WO1997015345A1 - Anti-infection catheter arrangement - Google Patents

Anti-infection catheter arrangement Download PDF

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Publication number
WO1997015345A1
WO1997015345A1 PCT/EP1996/004618 EP9604618W WO9715345A1 WO 1997015345 A1 WO1997015345 A1 WO 1997015345A1 EP 9604618 W EP9604618 W EP 9604618W WO 9715345 A1 WO9715345 A1 WO 9715345A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
reservoirs
volume
filled
filling
Prior art date
Application number
PCT/EP1996/004618
Other languages
German (de)
French (fr)
Inventor
Marion Giebel
Ülo PALM
Willehad Boemke
Original Assignee
Marion Giebel
Palm Uelo
Willehad Boemke
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 Marion Giebel, Palm Uelo, Willehad Boemke filed Critical Marion Giebel
Priority to EP96934807A priority Critical patent/EP0961627A1/en
Publication of WO1997015345A1 publication Critical patent/WO1997015345A1/en
Priority to US09/299,362 priority patent/US6146363A/en

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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
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0057—Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings

Definitions

  • the invention relates to an infection-preventing catheter arrangement of the type specified in the preamble of the patent claim.
  • a filling and suction device is provided with at least one active substance reservoir, the total volume of which corresponds exactly to the catheter filling volume.
  • the volumes must match, since on the one hand an active substance reservoir volume that is smaller than the catheter filling volume can lead to blood penetrating into the tip of the cannula and thus to signs of coagulation and clogging, and on the other hand an active substance reservoir that is larger than the catheter filling volume can penetrate the active substance into the patient's bloodstream and thus lead to the formation of resistance.
  • their disadvantage is their assignment for only one catheter type of a certain filling volume.
  • the filling and suction device which can be attached to the rear connector of the catheter is designed in such a way that the catheter volume in the area of the cannula tip can be filled with an agent which does not damage tissue and blood cells, while the actual active substance can be filled in on the connector side, preferably at least the same volume is removable.
  • the filling volume can also exceed the catheter volume since essentially only tissue-harmless substance can be pressed into the bloodstream. It is only important that the active substance only acts within the catheter and cannot get into the patient's body. This ensures that the highest possible concentration of active ingredient can be used while avoiding the otherwise occurring side effects and development of resistance.
  • a multi-chamber system which is derived from the above, is suitable for layering the at least two substances along the cannula column.
  • WO known type The objects of claims 2 to 5 known from this WO relating to the type of active substance and 6 to 8 and 10 to 25 relating to the filling and suction device are expressly claimed as advantageous developments of the present disclosure. Only claim 9 of the WO is to be modified in such a way that the catheter-side first reservoir contains the essentially tissue-harmless agent, preferably anticoagulant, in particular heparin, and the second reservoir contains the active substance.
  • REPLACEMENT BLA ⁇ (RULE 26) The invention is explained in more detail below with the aid of two preferred exemplary embodiments. Show it:
  • FIGS 3a and 3b another embodiment in partial longitudinal section
  • Figure 3c shows a cross section according to I-I in Figure 3a.
  • FIGS la to 2b illustrate the interaction of a filling and suction device 1 with a catheter 2 in a first embodiment.
  • the filling and suction device 1 essentially consists of a cylindrical housing 3, a first membrane 4, which divides the interior of the housing into two axially successive chambers 5 and 6, and a plunger 7, which forms the end of the device 1 facing away from the catheter .
  • the device 1 has a Luer thread 8 and a plug-in cone 9, which are assigned to a connector 10 of the catheter 2.
  • the plug cone 9 is closed at its tip with a second membrane 11.
  • the first chamber 5 delimited by the second membrane 11, the plug-in cone 9, part of the cylindrical housing 3 and the first membrane 4 is filled with heparin 12, while that of the first membrane 4, another part of the housing 3
  • REPLACEMENT BLA ⁇ (RULE 26) and the front surface of the stamp 7 delimited second chamber 6 contains an active substance, in particular an antibiotic, for example gentamycin 13.
  • This two-chamber system forms a closed unit, which is completely sterile in a corresponding packaging unit (not shown) with a protective cap (also not shown) for the second membrane 11.
  • the protective cap which is fastened to the Luer thread 8 of the device 1, is removed immediately before connection to the catheter 2, so that contamination, in particular the second membrane 11, by germs which are constantly present in the air is largely avoided.
  • the connection position of the device 1 to the catheter 2 is shown in FIG. 1b.
  • the stamp 7 can be screwed into the cylinder 3 by means of a screw cap 14.
  • the screw cap 14 can also be designed as a separate cap, which causes a translatory sterile movement.
  • FIGS. 1c and 1d show the catheter arrangement during and after filling the heparin 12 and the gentamycin 13 into the catheter 1.
  • the two membranes 4 and 11 have been destroyed by the stamp pressure.
  • the heparin 12 is pressed into the area of the cannula tip 15, the filling volume being dimensioned such that no heparin 12 or only a small amount 16 of the heparin 12 can escape from the cannula tip and enter the bloodstream. This does not cause toxic reactions.
  • the heparin 12 counteracts the formation of blood clots so that cannula blockages are avoided. It also represents
  • REPLACEMENT BLA ⁇ (RULE 26) 12 is a heparin rt
  • a column buffer is compared to the Gentanycin 13 which fills the RESIZE ß th part of the catheter volume.
  • the column buffer effectively shields the gentamycin 13 from the catheterized vessel even if the interface between the heparin 12 and the gentamycin 13 is blurred by mixing processes after a long period of time. Resistance formation due to the penetration of even small amounts of gentamycin 13 into the blood is therefore excluded.
  • a single device 1 of a certain size can be used for several types of catheter.
  • the antibiotic solution By screwing the cap 14 back, the antibiotic solution can be sucked back into the reservoir of the device 1.
  • the screw-back path can be somewhat longer than the screw-in path.
  • some body fluid is sucked out of the catheterized vessel, in particular blood, beyond the pure filling volume.
  • it is almost doubly ensured that no drug residues remain in the catheter that could be washed into the patient's body by a subsequent infusion.
  • the device 1 can also be examined for its germ content, for example.
  • the filling and suction device 1 is closed with a sterile cap 17 immediately after the disconnection from the catheter 2, as can be seen in FIG. 2b.
  • REPLACEMENT BLA ⁇ (RULE 26) A second embodiment is shown in Figures 3a, 3b and 3c.
  • the two chambers 5 'and 6' for heparin 12 and gentamycin 13 are not arranged axially one behind the other, but next to each other as parallel bores in a cylinder 3 '.
  • a modified stamp 7 'with two parallel push rods 18 and 19 ensures that the heparin-filled chamber 5' is emptied first and then the gentamycin-filled chamber 6 '.
  • a screw cap 14 ' is placed on the cylinder 3' and, in operative connection with the plunger 7 ', causes its translatory displacement.
  • a connecting element of high rigidity for example a coil spring 20, and a driver 22 provided with a seal 22 pushes the heparin 12 out of the filling and suction device via the push rod 18.
  • the push rod 19 also moves within a similar seal 21, whereby, however, no influence is exerted on the chamber 6 ′ filled with gentamycing, since this push rod 19 is provided with a driver 23 which is free inside the seal 21 in accordance with the depth of the heparin column Game.
  • the screw spring 20 is compressed, while the chamber 6' is emptied with the gentamycin 13.
  • 3b shows the end position after filling.
  • the two drivers 22 and 23 act in the opposite direction.
  • a stop 24 prevents the punch 7 'from being screwed out of the cylinder 3'.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Epidemiology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention concerns an anti-infection catheter arrangement comprising a catheter (2) which has a rigid or flexible cannula tube with a connection piece (10) at the distal end. A filling and suction device (1) comprising a plurality of active substance reservoirs can be attached to the connection piece (10), at least one of these reservoirs being filled with a substance which contains at least one antibiotic or chemotherapeutic or antiviral agent, preferably aminoglycoside, in particular gentamycin (13), in at least a minimum effective concentration. A further one of the reservoirs is filled with a substance which contains or forms at least one agent which is substantially harmless for tissue and blood cells, preferably an anticoagulant, in particular heparin (12), which can be introduced substantially in the region of the cannula tip (15). The total volume of the reservoirs corresponds at least to the catheter volume, optionally plus the volume of any intermediate parts, in particular a three-way tap.

Description

infektvorbeugende Katheteranordnunginfektvor b eugende catheter assembly
Die Erfindung betrifft eine infektvorbeugende Katheteranordnung der im Oberbegriff des Patentanspruchs angegebenen Art.The invention relates to an infection-preventing catheter arrangement of the type specified in the preamble of the patent claim.
Eine derartige Katheteranordnung ist aus der WO 91/06329 bekannt geworden. Dabei ist eine Einfüll- und Ansaugvorrichtung mit min¬ destens einem Wirkstoffreservoir vorgesehen, dessen Gesamtvolumen exakt dem Katheterfüllvolumen entspricht. Die Volumina müssen übereinstimmen, da einerseits ein Wirkstoffreservoirvolumen, das kleiner als das Katheterfüllvolumen ist, zu einem Eindringen von Blut in die Kanülenspitze und damit zu Gerinnungs- und Verstop¬ fungserscheinungen führen kann und andererseits ein Wirkstoff¬ reservoir, das größer als das Katheterfüllvolumen ist, zu einem Eindringen von Wirksubstanz in den Blutkreislauf des Patienten und damit zu einer Resistenzbildung führen kann. Nachteilig ist neben der geringen Fertigungstoleranz für das Volumen des Wirk¬ stoffreservoirs der Einfüll- und Ansaugvorrichtung deren Zuord¬ nung für nur einen Kathetertyp eines bestimmten Füllvolumens.Such a catheter arrangement has become known from WO 91/06329. A filling and suction device is provided with at least one active substance reservoir, the total volume of which corresponds exactly to the catheter filling volume. The volumes must match, since on the one hand an active substance reservoir volume that is smaller than the catheter filling volume can lead to blood penetrating into the tip of the cannula and thus to signs of coagulation and clogging, and on the other hand an active substance reservoir that is larger than the catheter filling volume can penetrate the active substance into the patient's bloodstream and thus lead to the formation of resistance. In addition to the low manufacturing tolerance for the volume of the active substance reservoir of the filling and suction device, their disadvantage is their assignment for only one catheter type of a certain filling volume.
Es besteht deshalb die Aufgabe, eine Katheteranordnung der ein¬ gangs angegebenen Art anzugeben, durch die ohne Resistenzbil¬ dungsgefahr die katheterbedingte Infektionsrate auch bei ferti¬ gungsfreundlicher, erhöhter Toleranzvorgabe drastisch reduziert ist. Dabei ist im Hinblick auf die große Anzahl ähnlichvolumiger Kathetertypen die Verwendbarkeit einer Einfüll- und Ansaugvor¬ richtung für mehrere Kathetertypen anzustreben.There is therefore the task of specifying a catheter arrangement of the type specified at the outset, by means of which the risk of infection due to the formation of a catheter is drastically reduced without the risk of resistance being formed, even with an increased tolerance specification which is friendly to production. In view of the large number of catheter types of similar volume, the usability of a filling and suction device for several catheter types is desirable.
ERSATZBLAπ(REGEL26) O 97/15345 PO7EP96/04618REPLACEMENT BLAπ (RULE 26) O 97/15345 PO7EP96 / 04618
Diese Aufgabe wird mit den kennzeichnenden Merkmalen des Patent¬ anspruchs gelöst.This object is achieved with the characterizing features of the patent claim.
Erfindungsgemäß ist die an das rückwärtige Anschlußstück des Ka¬ theters ansetzbare Einfüll- und Ansaugvorrichtung derart ausge¬ bildet, daß das Kathetervolumen im Bereich der Kanülenspitze mit einem Gewebe- und Blutzellen nicht schädigenden Mittel füllbar ist, während die eigentliche Wirksubstanz anschlußstückseitig einfüllbar ist, wobei vorzugsweise mindestens das gleiche Volu¬ men wieder abziehbar ist. Das Füllvolumen kann dabei daε Kathetervolumen auch übersteigen, da im wesentlichen nur gewebe¬ unschädliche Substanz in die Blutbahn gedrückt werden kann. Wichtig ist lediglich, daß die Wirksubstanz nur innerhalb des Katheters wirkt und nicht in den Körper des Patienten gelangen kann. Damit ist gewährleistet, daß die höchstmögliche Wirkstoff- konzentration bei Vermeidung der sonst auftretenden Neben¬ wirkungen und Resistenzentwicklungen zur Anwendung kommen kann. Um die Schichtung der mindestens zwei Substanzen längs der Kanülensäule zu realisieren, eignet sich ein Mehrkamraersystem der aus der o.g. WO bekannten Art. Die aus dieser WO bekannten Gegen¬ stände der Ansprüche 2 bis 5 bezüglich der Art der Wirksubstanz und 6 bis 8 sowie 10 bis 25 bezüglich der Einfüll- und Ansaug- vorrichtung werden ausdrücklich als vorteilhafte Weiterbil¬ dungen der vorliegenden Offenbarung beansprucht. Lediglich An¬ spruch 9 der WO ist dahingehend abzuwandeln, daß das katheter- seitige erste Reservoir das im wesentlichen gewebeunschädliche Mittel, vorzugsweise Antikoagulanz, insbesondere Heparin, und das zweite Reservoir die Wirksubstanz enthält.According to the invention, the filling and suction device which can be attached to the rear connector of the catheter is designed in such a way that the catheter volume in the area of the cannula tip can be filled with an agent which does not damage tissue and blood cells, while the actual active substance can be filled in on the connector side, preferably at least the same volume is removable. The filling volume can also exceed the catheter volume since essentially only tissue-harmless substance can be pressed into the bloodstream. It is only important that the active substance only acts within the catheter and cannot get into the patient's body. This ensures that the highest possible concentration of active ingredient can be used while avoiding the otherwise occurring side effects and development of resistance. A multi-chamber system, which is derived from the above, is suitable for layering the at least two substances along the cannula column. WO known type. The objects of claims 2 to 5 known from this WO relating to the type of active substance and 6 to 8 and 10 to 25 relating to the filling and suction device are expressly claimed as advantageous developments of the present disclosure. Only claim 9 of the WO is to be modified in such a way that the catheter-side first reservoir contains the essentially tissue-harmless agent, preferably anticoagulant, in particular heparin, and the second reservoir contains the active substance.
ERSATZBLAπ(REGEL26) Die Erfindung wird nachfolgend anhand zweier bevorzugter Ausfüh¬ rungsbeispiels näher erläutert. Es zeigen:REPLACEMENT BLAπ (RULE 26) The invention is explained in more detail below with the aid of two preferred exemplary embodiments. Show it:
Figur la, lb, lc und ld Anwendungsphasen einer erfindungsgemäßen Katheteranordnung während des Einfüllvorganges in schematisierter Darstellung,Figure la, lb, lc and ld application phases of a catheter assembly according to the invention during the filling process in a schematic representation,
Figur 2a und 2b Anwendungsphasen während des Ansaugvorganges,2a and 2b application phases during the suction process,
Figur 3a und 3b ein weiteres Ausführungsbeispiel in teilweise längsgeschnittener Darstellung undFigures 3a and 3b another embodiment in partial longitudinal section and
Figur 3c einen Querschnitt gemäß I-I in Figur 3a.Figure 3c shows a cross section according to I-I in Figure 3a.
Die Figuren la bis 2b veranschaulichen das Zusammenwirken einer Einfüll- und Ansaugvorrichtung 1 mit einem Katheter 2 in einem ersten Ausführungsbeispiel. Die Einfüll- und Ansaugvorrichtung 1 besteht im wesentlichen aus einem zylindrischen Gehäuse 3, einer ersten Membran 4, die den Gehäuseinnenraum in zwei axial hinter- einanderliegende Kammern 5 und 6 teilt sowie einem Stempel 7, welcher die katheterabgewandte stirnseitige Begrenzung der Vor¬ richtung 1 bildet. Zum Anschluß an den Katheter 2 weist die Vorrichtung 1 ein Luer-Gewinde 8 und einen Steckkonus 9 auf, welche einem Anschlußstück 10 des Katheters 2 zugeordnet sind. Der Steckkonus 9 ist an seiner Spitze mit einer zweiten Membran 11 verschlossen. Die von der zweiten Membran 11, dem Steckkonus 9, einem Teil des zylindrischen Gehäuses 3 und der erεten Membran 4 begrenzte erste Kammer 5 ist mit Heparin 12 gefüllt, während die von der ersten Membran 4, einem weiteren Teil des Gehäuses 3Figures la to 2b illustrate the interaction of a filling and suction device 1 with a catheter 2 in a first embodiment. The filling and suction device 1 essentially consists of a cylindrical housing 3, a first membrane 4, which divides the interior of the housing into two axially successive chambers 5 and 6, and a plunger 7, which forms the end of the device 1 facing away from the catheter . For connection to the catheter 2, the device 1 has a Luer thread 8 and a plug-in cone 9, which are assigned to a connector 10 of the catheter 2. The plug cone 9 is closed at its tip with a second membrane 11. The first chamber 5 delimited by the second membrane 11, the plug-in cone 9, part of the cylindrical housing 3 and the first membrane 4 is filled with heparin 12, while that of the first membrane 4, another part of the housing 3
33
ERSATZBLAπ(REGEL26) und der Frontfläche des Stempels 7 begrenzte zweite Kammer 6 eine Wirksubstanz, insbesondere ein Antibiotikum, zum Beispiel Gentamycin 13 enthält. Dieses Zweikammersystem bildet eine geschlossene Einheit, die völlig steril in einer nicht darge¬ stellten entsprechenden Verpackungseinheit mit einer ebenfalls nicht dargestellten Schutzkappe für die zweite Membran 11 vorliegt. Die Schutzkappe, welche an dem Luer-Gewinde 8 der Vorrichtung 1 befestigt ist, wird unmittelbar vor dem Anschluß an den Katheter 2 entfernt, damit eine Kontamination, insbesondere der zweiten Membran 11 durch in der Luft ständig vorhandene Keime weitestgehend vermieden wird.REPLACEMENT BLAπ (RULE 26) and the front surface of the stamp 7 delimited second chamber 6 contains an active substance, in particular an antibiotic, for example gentamycin 13. This two-chamber system forms a closed unit, which is completely sterile in a corresponding packaging unit (not shown) with a protective cap (also not shown) for the second membrane 11. The protective cap, which is fastened to the Luer thread 8 of the device 1, is removed immediately before connection to the catheter 2, so that contamination, in particular the second membrane 11, by germs which are constantly present in the air is largely avoided.
Die Anschlußposition der Vorrichtung 1 an den Katheter 2 ist in der Figur lb dargestellt. Der Stempel 7 ist mittels einer Schraubkappe 14 in den Zylinder 3 eindrehbar. Die Schraubkappe 14 kann auch als separate Überwurfkappe ausgeführt sein, wodurch eine translatorische Sterapelbewegung bewirkt wird.The connection position of the device 1 to the catheter 2 is shown in FIG. 1b. The stamp 7 can be screwed into the cylinder 3 by means of a screw cap 14. The screw cap 14 can also be designed as a separate cap, which causes a translatory sterile movement.
Figur lc und ld zeigen die Katheteranordnung während und nach dem Einfüllen des Heparins 12 und des Gentamycins 13 in den Katheter 1. Die beiden Membranen 4 und 11 sind durch den Stempeldruck zer¬ stört worden. Das Heparin 12 wird in den Bereich der Kanülen¬ spitze 15 gedrückt, wobei das Füllvolumen derart bemessen ist, daß kein Heparin 12 oder nur eine geringe Menge 16 des Heparins 12 aus der Kanülenspitze austreten und in die Blutbahn gelangen kann. Toxische Reaktionen werden dadurch nicht verursacht. Das Heparin 12 wirkt der Bildung von Blutgerinseln entgegen, so daß Kanülenverstopfungen vermieden werden. Außerdem stellt dasFIGS. 1c and 1d show the catheter arrangement during and after filling the heparin 12 and the gentamycin 13 into the catheter 1. The two membranes 4 and 11 have been destroyed by the stamp pressure. The heparin 12 is pressed into the area of the cannula tip 15, the filling volume being dimensioned such that no heparin 12 or only a small amount 16 of the heparin 12 can escape from the cannula tip and enter the bloodstream. This does not cause toxic reactions. The heparin 12 counteracts the formation of blood clots so that cannula blockages are avoided. It also represents
ERSATZBLAπ(REGEL26) Heparin 12 eine Art Säulenpuffer gegenüber dem Gentanycin 13 dar, welches den größten Teil des Kathetervolumens ausfüllt. Der Säulenpuffer schirmt das Gentamycin 13 von dem katheterisierten Gefäß auch dann noch wirksam ab, wenn die Grenzfläche zwischen dem Heparin 12 und dem Gentamycin 13 bei langer Verweildauer durch Vermischungsvorgänge verwischt ist. Resistenzbildungen durch das Eindringen auch geringer Mengen von Gentamycin 13 in das Blut sind damit ausgeschlossen. Je nach Füllvolumen der Vorrichtung 1 und Ähnlichkeit der Kathetervolumina verschiedener Kathetertypen kann eine einzige Vorrichtung 1 einer bestimmten Größe für mehrere Kathetertypen verwendet werden.REPLACEMENT BLAπ (RULE 26) 12 is a heparin rt A column buffer is compared to the Gentanycin 13 which fills the RESIZE ß th part of the catheter volume. The column buffer effectively shields the gentamycin 13 from the catheterized vessel even if the interface between the heparin 12 and the gentamycin 13 is blurred by mixing processes after a long period of time. Resistance formation due to the penetration of even small amounts of gentamycin 13 into the blood is therefore excluded. Depending on the filling volume of the device 1 and similarity of the catheter volumes of different types of catheter, a single device 1 of a certain size can be used for several types of catheter.
Durch das Zurückschrauben der Kappe 14 läßt sich die Antibiotika¬ lösung in das Reservoir der Vorrichtung 1 zurücksaugen. Der Rück- schraubweg kann gegenüber dem Einschraubweg etwas verlängert sein. Dadurch wird etwas Körperflüssigkeit aus dem katheterisier¬ ten Gefäß, insbesondere Blut, über das reine Füllungsvolumen hinaus angesaugt. Auf diese Weiεe ist zusätzlich zur Wirkung des Säulenpuffers guasi doppelt sichergestellt, daß keine Wirkstoff- rückstände im Katheter verbleiben, die durch eine nachfolgende Infusion in den Körper des Patienten eingespült werden könnten.By screwing the cap 14 back, the antibiotic solution can be sucked back into the reservoir of the device 1. The screw-back path can be somewhat longer than the screw-in path. As a result, some body fluid is sucked out of the catheterized vessel, in particular blood, beyond the pure filling volume. In this way, in addition to the effect of the column buffer, it is almost doubly ensured that no drug residues remain in the catheter that could be washed into the patient's body by a subsequent infusion.
Nach dem Ansaugvorgang kann die Vorrichtung 1 noch beispielsweise auf ihren Keimgehalt hin untersucht werden. Dazu wird die Ein¬ füll- und Ansaugvorrichtung 1 unmittelbar nach der Dekonnektion vom Katheter 2, wie in der Figur 2b ersichtlich, mit einer ste¬ rilen Kappe 17 verschlossen.After the suction process, the device 1 can also be examined for its germ content, for example. For this purpose, the filling and suction device 1 is closed with a sterile cap 17 immediately after the disconnection from the catheter 2, as can be seen in FIG. 2b.
ERSATZBLAπ(REGEL26) Ein zweites Ausführungsbeispiel ist in den Figuren 3a, 3b und 3c dargestellt. Dabei sind die beiden Kammern 5' und 6' für Heparin 12 und Gentamycin 13 nicht axial hintereinander, sondern neben¬ einander als parallele Bohrungen in einem Zylinder 3' angeordnet. Ein modifizierter Stempel 7' mit zwei parallelen Schubstangen 18 und 19 sorgt dafür, daß zuerst die heparingefüllte Kammer 5' entleert wird und danach die gentamycingefüllte Kammer 6'. Auf dem Zylinder 3' ist eine Schraubkappe 14' aufgesetzt, die in Wirkverbindung mit dem Stempel 7' dessen translatorische Ver¬ schiebung bewirkt. In einem ersten Hub wird über die Schubstange 18 ein Verbindungselement hoher Steifigkeit, beispielsweise einer Schraubenfeder 20, und einem mit einer Dichtung versehenen Mitnehmer 22 das Heparin 12 aus der Einfüll- und Ansaug- vorrichtung herausgedrückt. Gleichzeitig verschiebt sich auch die Schubstange 19 innerhalb einer gleichartigen Dichtung 21, wo¬ durch jedoch kein Einfluß auf die gentamycingfefüllte Kammer 6' ausgeübt wird, da diese Schubstange 19 mit einem Mitnehmer 23 versehen ist, der innerhalb der Dichtung 21 entsprechend der Tiefe der Heparinsäule freies Spiel hat. Bei Fortseztzung der Betätigung der Schraubkappe 14' wird die Schrauberfeder 20 zu¬ sammengedrückt, während die Kammer 6' mit dem Gentamycin 13 entleert wird. Die Endposition nach dem Einfüllen zeigt die Figur 3b. Beim Ansaugvorgang, der durch das Zurückschrauben der Schraubkappe 14' erfolgt, wirken die beiden Mitnehmer 22 und 23 in entgegengesetzter Richtung. Ein Anschlag 24 verhindert, daß der Stempel 7' aus dem Zylinder 3' herausschraubbar iεt.REPLACEMENT BLAπ (RULE 26) A second embodiment is shown in Figures 3a, 3b and 3c. The two chambers 5 'and 6' for heparin 12 and gentamycin 13 are not arranged axially one behind the other, but next to each other as parallel bores in a cylinder 3 '. A modified stamp 7 'with two parallel push rods 18 and 19 ensures that the heparin-filled chamber 5' is emptied first and then the gentamycin-filled chamber 6 '. A screw cap 14 'is placed on the cylinder 3' and, in operative connection with the plunger 7 ', causes its translatory displacement. In a first stroke, a connecting element of high rigidity, for example a coil spring 20, and a driver 22 provided with a seal 22 pushes the heparin 12 out of the filling and suction device via the push rod 18. At the same time, the push rod 19 also moves within a similar seal 21, whereby, however, no influence is exerted on the chamber 6 ′ filled with gentamycing, since this push rod 19 is provided with a driver 23 which is free inside the seal 21 in accordance with the depth of the heparin column Game. As the screw cap 14 'continues to be actuated, the screw spring 20 is compressed, while the chamber 6' is emptied with the gentamycin 13. 3b shows the end position after filling. During the suction process, which takes place by screwing the screw cap 14 ′ back, the two drivers 22 and 23 act in the opposite direction. A stop 24 prevents the punch 7 'from being screwed out of the cylinder 3'.
ERSATZBLAπ(REGEL26) Die Erfindung beschränkt sich nicht auf die vorstehend angegebe¬ nen Ausführungsbeispiele. Vielmehr ist eine Vielzahl von Vari¬ anten denkbar, welche auch bei grundsätzlich anders gearteten Ausführungen von der Erfindung Gebrauch machen.REPLACEMENT BLAπ (RULE 26) T he invention is not limited to the above-attached give ¬ NEN embodiments. Rather, a plurality of V ari ¬ distinctive conceivable, which make use even in fundamentally different embodiments of the invention.
ERSATZBLAπ(REGEL26)^ ERSATZBLAπ (REGEL26) ^

Claims

P A T E N T A N S P R U C HP A T E N T A N S P R U C H
Infektvorbeugende Katheteranordnung mit einem Katheter (l), der ein starres oder flexibles Kanülenrohr mit einem am rückwärtigen Ende vorgesehenen Anschlußstück (10) aufweist, wobei an das An¬ schlußstück (10) eine Einfüll- und Ansaugvorrichtung (1) mit meh¬ reren Wirkstoffreservoiren ansetzbar ist, von denen mindestenε eines mit einer Substanz, enthaltend mindestens ein Antibiotikum bzw. Chemotherapeutikum bzw. antivirales Mittel, vorzugsweise Aminoglycosid, vorzugsweise Gentamycin (13) in mindestens mini¬ maler Wirkkonzentration gefüllt ist,Infection-preventing catheter arrangement with a catheter (1) which has a rigid or flexible cannula tube with a connector (10) provided at the rear end, a filling and suction device (1) with a plurality of active substance reservoirs being attachable to the connector (10) at least one of which is filled with a substance containing at least one antibiotic or chemotherapeutic or antiviral agent, preferably aminoglycoside, preferably gentamycin (13) in at least a minimal active concentration,
d a d u r c h g e k e n n z e i c h n e t,characterized,
daß ein weiteres der Reservoire mit einer Substanz, enthaltend oder bildend mindestens ein im wesentlichen Gewebe- und Blutzel¬ len nicht schädigendes Mittel, vorzugsweise ein Antikoagulanz, insbesondere Heparin (12), gefüllt ist, wobei diese Substanz im wesentlichen in den Bereich der Kanülenspitze (15) einfüllbar ist und das Gesamtvolumen der Reservoire mindestens dem Katheter¬ füllvolumen, gegebenenfalls zuzüglich des Volumens von Zwischen¬ stücken, insbesondere eines Dreiwegehahnes, entspricht.that another of the reservoirs is filled with a substance containing or forming at least one agent which is essentially non-damaging to tissue and blood cells, preferably an anticoagulant, in particular heparin (12), this substance essentially in the area of the cannula tip ( 15) can be filled and the total volume of the reservoirs corresponds at least to the catheter filling volume, possibly plus the volume of intermediate pieces, in particular a three-way valve.
88th
ERSATZBLAπ(REGEL26) REPLACEMENT BLAπ (RULE 26)
PCT/EP1996/004618 1995-10-26 1996-10-24 Anti-infection catheter arrangement WO1997015345A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP96934807A EP0961627A1 (en) 1995-10-26 1996-10-24 Anti-infection catheter arrangement
US09/299,362 US6146363A (en) 1996-10-24 1999-04-26 Anti-infection catheter

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19539785.1 1995-10-26
DE1995139785 DE19539785A1 (en) 1995-10-26 1995-10-26 Catheter assembly

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US09/299,362 Continuation-In-Part US6146363A (en) 1996-10-24 1999-04-26 Anti-infection catheter

Publications (1)

Publication Number Publication Date
WO1997015345A1 true WO1997015345A1 (en) 1997-05-01

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Family Applications (1)

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PCT/EP1996/004618 WO1997015345A1 (en) 1995-10-26 1996-10-24 Anti-infection catheter arrangement

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EP (1) EP0961627A1 (en)
DE (1) DE19539785A1 (en)
WO (1) WO1997015345A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6613025B1 (en) 2000-05-25 2003-09-02 Scimed Life Systems, Inc. Method and apparatus for diagnostic and therapeutic agent delivery
DE10100069C1 (en) * 2001-01-02 2003-06-18 Klaus Affeld Infection protection system for longer-term, partial or total implants, is provided by forcing flow of bioactive fluid from external reservoir around porous surface

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3930039A1 (en) * 1989-09-06 1991-03-07 Palm Uelo Aarne Catheter infection prophylaxis - by flushing with mixture of antibiotics and protease
WO1991006329A1 (en) * 1990-11-02 1991-05-16 Marion Giebel Anti-infection catheter arrangement

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3930039A1 (en) * 1989-09-06 1991-03-07 Palm Uelo Aarne Catheter infection prophylaxis - by flushing with mixture of antibiotics and protease
WO1991006329A1 (en) * 1990-11-02 1991-05-16 Marion Giebel Anti-infection catheter arrangement

Also Published As

Publication number Publication date
DE19539785A1 (en) 1996-07-18
EP0961627A1 (en) 1999-12-08

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