Urine analysis device

Abstract

A urine analyzer (1) for analyzing a urine sample and determining the physicochemical properties of the urine sample, comprising a first sampler module (2) configured to be positioned connected to a user via a fluid passage, the first sampler module (2) including a first drain duct (20), the first drain duct (20) comprising a containment section (20a) configured to define a predetermined volume and hold a first portion of urine, and a discharge section (20b) configured to transport a second portion of urine outside the first sampler module (2), and a fluid passage connected to at least the discharge section (20b) for collecting the second portion of urine A urine analyzer (1) is provided, comprising: a diuretic bag (3) configured to do so; an analyzer (4) positioned in connection with a fluid passage to a containment section (20a) and configured to analyze at least a portion of a first urine sample; control means (5) operably connected to the analyzer (4) and configured to process at least data collected by the analyzer (4); and a support structure (10) configured to support a first sampler module (2), a bag (3), an analyzer (4), and a control means (5), wherein at least the bag (3) is detachably coupled to the support structure (10) and detached from the first sampler module (2).

Description

Technical Field

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

[0002] The device according to the invention can be placed in the vicinity of the bed, for example at least partially under the bed, and can be connected directly to the patient via a catheter. Specifically, the device can perform electrochemical urine analysis.

[0003] As is well known, urine testing is currently one of the main analytical methods for verifying or ruling out many medical conditions or problems, such as structural lesions, the presence of infectious agents, or changes in one or more organs. In particular, urine testing is a major form of kidney analysis and is therefore an important test for recognizing possible kidney dysfunction and thus the state of the kidneys themselves.

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

[0005] This analysis is currently performed as follows.

[0006] A catheter is connected to the patient, allowing medical staff to pump urine into a special container, such as a bag, from which the correct amount of urine can be drawn. This can be done either by a syringe or other similar instrument properly inserted into the bag or by any appropriate dropper for measuring the correct urine volume.

[0007] Next, the collected amount is diluted to reduce the interference of interfering substances that can lead to incorrect sample evaluation and thus incorrect analysis.

[0008] Once diluted, the urine sample is inserted into the analyzer, and the analyzer performs the analysis according to specific procedures.

[0009] In detail, reagents and / or chemical solutions are added to the urine sample to counteract the adverse effects of interfering substances that could lead to inaccurate analysis. These added components 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 ammonium ion content.

[0010] Once the sample is placed, for example, between two electrodes and ready for analysis, the potential difference between these electrodes can be measured and the content of the desired substance can be determined by performing the analysis. [Overview of the project]

[0011] The well-known technologies mentioned above have several major drawbacks.

[0012] In fact, the procedures used are particularly lengthy and require the continuous presence of healthcare professionals. In particular, the collection of the amount of urine to be analyzed, performed by the operator, introduces the possibility of sample contamination, in addition to a significant increase in testing time.

[0013] Another problem is the analysis itself, which is particularly complex and difficult to perform.

[0014] In particular, the content of urine, which is highly variable both from patient to patient and between different samples taken from the same patient, sometimes requires different dilutions with reagents.

[0015] Another important aspect is that the analysis is also a function of temperature, which has a decisive influence on the final result.

[0016] Therefore, these configurations make it difficult to adjust all parameters, resulting in suboptimal analysis of urine samples.

[0017] In this context, the fundamental technical problem underlying the present invention is to devise a urine analyzer that can substantially eliminate at least some of the aforementioned drawbacks.

[0018] Within the scope of this technical challenge, a key objective of the present invention is to devise a device that enables simple, rapid, and frequent analysis, including substantial monitoring of the patient's condition.

[0019] In fact, the basic organs for survival are the heart, lungs, and kidneys, and while there are various machines to monitor the heart and lungs by analyzing the respiratory and cardiovascular systems, the kidneys cannot be monitored with any known machine.

[0020] A further objective of the present invention is to realize a device that does not require the presence of medical personnel or auxiliary medical personnel, and therefore enables the analysis to be performed essentially automatically.

[0021] Specific technical problems and objectives are achieved by the urine analyzer described in attached claim 1.

[0022] Preferred technical solutions are highlighted in the dependent claims.

[0023] The features and advantages of the present invention will be made clear below by a detailed description of preferred embodiments of the invention with reference to the accompanying drawings. [Brief explanation of the drawing]

[0024] [Figure 1] A schematic front view of the urine analyzer according to the present invention is shown. [Figure 2] Details of the rigid rack forming the interface surface of the cartridge of the urine analyzer according to the present invention are illustrated. [Figure 3] This is a detail of the cartridge bag for the urine analyzer according to the present invention. [Figure 4a] This shows a perspective view of the cartridge of the urine analyzer according to the present invention, in which the opening extends across the entire interface surface. [Figure 4b]A perspective view of a cartridge of a urine analyzer according to the present invention is shown, where the opening extends over a part of the interface surface, especially in the plug, and includes a cover. [Figure 5a] Details of an interface sheet of a cartridge of a urine analyzer according to the present invention are illustrated, with a drain hole at the bottom visible and a guide having pins present. [Figure 5b] Details of an interface sheet of a cartridge of a urine analyzer according to the present invention, where several drain holes are visible at the bottom and a guide having an inlet is present. [Figure 6] A front view of an analysis station of a urine analyzer according to the present invention is shown. [Figure 7] A simplified functional diagram of a urine analyzer according to the present invention is shown.

Embodiments for Carrying Out the Invention

[0025] In this document, measured values, values, shapes, and geometric criteria (such as perpendicularity and parallelism) are to be considered, inter alia, apart from measurement errors or inaccuracies due to production and / or manufacturing errors, apart from slight differences from the values, measured values, shapes, or geometric criteria to which they are associated, when associated with words such as "about" or other similar terms such as "approximately" or "substantially". For example, when these terms are associated with a value, preferably, they indicate a difference of 10% or less of the value.

[0026] Furthermore, when used, terms such as "first", "second", "higher", "lower", "main", and "secondary" do not necessarily specify order, precedence of relationship, or relative position, and can simply be used to clearly distinguish their different components.

[0027] Unless otherwise specified, in the following descriptions, terms such as “processing,” “computing,” “decision,” and “calculation” refer to the operations and / or processes of a computer or similar electronic computing device that manipulate and / or transform physically represented data, such as the amount of electrons in the registers and / or memory of a computer system, a computer system, a register or other storage device, a transmission or information display device, or other data similarly represented as a physical quantity.

[0028] Unless otherwise indicated, the measurements and data reported herein shall be considered to have been taken in accordance with the International Standard Atmosphere (ICAO) (ISO 2533:1975).

[0029] Referring to the figure, the urine analyzer according to the present invention will be collectively referred to as 1.

[0030] In particular, it 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, by determining the values ​​of their physicochemical properties. More specifically, the device 1 measures the pH of the urine sample as well as the sodium, potassium, ammonium, and chloride content, while simultaneously measuring the instantaneous urine flow.

[0031] In short, the device 1 includes at least a first sampler module 2.

[0032] The first sampler module 2 is part of the inlet system for placing the fluid to be analyzed inside the apparatus 1. In particular, the first sampler module 2 is configured to be positioned connected to the user and the fluid passage.

[0033] Therefore, the first sampler module 2 allows urine to reach device 1 when urine is produced, and allows fluid to be introduced into device 1.

[0034] In this regard, more specifically, the first sampler module 2 preferably comprises a first drain duct 20. The first drain duct 20 is a passage through which urine passes to be processed by the device 1 before being discarded.

[0035] Preferably, the first drain duct 20 is a siphon conduit containing a coil that allows for automatic control of the flow of fluid, i.e., urine.

[0036] Therefore, the first drain duct 20 preferably comprises a receiving section 20a and a discharge section 20b.

[0037] The containment section 20a is essentially part of the first drainage duct 20 located upstream of the discharge section 20b.

[0038] The containment section 20a is actually configured to hold a first portion of the urine. For these purposes, the containment section 20a may substantially include a section of the first U-shaped drainage duct 20 that precedes the discharge section 20b. The latter is instead configured to transport a second portion of the urine out of the first sampler module 2.

[0039] Basically, when urine flows into the first drainage duct 20, it passes through the containment section 20a, and once it reaches a sufficient filling level, it begins to flow at least partially through the discharge section 20b, and as a result, the urine is partially discharged by the first sampler module 2.

[0040] Furthermore, the storage section 20a defines a predetermined volume. This makes it possible to determine the volume of the first portion of urine that is contained within the first sampler module 2.

[0041] The first sampler module 2 may include additional features.

[0042] In particular, the first sampler module 2 may include a cannula outlet 21.

[0043] If present, the cannula outlet 21 is connected to the discharge section 20b via a fluid passage. Therefore, the cannula outlet 21 is suitable for transporting urine out of the first sampler module 2 in a controlled manner.

[0044] The first sampler module 2 may also include a cannula inlet 22.

[0045] If present, the cannula inlet 22 is configured to connect to the user. Thus, the cannula inlet 22 is part of the first sampler module 2 that can be directly connected to the user.

[0046] Furthermore, the first sampler module 2 may also include a first tank 23.

[0047] The first tank 23 is essentially a collection tank for collecting urine from the patient. Preferably, the first tank 23 is connected to the fluid passage with the cannula inlet 22 and the containment section 20a. In other words, the first tank 23 is positioned between the cannula inlet 22 and the containment section 20a and is suitable for receiving urine before it enters the containment section of the first drainage duct 20.

[0048] Furthermore, the first tank 23 may include an inclined base plate configured to push urine toward the first drain duct 20 by gravity when the first sampler module 2 is in use.

[0049] The first sampler module 2 may also include a second drain duct 24. The second drain duct 24 may be a flow path that runs parallel to the first drain duct 20. More specifically, the second drain duct 24 is fluid-passage-connected to 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, the second drain duct 24 draws urine from the first tank 23 when the amount of urine in the first tank 23 exceeds a predetermined threshold level.

[0050] Therefore, essentially, the second drain duct 24 is a safety channel or empty-fill channel configured to prevent the first tank 23 from being abnormally filled and altering the proper function of the first sampler module 2.

[0051] Furthermore, the tank 23 may be equipped with a filter mesh in the upper part of the tank 23 relative to the ground, i.e., the part closest to the cannula inlet 22. If present, the filter net may include a mesh of a size that allows for the separation of foreign matter from the urine, such as clumps or organic sediment.

[0052] Therefore, the device 1 also includes a diuretic bag 3.

[0053] Bag 3 is essentially a tank, which can contain fluid, for example, by walls that are deformable or even rigid or partially deformable and partially rigid.

[0054] Therefore, bag 3 is impermeable to liquid. Furthermore, bag 3 is preferably connected to the discharge section 20b and the fluid passage. Thus, bag 3 is configured to collect a second urine portion, i.e., the urine discharge portion from the first sampler module 2.

[0055] The connection between the bag 3 and the discharge section 20b may be direct or indirect. Preferably, the connection between the pouch 3 and the discharge section 20b is made by the cannula outlet 21.

[0056] Furthermore, bag 3 is advantageously detached from the first sampler module 2.

[0057] Preferably, the bag 3 includes a nozzle 30.

[0058] The nozzle 30 is configured to accommodate at least a portion of the cannula outlet 21. Thus, the nozzle 30 is also substantially configured to make a fluid passage connection between the first sampler module 2 and the bag 3.

[0059] The outlet 30 may be a simple hole made in the wall of the bag 3, for example, at the top. In fact, preferably, the first module 2 is intended to be positioned above the bag 3 relative to the ground so that when in use, urine can flow into the bag 3 by gravity.

[0060] Alternatively, the nozzle 30 may include a specific restraining means, such as a quick connector that can firmly lock one end of the outlet cannula 21 to the wall of the bag 3, or a pre-perforated membrane configured to deform to allow a portion of the outlet cannula 21 to enter the bag 3.

[0061] Apparatus 1 also includes an analytical instrument 4.

[0062] The analyzer 4 itself is known and is configured to analyze at least a portion of the first urine sample. Therefore, the analyzer 4 is positioned connected to the housing 20a and the fluid passage.

[0063] Naturally, device 1 also includes control means 5.

[0064] 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. Naturally, the control means 5 may also be operably connected to other components of the apparatus 1, as further described below.

[0065] Preferably, in more detail, the analyzer 4 and control means 5 may be similar to the analyzer station and command and control unit, respectively, described in paragraph [0037-0052] of European Patent Application Publication No. 2510877, which is incorporated herein by reference.

[0066] Essentially, the analyzer 4 is suitable for performing electrochemical analysis of urine and has multiple electrodes, each suitable for determining at least one parameter for each of its physicochemical properties, such as potential difference. The analyzer 4 may comprise an analysis station with at least five electrodes, more specifically a reference electrode 46 and at least one ion-selective electrode 47, or other similar elements that can interact with the substance being analyzed, with the potential for further expansion.

[0067] In detail, at least one ion-selective electrode 47 is provided for each of the following properties to be analyzed: pH, sodium, potassium, ammonium, and chloride content. 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 electrode that is not used for this particular analysis but can later be used to detect further physicochemical properties of the urine sample.

[0068] The reference electrode 46 has a conductive element 46a, such as silver, housed in a chamber 46b that contains a fluid for maintaining the electrode 46 at a constant potential.

[0069] Each ion-selective electrode 47 is in contact with a medium and reacts with specific ions. More specifically, the ion-selective electrode 47 has an electrical connector 47a, such as a pin or even an electrical circuit, suitable for enabling an electrical connection between the ion-selective electrode 47 and a standard electrode 46 in the presence of the fluid to be analyzed; an ion-selective membrane 47b or other similar element that readily reacts with a given ion; a central body 47c that can accommodate almost all the elements constituting the ion-selective electrode 47 and defines two separate chambers; a connecting chamber 47d interposed between the membrane 47b and the connector 47a and suitable for accommodating a fluid that characterizes the electrode offset value, such as a saturated solution of KCl; and a containment chamber 47e adjacent to the ion-selective electrode 47 and suitable for accommodating urine.

[0070] In particular, the containment chamber 47e preferably includes a through-hole, and when the ion-selective electrode 47 is positioned in place, the containment chamber 47e forms a single conduit to allow the free passage of fluid between the chambers and to / from the analyzer 4. To avoid fluid leakage, a sealing element such as an O-ring 47f can be interposed between the electrodes.

[0071] Each ion-selective electrode 47 can react with only one of the substances being analyzed. Specifically, in the case of apparatus 1 for determining pH and the content of sodium, potassium, ammonium, and chloride, the ion-selective electrode 47 reacts sensitively to at least one of the following ions: H+, Na+, K+, NH4+, and Cl-.

[0072] This selection is carried out by an ion-selective 47b membrane that has been specially fabricated and optimized for the interacting elements.

[0073] For example, the membranes for H+ and Na+ ions are glassy matrices, while the membranes for K+, NH4+, and Cl- ions are high molecular weight polymer matrices.

[0074] Apparatus 1 may also have a thermostat 48 in the analyzer 4 that is suitable for adjusting the temperature of the fluid being analyzed and the calibrator while the fluid is in the analyzer 4. The thermostat 48 includes any element suitable for maintaining the urine temperature substantially constant, such as electrical resistance. Preferably, such a temperature is substantially 30°C to 45°C, and more preferably substantially 37°C.

[0075] Finally, each of the electrodes 46 and 47 is electrically connected to a control means 5 suitable for controlling a cleaning or calibration block, if present, which is suitable for analyzing the data collected by each ion-selective electrode 47, comparing the collected data with the data from the standard electrode 46, and enabling the preparation of the analyzer 4 before performing the analysis.

[0076] In addition to analyzing data from the analyzer 4, the control means 5 is preferably also connected to the first sampler module 2, more specifically, to the first sensor means 25. In fact, in at least one embodiment, the first sensor means 25 may be included between the cannula inlet 22 and the first drain duct 20. The latter is preferably an optical means operably connected to the control means 5 and configured to detect urine passing through the cannula inlet 22 or the first drain duct 20.

[0077] Naturally, the first sampler module 2 may further comprise a first pilot valve 26. If present, the latter may also 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.

[0078] 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 transport the first portion of the urine from the containment section 20a to the analyzer 4.

[0079] The first sampler module 2 preferably includes a ventilation duct 27. The ventilation duct 27 is preferably connected to two separate points of the first drain duct 20 and to the external environment via a fluid passage. More specifically, the ventilation duct 27 is positioned to be connected to the end of the housing 20a and to the external environment via a fluid passage. Thus, the ventilation duct 27 is allowed to receive the same pressure at both ends so that the urine collected in the housing 20a can remain stably in the siphon section, i.e., inside the housing 20a.

[0080] The cleaning or calibration block can be made with removable components.

[0081] In a preferred but non-exclusive implementation, the analyzer 4 may include an interface sheet 40 in addition to the analyzer station.

[0082] The interface sheet 40 is preferably operably connected to an analysis station including electrodes. Furthermore, the interface sheet 40 is essentially an open container capable of housing a tank, i.e., a removable component.

[0083] Advantageously, the interface sheet 40 is provided with multiple inlets 40a. Such inlets 40a may include any elements that allow for the insertion or overlapping of orifices or plugs or other connectable elements.

[0084] Preferably, the analyzer also includes a cartridge 41.

[0085] The cartridge 41 is an element available within the interface sheet 40. In detail, the cartridge 41 is preferably at least partially counterbored, like the interface sheet 40.

[0086] Furthermore, cartridge 41 can interact with inlet 40a.

[0087] Therefore, advantageously, the cartridge 41 includes an interface surface 42 and multiple bags 43.

[0088] The interface surface 42 is part of the cartridge 41 intended to directly interact with the inlet 40a. Therefore, preferably, the interface surface 42 includes multiple plugs 42a.

[0089] Therefore, plug 42a is configured to be coupled to inlet 40a. In detail, each 42a plug is coupled to its respective inlet 40a.

[0090] Of course, in alternative implementations, the interface sheet 40 may be equipped with a plug 42a, and the interface surface 42 may be equipped with an inlet 40a.

[0091] In either case, it is preferable that the cartridge 41 has a polarized insertion method in which each inlet 40a corresponds to a specific plug 42a in the interface sheet 40.

[0092] Furthermore, the plugs 42a and inlets 40a are configured to be coupled to the inlets 40a and plugs 42a, respectively, and the plugs 42a and inlets 40a on the interface surface 42 are advantageously connected to the respective bags 43 and fluid passages.

[0093] Each bag 43 is preferably impermeable to liquids. Furthermore, each bag contains a solution for calibration, cleaning, or control.

[0094] For example, a control solution is used to monitor the performance quality of an instrument or electrode over time, following the same procedure as the analysis.

[0095] Therefore, the cartridge 41 advantageously contains all the calibration, cleaning, and control materials separated within itself and is replaceable by connecting or disconnecting each bag 43 to the respective plug 42a or the respective inlet 40a on the interface surface 42.

[0096] The interface surface 42 is preferably a rigid rack in order to facilitate connection between the cartridge 41 and the interface sheet 40.

[0097] Conversely, preferably, the bag 43 is deformable. More specifically, each bag 43 has walls made of a double barrier film that is permeable only to gas. To facilitate coupling to the inlet 40a or plug 42a of the bag 3, each bag 43 is provided with a spout 43a. Thus, the spout 43a is configured to be accommodated in the respective plug 42a or the respective inlet 40a of the interface surface 42.

[0098] At the same time, each nozzle 43a may include a suction valve.

[0099] In particular, bag 43 may include at least one maximum and minimum calibrator containing fluids having known physicochemical properties to be analyzed, as well as high and low concentrations of the same physicochemical properties, respectively. Preferably, the high and low concentrations are close to the maximum and minimum concentrations relative to the values ​​estimated to be obtained by analysis.

[0100] More precisely, the maximum calibrator preferably consists of a fluid having a known pH and sodium, potassium, ammonium, and chloride content higher than the maximum values ​​that may be found in the urine sample, and the minimum calibrator preferably consists of a fluid having a known pH and sodium, potassium, ammonium, and chloride content lower than the minimum values ​​that may be found in the urine sample.

[0101] Furthermore, the cartridge 41 may, advantageously, include a casing 44.

[0102] If present, the casing 44 accommodates the bag 43.

[0103] Preferably, the casing 44 is made of a recyclable material, such as cardboard. Therefore, once the bag 43 is emptied, the casing 44 can be disposed of ecologically or reused.

[0104] Furthermore, the casing 44 preferably defines an open container shape and therefore preferably includes at least one opening 44a. Thus, the opening 44a faces the interface surface 42. In particular, the opening 44a may 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.

[0105] Alternatively, the opening 44a may face the interface surface 42 precisely at the position of the plug 42a, as shown in Figure 4b, for example. Furthermore, the opening 44a may be provided with a removable cover, such as a peel-off cover, which is suitable for covering the plug 42a or the inlet 40a when the cartridge 41 is not in use and allows the cartridge 41 to be connected to the interface sheet 40.

[0106] At the same time, the interface sheet 40 may have a flat bottom from which the inlet 40a or plug 42a is cut out. Alternatively, the interface sheet 40 may have a guide 40b. The guide 40a may be, for example, a bottom strip that protrudes from the rest of the bottom to form a raised portion.

[0107] If present, the guide 40b is positioned at the entrance 40a or plug 42a of the interface sheet 40. Furthermore, the guide 40b is advantageously bent in the opposite direction at the opening 44a. In this way, the guide 40b allows the housing 44 to be clamped to the guide 40b when the housing 40 is inserted into the interface sheet 40.

[0108] Since calibration fluid or cleaning fluid is primarily a liquid substance, the interface sheet may advantageously include drainage holes 40c.

[0109] If present, the drainage hole 40c is preferably a hole at the bottom of the interface sheet 40, and if a guide is present, it is preferably a hole in the portion not occupied by the guide 40b.

[0110] Therefore, the drain hole 40c is configured to allow liquid to flow out of the interface 40. This means that if there is an undesirable leak from the interface surface 42, the drain hole 40c may allow excess liquid to flow out.

[0111] Generally, the interface sheet 40 is connected as appropriate to other parts of the analyzer 4 and the control means 5.

[0112] To enable the transport of urine between various parts of the apparatus 1, the control means 5 includes not only electronic connection means for controlling various valves, solenoid valves, and other components of the apparatus 1, but also connectors for fluid passages between various parts, for example, between the first sampler module 2 and the analyzer 4.

[0113] For example, overall, the control means 5 is arranged in connection with at least the first sampler module 2 and the analyzer 4 via a fluid passage.

[0114] Therefore, the control means 5 may include a control station 50.

[0115] If present, the control station 50 is suitable for controlling device 1.

[0116] The control station 50 may also include, or be connected to, an export element such as a printer or mass storage device connection to enable the results to be printed and / or viewed on an external device such as a computer.

[0117] Furthermore, the control station 50 can be configured to allow analysis to be programmed at a predetermined time, or at a predetermined time interval, thereby enabling verification of the periodic operation of the device 1, and thus the correct performance of the analysis without the presence of an operator.

[0118] The control station 50 may include, in this regard, a screen or other similar element capable of displaying at least the results of the analysis, and a control element such as a keyboard capable of controlling the operation of the entire device 1. Alternatively, the screen may be of the touchscreen type and may, in addition to displaying data, enable control of the device 1.

[0119] The control means 5 can be connected to the bag suction valve 43 when the interface surface 42 of the cartridge 41 is connected to the plug 42a or inlet 40a of the interface sheet 40.

[0120] Furthermore, the control means 5 can be connected to the first pilot valve 26.

[0121] In this way, the control means 5 can control the flow entering and leaving the analysis device 4.

[0122] The control means 5 may, in particular, include a pump 51.

[0123] The pump 51 can be operably connected to at least the first pilot valve 26 and therefore can be arranged in connection with the fluid passage of the first pilot valve 26.

[0124] Furthermore, when cartridge 41 is connected to interface sheet 40, 51 may be connected to bag suction valve 43.

[0125] Therefore, the pump 51 can be configured to transport urine in a controlled manner from the first sampler module 2, i.e., from the containment section 20a to the analyzer 4, or it can be configured to transport calibration fluid or washing fluid from the bag 43, i.e., from the cartridge 41 to the rest of the analyzer 4.

[0126] In a preferred but non-exclusive implementation, the device 1 includes an acquisition means 6.

[0127] If present, the acquisition means 6 is operably connected to the bag 3.

[0128] Furthermore, they are configured to obtain at least a first parameter relating to the weight of the urine portion exiting the first sampler module 2 via the second urine portion, i.e., the discharge portion 20b.

[0129] Therefore, the control means 5 is preferably further operably connected to the acquisition means 6. Furthermore, the control means 5 is advantageously configured to calculate a second parameter relating to the volume of a second urine portion with respect to the first parameter, given a third predetermined parameter relating to urine density.

[0130] Basically, the control means 5 allows, for example, the control station 50 to set a known value for the urine density that constitutes the third parameter. Therefore, by obtaining the first parameter through the acquisition means 6, and knowing the weight of the second urine portion, it is possible to calculate the volume of the second urine portion, which is given by multiplying the ratio of weight, i.e., the first parameter, to density, i.e., the third parameter, by the acceleration due to gravity.

[0131] Once the second parameter, namely the total volume of the second urine portion, is obtained, it is possible to add the second parameter to a predetermined volume of the storage section 20a that contains the first urine portion.

[0132] In this way, the control means 5 can obtain the total volume of urine in the device 1.

[0133] Furthermore, the acquisition means 6 can be further configured to acquire a fourth parameter relating to the urine flow time in the first drain duct 20.

[0134] For example, a photoelectric cell can be used to measure the time it takes for urine to pass through a certain section of the drainage duct 20.

[0135] 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.

[0136] Device 1 may also include a second sampler module 7.

[0137] The second sampler module 7, if present, is operably connected to the analyzer 4. Therefore, the second sampler module 7 may include a shut-off valve 70 connected to the analyzer 4 via a fluid passage.

[0138] The shut-off valve 70 is preferably a reaction valve designed to allow the connection of fluid flow when a specific device is connected to the shut-off valve 70 itself.

[0139] For example, the shut-off valve 70 can be configured to allow the attachment of a Luer or Luer-lock syringe.

[0140] Generally, the shut-off valve is configured to house a syringe attachment containing the sampled urine so that the analyzer 4 can analyze the sampled urine.

[0141] Therefore, essentially, the second sampler module 7 allows the device to introduce a urine sample that has already been collected in a syringe.

[0142] 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.

[0143] The latter sensors 70a, if present, are advantageously optical. Furthermore, they are advantageously configured to detect the presence of a syringe engaged with the shut-off valve 70.

[0144] Therefore, the second sampler module 7 may further include a second pilot valve 71. 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 actuate the second pilot valve 71 and the pump 51 whenever the syringe is engaged 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] In detail, pump 51 may be a peristaltic pump.

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

[0148] Flushing prevents contamination by salinity from urine in the area of ​​the stop valve 70 and prevents contamination from urine between different users.

[0149] From a structural standpoint, the device 1 may include a support structure 10. The support structure 10 may essentially be a frame or container or any 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 sampler module 2, the bag 3, the analyzer 4, and the control means 5.

[0151] In addition, the support structure 10 may also be configured to support the acquisition means 6 and the second sampler module 7, if present.

[0152] In particular, advantageously, in addition to being detached from the first sampler module 2 as described above, bag 3 is also detachably constrained to the support structure 10.

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

[0154] Therefore, the restraint means 36 may 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 formed in the bag 3 and is configured to pass through the hook 36a.

[0156] Of course, the slot 36b can be formed in the support structure 10, and instead the hook 36a can be attached to the bag 3.

[0157] Furthermore, any type of equivalent means to the restraint 36 can be used.

[0158] The described implementation is particularly advantageous when the device 1 is equipped with acquisition 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 a support structure 10. Thus, the bag 3 can be precisely and detachably constrained to the load cell 60 via a detachable constraining means 36.

[0160] More specifically, this means that, for example, the hook 36a can be operably connected to the load cell 60. Thus, the slot 36b formed in the bag 3, which is configured to pass through the hook 36a, allows the bag 3 to be hung on the hook 36a so that when urine reaches the bag 3, the weight of the contents of the bag 3 itself, for example, a second portion of urine, is transmitted to the load cell 60.

[0161] In addition, the first sampler module 2 can be detachably coupled to the support structure 10, regardless of whether the bag 3 is connected to the support structure 10 or not. The first sampler module 2 can also be detached from the analyzer 4.

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

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

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

[0165] The connecting means 32 may be detachable or not.

[0166] For example, the connecting means 32 may include at least one strap 32a. The strap 32a is advantageously flexible and configured to allow the bag 3 and the first sampler module 2 to be supported on both sides of the hospital bed rail.

[0167] Of course, the connecting means 32 may also include a plurality of straps 32a. The latter can be released by a button or passed through special hollow guides formed in the first sampler module 2 and / or bag 3.

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

[0169] The compartment 10b may be located near the shut-off valve 70. More specifically, the compartment 10b may include the shut-off valve 70, for example, in its rear wall. Thus, the 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 inversely to the syringe tip.

[0171] The support structure 10 may further comprise a plurality of conduits and / or joints of the control means 5, and may connect at least some of the components of the apparatus 1, as well as, of course, the pump 51 or other similar mechanisms capable of moving the fluid to be analyzed, via fluid passage connections.

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

[0173] The apparatus 1, and therefore the control structure 10, may have a power supply system (not shown) comprising a battery and / or connecting cables that can supply power to components of the apparatus 1, such as the control means 5 and the analyzer 4, and connect the apparatus to an external power network.

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

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

[0176] In particular, the cartridge 41 connects the plug 42a to the inlet 40a.

[0177] Once this operation is complete, the apparatus 1 is ready for use, and a fluid sample to be analyzed, typically urine, can be introduced via the first sampler module 2 or the second sampler module 7.

[0178] In detail, when using the second sampler module 7, the sampled urine is manually inserted by a healthcare professional or an auxiliary healthcare professional, for example, by inserting a syringe into compartment 10b engaged with the stop valve 70.

[0179] Alternatively, introduction is performed via a first sampler module 2 that is directly connected to the patient via a catheter, allowing urine to flow directly into device 1.

[0180] In this case, the urine reaches the first tank 23 via the cannula inlet 22, where it is transported to the first drain duct 20. Specifically, the urine first reaches the containment section 20a, where a first portion of the urine, determined by a predetermined volume, is collected. Subsequently, if the urine exceeds the volume that can be contained in the containment section 20a, the urine can flow out from the discharge section 20b. In some cases, if the fluid flow reaching the first sampler module 2 is excessive and the level of the first collection tank 23 exceeds a predetermined level, the excess fluid, i.e., the portion above the level, is discharged directly into the bag 3 through the second drain duct 24, which functions as an overflow drain pipe, preventing the excess amount from altering the proper functioning of the first sampler module 2.

[0181] The fluid in the first tank 23 may also pass through the first sensor means 25 under the influence of gravity before reaching the first drain duct 20. For example, urine passing through the first optical sensor means 25 may interrupt a continuous signal emitted by a light beam, i.e., a light emitter, and detected by a photosensitive element.

[0182] In detail, urine interposed between the emitter and the photosensitive element blocks the light beam incident on the element, and therefore, the control means 5, appropriately positioned in the current / data path connection between the first sensor means 25 and the photosensitive element, detects the interruption of the continuous signal and suspends reading of the continuous signal for a time equal to the interruption time. The latter time can be sampled by the control means 5 to determine a fourth parameter.

[0183] 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 a first portion of urine is collected, from which a second portion of urine exceeding a predetermined volume reaches the discharge section 25b and is then discharged into the bag 3.

[0184] More specifically, the first portion of the fluid corresponding to the amount being analyzed remains inside the containment section 20a thanks to a structure by a ventilation duct 27 that allows the end of the containment section 20a to have the same pressure, thereby enabling the fluid to remain between the two pressures, by communicating the end of the containment section 20a with the external environment.

[0185] At this point, device 1 is ready to perform the analysis of the urine sample.

[0186] Of course, thanks to the acquisition means, the control means 5 can evaluate the total volume of urine that has passed through the device.

[0187] In fact, since bag 3 is suspended from load cell 60 by hook 36a, load cell 60 can measure the weight of the second portion of urine collected in the bag.

[0188] By obtaining the weight that determines the first parameter, and knowing the third parameter relating to the density of the urine and the known constant of gravitational acceleration, it is possible to determine the second parameter relating to the volume of the second part of the urine. Since the volume of the first part of the urine can be determined from a predetermined volume in the containment section 20a, the total volume of the urine can be determined by adding the second parameter to the predetermined volume, without employing special sensor means or other elements such as a dripper.

[0189] Furthermore, in the first sampler module 2, the urine flow rate can be determined by relating the total volume to the urine flow time.

[0190] However, before first use or after a certain number of analyses have been performed, device 1 may require calibration.

[0191] To perform the calibration, the largest and smallest calibrators are first analyzed; that is, a complete analysis of the largest and smallest calibrator samples is performed.

[0192] In particular, this analysis is performed at a standard temperature set by thermostat 48, preferably about 37°C.

[0193] Therefore, via the control means 5, for example, a fluid sample of the maximum calibrator is taken from the associated bag 43 of the cartridge 41 and sent to the analysis station of the analyzer 4, more precisely to the conduit and electrochemical sensor 47 formed by the containment chamber 47e.

[0194] In particular, each ion-selective membrane 47b selects at least one of each ion, and in some cases, selects similar ions along with the same ion.

[0195] Therefore, each ion-selective electrode 47 reacts with its own ion and, in some cases, with similar ions. Depending on the amount or concentration of 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 parameters.

[0196] The control parameters are functions of the selected ion and, if any, similar ions. Thus, the apparatus 1 can interpret the control parameters and estimate the physicochemical properties of the analyzed sample from them.

[0197] The ion-selective electrodes 47 have been found to be capable of selectively measuring each of the following ions: H+ ions (for pH measurement), K+ ions (for potassium measurement), Cl- ions (for chloride measurement), and NH4+ ions (for ammonium measurement). They independently select and measure each ion. In this case, the concentration of these ions is directly proportional to the potential difference measured by each ion-selective electrode 47. Therefore, the concentrations of each ion can be directly obtained from the control parameters obtained from the ion-selective electrodes 47 for H+, K+, Cl-, and NH4+.

[0198] In contrast, the control parameters measured by the ion-selective electrode 47 for Na+ ions (for sodium measurement) are functions of the concentrations of Na+ ions and, furthermore, H+ ions. In particular, the sodium concentration can be obtained from each control parameter and depends on the mathematical algorithm for the H+ ion concentration (at the same time, the H+ ion concentration can be obtained directly from each ion-selective electrode 47, as described above).

[0199] Furthermore, the control parameters measured by the ion-selective electrode 47 for NH4+ ions (for ammonium measurement) are functions of the concentrations of NH4+ ions and, furthermore, K+ ions. In particular, the ammonium concentration can be obtained by subtracting the K+ ion concentration from the relative control parameters using a mathematical algorithm (at the same time, the K+ ion concentration can be obtained directly from each ion-selective electrode 47 as described above).

[0200] In summary, the control means 5 first determines the control parameters, at least one of which directly determines at least one of the values ​​of the physicochemical properties to be determined. Subsequently, the same control means 5 determines further physicochemical properties according to the first parameter and the already determined physicochemical properties.

[0201] As a result, the control means 5 quantifies this potential difference based on the signals sent to electrodes 46 and 47, and thus determines the results of the analysis, namely, in this example, the pH and the content of sodium, potassium, ammonium, and chloride in the urine sample.

[0202] In conclusion, at the end of the analysis of the maximum value sample, the control means 5 determines, for each physicochemical property, the maximum pair indicating the content of the physicochemical property and the control parameter for the same property obtained by analyzing the maximum calibrator. For example, the maximum torque with respect to pH identifies two different values: pH content and potential difference, which are determined by the associated ion-selective electrode 47.

[0203] Once the analysis of the maximum calibrator sample is complete and the maximum torque described above is obtained, the control means 5 commands the discharge of the maximum calibrator sample, and the sample is sent to one of the bags 43 in the cartridge 41 for collecting the discharge.

[0204] Once extraction is complete, a second calibration is performed, which allows the minimum torque to be determined for each physicochemical property using a minimum calibrator, based on the relative control parameter and the relative value obtained with the minimum calibrator.

[0205] Once the two calibration analyses described above are complete, 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 path between the maximum and minimum torques, i.e., assigns a constant direction / variation of the values ​​of the physicochemical characteristics with respect to the control parameters, preferably on a logarithmic basis.

[0206] 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.

[0207] Once linearization is complete, the device 1 is calibrated and ready to perform analysis. For example, via the control station 50, the operator can select the physicochemical properties to be analyzed and initiate the analysis.

[0208] The control means 5 controls the entry of the urine to be analyzed into the conduit formed by the containment chamber 47e and performs the analysis of the urine sample at a temperature of approximately 37°C, which is appropriately controlled by the thermostat 48.

[0209] First, control parameters are determined for each physicochemical property, namely the potential difference between the reference electrode 46 and the ion-selective electrode 47.

[0210] Next, 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.

[0211] In particular, for each physicochemical property, the control means 5 reports control parameters related to the property for the associated linearization, and derives the corresponding value for the physicochemical property based on these parameters.

[0212] For example, when calculating pH, the electrochemical sensor corresponding to pH detects the potential difference between electrodes 46 and 47, i.e., the pH control parameter. This control parameter is then processed by the control means 5, which plots the parameter on a graph obtained by linearization, derives the pH torque, and thus obtains the pH value.

[0213] Once the analysis is complete, the results are displayed on a screen, printed, and / or stored in a special mass storage device.

[0214] The control means 5 controls the discharge of the fluid to be analyzed, i.e., the urine collected in the cartridge 41 in the bag 43, from the analysis station.

[0215] When bag 43 is emptied, that is, when the contents of bag 43, including the calibrator or flushing fluid, are gone, and / or when bag 43, which is designed to collect waste fluid, becomes full, cartridge 41 is removed and replaced.

[0216] As described above, the same series of steps are repeated using the control solution in the bag 43 of the cartridge 41, which has the function of verifying the quality status of the equipment over time by the analyzer 4 and the control means 5.

[0217] The present invention also includes a novel process for urine analysis. This process is advantageously carried out by the apparatus 1 described above.

[0218] In short, the process includes an initial acquisition phase.

[0219] At this stage, initial parameters relating to the weight of the second portion of urine in bag 3 are obtained by acquisition means 6.

[0220] Furthermore, this procedure includes a calculation step in which a second parameter relating to the volume of the second portion of urine in bag 3 is calculated by the control means 5. As already mentioned, the second parameter is calculated with respect to the first parameter based on a predetermined third parameter relating to the density of the urine and, of course, a known gravitational acceleration.

[0221] In addition, the procedure includes an additional step. In the additional step, the total urine volume is determined by adding a second parameter to a predetermined volume of the storage section 20a.

[0222] This procedure may further include a second acquisition step in which a fourth parameter relating to the urine flow time in the first drain duct 20 is acquired by the acquisition means 6. Thus, the procedure may include a splitting step, in which the control means 5 compares the volume of urine with the fourth parameter to determine the urine flow rate.

[0223] Of course, the process may include further steps.

[0224] For example, the procedure may first include a calibration step in which the instrument 1 is calibrated for analysis using the maximum and minimum calibrators described above.

[0225] This process includes an initial analysis step in which control parameters for each physical characteristic are determined. More specifically, it is preferable that the potential difference between electrode 46 and electrode 48 is determined for each characteristic at this stage.

[0226] Therefore, the calibration stage includes a maximum calibration step and a minimum calibration step to obtain the maximum and minimum torques for each characteristic under consideration. In detail, each torque identifies the value of its characteristic as a function of a control parameter, which is the potential difference between the reference electrode 46 and the ion-selective electrode 47 in the case of electrochemical analysis.

[0227] These maximum and minimum pairs consist of the control parameters obtained in the process described above and the maximum values ​​obtained, for example, by interpolation. In particular, the pairs are calculated taking into account not only the control parameters corresponding to the characteristic in question, but also the control parameters and / or values ​​for at least one other characteristic that may affect and thus change the results of the analysis.

[0228] Therefore, at these stages, the maximum and minimum pairs of pH and sodium, potassium, ammonium, and chloride content can be determined by interpolating various control parameters. Specifically, the sodium content value is determined based on the control parameter for sodium content and the first parameter for pH, and the ammonium content value is determined based on the control parameter for ammonium content and the control parameter for potassium content.

[0229] Once these two calibration steps are complete, this stage is concluded by a linearization step, in which the values ​​between the maximum and minimum torques are linearized, as described above.

[0230] Subsequently, there is a supply stage in which a certain amount of urine is supplied to the device, for example, via the first sampler module 2. Alternatively, this supply stage can be performed in parallel with or before the calibration stage.

[0231] Once the sample is inserted and instrument 1 is calibrated, an analysis phase is initiated, which includes two sub-stages.

[0232] In the initial analytical sub-stage, 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.

[0233] Once these potentials are identified, the first analysis sub-step is completed and the second analysis sub-step is started, in which the value of each characteristic is determined by comparing the control parameters obtained in the first analysis sub-step with the results of the linearization step described above.

[0234] Finally, the procedure can specify several of the aforementioned analytical steps to be performed at regular time intervals so that the patient's condition can be monitored substantially continuously.

[0235] The urine analyzer 1 according to the present invention achieves important advantages.

[0236] In fact, the analyzer allows for the evaluation of all physicochemical parameters of interest related to the urine sample by always knowing the total volume of urine being evaluated. In particular, the measurement of volume is simple, automatic, and autonomous.

[0237] Therefore, it is not necessary to know the initial volume of the sampled urine.

[0238] Furthermore, thanks to the second sampler module 7, it is also possible to use urine that has already been sampled, for example, by a syringe.

[0239] The latter, thanks to the shut-off valve 7 and compartment 10b, enables stable and efficient coupling of syringes regardless of the type of coupling.

[0240] Furthermore, at the end of the analysis, the shut-off valve 70 is flushed by a pump 51 that draws washing solution from the bag 43 of the cartridge 41 by operating the flushing valve 72. This makes it possible to analyze urine from different patients without contaminating each other, and also avoids any contamination of the area of ​​the shut-off valve 70 due to the salt content in the urine.

[0241] Furthermore, the first sampler module 2 and bag 3 can be removed from the support structure 10, and therefore, by simply replacing the first sampler module 2 and bag 3, at least a portion of the same device 1 can be used for another patient.

[0242] Furthermore, the fact that the bags 43 are collected in a single cartridge 41 makes it easy for any user, even a non-expert, to manage the calibration and cleaning blocks.

[0243] Therefore, in general, the apparatus 1 enables simple, rapid, and frequent analysis.

[0244] Furthermore, device 1 does not require the presence of medical professionals or auxiliary medical professionals, and therefore enables the analysis to be performed essentially automatically.

[0245] The present invention allows for modifications within the concept of the invention as defined by the claims.

[0246] Here, all details can be replaced with equivalent elements, and the material, shape, and size can be arbitrary.

Claims

1. A urine analyzer (1) for analyzing a urine sample and determining the values ​​of the physicochemical properties of the urine sample, A first sampler module (2) configured to be positioned connected to a user and a fluid passage, the first sampler module (2) includes a first drain duct (20), the first drain duct (20) comprising a containment section (20a) configured to define a predetermined volume and hold the first portion of the urine, and a discharge section (20b) configured to transport the second portion of the urine out of the first sampler module (2), A diuretic bag (3) is configured to be connected to at least the discharge section (20b) and a fluid passage to collect the second portion of the urine, An analyzer (4) is arranged in connection with the aforementioned containment section (20a) via a fluid passage and is configured to analyze at least a portion of the first part of the urine, Control means (5) is operably connected to the analysis device (4) and configured to process at least the data collected by the analysis device (4), A support structure (10) configured to support the first sampler module (2), the bag (3), the analyzer (4), and the control means (5), It is characterized by having, Apparatus (1) wherein at least the bag (3) is detachably restrained to the support structure (10) and detached from the first sampler module (2).

2. The apparatus (1) according to claim 1, wherein the bag (3) is detachably restrained to the structure (10) by a detachable restraining means (36) comprising a hook (36a) integral with the structure (10) and a slot (36b) formed in the bag (3) and configured to pass through the hook (36a).

3. The apparatus (1) according to claim 1 or 2, wherein the first sampler module (2) comprises a cannula outlet (21) that connects to the discharge section (20b) via a fluid passage, and the bag includes a nozzle (30) configured to accommodate at least a portion of the cannula outlet (21) in order to connect the fluid passage between the first sampler module (2) and the bag (3).

4. The apparatus (1) according to any one of claims 1 to 3, wherein the first sampler module (2) is also detachably constrained to the support structure (10) and detached from the analyzer (4).

5. The apparatus (1) according to any one of claims 1 to 4, wherein the structure (10) comprises a housing (10a) configured to house the first sampler module (2), and the first sampler module (2) is inserted into the housing (10a) by support and restraint.

6. The apparatus (1) according to any one of claims 1 to 5, wherein the first sampler module (2) and the bag (3) are interconnected by connecting means (32).

7. The apparatus (1) according to any one of claims 1 to 6, wherein the connecting means (32) comprises at least one flexible strap (32a) configured to allow the bag (3) and the first sampler module (2) to be supported on both sides of a hospital bed rail.

8. The apparatus (1) according to any one of claims 1 to 7, wherein the first sampler module (2) comprises a cannula inlet (22) configured to be connected to the user, a first tank (23) connected to the cannula inlet (22) and the housing (20a) via a fluid passage, and a second drainage duct (24) connected to the first tank (23) and the cannula outlet (21) via a fluid passage, configured to transport the urine from the first tank (23) to the cannula outlet (21) when the urine in the first tank (23) exceeds a predetermined threshold level.

9. The apparatus (1) according to any one of claims 1 to 8, further comprising an acquisition means (6) operably connected to the bag (3) and configured to acquire at least a first parameter relating to the weight of the second urine portion, wherein the control means (5) is further operably connected to the acquisition means (6) and configured to calculate a second parameter relating to the volume of the second urine portion with respect to the first parameter, given a third predetermined parameter relating to the density of the urine, and to obtain the total volume of the urine by adding the second parameter with the predetermined volume of the storage portion (20a).

10. The apparatus (1) according to any one of claims 1 to 9, wherein the support structure (10) is configured to also support the acquisition means (6), and the acquisition means (6) comprises a load cell (60) that is constrained to the support structure (10) and operably connected to the hook (36a).

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