HK1154222B - Modular sensor cassette - Google Patents

Description

Modular sensor cartridge

Technical Field

The invention relates to a sensor cartridge (sensorkassete) which can be inserted into an analyzer (analyzer), having a continuous (durchgehenden) measuring channel (Messkanal) for receiving a fluid medium and having a sensor element (sensorrischen element) for determining a chemical and/or physical parameter of the fluid medium.

Background

Measurement systems for determining a plurality of parameters in body fluids represent an important component of clinically significant analytical methods. In particular, rapid and precise measurement of the so-called emergency parameters (notfallfarameters) is in the forefront here.

In medicine, the "Point-of-Care Testing" (or POCT for short) is used to indicate a diagnostic test which is not carried out in a central laboratory, but in a hospital directly in a hospital ward, in an intensive Care unit, in an anesthesia situation, but also in an outpatient department, in dialysis, in an outpatient department of a medical practitioner, or during patient transport. POCT has the advantage that the results are already available after a short time, since on the one hand the transport of the sample to a special laboratory is dispensed with and, on the other hand, the time schedule of the laboratory does not have to be taken into account.

It usually involves the determination of so-called emergency parameters, such as blood gas (Blutgase) (O)₂，CO₂) Value of (A), pH value, electrolyte: (A)Li⁺，Na⁺，K⁺，Mg⁺⁺，Ca⁺⁺，Cl^-) Of metabolites (glucose, lactate, urea, creatinine), bilirubin and haemoglobin derivatives (O)₂Hb, HHb, COHb, MetHb), hematocrit values, determination of renal function values, blood coagulation values, markers for heart disease (Marker) and other measurements. However, urinalysis, the generation of blood cell counts or the rapid detection of pathogens can also be achieved by means of point-of-care methods.

Many point-of-care tests are designed as test strips. However, if a plurality of parameters have to be determined simultaneously or in conjunction, preferably a nearly fully automated measuring instrument or analyzer (analyzer) is applied, which is capable of determining the entire parameter set (parameter) simultaneously. Quite generally, the determination of a parameter set is understood to mean the determination of a plurality of individual parameters in the measurement range. In this case, it is preferred that parameters are determined together, which can be determined either simply together on the basis of a common measurement principle (for example hemoglobin derivatives (by means of a measurement spectrum), different electrolytes or metabolites (by means of similar electrochemical or optical detection methods)), or are correlated for the diagnostic evaluation of the analysis results (for example the concentration of different heart-related markers for the differential diagnosis of heart diseases or for the occurrence of metabolic abnormalities in the gas metabolism)The concentration of the different hemoglobin derivatives differentially diagnosed).

The measurements are usually carried out in interchangeable measuring chambers, which are usually equipped with electrochemical sensor elements (electrodes) and/or optical sensor elements (optodes). In addition, photometry/spectroscopy (photometrische/spktroskiopsche method) is also used here, wherein the optical properties of the color reaction or the sample to be determined are used for detection. In this case, a special region is present in the sample channel, which is designed, for example, as an optical cuvette (optical measurement window), which can likewise be regarded as a sensor element in the sense of the present application.

The invention relates in particular to such a device in which the measuring chamber, into which the medium to be examined, such as for example blood, is introduced, is configured as a measuring channel. In this case, the medium to be examined comes into contact with the sensor element in the measuring chamber in order to make possible the actual measuring process. In this case, a plurality of different sensor elements can be combined to form a group of sensor elements (sensor array), which are arranged in a common housing or on a common carrier.

In this connection, a measuring cell block of an analyzer is known from document US5,074,157 a (marsoner), which can be expanded modularly. The range of applications of the instrument can be extended by the engagement of other modules (Ankopplung). In order to ensure the necessary tightness of the connection points of the individual modules, the coupling pieces of the modules have sealing rings. The bypass channel can be led out of the measuring channel connecting the individual measuring chambers to the connecting pieces of the module, to which further measuring chambers can be plugged. This allows an enlargement of the measurement path, by means of which the parameter set can be enlarged if necessary. In order to ensure that a predetermined sample temperature is maintained, it is proposed to insert the module into a thermostatable receiving block. The individual modules are detachably connected to one another, and the measurement chamber block formed by the modules cannot be inserted into the receptacle (Aufnahme) of the analyzer in the form of an interchangeable sensor cartridge.

Document US 6,960,466 a (Pamidi et al) describes a sensor cartridge containing a number of individual measuring electrodes for determining different point-of-care immediate parameters (e.g. blood gases, electrolytes, and metabolites), which are mounted on a common support.

Document EP 0846947B 1(Huber et al) describes a sensor cartridge with a flat-formed electrochemical and/or optical sensor, which is present on a common sensor component.

In the case of the two last-mentioned known embodiments, it is disadvantageous that, for example, different sensor elements requiring different operating conditions (for example different operating temperatures) are present on a single carrier part or sensor part. It is also disadvantageous that the entire sensor cartridge with all sensor elements becomes a waste item when a single sensor element is defective. Furthermore, the less flexibility of the known cartridge is disadvantageous when a decrease or an increase of the parameter set is involved. Therefore, new solutions must be sought for a more flexible set of parameters.

Disclosure of Invention

The solution of the proposed object results in a sensor cartridge comprising at least two fixedly (fest) connected to one another but separately produced modules, each having a housing and a measuring channel section (Messkanalabschnitt), wherein the measuring channel sections of adjacent modules are connected by means of a fluid connection (Kopplung) to form a continuous measuring channel, and wherein at least one of the modules connected to one another is designed as a sensor module and has a sensor array with at least two preferably flat sensor elements. At least the modules, however preferably each module, therefore have a plurality of sensor elements.

In addition, a memory element is associated with the sensor cartridge according to the invention, on which memory element, in particular for the structure of the sensor cartridge consisting of the respective modules, information specific to the sensor cartridge is stored. By means of this common memory element, the individual modules of the sensor cartridge are combined into an integral unit.

When the sensor cartridge according to the invention is inserted into an analyzer, this information specific to the sensor cartridge is transmitted to the analyzer, for example by means of a special reading device which is present in the analyzer. The reading in of the sensor-specific information can be effected automatically (for example by a reader integrated in the analyzer when the sensor cartridge is inserted) or even manually (for example by inputting the information by means of an input device), and the sensor-specific information is transmitted to the analyzer in this way.

In principle, each such device can be used as a storage element, i.e. it can store information and can provide the information to the analyzer. Preferably, such a device is used as a memory element, i.e. it can automatically provide information specific to the sensor cartridge to the corresponding reading device of the analyzer. Such preferred means can be in particular an electronic memory element, for example a memory chip, preferably a rewritable memory chip, or a memory card (for example a flash memory), or even an RFID Transponder (RFID-Transponder) or a magnetic strip, which transmits information specific to the sensor cartridge according to the invention to a corresponding reading device in the analyzer when the sensor cartridge is inserted into the analyzer.

Other possible memory elements are optical codes, for example one-dimensional or two-dimensional bar codes, which can likewise be read automatically by means of a bar code scanner.

It is also possible, in addition to the automatic transmission possibility, to also provide manual input of information specific to the sensor cartridge, which can be realized, for example, by means of an input unit (keyboard) of the analyzer.

According to the invention, a memory element is associated with each sensor cartridge according to the invention, which memory element contains information specific to the respective sensor cartridge. This association is preferably achieved in that the memory element is fixedly connected to the sensor cartridge, so that a clear association is ensured. This can be achieved, for example, by fixing the memory element on the sensor cartridge or integrating it into the sensor cartridge, for example, by loading (miteinbauen) the memory element into the sensor cartridge or by gluing it on during assembly of the sensor cartridge. In principle, it is also possible to arrange the memory element separately from the sensor cartridge, wherein in this case it must be ensured by other measures, for example by a corresponding coding (for example a digital coding) on the sensor cartridge and the memory element that the association of the sensor cartridge and the memory element is unambiguous in order to associate the correct specific information with the respective sensor cartridge.

In general, all such information can be regarded as information specific to the respective sensor cartridge, i.e. which at least describes the way in which the sensor cartridge is composed of individual modules.

Information describing the modular structure of the sensor cartridge is, for example, information about the type of module used (for example, sensor module or dummy module (dummyodul); and, if appropriate, also other information about the type of module (for example, electrochemical, optical or photometric/spectroscopic measurement module) or the use of the measurement module (for example, blood gas module, electrolyte module, metabolite module, oxygen content determination module)) and about the arrangement or position of the individual modules within the sensor cartridge, for example, in which order the individual modules are arranged along the continuous measurement channel.

In a preferred embodiment, the information specific to the respective sensor cartridge also includes information which describes the manner of arrangement of the individual sensor elements (or even the empty regions within the modules) in the respective module and/or their use and handling.

The information describing the structure and use of the individual modules is for example information about the arrangement, handling and/or use of the individual sensor elements within the respective module.

In the case of an electrochemical sensor module, this can be, for example, information which describes the arrangement and/or occupancy of individual (electrical) contacts within a measuring region/window (abbreifbereich/Fenster) of the sensor module and, for example, whether such contacts are connected and with which electrochemical sensor element, and how they should be used.

In the case of an optical sensor module, this can be, for example, information which describes the arrangement and/or occupancy of the individual signal tapping regions (signalabgreifenden beeriche) within the tapping region/window of the sensor module and, for example, whether such signal tapping regions are connected and with which optical sensor element, and how they should be used.

In the case of photometric/spectroscopic sensor modules, this can be, for example, information which describes the arrangement of individual optical measurement windows or cuvettes in the measurement channel and/or their use in the respective module.

In addition to this information about the manner of arrangement of the individual sensor elements in the respective module and/or their use and handling, module-specific information can also be contained which describes the arrangement and use of the individual fluidic interfaces (fluischer anschlusse) within the respective module.

Information about the respective module can then, for example, be contained which describes the type or use of the interface for the individual fluids (for example the fluidic interface of the measurement channel (inlet interface of the sensor cartridge, outlet interface of the sensor cartridge, connection interface between the individual modules) or the bypass or auxiliary interface for the fluids (for example for the transport of a reference electrolyte in the case of an electrochemical measurement module or for the transport of reagents required for analyte determination (analytical testing)) or even a blank or blind interface (for example in the case of a dummy module)).

Furthermore, module-specific information can also be contained, which describes the arrangement and use of the specific thermal contact zones within the respective module.

For example, information about the respective module can be contained, which describes the actuation of the individual thermal contact zones by the analyzer, for example information about which thermal contact zones have to be thermostated to which temperature. Alternatively, the temperature controller may also be located within the module itself. In this case, information about the respective module can be contained, which describes the arrangement of the electrical contacts on the module side necessary for the actuation of the module and/or their respective use.

In addition, module-specific information can also be contained, which describes the arrangement and use of certain fluid control elements (e.g. pumps or valves) in the respective module.

For example, information about the respective module can be contained, which describes the use and actuation of the individual fluid control elements by an analyzer-side or module-side actuator (Aktuatoren).

Such information directed to the respective module is preferably stored at least partially on the memory element and can thus be transmitted to the analyzer together with information specific to the sensor cartridge. Alternatively, it is also possible that all or part of the information relating to the module is already stored in the memory of the analyzer, so that, in the knowledge of the information contained at least on the memory element and transferable from the memory element to the analyzer (which information describes the modular structure of the sensor cartridge), a corresponding linking of these information and thus the information necessary for the correct operation of the sensor cartridge can be made available in the analyzer.

In a further preferred embodiment, the information specific to the respective sensor cartridge further comprises information which describes the type of the individual sensor elements and/or their use and handling.

Such information includes, for example, all information which is required for the operation of the sensor element and/or which is used for detecting the parameter to be determined by means of the sensor element. Such information is often provided to the interchangeable sensor elements in standardized form in the form of stored data and contains, for example, information about the type of sensor element, manufacturing information (e.g. lot number), characteristic curve data and/or calibration information or durability information of the respective sensor element (e.g. service life, expiration date, number of possible measurements).

Such information directed to the respective sensor element is preferably stored at least partially on the memory element and can thus be transmitted to the analyzer together with information specific to the sensor cartridge and optionally also with other information directed to the respective module. Alternatively, it is also possible that all or part of the information relating to the respective sensor element is already stored in the memory of the analyzer, so that, in the knowledge of the information contained at least on the memory element and transferable from the memory element to the analyzer, which describes the modular structure of the sensor cartridge (and optionally also with other information directed to the respective module), a corresponding linking of these information and thus the information necessary for a correct operation of the sensor cartridge can be realized in the analyzer.

A cartridge according to the invention can have at least one sensor module and at least one dummy module, which is implemented essentially identically to the corresponding sensor module structure, with the exception of the missing sensor element. The dummy module therefore differs from the sensor module in that it has no sensor element, however, is otherwise substantially of the same design and, for example, has a fluidic and electrical interface at a similar location to the sensor module. The outer dimensions of the sensor cartridge can thus be kept constant.

It is particularly advantageous that cassettes constructed from different modules, used in one analyzer type, have compatible dimensions and interface regions. The modular construction ensures a high flexibility. For example, new parameters and parameter sets can likewise be developed after the analyzer has been put on the market, without having to adapt the hardware of the instruments already present on the market. In addition, different modules which can determine different parameters or parameter groups can be fitted in different configurations, so that different sensor cartridges can be provided to the user in a simple manner, in accordance with their requirements. The production costs of such different sensor cartridges can be significantly reduced by such a modular construction. Furthermore, it is also possible to use sensor modules with different sensor elements for determining the same parameters for determining these parameters, which may be based on different sensing principles or may cover different concentration ranges of the analyte, for example.

As an alternative to the sample input by means in the analyzer, the sample input can likewise be realized by a special module (sample input module) connected to the modular cartridge.

The sensor module of the sensor cartridge according to the present invention includes, for example:

a) the support element, that is to say the sensor component on which a sensor element or even a series of sensor elements (sensor array) is mounted,

b) a cover part, in which a continuous measuring channel or a measuring channel section is formed, is used for the through-flow of the fluid medium.

c) Optionally, a sealing element for sealing of the measurement channel, wherein the sealing element is present between the holder part and the cover part or is molded (with) at the cover part.

d) A first opening at one end of the measurement channel for joining another module,

e) a second opening at the other end of the measurement channel for coupling to an analytical instrument or another module.

Connections between sensor member and cover, e.g.

By means of sealing elements

By adhesion

By welding (thermally or by means of ultrasound)

To be implemented.

There may be further sealing elements at the connection points of the measuring channel sections of the individual modules, or the seals may be formed by welding. The fixed joining of the modules can be achieved by mechanical snapping, welding or gluing. The fixed joining of the modules is understood in particular to mean that the individual modules are connected during the production of the sensor cartridge in such a way that the modules cannot be separated by simple means, preferably by the user of the sensor cartridge, without destroying the sensor cartridge. The modularly constructed sensor cartridge therefore appears to the user as a single component (consumable) to be inserted into the analyzer.

The modular sensor cartridge has at least two fluidic connection points for an analyzer for the entry or exit of sample medium and functional fluids (e.g. calibration fluids, QC fluids and wash fluids) and, if necessary, further fluidic connection points for an analyzer for auxiliary fluids (e.g. internal electrolytes or reagents for reference electrodes).

In principle, the sensor elements for the respective parameter values to be determined can be assigned to different sensor modules. Preferably, however, there is a separate sensor module for each of the blood gas, electrolyte, metabolite etc. parameter sets or even other parameter sets.

Many variations of individual sensor modules are possible. Then, for example, a first variant of the module for determining the electrolyte value comprises a module for measuring the complete electrolyte (Li)⁺，Na⁺，K⁺，Ca²⁺，Cl^-，Mg²⁺) The sensor element of (1). The second variant for example comprises the electrolyte (Na) most frequently required for the measurement⁺，K⁺，Ca²⁺，Cl^-) The sensor element of (1).

Similarly, a first variant of the module for determining metabolite values comprises a sensing element for measuring a broad set of metabolites (glucose, lactate, urea, creatinine). A second variant of the module comprises a sensing element for measuring the most frequently required set of metabolites (glucose, lactate).

This has the advantage that only these sensor elements have to be processed on the factory side, i.e. they are used in practice as well. In particular in the production of sensor elements, such as in particular chemical sensor elements, which are made of different materials and are produced in a plurality of production steps, the rejection rate is generally high when all sensor elements are integrated into a single sensor component. Generally, a sensor element is manufactured with a certain rejection rate. The rejection rate increases accordingly when processing a plurality of sensor elements on a single sensor component. The production and assembly of a large number of sensor components, each with a sensor element, is likewise cost-intensive if the sensor cartridge contains a large number of different parameters. It has proven to be particularly advantageous to combine sensor elements into sensor element groups on as few as possible sensor components. Particularly advantageous here are sensor elements which are constructed analogously and can be produced using the same process steps and process methods, such as, for example, a set of blood gas electrodes, a set of ion-selective electrodes (ionenelktiren), a set of amperometric biosensors (amperometric biosensors), etc., each being processed on a substrate. The same applies to optical sensors. Such an arrangement for an optical sensor is shown, for example, in document US5,351,563 or document US 6,652,810.

Finally, a sensor module for photometric/spectroscopic evaluation methods can also be provided. Such sensor modules comprise a special region within the sample channel (or at least in fluidic connection with the sample channel, for example arranged in the side channel) which is designed as an optical cuvette (optical measurement window), which can likewise be regarded as a sensor element in the sense of the present application. Examples of such detection methods and sensing principles are the measurement of hemoglobin derivatives and bilirubin or the photometry of HbA1 c. Exemplary arrangements for this are described in particular in document EP 1445020 a1, document US 6,582,964 or document US 6,388,752.

It is also possible to add reagents via further connection points at the module, whereby a detection reaction, for example a color reaction, is triggered and the corresponding parameter is determined, for example, photometrically. An example is the photometric method of HbA1 c.

Other sensor modules may comprise sensing elements based on immunological methods, for example for the determination of certain cardiac-related markers such as NTproBNP or troponin, etc. In such immunological detection methods, for the analyte determination, the addition of further reagents (e.g. antibodies, labels, washing solutions) is necessary, which can either be introduced into the respective sensor module via additional fluidic interfaces (in the sense of fluidic auxiliary interfaces) or are already present in the sensor module. This sensor detection principle can be a photometric or spectroscopic detection method (for example, detection by means of a gold-labeled antibody or a dye-labeled antibody), but other detection methods are likewise conceivable in principle.

Furthermore, a module for determining coagulation parameters can also be provided. Likewise, in the determination of coagulation parameters, which are mostly based on enzymatic reactions, for the analyte determination, the addition of further reagents (for example labeled specific substrates) is necessary, which can either be introduced into the respective sensor module via an additional fluidic interface (in the sense of a fluidic auxiliary interface) or are already present in the sensor module. This sensor detection principle can be photometric or spectroscopic detection methods (for example, the detection of colored reaction products of an enzymatic reaction), but other detection methods (for example, the detection of electrochemically activated reaction products of an enzymatic reaction by means of electrochemical detection methods) are likewise conceivable in principle.

Drawings

The invention is further illustrated by the following figures. Wherein:

fig. 1 shows a modular sensor cartridge according to the invention with three sensor modules in a schematic plan view;

fig. 2 shows a variant of the sensor cartridge according to fig. 1 with two sensor modules combined into one dual module (doppelmodule);

fig. 3 shows a variant of the sensor cartridge according to fig. 1, in which case a sensor module is replaced by a dummy module;

fig. 4 shows a variant of the sensor cartridge according to fig. 2, in which case a region D without sensor elements is implemented in a dual module,

fig. 5 shows a specific embodiment of a modular sensor cartridge in a three-dimensional representation.

Fig. 6 shows the modular sensor cartridge according to fig. 5 in an exploded view; and

fig. 7 shows another specific embodiment of a modular sensor cartridge in a three-dimensional representation.

Detailed Description

The sensor cartridge 1, which is schematically illustrated in fig. 1, can be inserted into a receptacle of an analyzer, not illustrated in any more detail, and has a continuous measuring channel 2 (illustrated in dashed lines) for receiving fluid media, such as, for example, a sample liquid, a calibration medium, a quality control medium and a washing medium. In the sensor cartridge 1, sensor elements 3, 4 are arranged for determining chemical and/or physical parameters of the fluid medium. The sensor cartridge 1 according to fig. 1 comprises three modules 5 which are fixedly connected to one another and are of substantially similar design, each having a measurement channel section 9 in a housing 7, wherein the measurement channel sections of adjacent modules are connected by a fluidic connection 11 to form a continuous measurement channel 2. Each of the modules 5 is embodied in the example shown as a sensor module for different types of sensor elements, the first two modules having electrochemical sensors 3 and the last module 5 with a gripping element (gripping) 12 having, for example, an optical sensor 4.

In the case of the module 5 with the electrochemical sensor 3, electrical contacts 13 are shown, which can be contacted by corresponding contact pins of the analyzer via windows 14 in the module 5. This fact in this connection corresponds substantially to those of the document EP 0846947B 1 cited at the outset. The fluidic interface of the sensor cartridge 1 to the analyzer is identified with 15. In this last module 5 with the gripping element 12, which contains the optical sensor 4, signal tapping regions are formed in windows 14 (not explicitly shown), which are each connected to an optical sensor 4 and transmit their respective response to an analyzer for parameter determination.

As can be seen from the comparative illustration of the embodiment variants of the sensor cartridge 1 according to fig. 1 to 4, the outer dimensions of the individual variants are compatible despite the different sensor modules, which also applies in particular to the shape and position of the fluidic interfaces 15. In the case shown in fig. 1, the fluidic interfaces 15 of the two outer modules are configured as sensor cartridge-side inlets or outlets of the continuous measurement channel 2, which make possible fluidic interfaces to the analyzer for the purpose of introducing sample liquids and/or functional fluids or the like. The fluidic interface 15 of the intermediate sensor module can be used here as a bypass or auxiliary interface for fluids (for example for the transport of a reference electrolyte in the case of an electrochemical measurement module or for the transport of reagents required for analyte determination).

Then, for example, according to the embodiment variant of fig. 2, two individual modules can be combined to form a longer module 6 with a housing 8, wherein the module 6 has a double length of the module 5. In the arrangement shown here, one of the two fluidic interfaces 15 of the module 6 is designed as an inlet or outlet of the continuous measurement channel 2 on the sensor cartridge side, while the other fluidic interface is designed here as a fluidic bypass interface or auxiliary interface (for example for the transport of a reference electrolyte in the case of an electrochemical measurement module or for the transport of reagents required for the analyte determination).

A module can in principle likewise contain sensor elements based on different detection principles. For example, the module shown on the left in fig. 2 may contain electrochemical sensor elements in its left region and further sensor elements, for example optical sensor elements, in its right region.

Furthermore, according to the embodiment variant in fig. 3, the sensor cartridge 1 can have two sensor modules 5 and a dummy module 5 '(in the middle), which dummy module 5' substantially corresponds to the sensor modules 5, with the exception of the missing sensor elements. In this case, the fluid connection 15 of the dummy module 5' is designed as a blank connection or blind connection.

As shown in fig. 4, it is also possible to provide a module 6' in the sensor cartridge 1, which has a sensor array with the sensor unit 3 and an empty area D without sensor elements. With this type of construction, the same outer dimensions are achieved even in the case of modified installations with sensor elements. The dummy module 5 '(fig. 3) or the clearance region D (fig. 4) of the module 6' can have a fluidic interface 15, which is implemented as a clearance interface.

According to the invention, the sensor modules 5, 6 and the dummy modules 5 ', 6' of a sensor cartridge 1 jointly have dimensions and fluidic interfaces 15 adapted to the receptacle of the analyzer. The same applies to the electrical contacts 13 or other signal tapping regions in the window 14.

In fig. 5 and 6, a specific embodiment of a modular sensor cartridge 1 is shown, the sensor cartridge 1 comprising a single module 5 (with a grip (griffeit) 12 fixedly connected thereto) and a double module 6 with two fluidic interfaces 15. As can be seen in particular from fig. 6, a series of electrochemical sensor elements 3 are mounted on the carrier part 16, which are connected to the contacts 13 via conductor paths. The electrical contacts are tapped by the analyzer through the windows 14 of the modules 5, 6.

The individual modules 5, 6 of the sensor cartridge 1 are connected to one another by means of a fixed mechanical snap-in connection, for example by means of a snap-in element 17 (with a seal 18 interposed between them). The fixed connection can likewise be formed by welding or by gluing.

A memory element 19 is arranged as a memory chip on one of the modules 5, 6 of the sensor cartridge 1, on which information specific to the sensor cartridge 1, in particular about the structure of the sensor cartridge 1 formed by the respective module 5, 6, is stored, which information is read out automatically after the sensor cartridge 1 has been inserted into the analyzer.

The support member 16 (e.g. its back side) may act as a thermal contact zone through which the individual modules 5, 6 in the analyser may be thermostated to different operating temperatures. As can be seen from fig. 6, the thermal contact regions of the adjacent modules 5, 6 of the sensor cartridge 1 can be thermally decoupled (for example by corresponding spacing of the support elements 16 or by thermally insulating material).

The sensor modules 5, 6 can have optical passage areas for the excitation beam and the measurement beam, provided that the optical sensor 4 is present in the module. Optical windows (transparent cuvettes) can additionally be provided for transmission measurements (transmission measurement) or reflection measurements. Thus, for example, the hemoglobin values can be determined by means of spectroscopic methods.

The dummy modules 5 ', 6' may likewise comprise thermal contact zones for preheating or cooling the sample and functional fluids, for example in order to at least partially preheat these sample and functional fluids to the operating temperature necessary for the subsequent sensor module. Alternatively, a temperature controller can also be present in the module itself, which is actuated by the analyzer in a corresponding manner, for example by corresponding electrical contacts.

Thus, the sensor modules 5, 6 may be thermostated at different operating temperatures, e.g., the sensors of the first module may be operated at body temperature (e.g., blood gas sensors at 37 ℃) and the sensors of the second module may be operated at a lower temperature (e.g., metabolite sensors or electrolyte sensors at 30 ℃).

This makes it possible to achieve greater operating stability in the case of sensitive biochemical sensors.

For operation at different temperatures, it is particularly advantageous if the sensor modules 5, 6 are at least partially thermally decoupled at the contact points, for example by means of a material with a low thermal conductivity.

The individual modules of the sensor cartridge can likewise have regions with fluidic elements (fluidikelementers) or fluidic functions integrated in the fluid path, which comprise, for example, valve functions or pump functions. Thereby acting on the fluid flowing through the fluid passage by means of the respective actuator. Then, for example, a valve can be used, by means of which the fluid path is opened or closed. On the other hand, pumps for conveying the fluid can be integrated in the individual modules. It is not necessary here for all components of the fluidic element or the fluidic function to be contained in the module. The fluidic element or certain components of the fluidic function can likewise be arranged on the analyzer side and then act on the respective module-side partial element in order to bring about a fluidic action in the interaction. Examples of this are peristaltic pumps with a rotor on the analyzer side and a hose on the module side or even check valves with a plunger arranged on the analyzer side and a corresponding compressible hose section arranged on the module side.

Preferably, the modular sensor cartridge is assembled in the factory and packaged in a suitable container in a manner that is ready for use by the user.

Description of an exemplary sensor cartridge:

example 1:

modular sensor cartridge 1 (see fig. 5 and 6) for determining a blood value (bluttert) uses two transmissionsThe sensor modules 5, 6 are realized in that they are inseparably connected on the factory side by a snap connection. The first module 5 of the sensor cartridge contains a device for determining a blood gas parameter (pO)₂，pCO₂) pH and hematocrit sensing elements, the second module 6 contains sensors for measuring metabolite values (glucose, lactate) and electrolyte concentrations (Na)⁺，K⁺，Ca²⁺，Cl^-.) of the sensor element. The module 6 furthermore contains a reference electrode (depicted here by two conductor circuits on the left mounted on a carrier 16 of the module 6), which is supplied with the functional fluid (internal electrolyte liquid) by the analyzer via a fluid connection 15 on the right of the module 6.

The sensor modules 5, 6 have different geometrical dimensions in this example.

Not explicitly shown in this figure are sealing elements between the bracket parts 16 and the corresponding upper housing parts of the respective modules. The sealing element defines, in interaction with the respective support and the upper part of the housing, a fluid channel within the respective module, in particular also the measuring channel.

The second module 6 is almost double as long as the first module 5 (minus the grip 12). The two modules were run at different temperatures (37 ℃ or 30 ℃).

Example 2:

alternatively, the second module 6 from example 1 is replaced by two short modules 5 (see fig. 7), wherein one module contains an electrolyte sensor and the other module contains a metabolite sensor. Hereby, one obtains a modular sensor cartridge 1 according to the invention with a blood gas module (with a grip 12), an electrolyte module (in the middle) and a metabolite module. The location and use of the fluidic interfaces 15 is shown here only schematically.

The type and arrangement of the modules within the sensor cartridge is in principle not limited. In principle, therefore, in addition to the sensor module and the dummy module, further modules can be inserted which can assume a special function. For example, a special sample input module can be inserted, which has special devices (for example, interfaces for calibration or injection) by means of which the sample liquid to be tested can be introduced into the sensor cartridge. In addition, special sample inlet modules and/or sample outlet modules can likewise be inserted, which are arranged at the ends in the sensor cartridge and which cause the sample liquid or other functional fluids to be transported to or away from other modules arranged in the middle in the sensor cartridge. This special sample inlet module and/or sample outlet module can thus serve as universally placeable contact points for the fluid to the analyzer, which connects the sample channels of the sensor cartridge to the corresponding fluidic sections in the analyzer, so that all other (internal) modules can in principle be equipped with the same dimensions and interfaces, whereby these modules can in principle be combined without restriction.

Claims (19)

1. A sensor cartridge (1) that can be put into a housing of an analyzer, the sensor cartridge (1) comprising:

a continuous measuring channel (2) for receiving a fluid medium and a sensor element (3, 4) for determining at least one of a chemical parameter and a physical parameter of the fluid medium;

at least two modules (5, 5 ', 6, 6') which are fixedly connected to one another but are produced separately and each of which has a housing (7, 8) and a measuring channel section (9, 10),

wherein the measuring channel sections (9, 10) of adjacent modules are fixedly connected to the continuous measuring channel (2) by means of a fluid connection (11),

at least one module (5, 6) is designed as a sensor module and has a sensor array with at least two sensor elements (3, 4),

the modules collectively define a sensor cartridge having dimensions corresponding to dimensions of a receptacle of the analyzer, an

When the sensor cartridge is inserted into the receptacle of the analyzer, the fluidic connections of the sensor cartridge are aligned with corresponding fluidic connections of the receptacle of the analyzer, an

A memory element (19) on the sensor cartridge (1), information being stored on the memory element (19) and being read by the analyzer when the sensor cartridge is inserted into the housing of the analyzer.

2. The sensor cartridge (1) according to claim 1, characterized in that at least one sensor module is a dummy module (5 ', 6'), which dummy module (5 ', 6') is essentially structurally identical to the respective sensor module (5, 6) apart from the missing sensor elements.

3. Sensor cartridge (1) according to claim 1, characterized in that at least one sensor module has a sensor array with at least two sensor elements (3, 4) and has a clearance area (D) which is free of sensor elements.

4. Sensor cartridge (1) according to claim 1, characterized in that at least two modules (5, 5 ', 6, 6') of the sensor cartridge (1) are connected to each other by means of fixed mechanical snaps.

5. The sensor cartridge (1) according to claim 1, characterized in that at least two modules (5, 5 ', 6, 6') of the sensor cartridge (1) are fixedly connected to each other by at least one of: snap elements (17), welded connections and adhesive connections.

6. Sensor cartridge (1) according to claim 1, characterized in that the module (5, 5 ', 6, 6') has one or more thermal contact zones.

7. Sensor cartridge (1) according to claim 6, characterized in that the thermal contact zones are configured such that the modules (5, 5 ', 6, 6') can be set to different operating temperatures.

8. The sensor cartridge (1) according to claim 6, characterized in that the thermal contact areas of adjacent modules (5, 5 ', 6, 6') of the sensor cartridge (1) are thermally decoupled.

9. Sensor cartridge (1) according to claim 1, characterized in that the modules (5, 5 ', 6, 6') on the edge side of the sensor cartridge (1) have a gripping element (12).

10. The sensor cartridge (1) according to claim 1, characterized in that the information stored on the memory element (19) is information specific to the sensor cartridge (1) describing the type of modules (5, 5 ', 6, 6') used and their arrangement or position within the sensor cartridge (1).

11. The sensor cartridge (1) according to claim 1, characterized in that information describing the manner of arrangement of the individual sensor elements (3, 4) or the clearance areas (D) within the respective module (5, 5 ', 6, 6') and/or instructions for the analyzer regarding the use of the module is further stored on the memory element (19).

12. Sensor cartridge (1) according to claim 11, characterized in that information is further stored on the memory element (19) which describes the arrangement and/or the use of electrical contacts or other signal transmission areas, fluidic interfaces, thermal contact areas and/or fluidic control elements within the individual modules.

13. Sensor cartridge (1) according to claim 1, characterized in that information is further stored on the memory element (19) which describes the type of the individual sensor elements (3, 4) and/or their use and manipulation.

14. The sensor cartridge (1) according to claim 13, characterized in that information describing the production information, characteristic curve data and/or calibration information or durability information of the respective sensor element (3, 4) is further stored on the memory element (19).

15. The sensor cartridge (1) according to claim 1, characterized in that the memory element (19) is an electronic memory element.

16. Sensor cartridge (1) according to claim 1, characterized in that the memory element is selected from the group: memory chip, memory card, RFID-transponder, magnetic stripe, optical coding.

17. Sensor cartridge (1) according to claim 16, characterized in that the optical code is a one-dimensional or two-dimensional bar code.

18. The sensor cartridge (1) according to claim 1, characterized in that the memory element (19) is fixedly connected with the sensor cartridge (1).

19. The sensor cartridge (1) according to claim 18, characterized in that the memory element (19) is fixedly connected with the sensor cartridge (1) by one of: when the sensor cartridge (1) is assembled, a memory element (19) is placed together in the sensor cartridge (1) or the memory element (19) is mounted on the sensor cartridge (1).