Urine analysis equipment

Abstract

There is provided a urine analysis device (1) capable of analyzing a urine sample to determine physical-chemical characteristic values of the urine sample, the device comprising: a first sampler module (2) configured to establish a fluid channel connection with a user and comprising a first drainage channel (20), the first drainage channel comprises a containing part (20a) which defines a predetermined volume and is configured to contain a first urine part, and a discharge part (20b) which is configured to convey a second urine part out of the first sampler module (2); a urine bag (3) establishing a fluid channel connection with at least the discharge portion (20b) and configured to collect the second urine portion; an analysis device (4) establishing a fluid channel connection with the containing portion (20a) and configured to analyze at least part of the first urine portion; control means (5) operably connected to the analysis means (4) and configured to process at least the data collected by the analysis means (4); and a second sampler module (7) operably connected to the analysis device (4) and comprising a shut-off valve (70) establishing a fluid channel connection with the analysis device (4), the shut-off valve being configured to receive a syringe interface comprising sampled urine such that the analysis device (4) is able to analyze the sampled urine.

Description

TECHNICAL FIELD

[0001] The present invention relates to a urine analysis device of the type described in the preamble of the first claim.

[0002] The device according to the present invention can be placed near a bed, for example at least partially below the bed, and can be connected directly to the patient through a catheter. In particular, the device is able to perform electrochemical urine analysis. BACKGROUND

[0003] As is known, urine tests are one of the main analysis methods currently used to confirm or rule out various pathologies or problems, such as structural damage, presence of infectious agents, and even functional changes in one or more organs. In particular, urine tests are the main form of analysis of the kidneys, and therefore have great importance for identifying possible renal dysfunctions and the state of the kidneys themselves.

[0004] One of the main analysis types is electrochemical analysis, which determines the pH value, sodium, potassium, ammonium and chloride content in the urine by calculating the potential difference between a pair of electrodes.

[0005] The analysis is currently performed in the following manner.

[0006] A catheter is attached to the patient, and the urine is conveyed through a pump to a special container, such as a bag, from which the medical staff extracts a sample of the correct amount of urine. This can be done by inserting a syringe or other similar instrument into the bag, or by measuring the correct amount of urine with a suitable dropper.

[0007] The sample is then diluted to reduce the effects of interfering substances, which can cause the sample evaluation to be inaccurate, thus leading to an incorrect analysis.

[0008] The diluted urine sample is placed in the analysis device, which performs the analysis through a specific program.

[0009] In particular, reagents and / or chemical solutions are added to the urine sample to counteract the negative effects of interfering substances that can cause an incorrect analysis. These added components vary depending on the type of analysis to be performed, for example they can include urease for urea analysis, and cation exchange columns to remove or reduce the content of high ammonium ions.

[0010] When the sample is ready for analysis, for example it is placed between two electrodes, the content of the target substance is determined by performing the analysis by measuring the potential difference between these electrodes.

[0011] The above-described prior art has several significant drawbacks.

[0012] In fact, the operating procedure is particularly long and requires the continuous presence of medical personnel. In particular, the urine sample collection procedure to be performed by the operator, in addition to significantly increasing the detection time, can cause contamination of the sample.

[0013] Another problem lies in the fact that the analysis procedure itself is particularly complex and difficult to perform.

[0014] In particular, the urine composition varies not only from patient to patient, but also from sample to sample of the same patient, so that different dilutions of the reagents are often required.

[0015] Another critical factor is that the analysis procedure is also affected by the temperature, which has a decisive role on the final result.

[0016] These factors make it difficult to adjust all the parameters and, consequently, the analysis of the urine sample is not optimal. SUMMARY

[0017] In this context, the technical task underlying the present application is to design a urine analysis device which substantially eliminates at least some of the above-mentioned drawbacks.

[0018] Within the scope of this technical task, an important object of the present application is to design a device which allows simple, rapid and frequent analysis and which enables substantial monitoring of the patient's condition.

[0019] In fact, the vital organs are the heart, the lungs and the kidneys, and although there are various devices for monitoring the cardiorespiratory function by analysing the respiratory and cardiovascular system, there is currently no known device for monitoring the kidneys.

[0020] Another object of the present application is a device which does not require the presence of medical personnel and auxiliary medical personnel, i.e. a device which substantially allows automated analysis.

[0021] The above technical task and objects are achieved by means of the urine analysis device according to claim 1 attached hereto. The preferred technical solutions are specified in the dependent claims. BRIEF DESCRIPTION OF DRAWINGS

[0022] The features and advantages of the present application will be clarified by means of the detailed description of a preferred embodiment thereof, in connection with the attached drawings, in which Figure 1 a schematic front view of a urine analysis device according to the present application is shown; Figure 2 a detailed view of a rigid support constituting the surface of the cartridge interface of a urine analysis device according to the present application is shown; Figure 3 is a detailed view of a cartridge pocket of a urine analysis device according to the present application; Figure 4a A perspective view of the barrel of the urine analysis apparatus according to the present invention is shown, wherein the opening extends to cover the entire interface surface; Figure 4b A perspective view of the feed cylinder of the urine analysis device according to the present invention is shown, wherein the opening extends to cover a portion of the interface surface (partially at the plug) and includes a cover. Figure 5a A detailed view of the interface seat of the urine analysis device barrel according to the present invention is shown, wherein the bottom drain hole is visible and is provided with a guide structure having pins; Figure 5b A detailed view of the urine analysis device barrel interface seat according to the present invention shows that multiple drainage holes are visible at the bottom and a guide structure is provided, the guide structure having an inlet; Figure 6 A front view of the analysis station of the urine analysis device according to the present invention is depicted; and Figure 7 A simplified functional block diagram of the urine analysis device according to the present invention is shown. Detailed Implementation

[0023] In this document, when measured values, numerical values, shape and geometric references (such as perpendicularity and parallelism) are associated with "about" or other similar terms (e.g., "approximately" or "generally"), it should be considered to exclude inaccuracies caused by measurement errors or manufacturing / production errors, and in particular, slight deviations from the associated values, measurement results, shape or geometric references are permitted. For example, if these terms are associated with numerical values, they preferably indicate a deviation of no more than 10% of that value.

[0024] Furthermore, the use of terms such as "first," "second," "higher," "lower," "primary," and "secondary" does not necessarily indicate order, priority, or relative position, but is only used to clearly distinguish different components.

[0025] Unless otherwise stated, as discussed below, terms such as “processing,” “computing,” “determining,” “operation,” and similar terms refer to operations and / or processes performed by a computer or similar electronic computing device that process and / or convert data into physical form—such as electronic values ​​in registers and / or data in memory within a computer system, and other similar data that are physical values ​​within the computer system and stored in registers or other storage, transmission, or information display devices. Unless otherwise stated, the measurement data and results reported herein shall be deemed to have been performed under the conditions of the International Standard Atmosphere ICAO (ISO 2533:1975).

[0026] Referring to the accompanying drawings, the urine analysis apparatus according to the present invention is collectively referred to as 1.

[0027] In particular, the device can be used for the analysis of a urine sample, preferably directly by determining its physical-chemical characteristic values, i.e. without the need to add reagents or solutions. More in particular, the device 1 can determine the pH value and the sodium, potassium, ammonium and chloride content of a urine sample, while determining its instantaneous urine flow rate.

[0028] The device 1 comprises at least one first sampling module 2.

[0029] The first sampling module 2 is part of an inlet system for placing the fluid to be analyzed inside the device 1. In particular, the first sampling module 2 is configured to establish a fluid channel connection with the user.

[0030] Therefore, the first sampling module 2 enables the urine to reach the device 1 at the time of discharge and to quantify the fluid entering the device 1.

[0031] In this regard, more in detail, the first sampling module 2 preferably comprises a first drainage tube 20. The first drainage tube 20 is a channel through which the urine passes in order to be processed by the device 1 before being disposed.

[0032] Preferably, the first drainage tube 20 is a siphon duct comprising a coil that allows the flow of fluid, i.e. urine, to be managed automatically.

[0033] Therefore, the first drainage tube 20 preferably comprises a containment portion 20a and a discharge portion 20b.

[0034] The containment portion 20a is substantially a portion of the first drainage tube 20 arranged upstream of the discharge portion 20b.

[0035] The containment portion 20a is in fact configured to retain a first portion of urine. To this end, the containment portion 20a can substantially comprise a section of the U-shaped first drainage tube 20 located upstream of the discharge portion 20b. The discharge portion 20b, on the other hand, is configured to convey a second portion of urine out of the first sampling module 2.

[0036] Basically, when the urine flows into the first drainage tube 20, it flows through the containment portion 20a and, once it has reached a sufficient filling level, it starts to flow at least partially through the discharge portion 20b, so that part of the urine is discharged from the first sampling module 2.

[0037] Furthermore, the containment portion 20a defines a predetermined volume. Therefore, it is possible to know the volume of the first portion of urine that remains in the first sampling module 2.

[0038] The first sampling module 2 can comprise additional features.

[0039] In particular, the first sampling module 2 can comprise a catheter outlet 21.

[0040] If present, the conduit outlet 21 is in fluid passage connection with the discharge portion 20b. Thus, the conduit outlet 21 is adapted to direct urine out of the first sampling module 2 in a controlled manner.

[0041] The first sampling module 2 can further comprise a conduit inlet 22.

[0042] If present, the conduit inlet 22 is configured to be connected to a user. Thus, the conduit inlet 22 is the portion of the first sampling module 2 that needs to be directly connected to a user.

[0043] Furthermore, the first sampling module 2 can further comprise a first reservoir 23.

[0044] The first reservoir 23 is essentially a collection tank for collecting urine from a patient. Thus, preferably, the first reservoir 23 is in fluid passage connection with the conduit inlet 22 and the containment portion 20a. In other words, the first reservoir 23 is disposed between the conduit inlet 22 and the containment portion 20a, adapted to receive urine before it enters the containment portion of the first drainage tube 20.

[0045] Furthermore, the first reservoir 23 can comprise an inclined base plane configured to push urine towards the first drainage tube 20 by gravity when the first sampling module 2 is in use.

[0046] The first sampling module 2 can further comprise a second drainage tube 24. The second drainage tube 24 can be a passage disposed in parallel with the first drainage tube 20. In more detail, the second drainage tube 24 is in fluid passage connection with the first reservoir 23 and the conduit outlet 21. The second drainage tube 24 is configured to transport urine from the first reservoir 23 to the conduit outlet 21. Preferably, the second drainage tube 24 draws urine from the first reservoir 23 when the urine in the first reservoir 23 exceeds a predetermined threshold level.

[0047] Thus, essentially, the second drainage tube 24 acts as a safety or empty-full passage, configured to prevent the first reservoir 23 from being abnormally filled, which would affect the normal functioning of the first sampling module 2.

[0048] Furthermore, the reservoir 23 can be provided with a filter mesh at an upper portion (i.e. close to the conduit inlet 22) of the relative position on the ground. The filter mesh, if present, has a mesh size designed to separate foreign substances (e.g. clots, organic precipitates, etc.) in the urine.

[0049] The device 1 thus further comprises a urine bag 3.

[0050] The bag 3 is essentially a reservoir, for example enclosed by a deformable wall, or a rigid wall, or a partially deformable and partially rigid wall, which can be used to contain a fluid.

[0051] Therefore, the bag 3 has liquid impermeability. Moreover, the bag 3 is preferably in fluid passage connection with the discharge portion 20b. Therefore, in this way, the bag 3 is configured to collect the second urine portion, i.e. the urine output portion from the first sampling module 2.

[0052] The bag 3 can be in direct or indirect connection with the discharge portion 20b. Preferably, the connection between the bag 3 and the discharge portion 20b is through the conduit outlet 21.

[0053] Moreover, the bag 3 is advantageously separate from the first sampling module 2.

[0054] Preferably, the bag 3 comprises a nozzle 30.

[0055] The nozzle 30 is configured to house at least a portion of the conduit outlet 21. Therefore, the nozzle 30 is also substantially configured to establish a fluid passage connection between the first sampling module 2 and the bag 3.

[0056] The outlet 30 can be a simple hole formed in a wall of the bag 3, for example the top. In fact, preferably, the first module 2 is positioned above the bag 3 with respect to the ground when in use, so that the urine can flow into the bag 3 by gravity.

[0057] Alternatively, the nozzle 30 can comprise specific constraint means, for example a quick connector able to firmly lock one end of the discharge conduit 21 to a wall of the bag 3, or a pre-drilled membrane configured to be deformable to allow the partial entry of the discharge conduit 21 into the bag 3.

[0058] The device 1 also comprises an analysis apparatus 4.

[0059] The analysis apparatus 4 is a known apparatus, configured for analyzing at least a portion of the first urine portion. Therefore, the analysis apparatus 4 is connected to the containment portion 20a by means of a fluid passage connection.

[0060] Of course, the device 1 also comprises control means 5.

[0061] These control means 5 are operatively connected to at least the analysis apparatus 4. Moreover, they are at least configured to process the data collected by the analysis apparatus 4. Obviously, the control means 5 can also be operatively connected to other components of the device 1, as further detailed below.

[0062] Preferably, in particular the analysis apparatus 4 and the control means 5 can be similar to the analysis station and the command and control unit described in patent application EP-A-2510877, paragraphs [0037-0052], the contents of which are incorporated herein by reference.

[0063] Essentially, the analytical device 4 is suitable for electrochemical analysis of urine and has multiple electrodes, each suitable for determining at least one parameter (e.g., potential difference) for the detection of various physicochemical properties. The analytical device 4 may include an analytical station comprising at least five electrodes and with the possibility of further expansion, more specifically, including a reference electrode 46 and at least one ion-selective electrode 47, or other similar elements capable of interacting with the analyte.

[0064] Specifically, at least one ion-selective electrode 47 is provided for each of the following characteristics to be analyzed: pH value, sodium, potassium, ammonium, and chloride content. For example, Figure 6 An analytical station equipped with six ion-selective electrodes 47 is shown: one for pH analysis, four for detecting the content of sodium, potassium, ammonium and chloride, and a sixth not used for this specific analysis but which can be used later to detect another physicochemical property of the urine sample.

[0065] The reference electrode 46 has a conductive element 46a (e.g., silver) housed in a chamber 46b containing fluid to maintain the electrode 46 at a constant potential.

[0066] Each ion-selective electrode 47 is in contact with a medium and reacts with a specific ion. More specifically, the ion-selective electrode 47 has: an electrical connector 47a (e.g., a pin or even a circuit) that enables the ion-selective electrode 47 to be electrically connected to a standard electrode 46 in the presence of the fluid to be analyzed; an ion-sensitive membrane 47b or other similar element suitable for reacting with a given ion; and a central body 47c that can accommodate almost all the elements constituting the ion-selective electrode 47 and defines two separate chambers: a connection chamber 47d (located between the membrane 47b and the connector 47a, capable of accommodating a fluid characterizing the electrode offset, such as a saturated KCl solution), and a receiving chamber 47e adjacent to the ion-selective electrode 47 (suitable for accommodating urine).

[0067] Specifically, the receiving chambers 47e preferably include through holes, such that when the ion-selective electrode 47 is in place, each receiving chamber 47e forms a single channel, thereby allowing free flow of fluid between the chambers and into and out of the analyzer 4. To prevent fluid leakage, sealing elements (e.g., O-rings 47f) may be provided between the electrodes.

[0068] Each ion-selective electrode 47 can react with only one analyte. Specifically, in the device 1 used to determine pH and the content of sodium, potassium, ammonium, and chloride, the ion-selective electrode 47 is sensitive to at least one of the following ions: H+ + Na + K + NH4 + and Cl - .

[0069] This selection is carried out by means of ion-sensitive membranes 47b, which are specifically manufactured and optimized for the element to be measured.

[0070] For example, for H + and Na + membranes, the membrane is of a glass matrix, while for K + , NH4 + and Cl - membranes, the membrane is of a high-molecular weight polymer matrix.

[0071] The apparatus 1 can also be equipped with a thermostat 48 at the analysis device 4 for regulating the temperature of the fluid to be analyzed and of the calibration liquid when it is inside the analysis device 4. The thermostat 48 comprises any element suitable for maintaining the temperature of the urine substantially constant, such as an electric resistance element. Preferably, the temperature is substantially between 30°C and 45°C, more preferably it is substantially 37°C.

[0072] Finally, each of the electrodes 46 and 47 is electrically connected to the control device 5, which is suitable for analyzing the data collected by the respective ion-selective electrode 47, comparing the data collected with the data of the standard electrode 46 and, in the presence of a washing or calibration module, for controlling said washing or calibration module in order to prepare the analysis device 4 before performing the analysis.

[0073] The control device 5, in addition to analyzing the data coming from the analysis device 4, is preferably also connected to the first sampling module 2, more particularly to the first sensor device 25. In fact, in at least one embodiment, one of the conduit inlet 22 and the first drain 20 can comprise the first sensor device 25. The latter is preferably an optical device, which is operatively connected to the control device 5 and is configured to detect the passage of urine through the conduit inlet 22 or the first drain 20.

[0074] Naturally, the first sampling module 2 can also comprise a first pilot valve 26. If the first pilot valve 26 is present, the first pilot valve 26 is also operatively connected to the control device 5. Therefore, the control device 5 can be configured to activate the first pilot valve 26 when the urine flows through the conduit inlet 22 or the first drain 20.

[0075] The first pilot valve 26 can be arranged substantially between the analysis device 4 and the first drain 20, in particular the containment portion 20a thereof, and is configured to convey the first portion of urine from the containment portion 20a to the analysis device 4.

[0076] The first sampling module 2 preferably comprises a ventilation duct 27. The ventilation duct 27 is preferably in fluid communication with two separate points of the first drainage tube 20 and the external environment. More specifically, the ventilation duct 27 is in fluid communication with the two ends of the containment portion 20a and the external environment. In this way, the ventilation duct 27 allows the urine collected in the containment portion 20a to be subjected to the same pressure at the two ends, thus enabling stable retention inside the siphon portion, i.e. the containment portion 20a.

[0077] The washing or calibration module can be constituted by removable components.

[0078] In a preferred, but not exclusive, embodiment, the analysis device 4 can comprise, in addition to the analysis station, an interface seat 40.

[0079] The interface seat 40 is preferably operatively connected to the analysis station comprising the electrodes. Furthermore, the interface seat 40 is essentially a tank, i.e. an open container which can house removable components.

[0080] Advantageously, the interface seat 40 comprises a plurality of inlets 40a. Such inlets 40a can comprise apertures, plugs or any element which allows the insertion or covering of other couplable elements.

[0081] Preferably, the analysis device further comprises a cartridge 41.

[0082] The cartridge 41 is a usable element inside the interface seat 40. In particular, the cartridge 41 preferably has at least partially the inverse shape of the interface seat 40.

[0083] Furthermore, the cartridge 41 is adapted to interact with the inlets 40a.

[0084] Therefore, advantageously, the cartridge 41 comprises an interface surface 42 and a plurality of pockets 43.

[0085] The interface surface 42 is the portion of the cartridge 41 which is intended to directly interact with the inlets 40a. Therefore, preferably, the interface surface 42 comprises a plurality of plugs 42a.

[0086] Therefore, the plugs 42a are configured to couple with the inlets 40a. In particular, each plug 42a couples with a respective inlet 40a.

[0087] Naturally, in another embodiment, the interface seat 40 can comprise the plugs 42a and the interface surface 42 can comprise the inlets 40a.

[0088] In any case, the cartridge 41 has a way of being inserted in the interface seat 40 oriented, since the inlets 40a preferably each correspond to a specific plug 42a.

[0089] Moreover, the plugs 42a or the inlets 40a are respectively configured to be coupled with the inlets 40a or the plugs 42a; and, advantageously, the plugs 42a or the inlets 40a of the interface surface 42 are each in fluid communication with a respective bag 43.

[0090] Each bag 43 is preferably liquid impermeable. Moreover, each bag comprises a calibration or cleaning or control solution.

[0091] For example, the control solution is used to monitor the performance quality of the instrument or of the electrodes over time, and to follow the same procedures as the analysis.

[0092] Therefore, the cartridge 41 advantageously comprises all the calibration, cleaning and control substances independently inside it, and can be replaced by coupling a respective bag 43 to a respective plug 42a or removing a respective bag 43 from a respective inlet 40a of the interface surface 42.

[0093] To facilitate the connection of the cartridge 41 to the interface seat 40, the interface surface 42 is preferably a rigid support.

[0094] Conversely, the bags 43 are preferably deformable structures. More in detail, each bag 43 comprises a wall consisting of a double barrier membrane that allows only the passage of gases. To facilitate the engagement of the bags 43 with the inlets 40a or the plugs 42a, each bag 43 is provided with a spout 43a. The spout 43a is respectively configured to be housed in a corresponding plug 42a or in a corresponding inlet 40a of the interface surface 42.

[0095] At the same time, each spout 43a can comprise a suction valve.

[0096] In particular, the bags 43 can comprise at least one highest calibration liquid and one lowest calibration liquid, which comprise a fluid with known physical-chemical characteristics to be analyzed, and respectively a high content and a low content of the same physical-chemical characteristics. The high content and the low content are preferably respectively close to the maximum content and to the minimum content of the presumed values obtainable by the analysis.

[0097] More precisely, the highest calibration comprises a fluid with known pH value and content of sodium, potassium, ammonium and chloride, and the content is preferably higher than the maximum value that can be present in the urine sample; while the lowest calibration liquid comprises a fluid with known pH value and content of sodium, potassium, ammonium and chloride, and the content is preferably lower than the minimum value that can be present in the urine sample.

[0098] Moreover, the cartridge 41 can advantageously also comprise a casing 44.

[0099] If present, the casing 44 houses the bags 43. Preferably, the casing 44 is made of recyclable material, for example cardboard. Therefore, the casing 44 can be ecologically disposed of or reused after emptying the bags 43.

[0100] Furthermore, the housing 44 is preferably defined as an open container shape, and thus preferably comprises at least one opening 44a. The opening 44a is directed towards the interface surface 42. In particular, the opening 44a can be open over the entire interface surface 42, such that the interface surface 42 is completely directed towards the interface surface 42, e.g. as shown. Figure 4a

[0101] Alternatively, the opening 44a can be directed exactly towards the interface surface 42 at the plug 42a, e.g. as shown. Figure 4b

[0102] At the same time, the interface housing 40 can comprise a flat bottom, on which the inlet 40a or the plug 42a is formed. Alternatively, the interface housing 40 can comprise a guiding structure 40b. The guiding structure 40a can be, for example, a bottom strip protruding from the rest of the bottom, to form a protruding portion.

[0103] If present, the guiding structure 40b is located at the inlet 40a or the plug 42a of the interface housing 40. Furthermore, the guiding structure 40b is advantageously bent back at the opening 44a. In this way, the guiding structure 40b allows the outer housing 44 to snap onto the guiding structure 40b when the outer housing 40 is inserted into the interface housing 40.

[0104] Since the calibration or cleaning solution is mainly a liquid substance, the interface seat can preferably comprise a drain 40c.

[0105] The drain 40c, if present, is preferably a hole in the bottom of the interface seat 40, and preferably in the portion not occupied by the guiding structure 40b, if present.

[0106] Thus, the drain 40c is configured to allow liquid to flow out of the interface seat 40. This means that, in the event of an accidental leak of the interface surface 42, the drain 40c can allow the excess liquid to flow out.

[0107] Generally, the interface seat 40 remains in proper connection with the rest of the analysis device 4 and with the control device 5.

[0108] In order to enable the transport of urine between the parts of the apparatus 1, the control device 5 comprises not only electronic connection means for controlling the various valves, solenoids and other components of the apparatus 1, but also connectors for the passage of fluid between the components, e.g. between the first sampling module 2 and the analysis device 4.

[0109] For example, in general, the control device 5 forms a fluid passage connection with at least the first sampling module 2 and the analysis device 4. ​​

[0110] Therefore, the control device 5 can comprise a console 50.

[0111] The console 50, if present, is suitable for controlling the apparatus 1.

[0112] The console 50 can also comprise or be connected to output elements, such as printers or mass storage devices, to be able to print the results and / or view them through external devices, such as computers.

[0113] Furthermore, the console 50 allows programming the analysis at preset times, or alternatively at preset time intervals, so that the apparatus 1 can be operated regularly and perform the analysis correctly even in the absence of the operator.

[0114] The console 50 can comprise a screen or other similar element, which is at least able to display the results of the analysis, and control elements, such as a keyboard, to control the operation of the entire apparatus 1. Alternatively, the screen can be of the touch screen type, which can be used to control the apparatus 1 in addition to displaying the data.

[0115] When the interface surface 42 of the cartridge 41 is connected to the plug 42a or to the inlet 40a of the interface seat 40, the control device 5 can be connected to the suction valve of the bag 43.

[0116] Furthermore, the control device 5 can be connected to the first pilot valve 26.

[0117] In this way, the control device 5 can control the inflow and outflow of the analysis device 4.

[0118] The control device 5 can comprise, in particular, a pump 51.

[0119] The pump 51 can be operatively connected to at least the first pilot valve 26, so as to establish a fluid passage connection therewith.

[0120] Furthermore, when the cartridge 41 is connected to the interface seat 40, the pump 51 can be connected to the bag suction valve 43.

[0121] Therefore, the pump 51 can be configured to convey the urine from the first sampling module 2, i.e. from the containment portion 20a, to the analysis device 4 in a controlled manner, or to convey the calibration or cleaning fluid from the bag 43, i.e. from the cartridge 41, to the rest of the analysis device 4.

[0122] In a preferred, but not limiting, embodiment, the apparatus 1 comprises a collection device 6.

[0123] If present, the collection device 6 is operatively connected to the bag 3.

[0124] Furthermore, the collection device 6 is configured to acquire at least one first parameter related to the weight of the second urine portion, i.e. the urine portion exiting the first sampling module 2 through the discharge portion 20b.

[0125] Therefore, preferably, the control device 5 is also operatively connected to the collection device 6. Furthermore, the control device 5 is advantageously configured to calculate a second parameter related to the volume of the second urine portion, in combination with the first parameter, as a function of a predetermined third parameter related to the density of the urine.

[0126] Basically, the control device 5 allows to set (e.g. through the console 50) a known value of the density of the urine as the third parameter. Therefore, by knowing the weight of the second urine portion (i.e. acquiring the first parameter) through the collection device 6, it is possible to calculate the volume of the second urine portion - which is directly derived from the ratio between the weight (i.e. the first parameter) and the density (i.e. the third parameter) multiplied by the acceleration of gravity.

[0127] Once the second parameter (i.e. the total volume of the second urine portion) is obtained, it can be added to the predetermined volume of the containment portion 20a (containing the first urine portion).

[0128] In this way, the control device 5 can obtain the total volume of the urine in the device 1.

[0129] Furthermore, the collection device 6 can also be configured to acquire a fourth parameter related to the time of flow of the urine within the first drainage tube 20.

[0130] For example, a photocell can be used to determine the time required for the urine to flow through a certain section of the drainage tube 20.

[0131] Therefore, the control device 5 can be further configured to associate the total volume of the urine with the fourth parameter to determine the flow rate of the urine.

[0132] The device 1 can also comprise a second sampler module 7.

[0133] If the second sampler module 7 is present, it is operatively connected to the analysis device 4. Therefore, the second sampler module 7 can comprise a shut-off valve 70 which forms a fluid passage connection with the analysis device 4.

[0134] The shut-off valve 70 is preferably a reaction valve designed to allow the fluid flow connection when a specific device is connected to the shut-off valve 70 itself.

[0135] For example, the shut-off valve 70 can be configured to allow the connection of a Luer or Luer lock syringe.

[0136] Typically, the shut-off valve is configured to accommodate a syringe accessory containing the sampled urine, so that the analysis device 4 can perform an analysis on the sampled urine.

[0137] The second sampler module 7 thus substantially allows the introduction of the urine collected in the syringe into the device.

[0138] The shut-off valve 70 is preferably operatively connected to the control device 5. Moreover, the shut-off valve 70 can comprise second sensor means 70a.

[0139] Advantageously, the second half-sensor 70a, if present, is of the optical type. Moreover, advantageously, the second half-sensor 70a is configured to detect the presence of a syringe engaged in the shut-off valve 70.

[0140] The second sampler module 7 thus can also comprise a second pilot valve 71. The second pilot valve 71, like the first pilot valve 26, is operatively connected to the pump 51. The control device 5 can thus be configured to activate the second pilot valve 71 and the pump 51 when a syringe is engaged in the shut-off valve 70.

[0141] The second pilot valve 71, like the first pilot valve 26, can be a solenoid valve.

[0142] In particular, the pump 51 can be a peristaltic pump.

[0143] The sampler module 7 can also comprise a flushing valve 72. If present, the flushing valve 72 is preferably operatively connected to the pump 51 and is able to flush any urine residues remaining in the shut-off valve 70 and / or in the fluid line section connected to the analysis device 4. The flushing valve 72 can also be a solenoid valve.

[0144] By flushing, it is possible to avoid the formation of dirt in the area of the shut-off valve 70 due to the salinity of the urine and to prevent the urine of different users from contaminating each other.

[0145] From a structural point of view, the device 1 can comprise a support structure 10. The support structure 10 can essentially be a frame, a container or any other element able to support one or more components of the device 1.

[0146] The support structure 10 is thus configured to support at least the first sampling module 2, the bag 3, the analysis device 4 and the control device 5.

[0147] Moreover, the support structure 10 can also be configured to support the collection medium 6 and the second sampler module 7, if present.

[0148] It is particularly advantageous that the bag 3, in addition to being separate from the first sampling module 2 as described above, is also removably attached to the support structure 10.

[0149] In particular, the bag 3 is removably constrained to the structure 10 by means of constraining means 36. The constraining means 36 are preferably disassemblable.

[0150] It can thus comprise at least one hook 36a and one slot 36b.

[0151] The hook 36a is preferably attached to the structure 10. The slot 36b is formed on the bag 3 and is configured to be threaded on the hook 36a.

[0152] Of course, the slot 36b can also be formed on the support structure 10, while the hook 36a can be attached to the bag 3.

[0153] Furthermore, any type of equivalent constraint device 36 can be used.

[0154] The described embodiments are particularly advantageous when the device 1 is equipped with the collection device 6.

[0155] In fact, the latter can comprise a load cell 60. The load cell 60 is itself of the prior art and is preferably constrained to the support structure 10. In this way, the bag 3 can be removably and precisely constrained to the load cell 60 by means of the removable constraint device 36.

[0156] This means, more specifically, that for example the hook 36a is operatively connected to the load cell 60. The ring 36b formed on the bag 3 is therefore configured to be threaded on the hook 36a, so that the bag 3 can be hung on the hook 36a, thus transmitting the weight of the contents of the bag 3 itself (for example urine when the second urine fraction reaches the bag 3) to the load cell 60.

[0157] Furthermore, with respect to the bag 3, the first sampling module 2 can also be removably constrained to the support structure 10, whether or not the bag 3 is connected to the support structure 10. Moreover, the first sampling module 2 can also be separated from the analysis device 4.

[0158] In this regard, the structure 10 can comprise a housing 10a.

[0159] The housing 10a can therefore be configured to house the first sampling module 2.

[0160] The first sampling module 2 and the bag 3 can be independent of each other. Alternatively, they can be connected to each other by means of the connection device 32.

[0161] The connection device 32 can be disassemblable or not.

[0162] For example, the connection device 32 can comprise at least one strap 32a. Advantageously, the strap 32a is flexible and is configured to allow the bag 3 and the first sampling module 2 to be supported on opposite sides of the bed rail.

[0163] Of course, the connection device 32 can also comprise a plurality of straps 32a. The latter can be fixed by means of buttons or screwed into specific hollow guides formed on the first sampling module 2 and / or on the bag 3.

[0164] The support structure 10 can also comprise a chamber 10b.

[0165] The chamber 10b can be arranged near the stop valve 70. More specifically, the chamber 10b can comprise the stop valve 70, for example at the rear wall. The chamber 10b is thus configured to house, preferably stably, at least part of the tip of the syringe.

[0166] The chamber 10b can thus be provided in a shape corresponding to the syringe needle.

[0167] The support structure 10 can also comprise a plurality of conduits and / or fittings of the control device 5 and is able to connect at least part of the components of the apparatus 1 in a fluid passage connection, and naturally the support structure 10 also comprises the pump 51 or other similar mechanism able to move the fluid to be analyzed.

[0168] The support structure 10 can also support the console 50.

[0169] The apparatus 1 and its support structure 10 can be provided with a power supply system not shown in the figures, able to power the components of the apparatus 1, such as the control device 5 and the analysis device 4, which can consist of a battery and / or of a connection cable able to connect the apparatus to an external power supply network.

[0170] The operating procedure of the urine analysis apparatus 1, described above from a structural point of view, is as follows.

[0171] First of all, the apparatus 1 is prepared by inserting the cartridge 41 into the interface seat 40.

[0172] In particular, the cartridge 41 couples the plug 42a with the inlet 40a.

[0173] Once this operation has been completed, the apparatus 1 is ready for use and the fluid sample to be analyzed, usually urine, can be introduced through the first sampling module 2 or the second sampler module 7.

[0174] In particular, when the second sampler module 7 is used, the sampling urine is manually injected by a medical or nursing staff, for example by inserting a syringe into the chamber 10b engaged with the stop valve 70.

[0175] Alternatively, it is introduced through the first sampling module 2, which directly connects the patient through a conduit, so that the urine can flow directly into the apparatus 1.

[0176] In this case, the urine enters the first tank 23 through the conduit inlet 22 and is then conveyed to the first drainage tube 20. In particular, the urine first enters the containment portion 20a, where a first portion of urine is collected, defined by a predetermined volume; when the quantity of urine exceeds the volume of the containment portion 20a, the excess portion can flow out from the discharge portion 20b. In some cases, if the flow rate of fluid reaching the first sampling module 2 is too high and the level of the first collection tank 23 exceeds a predetermined level, the excess portion of fluid, i.e. the portion that exceeds the level, will be discharged directly into the bag 3 through the second drainage tube 24, which acts as an overflow discharge, thus preventing the excess liquid from affecting the proper functioning of the first sampling module 2.

[0177] The fluid in the first tank 23 can also flow, under the action of gravity, through the first sensor device 25 before reaching the first drainage tube 20. For example, the urine flowing through the first optical sensor device can interrupt the light beam, i.e. the continuous signal emitted by the light emitter and detected by the photosensitive element.

[0178] In particular, the urine intervenes between the emitter and the photosensitive element, interrupting the light beam that falls on the element, and therefore the control device 5, to which the photosensitive element of the first sensor device 25 is connected in a current / data passage, detects the interruption of the continuous signal and interrupts the reading of said continuous signal for a time that is at least equal to the interruption time. The control device 5 can sample the interruption time to determine the fourth parameter.

[0179] In particular, the fluid to be analyzed, after passing through the first sensor device 25, reaches the collection siphon, which is defined by the containment portion 20a, where the first portion of urine is collected, and the second portion of urine that exceeds the predetermined volume reaches the discharge portion 25b, which is then discharged into the bag 3.

[0180] In particular, the first portion of fluid to be analyzed, corresponding to the quantity to be analyzed, remains inside the containment portion 20a due to the structural design, and the ventilation duct 27 allows the end of the containment portion 20a to communicate with the external environment, so that said end has the same pressure, thus allowing the fluid to remain between the two pressures.

[0181] At this point, the device 1 is ready to perform the analysis on the sample of urine.

[0182] Naturally, thanks to the collection medium, the control device 5 is able to evaluate the total volume of urine that has flowed through the device.

[0183] In fact, since the bag 3 is suspended by the hook 36a on the load cell 60, the load cell 60 is able to determine the weight of the second portion of urine collected in the bag.

[0184] After obtaining the weight defining the first parameter, by means of the third parameter known to be correlated to the density of the urine and the acceleration of gravity, which is a known constant, the second parameter correlated to the volume of the second portion of urine is determined. Since the volume of the first portion of urine is known from the predetermined volume of the containment portion 20a, by adding the second parameter to the predetermined volume, the total volume of the urine is obtained without the need to use special sensor devices or other elements (e.g. a pipette).

[0185] Furthermore, by correlating the total volume to the time of flow of the urine in the first sampling module 2, the flow rate of the urine is also obtained.

[0186] However, the apparatus 1 can need to be calibrated before the first use or after a certain number of analyses have been performed.

[0187] To perform the calibration, first the highest and lowest calibration liquids are analysed, i.e. a complete analysis is performed on the samples of the highest and lowest calibration liquids.

[0188] In particular, the analysis is performed at a standard temperature set by the thermostat 48, and this temperature is preferably around 37°C.

[0189] Therefore, by means of the control device 5, a sample of fluid (e.g. the highest calibration liquid) is extracted from the relative bag 43 of the cartridge 41 and is sent to the analysis station of the analysis device 4, more precisely into the conduit formed by the containment chamber 47 and the electrochemical sensor 47.

[0190] In particular, each ion-selective membrane 47b selects at least one respective ion, and in some cases the same respective ion or similar ions are selected together.

[0191] Therefore, each ion-selective electrode 47 reacts with the respective ion and, possibly, with similar ions present. According to the number or concentration of ions with which each ion-selective electrode 47 interacts, the electrode 47 measures a potential difference with respect to the reference electrode 46, determining a control parameter.

[0192] The control parameter is a function of the selected ion and, possibly, of similar ions present. Therefore, the apparatus 1 is able to interpret the control parameter and deduce therefrom the physical-chemical characteristics of the sample being analysed.

[0193] It is determined that the ion-selective electrodes 47 are able to select and measure the respective ions consisting of H+ions (for pH measurement), K+ions (for potassium measurement), Cl"ions (for chlorine measurement), NH4+ions (for ammonium measurement). They select and measure the respective ions by themselves. The concentration of these ions is directly proportional to the potential difference measured by the respective ion-selective electrode 47. From the control parameters relating to H+, K+, Cl"and NH4+obtained from the ion-selective electrodes 47, the concentration of the respective ions is directly obtained.

[0194] By contrast, the control parameter measured by the ion-selective electrode 47 in relation to the Na+ions (for the sodium measurement) is a function of the Na+ion concentration and of the H+ion concentration. In particular, the sodium concentration is obtainable from the respective control parameter and a mathematical algorithm dependent on the hydrogen ion concentration (which, as mentioned above, is in turn directly obtainable from the respective ion-selective electrode 47).

[0195] Furthermore, the control parameter measured by the ion-selective electrode 47 in relation to the NH4+ions (for the ammonium measurement) is a function of the NH4+ion concentration and of the K+ion concentration. In particular, the ammonium concentration is obtainable from the relative control parameter minus a mathematical algorithm of the K+ion concentration (which, as mentioned above, is in turn directly obtainable from the respective ion-selective electrode 47).

[0196] In summary, the control device 5 first determines the control parameters, at least one of which directly determines at least one of the physical-chemical characteristic values to be determined. Subsequently, the same control device 5 determines the other physical-chemical characteristics from the first parameters and the physical-chemical characteristics already determined.

[0197] The control device 5 then, on the basis of the signals sent to the electrodes 46 and 47, quantifies the potential difference and determines therefrom the analysis results, i.e. in the present example the pH value and the contents of sodium, potassium, ammonium and chloride of the urine sample.

[0198] In summary, after completion of the analysis of the highest calibration liquid sample, the control device 5 determines for each physical-chemical characteristic a maximum couple of values, which indicates the content of the physical-chemical characteristic and the control parameter related to the same characteristic obtained by analysis of the highest calibration liquid. For example, the pH-related highest torque can identify two independent values, i.e. the pH content and the potential difference determined by the respective ion-selective electrode 47.

[0199] After completion of the analysis of the highest calibration liquid sample and of the aforementioned highest torque, the control device 5 commands the discharge of the highest calibration liquid sample, which is sent to one of the bags 43 of the cartridge 41 for collection of waste liquids.

[0200] After completion of the unloading, a second calibration is performed, by using the lowest calibration liquid, which makes it possible to determine for each physical-chemical characteristic a lowest torque constituted by the relative control parameter and the relative value of the lowest calibration liquid.

[0201] After completion of the two calibration analyses described above, the control device 5 can linearize the values between the maximum torque and the minimum torque for each physical-chemical characteristic. Linearization means that the control device 5 sets a linear progression between the maximum torque and the minimum torque, i.e. assigns a constant progression / variation, preferably based on a logarithmic reference, for the physical-chemical characteristic values with respect to the control parameter.

[0202] In particular, the control device 5 can perform a logarithmic scale linearization for each of the physical-chemical characteristics, i.e. a linearization between the first parameter and the logarithm of the value of the physical-chemical characteristic.

[0203] Once the linearization is completed, the apparatus 1 is calibrated and ready for analysis, and the operator, for example through the console 50, can select the physical-chemical characteristics to be analyzed and start the analysis operation.

[0204] The control device 5 controls the entry of the urine to be analyzed into the duct formed by the containment chamber 47e and performs the analysis of the urine sample at a temperature of about 37°C, accurately controlled by the thermostat 48.

[0205] First, for each physical-chemical characteristic, the control parameter is determined, i.e. the potential difference between the reference electrode 46 and the ion-selective electrode 47.

[0206] Subsequently, the control device 5 calculates the value of each physical-chemical characteristic by comparing the control parameter obtained from the analysis of the sample with the linearization results described above.

[0207] In particular, for each physical-chemical characteristic, the control device 5 notes the control parameter of the corresponding characteristic on the linearization curve relating to it and derives the corresponding value of the physical-chemical characteristic therefrom.

[0208] By way of example, for the pH value, the electrochemical sensor detects the potential difference between the electrodes 46 and 47, i.e. the pH control parameter. This control parameter is subsequently processed by the control device 5, which plots it on the graph obtained in the linearization and derives the pH torque and thus the pH value.

[0209] Once the analysis is completed, the results are displayed on the screen, printed and / or stored on a dedicated mass storage device.

[0210] The control device 5 controls the discharge of the fluid to be analyzed (i.e. urine) from the analysis station, which is collected in the bag 43 of the cartridge 41.

[0211] When the contents of the bag 43 are exhausted, i.e. the contents of the bag 43 containing the calibration or flushing liquid have been exhausted and / or the bag 43 for collecting the waste liquid is full, the cartridge 41 will be removed and replaced.

[0212] The similar procedure is repeated with the control solutions inside the bags 43 of the cartridge 41, whose function, as described above, is to verify the state of quality of the instrument over time through the analysis device 4 and the control device 5.

[0213] The present application also comprises a new process for the analysis of urine. The process is advantageously carried out by means of the apparatus 1 described above.

[0214] Briefly, the process comprises an initial acquisition phase.

[0215] At this stage, the initial parameter relating to the weight of the second portion of urine in the bag 3 is acquired by the acquisition device 6.

[0216] Furthermore, the process also comprises a calculation step in which the control device 5 calculates a second parameter relating to the volume of the second portion of urine in the bag 3. As mentioned previously, the second parameter is calculated as a function of the first parameter, a third predetermined parameter relating to the density of the urine and the known acceleration due to gravity.

[0217] Furthermore, the method also comprises an addition step. In the addition step, the second parameter is added to the predetermined volume of the containment portion 20a to obtain the total volume of urine.

[0218] The method can further comprise a second acquisition step in which the acquisition device 6 acquires a fourth parameter relating to the time of flow of the urine in the first drainage tube 20. The method can thus comprise a split step. In the split step, the control device 5 associates the total volume of urine with the fourth parameter to determine the flow rate of the urine.

[0219] Of course, the process can comprise further steps.

[0220] For example, the initial phase can be preceded by a calibration phase in which the apparatus 1 is calibrated for analysis using the highest and lowest calibration liquids described above.

[0221] This phase comprises an initial analysis step in which the control parameter of each physical property is determined. In particular, in this phase the potential difference between the electrodes 46 and 48 is preferably measured for each property.

[0222] The calibration phase thus comprises a highest calibration step and a lowest calibration step, by means of which the maximum and minimum torque of each property under consideration is obtained. In particular, each torque identifies the value of the property as a function of the control parameter, i.e. the potential difference between the reference electrode 46 and the ion-selective electrode 47 in the case of electrochemical analysis.

[0223] These maximum and minimum values are obtained by means of the control parameter obtained in the steps described above and by means of the maximum value obtained by interpolation, for example. In particular, when calculating these pairs of values, not only the control parameter corresponding to the property under consideration is taken into account, but also the control parameter and / or the value of at least another property which can influence and alter the result of the analysis.

[0224] Therefore, in these phases, the maximum-minimum pairs of values of pH and of sodium, potassium, ammonium and chloride content are determined by interpolating the various control parameters. In particular, the sodium content values are determined as a function of the control parameter relating to the sodium content and of the first parameter relating to the pH value, while the ammonium content values are determined as a function of the control parameter relating to the ammonium content and of the control parameter relating to the potassium content.

[0225] After the two calibration steps described above, the phase ends with a linearization step, in which the values between the maximum and minimum torques are linearized in the manner described above.

[0226] Subsequently, a sample phase is entered, in which a quantity of urine is fed into the device, for example by means of the first sampler module 2. Alternatively, this feeding phase can also be performed in parallel with or before the calibration phase.

[0227] When the sample has been injected and the device 1 has completed the calibration, the analysis phase is started, which comprises two sub-phases.

[0228] In the first analysis sub-phase, an electrochemical analysis is performed on the sample and the control parameter, i.e. the potential difference between the reference electrode 46 and the ion-selective electrode 47, is determined for each of the physical-chemical characteristics to be analyzed.

[0229] Once these potentials have been identified, the first analysis sub-step is completed and the second analysis sub-step is started. In this step, the values of the characteristics are determined by comparing the control parameter obtained in the first analysis sub-step with the results of the linearization step described above.

[0230] Finally, the program can be set to perform the analysis phase described above several times in fixed time intervals, in order to perform a substantially continuous monitoring of the patient's condition.

[0231] The urine analysis device 1 according to the present application has important advantages.

[0232] In fact, the analysis device is able to evaluate all the target physical-chemical parameters relating to the urine sample and always has information on the total volume of the urine being evaluated. In particular, the volume determination is performed in a simple, automatic and autonomous manner.

[0233] Therefore, it is not necessary to know the initial quantity of urine collected.

[0234] Furthermore, with the aid of the second sampler module 7, it is also possible to use urine that has already been collected, for example a sample collected by means of a syringe.

[0235] The second sampler module 7 is able to couple stably and efficiently with a syringe, without being limited by the coupling mode, by means of the shut-off valve 70 and the chamber 10b.

[0236] In addition, at the end of the analysis, the stop valve 70 is flushed by operating the flushing valve 72 and drawing the washing solution from the bag 43 of the cartridge 41 by the pump 51. This allows the urine samples of different patients to be kept from contaminating each other during the analysis, while preventing the formation of incrustations in the area of the stop valve 70 due to the salt content of the urine.

[0237] Furthermore, the first sampling module 2 and the bag 3 can be removed from the support structure 10, so that at least part of the components of the same device 1 can be used for other patients, simply by replacing the first sampling module 2 and the bag 3.

[0238] Furthermore, the design of the bag 43 concentrated in a single cartridge 41 makes the management of the calibration and cleaning module simpler, even for non-specialized personnel.

[0239] Overall, the device 1 can allow simple, quick and high-frequency sample analysis.

[0240] Furthermore, the device 1 does not require the intervention of medical or paramedical personnel, thus allowing a substantially fully automated analysis process.

[0241] The present application can be subject to variations within the scope of the inventive concept defined in the claims. Here all the details can be replaced by equivalent elements and the materials, shapes and dimensions can be anything.

Claims

1. Urine analysis device (1) able to analyze a urine sample to determine a physical-chemical characteristic value of said urine sample, said urine analysis device (1) comprising: - a first sampler module (2) configured to establish a fluid passage connection with a user and comprising a first drainage tube (20), said first drainage tube (20) comprising - a containing portion (20a) defining a predetermined volume and configured to retain a first urine portion of said urine; - a discharge portion (20b) configured to lead a second urine portion of said urine out of said first sampler module (2); - a urine bag (3) at least in fluid passage connection with said discharge portion (20b) and configured to collect said second urine portion; - an analysis apparatus (4) in fluid passage connection with said containing portion (20a) and configured to analyze at least a portion of said first urine portion; - a control apparatus (5) operatively connected with said analysis apparatus (4) and configured to process at least data collected by said analysis apparatus (4); and characterized in that said urine analysis device (1) further comprises - a second sampler module (7) operatively connected with said analysis apparatus (4) and comprising a shut-off valve (70) in fluid passage connection with said analysis apparatus (4), said second sampler module (7) being configured to receive the insertion of a syringe comprising a sample urine, so that said analysis apparatus (4) can analyze said sample urine.

2. Device (1) according to claim 1, wherein said shut-off valve (70) is configured to allow the engagement of a luer or luer lock syringe.

3. Device (1) according to any one of the preceding claims, wherein said shut-off valve (70) is operatively connected with said control apparatus (5) and comprises second optical sensor means (70a) configured to detect whether said syringe is engaged in said shut-off valve (70).

4. Device (1) according to any one of the preceding claims, wherein said second sampler module (7) further comprises a second pilot valve (71), said control apparatus (5) comprises a pump (51) operatively connected at least with said pilot valve (71), and wherein said control apparatus (5) is configured to activate said second pilot valve (71) and said pump (51) when said syringe is engaged in said shut-off valve (70).

5. Device (1) according to the preceding claim, wherein said second sampler module (7) further comprises a flush valve (72) operatively connected with said pump (51), and wherein said control apparatus (5) is configured to activate said second flush valve (72) and said pump (51) when said pilot valve (71) is activated.

6. Device (1) according to any one of claims 4 to 5, wherein said second pilot valve (71) and / or said flush valve (72) each comprise a solenoid valve, and said pump (51) is a peristaltic pump.

7. The device (1) according to any one of the preceding claims, comprising a support structure (10) configured to support the first sampling module (2), the bag (3), the analysis means (4), the control means (5) and the second sampler module (7), wherein the support structure (10) comprises a chamber (10b) configured to house at least a portion of the tip of the syringe and comprising the shut-off valve (70).

8. The apparatus (1) according to any one of the preceding claims, wherein the first sampling module (2) comprises: a catheter inlet (22) configured to be connected to the user, a first reservoir (23) in fluid communication with the catheter inlet (22) and with the containing portion (20a), and a second drain (24) in fluid communication with the first reservoir (23) and with the catheter outlet (21), the second drain (24) being configured to convey the urine from the first reservoir (23) to the catheter outlet (21) when the urine in the first reservoir (23) exceeds a predetermined threshold level.

9. The device (1) according to claim 7, wherein one of the catheter inlet (22) and the first drain (20) comprises first optical sensor means (25) operatively connected to the control means (5) and configured to detect the flow of the urine through the catheter inlet (22) or the first drain (20), wherein the first sampling module (2) further comprises first pilot valve means (26) operatively connected to the control means (5), and wherein the control means (5) are configured to activate the first pilot valve means (26) when the urine flows through the catheter inlet (22) or the first drain (20).

10. The device (1) according to any one of the preceding claims, further comprising acquisition means (6) operatively connected to the bag (3) and configured to acquire at least a first parameter relating to the weight of the second portion of urine, wherein the control means (5) are further operatively connected to the acquisition means (6) and are configured to calculate a second parameter relating to the volume of the second portion of urine as a function of a third predetermined parameter relating to the density of the urine, combining the first parameter, and to add the second parameter to a predetermined volume of the containing portion (20a) to obtain the total volume of urine.

11. The apparatus (1) according to any one of the preceding claims, wherein, the support structure (10) is configured to support also the acquisition means (6), and the acquisition means (6) comprise a load cell (60) constrained to the support structure (10), and the hook (36a) is operatively connected to the load cell (60) and comprises a load cell (60) constrained to the support structure (10), and the bag (3) is removably constrained to the load cell (60) by means of removable constraint means (36).

Images