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 EP20040009538 EP04009538A EP1495808B1 EP 1495808 B1 EP1495808 B1 EP 1495808B1 EP 20040009538 EP20040009538 EP 20040009538 EP 04009538 A EP04009538 A EP 04009538A EP 1495808 B1 EP1495808 B1 EP 1495808B1
Authority
EP
European Patent Office
Prior art keywords
disposable cassette
characterised
port
sample
cassette according
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
EP20040009538
Other languages
German (de)
French (fr)
Other versions
EP1495808A1 (en
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
Priority to DE2003130804 priority Critical patent/DE10330804A1/en
Priority to DE10330804 priority
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP1495808A1 publication Critical patent/EP1495808A1/en
Application granted granted Critical
Publication of EP1495808B1 publication Critical patent/EP1495808B1/en
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 status is Revoked legal-status Critical
Anticipated expiration legal-status Critical

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02Adapting objects or devices to another
    • B01L2200/026Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/10Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14Process control and prevention of errors
    • B01L2200/148Specific details about calibrations
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16Reagents, handling or storing thereof
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0809Geometry, shape and general structure rectangular shaped
    • B01L2300/0816Cards, e.g. flat sample carriers usually with flow in two horizontal directions
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0861Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0867Multiple inlets and one sample wells, e.g. mixing, dilution
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/04Moving fluids with specific forces or mechanical means
    • B01L2400/0475Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0487Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure fluid pressure, pneumatics
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/06Valves, specific forms thereof
    • B01L2400/0633Valves, specific forms thereof with moving parts
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/505Containers for the purpose of retaining a material to be analysed, e.g. test tubes flexible containers not provided for above

Description

  • The invention relates to a disposable cassette according to the preamble of claim 1.
  • 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.
  • The aforementioned 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.
  • 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.
  • 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.
  • Preferred embodiments of the invention will become apparent from the subsequent claims to the main claim.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • The actuators, such as valves or a diaphragm pump, are advantageously arranged in the area of the fluid paths.
  • 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 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.
  • 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.
  • 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.
  • 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.
EP20040009538 2003-07-08 2004-04-22 Disposable cassette with integrated liquid container Revoked EP1495808B1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
DE2003130804 DE10330804A1 (en) 2003-07-08 2003-07-08 disposable cartridge
DE10330804 2003-07-08

Publications (2)

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

Family

ID=33441660

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20040009538 Revoked EP1495808B1 (en) 2003-07-08 2004-04-22 Disposable cassette with integrated liquid container

Country Status (7)

Country Link
US (1) US7384409B2 (en)
EP (1) EP1495808B1 (en)
JP (1) JP4414294B2 (en)
CN (1) CN100403982C (en)
AT (1) AT332749T (en)
DE (2) DE10330804A1 (en)
ES (1) ES2268530T3 (en)

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US9213043B2 (en) 2012-05-15 2015-12-15 Wellstat Diagnostics, Llc Clinical diagnostic system including instrument and cartridge
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Also Published As

Publication number Publication date
DE10330804A1 (en) 2005-04-28
CN100403982C (en) 2008-07-23
US7384409B2 (en) 2008-06-10
CN1593338A (en) 2005-03-16
EP1495808A1 (en) 2005-01-12
DE502004000946D1 (en) 2006-08-24
US20050010135A1 (en) 2005-01-13
AT332749T (en) 2006-08-15
JP4414294B2 (en) 2010-02-10
JP2005031079A (en) 2005-02-03
ES2268530T3 (en) 2007-03-16

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