WO1999024103A1 - Device for the fixation of a percutaneous flexible line - Google Patents

Device for the fixation of a percutaneous flexible line Download PDF

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Publication number
WO1999024103A1
WO1999024103A1 PCT/DE1998/003285 DE9803285W WO9924103A1 WO 1999024103 A1 WO1999024103 A1 WO 1999024103A1 DE 9803285 W DE9803285 W DE 9803285W WO 9924103 A1 WO9924103 A1 WO 9924103A1
Authority
WO
WIPO (PCT)
Prior art keywords
hose
fixing device
support plate
swivel bracket
support wall
Prior art date
Application number
PCT/DE1998/003285
Other languages
German (de)
French (fr)
Inventor
Gudrun Pausch
Ralf Jaeckel
Original Assignee
Medi-Globe Gmbh
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Medi-Globe Gmbh filed Critical Medi-Globe Gmbh
Priority to JP2000520187A priority Critical patent/JP2001522664A/en
Priority to EP98962239A priority patent/EP1030707A1/en
Publication of WO1999024103A1 publication Critical patent/WO1999024103A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0213—Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body
    • A61M2025/0233—Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/024—Holding devices, e.g. on the body having a clip or clamp system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0246—Holding devices, e.g. on the body fixed on the skin having a cover for covering the holding means

Definitions

  • Fixing device for fastening a percutaneously laid hose
  • the invention relates to a fixing device for attaching a percutaneously laid tube to the skin, with a support plate which has a hole for the passage of the tube and deflects the tube emerging from the skin by approximately 90 °.
  • Such a fixing device is known from WO 94/08648. It is primarily used for percutaneous endoscopically controlled gastrostomy (PEG) and is used to fix a percutaneous probe.
  • PEG percutaneous endoscopically controlled gastrostomy
  • percutaneous endoscopically controlled gastrostomy which is described, for example, in DE 91 12 338 UI, a tube is pulled through a hole in the abdominal wall over the mouth into the stomach lumen until a
  • Retaining element of the tube lies against the inner wall of the stomach and the tube emerges percutaneously from the stomach.
  • the hose is used for example as a probe for enteral nutrition He ⁇ . It needs to be fixed on the outside of the abdominal wall to avoid unintentional shifting.
  • a fixing device as is known from WO 94/08648 has a support plate which is provided with a hole for the passage of the hose and is placed against the patient's abdominal wall.
  • a support wall protrudes from the support plate, which is provided on its circumferential edge with an open channel which is semicircular in cross section. The channel extends through a first portion which is perpendicular to the platen, and extends an arcuate adjoining second region ⁇ parallel to the platen. In this way it is achieved that the tube initially emerges vertically from the patient's body, but is then deflected parallel to the skin surface.
  • the support plate is provided in the two areas mentioned with integrally molded hold-downs, which close the circumference of the channel and together with the channel form eyelets through which the hose must be threaded.
  • a problem with this fixing device is that the cross section of the tube is changed after it has been inserted into the fixing device.
  • the invention has for its object to provide a Fixiervorrich- device that allows easy insertion of the hose and a slight displacement of the hose to adapt to the individual circumstances, but is nevertheless able to squeeze the hose without squeezing and without kinks fix.
  • Claim 1 specified features.
  • the holding-down device which presses the hose into the groove of the supporting wall, consists of a swivel bracket which is articulated to the support plate and can be swiveled about an axis.
  • the hole for the passage of the hose is between the axis of the swivel bracket and the support wall. Therefore, the swivel bar can in the longitudinal direction of the hose is pivoted ⁇ the.
  • the support plate can be easily moved and adjusted in the longitudinal direction of the hose when the swivel bracket is open. With the swivel bracket folded down, however, the hose is fixed. This fixation takes place exclusively due to the tension in the hose material, so that the cross-section of the fixed hose is not changed. In particular, there is no kinking or crushing. This is an important requirement for an optimal flow rate of the food supplied through the tube.
  • Another advantage of the invention is that the fixing device enables hand operation because the support plate can be easily moved when the swivel bracket is open, and on the other hand the swivel bracket can be pressed down and locked with one hand.
  • the support plate is made of flexible material, while the swivel bracket consists of a rigid material.
  • the soft, elastic material of the support plate allows the support plate to lie against the skin in a skin-friendly manner and can also be used as a locking device to hold the swivel bow.
  • the swivel bracket preferably contains an integrally formed channel which, when the swivel bracket is closed, is complemented by the channel of the support wall to form a circular tube cross section.
  • a circumferentially closed pipe cross-section is created via the 90 ° deflection of the hose, which surrounds and shapes the hose. In this way kinking of the hose is reliably avoided, even if a pull is exerted on the hose.
  • the support plate preferably has an essentially triangular shape and it forms triangular wings projecting laterally from the support wall.
  • the point of passage of the probe is preferably near the base of this triangle. This results in a very uniform pressure distribution so that local surface pressures are avoided. This creates optimal wearing comfort, which is important because the fixation device can also be used for a tube probe that is used for enteral long-term nutrition, that is to say is used over a longer period of time. There is also the option of plastering.
  • the invention further relates to a gastrostomy set, which has a hose provided with a retaining element and a Has fixing device.
  • a gastrostomy set which has a hose provided with a retaining element and a Has fixing device.
  • the swivel bracket of the fixing device and the hose are coordinated so that the hose is not squeezed or bent when the swivel bracket is closed or its cross-section is not changed.
  • FIG. 1 is a perspective view of a fixing device before it is attached to a tube that passes percutaneously through the abdominal wall
  • FIG. 2 is a view from the direction of arrow II of FIG. 1,
  • FIG. 3 shows a cross section along the line III-III of FIG. 2, but with the swivel bracket closed
  • Fig. 4 is a plan view of the fixing device
  • FIG. 5 is an end view of the fixing device from the direction of arrows V-V of FIG. 3rd
  • a tube 10 is provided as an enteral feeding tube.
  • This hose 10 has a disc-shaped retaining element 11 at one end and a thread loop 13 at the opposite end 12.
  • the tube 10 is inserted end 12 forward through the esophagus into the stomach and then with the help of a guide thread, which is knotted with the thread loop 13, through the previously punctured abdominal wall 14 and stomach anterior wall 15 to the distal, so that the end 12 of the Hose 10 can be pulled out of the patient's body.
  • the retention element 11 lies against the inside of the stomach wall 15.
  • the fixing device 16 which is placed against the skin 17 of the patient from the outside, serves to fix the tube 10.
  • the fixing device 16 has a support plate 18 which essentially has the shape of a simultaneous triangle with rounded corners. There is a hole 19 in the receiving plate 18 for the passage of the hose 10. The hose end 12 is first inserted through this hole 19 and then the support plate 18 is shifted on the hose 19 until its underside bears against the skin 17.
  • the support plate 18 is molded onto an upstanding support wall 20, in the top of which there is a longitudinal channel 21.
  • the channel 21 has a semicircular cross section and it serves to receive the one circumferential half of the hose 10.
  • the channel 21 extends, as shown in FIG. 3, in an arc 22 to the hole 19.
  • the hose 10 emerging from the hole 19 is in the arc 22 on the circumference of the support wall 20 is bent through 90 ° and then runs in the groove 21 parallel to the support plate.
  • a pivot bracket 23 is pivotally mounted about an axis 24.
  • the hole 19 lies between the axis 24 and the support wall 20.
  • the axis 24 consists of lateral approaches of the swivel bracket which penetrate into corresponding recesses in side parts 25 of the support plate 18.
  • the side parts 25 are elevations which are present laterally next to the support wall 20, a groove 26 (FIG. 5) being present between the support wall 20 and each of the elevations 25.
  • the swivel bracket 23 has the shape of an elongated blade with two parallel side flanks 27 and an arched central part 28 which connects the side flanks 27. On the side flanks there are laterally protruding locking elements 29 which engage in recesses in the side parts 25 when the swivel bracket 23 has been pressed into the closed position according to FIG. 3.
  • the swivel bracket 23 contains a semicircular channel 30 which follows the groove 21 of the support wall 20 and which complements this channel to form a circular tube cross section for receiving the hose 10. This channel 30 also extends through the bending region of the swivel bracket 23 opposite the bend 22, so that the hose 10 is circumferentially encompassed and shaped in the 90 ° bend.
  • the tube cross-section which is formed from the profile of the channel 21 and the channel 30, corresponds exactly to the outer cross-section of the hose 10, so that the hose is received appropriately.
  • the hose 10 is fixed by the 90 ° bend and the friction which arises at this bend.
  • the closed swivel bracket 23 can be folded up into the open position by reaching under an extension 31 which projects from the end of the swivel bracket. Such an opening force pushes the locking elements 29 out of the recesses receiving them. On the other hand, the swivel bracket 23 can be brought into engagement with the support plate 18 by simply pressing it down.
  • the support plate 18 is preferably made of flexible material, while the swivel bracket 23 is preferably made of hard or tough elastic plastic.
  • Triangular wings 33 protrude on both sides of the swivel bracket 23, in which the support plate is very thin and thus also flexible. These wings can be taped to the patient's skin. In the area of the wings 33, sharp corners are avoided, so that there is an even pressure distribution without the risk of sharp indentations.
  • the hole 19 is located between the center of the support plate and the base facing away from the bent tube 10, that is to say offset to the base.
  • the fixing device 16 is threaded onto the hose and attached to the skin 17.
  • the appropriate distance of the fixing device 16 from the retaining element 11 can be set.
  • length markings are provided on the hose 10.
  • the fixing of the fixing device is fixed to the patient's body with adhesive plaster. If necessary, the swivel bracket can be opened again to carry out maintenance and / or readjustment of the fixing device.

Abstract

The present invention relates to a fixation device (16) used for attaching a flexible line (10) or any other catheter extending through the abdominal wall (14) or percutaneously applied in any other location during a percutaneous endoscopic gastrostomy (PEG). The fixation device comprises a resting plate (18) fitted with a support wall (20) on which the flexible line (10) is placed. In order to attach the flexible line, a pivoting flap (23) is folded and clicked into a closed position. The flexible line extending outside the abdominal wall is then folded at an angle of 90° without modifying its cross section.

Description

Beschreibungdescription
Fixiervorrichtung zur Befestigung eines percutan verlegten SchlauchsFixing device for fastening a percutaneously laid hose
Die Erfindung betrifft eine Fixiervorrichtung zur Befestigung eines percutan verlegten Schlauchs an der Haut, mit einer Auf- lageplatte, die ein Loch für den Durchtritt des Schlauchs aufweist und den aus der Haut austretenden Schlauch um etwa 90° umlenkt .The invention relates to a fixing device for attaching a percutaneously laid tube to the skin, with a support plate which has a hole for the passage of the tube and deflects the tube emerging from the skin by approximately 90 °.
Eine derartige Fixiervorrichtung ist bekannt aus WO 94/08648. Sie wird in erster Linie bei der percutanen endoskopisch kontrollierten Gastrosto ie (PEG) benutzt und dient zur Fixierung einer percutanen Sonde. Bei der percutanen endoskopisch kontrollierten Gastrostomie, die beispielsweise in DE 91 12 338 UI beschrieben ist, wird ein Schlauch durch ein Loch in der Bauchdecke über den Mund in das Magenlumen gezogen, bis einSuch a fixing device is known from WO 94/08648. It is primarily used for percutaneous endoscopically controlled gastrostomy (PEG) and is used to fix a percutaneous probe. In percutaneous endoscopically controlled gastrostomy, which is described, for example, in DE 91 12 338 UI, a tube is pulled through a hole in the abdominal wall over the mouth into the stomach lumen until a
Rückhalteelement des Schlauches an der Mageninnenwand anliegt und der Schlauch percutan aus dem Magen heraustritt. Der Schlauch dient beispielsweise als Sonde für die enterale Er¬ nährung. Er bedarf einer Fixierung an der Außenseite der Bauchwand, um unbeabsichtigte Verschiebungen zu vermeiden.Retaining element of the tube lies against the inner wall of the stomach and the tube emerges percutaneously from the stomach. The hose is used for example as a probe for enteral nutrition He ¬. It needs to be fixed on the outside of the abdominal wall to avoid unintentional shifting.
Eine Fixiervorrichtung wie sie aus WO 94/08648 bekannt ist, weist eine Auflageplatte auf, die mit einem Loch für den Durchtritt des Schlauchs versehen ist und gegen die Bauchwand des Patienten gelegt wird. Von der Auflageplatte steht eine Stützwand ab, die an ihrem umfänglichen Rand mit einer im Querschnitt halbkreisförmigen offenen Rinne versehen ist. Die Rinne erstreckt sich durch einen ersten Bereich, der senkrecht zu der Auflageplatte verläuft, und einen bogenförmig daran anschließenden zweiten Bereich, der parallel zu der Auflage¬ platte verläuft. Auf diese Weise wird erreicht, daß der Schlauch zwar zunächst senkrecht aus dem Patientenkörper austritt, dann aber parallel zur Hautoberfläche umgelenkt wird. Die Auflageplatte ist in den beiden genannten Bereichen mit fest angeformten Niederhaltern versehen, welche den Umfang der Rinne schließen und zusammen mit der Rinne Ösen bilden, durch die der Schlauch hindurchgefädelt werden muß. Bei dieser Fixiervorrichtung besteht eine Schwierigkeit darin, daß der Schlauch nach dem Einlegen in die Fixiervorrichtung in seinem Querschnitt verändert wird.A fixing device as is known from WO 94/08648 has a support plate which is provided with a hole for the passage of the hose and is placed against the patient's abdominal wall. A support wall protrudes from the support plate, which is provided on its circumferential edge with an open channel which is semicircular in cross section. The channel extends through a first portion which is perpendicular to the platen, and extends an arcuate adjoining second region ¬ parallel to the platen. In this way it is achieved that the tube initially emerges vertically from the patient's body, but is then deflected parallel to the skin surface. The support plate is provided in the two areas mentioned with integrally molded hold-downs, which close the circumference of the channel and together with the channel form eyelets through which the hose must be threaded. A problem with this fixing device is that the cross section of the tube is changed after it has been inserted into the fixing device.
Der Erfindung liegt die Aufgabe zugrunde, eine Fixiervorrich- tung zu schaffen, die ein einfaches Einführen des Schlauchs und ein leichtes Verschieben des Schlauchs zur Anpassung an die individuellen Gegebenheiten ermöglicht, gleichwohl jedoch in der Lage ist, den Schlauch abquetschungsfrei und knickfrei in rechtwinkliger Führung zu fixieren.The invention has for its object to provide a Fixiervorrich- device that allows easy insertion of the hose and a slight displacement of the hose to adapt to the individual circumstances, but is nevertheless able to squeeze the hose without squeezing and without kinks fix.
Die Lösung dieser Aufgabe erfolgt erfindungsgemäß mit den imThis object is achieved with the im
Patentanspruch 1 angegebenen Merkmalen.Claim 1 specified features.
Bei der erfindungsgemäßen Fixiervorrichtung besteht der Nie- derhalter, der den Schlauch in die Rinne der Stützwand drückt, aus einem Schwenkbügel, der gelenkig mit der Auflageplatte verbunden ist und um eine Achse geschwenkt werden kann. Das Loch für den Durchtritt des Schlauchs befindet sich zwischen der Achse des Schwenkbügels und der Stützwand. Daher kann der Schwenkbügel in Längsrichtung des Schlauchs verschwenkt wer¬ den. Bei hochgeklapptem Schwenkbügel geht der Schlauch geradlinig durch die Auflageplatte hindurch. Beim Herunterklappen des Schwenkbügels wird der Schlauch von dem Schwenkbügel erfaßt und auf die Umfangsflache der Stützwand gebogen. Daher kann die Auflageplatte bei geöffnetem Schwenkbügel leicht in Längsrichtung des Schlauches verschoben und justiert werden. Bei heruntergeklapptem Schwenkbügel erfolgt jedoch eine Fixierung des Schlauchs. Diese Fixierung findet ausschließlich aufgrund der Spannung im Schlauchmaterial statt, so daß der Quer- schnitt des fixierten Schlauchs nicht verändert wird. Insbesondere erfolgt kein Abknicken oder Quetschen. Dies ist eine wichtige Voraussetzung für eine optimale Flußrate der durch den Schlauch zugeführten Nahrung. Ein weiterer Vorteil der Erfindung besteht darin, daß die Fixiervorrichtung eine Emhandbedienung ermöglicht, weil die Auflageplatte bei geöffnetem Schwenkbugel leicht verschoben werden kann, und andererseits der Schwenkbugel mit einer Hand niedergedruckt und verrastet werden kann.In the fixing device according to the invention, the holding-down device, which presses the hose into the groove of the supporting wall, consists of a swivel bracket which is articulated to the support plate and can be swiveled about an axis. The hole for the passage of the hose is between the axis of the swivel bracket and the support wall. Therefore, the swivel bar can in the longitudinal direction of the hose is pivoted ¬ the. When the swivel bracket is folded up, the hose goes straight through the support plate. When the swivel bracket is folded down, the hose is gripped by the swivel bracket and bent onto the peripheral surface of the support wall. Therefore, the support plate can be easily moved and adjusted in the longitudinal direction of the hose when the swivel bracket is open. With the swivel bracket folded down, however, the hose is fixed. This fixation takes place exclusively due to the tension in the hose material, so that the cross-section of the fixed hose is not changed. In particular, there is no kinking or crushing. This is an important requirement for an optimal flow rate of the food supplied through the tube. Another advantage of the invention is that the fixing device enables hand operation because the support plate can be easily moved when the swivel bracket is open, and on the other hand the swivel bracket can be pressed down and locked with one hand.
Gemäß einer bevorzugten Ausgestaltung der Erfindung besteht die Auflageplatte aus weichelastischem Material, wahrend der Schwenkbugel aus einem starren Material besteht. Das weich- elastische Material der Auflageplatte ermöglicht ein hautfreundliches Anliegen der Auflageplatte an der Haut und kann gleichzeitig als Rastvorrichtung zum Festhalten des Schwenkbugeis benutzt werden.According to a preferred embodiment of the invention, the support plate is made of flexible material, while the swivel bracket consists of a rigid material. The soft, elastic material of the support plate allows the support plate to lie against the skin in a skin-friendly manner and can also be used as a locking device to hold the swivel bow.
Vorzugsweise enthalt der Schwenkbugel einen angeformten Kanal, welcher sich bei geschlossenem Schwenkbugel mit der Rinne der Stutzwand zu einem kreisförmigen Rohrquerschnitt ergänzt. Auf diese Weise entsteht über die 90°-Umlenkung des Schlauchs ein umfangsmaßig geschlossener Rohrquerschnitt, der den Schlauch umfangt und formt. Auf diese Weise wird ein Knicken des Schlauchs sicher vermieden, selbst wenn ein Zug auf den Schlauch ausgeübt wird.The swivel bracket preferably contains an integrally formed channel which, when the swivel bracket is closed, is complemented by the channel of the support wall to form a circular tube cross section. In this way, a circumferentially closed pipe cross-section is created via the 90 ° deflection of the hose, which surrounds and shapes the hose. In this way kinking of the hose is reliably avoided, even if a pull is exerted on the hose.
Die Auflageplatte hat vorzugsweise im wesentlichen dreieckige Form und sie bildet seitlich von der Stutzwand abstehende dreieckige Flügel. Die Durchtrittsstelle der Sonde befindet sich vorzugsweise m der Nahe der Basis dieses Dreiecks. Dadurch wird eine sehr gleichmaßige Druckverteilung erreicht, so daß ortliche Flachenpressungen vermieden werden. Dadurch entsteht ein optimaler Tragekomfort, was wichtig ist, weil die Fixiervorrichtung auch für eine Schlauchsonde verwendbar ist, die für die enterale Langzeiternahrung dient, also über einen längeren Zeitraum hinweg benutzt wird. Außerdem besteht die Möglichkeit der Pflasterflxierung.The support plate preferably has an essentially triangular shape and it forms triangular wings projecting laterally from the support wall. The point of passage of the probe is preferably near the base of this triangle. This results in a very uniform pressure distribution so that local surface pressures are avoided. This creates optimal wearing comfort, which is important because the fixation device can also be used for a tube probe that is used for enteral long-term nutrition, that is to say is used over a longer period of time. There is also the option of plastering.
Gegenstand der Erfindung ist ferner ein Gastrostomie-Set, der einen mit einem Ruckhalteelement versehenen Schlauch und eine Fixiervorrichtung aufweist. Hierbei sind der Schwenkbügel der Fixiervorrichtung und der Schlauch so aufeinander abgestimmt, daß der Schlauch bei geschlossenem Schwenkbügel nicht ge¬ quetscht oder geknickt wird bzw. in seinem Querschnitt nicht verändert wird.The invention further relates to a gastrostomy set, which has a hose provided with a retaining element and a Has fixing device. Here, the swivel bracket of the fixing device and the hose are coordinated so that the hose is not squeezed or bent when the swivel bracket is closed or its cross-section is not changed.
Im folgenden wird unter Bezugnahme auf die Zeichnungen ein Ausführungsbeispiel der Erfindung näher erläutert.In the following an embodiment of the invention will be explained with reference to the drawings.
Es zeigen:Show it:
Fig. 1 eine perspektivische Darstellung einer Fixiervorrichtung vor ihrer Befestigung an einem Schlauch, der percutan durch die Bauchdecke hindurchgeht,1 is a perspective view of a fixing device before it is attached to a tube that passes percutaneously through the abdominal wall,
Fig. 2 eine Ansicht aus Richtung des Pfeiles II von Fig. 1,2 is a view from the direction of arrow II of FIG. 1,
Fig. 3 einen Querschnitt entlang der Linie III-III von Fig. 2, jedoch bei geschlossenem Schwenkbügel,3 shows a cross section along the line III-III of FIG. 2, but with the swivel bracket closed,
Fig. 4 eine Draufsicht der Fixiervorrichtung undFig. 4 is a plan view of the fixing device and
Fig. 5 eine Stirnansicht der Fixiervorrichtung aus Richtung der Pfeile V-V von Fig. 3.5 is an end view of the fixing device from the direction of arrows V-V of FIG. 3rd
Gemäß Fig. 1 ist ein Schlauch 10 als enterale Ernährungssonde vorgesehen. Dieser Schlauch 10 weist an einem Ende ein scheibenförmiges Rückhalteelement 11 und am entgegengesetzten Ende 12 eine Fadenschlinge 13 auf. Der Schlauch 10 wird mit dem Ende 12 voran durch die Speiseröhre in den Magen eingeführt und dann mit Hilfe eines Führungsfadens, der mit der Fadenschlinge 13 verknotet ist, durch die zuvor punktierte Bauchwand 14 und Magenvorderwand 15 nach distal ausgeführt, so daß das Ende 12 des Schlauchs 10 aus dem Patientenkörper herausge- zogen werden kann. Dabei legt sich das Rückhalteelement 11 gegen die Innenseite der Magenvorderwand 15. Zur Fixierung des Schlauchs 10 dient die Fixiervorrichtung 16, die von außen gegen die Haut 17 des Patienten gesetzt wird.1, a tube 10 is provided as an enteral feeding tube. This hose 10 has a disc-shaped retaining element 11 at one end and a thread loop 13 at the opposite end 12. The tube 10 is inserted end 12 forward through the esophagus into the stomach and then with the help of a guide thread, which is knotted with the thread loop 13, through the previously punctured abdominal wall 14 and stomach anterior wall 15 to the distal, so that the end 12 of the Hose 10 can be pulled out of the patient's body. The retention element 11 lies against the inside of the stomach wall 15. The fixing device 16, which is placed against the skin 17 of the patient from the outside, serves to fix the tube 10.
Die Fixiervorrichtung 16 weist eine Auflageplatte 18 auf, die im wesentlichen die Form eines gleichzeitigen Dreiecks mit abgerundeten Ecken hat. In der Aufnahmeplatte 18 befindet sich ein Loch 19 für den Durchtritt des Schlauchs 10. Durch dieses Loch 19 wird zunächst das Schlauchende 12 hindurchgesteckt und dann wird die Auflageplatte 18 auf dem Schlauch 19 verschoben, bis sie mit ihrer Unterseite an der Haut 17 anliegt.The fixing device 16 has a support plate 18 which essentially has the shape of a simultaneous triangle with rounded corners. There is a hole 19 in the receiving plate 18 for the passage of the hose 10. The hose end 12 is first inserted through this hole 19 and then the support plate 18 is shifted on the hose 19 until its underside bears against the skin 17.
Der Auflageplatte 18 angeformt ist eine aufragende Stützwand 20, in deren Oberseite sich eine längslaufende Rinne 21 befindet. Die Rinne 21 hat halbkreisförmigen Querschnitt und sie dient zur Aufnahme der einen Umfangshälfte des Schlauches 10. Die Rinne 21 erstreckt sich, wie Fig. 3 zeigt, in einem Bogen 22 bis zu dem Loch 19. Der aus dem Loch 19 austretende Schlauch 10 wird in dem Bogen 22 am Umfang der Stützwand 20 um 90° umgebogen und verläuft dann in der Rinne 21 parallel zur Auflageplatte.The support plate 18 is molded onto an upstanding support wall 20, in the top of which there is a longitudinal channel 21. The channel 21 has a semicircular cross section and it serves to receive the one circumferential half of the hose 10. The channel 21 extends, as shown in FIG. 3, in an arc 22 to the hole 19. The hose 10 emerging from the hole 19 is in the arc 22 on the circumference of the support wall 20 is bent through 90 ° and then runs in the groove 21 parallel to the support plate.
An der Auflageplatte 18 ist ein Schwenkbügel 23 um eine Achse 24 schwenkbar gelagert. Das Loch 19 liegt zwischen der Achse 24 und der Stützwand 20. Die Achse 24 besteht aus seitlichen Ansätzen des Schwenkbügels, die in entsprechende Ausnehmungen von Seitenteilen 25 der Auflageplatte 18 eindringen. Die Seitenteile 25 sind Erhebungen, die seitlich neben der Stützwand 20 vorhanden sind, wobei zwischen der Stützwand 20 und jeder der Erhebungen 25 eine Nut 26 (Fig. 5) vorhanden ist.On the support plate 18, a pivot bracket 23 is pivotally mounted about an axis 24. The hole 19 lies between the axis 24 and the support wall 20. The axis 24 consists of lateral approaches of the swivel bracket which penetrate into corresponding recesses in side parts 25 of the support plate 18. The side parts 25 are elevations which are present laterally next to the support wall 20, a groove 26 (FIG. 5) being present between the support wall 20 and each of the elevations 25.
Der Schwenkbügel 23 hat die Form einer länglichen Schaufel mit zwei parallelen Seitenflanken 27 und einem bogenförmig gewölbten Mittelteil 28, welches die Seitenflanken 27 verbindet. An den Seitenflanken befinden sich seitlich abstehende Rastele- mente 29, die in Ausnehmungen der Seitenteile 25 einrasten, wenn der Schwenkbügel 23 in die Schließstellung gemäß Fig. 3 gedrückt wurde. Der Schwenkbügel 23 enthält einen halbkreisförmigen Kanal 30, der der Rinne 21 der Stützwand 20 folgt und der sich mit dieser Rinne zu einem kreisförmigen Rohrquerschnitt zur Aufnahme des Schlauchs 10 ergänzt. Dieser Kanal 30 erstreckt sich auch durch den dem Bogen 22 gegenüberliegenden Biegebereich des Schwenkbügels 23, so daß der Schlauch 10 in der 90° -Biegung umfangsmaßig umfaßt und geformt wird. Der Rohrquerschnitt, der aus dem Profil der Rinne 21 und des Kanals 30 gebildet wird, entspricht exakt dem Außenquerschnitt des Schlauchs 10, so daß der Schlauch passend aufgenommen wird. Die Fixierung des Schlauchs 10 erfolgt durch die 90°- Umbiegung und die an dieser Biegung entstehende Reibung.The swivel bracket 23 has the shape of an elongated blade with two parallel side flanks 27 and an arched central part 28 which connects the side flanks 27. On the side flanks there are laterally protruding locking elements 29 which engage in recesses in the side parts 25 when the swivel bracket 23 has been pressed into the closed position according to FIG. 3. The swivel bracket 23 contains a semicircular channel 30 which follows the groove 21 of the support wall 20 and which complements this channel to form a circular tube cross section for receiving the hose 10. This channel 30 also extends through the bending region of the swivel bracket 23 opposite the bend 22, so that the hose 10 is circumferentially encompassed and shaped in the 90 ° bend. The tube cross-section, which is formed from the profile of the channel 21 and the channel 30, corresponds exactly to the outer cross-section of the hose 10, so that the hose is received appropriately. The hose 10 is fixed by the 90 ° bend and the friction which arises at this bend.
Der geschlossene Schwenkbügel 23 kann in die Öffnungsstellung hochgeklappt werden, indem man unter einen Ansatz 31 greift, der von dem Ende des Schwenkbügels absteht. Durch eine solche Öffnungskraft werden die Rastelemente 29 aus den sie aufnehmenden Ausnehmungen herausgedrückt. Andererseits kann der Schwenkbügel 23 durch bloßes Niederdrücken zum Einrasten an der Auflageplatte 18 gebracht werden.The closed swivel bracket 23 can be folded up into the open position by reaching under an extension 31 which projects from the end of the swivel bracket. Such an opening force pushes the locking elements 29 out of the recesses receiving them. On the other hand, the swivel bracket 23 can be brought into engagement with the support plate 18 by simply pressing it down.
Die Auflageplatte 18 besteht vorzugsweise aus weichelastischem Material, während der Schwenkbügel 23 vorzugsweise aus hartem oder zähelastischem Kunststoff besteht.The support plate 18 is preferably made of flexible material, while the swivel bracket 23 is preferably made of hard or tough elastic plastic.
Aus Fig. 4 ist die dreieckförmige Grundrißform der Auflage- platte 18 erkennbar. Beidseitig des Schwenkbügels 23 stehen dreieckige Flügel 33 ab, in denen die Auflageplatte sehr dünn und somit auch flexibel ist. Diese Flügel können mit Pflaster an die Haut des Patienten angeklebt werden. Im Bereich der Flügel 33 werden spitze Ecken vermieden, so daß sich eine gleichmäßige Druckverteilung ohne die Gefahr von spitzen Eindrückungen ergibt. Das Loch 19 befindet sich zwischen dem Mittelpunkt der Auflageplatte und der den gebogenen Schlauch 10 abgewandten Basis, also zu der Basis hin versetzt.The triangular outline shape of the support plate 18 can be seen from FIG. Triangular wings 33 protrude on both sides of the swivel bracket 23, in which the support plate is very thin and thus also flexible. These wings can be taped to the patient's skin. In the area of the wings 33, sharp corners are avoided, so that there is an even pressure distribution without the risk of sharp indentations. The hole 19 is located between the center of the support plate and the base facing away from the bent tube 10, that is to say offset to the base.
Nachdem der Schlauch 10 in der Weise verlegt wurde, wie dies anhand von Fig. 1 erläutert wurde, wird die Fixiervorrichtung 16 auf den Schlauch aufgefädelt und an die Haut 17 angesetzt. Durch Verschieben der Fixiervorrichtung auf dem Schlauch kann der geeignete Abstand der Fixiervorrichtung 16 von dem Rückhalteelement 11 eingestellt werden. Hierzu sind an dem Schlauch 10 (nicht dargestellte) Längenmarkierungen vorgesehen. Danach folgt die Fixierung der Fixiervorrichtung durch Herunterklappen des Schwenkbügels 23. Schließlich wird die Fixiervorrichtung mit Heftpflaster an dem Körper des Patienten fixiert. Bei Bedarf kann der Schwenkbügel wieder geöffnet werden, um eine Pflege und/oder Nachjustierung der Fixiervorrichtung vorzunehmen. After the hose 10 has been laid in the manner described with reference to FIG. 1, the fixing device 16 is threaded onto the hose and attached to the skin 17. By moving the fixing device on the hose the appropriate distance of the fixing device 16 from the retaining element 11 can be set. For this purpose, length markings (not shown) are provided on the hose 10. This is followed by the fixing of the fixing device by folding down the swivel bracket 23. Finally, the fixing device is fixed to the patient's body with adhesive plaster. If necessary, the swivel bracket can be opened again to carry out maintenance and / or readjustment of the fixing device.

Claims

Patentansprüche claims
1. Fixiervorrichtung zur Befestigung eines percutan verlegten Schlauchs (10) an der Haut (17), mit einer Auflageplatte (18), die ein Loch (19) für den Durchtritt des Schlauchs (10) und daran anschließend eine Stutzwand (20) mit einer einen Teil des Schlauchumfangs aufnehmenden, den Schlauch etwa parallel zur Auflageplatte (18) umbiegenden Rinne (21) aufweist, und mit einem Niederhalter, der den Schlauch m der Rinne halt, d a d u r c h g e k e n n z e i c h n e t , daß der Niederhalter aus einem Schwenkbugel (23) besteht, der um eine quer zur Stutzwand (20) verlaufende Achse (25) schwenkbar ist, wobei das Loch (19) zwischen der Achse (25) des Schwenkbugeis (23) und der Stutzwand (20) angeordnet ist.1. Fixing device for attaching a percutaneously laid hose (10) to the skin (17), with a support plate (18) which has a hole (19) for the passage of the hose (10) and then a support wall (20) with a part of the circumference of the tube, the tube (21) bending approximately parallel to the support plate (18), and with a hold-down device that holds the hose m of the channel, characterized in that the hold-down device consists of a swivel bracket (23) which is arranged around an axis (25) extending transversely to the support wall (20) can be pivoted, the hole (19) being arranged between the axis (25) of the swivel bend (23) and the support wall (20).
2. Fixiervorrichtung nach Anspruch 1, d a d u r c h g ek e n n z e i c h n e t , daß die Auflageplatte (18) aus weichelastischem Material und der Schwenkbugel (23) aus einem starren zahelastischen Material besteht.2. Fixing device according to claim 1, so that the support plate (18) consists of soft-elastic material and the swivel bracket (23) consists of a rigid, number-elastic material.
3. Fixiervorrichtung nach Anspruch 1 oder 2, d a d u r c h g e k e n n z e i c h n e t , daß der Schwenkbugel (23) einen angeformten Kanal (30) aufweist, welcher sich bei geschlosse- nem Schwenkbugel mit der Rinne (21) der Stutzwand (20) zu einem kreisförmigen Rohrquerschnitt ergänzt.3. Fixing device according to claim 1 or 2, so that the pivoting bracket (23) has an integrally formed channel (30) which, when the pivoting bracket is closed, is complemented by the channel (21) of the support wall (20) to form a circular tube cross section.
4. Fixiervorrichtung nach einem der Ansprüche 1 bis 3, d ad u r c h g e k e n n z e i c h n e t , daß der Schwenkbugel (23) Rastelemente (29) aufweist, d e bei geschlossenem4. Fixing device according to one of claims 1 to 3, d ad u r c h g e k e n n z e i c h n e t that the swivel bracket (23) has latching elements (29), d e when closed
Schwenkbugel mit Rastelementen der Auflageplatte (18) zusammengreifen.Grip the swivel bracket with the locking elements of the support plate (18).
5. Fixiervorrichtung nach einem der Ansprüche 1 bis 4, d a- d u r c h g e k e n n z e i c h n e t , daß die Auflageplatte5. Fixing device according to one of claims 1 to 4, d a-d u r c h g e k e n n z e i c h n e t that the platen
(18) beidseitig der Stutzwand Nuten (26) aufweist, m die Sei- tenflanken (27) des Schwenkbugeis (23) eingreifen. (18) has grooves (26) on both sides of the support wall, m engage the side flanks (27) of the swivel bend (23).
6. Fixiervorrichtung nach einem der Ansprüche 1 bis 5, d a- d u r c h g e k e n n z e i c h n e t , daß die Auflageplatte (18) im wesentlichen dreieckige Form hat und seitlich von der Stützwand (20) abstehende dreieckige Flügel (33) bildet, und daß das Loch (19) sich zwischen dem Mittelpunkt der Auflageplatte (18) und der der Stützwand (20) abgewandten Basis der Auflageplatte angeordnet ist.6. Fixing device according to one of claims 1 to 5, d a- characterized in that the support plate (18) has a substantially triangular shape and laterally from the support wall (20) projecting triangular wings (33), and that the hole (19) is arranged between the center of the support plate (18) and the base of the support plate facing away from the support wall (20).
7.Gastrostomie-Set zur percutanen endoskopisch kontrollierten Gastrostomie, mit einem Schlauch (10), der ein Rückhalteele¬ ment (11) aufweist, und einer Fixiervorrichtung (16) nach einem der Ansprüche 1 bis 6, wobei der Schwenkbügel (23) und der Schlauch (10) so aufeinander abgestimmt sind, daß bei geschlossenem Schwenkbügel (23) der Querschnitt des Schlauches (10) nicht verändert wird. 7. gastrostomy set for percutaneous endoscopically controlled gastrostomy, with a tube (10) having a retaining element (11), and a fixing device (16) according to one of claims 1 to 6, wherein the swivel bracket (23) and Hose (10) are coordinated so that the cross-section of the hose (10) is not changed when the swivel bracket (23) is closed.
PCT/DE1998/003285 1997-11-11 1998-11-10 Device for the fixation of a percutaneous flexible line WO1999024103A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2000520187A JP2001522664A (en) 1997-11-11 1998-11-10 Fixing device for fixing percutaneously laid tubes
EP98962239A EP1030707A1 (en) 1997-11-11 1998-11-10 Device for the fixation of a percutaneous flexible line

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE1997149741 DE19749741C1 (en) 1997-11-11 1997-11-11 Fixing patch for medical percutaneous tube
DE19749741.1 1997-11-11

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JP (1) JP2001522664A (en)
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CN113368368A (en) * 2021-05-17 2021-09-10 浙江大学医学院附属第一医院 Dialysis tube fixing device for nephrology department and fixing method thereof

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US7749199B2 (en) 2002-02-16 2010-07-06 Goma Medical Limited Catheter clamp
WO2006085085A1 (en) * 2005-02-11 2006-08-17 Unomedical Limited A device for fixating a tube relative to a skin surface part of a patient or person and an assembly of the tube and the device
EP1698368A1 (en) * 2005-02-11 2006-09-06 Unomedical Limited A device for fixating a tube
CN113368368A (en) * 2021-05-17 2021-09-10 浙江大学医学院附属第一医院 Dialysis tube fixing device for nephrology department and fixing method thereof

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EP1030707A1 (en) 2000-08-30
JP2001522664A (en) 2001-11-20

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