EP2191807B1 - Connector for packaging containing medical fluids and packaging for medical fluids - Google Patents

Connector for packaging containing medical fluids and packaging for medical fluids Download PDF

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Publication number
EP2191807B1
EP2191807B1 EP10002916.4A EP10002916A EP2191807B1 EP 2191807 B1 EP2191807 B1 EP 2191807B1 EP 10002916 A EP10002916 A EP 10002916A EP 2191807 B1 EP2191807 B1 EP 2191807B1
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EP
European Patent Office
Prior art keywords
shaped portion
membrane
spike
connector
dish
Prior art date
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Expired - Lifetime
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EP10002916.4A
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German (de)
French (fr)
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EP2191807A3 (en
EP2191807A2 (en
Inventor
Torsten Brandenburger
Ismael Rahimy
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Fresenius Kabi Deutschland GmbH
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Fresenius Kabi Deutschland GmbH
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Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
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Publication of EP2191807A3 publication Critical patent/EP2191807A3/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • 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
    • 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
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • 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
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means

Definitions

  • the invention relates to a self-sealing membrane for a connector for medicinal liquids containing packaging, in particular infusion or transfusion bag, which serves to remove a liquid from the bag.
  • the WO 96/23545 describes an infusion bag with an injection part and a removal part.
  • the injection part serves to supply a medicament by means of a syringe. It comprises a tubular connection part which is closed by a protective cap designed as a break-off part.
  • a self-sealing septum is seated in the opening portion of the connector while a pierceable membrane is disposed in the connector so that the septum will not contact the solution prior to use of the infusion bag.
  • the removal part is used to remove the solution by means of a spike.
  • a self-sealing septum does not have the removal part, otherwise the structure is similar to that of the injection part.
  • a connector for taking an infusion solution is also in the DE 197 28 775 C2 described.
  • the tubular connection part of the known removal part is closed by a flat membrane, which is integral with the connection part.
  • connection between spike and removal part is not secured against slipping out. If the bag hangs on the tripod, there is a risk that the connection between the spike and the removal part will come off due to an unintentional pull on the hose line.
  • the WO 94/03373 A1 describes a closure of an ampule having a plug-shaped inner portion and a flat outer portion.
  • the plug-shaped inner portion has a diaphragm in the center, which has a target region at the top and a cross channel at the bottom.
  • the diaphragm of the plug-shaped inner portion is enclosed by a downwardly extending cylindrical portion into which the cannula is inserted.
  • the cylindrical portion has an upper portion for guiding the cannula and a lower portion sealingly surrounding the cannula.
  • the invention has for its object to provide a self-sealing membrane for a connector for medicinal liquids containing packaging, in particular infusion or transfusion bag, which seals the packaging safely after pulling out the spike.
  • the membrane of the invention is arranged in a connector in the connection part for receiving the spike for the removal of the liquid.
  • the self-sealing membrane prevents leakage of liquid from the package after pulling out the spike.
  • the self-sealing membrane has an annular portion which merges into a plate-shaped portion, wherein the annular portion of the membrane sealingly surrounds the spike when piercing the plate-shaped portion.
  • the special design of the membrane with the annular and plate-shaped portion ensures on the one hand, that the spike is securely guided when piercing the membrane and on the other ensures that the membrane after pulling out of the spike seals securely even at relatively high internal pressure in the package again , It has been shown in experiments that the special design of the membrane for the immediate reclosure is crucial, with increasing internal pressure in the packaging, the sealing of the membrane is still increased. The secure seal is not due to the volume of material, but the special geometry of the membrane.
  • the material of the plate-shaped portion of the membrane is preferably weakened, so that the membrane with the spike can be particularly easily pierced.
  • the membrane is pre-slit crosswise. But it can also be star-shaped or the like. Pre-slit or provided only with a simple slot.
  • the tubular connection part of the connector is composed of a lower and an upper portion, wherein the portions are set snapping.
  • the self-sealing membrane is preferably clamped with elastic deformation thereof between the lower and upper portions. Consequently, the assembly of the connector can be done easily by pressing the items. But it is also possible that the items are welded together and / or glued together.
  • a further particularly preferred embodiment provides that adjoins the annular portion of the membrane, an outer portion which is clamped between the two sections.
  • a second pierceable membrane is preferably disposed to form a space below the self-sealing membrane.
  • the second diaphragm is expediently an integral part of the tubular connecting piece.
  • the spike is held in the eingochenenen position by the arched membrane clamped. As a result, the holding force of the spike is increased in the removal position, whereby accidental slipping is prevented.
  • both parts may have a toothing or the like, which also ensures an exact alignment of the parts during compression. Moreover, the risk of damage to the two membranes is particularly low when compressing the items.
  • the breakable closure part of the connector which serves as a tamper-evident closure, is preferably connected to the attachment part via a ring-break zone.
  • the break-off closure part preferably has a grip part which is designed in the manner of an arrow pointing upwards, it can immediately be recognized that the connector is a removal part but not an injection part.
  • the arrow is a recess in the handle part, which is immediately recognizable, without labels or the like are required. Thus, confusion of withdrawal and Zusufitzteil a packaging containing medical fluids can be avoided.
  • the lower part of the connector preferably has an upwardly pointing arrow, which is formed as a raised structure, preferably in a recessed grip.
  • the upward pointing arrow of the lower connector part allows even after canceling the closure part a unique assignment of the connector as a removal part.
  • the designed as a removal part connector 20 for medical liquid containing packaging, in particular infusion or transfusion bag has a tubular connection part 1, which is composed of a packaging side, lower portion 2 and a connection-side, upper portion 3.
  • the tubular connection part 1 consequently has an upper and a lower opening 1a, 1b.
  • the connector 20 is an injection molded part made of polypropylene.
  • the lower portion 2 of the tubular connection part 1 has a lower cylindrical portion 4, which merges into an upper sleeve-shaped portion 5.
  • the cylindrical portion 4 of the lower portion 2 can be inserted into a connecting piece of a film bag and welded or glued to the nozzle or welded directly into the foil bag without nozzle.
  • the cylindrical portion 4 is closed at its upper end with a pierceable membrane 6, which is an integral part of the lower portion 2.
  • the injected membrane is curved downwards. Alternatively, the membrane can also be curved upwards.
  • the upper portion 3 of the tubular connection part 1 is set in snapping on the lower portion 2, wherein the upper portion 3 has a cylindrical portion 7 which surrounds the lower portion 2.
  • the inner wall of the cylindrical portion 7 of the upper portion 3 has a circumferential groove 8, in a circumferential projection 9 on the outer wall of the sleeve-shaped portion 5 of the lower portion 2 during compression of the two sections 2, 3 snaps.
  • a self-sealing membrane 10 made of an elastic material, which is also referred to as a septum, held the same under elastic preforming clamping.
  • the self-sealing membrane 10 has an outer portion 11 which is clamped between the lower and upper portion 2, 3 of the tubular connection part 1.
  • the outer portion 11 is followed by an upper, annular portion 12, which merges to form a trough-shaped recess 13 at the top of the membrane 10 in a lower plate-shaped portion 14.
  • the plate-shaped portion 14 is pre-slit crosswise or star-shaped, so that although the elastic material is weakened, but not severed.
  • a cap-shaped closure part 16 which closes the upper opening 1a of the connection part 1, adjoins the upper part 3 of the tubular connection part 1 via a ring breaking zone 31.
  • the closure part 16 merges into a flat grip part 17, which is provided with a recess 18 in the form of an arrow 19 pointing upwards. In the direction of the arrow 19 it can immediately be recognized that the connector 20 is not the injection part 40 but the removal part.
  • FIG. 2 shows an infusion bag filled with an infusion solution 21, which has the connector 20 for taking the infusion solution and another connector 40 for injecting a solution into the infusion bag 21.
  • the infusion bag 21 consists of two film layers 24, which are welded together at the lower and upper edges 25, 26 and the longitudinal edges 27, 28. In the upper edge 25 of the infusion bag, two connecting pieces 29, 30 are welded.
  • the tubular connecting pieces of the injection and removal part 40, 20 are inserted into the connecting pieces 29, 30 and connected to the nozzle during sterilization.
  • the tubular connecting pieces of the tamper-evident closures can, however, also be formed on an insert piece designed in the manner of a shuttle or round, which is welded between the two foil layers.
  • FIG. 3 shows the Zuspritzteil 40 of the film bag 21 in a sectional view.
  • the injection part 40 has a similar structure as the extraction part 20. The corresponding parts are therefore provided with the same reference numerals.
  • the injection part 40 has a tubular connection part 1 ', which is composed of a lower and an upper portion 2', 3 '.
  • the two sections 2 ', 3' are defined with the interposition of a self-sealing membrane 10 'snapping, in which a projecting lug 8' of the lower portion 2 'in a groove 9' of the upper portion 3 'engages.
  • a flat membrane 6' is injected, which may also be curved.
  • the break-off part 16 of the removal part 20 is stopped by turning or breaking it, so that the self-sealing membrane 10 is exposed.
  • the spike of a known transfer system is now inserted, whereby the pre-slit membrane 10 is pierced and the downwardly curved membrane 6 is pierced.
  • the trough-shaped recess 13 serves as a guide for the spike.
  • the spike will be with the annular portion t 12 of the membrane 10 sealed. Due to the special design of the injected membrane 6, the spike is held firmly in the tubular connection part 1.
  • the infusion solution can be removed.
  • the self-sealing membrane 10 seals the dispensing part 20 securely even at a relatively high internal pressure. Moreover, with the special design of the injected membrane 6, the mechanical strength of the removal part 20 is increased.
  • the injection part 40 serves to inject an active substance into the infusion solution.
  • the self-sealing membrane 10' and the injected membrane 6 ' are pierced again with the injection needle of a syringe. After pulling out the needle, the injection part seals again.

Abstract

The tubular connector (1), for packs containing medical fluids, holds a spike to extract the fluid, together with upper and lower openings (1a,1b). The upper opening is closed by a snap-off section (16). The connector contains a self-sealing membrane (10), penetrated by the spike to extract the fluid. The self-sealing membrane has an upper ring section (12), which transits into a recessed trough section (13) with a flat plate (14). As the spike penetrates through the membrane plate, the ring section forms a sealing shroud around it.

Description

Die Erfindung bezieht sich auf eine selbstabdichtende Membran für einen Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen, insbesondere Infusions- oder Transfusionsbeutel, der zur Entnahme einer Flüssigkeit aus dem Beutel dient.The invention relates to a self-sealing membrane for a connector for medicinal liquids containing packaging, in particular infusion or transfusion bag, which serves to remove a liquid from the bag.

Die WO 96/23545 beschreibt einen Infusionsbeutel mit einem Zuspritzteil und einem Entnahmeteil. Der Zuspritzteil dient zum Zuführen eines Medikaments mittels einer Injektionsspritze. Er umfasst einen rohrförmigen Anschlussteil, der von einer als Abbrechteil ausgebildeten Schutzkappe verschlossen ist. Im Öffnungsbereich des Anschlussteils sitzt ein selbstabdichtendes Septum, während in dem Anschlussteil eine durchstechbare Membran angeordnet ist, so dass das Septum vor dem Gebrauch des Infusionsbeutels nicht mit der Lösung in Berührung kommt. Der Entnahmeteil dient zur Entnahme der Lösung mittels eines Spike. Ein selbstabdichtendes Septum weist der Entnahmeteil nicht auf, ansonsten ist der Aufbau ähnlich wie der des Zuspritzteils.The WO 96/23545 describes an infusion bag with an injection part and a removal part. The injection part serves to supply a medicament by means of a syringe. It comprises a tubular connection part which is closed by a protective cap designed as a break-off part. A self-sealing septum is seated in the opening portion of the connector while a pierceable membrane is disposed in the connector so that the septum will not contact the solution prior to use of the infusion bag. The removal part is used to remove the solution by means of a spike. A self-sealing septum does not have the removal part, otherwise the structure is similar to that of the injection part.

Ein Konnektor zur Entnahme einer Infusionslösung ist auch in der DE 197 28 775 C2 beschrieben. Der rohrförmige Anschlussteil des bekannten Entnahmeteils wird von einer flachen Membran verschlossen, die mit dem Anschlussteil einstückig ist.A connector for taking an infusion solution is also in the DE 197 28 775 C2 described. The tubular connection part of the known removal part is closed by a flat membrane, which is integral with the connection part.

Die bekannten Entnahmeteile haben sich in der Praxis bewährt. Ein Nachteil liegt aber darin, dass der Infusionsbeutel nach dem Herausziehen des Spike nicht wieder verschlossen ist. Daher besteht die Gefahr, dass die Infusionslösung ausläuft. Dies ist besonders nach der Zumischung von Zytostatika kritisch.The known removal parts have proven themselves in practice. One disadvantage, however, is that the infusion bag is not closed again after pulling out the spike. Therefore, there is a risk that the infusion solution will leak. This is especially critical after the admixture of cytostatics.

Ein weiterer Nachteil ist, dass die Verbindung zwischen Spike und Entnahmeteil nicht gegen Herausrutschen gesichert ist. Wenn der Beutel am Stativ hängt, besteht die Gefahr, dass sich die Verbindung von Spike und Entnahmeteil aufgrund eines unbeabsichtigten Zugs an der Schlauchleitung löst.Another disadvantage is that the connection between spike and removal part is not secured against slipping out. If the bag hangs on the tripod, there is a risk that the connection between the spike and the removal part will come off due to an unintentional pull on the hose line.

Nachteilig ist auch, dass die eingespritzte Membran, die den Anschlussteil des Entnahmeteils verschließt, größeren mechanischen Beanspruchungen nicht immer Stand hält. So hat sich in Fallversuchen gezeigt, dass die Membran einzelner Entnahmeteile zu Bruch ging.Another disadvantage is that the injected membrane, which closes the connection part of the removal part, does not always withstand greater mechanical stresses. For example, it has been shown in falling tests that the membrane of individual removal parts was broken.

Die WO 94/03373 A1 beschreibt einen Verschluss einer Ampulle, der einen stopfenförmigen inneren Abschnitt und einen flachen äußeren Abschnitt aufweist. Der stopfenförmige innere Abschnitt weist im Zentrum ein Diaphragma auf, das an der Oberseite eine target region und an der Unterseite einen cross channel aufweist. Das Diaphragma des stopfenförmigen inneren Abschnitts wird von einem sich nach unten erstreckenden zylindrischen Abschnitt umschlossen, in den die Kanüle eingeführt wird. Der zylindrischen Abschnitt weist einen oberen Bereich zum Führen der Kanüle und einen unteren Bereich auf, der die Kanüle dichtend umschließt.The WO 94/03373 A1 describes a closure of an ampule having a plug-shaped inner portion and a flat outer portion. The plug-shaped inner portion has a diaphragm in the center, which has a target region at the top and a cross channel at the bottom. The diaphragm of the plug-shaped inner portion is enclosed by a downwardly extending cylindrical portion into which the cannula is inserted. The cylindrical portion has an upper portion for guiding the cannula and a lower portion sealingly surrounding the cannula.

Der Erfindung liegt die Aufgabe zugrunde, eine selbstabdichtende Membran für einen Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen, insbesondere Infusions- oder Transfusionsbeutel zu schaffen, die nach dem Herausziehen des Spike die Verpackung sicher abdichtet.The invention has for its object to provide a self-sealing membrane for a connector for medicinal liquids containing packaging, in particular infusion or transfusion bag, which seals the packaging safely after pulling out the spike.

Die Lösung dieser Aufgabe erfolgt erfindungsgemäß mit den Merkmalen des Patentanspruchs 1. Vorteilhafte Ausführungsformen der Erfindung sind Gegenstand der Unteransprüche.The solution of this object is achieved according to the invention with the features of claim 1. Advantageous embodiments of the invention are the subject of the dependent claims.

Die erfindungsgemäße Membran ist in einem Konnektor in dem Anschlussteil zur Aufnahme des Spike für die Entnahme der Flüssigkeit angeordnet. Die selbstabdichtende Membran verhindert das Auslaufen der Flüssigkeit aus der Verpackung nach dem Herausziehen des Spike.The membrane of the invention is arranged in a connector in the connection part for receiving the spike for the removal of the liquid. The self-sealing membrane prevents leakage of liquid from the package after pulling out the spike.

Von Vorteil ist, dass die selbstabdichtende Membran ein ringförmiges Teilstück aufweist, das in ein tellerförmiges Teilstück übergeht, wobei das ringförmige Teilstück der Membran den Spike beim Durchstechen des tellerförmigen Teilstücks abdichtend umschließt.It is advantageous that the self-sealing membrane has an annular portion which merges into a plate-shaped portion, wherein the annular portion of the membrane sealingly surrounds the spike when piercing the plate-shaped portion.

Die besondere Ausbildung der Membran mit dem ringförmigen und tellerförmigen Teilstück stellt zum einen sicher, dass der Spike beim Anstechen der Membran sicher geführt wird und gewährleistet zum anderen, dass die Membran nach dem Herausziehen des Spike auch bei relativ hohem Innendruck in der Verpackung wieder sicher abdichtet. Es hat sich in Versuchen gezeigt, dass die besondere Ausbildung der Membran für den sofortigen Wiederverschluss ausschlaggebend ist, wobei mit zunehmenden Innendruck in der Verpackung die Abdichtung der Membran noch erhöht wird. Die sichere Abdichtung ist nicht auf das Materialvolumen, sondern die besondere Geometrie der Membran zurückzuführen.The special design of the membrane with the annular and plate-shaped portion ensures on the one hand, that the spike is securely guided when piercing the membrane and on the other ensures that the membrane after pulling out of the spike seals securely even at relatively high internal pressure in the package again , It has been shown in experiments that the special design of the membrane for the immediate reclosure is crucial, with increasing internal pressure in the packaging, the sealing of the membrane is still increased. The secure seal is not due to the volume of material, but the special geometry of the membrane.

Bei dem erfindungsgemäßen Konnektor ist das Material des tellerförmigen Teilstücks der Membran vorzugsweise geschwächt, so dass sich die Membran mit dem Spike besonders leicht durchstechen lässt. Vorzugsweise ist die Membran kreuzweise vorgeschlitzt. Sie kann aber auch sternförmig oder dgl. vorgeschlitzt oder nur mit einem einfachen Schlitz versehen sein.In the connector according to the invention, the material of the plate-shaped portion of the membrane is preferably weakened, so that the membrane with the spike can be particularly easily pierced. Preferably, the membrane is pre-slit crosswise. But it can also be star-shaped or the like. Pre-slit or provided only with a simple slot.

Bei einer besonders bevorzugten Ausführungsform ist der rohrförmige Anschlussteil des Konnektors aus einem unteren und einem oberen Teilstück zusammengesetzt, wobei die Teilstücke einschnappend festgelegt sind. Die selbstabdichtende Membran ist vorzugsweise unter elastischer Verformung derselben zwischen dem unteren und oberen Teilstück klemmend gehalten. Folglich kann die Montage des Konnektors auf einfache Weise durch das Verpressen der Einzelteile erfolgen. Es ist aber auch möglich, dass die Einzelteile miteinander verschweißt und/oder verklebt werden.In a particularly preferred embodiment, the tubular connection part of the connector is composed of a lower and an upper portion, wherein the portions are set snapping. The self-sealing membrane is preferably clamped with elastic deformation thereof between the lower and upper portions. Consequently, the assembly of the connector can be done easily by pressing the items. But it is also possible that the items are welded together and / or glued together.

Eine weitere besonders bevorzugte Ausführungsform sieht vor, dass sich an das ringförmigen Teilstück der Membran ein äußerer Abschnitt anschließt, der zwischen den beiden Teilstücken eingespannt ist.A further particularly preferred embodiment provides that adjoins the annular portion of the membrane, an outer portion which is clamped between the two sections.

Um zu verhindern, dass die selbstabdichtende Membran in dem rohrförmigen Anschlussstück vor dem Gebrauch des Infusions- und Transfusionsbeutel mit der darin enthaltenden Lösung in Berührung kommt, ist vorzugsweise unter Bildung eines Zwischenraums unterhalb der selbstabdichtenden Membran eine zweite durchstechbare Membran angeordnet. Die zweite Membran ist zweckmäßigerweise einstückiger Bestandteil des rohrförmigen Anschlussstücks.In order to prevent the self-sealing membrane in the tubular fitting from contacting the solution contained therein prior to use of the infusion and transfusion bag, a second pierceable membrane is preferably disposed to form a space below the self-sealing membrane. The second diaphragm is expediently an integral part of the tubular connecting piece.

In Versuchen hat sich gezeigt, dass die Verwendung einer nach oben oder unten gewölbten Membran anstelle einer Flachmembran zu einer Erhöhung der Fallfestigkeit führt. Da die zweite Membran nach oben oder unten gekrümmt ausgebildet ist, hält der erfindungsgemäiBe Konnektor relativ großen mechanischen Beanspruchungen stand.Experiments have shown that the use of an upwardly or downwardly curved membrane instead of a flat membrane leads to an increase in the fall resistance. Since the second membrane is curved upward or downward, the connector according to the invention withstands relatively high mechanical stresses.

Neben der Erhöhung der Fallfestigkeit ist noch von Vorteil, dass der Spike in der eingestochenen Position von der gewölbten Membran klemmend gehalten wird. Dadurch wird die Haltekraft des Spike in der Entnahmeposition erhöht, wodurch ein unbeabsichtigtes Herausrutschen verhindert wird.In addition to increasing the drop resistance is also advantageous that the spike is held in the eingochenenen position by the arched membrane clamped. As a result, the holding force of the spike is increased in the removal position, whereby accidental slipping is prevented.

Um Ober- und Unterteil des Anschlussstücks gegen radiale Verdrehung zu sichern, können beide Teile eine Verzahnung oder dergleichen aufweisen, die auch eine exakte Ausrichtung der Teile beim Zusammenpressen sicherstellt. Im übrigen ist beim Zusammenpressen der Einzelteile die Gefahr einer Beschädigung der beiden Membranen besonders gering.In order to secure the upper and lower part of the connecting piece against radial rotation, both parts may have a toothing or the like, which also ensures an exact alignment of the parts during compression. Moreover, the risk of damage to the two membranes is particularly low when compressing the items.

Der abbrechbare Verschlussteil des Konnektors, der als Originalitätsverschluss dient, ist vorzugsweise über eine Ringbruchzone an dem Anschlussteil angeschlossen.The breakable closure part of the connector, which serves as a tamper-evident closure, is preferably connected to the attachment part via a ring-break zone.

Da der abbrechbare Verschlussteil vorzugsweise einen Griffteil aufweist, der nach Art eines nach oben zeigenden Pfeils ausgebildet ist, kann sofort erkannt werden, dass es sich bei dem Konnektor um einen Entnahmeteil, nicht aber einen Zuspritzteil handelt. Vorteilhafterweise ist der Pfeil eine Aussparung in dem Griffteil, die sofort erkennbar ist, ohne dass Beschriftungen oder dergleichen erforderlich sind. Somit können Verwechslungen von Entnahme- und Zuspritzteil einer medizinische Flüssigkeiten enthaltenden Verpackung vermieden werden.Since the break-off closure part preferably has a grip part which is designed in the manner of an arrow pointing upwards, it can immediately be recognized that the connector is a removal part but not an injection part. Advantageously, the arrow is a recess in the handle part, which is immediately recognizable, without labels or the like are required. Thus, confusion of withdrawal and Zusufitzteil a packaging containing medical fluids can be avoided.

Auch der untere Teil des Anschlussstücks weist vorzugsweise einen nach oben weisenden Pfeil auf, der als erhabene Struktur, vorzugsweise in einer Griffmulde ausgebildet ist. Der nach oben weisende Pfeil des unteren Anschlussstückteils erlaubt auch nach dem Abbrechen des Verschlussteils eine eindeutige Zuordnung des Konnektors als Entnahmeteil.Also, the lower part of the connector preferably has an upwardly pointing arrow, which is formed as a raised structure, preferably in a recessed grip. The upward pointing arrow of the lower connector part allows even after canceling the closure part a unique assignment of the connector as a removal part.

Im Folgenden wird ein Ausführungsbeispiel der Erfindung unter Bezugnahme auf die Zeichnungen näher erläutert.In the following an embodiment of the invention will be explained in more detail with reference to the drawings.

Es zeigen:

Figur 1
Einen als Entnahmeteil ausgebildeten Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen in geschnittener Darstellung,
Figur 2
einen Infusionsbeutel mit dem Entnahmeteil von Figur 1 und einem Zuspritzteil und
Figur 3
der Zuspritzteil des Infusionsbeutels von Figur 2 in geschnittener Darstellung.
Show it:
FIG. 1
A cut-away, as a removal part formed connector for medicinal liquids containing packaging,
FIG. 2
an infusion bag with the withdrawal part of FIG. 1 and an injection part and
FIG. 3
the injection part of the infusion bag of FIG. 2 in a cutaway view.

Der als Entnahmeteil ausgebildete Konnektor 20 für medizinische Flüssigkeiten enthaltende Verpackungen, insbesondere Infusions- oder Transfusionsbeutel, weist einen rohrförmigen Anschlussteil 1 auf, der aus einem verpackungsseitigen, unteren Teilstück 2 und einem anschlussseitigen, oberen Teilstück 3 zusammengesetzt ist. Der rohrförmige Anschlussteil 1 weist folglich eine obere und eine untere Öffnung 1a, 1b auf. Der Konnektor 20 ist ein Spritzgießteil aus Polypropylen.The designed as a removal part connector 20 for medical liquid containing packaging, in particular infusion or transfusion bag, has a tubular connection part 1, which is composed of a packaging side, lower portion 2 and a connection-side, upper portion 3. The tubular connection part 1 consequently has an upper and a lower opening 1a, 1b. The connector 20 is an injection molded part made of polypropylene.

Das untere Teilstück 2 des rohrförmigen Anschlussteils 1 weist einen unteren zylindrischen Abschnitt 4 auf, der in einen oberen hülsenförmigen Abschnitt 5 übergeht. Der zylindrische Abschnitt 4 des unteren Teilstücks 2 kann in einen Anschlussstutzen eines Folienbeutels eingeschoben und mit dem Stutzen verschweißt oder verklebt werden oder direkt in den Folienbeutel ohne Stutzen eingeschweißt werden. Der zylindrische Abschnitt 4 ist an seinem oberen Ende mit einer durchstechbaren Membran 6 verschlossen, die einstückiger Bestandteil des unteren Teilstücks 2 ist. Die eingespritzte Membran ist nach unten gekrümmt. Alternativ kann die Membran aber auch nach oben gewölbt sein.The lower portion 2 of the tubular connection part 1 has a lower cylindrical portion 4, which merges into an upper sleeve-shaped portion 5. The cylindrical portion 4 of the lower portion 2 can be inserted into a connecting piece of a film bag and welded or glued to the nozzle or welded directly into the foil bag without nozzle. The cylindrical portion 4 is closed at its upper end with a pierceable membrane 6, which is an integral part of the lower portion 2. The injected membrane is curved downwards. Alternatively, the membrane can also be curved upwards.

Das obere Teilstück 3 des rohrförmigen Anschlussteils 1 ist einschnappend auf dem unteren Teilstück 2 festgelegt, wobei das obere Teilstück 3 einen zylindrischen Abschnitt 7 aufweist, der das untere Teilstück 2 umschließt. Die Innenwand des zylindrischen Abschnitts 7 des oberen Teilstücks 3 weist eine umlaufende Nut 8 auf, in die ein umlaufender Vorsprung 9 an der Außenwand des hülsenförmigen Abschnitts 5 des unteren Teilstücks 2 beim Zusammenpressen der beiden Teilstücke 2, 3 einschnappt.The upper portion 3 of the tubular connection part 1 is set in snapping on the lower portion 2, wherein the upper portion 3 has a cylindrical portion 7 which surrounds the lower portion 2. The inner wall of the cylindrical portion 7 of the upper portion 3 has a circumferential groove 8, in a circumferential projection 9 on the outer wall of the sleeve-shaped portion 5 of the lower portion 2 during compression of the two sections 2, 3 snaps.

Zwischen dem unteren und oberen Teilstück 2, 3 des rohrförmigen Anschlussteils 1 wird eine selbstabdichtende Membran 10 aus einem elastischen Material, die auch als Septum bezeichnet wird, unter elastischer Vorformung derselben klemmend gehalten. Die selbstabdichtende Membran 10 weist einen äußeren Abschnitt 11 auf, der zwischen dem unteren und oberen Teilstück 2, 3 des rohrförmigen Anschlussteils 1 verklemmt ist. An den äußeren Abschnitt 11 schließt sich ein oberes, ringförmiges Teilstück 12 an, das unter Bildung einer muldenförmigen Vertiefung 13 an der Oberseite der Membran 10 in ein unteres tellerförmiges Teilstück 14 übergeht. Im Zentrum 15 ist das tellerförmige Teilstück 14 kreuzweise oder sternförmig vorgeschlitzt, so dass das elastische Material zwar geschwächt, aber nicht durchtrennt ist.Between the lower and upper part 2, 3 of the tubular connection part 1, a self-sealing membrane 10 made of an elastic material, which is also referred to as a septum, held the same under elastic preforming clamping. The self-sealing membrane 10 has an outer portion 11 which is clamped between the lower and upper portion 2, 3 of the tubular connection part 1. The outer portion 11 is followed by an upper, annular portion 12, which merges to form a trough-shaped recess 13 at the top of the membrane 10 in a lower plate-shaped portion 14. In the center 15, the plate-shaped portion 14 is pre-slit crosswise or star-shaped, so that although the elastic material is weakened, but not severed.

An das obere Teilstück 3 des rohrförmigen Anschlussteils 1 schließt sich über eine Ringbruchzone 31 ein kappenförmiger Verschlussteil 16 an, der die obere Öffnung 1a des Anschlussteils 1 verschließt. Der Verschlussteil 16 geht in einen flachen Griffteil 17 über, der mit einer Aussparung 18 in Form eines nach oben zeigenden Pfeils 19 versehen ist. An der Richtung des Pfeils 19 kann sofort erkannt werden, dass es sich bei dem Konnektor 20 nicht um den Zuspritzteil 40, sondern den Entnahmeteil handelt.A cap-shaped closure part 16, which closes the upper opening 1a of the connection part 1, adjoins the upper part 3 of the tubular connection part 1 via a ring breaking zone 31. The closure part 16 merges into a flat grip part 17, which is provided with a recess 18 in the form of an arrow 19 pointing upwards. In the direction of the arrow 19 it can immediately be recognized that the connector 20 is not the injection part 40 but the removal part.

Die Seitenansicht des Konnektors 20 von Figur 1 ist in Figur 2 dargestellt. Figur 2 zeigt einen mit einer Infusionslösung gefüllten Infusionsbeutel 21, der über den Konnektor 20 zur Entnahme der Infusionslösung und einen weiteren Konnektor 40 zum Zuspritzen einer Lösung in den Infusionsbeutel 21 verfügt.The side view of the connector 20 of FIG. 1 is in FIG. 2 shown. FIG. 2 shows an infusion bag filled with an infusion solution 21, which has the connector 20 for taking the infusion solution and another connector 40 for injecting a solution into the infusion bag 21.

An der Außenwand des zylindrischen Abschnitts 7 des oberen Teilstücks 3 weist der rohrförmige Anschlussteil 1 des Konnektors 20 zwei gegenüberliegende Griffmulden 21 auf, die jeweils von vorspringenden Stegen 22 gebildet werden, die im Abstand zueinander angeordnet sind. Zwischen den Stegen 22 ist an der Außenwand des zylindrischen Abschnitts 7 als erhabene Struktur ein weiterer Pfeil 23 ausgebildet, der ebenfalls nach oben zeigt, um den Konnektor 20 als Entnahmeteil auszuweisen.On the outer wall of the cylindrical portion 7 of the upper portion 3, the tubular connection part 1 of the connector 20 on two opposite recessed grips 21, which are each formed by projecting webs 22 which are spaced from each other. Between the webs 22, a further arrow 23 is formed on the outer wall of the cylindrical portion 7 as a raised structure, which also points upwards to identify the connector 20 as a removal part.

Der Infusionsbeutel 21 besteht aus zwei Folienlagen 24, die am unteren und oberen Rand 25, 26 sowie den längslaufenden Rändern 27, 28 miteinander verschweißt sind. In den oberen Rand 25 des Infusionsbeutels sind zwei Anschlussstutzen 29, 30 eingeschweißt. Die rohrförmigen Anschlussstücke des Zuspritz- und Entnahmeteils 40, 20 sind in die Anschlussstutzen 29, 30 eingeschoben und mit den Stutzen beim Sterilisieren verbunden. Die rohrförmigen Anschlussstücke der Originalitätsverschlüsse können aber auch an ein nach Art eines Schiffchens ausgebildetes oder rundes Einsatzstück angeformt sein, das zwischen den zwei Folienlagen eingeschweißt ist.The infusion bag 21 consists of two film layers 24, which are welded together at the lower and upper edges 25, 26 and the longitudinal edges 27, 28. In the upper edge 25 of the infusion bag, two connecting pieces 29, 30 are welded. The tubular connecting pieces of the injection and removal part 40, 20 are inserted into the connecting pieces 29, 30 and connected to the nozzle during sterilization. The tubular connecting pieces of the tamper-evident closures can, however, also be formed on an insert piece designed in the manner of a shuttle or round, which is welded between the two foil layers.

Figur 3 zeigt den Zuspritzteil 40 des Folienbeutels 21 in geschnittener Darstellung. Der Zuspritzteil 40 hat einen ähnlichen Aufbau wie der Entnahmeteil 20. Die einander entsprechenden Teile sind daher mit den gleichen Bezugszeichen versehen. Der Zuspritzteil 40 weist einen rohrförmigen Anschlussteil 1' auf, der aus einem unteren und einem oberen Teilstück 2', 3' zusammengesetzt ist. Die beiden Teilstücke 2', 3' sind unter Zwischenlage einer selbstabdichtenden Membran 10' einschnappend festgelegt, in dem ein vorspringender Ansatz 8' des unteren Teilstücks 2' in eine Nut 9' des oberen Teilstücks 3' greift. In das untere Teilstück 2' ist eine Flachmembran 6' eingespritzt, die aber auch gewölbt sein kann. FIG. 3 shows the Zuspritzteil 40 of the film bag 21 in a sectional view. The injection part 40 has a similar structure as the extraction part 20. The corresponding parts are therefore provided with the same reference numerals. The injection part 40 has a tubular connection part 1 ', which is composed of a lower and an upper portion 2', 3 '. The two sections 2 ', 3' are defined with the interposition of a self-sealing membrane 10 'snapping, in which a projecting lug 8' of the lower portion 2 'in a groove 9' of the upper portion 3 'engages. In the lower portion 2 'is a flat membrane 6' is injected, which may also be curved.

An das obere Teilstück 3' des rohrförmigen Anschlussteils 1' schließt sich wieder über eine Ringbruchzone 31' ein kappenförmiges Abbrechteil 16' an, der in einen flachen Griffteil 17' übergeht. In dem Griffteil 17' ist als Aussparung ein nach unten weisender Pfeil 19' ausgebildet. An der Außenwand des oberen Teilstücks 3' befinden sich wieder innerhalb von Griffmulden 21' nach unten weisende Pfeile 23' zur Kennzeichnung der Flussrichtung.At the upper portion 3 'of the tubular connecting part 1' is followed again via a ring breaking zone 31 'a cap-shaped break-off part 16', which merges into a flat handle portion 17 '. In the grip part 17 ', a downwardly pointing arrow 19' is formed as a recess. On the outer wall of the upper portion 3 'are again within handle recesses 21' downwardly facing arrows 23 'to identify the flow direction.

Zum Entnehmen von Infusionslösung wird der Abbrechteil 16 des Entnahmeteils 20 durch Drehen oder Brechen desselben abgebrochen, so dass die selbstabdichtende Membran 10 freiliegt. In den rohrförmigen Anschlussteil 1 des Entnahmeteils 20 wird nun der Spike eines bekannten Überleitungssystems eingeschoben, wodurch die vorgeschlitzte Membran 10 durchstochen und die nach unten gewölbte Membran 6 durchstoßen wird. Dabei dient die muldenförmige Vertiefung 13 als Führung für den Spike. Der Spike wird mit dem ringförmigen Teilstück t 12 der Membran 10 abgedichtet. Aufgrund der besonderen Ausbildung der eingespritzten Membran 6 wird der Spike fest in dem rohrförmigen Anschlussteil 1 gehalten.To remove infusion solution, the break-off part 16 of the removal part 20 is stopped by turning or breaking it, so that the self-sealing membrane 10 is exposed. In the tubular connection part 1 of the removal part 20, the spike of a known transfer system is now inserted, whereby the pre-slit membrane 10 is pierced and the downwardly curved membrane 6 is pierced. The trough-shaped recess 13 serves as a guide for the spike. The spike will be with the annular portion t 12 of the membrane 10 sealed. Due to the special design of the injected membrane 6, the spike is held firmly in the tubular connection part 1.

Darauf hin kann die Infusionslösung entnommen werden. Wenn der Spike wieder herausgezogen ist, dichtet die selbstabdichtende Membran 10 den Entnahmeteil 20 auch bei einem relativ hohen Innendruck sicher ab. Im übrigen wird mit der besonderen Ausbildung der eingespritzten Membran 6 die mechanische Festigkeit des Entnahmeteils 20 erhöht.Then the infusion solution can be removed. When the spike is pulled out again, the self-sealing membrane 10 seals the dispensing part 20 securely even at a relatively high internal pressure. Moreover, with the special design of the injected membrane 6, the mechanical strength of the removal part 20 is increased.

Der Zuspritzteil 40 dient dazu, der Infusionslösung eine Wirksubstanz zuzuspritzen. Hierzu wird wieder nach Entfernen des Abbrechteils 16' die selbstabdichtende Membran 10' und die eingespritzte Membran 6' mit der Injektionsnadel einer Spritze durchstochen. Nach Herausziehen der Nadel dichtet das Zuspritzteil wieder ab.The injection part 40 serves to inject an active substance into the infusion solution. For this purpose, after removal of the break-off part 16 ', the self-sealing membrane 10' and the injected membrane 6 'are pierced again with the injection needle of a syringe. After pulling out the needle, the injection part seals again.

Claims (3)

  1. Arrangement comprising
    a) a spike as a tubular withdrawal device and
    b) a self-sealing membrane for use in withdrawal sites for containers for medical liquids,
    - with an inner dish-shaped portion (14), which can be penetrated by the spike,
    - with an outer ring-shaped portion (11) for securing the membrane on the withdrawal site and
    - with an inner ring-shaped portion (12), which connects the outer ring-shaped portion (11) to the dish-shaped portion (14), wherein
    - the internal diameter of the inner ring-shaped portion (12) decreases from the outer ring-shaped portion (11) to the inner dish-shaped portion (14),
    - the inner ring-shaped portion (12) and the dish-shaped portion (14) together form a bowl-shaped depression (13) which is designed in such a way that the inner ring-shaped portion (12) sealingly surrounds the spike during the penetration of the dish-shaped portion (14), and
    - the outer ring-shaped portion (11) for securing the membrane on the withdrawal site has a T shape with a stem which merges into the inner ring-shaped portion (12) .
  2. Arrangement according to Claim 1, characterized in that the obliquely inwardly extending face of the inner ring-shaped portion (12) directed towards the spike is composed of an upper, outer straight face and a lower, inner curved face, wherein the upper oblique face has a lesser inclination than the lower oblique face.
  3. Arrangement according to Claim 1 or 2, characterized in that the material of the inner dish-shaped portion (14) is weakened, preferably slit.
EP10002916.4A 2002-05-27 2003-02-24 Connector for packaging containing medical fluids and packaging for medical fluids Expired - Lifetime EP2191807B1 (en)

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EP20030706563 EP1507502B1 (en) 2002-05-27 2003-02-24 Connector for packaging containing medical fluids and packaging for medical fluids

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JP4483037B2 (en) * 2000-06-20 2010-06-16 味の素株式会社 Resin container for enclosing medical liquid and port member
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
US6893428B2 (en) * 2000-11-27 2005-05-17 Benjamin R. Willemstyn Over-wrap bag enclosure for sterile connectors

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023148320A1 (en) * 2022-02-04 2023-08-10 Fresenius Kabi Deutschland Gmbh Infusion bag, and method for producing same

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DE50312773D1 (en) 2010-07-15
JP2005527301A (en) 2005-09-15
US8118802B2 (en) 2012-02-21
CN1655750A (en) 2005-08-17
JP4526382B2 (en) 2010-08-18
AU2003208752B2 (en) 2008-07-10
PL212919B1 (en) 2012-12-31
NO20045169L (en) 2005-02-17
PT1507502E (en) 2010-06-28
HK1081430A1 (en) 2006-05-19
NO328168B1 (en) 2009-12-21
KR20050012753A (en) 2005-02-02
ATE469630T1 (en) 2010-06-15
EP2191807A3 (en) 2011-06-01
DE10223560B4 (en) 2006-01-19
EP1507502A1 (en) 2005-02-23
US20050215943A1 (en) 2005-09-29
DE10223560A1 (en) 2003-12-18
IN2012DN01252A (en) 2015-05-15
EP2191807A2 (en) 2010-06-02
DK1507502T3 (en) 2010-09-20
MXPA04011784A (en) 2005-03-31
CN100398084C (en) 2008-07-02
CA2487551A1 (en) 2003-12-04
ES2343456T3 (en) 2010-08-02
ZA200409019B (en) 2007-08-29
US20110022024A1 (en) 2011-01-27
BRPI0311342B8 (en) 2021-06-22
SI1507502T1 (en) 2010-10-29
WO2003099191A1 (en) 2003-12-04
KR100944420B1 (en) 2010-02-26
EP1507502B1 (en) 2010-06-02
AU2003208752A1 (en) 2003-12-12
CA2487551C (en) 2014-05-20
AU2003208752B8 (en) 2008-07-31
BR0311342B1 (en) 2013-12-31
PL373496A1 (en) 2005-09-05
US7828787B2 (en) 2010-11-09
BR0311342A (en) 2005-03-22

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