EP0975301B1 - Sterile connector - Google Patents

Sterile connector Download PDF

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Publication number
EP0975301B1
EP0975301B1 EP98922774A EP98922774A EP0975301B1 EP 0975301 B1 EP0975301 B1 EP 0975301B1 EP 98922774 A EP98922774 A EP 98922774A EP 98922774 A EP98922774 A EP 98922774A EP 0975301 B1 EP0975301 B1 EP 0975301B1
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EP
European Patent Office
Prior art keywords
connector
coupler
membrane
sterile connector
protective cap
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
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EP98922774A
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German (de)
French (fr)
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EP0975301A1 (en
Inventor
Bernd Knierbein
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Fresenius SE and Co KGaA
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Fresenius SE and Co KGaA
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Publication of EP0975301A1 publication Critical patent/EP0975301A1/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
    • 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

Definitions

  • the invention relates to a sterile connector for connecting a hose line to a container containing a medical liquid, in particular a container filled with a liquid for enteral nutrition.
  • a foil bag for medical fluids with a sterile connector for connecting a hose line is known from US-A-4201406.
  • the bag has a tubular connecting piece which can be pierced with a Membrane is closed.
  • the membrane of the well-known connector is a plastic plate that is an integral part of the connection piece.
  • the hose line to be connected to the connector also has a Spike marked spike.
  • the spike is made of a tubular Surround the body concentrically, which can be pushed onto the connecting piece.
  • the piercing mandrel is inserted into the connecting piece inserted, causing the membrane to be pierced and the fluid connection between the inside of the bag and the hose line connected to the spike will be produced.
  • the film bag can be closed sterile be, however, proves to be disadvantageous that the lying in front of the membrane Part of the connection piece is unprotected. There is therefore a risk that the Piercing the membrane germs are introduced into the bag.
  • DE 2458220 A1 describes a sterile connector that has a tubular Lower part and a tubular upper part comprises a pierceable membrane closes, which is an integral part of the upper part.
  • the lower part of the Connector is welded to the bag and the bag is through the Bottom part opening filled. After filling the bag, the top part inserted in the lower part, whereby the upper and lower part have flanges, that are sealed together.
  • a tear-off cover is provided for the upper part of the connector.
  • EP 0732114 A1 describes a film bag for a liquid for enteralization Nutrition, which is applied to the pouch film from the outside Connector.
  • the essentially tubular connector has on its end of the bag on a flange that is flat on the outside of the bag film rests.
  • the pierceable membrane of the film of the bag itself.
  • connection piece for a flexible film bag known, which is closed by a membrane.
  • the membrane can with a piercing spike integrated in the protective cap Improvement of the gas barrier is proposed as a membrane as a membrane use that is welded to the underside of the connector.
  • the invention is based, one for the sterilization in the task Autoclaves to create a suitable connector that provides high security against Germination of the container offers, easy to handle and large Lots can be produced inexpensively.
  • the pierceable membrane is as a the channel-shaped recess, preferably the entire bottom of the Connection piece covering film formed on the underside of the the bag film is welded weldable connector. Therefore the connector does not need to be attached to the outside of the bag film be, but the connector can be with the inside of the film are welded, as is the case with the known connectors whose Membrane is an integral part of the connector. With such a Welded joint, production security is improved.
  • the protective cap that closes the tubular upper part of the connection piece is designed as a break-off part, the one-piece part of the connector is. Due to the one-piece design, additional processes after the Sterilization, such as drying, disinfecting, screwing etc. are not necessary. This is This is particularly advantageous in the case of flexible packaging, since the effort for additional steps after sterilization is particularly high here.
  • the protective cap Before inserting the piercing mandrel into the channel-shaped recess of the The protective cap is removed from the connector by turning the same canceled. Since the tubular section of the connector only now exposed, there is little risk that when inserting the mandrel Germs are introduced into the container.
  • the protective cap is not only used for bacterial protection of the puncture site, but also provides a tamper-evident seal represents.
  • the membrane film can be sterile with the directly after the injection molding Bottom of the connector are welded so that the space in front of the Membrane is tightly closed. In the event that this weld is not under sterile conditions, a drop of water can enter the closed cavity to be introduced during sterilization evaporates, permitting safe sterilization of the cavity.
  • the membrane film preferably has an oxygen barrier of less than 1 cm 3 / m 2 d bar.
  • the protective cap has a relatively small diameter and the wall of the protective cap in the area of the ring break zone relative is thin-walled, so that the protective cap can be easily broken off. Therefore, at the upper edge of the tubular upper part of the connector circumferential approach, which is followed by a receptacle, that seals the spike.
  • a receptacle for a spike is known from US-A-4523691.
  • the bottom edge of the protective cap, which has a relatively small diameter is with the inside projecting approach connected via a ring fracture zone.
  • the connector according to the invention can be used in medical packaging units different training can be used.
  • a preferred area of application are with a medical fluid, especially a fluid for enteral nutrition, filled foil bags.
  • the connector 1 manufactured as an injection molded part from polypropylene comprises a Connection piece 2 with a lower part 3 designed in the manner of a boat and a tubular upper part 4 and a protective cap 5.
  • the lower part 3 has a tubular section 6 with two radially protruding wing-like approaches 7, 8 is provided, which lie in one plane.
  • the wing-like Lugs 7, 8 carry ribs 9 which are pointed towards the ends of the lugs run.
  • the lower part 3 is known with the inside of the bag film Welded foil bags for medical fluids.
  • the tubular upper part 4, which connects to the lower part 3, is with a External thread 10 provided for screwing on a union nut.
  • the upper part 4 On his upper edge, the upper part 4 has a circumferential, inwardly projecting Approach 11, which in a receptacle 12 for the rotation-proof reception of a Spike passes.
  • the receiving piece 12 has a rectangular shape Cross-section with rounded corners, which corresponds to the cross-section of the spike equivalent.
  • the protective cap closing the upper part 4 of the connector 1 5 is provided in the region of its lower edge with an annular break zone 13 and connected to the inwardly projecting neck 11 of the upper part 4, wherein the protective cap has a cylindrical recess 14.
  • the as a break off part Protective cap 5 is formed with two radially projecting wings 15, 16 Mistake. To open the connector, the protective cap 5 is about its longitudinal axis rotated so that the wall of the annular weakening zone 13th breaks.
  • the channel-shaped recess 17 of the connector 1 is closed with a film 18 which has an oxygen permeability less than 1 cm 3 / m 2 d bar.
  • the membrane film 18 is welded to the underside of the lower connector part 3. It extends almost over the entire lower surface of the connector and is enclosed by a peripheral edge 3a.
  • Figure 4 shows the connector assembly consisting of the connector 1 and the spike 19 with spigot 20.
  • the tubular spike 19 has a tip 21 at one end and can be attached to it the other end with a plastic tube, not shown in the figures of a hose line system, which is in the upper approach 22nd of the piercing mandrel 19 is inserted.
  • the spike seals against from the inner receptacle 12 of the connector top 4.
  • the piercing mandrel 19 has a circumferential one Edge 23, which is in the retracted position of the mandrel on the supports the upper edge of the connector upper part 4.
  • the union nut 20 is on ribbed on the outside. The nut is against losing by one circumferential web 24 on the hose-side end piece 22 of the piercing mandrel 19 secured.
  • FIG. 5 shows the connector arrangement with pierced membrane film 18 and screwed union nut 20.
  • the circumferential neck 23 on the outside the piercing mandrel 19 is in this position between the tubular Connector upper part 4 and the inwardly projecting edge 25 of the union nut 20 jammed. In this position the tip of the spike extends through the membrane film into the inside of the bag.
  • FIG. 6 shows a foil bag which is filled with a medical liquid for the enteral nutrition is filled.
  • the bag consists of two superimposed, at their edges welded together plastic films 26, which have a sealing layer made of polypropylene on the inside and with the Lower part 3 of the connector 1 of the connector are welded. After this Twisting off the protective cap 5 is connected to a hose system Spike inserted and tightened by means of the union nut, whereby the fluid connection between the inside of the bag and the tube system will be produced.

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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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Bag Frames (AREA)

Description

Die Erfindung betrifft einen sterilen Konnektor zum Anschluß einer Schlauchleitung an einen Behälter, der eine medizinische Flüssigkeit enthält, insbesondere an einen Behälter, der mit einer Flüssigkeit zur enteralen Ernährung befüllt ist.The invention relates to a sterile connector for connecting a hose line to a container containing a medical liquid, in particular a container filled with a liquid for enteral nutrition.

Ein Folienbeutel für medizinische Flüssigkeiten mit einem sterilen Konnektor zum Anschluß einer Schlauchleitung ist aus der US-A-4201406 bekannt. Der Beutel weist einen schlauchförmigen Anschlußstutzen auf, der mit einer durchstechbaren Membran verschlossen ist. Die Membran des bekannten Konnektors ist ein Kunststoffplättchen, das einstückiger Bestandteil des Anschlußstutzens ist. Die an den Konnektor anzuschließende Schlauchleitung weist einen auch als Spike bezeichneten Einstechdorn auf. Der Spike wird von einem rohrförmigen Körper konzentrisch umgeben, der sich auf den Anschlußstutzen aufschieben läßt. Zum Anschluß der Schlauchleitung wird der Einstechdorn in den Anschlußstutzen eingeschoben, wodurch die Membran durchstochen und die Fluidverbindung zwischen dem Beutelinneren und der an den Spike angeschlossenen Schlauchleitung hergestellt wird.A foil bag for medical fluids with a sterile connector for connecting a hose line is known from US-A-4201406. The The bag has a tubular connecting piece which can be pierced with a Membrane is closed. The membrane of the well-known connector is a plastic plate that is an integral part of the connection piece. The hose line to be connected to the connector also has a Spike marked spike. The spike is made of a tubular Surround the body concentrically, which can be pushed onto the connecting piece. To connect the hose line, the piercing mandrel is inserted into the connecting piece inserted, causing the membrane to be pierced and the fluid connection between the inside of the bag and the hose line connected to the spike will be produced.

Mit dem bekannten Konnektor kann der Folienbeutel zwar steril verschlossen werden, als nachteilig erweist sich jedoch, daß der vor der Membran liegende Teil des Anschlußstutzens ungeschützt ist. Somit besteht die Gefahr, daß beim Durchstechen der Membran Keime in den Beutel eingebracht werden.With the known connector, the film bag can be closed sterile be, however, proves to be disadvantageous that the lying in front of the membrane Part of the connection piece is unprotected. There is therefore a risk that the Piercing the membrane germs are introduced into the bag.

Es sind auch Konnektoren mit lösbaren Kunststoffverschlüssen, z.B. Schraubkappen, bekannt. In der Praxis hat sich jedoch gezeigt, daß beim Sterilisieren von mit Schraubkappen verschlossenen Konnektoren im Autoklaven die Gefahr der Undichtigkeit besteht. Daher werden vielfach O-Ringe aus Silikon eingesetzt, die während der Sterilisation auftretende Spalte abdichten. Nachteilig ist, daß Silikonringe in Bezug auf die erforderliche Reinheit des Materials verhältnismäßig aufwendig in der Herstellung sind. Ferner wird die Montage der Konnektoren durch die zusätzlichen Dichtelemente erschwert.There are also connectors with detachable plastic closures, e.g. screw caps, known. In practice, however, it has been shown that when sterilizing connectors sealed with screw caps in the autoclave There is a leak. Therefore, O-rings made of silicone are often used Seal gaps that occur during sterilization. The disadvantage is that silicone rings relative to the required purity of the material are complex to manufacture. Furthermore, the assembly of the connectors complicated by the additional sealing elements.

Die DE 2458220 A1 beschreibt einen sterilen Konnektor, der ein rohrförmiges Unterteil und ein rohrförmiges Oberteil umfaßt, das eine durchstechbare Membran verschließt, die einstückiger Bestandteil des Oberteils ist. Das Unterteil des Anschlußstücks wird mit dem Beutel verschweißt und der Beutel wird durch die Öffnung des Unterteils befüllt. Nach dem Befüllen des Beutels wird das Oberteil in das Unterteil eingesetzt, wobei Ober- und Unterteil über Flansche verfügen, die miteinander versiegelt werden. Zum Abdecken der Einstichöffnung ist an dem Oberteil des Anschlußstücks ein abreißbarer Verschlußdeckel vorgesehen.DE 2458220 A1 describes a sterile connector that has a tubular Lower part and a tubular upper part comprises a pierceable membrane closes, which is an integral part of the upper part. The lower part of the Connector is welded to the bag and the bag is through the Bottom part opening filled. After filling the bag, the top part inserted in the lower part, whereby the upper and lower part have flanges, that are sealed together. To cover the puncture opening is on the A tear-off cover is provided for the upper part of the connector.

Die EP 0732114 A1 beschreibt einen Folienbeutel für eine Flüssigkeit zur enteralen Ernährung, der über einen von außen auf die Beutelfolie aufgebrachten Konnektor verfügt. Der im wesentlichen rohrförmige Konnektor weist an seinem beutelseitigen Ende einen Flansch auf, der flach auf der Außenseite der Beutelfolie aufliegt. Bei dem bekannten Konnektor wird die durchstechbare Membran von der Folie des Beutels selbst gebildet. Beim Einschieben des Einstechdorns in den Konnektor wird die Beutelfolie durchstoßen, so daß die Fluidverbindung zum Beutelinneren hergestellt ist. Zur Sicherung des Einstechdorns ist eine Überwurfmutter vorgesehen, die mit dem rohrförmigen Konnektor verschraubt wird.EP 0732114 A1 describes a film bag for a liquid for enteralization Nutrition, which is applied to the pouch film from the outside Connector. The essentially tubular connector has on its end of the bag on a flange that is flat on the outside of the bag film rests. In the known connector, the pierceable membrane of the film of the bag itself. When inserting the spike into the Connector is pierced through the bag film, so that the fluid connection to Bag interior is made. A union nut is used to secure the spike provided, which is screwed to the tubular connector.

Folienbeutel mit einem Konnektor, dessen Membran aus der Beutelfolie selbst besteht, werden im allgemeinen aseptisch befüllt, d.h. die Beutel werden nach der Befüllung nicht mehr im Autoklaven sterilisiert. Ein Vorteil derartiger Folienbeutel liegt in der verbesserten Gasundurchlässigkeit des gesamten Gebindes, da der Beutelinhalt vollständig von der gasdichten Folie verschlossen ist. Nachteilig ist jedoch, daß sich der im allgemeinen aus Polyethylen bestehende Konnektor nicht mit der im allgemeinen aus PET (Polyethylenterephthalat) bestehenden Außenschicht der Beutelfolie verschweißen, sondern nur verkleben läßt. Eine derartige Klebeverbindung führt aber im allgemeinen zu einer schlechteren Produktionssicherheit als eine Schweißverbindung.Foil bags with a connector, the membrane of which is made from the bag foil itself are generally filled aseptically, i.e. the bags are after the Filling no longer sterilized in an autoclave. An advantage of such foil bags lies in the improved gas impermeability of the entire container, since the The contents of the bag are completely sealed by the gas-tight film. The disadvantage is however, that the connector, which is generally made of polyethylene, is not with the outer layer generally made of PET (polyethylene terephthalate) the bag film welded, but only lets glue. A however, such an adhesive connection generally leads to a poorer one Production security as a welded joint.

Aus der als nächstliegender Stand der Technik geltenden EP-A-0 493 723 ist ein Anschlußstück für einen flexiblen Folienbeutel bekannt, das von einer Membran verschlossen ist. Die Membran kann mit einem in der Schutzkappe integrierten Einstechdorn durchstochen werden Zur Verbesserung der Gasbarriere wird vorgeschlagen, als Membran eine Folie zu verwenden, die mit der Unterseite des Anschlußstücks verschweißt ist.From the EP-A-0 493 723, which is considered to be the closest prior art, there is a connection piece for a flexible film bag known, which is closed by a membrane. The membrane can with a piercing spike integrated in the protective cap Improvement of the gas barrier is proposed as a membrane as a membrane use that is welded to the underside of the connector.

Der Erfindung liegt die Aufgabe zugrunde, einen für die Sterilisation im Autoklaven geeigneten Konnektor zu schaffen, der eine hohe Sicherheit gegen Verkeimen des Behälters bietet, sich leicht handhaben und in großen Stückzahlen kostengünstig herstellen läßt.The invention is based, one for the sterilization in the task Autoclaves to create a suitable connector that provides high security against Germination of the container offers, easy to handle and large Lots can be produced inexpensively.

Die Lösung dieser Aufgabe erfolgt erfindungsgemäß mit den im Patentanspruch 1 angegebenen Merkmalen.This object is achieved with the im Claim 1 specified features.

Bei dem Konnektor gemäß der Erfindung ist die durchstechbare Membran als ein die kanalförmige Ausnehmung, vorzugsweise die gesamte Unterseite des Anschlußstücks abdeckende Folie ausgebildet, die auf die Unterseite des mit der Beutelfolie verschweißbaren Anschlußstücks aufgeschweißt ist. Daher braucht das Anschlußstück nicht an der Außenseite der Beutelfolie befestigt zu werden, sondern das Anschlußstück kann mit der Innenseite der Folie verschweißt werden, wie es bei dem bekannten Konnektoren der Fall ist, deren Membran einstückiger Bestandteil des Anschlußstücks ist. Mit einer derartigen Schweißverbindung wird die Produktionssicherheit verbessert.In the connector according to the invention the pierceable membrane is as a the channel-shaped recess, preferably the entire bottom of the Connection piece covering film formed on the underside of the the bag film is welded weldable connector. Therefore the connector does not need to be attached to the outside of the bag film be, but the connector can be with the inside of the film are welded, as is the case with the known connectors whose Membrane is an integral part of the connector. With such a Welded joint, production security is improved.

Ein weiterer Vorteil ist, daß mit der aufgeschweißten Folie, die Gasdichtigkeit gegenüber dem bekannten Folienbeuteln deutlich verbessert wird, sofern die aufgeschweißte Folie eine höhere Gasdichtigkeit hat, als das Material, aus dem die Membran der bekannten Konnektoren besteht. Die Folienmembran kann aus gasdichten Kunststoffen wie EVOH (Ethylenvinylalkoholcopolymere) oder auch Beschichtungen von Foliensubstraten wie SiOx oder AlOx bestehen. Another advantage is that with the welded film, the gas tightness is significantly improved compared to the known film bags, provided that the welded film has a higher gas tightness than the material from which the membrane of the known connectors is made. The film membrane can consist of gas-tight plastics such as EVOH (ethylene vinyl alcohol copolymers) or also coatings on film substrates such as SiO x or AlO x .

Die Schutzkappe, die das rohrförmige Oberteil des Anschlußstücks verschließt, ist als Abbrechteil ausgebildet, das einstückiger Bestandteil des Anschlußstücks ist. Aufgrund der einstückigen Ausführung können zusätzliche Prozesse nach der Sterilisation, wie Trocknen, Desinfizieren, Aufschrauben etc. entfallen. Dies ist insbesondere bei flexiblen Verpackungen von Vorteil, da der Aufwand für zusätzliche Schritte nach der Sterilisation hier besonders hoch ist.The protective cap that closes the tubular upper part of the connection piece is designed as a break-off part, the one-piece part of the connector is. Due to the one-piece design, additional processes after the Sterilization, such as drying, disinfecting, screwing etc. are not necessary. This is This is particularly advantageous in the case of flexible packaging, since the effort for additional steps after sterilization is particularly high here.

Vor dem Einführen des Einstechdorns in die kanalförmige Ausnehmung des Anschlußstücks wird die Schutzkappe von dem Anschlußstück durch Drehen derselben abgebrochen. Da der rohrförmige Abschnitt des Anschlußstücks erst jetzt freiliegt, besteht eine nur geringe Gefahr, daß beim Einführen des Dorns Keime in den Behälter eingebracht werden. Die Schutzkappe dient nicht nur zum bakteriellen Schutz der Einstichstelle, sondern stellt auch einen Originalitätsverschluß dar.Before inserting the piercing mandrel into the channel-shaped recess of the The protective cap is removed from the connector by turning the same canceled. Since the tubular section of the connector only now exposed, there is little risk that when inserting the mandrel Germs are introduced into the container. The protective cap is not only used for bacterial protection of the puncture site, but also provides a tamper-evident seal represents.

Von Vorteil ist, daß zum dichten Abschluß des Anschlußstücks keine elastomeren Bauteile wie Silikon-O-Ringe benötigt werden, die mit größerem Herstell- und Montageaufwand verbunden sind, und daß die Sortenreinheit der gesamten Konnektoranordnung gewährleistet ist. Gegenüber Konnektoren mit einstückiger Membran, die über eine abbrechbare Schutzkappe verfügen, ist die Herstellung des erfindungsgemäßen Konnektors auch deshalb vereinfacht, da das im Spritzgießverfahren herzustellende Bauteil keine Kavitäten aufweist. Nach dem Spritzgießen kann das Anschlußstück in der Verschlußkappe ohne weiteres entformt werden, da die Membranfolie, die die kanalförmige Ausnehmung verschließt, erst nach der Entformung des Anschlußstücks aufgeschweißt wird.The advantage is that no elastomeric to seal the connector Components such as silicone O-rings are required, which have a larger manufacturing and Assembly costs are connected, and that the variety of the whole Connector arrangement is guaranteed. Compared to connectors with one-piece Membrane that have a breakable protective cap is the manufacture of the connector according to the invention also simplified because this is in the injection molding process Component to be manufactured has no cavities. After injection molding can easily demold the connector in the cap are, because the membrane film that closes the channel-shaped recess, only after the demolding of the connector is welded on.

Die Membranfolie kann direkt nach dem Spritzgießen im sterilen Zustand mit der Unterseite des Anschlußstücks verschweißt werden, so daß der Raum vor der Membran dicht verschlossen ist. Für den Fall, daß diese Verschweißung nicht unter sterilen Bedingungen erst später erfolgt, kann ein Wassertropfen in den abgeschlossenen Hohlraum eingebracht werden, der während der Sterilisation verdampft und so die sichere Sterilisation des Hohlraumes erlaubt.The membrane film can be sterile with the directly after the injection molding Bottom of the connector are welded so that the space in front of the Membrane is tightly closed. In the event that this weld is not under sterile conditions, a drop of water can enter the closed cavity to be introduced during sterilization evaporates, permitting safe sterilization of the cavity.

Zur signifikanten Verbesserung der Gasbarriere weist die Membranfolie vorzugsweise eine Sauerstoffbarriere kleiner als 1 cm3/m2 d bar auf.To significantly improve the gas barrier, the membrane film preferably has an oxygen barrier of less than 1 cm 3 / m 2 d bar.

Vorteilhaft ist, wenn die Schutzkappe einen relativ kleinen Durchmesser hat und die Wand der Schutzkappe im Bereich der Ringbruchzone relativ dünnwandig ausgebildet ist, so daß sich die Schutzkappe leicht abbrechen läßt. Daher ist am oberen Rand des rohrförmigen Oberteils des Anschlußstücks ein umlaufender Ansatz vorgesehen, an den sich ein Aufnahmestück anschließt, das den Einstechdorn abdichtend aufnimmt. Ein Aufnahmestück für einen Einstechdorn ist aus der US-A-4523691 bekannt. Der untere Rand der Schutzkappe, die einen relativ kleinen Durchmesser hat, ist mit dem nach innen vorspringenden Ansatz über eine Ringbruchzone verbunden.It is advantageous if the protective cap has a relatively small diameter and the wall of the protective cap in the area of the ring break zone relative is thin-walled, so that the protective cap can be easily broken off. Therefore, at the upper edge of the tubular upper part of the connector circumferential approach, which is followed by a receptacle, that seals the spike. A receptacle for a spike is known from US-A-4523691. The bottom edge of the protective cap, which has a relatively small diameter is with the inside projecting approach connected via a ring fracture zone.

Das Anschlußstück mit dem Abbrechteil ist vorteilhafterweise ein Spritzgießteil aus Polypropylen, so daß sich die bekannten Beutelfolien, die eine Siegelschicht an ihrer Innenseite aus dem gleichen Material aufweisen, ohne weiteres mit dem Anschlußstück verschweißen lassen. Die miteinander verschweißten Teile weisen einen höheren Schmelzpunkt als die Sterilisationstemperatur auf und können daher im Autoklaven sterilisiert werden.The connector with the break-off part is advantageously an injection molded part made of polypropylene, so that the well-known pouch films, the one Sealing layer on the inside of the same material without have another welded to the connector. The one with the other welded parts have a higher melting point than that Sterilization temperature and can therefore be sterilized in an autoclave become.

In einer weiteren bevorzugten Ausführungsform weist die Schutzkappe sich in radialer Richtung erstreckende Flügel auf, so daß sich diese leicht greifen und das zum Abbrechen derselben erforderliche Drehmoment leicht aufbringen läßt. Die Schutzkappe ist so gestaltet, daß sie auch von ungeübten oder älteren Personen, beispielsweise im Home-Care-Bereich, leicht geöffnet werden kann.In a further preferred embodiment, the protective cap is in radial direction extending wings, so that they grip easily and easily apply the torque required to break it off leaves. The protective cap is designed so that it can also be used by inexperienced or older people People, for example in the home care area, can be easily opened.

Der erfindungsgemäße Konnektor kann in medizinischen Verpackungseinheiten unterschiedlichster Ausbildung Verwendung finden. Ein bevorzugtes Anwendungsgebiet sind mit einer medizinischen Flüssigkeit, insbesondere einer Flüssigkeit für die enterale Ernährung, befüllte Folienbeutel.The connector according to the invention can be used in medical packaging units different training can be used. A preferred area of application are with a medical fluid, especially a fluid for enteral nutrition, filled foil bags.

Im folgenden wird ein Ausführungsbeispiel der Erfindung unter Bezugnahme auf die Zeichnungen näher erläutert.The following is an embodiment of the invention with reference to FIG the drawings explained in more detail.

Es zeigen:

Figur 1
eine bevorzugte Ausführungsform des Konnektors in geschnittener Darstellung,
Figur 2
den Konnektor von Figur 1 in der Draufsicht,
Figur 3
den Konnektor von Figur 1 aus der Ansicht des Pfeils III von Figur 1,
Figur 4
eine bevorzugte Ausführungsform einer Konnektoranordnung bestehend aus dem Konnektor von Figur 1 und einem Einstechdorn mit Überwurfmutter, wobei der Einsiechdorn in das Anschlußstück eingeschoben, die Folienmembran aber noch nicht durchstochen ist,
Figur 5
die Konnektoranordnung von Figur 4, wobei die Folienmembran durchstochen ist und
Figur 6
eine vereinfachte Darstellung eines Folienbeutels mit dem Konnektor von Figur 1.
Show it:
Figure 1
a preferred embodiment of the connector in a sectional view,
Figure 2
1 in top view,
Figure 3
the connector of Figure 1 from the view of arrow III of Figure 1,
Figure 4
1 shows a preferred embodiment of a connector arrangement consisting of the connector from FIG. 1 and a piercing mandrel with a union nut, the piercing mandrel being pushed into the connecting piece, but the film membrane has not yet been pierced,
Figure 5
the connector arrangement of Figure 4, wherein the film membrane is pierced and
Figure 6
a simplified representation of a foil bag with the connector of Figure 1.

Der als Spritzgießteil aus Polypropylen hergestellte Konnektor 1 umfaßt ein Anschlußstück 2 mit einem nach Art eines Schiffchens ausgebildeten Unterteil 3 und einem rohrförmigen Oberteil 4 sowie einer Schutzkappe 5. Das Unterteil 3 weist einen rohrförmigen Abschnitt 6 auf, der mit zwei radial abstehenden flügelartigen Ansätzen 7, 8 versehen ist, die in einer Ebene liegen. Die flügelartigen Ansätze 7, 8 tragen Rippen 9, die zu den Enden der Ansätze hin spitz zulaufen. Das Unterteil 3 wird mit der Innenseite der Beutelfolie der bekannten Folienbeutel für medizinische Flüssigkeiten verschweißt.The connector 1 manufactured as an injection molded part from polypropylene comprises a Connection piece 2 with a lower part 3 designed in the manner of a boat and a tubular upper part 4 and a protective cap 5. The lower part 3 has a tubular section 6 with two radially protruding wing-like approaches 7, 8 is provided, which lie in one plane. The wing-like Lugs 7, 8 carry ribs 9 which are pointed towards the ends of the lugs run. The lower part 3 is known with the inside of the bag film Welded foil bags for medical fluids.

Das rohrförmige Oberteil 4, das sich an das Unterteil 3 anschließt, ist mit einem Außengewinde 10 zum Aufschrauben einer Überwurfmutter versehen. An seinem oberen Rand weist das Oberteil 4 einen umlaufenden, nach innen vorspringenden Ansatz 11 auf, der in ein Aufnahmestück 12 zur verdrehsicheren Aufnahme eines Einstechdorns übergeht. Das Aufnahmestück 12 weist einen rechteckförmigen Querschnitt mit abgerundeten Ecken auf, der dem Querschnitt des Einstechdorns entspricht. Die das Oberteil 4 des Anschlußstücks 1 verschließende Schutzkappe 5 ist im Bereich ihres unteren Randes mit einer Ringbruchzone 13 versehen und mit dem nach innen vorspringenden Ansatz 11 des Oberteils 4 verbunden, wobei die Schutzkappe eine zylindrische Ausnehmung 14 aufweist. Die als Abbrechteil ausgebildete Schutzkappe 5 ist mit zwei radial abstehenden Flügeln 15, 16 versehen. Zum Öffnen des Konnektors wird die Schutzkappe 5 um ihre Längsachse gedreht, so daß deren Wand an der ringförmigen Schwächungszone 13 bricht.The tubular upper part 4, which connects to the lower part 3, is with a External thread 10 provided for screwing on a union nut. On his upper edge, the upper part 4 has a circumferential, inwardly projecting Approach 11, which in a receptacle 12 for the rotation-proof reception of a Spike passes. The receiving piece 12 has a rectangular shape Cross-section with rounded corners, which corresponds to the cross-section of the spike equivalent. The protective cap closing the upper part 4 of the connector 1 5 is provided in the region of its lower edge with an annular break zone 13 and connected to the inwardly projecting neck 11 of the upper part 4, wherein the protective cap has a cylindrical recess 14. The as a break off part Protective cap 5 is formed with two radially projecting wings 15, 16 Mistake. To open the connector, the protective cap 5 is about its longitudinal axis rotated so that the wall of the annular weakening zone 13th breaks.

Die kanalförmige Ausnehmung 17 des Anschlußstücks 1 ist mit einer Folie 18 verschlossen, die eine Sauerstoffdurchlässigkeit kleiner als 1 cm3/m2 d bar aufweist. Die Membranfolie 18 ist mit der Unterseite des Anschlußstückunterteils 3 verschweißt. Sie erstreckt sich nahezu über die gesamte untere Fläche des Anschlußstücks und wird von einem umlaufenden Rand 3a umschlossen.The channel-shaped recess 17 of the connector 1 is closed with a film 18 which has an oxygen permeability less than 1 cm 3 / m 2 d bar. The membrane film 18 is welded to the underside of the lower connector part 3. It extends almost over the entire lower surface of the connector and is enclosed by a peripheral edge 3a.

Figur 4 zeigt die Konnektoranordnung bestehend aus dem Anschlußstück 1 und dem Einstechdorn 19 (Spike) mit Überwurfmutter 20. Der rohrförmige Einstechdorn 19 weist an einem Ende eine Spitze 21 auf und kann mit seinem anderen Ende mit einem in den Figuren nicht dargestellten Kunststoffschlauch eines Schlauchleitungssystems verbunden werden, der in den oberen Ansatz 22 des Einstechdorns 19 eingeschoben wird. Der Einstechdorn dichtet gegenüber dem inneren Aufnahmestück 12 des Anschlußstückoberteils 4 ab.Figure 4 shows the connector assembly consisting of the connector 1 and the spike 19 with spigot 20. The tubular spike 19 has a tip 21 at one end and can be attached to it the other end with a plastic tube, not shown in the figures of a hose line system, which is in the upper approach 22nd of the piercing mandrel 19 is inserted. The spike seals against from the inner receptacle 12 of the connector top 4.

Unterhalb des Schlauchanschlußes 22 weist der Einstechdorn 19 einen umlaufenden Rand 23 auf, der sich in der eingeschobenen Stellung des Dorns an dem oberen Rand des Anschlußstückoberteils 4 abstützt. Die Überwurfmutter 20 ist an ihrer Außenseite gerippt. Gegen Verlieren ist die Überwurfmutter durch einen umlaufenden Steg 24 an dem schlauchseitigen Endstück 22 des Einstechdorns 19 gesichert.Below the hose connection 22, the piercing mandrel 19 has a circumferential one Edge 23, which is in the retracted position of the mandrel on the supports the upper edge of the connector upper part 4. The union nut 20 is on ribbed on the outside. The nut is against losing by one circumferential web 24 on the hose-side end piece 22 of the piercing mandrel 19 secured.

Beim Aufschrauben der Überwurfmutter 20 wird der Einstechdorn in axialer Richtung auf die Membranfolie 21 zubewegt, wobei diese durchstochen wird. Figur 5 zeigt die Konnektoranordnung mit durchstochener Membranfolie 18 und aufgeschraubter Überwurfmutter 20. Der umlaufende Ansatz 23 an der Außenseite des Einstechdorns 19 ist in dieser Position zwischen dem rohrförmigen Anschlußstückoberteil 4 und dem nach innen vorspringenden Rand 25 der Überwurfmutter 20 verklemmt. In dieser Position erstreckt sich die Spitze des Einstechdorns durch die Membranfolie hindurch in das Beutelinnere.When the union nut 20 is screwed on, the piercing mandrel becomes axial Moved towards the membrane film 21, which is pierced. FIG. 5 shows the connector arrangement with pierced membrane film 18 and screwed union nut 20. The circumferential neck 23 on the outside the piercing mandrel 19 is in this position between the tubular Connector upper part 4 and the inwardly projecting edge 25 of the union nut 20 jammed. In this position the tip of the spike extends through the membrane film into the inside of the bag.

Figur 6 zeigt einen Folienbeutel, der mit einer medizinischen Flüssigkeit für die enterale Ernährung gefüllt ist. Der Beutel besteht aus zwei übereinanderliegenden, an ihren Rändern miteinander verschweißten Kunststoffolien 26, die auf ihrer Innenseite eine Siegelschicht aus Polypropylen aufweisen und mit dem Unterteil 3 des Anschlußstücks 1 des Konnektors verschweißt sind. Nach dem Abdrehen der Schutzkappe 5 wird der mit einem Schlauchsystem verbundene Einstechdorn eingeschoben und mittels der Überwurfmutter festgezogen, wodurch die Fluidverbindung zwischen dem Beutelinneren und dem Schlauchsystem hergestellt wird.FIG. 6 shows a foil bag which is filled with a medical liquid for the enteral nutrition is filled. The bag consists of two superimposed, at their edges welded together plastic films 26, which have a sealing layer made of polypropylene on the inside and with the Lower part 3 of the connector 1 of the connector are welded. After this Twisting off the protective cap 5 is connected to a hose system Spike inserted and tightened by means of the union nut, whereby the fluid connection between the inside of the bag and the tube system will be produced.

Claims (7)

  1. Sterile connector for linking a pipe to a tank containing a medicinal liquid,
    with a coupler (2) that is provided with a channel-type cavity (17) sealed by a pierce-through membrane (18), whereby the pierce-through membrane (18) is formed as a foil covering the channel-type cavity (17), which is welded to the lower side of the coupler and whereby the coupler has a lower section (3) that can be inserted into the tank wall and sealed against the tank wall, and a tubular upper section (4) to take a push-in pin to which the pipe is connected, and whereby a protective cap (5) intended as a stop element is provided that closes a tubular upper section (4) of the coupler (2), characterised in that the upper edge of the tubular upper section (4) has an inwards-directed annular shoulder (11) to which a holder (12) is joined that takes and seals the push-in pin, whereby the lower edge of the protective cap (5) is connected to the annular shoulder (11) and provided with an annular break zone (13) in the area of its lower edge.
  2. Sterile connector according to claim 1, characterised in that the foil has an oxygen barrier of less than 1 cm3/m2 d bar.
  3. Sterile connector according to claim 1 or 2, characterised in that the coupler (2) and the protective cap (5) are made of polypropylene.
  4. Sterile connector according to one of claims 1 to 3, characterised in that a border (3a) surrounding the foil is provided on the underside of the coupler.
  5. Sterile connector according to one of claims 1 to 4, characterised in that the tubular upper section (4) of the coupler (2) is provided with an external thread (10) to which a union nut (20) can be screwed.
  6. Tank with a sterile connector (1) according to one of claims 1 to 5.
  7. Tank in according to claim 6, characterised in that the tank is a foil bag filled with a medicinal liquid, particularly a liquid for intestinal feeding.
EP98922774A 1997-04-26 1998-04-24 Sterile connector Expired - Lifetime EP0975301B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19717765A DE19717765C1 (en) 1997-04-26 1997-04-26 Sterile connector and foil pouch with a sterile connector
DE19717765 1997-04-26
PCT/EP1998/002438 WO1998048765A1 (en) 1997-04-26 1998-04-24 Sterile connector

Publications (2)

Publication Number Publication Date
EP0975301A1 EP0975301A1 (en) 2000-02-02
EP0975301B1 true EP0975301B1 (en) 2002-07-31

Family

ID=7827891

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98922774A Expired - Lifetime EP0975301B1 (en) 1997-04-26 1998-04-24 Sterile connector

Country Status (10)

Country Link
US (1) US6485479B1 (en)
EP (1) EP0975301B1 (en)
JP (1) JP2001522280A (en)
KR (1) KR100502245B1 (en)
CN (1) CN1232240C (en)
AR (1) AR011468A1 (en)
BR (1) BR9809308A (en)
DE (2) DE19717765C1 (en)
ES (1) ES2181221T3 (en)
WO (1) WO1998048765A1 (en)

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Also Published As

Publication number Publication date
JP2001522280A (en) 2001-11-13
WO1998048765A1 (en) 1998-11-05
DE19717765C1 (en) 1999-02-25
KR20010020210A (en) 2001-03-15
DE59805003D1 (en) 2002-09-05
CN1232240C (en) 2005-12-21
CN1253489A (en) 2000-05-17
EP0975301A1 (en) 2000-02-02
ES2181221T3 (en) 2003-02-16
BR9809308A (en) 2000-07-04
US6485479B1 (en) 2002-11-26
KR100502245B1 (en) 2005-07-22
AR011468A1 (en) 2000-08-16

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