EP1721595A1 - Container for providing medical fluids - Google Patents

Container for providing medical fluids Download PDF

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Publication number
EP1721595A1
EP1721595A1 EP05010458A EP05010458A EP1721595A1 EP 1721595 A1 EP1721595 A1 EP 1721595A1 EP 05010458 A EP05010458 A EP 05010458A EP 05010458 A EP05010458 A EP 05010458A EP 1721595 A1 EP1721595 A1 EP 1721595A1
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EP
European Patent Office
Prior art keywords
bag
seal
valve
container
container 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
EP05010458A
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German (de)
French (fr)
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EP1721595B2 (en
EP1721595B1 (en
Inventor
Matthias Wesseler
Martin Dr. Renken
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B Braun Avitum AG
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B Braun Medizintechnologie GmbH
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Application filed by B Braun Medizintechnologie GmbH filed Critical B Braun Medizintechnologie GmbH
Priority to EP05010458.7A priority Critical patent/EP1721595B2/en
Publication of EP1721595A1 publication Critical patent/EP1721595A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers

Definitions

  • the invention relates to a container for the provision of medical fluids, in particular a bag for a rinsing solution for dialysis, wherein the container at least one port is fluid-tightly connected, having a connecting device, such as a Luer connection, at the free end and in the provision sealed with a crushing seal.
  • a connecting device such as a Luer connection
  • two ports are each welded from a flexible tube in the edge region of the foil bag and provided at the free end with a protective cap which is screwed onto the Luer thread at the free end of the tube.
  • a tamper-evident crucible is formed, which can be opened by kinking the tube.
  • the flexible hose is compressed by a clamp.
  • Tubing welding is a difficult process to control in the manufacture of such a bag because capillary welding can easily occur between the two layers of film of the bag when the tube is being welded.
  • the detachable flexible hose is also costly.
  • the hose must be made relatively thick-walled, so that a sufficient stability when inserting a plug required for welding is present.
  • the internal, sterile-tight tamper-evident closure complicates the validated sterilization of the connection area.
  • the space within the Luer-Lock cone between the tamper-evident closure and the outer protective cap is not sterilized during the sterilization process because it is not in contact with the sterilized solution to which the physical / microbiological process validation refers. Therefore, an additional transfer bag is usually required.
  • the invention has the object of providing a container of the type described in such a way that at low cost in the manufacture also handling is simplified.
  • the designed as a removal connector port is provided near the free end with a valve device and at the outer end with the originality-crushing seal.
  • the valve is after breaking the breaker seal by a connection device, such as the tubular approach of a Luer-Lock (male), on a hose or the like operable.
  • the tamper-evident closure limits the connection or connection area on the outside and is connected to the front side of the removal connector, the sterility of the connection area is ensured and a repacking bag for maintaining the sterility of the connection area can be dispensed with. Due to the external quality seal, which is not covered by any protective cap, the usability state is immediately recognizable. By the valve means results in a shut-off possibility on the bag to separate the partially filled bag from a flushing system, without a separate terminal is required.
  • Fig. 1 shows a bag 1 in a front view, Fig. 1a in a side view and Fig. 1b in a view from below.
  • the bag 1 consists of two films along each other along their edge 1a are welded.
  • two extraction connectors 2 are welded at a distance from each other in the edge region 1 a.
  • Fig. 2 shows an enlarged view of a section of a removal connector in the view of Fig. 1 and Fig. 2a shows a staggered by 90 ° section through the removal connector in the view of Fig. 1 a.
  • the two removal connectors 2 have in the connection area 2a a polygonal, in particular diamond-shaped cross-section, which can be pressed flat during welding in the edge region 1a of the bag 1, so that a welding of the removal connector with the bag films without a core is possible, the Einschwei A flexible hose is required.
  • the thin-walled polygonal region 2a of the removal connector 2 merges into a thicker-walled middle region 2b, which in this exemplary embodiment results in a stiff tubular cross-section.
  • 2c is a connection sleeve with a groove on the front side, in which an axially projecting flange of a disk-shaped end part 2d is inserted or welded in a fluid-tight manner.
  • This disk-shaped end part 2d has in the middle a smaller diameter pipe socket 2e, in which a valve 3 is inserted and which has a luer thread on the outer circumference.
  • a crushing seal 4 is formed or welded in the form of a disc.
  • the valve 3 consists of an elastomeric disk, which - as shown in FIG. 5 - starting thinner from a thicker peripheral edge and in the thin central region with a z. B. pierced with a needle hole 3a is provided. If this disc of flexible plastic from the pipe socket La of a Luer-Lock-male L is applied, so widens the hole in the middle, as shown in Fig. 5b shows, and releases the flow for the liquid in the bag. In the relaxed state of the valve disc 3, however, no liquid is allowed to pass, unless the pressure of the liquid is too high. By tightening the Luer-Lock L, the valve disc 3 is widened to release the flow.
  • connection device can be designed so that by slightly loosening the Luer-L lock the valve disc 3 closes again, as shown in FIG. 5c in the enlarged view of the valve, without the hose S is completely detached from the bag. In this way, a switchability of the valve is achieved without a connection hose S is released from the removal connector 2.
  • the valve 3 made of an elastomer disc fulfills several functions. In addition to the valve function, which can be switched by pressure of the Luer-Lock-male, there is a radial guidance and sealing of the cone tip of the Luer-Lock-male.
  • the wall of the Luer-Lock-female on the removal connector or the Luer thread on the pipe socket 2e can not be performed exactly conical standard for injection molding technical reasons because of the outer crushing crucible 4 and the necessary demolding of réellekems.
  • the concave shape of the valve disc 3 serves as a guide and hydraulic sealing of the pipe socket La of the Luer lock male.
  • valve for water vapor is permeable through the hole 3a in the middle of the valve disc 3, so that during sterilization, the sterility of a present between the valve 3 and crucible 4 Konnetechnischsraumes 5 is ensured.
  • the Konnetechnischsraum 5 in the pipe socket 2e of the removal connector 2 is through the hole 3a in the valve disc within the solution space, which is closed by the crushing seal 4 and is bounded by the foil bag 1 and the removal connector 2.
  • Fig. 3 to 5 show a further embodiment, wherein the same reference numerals are used for the same or corresponding elements.
  • two removal connectors 20 are welded into the film 1b of the bag on the front side of the bag 1, wherein the removal connector 20 has the reproduced in Fig. 4 cross-sectional shape.
  • an outwardly projecting region 20b is formed on a round or oval flange region 20a, which has wall sections approximately perpendicular to one another in the sectional view of FIG. 4, wherein on the downwardly inclined wall section 20c the tube extension 2e of the removal -Konnektors 2 (Fig. 2) is formed, which receives the valve disc 3.
  • This tube extension 2e as shown in Fig. 3b in a side view of the bag, obliquely arranged inclined downwards.
  • 30 denotes a filling connector in FIG. 3, which is welded in the same way to the film 1b of the bag 1 via a flange region 30a.
  • 30b is a shutter disc referred to, which is welded to the filling connector 30 and closes it.
  • FIG. 5 shows the removal connector 20 in the provision, wherein a connection tube S with a luer lock male L is to be connected to the bag.
  • the crushing seal 4 is first aborted from the pipe neck 2e, with no liquid emerging through the closed position of the valve disk 3 reproduced in an enlarged view.
  • the female thread Lb of the Luer-Lock is screwed onto the pipe socket 2e, the pipe socket La penetrating into the pipe socket 2e.
  • the pipe stub La deforms the valve disk 3 such that the small-diameter opening 3a is expanded, as shown in the enlarged view in FIG. 5b.
  • valve 3 is opened and liquid can flow out into the connection hose S. If the sleeve Lb of the Luer-lock is then detached from the removal connector 20 or its tube extension 2e, while the bag 1 is still filled with liquid approximately halfway, then the elastic material of the valve disc 3 relaxes again, as a result of which the opening 3a in the thin region of the valve disc closes so far that no liquid emerges, as shown in FIG. 5c.
  • the diameter of the disc-shaped crushing crucible 4 is advantageously larger than the outer diameter of the tube extension 2e. As a result, the removal of the refractive seal is facilitated and it is the usability state easily recognizable by this relatively large-scale refractive seal.
  • valve disc 3 instead of the reproduced valve disc 3, another embodiment of a valve can be provided, which is adjustable from the outside through the protruding tubular extension La of a Luer-Lock in the open position and automatically or by the pressure of the liquid in the bag is moved back into the closed position.
  • the described embodiment in the form of the valve disc 3 forms a particularly inexpensive solution.
  • the inventive design of a removal connector can for different containers, such.
  • vials, bottles and the like are used and is not limited to a rinsing solution bag, in which two of the described removal connectors 2, 20 are provided at a distance of about 20 to 40 mm from each other to a circulation of the rinsing solution through the bag. 1 to enable.

Abstract

The bag (1) is made of two sheets of plastic joined at their outer edges (1a) by welding and fitted with two fluid removal connectors (2). The upper edge (2a) of each of the connectors (2) is of a polygonal shape, facilitating an easy joining as well as a completely flat folding of the bag (1). The connectors (2) are fitted with valve elements in the shape of flexible disks, positioned between the welding seams and protection seals located at their lower ends (5).

Description

Die Erfindung betrifft einen Behälter für die Bereitstellung medizinischer Flüssigkeiten, insbesondere einen Beutel für eine Spüllösung für die Dialyse, wobei mit dem Behälter wenigstens ein Port fluiddicht verbunden ist, der eine Verbindungseinrichtung, beispielsweise eine Luer-Verbindung, am freien Ende aufweist und in der Bereitstellung mit einem Brechsiegel verschlossen ist.The invention relates to a container for the provision of medical fluids, in particular a bag for a rinsing solution for dialysis, wherein the container at least one port is fluid-tightly connected, having a connecting device, such as a Luer connection, at the free end and in the provision sealed with a crushing seal.

Bei einem bekannten Beutel für eine Spüllösung sind zwei Ports aus jeweils einem flexiblen Schlauch in den Randbereich des Folienbeutels eingeschweißt und am freien Ende mit einer Schutzkappe versehen, die auf das Luer-Gewinde am freien Ende des Schlauches aufgeschraubt ist. Innerhalb des Schlauches ist ein Originalitäts-Brechsiegel ausgebildet, das durch Abknicken des Schlauches geöffnet werden kann. Zum Absperren des Ports wird der flexible Schlauch durch eine Klemme zusammengedrückt.In a known bag for a rinsing solution two ports are each welded from a flexible tube in the edge region of the foil bag and provided at the free end with a protective cap which is screwed onto the Luer thread at the free end of the tube. Within the tube, a tamper-evident crucible is formed, which can be opened by kinking the tube. To shut off the port, the flexible hose is compressed by a clamp.

Die Schlaucheinschweißung ist ein schwer zu beherrschender Prozess bei der Herstellung eines solchen Beutels, weil es beim Einschweißen des Schlauches zwischen den beiden Folienlagen des Beutels leicht zu Kapillaren kommen kann. Der abklemmbare flexible Schlauch ist zudem kostenaufwendig. Der Schlauch muss relativ dickwandig ausgebildet sein, damit eine hinreichende Stabilität beim Einführen eines zum Verschweißen erforderlichen Stopfens vorhanden ist. Der innenliegende sterildichte Originalitätsverschluss erschwert die validierte Sterilisation des Konnektionsbereichs. Der Raum innerhalb des Luer-Lock-Konus zwischen Originalitätsverschluss und äußerer Schutzkappe wird beim Sterilisationsprozess nicht mitsterilisiert, da er nicht mit der sterilisierten Lösung, auf welche sich die physikalisch/mikrobiologische Prozessvalidierung bezieht, in Kontakt steht. Deshalb ist in der Regel einen zusätzlichen Umbeutel erforderlich.Tubing welding is a difficult process to control in the manufacture of such a bag because capillary welding can easily occur between the two layers of film of the bag when the tube is being welded. The detachable flexible hose is also costly. The hose must be made relatively thick-walled, so that a sufficient stability when inserting a plug required for welding is present. The internal, sterile-tight tamper-evident closure complicates the validated sterilization of the connection area. The space within the Luer-Lock cone between the tamper-evident closure and the outer protective cap is not sterilized during the sterilization process because it is not in contact with the sterilized solution to which the physical / microbiological process validation refers. Therefore, an additional transfer bag is usually required.

Der Erfindung liegt die Aufgabe zugrunde, einen Behälter der eingangs angegebenen Art so auszubilden, dass bei geringem Kostenaufwand bei der Herstellung zudem die Handhabung vereinfacht wird.The invention has the object of providing a container of the type described in such a way that at low cost in the manufacture also handling is simplified.

Dies wird erfindungsgemäß dadurch erreicht, dass der als Entnahme-Konnektor ausgebildete Port nahe dem freien Ende mit einer Ventileinrichtung und am äußeren Ende mit dem Originalitäts-Brechsiegel versehen ist. Vorzugsweise ist das Ventil nach Brechen des Brechsiegels durch eine Anschlusseinrichtung, beispielsweise den rohrförmigen Ansatz eines Luer-Lock (male), an einem Schlauch oder dergleichen betätigbar.This is inventively achieved in that the designed as a removal connector port is provided near the free end with a valve device and at the outer end with the originality-crushing seal. Preferably, the valve is after breaking the breaker seal by a connection device, such as the tubular approach of a Luer-Lock (male), on a hose or the like operable.

Da bei der erfindungsgemäßen Ausgestaltung der Originalitätsverschluss den Verbindungs- bzw. Anschlussbereich außen begrenzt und mit der Stirnseite des Entnahme-Konnektor verbunden ist, wird die Sterilität des Konnektionsbereiches gewährleistet und es kann ein Umbeutel zur Aufrechterhaltung der Sterilität des Konnektionsbereiches entfallen. Durch das außen liegende Qualitäts-Brechsiegel, das von keiner Schutzkappe abgedeckt ist, ist der Verwendbarkeitszustand sofort erkennbar. Durch die Ventileinrichtung ergibt sich eine Absperrmöglichkeit am Beutel, um den teilgefüllten Beutel von einem Spülsystem zu trennen, ohne dass eine separate Klemme erforderlich ist.Since, in the embodiment according to the invention, the tamper-evident closure limits the connection or connection area on the outside and is connected to the front side of the removal connector, the sterility of the connection area is ensured and a repacking bag for maintaining the sterility of the connection area can be dispensed with. Due to the external quality seal, which is not covered by any protective cap, the usability state is immediately recognizable. By the valve means results in a shut-off possibility on the bag to separate the partially filled bag from a flushing system, without a separate terminal is required.

Für die Dialyse ergibt sich auf diese Weise ein besonders kostengünstiger Spüllösungsbeutel, der vollständig aus Nicht-PVC-Materialien hergestellt werden kann und einfach zu handhaben ist.For dialysis, this results in a particularly cost-effective flushing bag, which can be made entirely of non-PVC materials and is easy to handle.

Eine beispielsweise Ausführungsform der Erfindung wird nachfolgend anhand der Zeichnung näher erläutert. Es zeigen

Fig. 1
einen Beutel mit zwei Entnahme-Konnektoren in einer Vorderansicht, einer Seitenansicht und in einer Ansicht von unten,
Fig. 2
einen Entnahme-Konnektor in um 90° versetzten Schnittansichten mit jeweils einer Stirnansicht der Anschlussseite,
Fig. 3
eine weitere Ausführungsform eines Beutels in gleichen Ansichten wie in Fig. 1,
Fig. 4
einen Schnitt durch einen Entnahmekonnektor des Beutels nach Fig. 3, und
Fig. 5
verschiedene Stadien des Verbindens eines Schlauchs mit dem Entnahme-Konnektor nach Fig. 4 mit vergrößerter Darstellung des Ventilbereichs.
An exemplary embodiment of the invention will be explained in more detail with reference to the drawing. Show it
Fig. 1
a bag with two extraction connectors in a front view, a side view and a bottom view,
Fig. 2
a removal connector in 90 ° offset sectional views, each with a front view of the connection side,
Fig. 3
a further embodiment of a bag in the same views as in Fig. 1,
Fig. 4
a section through a removal connector of the bag of Fig. 3, and
Fig. 5
various stages of connecting a hose with the extraction connector of FIG. 4 with an enlarged view of the valve area.

Fig. 1 zeigt einen Beutel 1 in einer Vorderansicht, Fig. 1a in einer Seitenansicht und Fig. 1b in einer Ansicht von unten. Der Beutel 1 besteht aus zwei Folien, die längs ihres Randes 1a miteinander verschweißt sind. An der Unterseite des Beutels 1 sind in den Randbereich 1 a zwei Entnahme-Konnektoren 2 in einem Abstand voneinander eingeschweißt. Fig. 2 zeigt in vergrößerter Darstellung einen Schnitt eines Entnahme-Konnektors in der Ansicht der Fig. 1 und Fig. 2a zeigt einen um 90° versetzten Schnitt durch den Entnahme-Konnektor in der Ansicht der Fig. 1 a. Die beiden Entnahme-Konnektoren 2 haben im Anschlussbereich 2a einen polygonförmigen, insbesondere rautenförmigen Querschnitt, der beim Einschweißen in den Randbereich 1a des Beutels 1 flach zusammengedrückt werden kann, sodass eine Verschweißung des Entnahme-Konnektors mit den Beutelfolien ohne Kern möglich ist, der beim Einschwei-ßen eines flexiblen Schlauches erforderlich ist.Fig. 1 shows a bag 1 in a front view, Fig. 1a in a side view and Fig. 1b in a view from below. The bag 1 consists of two films along each other along their edge 1a are welded. At the bottom of the bag 1, two extraction connectors 2 are welded at a distance from each other in the edge region 1 a. Fig. 2 shows an enlarged view of a section of a removal connector in the view of Fig. 1 and Fig. 2a shows a staggered by 90 ° section through the removal connector in the view of Fig. 1 a. The two removal connectors 2 have in the connection area 2a a polygonal, in particular diamond-shaped cross-section, which can be pressed flat during welding in the edge region 1a of the bag 1, so that a welding of the removal connector with the bag films without a core is possible, the Einschwei A flexible hose is required.

Der dünnwandige Polygonbereich 2a des Entnahme-Konnektor 2 geht in einen dickwandigeren Mittelbereich 2b über, der bei diesem Ausführungsbeispiel einen steifen rohrförmigen Querschnitt ergibt. Mit 2c ist eine Verbindungsmuffe mit einer Nut auf der Stirnseite bezeichnet, in die ein axial vorstehender Flansch eines scheibenförmigen Endteil 2d fluiddicht eingesetzt oder eingeschweißt ist. Dieses scheibenförmige Endteil 2d weist in der Mitte einen im Durchmesser kleineren Rohransatz 2e auf, in dem ein Ventil 3 eingesetzt ist und der auf dem Außenumfang ein Luer-Gewinde aufweist. An der äußeren Stirnseite dieses Rohransatzes 2e ist ein Brechsiegel 4 in Form einer Scheibe angeformt oder angeschweißt.The thin-walled polygonal region 2a of the removal connector 2 merges into a thicker-walled middle region 2b, which in this exemplary embodiment results in a stiff tubular cross-section. 2c is a connection sleeve with a groove on the front side, in which an axially projecting flange of a disk-shaped end part 2d is inserted or welded in a fluid-tight manner. This disk-shaped end part 2d has in the middle a smaller diameter pipe socket 2e, in which a valve 3 is inserted and which has a luer thread on the outer circumference. On the outer end side of this pipe socket 2e a crushing seal 4 is formed or welded in the form of a disc.

Bei dem dargestellten Ausführungsbeispiel besteht das Ventil 3 aus einer Elastomerscheibe, die - wie Fig. 5 zeigt - ausgehend von einem dickeren Umfangsrand nach innen dünner wird und im dünnen Mittelbereich mit einem z. B. mit einer Nadel eingestochenen Loch 3a versehen ist. Wird diese Scheibe aus flexiblem Kunststoff von dem Rohrstutzen La eines Luer-Lock-male L beaufschlagt, so weitet sich das Loch in der Mitte auf, wie Fig. 5b zeigt, und gibt den Durchfluss für die Flüssigkeit im Beutel frei. Im entspannten Zustand der Ventilscheibe 3 wird dagegen keine Flüssigkeit durchgelassen, sofern der Druck der Flüssigkeit nicht zu hoch ist. Mit dem Festziehen des Luer-Lock L wird die Ventilscheibe 3 zur Freigabe des Durchflusses aufgeweitet. Diese Anschlusseinrichtung kann so ausgelegt werden, dass durch leichtes Lösen des Luer-Lock L die Ventilscheibe 3 wieder schließt, wie Fig. 5c in der vergrößerten Darstellung des Ventils zeigt, ohne dass der Schlauch S vollständig vom Beutel gelöst wird. Auf diese Weise wird eine Schaltbarkeit des Ventils erreicht, ohne dass ein Anschlussschlauchs S von dem Entnahme-Konnektor 2 gelöst wird.In the illustrated embodiment, the valve 3 consists of an elastomeric disk, which - as shown in FIG. 5 - starting thinner from a thicker peripheral edge and in the thin central region with a z. B. pierced with a needle hole 3a is provided. If this disc of flexible plastic from the pipe socket La of a Luer-Lock-male L is applied, so widens the hole in the middle, as shown in Fig. 5b shows, and releases the flow for the liquid in the bag. In the relaxed state of the valve disc 3, however, no liquid is allowed to pass, unless the pressure of the liquid is too high. By tightening the Luer-Lock L, the valve disc 3 is widened to release the flow. This connection device can be designed so that by slightly loosening the Luer-L lock the valve disc 3 closes again, as shown in FIG. 5c in the enlarged view of the valve, without the hose S is completely detached from the bag. In this way, a switchability of the valve is achieved without a connection hose S is released from the removal connector 2.

Das Ventil 3 aus einer Elastomerscheibe erfüllt mehrere Funktionen. Neben der Ventilfunktion, die durch Druck des Luer-Lock-male schaltbar ist, ergibt sich eine radiale Führung und Abdichtung der Konusspitze des Luer-Lock-male. Die Wandung des Luer-Lock-female am Entnahme-Konnektor bzw. des Luer-Gewindes am Rohransatz 2e kann aus spritzgusstechnischen Gründen wegen des außenliegenden Brechsiegels 4 und der erforderlichen Entformung des Innenkems nicht exakt normgerecht konisch ausgeführt werden. Die konkave Form der Ventilscheibe 3 dient hierbei als Führung und hydraulische Abdichtung des Rohrstutzens La des Luer-Lock-male. Schließlich ist durch das Loch 3a in der Mitte der Ventilscheibe 3 das Ventil für Wasserdampf durchlässig, sodass während der Sterilisation die Sterilität eines zwischen Ventil 3 und Brechsiegel 4 vorhandenen Konnektionsraumes 5 gewährleistet wird. Der Konnektionsraum 5 in dem Rohransatz 2e des Entnahme-Konnektors 2 liegt durch das Loch 3a in der Ventilscheibe innerhalb des Lösungsraums, der vom Brechsiegel 4 verschlossen ist und vom Folienbeutel 1 und dem Entnahme-Konnektor 2 begrenzt wird.The valve 3 made of an elastomer disc fulfills several functions. In addition to the valve function, which can be switched by pressure of the Luer-Lock-male, there is a radial guidance and sealing of the cone tip of the Luer-Lock-male. The wall of the Luer-Lock-female on the removal connector or the Luer thread on the pipe socket 2e can not be performed exactly conical standard for injection molding technical reasons because of the outer crushing crucible 4 and the necessary demolding of Innenkems. The concave shape of the valve disc 3 serves as a guide and hydraulic sealing of the pipe socket La of the Luer lock male. Finally, the valve for water vapor is permeable through the hole 3a in the middle of the valve disc 3, so that during sterilization, the sterility of a present between the valve 3 and crucible 4 Konnektionsraumes 5 is ensured. The Konnektionsraum 5 in the pipe socket 2e of the removal connector 2 is through the hole 3a in the valve disc within the solution space, which is closed by the crushing seal 4 and is bounded by the foil bag 1 and the removal connector 2.

Fig. 3 bis 5 zeigen eine weitere Ausführungsform, wobei für gleiche bzw. entsprechende Elemente die gleichen Bezugszeichen verwendet sind. Bei dieser Ausführungsform sind auf der Vorderseite des Beutels 1 zwei Entnahme-Konnektoren 20 in die Folie 1b des Beutels eingeschweißt, wobei der Entnahme-Konnektor 20 die in Fig. 4 wiedergegebene Querschnittsform hat.Fig. 3 to 5 show a further embodiment, wherein the same reference numerals are used for the same or corresponding elements. In this embodiment, two removal connectors 20 are welded into the film 1b of the bag on the front side of the bag 1, wherein the removal connector 20 has the reproduced in Fig. 4 cross-sectional shape.

Wie Fig. 4 zeigt, ist an einem runden oder ovalen Flanschbereich 20a ein nach außen vorstehender Bereich 20b angeformt, der in der Schnittansicht der Fig. 4 etwa senkrecht zueinander liegende Wandabschnitte aufweist, wobei an dem nach unten geneigten Wandabschnitt 20c der Rohransatz 2e des Entnahme-Konnektors 2 (Fig. 2) angeformt ist, der die Ventilscheibe 3 aufnimmt. Dieser Rohransatz 2e ist, wie Fig. 3b in einer Seitenansicht des Beutels zeigt, schräg nach unten geneigt angeordnet.As FIG. 4 shows, an outwardly projecting region 20b is formed on a round or oval flange region 20a, which has wall sections approximately perpendicular to one another in the sectional view of FIG. 4, wherein on the downwardly inclined wall section 20c the tube extension 2e of the removal -Konnektors 2 (Fig. 2) is formed, which receives the valve disc 3. This tube extension 2e, as shown in Fig. 3b in a side view of the bag, obliquely arranged inclined downwards.

Zur Verbindung des Entnahme-Konnektors 20 mit dem Beutel 1 wird in die vordere Folie 1b ein der Umfangsform des Flanschbereiches 20a entsprechendes Loch eingestanzt und der Entnahme-Konnektor 20 so eingesetzt, dass der Flanschbereich 20a an der Innenseite der Folie 1b anliegt. Hierauf wird die Folie 1b mit dem Flanschbereich 20a verschweißt.To connect the extraction connector 20 to the bag 1, a hole corresponding to the peripheral shape of the flange portion 20a is punched in the front sheet 1b, and the removal connector 20 is inserted so that the flange portion 20a abuts against the inside of the sheet 1b. Thereafter, the film 1b is welded to the flange portion 20a.

Mit 30 ist in Fig. 3 ein Füll-Konnektor bezeichnet, der in der gleichen Weise über einen Flanschbereich 30a mit der Folie 1b des Beutels 1 verschweißt wird. Mit 30b ist eine Verschlussscheibe bezeichnet, die mit dem Füll-Konnektor 30 verschweißt ist und diesen verschließt.30 denotes a filling connector in FIG. 3, which is welded in the same way to the film 1b of the bag 1 via a flange region 30a. With 30b is a shutter disc referred to, which is welded to the filling connector 30 and closes it.

Fig. 5 zeigt den Entnahme-Konnektor 20 in der Bereitstellung, wobei ein Anschlussschlauch S mit einem Luer-Lock-male L an dem Beutel angeschlossen werden soll. Hierzu wird zunächst das Brechsiegel 4 vom Rohransatz 2e abgebrochen, wobei durch die in vergrößerter Ansicht wiedergegebene Schließstellung der Ventilscheibe 3 keine Flüssigkeit austritt. Hierauf wird, wie Fig. 5b zeigt, die mit Innengewinde versehene Muffe Lb des Luer-Lock auf den Rohransatz 2e aufgeschraubt, wobei der Rohrstutzen La in den Rohransatz 2e eindringt. Während des Festziehens verformt der Rohrstutzen La die Ventilscheibe 3 derart, dass die im entspannten Zustand kleine Öffnung 3a aufgeweitet wird, wie dies die vergrößerte Ansicht in Fig. 5b zeigt. In diesem Zustand ist das Ventil 3 geöffnet und Flüssigkeit kann in den Anschlussschlauch S ausströmen. Wird hierauf die Muffe Lb des Luer-Lock vom Entnahme-Konnektor 20 bzw. dessen Rohransatz 2e gelöst, während der Beutel 1 beispielsweise noch etwa zur Hälfte mit Flüssigkeit gefüllt ist, so entspannt sich das elastische Material der Ventilscheibe 3 wieder, wodurch die Öffnung 3a im dünnen Bereich der Ventilscheibe sich so weit schließt, dass keine Flüssigkeit austritt, wie dies Fig. 5c zeigt.FIG. 5 shows the removal connector 20 in the provision, wherein a connection tube S with a luer lock male L is to be connected to the bag. For this purpose, the crushing seal 4 is first aborted from the pipe neck 2e, with no liquid emerging through the closed position of the valve disk 3 reproduced in an enlarged view. Then, as shown in FIG. 5b, the female thread Lb of the Luer-Lock is screwed onto the pipe socket 2e, the pipe socket La penetrating into the pipe socket 2e. During tightening, the pipe stub La deforms the valve disk 3 such that the small-diameter opening 3a is expanded, as shown in the enlarged view in FIG. 5b. In this state, the valve 3 is opened and liquid can flow out into the connection hose S. If the sleeve Lb of the Luer-lock is then detached from the removal connector 20 or its tube extension 2e, while the bag 1 is still filled with liquid approximately halfway, then the elastic material of the valve disc 3 relaxes again, as a result of which the opening 3a in the thin region of the valve disc closes so far that no liquid emerges, as shown in FIG. 5c.

Der Durchmesser des scheibenförmigen Brechsiegels 4 ist vorteilhafterweise größer als der Außendurchmesser des Rohransatzes 2e. Hierdurch wird das Entfernen des Brechsiegels erleichtert und es ist der Verwendbarkeitszustand durch dieses relativ großflächige Brechsiegel gut erkennbar.The diameter of the disc-shaped crushing crucible 4 is advantageously larger than the outer diameter of the tube extension 2e. As a result, the removal of the refractive seal is facilitated and it is the usability state easily recognizable by this relatively large-scale refractive seal.

Anstelle der wiedergegebenen Ventilscheibe 3 kann auch eine andere Ausgestaltung eines Ventils vorgesehen werden, das von außen durch den vorstehenden rohrförmigen Ansatz La eines Luer-Lock in die Öffnungsstellung verstellbar ist und selbsttätig oder durch den Druck der Flüssigkeit im Beutel wieder in die Schließstellung bewegt wird. Die beschriebene Ausgestaltung in Form der Ventilscheibe 3 bildet eine besonders kostengünstige Lösurig.Instead of the reproduced valve disc 3, another embodiment of a valve can be provided, which is adjustable from the outside through the protruding tubular extension La of a Luer-Lock in the open position and automatically or by the pressure of the liquid in the bag is moved back into the closed position. The described embodiment in the form of the valve disc 3 forms a particularly inexpensive solution.

Es ist auch möglich, ein manuell schaltbares Ventil am Entnahme-Konnektor vorzusehen, beispielsweise ein Ventil mit einem drehbaren Hahn, jedoch ist eine solche Ausgestaltung kostenaufwendig in der Herstellung. Weiterhin ist es möglich, den Port abknickbar auszugestalten, wobei ein Filmgelenk das Abknicken erleichtern kann und der Port in der abgeknickten Position beispielsweise durch eine Klemm- oder Rasteinrichtung verbleibt. Bei einer solchen Ausgestaltung wird der Mittelbereich des Entnahme-Konnektor 2 dünnwandig gestaltet, damit ein Abknicken möglich ist. Auch bei einer solchen Ausgestaltung einer Ventileinrichtung durch Abknicken ist eine vollständige Sterilisation des Lösungsraumes zwischen Brechsiegel 4 und Beutel 1 gewährleistet.It is also possible to provide a manually switchable valve on the removal connector, for example a valve with a rotatable valve, but such a design is costly to manufacture. Furthermore, it is possible to design the port kinkable, with a film hinge can facilitate kinking and the port remains in the bent position, for example, by a clamping or locking device. In such a Design of the central region of the removal connector 2 is designed thin-walled, so that a kinking is possible. Even with such a configuration of a valve device by kinking a complete sterilization of the solution space between crushing seal 4 and bag 1 is ensured.

Die erfindungsgemäße Ausgestaltung eines Entnahme-Konnektor kann für verschiedene Behälter, wie z. B. Vials, Flaschen und dergleichen verwendet werden und ist nicht auf einen Spüllösungsbeutel beschränkt, bei dem zwei der beschriebenen Entnahme-Konnektoren 2, 20 in einem Abstand von etwa 20 bis 40 mm voneinander vorgesehen werden, um eine Zirkulation der Spüllösung durch den Beutel 1 zu ermöglichen.The inventive design of a removal connector can for different containers, such. As vials, bottles and the like are used and is not limited to a rinsing solution bag, in which two of the described removal connectors 2, 20 are provided at a distance of about 20 to 40 mm from each other to a circulation of the rinsing solution through the bag. 1 to enable.

Claims (7)

Behälter für die Bereitstellung medizinischer Flüssigkeiten, insbesondere Beutel für eine Spüllösung für die Dialyse,
wobei mit dem Behälter ein Port fluiddicht verbunden ist, der eine Anschlusseinrichtung am freien Ende aufweist und in der Bereitstellung mit einem Brechsiegel verschlossen ist,
dadurch gekennzeichnet,
dass der Port als Entnahme-Konnektor (2, 20) ausgebildet ist, der am äußeren Ende mit dem Brechsiegel (4) verschlossen ist, wobei der Entnahme-Konnektor zwischen Brechsiegel (4) und Verbindung mit dem Behälter (1) mit einer Ventileinrichtung (3) versehen ist.Container for providing medical fluids, in particular bags for rinsing solution for dialysis,
wherein a port is fluid-tightly connected to the container, which has a connection device at the free end and is sealed in the provision with a refractive seal,
characterized,
in that the port is designed as a removal connector (2, 20) which is closed at the outer end with the refractive seal (4), wherein the removal connector between refractive seal (4) and connection to the container (1) with a valve device ( 3) is provided. Behälter nach Anspruch 1, wobei die Ventileinrichtung (3) nach Brechen des Brechsiegels (4) durch eine Anschlusseinrichtung (La) betätigbar ist.A container according to claim 1, wherein the valve means (3) is operable after breaking the crushing seal (4) by a connection means (La). Behälter nach Anspruch 2, wobei die Ventileinrichtung als Ventilscheibe (3) aus flexiblem Material ausgebildet ist, die eine von radial außen nach innen abnehmende Dicke und in der Mitte eine kleine Öffnung (3a) aufweist, durch die Flüssigkeit nicht austritt, die aber für den Flüssigkeitsdurchtritt aufweitbar ist.A container according to claim 2, wherein the valve means is formed as a valve disk (3) of flexible material having a thickness decreasing from radially outward inwards and in the middle a small opening (3a) through which liquid does not escape, but which for the Liquid passage is expandable. Behälter nach einem der Ansprüche 1 bis 3, wobei das Brechsiegel (4) an der äußeren Stirnseite eines Rohransatzes (2e) des Entnahme-Konnektor (2, 20) angeformt oder angeschweißt ist.Container according to one of claims 1 to 3, wherein the crushing seal (4) on the outer end side of a pipe socket (2e) of the removal connector (2, 20) is integrally formed or welded. Behälter nach Anspruch 4, wobei das Brechsiegel (4) scheibenförmig ausgebildet ist mit einem Durchmesser größer als der des Rohransatzes (2e).Container according to claim 4, wherein the crushing seal (4) is disk-shaped with a diameter larger than that of the pipe socket (2e). Behälter nach einem der Ansprüche 1 bis 5, wobei der Entnahme-Konnektor (2) im Verbindungsbereich mit einem Folienbeutel (1) einen flexiblen Polygonquerschnitt (2a) aufweist und in den Randbereich (1a) des Folienbeutels zwischen zwei Folien eingeschweißt ist.Container according to one of claims 1 to 5, wherein the removal connector (2) in the connection region with a foil bag (1) has a flexible polygonal cross-section (2a) and is welded into the edge region (1a) of the film bag between two films. Behälter nach einem der Ansprüche 1 bis 5, wobei der Entnahme-Konnektor (20) im Verbindungsbereich mit einem Folienbeutel einen Flanschbereich (20a) aufweist, der mit einer Folie (1b) des Beutels (1) verschweißt ist, die eine Durchtrittsöffnung aufweist.Container according to one of claims 1 to 5, wherein the removal connector (20) in the connection region with a foil bag has a flange portion (20a) which is welded to a film (1b) of the bag (1) having a passage opening.
EP05010458.7A 2005-05-13 2005-05-13 Container for providing medical fluids Active EP1721595B2 (en)

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EP05010458.7A EP1721595B2 (en) 2005-05-13 2005-05-13 Container for providing medical fluids

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EP1721595A1 true EP1721595A1 (en) 2006-11-15
EP1721595B1 EP1721595B1 (en) 2013-07-10
EP1721595B2 EP1721595B2 (en) 2021-08-11

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* Cited by examiner, † Cited by third party
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US20210187495A1 (en) * 2017-06-22 2021-06-24 Texas Heart Institute Multi-compartment biological fluid storage device

Citations (3)

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Publication number Priority date Publication date Assignee Title
US4516977A (en) 1983-02-17 1985-05-14 Fresenius, Ag Storage bag
EP1084691A2 (en) * 1999-09-14 2001-03-21 Fresenius Medical Care Deutschland GmbH Insert for medical pouch
JP2003325675A (en) * 2002-05-17 2003-11-18 Fukai Kogyo Kk Seal valve and injector connection port

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Publication number Priority date Publication date Assignee Title
US5509433A (en) † 1993-10-13 1996-04-23 Paradis; Joseph R. Control of fluid flow
DE19728775C2 (en) † 1997-07-05 2002-01-31 Fresenius Ag Tamper-evident seal for packaging containing medical liquids
DE10030474C1 (en) † 2000-06-21 2002-02-21 Fresenius Kabi De Gmbh Connector for infusion or transfusion bag comprises cylindrical connection piece closed by self-sealing septum and with catches positioned diametrically opposite each which are biased outwards at base by flexible strips
US6994699B2 (en) † 2002-06-12 2006-02-07 Baxter International Inc. Port, a container and a method for accessing a port
DE10348016B4 (en) † 2003-10-15 2007-05-03 Fresenius Kabi Deutschland Gmbh Connector for medical fluid containing packaging and packaging for medical fluids

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Publication number Priority date Publication date Assignee Title
US4516977A (en) 1983-02-17 1985-05-14 Fresenius, Ag Storage bag
EP1084691A2 (en) * 1999-09-14 2001-03-21 Fresenius Medical Care Deutschland GmbH Insert for medical pouch
JP2003325675A (en) * 2002-05-17 2003-11-18 Fukai Kogyo Kk Seal valve and injector connection port

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Title
PATENT ABSTRACTS OF JAPAN vol. 2003, no. 12 5 December 2003 (2003-12-05) *
PATENT ABSTRACTS OF JAPAN, vol. 2003, no. 12, pages 5

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210187495A1 (en) * 2017-06-22 2021-06-24 Texas Heart Institute Multi-compartment biological fluid storage device

Also Published As

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EP1721595B2 (en) 2021-08-11
EP1721595B1 (en) 2013-07-10

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