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WO2001010486A1 - Device for extracting a liquid from a container in sterile conditions - Google Patents

Device for extracting a liquid from a container in sterile conditions Download PDF

Info

Publication number
WO2001010486A1
WO2001010486A1 PCT/DE2000/002660 DE0002660W WO0110486A1 WO 2001010486 A1 WO2001010486 A1 WO 2001010486A1 DE 0002660 W DE0002660 W DE 0002660W WO 0110486 A1 WO0110486 A1 WO 0110486A1
Authority
WO
WIPO (PCT)
Prior art keywords
liquid
removal
removal device
channel
cone
Prior art date
Application number
PCT/DE2000/002660
Other languages
German (de)
French (fr)
Inventor
Roland Gerlach
Jürgen Reuter
Peter Heise
Original Assignee
Caremed Medical Produkte Ag
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 Caremed Medical Produkte Ag filed Critical Caremed Medical Produkte Ag
Publication of WO2001010486A1 publication Critical patent/WO2001010486A1/en

Links

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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/165Filtering accessories, e.g. blood filters, filters for infusion liquids
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2055Connecting means having gripping means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068Venting means
    • A61J1/2075Venting means for external venting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079Filtering means
    • A61J1/2082Filtering means for gas filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079Filtering means
    • A61J1/2086Filtering means for fluid filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/165Filtering accessories, e.g. blood filters, filters for infusion liquids
    • A61M2005/1657Filter with membrane, e.g. membrane, flat sheet type infusion filter
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/75General characteristics of the apparatus with filters
    • A61M2205/7518General characteristics of the apparatus with filters bacterial

Definitions

  • Removal device for the sterile removal of a liquid from a container
  • the invention relates to a removal device for the sterile removal of a liquid from a container, in particular for the removal of liquids from medical containers by means of syringes or infusion devices, according to the preamble of claim 1.
  • Devices of this type are used in particular to protect the patient from bacterial contamination.
  • DE 3820204 AI describes a device for the filtered supply or removal of liquids into or from a container, in particular a bottle, in which separate chambers for the liquid channel and the air channel are arranged in a carrier plate, each containing filter elements.
  • the device has the disadvantage of complicated manufacture and handling.
  • DE 4010202 AI describes an extraction spike which has an extraction channel and an air channel for pressure equalization.
  • the air duct is connected to the atmosphere by an air filter on the side.
  • the removal spike is provided with a cone for attaching a syringe, for example, and a Luer lock attachment for holding the syringe.
  • This removal spike has the disadvantage that the removal material can only be removed unfiltered. This means a risk of infection for the patient, since any particles and germs are not filtered out.
  • the invention is based on the object of specifying a removal device for the sterile removal of liquids from a container of the type mentioned at the outset which, with little technical effort, ensures flow-efficient filtering of the removed liquid and a compact and material-saving design.
  • the essence of the invention consists in that a liquid filter with an angle ⁇ to the longitudinal axis of the channel is arranged in the channel in the piercing mandrel through which the liquid to be removed flows.
  • the angle is in the range between 3 to 10 degrees, preferably 6 degrees.
  • a favorable flow rate is thus achieved and there are no dead water areas in the filter chamber in which vortices can form.
  • pressure equalization between the atmosphere and the interior of the container is ensured via an air duct with an air filter in the spike during the removal of the liquid.
  • an extraction cone is advantageously provided, in which, for example, a syringe cone engages.
  • a luer lock attachment known per se can advantageously be provided coaxially with the removal cone.
  • the Luer lock approach is advantageously arranged coaxially with the removal cone.
  • the protective sleeve has openings around the Luer lock attachment through which liquid can escape if necessary.
  • FIG. 1 shows a container with the liquid to be removed and an attached removal spike according to the invention in section.
  • FIG. 2 shows an enlarged section from FIG. 1 in the area of the filter chamber.
  • FIG. 3a shows an enlarged section from FIG. 1 in the region of the removal cone.
  • FIG. 3b shows an enlarged section from FIG. 1 in the area of the Luer lock attachment.
  • FIG. 1 shows the exemplary removal device for the liquid transport from a container 4 (bottle, bag, Blasco) to a removal cone 5, from which the liquid can be removed using a syringe (not shown) or an infusion device (also not shown).
  • a corresponding syringe attachment 18 is indicated in FIGS. 3a and 3b.
  • the removal device essentially consists of a piercing mandrel 1 with a channel 6, a filter chamber 7 and a liquid filter 8.
  • the liquid flows through the channel 6 into a first half of the filter chamber 7, flows through the liquid filter 8, passes into a second half of the filter chamber 8 and finally flows into the removal cone 5.
  • the liquid filter 8 in the filter chamber 7 is opposite the longitudinal axis of the channel 6 arranged at an angle.
  • the inclination of the angle is 6 degrees in the exemplary embodiment.
  • This relatively slight inclination of the liquid filter 8 has the advantage over horizontally or vertically installed filters that the flow undergoes almost no redirection and thus no stagnation and vortex areas, also known as so-called dead water areas, occur in which suspended particles can be deposited.
  • FIG. 2 shows an enlarged section from FIG. 1 with direction lines which indicate the direction of flow of the liquid removed. It is obvious that the liquid flows through the filter chamber 7 relatively freely without the formation of dead water areas.
  • filtered air flows into the container 4 in a known manner via an air filter 10 known per se and an air duct 11.
  • Removal device here combined with a cover of the filter chamber 7, a handle plate 2 arranged, which is provided with superimposed transverse ribs. The user can put his thumb on the grip plate 2 and thus has a good grip when
  • a known Luer lock attachment 12 is arranged coaxially with the removal cone 5. This ensures an exact coupling of the removal device with the respective attachment devices, e.g. guaranteed a syringe.
  • the Luer lock attachment 12 is surrounded by a rubber-elastic protective dome 13.
  • a cover cap 3 is provided in the example, which is connected to the protective dome 13 via an elastic web 16.
  • the cover cap 3 has a peripheral edge 14 and a truncated cone 15.
  • This cover cap 3, in combination with the protective dome 13, advantageously enables the entire combination of Luer lock attachment 12 and removal cone 5 to be covered.
  • the truncated cone 15 engages sealingly in the removal cone 5 and the peripheral edge 14 simultaneously overlaps the Luer lock attachment 12.
  • openings 17 are provided all around, which enable any liquids that may occur to be drained and thus prevent increased bacterial growth in a moist chamber. This minimizes possible bacterial contamination.
  • a syringe cone 18 is inserted into the removal cone 5 of the removal device.
  • Protection dome 13 is relaxed at this time. If a lock 19 of the Luer lock attachment 12 is used, the rubber-elastic protective dome 13 is deformed and releases the Luer lock attachment 12 of the removal device. After the liquid has been withdrawn and the Luer lock attachment 12 has been unlocked, the relaxed state according to FIG. 1 is automatically restored. The Luer lock attachment 12 and the removal cone 5 are protected against contamination from the outside. To further protect the removal device, the cover cap 3 is closed manually.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

The invention relates to a device for extracting a liquid from a container, especially a medical container, in sterile conditions. Said device is composed of a needle comprising a flow channel for the liquid and a liquid filter for filtering the extracted liquid. Said liquid filter (89 is placed in the channel at an angle ( alpha ) comprised between 3 and 10 degrees, preferably 6 degrees, in relation to the longitudinal axis of the channel (6). In addition, the liquid filter (8) is located in a filter chamber (7) inside the channel (6), whereby the longitudinal axis of said filter chamber (7) extends along the longitudinal axis of the channel (6).

Description

Beschreibung description
Entnahmevorrichtung zur sterilen Entnahme einer Flüssigkeit aus einem BehälterRemoval device for the sterile removal of a liquid from a container
Technisches GebietTechnical field
Die Erfindung betrifft eine Entnahmevorrichtung zur sterilen Entnahme einer Flüssigkeit aus einem Behälter, insbesondere für die Entnahme von Flüssigkeiten aus medizinischen Behältnissen mittels Spritzen oder Infusionsvorrichtungen, nach dem Oberbegriff des Anspruchs 1.The invention relates to a removal device for the sterile removal of a liquid from a container, in particular for the removal of liquids from medical containers by means of syringes or infusion devices, according to the preamble of claim 1.
Derartige Vorrichtungen dienen insbesondere zum Schutz des Patienten vor einer bakteriellen Kontamination.Devices of this type are used in particular to protect the patient from bacterial contamination.
Stand der TechnikState of the art
In der DE 3820204 AI ist eine Vorrichtung zum gefilterten Zuführen bzw. Entnehmen von Flüssigkeiten in bzw. aus einem Behältnis, insbesondere einer Flasche beschrieben, bei der in einer Trägerplatte separate Kammern für den Flüssigkeitskanal und den Luftkanal angeordnet sind, die jeweils Filterelemente enthalten. Die Vorrichtung hat den Nachteil einer komplizierten Fertigung und Handhabung. Außerdem ist ein höherer Strömungswiderstand vorhanden, der für das Entnehmen der Medien einen langen Zeitraum erfordert.DE 3820204 AI describes a device for the filtered supply or removal of liquids into or from a container, in particular a bottle, in which separate chambers for the liquid channel and the air channel are arranged in a carrier plate, each containing filter elements. The device has the disadvantage of complicated manufacture and handling. In addition, there is a higher flow resistance, which requires a long period of time for removing the media.
In der DE 4010202 AI ist ein Entnahme-Spike beschrieben, der einen Entnahmekanal und einen Luftkanal zum Druckaus- gleich besitzt. Der Luftkanal ist durch ein seitlich angeordnetes Luftfilter mit der Atmosphäre verbunden. Gegenüber dem Einstechdorn ist der Entnahme-Spike mit einem Konus zum Ansetzen beispielsweise einer Spritze und einem Luer-Lockansatz zum Halten der Spritze versehen. Dieser Entnahme-Spike hat den Nachteil, dass das Entnahmegut nur ungefiltert entnommen werden kann. Das bedeutet für den Patienten eine Infektionsgefahr, da eventuelle Partikel und Keime nicht ausgefiltert werden.DE 4010202 AI describes an extraction spike which has an extraction channel and an air channel for pressure equalization. The air duct is connected to the atmosphere by an air filter on the side. Compared to the piercing mandrel, the removal spike is provided with a cone for attaching a syringe, for example, and a Luer lock attachment for holding the syringe. This removal spike has the disadvantage that the removal material can only be removed unfiltered. This means a risk of infection for the patient, since any particles and germs are not filtered out.
Darstellung der ErfindungPresentation of the invention
Der Erfindung liegt die Aufgabe zu Grunde, eine Entnahme- Vorrichtung zur sterilen Entnahme von Flüssigkeiten aus einem Behälter der eingangs genannten Art anzugeben, die bei geringen technischen Aufwand eine strömungsgünstige Filterung der entnommenen Flüssigkeit und eine kompakte und materialsparende Bauweise gewährleistet.The invention is based on the object of specifying a removal device for the sterile removal of liquids from a container of the type mentioned at the outset which, with little technical effort, ensures flow-efficient filtering of the removed liquid and a compact and material-saving design.
Die Erfindung löst die Aufgabe durch die im kennzeichnenden Teil des Anspruchs 1 genannten Merkmale. Vorteilhafte Weiterbildungen der Erfindung sind in den Unteransprüchen gekennzeichnet und werden nachstehend zusammen mit der Beschreibung der bevorzugten Ausführung der Erfindung, einschließlich der Zeichnung, näher dargestellt.The invention solves the problem by the features mentioned in the characterizing part of claim 1. Advantageous developments of the invention are characterized in the subclaims and are described in more detail below together with the description of the preferred embodiment of the invention, including the drawing.
Der Kern der Erfindung besteht darin, dass in den Kanal im Einstechdorns, durch den die zu entnehmende Flüssigkeit fließt, ein Flüssigkeitsfilter mit einem Winkel α zur Längsachse des Kanals angeordnet ist. Der Winkel liegt im Bereich zwischen 3 bis 10 Grad, vorzugsweise 6 Grad.The essence of the invention consists in that a liquid filter with an angle α to the longitudinal axis of the channel is arranged in the channel in the piercing mandrel through which the liquid to be removed flows. The angle is in the range between 3 to 10 degrees, preferably 6 degrees.
Insbesondere bei der Ausführung nach Anspruch 2 wird damit eine günstige Strömungsgeschwindigkeit erzielt und es bilden sich in der Filterkammer keine Totwassergebiete, in denen sich Wirbel ausbilden können. In bekannter Weise wird über einen Luftkanal mit einem Luftfilter im Einstechdorn während der Entnahme der Flüssigkeit für den Druckausgleich zwischen der Atmosphäre und dem Innenraum des Behältnisses gesorgt.In particular in the embodiment according to claim 2, a favorable flow rate is thus achieved and there are no dead water areas in the filter chamber in which vortices can form. In a known manner, pressure equalization between the atmosphere and the interior of the container is ensured via an air duct with an air filter in the spike during the removal of the liquid.
Zur besseren Handhabung der Entnahmevorrichtung hat es sich als vorteilhaft erwiesen, im mittleren Bereich eine Griffplatte vorzusehen, die mit oberflächlich angeordneten Querrippen versehen ist.For better handling of the removal device, it has proven to be advantageous to provide a handle plate in the central region which is provided with transverse ribs arranged on the surface.
Am dem Ende der Entnahmevorrichtung, die dem Einstechdorn gegenüber liegt, ist in vorteilhafter Weise ein Entnahmekonus vorgesehen, in den beispielsweise ein Spritzenkegel eingreift.At the end of the removal device, which lies opposite the piercing mandrel, an extraction cone is advantageously provided, in which, for example, a syringe cone engages.
Koaxial zum Entnahmekonus kann in vorteilhafter Weise ein an sich bekannter Luer-Lockansatz vorhanden sein. Dabei ist der Luer-Lockansatz in vorteilhafter Weise koaxial zum Entnahmekonus angeordnet.A luer lock attachment known per se can advantageously be provided coaxially with the removal cone. The Luer lock approach is advantageously arranged coaxially with the removal cone.
Zum Schutz der Kombination aus Entnahmekonus und Luer- Lockansatz gegen Kontamination während der Zeit der Nicht- nutzung ist es vorteilhaft, elastische Schutzmanschetten oder Abdeckkappen vorzusehen. Dabei ist es vorteilhaft, dass die Schutzmanschette um den Luer-Lockansatz Durchbrüche aufweist, durch die im Bedarfsfall Flüssigkeit austreten kann.To protect the combination of the extraction cone and Luer lock attachment against contamination during the period of non-use, it is advantageous to provide elastic protective sleeves or cover caps. It is advantageous that the protective sleeve has openings around the Luer lock attachment through which liquid can escape if necessary.
An Stelle des Entnahmekonus oder des Luer-Lockansatzes kann jeweils auch ein anderer technologisch passender Verbindungsansatz vorgesehen sein.Instead of the removal cone or the Luer lock attachment, another technologically suitable connection attachment can also be provided.
Die Vorteile der Erfindung bestehen insbesondere in Folgendem:The advantages of the invention are in particular:
Bezüglich der Hygiene werden die gesamte kompakte Bauweise der Entnahmevorrichtung und damit auch der Patient auf drei verschiedene Arten vor bakterieller Kontamination geschützt:With regard to hygiene, the entire compact design of the removal device and thus also the patient three different types protected against bacterial contamination:
keine Totwassergebiete vor und hinter dem Flüssig- keitsfilter, in denen ein verstärktes Bakterien- Wachstum während der Entnahme- und Standzeit auftreten kann;no dead water areas in front of and behind the liquid filter, in which increased bacterial growth can occur during the withdrawal and service life;
Schutz des Entnahmekonus und des Luer-Lockansatzes vor Kontamination durch die elastische Manschette während der Anwendung und die Abdeckkappe während der Standzeiten;Protection of the extraction cone and the Luer lock attachment against contamination by the elastic cuff during use and the cover cap during downtimes;
Drainage der elastischen Manschette bei versehentlich übergelaufenen Flüssigkeitsresten über die Durchbrüche, die bei vermehrten Flüssigkeitsan- sammlungen zu verstärkten Bakterienwachstum führen können. Gute Durchlüftung und Trocknung des gesamten Innenraums (keine feuchte Kammer) .Drainage of the elastic cuff in the event of accidental overflow of liquid residues via the breakthroughs, which can lead to increased bacterial growth if the liquid accumulates. Good ventilation and drying of the entire interior (no damp chamber).
Hinsichtlich der Handhabung sind folgende Vorteile hervorzuheben:The following advantages should be emphasized with regard to handling:
kleines Filter und damit kompakte Bauweise, da Strömungswiderstände gering sind;small filter and thus compact design, since flow resistances are low;
ergonomische Gestaltung zum sicheren Handling mit abrutschsicheren Querrippen;ergonomic design for safe handling with non-slip cross ribs;
Möglichkeit der Integration des bakteriendichten Luftfilters in die Griffgeometrie;Possibility of integrating the bacteria-proof air filter into the handle geometry;
- Einhandbedienung der Abdeckkappe.- One-hand operation of the cover cap.
Nachfolgend wird die Erfindung an einem Ausführungsbeispiel näher erläutert. Dabei wird die erfindungsgemäße Entnahmevorrichtung an einem Entnahme-Spike für medizinische Flüssigkeiten angewendet. Figur 1 zeigt ein Behältnis mit der zu entnehmenden Flüssigkeit und einem angesteckten erfindungsgemäßen Entnahme- Spike im Schnitt.The invention is explained in more detail below using an exemplary embodiment. The removal device according to the invention is applied to a removal spike for medical fluids. Figure 1 shows a container with the liquid to be removed and an attached removal spike according to the invention in section.
Figur 2 zeigt einen vergrößerten Ausschnitt aus Figur 1 im Bereich der Filterkammer.FIG. 2 shows an enlarged section from FIG. 1 in the area of the filter chamber.
Figur 3a zeigt einen vergrößerten Ausschnitt aus Figur 1 im Bereich des Entnahmekonus.FIG. 3a shows an enlarged section from FIG. 1 in the region of the removal cone.
Figur 3b zeigt einen vergrößerten Ausschnitt aus Figur 1 im Bereich des Luer-Lockansatzes.FIG. 3b shows an enlarged section from FIG. 1 in the area of the Luer lock attachment.
Figur 1 zeigt die beispielhafte Entnahmevorrichtung für den Flüssigkeitstransport aus einem Behältnis 4 (Flasche, Beutel, Blasco) zu einem Entnahmekonus 5, aus dem die Flüssigkeit mit einer nicht dargestellten Spritze oder einem ebenfalls nicht dargestellten Infusionsgerät entnom- men werden kann. In den Figuren 3a und 3b ist ein entsprechender Spritzenansatz 18 angedeutet.FIG. 1 shows the exemplary removal device for the liquid transport from a container 4 (bottle, bag, Blasco) to a removal cone 5, from which the liquid can be removed using a syringe (not shown) or an infusion device (also not shown). A corresponding syringe attachment 18 is indicated in FIGS. 3a and 3b.
Die Entnahmevorrichtung besteht im Wesentlichen aus einem Einstechdorn 1, mit einem Kanal 6, einer Filterkammer 7 und einem Flüssigkeitsfilter 8.The removal device essentially consists of a piercing mandrel 1 with a channel 6, a filter chamber 7 and a liquid filter 8.
Bei der Entnahme fließt die Flüssigkeit über den Kanal 6 in eine erste Hälfte der Filterkammer 7, durchströmt das Flüssigkeitsfilter 8, gelangt in eine zweite Hälfte der Filterkammer 8 und fließt schließlich in den Entnahmekonus 5. Der Flüssigkeitsfilter 8 in der Filterkammer 7 ist gegenüber der Längsachse des Kanals 6 in einem Winkel angeordnet. Die Neigung des Winkels beträgt im Aus- führungsbeispiel 6 Grad. Diese relativ geringe Neigung des Flüssigkeitsfilters 8 hat gegenüber horizontal oder vertikal eingebauten Filtern den Vorteil, dass die Strömung nahezu keine Umlenkung erfährt und damit keine Stagnations- und Wirbelgebiete, auch als sogenannte Totwassergebiete bezeichnet, auftreten, in denen sich Schwebeteilchen ablagern können. Gleichzeitig wird eine lange Verweildauer der Infusions- bzw. Injektionsflüssigkeit in der Filterkammer 7 vermieden, die eine rasche Vermehrung eventuell vorhandener Bakterien fördern würde. Zusätzlich bewirkt die minimale Umlenkung des Flüssigkeitsstromes geringe Widerstände, die dem Anwender eine leichtere Entnahme ermöglicht.During the removal, the liquid flows through the channel 6 into a first half of the filter chamber 7, flows through the liquid filter 8, passes into a second half of the filter chamber 8 and finally flows into the removal cone 5. The liquid filter 8 in the filter chamber 7 is opposite the longitudinal axis of the channel 6 arranged at an angle. The inclination of the angle is 6 degrees in the exemplary embodiment. This relatively slight inclination of the liquid filter 8 has the advantage over horizontally or vertically installed filters that the flow undergoes almost no redirection and thus no stagnation and vortex areas, also known as so-called dead water areas, occur in which suspended particles can be deposited. At the same time, a long residence time of the infusion or injection liquid in the filter chamber 7 is avoided, which would promote a rapid multiplication of any bacteria that may be present. In addition, the minimal deflection of the liquid flow causes low resistances, which enables the user to remove it more easily.
Figur 2 zeigt einen vergrößerten Ausschnitt aus Figur 1 mit Richtungslinien, die die Fließrichtung der entnommenen Flüssigkeit angeben. Dabei ist offensichtlich, dass die Flüssigkeit relativ frei ohne Ausbildung von Totwasser- gebieten die Filterkammer 7 durchfließt.FIG. 2 shows an enlarged section from FIG. 1 with direction lines which indicate the direction of flow of the liquid removed. It is obvious that the liquid flows through the filter chamber 7 relatively freely without the formation of dead water areas.
Zur Gewährleistung des Druckausgleichs während der Entnahme der Flüssigkeit strömt in bekannter Weise über ein an sich bekanntes Luftfilter 10 und einen Luftkanal 11 gefilterte Luft in das Behältnis 4 ein.To ensure pressure equalization during the removal of the liquid, filtered air flows into the container 4 in a known manner via an air filter 10 known per se and an air duct 11.
Zur besseren Handhabung ist im mittleren Bereich derFor better handling, the
Entnahmevorrichtung, hier kombiniert mit einer Abdeckung der Filterkammer 7, eine Griffplatte 2 angeordnet, die mit oberflächlich angeordneten Querrippen versehen ist. Auf der Griffplatte 2 kann der Anwender seinen Daumen legen und hat dadurch eine gute Grifffestigkeit beimRemoval device, here combined with a cover of the filter chamber 7, a handle plate 2 arranged, which is provided with superimposed transverse ribs. The user can put his thumb on the grip plate 2 and thus has a good grip when
Einstechen der Entnahmevorrichtung in das Behältnis 4.Inserting the removal device into the container 4.
Koaxial zum Entnahmekonus 5 ist ein bekannter Luer-Lockansatz 12 angeordnet. Damit wird eine exakte Kupplung der Entnahmeeinrichtung mit den jeweiligen Ansatzgeräten, z.B. eine Spritze gewährleistet.A known Luer lock attachment 12 is arranged coaxially with the removal cone 5. This ensures an exact coupling of the removal device with the respective attachment devices, e.g. guaranteed a syringe.
Für die vorgesehene Anwendung der Entnahmevorrichtung für medizinische Flüssigkeiten ist der Gewährleistung von Sauberkeit von größter Bedeutung. Zu diesem Zweck ist der Luer-Lockansatz 12 mit einem gummielastischen Schutzdom 13 umgeben.For the intended use of the medical fluid dispenser, the guarantee of Cleanliness is paramount. For this purpose, the Luer lock attachment 12 is surrounded by a rubber-elastic protective dome 13.
Bei Nichtbenutzung der Entnahmevorrichtung, wenn keine Spritze angekuppelt ist, streckt sich der Schutzdom 13 durch seine gummielastischen Kräfte selbstständig, so dass von außen her keine Kontamination des Luer-Lockansatzes 12 möglich ist (Figur 1) .When the removal device is not in use, when no syringe is coupled, the protective dome 13 stretches automatically due to its rubber-elastic forces, so that contamination of the Luer lock attachment 12 is not possible from the outside (FIG. 1).
Weiterhin ist im Beispiel eine Abdeckkappe 3 vorgesehen, die über einen elastischen Steg 16 mit dem Schutzdom 13 verbunden ist. Die Abdeckkappe 3 weist einen umlaufenden Rand 14 und einen Kegelstumpf 15 auf. Diese Abdeckkappe 3 ermöglicht in Kombination mit dem Schutzdom 13 in vorteilhafter Weise das Abdecken der gesamten Kombination Luer- Lockansatz 12 und Entnahmekonus 5. Dabei greift der Kegelstumpf 15 dichtend in den Entnahmekonus 5 ein und der umlaufende Rand 14 übergreift gleichzeitig den Luer- Lockansatz 12. Beim Aufsetzen der Schutzkappe wird der Schutzdom 13 zusammengedrückt, wie es in ähnlicher Weise in Figur 3b durch einen Spritzenkegel 18 erfolgt.Furthermore, a cover cap 3 is provided in the example, which is connected to the protective dome 13 via an elastic web 16. The cover cap 3 has a peripheral edge 14 and a truncated cone 15. This cover cap 3, in combination with the protective dome 13, advantageously enables the entire combination of Luer lock attachment 12 and removal cone 5 to be covered. The truncated cone 15 engages sealingly in the removal cone 5 and the peripheral edge 14 simultaneously overlaps the Luer lock attachment 12. When the protective cap is put on, the protective dome 13 is compressed, as is done in a similar way in FIG. 3b by a syringe cone 18.
Im Boden des Schutzdomes 13 sind umlaufend Durchbrüche 17 angebracht, die eine Drainage eventuell auftretender Flüssigkeiten ermöglichen und damit ein vermehrtes Bakterienwachstum in einer feuchten Kammer verhindern. Eine mögliche bakterielle Kontamination wird damit auf ein Minimum herabgesetzt.In the bottom of the protective dome 13, openings 17 are provided all around, which enable any liquids that may occur to be drained and thus prevent increased bacterial growth in a moist chamber. This minimizes possible bacterial contamination.
Wie in Figur 3a dargestellt ist, wird bei einer Flüssig- keitsentnah e aus dem Behältnis 4 (z.B. mit einer Spritze) bei geöffneter Abdeckkappe 3 ein Spritzenkegel 18 in den Entnahmekonus 5 der Entnahmevorrichtung gesteckt. DerAs shown in FIG. 3a, when a liquid is removed from the container 4 (e.g. with a syringe) and the cap 3 is open, a syringe cone 18 is inserted into the removal cone 5 of the removal device. The
Schutzdom 13 ist zu diesem Zeitpunkt entspannt. Wenn eine Verriegelung 19 des Luer-Lockansatzes 12 zum Einsatz kommt, wird der gummielastische Schutzdom 13 deformiert und gibt den Luer-Lockansatz 12 der Entnahmevorrichtung frei. Nach der Flüssigkeitsentnahme und Entriegelung des Luer-Lockansatzes 12 stellt sich selbsttätig wieder der entspannte Zustand entsprechend Figur 1 ein. Der Luer- Lockansatz 12 und der Entnahmekonus 5 sind vor Kontamination von außen geschützt. Zum weiteren Schutz der Entnahmevorrichtung wird die Abdeckkappe 3 manuell geschlossen. Protection dome 13 is relaxed at this time. If a lock 19 of the Luer lock attachment 12 is used, the rubber-elastic protective dome 13 is deformed and releases the Luer lock attachment 12 of the removal device. After the liquid has been withdrawn and the Luer lock attachment 12 has been unlocked, the relaxed state according to FIG. 1 is automatically restored. The Luer lock attachment 12 and the removal cone 5 are protected against contamination from the outside. To further protect the removal device, the cover cap 3 is closed manually.
Liste der verwendeten BezugszeichenList of the reference symbols used
1 Einstechdorn 2 Griffplatte 3 Abdeckkappe 4 Behältnis 5 Entnahmekonus 6 Kanal 7 Fi1terkammer 8 Flüssigkeitsfilter 9 10 Luftfilter1 spike 2 handle plate 3 cover cap 4 container 5 extraction cone 6 channel 7 filter chamber 8 liquid filter 9 10 air filter
11 Luftkanal 12 Luer-Lockansatz11 Air duct 12 Luer lock attachment
13 Schutzdorn 14 Rand13 protective pin 14 edge
15 Kegelstumpf 16 Steg15 truncated cone 16 bridge
17 Durchbruch 18 Spritzenkegel17 breakthrough 18 syringe cone
19 Verriegelung 2019 Lock 20
21 2221 22
23 2423 24
25 2625 26
27 28 27 28

Claims

Ansprüche Expectations
1. Entnahmevorrichtung zur sterilen Entnahme einer Flüssigkeit aus einem Behälter, insbesondere aus medizinischen Behältnissen, mit einem Einstechdorn, in dem ein Kanal zum Abfluss der Flüssigkeit vorhanden ist, und einem Flüssigkeitsfilter zum Filtern der entnommenen Flüssigkeit, dadurch gekennzeichnet, dass der Flüssigkeitsfilter (8) innerhalb des Kanals (6) mit einem Winkel (α) zur Längsachse des Kanals (6) zwischen 3 bis 10 Grad, vorzugsweise 6 Grad, angeordnet ist.1. Removal device for the sterile removal of a liquid from a container, in particular from medical containers, with a piercing mandrel in which a channel for draining off the liquid is present, and a liquid filter for filtering the removed liquid, characterized in that the liquid filter (8) is arranged within the channel (6) at an angle (α) to the longitudinal axis of the channel (6) between 3 to 10 degrees, preferably 6 degrees.
2. Entnahmevorrichtung nach Anspruch 1, dadurch gekennzeichnet, dass der Flüssigkeitsfilter (8) innerhalb des Kanals (6) in einer Filterkammer (7) angeordnet ist, wobei die Längsachse der Filterkammer (7) in der Längsachse des Kanals (6) liegt.2. Removal device according to claim 1, characterized in that the liquid filter (8) within the channel (6) in a filter chamber (7) is arranged, wherein the longitudinal axis of the filter chamber (7) lies in the longitudinal axis of the channel (6).
3. EntnahmeVorrichtung nach Anspruch 1 oder 2 , dadurch gekennzeichnet, dass an dem Ende der Entnahmevorrichtung, die dem Einstechdorn (1) gegenüber liegt, ein Entnahmekonus (5) vorhanden ist.3. Removal device according to claim 1 or 2, characterized in that a removal cone (5) is present at the end of the removal device, which is opposite the piercing mandrel (1).
4. Entnahmevorrichtung nach Anspruch 1 oder 2 , dadurch gekennzeichnet, dass an dem Ende der Entnahmevorrichtung, die dem Einstechdorn (1) gegenüber liegt, ein Luer-Lockansatz (12) vorhanden ist.4. Removal device according to claim 1 or 2, characterized in that at the end of the removal device, which is opposite the piercing mandrel (1), a Luer lock attachment (12) is present.
5. EntnahmeVorrichtung nach Anspruch 4 , dadurch gekennzeichnet, dass am Luer-Lockansatzes (12) eine elastische Manschette vorhanden ist, die vorzugsweise Durchbrüche5. Removal device according to claim 4, characterized in that an elastic sleeve is present on the Luer lock attachment (12), which preferably has openings
(17) zum Austritt von Flüssigkeit aufweist.(17) for the escape of liquid.
6. Entnahmevorrichtung nach Anspruch 3 und 5, dadurch gekennzeichnet, dass der Luer-Lockansatzes (12) koaxial zum Entnahmekonus (5) angeordnet ist. Entnahmevorrichtung nach Anspruch 3 oder 6, dadurch gekennzeichnet, dass eine Abdeckkappe (3) vorhanden ist, welche einen Rand (14) und einen Kegelstumpf (15) aufweist, derart dass bei Anwendung der Abdeckkappe (3) der Kegelstumpf (15) dichtend in den Entnahmekonus (5) eingreift und der Rand (14) passend den Luer-Lockansatz (12) übergreift, wobei die Abdeckkappe (3) vorzugsweise elastisch mit dem Schutzdom (13) verbunden ist.6. Removal device according to claim 3 and 5, characterized in that the Luer lock extension (12) is arranged coaxially to the removal cone (5). Extraction device according to claim 3 or 6, characterized in that a cover cap (3) is present which has an edge (14) and a truncated cone (15), such that when the cover cap (3) is used, the truncated cone (15) seals in the Removal cone (5) engages and the edge (14) fits over the Luer lock projection (12), the cover cap (3) being preferably elastically connected to the protective dome (13).
Entnahmevorrichtung nach einem der Ansprüche 1 bis 7 , dadurch gekennzeichnet, dass parallel zur Längsachse des Einstechdorns (1) eine Griffplatte (2) , insbesondere mit Querrippen, vorhanden ist. Removal device according to one of claims 1 to 7, characterized in that a handle plate (2), in particular with transverse ribs, is present parallel to the longitudinal axis of the piercing mandrel (1).
PCT/DE2000/002660 1999-08-04 2000-08-04 Device for extracting a liquid from a container in sterile conditions WO2001010486A1 (en)

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DE29913550U DE29913550U1 (en) 1999-08-04 1999-08-04 Withdrawal device with air filter and liquid filter for the sterile removal of liquids from containers

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WO2003086268A1 (en) * 2002-04-11 2003-10-23 Pharmacia Corporation File ampoule system
CN104998318A (en) * 2014-04-18 2015-10-28 美国昊朗国际公司 Vein treatment device
CN105561432A (en) * 2015-12-19 2016-05-11 安徽宏宇五洲医用器材有限公司 Non-gravity type suspension-avoiding transfusion device
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EP2811964B1 (en) * 2012-02-07 2017-06-14 Yukon Medical, LLC Transfer device with fluid filter

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Publication number Priority date Publication date Assignee Title
WO2003043564A1 (en) * 2001-11-22 2003-05-30 Aries S.R.L. Transferring device
WO2003086268A1 (en) * 2002-04-11 2003-10-23 Pharmacia Corporation File ampoule system
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CN105561432A (en) * 2015-12-19 2016-05-11 安徽宏宇五洲医用器材有限公司 Non-gravity type suspension-avoiding transfusion device
WO2021014848A1 (en) * 2019-07-22 2021-01-28 テルモ株式会社 To-be-administered drug solution adjusting tool, to-be-administered drug solution adjusting kit, and method for adjusting to-be-administered drug solution using the same

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