Detection device for determining a release criterion for a fill level determination system

Abstract

The invention relates to a detection device for determining a release criterion for a fill level determination system (1), which determines a fill level of a medical fluid in a container (300), comprising: a position detector (113) configured to determine a position of the fill level determination system (1), an acceleration detector (113) configured to determine an acceleration of the level determination system (1), wherein fill level measurement values of the fill level determination system (1) are recorded as a plausibility measurement if the determined position lies within a tolerance range around a reference position and if the acceleration lies within a tolerance range, and the release criterion is granted on the basis of the plausibility measurement if a fill level measurement value of the fill level determination system (1) does not show an excessive change from a previous fill level measurement value.

Description

[0001] Detection device for determining a release criterion for a fill level determination system

[0002] FIELD OF THE INVENTION

[0003] The present invention relates generally and particularly to a detection device for determining a release criterion for a fill level determination system. Furthermore, the present invention relates to a fill level determination system, a container for a fill level determination system, and a method for determining a release criterion for a fill level determination system.

[0004] BACKGROUND OF THE INVENTION

[0005] Containers for holding medical fluids are generally known. These containers can be used as urine bags or urine measurement systems to hold a patient's urine for monitoring and care. Furthermore, the containers can hold patient fluids for drainage purposes, for example, those to be removed from wounds after surgery. Furthermore, the containers can deliver medical fluids to a patient, for example, as infusions (infusion bags). When using all of these container types that hold medical fluids, determining the change in the fill level in the container over the course of treatment is always part of the monitoring and care of the patient.

[0006] The patient can be monitored and cared for in hospitals, on normal wards, intensive care units, in nursing homes or in home care.

[0007] Furthermore, it is known that a scale for reading the fill level is provided on the containers. Devices for measuring the fill level are also known. These use various measurement methods, such as weighing or capacitive level determination.

[0008] The object of the present invention is to provide an improved system for determining the fill level of a medical fluid in a container.

[0009] During a fill level measurement, the position, acceleration, or compression of the container can change the fill level and thus also create a measurement error when determining the fill level. Furthermore, some containers for holding medical fluids are flexible, for example bags. Since flexible bags themselves are not capable of standing vertically, an accurate fill level measurement is only possible if they have previously been held in a defined, vertical position using a holding system, usually hanging sideways on the patient's bed. However, when the patient is transported in bed, the bag is often removed and placed in the patient bed. Due to the resulting freely deforming bag, a reliable fill level measurement is no longer possible.

[0010] Strong accelerations can also lead to measurement errors. These can occur, for example, if the patient has already regained mobility and is walking to the toilet with the container. The acceleration of walking leads to changes in the position of the container and the formation of waves in the container, making reliable level measurement impossible.

[0011] In addition, pressing on the container can also lead to measurement errors. Such errors can occur, for example, if the patient compresses the urine bag hanging on the side of the bed, for example, by pulling a bedside table on wheels closer to the bed, causing the urine bag to become trapped between the bed and the bedside table.

[0012] In order to solve the problem of these measurement errors, a detection device according to the invention is provided which only allows a fill level measurement, i.e. determines a release criterion, if the above measurement errors are not to be expected.

[0013] Such a detection device is advantageous for level measurement on many different containers in the aforementioned application areas. To enable the use of this detection device on the various containers, a level determination system according to the invention is provided, which comprises the detection device and is modular, allowing the determination of a release criterion for a level measurement on many different container types.

[0014] SUMMARY OF THE INVENTION

[0015] According to a first aspect, the present invention provides a detection device for determining a release criterion for a fill level determination system according to claim 1.

[0016] According to a second aspect, the present invention provides a fill level determination system for determining a fill level criterion of a medical fluid in a container according to claim 2.

[0017] According to a third aspect, the present invention provides a container for a level determination system according to claim 30.

[0018] According to a fourth aspect, the present invention provides a method for determining a release criterion for a fill level determination system according to claim 31. Further aspects and features of the present invention emerge from the dependent claims, the attached figures and the following description of preferred embodiments.

[0019] BRIEF DESCRIPTION OF THE DRAWING

[0020] Embodiments of the invention will now be described by way of example and with reference to the accompanying figures. Shown in:

[0021] Fig. 1 shows a fill level determination system according to an embodiment;

[0022] Fig. 2 shows a control device for a fill level determination system according to an embodiment;

[0023] Fig. 3a shows a control device according to an embodiment;

[0024] Fig. 3b shows a control device according to an embodiment;

[0025] Fig. 4a shows a level measuring arrangement according to an embodiment;

[0026] Fig. 4b shows a level measuring arrangement according to an embodiment;

[0027] Fig. 5a shows a level measuring arrangement according to an embodiment;

[0028] Fig. 5b shows a level measuring arrangement according to an embodiment;

[0029] Fig. 5c shows a level measuring arrangement according to an embodiment;

[0030] Fig. 5d shows a level measuring arrangement according to an embodiment;

[0031] Fig. 6a shows a container according to an embodiment;

[0032] Fig. 6b shows a container according to an embodiment;

[0033] Fig. 6c shows a container according to an embodiment;

[0034] Fig. 6d shows a container according to an embodiment;

[0035] Fig. 6e shows a container according to an embodiment;

[0036] Fig. 6f shows a container according to an embodiment;

[0037] Fig. 6g shows a container according to an embodiment;

[0038] Fig. 6h a container according to an embodiment;

[0039] Fig. 7 shows a control device and a fill level measuring arrangement according to an embodiment;

[0040] Fig. 8 shows a control device, a fill level measuring arrangement, and a container according to an embodiment; Fig. 9a shows a control device, a fill level measuring arrangement, and a container according to an embodiment;

[0041] Fig. 9b shows a control device, a level measuring arrangement and a container according to an embodiment;

[0042] Fig. 9c shows a cross section through the pocket of the container with the level measuring arrangement and the back-side clamping device according to the embodiment of Fig. 9b;

[0043] Fig. 9d shows a cross section through the pocket of the container with the level measuring arrangement according to an embodiment;

[0044] Fig. 9e shows a control device, a level measuring arrangement and a container according to an embodiment in a side view;

[0045] Fig. 9f shows a control device, a level measuring arrangement and a container according to an embodiment in a side view;

[0046] Fig. 9g shows a cross section through the pocket of the container with the level measuring arrangement according to an embodiment;

[0047] Fig. 9h shows a cross section through the pocket of the container with the level measuring arrangement according to the embodiment of Fig. 9g;

[0048] Fig. 9i shows a rear side of the container according to an embodiment;

[0049] Fig. 9j shows a rear side of the container according to an embodiment;

[0050] Fig. 9k shows a control device, a level measuring arrangement and a container according to an embodiment;

[0051] Fig. 91 shows a control device, a level measuring arrangement and a container according to an embodiment;

[0052] Fig. 9m shows a control device, a level measuring arrangement and a container according to an embodiment;

[0053] Fig. 10 shows a control device, a fill level measuring arrangement and a container according to an embodiment;

[0054] Fig. 11 shows a control device and a fill level measuring arrangement according to an embodiment;

[0055] Fig. 12 shows a control device, a fill level measuring arrangement, and a container according to one embodiment; Fig. 13 shows a control device, a fill level measuring arrangement, and a container according to one embodiment;

[0056] Fig. 14 shows a control device and a fill level measuring arrangement according to an embodiment;

[0057] Fig. 15 shows a control device, a level measuring arrangement and a container according to an embodiment;

[0058] Fig. 16 is a flow chart of an exemplary level measurement; and

[0059] Fig. 17 an embodiment of a general-purpose computer.

[0060] DESCRIPTION OF EMBODIMENTS

[0061] Figure 1 illustrates an embodiment in accordance with the present invention. Before proceeding with a detailed description, general explanations of the embodiments follow.

[0062] According to the invention, a detection device for determining a release criterion for a fill level determination system that determines a fill level of a medical fluid in a container comprises: a position detector that is configured to determine a position of the fill level determination system, an acceleration detector that is configured to determine an acceleration of the fill level determination system, wherein fill level measurement values ​​of the fill level determination system are recorded as a plausibility measurement if the determined position lies within a tolerance range around a reference position and if the acceleration lies within a tolerance range and the release criterion is issued based on the plausibility measurement if a fill level measurement value of the fill level determination system does not show an excessive change compared to a previous fill level measurement value.

[0063] The attitude detector and the acceleration detector can be part of an Inertial Measurement Unit (IMU). IMUs consist of an accelerometer that measures acceleration along the three axes (including gravitational acceleration) and a gyroscope that measures the rate of angular change (in degrees per second) during rotation around the three axes.

[0064] Position detection can be performed using an accelerometer. For example, the acceleration in an absolutely vertical position along the z-axis corresponds to 1g, and the acceleration on the x and y axes corresponds to 0g. The absolutely vertical position is an example of a reference position. In the case of an inclination, the acceleration due to gravity is projected proportionally onto the x and y axes, allowing the position in space to be calculated. This makes it easy to check whether the container and IMU are in a vertical position (within the tolerance limits around the reference position). This applies as long as the relative alignment between the container and IMU remains constant. Inclinations within the tolerance range are considered tolerable inclinations, which, if left uncorrected, would cause a measurement error. However, these can be corrected (although the correction depends on the geometry of the container).

[0065] Acceleration detection can be performed using an accelerometer and gyroscope, as both functional units (accelerometer and gyroscope) must be used to measure the six degrees of freedom of acceleration. The accelerometer measures three translational degrees of freedom, and the gyroscope measures three rotational degrees of freedom.

[0066] This allows you to check whether the container and IMU are in a stationary position within the tolerance limits. However, if excessive acceleration is detected (e.g., a patient is walking with the system), the release criterion is not met, and the measurement is discarded, as the same acceleration also acts on the fluid in the container, causing wave motion and inducing an inaccurate measurement.

[0067] The release criterion may also not be granted based on the measurement of the fill level in the container, for example, if an excessive change in the fill level is measured. An excessive increase is, for example, a fill level change that exceeds a predetermined threshold. This is also time-dependent. A larger change is plausible between two fill level values ​​that are one hour apart than between two fill level values ​​that are one minute apart. Thus, an excessive change can occur if a gradient in the fill level is exceeded (undershot) over time between the fill level measurement and the previous fill level measurement. Alternatively, a different threshold can be used for different time intervals between the fill level measurement and the previous fill level measurement.

[0068] If acceleration and position are within tolerances and no excessive increase is detected, the release criterion is granted and the measured values ​​are classified as plausible. This allows a fill level criterion to be determined from the plausible measured values.

[0069] According to the invention, a fill level determination system for determining a fill level criterion of a medical fluid in a container comprises: the container configured to hold a medical fluid, a fill level measuring arrangement configured to acquire measured values ​​corresponding to a fill level criterion of the container, a detection device as described above, and a control unit. The control unit and the fill level measuring arrangement are configured to be connectable to one another, and the fill level measuring arrangement and the container are configured to be connectable to one another. The fill level criterion is determined when the control unit and the fill level measuring arrangement, as well as the fill level measuring arrangement and the container, are connected. The control unit can have connectivity.This can be implemented using an integrated wireless communication technology, such as Bluetooth (also BLE), WLAN, RFID (also NFC), or mobile communications, to transmit measurement data. An online function can be implemented, which transmits data to a hospital information system (HIS) or patient data management system (PDMS), and an offline function, which temporarily stores the data locally and transmits it upon the next connection or disconnection.

[0070] Online function (push).

[0071] The fill level determination system can detect the fill level in the container (including emptying) and output the fill level, for example, in millimeters. A display can be provided for this purpose, or the fill level can be transmitted to a server or a terminal device via a communication unit. The fill level measurement can, for example, have an accuracy of + / - 5%.

[0072] The level determination system integrates a position and acceleration sensor into the detection device to distinguish between valid and invalid measurement conditions (e.g., tilt, movement, compression). This allows the release criterion to be determined.

[0073] The level determination system can integrate one or more temperature sensors that measure the ambient temperature.

[0074] The level determination system can also provide computing power and memory (SRAM, Flash, SD card) for local data processing. This can be provided especially when implementing the offline function. Furthermore, these can be used for the calculations in steps S12 to S17 (Fig. 17).

[0075] The level detection system can also include a battery, along with (wireless) charging and monitoring electronics to power the system. Such energy management enables battery operation. Battery operation can also be provided by plug-in charging or wireless charging via induction.

[0076] Pairing at least two of the control unit, the container, and the level measuring device enables a compatibility check. Furthermore, the pairing can establish a connection to a patient or a digital patient record (on a server). An RFID device can be provided for the pairing, which is located in each of the control unit, the container, and the level measuring device.

[0077] In order to enable an assessment of the liquid properties in poor lighting conditions, a container lighting system can be provided that illuminates the container and the fluid inside.

[0078] This illumination can be activated, for example, by detecting an approach or a gesture, for a specific time interval. Likewise, the display can be switched on from a standby state by detecting an approach or a gesture.

[0079] Connectivity can be used to connect end devices such as a smartphone or smartwatch, for example via an app. This allows the measured values ​​to be transmitted to the nursing staff on a device and displayed with the corresponding generated visualizations. The visualizations can, for example, be generated on a server or the end device and include a fill level history over time. This server can also include the HIS or PDMS. Furthermore, notifications can be used to signal to the nursing staff when action is required. A need for action could, for example, be a full container; additional patient data can be provided, which could also include a specific room in the hospital or care facility.

[0080] Nursing staff can also be shown an approximate location of the level control system, for example a specific device in a specific building on a specific floor in a specific room.

[0081] Connectivity via RFID enables the reading of an RFID tag on the container by controlling an RFID device on the smartphone, and thus an assignment as to whether the container is used or unused, or to which patient the container is assigned, or how long the container has been in use.

[0082] Connectivity via RFID enables communication with the control unit by controlling an RFID device on the smartphone, for example, for setup processes in which a connection to a wireless network is established, patient data is transferred, or a connection to a patient record is created.

[0083] To ensure modularity between the control unit and the level measurement system, a mounting mechanism for an interchangeable level measurement system can be implemented. The mounting device also establishes an electrical connection for data transmission, for example, via a standardized interface. Thus, the mounting mechanism serves as a communicating mount.

[0084] The level determination system can communicate with a server that receives data from the various devices, each comprising a container, a level measurement system, a control unit, and a detection device. The server can be operated in a local network or the cloud, and data can be stored, visualized, and analyzed, and forwarded to and stored in hospital information systems or smartphones / watches. The server can be integrated into the level determination system. Using RFID technology, the end devices can read and write RFID tags on the container by controlling the smartphone's RFID device.

[0085] To enable battery operation, the level control system can also include a charging infrastructure. This can include a wall shelf, a stand, etc. for storage with integrated charging capability. The transfer of electrical energy during the charging process can be achieved through inductive charging via mats, inductive charging via a "puck"—which is positioned correctly by magnets—or a contact plug with magnetic positioning.

[0086] There are versions in which the control unit and the level measuring arrangement can be connected to each other using a standardized interface.

[0087] There are designs in which the container comprises a holder and the level measuring arrangement and the container are designed to be connectable to one another by means of the holder.

[0088] There are designs in which the holder on the container comprises a flexible pocket which is designed to accommodate the level measuring arrangement according to a sword-sheath principle.

[0089] The holder for the level measurement assembly on the container can be attached, for example, to the front or back of the bag, or more precisely, to any surface of the container that is parallel to the vertical. The mounting position provides the reference position for position determination.

[0090] The holder can be a flexible, thin-walled, as tightly cut as possible film pocket, e.g. by means of flexible film welded or glued onto the wall.

[0091] There are designs in which the level measuring arrangement includes a back-side clamping device that generates a clamping force in the flexible pocket.

[0092] The tension force allows the film of the pocket to be pulled flat, particularly on the inside between the level measurement device and the fluid in the container. This prevents air bubbles that could distort the measurement. Due to its dielectric constant, air is suitable as an insulator for capacitive measurements, which means that air bubbles can distort the measurement. The tensioning device can generate a tension force both orthogonal to and parallel to the insertion direction of the pocket.

[0093] There are designs in which the container comprises a counter-bearing configured to secure the back-side clamping device in the pocket. There are designs in which the back-side clamping device is designed with a locking element, and the locking element (207) engages in the counter-bearing (309), thereby generating the clamping force.

[0094] The locking element can generate a clamping force along the insertion direction of the pocket.

[0095] There are versions in which the back-side clamping device is designed with a semi-tubular profile.

[0096] The semi-tubular profile creates an air cushion along the entire back of the level measuring assembly, shielding it from the outside of the container. This allows the insulating effect of the air to be utilized here.

[0097] There are versions where the back tensioning device is inflatable. This also allows for an air cushion along the entire back of the level measuring assembly.

[0098] There are designs in which the back-side tensioning device comprises a spring device. The tensioning force can be generated by the spring force. A holding mechanism can also be included that holds the back-side tensioning device in a compressed position of the spring device, for example, for inserting or removing the back-side tensioning device.

[0099] There are designs in which the locking element is designed as a lever that locks into the counter bearing, whereby the back-side clamping device is spread away from the level measuring arrangement, so that the clamping force is generated.

[0100] There are versions in which the back-side clamping device is designed to be bendable and can be locked into the counter bearing when bent.

[0101] There are designs in which the holder on the container comprises a stiffened pocket which is designed to accommodate the level measuring arrangement according to a sword-sheath principle.

[0102] The stiffened pocket can be a plastic “sword scabbard,” e.g., a stiffened plastic part welded or glued to the wall.

[0103] There are designs in which the stiffened pocket includes a stiffener on one wall towards the inside of the container.

[0104] There are designs in which the stiffening is a frame. There are designs in which the level measuring arrangement and the container are designed to be connected to each other by means of adhesion.

[0105] Fastening by means of adhesion can be achieved, for example, using double-sided adhesive tape, which can be applied in advance to the level measuring arrangement, which is then disposed of with the container after use, for example.

[0106] There are designs in which the level measuring arrangement is printed on the container, whereby the level measuring arrangement and the container are designed to be connectable to each other.

[0107] All types of connection between the level measurement assembly and the container must bring the sensor into reliable contact with the container wall, as air is a good dielectric insulator, and varying air cushions between the sensor and the container wall would therefore at least distort a capacitive measurement of the container's level. A mechanism, such as a spring leaf, can be integrated into the rear inner wall of the pocket or scabbard, which presses the sensor firmly against the container wall, thus ensuring repeatable positioning.

[0108] There are versions where the container includes a urine bag.

[0109] There are versions in which the container includes a urine measuring system.

[0110] There are versions in which the container includes an infusion bag.

[0111] There are versions in which the container includes a chest drain.

[0112] There are versions in which the container includes a ventricular drain.

[0113] There are versions where the container includes a surgical drain.

[0114] Other containers are used, for example, for bag-shaped drains, bottle-shaped drains, infusion bottles and gastric tubes.

[0115] In general, the container may comprise a drain valve, e.g. a pinch valve, which can be actuated by an electromechanical unit, for example on the level measuring arrangement.

[0116] There are versions in which the container includes an RFID device.

[0117] The RFID device can enable linking of the container with the patient, the level measurement system, and the control unit. This linking also allows containers to be excluded, for example, for compatibility reasons.

[0118] The RFID device can enable detection of the container's presence by the control unit or the fill level measurement system. Furthermore, it can enable identification of the container, writing patient data to the container's RFID device, checking the compatibility of the container and the fill level measurement system, comparing the container and the associated patient, preventing confusion between patients, preventing the reuse of used containers, and preventing the use of unauthorized consumables (non-original, expired, recalled, etc.).

[0119] The patient-container pairing can be triggered automatically when the container's RFID device is detected. Furthermore, when the control unit is paired with the container's RFID device, patient information (e.g., name, date of birth) can be automatically transferred and written to the container's RFID device.

[0120] There are designs in which the control unit is configured to read the RFID device of the container by means of a further RFID device and to determine whether the container is compatible with the fill level measuring arrangement and the control unit and has not yet been used, so that if the container is compatible and has not yet been used, the RFID device is used to write to the RFID device of the container that the container is (now) used.

[0121] There are designs in which, when writing to the container's RFID device using the additional RFID device, patient-related data is also written to the container's RFID device.

[0122] There are versions in which the control unit includes the additional RFID device.

[0123] The control unit thus integrates an RFID device to identify containers and to enable bidirectional communication with end devices such as smartphones.

[0124] There are designs in which the container comprises an outlet valve, and the level measuring arrangement comprises an actuator configured to actuate the outlet valve. The actuator can also be arranged separately from the level measuring arrangement and be communicatively connected to the control unit so that it can be controlled by it.

[0125] The actuator can be controlled by the control unit or an electronic component of the level measuring device, for example, when the fill level in the container reaches a predetermined value, such as a maximum. This can then be used to control an (electromagnetic) valve for automatic container emptying.

[0126] There are designs in which the control unit comprises a diagnostic device that is designed to analyze the fluid spectrometrically.

[0127] The spectrometric analysis can be provided, for example, by a mini-spectrometer and a broadband radiation source. This is explained in more detail in WO2023 / 062224, for example. There are embodiments in which the control unit includes a display configured to show information about the specific fill level criterion.

[0128] The display can implement a human-machine interface (HMI) consisting of a touchscreen and status LED and can be intended for the visualization of information and for local operation.

[0129] A brightness sensor can be integrated to adjust the display brightness to the ambient brightness.

[0130] The status LED can signal the status of the fill level detection system or the patient—by evaluating the fill level measurement—when the display is in standby mode, for example. The status LED can use different color codes (green, yellow, red) or flashing codes for this purpose.

[0131] The display can be designed as a touchscreen that can be operated with gloves.

[0132] There are designs in which the control device comprises a presence detector which is configured to detect the approach of a person or a gesture of a person, whereby the display is switched on from a standby state due to the approach or the gesture.

[0133] The person in this case can be a user, e.g. the nursing staff. A gesture can be, for example, a swipe with the hand above the display or a swipe with the

[0134] Foot under the level control system (if it is mounted on the side of the patient bed).

[0135] There are designs in which the control unit comprises a power supply device which is designed to supply the control unit with power.

[0136] There are designs in which the level measuring arrangement comprises electrodes which are designed to capacitively determine level measurement values ​​by means of which the level criterion of the container can be determined.

[0137] The measured values ​​of the electrodes can be corrected by environmental reference electrodes, fluid reference electrodes and temperature sensors that measure both the environmental and fluid temperatures.

[0138] A standardized interface, e.g., I2C, SPI, UART, or CAN bus, can be provided to connect the level measurement system to the control unit. An additional electronic component designed to control the sensors and an actuator can also be provided on the level measurement system. Furthermore, a mounting mechanism for interchangeable connection to the control unit can be provided, thus creating a mechanical connection, while the interface provides the communication connection. This mounting mechanism is, for example, a plug-in connection and enables quick assembly of the (modular) level determination system.

[0139] The dimensions of the level measurement assembly can be adapted to different container sizes using various designs. The electrode design, as described above, or the carrier material can also be varied depending on the application. The level measurement assembly can also be provided with or without an actuator that opens and closes a drain valve. There may be variants in which the level measurement assembly, or at least the sensors such as the electrodes, are designed as a reusable or disposable part, whereby the disposable part can be disposed of with the container after being attached and used.

[0140] The level measuring arrangement may contain one or more temperature sensors for measuring the liquid temperature through the bag wall.

[0141] There are designs in which the level measuring arrangement comprises a printed circuit board and the electrodes are formed on the printed circuit board.

[0142] There are versions in which the printed circuit board is dimensionally stable.

[0143] There are versions in which the printed circuit board is flexible.

[0144] The carrier material of the level measuring arrangement can be a rigid PCB, a flex PCB (allows adaptation to flexible or round container geometries) or printed electronics (also printed directly on the container; enables cost-effective disposable sensors).

[0145] There are designs in which the level measuring arrangement comprises an electronic device which is designed to determine the measured values ​​using the electrodes.

[0146] For example, in a capacitive measurement, the sensor technology of the level measurement system includes continuous electrodes (Texas Instruments, Ti FDC1004) that run vertically along the container in the reference position. Environmental reference electrodes and liquid reference electrodes can also be included. The electrodes can also be designed to run at an angle to the vertical direction.

[0147] Furthermore, instead of the continuous electrodes, segmented electrodes with variable steps (Infineon PSoC Cap Sense) can be provided.

[0148] The electrodes can also be arranged as parallel electrodes for measuring multiple liquid columns next to each other. Alternatively, and in combination, an alternative method for level measurement can be provided. For example, the level can be measured using inductive detection of a magnetic float in a riser pipe or a vertical array of detectors (segmented presence detectors, e.g., optical detectors (diode array, CCD array), or an array of temperature sensors), or by measuring the bag weight. Other alternative methods can include standard procedures using, for example, a pressure sensor, a float, an ultrasonic sensor, a time-of-flight sensor, or a laser.

[0149] It may include an actuator configured to perform a drain (drain valve) for emptying a container in the urine measurement system design by means of electromechanical control. To do so, the actuator opens a valve of the container, for example, a pinch valve, which the actuator can squeeze when closed and does not squeeze when open. The actuator may also include a pump that, for example, pumps a defined fluid volume per cycle.

[0150] There are designs in which the control unit is set up to carry out a correction of the fill level criterion based on the determined position of the position detector of the detection device when the release criterion is granted.

[0151] The control unit is therefore designed to correct position-dependent measurement errors when the container is hanging at an angle.

[0152] According to the invention, a container for a fill level determination system according to one of the embodiments described above.

[0153] According to the invention, a method for determining a release criterion for a fill level determination system that determines a fill level of a medical fluid in a container, comprising the steps of: determining a position of the fill level determination system, determining an acceleration of the fill level determination system, recording fill level measured values ​​of the fill level determination system as a plausibility measurement if the determined position lies within a tolerance range around a reference position and if the acceleration lies within a tolerance range, and issuing the release criterion based on the plausibility measurement if a fill level measured value of the fill level determination system does not show an excessive change compared to a previous fill level measured value.

[0154] Returning to Fig. 1, this illustrates a level determination system according to an embodiment.

[0155] The fill level determination system 1 comprises a control unit 100, a fill level measuring arrangement 200, and a container 300. Furthermore, the fill level determination system 1 may include a network 400, a server 401, and a terminal 402. The fill level determination system 1 is designed modularly, so that various control units 100, fill level measuring arrangements 200, and containers 300 can be connected to one another or can be interchanged. The control unit 100 is connected to the fill level measuring arrangement 200 and receives data indicative of a fill level in the container 300. These can be, for example, measured values ​​from the fill level measuring arrangement 200 that are read directly by the sensors, a measured fill level, or a measured fill level corrected for position. Furthermore, the control unit 100 can receive information from the fill level measuring arrangement 200 that identifies the configuration of the fill level measuring arrangement 200.

[0156] The control unit 100 and, alternatively or additionally, the fill level measuring arrangement 200 are connected to the container 300. Information about the design of the container 300 and whether the container has already been used is transmitted. Additionally, the control unit 100 and the fill level measuring arrangement 200 can transmit patient-specific information to the container 300 and write it to a memory that may be included on the container 300 (using RFID).

[0157] The control unit 100 can communicate with the server 401 and the terminal 402 via the network 400. The server 401 and the terminal 402 can also communicate with each other via the network.

[0158] Thus, the control unit 100 can transmit fill level measurements (the fill level criterion) as well as information that identifies the control unit 100 or the patient, for example, an identification number (ID) of the device or patient, to the server 401, and the server 401 can store these fill level measurements in the corresponding patient file. Furthermore, the control unit 100 can transmit fill level measurements (the fill level criterion) as well as information that identifies the control unit 100 or the patient (ID) to the terminal 402, wherein the terminal 402 is assigned to the responsible nursing staff. The responsible nursing staff can be determined using the patient file (and a shift schedule).

[0159] Both server 401 and terminal 402 can be configured to graphically display the fill level measurements. A need for action can be determined either by the control unit 100, the server 401, or the terminal 402, which can be communicated to the responsible nursing staff via the terminal 402. A need for action can, for example, be a (nearly) full container 300.

[0160] Fig. 2 shows a control device for a fill level determination system according to an embodiment.

[0161] The control unit 100 comprises a microcontroller 108, a display 107, a communication unit 109, a status LED 101, a container illumination 102, an energy management arrangement 103, and a sensor arrangement 112. Furthermore, the replaceable fill level measuring arrangement 200 is also shown. The microcontroller 108 is configured to perform the control functions of the control unit 100. Furthermore, the microcontroller 108 can display information on the display 107. This information can include, among other things, fill level measurements, patient data, or status information of the control unit, such as the charge level. The microcontroller 108 can also have a memory on which data can be stored locally. The memory can also be included in the control unit 100.

[0162] The display 107 can display the information and also include a touch unit as an input device of the control unit 100, with which a user (for example nursing staff) can operate the control unit 100.

[0163] A patient status determined based on the fill level measurements can also be indicated by the status LED 101. Furthermore, the status LED can also indicate a status of the control unit 100 or the fill level determination system 1. Such a status can be, for example, that the position or acceleration is outside the tolerance range or that an excessive change in the fill level has been detected, so that no fill level measurement is performed (no release criterion). Furthermore, a missing connection to a network, a full container, or a low charge level can also be indicated.

[0164] The container lighting 102 can be switched on to check the fluid in the container, for example by color, in poor lighting conditions (dark room).

[0165] The energy management arrangement 103 comprises a charging device 104, a charging controller 105, and a battery 106. The charging controller 105 controls the energy input by the charging device 104 and the energy storage and release by the battery 106 in order to supply the control unit 100 (and the level measuring arrangement 200) with energy.

[0166] The charging device 104 can be an inductive charging device that receives energy contactlessly from outside the control unit 100. The charging device 104 can also receive energy via a plug.

[0167] The communication unit 109 comprises communication devices according to common standards, for example, for WLAN 110 or mobile radio 111. A communication device for (Low Energy) Bluetooth can also be provided. This allows the control unit 100 to communicate with devices such as servers and terminals directly or via a network.

[0168] The sensor arrangement 112 comprises an inertial measurement unit 113 (Inertial Measurement Unit, IMU), an NFC reader 114, a presence detector 115 and a diagnostic device 116.

[0169] The inertial measuring unit 113 measures the acceleration and position of the control unit 100 and the associated fill level measuring arrangement 200, as well as the container (300 in Fig. 1). Thus, the inertial measuring unit 113 determines the acceleration and position for determining the release criterion for the fill level measurement by the fill level measuring arrangement 200.

[0170] The NFC reader 114 is an RFID device that can communicate with an RFID device in the container (300 in Fig. 1) or a terminal device (402 in Fig. 1). During communication, information for identifying the control unit 100, the fill level measuring arrangement, the container, and the terminal device can be transmitted, for example, to check compatibility. Patient data and the usage status of the container can also be transmitted during communication.

[0171] The presence detector 115 detects the presence or gesture of a user (a caregiver). Based on the detection, the display 107 can then be switched on from a standby state or the container lighting 102 can be switched on. The presence detector 115 can comprise a motion detector or an infrared camera.

[0172] The diagnostic device 116 comprises a broadband radiation source and an optical detector, for example a spectrometer for spectrometric analysis of the medical fluid flowing through a tube from or into the container 300.

[0173] Furthermore, a brightness detector can also be arranged in the sensor arrangement 112, which is configured to detect the brightness in the environment of the control unit 100. The brightness of the display 107 can then be adjusted based on the brightness.

[0174] The standby state of the display can be initiated based on a past time interval and, for example, the detected brightness.

[0175] The level measuring arrangement 200 comprises an electronic unit (electronic component) 201 with electrodes for level measurement and an actuator 202, which can be arranged in some embodiments. The actuator 202 operates an outlet valve on the container (300 in Fig. 1).

[0176] The actuator 202 can be controlled by the microcontroller 108 or the electronics unit 201, for example, when the measured fill level has reached a certain level and no inflow is detected.

[0177] The sensor arrangement 112 or parts of the sensor arrangement 112 can also be arranged on the fill level measuring arrangement 200, wherein evaluation steps in determining the release criterion can also be carried out by the electronic unit 201.

[0178] Fig. 3a shows a control unit according to one embodiment. The control unit 100 includes a display 107 on the top of a housing 120, which includes integrated circuits and devices implementing the functional blocks shown in Fig. 2.

[0179] Fig. 3b shows a control device according to an embodiment.

[0180] The control unit 100 includes a display 107 on top of a housing 120, which includes integrated circuits and devices that implement the functional blocks shown in Fig. 2.

[0181] Furthermore, the control unit 100 comprises the diagnostic device 116 in a housing section that can accommodate a hose leading into the container (300 in Fig. 1).

[0182] Fig. 4a shows a level measuring arrangement according to an embodiment.

[0183] The level measuring arrangement 200 is designed as a measuring blade and comprises a section in the measuring blade which accommodates the electronic unit 201 with electrodes for measuring the level in the container.

[0184] Fig. 4b shows a level measuring arrangement according to an embodiment.

[0185] The level measuring arrangement 200 is designed as a measuring blade and comprises a section in the measuring blade which accommodates the electronic unit 201 with electrodes for measuring the level in the container, as well as a second section which can function as a holder and accommodates the actuator 202.

[0186] Fig. 5a shows a level measuring arrangement according to an embodiment.

[0187] The level measuring arrangement 200 comprises an electronics unit 201, measuring electrodes 201a, ambient reference electrodes 201b, fluid reference electrodes 201c and a standardized interface 203 on a carrier material 204 and a fastening mechanism 205.

[0188] The carrier material 205 can be a flexible, rigid, or printed circuit board. The electrical connections of the components arranged on the carrier material 205 are formed in the carrier material 205.

[0189] The electronics unit 201 determines a capacitance between the measuring electrodes 201a, the ambient reference electrodes 201b, and the fluid reference electrodes 201c. The capacitance between the measuring electrodes 201a is corrected using the measured values ​​of the reference electrodes.

[0190] The corrected capacitance values ​​or a fill level determined from them by the electronics unit 201 can be transmitted from the electronics unit 201 to the control unit (100 in Figs. 1 and 2) via the standardized interface 203. The fill level measuring arrangement 200 is further configured to be connectable to the control unit via the fastening mechanism 205. The fastening mechanism 205 includes, for example, pins that can be plugged into the control unit.

[0191] Fig. 5b shows a level measuring arrangement according to an embodiment.

[0192] The level measuring arrangement 200 comprises an electronics unit 201, segmented measuring electrodes 201a and a standardized interface 203 on a carrier material 204 and a fastening mechanism 205.

[0193] The carrier material 205 can be a flexible, rigid, or printed circuit board. The electrical connections of the components arranged on the carrier material 205 are formed in the carrier material 205.

[0194] The electronics unit 201 determines a capacitance between each of the segmented measuring electrodes 201a. The fill level can be determined by comparing the capacitances between the individual segments, which are arranged at the same height.

[0195] The fill level can be transmitted from the electronic unit 201 to the control unit (100 in Fig. 1 and 2) via the standardized interface 203.

[0196] The fill level measuring arrangement 200 is further configured to be connectable to the control unit via the fastening mechanism 205. The fastening mechanism 205 includes, for example, pins that can be plugged into the control unit.

[0197] Not shown but may also be included are the reference electrodes shown in Fig. 5a.

[0198] Fig. 5c shows a level measuring arrangement according to an embodiment.

[0199] The level measuring arrangement 200 comprises an electronics unit 201, segmented measuring electrodes 201a and a standardized interface 203 on a carrier material 204 and a fastening mechanism 205.

[0200] The carrier material 205 can be a flexible, rigid, or printed circuit board. The electrical connections of the components arranged on the carrier material 205 are formed in the carrier material 205.

[0201] The electronics unit 201 determines a capacitance between each of the segmented measuring electrodes 201a. The fill level can be determined by comparing the capacitances between the individual segments.

[0202] The fill level can be transmitted from the electronics unit 201 to the control unit (100 in Figs. 1 and 2) via the standardized interface 203. The fill level measuring arrangement 200 is further configured to be connectable to the control unit via the fastening mechanism 205. The fastening mechanism 205 includes, for example, pins that can be plugged into the control unit.

[0203] Not shown but may also be included are the reference electrodes shown in Fig. 5a.

[0204] Fig. 5d shows a level measuring arrangement according to an embodiment.

[0205] The level measuring arrangement 200 comprises an electronics unit 201, segmented measuring electrodes 201a and a standardized interface 203 on a carrier material 204 and a fastening mechanism 205. It also includes the actuator 202.

[0206] The carrier material 205 can be a flexible, rigid, or printed circuit board. The electrical connections of the components arranged on the carrier material 205 are formed in the carrier material 205.

[0207] The electronics unit 201 determines a capacitance between each of the segmented measuring electrodes 201a. The fill level can be determined by comparing the capacitances between the individual segments, which are arranged at the same height. Several columns of measuring electrodes 201a are configured, which can determine the fill level in several columns in a corresponding container (300 in Fig. 1).

[0208] The fill level can be transmitted from the electronic unit 201 to the control unit (100 in Fig. 1 and 2) via the standardized interface 203.

[0209] The fill level measuring arrangement 200 is further configured to be connectable to the control unit via the fastening mechanism 205. The fastening mechanism 205 includes, for example, pins that can be plugged into the control unit.

[0210] The actuator 202 can be controlled by the electronic unit 201 or the control unit (100 in Fig. 2) to operate a drain valve of the container.

[0211] Not shown but may also be included are the reference electrodes shown in Fig. 5a.

[0212] Fig. 6a shows a container according to an embodiment.

[0213] The container 300 is designed with a hose 301 as an inlet. In the illustrated form, the container is a (urine) bag and serves to collect urine from a patient on a normal ward of a hospital or nursing facility.

[0214] Fig. 6b shows a container according to one embodiment. The container 300 is configured with a hose 301 as an inlet. In the illustrated form, the container is a drain and serves to collect fluids from a patient's wound, for example, after a patient's surgery.

[0215] Fig. 6c shows a container according to an embodiment.

[0216] The container 300 is designed with a tube 301 as a drain. In the illustrated form, the container is an infusion bag and serves for the storage and scheduled delivery of medications, nutrients, and minerals into a patient's bloodstream.

[0217] Fig. 6d shows a container according to an embodiment.

[0218] The container 300 is configured with a hose 301 as an inlet, an upper container 302, a lower container 303, and a transition 304. The upper container is used to measure the fill level, wherein the upper container has several gaps in which columns of liquid can accumulate, each of which can overflow into the next gap. A fill level measurement can then be carried out using the several columns of electrodes of the fill level measuring arrangement according to Fig. 5d. Transition 304 comprises a valve that is operated by the actuator (202 in Fig. 5d). This valve can be a pinch valve, which only requires a flexible hose on the container 300. The actuator pinches the hose to close the valve. In the form shown, the container is a urine measuring system and is used to collect urine from a patient in an intensive care unit of a hospital.

[0219] Fig. 6e shows a container according to an embodiment.

[0220] Container 300 is configured with a tube 301 as an inlet. In the illustrated form, the container is a thoracic drain and serves to collect fluids from a patient's wound, for example, after a patient's surgery. The container has several columns in which columns of fluid can accumulate, each of which can overflow into the next column. A fill level measurement can then be performed using the several columns of electrodes of the fill level measuring arrangement shown in Fig. 5d.

[0221] Fig. 6f shows a container according to an embodiment.

[0222] The container 300 is configured with a tube 301 as an inlet. In the illustrated form, the container is a surgical drain in bottle form and serves to collect fluids from a patient's wound, for example, after a patient's surgery.

[0223] Fig. 6g shows a container according to one embodiment. The container 300 is configured with a tube 301 as an inlet. In the illustrated form, the container is a ventricular drain and serves to collect a patient's cerebrospinal fluid, for example, after a patient's surgery.

[0224] Fig. 6h shows schematically a container according to an embodiment.

[0225] The container 300 additionally has an RFID device 306, which can be applied (glued) to a surface of the container 300. The RFID device 306 can be an NFC tag and can store patient data as well as a usage status (whether the container 300 has already been used). Furthermore, the RFID device 306 can also transmit an ID, wherein the usage status is stored for this ID, for example, in a server (401 in Fig. 1), control device (100 in Fig. 1), or terminal device (402 in Fig. 1).

[0226] The RFID device 306 can be applied to each of the containers 300 of Fig. 5a to 5g.

[0227] Fig. 7 shows a control device and a level measuring arrangement according to an embodiment.

[0228] The fill level measuring arrangement 200 is connected to the rear of the control unit 100. This connection is implemented, for example, by a fastening mechanism and a standardized interface. The illustrated fill level measuring arrangement 200 is configured as shown in Fig. 4a, and the illustrated control unit 100 is configured as shown in Fig. 3a.

[0229] Fig. 8 shows a control device, a level measuring arrangement and a container according to an embodiment.

[0230] The fill level measuring arrangement 200 and the control unit 100, which are designed as shown in Fig. 7, are shown on the container 300. The container is designed as shown in Fig. 6a.

[0231] The level measuring arrangement 200 rests against the back of the container 300. The connection between the container 300 and the level measuring arrangement 200 can be an adhesive connection.

[0232] Fig. 9a shows a control device, a level measuring arrangement and a container according to an embodiment.

[0233] The fill level measuring arrangement 200 and the control unit 100, which are designed as shown in Fig. 7, are shown on the container 300. The container is designed as shown in Fig. 6a.

[0234] The level measuring arrangement 200 is inserted into a flexible pocket 307 of the container 300. The level measuring arrangement 200 and the pocket 307 are connected according to the sword-sheath principle and thus the level measuring arrangement 200 rests against the rear of the container 300.

[0235] The pocket 307 can be made of the same material as the outer wall of the container 300 and can be welded to the outer wall of the container. Fig. 9b shows a control device, a level measuring arrangement, and a container according to one embodiment.

[0236] The control unit 100 is designed as shown in Fig. 9a. The fill level measuring arrangement 200 is inserted into the pocket 307 and, in addition to the design shown in Fig. 9a, includes a back-side clamping element 206 and a locking element 207. In addition to the design shown in Fig. 9a, the container 300 includes a counter-bearing 309 designed as a carrying device.

[0237] The locking element 207 is connected to the rear clamping element 206. The locking element 207 engages the counter-bearing 309 of the container 300, thereby pressing the rear clamping element 206 into the pocket 307. The locking element can have a recess (not shown) on its surface where it engages the counter-bearing 309 of the container 300 to ensure engagement. The rear clamping element 206 is configured along the rear side of the level measuring arrangement 200. The rear clamping element 206 is connected to the level measuring device 200 or bears against it.

[0238] Due to the dimensioning of the back-side tensioning element 206, when the back-side tensioning element 206 is inserted together with the level measuring arrangement 200 into the pocket 307, a tensioning force is generated in the film of the pocket by stretching the film over the back-side tensioning element 206. The tensioning force, represented by the arrows 310, stretches the film, which is arranged towards the outer area of ​​the container. The horizontal tensioning force can be generated solely by the geometric shape of the back-side tensioning element 206, in that the circumference of the pocket is smaller than the circumference required to span the level measuring arrangement 200 and the back-side tensioning element 206. The stretching in the material of the pocket generates the tensioning force. With the snap-in element 207, a vertical tensioning force can also be generated by pressing the level measuring arrangement 200 and the back-side tensioning element 206 into the pockets.

[0239] Furthermore, the tension force also stretches the film toward the interior of the container 300 over the surface of the level measuring arrangement 200 there. This tension force prevents air bubbles between the film and the level measuring arrangement 200. Such air bubbles have the dielectric constant of air, which has an insulating effect in a capacitive method for measuring the level in the container 300 and thus interferes with the measurement. This improves the level measurement.

[0240] To further improve the drainage of air from possible air bubbles between the film and the surface of the level measuring arrangement 200, the surface can be provided with a structure that has air channels. Furthermore, the level measuring arrangement 200 can also have holes that allow air to flow from the air bubbles. Because the air now collects in the pocket on the back side of the level measuring arrangement 200, on which the back-side clamping element 206 is formed, an insulating effect is created on the back side by the air with the corresponding dielectric constant. However, since this side faces the outside of the container 300, this area should not influence the measurement. Shielding this area using the air in the pocket thus further improves the measurement.This allows, for example, influences from a patient bed that may be located in this area to be shielded.

[0241] Fig. 9c shows a cross section through the pocket of the container with the level measuring arrangement and the back-side clamping device according to the embodiment of Fig. 9b.

[0242] Shown is a section of the wall of the container 300, with the interior of the container 300 being above the wall and the exterior of the container 300 being below the wall. The fill level measuring arrangement 200 and the back-side tensioning device 206 are arranged in the pocket 307. The film is stretched over the back-side tensioning device 206 and thus lies flat on the surface of the fill level measuring arrangement 200, with the surface against which the film rests facing the interior of the container 300.

[0243] Thus, as described with reference to Fig. 9b, air bubbles between the film of the pocket 307 and the surface of the level measuring arrangement 200 are displaced. The film of the pocket 307 is the film that lies between the level measuring arrangement 200 and the inside of the container 300. Thus, an air cushion is also created in the pocket 307 between the level measuring arrangement 200 and the outside of the container 300. Furthermore, the back-side clamping device 206 has a half-pipe-like cross-section, whereby the air cushion is also arranged within the back-side clamping device 206. Thus, interference with the level measurement by air bubbles is avoided and the outside area is shielded.

[0244] Fig. 9d shows a cross section through the pocket of the container with the level measuring arrangement according to an embodiment.

[0245] Alternatively, a clamping force can also be generated by a bent level measuring arrangement 200. The level measuring arrangement 200 can also be flexible and resilient, thus generating the clamping force itself. By bending the level measuring arrangement 200, the film is pulled smoothly over the surface of the level measuring arrangement 200 towards the inside of the container 300, thereby displacing the air bubbles between them. Furthermore, the bend also forms an air cushion towards the outside of the container 300. This prevents interference with the level measurement by air bubbles and shields the outside area. Fig. 9e shows a control unit, a level measuring arrangement, and a container according to one exemplary embodiment in a side view.

[0246] The control unit 100 is designed as shown in Fig. 9a. The fill level measuring arrangement 200 is inserted into the pocket 307 and, in addition to the design shown in Fig. 9a, includes a back-side clamping element 206, a locking element 207, and a locking device 210.

[0247] The clamping element 206 is rotatably mounted on the base side (by means of a pivot joint 212) on the level measuring arrangement 200. The locking element 207 is designed as a rotatable lever (rotates around pivot joint 211) and can generate or vary the clamping force 310 by turning it.

[0248] The engagement element 207 can spread the back-side clamping element 206 away from the level measuring arrangement 200, so that the pocket 307 is stretched by the distance from the back-side clamping element 206 from the level measuring arrangement 200, thereby generating the clamping force.

[0249] The locking element 207 designed as a lever enables the simple, stress-free insertion of the level measuring arrangement 200 into the pocket 307 and the build-up of the clamping force by folding the locking element 207 in an inserted end position.

[0250] When the locking element 207 is folded, it engages in the locking device 210 in an end position of the folding movement. The locking device 210 can be configured on the fill level measuring arrangement 200, the control unit 100, or the container.

[0251] If the locking device 210 is configured on the container 300, the locking element 207 is prevented from being turned over before reaching the inserted end position, since the locking element 207 can only be locked into the locking device 210 in this end position, whereby a vertical clamping force (310) is also built up.

[0252] The locking device 210 can be designed as a counter-bearing on the container 300, for example, the counter-bearing 309 designed as a carrying device, as shown in Fig. 9b. The counter-bearing generates the vertical clamping force 310.

[0253] Fig. 9f shows a control device, a fill level measuring arrangement and a container according to an embodiment in a side view.

[0254] In comparison to the embodiment in Fig. 9e, the clamping element 206 is designed to be bendable and also fulfills the function of the locking element, whereby the locking element is included in the clamping element 206.

[0255] The clamping element 206 is arranged on the base side of the level measuring arrangement 200 (it can be mounted there by means of a swivel joint). When the level measuring arrangement 200 is inserted into the pocket 307 together with the clamping element 206, the level measuring arrangement 200 and the clamping element 206 run close to each other (substantially parallel), for example, so that the pocket 307 is not stretched. Once the level measuring arrangement 200 has reached its inserted end position in the pocket 307, the flexible clamping element 206 can be pushed further into the pocket. In doing so, the clamping element 206 moves away from the level measuring arrangement 200, for example, by forming an arc. Thus, in the bent state of the bendable clamping element 206, the pocket is stretched by the distance of the bendable clamping element 206 from the level measuring arrangement 200 and a clamping force 310 is generated.

[0256] The upper free end of the clamping element 206 is then engaged in the locking device 210. The locking device 210 can be configured on the level measuring arrangement 200, the control unit 100, or the container.

[0257] If the locking device 210 is configured on the container 300, a vertical clamping force (310) is also generated. The locking device 210 can be configured as a counter-bearing on the container 300, for example, the counter-bearing 309 configured as a support device, as shown in Fig. 9b. The counter-bearing generates the vertical clamping force 310.

[0258] Fig. 9g shows a cross section through the pocket of the container with the level measuring arrangement according to an embodiment.

[0259] Further alternatively, a clamping force can also be generated by a spring device 206a. The spring device 206a can be included in the back-side clamping device 206. The back-side clamping device 206 can be inserted into or removed from the pocket 307 in a state in which the spring device 206a is compressed and thus preloaded. This is achievable by the reduced height of the back-side clamping device 206 above the fill level measuring arrangement 200. Fig. 9e shows the compressed state. The pocket 307 does not rest against the back-side clamping device 206, and a clamping force is not generated in this state.

[0260] Fig. 9h shows a cross section through the pocket of the container with the level measuring arrangement according to the embodiment of Fig. 9g.

[0261] Once the target position of the back-side tensioning device 206 is reached during insertion, the spring device 206a can be decompressed. The spring device 206a expands and presses the tensioning device 206 against the inner wall of the pocket 307. Fig. 9h shows the decompressed state of the spring device 206a, in which the tensioning force in the pocket 307 is generated by the spring device 206a. The spring device 206a can be compressed, for example, by a user, by hand. For example, by pressing on the back-side tensioning device 206. Furthermore, a holding mechanism (not shown) can be provided that holds the back-side tensioning device 206 in a position in which the spring device 206a is compressed.This holding mechanism can have a separate actuation mechanism with which the user can release the holding mechanism and thus rebound the back-side tensioning device 206 from the retained compressed position. This actuation mechanism can be coupled to a locking element (such as 207 in Fig. 9b). As soon as the locking element engages a portion of the carrying device (such as 309 in Fig. 9b) of the container 300, the holding mechanism is released and thus the back-side tensioning device 206 can rebound from the retained compressed position.

[0262] To remove the back clamping device 206, the spring device 206a, and the level measuring assembly 200, the clamping element 207 can be pressed against the level measuring assembly 200, thereby compressing the spring device 206a. The back clamping device 206 and the spring device 206a can be held in this position by the holding mechanism, thereby facilitating the removal of the back clamping device 206, the spring device 206a, and the level measuring assembly 200 from the pocket 307.

[0263] The described mechanism could also be driven by actuators (electrical, magnetic, pneumatic, hydraulic, piezoelectric, etc.) instead of the spring device 206a, since the level measuring arrangement 200 has its own power supply.

[0264] Fig. 9i shows a rear side of the container according to an embodiment.

[0265] The rear side of the container 300 is shown from the outside of the container 300. The container comprises a pocket 307 and a stiffener 307b in the pocket 307. The stiffener 307b is formed in the pocket on the film toward the interior of the container 300. Thus, when the fill level measuring arrangement (not shown) is inserted, the stiffener 307b lies between the fill level measuring arrangement and the interior of the container. The stiffener 307b can be applied to the film of the container 300, or the film of the container 300 can be made thicker, at least in the pocket 307, to create the stiffener 307b.

[0266] The stiffener 307b prevents wrinkles that could create air bubbles between the film and the interior of the container 300 and the level measurement assembly. Such air bubbles have the dielectric constant of air, which has an insulating effect in a capacitive level measurement method in the container 300 and thus interferes with the measurement. This improves the level measurement.

[0267] Fig. 9j shows a rear side of the container according to one embodiment. The rear side of the container 300 is shown from the outside of the container 300. The container comprises a pocket 307 and a stiffener 307c in the pocket 307. Compared to the stiffener 307b from Fig. 9i, the stiffener 307c is designed as a frame. The stiffener 307c can tension the film towards the interior of the container 300 and thus prevent air bubbles between a fill level measuring arrangement (not shown) and the film towards the interior of the container 300. The stiffener 307c can encircle a contact area of ​​an electrode array of the fill level measuring arrangement, thereby building up a tension force that smooths the film of the bag's rear wall on the inside to prevent wrinkles in which air bubbles can collect.

[0268] Fig. 9k shows a control device, a level measuring arrangement and a container according to an embodiment.

[0269] The embodiment according to Fig. 9g is a modification of the embodiment according to Fig. 9b. Here, the back-side tensioning element 206 has a check valve (not shown) and a connection 208 and can be inflatable via these in order to generate the tensioning force within the pocket 307. For inflation, a pump or a syringe, for example, can be connected to the connection. During inflation, the back-side tensioning device expands and thus stretches the material of the pocket 307, thereby generating the tensioning force. The check valve maintains the pressure inside the back-side tensioning device 206. The inflatable back-side tensioning device 206 can also be combined with a snap-in element as shown in Fig. 9b.

[0270] Fig. 91 shows a control device, a level measuring arrangement and a container according to an embodiment.

[0271] The pocket 307 is made of an elastic material and is dimensioned such that a clamping force is generated when the level measuring arrangement 200 is inserted into the pocket 307 and stretches it.

[0272] Fig. 9m shows a control device, a level measuring arrangement and a container according to an embodiment.

[0273] A sealing area 209 is formed on the level measuring assembly 200, which seals the pocket so that air can be sucked out of the pocket via port 208 and a check valve (not shown). A pump or syringe, for example, can be connected to port 208 to suck out the air.

[0274] In the case of back-side clamping devices that can be inserted into the pocket separately from the level measuring arrangement 200, the friction between the level measuring arrangement 200 and the back-side clamping device and the interior of the pocket 307 is also simplified by the separate insertion or, during disassembly, the separate withdrawal.

[0275] An analogous effect to the improved measurement described with reference to Fig. 9b to m can also be achieved for a level measuring arrangement 200 printed as electrode arrays on the container 300, e.g., with electronic ink, or as disposable sensors glued to the container. By gluing or printing, the air bubbles can be avoided, but at the expense of the reusability of the level measuring arrangement 200, which is then disposed of with the container. The shielding of the outer area can be achieved, for example, by gluing an air-containing strip, such as a foam strip or bubble wrap, to the outside of the level measuring arrangement 200 on the container 300.

[0276] Fig. 10 shows a control device, a level measuring arrangement and a container according to an embodiment.

[0277] The fill level measuring arrangement 200 and the control unit 100, which are designed as shown in Fig. 7, are shown on the container 300. The container 300 is designed as shown in Fig. 6a.

[0278] The level measuring arrangement 200 is inserted into a rigid pocket 308 of the container 300. The level measuring arrangement 200 and the pocket 308 are connected according to the sword-sheath principle and thus the level measuring arrangement 200 rests against the rear of the container 300.

[0279] The pocket 308 may be made of a rigid plastic and bonded to the outer wall of the container, whereby the pocket provides rigidity to the container wall which improves the accuracy of the level measurement due to a reduced curvature of the container wall.

[0280] Fig. 11 shows a control device and a level measuring arrangement according to an embodiment.

[0281] The fill level measuring arrangement 200 is connected to the rear of the control unit 100. This connection is implemented, for example, by a fastening mechanism and a standardized interface. The illustrated fill level measuring arrangement 200 is configured as shown in Fig. 4a, and the illustrated control unit 100 is configured as shown in Fig. 3b, with a diagnostic device 116.

[0282] Fig. 12 shows a control device, a level measuring arrangement and a container according to an embodiment.

[0283] The fill level measuring arrangement 200 and the control unit 100, which are designed as shown in Fig. 11, are shown on the container 300. The container is designed as shown in Fig. 6b.

[0284] The level measuring assembly 200 rests against the rear of the container 300. The connection between the container 300 and the level measuring assembly 200 can be an adhesive bond. The level measuring assembly 200 and the container 300 can also be connected via a flexible pocket on the rear wall of the container, as this connection is already shown in Fig. 9.

[0285] Fig. 13 shows a control device, a level measuring arrangement and a container according to an embodiment.

[0286] The fill level measuring arrangement 200 and the control unit 100, which are designed as shown in Fig. 11, are shown on the container 300. The container 300 is designed as shown in Fig. 6b.

[0287] The level measuring arrangement 200 is inserted into a rigid pocket 308 of the container 300. The level measuring arrangement 200 and the pocket 308 are connected according to the sword-sheath principle and thus the level measuring arrangement 200 rests against the rear of the container 300.

[0288] The pocket 308 may be made of a rigid plastic and bonded to the outer wall of the container, whereby the pocket provides rigidity to the container wall which improves the accuracy of the level measurement due to a reduced curvature of the container wall.

[0289] The hose 301 of the container 300 is guided through the diagnostic device 116 when the container 300 is connected to the level measuring assembly 200. Thus, fluid flowing through the hose 301 can be analyzed by the diagnostic device 116.

[0290] Fig. 14 shows a control device and a level measuring arrangement according to an embodiment.

[0291] The fill level measuring arrangement 200 is connected to the rear of the control unit 100. This connection is implemented, for example, by a fastening mechanism and a standardized interface. The illustrated fill level measuring arrangement 200 is configured as shown in Fig. 4b, and the illustrated control unit 100 is configured as shown in Fig. 3a. The fill level measuring arrangement 200 has a holder with an actuator 202.

[0292] Fig. 15 shows a control device, a level measuring arrangement and a container according to an embodiment.

[0293] The fill level measuring arrangement 200 and the control unit 100, which are designed as shown in Fig. 14, are shown on the container 300. The container 300 is designed as shown in Fig. 6d.

[0294] The holder with actuator 202 of the level measuring assembly 200 holds the container 300 at the transition 304 between the upper container 302 and the lower container 303. The level measuring assembly 200 rests against the rear of the upper container 302 and measures the fill level there. The fill level of several gaps in the upper container can also be measured, as already described with reference to Figs. 5d and 6d. The actuator 202 can close the transition 304 by squeezing it.

[0295] Fig. 16 shows a flowchart of an example level measurement. The level measurement is performed by the control unit. After the control unit starts up, the system is initialized in step S1. In step S2, a check is carried out to determine whether and which level measurement device is connected. If no level measurement device is connected, step S2 is repeated, and an error message may be output. If a level measurement device is connected, step S3 follows.

[0296] In step S3, a check is made to see whether the control unit is connected to a network. If the control unit is not connected to a network, step S3 is repeated, and an error message may be displayed. If the control unit is connected to a network, step S4 follows.

[0297] In step S4, a check is performed to determine whether the control unit is linked to an electronic patient record (for example, on server 401 in Fig. 1). If the control unit is not linked to an electronic patient record, step S4 is repeated, and an error message may be output. If the control unit is linked to an electronic patient record, step S5 follows.

[0298] In step S5, a check is made to see whether the container has been recognized (using its NFC tag). If the container has not been recognized, step S5 is repeated, and an error message may be displayed. If the container has been recognized, step S6 follows.

[0299] In step S6, a check is performed to determine whether the container is new, an approved container, and compatible with the level measurement system. In addition, a mathematical conversion function is loaded that depends on the geometry of the container and level measurement system, which is required in steps S12 to S17 to convert and correct the measurement data. If this is not the case, step S6 is repeated, and an error message may be issued. If this is the case, step S7 follows.

[0300] In step S7, the measurement begins. Capacitive measured values ​​from the level measurement system are acquired, but these are not yet released. Furthermore, measured values ​​from an inertial measurement unit (IMU) are acquired.

[0301] In step S8, a check is carried out to determine whether the position of the control unit, and thus also of the container, measured by the IMU lies within a tolerance range around a reference position (vertical). If the position is not within the tolerance range, step S7 follows. An error message may be output when jumping to step 7. If the measured position is within the tolerance range, step S9 follows.

[0302] In step S9, a check is made to determine whether the acceleration measured by the IMU is within a tolerance range. If the acceleration is not within the tolerance range, step S7 follows. An error message can be output when jumping to step 7. If the measured acceleration is within the tolerance range, step S10 follows. In step S10, the measured values ​​from the fill level measurement system are recorded and evaluated as a plausibility measurement.

[0303] In step S11, the plausibility measurement is used to check whether an excessive change in the fill level has been measured compared to a previously measured level (comparing the change with a threshold value). If an excessive change is detected, step S7 follows. An error message may be output when jumping to step 7. If no excessive change is detected, a release criterion is issued for the measured values ​​of the fill level measurement system in the plausibility measurement.

[0304] In step S12, the capacitive measured values ​​from the plausibility measurement are converted into a fill level. This is done using the conversion function loaded in step S6, which depends on the geometry of the detected containers and the fill level measurement setup.

[0305] In step S13, the determined fill level is converted into a volume. This is done using the conversion function loaded in step S6, which depends on the geometry of the detected containers and the level measurement setup.

[0306] In step S14, the deviation of the position measured by the IMU from the reference position is determined. This is done using the conversion function loaded in step S6, which depends on the geometry of the detected containers and the level measurement setup.

[0307] In step S15, the determined volume is corrected based on the determined deviation. This is done using the conversion function loaded in step S6, which depends on the geometry of the detected containers and the level measurement setup.

[0308] In step S16 the temperature of the liquid and the temperature of the environment are recorded.

[0309] In step S17, a further correction of the corrected volume is performed based on the temperature measurements. This results in a corrected fluid volume. For this purpose, the conversion function loaded in step S6 is used, which depends on the geometry of the detected containers and the level measurement arrangement.

[0310] In step S18, the corrected fluid volume is stored locally on the control unit.

[0311] In step S19 the corrected fluid volume is shown on the display.

[0312] In step S20, the corrected fluid volume is transmitted to the server.

[0313] In step S21, the corrected fluid volume is transmitted (saved) to the patient record.

[0314] In step S22, a check is made to determine whether another measurement should be performed. If another measurement is to be performed, the process continues with step S7. If no further measurement is to be performed, the measurement ends. Fig. 17 illustrates an embodiment of a general-purpose computer 500. The general-purpose computer 500 is an example of a control device according to Fig. 2, which includes a circuit configured to execute the method according to the present technology (e.g., the method of Fig. 17).

[0315] Embodiments that use software, firmware, programs, or the like to perform the methods described herein may be installed on the computer 500, which is then suitably configured for the corresponding embodiment.

[0316] The computer 500 has a central processing unit (CPU) 501, which can execute various types of procedures and methods as described herein, for example, according to programs stored in a read-only memory (ROM) 502; stored in a memory 507 and loaded into a random-access memory (RAM) 503; stored on a medium 510 that can be inserted into a corresponding drive 509; etc.

[0317] The CPU 501, the ROM 502, and the RAM 503 are connected to a bus 511, which in turn is connected to an input / output interface 504. The number of CPUs, memories, and storage is only exemplary, and those skilled in the art will understand that the computer 500 can be adapted and configured to meet specific requirements that arise when used as a control device according to the present technology.

[0318] Several components are connected to the input / output interface 504: an input 505, an output 506, a memory 507, a communication interface 508 and the drive 509 into which a medium 510 (compact disk (CD), digital video disc (DVD), CompactFlash memory or the like) can be inserted.

[0319] Input 505 may include a pointing device (mouse, graphics tablet, or the like), a keyboard, a microphone, a camera, a touch screen, a gaze tracking unit, etc. The input may further receive any measurements from sensors described in Fig. 2.

[0320] The output 506 may include a display (liquid crystal display (LCD), cathode ray tube (CRT), light-emitting diode (LED), etc.; e.g., included in a touch screen), speakers, etc. The output may further provide control signals to actuators, as described in Fig. 2. The storage 507 may include a hard disk, a solid-state drive (SSD), a flash drive, and the like.

[0321] The communication interface 508 may be adapted to communicate, for example, via a local area network (LAN), wireless local area network (WLAN), mobile telecommunications system (GSM, UMTS, LTE, NR, etc.), Bluetooth, near-field communication (NFC), infrared, etc.

[0322] It is noted that the above description relates only to an exemplary configuration of computer 500. Alternative configurations may be implemented with additional or different sensors, memory devices, interfaces, or the like. For example, communication interface 158 may support radio access technologies other than the mentioned UMTS, LTE, and NR.

[0323] LIST OF REFERENCE SYMBOLS

[0324] 1 level determination system

[0325] 100 control unit

[0326] 101 Status LED

[0327] 102 Container lighting

[0328] 103 Energy management order

[0329] 104 Charging device

[0330] 105 charging controller

[0331] 106 Battery

[0332] 107 Advertisement

[0333] 108 microcontrollers

[0334] 109 Communication unit

[0335] 110 Wi-Fi

[0336] 111 mobile phone

[0337] 112 Sensor arrangement

[0338] 113 inertial measuring unit

[0339] 114 NFC readers

[0340] 115 Presence detector

[0341] 116 Diagnostic device

[0342] 200 level measuring arrangement

[0343] 201 Electronic unit (electronic component)

[0344] 201a measuring electrodes

[0345] 201b Ambient reference electrodes

[0346] 201c Fluid reference electrodes

[0347] 202 Actuator

[0348] 203 standardized interface

[0349] 204 Carrier material

[0350] 205 Fastening mechanism

[0351] 206 clamping element

[0352] 206a spring device

[0353] 208 connection

[0354] 209 Sealing area

[0355] 210 locking device

[0356] 211 Swivel joint 212 Swivel joint

[0357] 300 containers

[0358] 301 hose

[0359] 302 upper container 303 lower container

[0360] 304 Transition

[0361] 306 RFID device (NFC tag)

[0362] 307 flexible bag

[0363] 307b stiffener 307c (frame-shaped) stiffener

[0364] 308 stiff bag

[0365] 309 Counter bearing

[0366] 310 arrows (tension force)

[0367] 400 Network 401 Server

[0368] 402 Device

Claims

PATENT CLAIMS 1. A detection device for determining a release criterion for a fill level determination system (1) that determines a fill level of a medical fluid in a container (300), comprising: a position detector (113) that is configured to determine a position of the fill level determination system (1), an acceleration detector (113) that is configured to determine an acceleration of the fill level determination system (1), wherein fill level measurement values ​​of the fill level determination system (1) are recorded as a plausibility measurement if the determined position lies within a tolerance range around a reference position and if the acceleration lies within a tolerance range, and the release criterion is issued based on the plausibility measurement if a fill level measurement value of the fill level determination system (1) does not show an excessive change compared to a previous fill level measurement value.

2. A fill level determination system (1) for determining a fill level criterion of a medical fluid in a container (300), comprising: the container (300) configured to hold a medical fluid, a fill level measuring arrangement (200) configured to record measured values ​​that correspond to a fill level criterion of the container (300), a detection device according to claim 1, and a control unit (100), wherein the control unit (100) and the fill level measuring arrangement (200) are configured to be connectable to one another and the fill level measuring arrangement (200) and the container (300) are configured to be connectable to one another, wherein the fill level criterion is determined in a connected state of the control unit (100) and the fill level measuring arrangement (200) as well as of the fill level measuring arrangement (200) and the container (300).

3. Fill level determination system (1) according to claim 2, wherein the control unit (100) and the fill level measuring arrangement (200) are arranged to be connectable to one another by means of a standardized interface (203).

4. Fill level determination system (1) according to claim 2 or 3, wherein the container (300) comprises a holder and the fill level measuring arrangement (200) and the container (300) are arranged to be connectable to one another by means of the holder.

5. Level determination system (1) according to claim 4, wherein the holder on the container (300) comprises a flexible pocket (307) which is designed to receive the level measuring arrangement (200) according to a sword-sheath principle.

6. Level determination system (1) according to claim 5, wherein the level measuring arrangement (200) comprises a back-side tensioning device (206) which generates a tensioning force in the flexible pocket (307).

7. Fill level determination system (1) according to claim 6, wherein the container (300) comprises a counter bearing (309, 210) which is designed to fix the back-side clamping device (206) in the pocket (307).

8. Fill level determination system (1) according to claim 7, wherein the back-side clamping device (206) is designed with a locking element (207) and the locking element (207) locks into the counter bearing (309) so that the clamping force is generated.

9. Level determination system (1) according to one of claims 6 to 8, wherein the back-side clamping device (206) is designed with a semi-tubular profile.

10. Level determination system (1) according to one of claims 6 to 8, wherein the back-side tensioning device (206) is inflatable.

11. Level determination system (1) according to one of claims 6 to 8, wherein the back-side tensioning device (206) comprises a spring device (206a).

12. Level determination system (1) according to claim 8, wherein the locking element (207) is designed as a lever which locks into the counter bearing (309), whereby the back-side clamping device (206) is spread apart from the level measuring arrangement (200) so that the clamping force is generated.

13. Level determination system (1) according to claim 7, wherein the back-side clamping device (206) is designed to be bendable and can be locked in the counter bearing (309, 210) in a bent state.

14. Level determination system (1) according to claim 4, wherein the holder on the container (300) comprises a stiffened pocket (308) which is designed to receive the level measuring arrangement (200) according to a sword-sheath principle.

15. Level determination system (1) according to claim 14, wherein the stiffened pocket (308) comprises a stiffener (307b, 307c) on a wall towards the inside of the container (300).

16. Level determination system (1) according to claim 15, wherein the stiffener (307c) is a frame.

17. Level determination system (1) according to claim 2 or 3, wherein the level measuring arrangement (200) and the container (300) are arranged to be connectable to one another by means of adhesion.

18. Level determination system (1) according to claim 2 or 3, wherein the level measuring arrangement (200) is printed on the container (300), whereby the level measuring arrangement (200) and the container (300) are arranged to be connectable to one another.

19. Level determination system (1) according to one of claims 2 to 18, wherein the container (300) comprises a urine bag.

20. Level determination system (1) according to one of claims 2 to 18, wherein the container (300) comprises a urine measuring system.

21. Level determination system (1) according to one of claims 2 to 18, wherein the container (300) comprises an infusion bag.

22. Level determination system (1) according to one of claims 2 to 18, wherein the container (300) comprises a thoracic drain.

23. Level determination system (1) according to one of claims 2 to 18, wherein the container (300) comprises a ventricular drain.

24. Level determination system (1) according to one of claims 2 to 18, wherein the container (300) comprises a surgical drain.

25. Level determination system (1) according to one of claims 2 to 24, wherein the container (300) comprises an RFID device (306).

26. Fill level determination system (1) according to claim 25, wherein the control unit (100) is configured to read the RFID device (306) of the container (300) by means of a further RFID device (114) and to determine whether the container (300) is compatible with the fill level measuring arrangement (200) and the control unit (100) and has not yet been used, such that if the container (300) is compatible and has not yet been used, the RFID device (114) writes to the RFID device (306) of the container (300) that the container (300) is used.

27. Fill level determination system (1) according to claim 25, wherein when writing by means of the further RFID device (114) to the RFID device (306) of the container (300), patient-related data are also written to the RFID device (306) of the container (300).

28. Level determination system (1) according to one of claims 25 to 27, wherein the control unit (100) comprises the further RFID device (114).

29. Level determination system (1) according to one of claims 2 to 28, wherein the container (300) comprises an outlet valve (304) and the level measuring arrangement (200) comprises an actuator (202) which is configured to actuate the outlet valve (304).

30. Level determination system (1) according to one of claims 2 to 29, wherein the control unit (100) comprises a diagnostic device (116) configured to spectrometrically analyze the fluid.

31. Fill level determination system (1) according to one of claims 2 to 30, wherein the control unit (100) comprises a display (107) configured to display information about the determined fill level criterion.

32. Fill level determination system (1) according to claim 31, wherein the control device (100) comprises a presence detector (115) configured to detect an approach of a person or a gesture of a person, wherein the display (107) is switched on from a standby state due to the approach or the gesture.

33. Fill level determination system (1) according to one of claims 2 to 32, wherein the control unit (100) comprises an energy management arrangement (103) which is configured to supply the control unit with energy.

34. Level determination system (1) according to one of claims 2 to 33, wherein the level measuring arrangement (200) comprises electrodes (201a) which are configured to capacitively determine level measurement values.

35. Level determination system (1) according to one of claims 2 to 34, wherein the level measuring arrangement (200) comprises a printed circuit board (204) and the electrodes are formed on the printed circuit board (204).

36. Level determination system (1) according to claim 35, wherein the printed circuit board (204) is dimensionally stable.

37. Level determination system (1) according to claim 35, wherein the printed circuit board (204) is flexible.

38. Fill level determination system (1) according to one of claims 34 to 37, wherein the fill level measuring arrangement (200) comprises an electronic component (201) which is configured to carry out the determination of the measured values ​​using the electrodes (201a).

39. Fill level determination system (1) according to one of claims 2 to 38, wherein the control unit (100) is configured to carry out a correction of the fill level criterion based on the determined position of the position detector (113) of the detection device when the release criterion is granted.

40. Container (300) for a level determination system (1) according to one of claims 2 to 39.

41. A method for determining a release criterion for a fill level determination system (1) that determines a fill level of a medical fluid in a container (300), comprising the steps: Determining a position of the level determination system (1), Determining an acceleration of the level determination system (1), Recording level measurement values ​​of the level determination system (1) as a plausibility measurement if the determined position is within a tolerance range around a reference position and if the acceleration is within a tolerance range, and Granting the release criterion based on plausibility measurement if a level measurement value of the level determination system (1) does not show an excessive change compared to a previous level measurement value.

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