WO2024094253A1 - Dispositif et procédé pour déterminer le débit urinaire et/ou les données biochimiques de l'urine d'un utilisateur, récipient et bandelette de test urinaire - Google Patents

Dispositif et procédé pour déterminer le débit urinaire et/ou les données biochimiques de l'urine d'un utilisateur, récipient et bandelette de test urinaire Download PDF

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Publication number
WO2024094253A1
WO2024094253A1 PCT/DE2023/100805 DE2023100805W WO2024094253A1 WO 2024094253 A1 WO2024094253 A1 WO 2024094253A1 DE 2023100805 W DE2023100805 W DE 2023100805W WO 2024094253 A1 WO2024094253 A1 WO 2024094253A1
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WO
WIPO (PCT)
Prior art keywords
urine
vessel
test strip
flow rate
sensor
Prior art date
Application number
PCT/DE2023/100805
Other languages
German (de)
English (en)
Other versions
WO2024094253A4 (fr
Inventor
Stefan Siemer
Sebastian Heidrich
Original Assignee
Streamcheck GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE202022106218.8U external-priority patent/DE202022106218U1/de
Priority claimed from DE202023101025.3U external-priority patent/DE202023101025U1/de
Application filed by Streamcheck GmbH filed Critical Streamcheck GmbH
Publication of WO2024094253A1 publication Critical patent/WO2024094253A1/fr
Publication of WO2024094253A4 publication Critical patent/WO2024094253A4/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/207—Sensing devices adapted to collect urine
    • A61B5/208—Sensing devices adapted to collect urine adapted to determine urine quantity, e.g. flow, volume
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1477—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means non-invasive
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/493—Physical analysis of biological material of liquid biological material urine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/007—Devices for taking samples of body liquids for taking urine samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0431—Portable apparatus, e.g. comprising a handle or case
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/08—Sensors provided with means for identification, e.g. barcodes or memory chips

Definitions

  • the present invention relates to a device and a method for determining the urine flow rate and/or the biochemical data of the urine of a user according to the preamble of the first and 15th patent claims as well as a suitable vessel according to claim 18 and a urine test strip according to claim 19.
  • the amount of urine released when emptying the bladder or the flow rate of the urine stream also provides clues to possible diseases such as an enlarged prostate, which leads to a narrowing of the urethra and thus affects the flow rate.
  • the biochemical composition of urine can be examined using self-tests in the person's usual environment, but this often involves a subjective and by no means professional evaluation of the test.
  • Tests that relate to both the flow rate and the biochemical composition of urine are often more complex and are usually carried out in doctors' offices or hospitals. Since many of the affected people shy away from going to a specialist or consider it unnecessary due to symptoms that are not yet too severe, many diseases remain undetected that could be treated more effectively if they were detected at an early stage.
  • Indwelling catheters are known for medical applications, as disclosed, for example, in the publication US 2017/0035342 A1, but they are not suitable for home use.
  • WO 2019/231513 A1 describes a uroflowmeter and a method for processing the data generated thereby.
  • the uroflowmeter is a handheld device.
  • the uroflowmeter comprises a handle, a flow chamber connected to the handle, and a sensor connected to the flow chamber that detects a parameter of the urine collected in the flow chamber.
  • the uroflowmeter may contain both reusable and disposable components. As a uroflowmeter, it can identify and record data that the flow rate over the measured duration of a urination, but it can also time-stamp the voiding process and transmit the data to an external data collection center for additional analysis and inclusion in a comprehensive voiding report or voiding diary.
  • the urine is first collected in the uroflowmeter, which must be emptied and cleaned after use. A biochemical analysis of the urine is not planned.
  • DE 10 2014 008 760 A1 discloses a urine flow measuring device for single use, which comprises a substantially funnel-shaped collecting container with a lower end having an outlet opening for receiving urine fluid whose maximum flow rate (Qmax) is to be measured, wherein a flow measuring device for measuring the maximum flow rate (Qmax) is arranged at the outlet opening.
  • This device also does not allow analysis of the biochemical composition of the urine and has a complicated technical structure.
  • EP 3331 450 B1 describes a device for determining physiological data by analyzing human excrement in a toilet using at least one indicator and/or sensor, and a method for determining physiological data by analyzing human excrement in a toilet by measuring urine and/or stool values. This is done using a measuring system in which an indicator or sensor can be brought into a measuring position for each measurement by means of an arm in which there is sufficient contact with the urine or stool to be examined, the indicator or sensor being designed as an independent unit, and a corresponding method in which a plurality of previously determined values are measured and then further processed and, if necessary, forwarded.
  • the disadvantage of this device is that it has to be attached to a toilet and cannot be used hand-held.
  • the publication US 2019/0365307 A1 also discloses a device for measuring urine flow, which has a handle and can record the weight of the urine released. Furthermore, a camera can be provided for recording the fill level of a vessel that is connected to the handle. Where the camera for recording the fill level is arranged is not explained.
  • an ambulatory device for measuring urine flow comprising a portable hand-held container, a flow measuring device located in the container and a means for collecting the data collected by the flow measuring device.
  • the flow measurement is relatively complex and biochemical data of the urine are not recorded.
  • the document EP 3 412 206 A1 discloses a portable device for measuring urine weight and a container provided for this purpose, which can be disposed of in the toilet bowl.
  • the device has a holding unit with a handle.
  • the holding unit has a clamp for clamping the upper edge of the container. After the clamp is released, the container falls into the toilet and dissolves.
  • a weight sensor is provided in the handle for recording the weight of the container.
  • the disadvantages here are the complex design of the clamp and the container and that the important biochemical data of the urine are not recorded.
  • the devices known to date either do not perform uroflowmetry and/or biochemical analysis of urine or are too large and too cumbersome to operate and in some cases are not suitable for home use.
  • a device in the form of a handheld device is known, with which the urine flow rate can also be determined.
  • the device has a vessel for receiving a user's urine, which has two capacitive sensors in its wall.
  • a circuit board device integrated on the vessel comprises a first capacitive sensor configured to measure a first capacitance within a contained volume with known dimensions, wherein the first capacitance changes when a substance is absorbed into the contained volume.
  • a second capacitive sensor is also provided with a plurality of trigger points at a plurality of corresponding known heights within the contained volume, wherein the second capacitive sensor is configured to detect when the substance absorbed into the contained volume has reached each of the corresponding known heights within the contained volume and wherein the volume of the substance is determined based on data from the first capacitive sensor and the second capacitive sensor.
  • An electronic part is provided beneath the container to which the container is connected.
  • the container has a coupling element, e.g. a thread or a bayonet lock. It is suggested that the container part can be disposable. However, due to its complex design, this is a high cost factor.
  • the electronic assembly can have sensors for recording biochemical data that is fed via the container section 102. This is also very complex.
  • urine test strips are usually used to determine the biochemical data of urine. These are dipped into the urine that has been collected in a container.
  • a urine test for home use therefore has a urine test strip and a color scale for its evaluation. Depending on the test, discoloration may appear on the test strip after a while. This must be compared visually with the scale on the packaging, which can determine which substances are present in the urine and in which concentration. This may mean that the user does not evaluate the urine test strip correctly. Furthermore, the data is not saved.
  • a device for measuring urine flow and for determining the biochemical composition of a user's urine stream comprising a flow region surrounded by an edge region, which can be manually brought into a measuring position.
  • the device also has at least two first sensors for contactless detection of the flow rate of the urine stream and means for contactless detection of the biochemical composition of the urine stream, wherein the first sensors are arranged on or in the edge region and have a detection field arranged in the flow region of the device or pointing towards the flow region, and wherein the first sensors are optical sensors and/or ultrasonic sensors.
  • the invention is based on the object of providing a device and a method as well as a vessel and a test strip for simple urological prevention, which has a simple structural design, can be manually brought into a measuring position by a user and with which a urine flow rate and/or the biochemical data of the user's urine can be determined.
  • the device according to the invention is designed in the form of a hand-held device and is intended in particular for domestic use for determining the urine flow rate and/or determining the biochemical data of the urine of a user and has a receptacle in which a replaceable vessel for collecting the user's urine during micturition can be positioned, wherein the receptacle with the vessel can be manually brought into a measuring position below the exit of the user's urethra, wherein the device has means for detecting the urine flow rate. Rate and/or for determining the biochemical data of the urine, wherein at least one urine test strip is arranged in the vessel for recording the biochemical data.
  • the solution according to the invention makes it possible for the first time to record the urinary flow rate (uroflow) and/or the biochemical data of a user's urine using a handheld device.
  • the urinary flow rate and the biochemical data can be recorded together or separately during a measurement process for a user's micturition.
  • the device has at least one first sensor for detecting the weight and/or volume of urine collected in the vessel during micturition.
  • At least one second optical sensor is present, which determines the biochemical values of the urine by contactless detection of the urine test strip arranged in the vessel.
  • the first and/or the second sensor are preferably arranged in/on the receptacle for the vessel or in/on a handle which is connected to the receptacle.
  • the device has an annular and circumferentially closed or annular and circumferentially open receptacle.
  • the holder can also be designed like a clamp and grip the vessel at the top in the area of its rim.
  • the holder is ring-shaped, it has an inner diameter into which the vessel can be inserted so that a base area protrudes through the ring-shaped holder.
  • the vessel then clamps itself with its outer diameter in the inner diameter of the ring-shaped holder, for example, or rests with an edge or edge area on the top of the ring-shaped holder.
  • this advantageously has at least one means which fixes the vessel in the annular receptacle during a pivoting movement for pouring out the urine, so that the vessel does not fall into the toilet when the urine is poured out.
  • the data recorded during a measuring cycle with the first sensor and/or the second sensor can furthermore advantageously be transmitted to a terminal device and can be evaluated and displayed therein by means of an evaluation unit/evaluation electronics. This makes it possible, for example, to use the recorded and stored data to carry out a trend analysis of the data collected over a period of time.
  • the device comprises means for detecting the duration of micturition and that a signal processing unit evaluates the increase in the weight of the vessel during the duration of micturition and determines the urine flow rate taking this period of time into account.
  • an inclination sensor that is arranged on/in the handle or on/in the holder of the container. This can be used, for example, to detect the tipping of the container due to the change in inclination.
  • the replaceable container can be designed for single use or for use over a period of one day, although the urine should be emptied after each micturition.
  • the preferred container is a paper cup with a circumference that tapers towards the bottom and an outwardly curved upper edge.
  • At least one urine test strip and/or a barcode and/or a QR code is arranged inside the container in the detection area of the optical sensor.
  • the urine test strip is glued in, for example, and the barcode and/or QR code is preferably printed on.
  • the urine test strip can also be printed on if necessary.
  • the urine test strip(s) and/or the barcode and/or the QR code are preferably provided on the inside of the surrounding wall and/or on the inside of the bottom of the vessel. It is also possible for the vessel to have at least one marking on its inside for positioning the at least one urine test strip.
  • At least one marking for positioning the vessel in the receptacle can also be provided on an outer wall of the vessel.
  • the urine test strip may have an adhesive surface on its back for attachment to an inner surface of a container.
  • the weight of the vessel is advantageously transmitted via the holder of the vessel by means of a connecting region of a transmission element to the load cell arranged in the holder or in the handle.
  • At least one lighting device in particular an LED, is arranged in an edge area of the holder and/or on the handle, pointing in the direction of the urine test strip.
  • a lighting device in particular an LED
  • several LEDs are provided in the area of the camera or around the camera, or a camera with appropriate lighting is used.
  • a storage medium for storing the urine flow rate and/or the biochemical data of the urine over a period of several days/weeks/months can be provided directly in the device or in the evaluation unit.
  • the invention further relates to a method for determining the urine flow rate and/or determining the biochemical data of the urine of a user with the device according to the invention, wherein the user's urine is first collected during micturition in a vessel positioned in a receptacle and the urine flow rate is recorded using at least one means for recording the urine flow rate. The urine is then poured out of the vessel.
  • the urine is poured out of the container by rotating the device after the user has finished urinating, while the container remains in the holder, and then the urine test strip arranged in the container and moistened with urine is detected by a second sensor in the form of an optical sensor.
  • the data of the first means and/or the data of the optical sensor are displayed in the device and/or transmitted to a terminal device and displayed and stored therein.
  • the user can select, as required, whether only the urine flow rate or only the biochemical data should be measured for a micturition, or whether both the urine flow rate and the biochemical data should be recorded.
  • the advantage is that the container can be disposed of after use and replaced with a new container. The user therefore does not necessarily have to clean the device after use. Of course, it can also simply be rinsed under water after removing/disposing of the container from the holder.
  • the device itself has an extremely simple structure and requires little space.
  • the device has means for recording the duration of micturition and advantageously a signal processing unit evaluates the increase in weight during the duration of micturition and determines the urine flow rate therefrom.
  • the device also has an inclination sensor. Then a start signal can be triggered when micturition begins and the inclination sensor can detect the sideways tipping of the vessel and this can be interpreted as the end of micturition, for example. The time period in between is used in conjunction with the weight or volume of urine collected during micturition to calculate the urine flow rate.
  • the first sensor is designed as a load cell and is arranged in particular together with the optical sensor and the inclination sensor in the handle or the holder of the vessel.
  • the receptacle for detachably holding the vessel is preferably ring-shaped or clamp-like.
  • the vessel is inserted from above with its base into the ring-like holder.
  • the latter preferably grips the upper edge of the vessel.
  • the replaceable container is designed for single use for one micturition or can be used several times a day for one micturition each, for example to record the volume of urine excreted over a day.
  • the volume is determined and this is added up via the evaluation unit according to the desired period of time - e.g. one day.
  • the weight of the vessel is preferably transmitted via the holder of the vessel by means of a transmission element to a load cell arranged in the holder or in the handle.
  • the optical sensor is designed in particular as a camera and is also arranged in the holder or handle of the device.
  • the detection field of the camera should detect the urine test strip and/or the QR code, or the urine test strip and/or the barcode and/or the QR code is/are arranged on the wall of the container in the detection area of the optical sensor.
  • the QR code or barcode arranged in the container is used to identify whether it is the container intended for the application.
  • a lighting device for illumination, which is preferably arranged in the area/next to the camera on the holder and/or on the handle pointing in the direction of the urine test strip.
  • an interface is provided for transmitting the data detected by the first sensor and/or by the optical sensor and/or by the inclination sensor to an evaluation unit, preferably to a computer and/or a mobile phone and/or a tablet.
  • the preferred container is a recyclable paper or cardboard cup or a plastic cup with an outward-curved upper rim.
  • the invention thus also relates to a vessel for the device according to the invention, which has a urine test strip or a marking for attaching the urine test strip on an inner side and/or wherein the vessel has a barcode and/or QR code on its inner side.
  • the vessel preferably has at least one urine test strip or at least one marking for positioning a urine test strip on an inner wall of its peripheral wall and/or on the inside of the bottom.
  • the container can have a barcode and/or QR code on its inner wall.
  • the vessel can also have at least one marking on its outer wall for its positioning so that it can be inserted into the receptacle in a certain, predetermined position.
  • a container can be used which only has a marking for attaching a urine test strip.
  • a urine test strip with an adhesive backing is used. This is then stuck into the container in the area of the marking.
  • the QR code that is initially captured by the camera guarantees that a suitably certified container is used. If this is not the case, an error message appears and no Measurement carried out. If a proper container is inserted into the device, the measurement process and micturition can take place, whereby the duration and weight of the urine are first recorded. The container is then emptied and the urine test strip moistened with urine is read using the camera, which allows the biochemical data of the urine to be determined. For this purpose, all data is preferably transmitted wirelessly (WLAN, Bluetooth or similar) to the end device and evaluated. This is preferably done using an app and corresponding software.
  • WLAN wireless local area network
  • “Measuring urine flow or measuring the urine flow rate” in the sense of the invention is understood to mean the detection of the “flow rate” of the urine or of the urine collected in the vessel during the duration of a micturition.
  • the flow rate in ml/s and/or a total volume in a unit of time and/or the flow profile in a unit of time can advantageously be detected.
  • the device according to the invention makes it possible to carry out a determination of the biochemical composition of the urine stream essentially simultaneously with the urine flow measurement or shortly thereafter if a urine test strip is arranged in the device or the urine test strip is integrated in the container.
  • the time recording of the duration of micturition can also be done via a time recording unit integrated into the device, which, for example, starts recording the time as soon as the first sensor registers the beginning of urine intake into the vessel.
  • the time recording ends as soon as the urine intake into the vessel also stops, i.e. the weight does not increase.
  • the device has a handle that is designed to be grasped by a user.
  • the handle can be omitted and the user can hold the holder for the vessel.
  • the holder can, for example, have a corresponding grip area.
  • the transmission element for transmitting the weight is preferably a metallic bending strip which is coupled to a load cell in the holder or in the handle.
  • control unit as well as a switch for switching the device on and off and optionally a second switch for starting and ending the detection by the sensors are preferably also located in the holder or handle.
  • the optical sensor is able to detect the urine test strip and a color change of the urine test strip.
  • the urine test strip can detect the biochemical composition of the urine.
  • the presence of at least one parameter selected from erythrocytes, proteins, sugar, ketones, leukocytes, bilirubin and/or urobilinogen in the urine stream can be detected.
  • an increased concentration of red blood cells in the urine can indicate a possible inflammation or infection of the urinary tract and/or prostate, and in rarer cases, tumors such as kidney or bladder cancer, or kidney stones.
  • a red blood cell count of 100 cells/ml can be considered harmless.
  • An increased concentration of leukocytes can also indicate inflammation and/or infections of the bladder or kidney.
  • albumin concentration When testing for the presence of proteins, the concentration of albumin is particularly important. An increase in the albumin concentration can indicate kidney damage in diabetes mellitus or high blood pressure.
  • An increased concentration of sugar, especially glucose in the urine, can be an indication of increased blood sugar levels and/or diabetes mellitus.
  • the concentration of glucose in the urine can also be increased during pregnancy or in some types of cancer.
  • ketones as breakdown products of fatty acids in the urine can occur, for example, in a high-fat diet or during intensive fasting, but can also be a sign of metabolic imbalance in diabetics and/or pregnant women.
  • Elevated bilirubin and/or urobilinogen levels in the urine can indicate liver disease, among other things.
  • the cause can also be a blockage of the bile flow caused by gallstones, inflammation or tumors.
  • erythrocytes can be detected from a quantity of 5 erythrocytes/ml urine and/or proteins from a quantity of 10 mg/dl urine and/or sugar from a quantity of 40 mg/dl urine.
  • pH value of the urine may also be necessary to determine the pH value of the urine to be examined.
  • a change in the pH value can occur, for example, in cases of diarrhoea or diabetes.
  • the discoloration of the urine test strip that occurs after contact with urine is detected by the optical sensor and evaluated by an evaluation unit.
  • the evaluation unit can be located internally in the device or externally, with the data recorded by the device being transmitted to the evaluation unit.
  • the optical sensor can also register any visual abnormalities in the urine stream that are immediately detected by the optical sensor, such as a noticeable red discoloration or cloudiness. This alone can provide limited conclusions about the biochemical composition of the urine.
  • At least one lighting device for illuminating the detection field of the optical sensor is arranged on or in the receptacle of the vessel or on/in the handle.
  • the recorded data is preferably processed by a processor arranged in the device and then transmitted to the evaluation unit.
  • the results can be evaluated and displayed using an app.
  • the device has an integrated evaluation unit and a display device and that the recorded data are evaluated directly in the device and the results are displayed. This is particularly easy to do for the urine flow rate.
  • the device can have one or more signal lights which emit a signal when predetermined critical limit values are exceeded or not reached.
  • the user is informed in the event of a deviation of the recorded data from standard or normal values, for example supplemented by a reference to a necessary visit to the doctor.
  • the device comprises a storage medium for storing the data detected by the first sensor and by the optical sensor.
  • the device preferably has a receptacle for at least one battery or at least one rechargeable battery for power supply, which can be arranged in the receptacle or in the handle, wherein an arrangement in the handle is to be regarded as a preferred arrangement.
  • the inventive design of the device provides an easy-to-use device for home use that enables early detection of urological indicators in urine flow.
  • users can discreetly and in private draw conclusions about the state of health of their body and, if necessary, seek additional advice from a specialist if the results of the examination indicate an illness or other change in the body.
  • the inventive arrangement of the urine test strip in the container makes it possible not to touch the urine test strip during and after use.
  • the device offers a simple health check for the early detection of prostate, kidney or bladder diseases, for example. In older patients in particular, a prostate/kidney/bladder disease that is detected too late can lead to significant functional disorders.
  • the easy-to-perform self-test allows any unusual findings or changes to be quickly identified over time and a specialist to be consulted.
  • Functional abnormalities changes in urine flow, e.g. enlarged prostate or urethral strictures
  • composition of urine components are evaluated and recorded. These results are stored digitally and can be viewed by the user and evaluated by a doctor.
  • the longitudinal measurement is easy to repeat and makes it possible to determine changes that occur over time. It is also possible to monitor the progression of previously diagnosed diseases such as diabetes, bladder cancer, urinary tract infections, kidney and/or bladder diseases, gout (ketones as a metabolic product of fat breakdown), stones and/or cancer.
  • diseases such as diabetes, bladder cancer, urinary tract infections, kidney and/or bladder diseases, gout (ketones as a metabolic product of fat breakdown), stones and/or cancer.
  • the device is advantageously designed as a handheld device and can therefore be used anywhere. It is possible to use the device at home, take it with you on vacation or generally use it anywhere, e.g. in the toilet of a rest stop, hotel or restaurant or even outdoors.
  • the device according to the invention can be positioned near the toilet or urinal before and after use, for example on the toilet paper holder or on a separate holder that can be easily positioned on the wall or on the floor.
  • the device according to the invention in medical facilities, such as routine fever measurements, for routine urine tests, without placing excessive strain on the staff.
  • Figure 1 a schematic side view of a device according to the invention
  • Figure 2 a schematic side view according to Figure 1 with an inserted vessel, and a partial section of the vessel
  • Figure 3 a three-dimensional representation of the device with inserted vessel, which has two opposite pouring recesses
  • Figure 4 a front view of the device with the vessel inserted
  • Figure 5 a representation of the device with an inserted vessel, which has only one pouring opening opposite the handle
  • Figure 6 a schematic side view of a device according to the invention from without
  • Handle in which the camera is integrated into the holder on an upward-facing bar.
  • Figure 7 Housing area with camera and LED lighting
  • Figure 9 shows a vessel inserted into the ring-shaped holder, with its edge resting on the upper side of the holder.
  • Figure 10 shows the top view of a container with urine test strips and QR code on the bottom.
  • Figure 1 shows a schematic side view of a device according to the invention in side view without a vessel and Figures 2 to 4 show representations with a detachably inserted vessel 10.
  • the device has an annular receptacle 1 for inserting the vessel 10 and a handle 2.
  • the handle 2 is inclined with its longitudinal axis A2 in relation to the longitudinal axis A1 of the receptacle 1 at an angle a (see Figure 1).
  • a housing 3 is integrated into the handle 2 at the end on the receiving side, in which at least one camera 4 is arranged, which faces inwards towards the vessel 10.
  • a web 5 extends from the receiving end 1 to the handle 2.
  • the web 5 is connected to the handle 2 via a connecting area 6, which in turn is operatively connected to a load cell 7 integrated in the handle 2 (only shown in Figure 1).
  • a power supply integrated into the handle 2 e.g. at least one battery
  • an inclination sensor and an electronic assembly integrated into the handle 2 for recording and forwarding the data recorded by the sensors to a terminal device.
  • the handle 2 further comprises at least one switch 8, via which the device or the electronic elements integrated therein can be activated.
  • the annular receptacle 1 has an inner diameter d1 for receiving a vessel 10 (see Figures 2 to 4).
  • the receptacle 1 advantageously has orientation aids on its outer diameter for inserting the vessel 10, here opposing orientation aids 9.1, each preferably offset by 90° to the web 5, as well as an orientation aid 9.2 arranged between them.
  • the web 5 has at its upper end in the direction of the vessel a recess 5.1 and above this a projection 5.2 pointing in the direction of the vessel 10.
  • the projection 5.2 and the edge 11 overlap by an amount a.
  • the vessel 10 is not only fixed circumferentially via the inner diameter d1 of the receptacle 1, but is also axially fixed in the device.
  • the vessel 10 cannot slip out of the receptacle 1 in an undesirable manner.
  • the vessel 10 according to Figure 2 and Figures 3 and 4 has an upper edge 11 curved radially outwards, a peripheral wall 12 with an inner surface 12.1 and an outer surface 12.2. Furthermore, there is a peripheral support edge 13 and a base 14 at the bottom. In the edge 11, two opposing, in particular triangular, recesses 15 are preferably made here, which serve to pour out the urine. The support edge 13 can also be omitted if necessary.
  • the urine test strip 16 is arranged, for example, transversely on the inner surface 12.2 of the vessel 10, at a height h above the base 14, so that the camera 4 can capture it with its detection field open in a 16 ß. If necessary, the urine test strip 16 can also be arranged inside on the base 14 (not shown here).
  • a QR code 17 is printed on the inner surface 12.2, which is also captured by the camera 4 and is used to read out whether a container 10 intended for the application is being used.
  • the wall 12 of the vessel 10 is inclined at an angle y in the order of magnitude of 2° to 20° in relation to the longitudinal axis A10 of the vessel 10. This advantageously results in an angle ö when the urine stream 18 hits the inner wall 12.1, preferably in the area of the urine test strip 16, in the order of magnitude of 20° to 40°, in particular of 30° +/- 5°, whereby splashing of the urine stream 17 when it hits the wall 12 is reduced.
  • Figures 3 and 4 show further views of the embodiment according to Figure 2 with a vessel 10 received in the holder 1.
  • the elements arranged on the inside of the inner wall in the form of urine test strips 16 (arranged transversely or alternatively lengthwise on the inside of the vessel 10) and QR code 17 on the inside of the vessel 10 are indicated by dashed lines in Figures 3 and 4.
  • a vessel 10 is arranged in the device according to the invention, which has a recess 15 opposite the handle 2 for emptying the urine.
  • the urine test strip 16 is arranged on the inside of the vessel under the recess 15, running from top to bottom.
  • the QR code 17 also in the detection field of the camera (not visible here), which is arranged in the housing 3.
  • a switch 8.1 for switching on and off can be provided on the side of the handle, for example.
  • Figure 6 shows a variant without a handle.
  • the ring-shaped holder 1 is essentially designed as in Figure 1, but has a handle area 19 on its outer circumference.
  • the web 5 has the housing 3 for the camera 4 at its upper end and the load cell and/or the inclination sensor as well as the necessary electronic components, switches and the power supply are integrated in the housing 3 and/or the web 5, which are arranged in the handle in the aforementioned variants.
  • the vessel 10 is also accommodated as in the aforementioned variants.
  • the vessel 10 is tilted by pivoting/rotating the holder 1 in one direction or the other and the urine is poured out through one of the recesses 15. The vessel 10 can then be removed and disposed of.
  • the optical sensor/camera 4 In order to ensure an optimal detection field of the optical sensor/camera 4 which receives the urine test strip 16, the optical sensor/camera 4 is arranged at an unspecified height above the edge 11 of the vessel 1 and is inclined towards the urine test strip 16.
  • the first sensor is designed as a load cell 7 and is connected to the connection area 6. In this way, the first sensor in the form of the load cell 7 can detect the weight of the vessel 1 and thus also in particular of the urine in the vessel 1.
  • the changing weight of the vessel 10 during urination is recorded and thus determines how much urine the user micturates per period of time. This value is the urine flow rate.
  • Figure 7 shows the housing 3 of the camera 4 on the handle 2 or the bridge 5 in the front view.
  • at least one LED 20 is provided on both sides of the camera 4 for illumination.
  • the cross section of the connection area 6 to the bridge 5 is also visible.
  • Figure 8 shows a variant of the vessel 10 with an upper radially outward-pointing edge 11, a peripheral wall 12 with an inner wall 12.1 and an outer wall 12.2, a lower peripheral support edge 13 and a bottom 14.
  • the urine test strip 16 and the QR code 17 are arranged here on the inside of the base 14. Two recesses 15 are provided opposite each other in the upper edge 11. Alternatively, only one recess 15 indicated by dashed lines could be provided, or even three recesses 15.
  • At least one marking 10a can be present on the outer wall 12.2 of the vessel 10, which serves as a positioning aid when inserting the vessel 10 into the receptacle 1.
  • the vessel 10 reduces in its outer diameter from top to bottom, so that its base area can first be easily inserted into the annular receptacle 1.
  • the inner diameter of the annular receptacle 1 here corresponds approximately to the outer diameter of the vessel 10 in its upper third, so that the upper edge 11 still protrudes slightly above the receptacle 1.
  • the vessel 10 provided with the recesses 15 should protrude far enough over the receptacle 1 that the recesses 15 are located above it, so that when the urine is poured out, it does not come into contact with the receptacle 1.
  • the vessel 10 has no recesses 15 and the urine test strip 16 and the QR code 17 (see Figure 10) are located inside on the bottom 14.
  • the edge 11 of the vessel 10 is closed on the circumference and, according to Figure 9, rests on the upper side (not designated) of the annular receptacle 1.
  • the camera 4 which is preferably arranged in a housing 3 on the handle 2, is positioned above the vessel 10 in such a way that it covers the bottom area 14 of the vessel 10 and thus the located urine test strip 16 and, if present, also the QR code 17 with its detection angle ß.
  • Figure 10 shows the top view of the vessel 10 according to Figure 9.
  • the outer diameter D12.2 of the outer wall 12.2 of the wall of the vessel 10 below the edge 11 is slightly smaller than the inner diameter d1 of the annular receptacle 1, so that the vessel can be inserted into the receptacle 1 such that it rests with its edge 11 on the upper side of the receptacle 1.
  • the urine in the vessel 10 can be poured out by tilting the holder 1 and the vessel 10 therein without the holder 1 being wetted with urine.
  • a projection 5.2 is provided on the holder, which reaches over the edge 11 of the vessel 10 at the top and fixes it in the holder 1 when tilted.
  • a manually operable locking element could also be provided (not shown), which engages over the edge 11 by turning or sliding to fix the vessel 10.
  • the vessel 10 has a rim 13, which could, however, also be omitted.
  • the urine test strip 16 is arranged on the bottom 14 of the vessel 10, it can preferably be aligned lengthways to the camera 4 (in the direction of extension of the handle 2, see Figure 9) or also transversely to it and the camera 4 can be set in terms of its detection field in particular exactly to the urine test strip 16, which enables a good resolution.
  • the camera 4 should also capture the QR code 17 if this is also arranged on the bottom.
  • the vessel 10 should be positioned accordingly in the holder 1, for which a marking 10a can be provided on the outside of the vessel 10 and at least one orientation aid 9.1 and/or 9.2 (see Figures 3 and 4) on the outside of the holder 1.
  • the at least one marking on the vessel 10 and the orientation aid(s) on the holder 1 can of course also be arranged in other positions in order to realize the desired orientation of the vessel 1 with the urine test strip 16 on the bottom in relation to the camera 4.
  • the urine flow rate is recorded as in the examples described above.
  • a container or vessel 10 made of paper, cardboard or plastic is used, such as is used as a commercially available disposable packaging material (such as disposable food containers).
  • the edge 11 can grip/snap under the projection 5.2 when inserted into the holder 1. If the container 10 is to be removed, the edge 11 is pushed out of the position below the projection 5.2 by gently pressing.
  • the vessel can have a urine test strip printed or glued onto its inside.
  • the QR code is preferably printed.
  • the invention describes an extremely practical device for home urological care for everyone.
  • the data is stored in an app on the mobile phone and displayed visually. In the event of deviations from the (normal) values, the user is informed and advised that a visit to the doctor is necessary.
  • the device according to the invention in medical facilities, for example for routine urine tests such as routine fever measurements, without placing excessive strain on the staff.
  • Another feature of the invention is that instead of contactless recording of the biochemical data, a replaceable urine strip is used. This is also recorded and evaluated contactless by a camera.
  • the urine test allows conclusions to be drawn about the health of the person being examined and changes that occur over time as well as a follow-up of diseases. These can be, for example: blood sugar, bladder cancer, urinary tract infections, kidney and/or bladder diseases, gout (ketones are a metabolic product of fat breakdown!), follow-up of stones, cancer, the pH value - this is changed in the case of diarrhea, diabetes, red blood cells: inflammation, infections, cancer, urinary stones, white blood cells: inflammation, infections.
  • the solution according to the invention provides a mobile medical product, preferably for domestic use.
  • the device has in particular a handle 2 and a preferably round holder/receptacle 1 for an exchangeable container 10.
  • the urine measuring strip 16 attached to the container 10 can detect up to 10 biomarkers via the camera 4.
  • All of this data should be saved on a mobile phone and on the cloud server in order to obtain a long-term history of the measured data.
  • the data can be viewed at any time in the associated app. For example, after 3-6 months or at least 12 valid measurements, the user can request a report, which can then be used as a PDF to present to the family doctor or urologist.
  • the opening in the housing 3 for the LED flashes of the LEDs 20 (lighting) and the camera 4 are preferably covered by a tinted pane, in particular a plastic pane (not shown). It is possible to manufacture the handpiece in the form of the handle and the holder from one component and to provide a “weak point” for deformation between the handpiece (handle) and the cup ring (holder) and to attach suitable strain gauges there which are connected to the load cell for weight detection.
  • markings are provided on the ring/holder to enable the cup to be aligned in the ring.
  • the preferred container is a cardboard cup (coated) in a standard format, which should have a cup volume of approx. 900ml and a usable volume of approx. 750ml.
  • the surface of the paper cup should be printable in order to print markings for alignment and also the QR code in the camera's field of view.
  • the device When using the app for the first time, the device is paired with the app via Bluetooth.
  • Personal data is entered on the end device.
  • the measurements can then begin, and the OR code recorded by the camera is assigned to the user. After the measurement, the data obtained is displayed to the user on the device and saved there.
  • the temporal measurement history as well as a corresponding medical evaluation are displayed for the biochemical data.
  • the trend analysis for uroflowmetry displays average values for micturition volume, max. flow, micturition time and PUR in different temporal dimensions:
  • the desired evaluation time window can be freely selected via the app.
  • the solution according to the invention enables early urological detection at home with K-supported urine analysis via app. Thanks to long-term measurement, urological diseases can be counteracted in good time and one's own quality of life can be maintained and improved. For example, urine flow and biochemical data are measured twice a week or more often when urinating. They are then automatically sent to the Streamcheck app. The app creates a trend analysis of the health values recorded in the form of the so-called Uroflow curve. It also shows whether the amount of biomarkers in the urine corresponds to the normal value.
  • a preferred KL-supported evaluation of the urine data takes place directly in the Streamcheck app. Even the smallest anomalies are detected in this way. In this case, the user is given concrete recommendations for further action.
  • the uroflow data and biochemical values can be discussed with a medical professional using a report created in the app.
  • the Streamcheck medical product according to the invention includes an easy-to-use measuring device. This is used to collect valuable information from the urine on the toilet at home - including information on urine flow and the volume and duration of emptying.
  • the integrated urine test strip also analyses biochemical data that provides information about ten biomarkers, such as the sugar and protein content of the urine, and thus indicates possible diseases of the bladder or kidney.
  • the collected data is then saved in the “Streamcheck app” and documented in the form of a trend analysis based on Kl. This means that even minor changes in the urine can be noticed at an early stage.
  • a detailed trend analysis of the urine using Streamcheck allows early detection of minimal To detect deviations in health values and thus first signals of urological diseases.
  • Urological prophylaxis can therefore be carried out effectively and in accordance with guidelines.
  • the device according to the invention can be used to measure the biochemical data.
  • the maximum flow rate of urine should ideally be 30 ml/s. Urethral obstruction due to benign prostatic hyperplasia or bladder emptying dysfunction can cause a low QMax value.
  • the bladder should empty as quickly as possible and with a steady flow of urine. If it takes longer than 40 seconds, this could also indicate a bladder emptying disorder.
  • the uroflow curve illustrates the bladder emptying pattern (stop-and-go) and registers possible dripping or bladder congestion, which could be the first symptoms of a urological disease.
  • the volume indicates the amount of urine voided.
  • Bladder capacity or overactivity can affect the volume.
  • Uroflowmetry is a medical procedure used to diagnose potential damage to the bladder or urinary tract early and painlessly.
  • Streamcheck therefore offers the ideal combination of monitoring important health values and detailed urine flow measurement to both detect the first signs of bladder emptying disorders and to counteract acute bladder or kidney diseases in good time.

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Abstract

L'invention concerne un dispositif et un procédé pour déterminer le débit urinaire et/ou déterminer les données biochimiques de l'urine d'un utilisateur, en particulier pour l'utilisation domestique, ainsi qu'un récipient et une bandelette de test urinaire à cet effet, le dispositif se présentant sous la forme d'un appareil à main, comportant un logement (1) dans lequel un récipient (10) remplaçable peut être positionné pour recueillir l'urine de l'utilisateur pendant une miction, ce logement pouvant être amené manuellement avec le récipient dans une position de mesure au-dessous de la sortie de l'urètre de l'utilisateur, ainsi que des moyens pour détecter le débit urinaire et/ou pour déterminer les données biochimiques de l'urine, au moins une bandelette de test urinaire (16) étant disposée dans le récipient (10) pour détecter les données biochimiques. Selon le procédé, le débit urinaire est détecté à l'aide d'au moins un moyen pour détecter le débit urinaire et/ou pour déterminer les données biochimiques de l'urine, l'urine est versée hors du récipient après la fin de la miction de l'utilisateur par un mouvement de rotation du dispositif, le récipient (10) restant dans le logement (1), puis la bandelette de test urinaire (16) mouillée par l'urine est détectée au moyen d'un deuxième capteur sous la forme d'un capteur optique pour déterminer les données biochimiques. À cet effet, le récipient présente sur sa face intérieure au moins une bandelette de test urinaire (16) et cette bandelette de test urinaire (16) peut être pourvue d'une surface adhésive sur sa face arrière.
PCT/DE2023/100805 2022-11-04 2023-11-02 Dispositif et procédé pour déterminer le débit urinaire et/ou les données biochimiques de l'urine d'un utilisateur, récipient et bandelette de test urinaire WO2024094253A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
DE202022106218.8U DE202022106218U1 (de) 2022-11-04 2022-11-04 Vorrichtung zur Bestimmung der Harnfluss-Rate eines Nutzers
DE202022106218.8 2022-11-04
DE202023101025.3U DE202023101025U1 (de) 2023-03-03 2023-03-03 Vorrichtung zur Bestimmung der Harnfluss-Rate und/oder der biochemischen Daten des Urins eines Nutzers, Gefäß und Teststreifen
DE202023101025.3 2023-03-03
DE202023106304 2023-10-30
DE202023106304.7 2023-10-30

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WO2024094253A4 WO2024094253A4 (fr) 2024-06-27

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Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050288608A1 (en) 2004-05-07 2005-12-29 Jacques Corcos Ambulatory device for measuring urine flow
US20130041236A1 (en) * 2010-04-28 2013-02-14 Siemens Healthcare Diagnostics Inc. Sample analysis system and method of use
DE102014008760A1 (de) 2013-07-16 2015-01-22 Simone Beck-Gschaidmeier Harnflussmessgerät
WO2015038717A1 (fr) * 2013-09-11 2015-03-19 Wellumina Health, Inc. Système pour le test diagnostique d'échantillons liquides
US20170035342A1 (en) 2015-08-05 2017-02-09 Art Healthcare Ltd. Point of care urine analyzer
EP3351304A1 (fr) * 2017-01-24 2018-07-25 Thomas Meseg Gobelet de test pour l'analyse d'un échantillon de fluide, dispositif d'analyse d'un échantillon de fluide, kit de pièces et procédé
EP3412206A1 (fr) 2017-06-09 2018-12-12 Centre Hospitalier Universitaire de Liège Dispositif de mesure du poids de miction portable
EP3331450B1 (fr) 2015-08-03 2019-11-06 Medipee Gmbh Dispositif et procédé d'analyse mobile d'excréments dans les toilettes
WO2019231513A1 (fr) 2018-06-01 2019-12-05 ClearTrac Technologies, LLC Débitmètre urinaire
US20200209044A1 (en) 2017-05-22 2020-07-02 Stream DX, Inc Capacitive measurement device with minimized sensitivity to manufacturing variability and environmental changes

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050288608A1 (en) 2004-05-07 2005-12-29 Jacques Corcos Ambulatory device for measuring urine flow
US20130041236A1 (en) * 2010-04-28 2013-02-14 Siemens Healthcare Diagnostics Inc. Sample analysis system and method of use
DE102014008760A1 (de) 2013-07-16 2015-01-22 Simone Beck-Gschaidmeier Harnflussmessgerät
WO2015038717A1 (fr) * 2013-09-11 2015-03-19 Wellumina Health, Inc. Système pour le test diagnostique d'échantillons liquides
EP3331450B1 (fr) 2015-08-03 2019-11-06 Medipee Gmbh Dispositif et procédé d'analyse mobile d'excréments dans les toilettes
US20170035342A1 (en) 2015-08-05 2017-02-09 Art Healthcare Ltd. Point of care urine analyzer
EP3351304A1 (fr) * 2017-01-24 2018-07-25 Thomas Meseg Gobelet de test pour l'analyse d'un échantillon de fluide, dispositif d'analyse d'un échantillon de fluide, kit de pièces et procédé
US20200209044A1 (en) 2017-05-22 2020-07-02 Stream DX, Inc Capacitive measurement device with minimized sensitivity to manufacturing variability and environmental changes
EP3412206A1 (fr) 2017-06-09 2018-12-12 Centre Hospitalier Universitaire de Liège Dispositif de mesure du poids de miction portable
WO2019231513A1 (fr) 2018-06-01 2019-12-05 ClearTrac Technologies, LLC Débitmètre urinaire
US20190365307A1 (en) 2018-06-01 2019-12-05 ClearTrac Technologies, LLC Uroflowmeter

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