EP2847084A1 - Bouchon de fermeture - Google Patents

Bouchon de fermeture

Info

Publication number
EP2847084A1
EP2847084A1 EP13722394.7A EP13722394A EP2847084A1 EP 2847084 A1 EP2847084 A1 EP 2847084A1 EP 13722394 A EP13722394 A EP 13722394A EP 2847084 A1 EP2847084 A1 EP 2847084A1
Authority
EP
European Patent Office
Prior art keywords
cap
container
flange
plugs
region
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
EP13722394.7A
Other languages
German (de)
English (en)
Other versions
EP2847084B1 (fr
Inventor
Joachim Beine
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.)
B Braun Melsungen AG
Original Assignee
B Braun Melsungen AG
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 B Braun Melsungen AG filed Critical B Braun Melsungen AG
Priority to EP13722394.7A priority Critical patent/EP2847084B1/fr
Publication of EP2847084A1 publication Critical patent/EP2847084A1/fr
Application granted granted Critical
Publication of EP2847084B1 publication Critical patent/EP2847084B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • B65D41/00—Caps, e.g. crown caps or crown seals, i.e. members having parts arranged for engagement with the external periphery of a neck or wall defining a pouring opening or discharge aperture; Protective cap-like covers for closure members, e.g. decorative covers of metal foil or paper
    • B65D41/02—Caps or cap-like covers without lines of weakness, tearing strips, tags, or like opening or removal devices
    • B65D41/28—Caps combined with stoppers
    • 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
    • A61J1/1475—Inlet or outlet ports
    • A61J1/1487—Inlet or outlet ports with friction fit, e.g. connecting tubes directly to a protruding port
    • 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
    • B65D39/00—Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B65D39/04—Cup-shaped plugs or like hollow flanged members
    • 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
    • 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
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
    • F04C2270/00—Control; Monitoring or safety arrangements
    • F04C2270/04—Force
    • F04C2270/042—Force radial
    • F04C2270/0421—Controlled or regulated

Definitions

  • the invention relates to a cap with a flange for connection to a flange of an infusion solution container, wherein the cap has at least one integrated stopper for the removal or introduction of liquids from or into the container and for resealing after the removal or the introduction of liquid.
  • a freeze-drying plug made of rubber-elastic material, consisting of a pin and an associated one-piece, circle-shaped flange.
  • the pin includes a cavity surrounding the pin longitudinal axis which is open to the free pin end face and extends to a central closed wall portion of the flange.
  • a first portion of the pin located between a first transverse plane defined by the lower boundary surface of the flange and a second plane has a closed outer peripheral surface having a maximum diameter.
  • a subsequent second section includes a passage communicating with the cavity, as well as a plurality of protruding barriers.
  • DE 10 2008 060 457 A1 describes a production method for a closure.
  • a method for producing a closure (1) for a sterile medicament container it is provided that in an inelastic closure body (2) having at least one puncture opening (11), an elastic sealing element (3) is used, which at least one Closing opening (11) sealing.
  • the sealing element (3) is materially connected to the closure body (2), in which on the sealing element (3) and the closure body (2) mating areas (12,13) are melted prior to insertion, wherein the fused areas (12, 13) upon insertion of the sealing element (3) are brought into contact with each other, cool and connect.
  • DE-PS 25 04 253 describes a container for storing and dispensing sterile solutions.
  • this container comprises a tightly closed inlet device with a laterally projecting at the end of a neck integrally formed with the neck wall, the opening of the neck before enclosing flange, wherein further in a space enclosed by a side wall of the inlet device space at least one passage is arranged and the Side wall at one end surrounding lateral projecting flange covers the flange provided on the neck and is tightly connected thereto.
  • EP 1 211 184 A1 describes a closure cap with a disk-shaped flange suitable for connection to a disc-shaped flange of an infusion solution container, the cap having at least one integrated plug suitable for the removal and introduction of liquid from or into the Container and for resealing after removal or introduction of liquid.
  • the directed towards the bottle mouth body has a displacer, wherein the liquid of the infusion solution container is directly connected to the plug 1 in combination.
  • the cap is clipped with the infusion solution container.
  • the removal or introduction of the liquid from or into the container thus takes place in the region outside the displacement body.
  • an annular seal in a groove of the lateral surface of the displacement body which here fulfills the sealing function, is described without reference number. Thus, the body can not dive into the bottle mouth of the infusion solution container without effort.
  • a sealing plug 3 which extends into the open end of the tube with a cylindrical sealing section and seals the tube there with respect to the inner wall 13, is inserted in perfect register with the closure of the tube 2 so that the cylindrical sealing section 9 does not undersize the bottle mouth. but rather has an excess of the bottle mouth, so that it can not dip into this without effort.
  • the problem with the closure caps described in the prior art is the permanent connection of these with the bottle mouth of the infusion solution container.
  • the state of the art makes its own to press the plug into the mouth of the bottle, as is customary, for example, in the closure of sparkling wine corks.
  • the flange of the Sparkling wine cork limits the immersion depth of the cork into the bottle. In this case, however, a removal or introduction of liquid from or into the container or a re-seal after the removal or the introduction of liquid into the container is not possible without completely removing the cork.
  • the object of the present invention is further to reduce the dead volume in the area of the bottle mouth of an infusion solution container.
  • the present invention is in particular a closure or access cap 1 for removing solutions, in particular outside of rigid container systems.
  • the cap 1 is placed on the rim or flange provided on the container and connected here cohesively or non-positively with the infusion solution container.
  • the construction of the cap 1 according to the invention is particularly tailored to open containers, generally made by extrusion blown (EBM) or injection stretch blown (ISBM).
  • EBM extrusion blown
  • ISBM injection stretch blown
  • the geometry of the flanges corresponds to the degree of ovality of the Flanschkorpuses and can be carried out accordingly circular or elliptical.
  • the entire system consists structurally of the actual cap body 1 with the connecting flange 2, the inserted plug 3 for injecting or removing solutions with re-sealing, their designed as receiving areas for infusion solution channels 5a, 5b and in particular a sealing film 8 with originality.
  • the latter can, depending on the design, in principle be sealed over the whole area on the cap 1 or only partially in the region of the stopper 3.
  • a separating membrane is preferably injected radially inwards. This can be integrally connected to the cap body 1 depending on the design or consist of two parts, which are connected to one another in a material-locking manner, for example, in a separate joining process.
  • connection of the plug 3 with the cap body 1 can be done in principle by joining, for example, laser welding, Verbörderln the receiving cups or clamps with holding a separate part.
  • the sealing of the cover sheet 10 takes place - as the name implies - via a sealing process, which represents the appropriate technology for films of this type. It thus corresponds to commercially available caps 1, depending on the type of components used.
  • the container systems for infusion solutions available on the market contain a greater or lesser amount of air above the solution level. This allows for a uniform flow or withdrawal rate, depending on the flexibility of the container, and also controls the residual volume remaining in the container after infusion.
  • the so-called headspace but also the penetration depth of the infusion spike or that is located around the spike, not responsible for the spike opening volumes. This is where the essence of the present invention begins.
  • the plug 3 or the septum is laid inwards into the bottle mouth.
  • the open mouth region, in particular ISBM-produced container allows such a construction.
  • the cap body 1 which points into the mouth area of the bottle fills the bottleneck volume almost completely and drastically reduces the residual volume in the container after removal. Because the cap body 1 located in the mouth region bridges the liquid volume not detected by the spike, the residual volume can be drastically reduced to values of, for example, less than 2 ml.
  • channels 5a, 5b are made possible in particular by communicating channels 5a, 5b between the two puncture openings and further channels which extend in the direction of the circumference of the body of the cap 1.
  • the channels 5a, 5b become tubes to be communicated and thereby allow, also the emptying of the unused puncture site, in the event that more than one stopper is provided.
  • the cap 1 according to the invention is suitable with a particular circular disc-shaped flange 2 for connection to a likewise in particular circular disc-shaped flange 2 of an infusion solution container.
  • the connection of the two flanges 2 can be done either by external heat input, such as infrared welding or internal heat generation by ultrasound, vertical or oscillating. In addition to welding, gluing, pressing or clipping is also possible.
  • An encapsulation of the components is also a way the Closure cap 1 according to the invention to be connected to the infusion solution container.
  • the cap 1 or displacer 4 it is important for the purposes of the present invention that it has an undersize or is conical, but does not seal the bottleneck. While an interference fit is produced in the prior art, according to the invention a gap remains between the displacement body 4 and the neck of the bottle which fills with liquid in use and also forms an optionally colored capillary gap depending on the coloring of the liquid. Undersize in the sense of the present invention means that the displacement body 4 can slide without force, similar to a piston in a cylinder of an internal combustion engine, here the neck of the bottle.
  • the plugs 3 may be formed as a septum, which are microbiologically sealingly connected to the cap 1 according to known methods.
  • the closure cap 1 according to the invention can also have further webs 9 in the region of the disk-shaped flange 2. These extend over a planar annular boundary surface of the flange 2 in a length which allows a positive, cohesive or non-positive connection of this flange 2 with a flange 2 of the infusion solution container.
  • the preferably annular bearing surface of the Flange 2 has a larger radius than the also annular boundary surface, which is covered by the grooves 7.
  • additional injection volumes can be added for the injection region in addition to the container solution with a conventional hypodermic needle.
  • the withdrawal port may be pierced with a commercial spike for administration of the solution as in the prior art.
  • the removal of the solution can also be done via a needle-free access, which eliminates the use of a needle.
  • FIG. 1 shows a closure cap 1 according to the invention with a circular disc-shaped flange 2, which is reproduced for connection to a likewise circular disc-shaped flange 2 of an infusion solution container (not shown).
  • the cap 1 herein comprises two integral plugs 3a, 3b for withdrawing or introducing liquid from or into the container, and for resealing after removal or introduction of liquid. According to the invention, however, it is not absolutely necessary for two plugs 3a, 3b to be integrated in the cap 1.
  • an essential embodiment of the present invention is to integrate only one plug 3a in the cap 1 according to the invention.
  • the plugs 3a, 3b are preferably made of elastic material, in particular of a thermoplastic material, and connected in a conventional manner to the body microbiologically sealing.
  • the cap 1 also has a body 4 directed inwards, in the direction of the bottle mouth, which is designed in the form of a displacement body 4. With the help of this displacement body 4, the dead volume of the container is reduced overall. Contrary to the prior art, the displacer 4 (not shown) with respect to the bottle mouth preferably an undersize, so that this displacer 4 can dive without effort in this bottle mouth.
  • the Fig. 1 also shows the sealing film 10, which covers the two plugs 3a, 3b here. Further recognizable are the channels 5a, 5b, with the communicating passages / cuts 6a, 6b, 6c, 6d. These allow the fluid exchange between the channels 5a, 5b, especially if they extend only over part of the length of the body 4.
  • the passages / cuts of the channels are shown in FIG. 2 again clearly highlighted.
  • the communicating channels 5a, 5b thus allow the residual volume from the injection area to flow into the removal area for removal there.
  • 4 passages / cuts 7a, 7b, 7c, 7d are present in the outer periphery of the displacement body, allow the complete flushing all areas of the bottle mouth.
  • the passages 6a, 6b, 6c, 6d, 7a, 7b, 7c, 7d allow the insertion of the plug 1 into the neck of the bottle, in particular if the body 4 is not made undersized with respect to the neck of the bottle.
  • the radial surface of the displacement body 4 of the closure cap 1 in the region of the bottle mouth has webs 6 which extend from the flange 2 in the direction of the infusion solution container. These webs 6 allow complete flushing of this area between the cap 1 and the bottle mouth of the infusion solution container, which is extremely important for a later sterilization. This guarantee of sterilization of this area can also be promoted, inter alia, that also has a planar annular boundary surface of the flange 2 also webs 7, which allows complete flushing of the flange of the bottle neck in this area. In this way it can be ensured that even after the connection of the cap 1 with the infusion solution container, all areas in contact with the liquid can be sterilized.
  • the present invention further comprises a corresponding infusion solution container with the above-defined cap 1, which are welded together, glued, pressed or clipped together.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)

Abstract

L'invention porte sur un bouchon de fermeture (1) comportant une bride permettant un raccord à une bride (2) d'un contenant de solution d'infusion. Le bouchon (1) comporte au moins un dispositif d'obturation intégré (3a,3b) permettant de retirer des liquides du contenant ou d'introduire des liquides dans le contenant, ainsi que de réaliser à nouveau l'étanchéité après ledit vidage ou ledit remplissage.
EP13722394.7A 2012-05-09 2013-05-08 Capuchon de fermeture Not-in-force EP2847084B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP13722394.7A EP2847084B1 (fr) 2012-05-09 2013-05-08 Capuchon de fermeture

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP20120167271 EP2662303A1 (fr) 2012-05-09 2012-05-09 Capuchon de fermeture
EP13722394.7A EP2847084B1 (fr) 2012-05-09 2013-05-08 Capuchon de fermeture
PCT/EP2013/059621 WO2013167672A1 (fr) 2012-05-09 2013-05-08 Bouchon de fermeture

Publications (2)

Publication Number Publication Date
EP2847084A1 true EP2847084A1 (fr) 2015-03-18
EP2847084B1 EP2847084B1 (fr) 2017-07-12

Family

ID=48430753

Family Applications (2)

Application Number Title Priority Date Filing Date
EP20120167271 Withdrawn EP2662303A1 (fr) 2012-05-09 2012-05-09 Capuchon de fermeture
EP13722394.7A Not-in-force EP2847084B1 (fr) 2012-05-09 2013-05-08 Capuchon de fermeture

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP20120167271 Withdrawn EP2662303A1 (fr) 2012-05-09 2012-05-09 Capuchon de fermeture

Country Status (4)

Country Link
US (1) US9731872B2 (fr)
EP (2) EP2662303A1 (fr)
CN (1) CN104379463B (fr)
WO (1) WO2013167672A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWD190916S (zh) 2016-10-10 2018-06-11 Ｂ 布朗梅爾松根股份公司 用於藥物容器的蓋子系統
CN112618359B (zh) * 2020-11-25 2022-06-07 安徽华能医用橡胶制品股份有限公司 一种输液用胶塞
EP4082599A1 (fr) * 2021-04-30 2022-11-02 B. Braun Melsungen AG Capuchon de conteneur de fluide, conteneur de fluide comprenant un tel capuchon et procédé de fabrication d'un tel capuchon
CN115107285B (zh) * 2022-06-16 2024-04-02 乾德生物医疗技术(重庆)有限公司 血液净化装置的制造方法

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US1871907A (en) * 1931-04-30 1932-08-16 Crown Cork & Seal Co Metal cap for closing paper containers
US2649090A (en) * 1950-09-29 1953-08-18 American Cyanamid Co Rubber closure for pharmaceutical vials
US3059798A (en) * 1960-02-25 1962-10-23 King Seeley Thermos Co Stopper for vacuum bottle assembly or the like
BE794248A (fr) * 1972-02-22 1973-05-16 Baxter Laboratories Inc Perfectionnements apportes aux fermetures steriles pour bouteilles ou flacons a solution
US3905368A (en) 1974-02-15 1975-09-16 Cutter Lab Pierceable access port assembly
DE3310265A1 (de) * 1983-03-22 1984-09-27 Gerhard 7166 Sulzbach-Laufen Hansen Aufreissverschluss fuer einen behaelter
DE3744174A1 (de) 1987-12-24 1989-07-06 Helvoet Pharma Gefriertrocknungs-stopfen
US5320237A (en) * 1992-07-13 1994-06-14 Stolzman Michael L Sealed closure for drum
US5385253A (en) * 1992-09-02 1995-01-31 Baxter International Inc. Port closure
DE4428434A1 (de) * 1994-08-11 1996-02-15 Boehringer Ingelheim Kg Verschlußkappe und Verfahren zur gasblasenfreien Füllung von Behältern
DE19500460A1 (de) * 1995-01-10 1996-07-11 Pohl Gmbh & Co Kg Anordnung an Infusionsflaschen oder dergleichen
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JP3852672B2 (ja) 1999-04-20 2006-12-06 株式会社ジェイ・エム・エス 容器用キャップ及び液体連通用アダプタ
US6716396B1 (en) * 1999-05-14 2004-04-06 Gen-Probe Incorporated Penetrable cap
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US8303914B2 (en) * 2003-01-06 2012-11-06 Becton, Dickinson And Company Tube closure with removable septum for direct instrument access
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CL2007002373A1 (es) * 2006-08-17 2008-01-11 Zork Pty Ltd Un cierre de botella para botellas que contienen liquidos a alta presion,con el cierre teniendo una primera parte y una segunda parte,donde la primera parte tiene una porcion adaptada para recibir una porcion de una seccion superior de un cuello de botella,y una segunda parte que encaja sobre la primera parte.
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DE102008060457A1 (de) 2008-12-09 2010-06-10 West Pharmaceutical Services Deutschland Gmbh & Co. Kg Herstellungsverfahren für einen Verschluss
DE102008060864A1 (de) * 2008-12-09 2010-06-10 Fresenius Kabi Deutschland Gmbh Verschlusskappe für Behältnisse zur Aufnahme von medizinischen Flüssigkeiten und Behältnis zur Aufnahme von medizinischen Flüssigkeiten
EP2759284A1 (fr) * 2013-01-28 2014-07-30 B. Braun Melsungen AG Capuchon destiné à un contenant pharmaceutique

Also Published As

Publication number Publication date
US9731872B2 (en) 2017-08-15
EP2662303A1 (fr) 2013-11-13
CN104379463A (zh) 2015-02-25
EP2847084B1 (fr) 2017-07-12
US20150069008A1 (en) 2015-03-12
CN104379463B (zh) 2016-10-05
WO2013167672A1 (fr) 2013-11-14

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