Fluid analysis module and fluid analyzer

Abstract

The present invention relates to a fluid analysis module, which has the following components and is particularly suitable for blood analysis: a module housing with a fluid input port; at least one fluid sensor integrated inside the module housing, the fluid sensor having a sensor surface that can be fluidically connected to the fluid input port; a cavity integrated inside the module housing, the cavity being fluidically connected to the sensor surface of the at least one fluid sensor; at least one first liquid container installed inside the cavity, the first liquid container being fluidically connected to the sensor surface of the at least one fluid sensor; and at least one module housing surface, on which a partition wall of elastic, fluid-tight film-like structure is at least partially installed, at least one fluid functional element in the form of a straight-through valve and at least one fluid functional element in the form of a delivery pump are installed below the partition wall and are constructed so that the fluid functional element can operate in at least one of the following ways by only local mechanical deformation of the partition wall: a) only fluid is delivered from the fluid input port through the sensor surface to the cavity, and b) only liquid stored in the at least one liquid container is delivered from the liquid container through the sensor surface to the cavity.

Description

Technical Field

[0001] The invention relates to a fluid analysis module which can detect the composition of a fluid in a sensory manner. The fluid analysis module is particularly suitable for analyzing biological fluids, preferably blood, which is taken from a patient in portions or for analyzing the blood during an extracorporeal blood circulation process within the framework of a continuously repeated measurement procedure. Background Art

[0002] From DE 10 2011 056 271 A1, a fluid analysis module of the type described is known, which is basically composed of three mutually connected, plate-shaped functional units, namely a carrier plate, a so-called fluid board and a sensor card. A storage chamber and a receiving volume are included inside the carrier plate, and in addition, a sensor liquid for cleaning the sensor surface is stored in the storage chamber and the receiving volume. The fluid board directly mounted on the carrier plate is fluidically connected to the receiving volume present inside the carrier plate. The fluid board includes a plurality of fluid channels, in which valves and pumps are arranged, by means of which the fluid stored inside the carrier plate and the body fluid also supplied through separate channels can be conveyed along a certain pre-given fluid channel. The sensor board equipped with a sensor closes the fluid channel contained in the fluid board in a fluid-tight manner on one side and directly contacts the fluid guided inside the fluid channel. Away from the fluid channel, the sensor board has sensor contacts, which are in electrical contact with a measuring module, and the fluid analysis module can be releasably fixedly coupled to the measuring module.

[0003] From US Pat. No. 6,171,238 B1, a mobile handheld measuring instrument with a biosensor is known, wherein the amperometric biosensor is arranged in a measuring point, and a cleaning liquid stored in a storage bag and a fluid sample that can be added through a sample opening can be supplied to the measuring point as required via a hose delivery system. All fluids flowing through the measuring point arrive in a correspondingly arranged garbage bag. The mobile handheld measuring instrument has an evaluation unit, a display unit and also an energy storage unit, thereby enabling self-sufficient operation.

[0004] The publication US 4,479,762 A describes a module for plasma separation, in which the blood of a donor is conveyed into the module, in which the plasma is separated from the donor blood and the red blood cells remaining in the blood are returned to the donor. The module has a fluid line system with a liquid container, which can be releasably contacted via a fluid-tight elastic separating membrane with an external actuator system, which can induce a fluid flow within the fluid line system by a pulsating pressure effect.

[0005] The publication US Pat. No. 5,062,774 A describes a fluid pump system to which a plurality of liquid containers can be connected and which is capable of producing any fluid mixture consisting of various fluids.

[0006] However, all known fluid analysis modules have the disadvantage that they are technically demanding and therefore cost-intensive functional units due to their complexity and the optimally miniaturized integration of a plurality of different functional components. In particular, in biomedical applications of fluid analysis modules for examining a large number of different measurement samples, for example different human blood samples, in order to avoid cross contamination, they are usually designed as disposable items, so-called throwaway items. Summary of the invention

[0007] The object of the present invention is to construct a fluid analyzer of the aforementioned type in a structural form that is as complex and miniaturized as possible, in which the fluid analyzer contains to a large extent all components for supplying, measuring and draining the corresponding fluid, and in which the fluid analyzer is constructed as cost-effectively as possible and is suitable for easy drainage, i.e. without the aid of any electronic components.

[0008] The solution to the object of the invention is specified in claim 1. The subject matter of claim 10 is a fluid analyzer which can be used in a preferred manner according to claims 11 and 12 for analyzing biological fluids.

[0009] The fluid analysis module according to the solution is constructed as a unified structural unit and a module housing is provided, which has one, preferably a single fluid input port. At least one fluid sensor is integrated inside the module housing, and the fluid sensor has a sensor surface that can be fluidically connected to the fluid input port. In addition, a cavity is arranged inside the module housing, and the cavity can be fluidically connected to the sensor surface of at least one fluid sensor. At least one first liquid container is installed inside the cavity, and the first liquid container can be fluidically connected to the sensor surface of at least one fluid sensor. In addition, the module housing has at least one module housing surface, on which a partition wall of elastic, fluid-tight film-like structure is at least partially installed, at least one fluid function element in the form of a straight-through valve and at least one fluid function element in the form of a delivery pump are installed below the partition wall, and the fluid function element is constructed so that the fluid function element can be operated in at least one of the following ways by only local mechanical deformation of the partition wall:

[0010] - merely delivering fluid from the fluid input port through the sensor surface into the cavity, and

[0011] Only liquid stored in the at least one liquid container is conveyed from the liquid container through the sensor surface into the cavity.

[0012] Preferably, at least one second liquid container is installed inside the cavity, which second liquid container can be fluidically connected to the sensor surface of at least one fluid sensor by means of at least two fluid function elements and / or at least one further fluid function element in the form of a through valve or a transfer pump. In particular, for analyzing biological fluids, primarily blood, it is necessary to clean and calibrate the sensor surface before carrying out a blood measurement. Therefore, the sensor flushing liquid or calibration liquid is located in the first liquid container installed inside the cavity, and the calibration liquid is located in the second liquid container installed inside the cavity.

[0013] Since the chamber also serves as a collection volume or discharge volume not only for the fluid to be measured, for example blood, but also for the liquid stored in at least one liquid container installed inside the chamber, the at least one liquid container is designed in the form of a fluid-tight elastic bag. When the at least one bag is emptied, the bag volume decreases and at the same time the receiving volume for the fluid to be discharged increases inside the chamber, which also has a constant chamber volume.

[0014] The module housing can be divided into a measuring carrier area and a cavity area, that is, the measuring carrier is mounted on the cavity in an inseparable manner and delimits the cavity at least on one side. In this case, the measuring carrier has an upper side facing away from the cavity, on which a partition wall of elastic, fluid-tight, film-like construction is at least partially mounted.

[0015] The fluid input port is mounted in the region of the measuring carrier and is fluidically connected to the sensor surface of at least one fluid sensor along at least one fluid line inside the measuring carrier, which leads from the fluid sensor inside the measuring carrier and into the cavity. In order to control the fluid flow between the fluid input port, the sensor surface and the cavity, at least one of the fluid function elements in the form of a through valve is arranged along at least one of the fluid lines, and the fluid line can be fluidically connected to at least one fluid function element in the form of a delivery pump.

[0016] For the necessary cleaning or calibration of the sensor surface, at least one liquid container is fluidically connected to the sensor surface of at least one fluid sensor via a fluid line that opens into the region of the measuring carrier, at least one fluid line leading from the fluid sensor within the measuring carrier and opening into the cavity. In this case, at least one of the fluid function elements in the form of a through valve (13) is also arranged along at least one of the fluid lines, wherein the fluid line can be fluidically operatively connected to at least one fluid function element in the form of a delivery pump.

[0017] At least one fluid function element in the form of a through valve is designed as a fluid channel section that is open to the module housing surface and is spanned by an elastic, fluid-tight, film-like partition wall. For the purpose of valve actuation or valve control, it is necessary to locally deform the partition wall under force so that the fluid channel section is locally sealed in a fluid-tight manner by means of the locally deformed partition wall. For this purpose, an external actuator in the form of a stroke-adjusting actuator is preferably used, which is mounted adjacent to the partition wall and can locally deform the partition wall.

[0018] At least one fluid function element in the form of a delivery pump is designed as a fluid channel section open to the module housing surface, which is spanned by an elastic, fluid-tight, film-like partition wall. In order to activate the pump, it is necessary to locally deform the partition wall under force so that the fluid channel section indirectly or directly with the locally deformed partition wall encloses a delivery volume that creeps in the direction of the fluid channel, similar to the hose pump principle.

[0019] Furthermore, at least two freely accessible electrode surfaces are mounted on at least one module housing surface and are electrically connected to at least one fluid sensor.

[0020] In order not only to mechanically control the fluid function element but also to make electrical contacts of at least one fluid sensor inside the fluid analysis module, a control and evaluation unit is required which can be releasably fixedly coupled to the fluid analysis module so that a mechanical adjustment element arranged on one side of the control and evaluation unit can cooperate with the fluid function element via a partition wall of elastic, fluid-tight, film-like construction. In addition, the electrical connection between the control and evaluation unit and the at least one fluid sensor can be established via at least two electrode surfaces which are freely mounted on the surface of the module housing.

[0021] Advantageously, the fluid analyzer, which is composed of a fluid analysis module and a control and evaluation unit, is characterized in that all electronic components which are not in contact with the fluid to be measured sensor-wise are mounted on the control and evaluation unit side. In contrast, the fluid analysis module as a whole consists of purely mechanical components and, in particular in a suitable configuration of the fluid sensor, contains no electronic components.

[0022] Fluid analyzers are particularly suitable for the sensory analysis of biological fluids, such as blood, cerebrospinal fluid, serum and urine. For these applications, a liquid container with a flushing or calibration liquid and another liquid container with a calibration liquid for the sensor surface are contained within the chamber. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The present invention is described below by way of example according to an embodiment with reference to the accompanying drawings without limiting the general inventive concept. In the accompanying drawings:

[0024] Figure 1 shows a schematic structure of a fluid analysis module with a coupled control and evaluation unit, which is designed according to the solution,

[0025] Figure 2 A diagram showing a fluid function element in the form of a through valve, and

[0026] Figure 3 The diagram shows a fluid function element in the form of a delivery pump. DETAILED DESCRIPTION

[0027] Figure 1 The schematic structure of a fluid analysis module 1 is shown, which is mechanically coupled to a control and evaluation unit via a mechanically detachable interface 2. The fluid analysis module 1 in conjunction with the control and evaluation unit 3 forms a fluid analyzer.

[0028] Figure 1The fluid analysis module 1 shown in FIG. 1 is surrounded by a module housing 4 and thus realizes a uniform or uniformly manipulable structural form. The fluid analysis module 1 can be functionally divided into a measurement carrier area 5 and a chamber area 6. The chamber area 6 has a chamber 7, in which two liquid containers 8, 9 configured as elastic bags are placed. The bag-shaped liquid containers 8, 9 are loosely arranged inside the chamber 7 except for the fluid lines leading to the measurement carrier area 5.

[0029] The measuring carrier 5* has a fluid inlet port 10, through which a liquid to be analyzed sensory-wise or a fluid to be analyzed sensory-wise, for example blood, can be introduced into the measuring carrier 5*. Located within the measuring carrier 5* is at least one fluid sensor 12 having at least one sensor surface 11, within which the fluid to be examined sensory-wise is guided through the at least one sensor surface.

[0030] The fluid entering the measuring carrier 5* through the fluid input port 10 is guided to the fluid sensor 12 through the fluid lines 15 and 16. The fluid line 17 is arranged inside the measuring carrier 5* to lead out from the fluid sensor 12, and the fluid flowing through the fluid sensor 12 flows directly into the volume of the cavity 7 through the fluid line, which is used as a fluid collection cavity or a discharge cavity.

[0031] In order to ensure a defined flow along the fluid lines 15, 16 and 17, fluid function elements 13 and 14 are arranged inside the measuring carrier 5*. Figure 1 The fluid function element 13 arranged between the fluid lines 15 and 16 is constructed in the form of a valve and realizes the connection between the fluid lines 15 and 16. The fluid function element 14 arranged along the fluid line 17 is used as a delivery pump and ensures a controlled flow along the corresponding fluid line. The fluid function elements 13, 14 can be installed in areas along the fluid line that are different from the drawings according to the design.

[0032] In order to clean or calibrate the sensor surface 11 of the fluid sensor 12, a flushing liquid or a calibration liquid is introduced from a fluid reservoir 8 storing the flushing liquid or the calibration liquid through fluid lines 18 and 16 to the fluid sensor 12, and the flushing liquid or the calibration liquid is finally discharged into the cavity volume of the cavity 7 again through the fluid line 17. For this purpose, the valve control of the fluid function element 13 is required in such a way that the supply line along the fluid line 15 is closed and only the fluid lines 18 and 16 are fluidically connected.

[0033] For sensor calibration, a calibration liquid is stored in the liquid container 9, which reaches the fluid sensor 12 via the fluid lines 19 and 16 and is conveyed from the fluid sensor via the fluid line 17 to the collection volume of the chamber 7. In this case, the valve control of the fluid function element 13 also needs to be carried out in a corresponding manner, that is, the fluid lines 15 and 18 are closed, while the fluid line 19 for the calibration liquid to flow into the fluid sensor 12 is opened.

[0034] exist Figure 2 1 shows a cross section through a fluid function element in the form of a valve 13. Thus, for example Figure 2 The fluid line 15 shown in FIG. 1 has a recess 21 which is open toward the module housing surface 20 and is spanned by an elastic, fluid-tight, film-like partition wall 22. If the flow path along the fluid channel 15 needs to be closed, the partition wall 22 needs to be deformed by force so that the deformation results in a fluid-tight closure in some areas within the fluid line 15. For this purpose, an adjusting element 23 is advantageously used, which is mounted on the side of the control and evaluation unit 3.

[0035] At least along Figure 1 Each of the fluid channels 15, 18 and 19 shown in FIG. 1 is respectively arranged according to Figure 2 Constructed fluid functional elements.

[0036] Figure 3 A possible embodiment for realizing a fluid function element in the form of a delivery pump is shown. It is assumed that the fluid channel 17 has a groove 21 oriented toward the module housing surface 20, which is spanned by an elastic, fluid-tight, film-like partition wall 22. In order to exert a fluid flow in the delivery direction 24, at least three adjustment elements 23 installed on the side of the control and evaluation unit 3 are in contact with the partition wall 22 with mutually coordinated adjustment path strokes, which need to be deformed so that the partition wall and the fluid channel wall enclose a delivery volume 27 that creeps in the delivery direction 24.

[0037] Finally, at least two electrode surfaces 25 are mounted on the module housing surface 20 , via which the fluid sensor signals can be detected. For this purpose, the control and evaluation unit 3 has corresponding electrode contacts 26 .

[0038] The fluid analysis module 1 according to the solution consists of components that can be realized simply and cost-effectively and is particularly suitable as a disposable product or disposable item. Since the fluid analysis module 1 does not contain any electrical components, the drainage is not a problem. All actuators and electronic components are mounted on the control and evaluation unit 3 and are operatively connected to the fluid analyzer only via a fluid-tight partition wall, that is, the control and evaluation unit is not exposed to contamination during the measurement process or measurement cycle.

[0039] Reference numerals list

[0040] 1Fluid Analysis Module

[0041] 2 Mechanical interface

[0042] 3Control and evaluation unit

[0043] 4 module housing

[0044] 5. Measuring the bearing area

[0045] 6-cavity area

[0046] 7 chambers

[0047] 8First liquid container

[0048] 9 Second liquid container

[0049] 10 Fluid input ports

[0050] 11Sensor surface

[0051] 12 Fluid Sensor

[0052] 13 Fluid function element in the form of a straight-through valve

[0053] 14 Fluid function element in the form of a delivery pump

[0054] 15, 16, 17, 18, 19 fluid pipeline

[0055] 20 Module shell surface

[0056] 21 grooves

[0057] 22 partition wall

[0058] 23Regulator

[0059] 24 conveying direction

[0060] 25Electrode surface

[0061] 26 electrode contacts

[0062] 27 delivery volume.

Claims

1. A fluid analysis module (1), comprising: a module housing (4) with a fluid input port (10), the fluid analysis module (1) being surrounded by the module housing (4), - at least one fluid sensor (12) integrated in the module housing (4), the fluid sensor having a sensor surface (11) which can be fluidically connected to the fluid input port (10), - a cavity (7) integrated in the module housing (4), the cavity being fluidically connectable to the sensor surface (11) of the at least one fluid sensor (12), - at least one first liquid container (8) mounted in the cavity (7), the first liquid container being fluidically connectable to the sensor surface (11) of the at least one fluid sensor (12), and - At least one module housing surface (20) on which a partition wall (22) of elastic, fluid-tight membrane-like construction is at least partially mounted, at least one fluid function element in the form of a through valve (13) with valve control and at least one fluid function element in the form of a delivery pump (14) are mounted below the partition wall, and the fluid function elements are constructed so that the fluid function elements (13, 14) can be operated in at least one of the following ways by only local mechanical deformation of the partition wall: - only fluid is delivered from the fluid input port through the sensor surface (11) into the cavity (7), and - only liquid stored in the at least one liquid container (8) is delivered from the liquid container (8) through the sensor surface (11) into the cavity (7), and the fluid function element (13) ensures through its valve control that there is no fluid connection between the fluid input port (10) and the sensor surface (11), wherein At least two freely accessible electrode surfaces (25) are mounted on at least one module housing surface (20), the electrode surfaces being electrically connected to the at least one fluid sensor (12), wherein the module housing (4) can be divided into an area of ​​a measuring carrier (5) and a cavity area (6), the measuring carrier (5) being mounted inseparably on the cavity (7) and defining the cavity at least on one side, the measuring carrier (5) having an upper side facing away from the cavity (7), on which the elastic, fluid-tight, membrane-like partition wall (22) is at least partially mounted.

2. The fluid analysis module according to claim 1, characterized in that: At least one second liquid container (9) is installed inside the chamber (7), and the second liquid container can be fluidically connected to the sensor surface (11) of the at least one fluid sensor (12) by means of at least two of the fluid function elements (13, 14) and / or at least one other fluid function element in the form of a through valve or a delivery pump.

3. The fluid analysis module according to claim 1 or 2, characterized in that: The at least one liquid container (8) is designed in the form of a fluid-tight elastic bag.

4. The fluid analysis module according to claim 1 or 2, characterized in that: The fluid inlet port (10) is mounted in the region of the measuring carrier (5) and is fluidically connected to a sensor surface (11) of the at least one fluid sensor (12) along at least one fluid line (15, 16) inside the measuring carrier (5), at least one fluid line (17) leads from the fluid sensor inside the measuring carrier (5) and opens into the chamber (7), and at least one of the fluid function elements in the form of a through valve (13) is arranged along at least one of the fluid lines (15, 16, 17), and the fluid line (17) can be fluidically connected to at least one fluid function element in the form of a delivery pump (14).

5. The fluid analysis module according to claim 1 or 2, characterized in that: The at least one liquid container is fluidically connected to the sensor surface (11) of the at least one fluid sensor (12) via a fluid line (18, 19) leading into the region of the measuring carrier (5), at least one fluid line (17) leads from the fluid sensor inside the measuring carrier (5) and leads into the chamber (7), and at least one of the fluid function elements in the form of a through valve (13) is arranged along at least one of the fluid lines (18, 19), and the fluid lines (18, 19) can be fluidically connected to at least one fluid function element in the form of a delivery pump (4).

6. The fluid analysis module according to claim 1 or 2, characterized in that: At least one fluid function element in the form of a through valve (13) is a fluid channel section which is constructed to be open toward the module housing surface (20), the fluid channel section is spanned by the elastic, fluid-tight membrane-like partition wall (22), and the partition wall (20) can be locally deformed by force so that the fluid channel section is locally sealed in a fluid-tight manner by means of the locally deformed partition wall (22).

7. The fluid analysis module according to claim 1 or 2, characterized in that: At least one fluid function element in the form of a delivery pump (14) is a fluid channel section that is constructed open to the module housing surface (20), which is spanned by the elastic, fluid-tight membrane-like partition wall (22), and the partition wall (22) can be locally deformed by force so that the fluid channel section indirectly or directly encloses a delivery volume (27) that creeps in the direction of the fluid channel with the locally deformed partition wall (22).

8. A fluid analyzer comprising a fluid analysis module according to any one of claims 1 to 7, characterized in that: A control and evaluation unit (3) is provided, the fluid analysis module (1) being releasably fixedly coupled to the control and evaluation unit so that a mechanical adjustment element provided on one side of the control and evaluation unit (3) can cooperate with the fluid function element via the elastic, fluid-tight, membrane-like partition wall (22), and an electrical connection between the control and evaluation unit (3) and the at least one fluid sensor (12) can be established via at least two electrode surfaces (25) freely mounted on the module housing surface (20).

9. Use of the fluid analysis module according to any one of claims 1 to 7 as an analyzer for biological fluids, wherein the biological fluids include blood, cerebrospinal fluid, serum, urine, and reperfusion fluid.

10. The use according to claim 9, characterized in that: A liquid container (8) containing a flushing liquid or a calibration liquid and another liquid container (9) containing a calibration liquid are contained inside the chamber (7).

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