EP1495808A1 - Disposable cassette with integrated liquid container - Google Patents

Disposable cassette with integrated liquid container Download PDF

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Publication number
EP1495808A1
EP1495808A1 EP04009538A EP04009538A EP1495808A1 EP 1495808 A1 EP1495808 A1 EP 1495808A1 EP 04009538 A EP04009538 A EP 04009538A EP 04009538 A EP04009538 A EP 04009538A EP 1495808 A1 EP1495808 A1 EP 1495808A1
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EP
European Patent Office
Prior art keywords
disposable cassette
cassette according
port
sample
disposable
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP04009538A
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German (de)
French (fr)
Other versions
EP1495808B1 (en
Inventor
Uwe Lapp
Stephan c/o Demirci Frey
Michael Fischer
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Fresenius Medical Care Deutschland GmbH
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Fresenius Medical Care Deutschland GmbH
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Publication of EP1495808A1 publication Critical patent/EP1495808A1/en
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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/10—Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/148—Specific details about calibrations
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16—Reagents, handling or storing thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0816—Cards, e.g. flat sample carriers usually with flow in two horizontal directions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0867—Multiple inlets and one sample wells, e.g. mixing, dilution
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0487—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure fluid pressure, pneumatics
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0633—Valves, specific forms thereof with moving parts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/505—Containers for the purpose of retaining a material to be analysed, e.g. test tubes flexible containers not provided for above

Definitions

  • the invention relates to a disposable cassette according to the preamble of claim 1.
  • cassette systems can also be used in the field of analysis technology apply favorably.
  • the object of the invention is to provide a disposable cassette for analysis purposes in which, for example, gases or electrolytes in whole blood, serum or urine are measurable. All liquids, d. H. the one to analyze Sample as well as calibration solutions to be used for analysis the disposable cassette remain.
  • the disposable cassette which is as interchangeable Component of an analyzer is used, a sample input provided.
  • a sample input provided in the Disposable cassette is at least one preferably designed as a bag container with a liquid, for example a calibration liquid, as well as at least one Waste container, preferably waste bags, integrated, the sample input and the various bags with each other via fluid paths integrated in the disposable cassette are connectable.
  • At least one bag that is a corresponding calibration fluid contains, next to the compulsory waste bag available.
  • multiple measurements are possible, which, as previously stated, also Due to the fact that all fluid paths are flushable within the cassette and There is a sample input in the cassette, but no liquid outlet gives. The used liquid is collected in the corresponding waste bag.
  • two provided with calibration liquid bags are provided, is a Two-point calibration possible. Such a two-point calibration is essential more accurate than a one-point calibration.
  • the trained in the form of a port sample input by means of a Slider closable In this case, the slide machine by the analyzer, in which the disposable cassette is used, for example via a machine side be provided provided driver. After appropriate introduction The sample can close the disposable cassette by closing the slide be concluded that a closed circuit within the disposable cassette is present. After expiry of the useful life, the closure of the sample entrance serves to hermetically seal that contaminated disposable to it safe to dispose of.
  • the port via a via a Film hinge hinged plastic flap lockable over the aforementioned Slider is tightly pressed with the edge of the port. Through the plastic flap a liquid-tight closure is ensured.
  • the sample port can be lined inside with a flexible plastic material be.
  • This flexible plastic material is preferably the flexible plastic material, which limits the fluid paths and recesses is intended for the actuators and the execution according to the earlier application DE 102 39 597 corresponds.
  • the sample port itself can be a first in the Cassette in the form of an Englumigen channel leading fluid path subsequent have a slightly flared channel to which a cylindrical connection to connect a Luer connector connects. Due to this configuration It is possible to fill the disposable cassette with a blood capillary ( ⁇ 1.26 to 2.7 mm) or through a needle, such as a syringe needle or to allow a cannula, as well as by a Luer connector. Based on these Design of the sample port, the sample in various ways be entered. First, the sample can be introduced via a syringe, by inserting the luer taper and manually insert the sample into the disposable cassette is injected into it. Then the syringe is removed and the plastic flap closed by the gate
  • An alternative filling option results from a blood capillary, which is in the lower, smaller cone is used. Since the capillary is open at the top, the User interacting with disposable cartridge Disposable pump activate, which promotes the desired sample in the sample channel. After that, the Capillary be removed and the plastic flap can by means of the gate valve be closed.
  • the sample In the event that the sample is to be removed from the inside of the syringe, there are it's another option. It becomes a Ansaugkapillare on the Luerkonus one Syringe attached. This system is used in the luer cone of the sample port. Since the aspiration capillary is open at the side, air can enter the syringe from the front flow in. Therefore, the user can activate the disposable pump, the conveys the sample into the sample channel within the disposable cassette. After that you can he can remove the system and the plastic flap by means of the gate valve close.
  • a flows through the fluid paths of the Disposable cassette with the pouches in connection with flushing channel at the proximal End of the rehearsal port.
  • This allows a complete flushing of the fluid paths the cassette.
  • the mouth region of the flushing channel is connected to the cylindrical Connector for connecting the Luer connector provided in the sample port is, in connection.
  • the actuators such as valves, are advantageous or a diaphragm pump.
  • a channel structure 14 is formed which correspondingly by means of flexible elastomeric material DE 102 39 597 of the same applicant in a known manner are covered.
  • the plastic injection-molded part 12 has a cup-shaped recessed Area 16, in which three bags of calibration liquid 18 and a waste bag 20 lie.
  • the provided with calibration fluid bag 18, the unused Condition of the disposable cassette 10 are closed, are over targeted to opening input areas connected to channels 14.
  • the waste bag 20 is at 28 also connected to the channels 14.
  • In the channel system 14 are a series of Actuators in the form of valves 30 and a pump 32 available.
  • valves 30 and the pump 32 are each provided flexible plastic layers, the can be actuated by not shown here machine-side plunger. For closer Function can be made to DE 102 39 597.
  • valves 30 and the pump 32 may be liquid in the duct system 14 targeted.
  • the measuring path is designated by 60 in FIG.
  • a sample port 3 To enter a sample fluid, such as whole blood, serum or urine, is a sample port 3, as shown enlarged in Figure 3, available.
  • the sample port is about a hinged by means of a film hinge 36 plastic flap 38 liquid-tight lockable.
  • the flap 38 is doing by moving a Slider 40 in the direction of arrow a sealingly pressed against the surface of the port 34.
  • the slider 40 has a driver 42, via the slider is the machine side in or against the arrow direction displaced.
  • the sample port 34 is connected to the channel system 14 via a first channel 44 Connection.
  • the narrow channel 44 is followed by a slightly conical widening Channel region 46, which widens to a cylindrical port 48, which is designed as a connection of a Luer connector.
  • the wall of this cylindrical portion and the slightly flared channel 46 can with flexible plastic, preferably the same material as the Kanalabdekkung be lined.
  • a second English channel 50 extends parallel to first channel 44, however, to the proximal end of the sample port 34, where he with the cylindrical portion 48 of the sample port 34 is in communication.
  • To Closing the plastic flap 38 can by introducing rinse liquid over the channel 50, the entire sample port 48 are flushed out, the consumed Liquid over the channel 44, the channels 14 due to the pumping action the pump 32 is pumpable into the waste bag 20.
  • Disposable cassette 10 is in the analyzer, not shown here inserted and tightly pressed. Usually, the disposable cassettes for a Service life of 24 hours or about 10 to 30 measurements designed. After appropriate Use can be made by closing the slider 40 and the plastic flap 38 the contaminated disposable cassette hermetically sealed and after Removal be disposed of safely from the analyzer.
  • the disposable cassette according to the invention is a cost-effective system given the hand in which the input port for blood urine and serum samples suitable.
  • the sample volume can be kept quite small, being in here illustrated embodiment, a sample volume of up to 150 ul inclusive the volume can be realized to the end of the sample channel.
  • the Probenport can be used for both syringes and capillaries.
  • Disposable cassette is such a favorable flow can be realized that only one low tendency to hemolysis. In the input port system there are dead spaces avoided. After sample entry, the entire system is equipped with an internal rinse solution flushable. A maintenance of the disposable cassette is eliminated.
  • the slider 40 can also realized not shown detent positions for the port be a clear open or closed state Show

Abstract

Single use cassette for a medical analysis unit has at least a sample inlet, at least a membrane pump, valves, measuring section and fluid paths integrated within the cassette. The cassette has at least an integral container in which a calibration liquid is stored as well as at least a waste container.

Description

Die Erfindung betrifft eine Einwegkassette nach dem Oberbegriff des Anspruchs 1.The invention relates to a disposable cassette according to the preamble of claim 1.

In medizinischen Geräten kommen häufig Kunststoff-Einmalartikeln mit fluidführenden Kanälen zum Einsatz. Als Alternative zu herkömmlichen Schlauchsystemen haben sich hier entsprechende Kassettensysteme bewährt. In diesen Kassettensystem sind die entsprechenden Fluidwege gebildet. Das durch die Fluidwege fließende Fluid wird mittels entsprechender Aktoren eingeführt. So sind beispielsweise Ventile eingesetzt, über die die Fluidwege durchgeschaltet oder verschlossen werden. Zum anderen sind in derartigen Kassettensystemen Pumpen zur Förderung des Fluids integriert. Im Bereich der medizinischen Anwendung sind bereits einmal Kassettensysteme bekannt, bei denen ein starrer Teil vorgesehen ist, in welchem Kanäle und Kammern eingelassen sind. Dieser starre Teil wird durch eine durchgehend flexible Folie abgedeckt. Gemäß der DE 102 39 597 wird diese flexible Folie durch flexibel ausgebildete Bereiche im starren Teil gebildet, wobei die starren und flexiblen Bereiche unter Verwendung einer Zwei-Komponenten-Spritzgusstechnologie einstückig herstellbar sind. In medical devices often plastic disposable articles come with fluid-carrying Channels used. As an alternative to conventional hose systems have proven appropriate cassette systems here. In this cassette system the corresponding fluid paths are formed. The fluid flowing through the fluid paths Fluid is introduced by means of appropriate actuators. Such are, for example Used valves through which the fluid paths are switched or closed. On the other hand, in such cassette systems pumps for promotion integrated of the fluid. In the field of medical application are already once Cassette systems are known in which a rigid part is provided, in which Channels and chambers are embedded. This rigid part is going through a continuous covered with flexible foil. According to DE 102 39 597, this flexible film formed by flexible trained areas in the rigid part, wherein the rigid and flexible areas using a two-component injection molding technology can be produced in one piece.

Die vorgenannten Kassettensysteme lassen sich auch im Bereich der Analysentechnik vorteilhaft anwenden.The aforementioned cassette systems can also be used in the field of analysis technology apply favorably.

Aufgabe der Erfindung ist es, eine Einwegkassette für Analysenzwecke zur Verfügung zu stellen, bei der beispielsweise Gase oder Elektrolyten in Vollblut, Serum oder Urin messbar sind. Dabei sollen alle Flüssigkeiten, d. h. die zu analysierende Probe wie auch entsprechend zur Analyse zu verwendende Kalibrierlösungen in der Einwegkassette verbleiben.The object of the invention is to provide a disposable cassette for analysis purposes in which, for example, gases or electrolytes in whole blood, serum or urine are measurable. All liquids, d. H. the one to analyze Sample as well as calibration solutions to be used for analysis the disposable cassette remain.

Erfindungsgemäß wird diese Aufgabe durch die Kombination der Merkmale des Anspruchs 1 gelöst. Demnach ist in der Einwegkassette, die als auswechselbarer Bestandteil eines Analysengerätes dient, ein Probeneingang vorgesehen. In der Einwegkassette ist mindestens ein vorzugsweise als Beutel ausgestalteter Behälter mit einer Flüssigkeit, beispielsweise einer Kalibrierflüssigkeit, sowie mindestens ein Abfallbehälter, vorzugsweise Abfallbeutel, integriert, wobei der Probeneingang und die verschiedenen Beutel über in der Einwegkassette integrierte Fluidwege miteinander verbindbar sind.According to the invention, this object is achieved by the combination of the features of Claim 1 solved. Accordingly, in the disposable cassette, which is as interchangeable Component of an analyzer is used, a sample input provided. In the Disposable cassette is at least one preferably designed as a bag container with a liquid, for example a calibration liquid, as well as at least one Waste container, preferably waste bags, integrated, the sample input and the various bags with each other via fluid paths integrated in the disposable cassette are connectable.

Es ist der besondere Vorteil des diese erfindungsgemäße Einwegkassette verwendenden Blutanalysengerätes, dass sich alle Fluidwege in der Einwegkassette befinden ohne direkten Kontakt zum Analysengerät. Ein weiterer Vorteil besteht darin, dass mit einer Einwegkassette mehrere Messungen durchgeführt werden können. Der in die Kassette integrierte Abfallbeutel sorgt dafür, dass keine Flüssigkeit die Einwegkassette verlassen und dass die Einwegkassette mit dem Flüssigkeiten nach der Messreihe hygienisch entsorgt werden kann. Mit der erfindungsgemäßen Einwegkassette ist es also möglich, eine Probe einzufüllen und zu messen, wobei beim Einfüllen der Probe das in den Leitungen befindliche Fluid, insbesondere die Kalibrierflüssigkeit verdrängt wird. Nach Messung der Probe wird die Kassette mit Kalibrierflüssigkeit gespült, so daß die Probe mit der Kalibrierflüssigkeit in den Abfallbeutel gespült wird. Die Sensoren werden anschließend neu kalibriert. Die Kassette ist damit bereit, eine neue Probe aufzunehmen. Dieser Kreislauf kann ca. 30 mal und noch häufiger wiederholt werden. Dabei kommt der Spülbarkeit des Ports, wie sie vorzugsweise beansprucht wird, eine große Bedeutung zu.It is the particular advantage of using this disposable cassette according to the invention Blood Analyzer that all fluid paths are in the disposable cassette without direct contact to the analyzer. Another advantage is that with a disposable cassette several measurements can be performed. The waste bag integrated into the cassette ensures that no liquid is present Leave the disposable cassette and that the disposable cassette with the liquids can be disposed of hygienically after the measurement series. With the invention Disposable cassette so it is possible to fill a sample and measure, with when filling the sample, the fluid in the lines, in particular the Calibration liquid is displaced. After measuring the sample, the cassette with Rinsing the calibration liquid, so that the sample with the calibration liquid in the waste bag is rinsed. The sensors are then recalibrated. The cassette is ready to accept a new sample. This cycle can be about 30 times and more often be repeated. Here comes the flushability of the port, as it is preferably claimed to be of great importance.

Bevorzugte Ausgestaltungen der Erfindung ergeben sich aus den sich an den Hauptanspruch anschließenden Unteransprüchen.Preferred embodiments of the invention will become apparent from the to the Main claim subsequent claims.

So ist beispielsweise mindestens ein Beutel, der eine entsprechende Kalibrierflüssigkeit enthält, neben dem obligatorisch vorgesehenen Abfallbeutel vorhanden. Hierdurch sind Mehrfachmessungen möglich, was ja wie zuvor ausgeführt, auch dadurch bedingt ist, dass alle Fluidwege spülbar innerhalb der Kassette liegen und es in der Kassette zwar einen Probeneingang, aber keinen Flüssigkeitsausgang gibt. Die verbrauchte Flüssigkeit wird im entsprechenden Abfallbeutel gesammelt. Soweit zwei mit Kalibrierflüssigkeit vorgesehene Beutel vorgesehen sind, ist eine Zwei-Punkt - Kalibrierung möglich. Eine derartige Zweipunktkalibrierung ist wesentlich genauer als eine Ein.Punkt-Kalibrierung.For example, at least one bag that is a corresponding calibration fluid contains, next to the compulsory waste bag available. As a result, multiple measurements are possible, which, as previously stated, also Due to the fact that all fluid paths are flushable within the cassette and There is a sample input in the cassette, but no liquid outlet gives. The used liquid is collected in the corresponding waste bag. As far as two provided with calibration liquid bags are provided, is a Two-point calibration possible. Such a two-point calibration is essential more accurate than a one-point calibration.

Vorteilhaft ist der in Form eines Ports ausgebildete Probeneingang mittels eines Schiebers verschließbar. Dabei kann der Schieber maschinell von dem Analysengerät, in welchem die Einwegkassette einsetzbar ist, beispielsweise über einen maschinenseitig vorgesehenen Mitnehmer verstellbar sein. Nach entsprechender Einführung der Probe kann durch Schließen des Schiebers die Einwegkassette soweit geschlossen werden, dass ein geschlossener Kreislauf innerhalb der Einwegkassette vorliegt. Nach Ablauf der Nutzungsdauer dient der Verschluss des Probeneingangs dazu, dass kontaminierte Disposable hermetisch zu verschließen, um es gefahrlos entsorgen zu können.Advantageously, the trained in the form of a port sample input by means of a Slider closable. In this case, the slide machine by the analyzer, in which the disposable cassette is used, for example via a machine side be provided provided driver. After appropriate introduction The sample can close the disposable cassette by closing the slide be concluded that a closed circuit within the disposable cassette is present. After expiry of the useful life, the closure of the sample entrance serves to hermetically seal that contaminated disposable to it safe to dispose of.

Gemäß einer weiteren bevorzugten Ausgestaltung ist der Port über eine über ein Filmscharnier angelenkte Kunststoffklappe verschließbar, die über den vorgenannten Schieber dicht mit dem Rand des Ports verpressbar ist. Durch die Kunststoffklappe wird ein flüssigkeitsdichter Verschluss gewährleistet. According to a further preferred embodiment, the port via a via a Film hinge hinged plastic flap lockable over the aforementioned Slider is tightly pressed with the edge of the port. Through the plastic flap a liquid-tight closure is ensured.

Der Probenport kann im Inneren mit einem flexiblen Kunststoffmaterial ausgekleidet sein. Bei diesem flexiblen Kunststoffmaterial handelt es sich vorzugsweise um das flexible Kunststoffmaterial, das zur Begrenzung der Fluidwege und Ausnehmungen für die Aktoren vorgesehen ist und der Ausführung gemäß der früheren Anmeldung DE 102 39 597 entspricht. Der Probenport selbst kann einen an einen ersten in die Kassette in Form eines englumigen Kanals führenden Fluidweg anschließenden sich leicht konisch erweiternden Kanal aufweisen, an den sich ein zylindrischer Anschluss zum Anschluss eines Luer-Konnektors anschließt. Aufgrund dieser Ausgestaltung ist es möglich, eine Befüllung der Einwegkassette durch eine Blutkapillare (⊘ 1,26 bis 2,7 mm) oder durch eine Nadel, beispielsweise eine Spritzennadel oder eine Kanüle, wie auch durch einen Luer-Konnektor zu ermöglichen. Aufgrund dieser Ausgestaltung des Probenports kann die Probe auf verschiedene Art und Weise eingegeben werden. Zunächst kann die Probe über eine Spritze eingeführt werden, indem der Luerkonus eingesetzt wird und die Probe in die Einwegkassette manuell hineingespritzt wird. Danach wird die Spritze entnommen und die Kunststoffklappe mittels des Sperrschiebers verschlossen.The sample port can be lined inside with a flexible plastic material be. This flexible plastic material is preferably the flexible plastic material, which limits the fluid paths and recesses is intended for the actuators and the execution according to the earlier application DE 102 39 597 corresponds. The sample port itself can be a first in the Cassette in the form of an Englumigen channel leading fluid path subsequent have a slightly flared channel to which a cylindrical connection to connect a Luer connector connects. Due to this configuration It is possible to fill the disposable cassette with a blood capillary (⊘ 1.26 to 2.7 mm) or through a needle, such as a syringe needle or to allow a cannula, as well as by a Luer connector. Based on these Design of the sample port, the sample in various ways be entered. First, the sample can be introduced via a syringe, by inserting the luer taper and manually insert the sample into the disposable cassette is injected into it. Then the syringe is removed and the plastic flap closed by the gate valve.

Eine alternative Befüllmöglichkeit ergibt sich über eine Blutkapillare, die in den unteren, kleineren Konus eingesetzt wird. Da die Kapillare oben offen ist, kann der Anwender eine mit der Einwegkassette zusammenwirkende Disposable-Pumpe aktivieren, die die gewünschte Probe in den Probenkanal fördert. Danach kann die Kapillare entnommen werden und die Kunststoffklappe kann mittels des Sperrschiebers verschlossen werden.An alternative filling option results from a blood capillary, which is in the lower, smaller cone is used. Since the capillary is open at the top, the User interacting with disposable cartridge Disposable pump activate, which promotes the desired sample in the sample channel. After that, the Capillary be removed and the plastic flap can by means of the gate valve be closed.

Für den Fall, dass die Probe aus dem Spritzeninneren entnommen werden soll, gibt es eine weitere Option. Es wird eine Ansaugkapillare auf den Luerkonus einer Spritze aufgesetzt. Dieses System wird in den Luerkonus des Probenportes eingesetzt. Da die Ansaugkapillare seitlich offen ist, kann von vorne in die Spritze Luft nachströmen. Deshalb kann der Anwender die Disposable-Pumpe aktivieren, die die Probe in den Probenkanal innerhalb der Einwegkassette fördert. Danach kann er das System entnehmen und kann die Kunststoffklappe mittels des Sperrschiebers verschließen. In the event that the sample is to be removed from the inside of the syringe, there are it's another option. It becomes a Ansaugkapillare on the Luerkonus one Syringe attached. This system is used in the luer cone of the sample port. Since the aspiration capillary is open at the side, air can enter the syringe from the front flow in. Therefore, the user can activate the disposable pump, the conveys the sample into the sample channel within the disposable cassette. After that you can he can remove the system and the plastic flap by means of the gate valve close.

Gemäß einer vorteilhaften Ausführungsvariante mündet ein über die Fluidwege der Einwegkassette mit den Beuteln in Verbindung stehender Spülkanal am proximalen Ende des Probenportes. Dies ermöglicht eine vollständige Ausspülung der Fluidwege der Kassette. Der Mündungsbereich des Spülkanals steht mit dem zylindrischen Anschluss zum Anschluss des Luer-Konnektors, der im Probenport vorgesehen ist, in Verbindung. Beim Spülen, das bei flüssigkeitsdicht verschlossenem Port erfolgt, wird also der gesamte Portbereich mit Spülflüssigkeit durchströmt und die Spülflüssigkeit wird in den ersten englumigen Kanal geführt und über die in der Einwegkassette integrierten Fluidwege bis hin zum Abfallbeutel befördert.According to an advantageous embodiment, a flows through the fluid paths of the Disposable cassette with the pouches in connection with flushing channel at the proximal End of the rehearsal port. This allows a complete flushing of the fluid paths the cassette. The mouth region of the flushing channel is connected to the cylindrical Connector for connecting the Luer connector provided in the sample port is, in connection. When rinsing, the liquid-tight sealed port takes place, so the entire port area is flushed with rinsing liquid and the Rinsing liquid is led into the first English channel and over in the Disposable cassette integrated fluid paths transported to the waste bag.

Vorteilhaft sind im Bereich der Fluidwege die Aktoren, wie beispielsweise Ventile oder eine Membranpumpe, angeordnet.In the area of the fluid paths, the actuators, such as valves, are advantageous or a diaphragm pump.

Weitere Einzelheiten und Vorteile der Erfindung werden anhand eines in der Zeichnung dargestellten Ausführungsbeispiels näher erläutert. Es zeigen:

Fig. 1:
die Draufsicht auf eine Einwegkassette gemäß einer ersten Ausführungsform der vorliegenden Erfindung, teilweise geschnitten,
Fig. 2:
einen Schnitt entsprechend der Schnittlinie II-II durch Fig. 1 und
Fig.3:
einen vergrößerten Schnitt durch den Probenport der Einwegkassette gemäß Fig. 1.
Further details and advantages of the invention will be explained in more detail with reference to an embodiment shown in the drawing. Show it:
Fig. 1:
the top view of a disposable cassette according to a first embodiment of the present invention, partially in section,
Fig. 2:
a section along the section line II-II through Fig. 1 and
3 shows:
an enlarged section through the sample port of the disposable cassette of FIG. 1st

In der in den Figuren 1 und 2 dargestellten Einwegkassette 10 ist zum Zwecke der Fluidführung in einem ersten Teil 12, das als Kunststoffspritzgussteil ausgeführt ist, eine Kanalstruktur 14 ausgebildet, welche mittels flexiblen Elastomermaterials entsprechend der DE 102 39 597 der gleichen Anmelderin in bekannter Art und Weise abgedeckt sind. Das Kunststoffspritzgussteil 12 weist einen schalenförmig vertieften Bereich 16 auf, in welchem drei Beutel mit Kalibrierflüssigkeit 18 und ein Abfallbeutel 20 liegen. Die mit Kalibrierflüssigkeit versehenen Beutel 18, die in ungebrauchtem Zustand der Einwegkassette 10 verschlossen sind, sind über gezielt zu öffnende Eingabebereiche mit Kanälen 14 verbunden. Der Abfallbeutel 20 ist bei 28 ebenfalls mit den Kanälen 14 verbunden. Im Kanalsystem 14 sind eine Reihe von Aktoren in Form von Ventilen 30 bzw. einer Pumpe 32 vorhanden. Bei den Ventilen 30 bzw. der Pumpe 32 sind jeweils flexible Kunststoffschichten vorgesehen, die über hier nicht näher dargestellte maschinenseitige Stößel betätigbar sind. Zur näheren Funktion kann auf die DE 102 39 597 verwiesen werden. Durch entsprechende Steuerung der Ventile 30 bzw. der Pumpe 32 kann Flüssigkeit im Kanalsystem 14 gezielt gefördert werden. Mit 60 ist in Figur 1 die Meßstrecke bezeichnet.In the disposable cassette 10 shown in Figures 1 and 2 is for the purpose of Fluid guide in a first part 12, which is designed as a plastic injection molded part, a channel structure 14 is formed which correspondingly by means of flexible elastomeric material DE 102 39 597 of the same applicant in a known manner are covered. The plastic injection-molded part 12 has a cup-shaped recessed Area 16, in which three bags of calibration liquid 18 and a waste bag 20 lie. The provided with calibration fluid bag 18, the unused Condition of the disposable cassette 10 are closed, are over targeted to opening input areas connected to channels 14. The waste bag 20 is at 28 also connected to the channels 14. In the channel system 14 are a series of Actuators in the form of valves 30 and a pump 32 available. At the valves 30 and the pump 32 are each provided flexible plastic layers, the can be actuated by not shown here machine-side plunger. For closer Function can be made to DE 102 39 597. By appropriate Control of the valves 30 and the pump 32 may be liquid in the duct system 14 targeted. The measuring path is designated by 60 in FIG.

Zur Eingabe einer Probenflüssigkeit, beispielsweise Vollblut, Serum oder Urin, ist ein Probenport 3, wie er in Figur 3 vergrößert dargestellt ist, vorhanden. Der Probenport ist über eine mittels eines Filmscharniers 36 angelenkte Kunststoffklappe 38 flüssigkeitsdicht verschließbar. Die Klappe 38 wird dabei durch Verschieben eines Schiebers 40 in Pfeilrichtung a dichtend an die Oberfläche des Ports 34 angedrückt. Zur Freigabe wird der Schieber 40 in entgegengesetzter Pfeilrichtung zur Pfeilrichtung a verschoben. Der Schieber 40 weist einen Mitnehmer 42 auf, über den der Schieber maschinenseitig in oder gegen die Pfeilrichtung verschiebbar ist. Der Probenport 34 steht über einen ersten Kanal 44 mit dem Kanalsystem 14 in Verbindung. An den englumigen Kanal 44 schließt sich ein leicht konisch erweiternder Kanalbereich 46 an, der sich zu einem zylindrischen Anschluss 48 erweitert, der als Anschluss eines Luer-Konnektors ausgebildet ist. Die Wandung dieses zylindrischen Bereichs sowie des sich leicht konisch erweiternden Kanals 46 kann mit flexiblem Kunststoff, vorzugsweise demselben Material, wie die Kanalabdekkung ausgekleidet sein. Ein zweiter englumiger Kanal 50 erstreckt sich parallel zum ersten Kanal 44, allerdings bis zum proximalen Ende des Probenports 34, wo er mit dem zylindrischen Bereich 48 des Probenports 34 in Verbindung steht. Nach Schließen der Kunststoffklappe 38 kann durch Einleiten von Spülflüssigkeit über den Kanal 50 der gesamte Probenport 48 ausgespült werden, wobei die verbrauchte Flüssigkeit über den Kanal 44, die Kanäle 14 aufgrund der Pumpwirkung der Pumpe 32 in den Abfallbeutel 20 pumpbar ist. To enter a sample fluid, such as whole blood, serum or urine, is a sample port 3, as shown enlarged in Figure 3, available. The sample port is about a hinged by means of a film hinge 36 plastic flap 38 liquid-tight lockable. The flap 38 is doing by moving a Slider 40 in the direction of arrow a sealingly pressed against the surface of the port 34. To release the slider 40 in the opposite direction of the arrow to Arrow direction a shifted. The slider 40 has a driver 42, via the slider is the machine side in or against the arrow direction displaced. The sample port 34 is connected to the channel system 14 via a first channel 44 Connection. The narrow channel 44 is followed by a slightly conical widening Channel region 46, which widens to a cylindrical port 48, which is designed as a connection of a Luer connector. The wall of this cylindrical portion and the slightly flared channel 46 can with flexible plastic, preferably the same material as the Kanalabdekkung be lined. A second English channel 50 extends parallel to first channel 44, however, to the proximal end of the sample port 34, where he with the cylindrical portion 48 of the sample port 34 is in communication. To Closing the plastic flap 38 can by introducing rinse liquid over the channel 50, the entire sample port 48 are flushed out, the consumed Liquid over the channel 44, the channels 14 due to the pumping action the pump 32 is pumpable into the waste bag 20.

Durch dieses Spülen kann eine alte Blutprobe oder eine alte Kalibrierlösung durch frische Kalibrierlösung ersetzt werden. Die in ihrem Aufbau und ihrer Funktion dargestellte Einwegkassette 10 wird in das hier nicht näher dargestellte Analysengerät eingelegt und dicht verpresst. Üblicherweise werden die Einwegkassetten für eine Nutzungsdauer von 24 Stunden oder ca.10 bis 30 Messungen konzipiert. Nach entsprechender Nutzung kann über Verschließen des Schiebers 40 und der Kunststoffklappe 38 die kontaminierte Einwegkassette hermetisch verschlossen und nach Entnahme aus dem Analysegerät gefahrlos entsorgt werden.This rinse allows an old blood sample or an old calibration solution to pass through fresh calibration solution should be replaced. The illustrated in their structure and function Disposable cassette 10 is in the analyzer, not shown here inserted and tightly pressed. Usually, the disposable cassettes for a Service life of 24 hours or about 10 to 30 measurements designed. After appropriate Use can be made by closing the slider 40 and the plastic flap 38 the contaminated disposable cassette hermetically sealed and after Removal be disposed of safely from the analyzer.

Mittels der erfindungsgemäßen Einwegkassette ist ein kostengünstiges System an die Hand gegeben, bei dem sich der Eingabenport für Blut- Urin- und Serumproben eignet. Das Probenvolumen kann recht klein gehalten werden, wobei in der hier dargestellten Ausführungsform ein Probenvolumen von maximal 150 µl einschließlich des Volumens bis zum Ende des Probenkanals verwirklicht werden kann. Der Probenport ist sowohl für Spritzen, als auch Kapillaren verwendbar. Mittels der Einwegkassette ist ein so günstiger Strömungsverlauf realisierbar, dass nur eine geringe Hämolyseneigung besteht. Im System des Eingabenports sind Toträume vermieden. Nach Probeneingabe ist das gesamte System mit einer internen Spüllösung spülbar. Ein Wartungsaufwand der Einwegkassette entfällt. Mittels des Schiebers 40 können auch hier nicht näher dargestellte Rastpositionen für den Port verwirklicht werden, die einen eindeutigen geöffneten bzw. geschlossenen Zustand anzeigenBy means of the disposable cassette according to the invention is a cost-effective system given the hand in which the input port for blood urine and serum samples suitable. The sample volume can be kept quite small, being in here illustrated embodiment, a sample volume of up to 150 ul inclusive the volume can be realized to the end of the sample channel. Of the Probenport can be used for both syringes and capillaries. By means of Disposable cassette is such a favorable flow can be realized that only one low tendency to hemolysis. In the input port system there are dead spaces avoided. After sample entry, the entire system is equipped with an internal rinse solution flushable. A maintenance of the disposable cassette is eliminated. By means of the slider 40 can also realized not shown detent positions for the port be a clear open or closed state Show

Claims (13)

Einwegkassette als auswechselbarer Bestandteil eines Analysengerätes mit mindestens einem Probeneingang, mindestens einer Membranpumpe, Ventilen, einer Meßstrecke und in der Kassette integrierten Fluidwegen
dadurch gekennzeichnet, daß in der Einwegkassette mindestens ein Behälter mit einer Flüssigkeit, beispielsweise einer Kalibrierflüssigkeit, sowie mindestens ein Abfallbehälterl integriert sind.Disposable cassette as a replaceable component of an analyzer with at least one sample input, at least one diaphragm pump, valves, a measuring path and in the cassette integrated fluid paths
characterized in that in the disposable cassette at least one container with a liquid, such as a calibration liquid, and at least one Abfallbehälterl are integrated. Einwegkassette nach Anspruch 1, dadurch gekennzeichnet, daß mindestens zwei Beutel mit Kalibrierflüssigkeit vorhanden sind.Disposable cassette according to claim 1, characterized in that at least two bags of calibration liquid are present. Einwegkassette nach Anspruch 1 oder 2, dadurch gekennzeichnet, daß der in Form eines Ports ausgebildete Probeneingang mittels eines Schiebers verschließbar ist. Disposable cassette according to Claim 1 or 2, characterized in that the sample input formed in the form of a port can be closed by means of a slide. Einwegkassette nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, daß der Port über eine über ein Filmschamier angelenkte Kunststoffklappe verschließbar ist, die über den Schieber dicht mit dem Rand des Ports verpreßbar ist.Disposable cassette according to one of Claims 1 to 3, characterized in that the port can be closed by means of a plastic flap which is articulated via a film hinge and which can be pressed tightly with the edge of the port via the slide. Einwegkassette nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, daß das Innere des Probenportes mit einem flexiblen Kunststoffmaterial ausgekleidet ist.Disposable cassette according to one of claims 1 to 4, characterized in that the interior of the sample port is lined with a flexible plastic material. Einwegkassette nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, daß der Probenport einen an einen ersten in die Kassette in Form eines englumigen Kanals führenden Fluidweg anschließenden sich leicht konisch erweiternden Kanal aufweist, an den sich ein zylindrischer Anschluß zum Anschluß eines Luerkonnektors anschließt.Disposable cassette according to one of Claims 1 to 3, characterized in that the sample port has a slightly conically widening channel adjoining a first fluid path leading into the cassette in the form of an English channel, followed by a cylindrical connection for connecting a Luerkonnector. Einwegkassette nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, daß ein über die Fluidwege der Einwegkassette mit den Beuteln in Verbindung stehende Spülkanal am proximalen Ende des Probenports mündet.Disposable cassette according to one of Claims 1 to 6, characterized in that a flushing channel communicating with the bags via the fluid paths of the disposable cassette opens at the proximal end of the sample port. Einwegkassette nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, daß im Bereich der Fluidwege Aktoren, wie Membranpumpen oder Ventile, angeordnet sind.Disposable cassette according to one of Claims 1 to 7, characterized in that actuators, such as diaphragm pumps or valves, are arranged in the region of the fluid paths. Einwegkassette nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, daß alle zur mehrfachen Messung notwendigen Fluidwege innerhalb einer Kassette liegen.Disposable cassette according to one of the preceding claims, characterized in that all the fluid paths necessary for multiple measurements lie within a cassette. Einwegkassette nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, daß die Kassette keine Ausgänge besitzt. Disposable cassette according to one of the preceding claims, characterized in that the cassette has no outputs. Einwegkassette nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, daß die Behälter Beutel aus Aluminiumverbundfolie sind.Disposable cassette according to one of the preceding claims, characterized in that the containers are bags of composite aluminum foil. Einwegkassette nach einem der vorangehenden Ansprüche, dadurch gekennzeichnet, daß die Einwegkassette spülbar ist.Disposable cassette according to one of the preceding claims, characterized in that the disposable cassette is flushable. Einwegkassette nach Anspruch 12, dadurch gekennzeichnet, daß die Spülung durch einen spülbaren Port erfolgt.Disposable cassette according to Claim 12, characterized in that the flushing takes place through a flushable port.
EP04009538A 2003-07-08 2004-04-22 Disposable cassette with integrated liquid container Revoked EP1495808B1 (en)

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DE10330804A DE10330804A1 (en) 2003-07-08 2003-07-08 disposable cartridge
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Also Published As

Publication number Publication date
DE10330804A1 (en) 2005-04-28
CN100403982C (en) 2008-07-23
ES2268530T3 (en) 2007-03-16
US7384409B2 (en) 2008-06-10
US20050010135A1 (en) 2005-01-13
EP1495808B1 (en) 2006-07-12
ATE332749T1 (en) 2006-08-15
JP4414294B2 (en) 2010-02-10
JP2005031079A (en) 2005-02-03
CN1593338A (en) 2005-03-16
DE502004000946D1 (en) 2006-08-24

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