EP0761198B1 - Percutaneous enteral feeding catheter - Google Patents

Percutaneous enteral feeding catheter Download PDF

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Publication number
EP0761198B1
EP0761198B1 EP96114109A EP96114109A EP0761198B1 EP 0761198 B1 EP0761198 B1 EP 0761198B1 EP 96114109 A EP96114109 A EP 96114109A EP 96114109 A EP96114109 A EP 96114109A EP 0761198 B1 EP0761198 B1 EP 0761198B1
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EP
European Patent Office
Prior art keywords
catheter
connector part
duct
catheter tube
bulb
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP96114109A
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German (de)
French (fr)
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EP0761198A1 (en
Inventor
Rüdiger Ufermann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius SE and Co KGaA
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Fresenius SE and Co KGaA
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Filing date
Publication date
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Publication of EP0761198A1 publication Critical patent/EP0761198A1/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
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0015—Gastrostomy feeding-tubes
    • 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
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0034—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
    • A61J15/0038—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type
    • A61J15/0042—Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type inflatable
    • 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
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0053—Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin
    • A61J15/0065—Fixing means and tube being one part
    • 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
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/0092—Valves on feeding tubes

Definitions

  • the invention relates to a catheter for percutaneous enteral nutrition.
  • Gastrostomy probes for enteral nutrition are known to use of a balloon are secured against slipping out. After the introduction of the Catheter through the stoma into the stomach, the balloon is filled with air from the outside or filled with a liquid. This causes the balloon to expand and closes the stoma from the inside. A movable locking ring that fits on the Probe tube is pulled up, supports the catheter from the outside Abdominal wall.
  • US-A-4,701,163 describes such a catheter for percutaneous enteral Nutrition.
  • the catheter has a catheter tube attached to its proximal end with a connector part for connecting a transfer device or a bladder syringe.
  • the one enveloping the catheter tube The balloon stands in via a channel with a connector Flow connection that protrudes laterally from the connector part.
  • To the A pump or the like can be connected to the connector Fill the balloon with air or a liquid.
  • a valve element in the feed channel switched is to prevent that Filling medium emerges from the balloon.
  • a catheter for percutaneous enteral nutrition which has several connectors for connecting a transfer device and a filling element is also off known from US-A-4,642,092.
  • the invention is based, a relatively simple task to create catheters for percutaneous enteral nutrition, whose support body can have a low overall height.
  • the connector part is for connecting one Filling device, for example a pump or the like., In the support body integrated.
  • the connector part is in one piece with the support body Closure element made of a pierceable, self-sealing material formed, which closes the channel for supplying the filling medium.
  • the Connector part forms in the catheter according to the invention as it were Closure element. It can be made of the same or a different material than the support body are made of a different material Connector part connected to the support body by gluing or welding is.
  • the support body and the connector part preferably consist of same material, especially silicone, so that the support body together can be inexpensively manufactured with the connector part in the injection molding process.
  • the connector part can be designed as a short projecting connector that does not appear disruptive.
  • the wall of the connector part is easy with a Pierce the needle. After removing the needle, the connector part seals the Channel for supplying the medium from airtight or liquid-tight.
  • the connector part is a cylindrical body into which the channel to Feeding the filling medium extends.
  • the connector part is preferred Part of a flexible tab made of a plate-shaped element protrudes, which can be placed on the abdominal wall. The channel to The filling medium then extends through the connector part the tab, the plate-shaped element and the wall of the Catheter tube right into the balloon. That of the plate-shaped element protruding tab can be easily gripped by hand to fill the medium inject.
  • the Connector part not only a means for feeding a filling medium, but also provides a captive secured to the plate-shaped element Closure element, with which the channel for feeding the nutrient solution can be closed tightly.
  • the balloon is advantageously through an annular space in the wall of the Catheter tube formed.
  • the catheter tube can be used as an injection molded part a wall slotted in the axial direction, the distal end of the outer tube wall with the distal end of the inner Hose wall is glued or welded.
  • a tubular body from the catheter tube elastic material to put on at its upper and lower edges the catheter tube is glued or welded.
  • the catheter tube is provided with a plurality of balloons arranged one above the other, which each extend over part of the length of the catheter tube.
  • Each balloon is via a channel with a separate connector part connected so that the balloons are filled individually with the filling medium can.
  • either one or the other balloon filled can also be provided only in an annular space, which differs from the extends the lower edge of the support plate to the lip valve. If in the Annually air is blown, only the part of the catheter tube expands balloon-like that protrudes into the gastric lumen. The other part has in Stoma channel a sealing function.
  • the connector parts are advantageously on the plate-shaped element of the support body appropriate.
  • one of the connector parts can be an integral part of the Be tab to a closure element for the channel for feeding the To get nutrient solution.
  • Outer wall of the balloon made of two superimposed layers different material, with the inner layer of one flexible, sealing material and the outer layer of a harder Material than the inner layer is made of.
  • the harder outer skin gives that Balloon the necessary stability and resistance. This will reduce the service life extended.
  • the two layers are preferably not flat with one another connected, but only at their upper and lower edges glued or welded so that they move against each other can.
  • To ensure the necessary flexibility is advantageously between the inner and outer layers of the Balloon outer wall a gel-like, evenly distributed mass locked in.
  • the support body has the entire surface on the abdominal wall advantageously projecting elements on its underside, in particular Pimples on.
  • the catheter according to the invention is preferably a suitable for that Connector part of the support body attachable adapter piece provided to the a filling element, e.g. a pump or syringe can be connected.
  • a filling element e.g. a pump or syringe
  • the adapter piece is integrated with a cannula, which the connector part at Attaching the adapter piece to create a flow connection between the balloon and the filler that can be connected to the adapter pierces. Since the cannula is integrated into the adapter piece, Avoid injuries.
  • the arrangement consisting of the catheter and the adapter piece comprises in an advantageous embodiment still a rod-shaped stylet, the front the catheter is inserted into the catheter tube. This gives the catheter tube the necessary for insertion Stability.
  • the catheter has a circular disc shape on the abdominal wall of the Patient support plate 1, from which a catheter tube 2 extends.
  • Channel 3 of the catheter tube for supplying a nutrient solution in the gastric lumen is at its distal end with a lip valve 4 closed, the two extending from the distal end of the tube Has lips 5.5 ', which lie close together.
  • the lip valve 4 allows a liquid flow from the catheter tube 2 into the Gastric lumen, however, reverse fluid flow is not possible.
  • the circular disc-shaped support plate 1 and the catheter tube 2 with the Lip valve 4 consist of a flexible material, preferably silicone. Numerous knobs 30 are provided on the underside of the support plate 1.
  • a filling medium e.g. Air or a liquid
  • Reference numeral 7 designates the circumferential adhesive point at which the lower one End of the outer tube wall of the slit in the axial direction Catheter tube forming the annulus with the inner one Hose wall is glued.
  • a cylindrical Molded connector part 9 which consists of a pierceable, self-sealing Material, preferably the same material, e.g. Silicone like that Support plate, the tab and the catheter tube.
  • a cylindrical shaft 10 is formed, which in a channel 11 opens, which is through the tab 8 and the hose wall 12 of the Catheter extends into the annular space 6.
  • a cylindrical recess 24 provided to which the channel 3 of the catheter tube 2 for feeding a nutrient solution.
  • the inside diameter of the recess 24 corresponds to the outer diameter of the molded on the tab 8 Connector part 9, so that this to close the filling opening in the Recess can be inserted.
  • the catheter arrangement further comprises an adapter piece 13 for the connection a syringe to inflate the balloon.
  • One end piece of the adapter piece 13 is a Luer lock connector 14 with a funnel-shaped recess 15 and an external thread 16, while the other end piece with a cylindrical recess 17 is provided so that the adapter piece 13 fit onto the cylindrical connector part 9 of the catheter 1 leaves.
  • the catheter-side connector part 9 and the recess 17 of the adapter piece 13 can also be conical.
  • a pointed cannula 19 used, which extends into the cylinder space 17 and a Flow connection between the conical recess 15 and the produces cylindrical recess 17.
  • the adapter piece 13 is opened the connector part 9 attached to the catheter, the cannula 19 Connector part 9 pierces and into the connector shaft 10 of the tab 8 penetrates.
  • a conventional syringe is attached to the Luer lock connector 14 or a hose line connected to an air pump. Then the Balloon filled with air and the adapter piece 13 is pulled off again, whereby the opening in the connector part 9 closes again in a self-sealing manner.
  • the Adapter piece 13 can also be in a syringe or in the connecting part Pump be integrated.
  • the Catheter arrangement still a stylet 20, which consists of a round with a External thread 20 'provided rod 21 with a handle 22.
  • the rod 21 of the stylet has a cylindrical one Paragraph 23, which with the stylet inserted in the recess 24 in Center of the support plate 1 sits.
  • the channel 3 of the catheter tube 2 to Feeding the nutrient solution is provided with an internal thread 25.
  • FIG. 3 shows the distal end piece of the catheter tube 31 of another Embodiment of the catheter
  • Fig. 4 shows the catheter in plan view shows.
  • the catheter differs from that with reference to that in FIG the fig. 1 and 2 embodiments described in that Catheter tube are formed two superimposed balloons that can be inflated individually and an individual adjustment of the shaft length allow.
  • Figs. 3 and 4 are the parts of the catheter that correspond to the parts of the Embodiment according to FIGS. 1 and 2 correspond with the same Provide reference numerals.
  • the two annular spaces 6 ', 6 "of the balloons are in each case via a channel in the hose wall which cannot be seen in FIG. 3 12 connected to a connector part.
  • the lower annular space 6 stands with Connector part 9 on the tab 8 of the catheter in connection.
  • Connector part 9 is a second connector part 26 on the support plate provided (Fig. 4).
  • the outer wall of the balloon consists of two superimposed layers 27, 28 of different materials.
  • the inner layer 27 consists of a flexible sealing material and the outer layer 28 of a harder material than the inner layer.
  • the the two layers are not flat with one another in the region of the annular space connected.
  • a gel-like material 29 is between the layers 27, 28 included to increase flexibility.
  • the harder outer skin gives the balloon the necessary stability and resistance.

Abstract

A supporting body (1) placed on the stomach has a catheter hose (2) protruding from it and with a feed passage (3) for the nutrient solution. A balloon (6) on the hose is supplied via a connector (9) and passage (11) from a filler unit (13). The connector is formed by a sealing component integral with the body and of puncturable self-sealing material, and which seals off the passage (11). It can have a cylindrical body into which the passage extends. The supporting body can comprise a flat component from which a flexible lug (8) protrudes and on which the connector is situated. The passage (11) delivering the filler medium (13) can pass from the connector through the lug, the flat component and the catheter hose wall into the balloon (6).

Description

Die Erfindung betrifft einen Katheter für die perkutane enterale Ernährung.The invention relates to a catheter for percutaneous enteral nutrition.

Es sind Gastrostomie-Sonden zur enteralen Ernährung bekannt, die mittels eines Ballons gegen Herausrutschen gesichert sind. Nach Einführung des Katheters durch das Stoma in den Magen wird der Ballon von außen mit Luft oder einer Flüssigkeit gefüllt. Dadurch weitet sich der Ballon auf und verschließt das Stoma von innen. Ein bewegbarer Verschlußring, der auf den Sondenschlauch aufgezogen ist, stützt den Katheter von außen an der Bauchdecke ab.Gastrostomy probes for enteral nutrition are known to use of a balloon are secured against slipping out. After the introduction of the Catheter through the stoma into the stomach, the balloon is filled with air from the outside or filled with a liquid. This causes the balloon to expand and closes the stoma from the inside. A movable locking ring that fits on the Probe tube is pulled up, supports the catheter from the outside Abdominal wall.

US-A-4,701,163 beschreibt einen derartigen Katheter für die perkutane enterale Ernährung. Der Katheter weist einen Katheterschlauch auf, der an seinem proximalen Ende mit einem Konnektorteil zum Anschluß eines Überleitgerätes oder einer Blasenspritze versehen ist. Der den Katheterschlauch umhüllende Ballon steht über einen Kanal mit einem Anschlußstück in Strömungsverbindung, das seitlich von dem Konnektorteil absteht. An dem Anschlußstück kann eine Pumpe oder dgl. angeschlossen werden, um den Ballon mit Luft oder einer Flüssigkeit zu befüllen. Um zu verhindern, daß das Füllmedium aus dem Ballon austritt, ist in den Zuführkanal ein Ventilelement geschaltet. US-A-4,701,163 describes such a catheter for percutaneous enteral Nutrition. The catheter has a catheter tube attached to its proximal end with a connector part for connecting a transfer device or a bladder syringe. The one enveloping the catheter tube The balloon stands in via a channel with a connector Flow connection that protrudes laterally from the connector part. To the A pump or the like can be connected to the connector Fill the balloon with air or a liquid. To prevent that Filling medium emerges from the balloon is a valve element in the feed channel switched.

Ein Katheter für die perkutane enterale Ernährung, der mehrere Konnektoren zum Anschluß eines Überleitgeräts und eines Füllorgans aufweist, ist auch aus der US-A-4,642,092 bekannt.A catheter for percutaneous enteral nutrition, which has several connectors for connecting a transfer device and a filling element is also off known from US-A-4,642,092.

Die bekannten Katheter der oben genannten Art haben sich in der Praxis bewährt. Als störend wird jedoch, der aus der Bauchdecke herausragende Katheterschlauch mit den Konnektoren und dem Ventilelement empfunden.The known catheters of the type mentioned above have been put into practice proven. However, the one that protrudes from the abdominal wall is annoying Perceived catheter tube with the connectors and the valve element.

Neben den Kathetern, die einen bewegbaren Verschlußring aufweisen, sind noch Sonden mit einem auf die Bauchdecke auflegbaren Stützkörper bekannt. Diese Katheter haben den Nachteil, daß der Stützkörper insbesondere wegen den Abmessungen des Ventilelements eine relativ große Bauhöhe aufweist. Als nachteilig erweist sich ferner der relativ große Aufwand bei der Herstellung des Katheters, der auf den Anschluß des aus mehreren Teilen bestehenden Ventilelements an den Stützkörper zurückzuführen ist.In addition to the catheters, which have a movable locking ring still known probes with a support body which can be placed on the abdominal wall. These catheters have the disadvantage that the support body in particular because the dimensions of the valve element has a relatively large overall height. As Another disadvantage is the relatively large outlay in production of the catheter that connects to the multi-part connector Valve element is due to the support body.

Der Erfindung liegt die Aufgabe zugrunde, einen relativ einfach herzustellenden Katheter für die perkutane enterale Ernährung zu schaffen, dessen Stützkörper eine geringe Bauhöhe aufweisen kann.The invention is based, a relatively simple task to create catheters for percutaneous enteral nutrition, whose support body can have a low overall height.

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 erfindungsgemäßen Katheter ist der Konnektorteil zum Anschluß eines Füllorgans, beispielsweise einer Pumpe oder dgl., in den Stützkörper integriert. Der Konnektorteil ist als mit dem Stützkörper einstückiges Verschlußelement aus einem durchstechbaren, selbstdichtenden Material ausgebildet, das den Kanal zum Zuführen des Füllmediums verschließt. Der Konnektorteil bildet bei dem erfindungsgemäßen Katheter gleichsam das Verschlußelement. Er kann aus dem gleichen oder einem anderen Material als der Stützkörper bestehen, wobei der aus einem anderen Material bestehende Konnektorteil durch Klebung oder Schweißung mit dem Stützkörper verbunden ist. Vorzugsweise bestehen der Stützkörper und der Konnektorteil aus dem gleichen Material, insbesondere Silikon, so daß sich der Stützkörper zusammen mit dem Konnektorteil kostengünstig im Spritzgießverfahren herstellen läßt. Der Konnektorteil kann als kurzes vorstehendes Anschlußstück ausgebildet werden, das nicht störend in Erscheinung tritt.In the catheter according to the invention, the connector part is for connecting one Filling device, for example a pump or the like., In the support body integrated. The connector part is in one piece with the support body Closure element made of a pierceable, self-sealing material formed, which closes the channel for supplying the filling medium. The Connector part forms in the catheter according to the invention as it were Closure element. It can be made of the same or a different material than the support body are made of a different material Connector part connected to the support body by gluing or welding is. The support body and the connector part preferably consist of same material, especially silicone, so that the support body together can be inexpensively manufactured with the connector part in the injection molding process. The connector part can be designed as a short projecting connector that does not appear disruptive.

Um den Ballon des erfindungsgemäßen Katheters mit Luft oder einem flüssigen Medium zu befüllen, wird die Wandung des Konnektorteils einfach mit einer Nadel durchstoßen. Nach Entfernen der Nadel dichtet der Konnektorteil den Kanal zum Zuführen des Mediums wieder luft- bzw. flüssigkeitsdicht ab.Around the balloon of the catheter according to the invention with air or a liquid To fill medium, the wall of the connector part is easy with a Pierce the needle. After removing the needle, the connector part seals the Channel for supplying the medium from airtight or liquid-tight.

Bei einer bevorzugten Ausführungsform des erfindungsgemäßen Katheters ist der Konnektorteil ein zylinderischer Körper, in den sich der Kanal zum Zuführen des Füllmediums erstreckt. Der Konnektorteil ist vorzugsweise Bestandteil einer flexiblen Lasche, die von einem plattenförmigen Element absteht, das auf die Bauchdecke aufgelegt werden kann. Der Kanal zum Zuführen des Füllmediums erstreckt sich dann von dem Konnektorteil durch die Lasche, das plattenförmige Element und die Wandung des Katheterschlauchs bis in den Ballon. Die von dem plattenförmigen Element abstehende Lasche läßt sich leicht mit der Hand fassen, um das Füllmedium zu injizieren.In a preferred embodiment of the catheter according to the invention the connector part is a cylindrical body into which the channel to Feeding the filling medium extends. The connector part is preferred Part of a flexible tab made of a plate-shaped element protrudes, which can be placed on the abdominal wall. The channel to The filling medium then extends through the connector part the tab, the plate-shaped element and the wall of the Catheter tube right into the balloon. That of the plate-shaped element protruding tab can be easily gripped by hand to fill the medium inject.

In einer weiteren bevorzugten Ausführungsform ist in dem plattenförmigen Element des Stützkörpers eine in den Kanal zum Zuführen der Nährlösung übergehende zylindrische Ausnehmung vorgesehen, die derart ausgebildet ist, daß der an der flexiblen Lasche vorgesehene Konnektorteil passend in die Ausnehmung eingesteckt werden kann. Bei dieser Ausführungsform bildet der Konnektorteil nicht nur ein Mittel zum Zuführen eines Füllmediums, sondern stellt auch eine unverlierbar an dem plattenförmigen Element gesichertes Verschlußelement dar, mit dem sich der Kanal zum Zuführen der Nährlösung dicht verschließen läßt.In a further preferred embodiment is in the plate-shaped Element of the support body one in the channel for feeding the nutrient solution Transitional cylindrical recess is provided, which is designed such that the connector part provided on the flexible tab fits into the Recess can be inserted. In this embodiment, the Connector part not only a means for feeding a filling medium, but also provides a captive secured to the plate-shaped element Closure element, with which the channel for feeding the nutrient solution can be closed tightly.

Der Ballon wird vorteilhafterweise durch einen Ringraum in der Wandung des Katheterschlauchs gebildet. Der Katheterschlauch kann als Spritzgießteil mit einer in axialer Richtung geschlitzten Wandung hergestellt werden, wobei das distale Ende der äußeren Schlauchwandung mit dem distalen Ende der inneren Schlauchwandung verklebt oder verschweißt wird. Alternativ ist es aber auch möglich, über den Katheterschlauch einen schlauchförmigen Körper aus elastischem Material zu stülpen, der an seinem oberen und unteren Rand mit dem Katheterschlauch verklebt oder verschweißt wird.The balloon is advantageously through an annular space in the wall of the Catheter tube formed. The catheter tube can be used as an injection molded part a wall slotted in the axial direction, the distal end of the outer tube wall with the distal end of the inner Hose wall is glued or welded. Alternatively, it is possible, a tubular body from the catheter tube elastic material to put on at its upper and lower edges the catheter tube is glued or welded.

Um eine sichere Fixierung des Katheters auch bei unterschiedlichen Stomalängen zu ermöglichen, sind in einer bevorzugten Ausführungsform an dem Katheterschlauch mehrere übereinander angeordnete Ballone vorgesehen, die sich jeweils über einen Teil der Länge des Katheterschlauchs erstrecken. Jeder Ballon ist über einen Kanal mit einem separaten Konnektorteil verbunden, so daß die Ballone einzeln mit dem Füllmedium gefüllt werden können. In Abhängigkeit von der Länge des Stomas wird entweder der eine oder der andere Ballon gefüllt. Zur Anpassung an unterschiedliche Stomalängen kann aber auch nur ein Ringraum vorgesehen sein, der sich vom unteren Rand der Stützplatte bis zum Lippenventil erstreckt. Wenn in den Ringraum Luft geblasen wird, dehnt sich nur der Teil des Katheterschlauchs ballonartig aus, der in das Magenlumen ragt. Der andere Teil hat im Stomakanal eine dichtende Funktion.In order to securely fix the catheter even with different In a preferred embodiment, enabling ostomy lengths are available the catheter tube is provided with a plurality of balloons arranged one above the other, which each extend over part of the length of the catheter tube. Each balloon is via a channel with a separate connector part connected so that the balloons are filled individually with the filling medium can. Depending on the length of the stoma, either one or the other balloon filled. To adapt to different However, stoma lengths can also be provided only in an annular space, which differs from the extends the lower edge of the support plate to the lip valve. If in the Annually air is blown, only the part of the catheter tube expands balloon-like that protrudes into the gastric lumen. The other part has in Stoma channel a sealing function.

Bei einem Katheter, der mehrere Ballone aufweist, sind die Konnektorteile vorteilhafterweise an dem plattenförmigen Element des Stützkörpers angebracht. Einer der Konnektorteile kann jedoch einstückiger Bestandteil der Lasche sein, um ein Verschlußelement für den Kanal zum Zuführen der Nährlösung zu erhalten. In the case of a catheter that has several balloons, the connector parts are advantageously on the plate-shaped element of the support body appropriate. However, one of the connector parts can be an integral part of the Be tab to a closure element for the channel for feeding the To get nutrient solution.

In vorteilhafter Ausgestaltung des erfindungsgemäßen Katheters wird die Außenwand des Ballons aus zwei übereinanderliegenden Schichten unterschiedlichen Materials gebildet, wobei die innere Schicht aus einem flexiblen, abdichtenden Material und die äußere Schicht aus einem härteren Material als die innere Schicht besteht. Die härtere Außenhaut verleiht dem Ballon die notwendige Stabilität und Resistenz. Dadurch wird die Standzeit verlängert. Die beiden Schichten sind vorzugsweise nicht flächig miteinander verbunden, sondern nur an ihren oberen und unteren Rändern miteinander verklebt oder verschweißt, so daß sich diese gegeneinander verschieben können. Um die erforderliche Flexibilität zu gewährleisten, ist vorteilhafterweise zwischen der inneren und äußeren Schicht der Ballonaußenwand eine gelartige, sich gleichmäßig verteilende Masse eingeschlossen.In an advantageous embodiment of the catheter according to the invention Outer wall of the balloon made of two superimposed layers different material, with the inner layer of one flexible, sealing material and the outer layer of a harder Material than the inner layer is made of. The harder outer skin gives that Balloon the necessary stability and resistance. This will reduce the service life extended. The two layers are preferably not flat with one another connected, but only at their upper and lower edges glued or welded so that they move against each other can. To ensure the necessary flexibility is advantageously between the inner and outer layers of the Balloon outer wall a gel-like, evenly distributed mass locked in.

Damit im Sinne einer ausreichenden Belüftung der Stützkörper nicht ganzflächig auf der Bauchdecke aufliegt, weist der Stützkörper vorteilhafterweise an seiner Unterseite vorspringende Elemente, insbesondere Noppen auf.So that in the sense of adequate ventilation of the support body not The support body has the entire surface on the abdominal wall advantageously projecting elements on its underside, in particular Pimples on.

Zur Erhöhung der Sicherheit und zur Vereinfachung der Handhabung des erfindungsgemäßen Katheters ist vorzugsweise ein passend auf das Konnektorteil des Stützkörpers aufsteckbares Adapterstück vorgesehen, an das ein Füllorgan, z.B. eine Pumpe oder Spritze, angeschlossen werden kann. In das Adapterstück ist eine Kanüle integriert, die den Konnektorteil beim Aufsetzen des Adapterstücks zur Herstellung einer Strömungsverbindung zwischen dem Ballon und dem an das Adapterstück anschließbaren Füllorgan durchstößt. Da die Kanüle in das Adapterstück integriert ist, werden Verletzungen vermieden.To increase security and simplify the handling of the The catheter according to the invention is preferably a suitable for that Connector part of the support body attachable adapter piece provided to the a filling element, e.g. a pump or syringe can be connected. In the adapter piece is integrated with a cannula, which the connector part at Attaching the adapter piece to create a flow connection between the balloon and the filler that can be connected to the adapter pierces. Since the cannula is integrated into the adapter piece, Avoid injuries.

Die aus dem Katheter und dem Adapterstück bestehende Anordnung umfaßt in einer vorteilhaften Ausführungsform noch einen stabförmigen Mandrin, der vor dem Verlegen des Katheters in den Katheterschlauch eingeschoben wird. Dieser verleiht dem Katheterschlauch die für das Einführen erforderliche Stabilität.The arrangement consisting of the catheter and the adapter piece comprises in an advantageous embodiment still a rod-shaped stylet, the front the catheter is inserted into the catheter tube. This gives the catheter tube the necessary for insertion Stability.

Es hat sich gezeigt, daß sich beim Einschieben eines stabförmigen Mandrin in einen flexiblen Katheterschlauch sich derselbe leicht wellenförmig verformt. Eine derartige Verformung des Katheterschlauchs kann dadurch vermieden werden, daß der Katheterschlauch mit einem Innengewinde und der stabförmige Mandrin mit einem Außengewinde versehen ist. Der stabförmige Mandrin läßt sich dann in den Katheterschlauch einschrauben, wobei die Steigung des Gewindes derart bemessen sein sollte, daß nur wenige Umdrehungen erforderlich sind.It has been shown that when inserting a rod-shaped stylet in a flexible catheter tube which deforms slightly in a wavy manner. Such a deformation of the catheter tube can be avoided be that the catheter tube with an internal thread and the rod-shaped stylet is provided with an external thread. The rod-shaped The stylet can then be screwed into the catheter tube, the The pitch of the thread should be such that only a few Revolutions are required.

Im folgenden werden mehrere Ausführungsbeispiele der Erfindung unter Bezugnahme auf die Zeichnungen näher erläutert.The following are several embodiments of the invention Reference to the drawings explained in more detail.

Es zeigen:

Fig. 1
eine bevorzugte Ausführungsform der Katheteranordnung umfassend Katheter, Adapterstück und Mandrin in schematischer Darstellung,
Fig. 2
den Katheter von Fig. 1 in der Draufsicht,
Fig. 3
einen Schnitt durch den Katheterschlauch einer weiteren Ausführungsform des Katheters,
Fig. 4
den Katheter der Ausführungsform von Fig. 3 in der Draufsicht und
Fig. 5
einen Ausschnitt des Ringraums einer Ausführungsform des Katheterschlauchs, bei der die Außenwandung des Ballons aus zwei Materialschichten besteht.
Show it:
Fig. 1
a preferred embodiment of the catheter arrangement comprising catheter, adapter piece and stylet in a schematic representation,
Fig. 2
1 in top view,
Fig. 3
3 shows a section through the catheter tube of a further embodiment of the catheter,
Fig. 4
the catheter of the embodiment of Fig. 3 in plan view and
Fig. 5
a section of the annular space of an embodiment of the catheter tube, in which the outer wall of the balloon consists of two layers of material.

Der Katheter weist eine kreisscheibenförmige sich an der Bauchdecke des Patienten abstützende Platte 1 auf, von der sich ein Katheterschlauch 2 erstreckt. Der Kanal 3 des Katheterschlauchs zum Zuführen einer Nährlösung in das Magenlumen ist an seinem distalen Ende mit einem Lippenventil 4 verschlossen, das zwei sich von dem distalen Ende des Schlauchs erstreckende Lippen 5,5' aufweist, die dicht aufeinanderliegen. Das Lippenventil 4 erlaubt zwar eine Flüssigkeitsströmung aus dem Katheterschlauch 2 in das Magenlumen, eine umgekehrte Flüssigkeitsströmung ist jedoch nicht möglich. Die kreisscheibenförmige Stützplatte 1 und der Katheterschlauch 2 mit dem Lippenventil 4 bestehen aus einem flexiblen Material, vorzugsweise Silikon. An der Unterseite der Stützplatte 1 sind zahlreiche Noppen 30 vorgesehen.The catheter has a circular disc shape on the abdominal wall of the Patient support plate 1, from which a catheter tube 2 extends. Channel 3 of the catheter tube for supplying a nutrient solution in the gastric lumen is at its distal end with a lip valve 4 closed, the two extending from the distal end of the tube Has lips 5.5 ', which lie close together. The lip valve 4 allows a liquid flow from the catheter tube 2 into the Gastric lumen, however, reverse fluid flow is not possible. The circular disc-shaped support plate 1 and the catheter tube 2 with the Lip valve 4 consist of a flexible material, preferably silicone. Numerous knobs 30 are provided on the underside of the support plate 1.

An dem distalen Endstück des Katheterschlauchs 2 ist in dessen Schlauchwandung ein Ringraum 6 ausgebildet, der mit einem Füllmedium, z.B. Luft oder einer Flüssigkeit, gefüllt wird, so daß sich der Katheterschlauch in seinem unteren Teil nach Art eines Ballons aufweitet. Mit dem Bezugszeichen 7 ist die umlaufende Klebestelle bezeichnet, an der das untere Ende der äußeren Schlauchwandung des in axialer Richtung geschlitzten Katheterschlauchs unter Bildung des Ringraums mit der inneren Schlauchwandung verklebt ist.At the distal end of the catheter tube 2 is in the An annular space 6 formed with a filling medium, e.g. Air or a liquid, is filled so that the catheter tube expands in the lower part like a balloon. With the Reference numeral 7 designates the circumferential adhesive point at which the lower one End of the outer tube wall of the slit in the axial direction Catheter tube forming the annulus with the inner one Hose wall is glued.

Von der Stützplatte 1 des Katheters erstreckt sich in radialer Richtung eine flexible Lasche 8 mit rechteckförmigem Querschnitt, die mit der Stützplatte 1 einstückig ist. An dem freien Ende der Lasche 8 ist ein zylindrisches Konnektorteil 9 angeformt, das aus einem durchstechbaren, selbstdichtenden Material, vorzugsweise dem gleichen Material, z.B. Silikon, wie die Stützplatte, die Lasche und der Katheterschlauch besteht. In dem zylindrischen Konnektorteil 9 ist ein zylindrischer Schacht 10 ausgebildet, der in einen Kanal 11 mündet, der sich durch die Lasche 8 und die Schlauchwandung 12 des Katheters in den Ringraum 6 erstreckt. One extends from the support plate 1 of the catheter in the radial direction flexible tab 8 with a rectangular cross section, which with the support plate 1 is in one piece. At the free end of the tab 8 is a cylindrical Molded connector part 9, which consists of a pierceable, self-sealing Material, preferably the same material, e.g. Silicone like that Support plate, the tab and the catheter tube. In the cylindrical Connector part 9, a cylindrical shaft 10 is formed, which in a channel 11 opens, which is through the tab 8 and the hose wall 12 of the Catheter extends into the annular space 6.

Im Zentrum der Stützplatte 1 des Katheters ist eine zylindrische Ausnehmung 24 vorgesehen, an die sich der Kanal 3 des Katheterschlauchs 2 zum Zuführen einer Nährlösung anschließt. Der Innendurchmesser der Ausnehmung 24 entspricht dem Außendurchmesser des an der Lasche 8 angeformten Konnektorteils 9, so daß dieser zum Verschließen der Füllöffnung in die Ausnehmung eingesteckt werden kann.In the center of the support plate 1 of the catheter is a cylindrical recess 24 provided to which the channel 3 of the catheter tube 2 for feeding a nutrient solution. The inside diameter of the recess 24 corresponds to the outer diameter of the molded on the tab 8 Connector part 9, so that this to close the filling opening in the Recess can be inserted.

Die Katheteranordnung umfaßt ferner ein Adapterstück 13 für den Anschluß einer Spritze zum Aufblasen des Ballons. Das eine Endstück des Adapterstücks 13 ist als Luer-Lock-Konnektor 14 mit einer trichterförmigen Ausnehmung 15 und einem Außengewinde 16 ausgebildet, während das andere Endstück mit einer zylindrischen Ausnehmung 17 versehen ist, so daß sich das Adapterstück 13 passend auf den zylindrischen Konnektorteil 9 des Katheters 1 aufstecken läßt. Zur besseren Abdichtung können der katheterseitige Konnektorteil 9 und die Ausnehmung 17 des Adapterstücks 13 auch konisch geformt sein.The catheter arrangement further comprises an adapter piece 13 for the connection a syringe to inflate the balloon. One end piece of the adapter piece 13 is a Luer lock connector 14 with a funnel-shaped recess 15 and an external thread 16, while the other end piece with a cylindrical recess 17 is provided so that the adapter piece 13 fit onto the cylindrical connector part 9 of the catheter 1 leaves. For better sealing, the catheter-side connector part 9 and the recess 17 of the adapter piece 13 can also be conical.

In dem Steg 18 zwischen der konischen Ausnehmung 15 und der zylindrischen Ausnehmung 17 des Adapterstücks 13 ist eine angespitzte Kanüle 19 eingesetzt, die sich bis in den Zylinderraum 17 erstreckt und eine Strömungsverbindung zwischen der konischen Ausnehmung 15 und der zylindrischen Ausnehmung 17 herstellt.In the web 18 between the conical recess 15 and the cylindrical Recess 17 of adapter piece 13 is a pointed cannula 19 used, which extends into the cylinder space 17 and a Flow connection between the conical recess 15 and the produces cylindrical recess 17.

Nach dem Einführen des Katheterschlauchs 2 wird das Adapterstück 13 auf den katheterseitigen Konnektorteil 9 aufgesteckt, wobei die Kanüle 19 den Konnektorteil 9 durchstößt und in den Konnektorschacht 10 der Lasche 8 eindringt. An den Luer-Lock-Anschlußteil 14 wird eine herkömmliche Spritze oder eine Schlauchleitung mit einer Luftpumpe angeschlossen. Dann wird der Ballon mit Luft gefüllt und das Adapterstück 13 wird wieder abgezogen, wobei sich die Öffnung im Konnektorteil 9 wieder selbstdichtend verschließt. Das Adapterstück 13 kann aber auch in eine Spritze oder in den Anschlußteil einer Pumpe integriert sein. After the catheter tube 2 has been inserted, the adapter piece 13 is opened the connector part 9 attached to the catheter, the cannula 19 Connector part 9 pierces and into the connector shaft 10 of the tab 8 penetrates. A conventional syringe is attached to the Luer lock connector 14 or a hose line connected to an air pump. Then the Balloon filled with air and the adapter piece 13 is pulled off again, whereby the opening in the connector part 9 closes again in a self-sealing manner. The Adapter piece 13 can also be in a syringe or in the connecting part Pump be integrated.

Um den Katheterschlauch 2 einführen zu können, umfaßt die Katheteranordnung noch einen Mandrin 20, der aus einem runden mit einem Außengewinde 20' versehenen Stab 21 mit einem Griffteil 22 besteht. Unterhalb des Griffteils 22 weist der Stab 21 des Mandrin einen zylindrischen Absatz 23 auf, der bei eingesetztem Mandrin in der Ausnehmung 24 im Zentrum der Stützplatte 1 sitzt. Der Kanal 3 des Katheterschlauchs 2 zum Zuführen der Nährlösung ist mit einem Innengewinde 25 versehen. Vor dem Einführen des Katheterschlauchs wird der Mandrin in das Lumen des Schlauchs eingeschraubt, so daß der Schlauch seine Flexibilität verliert.In order to be able to insert the catheter tube 2, the Catheter arrangement still a stylet 20, which consists of a round with a External thread 20 'provided rod 21 with a handle 22. Below the grip part 22, the rod 21 of the stylet has a cylindrical one Paragraph 23, which with the stylet inserted in the recess 24 in Center of the support plate 1 sits. The channel 3 of the catheter tube 2 to Feeding the nutrient solution is provided with an internal thread 25. Before the The stylet is inserted into the lumen of the catheter tube Screwed hose so that the hose loses its flexibility.

Fig. 3 zeigt das distale Endstück des Katheterschlauchs 31 einer weiteren Ausführungsform des Katheters, während Fig. 4 den Katheter in der Draufsicht zeigt. Der Katheter unterscheidet sich von dem unter Bezugnahme auf die in den Fign. 1 und 2 beschriebenen Ausführungsbeispielen dadurch, daß in dem Katheterschlauch zwei übereinander angeordnete Ballone ausgebildet sind, die sich einzeln aufblasen lassen und eine individuelle Anpassung der Schaftlänge erlauben. In den Fign. 3 und 4 sind die Teile des Katheters, die den Teilen der Ausführungsform gemäß der Fign. 1 und 2 entsprechen, mit den gleichen Bezugszeichen versehen. Die beiden Ringräume 6', 6" der Ballone sind jeweils über einen in Fig. 3 nicht erkennbaren Kanal in der Schlauchwandung 12 mit einem Konnektorteil verbunden. Der untere Ringraum 6' steht mit dem Konnektorteil 9 an der Lasche 8 des Katheters in Verbindung. Zum Befüllen des oberen Ringraums 6" ist ein zweiter Konnektorteil 26 an der Stützplatte vorgesehen (Fig. 4). Je nach der Länge des Magenstomas kann nach dem Einführen des Katheters entweder der untere oder der obere Ballon aufgeblasen werden.3 shows the distal end piece of the catheter tube 31 of another Embodiment of the catheter, while Fig. 4 shows the catheter in plan view shows. The catheter differs from that with reference to that in FIG the fig. 1 and 2 embodiments described in that Catheter tube are formed two superimposed balloons that can be inflated individually and an individual adjustment of the shaft length allow. In Figs. 3 and 4 are the parts of the catheter that correspond to the parts of the Embodiment according to FIGS. 1 and 2 correspond with the same Provide reference numerals. The two annular spaces 6 ', 6 "of the balloons are in each case via a channel in the hose wall which cannot be seen in FIG. 3 12 connected to a connector part. The lower annular space 6 'stands with Connector part 9 on the tab 8 of the catheter in connection. For filling of the upper annular space 6 "is a second connector part 26 on the support plate provided (Fig. 4). Depending on the length of the gastric stoma, after the Inserting the catheter inflated either the lower or the upper balloon become.

Fig. 5 zeigt einen Ausschnitt einer weiteren Ausführungsform des Katheterschlauchs im Bereich des Ringraums 6. Bei diesem Ausführungsbeispiel besteht die Außenwand des Ballons aus zwei übereinanderliegenden Schichten 27, 28 unterschiedlichen Materials. Die innere Schicht 27 besteht aus einem flexiblen abdichtenden Material und die äußere Schicht 28 aus einem härteren Material als die innere Schicht. Die beiden Schichten sind im Bereich des Ringraums nicht flächig miteinander verbunden. Zwischen den Schichten 27, 28 ist ein gelartiges Material 29 eingeschlossen, um die Flexibilität zu erhöhen. Die härtere Außenhaut verleiht dem Ballon die notwendige Stabilität und Resistenz.5 shows a section of a further embodiment of the Catheter tube in the area of the annulus 6. In this In the exemplary embodiment, the outer wall of the balloon consists of two superimposed layers 27, 28 of different materials. The inner layer 27 consists of a flexible sealing material and the outer layer 28 of a harder material than the inner layer. The the two layers are not flat with one another in the region of the annular space connected. A gel-like material 29 is between the layers 27, 28 included to increase flexibility. The harder outer skin gives the balloon the necessary stability and resistance.

Claims (13)

  1. A catheter for percutaneous enteral feeding with
    a support member (1) adapted to be laid on the abdominal wall,
    extending from the support member (1), a catheter tube (2) with a duct (3) for transporting a nutrient solution,
    at least one bulb provided on the catheter tube (2) and
    at least one connector part (9) for connecting a filling member by a duct (11) to the bulb for establishing flow,
    characterised in that for connecting the filling member, the connector part (9) is constructed from a pierceable self-sealing material as an occluding element integral with the support member (1) and which occludes the duct (11) for feeding the filling medium.
  2. A catheter according to claim 1, characterised in that the connector part (9) is a cylindrical body into which extends the duct (11) for feeding the filling medium.
  3. A catheter according to claim 1 or 2, characterised in that the support member comprises a plate-shaped element (1) adapted to be placed on the abdominal wall and, projecting from the said element, a flexible tab (8) on which the connector part (9) is provided, whereby the duct (11) for feeding the filling medium extends from the connector part (9) through the tab (8), the plate-shaped element (1) and the walls of the catheter tube (2) and into the bulb.
  4. A catheter according to claim 3, characterised in that there is in the plate-shaped element (1) of the support member an merging into the duct (3) for transporting the nutrient solution a cylindrical recess (24) which is so constructed that the connector part (9) provided on the flexible tab (8) can be fitted into the recess.
  5. A catheter according to one of claims 1 to 4, characterised in that the bulb is formed by an annular space (6) in the walls of the catheter tube (2).
  6. A catheter according to one of claims 1 to 5, characterised in that there are on the catheter tube (2) a plurality of superposed bulbs which are in each case connected by a duct to in each case a connector part (9, 26) so that the bulbs can be individually filled with filling medium.
  7. A catheter according to one of claims 1 to 6, characterised in that the outer wall of the bulb consists of two superposed layers (27, 28) of different material, the inner layer (27) consisting of a flexible sealing material while the outer layer (28) of the outer wall of the bulb consists of a harder material than the inner layer.
  8. A catheter according to claim 7, characterised in that a gel-like mass (29) is enclosed between the inner layer (27) and the outer layer (28) of the outer wall of the bulb.
  9. A catheter according to one of claims 1 to 8, characterised in that a lip valve (4) occluding the duct (3) for transporting nutrient solution is disposed at the distal end of the catheter tube (2).
  10. A catheter according to one of claims 3 to 9, characterised in that the plate-shaped element (1) of the support member has on its under side projecting elements (30), particularly knobs.
  11. A catheter arrangement with a catheter according to one of claims 1 to 10 and an adaptor piece (13) which can be fitted onto the connector part of the support member for connecting a filling member, whereby a cannula (19) is so integrated into the adaptor piece that when the adaptor piece is fitted on, the connector part is pierced to form a flow connection between the bulb and the filling member which is adapted to be connected to the adaptor piece.
  12. A catheter arrangement according to claim 11, characterised in that the catheter arrangement comprises a rod-shaped mandrel (20) which can be pushed into the catheter tube (2).
  13. A catheter arrangement according to claim 12, characterised in that the rod-shaped mandrel (20) has an external screw thread (20') and the duct (3) of the catheter tube (2) is provided with an internal screw thread (25).
EP96114109A 1995-09-12 1996-09-04 Percutaneous enteral feeding catheter Expired - Lifetime EP0761198B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19533749A DE19533749A1 (en) 1995-09-12 1995-09-12 Stoma gastrostomy probe with flat retention plate and optional variable shaft length
DE19533749 1995-09-12

Publications (2)

Publication Number Publication Date
EP0761198A1 EP0761198A1 (en) 1997-03-12
EP0761198B1 true EP0761198B1 (en) 2001-12-12

Family

ID=7771946

Family Applications (1)

Application Number Title Priority Date Filing Date
EP96114109A Expired - Lifetime EP0761198B1 (en) 1995-09-12 1996-09-04 Percutaneous enteral feeding catheter

Country Status (7)

Country Link
EP (1) EP0761198B1 (en)
AT (1) ATE210419T1 (en)
DE (2) DE19533749A1 (en)
DK (1) DK0761198T3 (en)
ES (1) ES2165949T3 (en)
NO (1) NO311331B1 (en)
PT (1) PT761198E (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10055281B4 (en) 2000-11-08 2004-12-23 Fresenius Kabi Deutschland Gmbh Adapter for a PEG probe
DE10131152B4 (en) * 2001-04-30 2004-05-27 Nutricia Healthcare S.A. Medical balloon button system

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4102342A (en) * 1975-12-29 1978-07-25 Taichiro Akiyama Valved device
WO1990012611A1 (en) * 1989-04-21 1990-11-01 Ash Medical Systems, Inc. Non-intravascular infusion access device
AU2167892A (en) * 1991-05-03 1992-12-21 Steven F. Bierman Sideport connector for catheterization system
US5267969A (en) * 1992-10-08 1993-12-07 Abbott Laboratories External retaining device for feeding tube or the like
DK0683684T3 (en) * 1993-01-07 2001-11-05 Medical Innovations Corp Catheter system for gastrostomy

Also Published As

Publication number Publication date
NO311331B1 (en) 2001-11-19
NO963590L (en) 1997-03-13
ES2165949T3 (en) 2002-04-01
DE59608419D1 (en) 2002-01-24
EP0761198A1 (en) 1997-03-12
ATE210419T1 (en) 2001-12-15
DK0761198T3 (en) 2002-03-18
PT761198E (en) 2002-05-31
DE19533749A1 (en) 1997-03-13
NO963590D0 (en) 1996-08-28

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