Mobile device and method for analysing a fluid, in particular cerebrospinal fluid

Abstract

The invention relates to a device designed to measure and / or influence a property of a body fluid, in particular cerebrospinal fluid, provided in a fluidics module of the device. The device comprises the fluidic module, a reusable base part for receiving the fluidic module, a connecting tube or a tube coupling designed to connect the device to a body fluid source, in particular a patient, such that the body fluid can be guided through the connecting tube or the tube coupling into the fluidic module of the device, and a microfluidic chip arranged on or in the fluidic module and designed to influence the property of the body fluid.

Description

On the other hand, to connect the pump to the fluidic module, a plurality of at least two pressure connection couplings may be provided on the base unit and the fluidic module, respectively, so that, for example, negative pressure can be supplied to the fluidic module separately from positive pressure. Alternatively or cumulatively, a control pressure connection coupling may be provided to control a pneumatic device within the fluidic module. The positive pressure and / or the negative pressure can advantageously be used to influence a fluid flow within the fluidic module. Alternatively or cumulatively, the body fluid can be drawn in by means of negative pressure, for instance from a ventricular drainage or from a patient into the body fluid reservoir. Alternatively or cumulatively, positive pressure may be used to further convey the body fluid within the fluidics module, for example from the body fluid reservoir to the microfluidic chip. The body fluid reservoir can be subjected to negative pressure and / or positive pressure. By applying negative pressure, the body fluid can then be drawn from the connecting line into the body fluid reservoir. By applying positive pressure, body fluid stored in the body fluid reservoir can be conveyed toward the microfluidic chip. The device, and especially the base module, is further preferably configured to accommodate at least one of the following components: a control module configured to control the further transport of the body fluid within the fluidic module and / or to control the measuring device, wherein control commands from the control module can be transmitted to the fluidic module via the at least one pressure connection and / or via electrical contacts, an evaluation module for evaluating the data obtained from the fluidic module, for instance the measuring device, and for providing a diagnostic result regarding the properties of the body fluid, a storage module for storing the measurement data obtained from the fluidic module, so that, for example, the measurement can be continued without interruption even if the fluidic module is replaced, a pump controller for controlling the pump arranged in the device, wherein the pump controller can be supplied with sensor data from the fluidic module for control purposes, a wireless communication device for connecting, for example, to a hospital network for data exchange with it, and / or a power supply device comprising a power connection and / or an energy storage device. The control module may be configured to close the access in the event of a fault detection in the body fluid delivery, i.e., for example to act in response to the fluid detector described above, and / or to act on a control valve (solenoid valve) located in the fluidic module or on the ventricular drainage to shut off the fluid flow. In general, the terms “control pressure” and “control” are used in this specification in connection with the pneumatic control of the fluidic module 40, whereby these terms are to be understood to encompass both feed-forward control and feed-back control, as appropriate. Since the device 1 described here is designed with particular simplicity regarding the provision and delivery of the body fluid 95 in the fluidic module 40, and since, due to its special design, no regulated pumps are required—but rather pumps and valves can simply be switched “on” and “off”—this case actually involves control of the respective components. However, this should not preclude the possibility that the fluid pump 20 or the flow rate may be controllable, i.e., regulated in response to sensor data. Within the scope of the present description, the fluidic module is also described as a standalone component in which a fluid interface—such as, for instance, a connecting line or a hose coupling—is provided to connect the fluidic module to a source of body fluid, for example a patient. Thus, the body fluid can be fed through the connecting line or the hose coupling into the fluidic module of the device. The fluidic module further comprises a microfluidic chip arranged on or within the fluidic module, which is configured to influence the properties of the body fluid. The present description also covers the microfluidic chip, for instance designed for use in a device described above for measuring and / or influencing a property of a body fluid. The microfluidic chip comprises an inlet channel, a bifurcation, a first and a second outlet opening, and a separation device for separating a portion of the body fluid—for example, pieces, particles, or cells, from the body fluid in the region of the bifurcation, such that the portion of the body fluid can be fed to the first outlet opening and a purified body fluid can be fed to the second outlet opening. Within the microfluidic chip, the separation device may be configured to direct the portion of the body fluid—for example by means of acoustophoresis—into a central portion of the inlet channel. The purified body fluid can then divert into a side region of the inlet channel, such that, in the region of the bifurcation and under the influence of a fluid flow, the portion of the body fluid is directed to the first outlet opening and the purified body fluid is directed to the second outlet opening of the microfluidic chip. The separation device may further comprise a piezoelectric transducer. The microfluidic chip may comprise a glass wafer and / or a silicon wafer; if applicable, the glass wafer is bonded to the silicon wafer. The present description also covers a method for diagnosing a body fluid, for example liquor, for instance using the device described above and / or the fluidic module or microfluidic chip described above. The method comprises the following steps: introducing the body fluid into a fluidic module; directing the body fluid to a microfluidic chip arranged in or on the fluidic module to influence a property of the body fluid—for example, to separate erythrocytes and / or leukocytes from the body fluid—by means of or within the microfluidic chip; conveying the body fluid further to a measuring device arranged in or on the fluidic module to determine the same or another property of the body fluid, and conveying the body fluid from the measuring device into a waste material collection volume arranged in the fluidic module. The method may further include the step of beginning to deliver the body fluid in the fluidic module as soon as a body fluid reservoir located in the fluidic module is sufficiently filled with the body fluid. The steps of delivering the body fluid may, for example, be performed by means of a delivery pump located in the device, for instance in a base module of the device. The device may further be configured as a mobile device. The method may be configured as a point-of-care diagnostic method. The device proposed here may be configured to automatically perform a concentration measurement of fHb and its derivatives in CSF samples. These may be either repeated measurements, in which CSF is collected, for example, over several days from the tubing system of a ventricular or lumbar drainage. Or it may involve a single measurement, in which the CSF sample is obtained via a lumbar puncture (LP). The following diagram describes the device’s structure once again in different terms: The system consists of the reusable medical device (MD), which contains all electronic components, and a disposable unit that comes into contact with the patient’s CSF and can be discarded and replaced between uses on different patients. The reusable MD may include an embedded system that controls a pump, multiple valves, a cell sorting mechanism, various different sensors such as flow, pressure, and temperature, as well as an optical detection unit. Measurement results and user inputs are displayed via the human-machine interface (HMI), such as a touchscreen or similar device. Fluid flows can for example be controlled by valves; however, these are advantageously not part of the disposable product. Depending on the automatically controlled valve setting, the pump can selectively draw in and expel fluid. To perform a measurement, the CSF sample is drawn into the reservoir until a specific volume is reached, which is detected by a level sensor. The sample is then pushed into the cell sorting mechanism, which separates the erythrocytes and / or leukocytes from the sample. Cell sorting is achieved by acoustophoresis. A fluid channel is stimulated by ultrasound via a piezoelectric element to concentrate the erythrocytes and / or leukocytes in a specific region of the channel and separate them from the purified CSF. Feedback control of the separation parameter setpoints is used to stabilize the cell focusing process based on a sensor measurement of the separation performance. Subsequently, the spectrophotometric detection unit measures photon absorption in the cell-poor CSF. Based on the absorption at specific wavelengths or within specific spectral ranges, the concentration of fHb and its derivatives can be calculated by the integrated processor and displayed to the user on the HMI. Finally, CSF and cellular material are collected in the waste bag (residual material collection volume). An additional fluid path can enable flushing of the single-use system with a cleaning solution. The system with the single-use components can be designed, for example, for repeated automated measurements over a period of up to 10 days on a single patient. Key components of this description are the cell-fluid separation unit (microfluidic chip), the pump and valve configuration—used, for example, to direct CSF or rinse solution through the flow paths—and the measurement unit or photometric detection unit. The architecture and interconnection of the blocks into a single system for CSF analysis enable a completely novel system that offers a multitude of innovations and thereby defines a new class of devices that is also POC-capable (can be used at the point of care). Furthermore, the system’s design as a compact, mobile device—for example, featuring a reusable base module and an easily interchangeable analysis unit with a fluidic connection to the CSF outflow—contributes to its use as a point-of-care diagnostic device. Alternative solutions are possible for the technical implementation of the individual functional subsystems; such alternative solutions are explicitly considered to be covered by this specification. Cell sorting can be realized by any type of separation method, with different control mechanisms if necessary. Examples include surface acoustic wave acoustophoresis The optical detection unit is either a broadband spectrometer covering the analyte’s spectral absorption range or an array of light sources with specific, narrow-band spectra tailored to the analyte’s absorption peaks. The photometric measurement can be performed in a separate cuvette in which the analyte is collected, or alternatively in-flow on the microfluidic chip. Finally, the pump does not need to be of a specific type, but merely needs to meet the fluidic requirements of the system. The invention will now be described in more detail below with reference to the figures and using examples of embodiments. In this context, similar or identical elements are sometimes denoted by the same reference numerals, and the features of the various embodiments may be combined with one another. Brief Description of the Figures The figures show: Fig. 1               the schematic structure of a first embodiment of the device, Fig. 2               a schematic structure of another embodiment of the device, Fig. 3               a schematic structure of a further embodiment of the device, Fig. 4               Schematic structure of another embodiment of the device, Fig. 5               Schematic structure of another embodiment of the device, Fig. 6               Schematic structure of another embodiment of the device, Fig. 7               Schematic structure of another embodiment of the device, Fig. 8               Schematic structure of another embodiment of the device, Fig. 8                Schematic structure of a microfluidic chip, Fig. 9               Microscopic view of a prototype microfluidic chip in use showing the separation of body fluid, Fig. 10              A flowchart of the process. Detailed Description of the Invention Fig. 1 shows a first embodiment of the device 1, which in this embodiment comprises a base unit 10 and a fluidic module 40 arranged on or held by it. The illustrations are schematically chosen and show the information essential to the present description. For example, the base unit 10 may be designed as a cart or as a small, easy-to-handle, and, for instance, portable device of the size of the LiquoGuard® devices manufactured by the applicant, Moller Medical. The fluidic module 40 may be mounted on the base unit 10 using a cassette-style mounting mechanism or simply via locking tabs on the base unit 10. Particular attention is paid, when connecting the base unit 10 to the fluidic module 40, to ensuring a fluid-tight connection of fluid connections—in this case, the connection between pressure port 32 and pressure port 84—and / or to ensuring a secure connection of electrical connectors, if necessary or advantageous. The fluidic module 40 includes a connecting line 5, which in this case, as a directly connected line 41, extends directly to the body fluid reservoir 55 in the fluidic module 40 and is connected at its other end to the body fluid source 2. The body fluid source 2 can be a fluid container, schematically depicted as a Petri dish in Fig. 1, into which the body fluid 95 has previously been introduced. In this case, the device 1 is completely independent of any patient to be treated and is not connected to the patient. The device 1 is then purely an analytical device for a test sample 2 provided in an external body fluid source 2, which is supplied, at least in part, to the fluidic module 40. For example, the connecting line 5 may be provided with strain relief in the area of the housing passage 49 of the fluidic module housing 48, or may be crimped or thickened at that point on the housing 48, but the connecting line 5 otherwise forms a continuous line with the inlet line 41. Body fluid 95 can be introduced into the fluidic module 40 via the connecting line 5. If necessary, the hydrostatic force distribution between measurement sample 2 and the fluidic module 40 can be adjusted so that the body fluid 95 flows automatically into the reservoir 55 until a measurement level is reached. For example, the measurement level in the reservoir 55 may be above the height of the inlet opening of connection line 5 on the reservoir 55, so that the liquid level 56 in the reservoir 55 covers the inlet opening and thus stops the inflow of additional body fluid 95. Typically, however, it is preferable to be able to control or regulate the fluid flow into fluidic module 40 and within the fluidic module 40. In this case—or if the body fluid 95 does not flow into the device 1 automatically—the inflow and distribution within the fluidic module 40 can be controlled by means of the pump 20 arranged in the base unit 10. In this embodiment, the pump 20 is connected to the fluidic module 40 via the pressure connection 32. More specifically, the connection within the fluidic module 40 leads via the pressure connection 82 and the connecting line 84 to the body fluid reservoir 55. Consequently, the reservoir 55 can advantageously act to a certain extent as a pressure-compensating volume, such that when a vacuum is applied to the reservoir 55, a gentle suction is established on the connecting line 5 and thus on the body fluid source 2. The reservoir 55 is filled until a measured fill level 56 is established within the reservoir 55. This can be monitored, for example, by a fill-level sensor 57. Thereafter, the pump 20 can be switched over to generate an overpressure, which can in turn be applied to the reservoir 55. If necessary, the system can be adjusted hydrostatically so that no pressure is exerted on the connecting line 5, or a check valve, switching valve, or other means—such as a shut-off device—can be provided in or on the connecting line 5 to prevent excess pressure from acting back on the body fluid source. A line 42 is connected to the body fluid reservoir 55, which connects to a microfluidic chip 60. Thus, the body fluid 95 can flow from the reservoir 55 to the microfluidic chip 60. It is preferable for the fluid 95 to be conveyed under slight pressure so that a stationary fluid column rests against the microfluidic chip 60, ensuring that the fluid flows continuously without interruption, which could otherwise interfere with the operation of the microfluidic chip 60 or the downstream measuring device 70. The microfluidic chip 60 comprises two outlets 62, 63 (see Figs. 8, 9), which connect, on the one hand, to the measuring device 70 via the inlet line 43 and, on the other hand, to a residual material collection volume 75 via the inlet line 45. Separated components of the body fluid 95 can be discharged via line 45, whereas the remaining body fluid 95, without these components, is supplied to the measuring device 70 via line 43. The presence of this fluid component is a property of the body fluid 95; the separation of the fluid component constitutes an influence on or a change in the property of the body fluid 95. Using the measuring device 70, this or another property of the body fluid 95 can be determined—for example, the presence of this or another fluid component. If the fluid 95 is CSF and the liquid component consists of blood cells, the microfluidic chip 60 separates blood cells from the CSF. The measuring device 70 can then be used, for example, to detect hemoglobin in the CSF. Alternatively or cumulatively, it may be advantageous to position a measuring device between the microfluidic chip 60 and the residual material collection volume 75 that detects or quantifies the presence of blood cells. After measurement with the measuring device 70, the body fluid 95 is also fed into the residual material collection volume 75. The residual material collection volume 75 then serves as a “waste collector” within the fluidic module 40 to collect the residual materials, so that the fluidic module 40 requires no additional connections and, especially, remains clinically sterile. Once the residual material collection volume 75 is full, the fluidic module can be replaced to continue the measurements. Depending on the circumstances, the fluidic module can be disposed of, recycled, or reused after appropriate cleaning. Advantageously, such recycling, if desired, takes place outside the clinical environment and can instead be carried out at a facility equipped for this purpose. This may involve the complete reprocessing of the fluidic module 40 or simply the removal of valuable parts suitable for reuse. If necessary, the fluidic module 40 may also be designed such that certain components are removable and must be removed from the fluidic module 40 by the hospital staff prior to its disposal. These may include sensors that can be detached from the fluidic module 40, for example, via push buttons or other mechanical or electrically operated ejection mechanisms, and can be reused without these parts being contaminated with body fluid 95 or other undesirable fluids. To avoid repetition, the following discussion will focus on differences from the configuration shown in Fig. 1. Otherwise, the description provided for Fig. 1 applies, mutatis mutandis, to the embodiments shown in Figures 2 through 7. Referring to Fig. 2, a further embodiment of the device 1 is shown, wherein the connecting line 5 is connected on the body fluid source side to a drainage 4 and terminates on the fluidic module side at a hose coupling 8 arranged on the fluidic module 40. In other words, the connecting line 5 is a separate component that can be plugged into the fluidic module 40. This embodiment may be more practical to use and also allows for the use of a connection line 5 adapted to the specific application, depending on the location of use. Furthermore, in this embodiment, the hose coupling 51 on the fluidic module 40 can be designed such that it seals the line when the connection line 5 is disconnected. In other words, a check valve 52 may be integrated into the hose coupling 51 so that the fluid volume in the inlet line 41 cannot drain out of the fluidic module 40. This is advantageous for making the fluidic module 40 more hygienic. A check valve 52 may also be arranged separately from the hose coupling 51, for example at the inlet of the body fluid reservoir 55; the result is essentially the same. The body fluid reservoir 55 comprises a fluid level 56 up to which the body fluid 95 is filled before the subsequent measurement and / or manipulation of the body fluid 95 begins. Unlike the configuration shown in Fig. 1, the pressure connection line 84 is not connected directly to the reservoir 55, but rather downstream of it. In the base unit 10, an inlet-side and an outlet-side pressure sensor 28, 29 are each arranged next to the pump 20. With a suitable hydrostatic design, the pump 20 can, for example, draw in fluid until fluid is detected at the measuring point 85 in the connecting line 84. The fluid can then be conveyed into the microfluidic chip 60 by gravity, maintaining fluid pressure. Another check valve 59 is located upstream of the microfluidic chip 60. In this embodiment, the microfluidic chip 60 comprises only one outlet. For example, a property of the fluid 95 can be altered in this microfluidic chip 60 without the presence of a component to be separated that would need to be discharged separately. The altered fluid is fed via line 43 to the measuring volume 72 of the measuring device 70, where the fluid 95 is measured by a sensor 74. The measured fluid is then fed into the residual material collection volume 95. The residual material collection volume 95 is equipped with a level sensor 76, allowing the fill level or the reaching of a maximum fill level to be detected. If necessary, a signal can be output when the residual material collection volume 95 reaches a maximum fill level, so that the user is notified of the fill level and can take appropriate measures, such as replacing the fluidic module 40 with a new module 40. In the embodiment shown in Fig. 2, a flushing device 90 is further arranged in the fluidic module 40 for flushing the lines and, if applicable, reusable components with a flushing agent. To select the fluid to be introduced from line 42, the fluidic module 40 includes solenoid valves 58, 92 as control valves 58, 92. Thus, after the measurements are complete or upon request, the supply line 5 or the body fluid reservoir 55 can be disconnected using the control valve 58, and the microfluidic chip 60 and the measurement volume 72 can be flushed using the flushing device 90. If this can be performed as a certified hygienic process, it is conceivable that, after the flushing process is complete, clinical staff may be authorized to remove the microfluidic chip 60 and / or the measuring device 70 from the fluidic module 40 for reuse (possibly after additional cleaning). Another advantage of a device 1 as shown here is that the pumping process or the pumps 20, 21 cannot cause hemolysis. In this context, it is essentially irrelevant what type of fluid pump 20 is used; a simple and cost-effective diaphragm pump 20 is sufficiently effective, if only because the fluid 95 does not need to be conveyed through the pump 20, but rather the pump 20 can be positioned outside the fluid circuit or the lines 41, 42, 43, 44, 45 in contact with the fluid 95, and it acts on the fluidic module 40 from the outside, i.e., from the base unit 10. This advantage applies to all shown embodiments. With reference to Fig. 3, the same reference numerals again denote the same elements as explained in Figs. 1 and 2. The pump 20, which draws in air (positive pressure) or expels (negative pressure or vacuum) through the air inlet 36 and the pressure sensor 29, is connected to the fluidic module 40 via the pressure sensor 28—also shown in Fig. 2—and there (analogously to the embodiment shown in Fig. 1) directly pressurizes the body fluid reservoir 55. A flow sensor 53 is arranged in the inlet channel 41 of the fluidic module 40, by means of which a flow can be detected. This ensures a certain degree of certainty that body fluid 95 is actually entering the fluidic module 40. This helps to increase the reproducibility of the measurement results. The microfluidic chip 60 shown in Fig. 3 has two outputs, as shown in Fig. 1, to which the output lines 43 and 45 are connected. Furthermore, another control valve 73 (solenoid valve) is arranged between the measuring device 70 and the residual material collection volume 75, allowing the body fluid 95 to be drained from the measuring volume 72 in a controlled manner. This also allows for a certain degree of control over the fluid column extending from the body fluid reservoir 55 through the microfluidic chip 60 to the valve 73, so that the fluid flow through the fluidic module 40 can be influenced by controlling the valves 58 and 73. The embodiment shown in Fig. 3 has a dead volume reduced to a minimum, so that the requirement for body fluid (95), such as CSF, is further reduced. Furthermore, a filter may be inserted, for example, in the area of the tubing coupling 51, with the check valve 52, or in any case before the microfluidic chip 60—for example, with or within the check valve 59—for instance to filter out coagulated blood from the CSF. Overall, the entire fluidic module 40 could also be used as a filter to separate coagulated blood from the CSF if, instead of depositing the CSF in the residual material collection volume 75, the body fluid 95 purified in the microfluidic chip 60 were reused. Not shown is a bubble sensor that detects gas bubbles in the body fluid. Here, too, commercially available non-invasive sensors exist—for example, those based on ultrasonic measurement—which can reliably detect gas bubbles in a fluid. If necessary, the fluidic module 40 can be supplemented with such a bubble sensor. Fig. 4 shows another embodiment of the device, wherein the same reference numerals again denote the same elements as described previously. A fluid detection unit 54 is arranged at the inlet side of the fluidic module 40. For example, such a fluid detector 54 operates using an ultrasonic sensor, by means of which—based on a time-of-flight measurement of the ultrasonic source and the signal response delay—it can be determined whether a liquid is present in the inlet channel 41. Additionally, in this embodiment, a flow sensor 53 is also arranged in the inlet line 41. For example, the flow velocity can be determined using the flow sensor 53. If necessary, the fluid detection device 54 can be configured together with the flow sensor 53 as a combined component 53 / 54. In the embodiment shown in Fig. 4, the body fluid reservoir 55 is arranged at a fork in the inlet line 41. As shown in Fig. 1, the reservoir 55 in this embodiment can also be pressurized with positive pressure and / or negative pressure. In this embodiment, the pump 20 is connected to the body fluid reservoir 55 via two pressure ports 37, 38 and the mating ports 82, 84 of the fluidic module 40. To deliver fluid into the reservoir 55, a vacuum can be applied; to further deliver fluid within the fluidic module 40, positive pressure can be applied. The check valve 52 prevents backflow into the connecting line 5. Furthermore, an additional flow sensor 69 is arranged between the microfluidic chip 60 and the measuring device 70, thereby ensuring that body fluid 95 exits the microfluidic chip 60 into the supply line 43 and is thus available for measurement by the measuring device 70. This ensures that the function of the microfluidic chip 60 is monitored during the measurement. After separation in the microfluidic chip 60, the purified body fluid 95 is therefore directed, for example, to the measuring device 70, which can perform a spectrophotometric analysis. In the embodiment shown in Fig. 4, fluid control is implemented overall via solenoid valves 11, 12, 58, 73, 79, and 92. The solenoid valves can be controlled by a controller 33 (see Fig. 7)—that is, turned on and off—to achieve the corresponding fluid delivery in the fluidic module 40. Referring to Fig. 5, a further embodiment of the device 1 is shown, in which the pump 20 has been further simplified with regard to the relevant connections. Both negative pressure and positive pressure can be delivered to the fluidic module 40 via a single pressure connection 37. To achieve this, a switching device is arranged in the base unit 10; by means of the two solenoid valves, this device allows the pump to either draw in air via the air inlet 13 and air inlet filter 14 and to provide positive pressure at connection 37 via the path P>Patm. Alternatively, the switching device allows air to be extracted from the fluidic module 40, which is vented via the path P<Patm, the air outlet filter 16, and the air outlet 15. The advantage of this arrangement lies in the reduced number of pressure connections, since only one connection 37 is used and connection 38 is dispensable. Consequently, there are fewer connecting components between the base unit 10 and the fluidic module 40 that could potentially fail. Depending on the desired configuration, the fluidic module 40 can perform measurement and data storage autonomously, so that, if necessary, no electrical connections between the fluidic module 40 and the base unit 10 are required. On the other hand, it is likely to be more cost-effective and advantageous overall to provide electrical connections (see Fig. 7) and to also control the measuring device 70 and store the data in the base unit 10. Fig. 6 shows yet another embodiment of the device 1, in which the fluid control is carried out in this case via pneumatically controlled valves 58, 73, 79, 92. For this purpose, a plurality of switching outputs 30 are provided on the base unit 10 to apply switching pressures to the fluidic module 40 for the individual actuation of the respective pneumatic valves 58, 73, 79, 92. The arrangement of two separate pumps 20, 21 in the base unit 10 enables a reliable separation of the switching unit and the associated compressed air lines from the body fluid 95, since this ensures that no body fluid 95 enters the lines. This allows these components to be manufactured more cost-effectively or in compliance with less stringent requirements, if necessary. According to the embodiment shown in Fig. 6, the switching pump 21 is supplied with ambient air (or a gas) via the air inlet 22 and the inlet filter 23. A reserve pressure can be stored in a pressure accumulator 25, which can be filled to a reserve pressure based on the pressure sensor 24. If necessary, this can provide a different pressure range than that for the fluid delivery pump 20. For example, the operation of valves 58, 73, 79, and 92 may require a minimum pressure that should not be applied to the fluid side. The use of two pumps 20, 21 thus also ensures that the lines carrying body fluid are not subjected to excessive positive pressure. Finally, this allows for the use of a fluid pump 20 capable of very precise metering for the comparatively low negative pressures and positive pressures required for fluid delivery, and a (more cost-effective) coarser control pump 21 for the higher control pressures needed to operate the valves. The individual control lines can be pressurized or isolated from the pressure accumulator 25 via the control valves 31. Each pressure valve 58, 73, 79, 92 typically has a “default state,” such as for example “normally closed” or “normally open,” so that without pressure being applied, the respective valve assumes a fail-safe state. For example, valve 92 of the flushing device 90 is used in the “normally closed” failsafe state, so that the flushing agent can only enter the fluid-carrying lines when the associated valve 92 is pressurized and thus changes its open state from closed to open. Finally, with reference to Fig. 7, the embodiment shown in Fig. 6 is illustrated, with the electrical connecting lines 34 and the control module 33 additionally included in the schematic representation. In the control module 33, the embodiment shown also includes an evaluation module 93 for evaluating the measurement data generated by the measuring device 70. Using the evaluation module 93, the measurement can be evaluated simultaneously with device 1 and, if necessary, output to a display device. Similar to the example of the compact LiquoGuard device manufactured by the applicant, this can be displayed on a practical, large-format screen and, if necessary, additional information—such as other measured values—can be obtained, or the measurement can be influenced—for example, by changing the optical frequencies used for measurement with the sensor 74—via key inputs or a touchscreen. Furthermore, a memory module 94 is provided, by means of which the measurement data obtained with the measuring device 70 can be (temporarily) stored. In addition, the memory module 94 can also be used to store other parameters of the device 1, including status and operating data for the pumps 20, 21, data from the microfluidic chip 60, sensor data from the various fluid sensors in use, and the fill levels of the reservoirs 55, 75. Using the pump controller 97 and the corresponding control lines, it is possible, for example, to specify the operating direction of the fluid pump 20 (vacuum or positive pressure) or the control pressure of the control pump 21, as well as to control the corresponding (solenoid) valves 17, 18, 31. A wireless communication device 98 enables a data connection, for example, to the hospital network or to other communication systems, so that a user of the device 1 can be informed at any time during the measurement about the status or the availability of measurement results, and / or about the status of the device 1 e.g., whether it is ready for use or in an error state, and / or so that measurement data obtained in this way can be transmitted to a corresponding accessible patient record. Finally, the power supply unit 99 provides power to device 1. The power supply unit 99 may be designed as a rechargeable battery or energy storage device, or it may include a plug for connection to a local power source. Fig. 8 shows a simplified embodiment of device 1—compared to the previous embodiments—with a direct connection via interface 5 to the body fluid source 2. Device 1 comprises the fluidic module 40 and a pump 20 integrated into the base unit 10, which conveys the body fluid 95 into the fluidic module 40. The fluidic module 40 is designed to house the microfluidic chip 60, which enables the separation of components such as blood cells (erythrocytes, leukocytes) and / or blood serum proteins from the body fluid 95. In this embodiment, the measuring device 70 already monitors the microfluidic chip 60, so that the measurement can be performed directly on or in the vicinity of the microfluidic chip 60. In other words, the measurement can be performed in-flow on the microfluidic chip 60. The body fluid sample 2, filled with body fluid 95 up to fluid level 56, can be connected relatively freely to the device 1 via the interface 5, as shown in Fig. 8. The interface 5 may also be designed as a holder that not only ensures fluid communication or the withdrawal of body fluid from the body fluid source 2. Rather, the interface 5 may also be used to secure the body fluid source 2—for instance in the form of a reservoir—to the device 1. Once the measurement using the device 1 is complete, and thus no further body fluid 95 is required, it may be provided that the components of the device 1 that have been wetted by or have come into contact with body fluid 95 are flushed with a flushing fluid. For this purpose, the device may include a flushing fluid reservoir 90, which may be located, for example, in the fluidic module 40. A switching device 92 may be provided to switch between the flushing device 90 and the body fluid source 2. In the example shown in Fig. 8, this is depicted as a toggle switch. A switching valve may also be provided at this location. The body fluid flows through the inlet line 42 to the microfluidic chip 60. In the microfluidic chip 60, foreign substances are separated from the body fluid 95. Furthermore, in this example, the body fluid 95 is also measured by the measuring device 70 in the area of the microfluidic chip 60. The body fluid is further conveyed through the device by pump 20 and is ultimately fed via the inlet line 45 to the residual material collection volume 75. In this example, the residual material collection volume 75 is located within the fluidic module 40. It is also possible for the residual material collection volume 75, and / or the flushing agent of the flushing device 90, to be arranged outside the fluidic module, so that, for example, the flushing agent can be easily refilled and / or the residual material accumulated in the residual material collection volume 75 can be easily disposed of—for instance in the event that the fluidic module 40 is designed to be reusable. The measurement results can, for example, be displayed on a screen of the device 1 and / or transmitted to the hospital information system via the wireless communication device. This simplified embodiment enables an especially easy handling at the patient’s side and emphasizes the device’s in-situ analysis capability. The direct connection eliminates the need to transport the sample to the laboratory, which saves time and improves the accuracy of the results by minimizing sample aging and contamination. Fig. 9 shows an embodiment of a microfluidic chip 60 according to the present description, as it can also be used in the preceding Figures 1 through 7, with an inlet 61 and two outlet openings 62, 63. An inlet channel 64 is provided. The microfluidic chip 60 may be configured such that the body fluid 95 is manipulated in the region of the inlet channel 64. Thus, in the embodiment shown in Fig. 8, a separation device 80 is depicted that exerts a manipulative effect on the body fluid 95 via the inlet channel by means of a separation action. In this illustration, the separation device 80 is shown to the side of the inlet channel 64. The arrangement of the separation device 80 relative to the microfluidic chip 60 may depend on the mode of operation of the separation device 80, and an arrangement positioned below the microfluidic chip 60 (such that the two outlet channels 68 extend laterally to the left and right and are neither closer to nor farther from the separation device 80) is also provided. The side view is also chosen because, if the separation device 80 were positioned below the microfluidic chip 60, it would not be visible in the illustration. For example, the separation device 80 is configured to separate components 96 of the body fluid 95 from the remaining body fluid. In this case, it may be provided that the components to be separated are directed to the first outlet channel 67 and thus to the first outlet opening 62, while the body fluid 95 is directed toward the second outlet channels 68 and thus to the second outlet opening 63. This results in the separation of the components 96 to be separated from the remainder of the body fluid. For example, blood cells such as erythrocytes and / or leukocytes can be separated from CSF in this manner. Fig. 10 shows a photographic representation of a section of a microfluidic chip 60, wherein body fluid 95 is actually directed through the inlet channel 64 of the microfluidic chip 60, and a separation device 80, which is arranged beneath the microfluidic chip 60, causing the separation of the erythrocytes 96 (red) from the remaining body fluid 95 (white to slightly reddish). The remaining body fluid 95 diverts toward the edge of the inlet channel 64. Due to the adjacent flow from the inlet channel 64 toward the outlet channels 67, 68, the fluid flow splits in the region of the bifurcation 65, with the result that the components 96 to be separated are directed centrally and can be fed to the first outlet opening 62. The remaining body fluid 95 is directed around the outside into the outlet channels 68 and reaches the second outlet opening 63 (see Fig. 9). Subsequently, the remaining body fluid 95 can be directed to the measuring device 70, and the separated components can be directed to the residual material collection volume 75. The device may be equipped with one or more micropumps, such as a microfluidic peristaltic pump, in addition to or as an alternative to the fluid pump 20. Such a pump operates on a principle similar to that of the microfluidic chip 60, wherein a plurality of, for example, three microvalves can form a pump for delivering the body fluid 95. Finally, with reference to Fig. 11, a flowchart of a method 100 for measuring, influencing, or diagnosing a body fluid 95 is shown. In step 110, the body fluid 95 is introduced into the device 1 or the fluidic module 40. If necessary, step 115 involves detecting whether body fluid is present in the fluidic module 40, for example, using one or more flow sensors 53, 59. In step 120, the body fluid 95 is fed to the microfluidic chip 60 arranged on or within the fluidic module 40, so that the microfluidic chip 60 can be used to modify 130 the body fluid 95, such as for instance the separation of blood cells, such as erythrocytes and / or leukocytes 96, from the CSF 95, for example by means of the separation device 80. For this purpose, it may be advantageous if, for example, the detection 115 activates 125 a microfluidic chip 60 that was initially deactivated. In other words, activation 125 of the microfluidic chip 60 can occur in response to a detection 115 in the fluidic module 40. After modification 130 of the property of the body fluid 95, the body fluid 95 is transported 135 to a measuring device 70 for the purpose of measuring 140 the same property or another property of the body fluid 95. After the measurement 140 is complete, the body fluid 95 and / or its components 96 are finally disposed of 150 in the fluidic module 40. Any necessary diagnosis 160 can then be performed based on the measurement data collected during the measurement 140, for example using the evaluation module 93. Numerous experiments and tests were also conducted as part of the present disclosure. A prototype microfluidic chip was fabricated that is capable of separating blood cells, such as erythrocytes and / or leukocytes, from CSF using acoustic forces. The manipulation of cells using acoustic forces (acoustophoresis) is based on the generation of acoustic pressure in a microfluidic channel via a piezoelectric element. At a defined frequency, a standing acoustic wave is generated in the channel, with the pressure node(s) located in the center of the channel. The scattering of the acoustic waves by the cells generates a force known as the acoustic rotational force (Frad ), which pushes the cells toward the acoustic pressure node. Blood cells, such as erythrocytes and / or leukocytes, are focused in the center of the channel due to their positive acoustic contrast factor compared to blood plasma and CSF. The microfluidic chip 60 comprises, for example, a silicon base and was fabricated, for example, by double-sided photolithography on a silicon wafer with a diameter of 4 inches and a thickness of 500 pm ± 10 pm. The microfluidic channel and the access holes were fabricated using inductively coupled plasma deep reactive ion etching (ICP-DRIE, Bosch process, Estrellas, Oxford Instruments) on both the front and back sides with a channel depth of 200 pm ± 5 pm, a channel width of 700 ± 5 pm, and an access hole diameter of 1000 pm. A glass wafer (700 pm thick) was anodically bonded to the silicon wafer (SB6, SUSS MicroTec, Garching, Germany) and then cut into rectangular chips (11 mm x 58 mm) using a wafer saw (DAD3221, Disco Corporation). The piezoelectric transducer (20 mm x 20 mm x 2 mm, PZ26, Ferroperm Piezoceramics A / S, Kvistgard, Denmark) was bonded to the back of the diced chips using an epoxy resin (H20E, EPO-TEK). Two copper wires (0.25 mm in diameter) were bonded to the electrodes of the piezoelectric transducer using silver paste and superglue. The chip was clamped into a holder and sealed with O-rings using three flanged PTFE tubes (1 / 16 inch x 0.75 mm outer and inner diameters, respectively), which provide access to the inlet and two outlet ports. A modular in-vitro test setup was constructed to test the microfluidic chip. It includes an interface for connecting the particle separation device and the spectrophotometer, three syringe pumps (Nemesys 290N, low-pressure syringe pump, Cetoni GmbH, Korbussen, Germany), and tubing with a diameter of 0.75 mm. The electronics for operating the piezoelectric transducer include a waveform generator (Series 333500B, Keysight, CA, USA) and a High Wave 3.2 amplifier (Digitum Elektronik, Nurtingen, Germany). A camera (Toolcraft DigiMicro, Conrad Electronic, Hirschau, Germany) was used for imaging at the bifurcation of the microfluidic chip. In addition, the expanded test environment included a laboratory spectrometer (Photometer 4040v5+, Riele, Berlin, Germany) and a centrifuge (Universal 320 & Hematocrit Rotor, Hettich AG, Bach, Switzerland) to test the same samples in parallel. This allows tests of the present plasmapheresis chip to be evaluated and compared with the standard analysis (laboratory centrifuge). The microchips were tested using diluted porcine blood and CSF samples from six aSAH patients. The porcine samples were diluted with phosphate-buffered saline (PBS) to achieve the same hematocrit value as the CSF sample, while the patient samples were not diluted. To remove any air bubbles, the entire system—i.e., the tubes and the microfluidic chip—is flushed with the sample to be analyzed, and the residue is collected in a container. After the initial flushing of the system, the flow rate at the inlet is set to 60 pL / min and at the plasma outlet to -15 pL / min. At these flow rates, the device could be operated for hours without any stability issues. The flow rates and dilution ratios could be increased at the expense of operational stability. At a constant flow rate, the piezoelectric transducer is activated, causing the erythrocytes and / or leukocytes to move toward the center of the channel. The input signal for operating the piezoelectric transducer was selected as a sine wave with a frequency range of 1036-1050 kHz (half-wavelength matched to the channel width (A / 2 mode)) and a peak-to-peak amplitude of 28 V. The optimal operating point for the active blood particle separation device is determined by applying various voltages and frequencies to the piezoelectric transducer, as well as different flow rates at the inlet and outlet. The resulting efficiency of blood particle focusing is monitored. The separation of blood particles is clearly illustrated in a supplementary video (OxyHbMeter FunctionalPrinciple) to be made available online by the applicant; however, this can also be easily understood from the further description. In the supplementary video, the fluid flows from left to right and is separated as follows: waste 96 (separated red blood cells) is extracted in the center at the first outlet 62, and plasma or CSF 95 for CSF-Hb detection is located in the two side arms 68. After the entire dead volume has been drained into the tubes, the plasma or CSF 95 is collected in the corresponding syringe. The system continues to operate for approximately 70 minutes until 1 mL of plasma or CSF 95 has been collected in the plasma or CSF syringe. The collected plasma or CSF 95 is then analyzed using the spectrophotometer to determine the sample’s Hb concentration. Afterward, the device was cleaned with saline solution and ethanol so it could be reused for the next experiment. In a clinical setting, CSF samples were analyzed from six patients 2 who were being treated for SAH and hydrocephalus at the Neurocritical Care Unit of the University Hospital of Zurich and required external ventricular drainage 4. The study was approved by the local ethics committee of the Canton of Zurich, Switzerland, approval number 2021-01089. Written informed consent was obtained from the legal representatives, as all patients were incapable of giving informed consent, and the study was conducted in accordance with the Declaration of Helsinki and its amendments. The CSF 95 was not collected directly from the patients 2 but rather from a collection bag 2 containing CSF 95 drained over the previous 2 to 3 hours. The separation efficiency and hemolysis induced by the separation process of the microfluidic chip 60 were compared with conventional centrifugation (state of the art). The samples were centrifuged for 15 minutes at 3600 RCF, and the separated CSF 95 was analyzed spectrophotometrically. The measured Hb values of the centrifuged sample served as a baseline for verifying the values of the sample separated using the microfluidic chip 60. Five cuvette measurements were performed for the spectrophotometric analysis of both separation methods. Using the latest chip design and test setup, in vitro and clinical measurements were performed with diluted patient blood and CSF samples. These experiments were conducted to evaluate the separation efficiency and the hemolysis induced by the microfluidic chip 60 compared to conventional centrifugation. A scientific paper to be published shortly will discuss the results of the measurements in detail; these results are not relevant to the present specification at this time. Nevertheless, the contents of this paper, “OxyHbMeter - a novel bedside medical device for monitoring cell-free hemoglobin in the cerebrospinal fluid - proof of principle,” are hereby incorporated by reference. Furthermore, the aforementioned study, which supports the present patent, demonstrates the fundamental feasibility and (commercial) applicability of the device 1 shown in this specification. In summary, the results of the microfluidic chip 60 were very close to those of centrifugation. The photograph shown in Fig. 9 depicts the microfluidic chip 60 with the piezoelectric element 80 activated, with the channel 64 having reached its resonance frequency. The erythrocytes 96 from the human sample are concentrated in a narrow band in the center of channel 64 and therefore exit only through the central outlet 62. The novel bedside monitoring system is intended to enable continuous and non-invasive quantification of CSF without the need to clamp or puncture the CSF drainage system. Compared to daily CSF collection with manual processing of each sample, the OxyHbMeter would offer greater ease of use, reduce the risk of infection, and enable autonomous measurement of CSF-Hb concentration. This method could improve reproducibility and be integrated into an effective early warning system, for example, by providing a biomarker for predicting DCI. In the tests, which also form the basis of the scientific publication, the flow rates were selected heuristically to achieve stable particle focusing throughout the entire plasma or CSF extraction process. The Chip 60 used in this study had an optimal flow rate of 60 pL / min at the inlet and -15 pL / min at the CSF-outlet, which balanced the particle concentration and yield at the plasma and CSF-outlets and ensured stable operation over several hours. The effective flow rate was primarily limited by the length of the channel and the HCT value of the sample 95. Furthermore, the focusing intensity in the channel could be controlled by the voltage applied to the piezoelectric transducer 80; however, a higher voltage led to an increased temperature of the device, which damaged the cells. In this study, we applied a peak-to-peak voltage of 28 V and kept the operating temperature consistently below 30 °C. In general, it would be possible to achieve higher flow rates by increasing the channel length or raising the acoustic energy density in the channel through lateral control or active cooling, in order to increase throughput and thus the yield at the CSF outlet 63 in clinical scenarios. The experimental setup was designed with the syringe pumps tilted at a 45° angle. This delayed the sedimentation of blood cells, such as erythrocytes and / or leukocytes, at the bottom of the syringes, which enabled a stable HTC in sample 95 throughout the entire experiment. Processing the samples with the microfluidic device 60 in our in vitro setup took longer than centrifugation. In the future, however, this could lead to more standardized CSF-Hb measurements with faster and autonomous processing of the CSF 95. Samples no longer need to be sent to the laboratory for an indefinite period, nor are they subjected to varying centrifugation speeds. After separation of the CSF 95 using the microfluidic chip 60, the measured CSF-Hb values fell within a range similar to that of measurements obtained after centrifugation. There was hardly any additional hemolysis triggered by device 1. However, a major limitation of the clinical study conducted to date is the limited number of available clinical samples from aSAH patients. In the chosen test environment, a lower HCT value in sample 95 was more advantageous than a higher one, since higher viscosity is more likely to clog the channel and make the separation more prone to errors. Residual contamination in the system could be another cause of measurement differences, although chip 95 and all tubes were thoroughly cleaned before each experiment. Preliminary tests with the plasmapheresis chip 60 show that it is capable of continuously separating erythrocytes and / or leukocytes 96 from diluted blood and CSF samples 95, enabling standardized in-line biomarker testing. Unlike centrifugation, the microfluidic chip 60 does not cause additional hemolysis, and the performance and accuracy of the obtainable measurement results are fully comparable. The developed platform serves as a solid foundation for the future development of a point-of-care device 1, as has already been explained in great detail in this specification. We also envision a platform technology suitable for multiple applications: First, continuous measurement of CSF-Hb levels in aSAH could advance our understanding of DCI, biosignal analysis, and cognitive computing—initially in research and, in a second step, in timely treatment. The data would be processed in real time, and the results presented as a DCI prediction, prevention, and decision-support system. In-depth phenotyping and advanced biosignal analysis will also contribute to a profound understanding of the complex pathophysiology of DCI following aSAH. CSF-Hb as a biomarker for DCI could make it possible to identify high-risk patients as a target group for research into new medications, such as the hemoglobin-binding protein haptoglobin. Second, computed tomography (CT) is the diagnostic method of choice for diagnosing subarachnoid hemorrhage in patients with acute headaches. If a CT scan is not performed in a timely manner and sensitivity is low several days after the onset of headache, the diagnosis may be missed. A lumbar puncture enables the diagnosis of subarachnoid hemorrhage if xanthochromia is present in the supernatant of centrifuged CSF samples 95. Xanthochromia serves to distinguish the elevated erythrocyte count in the CSF associated with SAH from the elevated erythrocyte count following a traumatic lumbar puncture and is considered present when the absorption follows a characteristic oxyhemoglobin curve. False-positive test results can only be avoided if the CSF 95 is immediately centrifuged and analyzed by spectrophotometry. This procedure has thus far been reserved for highly specialized laboratory units, as the analytical methods require certified specialists. A POCT system could enable round-the-clock CSF spectrometry in the setting of an emergency department or intensive care unit. And third, not only could the more frequent and standardized determination of the CSF Hb level benefit from this separation principle, but so could other CSF analyses, such as cytology. The cellular composition of CSF provides important initial information about a broad spectrum of inflammatory diseases of the central nervous system. For cytometry, CSF samples must be centrifuged and analyzed immediately, ideally within one hour of collection. The principle of acoustic stophoresis is based on the generation of acoustic pressure in a microfluidic channel by a piezoelectric element. The acoustic pressure exerts an acoustic radiation force on the particles. At a defined frequency, a standing wave is generated in the channel with its node at the center of the channel. The resonance frequency (f) depends on the channel geometry and the fluid properties. The wavelength (A) is determined by the channel width (D) and the selected resonance mode (k). To focus the particles in the center of the channel across its width—which is utilized in this application for the geometric separation of a component 96 from the body fluid 95—the first mode is used, in which half the wavelength fits within the channel width (k = 1, A / 2 mode). The frequency depends on the wavelength and the speed of sound (c0) in the liquid used: c f = -0  with A = 2Dk A In a straight, rectangular microchannel environment, the acoustic wave can be approximated as a standing, resonant pressure wave of the following form Pac = Pacos(kz)sin(2nft) The acoustic radiation force is the time-averaged force acting on particles suspended in a fluid that are exposed to an acoustic standing wave field. The force results from differences between the particle and the surrounding fluid, such as compressibility (k), the density (p) of the fluid and the particle, the size of the particle, as well as the frequency and acoustic energy density of the standing acoustic wave. The acoustic radiation potential, also known as the Gorkov potential, (Urad ) is defined as: 1 Urad = 2nrp(fi----^pfn) 3Poco ,    -      . ,    ~    Kp f = 1 — K with K = -- 1                         Ko c p0 / 2 w f2^<vn) 2 Po£o = „  2 Po 2(p — 1) f2=lp+T   with P Pp 2 ( Pp P ) Po      2Pp - Po rp denotes the radius of the particle, while pp is the density, Kp and Cp are the sound speed of the particle. po, ko, and co denote the density, compressibility, and sound speed of the fluid. p~ and K represent the relative density and compressibility, while  <p_inA2 > and ( v_inA2 > represent the time-averaged impact pressure and the square of the velocity. fi is derived from the mass flow rate in conjunction with the compressibility, while f2 is determined from the translational motion. Based on the above terms and equations, the formula for the acoustic radiation force (Frad ), which acts on a particle in the direction of the acoustic pressure nodes of the standing wave field, is derived by taking the negative gradient of the Gor'kov potential: Frad = —Vurad = -43^3^1-1-^ — ^po^)) The magnitude and direction depend on the acoustic energy density Eacand the acoustic contrast factor ¢-for the fluid and the particle, respectively—and are expressed as: P - P2   -In 2 Eac=4po cO  4 p 1    1    1 / 5p-2   \ ¢ = 3^ + 2^=3(2^+2-^ In this equation, pa represents the pressure and va represents the velocity amplitude. The contrast factor can result in a negative number. In this case, the particles are pushed toward the pressure antinodes and away from the pressure nodes. In our application, the blood cells have a positive acoustic contrast factor relative to the fluid in which they are suspended—that is, blood plasma and CSF—which enables us to focus them at the pressure node and thereby separate them. It will be apparent to those skilled in the art that the embodiments described above are to be understood as examplary and that the invention is not limited to them, but may be varied in a variety of ways without departing from the scope of the claims. Furthermore, it is apparent that the features—regardless of whether they are disclosed in the specification, the claims, the figures, or elsewhere—also define, individually, essential elements of the invention, even if they are described in conjunction with other features. In all figures, identical reference numerals denote identical elements, such that descriptions of elements that may be mentioned in only one figure—or at least not in all figures—can also be applied to those figures for which the element is not explicitly described in the specification. List of Reference Numerals 1         Device 2         Body fluid source 4        Drainage 5          Interface, e.g., connecting line 8        Hose coupling 10        Base unit 11        Solenoid valve, “normally closed” 12        Solenoid valve, “normally open” 13         Air inlet 14          Air inlet filter 15        Air outlet 16        Exhaust filter 17        First control valve 18        Second control valve 20        (External or located in the base unit) fluid pump 21       Switching pump 22         Air inlet 23          Inlet filter 24       Pressure sensor 25       Pressure accumulator 28       Pressure sensor 29       Pressure sensor 30        Switch output 31        Control valve 32        Pressure connection in the base unit 33        Control unit 34        Control line 36        Air connection 37        Pressure connection in the base unit 38        Second pressure connection in the base unit 40        Fluidic module 41         Inlet line to the body fluid reservoir 42        Inlet line to the microfluidic chip 43        Inlet line to the measuring device 44        Inlet line from the measuring device to the residual material collection volume 45        Inlet line from the microfluidic chip to the residual material collection volumer 48       Fluidic module housing 49       Housing passage 51       Hose coupling 52        Check valve in the supply line 53       Flow sensor 54        Liquid detection 55       Body Fluid Reservoir 56        Liquid Level in the Body Fluid Reservoir 57        Level sensor in the body fluid reservoir 58        Control valve, e.g., solenoid valve 59        Check valve upstream of the microfluidic chip 60        Microfluidic chip 61          Inlet 62        First outlet opening 63       Second outlet opening 64        Inlet channel 65        Bifurcation 66       Wafer 67        First outlet channel 68       Second outlet channel 69       Flow sensor 70       Measuring device 72       Measuring device 73        Control valve, e.g., solenoid valve 74        Sensor, for instance an optical sensor 75        Residual material collection volume 76        Level sensor in the residual material volume 79        Control valve, e.g., solenoid valve 80       Separation device 82        Pressure connection on or inside the fluidic module 83        Second pressure connection on or in the fluidic module 84        Pressure connection line 85        Measurement point in the pressure connection line 86        Control connection 87       Second control connection 88        Third control connection 89        Fourth control connection 90        Flushing device 92        Switching device, switching valve, e.g., solenoid valve 93       Evaluation module 94       Storage module 95       Body Fluid 96       Separated components of body fluid 97       Pump control 98       Wireless communication device 99        Electrical power supply device 100      Method 110       Introduction 115       Detection of the body fluid in the fluidic module 120      Feeding the Body Fluid 125      Activation 130       Modification 135      Transportation 140     Measurement 150       Disposal of the body fluid and / or its components in the fluidic module

Claims

1. Device (1) adapted to measure and / or influence a property of a body fluid (95)—for example CSF—provided in a fluidic module ofthe device, the device comprisingthe fluidic module (40),a reusable base unit (10), adapted or configured to accommodate the fluidic module on or within the base unit,an interface (5, 51), for instance configured as a connecting line (5) or a hose coupling (8), adapted to connect the device to a body fluid source (2), for example a patient, wherein the body fluid source comprises a body fluid such that the body fluid can be fed into the fluidic module via the interface,a microfluidic chip (60) arranged on or within the fluidic module, adapted to modify the properties of the body fluid.

2. Device (1) according to the preceding claim, wherein the device is configured or designed as a mobile device and / or as a point-of-care diagnostic device.

3. Device (1) according to at least one of the preceding claims, wherein the property of the body fluid (95) is or comprises at least oneof the following:the presence of foreign bodies or foreign substances (96) in the body fluid; the presence of particles, suspended particles, or cells (96) such as blood cells and / or blood serum proteins in the body fluid; the presence of hemoglobin or a derivative thereof in the body fluid; and / orthe bilirubin level in the body fluid.

4. Device (1) according to at least one of the preceding claims,wherein the modification of the property of the body fluid comprises the separation of particles, suspended particles, or cells from the body fluid.

5. Device (1) according to at least one of the preceding claims, further comprising a measuring device (70) arranged in or on the fluidicmodule (40) for determining the property of the body fluid (95).

6. Device (1) according to the preceding claim, wherein the measuring device (70) is adapted to detect or quantify hemoglobin or aderivative thereof in the body fluid (95).

7. Device (1) according to one of the two preceding claims, wherein the measuring device (70) further comprises an optical sensor (74)arranged in or on the fluidic module (40), for example a spectrophotometer.

8. Device (1) according to at least one of the preceding claims, further comprising a body fluid reservoir (55) arranged in or on thefluidic module (40), which is arranged, in particular, upstream of the microfluidic chip (60).

9. Device (1) according to the preceding claim, wherein the body fluid reservoir (55) comprises a level sensor (57) or a level indicator.

10. Device (1) according to at least one of the preceding claims, further comprising at least one controllable valve (58, 73, 79, 92), forinstance a solenoid valve, in the fluidic module (40), for example arranged downstream of the body fluid reservoir (55).

11. Device (1) according to at least one of the preceding claims, further comprising a residual material collection volume (75) arrangedin or on the fluidic module (40).

12. Device (1) according to the preceding claim,wherein the residual material collection volume (75) comprises a reservoir.

13. Device (1) according to at least one of claims 11 or 12, wherein the residual material collection volume (75) is connected to themicrofluidic chip (60) such that residual material from the body fluid (95) can be discharged directly from the microfluidic chip into the residual material collection volume.

14. Device (1) according to at least one of claims 11 through 13, wherein the residual material collection volume (75) is connected to themeasuring device (70) according to claim 4, such that volumes of the body fluid (95) measured by the measuring device can be discharged into the residual material collection volume.

15. Device (1) according to at least one of claims 11 through 14,wherein the residual material collection volume (75) comprises a level sensor (76) or a level indicator for displaying the fill level of the residual material collection volume, such that, for instance when a maximum fill level is reached, information is put out or the fluidic module (40) can be replaced with a new fluidic module.

16. Device (1) according to at least one of the preceding claims, further comprising a flushing device (90) arranged in or on the fluidicmodule (40).

17. Device (1) according to at least one of the preceding claims, further comprising a check valve arranged on the fluidic module (40) onthe inlet side, for example upstream of the body fluid reservoir (55).

18. Device (1) according to at least one of the preceding claims, wherein the microfluidic chip (60) comprises an inlet channel (64)and / or a bifurcation (65).

19. Device (1) according to at least one of the preceding claims, wherein the microfluidic chip (60) comprises a separation device (80)for separating pieces, particles or cells from the body fluid (95).

20. Device (1) according to at least one of the preceding claims, wherein the separation device (80) comprises at least one piezoelectriccomponent, for instance a piezoelectric transducer.

21. Device (1) according to the preceding claim, wherein the separation device (80) is configured to provide acoustic pressure, forexample to provide acoustophoresis.

22. Device (1) according to at least one of the preceding claims, further comprising a gas bubble detection and / or separation devicearranged upstream of the microfluidic chip (60) for identifying and / or separating gaseous components from the body fluid (95).

23. Device (1) according to at least one of the preceding claims,wherein the interface (5, 51), for example configured as the connecting line, is adapted for connection to an external ventricular drainage (4).

24. Device (1) according to at least one of the preceding claims, wherein the interface (5, 51), for instance configured as the connectingline (5), is adapted for direct connection to the fluidic module (40).

25. Device (1) according to at least one of the preceding claims, wherein the fluidic module (40) is adapted for connection to theinterface (5, 51) or comprises it, wherein the interface is specifically configured as the connecting line (5).

26. Device (1) according to at least one of the preceding claims, wherein the fluidic module (40) comprises a hose coupling (51) forconnecting to the connecting line (5).

27. Device (1) according to at least one of the preceding claims, further comprising a fluid detector (54) arranged on or in the fluidicmodule (40) and configured to detect the presence of body fluid (95) in the fluidic module.

28. Device (1) according to at least one of the preceding claims, wherein the base unit (10) comprises a pump (20) for providing positivepressure and / or negative pressure.

29. Device (1) according to the preceding claim, configured such that the pump (20) can be connected to the fluidic module (40) so thatpositive pressure and / or negative pressure can be provided in the fluidic module.

30. Device (1) according to at least one of claims 28 or 29, wherein the pump (20) is connectable to the fluidic module (40) by means ofat least one pressure connection coupling (30, 37, 38).

31. Device according to at least one of claims 28 or 30, wherein, for connecting the pump (20) to the fluidic module (40), exactly onepressure connection coupling (82) is provided on the fluidic module, and via this single pressure connection coupling, both positive pressure and negative pressure can be supplied to the fluidic module.

32. Device according to at least one of claims 28 through 31, wherein, for connecting the pump (20) to the fluidic module (40), a pluralityof at least two pressure connection couplings (30, 37, 38, 82, 83, 86, 87, 88, 89) are provided on the base unit (10) and the fluidic module (40) to connect the pump (20) to the fluidic module (40), such that, for example, the negative pressure can be supplied to the fluidic module separately from the positive pressure.

33. Device (1) according to at least one of the preceding claims, further comprising a control pressure connection coupling (30, 86, 87,88, 89) for controlling a pneumatic device in the fluidic module (40).

34. Device (1) according to at least one of claims 28 through 33, wherein the positive pressure and / or the negative pressure can beused to influence a fluid flow in the fluidic module (40).

35. Device (1) according to at least one of claims 28 through, wherein the body fluid (95) can be drawn in by means of negativepressure, for instance from a ventricular drainage (4) or a body fluid source (2) into the body fluid reservoir (55).

36. Device (1) according to at least one of claims 28 through 35, wherein the body fluid can be further conveyed within the fluidicmodule (40) by means of positive pressure, for example from the body fluid reservoir (55) to the microfluidic chip.

37. Device (1) according to at least one of claims 28 through 36, wherein the body fluid reservoir (55) can be subjected to negativepressure and / or positive pressure, such that, by applying negative pressure, the body fluid (95) can be conveyed from the connecting line (5) into the body fluid reservoir (55), and / or by applying positive pressure, body fluid (95) stored in the body fluid reservoir (55) can be conveyed toward the microfluidic chip (60).

38. Device according to at least one of the preceding claims,wherein the base unit (10) is further adapted to house a control module (33) configured to control the further conveyance of the bodyfluid (95) within the fluidic module (40) and / or to control the measuring device (70), wherein control commands from the control module can be transmitted to the fluidic module via the at least one pressure connection and / or via electrical contacts.

39. Device (1) according to at least one of the preceding claims, wherein the base unit (10) is further adapted to house an evaluationmodule (93) for evaluating the data obtained by the fluidic module (40), for example the measuring device (70), and for providing a diagnostic result regarding the properties of the body fluid (95).

40. Device (1) according to at least one of the preceding claims, wherein the base unit (10) is further adapted to house a storagemodule (94) for storing the measurement data obtained by the fluidic module (40), so that, for instance, the measurement can be continued without interruption even when the fluidic module is replaced.

41. Device (1) according to at least one of the preceding claims, wherein the base unit (10) is further adapted to house a pump control(97) for controlling the pump (20) arranged in the base unit, wherein the pump control can be supplied with sensor data from the fluidic module for the purpose of control.

42. Device (1) according to at least one of the preceding claims, wherein the base unit (10) is further adapted to house a wirelesscommunication device (98) for connecting, for example, to a hospital network for exchanging data therewith.

43. Device (1) according to at least one of the preceding claims, wherein the base unit (10) is further adapted to house an electricalpower supply device (99) comprising a power connection and / or an energy storage device.

44. Device (1) according to at least one of the preceding claims,wherein the base unit (10), for instance together with the control module (33) according to the preceding claim, is configured to close off the access in the event of a fault detection in the body fluid delivery, i.e., for example to act in response to the fluid detector (54) according to claim 27 above, and / or to act on a control valve arranged in the fluidic module (40) or on the ventricular drainage (4) according to claim 23 to shut off the fluid flow.

45. Fluidic module (40) for a device (1), for instance according to at least one of the preceding claims, the fluidic module comprisingan interface (5, 51), for example configured as a connecting line (5) or a hose coupling (51), adapted to connect the fluidic module to a body fluid source (2), for instance a patient, or to a drainage (4), such that the body fluid can be fed into the fluidic module through the connecting line or the hose coupling, a microfluidic chip (60) arranged on or within the fluidic module and configured to influence a property of the body fluid.

46. Microfluidic chip (60), for example adapted for use in a device (1) for measuring and / or influencing a property of a body fluid, themicrofluidic chip comprising an inlet channel (64), a bifurcation (65), a first (62) and a second (63) outlet opening, a separation device (80) for separating a portion of the body fluid (95)—for example pieces, particles or cells (96)—from the body fluid in the region of the bifurcation, such that the portion of the body fluid can be supplied to the first outlet opening and a purified body fluid can be supplied to the second outlet opening.

47. Microfluidic chip (60) according to the preceding claim, wherein the separation device (80) is configured to direct the portion of thebody fluid (95), for instance by means of acoustophoresis, into a central portion of the inlet channel (64), and wherein the purified body fluid diverts into a lateral region of the inlet channel, such that, in the region of the bifurcation (65) and under the influence of afluid flow, the portion of the body fluid is directed to the first outlet opening (62) and the purified body fluid is directed to the second outlet opening (63) of the microfluidic chip.

48. Microfluidic chip (60) according to at least one of claims 46 or 47, wherein the separation device (80) comprises a piezoelectrictransducer.

49. Microfluidic chip (60) according to at least one of claims 46 through 48,wherein the microfluidic chip comprises a glass wafer.

50. Method (100) for diagnosing a body fluid (95), for example CSF, for instance using the device (1) and / or the fluidic module (40)and / or the microfluidic chip (60) according to at least one of the preceding claims, comprising the steps of introducing (110) the body fluid into a fluidic module (40), feeding (120) the body fluid to a microfluidic chip (60) arranged in or on the fluidic module to influence a property of the body fluid, for example to separate blood cells (96) from the body fluid, by means of or within the microfluidic chip, transporting (135) the body fluid to a measuring device (70) arranged in or on the fluidic module to determine the same or another property of the body fluid, conveying the body fluid from the measuring device into a residual material collection volume (75) arranged within the fluidic module.

51. Method (100) according to the preceding claim, further comprising the step of beginning to deliver the body fluid (95) in the fluidicsmodule (40) as soon as a body fluid reservoir (55) disposed in the fluidics module is sufficiently filled with the body fluid (95).

52. Method (100) according to at least one of claims 50 or 51, wherein the steps of delivering the body fluid (95) are performed bymeans of a delivery pump (20) disposed in a base unit (10).

53. Method (100) according to at least one of claims 50 through 52, wherein the device is a mobile device and the method is a point-of-care diagnostic method.

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