Flacon à réactif, système, procédé et appareil de manipulation de bouchons de fermeture et similaires
WO2015166134A1 (fr) 2014-04-28 2015-11-05 Thermo Fisher Scientific Oy Bouchon de flacon de réactif, système, procédé et appareil pour manipuler des bouchons de fermeture et similaire
US20180055734A1 (en) * 2015-03-27 2018-03-01 Fresenius Kabi Deutschland Gmbh Sealing cap for a container for holding a medical liquid
US11351090B2 (en) * 2015-03-27 2022-06-07 Fresenius Kabi Deutschland Gmbh Sealing cap for a container for holding a medical liquid
DE102016003253A1 (de) 2016-03-16 2017-09-21 Braunform Gmbh Modulierbare und adaptierbare Verschlusskappe für Behältnisse.
WO2017209250A1 (fr) * 2016-06-02 2017-12-07 大塚テクノ株式会社 Capuchon
JPWO2017209250A1 (ja) * 2016-06-02 2019-03-28 大塚テクノ株式会社 キャップ
CN110420120A (zh) * 2019-08-13 2019-11-08 永嘉企达知识产权咨询有限公司 一种塑料药瓶
CN110420120B (zh) * 2019-08-13 2021-12-17 山东金阳光医药包装有限公司 一种塑料药瓶

Also Published As

Publication number Publication date
EP1010635A3 (fr) 2001-05-02
DE19858715B4 (de) 2004-08-12
EP1010635B2 (fr) 2007-10-24
DE59908724D1 (de) 2004-04-08
DE19858715A1 (de) 2000-06-29
EP1010635B1 (fr) 2004-03-03
DE29824812U1 (de) 2002-09-12

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