EP1721595B2 - Container for providing medical fluids - Google Patents

Container for providing medical fluids Download PDF

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Publication number
EP1721595B2
EP1721595B2 EP05010458.7A EP05010458A EP1721595B2 EP 1721595 B2 EP1721595 B2 EP 1721595B2 EP 05010458 A EP05010458 A EP 05010458A EP 1721595 B2 EP1721595 B2 EP 1721595B2
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EP
European Patent Office
Prior art keywords
bag
valve
breakable seal
container
welded
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EP05010458.7A
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German (de)
French (fr)
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EP1721595B1 (en
EP1721595A1 (en
Inventor
Matthias Wesseler
Martin Dr. Renken
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B Braun Avitum AG
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B Braun Avitum AG
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Application filed by B Braun Avitum AG filed Critical B Braun Avitum AG
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 providing medical fluids according to the preamble of claim 1.
  • Patent Abstracts of Japan Vol2003, No. 12, 5 shows a valve inserted on the circumference of a hose line, through which a connecting line can be inserted transversely into the hose line and connected to a bag for medical fluid.
  • two ports each consisting of a flexible hose are welded into the edge area 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 hose.
  • a tamper-evident break seal is formed inside the hose, which can be opened by kinking the hose. To shut off the port, the flexible hose is compressed by a clamp.
  • the welding of the hose is a difficult process to control in the production of such a bag because capillaries can easily develop between the two film layers of the bag when the hose is welded in.
  • the clampable flexible hose is also expensive.
  • the hose must be made relatively thick-walled so that there is sufficient stability when inserting a plug required for welding.
  • the internal sterile-tight tamper-evident closure makes the validated sterilization of the connection area difficult.
  • the space within the Luer-Lock cone between the tamper-evident closure and the outer protective cap is not sterilized during the sterilization process, as it is not in contact with the sterilized solution to which the physical / microbiological process validation relates. Therefore, an additional bag is usually required.
  • the invention is based on the object of designing a container of the type specified at the outset in such a way that handling is also simplified with low manufacturing costs.
  • the port which is designed as a removal connector, is provided with a valve device near the free end and with the tamper-evident break seal at the outer end. After the break seal has been broken, the valve can preferably be actuated by a connection device, for example the tubular attachment of a Luer lock (male), on a hose or the like.
  • a connection device for example the tubular attachment of a Luer lock (male), on a hose or the like.
  • the tamper-evident closure delimits the connection area on the outside and is connected to the face of the removal connector, the sterility of the connection area is guaranteed and an outer bag to maintain the sterility of the connection area can be omitted. Thanks to the quality break seal on the outside, which is not covered by any protective cap, the usability status is immediately recognizable.
  • the valve device enables the bag to be shut off in order to separate the partially filled bag from a rinsing system without the need for a separate clamp.
  • Fig. 1 shows a bag 1 in a front view, Fig. 1a in a side view and Figure 1b in a view from below.
  • the bag 1 consists of two foils which are welded to one another along their edge 1a.
  • two removal connectors 2 are welded into the edge area 1 a at a distance from one another.
  • Fig. 2 shows an enlarged view of a section of a removal connector in the view of FIG Figures 1 and 2a shows a section offset by 90 ° through the removal connector in the view of FIG Fig. 1 a.
  • the two removal connectors 2 have a polygonal, in particular diamond-shaped, cross-section in the connection area 2a, which can be pressed flat when being welded into the edge area 1a of the bag 1, so that the removal connector can be welded to the bag films without a core -outside a flexible hose is required.
  • the thin-walled polygonal region 2a of the removal connector 2 merges into a thick-walled central region 2b, which in this exemplary embodiment results in a stiff tubular cross-section.
  • 2c designates a connecting sleeve with a groove on the end face, into which an axially protruding flange of a disk-shaped end part 2d is inserted or in a fluid-tight manner is shrink-wrapped.
  • This disc-shaped end part 2d has in the middle a tube extension 2e with a smaller diameter, in which a valve 3 is inserted and which has a Luer thread on the outer circumference.
  • a break seal 4 in the form of a disk is molded or welded onto the outer end face of this pipe extension 2e.
  • the valve 3 consists of an elastomer disc which - like Fig. 5 shows - starting from a thicker peripheral edge is thinner inward and in the thin central area with a z. B. is provided with a needle pierced hole 3a. If this disk made of flexible plastic is acted upon by the pipe socket La of a Luer lock male L, the hole widens in the middle, as Figure 5b shows, and releases the flow for the liquid in the bag. In the relaxed state of the valve disk 3, on the other hand, no liquid is let through, provided the pressure of the liquid is not too high. When the Luer-Lock L is tightened, the valve disc 3 is expanded to release the flow.
  • This connection device can be designed so that the valve disc 3 closes again by slightly loosening the Luer lock L, as Figure 5c shows in the enlarged representation of the valve without the hose S being completely detached from the bag. In this way, the valve can be switched without a connecting hose S being detached from the extraction connector 2.
  • the valve 3 made of an elastomer disc fulfills several functions. In addition to the valve function, which can be switched by pressing 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 extraction connector or of the Luer thread on the pipe socket 2e cannot be made exactly conical in accordance with the standards due to the external break seal 4 and the required demolding of the inner core.
  • the concave shape of the valve disk 3 serves as a guide and hydraulic seal for the pipe socket La of the Luer lock male.
  • the valve is permeable to water vapor through the hole 3a in the middle of the valve disk 3, so that the sterility of a connection space 5 present between valve 3 and break seal 4 is guaranteed during sterilization.
  • the connection space 5 in the pipe socket 2e of the removal connector 2 lies through the hole 3a in the valve disc within the solution space, which is closed by the break seal 4 and delimited by the foil bag 1 and the removal connector 2.
  • FIGS 3 to 5 show a further embodiment, the same reference symbols being used for identical or corresponding elements.
  • two removal connectors 20 are welded into the film 1b of the bag on the front side of the bag 1, the removal connector 20 being the same as shown in FIG Fig. 4 has reproduced cross-sectional shape.
  • an outwardly protruding area 20b is formed on a round or oval flange area 20a, which in the sectional view of FIG Fig. 4 has wall sections lying approximately perpendicular to one another, wherein on the downwardly inclined wall section 20c the pipe socket 2e of the removal connector 2 ( Fig. 2 ) is formed, which receives the valve disc 3.
  • This pipe socket 2e is how Figure 3b shows in a side view of the bag, inclined obliquely downward.
  • a hole corresponding to the circumferential shape of the flange area 20a is punched into the front film 1b and the removal connector 20 is inserted so that the flange area 20a rests against the inside of the film 1b.
  • the film 1b is then welded to the flange area 20a.
  • Fig. 3 denotes a filling connector which is welded in the same way to the film 1b of the bag 1 via a flange region 30a.
  • a closure disk is designated by 30b, which is welded to the filling connector 30 and closes it.
  • Fig. 5 shows the removal connector 20 in readiness, wherein a connection hose S with a Luer lock male L is to be connected to the bag.
  • the break seal 4 is first broken off from the pipe socket 2e, with no liquid escaping due to the closed position of the valve disc 3 shown in an enlarged view.
  • Figure 5b shows, the internally threaded socket Lb of the Luer lock screwed onto the pipe socket 2e, the pipe socket La penetrating into the pipe socket 2e.
  • the pipe socket La deforms the valve disk 3 in such a way that the opening 3a, which is small in the relaxed state, is widened, as shown in the enlarged view in FIG Figure 5b indicates.
  • valve 3 is open and liquid can flow out into the connection hose S. If the socket Lb of the Luer lock is then released from the removal connector 20 or its pipe attachment 2e while the bag 1 is still about half full with liquid, for example, the elastic material of the valve disc 3 relaxes again, whereby the opening 3a in the thin area of the valve disc closes so far that no liquid escapes like this Figure 5c indicates.
  • the diameter of the disc-shaped break seal 4 is greater than the outer diameter of the pipe socket 2e. This makes it easier to remove the break seal and the usability status can be easily recognized by this relatively large break seal.
  • valve disk 3 instead of the reproduced valve disk 3, another embodiment of a valve can be provided, which can be adjusted from the outside through the protruding tubular extension La of a Luer lock into the open position and automatically or through the pressure of the liquid in the bag back into the Closed position is moved.
  • the embodiment described in the form of the valve disk 3 forms a particularly inexpensive solution.
  • a manually switchable valve on the extraction connector for example a valve with a rotatable tap, but such a design is expensive to manufacture.
  • the port is also possible to design the port to be kinkable, with a film hinge being able to facilitate kinking and the port remaining in the kinked position, for example by means of a clamping or latching device.
  • the central area of the removal connector 2 is designed with thin walls so that it can be bent. Even with such a configuration of a valve device by kinking, complete sterilization of the solution space between break seal 4 and bag 1 is guaranteed.
  • the inventive design of a removal connector can be used for different containers such.
  • B. vials, bottles and the like can be used and is not limited to a rinsing solution bag in which two of the described extraction connectors 2, 20 are provided at a distance of about 20 to 40 mm from each other in order to allow the rinsing solution to circulate through the bag 1 to enable.

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  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Bag Frames (AREA)

Description

Die Erfindung betrifft einen Behälter für die Bereitstellung medizinischer Flüssigkeiten nach dem Oberbegriff des Anspruchs 1.The invention relates to a container for providing medical fluids according to the preamble of claim 1.

Ein derartiger Behälter ist aus US 4 516 977 A bekannt, wobei an einem schlauchförmigen Anschlussstutzen eine durchstoßbare Membran vorgesehen ist, die durch eine Kappe oder einen abziehbaren Schutzstreifen vor der Benutzung steril gehalten wird.Such a container is out U.S. 4,516,977 A known, wherein a pierceable membrane is provided on a tubular connection piece, which is kept sterile by a cap or a removable protective strip before use.

Patent Abstracts of Japan Bd2003, Nr. 12, 5 zeigt ein auf dem Umfang einer Schlauchleitung eingesetztes Ventil, durch das quer in die Schlauchleitung eine Anschlussleitung eingeführt werden kann, die mit einem Beutel für medizinische Flüssigkeit verbunden ist. Patent Abstracts of Japan Vol2003, No. 12, 5 shows a valve inserted on the circumference of a hose line, through which a connecting line can be inserted transversely into the hose line and connected to a bag for medical fluid.

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 each consisting of a flexible hose are welded into the edge area 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 hose. A tamper-evident break seal is formed inside the hose, which can be opened by kinking the hose. 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.The welding of the hose is a difficult process to control in the production of such a bag because capillaries can easily develop between the two film layers of the bag when the hose is welded in. The clampable flexible hose is also expensive. The hose must be made relatively thick-walled so that there is sufficient stability when inserting a plug required for welding. The internal sterile-tight tamper-evident closure makes the validated sterilization of the connection area difficult. The space within the Luer-Lock cone between the tamper-evident closure and the outer protective cap is not sterilized during the sterilization process, as it is not in contact with the sterilized solution to which the physical / microbiological process validation relates. Therefore, an additional 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 is based on the object of designing a container of the type specified at the outset in such a way that handling is also simplified with low manufacturing costs.

Diese Aufgabe wird durch einen Behälter mit den Merkmalen des Patentanspruchs 1 gelöst. Der als Entnahme-Konnektor ausgebildete Port ist 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 object is achieved by a container with the features of claim 1. The port, which is designed as a removal connector, is provided with a valve device near the free end and with the tamper-evident break seal at the outer end. After the break seal has been broken, the valve can preferably be actuated by a connection device, for example the tubular attachment of a Luer lock (male), on a hose or the like.

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 inventive design, the tamper-evident closure delimits the connection area on the outside and is connected to the face of the removal connector, the sterility of the connection area is guaranteed and an outer bag to maintain the sterility of the connection area can be omitted. Thanks to the quality break seal on the outside, which is not covered by any protective cap, the usability status is immediately recognizable. The valve device enables the bag to be shut off in order to separate the partially filled bag from a rinsing system without the need for a separate clamp.

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.This results in a particularly inexpensive rinsing solution bag for dialysis, 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 example embodiment of the invention is explained in more detail below with reference to the drawing. Show it
Fig. 1
a bag with two removal connectors in a front view, a side view and in a view from below,
Fig. 2
a removal connector in sectional views offset by 90 °, each with a front view of the connection side,
Fig. 3
a further embodiment of a bag in the same views as in FIG Fig. 1 ,
Fig. 4
a section through a removal connector of the bag Fig. 3 , and
Fig. 5
different stages of connecting a hose to the extraction connector Fig. 4 with enlarged representation 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 Figure 1b in a view from below. The bag 1 consists of two foils which are welded to one another along their edge 1a. On the underside of the bag 1, two removal connectors 2 are welded into the edge area 1 a at a distance from one another. Fig. 2 shows an enlarged view of a section of a removal connector in the view of FIG Figures 1 and 2a shows a section offset by 90 ° through the removal connector in the view of FIG Fig. 1 a. The two removal connectors 2 have a polygonal, in particular diamond-shaped, cross-section in the connection area 2a, which can be pressed flat when being welded into the edge area 1a of the bag 1, so that the removal connector can be welded to the bag films without a core -outside 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 thick-walled central region 2b, which in this exemplary embodiment results in a stiff tubular cross-section. 2c designates a connecting sleeve with a groove on the end face, into which an axially protruding flange of a disk-shaped end part 2d is inserted or in a fluid-tight manner is shrink-wrapped. This disc-shaped end part 2d has in the middle a tube extension 2e with a smaller diameter, in which a valve 3 is inserted and which has a Luer thread on the outer circumference. A break seal 4 in the form of a disk is molded or welded onto the outer end face of this pipe extension 2e.

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 elastomer disc which - like Fig. 5 shows - starting from a thicker peripheral edge is thinner inward and in the thin central area with a z. B. is provided with a needle pierced hole 3a. If this disk made of flexible plastic is acted upon by the pipe socket La of a Luer lock male L, the hole widens in the middle, as Figure 5b shows, and releases the flow for the liquid in the bag. In the relaxed state of the valve disk 3, on the other hand, no liquid is let through, provided the pressure of the liquid is not too high. When the Luer-Lock L is tightened, the valve disc 3 is expanded to release the flow. This connection device can be designed so that the valve disc 3 closes again by slightly loosening the Luer lock L, as Figure 5c shows in the enlarged representation of the valve without the hose S being completely detached from the bag. In this way, the valve can be switched without a connecting hose S being detached from the extraction 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 pressing 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 extraction connector or of the Luer thread on the pipe socket 2e cannot be made exactly conical in accordance with the standards due to the external break seal 4 and the required demolding of the inner core. The concave shape of the valve disk 3 serves as a guide and hydraulic seal for the pipe socket La of the Luer lock male. Finally, the valve is permeable to water vapor through the hole 3a in the middle of the valve disk 3, so that the sterility of a connection space 5 present between valve 3 and break seal 4 is guaranteed during sterilization. The connection space 5 in the pipe socket 2e of the removal connector 2 lies through the hole 3a in the valve disc within the solution space, which is closed by the break seal 4 and delimited 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. Figures 3 to 5 show a further embodiment, the same reference symbols being used for identical 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, the removal connector 20 being the same as shown in FIG Fig. 4 has reproduced 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 protruding area 20b is formed on a round or oval flange area 20a, which in the sectional view of FIG Fig. 4 has wall sections lying approximately perpendicular to one another, wherein on the downwardly inclined wall section 20c the pipe socket 2e of the removal connector 2 ( Fig. 2 ) is formed, which receives the valve disc 3. This pipe socket 2e is how Figure 3b shows in a side view of the bag, inclined obliquely downward.

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 removal connector 20 to the bag 1, a hole corresponding to the circumferential shape of the flange area 20a is punched into the front film 1b and the removal connector 20 is inserted so that the flange area 20a rests against the inside of the film 1b. The film 1b is then welded to the flange area 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.At 30, in Fig. 3 denotes a filling connector which is welded in the same way to the film 1b of the bag 1 via a flange region 30a. A closure disk is designated by 30b, 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 readiness, wherein a connection hose S with a Luer lock male L is to be connected to the bag. For this purpose, the break seal 4 is first broken off from the pipe socket 2e, with no liquid escaping due to the closed position of the valve disc 3 shown in an enlarged view. Then how Figure 5b shows, the internally threaded socket Lb of the Luer lock screwed onto the pipe socket 2e, the pipe socket La penetrating into the pipe socket 2e. During the tightening, the pipe socket La deforms the valve disk 3 in such a way that the opening 3a, which is small in the relaxed state, is widened, as shown in the enlarged view in FIG Figure 5b indicates. In this state, the valve 3 is open and liquid can flow out into the connection hose S. If the socket Lb of the Luer lock is then released from the removal connector 20 or its pipe attachment 2e while the bag 1 is still about half full with liquid, for example, the elastic material of the valve disc 3 relaxes again, whereby the opening 3a in the thin area of the valve disc closes so far that no liquid escapes like this Figure 5c indicates.

Der Durchmesser des scheibenförmigen Brechsiegels 4 ist erfindungsgemäß 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.According to the invention, the diameter of the disc-shaped break seal 4 is greater than the outer diameter of the pipe socket 2e. This makes it easier to remove the break seal and the usability status can be easily recognized by this relatively large break 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 disk 3, another embodiment of a valve can be provided, which can be adjusted from the outside through the protruding tubular extension La of a Luer lock into the open position and automatically or through the pressure of the liquid in the bag back into the Closed position is moved. The embodiment described in the form of the valve disk 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 extraction connector, for example a valve with a rotatable tap, but such a design is expensive to manufacture. It is also possible to design the port to be kinkable, with a film hinge being able to facilitate kinking and the port remaining in the kinked position, for example by means of a clamping or latching device. In such a configuration, the central area of the removal connector 2 is designed with thin walls so that it can be bent. Even with such a configuration of a valve device by kinking, complete sterilization of the solution space between break seal 4 and bag 1 is guaranteed.

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 be used for different containers such. B. vials, bottles and the like can be used and is not limited to a rinsing solution bag in which two of the described extraction connectors 2, 20 are provided at a distance of about 20 to 40 mm from each other in order to allow the rinsing solution to circulate through the bag 1 to enable.

Claims (4)

  1. Container for providing medical fluids, in particular bag for a flush solution for dialysis,
    wherein a port is connected to the container in a fluid-tight manner, said port having a connecting device at its free end, wherein the connecting device is closed with a breakable seal in the ready position,
    wherein the port is in the form of a withdrawal connector (2, 20) which is closed at the outer end by the breakable seal (4), the withdrawal connector being provided with a valve device (3) between the breakable seal (4) and the connection to the container (1),
    wherein the valve device (3), after the breakable seal (4) has been broken, is operable by means of a connecting device (La) which can be connected to the withdrawal connector (2, 20) and wherein the breakable seal (4) is formed or welded at the outer end face of a connecting piece (2e) of the withdrawal connector (2, 20), which has a Luer thread on the outer circumference and in which the valve device (3) is inserted and which thus forms the connection direction of the port, which is closed in the provision with the integrally formed or welded-on breakable seal (4), characterized in that the breakable seal (4) is in disk form, with a diameter greater than the diameter of the connecting piece (2e).
  2. Container according to claim 1, wherein the valve device is in the form of a valve disk (3) of flexible material, said valve disk (3) having a thickness that decreases from outside to inside in a radial direction and having a small opening (3a) in the middle through which fluid does not emerge but which can be enlarged for the passage of fluid.
  3. Container according to any one of claims 1 to 2, wherein the withdrawal connector (2) has a flexible polygonal cross-section (2a) in the connecting area to a film bag (1) and is welded between two films in the edge region (1a) of the film bag.
  4. Container according to any one of claims 1 to 2, wherein the withdrawal connector (20) has, in the connecting area to a film bag, a flange region (20a) which is welded to a film (1b) of the bag (1), said film (1b) having an opening.
EP05010458.7A 2005-05-13 2005-05-13 Container for providing medical fluids Active EP1721595B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP05010458.7A EP1721595B2 (en) 2005-05-13 2005-05-13 Container for providing medical fluids

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Application Number Priority Date Filing Date Title
EP05010458.7A EP1721595B2 (en) 2005-05-13 2005-05-13 Container for providing medical fluids

Publications (3)

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

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Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018237293A1 (en) * 2017-06-22 2018-12-27 Taylor Doris Anita Multi-compartment biological fluid storage device

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5509433A (en) † 1993-10-13 1996-04-23 Paradis; Joseph R. Control of fluid flow
DE19728775A1 (en) † 1997-07-05 1999-01-21 Fresenius Ag Security seal for packs containing medical fluids, especially infusion or transfusion bags
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
US20030233083A1 (en) † 2002-06-12 2003-12-18 Vincent Houwaert Port, a container and a method for accessing a port
WO2005037362A1 (en) † 2003-10-15 2005-04-28 Fresenius Kabi Deutschland Gmbh Connector for medical liquid-containing packages and medical liquid-containing packages

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3305365C2 (en) 1983-02-17 1989-06-29 Fresenius AG, 6380 Bad Homburg Storage bag
DE29916170U1 (en) * 1999-09-14 1999-12-30 Fresenius Medical Care De Gmbh Insert for medical foil bags
JP4118598B2 (en) * 2002-05-17 2008-07-16 フカイ工業株式会社 Seal valve and syringe connection port

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5509433A (en) † 1993-10-13 1996-04-23 Paradis; Joseph R. Control of fluid flow
DE19728775A1 (en) † 1997-07-05 1999-01-21 Fresenius Ag Security seal for packs containing medical fluids, especially infusion or transfusion bags
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
US20030233083A1 (en) † 2002-06-12 2003-12-18 Vincent Houwaert Port, a container and a method for accessing a port
WO2005037362A1 (en) † 2003-10-15 2005-04-28 Fresenius Kabi Deutschland Gmbh Connector for medical liquid-containing packages and medical liquid-containing packages

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EP1721595B1 (en) 2013-07-10
EP1721595A1 (en) 2006-11-15

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