Device for determining the urinary flow rate and / or the biochemical data of a user's urine, container and urine test strips

Abstract

Device in the form of a handheld device, especially for home use, for determining the urinary flow rate and / or determining the biochemical data of a user's urine, - with a receptacle (1) in which an interchangeable vessel (10) for collecting the user's urine during micturition can be positioned and wherein the receptacle with the vessel can be manually brought into a measuring position below the opening of the user's urethra, - wherein the device includes means for measuring the urinary flow rate and / or for determining the biochemical data of the urine, wherein at least one urine test strip (16) is arranged in the vessel (10) for recording the biochemical data.

Description

[0001] The present invention relates to a device 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 claims, as well as a vessel suitable therefor according to claim 18 and a urine test strip according to claim 19.

[0002] By examining a person's urine, extensive conclusions can be drawn about their physical well-being. This can reveal not only signs of diseases of the kidney and urinary system, but also metabolic disorders such as diabetes or liver disease.

[0003] 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.

[0004] 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.

[0005] Tests that assess both the flow rate and the biochemical composition of urine are often more complex and are usually performed in doctor's offices or hospitals. Since many affected individuals are reluctant to consult 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 through early detection.

[0006] Indwelling catheters are known for medical applications, as disclosed, for example, in the document US 2017 / 0035342 A1, but they are not suitable for home use.

[0007] WO 2019 / 231513 A1 describes a uroflowmeter and a method for processing the data generated thereby. In one aspect, 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 can contain both reusable and disposable components. As a uroflowmeter, it can identify and record data corresponding to the flow rate over the measured duration of a urinary void, but it can also time-stamp the voiding event 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 initially collected in the uroflowmeter, which must be emptied and cleaned after use.A biochemical examination of the urine is not planned.

[0008] DE 10 2014 008 760 A1 discloses a disposable urine flow measuring device comprising 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. A flow measuring device for measuring the maximum flow rate (Qmax) is arranged at the outlet opening. This device also does not allow for analysis of the biochemical composition of the urine and has a complicated technical design.

[0009] Finally, EP 3 331 450 B1 describes a device for determining physiological data by analyzing human excrement in a toilet using at least one indicator and / or sensor, as well as a method for determining physiological data by analyzing human excrement in a toilet by measuring urine and / or stool values. This is achieved by a measuring system in which, for each measurement, an indicator or sensor can be brought into a measuring position by means of an arm, in which sufficient contact with the urine or stool to be examined occurs, the indicator or sensor being designed as an independent unit, as well as a corresponding method in which a plurality of previously determined values ​​are measured and subsequently further processed and, if necessary, forwarded. A disadvantage of this device is that it must be mounted in a toilet and cannot be used hand-held.

[0010] US 2019 / 0365307 A1 also discloses a device for measuring urine flow, which has a handle and can detect the weight of the excreted urine. Furthermore, a camera can be provided for detecting the fill level of a container connected to the handle. Where the camera for detecting the fill level is located is not specified.

[0011] US 2005 / 0288608 A1 provides an ambulatory device for measuring urine flow, comprising a portable handheld container, a flow measuring device located in the container, and a means for collecting the data collected by the flow measuring device. Flow measurement is relatively complex, and biochemical data of the urine are not recorded.

[0012] EP 3 412 206 A1 discloses a portable device for measuring urine weight and a container provided therefor, which can be disposed of in the toilet bowl. The device comprises 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 to detect the weight of the container. The disadvantages are the complex design of the clamp and container, and the fact that the important biochemical data of the urine are not recorded.

[0013] 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 are sometimes not suitable for home use.

[0014] From the publication US 2020 / 0 209 044 A1, a device in the form of a handheld device is known, which can also be used to determine the urine flow rate. The device comprises a vessel for receiving a user's urine, which has two capacitive sensors in its wall. In a container section 102, a circuit board device integrated into 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 further 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 below the container, to which the container is connected. For this purpose, the container has a coupling element, e.g., a thread or a bayonet closure. It is suggested that the container part may be disposable. However, due to its complex design, this is a high cost factor.The electronic assembly may include sensors for capturing biochemical data, which are transmitted via the container section 102. This is also very complex.

[0015] To determine the biochemical data of urine, current technology typically uses urine test strips that are dipped into urine collected in a container. A urine test for home use thus includes a urine test strip and a color scale for its evaluation.

[0016] Depending on the test, discoloration may appear on the test strip after some time. This discoloration must be visually compared with the scale on the packaging to determine which substances are present in the urine and in what concentration. This may result in incorrect interpretation of the urine test strip by the user. Furthermore, the data is not saved.

[0017] To date, the detection of urine test strips using an optical sensor in the context of home use is not known.

[0018] A not yet published application discloses a device for measuring urine flow and for determining the biochemical composition of a user's urine stream, comprising a flow-through region surrounded by a peripheral region, which can be manually moved into a measuring position. The device further comprises 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 peripheral region and have a detection field arranged in the flow-through region of the device or directed towards the flow-through region, and wherein the first sensors are optical sensors and / or ultrasonic sensors. This device is very cost-intensive and can lead to undesirable measurement errors if the user holds it unsteadily.

[0019] The invention is based on the object of providing a device as well as a vessel and a test strip for simple urological screening, 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.

[0020] The problem is solved by the features of claims 1, 15, and 16. Further useful embodiments of the invention are the subject of the dependent claims.

[0021] The device according to the invention is designed in the form of a handheld 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 an exchangeable vessel for collecting the user's urine during urination 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 and / or for determining the biochemical data of the urine, wherein at least one urine test strip is arranged in the vessel for detecting the biochemical data.

[0022] The solution according to the invention makes it possible for the first time to record a user's urinary flow rate (uroflow) and / or the biochemical data of their urine using a handheld device. The urinary flow rate and the biochemical data can be recorded together or separately during a single measurement for a user's micturition.

[0023] In order to detect the urine flow rate, the device has at least one first sensor for detecting the weight and / or volume of the urine collected in the vessel during micturition.

[0024] To determine the biochemical data of the urine, 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.

[0025] The first and / or the second sensor are preferably arranged in / on the receptacle for the vessel or in / on a handle that adjoins the receptacle.

[0026] Advantageously, the device has a ring-shaped and circumferentially closed or ring-shaped and circumferentially open receptacle.

[0027] Alternatively, the holder can also be designed like a clamp and grip the vessel at the top in the area of ​​its rim.

[0028] If the receptacle is ring-shaped, it has an inner diameter into which the vessel can be inserted, so that its base extends through the ring-shaped receptacle. The vessel then clamps, for example, with its outer diameter in the inner diameter of the ring-shaped receptacle or rests with a rim or rim area on the top of the ring-shaped receptacle.

[0029] If the vessel is inserted into the annular receptacle, 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.

[0030] The data acquired 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.

[0031] 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.

[0032] Of course, it is also possible to provide one or more displays on the device with which the collected data can be shown to the user.

[0033] It is further possible for the device to comprise means for detecting the duration of micturition and for a signal processing unit to evaluate the increase in the weight of the vessel during the duration of micturition and to determine the urine flow rate taking this period into account.

[0034] It is also possible to equip the device with an inclination sensor located on / in the handle or on / in the container holder. This can be used, for example, to detect the container tipping over based on the change in inclination.

[0035] 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 urination.

[0036] The preferred container is a paper cup whose circumference tapers towards a base and which has an outwardly curved upper edge,

[0037] At least one urine test strip and / or a barcode and / or a QR code are located inside the container, within the detection range of the optical sensor. The urine test strip is glued in, for example, and the barcode and / or QR code are preferably printed. If necessary, the urine test strip can also be printed.

[0038] 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 container. It is also possible for the container to have at least one marking on its inside for positioning the at least one urine test strip.

[0039] Advantageously, at least one marking for positioning the vessel in the receptacle can also be provided on an outer wall of the vessel.

[0040] The urine test strip may have an adhesive surface on its back for attachment to the inner surface of a container.

[0041] The weight of the vessel is advantageously transmitted via the vessel holder by means of a connecting region of a transmission element to the load cell arranged in the holder or in the handle.

[0042] To ensure good illumination of the area to be captured by the camera (second sensor), at least one illumination device, in particular an LED, is arranged in an edge area of ​​the holder and / or on the handle, pointing toward the urine test strip. Preferably, several LEDs are provided in the area of ​​the camera or around the camera, or a camera with appropriate illumination is used.

[0043] Furthermore, 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 also be provided directly in the device or in the evaluation unit.

[0044] A method for determining the urine flow rate and / or determining the biochemical data of a user's urine using the device according to the invention is described below. First, the user's urine is collected during urination in a container 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 container.

[0045] To determine the biochemical data of the urine, the urine is poured out of the container by turning 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.

[0046] The data of the first means(s) 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.

[0047] 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.

[0048] The advantage is that the container can be disposed of after use and replaced with a new one. Therefore, the user does not necessarily have to clean the device after use. Of course, it can also be simply rinsed under water after removing / disposing of the container from the holder.

[0049] The device itself has an extremely simple structure and requires little space.

[0050] 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.

[0051] The device may also incorporate a tilt sensor. This triggers a start signal at the start of urination, and the tilt sensor detects the lateral tilt of the container, which can be interpreted as the end of urination, for example. The time interval between these two events, in conjunction with the weight or volume of urine collected during urination, is used to calculate the urine flow rate.

[0052] Preferably, 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.

[0053] The receptacle for the detachable holding of the vessel is preferably ring-shaped or clamp-like.

[0054] With the ring-shaped design, the container is inserted into the ring-shaped holder from above with its base. With a clamp-shaped holder, the holder preferably grips the upper edge of the container.

[0055] The replaceable container is designed for single use for urination or can be used several times a day for one urination each, for example to record the volume of urine excreted over a day.

[0056] For example, when measuring weight, the volume is determined and this is added up via the evaluation unit according to the desired period of time - e.g. one day.

[0057] The weight of the vessel is preferably transmitted via the vessel holder by means of a transmission element to a load cell arranged in the holder or in the handle.

[0058] The optical sensor is designed, in particular, as a camera and is also arranged in the holder or handle of the device. The camera's detection field should capture the urine test strip and / or the QR code, or the urine test strip and / or the barcode and / or the QR code are arranged on the wall of the container within the detection range of the optical sensor.

[0059] The QR code or barcode located in the container identifies whether it is the container intended for the application.

[0060] For illumination, a lighting device can be provided, which is preferably arranged in the area of / next to the camera on the holder and / or on the handle pointing towards the urine test strip.

[0061] In particular, 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.

[0062] It is advantageous to store the urine flow rate and / or the biochemical data of the urine over a period of several days / weeks / months, so that a trend analysis is possible.

[0063] The preferred container is a recyclable paper or cardboard cup or a plastic cup with an outwardly curved upper rim.

[0064] The invention thus also relates to a vessel for the device according to the invention, which vessel 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.

[0065] 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.

[0066] Furthermore, the container can have a barcode and / or QR code on its inner wall.

[0067] The vessel may also have at least one marking on its outer wall for positioning so that it can be inserted into the receptacle in a specific, predetermined position.

[0068] Instead of using a container with urine test strips attached inside, a container can also be used which only has a marking for attaching a urine test strip.

[0069] In this case, a urine test strip with an adhesive backing is used. This is then stuck into the container in the area marked.

[0070] The QR code, initially scanned with the camera, guarantees that a properly certified container is being used. If this is not the case, an error message appears and no measurement is taken. Once a properly certified container is inserted into the device, the measurement process and urination can begin, with the duration of the urination and the weight of the urine being recorded first. The container is then emptied, and the urine test strip moistened with urine is read by the camera, allowing the biochemical data of the urine to be determined. For this purpose, all data is transmitted to the device for evaluation, preferably wirelessly (Wi-Fi, Bluetooth, or similar). This is preferably done via an app and appropriate software.

[0071] "Urine flow measurement or measurement of the urinary effluent rate" within the meaning of the invention refers to the detection of the "flow rate" of the urine or of the urine collected in the vessel during the duration of urination. When detecting the flow rate of the urine stream, 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.

[0072] The device according to the invention makes it possible to carry out a determination of the biochemical composition of the urine stream essentially at the same time as 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.

[0073] The duration of urination can also be recorded using a time-recording unit integrated into the device, which, for example, begins recording as soon as the first sensor registers the beginning of urine absorption into the container. Recording ends as soon as urine absorption into the container also ceases, i.e., the weight stops increasing.

[0074] Advantageously, the device has a handle designed to be grasped by a user. Alternatively, the handle can be omitted, allowing the user to hold the receptacle for the container. For this purpose, the receptacle can, for example, have a corresponding gripping area.

[0075] The transmission element for transmitting the weight is preferably a metallic bending strip that is coupled to a load cell in the holder or handle.

[0076] Furthermore, the control unit, as well as a switch for switching the device on and off and optionally a second switch for starting and stopping the detection by the sensors are preferably also located in the holder or handle.

[0077] Because at least one urine test strip is arranged in the detection field of the optical sensor and the latter is designed as a camera, the optical sensor is able to detect the urine test strip and a color change of the urine test strip.

[0078] The urine test strip can detect the biochemical composition of the urine. Preferably, 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.

[0079] For example, an elevated 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. As a general rule, a red blood cell count of 100 cells / ml can be considered safe.

[0080] An increased concentration of leukocytes can also indicate inflammation and / or infections of the bladder or kidney.

[0081] When testing for protein, the concentration of albumin is particularly important. An increase in albumin concentration can indicate kidney damage in diabetes mellitus or hypertension.

[0082] An elevated concentration of sugar, especially glucose, in the urine can be an indication of elevated blood sugar levels and / or diabetes mellitus. The concentration of glucose in the urine can also be elevated during pregnancy or in certain types of cancer.

[0083] The presence of 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.

[0084] Elevated bilirubin and / or urobilinogen levels in the urine can indicate liver disease, among other things. However, the cause can also be a blockage of bile flow caused by gallstones, inflammation, or tumors.

[0085] In particular, erythrocytes can be detected at a level of 5 erythrocytes / ml urine and / or proteins at a level of 10 mg / dl urine and / or sugar at a level of 40 mg / dl urine. It may also be necessary to determine the pH of the urine being tested. An altered pH can occur, for example, in cases of diarrhea or diabetes.

[0086] 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 within the device or externally, with the data recorded by the device being transmitted to the evaluation unit.

[0087] The optical sensor can also detect visual abnormalities in the urine stream, such as a noticeable red discoloration or cloudiness. This alone can provide limited insight into the biochemical composition of the urine.

[0088] According to a preferred embodiment, 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.

[0089] The acquired data is preferably processed by a processor located in the device and then transmitted to the evaluation unit. The results can be evaluated and displayed via an app.

[0090] The device can also be provided with an integrated evaluation unit and a display device, and the recorded data can be evaluated directly in the device and the results displayed. This is particularly simple for the urine flow rate.

[0091] Advantageously, the device can have one or more signal lights which emit a signal when predetermined critical limit values ​​are exceeded or undershot.

[0092] It may also be provided that 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.

[0093] In a further embodiment, the device comprises a storage medium for storing the data detected by the first sensor and by the optical sensor.

[0094] Furthermore, 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.

[0095] 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. By examining their own urine discreetly and in private, users can draw conclusions about their body's state of health and, if necessary, seek additional advice from a specialist if the test results indicate an illness or other physical changes.

[0096] 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.

[0097] The device offers a simple health check for the early detection of, for example, prostate, kidney, or bladder diseases. Especially in older patients, delayed detection of prostate, kidney, or bladder disease can lead to significant dysfunction. The easy-to-perform self-test allows for rapid detection of abnormal findings or changes over time, allowing consultation with a specialist. Functional abnormalities (changes in urine flow due to, for example, prostate enlargement or urethral strictures) as well as the composition of urine components are evaluated and recorded. These results are stored digitally and can be viewed by the user and evaluated by a physician.

[0098] The longitudinal measurement is easily repeatable and allows for the detection of changes that occur over time. It also allows for monitoring the progression of previously diagnosed diseases such as hyperglycemia, bladder cancer, urinary tract infections, kidney and / or bladder disease, gout (ketones are a metabolic product of fat breakdown), stones, and / or cancer.

[0099] The device is advantageously designed as a handheld / 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 restroom of a motorway service station, a hotel or restaurant, or even outdoors.

[0100] For use at home, 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.

[0101] Of course, it is also possible to use 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.

[0102] The invention is explained in more detail below with reference to exemplary embodiments and associated figures, without being limited to these.

[0103] They show: Fig. 1: a schematic side view of a device according to the invention, Fig. 2: a schematic side view according to Fig. 1 with an inlaid vessel, and a partial section of the vessel, Fig. 3: a three-dimensional representation of the device with inserted vessel, which has two opposite pouring recesses, Fig. 4: a front view of the device with the vessel inserted, Fig. 5: a representation of the device with the vessel inserted, which has only one pouring opening opposite the handle, Fig. 6: a schematic side view of a device according to the invention without a handle, in which the camera is integrated into the receptacle on an upwardly facing web. Fig. 7 Housing area with camera and LED lighting, Fig. 8 vessel according to the invention in 3D view, Fig. 9 a vessel inserted into the ring-shaped receptacle, the edge of which rests on the upper side of the receptacle. Fig. 10 Top view of a container with urine test strips and QR code on the bottom.

[0104] Fig. 1 shows a schematic side view of a device according to the invention in side view without vessel and the Fig. 2 to 4 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 α (see Fig. 1).

[0105] A housing 3 is integrated into the handle 2 at the receiving end, in which at least one camera 4 is arranged, which faces inward toward the vessel 10. A web 5 extends from the receiving end 1 to the handle 2.

[0106] At its upper end, 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 in Fig. 1).

[0107] Not shown are a power supply integrated into the handle 2 (e.g. at least one battery) as well as 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.

[0108] The handle 2 further comprises at least one switch 8, via which the device or the electronic elements integrated therein can be activated.

[0109] The annular receptacle 1 has an inner diameter d1 for receiving a vessel 10 (see Fig. 2 to 4).

[0110] Furthermore, 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 therebetween.

[0111] 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.

[0112] When the vessel 10 is inserted, its outwardly curved upper edge 11 engages in the recess 5.1 and the projection 5.2 engages over the edge (see Fig. 2 to 4).

[0113] The projection 5.2 and the rim 11 overlap by an amount a. This not only secures the vessel 10 circumferentially across the inner diameter d1 of the receptacle 1, but also axially fixes it in the device. Furthermore, when the urine is poured out, the vessel 10 cannot accidentally slip out of the receptacle 1. To remove the vessel 10, its upper rim 11 is manually pushed out of the recess 5.1.

[0114] The vessel 10 according to Fig. 2 and the Fig. 3 and Fig. 4 has an upper, radially outwardly curved edge 11, a peripheral wall 12 with an inner surface 12.1 and an outer surface 12.2. Furthermore, a peripheral support edge 13 and a base 14 are provided at the bottom. Preferably, two opposing, particularly triangular, recesses 15 are provided in the edge 11, which serve to pour out the urine. The support edge 13 can also be omitted if necessary.

[0115] On the inner surface 12.2 of the container 10, the urine test strip 16 is arranged, for example, transversely, at a height h above the base 14, so that the camera 4 can capture it with its detection field open in a 16β. If necessary, the urine test strip 16 can also be arranged inside the base 14 (not shown here).

[0116] Furthermore, a QR code 17 is printed on the inner surface 12.2, which is also captured by the camera 4 and via which it is read whether a container 10 intended for the application is used.

[0117] The wall 12 of the vessel 10 is inclined at an angle γ in the range of 2° to 20° with respect to the longitudinal axis A10 of the vessel 10. Advantageously, this results in an angle δ in the range of 20° to 40°, in particular 30° + / - 5°, when the urine stream 18 strikes the inner wall 12.1, preferably in the area of ​​the urine test strip 16, thereby reducing splashing of the urine stream 17 upon impact with the wall 12.

[0118] The Fig. 3 and Fig. 4 show further views of the execution according to Fig. 2 with a vessel 10 accommodated in the receptacle 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 in the Fig. 3 and Fig. 4 indicated by dashed lines.

[0119] From the Fig. 3 and Fig. 4 it can be seen that the marking 10a of the vessel 10, which is applied on the outer wall 12.2, is aligned with the orientation aid 9.2 on the outside of the holder 1. Furthermore, the two opposing orientation aids 9.1 from the Fig. 4, which are curved outwards. The two edge recesses 15 in the vessel 10 are preferably positioned over the orientation aids 9.1 of the receptacle 1.

[0120] In Fig. 5, a vessel 10 is arranged in the device according to the invention, which vessel has a recess 15 opposite the handle 2 for emptying the urine. The urine test strip 16 is arranged inside the vessel below the recess 15, running from top to bottom. Next to the urine test strip 16 is the QR code 17, also within the detection field of the camera (not visible here), which is arranged in the housing 3. In addition to the switch 8 on the handle 2, which is pressed here, for example, during urination, a switch 8.1 for switching on and off can be provided, for example, on the side of the handle.

[0121] Fig. 6 shows a variant without a handle. The ring-shaped holder 1 is essentially the same as in Fig. 1, but has a gripping 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, which are arranged in the handle in the aforementioned variants, are integrated into the housing 3 and / or the web 5. The vessel 10 is also accommodated as in the aforementioned variants.

[0122] After urination is complete, the vessel 10 is tilted in one direction or the other by pivoting / rotating the holder 1, and the urine is poured out through one of the recesses 15. The vessel 10 can then be removed and disposed of.

[0123] 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.

[0124] The first sensor is designed as a load cell 7 and is connected to the connecting area 6. In this way, the first sensor in the form of the load cell 7 can detect the weight of the container 1 and thus also, in particular, the weight of the urine contained in the container 1.

[0125] In particular, the changing weight of the vessel 10 during urination is recorded, thus determining how much urine the user micturates per period of time. This value is the urinary flow rate.

[0126] Fig. Figure 7 shows the front view of the housing 3 of the camera 4 on the handle 2 or the bridge 5. Here, at least one LED 20 is provided for illumination on each side of the camera 4. The cross-section of the connecting area 6 to the bridge 5 is also visible.

[0127] Fig. 8 shows a variant of the vessel 10 with an upper radially outward-facing 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 base 14.

[0128] The urine test strip 16 and the QR code 17 are arranged 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.

[0129] Furthermore, 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 approximately corresponds to the outer diameter of the vessel 10 in its upper third, so that the upper edge 11 still protrudes slightly beyond the receptacle 1.

[0130] 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.

[0131] According to a variant published in the Fig. 9 and Fig. 10, the container 10 has no recesses 15 and the urine test strip 16 and the QR code 17 (see Fig. 10) are located inside on the bottom 14. The edge 11 of the vessel 10 is closed on the circumference and is located according to Fig. 9 on the upper side (not labeled) 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 captures the bottom area 14 of the vessel 10 and thus the urine test strip 16 located thereon and, if present, also the QR code 17 with its capture angle β.

[0132] Fig. 10 shows the top view of the vessel 10 according to Fig. 9.

[0133] The outer diameter D12.2 of the outer wall 12.2 of the wall of the vessel 10 below the rim 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 its rim 11 rests on the upper side of the receptacle 1.

[0134] Since the outer diameter D11 of the rim 11 of the vessel 10 is larger than the outer diameter D1 of the receptacle 1, the urine contained in the vessel 10 can be poured out by tilting the receptacle 1 and the vessel 10 contained therein, without the receptacle 1 becoming wet with urine. This variant also features a projection 5.2 on the receptacle, which extends over the top of the rim 11 of the vessel 10 and secures it in the receptacle 1 when tilted.

[0135] Instead of the projection 5.2, 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.

[0136] The vessel 10 has a rim 13, which could, however, also be omitted.

[0137] If the urine test strip 16 is arranged on the bottom 14 of the vessel 10, it can preferably be arranged lengthwise to the camera 4 (in the direction of extension of the handle 2, see Fig. 9) or perpendicular to it, and the camera 4's detection field can be precisely adjusted to the urine test strip 16, thereby enabling good resolution. Of course, the camera 4 should also detect the QR code 17, even if it is located on the floor.

[0138] With such an intended orientation of the urine test strip 16, the vessel 10 should be positioned accordingly in the receptacle 1, for which a marking 10a is provided on the outside of the vessel 10 and at least one orientation aid 9.1 and / or 9.2 is provided on the outside of the receptacle 1 (see Fig. 3 and Fig. 4) may be provided. The at least one marking on the vessel 10 and the orientation aid(s) on the receptacle 1 can, of course, also be arranged at other positions in order to realize the desired orientation of the vessel 1 with the urine test strip 16 on the bottom with respect to the camera 4.

[0139] However, it is also possible to position the urine test strip 16 and, if applicable, also the QR code 17 on the base 14, whereby it may not matter which orientation they have with respect to the camera 4, since they are always reliably detected by the camera 4 if the aperture angle β of the camera 4 captures the inside of the base 14 of the vessel 10 accordingly.

[0140] In this variant, therefore, preferably no alignment of the vessel 10 according to the position of the urine test strip 16 (and if present also of the QR code 17) is required, as in the variants in which the urine test strip is arranged inside on the wall 11 of the vessel 10. Therefore, in the embodiment according to Fig. 9 and Fig. 10 no positioning aids are required for the positional orientation of the vessel 10 on the holder 1 and on the container 10.

[0141] The urine flow rate is recorded as in the examples described above.

[0142] Preferably, a container or vessel 10 made of paper, cardboard or plastic is used, such as is used, for example, as a commercially available disposable packaging material (such as disposable food containers).

[0143] Since the wall 12 and the rim 11 can be slightly compressed manually, the rim 11 can grip / snap under the projection 5.2 when inserted into the receptacle 1. If the container 10 is to be removed, the rim 11 is pushed out of the position below the projection 5.2 by gently pressing it.

[0144] In the described embodiments, the vessel may have a printed or glued urine test strip on its inside.

[0145] It is also possible that there is a marking in the container that serves to stick a urine test strip in a desired position.

[0146] The QR code is preferably printed.

[0147] The invention describes an extremely practical device for home urological screening for everyone. The data is stored in a mobile phone app and displayed visually. In the event of deviations from the (normal) condition, the user is notified and advised of the need for a doctor's visit.

[0148] Of course, it is also possible to use the device according to the invention in medical facilities, for example for routine fever measurements, as well as for routine urine tests, without placing excessive strain on the staff.

[0149] The following data is collected in particular: 1. Flow rate a) ml / sb) Total volume / tc) Flow rate / t 2. Blood = Erys < 5 / ul 3. Protein = 10mg / dl 4. Sugar = 40 mg / dl.

[0150] Another feature of the invention is that, instead of contactless recording of biochemical data, a replaceable urine strip is used. This is also recorded and evaluated contactlessly by a camera. Urine testing allows conclusions to be drawn about the health of the person being examined, including changes that occur over time, and the monitoring of disease progression. These can include, for example, hyperglycemia, bladder cancer, urinary tract infections, kidney and / or bladder disease, gout (ketones are a metabolic product of fat breakdown!), monitoring of stones, cancer, the pH value—this can change in diarrhea, diabetes, red blood cells: inflammation, infections, cancer, kidney stones, white blood cells: inflammation, infections.

[0151] The inventive solution provides a mobile medical device, preferably for home use. The device has, in particular, a handle 2 and a preferably round holder / receptacle 1 for a replaceable container 10.

[0152] It is possible to measure urine flow during urination. The urine test strip 16 attached to the container 10 allows up to 10 biomarkers to be detected via the camera 4.

[0153] All of this data will be stored on a mobile phone and on the cloud server to maintain a long-term history of the measured data. The data can be viewed at any time using 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 submit to a family doctor or urologist.

[0154] The opening in the housing 3 for the LED flashes of the LEDs 20 (illumination) and the camera 4 are preferably covered by a tinted pane, in particular a plastic pane (not shown).

[0155] It is possible to manufacture the handle in the form of the grip and the holder from one component and to provide a "weak point" for deformation between the handle (grip) and the cup ring (holder) and to attach suitable strain gauges there that are connected to the load cell for weight recording.

[0156] Advantageously, markings are provided on the ring / receptacle to facilitate alignment of the cup within the ring. Alternatively, it is also possible to design the receptacle geometry oval or otherwise non-circular, thereby securing the position via a positive fit.

[0157] The preferred container is a standard-sized (coated) cardboard cup with a capacity of approximately 900ml and a usable volume of approximately 750ml. The surface of the paper cup should be printable to accommodate alignment markings and the QR code within the camera's field of view.

[0158] When using the app for the first time, the device is paired with the app via Bluetooth.

[0159] Personal data is entered on the end device.

[0160] Measurements can then begin, with the OR code captured by the camera being assigned to the user. After the measurement, the collected data is displayed and saved on the user's device.

[0161] Users can access a trend analysis of all measured values. This displays the time course of the biochemical data as well as a corresponding medical evaluation. The trend analysis for uroflowmetry displays averaged values ​​for micturition volume, maximum flow, micturition time, and PUR in various temporal dimensions: - Long-term average - Rolling mean - Quarterly change

[0162] The desired evaluation time window can be freely selected via the app.

[0163] The inventive solution enables early urological detection at home with K1-supported urine analysis via an app. Thanks to long-term monitoring, urological diseases can be counteracted in a timely manner and one's quality of life can be maintained and improved.

[0164] For example, urine flow and biochemical data are measured during urination twice a week or more often. These are then automatically transmitted to the Streamcheck app. The app creates a trend analysis of the recorded health values ​​in the form of a so-called uroflow curve. It also shows whether the amount of biomarkers in the urine corresponds to the normal value.

[0165] A preferred analysis of urine data, supported by a KL (clinician), takes place directly in the Streamcheck app. Even the smallest anomalies are detected. In these cases, the user is provided with specific recommendations for further action.

[0166] For example, every three months (or more often if necessary), the uroflow data and biochemical values ​​can be discussed with a medical professional using a report created in the app.

[0167] This allows early signs of urological diseases to be identified at a glance and treated in a timely manner

[0168] AI-based monitoring of collected data allows even the smallest abnormalities to be detected immediately. Early treatment reduces the risk of surgical interventions and irreparable long-term consequences.

[0169] The Streamcheck medical device according to the invention comprises an easy-to-use measuring device. It collects valuable information from urine on the toilet at home—including urine flow, volume, and duration of voiding.

[0170] The integrated urine test strip also analyses biochemical data that provides information on ten biomarkers, such as the sugar and protein content of the urine, and thus indicates possible bladder or kidney diseases.

[0171] The collected data is then stored in the "Streamcheck app" and documented in the form of a trend analysis based on AI. This allows even minor changes in urine to be detected early.

[0172] If any abnormalities are detected, users are provided with specific instructions for further action. Furthermore, a report for further medical use can be requested after three months and every six months thereafter.

[0173] A large proportion of men over 50 are affected by benign prostatic hyperplasia. In the worst case scenario, this can lead to irreparable damage to the bladder and kidneys—although many of these limitations are preventable.

[0174] A detailed trend analysis of urine using Streamcheck allows for early detection of minimal deviations in health values ​​and thus the first signs of urological diseases.

[0175] Urological prophylaxis can therefore be performed effectively and in compliance with guidelines. The risk of major surgical interventions and irreparable long-term consequences such as incontinence and loss of potency can be significantly reduced – and the quality of life of users can be maintained in the long term.

[0176] The unique combination of regular urine flow measurement, preferably including biochemical data, and Cl-based trend analysis makes Streamcheck an indispensable technology in urology.

[0177] In addition to the biochemical data, the following parameters can be checked / measured using the device according to the invention: Flow rate:

[0178] The maximum urine flow rate should ideally be 30 ml / s. Urethral obstruction due to benign prostatic hyperplasia or bladder dysfunction can cause a low QMax value. Duration of emptying

[0179] Bladder emptying should occur 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. Uroflow curve:

[0180] The uroflow curve illustrates the bladder emptying pattern (stop-and-go) and registers possible dribbling or bladder congestion, which could be the first symptoms of a urological disease. Excreted volume:

[0181] The volume indicates the amount of urine voided.

[0182] Bladder capacity or overactivity can affect the volume.

[0183] Uroflowmetry is a medical procedure used for the early and painless diagnosis of potential damage to the bladder or urinary tract.

[0184] It is crucial to carry out urine flow measurements regularly: important parameters include the flow rate of urine, the volume excreted, the duration of emptying and the bladder emptying pattern, preferably every two weeks.

[0185] Over time, the individual measurements can be combined to create a trend analysis, which reveals even a slight deterioration in the flow data. The Streamcheck app displays the trend analysis in the form of a uroflowmetry diagram.

[0186] During uroflowmetry, a variety of biochemical markers are also tested using an integrated urine test strip. If any of these values ​​remain outside the normal range for an extended period, a visit to a specialist is recommended.

[0187] Streamcheck thus offers the ideal combination of monitoring important health parameters and measuring urine flow in detail, both to detect the first signs of bladder emptying disorders and to counteract acute bladder or kidney diseases in a timely manner. List of reference symbols 1 recording 2 handles 3 housings 4 Camera 5 bridge 5.1 Recess 5.2 Advantage 6 Connection area 7 Load cell 8 switches 8.1 Switch 9.1 Guidance 9.2 Guidance 10 vessels 10.a Marking 11 Edge 12 Wall 12.1 Inner surface / inner wall 12.2 Outer surface / outer wall 13 Standing edge 14 Floor 15 Recess / cutout 16 urine test strips 17 QR code 18 Urine stream 19 Grip area a Amount of overlap A1 Longitudinal axis of the image A2 Longitudinal axis of the handle A10 Longitudinal axis of the vessel d1 inner diameter of the holder D1 Outer diameter of the holder D11 Outer diameter of the rim 11 D12.2 Outer diameter of the vessel 10 at the outer wall 12.2 below the rim 11 h height α Angle between longitudinal axis A1 and longitudinal axis A2 Angle of the detection field β γ Angle between wall 12 and longitudinal axis A10 δ Angle between urine stream 18 and inner wall 12.1 QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] US 2017 / 0035342 A1

[0006] WO 2019 / 231513 A1

[0007] DE 10 2014 008 760 A1

[0008] EP 3 331 450 B1

[0009] US 2019 / 0365307 A1

[0010] US 2005 / 0288 608 A1

[0011] EP 3 412 206 A1

[0012] US 2020 / 0 209 044 A1

[0014]

Claims

[1] Device in the form of a hand-held device, in particular for home use, for determining the urine flow rate and / or determining the biochemical data of the urine of a user, - with a receptacle (1) in which a replaceable vessel (10) for collecting the user's urine during micturition can be positioned, and wherein the receptacle with the vessel can be manually brought into a measuring position below the exit of the user's urethra, - the device comprising means for detecting the urine flow rate and / or for determining the biochemical data of the urine, wherein at least one urine test strip (16) is arranged in the vessel (10) for recording the biochemical data. [2] Device according to claim 1, characterized by that the device - for detecting the urine flow rate, at least one first sensor for detecting the weight and / or volume of the urine collected in the vessel (10) during micturition and / or - for determining the biochemical data of the urine, at least one second optical sensor for determining the biochemical values ​​of the urine by contactless detection of the urine test strip (16) arranged in the vessel, wherein the first and / or the second sensor is / are arranged in / on the annular receptacle or in / on a handle which adjoins the annular receptacle or in / on a web / connecting region (5) between the receptacle (1) and the handle (2). [3] Device according to one of the preceding claims, characterized by that the device has an annular and circumferentially closed or circumferentially open receptacle (1) or that the receptacle (1) is designed in the manner of a clamp. [4] Device according to claim 3, characterized by that the annular receptacle (10) has an inner diameter (d1) into which the vessel (10) can be inserted so that it engages with a bottom (14) through and the wall (12) of the annular receptacle (1). [5] Device according to claim 3 or 4, characterized by that it has at least one means (5.2) which fixes the vessel (10) in the annular receptacle (1) during a pivoting movement for pouring out the urine. [6] Device according to one of claims 2 to 5, characterized by that the first sensor is a load cell (7) and that the second sensor is a camera (4) and that the data recorded with the first sensor and / or the second sensor can be transmitted to a terminal device and can be evaluated and displayed therein by means of an evaluation unit / evaluation electronics and that a trend analysis of the data recorded over a period of time can be carried out. [7] Device according to one of claims 1 to 5, characterized by that the device has means for detecting the duration of micturition and that a signal processing unit evaluates the increase in the weight of the vessel (10) during the duration of micturition and determines the urine flow rate per time period. [8] Device according to one of claims 1 to 6, characterized by that it has an inclination sensor which is arranged on / in the handle (2) or on / in the receptacle (1) of the vessel (10) or in / on the web / connecting area (5). [9] Device according to one of the preceding claims, characterized by that the vessel (10) is a paper, cardboard or plastic cup, the circumference of which tapers towards a bottom (14) and which has an outwardly curved upper edge (11). [10] Device according to one of the preceding claims, characterized bythat at least one urine test strip (16) and / or a barcode and / or a QR code (17) is / are arranged inside the vessel (10) in the detection range of the second optical sensor. [11] Device according to one of the preceding claims, characterized by that the weight of the vessel (10) can be transmitted via the receptacle (1) of the vessel (10) by means of a connecting region (6) of a transmission element to the load cell (7) arranged in the receptacle (1) or in the handle (2). [12] Device according to one of the preceding claims, characterized by that at least one lighting device, in particular an LED (20), pointing in the direction of the urine test strip (16) is arranged on or in an edge region of the holder (1) and / or on the handle (2). [13] Device according to one of claims 2 to 12, comprising an interface for transmitting the data detected by the first sensor and / or by the optical sensor and / or by the inclination sensor and / or the duration of micturition measured by means of a time recording to an evaluation unit, preferably to a computer and / or a mobile phone and / or a tablet. [14] Device according to one of the preceding claims, comprising 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. [15] Vessel for a device according to claim 1, characterized bythat the vessel (10) has at least one urine test strip (16) and / or a barcode and / or a QR code and / or a marking for positioning the urine test strip (16) on an inner wall (12.1) of its wall (12) and / or on the inside of its base (14) and / or that the vessel (10) has at least one marking for positioning the urine test strip (16) on an outer wall (12.2) of the wall (12) in the receptacle (1). [16] Urine test strip for a vessel according to claim 15, characterized by that the urine test strip (16) has an adhesive surface on its back for attachment to an inner surface of a vessel (10).

Images