Urine analysis device

Abstract

The urine analyzer (1) is for analyzing a urine sample and determining its physicochemical properties, and includes a first sampling module (2). The module includes a first drain duct (20) configured to be in fluid communication with the user and having a containment section (20a) defining a predetermined volume and configured to hold a first fraction of urine, and a discharge section (20b) configured to discharge a second fraction of urine from the first sampling module (2); a urine bag (3) configured to be in fluid communication with at least the discharge section (20b) and to collect the second fraction; an analyzer (4) configured to be in fluid communication with the containment section (20a) and to analyze at least a portion of the first urine fraction; control means (5) configured to process at least the data collected by the analyzer (4); and a second sampling module (7) configured to be operably connected to the analyzer (4) and to be in fluid communication with the analyzer (4), including a shut-off valve (70), and configured to receive a syringe containing a urine sample, so that the analyzer (4) can analyze the urine sample.

Description

[Technical Field]

[0001] The present invention relates to a urine analyzer of the type defined in the preamble of claim 1.

[0002] The apparatus according to the present invention can be installed near the bed, for example, at least partially under the bed, and can be directly connected to the patient via a catheter. Specifically, the apparatus is capable of performing electrochemical urine analysis. [Background technology]

[0003] As is well known, urine testing is now one of the primary analytical techniques for identifying or ruling out many conditions and problems (such as structural damage, the presence of infectious pathogens, or dysfunction of one or more organs). In particular, urine testing is a major form of kidney analysis and is therefore an important test for recognizing the possibility of kidney dysfunction and, by extension, understanding the condition of the kidneys themselves.

[0004] One of the main analytical methods is electrochemical analysis, which calculates the potential difference between a pair of electrodes and uses this to determine the pH, sodium, potassium, ammonium, and chloride content in the urine. This analysis is currently performed as follows:

[0005] A catheter is inserted into the patient to allow urine to be drained into a special container such as a bag, from which a healthcare professional collects an appropriate amount of urine. This can be done using a syringe, other similar devices properly inserted into the bag, or by measuring the exact amount of urine using a suitable dropper.

[0006] The collected samples are then diluted. This reduces the influence of interfering substances that could lead to errors in sample evaluation and, consequently, errors in analytical results.

[0007] After diluting the urine sample, it is inserted into the analyzer, and the analysis is performed according to a predetermined procedure.

[0008] Specifically, reagents and / or chemical solutions are added to the urine sample to counteract the adverse effects of interfering substances that could lead to erroneous analytical results. The elements added vary depending on the analysis being performed and may include, for example, urease enzymes used in urea analysis, or cation exchange columns necessary to remove or reduce high concentrations of ammonium ions.

[0009] Once the sample is ready for analysis, it can be placed, for example, between two electrodes, and the content of the target substance can be determined by measuring the potential difference between these electrodes.

[0010] The aforementioned well-known methods have several significant drawbacks. In fact, the procedures used are particularly time-consuming and require the continuous presence of a healthcare professional. In particular, the collection of the urine volume to be analyzed, performed by the operator, introduces the possibility of sample contamination, in addition to a clear increase in testing time.

[0011] Another problem is the analysis itself, which is particularly complex and difficult to conduct.

[0012] In particular, the composition of urine varies greatly from patient to patient, and even between different samples collected from the same patient, so it is sometimes necessary to use different dilutions with reagents.

[0013] Another important point is that this analysis is also a function of temperature, and temperature has a decisive influence on the final result.

[0014] These factors make it difficult to adjust all parameters, resulting in a less-than-optimal analysis of urine samples. [Overview of the Initiative]

[0015] In this context, the fundamental technical problem of the present invention is to devise a urine analyzer that can substantially eliminate at least some of the aforementioned drawbacks.

[0016] Within the scope of this technical problem, an important object of the present invention is to devise a device that enables simple, rapid, and frequent analysis and substantially monitors the patient's condition.

[0017] In fact, the organs essential for survival are the heart, lungs, and kidneys. Although there are various devices for monitoring the heart and lungs by analyzing the respiratory and circulatory systems, the kidneys cannot be monitored by known devices.

[0018] A further object of the present invention is to realize a device that does not require the presence of medical staff or paramedical staff and can thus perform the analysis essentially automatically.

[0019] The urine analysis device according to appended claim 1 achieves the predetermined technical problems and objectives.

[0020] Preferred technical solutions are specified in the dependent claims.

Brief Description of the Drawings

[0021] The features and advantages of the present invention will be clarified below by a detailed description of the preferred embodiments of the present invention with reference to the accompanying drawings.

[0022] [Figure 1] FIG. 1 is a front schematic view of a urine analysis device according to the present invention. [Figure 2] FIG. 2 shows the details of a rigid rack forming the interface surface of a cartridge of a urine analysis device according to the present invention. [Figure 3] FIG. 3 shows the details of a bag of a cartridge of a urine analysis device according to the present invention. [Figure 4a] FIG. 4a is a perspective view of a cartridge of a urine analysis device according to the present invention, with the entire interface surface open. [Figure 4b] FIG. 4b is a perspective view of a cartridge of a urine analysis device according to the present invention, with a part of the interface surface, particularly the plug part, open and including a cover. [Figure 5a]Figure 5a shows details of the interface seat of the urine analyzer cartridge according to the present invention, with the drain hole at the bottom visible and a pin guide. [Figure 5b] Figure 5b is a detailed view of the interface seat of the urine analyzer cartridge according to the present invention, showing numerous drainage holes at the bottom and an inlet guide. [Figure 6] Figure 6 is a front view of the analysis station of the urine analyzer according to the present invention. [Figure 7] Figure 7 is a simplified functional diagram of the urine analyzer according to the present invention. [Modes for carrying out the invention]

[0023] In this document, measurements, shapes, and geometric criteria (such as perpendicularity and parallelism) associated with terms such as “approximately,” “roughly,” or “about,” or similar expressions such as “to a considerable extent,” shall be considered excluding measurement errors due to manufacturing tolerances or inaccuracies, and above all, excluding slight deviations from the measured value, shape, or geometric criteria. Or, when associated with similar terms such as “substantially,” they shall be considered excluding measurement errors due to manufacturing tolerances or inaccuracies, and above all, excluding slight deviations from the associated value, measured value, shape, or geometric criteria. For example, when these terms are associated with a value, preferably, the deviation shall not exceed 10% of that value.

[0024] Furthermore, when used, terms such as "first," "second," "superior," "inferior," "primary," and "secondary" do not necessarily indicate order, priority, or relative position, but are sometimes simply used to clearly distinguish different components.

[0025] Unless otherwise specified, the terms “processing,” “operation,” “decision,” and “calculation” in the following discussion refer to the operations and / or processes of a computer or similar electronic computing device that manipulate and / or transform physically represented data (e.g., electron quantities in registers), or other data similarly represented as physical quantities in registers or memory within a computer system, or in other storage devices, transmission devices, or information display devices within a computer system.

[0026] Unless otherwise specified, the measurements and data described in this text are assumed to have been conducted in accordance with the International Standard Atmosphere (ICAO) (ISO 2533:1975).

[0027] Referring to the drawings, the urine analyzer according to the present invention is collectively referred to as reference numeral 1.

[0028] In particular, the apparatus is designed to be used for the analysis of urine samples, preferably in their raw state, i.e., without the addition of reagents or solutions, to measure their physicochemical properties. More specifically, apparatus 1 measures the pH and sodium, potassium, ammonium, and chloride content of the urine sample, while simultaneously measuring its instantaneous urine flow rate.

[0029] Apparatus 1 includes at least a first sampling module 2.

[0030] The first sampling module 2 is part of the inlet system for placing the fluid to be analyzed into the apparatus 1. In particular, the first sampling module 2 is configured to communicate with the user and the fluid.

[0031] Therefore, the first sampling module 2 enables urine to reach the device 1 when it is discharged and measures the fluid entering the device 1.

[0032] In this regard, to explain in more detail, the first sampling module 2 preferably includes a first drainage duct 20. The first drainage duct 20 is a passage through which urine passes to be processed by the device 1 before being disposed of.

[0033] Preferably, the first drain duct 20 is a siphon conduit that includes a coil that allows for automatic control of the flow of a fluid, i.e., urine.

[0034] Therefore, the first drain duct 20 preferably includes a containment part 20a and a releasing part 20b.

[0035] The containment section 20a is essentially part of the first drainage duct 20, located upstream of the discharge section 20b.

[0036] The containment section 20a is configured to hold a first portion of urine. For this purpose, the containment section 20a may substantially include a section of the first U-shaped drainage duct 20 located upstream of the discharge section 20b. The discharge section 20b, on the other hand, is configured to discharge a second portion of urine from the first sampling module 2.

[0037] In summary, when urine flows into the first drainage duct 20, it passes through the containment section 20a, and once it reaches a sufficient filling level, at least a portion of it begins to flow through the discharge section 20b and is partially discharged by the first sampling module 2.

[0038] Furthermore, the storage section 20a defines a predetermined volume. Therefore, it is possible to determine the volume of the first fraction of urine that remains in the first sampling module 2.

[0039] The first sampling module 2 may include additional features.

[0040] In particular, the first sampling module 2 may include a cannula outlet 21.

[0041] If a cannula outlet 21 is present, it is connected to the discharge section 20b by a fluid passage. Therefore, the cannula outlet 21 is suitable for controlled discharge of urine from the first sampling module 2.

[0042] The first sampling module 2 may also include a cannula inlet 22.

[0043] If a cannula inlet 22 is present, it is configured to be connected to the user. Therefore, the cannula inlet 22 is part of the first sampling module 2, which should be directly connected to the user.

[0044] Furthermore, the first sampling module 2 may also include the first tank 23.

[0045] The first tank 23 is essentially a collection tank for collecting urine from the patient. Preferably, the first tank 23 is in fluid communication with the cannula inlet 22 and the containment section 20a. That is, the first tank 23 is positioned between the cannula inlet 22 and the containment section 20a and is suitable for receiving urine before it flows into the containment section of the first drainage duct 20.

[0046] Furthermore, the first tank 23 may have a sloped bottom surface configured to push urine toward the first drain duct 20 by gravity when the first sampling module 2 is in use.

[0047] The first sampling module 2 may include a second drain duct 24. The second drain duct 24 may be a flow path formed parallel to the first drain duct 20. More specifically, the second drain duct 24 is in fluid communication with the first tank 23 and the cannula outlet 21. The second drain duct 24 is configured to transport urine from the first tank 23 to the cannula outlet 21. Preferably, when the amount of urine in the first tank 23 exceeds a predetermined threshold level, the second drain duct 24 aspirates urine from the first tank 23.

[0048] Therefore, essentially, the second drain duct 24 is a safety channel, or empty-full channel, configured to prevent the first tank 23 from becoming abnormally filled and impairing the normal function of the first sampling module 2.

[0049] Furthermore, the tank 23 may be equipped with a filter mesh at the top of the tank 23 relative to the ground, i.e., in the portion closest to the cannula inlet 22. If a filter mesh is provided, its mesh size should be suitable for separating foreign matter such as blood clots and organic precipitates from the urine.

[0050] Therefore, device 1 also includes a diuresis bag 3.

[0051] Bag 3 is essentially a tank, partitioned by, for example, deformable walls, rigid walls, or partially deformable and partially rigid walls, and capable of containing fluid inside.

[0052] Therefore, bag 3 is impermeable to liquid. Furthermore, it is preferable that bag 3 is in fluid communication with the discharge section 20b. In this way, bag 3 is configured to collect a second urine portion, i.e., the urine discharged from the first sampling module 2.

[0053] The connection between bag 3 and discharge section 20b may be direct or indirect. Preferably, the connection between bag 3 and discharge section 20b is made by the cannula outlet 21.

[0054] Furthermore, bag 3 is advantageously separated from the first sampling module 2. Preferably, bag 3 includes a nozzle 30.

[0055] The nozzle 30 is configured to accommodate at least a portion of the cannula outlet 21.

[0056] Therefore, the nozzle 30 is also substantially configured to form a fluid communication between the first sampling module 2 and the bag 3.

[0057] The outlet 30 may be a simple hole provided in the wall surface, such as the top of the bag 3. In fact, preferably, the first module 2 is intended to be positioned above the bag 3 relative to the ground when in use, so that urine can flow into the bag 3 by gravity.

[0058] Alternatively, the nozzle 30 may be equipped with specific restraint means, such as a quick connector that securely fixes one end of the outlet cannula 21 to the wall of the bag 3, or a pre-perforated membrane that deforms so that a portion of the outlet cannula 21 enters the bag 3.

[0059] Apparatus 1 further includes an analytical device 4.

[0060] The analyzer 4 is a known device, but it is configured to analyze at least the first urine fraction. Therefore, the analyzer 4 is in fluid communication with the housing 20a.

[0061] Naturally, device 1 also includes control means 5.

[0062] The control means 5 are operably connected to at least the analyzer 4. Furthermore, they are configured to process data collected by at least the analyzer 4. Obviously, the control means 5 may also be operably connected to other components of the apparatus 1, as more specifically defined below.

[0063] Preferably, in more detail, the analyzer 4 and control means 5 may be similar to the analyzer station and command and control unit described in paragraph [0037-0052] of patent application EP-A-2510877 (incorporated by reference herein).

[0064] Essentially, the analyzer 4 is suitable for performing electrochemical analysis of urine and is equipped with multiple electrodes. Each electrode is suitable for measuring at least one parameter for each of its physicochemical properties, such as potential difference. The analyzer 4 may include an analysis station, which is equipped with at least five electrodes and is expandable. Expansion specifically includes a reference electrode 46, at least one ion-selective electrode 47, or other similar elements that can interact with the analyte.

[0065] Specifically, at least one ion-selective electrode 47 is provided for each of the properties to be analyzed (pH, sodium, potassium, ammonium, and chloride). For example, Figure 6 shows an analysis station equipped with six ion-selective electrodes 47: one for pH analysis, four for detecting sodium, potassium, ammonium, and chloride content, and a sixth that is not used for this particular analysis but can be used later to detect further physicochemical properties of the urine sample.

[0066] The reference electrode 46 has a conductive element 46a, for example, silver, housed in a chamber 46b that contains a fluid for maintaining the electrode 46 at a constant potential.

[0067] Each ion-selective electrode 47 contacts the medium and reacts with specific ions. More specifically, the ion-selective electrode 47 has the following: an electrical connector 47a (such as a pin or an electrical circuit), which can enable an electrical connection between the ion-selective electrode 47 and the reference electrode 46 in the presence of the fluid to be analyzed; an ion-sensitive membrane 47b or other similar element that reacts with specific ions; a central body 47c that can accommodate substantially all the elements constituting the ion-selective electrode 47 and defines two different chambers; a connection chamber 47d interposed between the membrane 47b and the connector 47a and capable of accommodating a fluid (such as a saturated potassium chloride solution) that characterizes the electrode offset value; and an accommodation chamber 47e adjacent to the ion-selective electrode 47 that can accommodate urine.

[0068] Specifically, after the ion-selective electrode 47 is disposed at a predetermined position, it is preferable that the accommodation chamber 47e has a through-hole such that the accommodation chamber 47e forms a single conduit and fluid can freely pass between the chambers and between the chambers and the analyzer 4. To prevent fluid leakage, a sealing member such as an O-ring 47f can be interposed between the electrodes.

[0069] Each ion-selective electrode 47 has the ability to react with only one type of the substances to be analyzed. Specifically, in the case of the apparatus 1 for measuring pH and the sodium, potassium, ammonium, and chloride contents, the ion-selective electrode 47 is sensitive to at least one of the H + 、Na + 、K + 、NH4 + 、Cl - ions.

[0070] The selection is made using an ion-sensitive membrane 47b that is specially manufactured and optimized for the interacting target element.

[0071] For example, the membranes for H + and Na + ions are glassy matrices, while for K + 、NH4 + and Cl -The membrane used for ions is a high molecular weight polymer matrix.

[0072] Apparatus 1 may include a thermostat 48 in the analyzer 4 that is suitable for adjusting the temperature of the fluid to be analyzed and the calibration solution (calibrator). The thermostat 48 includes any components suitable for maintaining the urine temperature substantially constant, such as an electrical resistor. Preferably, this temperature is substantially in the range of 30°C to 45°C, and more preferably substantially 37°C.

[0073] Finally, electrodes 46 and 47 are electrically connected to control means 5 suitable for controlling the presence of a washing or calibration block, in order to analyze the data collected by each ion-selective electrode 47, compare the collected data with the data from the standard electrode 46, and enable preparation before the analysis of the analyzer 4.

[0074] The control means 5 not only analyzes data from the analyzer 4 but is also preferably connected to the first sampling module 2, more specifically to the first sensor means 25. In fact, either the cannula inlet 22 or the first drain duct 20 may include the first sensor means 25 in at least one embodiment. The latter is preferably an optical means operably connected to the control means 5 and configured to detect the passage of urine through the cannula inlet 22 or the first drain duct 20.

[0075] Naturally, the first sampling module 2 may also include a first pilot valve 26.

[0076] If the latter is present, it may be operably connected to the control means 5. Thus, the control means 5 may be configured to activate the first pilot valve 26 when urine passes through the cannula inlet 22 or the first drainage duct 20.

[0077] The first pilot valve 26 may be substantially positioned between the analyzer 4 and the first drain duct 20, particularly the containment section 20a, and may be configured to guide the first fraction of urine from the containment section 20a to the analyzer 4.

[0078] The first sampling module 2 preferably includes a ventilation duct 27. The ventilation duct 27 is preferably in fluid communication with two separate points of the first drainage duct 20 and with the external environment. More specifically, the ventilation duct 27 is in fluid communication with both ends of the containment section 20a and with the external environment. This allows the ventilation duct 27 to ensure that the same pressure is applied to both ends of the urine collected in the containment section 20a, enabling the urine to remain stably in the siphon section, i.e., within the containment section 20a.

[0079] The cleaning or calibration block may consist of removable parts.

[0080] In a preferred but non-exclusive embodiment, the analyzer 4 may include an interface seat 40 in addition to the analysis station.

[0081] The interface seat 40 is preferably operably connected to an analysis station including electrodes. Furthermore, the interface seat 40 is essentially a tank, i.e., an open container capable of housing removable components.

[0082] An advantage is that the interface seat 40 includes multiple inlets 40a. These inlets 40a can include orifices, plugs, or any other elements that allow for the insertion or superposition of other connectable elements.

[0083] Preferably, the analyzer further includes a cartridge 41.

[0084] The cartridge 41 is an available element provided within the interface seat 40. Specifically, it is preferable that the cartridge 41, like the interface seat 40, has at least a portion of a counter-shaped form.

[0085] Furthermore, cartridge 41 is suitable for interaction with inlet 40a.

[0086] Therefore, advantageously, the cartridge 41 includes an interface surface 42 and a plurality of bags 43.

[0087] The interface surface 42 is the portion of the cartridge 41 intended to directly interact with the inlet 40a. Therefore, preferably, the interface surface 42 includes a plurality of plugs 42a.

[0088] Therefore, plug 42a is configured to be connected to inlet 40a. Specifically, each 42a plug is connected to its respective inlet 40a.

[0089] Naturally, in another embodiment, the interface seat 40 may include a plug 42a, and the interface surface 42 may include an inlet 40a.

[0090] In any case, it is preferable that the cartridge 41 has a polarity mode when inserted into the interface slot 40, and that each inlet 40a corresponds to a specific plug 42a.

[0091] Furthermore, the plug 42a or inlet 40a is configured to be connected to the inlet 40a or plug 42a, respectively. In addition, it is preferable that the plug 42a or inlet 40a on the interface surface 42 are in fluid communication with the corresponding bag 43, respectively.

[0092] Each bag 43 is preferably impermeable to liquids. Furthermore, each bag contains a calibration solution, a washing solution, or a control solution.

[0093] For example, a control solution is used to monitor the performance quality of instruments or electrodes over time, following the same procedure as the analysis.

[0094] Therefore, the cartridge 41 has the advantage of containing all calibration, cleaning, and control substances separately inside, and being replaceable by connecting each bag 43 or by removing them from each plug 42a or the inlet 40a of the interface surface 42.

[0095] The interface surface 42 is preferably a rigid rack in order to facilitate connection between the cartridge 41 and the interface seat 40.

[0096] Conversely, preferably, the bag 43 is deformable. More specifically, each bag 43 has a wall made of a double barrier film that is permeable only to gas. To facilitate connection of the bag 3 to an inlet 40a or plug 42a, each bag 43 is provided with a spout 43a. Thus, the spout 43a is configured to be housed in the corresponding plug 42a or inlet 40a on the interface surface 42.

[0097] At the same time, each nozzle 43a may include a suction valve.

[0098] In particular, bag 43 contains a fluid having known physicochemical properties to be analyzed, and may include at least one maximum calibrator and one minimum calibrator, each having a high content and a low content, respectively. Preferably, the high content and low content are close to the maximum contents and minimum contents, respectively, with respect to the values ​​expected to be obtained by the analysis.

[0099] More precisely, the maximum calibration solution consists of a fluid with a known pH and sodium, potassium, ammonium, and chloride content, preferably higher than the maximum values ​​found in the urine sample. On the other hand, the minimum calibration solution consists of a fluid with a known pH and sodium, potassium, ammonium, and chloride content, preferably lower than the minimum values ​​found in the urine sample.

[0100] Furthermore, the cartridge 41 can also be advantageously equipped with a casing 44.

[0101] If present, the casing 44 accommodates the bag 43.

[0102] Preferably, the casing 44 is made of a renewable material, such as corrugated cardboard. Therefore, after the casing 44 is emptied from the bag 43, it can be disposed of or reused in an environmentally friendly manner.

[0103] Furthermore, the casing 44 preferably defines the shape of an open container and therefore preferably includes at least one opening 44a. Thus, the opening 44a faces the interface surface 42. In particular, the opening 44a may be open across the entire interface surface 42 so that the interface surface 42 is fully facing the interface surface 42, as shown, for example, in Figure 4a.

[0104] Alternatively, the opening 44a may be positioned to precisely face the interface surface 42 in the plug 42a, as shown in Figure 4b, for example. Furthermore, the opening 44a may be provided with a cover, such as a tear-off cover, which is suitable for covering the plug 42a or the inlet 40a when the cartridge 41 is not in use and is removable to allow the cartridge 41 to be connected to the interface housing 40.

[0105] At the same time, the interface housing 40 may include a flat bottom surface from which the inlet 40a or plug 42a is cut. Alternatively, the interface housing 40 may include a guide 40b. The guide 40a may be, for example, a bottom strip that protrudes from the rest of the bottom surface and forms a raised portion.

[0106] If guide 40b is present, it is positioned at the entrance 40a or plug 42a of the interface housing 40. Furthermore, guide 40b is advantageously bent in the opposite direction at the opening 44a. In this way, guide 40b allows enclosure 44 to be clamped to guide 40b when enclosure 40 is inserted into interface housing 40.

[0107] Since calibration fluid or cleaning fluid is primarily a liquid substance, it is advantageous to provide a drain hole 40c in the interface seat.

[0108] If the drain hole 40c is present, it is preferably provided on the bottom surface of the interface seat 40, and if the guide 40b is present, it is preferably provided in a portion not occupied by the guide.

[0109] Therefore, the drain hole 40c is configured to allow liquid to flow out from the interface seat 40. This means that if even a small amount of unwanted leakage occurs from the interface surface 42, the drain hole 40c will allow the excess liquid to flow out.

[0110] Generally, the interface seat 40 is appropriately connected to the rest of the analyzer 4 and the control means 5.

[0111] To enable the transport of urine between various parts of the device 1, the control means 5 includes not only electronic connection means for controlling various valves, solenoid valves, and other components of the device 1, but also connectors for fluid passages between various parts, such as between the first sampling module 2 and the analyzer 4.

[0112] For example, the control means 5 as a whole is in fluid communication with at least the first sampling module 2 and the analyzer 4.

[0113] Therefore, the control means 5 may include a steering station 50.

[0114] If present, the steering station 50 is suitable for controlling device 1.

[0115] The steering station 50 may include, or be connected to, output elements such as a printer or mass storage device so that the results can be printed or displayed on an external device such as a computer.

[0116] Furthermore, the steering station 50 can be programmed to perform analyses at predetermined times or at predetermined time intervals. This ensures accurate analysis even during the regular operation of the device 1 and, consequently, in the absence of the operator.

[0117] In this regard, the steering station 50 may include at least a screen or similar element capable of displaying analysis results, and a control element such as a keyboard capable of controlling the operation of the entire device 1. Alternatively, the screen may be a touchscreen, enabling control of the device 1 in addition to displaying data.

[0118] The control means 5 is connectable to the suction valve of the bag 43 when the interface surface 42 of the cartridge 41 is connected to the plug 42a or the inlet 40a of the interface seat 40.

[0119] Furthermore, the control means 5 can be connected to the first pilot valve 26.

[0120] In this way, the control means 5 can control the inflow and outflow into the analysis device 4.

[0121] The control means 5 may, in particular, include a pump 51.

[0122] The pump 51 is operably connectable to at least the first pilot valve 26 and can therefore be positioned in fluid communication with the first pilot valve 26.

[0123] Furthermore, if the cartridge 41 is connected to the interface seat 40, the pump 51 can be connected to the bag suction valve 43.

[0124] Therefore, the pump 51 may be configured to transport urine from the first sampling module 2, i.e., the storage unit 20a, to the analyzer 4 in a controlled manner. Alternatively, it may be configured to transport calibration fluid or washing fluid from the bag 43, i.e., the cartridge 41, to the rest of the analyzer 4.

[0125] In a preferred but non-exclusive embodiment, the apparatus 1 includes acquisition means 6.

[0126] If present, the collection means 6 is operably connected to the bag 3.

[0127] Furthermore, these are configured to obtain a first parameter related to the weight of at least a second urine fraction, i.e., the urine fraction discharged from the first sampling module 2 via the discharge unit 20b.

[0128] Therefore, it is preferable that the control means 5 be operably connected to the collection means 6. Furthermore, the control means 5 is configured to calculate a second parameter relating to the volume of a second urine fraction in relation to a first parameter, when a predetermined third parameter relating to urine density is given.

[0129] Basically, the control means 5 allows setting a known urine density value that constitutes a third parameter, for example, via the steering station 50. Therefore, if the weight of the second urine fraction is known by the sampling means 6, i.e., by obtaining the first parameter, the volume of the second urine fraction can be simply calculated by multiplying the ratio of weight (i.e., the first parameter) to density (i.e., the third parameter) by the acceleration due to gravity.

[0130] After the second parameter, namely the total amount of the second urine fraction, is obtained, this second parameter can be added to the predetermined capacity of the storage section 20a that contains the first urine fraction.

[0131] In this way, the control means 5 can obtain the total amount of urine in the device 1.

[0132] Furthermore, the sampling means 6 may be further configured to acquire a fourth parameter related to the urine flow time within the first drainage duct 20.

[0133] For example, a photocell can be used to measure the time it takes for urine to pass through a portion of the drainage duct 20.

[0134] Therefore, the control means 5 can be further configured to associate the total urine volume with a fourth parameter in order to determine the urine flow rate.

[0135] Apparatus 1 may also include a second sampling module 7.

[0136] The second sampling module 7, if present, is operably connected to the analyzer 4. Therefore, the second sampling module 7 may include a shut-off valve 70 that is in fluid communication with the analyzer 4.

[0137] The shut-off valve 70 is preferably a reaction valve and is designed to allow fluid flow to be connected when a specific device is connected to the shut-off valve 70 itself.

[0138] For example, the shut-off valve 70 can be configured to allow the attachment of a Luer or Luer-lock syringe.

[0139] Generally, the shut-off valve is configured to house a syringe attachment containing the collected urine, thereby enabling the analyzer 4 to analyze the collected urine.

[0140] Therefore, the second sampling module 7 essentially allows the introduction of urine already collected with a syringe into the device 1.

[0141] The shut-off valve 70 is preferably operably connected to the control means 5. Furthermore, the shut-off valve 70 may include a second sensor means 70a.

[0142] A second half-sensor 70a, if present, is preferably optical. Furthermore, they are advantageously configured to detect the presence of a syringe attached to the shut-off valve 70.

[0143] Therefore, the second sampling module 7 may further include a second pilot valve 71.

[0144] The second pilot valve 71 may be operably connected to the pump 51, similar to the first pilot valve 26. Thus, the control means 5 may be configured to activate the second pilot valve 71 and the pump 51 each time the syringe engages with the shut-off valve 70.

[0145] The second pilot valve 71 can be a solenoid valve, similar to the first pilot valve 26.

[0146] Pump 51 can specifically be a peristaltic pump.

[0147] The sampling module 7 may include a flushing valve 72. If a flushing valve 72 is provided, it is preferably operably connected to the pump 51 and allows flushing of urine remaining in the shut-off valve 70 and / or in the fluid section connected to the analyzer 4. The flushing valve 72 may be a solenoid valve.

[0148] Flushing prevents contamination by salt in urine near the shut-off valve 70 and prevents contamination with urine from different users.

[0149] From a structural standpoint, the device 1 may include a support structure 10. The support structure 10 is essentially a frame or container, or other element that enables the support of one or more components of the device 1.

[0150] Therefore, the support structure 10 is configured to support at least the first sampling module 2, the bag 3, the analyzer 4, and the control means 5.

[0151] Furthermore, the support structure 10 may also be configured to support the sampling means 6 and the second sampling module 7, if present.

[0152] A particularly advantageous feature is that, as mentioned above, bag 3 is separated from the first sampling module 2 and is detachably attached to the support structure 10.

[0153] In particular, the bag 3 is detachably restrained to the structure 10 by a restraining means 36. The restraining means 36 is preferably resolvable.

[0154] Therefore, these can include at least one hook 36a and one slot 36b.

[0155] The hook 36a is preferably attached to the structure 10. The slot 36b is provided in the bag 3 and is configured so that the hook 36a can pass through (threaded).

[0156] Naturally, slot 36b is provided on the support structure 10, and hook 36a can also be attached to bag 3 instead.

[0157] Furthermore, all kinds of equivalent restraints 36 may be available.

[0158] The described implementation is particularly advantageous when the device 1 is equipped with a sampling means 6.

[0159] In fact, the latter may include a load cell 60. The load cell 60 itself is known and is preferably constrained on the support structure 10. Thus, the bag 3 is precisely and detachably constrained to the load cell 60 via a detachable constraining means 36.

[0160] Specifically, this means, for example, that the hook 36a can be operably connected to the load cell 60. Therefore, the loop 36b provided on the bag 3 is configured to pass through the hook 36a, and by suspending the bag 3 from the hook 36a, the weight of the contents of the bag 3 itself (for example, the second urine fraction that has reached the bag 3) can be transmitted to the load cell 60.

[0161] Furthermore, in addition to bag 3, and regardless of whether bag 3 is connected to the support structure 10 or not, the first sampling module 2 can also be detachably constrained to the support structure 10. The first sampling module 2 is also separable from the analyzer 4.

[0162] In this regard, the structure 10 may include a housing 10a.

[0163] Therefore, the housing 10a can be configured to accommodate the first sampling module 2.

[0164] The first sampling module 2 and the bag 3 may be independent of each other, or they may be connected to each other by the connecting means 32.

[0165] The connecting means 32 may be detachable or non-detachable.

[0166] For example, the connecting means 32 may include at least one strap 32a. The strap 32a is preferably flexible and configured so that the bag 3 and the first sampling module 2 can be supported on both sides of the railing of the hospital bed.

[0167] Naturally, the connection means 32 may also include multiple straps 32a. The latter can be detached with a button or threaded through special hollow guides formed in the first sampling module 2 and / or bag 3.

[0168] The support structure 10 may further include a compartment 10b.

[0169] Compartment 10b may be located near the shut-off valve 70. More specifically, compartment 10b may be configured to include the shut-off valve 70, for example, in the rear wall. Thus, compartment 10b is configured to preferably stably accommodate at least a portion of the tip of the syringe.

[0170] Therefore, compartment 10b can be shaped to face the tip of the syringe.

[0171] The support structure 10 may further constitute part of the control means 5 and may further include a plurality of conduits and / or fittings to which at least some of the components of the apparatus 1 and, of course, a pump 51 or other similar organ for moving the fluid to be analyzed can be connected in fluid communication.

[0172] The support structure 10 can also support the steering station 50.

[0173] Apparatus 1, and therefore control structure 10, may have a power supply system (not shown). This power supply system is capable of supplying power to components of apparatus 1 (e.g., control means 5 and analyzer 4) and consists of a battery and / or a connecting cable that connects the apparatus to an external power network.

[0174] The operation of the urine analyzer 1, which was structurally described above, is as follows:

[0175] First, the device 1 is prepared by inserting the cartridge 41 into the interface seat 40.

[0176] In particular, the cartridge 41 is configured such that the plug 42a is connected to the inlet 40a.

[0177] Once this operation is complete, the device 1 becomes ready for use, and the fluid sample to be analyzed (usually urine) can be introduced via the first sampling module 2 or the second sampling module 7.

[0178] Specifically, when using the second sampling module 7, the collected urine is manually inserted by a healthcare worker or paramedical operator, for example, by inserting a syringe into the compartment 10b fitted to the shut-off valve 70.

[0179] Alternatively, introduction is performed via the first sampling module 2. Since this is directly connected to the patient via a catheter, it allows urine to flow directly into the device 1. In this case, the urine reaches the first tank 23 via the cannula inlet 22, where it is guided to the first drain duct 20. Specifically, the urine first reaches the containment section 20a, where a first fraction of urine, defined as a predetermined volume, is collected. Subsequently, if the urine exceeds the volume contained in the containment section 20a, the urine may flow out from the discharge section 20b. In some cases, if the amount of fluid flowing into the first sampling module 2 is excessive and the water level in the first collection tank 23 exceeds a predetermined level, the excess fluid, i.e., the portion exceeding the water level, is discharged directly into the bag 3 through the second drain duct 24, which functions as an overflow drainage means, preventing the excess from interfering with the normal functioning of the first sampling module 2.

[0180] The fluid in the first tank 23 may also pass through the first sensor means 25 before reaching the first drain duct 20 under the influence of gravity. For example, urine passing through the first optical sensor means 25 may interrupt the light beam, i.e., the continuous signal emitted from the optical emitter and detected by the photosensitive element.

[0181] Specifically, urine intervenes between the radiator and the photosensitive element, blocking the light beam incident on the element. Therefore, the control means 5, appropriately positioned in connection with the photosensitive element of the first sensor means 25 and the current / data path, detects the interruption of the continuous signal and suspends reading of the continuous signal for a duration longer than the interruption time. The latter time is sampled by the control means 5 and used to determine the fourth parameter.

[0182] Specifically, after passing through the first sensor means 25, the fluid to be analyzed reaches a collection siphon defined by a containment section 20a where the first fraction of urine is collected. From there, the second fraction of urine exceeding a predetermined volume reaches the discharge section 25b and is subsequently discharged into the bag 3.

[0183] Specifically, the first fraction of the fluid corresponding to the amount to be analyzed remains within the containment section 20a. This is due to the shape of the ventilation duct 27 that connects the end of the containment section 20a to the external environment, resulting in the same pressure at both ends, and thus the fluid is held between the two pressures.

[0184] At this point, device 1 is ready to perform the analysis of the urine sample.

[0185] Naturally, thanks to the collection means, the control means 5 can evaluate the total amount of urine that has passed through the device.

[0186] In fact, since bag 3 is suspended from load cell 60 by hook 36a, load cell 60 can measure the weight of the second fraction of urine collected in the bag.

[0187] By obtaining the weight, this defines the first parameter, and if we know the third parameter related to the density of the urine and the gravitational acceleration, which is a known constant, it is possible to determine the second parameter related to the volume of the second fraction of urine. Since the volume of the first fraction of urine is known from the volume of a predetermined container 20a, by adding the second parameter to the predetermined volume, it is possible to determine the total volume of urine without employing special sensor means or other elements such as a dripper.

[0188] Furthermore, by relating the total volume to the urine flow time in the first sampling module 2, it is also possible to determine the urine flow rate.

[0189] However, calibration of device 1 may be required before initial use or after a certain number of analyses have been performed.

[0190] To perform this calibration, the maximum and minimum calibration solutions must first be analyzed. That is, a complete analysis of the maximum and minimum calibration solution samples must be performed.

[0191] In particular, this analysis is performed at a standard temperature set by thermostat 48, preferably about 37°C.

[0192] Therefore, via the control means 5, for example, a fluid sample of the maximum calibration solution is taken from the associated bag 43 of the cartridge 41 and sent to the analysis station of the analyzer 4, or more precisely, into the conduit formed by the containment chamber 47 and the electrochemical sensor 47.

[0193] In particular, each ion-selective membrane 47b selects at least one corresponding ion, and in some cases, selects similar ions along with the same corresponding ion.

[0194] Therefore, each ion-selective electrode 47 reacts with the corresponding ion and, possibly, with analogous ions. Depending on the amount or concentration of the ions that each ion-selective electrode 47 interacts with, the same electrode 47 measures the potential difference with respect to the reference electrode 46 and determines the control parameter.

[0195] The control parameters are functions of the selected ions and analogous ions (if any). Therefore, instrument 1 can interpret the control parameters and estimate the physicochemical properties of the analyte sample from them.

[0196] The ion-selective electrodes 47 have been confirmed to be able to select and measure the following ions: H + Ions (for pH measurement), K + Ions (for potassium measurement), Cl - Ions (for chloride measurement), NH4 + Ions (for ammonium measurement). These autonomously select and measure each ion. The concentration of these ions is directly proportional to the potential difference measured by the corresponding ion-selective electrode 47. Therefore, H obtained from the ion-selective electrode 47 + , K + Cl - NH4 +The concentration of each ion can be directly determined from the control parameters related to it. On the other hand, Na + The control parameter measured by the ion-selective electrode 47 for ions (for sodium measurement) is Na + Ion concentration and H + It is a function of ion concentration. In particular, sodium concentration can be obtained from each control parameter, H + The ion concentration depends on the mathematical algorithm (H + The ion concentrations can be obtained directly from each ion-selective electrode 47 in sequence, as described above.

[0197] Furthermore, NH4 is measured by the ion-selective electrode 47. + The control parameter for ions (for ammonium measurement) is NH4 + Ion concentration, and also K + It is a function of ion concentration. In particular, the ammonium concentration is given by the relative control parameter K + (K + The ion concentrations are obtained directly from each ion-selective electrode 47 in order, as described above.

[0198] In summary, the control means 5 first determines control parameters, at least one of which directly determines the value of at least one of the physicochemical properties to be determined. Subsequently, the same control means 5 determines further physicochemical properties based on the first parameter and the already determined physicochemical properties.

[0199] Therefore, the control means 5 quantifies this potential difference based on the signals sent to electrodes 46 and 47, thereby determining the analysis results, namely the pH and the content of sodium, potassium, ammonium, and chloride in the urine sample in this example.

[0200] In conclusion, upon completion of the analysis of the maximum sample, the control means 5 determines the maximum pair for each physicochemical property. This maximum pair represents the content of the physicochemical property and the control parameter associated with the same property obtained by the analysis of the maximum calibration solution. For example, the maximum torque related to pH identifies two different values: the pH content and the potential difference determined by the associated ion-selective electrode 47.

[0201] After the analysis of the maximum calibration fluid sample is complete and the aforementioned maximum torque is obtained, the control means 5 commands the discharge of the maximum calibration fluid sample. The discharged sample is sent to one of the bags 43 in the cartridge 41 for waste collection.

[0202] Once the discharge is complete, a second calibration is performed. This involves using a minimum calibration solution to determine the minimum torque for each physicochemical characteristic, which is formed by the relative control parameters and the relative values ​​obtained with the minimum calibration solution.

[0203] After completing the two calibration analyses described above, the control means 5 can perform linearization of the values ​​between the maximum and minimum torques for each physicochemical characteristic. Linearization means that the control means 5 assigns a linear course between the maximum and minimum torques. In other words, it means assigning a constant course / variation to the values ​​of the physicochemical characteristics for the control parameters, preferably on a logarithmic basis.

[0204] In particular, the control means 5 can perform linearization on a logarithmic scale for each physicochemical property, that is, linearization between the first parameter and the logarithm of the value of the physicochemical property.

[0205] Once linearization is complete, the apparatus 1 is calibrated and ready for analysis. This allows the operator, for example via the steering station 50, to select the physicochemical properties they wish to analyze and begin the analytical operation.

[0206] The control means 5 controls the flow of the urine to be analyzed into the conduit formed by the containment chamber 47e, and analyzes the urine sample at a temperature of approximately 37°C, which is appropriately controlled by the thermostat 48.

[0207] First, control parameters are determined for each physicochemical property, namely the potential difference between the reference electrode 46 and the ion-selective electrode 47.

[0208] Subsequently, the control means 5 calculates the individual physicochemical properties by comparing the control parameters obtained from the analysis of the sample described above with the linearization described above.

[0209] In particular, for each physicochemical property, the control means 5 reports the control parameters related to the property in the relevant linearization, and derives the corresponding value of the target physicochemical property based on these parameters.

[0210] For example, when calculating pH, an electrochemical sensor corresponding to pH detects the potential difference between electrodes 46 and 47, i.e., the pH control parameter. This control parameter is processed by the control means 5, plotted on a graph obtained by linearization, and the pH torque is derived, thereby obtaining the pH value.

[0211] Once the analysis is complete, the results are displayed on the screen, printed, and / or stored in a special mass storage device.

[0212] The control means 5 controls the discharge of the fluid to be analyzed (i.e., urine) from the analysis station, and the fluid is collected in a cartridge 41 in a bag 43.

[0213] When bag 43 is used up, that is, when the contents of bag 43, including the calibration solution or cleaning solution, are depleted, and / or when bag 43 for collecting waste liquid becomes full, cartridge 41 is removed and replaced.

[0214] The same procedure is repeated for the control solution in the bag 43 of cartridge 41. As mentioned above, these have the function of verifying the quality status of the instruments over time using the analyzer 4 and control means 5.

[0215] The present invention also includes a novel process for urine analysis. This process is advantageously carried out by the apparatus 1 described above.

[0216] In short, this process includes an initial sampling phase.

[0217] At this stage, the collection means 6 obtains initial parameters related to the weight of the second urine sample in bag 3.

[0218] Furthermore, this procedure includes a calculation step in which the control means 5 calculates a second parameter for the amount of second urine in bag 3. The second parameter is calculated in relation to the first parameter, as described above, assuming a third predetermined parameter relating to the density of the urine and, of course, a known gravitational acceleration.

[0219] Furthermore, this procedure includes an additional step. In the additional step, the total urine volume is calculated by adding a predetermined capacity of the containment section 20a to the second parameter.

[0220] Furthermore, the procedure may include a second sampling step in which a sampling means 6 obtains a fourth parameter related to the urine flow time in the first drainage duct 20. Thus, the procedure may include a splitting step. In the splitting step, the total volume of urine is associated with the fourth parameter by means of the control means 5, and the urine flow rate is determined.

[0221] Naturally, this process may involve further steps.

[0222] For example, the initial stage may include a calibration phase in which the instrument 1 is calibrated for analysis using the maximum and minimum calibration solutions described above.

[0223] This stage includes an initial analysis step in which the control parameters for each physical characteristic are determined. Specifically, it is preferable that the potential difference between electrodes 46 and 48 is determined for each characteristic at this stage.

[0224] Therefore, the calibration phase includes a maximum calibration step and a minimum calibration step, obtaining the maximum and minimum torques for each characteristic under consideration. Specifically, each torque is determined by identifying the value of that characteristic as a function of a control parameter, which in the case of electrochemical analysis is the potential difference between the reference electrode 46 and the ion-selective electrode 47.

[0225] These pairs of maximum and minimum values ​​consist of the control parameters obtained in the previous steps and the maximum values ​​obtained, for example, by interpolation. In particular, these pairs are calculated taking into account not only the control parameters corresponding to the properties under consideration, but also the control parameters and / or values ​​associated with at least one other property that may influence the analysis results and thereby alter the outcome.

[0226] In these stages, by interpolating various control parameters, pairs of maximum and minimum values ​​for pH and sodium, potassium, ammonium, and chloride content can be determined. Specifically, the sodium content value is determined based on a control parameter related to sodium content and a first parameter related to pH, while the ammonium content value is determined based on a control parameter related to ammonium content and a control parameter related to potassium content.

[0227] Once these two configuration steps are complete, this phase is finished by a linearization step, which linearizes the values ​​between the maximum and minimum torques, as described above.

[0228] Subsequently, an introduction step is provided in which urine is supplied to the device, for example, via the first sampling module 2. Alternatively, this supply phase can be performed in parallel with or prior to the calibration phase.

[0229] Once the sample is inserted and instrument 1 is calibrated, the analysis phase, which includes two subphases, begins.

[0230] In the first analytical substage, electrochemical analysis of the sample is performed, and control parameters, namely the potential difference between the reference electrode 46 and the ion-selective electrode 47, are determined for each physicochemical property being analyzed.

[0231] Once these potentials are identified, the first analysis substep is completed and the second analysis substep begins. In this step, the values ​​of each characteristic are determined by comparing the control parameters obtained in the first analysis substep with the results of the linearization step described above.

[0232] Finally, this procedure may stipulate that multiple of the above-described analysis phases be performed at predetermined time intervals in order to enable substantially continuous monitoring of the patient's condition.

[0233] The urine analyzer 1 according to the present invention achieves important advantages.

[0234] In fact, this analyzer can evaluate all physicochemical parameters of interest related to a urine sample and always know the total volume of urine measured. In particular, volume measurement is performed simply, automatically, and autonomously.

[0235] Therefore, it is not necessary to determine the initial volume of the collected urine.

[0236] Furthermore, the second sampling module 7 makes it possible to use urine collected, for example, with a syringe.

[0237] The latter, with its shut-off valve 7 and compartment 10b, enables stable and efficient connection of syringes regardless of the connection method.

[0238] Furthermore, at the end of the analysis, the shut-off valve 70 is cleaned by activating the washing valve 72 and drawing washing solution from the bag 43 of the cartridge 41 using the pump 51. This allows for the analysis of urine from different patients without cross-contamination, and also prevents contamination of the area around the shut-off valve 70 by salts in the urine.

[0239] Furthermore, the first sampling module 2 and bag 3 can be removed from the support structure 10, which allows at least a portion of the same device 1 to be used on another patient simply by replacing the first sampling module 2 and bag 3.

[0240] Furthermore, since the bag 43 is housed in a single cartridge 41, the management of the calibration and cleaning blocks is simple and can be easily performed by any user, even non-experts.

[0241] Therefore, in general, apparatus 1 enables simple, rapid, and frequent analysis.

[0242] In addition, device 1 does not require the presence of medical personnel or paramedical staff, and therefore enables the analysis to be performed essentially automatically.

[0243] The present invention can be modified in various ways within the scope of the concept of the invention as defined in the claims.

[0244] Here, all details can be replaced with equivalent elements, and the material, shape, and size can be anything you like.

Claims

1. A urine analyzer (1) capable of analyzing a urine sample and measuring the values ​​of the physicochemical properties of the urine sample, It is configured to be positioned in fluid communication with the user and includes a first sampling module (2) which includes a first drain duct (20), The first drain duct (20) is A storage section (20a) is configured to define a predetermined volume and to retain the initial fraction of urine, It includes a discharge unit (20b) configured to discharge a second fraction of urine from the first sampling module (2), The device also, A diuretic bag (3) is configured to be in fluid communication with at least the discharge section (20b) and to collect a second fraction of urine, An analyzer (4) is arranged in fluid communication with the containment section (20a) and is configured to analyze at least a portion of the first fraction of the urine, Control means (5) which is connected to at least the analyzer (4) and configured to process at least the data collected by the analyzer (4), Includes, The apparatus further includes a second sampling module (7) which is operably connected to the analyzer (4) and includes a shut-off valve (70) in fluid communication with the analyzer (4), and is configured to accept the insertion of a syringe containing a urine sample, so that the analyzer (4) can analyze the urine sample. Device (1).

2. The shut-off valve (70) is configured to allow the attachment of a Luer or Luer-lock syringe. The apparatus (1) according to claim 1.

3. The shut-off valve (70) includes a second optical sensor means (70a) operably connected to a control means (5) and configured to detect the presence of a syringe engaging with the shut-off valve (70), The apparatus (1) according to claim 1 or 2.

4. The second sampling module (7) includes a second pilot valve (71), The control means (5) includes a pump (51) operably connected to at least one pilot valve (71), The control means (5) is configured to operate the pilot valve (71) and the pump (51) as soon as the syringe engages with the shut-off valve (70). The apparatus (1) according to any one of claims 1 to 3.

5. The second sampling module (7) further includes a flushing valve (72) operably connected to the pump (51), The control means (5) is configured to operate the second flushing valve (72) and the pump (51) as soon as the pilot valve (71) starts operating. The apparatus (1) according to claim 4.

6. Each of the pilot valve (71) and / or flushing valve (72) includes a solenoid valve, and the pump (51) is a peristaltic pump. Apparatus (1) according to any one of claims 4 to 5.

7. The system includes a first sampling module (2), a bag (3), an analyzer (4), a control means (5), and a support structure (10) configured to support a second sampling module (7). The support structure (10) is configured to accommodate at least a portion of the tip of the syringe and includes a compartment (10b) containing a shut-off valve (70), Apparatus (1) according to any one of claims 1 to 6.

8. The first sampling module (2) A cannula inlet (22) configured to connect to the user, A first tank (23) is in fluid communication with the cannula inlet (22) and the housing section (20a), A second drain duct (24) is configured to communicate fluidly with the first tank (23) and the cannula outlet (21), and to transport urine from the first tank (23) to the cannula outlet (21) when the amount of urine in the first tank (23) exceeds a predetermined threshold level. including, Apparatus (1) according to any one of claims 1 to 7.

9. One of the cannula inlet (22) and the first drain duct (20) includes a first sensor means (25) operably connected to a control means (5) and configured to detect the passage of urine through the cannula inlet (22) or the first drain duct (20), The first sampling module (2) further includes a first pilot valve (26) operably connected to a control means (5), The control means 5 is configured to activate the first pilot valve 26 when urine passes through the cannula inlet 22 or the first drainage duct 20. The apparatus (1) according to claim 7.

10. The system further includes a collection means (6) operably connected to the bag (3) and configured to acquire a first parameter relating to at least the volume of a second urine fraction, The control means (5) is further operably connected to the collection means (6) and is configured to, when a predetermined third parameter related to urine density is given, to advantageously calculate a second parameter related to the volume of a second urine fraction in relation to the first parameter, and to obtain the total amount of urine by adding the second parameter to a predetermined capacity of the storage unit (20a). Apparatus (1) according to any one of claims 1 to 9.

11. The support structure (10) is configured to also support the sampling means (6), The sampling means (6) includes a load cell (60) constrained to the support structure (10), A hook (36a) operably connected to a load cell (60) includes a load cell (60) constrained to a support structure (10), The bag (3) is remotely restrained to the load cell (60) by a detachable restraint means (36). Apparatus (1) according to any one of claims 1 to 10.

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