EP2847084B1 - Closure cap - Google Patents

Closure cap Download PDF

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Publication number
EP2847084B1
EP2847084B1 EP13722394.7A EP13722394A EP2847084B1 EP 2847084 B1 EP2847084 B1 EP 2847084B1 EP 13722394 A EP13722394 A EP 13722394A EP 2847084 B1 EP2847084 B1 EP 2847084B1
Authority
EP
European Patent Office
Prior art keywords
cap
closure cap
container
stoppers
infusion solution
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.)
Not-in-force
Application number
EP13722394.7A
Other languages
German (de)
French (fr)
Other versions
EP2847084A1 (en
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
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B Braun Melsungen AG
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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/en
Publication of EP2847084A1 publication Critical patent/EP2847084A1/en
Application granted granted Critical
Publication of EP2847084B1 publication Critical patent/EP2847084B1/en
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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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 stopper made of rubber-elastic material, consisting of a pin and an associated one-piece circular-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 method of manufacturing 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 Fig.15, describes a cap with a disc-shaped flange according to the preamble of claim 1.
  • DE 103 40 538 A1 describes a sample container for holding liquids for medical analysis.
  • 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 object is achieved by a closure cap and an associated infusion solution container according to claim 1.
  • the present invention is in particular a closure or access cap 1 for the removal of 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 withdrawing solutions with resealing, their designed as receiving areas for infusion solution channels 5a, 5b and in particular a sealing film 10 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, 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 grooves.
  • 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.
  • a cap according to the invention 1 is shown with a circular disc-shaped flange 2, which (not shown) for connection to a likewise circular disc-shaped flange 2 of an infusion solution container.
  • 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.
  • 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 according to the invention 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.
  • a displacement body 4 With the help of this displacement body 4, the dead volume of the container is reduced overall.
  • the displacement body 4 opposite the bottle mouth (not shown) on an undersize, so that this displacement body 4 can dive without effort in this bottle mouth.
  • 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 in the Fig. 2 once 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.
  • passages / cuts 7 a, 7 b, 7 c, 7 d are present, which allow a complete flushing all areas of the bottle mouth.
  • Fig. 3 In the Fig. 3 is shown that the radial surface of the displacement body 4 of the closure cap 1 in the region of the bottle mouth webs 8, which extend from the flange 2 in the direction of the infusion solution container.
  • These webs 8 allow a 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 9, 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.

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  • 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)

Description

Gegenstand der Erfindung ist eine Verschlusskappe mit einem Flansch zur Verbindung mit einem Flansch eines Infusionslösungsbehälters, wobei die Kappe wenigstens einen integrierten Stopfen zur Entnahme oder zur Einbringung von Flüssigkeiten aus dem oder in den Behälter und zur Wiederabdichtung nach der Entnahme oder der Einbringung von Flüssigkeit aufweist.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.

DE 37 44 174 A1 beschreibt einen Gefriertrocknungs-Stopfen aus gummielastischem Material, bestehend aus einem Zapfen und einem damit verbundenen einstückigen, kreisschreibenförmigen Flansch. Der Zapfen enthält einen die Zapfen-Längsachse umgebenden Hohlraum, der zur freien Zapfenstirnseite offen ist und sich bis zu einem zentralen geschlossenen Wandungsteil des Flansches erstreckt. Ein erster Abschnitt des Zapfens, der zwischen einer durch die untere Begrenzungsfläche des Flansches gelegten ersten Querebene und einer zweiten Ebene gelegen ist, weist eine geschlossene äußere Umfangsfläche mit einem maximalen Durchmesser auf. Ein anschließender zweiter Abschnitt enthält einen mit dem Hohlraum kommunizierenden Durchlass, sowie mehrere vorstehende Hemmelemente. Die den Hohlraum seitlich begrenzende, mit zunehmender Annäherung an die freie Zapfen-Stirnseite ihren Durchmesser vergrößernde Innen-Randfläche liegt vollständig außerhalb eines Kegels, dessen Achse die Zapfen-Längsachse ist, dessen Spitze in der Querebene liegt und dessen Spitzenwinkel in Altgrad größer als ein nach einer speziellen Formel berechneter Wert ist. Hierdurch soll ein besonders gebrauchstüchtiger Stopfen erhalten werden, der den Einstich der Entnahmekanüle nicht hindert. In der Beschreibungseinleitung wird festgehalten, dass es bei Stopfen des Standes der Technik nachteilig ist, dass ein beachtliches Restvolumen von mit der Kanüle nicht entnehmbarer Lösung bzw. Suspension im Behälter verbleibt. Kern der technischen Lehre dieser Patentanmeldung ist somit die Ausbildung eines möglichst geringen Hohlraumes, wobei der Stopfen mit seiner geschlossenen äußeren Umfangsfläche fest in die Flaschenmündung eingepresst ist. DE 37 44 174 A1 describes a freeze-drying stopper made of rubber-elastic material, consisting of a pin and an associated one-piece circular-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. The cavity laterally limiting, with increasing proximity to the free pin end face its diameter-increasing inner edge surface is completely outside a cone whose axis is the pin longitudinal axis, the apex lies in the transverse plane and the apex angle in old degree greater than one after value calculated using a special formula. As a result, a particularly useful plug is to get the puncture the withdrawal cannula does not hinder. It is stated in the introduction to the description that it is disadvantageous in the case of stoppers of the prior art that a considerable residual volume of solution or suspension which can not be withdrawn with the cannula remains in the container. The core of the technical teaching of this patent application is thus the formation of the smallest possible cavity, wherein the plug with its closed outer peripheral surface is firmly pressed into the bottle mouth.

DE 10 2008 060 457 A1 beschreibt ein Herstellungsverfahren für einen Verschluss. Bei einem Verfahren zur Herstellung eines Verschlusses (1) für ein steriles Medikamentenbehältnis ist vorgesehen, dass in einen nicht-elastischen Verschlusskörper (2), der wenigstens eine Durchstichöffnung (11) aufweist, ein elastisches Dichtelement (3) eingesetzt wird, welches diese wenigstens eine Durchstichöffnung (11) dichtend verschließt. Das Dichtelement (3) wird mit dem Verschlusskörper (2) stoffschlüssig verbunden, in dem an dem Dichtelement (3) und dem Verschlusskörper (2) zueinander passende Bereiche (12,13) vor dem Einsetzen angeschmolzen werden, wobei die angeschmolzenen Bereiche (12, 13) bei Einsetzen des Dichtelements (3) miteinander in Kontakt gebracht werden, abkühlen und sich verbinden. DE 10 2008 060 457 A1 describes a method of manufacturing a closure. In 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 beschreibt einen Behälter zum Aufbewahren und Ausgeben steriler Lösungen. Insbesondere umfasst dieser Behälter eine dicht zu verschließende Einlassvorrichtung mit einem am Ende eines Halses seitlich abstehend einstückig mit der Halswand ausgebildeten, die Öffnung des Halses vorständig umschließenden Flanschs, wobei weiterhin in einem von einer Seitenwand der Einlassvorrichtung umschlossenen Raum wenigstens ein Durchlass angeordnet ist und ein die Seitenwand an deren einem Ende umgebender seitlicher abstehender Flansch den am Hals vorgesehenen Flansch überdeckt und mit diesem dicht verbunden ist. DE-PS 25 04 253 describes a container for storing and dispensing sterile solutions. In particular, 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 , Fig.15, beschreibt eine Verschlusskappe mit einem scheibenförmigen Flansch gemäß dem Oberbegriff des Anspruchs 1. DE 103 40 538 A1 beschreibt einen Probenbehälter zur Aufnahme von Flüssigkeiten für medizinische Analysen. Ein Verschlussstopfen 3, welcher sich mit einem zylindrischen Dichtabschnitt in das offene Ende des Röhrchens hinein erstreckt und dort gegenüber der Innenwandung 13 das Röhrchen abdichtet, wird passformgenau zum Verschluss des Röhrchens 2 eingesetzt, so dass damit der zylindrische Dichtabschnitt 9 kein Untermaß gegenüber der Flaschenmündung, sondern eher ein Übermaß gegenüber der Flaschenmündung aufweist, so dass dieser nicht ohne Kraftaufwand in diese eintauchen kann. EP 1 211 184 A1 , Fig.15, describes a cap with a disc-shaped flange according to the preamble of claim 1. DE 103 40 538 A1 describes a sample container for holding liquids for medical analysis. 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.

Problematisch bei den im Stand der Technik beschriebenen Verschlusskappen ist die dauerhafte Verbindung dieser mit der Flaschenmündung des Infusionslösungsbehälters. Hier macht sich der Stand der Technik zu eigen, den Stopfen in die Flaschenmündung hineinzupressen, wie dies beispielsweise beim Verschluss von Schaumweinkorken üblich ist. Der Flansch des Schaumweinkorkens begrenzt dabei die Eintauchtiefe des Korkens in die Flasche. Hierbei ist jedoch eine Entnahme oder Einbringung von Flüssigkeit aus den oder in den Behälter oder auch eine Wiederabdichtung nach der Entnahme oder der Einbringung von Flüssigkeit in den Behälter nicht möglich, ohne den Korken vollständig zu entfernen.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. Here, 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.

Die Aufgabe der vorliegenden Erfindung besteht weiter darin, das Totvolumen im Bereich der Flaschenmündung eines Infusionslösungsbehälters zu reduzieren.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.

Die vorliegende Aufgabe wird gelöst durch eine Verschlusskappe und einen damit verbundenen Infusionlösungsbehälter gemäß Anspruch 1. Bei der vorliegenden Erfindung handelt es sich insbesondere um eine Verschluss- oder Zugangskappe 1 zur Entnahme von Lösungen, insbesondere außerhalb starrer Behältersystemen. Die Kappe 1 wird auf den am Behälter vorgesehenen Rand oder Flansch aufgesetzt und hier stoffschlüssig oder kraftschlüssig mit dem Infusionslösungsbehälter verbunden. Die Konstruktion der erfindungsgemäßen Kappe 1 ist insbesondere auf offene Behälter zugeschnitten, die im Allgemeinen im Extrusionsblasverfahren (EBM) oder Spritz-Streckblasverfahren (ISBM) hergestellt werden. Vorzugsweise entspricht die Geometrie der Flansche dem Ovalitätsgrad des Flanschkorpuses und kann dementsprechend kreisrund oder elliptisch ausgeführt sein.The present object is achieved by a closure cap and an associated infusion solution container according to claim 1. The present invention is in particular a closure or access cap 1 for the removal of 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). Preferably, the geometry of the flanges corresponds to the degree of ovality of the Flanschkorpuses and can be carried out accordingly circular or elliptical.

Das Gesamtsystem besteht konstruktiv aus dem eigentlichen Kappenkörper 1 mit dem Verbindungsflansch 2, den eingelegten Stopfen 3 zum Zuspritzen oder Entnehmen von Lösungen mit Wiederabdichtung, deren als Aufnahmebereiche für Infusionslösung ausgeführten Kanäle 5a, 5b sowie insbesondere einer Siegelfolie 10 mit Originalitätsnachweis. Letztere kann abhängig von der Bauart prinzipiell ganzflächig auf die Kappe 1 aufgesiegelt werden oder auch nur partiell im Bereich der Stopfen 3.The entire system consists structurally of the actual cap body 1 with the connecting flange 2, the inserted plug 3 for injecting or withdrawing solutions with resealing, their designed as receiving areas for infusion solution channels 5a, 5b and in particular a sealing film 10 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.

Um der erfinderischen Kappe 1 Verdrängungseigenschaften für das Flaschenhalsvolumen zu geben, ist vorzugsweise innen radial eine Trennmembran angespritzt. Diese kann abhängig von der Ausführung einteilig mit dem Kappenkörper 1 verbunden sein oder aus zwei Teilen bestehen, die beispielsweise in einem separaten Fügeprozess stoffschlüssig miteinander verbunden werden.In order to give the inventive cap 1 displacement characteristics for the bottleneck volume, 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.

Die Verbindung der Stopfen 3 mit dem Kappenkörper 1 kann prinzipiell durch Fügen, beispielsweise Laserschweißen, Verbörderln der Aufnahmenäpfe oder Klemmen mit Gegenhalten eines separaten Teils erfolgen. Das Aufsiegeln der Deckfolie 10 erfolgt - wie der Name schon sagt - über einen Siegelprozess, der für Folien dieser Art die geeignete Technologie darstellt. Sie entspricht damit von der Art der verwendeten Komponenten her handelsüblichen Kappen 1.The 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.

Die am Markt befindlichen Behältersysteme für Infusionslösungen enthalten eine mehr oder weniger große Menge an Luft oberhalb des Lösungsspiegels. Diese ermöglicht abhängig von der Flexibilität des Behälters eine gleichmäßige Fluss- oder Entnahmerate und reguliert auch das nach der Infusion im Behälter verbleibende Restvolumen. Neben dem erwähnter Behälterluftvolumen, dem sogenannten Headspace, ist aber auch die Eindringtiefe des Infusionsspikes bzw. das um den Spike herum befindliche, nicht der Spikeöffnung erfassbare Volumen verantwortlich. Hier setzt der Kern der vorliegenden Erfindung an.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. In addition to the mentioned container air volume, 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.

Während die üblichen, am Markt befindlichen Kappensysteme für halbstarre Infusionslösungsbehälter einen nach außen gestellten Entnahmebereich aufweisen, der in seiner Gestaltung auf die Dimensionen der Kopfmembran der BFS-Container zugeschnitten ist, wird erfindungsgemäß der Stopfen 3, beziehungsweise das Septum nach innen in die Flaschenmündung verlegt. Der offene Mündungsbereich, insbesondere ISBM-hergestellte Behälter erlaubt eine derartige Bauweise. Der in den Mündungsbereich der Flasche zeigende Kappenkörper 1 füllt das Flaschenhalsvolumen nahezu vollständig aus und reduziert das Restvolumen im Behälter nach der Entnahme drastisch. Dadurch, dass der im Mündungsbereich liegende Kappenkörper 1 das vom Spike nicht erfasste Flüssigkeitsvolumen überbrückt, kann das Restvolumen drastisch auf Werte von beispielsweise unterhalb 2 ml verringert werden.While the usual capsule systems on the market for semi-rigid infusion solution containers have an outward removal region whose design is tailored to the dimensions of the head membrane of the BFS containers, according to the invention 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.

Diese geringen Totvolumina werden insbesondere durch kommunizierende Kanäle 5a, 5b zwischen den beiden Einstichöffnungen sowie weiteren Kanälen ermöglicht, die sich in Richtung des Umfangs des Korpus der Kappe 1 erstrecken. Somit werden die Kanäle 5a, 5b zu kommunizierenden Röhren und erlauben dadurch, auch das Leerlaufen der jeweils nicht benutzten Einstichstelle, für den Fall, dass mehr als ein Stopfen vorgesehen ist.These small dead volumes 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. Thus, 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.

Die erfindungsgemäße Verschlusskappe 1 ist mit einem insbesondere kreisscheibenförmigen Flansch 2 zur Verbindung mit einem ebenfalls insbesondere kreisscheibenförmigen Flansch 2 eines Infusionslösungsbehälters geeignet. Die Verbindung der beiden Flansche 2 kann entweder über externen Wärmeeintrag, beispielsweise Infrarotschweißen oder interne Wärmeerzeugung per Ultraschall, vertikal oder oszillierend erfolgen. Auch ist neben dem Verschweißen das Verkleben, Verpressen oder Verklipsen möglich. Eine Umspritzung der Komponenten ist ebenfalls eine Möglichkeit die erfindungsgemäße Verschlusskappe 1 mit dem Infusionslösungsbehälter zu verbinden.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.

In Bezug auf die dimensionale Ausführung des Kappen- 1 oder Verdrängerkörpers 4 ist es im Sinne der vorliegenden Erfindung von Bedeutung, dass dieser ein Untermaß aufweist, jedoch nicht abdichtend zum Flaschenhals erfolgt. Während im Stand der Technik ein Presssitz erzeugt wird, bleibt erfindungsgemäß zwischen dem Verdrängungskörper 4 und dem Flaschenhals ein Spalt, der sich bei Gebrauch mit Flüssigkeit füllt und abhängig von der Einfärbung der Flüssigkeit auch einen gegebenenfalls farbigen Kapillarspalt bildet. Untermaß im Sinne der vorliegenden Erfindung bedeutet, dass der Verdrängungskörper 4 ähnlich einem Kolben in einem Zylinder eines Verbrennungsmotors, hier des Flaschenhalses, ohne Kraftaufwand gleiten kann.With regard to the dimensional design of the cap 1 or displacer 4, it is important for the purposes of the present invention that it has an undersize, 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.

Am Verdrängerkörper 4 angebrachte Stege 8 im Bereich und entlang der zylindrischen Mantelfläche erlauben gezielt den Zugang der Flüssigkeit in diesen Bereich. Diese zunächst nachteilig erscheinende Eigenschaft der nicht abdichtenden Gestaltung macht die Validierung des Sterilisationsprozesses aber deutlich einfacher, da der Ringspalt den Zutritt der Behälterflüssigkeit in alle Bereiche des Flaschenhalses erlaubt und so als Indikator für eine erfolgte Autoklavierung auch eine Sterilisierung der Flaschenmündung erlaubt.On the displacer 4 mounted webs 8 in the area and along the cylindrical surface allow targeted access of the liquid in this area. However, this initially disadvantageous property of the non-sealing design makes the validation of the sterilization process significantly easier, since the annular gap allows the container liquid to enter all areas of the bottle neck and thus also sterilizes the bottle mouth as an indicator for a completed autoclaving.

Wie im Stand der Technik üblich, können die Stopfen 3 als Septum ausgebildet sein, die nach an sich bekannten Verfahren mikrobiologisch abdichtend mit der Kappe 1 verbunden sind. Neben den Stegen 8 des Verdrängerkörpers 4 kann die erfindungsgemäße Verschlusskappe 1 auch weitere Stege 9 im Bereich des scheibenförmigen Flanschs 2 aufweisen. Diese erstrecken sich über eine plane ringförmige Begrenzungsfläche des Flansches 2 in einer Länge, die eine formschlüssige, stoffschlüssige oder kraftschlüssige Verbindung dieses Flansches 2 mit einem Flansch 2 des Infusionslösungsbehälters ermöglicht. Dementsprechend weist die vorzugsweise kreisringförmige Auflagefläche des Flansches 2 einen größeren Radius auf, als die ebenfalls kreisringförmige Begrenzungsfläche, die durch Rillen umfasst ist.As is usual in the prior art, the plugs 3 may be formed as a septum, which are microbiologically sealingly connected to the cap 1 according to known methods. In addition to the webs 8 of the displacer 4, 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. Accordingly, the preferably annular bearing surface of the Flange 2 has a larger radius than the also annular boundary surface, which is covered by grooves.

Durch die, sich im Bereich der Kappe 1 befindlichen Stopfen 3 kann für den Zuspritzbereich zusätzlich zur Behälterlösung mit einer üblichen hypodermischen Nadel auch weiteres Zuspritzvolumina zugegeben werden. Der Entnahmeport kann zur Verabreichung der Lösung, wie im Stand der Technik auch, mit einem handelsüblichen Spike durchstochen werden. Je nach Anwendungsfall und Bauform kann die Entnahme der Lösung auch über einen Needle-free-Zugang erfolgen, was die Benutzung einer Nadel eliminiert.By means of the plug 3 located in the region of the cap 1, 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. Depending on the application and design, the removal of the solution can also be done via a needle-free access, which eliminates the use of a needle.

In der Fig. 1 wird eine erfindungsgemäße Verschlusskappe 1 mit einem kreisscheibenförmigen Flansch 2 dargestellt, der zur Verbindung mit einem ebenfalls kreisscheibenförmigen Flansch 2 eines Infusionslösungsbehälters (nicht dargestellt) wiedergegeben. Die Kappe 1 umfasst hier zwei integrierte Stopfen 3a, 3b zur Entnahme oder zur Einbringung von Flüssigkeit aus dem oder in den Behälter, und zur Wiederabdichtung nach der Entnahme oder der Einbringung von Flüssigkeit. Die Stopfen 3a, 3b werden vorzugsweise aus elastischem Material, insbesondere aus einem thermoplastischen Material hergestellt, und in an sich bekannter Weise mit dem Korpus mikrobiologisch abdichtend verbunden.In the Fig. 1 a cap according to the invention 1 is shown with a circular disc-shaped flange 2, which (not shown) for connection to a likewise circular disc-shaped flange 2 of an infusion solution container. 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. 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.

Die erfindungsgemäße Kappe 1 weist weiterhin einen nach innen, in Richtung der Flaschenmündung gerichteten Korpus 4 auf, der in Form eines Verdrängerkörpers 4 ausgebildet ist. Mit Hilfe dieses Verdrängerkörpers 4 wird das Totvolumen des Behälters insgesamt reduziert. Entgegen dem Stand der Technik weist der Verdrängerkörper 4 gegenüber der Flaschenmündung (nicht dargestellt) ein Untermaß auf, so dass dieser Verdrängerkörper 4 ohne Kraftaufwand in diese Flaschenmündung eintauchen kann.The cap 1 according to the invention 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 displacement body 4 opposite the bottle mouth (not shown) on an undersize, so that this displacement body 4 can dive without effort in this bottle mouth.

In der Fig. 1 weiterhin dargestellt ist die Siegelfolie 10, die hier die beiden Stopfen 3a, 3b überdeckt. Weiterhin erkennbar sind die Kanäle 5a, 5b, mit den kommunizierenden Durchlässe/Einschnitte 6a, 6b, 6c, 6d. Diese erlauben den Flüssigkeitsaustausch zwischen den Kanälen 5a, 5b, insbesondere wenn diese sich nur über einen Teil der Länge des Korpus 4 erstecken.In the Fig. 1 Also shown is 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.

Die Durchlässe/Einschnitte der Kanäle werden in der Fig. 2 noch einmal deutlich hervorgehoben. Die kommunizierenden Kanäle 5a, 5b erlauben somit, das Restvolumen aus dem Zuspritzbereich in den Entnahmebereich zur dortigen Entnahme abfließen zu lassen. Darüber hinaus sind auch in dem äußeren Umfang des Verdrängerkörpers 4 Durchlässe/Einschnitte 7a, 7b, 7c, 7d vorhanden, die ein vollständiges Umspülen sämtlicher Bereiche der Flaschenmündung erlauben.The passages / cuts of the channels are in the Fig. 2 once 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. In addition, in the outer periphery of the displacer 4 passages / cuts 7 a, 7 b, 7 c, 7 d are present, which allow a complete flushing all areas of the bottle mouth.

In der Fig. 3 ist dargestellt, dass die radiale Oberfläche des Verdrängerkörpers 4 der Verschlusskappe 1 im Bereich der Flaschenmündung Stege 8 aufweist, die sich von dem Flansch 2 in Richtung des Infusionslösungsbehälters erstrecken. Diese Stege 8 erlauben ein vollständiges Umspülen auch dieses Bereiches zwischen der Kappe 1 und der Flaschenmündung des Infusionslösungsbehälters, was für eine spätere Sterilisierung außerordentlich von Bedeutung ist. Diese Gewährleistung der Sterilisierung auch dieses Bereiches kann unter anderem dadurch gefördert werden, dass auch eine plane ringförmige Begrenzungsfläche des Flansches 2 ebenfalls Stege 9 aufweist, die auch in diesem Bereich ein vollständiges Umspülen des Gegenflansches des Flaschenhalses ermöglicht. Auf diese Weise kann gewährleistet werden, dass auch nach dem Verbinden der Kappe 1 mit dem Infusionslösungsbehälter alle mit der Flüssigkeit in Kontakt tretenden Bereiche sterilisiert werden können.In the Fig. 3 is shown that the radial surface of the displacement body 4 of the closure cap 1 in the region of the bottle mouth webs 8, which extend from the flange 2 in the direction of the infusion solution container. These webs 8 allow a 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 9, 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.

Die vorliegende Erfindung umfasst weiterhin einen entsprechenden Infusionslösungsbehälter mit der oben definierten Kappe 1, wobei diese miteinander verschweißt, verklebt, verpresst oder verclipst sind.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.

Claims (9)

  1. A closure cap (1) with a disk-shaped flange (2), which is connected with a disk-shaped flange of an infusion solution container, wherein the cap (1) has at least one integrated stopper (3a, 3b) for withdrawing or supplying liquid from, or into, the container and for resealing after the withdrawal or supply of liquid,
    wherein
    the cap (1) has a body (4) in the form of a displacer (4) directed inwardly in the direction of the bottle mouth of the infusion solution container, which reduces the dead volume of the container, the closure cap has two stoppers (3a, 3b), which are individually and independently accessible, said stoppers (3a, 3b) are respectively allocated to communicating channels (5a, 5b) in the area of the body (4), characterized in that said cap (1) is capable of being inserted into the bottle mouth without application of force because of an undersize with respect to the bottle mouth,
    said channels (5a, 5b) have one or more passages/notches (6a, 6b, 6c, 6d) in the circumferential area, which extend over part of the length of the body (4), wherein the passages/notches (6a, 6b, 6c, 6d) enable the exchange of liquid between the channels (5a, 5b), or together with passages/notches (7a, 7b, 7c, 7d) arranged in the outer circumference of said displacer (4), allow the liquid to flow throughout the areas of the bottle mouth,
    said cap (1) has ridges (9) in the area of a planar annular boundary surface of the flange (2), and
    said stoppers (3a, 3b) include an elastomer.
  2. The closure cap (1) according to claim 1, characterized in that said displacer (4) has a one-piece or multi-piece design.
  3. The closure cap (1) according to claim 1, characterized in that the surface of the displacer (4) has ridges (8) near the bottle mouth.
  4. The closure cap (1) according to claim 1, characterized in that said stoppers (3a, 3b) include, especially are made of, a thermoplastic elastomer.
  5. The closure cap (1) according to claim 1, characterized in that the stoppers (3a, 3b) are designed as septa that are connected with the cap (1) in a microbiologically sealing way.
  6. The closure cap (1) according to claim 1, characterized by having at least one removable sealing sheet (10), which covers the stopper or stoppers (3a, 3b).
  7. The closure cap (1) according to any of claims 1 to 4, characterized by being connected by a positive-locking, firmly bonding or friction-type connection with said infusion solution container in the area of the flange (2).
  8. The closure cap (1) according to claim 7, characterized by being welded, adhesive-bonded, press-bonded or clipped to said infusion solution container.
  9. An infusion solution container and the closure cap (1) according to any of claims 1 to 8, wherein said cap (1) is welded, adhesive-bonded, press-bonded or clipped to said container.
EP13722394.7A 2012-05-09 2013-05-08 Closure cap Not-in-force EP2847084B1 (en)

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EP13722394.7A EP2847084B1 (en) 2012-05-09 2013-05-08 Closure cap

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EP20120167271 EP2662303A1 (en) 2012-05-09 2012-05-09 Closure cap
PCT/EP2013/059621 WO2013167672A1 (en) 2012-05-09 2013-05-08 Closure cap
EP13722394.7A EP2847084B1 (en) 2012-05-09 2013-05-08 Closure cap

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CN115107285B (en) * 2022-06-16 2024-04-02 乾德生物医疗技术(重庆)有限公司 Method for manufacturing blood purification device

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WO2013167672A1 (en) 2013-11-14
EP2847084A1 (en) 2015-03-18
CN104379463A (en) 2015-02-25
US9731872B2 (en) 2017-08-15
US20150069008A1 (en) 2015-03-12
EP2662303A1 (en) 2013-11-13
CN104379463B (en) 2016-10-05

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