EP1495808B1 - Disposable cassette with integrated liquid container - Google Patents

Disposable cassette with integrated liquid container Download PDF

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Publication number
EP1495808B1
EP1495808B1 EP04009538A EP04009538A EP1495808B1 EP 1495808 B1 EP1495808 B1 EP 1495808B1 EP 04009538 A EP04009538 A EP 04009538A EP 04009538 A EP04009538 A EP 04009538A EP 1495808 B1 EP1495808 B1 EP 1495808B1
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EP
European Patent Office
Prior art keywords
disposable cassette
port
sample
cassette according
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.)
Revoked
Application number
EP04009538A
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German (de)
French (fr)
Other versions
EP1495808A1 (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 In medical devices plastic disposable articles with fluid-carrying channels are often used. As an alternative to conventional hose systems, corresponding cassette systems have proven themselves here. In this cassette system, the corresponding fluid paths are formed. The fluid flowing through the fluid paths is introduced by means of appropriate actuators. For example, valves are used through which the fluid paths are switched or closed. On the other hand, pumps for conveying the fluid are integrated in such cassette systems.
  • cassette systems are already known in which a rigid part is provided, in which channels and chambers are embedded. This rigid part is covered by a continuous flexible film. According to DE 102 39 597, this flexible film is formed by flexibly formed regions in the rigid part, wherein the rigid and flexible regions can be produced in one piece using a two-component injection molding technology.
  • cassette systems can also be advantageously used in the field of analysis technology.
  • 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 can be measured. All liquids, d. H. the sample to be analyzed as well as the calibration solutions to be used for analysis remain in the disposable cassette.
  • a sample input is provided in the disposable cassette, which serves as a replaceable component of an analyzer.
  • the disposable cassette at least one container preferably configured as a bag is integrated with a liquid, for example a calibration liquid, and at least one waste container, preferably waste bags, whereby the sample inlet and the various bags can be connected to one another via fluid paths integrated in the disposable cassette.
  • At least one bag containing a corresponding calibration liquid is present next to the compulsory waste bag.
  • multiple measurements are possible, which, as stated previously, is also due to the fact that all the fluid paths are flushable within the cassette and there is a sample inlet in the cassette, but no liquid outlet. The used liquid is collected in the corresponding waste bag.
  • a two-point calibration is possible. Such a two-point calibration is much more accurate than an one-point calibration.
  • the sample input formed in the form of a port can be closed by means of a slide.
  • the slider can be mechanically adjusted by the analyzer in which the disposable cassette is used, for example via a driver provided on the machine side. After appropriate introduction of the sample can be closed by closing the slide, the disposable cassette so far that a closed circuit is present within the disposable cassette. After the end of the useful life, the closure of the sample inlet serves to hermetically seal the contaminated disposables in order to dispose of them safely.
  • the port can be closed by means of a plastic flap hinged via a film hinge, which can be pressed tightly with the edge of the port via the aforementioned slider.
  • the plastic flap ensures a liquid-tight seal.
  • the sample port may be lined internally with a flexible plastic material.
  • This flexible plastic material is preferably the flexible plastic material which is provided for limiting the fluid paths and recesses for the actuators and corresponds to the embodiment according to the earlier application DE 102 39 597.
  • the sample port itself may have a slightly flared passageway adjoining a first fluid pathway leading into the cassette in the form of an English channel, followed by a cylindrical port for connection to a Luer connector. Due to this configuration, it is possible to allow a filling of the disposable cassette by a blood capillary ( ⁇ 1.26 to 2.7 mm) or by a needle, such as a syringe needle or a cannula, as well as by a Luer connector.
  • the sample can be input in various ways.
  • the sample may be introduced via a syringe by inserting the luer cone and manually injecting the sample into the disposable cassette. Thereafter, the syringe is removed and closed the plastic flap by means of the locking slide.
  • An alternative filling option results from a blood capillary, which is used in the lower, smaller cone. Because the capillary is open at the top, the user can activate a disposable pump that works with the disposable cartridge to deliver the desired sample to the sample channel. Thereafter, the capillary can be removed and the plastic flap can be closed by means of the locking slide.
  • an aspiration capillary is placed on the luer cone of a syringe. This system is used in the luer cone of the sample port. Since the suction capillary is open at the side, air can flow in from the front into the syringe. Therefore, the user can activate the disposable pump, which delivers the sample to the sample channel within the disposable cassette. Then he can remove the system and can close the plastic flap by means of the locking slide.
  • a flushing channel communicating with the bags via the fluid paths of the disposable cassette opens at the proximal end of the sample port. This allows a complete flushing of the fluid paths of the cassette.
  • the mouth region of the flushing channel communicates with the cylindrical connection for connecting the Luer connector, which is provided in the sample port.
  • the actuators such as valves or a diaphragm pump, are advantageously arranged in the area of the fluid paths.
  • a channel structure 14 is formed, which by means of flexible elastomer material according to the DE 102 39 597 of the same applicant in a known manner and Are covered.
  • the plastic injection-molded part 12 has a bowl-shaped recessed area 16, in which three bags with calibration liquid 18 and a waste bag 20 are located.
  • the provided with calibration fluid bag 18, the unused Condition of the disposable cassette 10 are closed, are connected via selectively targeted to input areas with channels 14.
  • the waste bag 20 is also connected to the channels 14 at 28.
  • a number of actuators in the form of valves 30 and a pump 32 are present.
  • valves 30 and the pump 32 flexible plastic layers are respectively provided which can be actuated by way of machine-side tappets (not illustrated here).
  • machine-side tappets not illustrated here.
  • DE 102 39 597 By appropriate control of the valves 30 and the pump 32, liquid in the channel system 14 can be selectively conveyed.
  • the measuring path is designated by 60 in FIG.
  • a sample port 3 For entering a sample liquid, for example whole blood, serum or urine, a sample port 3, as shown enlarged in FIG. 3, is present.
  • the sample port can be closed in a liquid-tight manner by means of a plastic flap 38 hinged by means of a film hinge 36.
  • the flap 38 is pressed by moving a slider 40 in the direction of arrow a sealingly against the surface of the port 34.
  • To release the slider 40 is moved in the opposite direction of the arrow to the arrow a direction.
  • the slider 40 has a driver 42, via which the slide is machine-side in or against the arrow direction displaced.
  • the sample port 34 communicates with the channel system 14 via a first channel 44.
  • the narrow channel 44 is followed by a slightly conically widening channel region 46, which widens to form a cylindrical connection 48, which is designed as a connection of a Luer connector.
  • the wall of this cylindrical portion and the slightly flared channel 46 may be lined with flexible plastic, preferably the same material as the channel cover.
  • a second channel 50 extends parallel to the first channel 44, but to the proximal end of the sample port 34, where it communicates with the cylindrical portion 48 of the sample port 34. After closing the plastic flap 38, the entire sample port 48 can be flushed out by introducing rinsing liquid through the channel 50, whereby the used liquid can be pumped via the channel 44, the channels 14 into the waste bag 20 due to the pumping action of the pump 32.
  • the disposable cassette 10 shown in its structure and function is placed in the analyzer not shown here and pressed tight. Typically, the disposable cassettes are designed for a useful life of 24 hours or about 10 to 30 measurements. After appropriate use can be hermetically sealed by closing the slide 40 and the plastic flap 38, the contaminated disposable cassette and disposed of safely after removal from the analyzer.
  • the disposable cassette By means of the disposable cassette according to the invention, a cost-effective system is provided, in which the input port for blood urine and serum samples is suitable.
  • the sample volume can be kept quite small, wherein in the embodiment shown here, a sample volume of a maximum of 150 .mu.l, including the volume to the end of the sample channel can be realized.
  • the sample port can be used for both syringes and capillaries.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Packages (AREA)
  • Devices For Use In Laboratory Experiments (AREA)

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 plastic disposable articles with fluid-carrying channels are often used. As an alternative to conventional hose systems, corresponding cassette systems have proven themselves here. In this cassette system, the corresponding fluid paths are formed. The fluid flowing through the fluid paths is introduced by means of appropriate actuators. For example, valves are used through which the fluid paths are switched or closed. On the other hand, pumps for conveying the fluid are integrated in such cassette systems. In the field of medical application, cassette systems are already known in which a rigid part is provided, in which channels and chambers are embedded. This rigid part is covered by a continuous flexible film. According to DE 102 39 597, this flexible film is formed by flexibly formed regions in the rigid part, wherein the rigid and flexible regions can be produced in one piece using a two-component injection molding technology.

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

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 can be measured. All liquids, d. H. the sample to be analyzed as well as the calibration solutions to be used for analysis remain in the disposable cassette.

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. Accordingly, a sample input is provided in the disposable cassette, which serves as a replaceable component of an analyzer. In the disposable cassette, at least one container preferably configured as a bag is integrated with a liquid, for example a calibration liquid, and at least one waste container, preferably waste bags, whereby the sample inlet and the various bags can be connected to one another via fluid paths integrated in the disposable cassette.

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 this invention disposable cassette using blood analyzer that all fluid paths are in the disposable cassette without direct contact with the analyzer. Another advantage is that multiple measurements can be made with a disposable cassette. The waste bag integrated into the cassette ensures that no liquid leaves the disposable cassette and that the disposable cassette containing the liquids can be hygienically disposed after the measurement series. With the disposable cassette according to the invention, it is thus possible to fill a sample and to measure, during the filling of the sample, the fluid in the lines, in particular the calibration liquid is displaced. After measuring the sample, the cassette is rinsed with calibration liquid, so that the sample is flushed with the calibration liquid into the waste bag. 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. In this case, the flushability of the port, as it is preferably claimed, is 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 subsequent claims to the main claim.

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.Thus, for example, at least one bag containing a corresponding calibration liquid is present next to the compulsory waste bag. As a result, multiple measurements are possible, which, as stated previously, is also due to the fact that all the fluid paths are flushable within the cassette and there is a sample inlet in the cassette, but no liquid outlet. The used liquid is collected in the corresponding waste bag. As far as two bags provided with calibration liquid are provided, a two-point calibration is possible. Such a two-point calibration is much more accurate than an 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 sample input formed in the form of a port can be closed by means of a slide. In this case, the slider can be mechanically adjusted by the analyzer in which the disposable cassette is used, for example via a driver provided on the machine side. After appropriate introduction of the sample can be closed by closing the slide, the disposable cassette so far that a closed circuit is present within the disposable cassette. After the end of the useful life, the closure of the sample inlet serves to hermetically seal the contaminated disposables in order to dispose of them safely.

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 can be closed by means of a plastic flap hinged via a film hinge, which can be pressed tightly with the edge of the port via the aforementioned slider. The plastic flap ensures a liquid-tight seal.

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 may be lined internally with a flexible plastic material. This flexible plastic material is preferably the flexible plastic material which is provided for limiting the fluid paths and recesses for the actuators and corresponds to the embodiment according to the earlier application DE 102 39 597. The sample port itself may have a slightly flared passageway adjoining a first fluid pathway leading into the cassette in the form of an English channel, followed by a cylindrical port for connection to a Luer connector. Due to this configuration, it is possible to allow a filling of the disposable cassette by a blood capillary (∅ 1.26 to 2.7 mm) or by a needle, such as a syringe needle or a cannula, as well as by a Luer connector. Due to this configuration of the sample port, the sample can be input in various ways. First, the sample may be introduced via a syringe by inserting the luer cone and manually injecting the sample into the disposable cassette. Thereafter, the syringe is removed and closed the plastic flap by means of the locking slide.

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 used in the lower, smaller cone. Because the capillary is open at the top, the user can activate a disposable pump that works with the disposable cartridge to deliver the desired sample to the sample channel. Thereafter, the capillary can be removed and the plastic flap can be closed by means of the locking slide.

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 is another option. An aspiration capillary is placed on the luer cone of a syringe. This system is used in the luer cone of the sample port. Since the suction capillary is open at the side, air can flow in from the front into the syringe. Therefore, the user can activate the disposable pump, which delivers the sample to the sample channel within the disposable cassette. Then he can remove the system and can close the plastic flap by means of the locking slide.

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 variant, a flushing channel communicating with the bags via the fluid paths of the disposable cassette opens at the proximal end of the sample port. This allows a complete flushing of the fluid paths of the cassette. The mouth region of the flushing channel communicates with the cylindrical connection for connecting the Luer connector, which is provided in the sample port. When rinsing, which is done with a liquid-tight sealed port, so the entire port area is flushed with rinsing liquid and the rinsing liquid is fed into the first Englumigen channel and transported through the integrated in the disposable fluid paths to the waste bag.

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

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
Figure 3:
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 cartridge 10 shown in Figures 1 and 2, for the purpose of fluid guidance in a first part 12, which is designed as a plastic injection molded part, a channel structure 14 is formed, which by means of flexible elastomer material according to the DE 102 39 597 of the same applicant in a known manner and Are covered. The plastic injection-molded part 12 has a bowl-shaped recessed area 16, in which three bags with calibration liquid 18 and a waste bag 20 are located. The provided with calibration fluid bag 18, the unused Condition of the disposable cassette 10 are closed, are connected via selectively targeted to input areas with channels 14. The waste bag 20 is also connected to the channels 14 at 28. In the duct system 14, a number of actuators in the form of valves 30 and a pump 32 are present. In the case of the valves 30 and the pump 32, flexible plastic layers are respectively provided which can be actuated by way of machine-side tappets (not illustrated here). For more detailed function, reference may be made to DE 102 39 597. By appropriate control of the valves 30 and the pump 32, liquid in the channel system 14 can be selectively conveyed. 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.For entering a sample liquid, for example whole blood, serum or urine, a sample port 3, as shown enlarged in FIG. 3, is present. The sample port can be closed in a liquid-tight manner by means of a plastic flap 38 hinged by means of a film hinge 36. The flap 38 is pressed by moving a slider 40 in the direction of arrow a sealingly against the surface of the port 34. To release the slider 40 is moved in the opposite direction of the arrow to the arrow a direction. The slider 40 has a driver 42, via which the slide is machine-side in or against the arrow direction displaced. The sample port 34 communicates with the channel system 14 via a first channel 44. The narrow channel 44 is followed by a slightly conically widening channel region 46, which widens to form a cylindrical connection 48, which is designed as a connection of a Luer connector. The wall of this cylindrical portion and the slightly flared channel 46 may be lined with flexible plastic, preferably the same material as the channel cover. A second channel 50 extends parallel to the first channel 44, but to the proximal end of the sample port 34, where it communicates with the cylindrical portion 48 of the sample port 34. After closing the plastic flap 38, the entire sample port 48 can be flushed out by introducing rinsing liquid through the channel 50, whereby the used liquid can be pumped via the channel 44, the channels 14 into the waste bag 20 due to the pumping action of the pump 32.

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 calibration solution to be replaced with fresh calibration solution. The disposable cassette 10 shown in its structure and function is placed in the analyzer not shown here and pressed tight. Typically, the disposable cassettes are designed for a useful life of 24 hours or about 10 to 30 measurements. After appropriate use can be hermetically sealed by closing the slide 40 and the plastic flap 38, the contaminated disposable cassette and disposed of safely after removal 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 anzeigen.By means of the disposable cassette according to the invention, a cost-effective system is provided, in which the input port for blood urine and serum samples is suitable. The sample volume can be kept quite small, wherein in the embodiment shown here, a sample volume of a maximum of 150 .mu.l, including the volume to the end of the sample channel can be realized. The sample port can be used for both syringes and capillaries. By means of the disposable cassette such a favorable flow pattern can be realized that only a slight tendency to hemolysis exists. In the input port system dead spaces are avoided. After sample entry, the entire system can be rinsed with an internal rinse solution. A maintenance of the disposable cassette is eliminated. By means of the slide 40 detent positions not shown here can be realized for the port, which indicate a clear open or closed state.

Claims (11)

  1. A disposable cassette (10) as a replaceable component part of an analysis apparatus comprising at least one sample inlet, at least one diaphragm pump (32), valves (30), a measuring section and fluid paths (14) integrated in the cassette, wherein at least one container (18) with a liquid, for example a calibration liquid, and at least one waste container (20), are integrated in the disposable cassette (10),
    characterised in that
    the disposable cassette is flushable, wherein flushing is effected by a port (48) which is flushable by way of a passage (50).
  2. A disposable cassette according to claim 1 characterised in that there are at least two bags (18) with calibration liquid.
  3. A disposable cassette according to claim 1 or claim 2 characterised in that the sample inlet which is in the form of a port (48) is closable by means of a slider (40).
  4. A disposable cassette according to one of claims 1 to 3 characterised in that the port (48) is closable by way of a plastic flap (38) which is hinged by way of a film hinge (36) and which can be pressed sealingly against the edge of the port (48) by way of the slider (40).
  5. A disposable cassette according to one of claims 1 to 4 characterised in that the interior of the sample port (48) is lined with a flexible plastic material.
  6. A disposable cassette according to one of claims 1 to 3 characterised in that the sample port (48) has a passage (46) which slightly conically enlarges and which adjoins a first fluid path leading into the cassette in the form of a narrow-lumen passage (46), the passage (46) being adjoined by a cylindrical connection for the connection of a luer connector.
  7. A disposable cassette according to one of claims 1 to 6 characterised in that a flushing passage which is in communication with the bags (18) by way of the fluid paths (14) of the disposable cassette (10) opens at the proximal end of the sample port.
  8. A disposable cassette according to one of claims 1 to 7 characterised in that actuators such as diaphragm pumps (32) or valves (30) are arranged in the region of the fluid paths.
  9. A disposable cassette according to one of the preceding claims characterised in that all fluid paths (14) necessary for multiple measurement are disposed within a cassette (10).
  10. A disposable cassette according to one of the preceding claims characterised in that the cassette has no outlets.
  11. A disposable cassette according to one of the preceding claims characterised in that the containers are bags (18) of composite aluminium foil.
EP04009538A 2003-07-08 2004-04-22 Disposable cassette with integrated liquid container Revoked EP1495808B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10330804A DE10330804A1 (en) 2003-07-08 2003-07-08 disposable cartridge
DE10330804 2003-07-08

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EP1495808A1 EP1495808A1 (en) 2005-01-12
EP1495808B1 true EP1495808B1 (en) 2006-07-12

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EP04009538A Revoked EP1495808B1 (en) 2003-07-08 2004-04-22 Disposable cassette with integrated liquid container

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US (1) US7384409B2 (en)
EP (1) EP1495808B1 (en)
JP (1) JP4414294B2 (en)
CN (1) CN100403982C (en)
AT (1) ATE332749T1 (en)
DE (2) DE10330804A1 (en)
ES (1) ES2268530T3 (en)

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Publication number Publication date
EP1495808A1 (en) 2005-01-12
ES2268530T3 (en) 2007-03-16
CN1593338A (en) 2005-03-16
ATE332749T1 (en) 2006-08-15
US20050010135A1 (en) 2005-01-13
CN100403982C (en) 2008-07-23
JP4414294B2 (en) 2010-02-10
DE502004000946D1 (en) 2006-08-24
DE10330804A1 (en) 2005-04-28
US7384409B2 (en) 2008-06-10
JP2005031079A (en) 2005-02-03

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