WO2001034230A1 - Syringe for medical administration of liquids for example medicaments - Google Patents

Syringe for medical administration of liquids for example medicaments Download PDF

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Publication number
WO2001034230A1
WO2001034230A1 PCT/EP2000/010709 EP0010709W WO0134230A1 WO 2001034230 A1 WO2001034230 A1 WO 2001034230A1 EP 0010709 W EP0010709 W EP 0010709W WO 0134230 A1 WO0134230 A1 WO 0134230A1
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WO
WIPO (PCT)
Prior art keywords
plunger
syringe
seal
piston
opening
Prior art date
Application number
PCT/EP2000/010709
Other languages
German (de)
French (fr)
Inventor
Lucien C. Olivier
Original Assignee
Olivier Lucien C
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 Olivier Lucien C filed Critical Olivier Lucien C
Priority to AU18547/01A priority Critical patent/AU1854701A/en
Publication of WO2001034230A1 publication Critical patent/WO2001034230A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3117Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3121Means preventing contamination of the medicament compartment of a syringe via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501Means for blocking or restricting the movement of the rod or piston
    • A61M5/31505Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit
    • A61M2005/31506Integral with the syringe barrel, i.e. connected to the barrel so as to make up a single complete piece or unit formed as a single piece, e.g. moulded
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501Means for blocking or restricting the movement of the rod or piston
    • A61M2005/31508Means for blocking or restricting the movement of the rod or piston provided on the piston-rod

Definitions

  • the invention relates to a syringe for the medical application of liquids, for. B. medication, with an application opening and a plunger opening having a syringe barrel and a plunger axially movable therein, the front end of which is designed as a piston sealed against the inner wall of the syringe barrel, and the rear part of which is led out of the plunger opening of the syringe barrel and ends in a handle , whereby the maximum extension length of the punch is limited by mechanical resistance elements that can be felt when removing the stamp.
  • Syringes of this type are also referred to as "perfuser syringes". These are disposable syringes with a volume of approximately 50 ml which are inserted into automatic perfusor pumps for filling. The medication is then drawn into the syringe by hand, and the syringe is then preferably used Intensive care units in clinics. The perfusors, which are now mostly computer-controlled, apply the medication from the syringes at precisely adjustable speeds of several milliliters per hour.
  • a syringe of the type mentioned is characterized by a further seal, which is effective over the entire circumference, just like the piston seal, between the outside of the plunger and the inner wall of the syringe barrel, the axial distance between the foremost sealing line the further seal and the most rearward sealing line of the piston is larger than the largest possible axial path of the plunger until the maximum extension length is reached.
  • Such a syringe is protected against contamination and turns out to be suitable for reducing the general consumption of generic syringes or perfuser syringes.
  • the syringes can be reused without restriction, so that an important contribution to avoiding waste is made.
  • a preferred development of the syringe according to the invention proposes that the piston has a double seal with two sealing lines which are offset axially to one another.
  • the mechanical resistance elements are integrally formed on the inner wall of the syringe barrel and that when the maximum extension length is reached, the plunger abuts the mechanical resistance elements in the region of the additional seal.
  • FIG. 1 shows a perspective, partially cut-open representation of a syringe according to the invention
  • FIG. 2 shows the syringe according to FIG. 1 in the maximum extended position
  • Fig. 3 is a view of a syringe according to the invention in the maximum extended position
  • Fig. 4 shows the syringe of Fig. 3 in the inserted position.
  • the syringe for the medical application of liquid medication also referred to as a perfusion syringe
  • the syringe for the medical application of liquid medication also referred to as a perfusion syringe
  • the syringe for the medical application of liquid medication is composed of a syringe cylinder 1 and a plunger 2 guided therein.
  • the plunger 3 of the syringe At the front end of the plunger there is the plunger 3 of the syringe, which is sealed over its entire circumference with respect to the inner wall 4 of the syringe barrel.
  • the piston 3 consists of a material with a high sealing effect, for. B. rubber or latex.
  • the material of the stamp itself can also take over the sealing.
  • the syringe barrel 1 is provided at its front end with an application opening 5, through which the medicament to be administered is dispensed.
  • the back of the syringe barrel 1 is completely open and in this way forms a plunger opening through which the plunger 2 passes.
  • the plunger 2 is provided at its end with a suitable handle 6, which can still be gripped even when the plunger 2 is completely retracted into the syringe cylinder 1.
  • Syringe barrel 1 and plunger 2 are made of a suitable plastic, e.g. B. polypropylene.
  • the cross-shaped punch 2 is provided with reinforcing webs 7.
  • Markings 8 on the transparent syringe cylinder 1 indicate the filling quantity of the working volume 9.
  • the working volume 9 is approximately 30 ml in the exemplary embodiment.
  • the stamp 2 is provided approximately at the middle of its length with a further seal 10 which, like the seal of the piston 3, is effective over the entire circumference.
  • the further seal 10 is located on the circumference of a circular disk 11, which is part of the stamp 2.
  • the actual sealing element is an annular seal which is inserted into a corresponding groove in the disk 11. In this way, the stamp 2 including the additional seal 10 can be produced inexpensively on conventional injection molding machines.
  • the further seal can also consist of the material of the stamp itself.
  • the seal of the piston 3 is divided into two and is composed of a front piston seal 12 and a rear piston seal 13. Here, only the front piston seal 12 takes over the limitation of the respective working volume 9, whereas the rear piston seal 13 offers additional security.
  • the condition to be observed is now that the path A ⁇ is greater than the path A max . If this condition is met, the rear seal 10 moves exclusively on a longitudinal section of the inner wall 4 which is not covered by either the front piston seal 12 or the rear piston seal 13 of the piston. The interior wall areas covered in both cases are separated by the difference ⁇ A shown in the drawing. The area .DELTA.A of the inner wall 4 of the syringe barrel 1 is therefore not covered by the rear seal 10 when the plunger is inserted, nor by one of the two plunger seals 12, 13 when the plunger is pulled out. A transfer and transfer of germs and other contaminants is therefore excluded.
  • mechanical resistance elements 14 are integrally formed on the inner wall 4 of the syringe barrel 1. These are located just in front of the rear punch opening of the syringe barrel, so that when the punch 2 is pulled out, the disk 11 abuts against the mechanical resistance elements 14 and in this way limits the extension length of the punch to the maximum working volume 9.
  • the additional seal 10 leads to the fact that introduced germs can get into the area of the seal 10 and are also carried away by it over the entire range of motion of this seal, but there is no transport via the additional “formed by the difference ⁇ A Threshold "instead. Germs and other contaminations therefore do not have the opportunity, even if the plunger 2 is actuated several times, to reach the area of the piston seals 12, 13 of the piston.

Abstract

A syringe for medical administration of liquids, for example medicaments, is disclosed. The injection pump has an injection cylinder (1), comprising an administration opening, a plunger opening and an axially displaceable plunger (2) arranged within said cylinder. The forward end of the plunger (2) forms a piston (3) with a seal against the inner surface (4) of the injection cylinder. The rearmost part of the plunger (2), which projects from the plunger opening, terminates in a grip-section (6). The maximum length of withdrawal (Amax) of the plunger is limited by the retraction of a perceptible mechanical resistance element (14). In order to achieve a permanent contamination protection and to be able to recycle the injection pump, a supplementary seal (10), which is just as effective as the piston seals (12, 13) around its entire circumference, between the outer surface of the plunger (2) and the inner surface (4) of the injection cylinder (1) is disclosed. The axial separation (AK) between the furthest forward sealing-line of the supplementary seal (10) and the furthest backward sealing-point of the piston (3) is greater than the greatest possible axial displacement of the plunger until the maximum length of withdrawal (Amax) is achieved.

Description

Spritze zur medizinischen Applikation von Flüssigkeiten, z. B. Medikamenten Syringe for the medical application of liquids, e.g. B. medication
Die Erfindung betrifft eine Spritze zur medizinischen Applikation von Flüssigkeiten, z. B. Medikamenten, mit einem eine Applikationsöffnung sowie eine Stempelöffnung aufweisenden Spritzenzylinder und einem darin axial bewegbaren Stempel, dessen vorderes Ende als gegenüber der Innenwandung des Spritzenzylinders abgedichteter Kolben ausgebildet ist, und dessen rückwärtiger Teil aus der Stempelöffnung des Spritzenzylinders herausgeführt ist und in einem Griffstück endet, wobei die maximale Auszuglänge des Stempels durch beim Ausziehen spürbare mechanische Widerstandselemente begrenzt wird.The invention relates to a syringe for the medical application of liquids, for. B. medication, with an application opening and a plunger opening having a syringe barrel and a plunger axially movable therein, the front end of which is designed as a piston sealed against the inner wall of the syringe barrel, and the rear part of which is led out of the plunger opening of the syringe barrel and ends in a handle , whereby the maximum extension length of the punch is limited by mechanical resistance elements that can be felt when removing the stamp.
Spritzen dieser Art werden auch als „Perfusorspritzen" bezeichnet. Dies sind Einwegspritzen von ca. 50 ml Volumen, die zum Befüllen in automatische Perfusorpumpen eingelegt werden. Von Hand werden daraufhin die Medikamente in die Spritze aufgezogen, die Verwendung der Spritze erfolgt dann anschließend vorzugsweise auf Intensivstationen von Kliniken. Die heute zumeist rechnergesteuert arbeitenden Perfusoren applizieren die Medikamente aus den Spritzen mit exakt einstellbaren Geschwindigkeiten von mehreren Millilitern pro Stunde.Syringes of this type are also referred to as "perfuser syringes". These are disposable syringes with a volume of approximately 50 ml which are inserted into automatic perfusor pumps for filling. The medication is then drawn into the syringe by hand, and the syringe is then preferably used Intensive care units in clinics The perfusors, which are now mostly computer-controlled, apply the medication from the syringes at precisely adjustable speeds of several milliliters per hour.
Konventionelle Spritzen der gattungsgemäßen Art müssen nach einmaligem Gebrauch weggeworfen werden, da sie bakteriell kontaminiert sind. Durch das Anfassen des Spritzenzylinders und das beim Befüllen notwendige Entlüften kommt es nahezu zwangsläufig zu einem Verschleppen von z. B. Hautkeimen des klinischen Personals in das sterile Medikamentenreservoir der Spritze. Nicht nur auf Intensivstationen entsteht so ein hoher Bedarf an diesen Spritzen, die als teurer Sondermüll entsorgt werden müssen. Eine Wiederaufbereitung der Spritzen ist angesichts der nur geringen Neubeschaffungskosten nicht lohnend. Setzt man eine durchschnittliche Applikationsgeschwindigkeit aller zum Einsatz kommenden Medikamente von nur 3 ml pro Stunde voraus, so würde mit einer Perfusorspritze, die am selben Patienten kontaminationsgeschützt wiederverwendbar wäre, bei einer Nutzung über 24 Stunden der Bedarf einer Intensivstation mindestens halbiert werden.Conventional syringes of the generic type must be thrown away after one use because they are contaminated with bacteria. By touching the syringe barrel and the necessary ventilation when filling, there is almost inevitably a carryover of z. B. Skin germs of clinical personnel in the sterile drug reservoir of the syringe. Not only In intensive care units there is a high demand for these syringes, which have to be disposed of as expensive hazardous waste. Reprocessing the syringes is not worthwhile, given the low cost of replacement. Assuming an average application speed of all medications used of only 3 ml per hour, a perfuser syringe that would be reusable against contamination on the same patient would at least halve the need for an intensive care unit if used over 24 hours.
Es soll daher eine Spritze zur medizinischen Applikation von Flüssigkeiten und insbesondere Medikamenten geschaffen werden, die kontaminationsgeschützt ist und den allgemeinen Verbrauch an solchen Spritzen senkt und damit u. a. zur Müllvermeidung beiträgt.It is therefore intended to create a syringe for the medical application of liquids and in particular medications, which is protected against contamination and which reduces the general consumption of such syringes and thus u. a. contributes to waste prevention.
Zur L ö s u n g dieser Problemstellung ist eine Spritze der eingangs genannten Art gekennzeichnet durch eine weitere, ebenso wie die Kolbendichtung über den gesamten Umfang wirksame Dichtung zwischen der Außenseite des Stempels und der Innenwandung des Spritzenzylinders, wobei der axiale Abstand zwischen der am weitesten vorne liegenden Dichtlinie der weiteren Dichtung und der am weitesten rückwärtigen Dichtlinie des Kolbens größer ist, als der größtmögliche Axialweg des Stempels bis zum Erreichen der maximalen Auszuglänge.To solve this problem, a syringe of the type mentioned is characterized by a further seal, which is effective over the entire circumference, just like the piston seal, between the outside of the plunger and the inner wall of the syringe barrel, the axial distance between the foremost sealing line the further seal and the most rearward sealing line of the piston is larger than the largest possible axial path of the plunger until the maximum extension length is reached.
Eine solche Spritze ist kontaminationsgeschützt und stellt sich als geeignet heraus, den allgemeinen Verbrauch gattungsgemäßer Spritzen bzw. Perfusorspritzen zu senken. Eine Wiederverwendung der Spritzen ist ohne Einschränkung möglich, so daß ein wichtiger Beitrag zur Müllvermeidung geleistet wird.Such a syringe is protected against contamination and turns out to be suitable for reducing the general consumption of generic syringes or perfuser syringes. The syringes can be reused without restriction, so that an important contribution to avoiding waste is made.
Der erzielbare Kontaminationsschutz konnte im Rahmen von Versuchen eindeutig bestätigt werden. Im Vorfeld dieser Versuche wurden die Funktionsmodelle zunächst konventionell sterilisiert. In vitro erfolgten vergleichende Kontaminationstests konventioneller Perfusorspritzen einerseits und der erfindungsgemäßen Perfusorspritze andererseits. Im Sinne eines „Crashtestes" wurden die Kolben massiv mit Testkeimen kontaminiert. Sodann wurden die Stempel im Spritzenzylinder hin- und herbewegt. Sofort erfolgte die erste Aspiration von Nährbouillon. Eine Probe hiervon wurde über 24 Stunden bei 37°C inkubiert. Weitere Aspirationen und Inkubationen erfolgten im Abstand von 1 , 2, 3, 4 und 24 Stunden. Die Identifikation einer Kontamination erfolgte für Testkeime Escherichia coli über einen ApiE-Test und für Testkeime SG 511 über den Nachweis der Koagulase.The achievable contamination protection could be clearly confirmed in tests. Before these tests were carried out, the functional models were first sterilized conventionally. Comparative contamination tests of conventional perfusion syringes on the one hand and the perfusion syringe according to the invention on the other hand were carried out in vitro. In the sense of a "crash test", the pistons were massively contaminated with test germs. The pistons were then moved back and forth in the syringe barrel. The first was carried out immediately Aspiration of nutrient broth. A sample of this was incubated at 37 ° C for 24 hours. Further aspirations and incubations took place at intervals of 1, 2, 3, 4 and 24 hours. Contamination was identified for test germs Escherichia coli using an ApiE test and for test germs SG 511 using the detection of coagulase.
Während die Aspirate der konventionellen Perfusorspritze bereits nach dem ersten Rückzug von Stempel bzw. Kolben kontaminiert waren, konnten die Testkeime bei der erfindungsgemäßen Perfusorspritze auch bei wiederholter Aspiration nach 24 Stunden nicht nachgewiesen werden. Ergänzend erfolgte die Prüfung an Spritzen mit geringerem Füllvolumen mit dem gleichen Ergebnis.While the aspirates of the conventional perfusion syringe were already contaminated after the first retraction of the plunger or plunger, the test germs could not be detected with the perfusion syringe according to the invention even after repeated aspiration after 24 hours. In addition, the test was carried out on syringes with a lower filling volume with the same result.
Mit einer bevorzugten Weiterbildung der erfindungsgemäßen Spritze wird vorgeschlagen, daß der Kolben eine Doppeldichtung mit zwei axial zueinander versetzten Dichtlinien aufweist.A preferred development of the syringe according to the invention proposes that the piston has a double seal with two sealing lines which are offset axially to one another.
In einer weiteren Ausgestaltung wird vorgeschlagen, daß die mechanischen Widerstandselemente an der Innenwand des Spritzenzylinders angeformt sind, und daß bei Erreichen der maximalen Auszugslänge der Stempel im Bereich der zusätzlichen Dichtung gegen die mechanischen Widerstandselemente stößt.In a further embodiment it is proposed that the mechanical resistance elements are integrally formed on the inner wall of the syringe barrel and that when the maximum extension length is reached, the plunger abuts the mechanical resistance elements in the region of the additional seal.
Einzelheiten der Erfindung werden nachfolgend anhand eines auf der Zeichnung dargestellten Ausführungsbeispieles erläutert. Darin zeigen:Details of the invention are explained below with reference to an embodiment shown in the drawing. In it show:
Fig. 1 in perspektivischer, teilweise aufgeschnittener Darstellung eine erfindungsgemäße Spritze;1 shows a perspective, partially cut-open representation of a syringe according to the invention;
Fig. 2 die Spritze nach Fig. 1 in maximal ausgezogener Stellung;FIG. 2 shows the syringe according to FIG. 1 in the maximum extended position;
Fig. 3 in einer Ansicht eine erfindungsgemäße Spritze in maximal ausgezogener Stellung undFig. 3 is a view of a syringe according to the invention in the maximum extended position and
Fig. 4 die Spritze nach Fig. 3 in eingeschobener Stellung. Die Spritze zur medizinischen Applikation von flüssigen Medikamenten, auch als Perfusorspritze bezeichnet, setzt sich aus einem Spritzenzylinder 1 und einem darin geführten Stempel 2 zusammen. Am vorderen Ende des Stempels befindet sich der Kolben 3 der Spritze, welcher gegenüber der Innenwandung 4 des Spritzenzylinders über seinen gesamten Umfang abgedichtet ist. Hierzu besteht der Kolben 3 aus einem Material mit hoher Abdichtwirkung, z. B. Kautschuk oder Latex. Jedoch kann auch das Material des Stempels selbst die Abdichtung übernehmen.Fig. 4 shows the syringe of Fig. 3 in the inserted position. The syringe for the medical application of liquid medication, also referred to as a perfusion syringe, is composed of a syringe cylinder 1 and a plunger 2 guided therein. At the front end of the plunger there is the plunger 3 of the syringe, which is sealed over its entire circumference with respect to the inner wall 4 of the syringe barrel. For this purpose, the piston 3 consists of a material with a high sealing effect, for. B. rubber or latex. However, the material of the stamp itself can also take over the sealing.
Der Spritzenzylinder 1 ist an seinem vorderen Ende mit einer Applikationsöffnung 5 versehen, über die das zu applizierende Medikament abgegeben wird. Die Rückseite des Spritzenzylinders 1 ist völlig offen und bildet auf diese Weise eine Stempelöffnung, durch die der Stempel 2 hindurchtritt. Der Stempel 2 ist an seinem Ende mit einem geeigneten Griffstück 6 versehen, welches auch bei vollständig in dem Spritzenzylinder 1 eingefahrenen Stempel 2 noch greifbar ist.The syringe barrel 1 is provided at its front end with an application opening 5, through which the medicament to be administered is dispensed. The back of the syringe barrel 1 is completely open and in this way forms a plunger opening through which the plunger 2 passes. The plunger 2 is provided at its end with a suitable handle 6, which can still be gripped even when the plunger 2 is completely retracted into the syringe cylinder 1.
Spritzenzylinder 1 und Stempel 2 bestehen aus einem geeigneten Kunststoff, z. B. Polypropylen.Syringe barrel 1 and plunger 2 are made of a suitable plastic, e.g. B. polypropylene.
Zur Verstärkung ist der im Querschnitt kreuzförmig gestaltete Stempel 2 mit Verstärkungsstegen 7 versehen. Markierungen 8 auf dem transparenten Spritzenzylinder 1 geben die Füllmenge des Arbeitsvolumens 9 an. Das Arbeitsvolumen 9 beträgt bei dem Ausführungsbeispiel ca. 30 ml.For reinforcement, the cross-shaped punch 2 is provided with reinforcing webs 7. Markings 8 on the transparent syringe cylinder 1 indicate the filling quantity of the working volume 9. The working volume 9 is approximately 30 ml in the exemplary embodiment.
Der Stempel 2 ist ungefähr auf der Mitte seiner Länge mit einer weiteren Dichtung 10 versehen, die ebenso wie die Dichtung des Kolbens 3 über den gesamten Umfang wirksam ist. Die weitere Dichtung 10 befindet sich auf dem Umfang einer kreisförmigen Scheibe 11 , die Bestandteil des Stempels 2 ist. Das eigentliche Dichtelement ist eine Ringdichtung, die in eine entsprechende Nut der Scheibe 11 eingesetzt ist. Auf diese Weise läßt sich der Stempel 2 einschließlich der zusätzlichen Dichtung 10 auf den herkömmlichen Spritzmaschinen kostengünstig herstellen. Die weitere Dichtung kann aber auch aus dem Material des Stempels selbst bestehen. Die Dichtung des Kolbens 3 ist zweigeteilt und setzt sich aus einer vorderen Kolbendichtung 12 und einer hinteren Kolbendichtung 13 zusammen. Hierbei übernimmt nur die vordere Kolbendichtung 12 die Begrenzung des jeweiligen Arbeitsvolumens 9, wohingegen die hintere Kolbendichtung 13 zusätzliche Sicherheit bietet.The stamp 2 is provided approximately at the middle of its length with a further seal 10 which, like the seal of the piston 3, is effective over the entire circumference. The further seal 10 is located on the circumference of a circular disk 11, which is part of the stamp 2. The actual sealing element is an annular seal which is inserted into a corresponding groove in the disk 11. In this way, the stamp 2 including the additional seal 10 can be produced inexpensively on conventional injection molding machines. The further seal can also consist of the material of the stamp itself. The seal of the piston 3 is divided into two and is composed of a front piston seal 12 and a rear piston seal 13. Here, only the front piston seal 12 takes over the limitation of the respective working volume 9, whereas the rear piston seal 13 offers additional security.
Zur Erzielung eines Kontaminationsschutzes wäre jedoch auch die Kombination der vorderen Kolbendichtung 12 mit der hinteren Kolbendichtung 13 unzureichend. Der Kontaminationsschutz wird vielmehr durch die weitere Dichtung 10 erzielt. Dazu sind die auf der Zeichnung dargestellten geometrischen Verhältnisse zu beachten. Diese lassen sich dahingehend zusammenfassen, daß in jeder Stellung des Stempels 2 relativ zu dem Spritzenzylinder 1 der axiale Abstand zwischen der Dichtlinie der weiteren Dichtung 10 und der am weitesten rückwärtigen Dichtlinie des Kolbens 3 größer ist, als der größtmögliche Axialweg des Stempels 2. In der Fig. ist mit Amax der größtmögliche Axialweg des Stempels 2 bis zum Erreichen der maximalen Auszugslänge eingezeichnet, d. h. jener Weg, der dem maximalen Arbeitsvolumen entspricht. Ferner eingezeichnet ist der axiale Abstand Aκ zwischen der durch die zusätzliche Dichtung 10 definierten Dichtlinie und der am weitesten rückwärtigen Dichtlinie des Kolbens 3. Diese am weitesten rückwärtige Dichtlinie des Kolbens 3 ist die durch die hintere Kolbendichtung 13 definierte Dichtlinie.However, the combination of the front piston seal 12 with the rear piston seal 13 would also be insufficient to achieve contamination protection. The contamination protection is rather achieved by the further seal 10. For this, the geometric relationships shown on the drawing must be observed. These can be summarized in such a way that in each position of the plunger 2 relative to the syringe cylinder 1, the axial distance between the sealing line of the further seal 10 and the most rearward sealing line of the piston 3 is greater than the largest possible axial path of the plunger 2. In the A max shows the largest possible axial path of the punch 2 until the maximum extension length is reached, ie the path which corresponds to the maximum working volume. Also shown is the axial distance A κ between the sealing line defined by the additional seal 10 and the most rearward sealing line of the piston 3. This most rearward sealing line of the piston 3 is the sealing line defined by the rear piston seal 13.
Die einzuhaltende Bedingung lautet nun, daß der Weg Aκ größer als der Weg Amax ist. Wird diese Bedingung eingehalten, so bewegt sich die hintere Dichtung 10 ausschließlich auf einem Längenabschnitt der Innenwandung 4, welcher weder von der vorderen Kolbendichtung 12, noch von der hinteren Kolbendichtung 13 des Kolbens überstrichen wird. Die in beiden Fällen überstrichenen Innenwandbereiche liegen in jedem Fall um die auf der Zeichnung eingetragene Differenz ΔA auseinander. Der Bereich ΔA der Innenwandung 4 des Spritzenzylinders 1 wird daher weder bei eingeschobenem Stempel durch die hintere Dichtung 10, noch bei ausgezogenem Stempel durch eine der beiden Kolbendichtungen 12, 13 überstrichen. Ein Übergang und Weitertragen von Keimen und anderen Kontaminationen ist daher ausgeschlossen. Um die maximale Auszuglänge des Stempels 2 zu begrenzen, sind an der Innenwandung 4 des Spritzenzylinders 1 mechanische Widerstandselemente 14 einstückig angeformt. Diese befinden sich kurz vor der hinteren Stempelöffnung des Spritzenzylinders, so daß beim Ausziehen des Stempels 2 die Scheibe 11 gegen die mechanischen Widerstandselemente 14 stößt und auf diese Weise die Auszugslänge des Stempels auf das maximale Arbeitsvolumen 9 begrenzt.The condition to be observed is now that the path A κ is greater than the path A max . If this condition is met, the rear seal 10 moves exclusively on a longitudinal section of the inner wall 4 which is not covered by either the front piston seal 12 or the rear piston seal 13 of the piston. The interior wall areas covered in both cases are separated by the difference ΔA shown in the drawing. The area .DELTA.A of the inner wall 4 of the syringe barrel 1 is therefore not covered by the rear seal 10 when the plunger is inserted, nor by one of the two plunger seals 12, 13 when the plunger is pulled out. A transfer and transfer of germs and other contaminants is therefore excluded. In order to limit the maximum extension length of the plunger 2, mechanical resistance elements 14 are integrally formed on the inner wall 4 of the syringe barrel 1. These are located just in front of the rear punch opening of the syringe barrel, so that when the punch 2 is pulled out, the disk 11 abuts against the mechanical resistance elements 14 and in this way limits the extension length of the punch to the maximum working volume 9.
Bei Anwendung der Spritzenpumpe führt die zusätzliche Dichtung 10 dazu, daß eingeschleppte Keime zwar in den Bereich der Dichtung 10 gelangen können, und von dieser auch über den gesamten Bewegungsbereich dieser Dichtung verschleppt werden, jedoch findet kein Transport über die durch die Differenz ΔA gebildete zusätzliche „Schwelle" statt. Keime und andere Kontaminationen haben daher auch bei mehrfacher Betätigung des Stempels 2 keine Gelegenheit, bis in den Bereich der Kolbendichtungen 12, 13 des Kolbens zu gelangen. When the syringe pump is used, the additional seal 10 leads to the fact that introduced germs can get into the area of the seal 10 and are also carried away by it over the entire range of motion of this seal, but there is no transport via the additional “formed by the difference ΔA Threshold "instead. Germs and other contaminations therefore do not have the opportunity, even if the plunger 2 is actuated several times, to reach the area of the piston seals 12, 13 of the piston.
BezuqszeichenlisteLIST OF REFERENCES
1 Spritzenzylinder1 syringe barrel
2 Stempel2 stamps
3 Kolben3 pistons
4 Innenwandung4 inner wall
5 Applikationsöffnung5 application opening
6 Griff stück6 handle pieces
7 Verstärkungssteg7 reinforcement bar
8 Markierung8 mark
9 Arbeitsvolumen9 working volume
10 Dichtung10 seal
11 Scheibe11 disc
12 vordere Kolbendichtung12 front piston seal
13 hintere Kolbendichtung13 rear piston seal
14 mechanisches Widerstandselement14 mechanical resistance element
Δ maximaler AuszugΔ maximum extract
Aκ Abstand der DichtungenA κ distance of the seals
ΔA Differenz ΔA difference

Claims

P a t e n t a n s p r ü c h e Patent claims
1. Spritze zur medizinischen Applikation von Flüssigkeiten, z. B. Medikamenten, mit einem eine Applikationsöffnung (5) sowie eine Stempelöffnung aufweisenden Spritzenzylinder (1) und einem darin axial bewegbaren Stempel (2), dessen vorderes Ende als gegenüber der Innenwandung (4) des Spritzenzylinders (1) abgedichteter Kolben (3) ausgebildet ist, und dessen rückwärtiger Teil aus der Stempelöffnung des Spritzenzylinders (1) herausgeführt ist und in einem Griffstück (6) endet, wobei die maximale Auszuglänge (Amax) des Stempels (2) durch beim Ausziehen spürbare mechanische Widerstandselemente (14) begrenzt wird, gekennzeichnet durch eine weitere, ebenso wie die Kolbendichtung (12, 13) über den gesamten Umfang wirksame Dichtung (10) zwischen der Außenseite des Stempels (2) und der Innenwandung (4) des Spritzenzylinders, wobei der axiale Abstand (Aκ) zwischen der am weitesten vorne liegenden Dichtlinie der weiteren Dichtung (10) und der am weitesten rückwärtigen Dichtlinie des Kolbens (3) größer ist, als der größtmögliche Axialweg des Stempels (2) bis zum Erreichen der maximalen Auszuglänge (Amax).1. Syringe for the medical application of liquids, e.g. B. medication, with an application opening (5) and a plunger opening having a syringe cylinder (1) and an axially movable plunger (2) therein, the front end of which is designed as a piston (3) sealed against the inner wall (4) of the syringe cylinder (1) , and the rear part of which is led out of the plunger opening of the syringe barrel (1) and ends in a handle (6), the maximum extension length (A max ) of the plunger (2) being limited by mechanical resistance elements (14) that can be felt when it is pulled out, characterized by a further, just like the piston seal (12, 13) over the entire circumference effective seal (10) between the outside of the plunger (2) and the inner wall (4) of the syringe barrel, the axial distance (A κ ) between the the most forward sealing line of the further seal (10) and the most rearward sealing line of the piston (3) is greater than the largest possible Axialw eg of the punch (2) until the maximum extension length (A max ) is reached.
2. Spritze nach Anspruch 1, dadurch gekennzeichnet, daß der Kolben (3) eine Doppeldichtung (12, 13) mit zwei axial zueinander versetzten Dichtlinien aufweist.2. Syringe according to claim 1, characterized in that the piston (3) has a double seal (12, 13) with two axially offset sealing lines.
3. Spritze nach Anspruch 1 oder Anspruch 2, dadurch gekennzeichnet, daß die mechanischen Widerstandselemente (14) an der Innenwand (4) des Spritzenzylinders (1) angeformt sind, und daß bei Erreichen der maximalen Auszuglänge (Amax) der Stempel (2) im Bereich der zusätzlichen Dichtung (10) gegen die mechanischen Widerstandselemente (14) stößt. 3. Syringe according to claim 1 or claim 2, characterized in that the mechanical resistance elements (14) on the inner wall (4) of the syringe barrel (1) are integrally formed, and that when the maximum extension length (A max ) is reached, the plunger (2) bumps in the area of the additional seal (10) against the mechanical resistance elements (14).
PCT/EP2000/010709 1999-11-10 2000-10-31 Syringe for medical administration of liquids for example medicaments WO2001034230A1 (en)

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DE19953978.2 1999-11-10
DE1999153978 DE19953978A1 (en) 1999-11-10 1999-11-10 Syringe for the medical application of liquids, e.g. B. medication

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004043825A1 (en) * 2002-11-12 2004-05-27 Henkel Kommanditgesellschaft Auf Aktien Dispensing device for a gel-type active substance preparation
US9718949B2 (en) 2010-08-20 2017-08-01 Becton, Dickinson And Company Recycled resin compositions and disposable medical devices made therefrom
US11324861B2 (en) 2011-11-04 2022-05-10 Becton, Dickinson And Company Recycled resin compositions and disposable medical devices made therefrom

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4030498A (en) * 1974-10-25 1977-06-21 Baxter Travenol Laboratories, Inc. Syringe
EP0505579A1 (en) * 1990-10-15 1992-09-30 Seikagaku Kogyo Co., Ltd. Injector supplied with medicine
US5395339A (en) * 1992-01-31 1995-03-07 Sherwood Medical Company Medical device with sterile fluid pathway
EP0687477A1 (en) * 1993-03-02 1995-12-20 Seikagaku Kogyo Kabushiki Kaisha Drug-containing syringe
US5752940A (en) * 1994-01-25 1998-05-19 Becton Dickinson And Company Syringe and method for lyophilizing and reconstituting injectable medication

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4030498A (en) * 1974-10-25 1977-06-21 Baxter Travenol Laboratories, Inc. Syringe
EP0505579A1 (en) * 1990-10-15 1992-09-30 Seikagaku Kogyo Co., Ltd. Injector supplied with medicine
US5395339A (en) * 1992-01-31 1995-03-07 Sherwood Medical Company Medical device with sterile fluid pathway
EP0687477A1 (en) * 1993-03-02 1995-12-20 Seikagaku Kogyo Kabushiki Kaisha Drug-containing syringe
US5752940A (en) * 1994-01-25 1998-05-19 Becton Dickinson And Company Syringe and method for lyophilizing and reconstituting injectable medication

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004043825A1 (en) * 2002-11-12 2004-05-27 Henkel Kommanditgesellschaft Auf Aktien Dispensing device for a gel-type active substance preparation
US9718949B2 (en) 2010-08-20 2017-08-01 Becton, Dickinson And Company Recycled resin compositions and disposable medical devices made therefrom
US11324861B2 (en) 2011-11-04 2022-05-10 Becton, Dickinson And Company Recycled resin compositions and disposable medical devices made therefrom

Also Published As

Publication number Publication date
AU1854701A (en) 2001-06-06
DE19953978A1 (en) 2001-12-06

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