EP1495808B1 - Cassette jetable avec un récipient intégré - Google Patents

Cassette jetable avec un récipient intégré 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
Authority
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
Other languages
German (de)
English (en)
Other versions
EP1495808A1 (fr
Inventor
Uwe Lapp
Stephan c/o Demirci Frey
Michael Fischer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland GmbH
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=33441660&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP1495808(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP1495808A1 publication Critical patent/EP1495808A1/fr
Application granted granted Critical
Publication of EP1495808B1 publication Critical patent/EP1495808B1/fr
Anticipated expiration legal-status Critical
Revoked legal-status Critical Current

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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.

Landscapes

  • 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)

Claims (11)

  1. Cassette jetable (10) comme composant interchangeable d'un appareil d'analyse avec au moins une entrée d'échantillon, au moins une pompe à membrane (32) des valves (30), un trajet de mesure et des voies de fluide (14) intégrées dans la cassette, sachant que dans la cassette jetable (10) sont intégrés au moins un réservoir (18) avec un liquide, par exemple un liquide de calibrage, ainsi qu'au moins un récipient à déchets (20),
    caractérisée en ce que
    la cassette jetable peut être rincée, sachant que le rinçage s'effectue par un port (48) rinçable par un canal (50).
  2. Cassette jetable selon la revendication 1, caractérisée en ce qu'il y a au moins deux sachets (18) avec du liquide de calibrage.
  3. Cassette jetable selon la revendication 1 ou 2, caractérisée en ce que l'entrée pour les échantillons configurée sous la forme d'un port (48) peut être fermée à l'aide d'un tiroir (40).
  4. Cassette jetable selon l'une des revendications 1 à 3, caractérisée en ce que le port (48) peut être fermé par un volet de plastique (38) articulé par une charnière pelliculaire (36), lequel volet peut être pressé jusqu'à étanchéité avec le bord du port (48) par l'intermédiaire du tiroir (40).
  5. Cassette jetable selon l'une des revendications 1 à 4, caractérisée en ce que l'intérieur du port pour les échantillons (48) est revêtu d'une matière plastique flexible.
  6. Cassette jetable selon l'une des revendications 1 à 3, caractérisée en ce que le port pour les échantillons (48) comprend une canalisation (46) s'élargissant de façon légèrement conique, qui se raccorde à une première voie du fluide conduisant dans la cassette sous la forme d'une canalisation (44) étroite, à laquelle se raccorde un raccord cylindrique (pour le raccordement d'un connecteur de Luer).
  7. Cassette jetable selon l'une des revendications 1 à 6, caractérisée en ce qu'une canalisation de rinçage se trouvant en communication avec les sachets (18) par les voies du fluide (14) de la cassette jetable (10) débouche à l'extrémité proximale du port pour les échantillons.
  8. Cassette jetable selon l'une des revendications 1 à 7, caractérisée en ce que dans la zone des voies du fluide sont disposés des actionneurs, comme des pompes à membrane (32) ou des valves (30).
  9. Cassette jetable selon l'une des revendications précédentes, caractérisée en ce que toutes les voies du fluide (14) nécessaires à une mesure multiple se trouvent à l'intérieur d'une cassette (10)
  10. Cassette jetable selon l'une des revendications précédentes, caractérisée en ce que la cassette ne possède pas de sorties.
  11. Cassette jetable selon l'une des revendications précédentes, caractérisée en ce que les récipients sont des sachets (18) en feuille composite d'aluminium.
EP04009538A 2003-07-08 2004-04-22 Cassette jetable avec un récipient intégré Revoked EP1495808B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10330804A DE10330804A1 (de) 2003-07-08 2003-07-08 Einwegkassette
DE10330804 2003-07-08

Publications (2)

Publication Number Publication Date
EP1495808A1 EP1495808A1 (fr) 2005-01-12
EP1495808B1 true EP1495808B1 (fr) 2006-07-12

Family

ID=33441660

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04009538A Revoked EP1495808B1 (fr) 2003-07-08 2004-04-22 Cassette jetable avec un récipient intégré

Country Status (7)

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

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US8116985B1 (en) 2006-03-17 2012-02-14 Battelle Memorial Institute Real time sampling, monitoring and exposure control of test animals
EP2465609B1 (fr) 2007-06-21 2016-12-28 Gen-Probe Incorporated Procédé pour mélanger le contenu d'une chambre de détection
GB0919568D0 (en) 2009-11-09 2009-12-23 Owen Mumford Ltd Skin stimulus
WO2012024658A2 (fr) 2010-08-20 2012-02-23 IntegenX, Inc. Système d'analyse intégrée
US10865440B2 (en) 2011-10-21 2020-12-15 IntegenX, Inc. Sample preparation, processing and analysis systems
US20150136604A1 (en) 2011-10-21 2015-05-21 Integenx Inc. Sample preparation, processing and analysis systems
DE102011056271A1 (de) 2011-12-12 2013-06-13 sense2care GmbH Vorrichtung zur Analyse von Patientenproben
DE102011056273B4 (de) 2011-12-12 2013-11-21 sense2care GmbH Fluidreservoir für eine Vorrichtung zur Analyse von Patientenproben
US9081001B2 (en) 2012-05-15 2015-07-14 Wellstat Diagnostics, Llc Diagnostic systems and instruments
US9625465B2 (en) 2012-05-15 2017-04-18 Defined Diagnostics, Llc Clinical diagnostic systems
US9213043B2 (en) 2012-05-15 2015-12-15 Wellstat Diagnostics, Llc Clinical diagnostic system including instrument and cartridge
CN110560187B (zh) 2013-11-18 2022-01-11 尹特根埃克斯有限公司 用于样本分析的卡盒和仪器
US10208332B2 (en) 2014-05-21 2019-02-19 Integenx Inc. Fluidic cartridge with valve mechanism
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EP3552690B1 (fr) 2014-10-22 2024-09-25 IntegenX Inc. Systèmes et procédés de préparation, de traitement et d'analyse d'échantillons
US10233491B2 (en) 2015-06-19 2019-03-19 IntegenX, Inc. Valved cartridge and system
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US11360065B2 (en) * 2018-03-16 2022-06-14 Teledyne Flir Detection, Inc. Calibration systems and methods for analyte detectors
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WO2024110567A1 (fr) * 2022-11-25 2024-05-30 Radiometer Medical Aps Sac à déchets pour déchets biologiques, tels que des déchets de dosage immunologique

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Also Published As

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

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