Station for urine analysis device, urine analysis device, associated methods
A compact urine analysis device with a rotating cartridge system addresses the bulkiness and flexibility issues of existing devices by enabling efficient urine injection and analysis within a toilet, allowing easy operation and communication with mobile terminals.
Patent Information
- Authority / Receiving Office
- FR · FR
- Patent Type
- Patents
- Current Assignee / Owner
- WITHINGS SAS
- Filing Date
- 2021-09-08
- Publication Date
- 2026-05-08
AI Technical Summary
Existing urine analysis devices for toilets are bulky, inflexible, and difficult to reload and operate with multiple types of test strips, requiring significant space outside or integration into the toilet.
A compact urine analysis device with a station and cartridge system, where the cartridge rotates within an annular housing, allowing test strips to be selectively positioned for injection and analysis without unwinding, featuring an injector, analyzer, and position sensor radially aligned for efficient operation.
The device optimizes urine analysis by enabling seamless injection and measurement without cartridge rotation, maintaining a compact design and facilitating easy cartridge replacement, while ensuring hygienic operation and communication with mobile terminals.
Smart Images

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Abstract
Description
Title of the invention: Station for urine analysis device, urine analysis device, associated methods. Technical field
[0001] This disclosure relates to urine analysis devices intended to be positioned inside toilets, either partially or completely. This disclosure also relates to a method for analyzing urine received in a toilet. Previous technique
[0002] Many biological parameters are reflected in an individual's urine. From a urine sample, it is possible, for example, to detect health problems such as a urinary tract infection, diabetes, or kidney failure. The urine sample can also reflect the quality of a diet, identify a fertile period or pregnancy, and detect drug or tobacco use. It is therefore beneficial to monitor various biological parameters periodically.
[0003] It is known to offer devices installed in toilets that have a urine analysis function. These devices are capable of collecting urine samples from the toilet and analyzing them in order to determine the level of a biological parameter.
[0004] A urine analysis device for mounting on a toilet rim is known from patent US20180188231. This device allows for analysis using a field-effect transistor.
[0005] Devices comprising test strips moving past an analysis section are proposed in documents US20170284925 and US 10383606.
[0006] However, such devices are bulky. In particular, they require a storage area for new and used test strips. These devices must therefore be positioned largely outside the toilet or integrated into it.
[0007] Furthermore, such devices are not flexible. It appears particularly difficult to reload new test strips and remove used strips. It also appears difficult to perform analyses requiring several types of strips.
[0008] There is therefore a need for a urine analysis device that does not have the disadvantages of the prior art. Summary
[0009] The present description aims to propose one or more solutions resolving at least some of the aforementioned drawbacks. In particular, the applicant has developed a new device comprising a station and a cartridge (also called a rotating support), described in document PCT / EP2021 / 055302. This application aims to propose improvements to the device and station described in that document.
[0010] A urine analysis station is proposed here, configured to cooperate with a cartridge, so as to form a urine analysis device. Various methods of using the urine analysis device are also proposed here.
[0011] In particular, the station comprises a housing intended to be positioned inside a toilet, i.e., located inside the toilet bowl. The housing includes the electronics necessary for the operation of the station and the device. The main body is positioned to receive a stream of urine when the user urinates. The station may include an annular housing within the casing, i.e., an annular-shaped void extending around an axis of rotation. The station may further include a urine injector positioned within the housing, in particular radially within the annular housing. The annular housing is configured to accommodate, wholly or partially, a cartridge that is rotatable within the station around the axis of rotation.The cartridge typically includes a rotating holder that accommodates a plurality of test holders (e.g., test strips) arranged along an arc. The test holders are attached to the rotating holder and remain attached to it during the use of the urine collection device. In other words, all test holders undergo the same rotational movement at any given time when the cartridge is rotated (e.g., in the case of test strips, there is no winding or unwinding of a strip film around a winder and / or unwinder). As the cartridge rotates within the station, the test holders can thus be selectively positioned in front of the urine injector, which can then inject a controlled volume of urine. To insert the cartridge into the main body, the latter may include a removable cover to allow access to the annular housing.The main body may also include an analyzer configured to analyze a test support. As before, when the cartridge is rotated within the station, the test supports can be selectively positioned in front of the analyzer, which can then obtain data on the test support directly opposite it. The analysis is typically optical, such as colorimetric. To correctly position the test support relative to the injector and / or the analyzer, the station may include a position sensor, which provides a localized position for each test support relative to the housing (and therefore to the annular housing). In particular, at least... Two components—the injector, the analyzer, and the position sensor—are positioned radially around the axis of rotation at the same location, allowing them to operate on the same test support without requiring cartridge rotation between position acquisition and injection, position acquisition and measurement, or injection and measurement. This optimizes both injection and analysis.
[0012] The test support comprises a reagent capable of reacting upon contact with urine. The reagent may be a dry reagent. In one embodiment, the test support is a test strip, but other supports may be used.
[0013] Here the term "radially" means along a radial direction. Such a radial direction is generally defined as a direction perpendicular to the axis of rotation (A) and passing through the axis of rotation (A).
[0014] In one embodiment, the injector is movable relative to the main body. In particular, an injection position is defined, in which the injector can deposit a few drops of urine onto a test support; a priming position, in which the injector can discharge urine to a drain; and a withdrawal position, in which the injector is not configured to be active. During cartridge rotations, the injector is typically in the withdrawal position. In one embodiment, the movement performed by the injector is a translation.
[0015] In particular, the injector is positioned radially internal to the annular housing, such that the annular housing surrounds the injector. Except for the distal end, which enters the annular housing due to the injector's movement, the rest of the injector remains radially internal to the annular housing. In certain positions (purge position and injection position), the entire injector remains radially internal to the annular housing. In the purge position, the distal end is even radially external to the annular housing.
[0016] The station may also include an electronic control unit (ECU) and a communication module (typically wireless) for bidirectional communication with a mobile terminal and / or a remote server. A battery in the housing provides power to all components.
[0017] This description covers several aspects. Some of them will be highlighted in the following paragraphs, but the description is not limited to them.
[0018] In one aspect (called a "curved injector"), a station for a urine analysis device is proposed, the station comprising: - a device, designed to be positioned inside a toilet, - an annular housing, around an axis of rotation, in the casing, the annular housing being configured to at least partially receive a cartridge mounted for rotation around the axis of rotation in the station and comprising a plurality of test supports, - an injector, positioned in the housing, and configured to inject a controlled volume of urine onto at least one test support, the injector being mounted to move in translation relative to the housing.
[0019] The injector may include a distal injection end whose translational movement is in a radial or substantially radial direction with respect to the axis of rotation.
[0020] “Substantially radial” may mean less than 5° on either side of the direction radial, or even less than 2°. The closer we are to a radial direction, the more margin we gain in terms of cartridge movement.
[0021] In particular, the injector is positioned radially internal to the annular housing, such that the annular housing surrounds the injector. Except for the distal end, which enters the annular housing due to radial movement, the rest of the injector remains radially internal to the annular housing. In certain positions (particularly the retraction position), the entire injector remains radially internal to the annular housing. In the priming position, the distal end is even radially external to the annular housing.
[0022] The injector can be driven in translation along a first axis, while the distal injection end moves in translation along a second axis, called the injection axis. The first axis of translation is not then coincident with the second axis, once the latter are projected onto a plane orthogonal to the axis of rotation. By "at the level," it is meant that the first axis carries the axis of the displacement actuator while the second axis carries the injection axis, the two axes being parallel but offset.
[0023] The injector may be curved. In other words, the injector, when projected onto a plane orthogonal to the axis of rotation, has a curved shape. This means that the injector channel that carries the fluid is curved.
[0024] The housing may include a central mechanical coupler on the axis of rotation, adapted to cooperate with the cartridge to rotate the latter. The second axis of translation may then pass through said mechanical coupler, and the first axis of translation may be offset from the mechanical coupler. The curved shape of the injector bypasses the mechanical coupler. Typically, the second axis of translation is separated from the first axis by a predetermined offset distance (for example, at least 5 mm and, for example, less than 15 mm or even 10 mm).
[0025] The injector may include a proximal end, opposite the distal end and configured to receive urine. The distal and proximal ends are then connected by an intermediate portion comprising two successive inverted bends. In particular, the bend closest to the distal end (bend distal) has a smaller radius of curvature than the nearest bend to the proximal end.
[0026] The injector can be rigid.
[0027] The station may include a displacement actuator, configured to move the injector, in particular in translation.
[0028] For the linear movement of the injector, the injector can be secured to a nut designed to receive a threaded rod driven in rotation by the movement actuator. The injector (604) can also be mounted on a carriage, and the carriage can absorb the forces transmitted by the movement actuator. For example, the carriage is driven in translation at the first axis. The nut can be mounted on the carriage.
[0029] The carriage may include a guide configured to cooperate with a housing guide to guide said carriage in translation. A sliding joint is provided that compensates for the parasitic torque generated by the offset between the injection shaft and the displacement actuator shaft.
[0030] The housing may include a urine collector, said collector being fluidically connected to the injector, in particular via the proximal end. The housing may include an electronic control unit, the electronic control unit being therefore located within the housing.
[0031] The station includes an analyzer (for example, an optical analyzer), positioned at least partially radially outside the annular housing and configured to optically analyze at least one test support. The analyzer can be positioned opposite the distal end of the injector (when projected in a plane orthogonal to the axis of rotation).
[0032] In one aspect (called "position sensor and injector"), a station for a urine analysis device is proposed, the station comprising: - a housing, intended to be positioned inside a toilet, - an annular housing, around an axis of rotation, in the housing, the annular housing being configured to receive at least partially a cartridge mounted to rotate around the axis of rotation in the station and comprising a plurality of test supports, - an injector, positioned in the housing, and configured to inject a controlled volume of urine onto a test support, when the strip is positioned in an injection zone of the annular housing, - a position sensor, configured to obtain the position of a marker associated with a test support of the cartridge when said marker is positioned in the injection zone or in a zone near the injection zone.
[0033] The term "injection zone" refers in particular to an angular range in the coordinate system around the axis of rotation. The injector and the position sensor are therefore arranged to interact with the same test support, without rotation of the cartridge between obtaining the position and the injection. In particular, the marker can be a test support itself.
[0034] The injection zone can correspond to the angle occupied by a single test support (in equivalent angular window). For example, the injection zone can correspond to an angular window of less than 5°, or even less than 2° on either side of the radial direction.
[0035] The proximity zone of the injection zone can correspond to an angular sector of less than 30° on either side of the injection zone (edges of the injection zone), or even less than 20°, or even less than 10°, or even less than 5°.
[0036] The injector may include a distal injection end, and the position sensor is radially aligned (by projection onto a plane orthogonal to the axis of rotation) with the distal end of the injector. The injector and the position sensor may be offset along the axis of rotation (by projection onto the axis of rotation).
[0037] The position sensor can be positioned at least partially radially outside the annular housing.
[0038] The housing may include an analyzer configured to analyze at least one test medium. In particular, the analyzer is an optical analyzer.
[0039] The injector can be configured to inject into an injection zone of the annular housing, and the analyzer can be configured to measure data in an analysis zone, the injection zone and the analysis zone being identical. The analyzer can be positioned radially opposite the distal end of the injector (when projected onto a plane orthogonal to the axis of rotation). The position sensor can be the analyzer (same material but different function). The injector can be mounted to move in translation relative to the housing along a direction of translation, to approach and / or pass through the annular housing.
[0040] The position sensor may alternatively or complementaryly include a mechanical follower, such as a cam follower, (which cooperates with the cartridge) or an electromagnetic module (which cooperates with a magnetic element of the cartridge).
[0041] In one aspect (called "analyzer and injector"), a station for a urine analysis device is proposed, the station comprising: - a device, designed to be positioned inside a toilet, - an annular housing around an axis of rotation, positioned in the casing, the annular housing being configured to at least partially receive a cartridge mounted for rotation around the axis of rotation in the station and comprising a plurality of test supports, - an analyzer, mounted in the housing, and configured to obtain information relating to the test support after urine injection, when the test support is in an analysis zone of the annular housing, - an injector, mounted in the housing, and configured to inject a controlled volume of urine onto a test support, when the test support is in an injection zone of the annular housing.
[0042] The analysis zone and the injection zone coincide. Therefore, there is no need to rotate the cartridge between injection and measurement by the analyzer. The analyzer and the injector are thus located at the same angular position around the axis of rotation (offset possible along the axis of rotation).
[0043] The station further includes a position sensor, configured to obtain the position of a marker associated with a test support of the cartridge, when said marker is positioned in the analysis zone or in a zone close to the analysis zone. The zone close to the analysis zone may correspond to an angular sector of less than 30° on either side of the injection zone, or even 20°, or even 10°, or even 5°. The analysis zone may, for its part, correspond to an angular sector less than or equal to the angle occupied by a single test support.
[0044] The injector can be mounted to move in translation within the housing.
[0045] The station may include a memory and a processor, said memory including instructions configured to implement the following steps: - (E3) injection of urine onto a test support by the injector, - (E4) measurement on the test support by the analyzer.
[0046] In particular, the instructions do not include rotating the cartridge between the injection step (E3) and the analysis step (E4). The instructions may include the measurement step (E4) starting before the end of the injection step (E3), for example, two seconds before the end or as soon as the first drop of urine is injected, or even before the first drop of urine is injected. This allows measurements to be obtained relating to the kinetics of the reactions taking place on the test support when it comes into contact with the urine.
[0047] A method of urine analysis is also proposed, utilizing the urine analysis device as described above, comprising the following steps: - (E3) injection of urine onto the test support, - (E4) measurement on the test support by the analyzer, in which the cartridge is not rotated between the injection step and the analysis step.
[0048] In one aspect (called "direct measurement of the test support position"), a station for a urine analysis device is proposed, the station comprising: - a housing, intended to be positioned inside a toilet, - a housing, within the casing, configured to at least partially receive a cartridge comprising a plurality of test holders, the cartridge being movably mounted inside the housing, - a position sensor, configured to directly measure the position of a cartridge test holder in the annular housing, i.e. relative to the housing.
[0049] In particular, the position sensor does not measure the position of the cartridge, more specifically not the position of the rotating cartridge support or the separator. Thus, any inaccuracy in the positioning of the test support on the rotating support is overcome by directly retrieving the position of the test support in the annular housing.
[0050] The position sensor may include a light source and an optical sensor, the light source being configured to emit light in the direction of a test support and the optical sensor being configured to receive the light.
[0051] The station may include an analyzer, the analyzer operating within an analysis zone of the housing, and the position sensor configured to directly measure the position of a test support located within the analysis zone. In particular, the analyzer may be located angularly at the same position as the optical position sensor (with or without offset along the axis of rotation A). The analysis zone may correspond to an angular sector less than or equal to the angle occupied by a single test support.
[0052] The analyzer can be the position sensor. In other words, the material forming the analyzer can be used as a position sensor.
[0053] The housing can be an annular housing, around an axis of rotation, in the casing, the annular housing being configured to receive at least partially a cartridge mounted to rotate around the axis of rotation in the station.
[0054] The position sensor can detect test media passing by when the cartridge is set in motion and is capable of receiving a signal that varies depending on whether or not a test media is present opposite the position sensor. The station may further include an electronic control unit with a processor and memory. The electronic control unit may be housed within the casing. The memory may contain instructions which, when executed by the processor of the electronic control unit, trigger the following steps: - (F1) scrolling of the test media in one direction, - (F2) analysis of the signal evolution during scrolling, - (F3) identification of a local extremum, - (F4) in response to said identification, reverse scrolling of the test media, - (F5) positioning of the test support that generated the first extremum.
[0055] The positioning (F5) may include: - after reverse scrolling of the test supports (F4), (F51) identification of a value in the vicinity of the local extremum value, - (F52) stop reverse scrolling of the test supports.
[0056] The identification of the local extremum (F3) consists of obtaining in succession at least three return signal values, corresponding to three different positions of the cartridge in the station and noting that the intermediate value is the highest, so that at the time of the identification of the local extremum, the test support is no longer opposite the position sensor.
[0057] When the housing is an annular housing, the scrolling can be a rotation of the cartridge.
[0058] The housing may include an injector, configured to inject urine onto the test support which is identified as being in position by the position sensor.
[0059] The station may include a drive actuator, for example a stepper motor, to drive the cartridge in motion. A signal value can be obtained at each step.
[0060] A method for positioning a test support using a device comprising a station as described above and a cartridge is also proposed. The method includes a step of directly measuring the position of a test support. More specifically, the method comprises the following steps: - (F1) scrolling the test supports in one direction, - (F2) analyzing the evolution of the signal during the scrolling, - (F3) identifying a local extremum, - (F4) in response to said identification, reverse scrolling of the test media, - (F5) positioning of the test support that generated the first extremum.
[0061] This description also covers a urine analysis device comprising a station (as described in the various aspects above) and a cartridge. The cartridge is configured to be at least partially received in the annular housing of the unit. Each test support is integral with the cartridge and is configured to be selectively positioned in front of the position sensor, the injector, and the analyzer. In particular, the test support is a test strip. This description also covers a kit comprising this station and one or more cartridges (cartridges with different types of test supports). Brief description of the drawings
[0062] Other features, details and advantages will become apparent upon reading the detailed description below, and upon analysis of the accompanying drawings, on which: Fig. 1.
[0063] [Fig.1] This figure schematically represents a cross-sectional view of toilets equipped with a urine analysis device according to the invention. Fig. 2
[0064] [Fig.2] This figure represents an exploded view of an embodiment of a urine analysis device. Fig. 3
[0065] [Fig.3] This figure represents a side view of a urine analysis station or device according to one embodiment. Fig. 4
[0066] [Fig.4] This figure represents a rear view of a urine analysis station or device according to one embodiment. Fig. 5
[0067] [Fig.5] This figure represents a cartridge cooperating with the station to form a urine analysis device, with a partial view without the cylindrical portion to better see the separator. Fig. 6
[0068] [Fig.6] This figure presents a cross-sectional view of the station along the plane orthogonal to the axis of rotation. Fig. 7
[0069] [Fig.7] This figure presents an isolated three-dimensional view of the injector. Fig. 8
[0070] [Fig.8] This figure presents a cross-sectional view of the analysis device along a plane orthogonal to the axis of rotation. Fig. 9
[0071] [Fig.9] This figure presents an isolated three-dimensional view of the carriage that carries the injector. Fig. 10
[0072] [Fig. 10] This figure presents a partial three-dimensional view of the station. Fig. 11
[0073] [Fig. 11] This figure presents a three-dimensional view of another embodiment of the position sensor. Fig. 12
[0074] [Fig. 12] This figure presents a cross-sectional view, along a plane passing through a radial direction and through the axis of rotation, of the injection zone, the analysis zone and the measurement zone, when the three zones are coincident. Fig. 13
[0075] [Fig. 13] This figure presents a schematic flattened view of a separator with housings and strips, to illustrate the irregularities. Fig. 14
[0076] [Fig. 14] This figure presents a schematic view of some components of the urine analysis device and its environment. Fig. 15
[0077] [Fig. 15] This figure shows the steps of a method for using the urine analysis device. Fig. 16
[0078] [Fig. 16] This figure presents a graph with the position sensor data. Fig. 17
[0079] [Fig. 17] This figure shows the steps of a method for positioning the strip in the injection zone or analysis zone of the urine analysis device. Description of embodiments
[0080] Figure 1 schematically illustrates a urine analysis device 100 mounted on a toilet 102. As is known, the toilet 102 comprises a water tank 104, a bowl 106, a seat 108, and a lid 110. The urine analysis device 100 is arranged on an inner wall 112 of the toilet bowl 106. Advantageously, the urine analysis device 100 is entirely contained within the toilet bowl, thus allowing it to be discreet.
[0081] The urine analysis device 100 can be positioned in the path of a urine stream produced by a user. The urine analysis device 100 receives a urine stream when a user urinates while seated in the toilet. The position of the urine analysis device is then suitable for any type of user, male or female, regardless of age. The user can then urinate in the toilet without worrying about the position of the urine analysis device.
[0082] The urine analysis device 100 can also be positioned in the path of a toilet flush from the reservoir 104. The urine analysis device 100 can thus be rinsed when the toilet is flushed. The urine analysis device 100 is hygienic.
[0083] The urine analysis device 100 can communicate with a mobile terminal 114 (such as a smartphone) and / or an external server 116. In one embodiment, the urine analysis device 100 communicates with the mobile terminal 114 (for example, directly via Bluetooth such as Bluetooth Low Energy) and the mobile terminal 114 communicates with the server 116 (via a cellular or Wi-Fi connection). In another embodiment, the urine analysis device 100 can communicate directly with the server 116 via a cellular network.
[0084] To initiate a measurement using the urine analysis device 100, an external activator 118 may be provided. The external activator 118 may include a button 120 and / or a biometric sensor 122. A screen 124 may be installed on the external activator 118 to display the data obtained by the urine analysis device 100. The latter and the external activator 118 communicate wirelessly.
[0085] As illustrated in the exploded view of [Fig. 2], the urine device 100 comprises a station 200 and a cartridge 202, removably mounted in the station 200. The station 200 includes, in particular, a housing 204 which, according to a particular embodiment, is formed as an assembly of two half-shells: a front shell 206 and a rear shell 208. The front and rear shells form a joint 210 of the housing, in a plane normal to axis A. Assembly of the urine analysis device is facilitated when the housing consists of the front and rear shells. The housing 204 contains a test kit (not visible in [Fig. 2] but visible in [Fig. 6]). The test set is intended to analyze the urine received in the urine analysis device 100. The station 200 further includes an annular housing 212, inside the housing 204, arranged around a rotation axis A.The annular housing 212 is configured to at least partially receive the cartridge 202, which is rotatably mounted about the axis of rotation A (once in position within the annular housing 212). The cartridge 202 comprises a plurality of test supports incorporating a reagent, for example, a dry reagent, arranged along a circle or an arc of a circle around the axis of rotation A. In one embodiment and for the remainder of this description, the test supports are test strips. In particular, the annular housing 212 may be partially delimited, with functional clearance, by an internal cover 214, mounted, for example, with the rear shell 208, to protect components of the test assembly. The internal cover 214 may include an external radial portion, to protect components radially external to the annular housing 212, and an internal radial portion, to protect components radially internal to the annular housing 212.
[0086] The annular housing 212 typically extends over 360° and forms a groove configured to partially receive the cartridge 202.
[0087] In the present description, the phrase "radially internal to the annular housing" means closer to the axis of rotation A than the annular housing is close to the axis of rotation A. Similarly, the phrase "radially external to the annular housing" means further from the axis of rotation A than the annular housing is far from the axis of rotation A.
[0088] The annular housing 212 is accessible, for example, by detaching the front shell 206 from the rear shell 208. The front shells 206 and rear shells 208 can be screwed together using a thread 216.
[0089] The station 200, in particular the housing 204, further includes a collection orifice 218, positioned, for example, on the rear shell 208 in [Fig. 2]. The collection orifice 218 can receive urine flowing by gravity onto the outer surface of the housing 204. More details on this collection orifice 218 will be given later.
[0090] The housing 204 is removably arranged in the toilet bowl 106. The analysis device 100 can then be removed or repositioned in the toilet. In addition, the urine analysis device 100 or the housing 204 can be removed to recharge a battery or to change the cartridge 202.
[0091] In the example illustrated in [Fig. 2], the housing 204 is arranged on the inner wall 112 of the toilet. The housing 204 is positioned by a fastening element 300, one embodiment of which is shown in particular in [Fig. 3]. The fastening element 300 may include magnets 302 and / or an adhesive / suction-cup surface. This configuration allows the housing to be easily removed or repositioned in the toilet. In another configuration, the urine analysis device 100 includes a hook attached to one end of the housing 204 and configured to attach at the other end to a rim of the toilet bowl 106 (under the seat 108, for example).
[0092] The station 200, in particular the housing 204, further includes a drain port 310, positioned on the rear shell 208 in [Fig. 3]. The collection port 218 can receive urine flowing by gravity onto the outer surface of the housing 204, and the drain port 310 allows the various fluids collected by the device 100 to be drained. More details on this drain port 310 will be given later.
[0093] General characteristics of the housing
[0094] As shown in Figures 2 to 4, the housing 204 has an external shape resembling a circular pebble. In other words, the housing has the shape of a flattened spheroid. The axis of rotation A is the median axis of the housing. The housing comprises a front face 304 and a rear face 306, substantially perpendicular to the axis A. The front face 304 typically includes the external surface of the front shell 206, and the rear face 306 includes, in particular, the external surface of the rear shell 208. Thus, urine can be collected directly from the faces 304 and 306 of the housing. The housing 204 serves as a urine collector.
[0095] The front face 304 is oriented towards the inside of the toilet bowl 106. The front face 304 is thus intended to receive urine when the user urinates while seated on the toilet. The rear face 306 faces the inner wall 112 of the toilet bowl 106. The front face 304 and the rear face 306 are connected by curved edges 308. Thus, the outer surface of the housing 204, consisting of the front face 304, the rear face 306, and the curved edges 308, is defined by curved lines, forming a generally convex object. The housing is, for example, devoid of edges. Urine The urine can run off the entire outer surface of the casing without detaching or forming air bubbles, which could compromise urine analysis. Application PCT / EP2021 / 055377 describes in detail the shape of casing 204 to allow for efficient urine collection.
[0096] In one embodiment, the housing 204 has a diameter, measured in the direction normal to axis A, of between 50 mm and 150 mm, for example, close to 100 mm. The housing 204 also has a thickness, measured along the direction of axis A, of between 15 mm and 50 mm, for example, close to 30 mm. Thus, the housing is compact enough to fit entirely inside the toilet bowl. The urine analysis device is discreet. Furthermore, the housing is sufficiently large to systematically come into contact with urine collected in the bowl. The user can then urinate in the toilet without worrying about the urine analysis device, or at least make a cursory attempt.
[0097] The outer surface of the casing is smooth. Thus, the stream of urine coming into contact with the casing adheres to and spreads over the outer surfaces of the casing. In one embodiment, the casing is made of a hydrophilic material. For example, the casing may be made of: a ceramic, a polyamide (PA), a silicone, or a hydrophilic polymer. The outer surface of the casing may also be treated with a hydrophilic surface treatment, for example, acuWet® from Aculon, a hydrophilic polymer, or Pebax® from Arkema.
[0098] The front shell 206 and the rear shell 208 are assembled to maintain the outer surface of the casing, defined by curved lines. The joint 210 between the front shell 206 and the rear shell 208 allows urine to flow between the front and rear surfaces. The impact of the joint on the urine flow on the casing is minimized.
[0099] As an alternative to screwing, the front shell 28 and the rear shell 30 can be assembled by gluing, clipping, magnetizing, bayonet fitting, or ultrasonic welding. Of course, other fastening methods can be used to assemble the front and rear shells. In the case of screwing, an internal portion of the front shell has a thread. The thread in the front shell is designed to cooperate with a tapped hole in the rear shell, or vice versa. The housing can thus be easily disassembled to access the test assembly inside the housing.
[0100] A sealing gasket may be present at the joint 210 between the hull The front and rear casings are sealed. Thus, the housing is watertight. The interior of the housing 204 is impermeable to urine, water from the water tank 104 or the toilet bowl 106, and any other type of contaminant. Only collection and drainage ports connect the exterior and interior of the housing, as described in more detail later.
[0101] In an embodiment not shown, the front shell 206 or the rear shell 208 includes a removable cover allowing the replacement of the cartridge 202. Rather than dismantling the front shell 206 to access the annular housing 212, it is then sufficient to remove the removable cover.
[0102] The removable hood can be attached to the 208 rear body by clipping, screwing, or a bayonet fitting. Of course, other fastening methods can be used to attach the removable hood to the 208 rear body. Alternatively, in another example, the removable hood could be attached to the 206 front body.
[0103] The removable cover is arranged in a watertight manner. For example, a joint between the removable cover and the rear housing 208 may include a sealing gasket. The interior of the housing 204 thus remains impermeable to urine, water from the water tank 104 or the bowl 106, and any other type of contaminant.
[0104] In the example illustrated in particular in [Fig.2] and as already mentioned, the removable cover is formed by the front shell 206 of the housing 204. The removable cover can then be removed by unscrewing the front shell 28 relative to the rear shell 30. The housing 22 has fewer joints that can be soiled and / or infiltrated by toilet water.
[0105] The housing 204 has a collection orifice 218, already shown in relation to [Fig. 2]. The collection orifice 218 can receive urine flowing by gravity onto the outer surface of the housing. Urine is collected directly from faces 305, 306 of the housing.
[0106] The collection orifice 218 is located on a lower end 402 of the housing 204. The lower end 404 is oriented towards the bottom of the bowl 106 when the housing 204 is positioned in the toilet bowl 106. This position corresponds to a normal operating position. This position allows for the collection of urine flowing by gravity over most of the outer surface of the housing.
[0107] In this case, a distance D separating the collection orifice 218 from a lower edge 404 of the housing is less than 40 mm, for example less than 20 mm. According to a particular embodiment, the collection orifice 218 is arranged a few millimeters above the lower edge of the housing. Alternatively, the collection orifice may be on the lower edge 404.
[0108] The collection orifice 218 is a circular opening, with a diameter, for example, between 0.3 mm and 2 mm. The diameter of the collection orifice can be chosen to maximize the volume of urine collected from the outer surface of the housing.
[0109] The housing 204 has a drain port 310, already shown in connection with [Fig.4]. The drain port 310 allows the urine analysis device 100 to be purged of excess urine.
[0110] The drain port 310 is separate from the collection port 218. The drain port 310 is also located on the lower end 404 of the housing 204, near the collection port 218. The drain port 310 is also a circular opening. The drain port 310 has a diameter between 0.3 mm and 2 mm. In the normal operating position, the drain port 310 can be located above the collection port 218 without cross-contamination.
[0111] The drain port 310 can also be located away from the collection port 32. The position of the drain port 310 can be chosen to facilitate access to the drain port by the test assembly 24.
[0112] Alternatively, the drain port can be the same as the collection port. A single port limits the number of openings into the housing. This reduces the risk of introducing contaminants or elements that could obstruct the test assembly.
[0113] The collection port 218 and / or the drain port 310 can be fitted with a metal mesh filter. The average mesh size of the filter is, for example, 20 microns. The filter prevents the introduction of contaminants or elements that could clog the test assembly and filters the urine received at the collection port.
[0114] In the illustrated examples, the collection port 218 and the drain port 310 are located on the rear face 306 of the housing (on the rear shell 208). The collection port 218 and the drain port 310 face the inner wall of the toilet bowl when the urine analysis device 100 is positioned in the toilet. This position allows the collection and drain ports to be concealed by the front face of the housing. This position also prevents the introduction of contaminants or elements that could obstruct the test assembly.
[0115] The 204 housing is not limited to the embodiments described above with regard to the figures, but is, on the contrary, susceptible to numerous variants accessible to those skilled in the art.
[0116] The casing can, in particular, take any geometric shape defined by curved lines. The casing can, in particular, have the shape of a diamond or an inverted teardrop. In this case, the casing has a point on its lower part to guide the urine towards the collection opening.
[0117] The collection port and the drain port can be on the front face of the housing. Thus, the urine running down the front face reaches the collection port more directly.
[0118] The collection and drainage openings may be located on a positive relief, such as a projection, or a negative relief, such as a groove or recess. Generally, the relief may have any geometry that allows the urine to be channeled. trickling down the casing and conveying it to the collection port without detaching from the casing or forming air bubbles.
[0119] In one embodiment, the collection port 218 is arranged on the front face 304, while the drain port 310 is located on the rear face 306.
[0120] Test assembly (injector and analyzer)
[0121] A cartridge and a test assembly for using test media from the cartridge, such as test strips (e.g., colorimetric strips or lateral flow strips), will be described (more details at the end of the description). The strips are also referred to herein as "test strips" or simply "strips." The test assembly includes, in particular, an injector and an analyzer (e.g., an optical analyzer). The cartridge 202 is rotated within the housing 204 by a drive actuator positioned in the housing 204, so that the test strips can pass successively past the injector and the analyzer. The test assembly also includes a position sensor for identifying the position of the strips within the housing. The position sensor can identify the position of the strip locally (and not necessarily absolutely).According to the embodiments, and in particular the embodiments which will be described later, the injector, the analyzer and / or the position sensor can be positioned in the housing 204 at the same angular location or at different angular positions, either radially internal or external to the annular housing 212.
[0122] The injector allows a controlled volume of urine to be injected onto a strip when said strip is in an injection zone ZI of the annular housing 212. The injection zone ZI corresponds to an angular window (around the axis of rotation) of the annular housing 212 inside which the injector is able to inject the urine onto the strip.
[0123] The analyzer allows analysis of a strip when said strip is in an analysis zone ZA of the annular housing 212. The analysis zone corresponds to a window or angular range (around the axis of rotation) within which the analyzer is able to take measurements on the strip.
[0124] The position sensor allows the position of the cartridge or strip to be determined when a marker associated with it is within a control zone ZC. The control zone ZC corresponds to a window or angular range (around the axis of rotation) within which the position sensor can determine the position of the cartridge or strip. In particular, the position measurement obtained by the position sensor is used to control the drive motor (feedback loop). In one embodiment, the position sensor can allow the station to know that a strip is indeed within the control zone, but not necessarily which strip it is. In another In this embodiment, the position sensor, coupled with a displacement counting from zero (described later), can make it possible to know exactly which strip is in the control area.
[0125] According to the embodiments which will be described later, the injection zone ZI, the analysis zone ZA and / or the control zone ZC may be confused, partially confused or distinct.
[0126] In particular, the analyzer can detect a color change in the test medium, which may be a strip (colorimetric analysis). The analyzer can then be an optical analyzer, with a light source and an optical sensor.
[0127] Cartridge
[0128] Fig. 5 illustrates an exploded view of one embodiment of cartridge 202. The cartridge 202 incorporates test holders designed to receive urine when the cartridge 202 is mounted in the station 200 and, in particular, in the annular housing 212. The test holder contains a reagent that reacts upon contact with urine. As illustrated in the figures, the test holders can be test strips 501 (for the remainder of this description, they will be referred to as test strips). The cartridge 202 includes a rotating holder 500, configured to be driven in rotation by the station 200. In normal use of the cartridge 202 and the urine analysis device 100, the strips 501 remain mounted in the rotating holder 500 and do not move relative to it. The strips are therefore attached to and fixed within the rotating holder 500.In particular, the 501 strips are not wound in a rewindable manner on the rotating support 500 for use: they are therefore not unwound during use.
[0129] In one embodiment, the rotating support 500 is a hollow cylindrical shape extending annularly around an axis which, when the cartridge 202 is mounted in the station 200, is the median axis A of the housing 204 (for convenience, a single axis A will be used to describe the various elements, called the axis of rotation A). In practice, the rotating support is generally symmetrical about the axis of rotation A. The rotating support 500 allows for the storage of a large number of test strips 501 while being sufficiently compact to be arranged inside the housing 204.
[0130] The cartridge 202 and the rotating support 500, as illustrated in the figures, extend over a full rotation and can complete a full rotation in the station 200. However, for reasons of space or to free up space for other components, a cartridge 202 extending over a portion of a rotation (for example, less than 180° or 90°) and rotating only a portion of a rotation (for example, less than 270°) may be used. In this case, the number of strips is typically lower than for the urine analysis device shown in the figures.
[0131] The strips are arranged in a circle or a portion of a circle, for example at a radial end of the rotating support 500 to maximize their number (the larger the radius, the larger the perimeter for installing strips). The circular arrangement ensures that the strips 501 are all equidistant from the axis of rotation A and, consequently, from the injector or analyzer (in particular, an optical sensor of the analyzer, which will be described later). This also ensures that the measurement protocol for each strip is identical. As illustrated in the figures, the strips 501 can generally be arranged in a circle or an arc of a circle. Thus, the strips 501 can be equidistant from the axis of rotation A. More specifically, each of the strips 501 can be a small, thin, and narrow strip extending longitudinally parallel to the axis A.Thus, the 501 strips are arranged parallel to each other.
[0132] By its shape and function, the cartridge 202 resembles a cylinder. In one embodiment, the cartridge substantially occupies the annular volume provided by the annular housing 212. A small functional clearance is provided to allow the cartridge to rotate without rubbing against the walls of the annular housing 212.
[0133] In this case, the outer diameter of the rotating support 500 can be between 30 mm and 130 mm, preferably about 60 mm. The height of the rotating support, measured along the direction of axis A, can be between 12 mm and 40 mm, preferably about 14 mm. The ratio between the diameter of the rotating support and the diameter of the housing 204 can be greater than or equal to 0.3, preferably greater than or equal to 0.5. This results in a very compact solution considering the large number of test strips available.
[0134] The rotating support 500 comprises an annular portion 502 and a cylindrical portion 504, extending from an external radial end of the annular portion 502. The cylindrical portion 504 typically extends from only one side of the annular portion 502 and is configured to fit into the annular housing 212 of the casing 204. The strips 501 are positioned along the cylindrical portion 504 (oriented parallel to the axis of rotation A) so that they can be passed selectively and / or successively in front of the injector and the analyzer. The annular portion 502, for its part, remains outside the annular housing 212 and serves, in particular, to stiffen the cylindrical portion 504 and / or to allow the cartridge 202 to rotate.
[0135] For this purpose, the annular portion 502 may further comprise a mechanical coupler 506 configured to engage with a mechanical coupler of the station 200, for example, a female mounting sleeve configured to engage with a shaft driven in rotation by the motor, or a male mounting shaft configured to engage with a female sleeve driven in rotation by the motor. In the example illustrated in the figures, an axial drive pinion 602 (visible in [Fig. 6]) is provided at the output of the reducer, and the female portion is formed by the hub 506 of the rotating support 500.
[0136] In one embodiment, the mechanical coupler 506 is located on the rotation axis A of the rotating support 500. However, in the example where the cartridge 202 is driven in rotation via a coupler on the cylindrical portion, the annular portion 502 may be without the female sleeve 602. The annular portion 502 could be mounted by any type of pivoting joint relative to the housing 204. The annular portion 502, with the exception of the mechanical coupler 506, when it is through-bolted at the axis A, can be shaped like a disc. The female sleeve and the hub may be reversed.
[0137] In one embodiment, the cartridge 202 includes a separator 508 having housings 510 for receiving the strips 501. The housings 510 and the strips 501 have similar dimensions which will be given at the end of the description.
[0138] The separator 508 is, for example, a flexible part, particularly made of elastomer, in the form of a strip or ribbon intended to be wound in the rotating support 500. The separator 508 extends along a longitudinal direction and can be wound against an inner wall of the annular portion 504 of the rotating support 500. The separator 508 comprises a first face having a plurality of recesses 510, each receiving one or more test strips 501. The first face can be covered by a lid to protect the strips when not in use. The separator 508 comprises a second face having, opposite each recess 510, at least one through hole 512 (for example, two, as illustrated in the transparent view of the annular portion 504). The recesses 510 are thus sealed. Thanks to the flexible separator 508, the insertion of the test strips 501 into the housings 510 can be done on a flat surface, which simplifies assembly.Once the separator 508 is installed, the housings 510 extend parallel to the direction of rotation A.
[0139] The cylindrical portion 504 is transparent, or includes transparent areas, particularly in relation to the housings 510. The cylindrical portion 504 is in contact with the separator 508, in particular the second face of the separator 508. During a colorimetric analysis, light can pass through the cylindrical portion 504, via the orifice through 512 to analyze the test strips.
[0140] The cylindrical portion 504 may, in particular, be made of polycarbonate. Indeed, polycarbonate has good light transmission properties, while remaining relatively inexpensive and compatible with an injection molding process.
[0141] The annular portion 502 of the rotating support 500 forms a base for supporting the separator 508. The cylindrical portion 504 receives the separator 508. The separator 508 is blocked in translation along direction A by contact with the annular portion 502. On the other side, an annular rim extending from one end of the cylindrical portion 504 and radially inwards allows the translation to be blocked along the other direction of A.
[0142] The rotating support 500, and more particularly the cylindrical portion 504, further includes a through-vent opening 514 to allow the injector to pass through the cartridge 202 and the annular housing 212 and to join a station drain circuit. The separator 508 does not cover the through-vent opening 514. This circuit will be described in detail later.
[0143] The cartridge 202 further includes an identifier 516, represented in [Fig. 5] by an RFID chip. The identifier 516 enables the station 200 to know which cartridge 202 has been inserted. The identifier 516 is typically a passive RFID tag.
[0144] According to another example not shown, the rotating support 500 could be a washer whose axis coincides with the median axis A of the housing. The washer then extends radially along a plane substantially perpendicular to the median axis A of the housing. The test strips can then be stored on one face of the washer, perpendicular to axis A. This configuration makes it possible, in particular, to adapt the rotating support to different housing shapes. Thus, the rotating support can be implemented in various urine analyzers.
[0145] Each compartment 510 can receive a single test strip. All the test strips 501 in compartments 510 can be of the same type. By same type, it is meant that they are sensitive to the same compounds contained in urine. The cartridge 202 is then suitable for a specific analysis.
[0146] Alternatively, the test strip 501 received in slot 510 may be of a different type than the test strip received in the adjacent slot. Thus, several types of analyses, requiring different types of test strips, can be performed from the same cartridge 202.
[0147] Alternatively, each housing 510 can contain a plurality of test strips 501 of different types. Thus, several types of analyses can be performed from the same housing.
[0148] As previously stated, each compartment 510 is covered and closed by a lid (visible in [Fig. 12] at reference 511). The lid hermetically seals the test strips 501 received in a compartment 510 of The external environment and neighboring housings are protected. Housing 510 becomes accessible for liquid injection, typically by piercing the seal (for example, with injector 604). Thus, before analysis, the test strip reagents are protected from potential contamination. Furthermore, after analysis, the seal may contain urine introduced into housing 510. The seal can be in the form of a continuous film. The film is adhered to the outer wall of the rotary support to cover the housings 510. This configuration facilitates the placement of the seal 511 on the rotary support 500. Alternatively, each housing 510 can be covered by a separate seal. This configuration helps limit the risk of contamination of test strips received in two adjacent housings. Alternatively, the test strips can be individually encapsulated.This configuration is particularly advantageous when test strips are joined to form a ribbon. The ribbon can be assembled in the rotating holder without requiring an additional cover. This simplifies assembly of the Urine Analysis Device 100. The cover is made of an inert material, such as silicone or acrylic. Ideally, the cover should be medical-grade to prevent contamination of the test strips with any unwanted substances contained within the cover. This ensures that the test strip reagents remain intact before analysis. Furthermore, the cover is transparent, preferably with a transparency rate exceeding 99%. This allows for colorimetric analysis of a test strip through the cover.
[0149] Drive actuator
[0150] When placed in the station 200, the cartridge 202 is mechanically coupled to a drive actuator 600 (Figures 6, 8, and 10) via its mechanical coupler 506 and a complementary mechanical coupler 602 of the station 200, to be driven in rotation about axis A. The cartridge 202 can then be selectively positioned to align a test strip with the injector, referenced 604, or the analyzer, referenced 606. The use of the cartridge 202 allows for a simple moving assembly with a single axis of rotation. Furthermore, this configuration reduces the constraints related to the positioning and arrangement of the injector 604 and the analyzer 606 in the analysis device 100.
[0151] The drive actuator 600 can be offset from the axis A and a gear train 608 (which can also act as a reducer) allows the complementary mechanical coupler 602 to be driven. The complementary mechanical coupler 602 of the station 200 is located on the axis of rotation A.
[0152] The drive actuator 600 can drive the cartridge 202 in a clockwise or counterclockwise direction. The cartridge can then quickly reach the desired position, following the shortest trajectory. This further reduces the constraints related to the positioning and arrangement of injector 604 and analyzer 100.
[0153] The drive actuator 600 is, for example, a drive motor, such as a stepper motor or a DC motor. Alternatively, the drive actuator 600 may involve a hydraulic or other system.
[0154] Fluidic circuit
[0155] The collection port 218 is fluidically connected to a collector 610, then a collection tube 612, then a pump 614, then a delivery tube 616, and finally the injector 604. The injector 604 is movable within the housing 204, so that the injector can move to selectively inject urine onto a test strip or into a drain tube 618 connected to the drain port 310, depending on the position of the cartridge 202 in the station 200. The urine collected by the collection port 218 is set in motion in the fluidic circuit by the pump 614. The delivery tube 616 may include a flexible portion (not shown in [Fig. 6], for example), particularly at its end which connects it to the injector, to accommodate the movement of the injector.
[0156] The injector 604 typically comprises three positions: a retraction position PR, an injection position PI, and a purge position PP. In the retraction position PR, the injector 604 does not impede the rotation of the cartridge 202 in the annular housing 212; in the injection position PI, the injector 604 allows the injection of urine onto a strip positioned in the injection zone ZI; in the purge position PP, the injector 604 is connected to the drain tube 618. Typically, in the retraction position PR, the injector 604 is entirely radially internal to the annular housing 212, fully retracted; in the injection position PI, the injector 604 is partially internal to the annular housing 212 and partially within the annular housing 212; In the purge position, the injector 604 is partially internal to the annular housing 212, partially in the annular housing 212 and partially external to the annular housing 212.For the injector to be in the PP purge position, the cartridge 202 must also be in the purge position, i.e. the purge orifice 514 of the rotating support 500 must be aligned with the injector 604 (radially aligned with a distal injection end of the injector).
[0157] The pump 614 can aspirate urine. The pump aspirates, for example, between 5 microliters and 1 mL, preferably about 20 microliters. Furthermore, the pump allows a sufficient volume of urine to be conveyed to the injector 604 to enable a conclusive analysis. The aspiration rate of the pump 614 is chosen according to the diameter of the collection port. Advantageously, the pump can aspirate urine from the collection port to the injector without forming air bubbles.
[0158] According to another phase, after urination and outside the flushing sequence, the pump 614 can also draw air from the collection port 218 and expel it via the discharge port 310. The pump then expels urine or water contained in the urine analysis device. Urine collected for analysis is thus protected from possible contamination by toilet water or a previous collection. According to another phase or embodiment, the pump 614 can draw water when the toilet is flushed to flush away the urine contained in the urine analysis device.
[0159] The pump 614 can be of various types. The pump 614 can be a miniaturized peristaltic pump. The pump 614 can be a miniaturized pneumatic pump system as detailed below. In the case where the pump 614 is a miniaturized pneumatic pump, this pneumatic system is configured to create a vacuum to draw urine from the collection port 218, and then a positive pressure to push the urine towards the injector 604 and the purge channel. The pump of the pneumatic system can be a rotary type pump, the direction of rotation selectively providing either a vacuum or a positive pressure. The pump of the pneumatic system can also be a piezoelectric type pump.
[0160] When urine is aspirated, the injector can be provided to be in a purge position to evacuate air until urine comes into pre-charge.
[0161] The solution presented allows precise control of the volume delivered to the urine analysis device.
[0162] Curved injector
[0163] In relation to Figures 6 to 8, the injector 604 will be described in more detail. The injector 604 comprises a distal end, referred to as the injection end, 700 and a proximal end 702, referred to as the connection end, which is typically configured to be connected to the delivery pipe 616 (in particular the flexible portion of the delivery pipe, which is not shown in [Fig. 6], so that the proximal end 702 opens to the atmosphere). The injector 604 may include a needle 704, and the distal end 700 may then be the tip of the needle 704. In order to inject urine onto the test strips 501, the injector 604 is movable in translation along a direction DT relative to the housing 204. A displacement actuator 620 is provided in the housing 204 to move the injector. The injector 604 is positioned radially within the annular housing 212 in the housing 204.Similarly, the displacement actuator 620 is also positioned radially inside the annular housing 212. However, due to the arrangement of the housings 510, the acceptable angular position for injection (called the injection window) is quite small. In the case of the injector described... In document PCT / EP2021055302 (specifically in Figure 20), the window is constrained by the inclination between a radial direction (along a radius of the circle defined by the housings) and a housing depth. Consequently, the number of drive motor steps required to correctly position the housing during injection is low.
[0164] The injector 604 illustrated in Figures 6 to 8 does not present these difficulties. According to one aspect, the injector 604 has a curved shape, so that the axis of translation at which the injector 604 is driven in translation is offset with respect to the axis of translation of the distal end 700. It is understood here that a portion of the injector that channels the fluid is curved (and that the path of the fluid substantially follows this curve). In particular, if we define a first axis T1, which is the axis at which the injector 604 receives the translational movement and a second axis T2, which is that of the displacement of the distal end 700, these two axes T1, T2 are not coincident when viewed from above or below (along the axis of rotation A) or when projected into a plane orthogonal to the axis of rotation A. This allows the displacement actuator 620 to be moved to a less congested region of the housing 204.The second axis T2 is parallel to the direction of translation DT.
[0165] According to one aspect, the injector 604 can also be defined by the offset (called the displacement) in the plane orthogonal to the axis A between the distal end 700 and the proximal end 702 of the injector. This offset is obtained in particular by a curved shape of the injector 604.
[0166] According to one aspect, the injector 604 can also be defined by the fact that it is located radially inside the annular housing 212 and that the distal end 700 moves in translation along a radial direction or substantially along a radial direction (i.e., radial to within a few degrees, for example 10°, preferably 5° and even 2° on either side of said radial direction, or even 1°). This radial movement is made possible by the curved shape (in projection onto a plane orthogonal to the axis of rotation A) of the injector 604.
[0167] The curved shape of the injector 604 allows it to bypass the mechanical coupler 602 located at the axis of rotation A, while the second axis T2 coincides with a radius of the circle defined by the housings. In other words, the distal end 700 moves along a radial direction, and therefore orthogonal to the operculum 511, the strip 501, and / or the bottom of the housing 510. Consequently, the first axis T1 does not pass through the mechanical coupler 602, but the second axis T2 does. Thus, the injector 604 does not interfere with a cylinder of radius R4 centered on the axis A. This leaves an axial space free where the hub of the cartridge support 500 is housed.
[0168] The first axis T1 is offset from the axis T2 (in a plane orthogonal to the axis of rotation) by a distance equal to less the radius R4 (R4 plus the thickness of a cover, plus a minimum functional clearance). The radius R4 can be at least 3 mm. R4 can be at least 5 mm. The offset distance is typically between 5 and 15 mm, or even between 5 and 10 mm.
[0169] The second axis T2 is advantageously radial or substantially radial (within 2°, or even 5°, or even 10° on either side of a radial direction).
[0170] The curvature of the injector 604 may include two successive inverted bends 706, 708 (see, in particular, [Fig. 7]). Specifically, between the distal end 700 and the proximal end 702, the injector 604 includes an intermediate portion 710. The two bends 706, 708 may be formed in the intermediate portion 710. Both bends 706, 708 are rounded to minimize disturbance to the fluid flow. The proximal bend 708 (the one closest to the proximal end 702) may have a shape complementary to the mechanical coupler 604 of the station 200 to allow the distal end 700 to have a maximum range of motion. To this end, the distal elbow 706 (closest to the distal end 700) may have a smaller radius of curvature, so that the intermediate portion is predominantly formed by the proximal elbow 708.The distal elbow 708 therefore has the essential function of allowing the injector 604 to be inserted into the housing 204, bypassing the mechanical coupler 602, and the proximal elbow 706 has the function of realigning the injector 604 (in particular to realign the needle 704) in a radial or substantially radial direction.
[0171] In one variant, it is the needle itself that is curved.
[0172] In one embodiment, the injector 604 is rigid. By rigid, it is understood that it does not deform during normal use of the device. In particular, the intermediate portion 710 is rigid.
[0173] In PR retraction position, injector 604 can be less than 2mm from mechanical coupler 604 (closest distance).
[0174] In the PP purge position, the distal end 700 of the injector 604 is radially external to the annular housing 212. The purge opening 514 can also serve as a zero marker for obtaining the position of the cartridge 202.
[0175] In one embodiment, the curvature of the injector 604 occurs only in a plane orthogonal to the axis of rotation A. In another embodiment, the injector may have a curvature that creates an offset along the axis of rotation A, so that the distal end 700 is higher or lower (along the axis of rotation A) than the proximal end 702. This allows for managing differences in level in the device 100.
[0176] Several options are possible for moving the injector 604 in translation. The displacement actuator 620, mounted in the housing 204, is intended to generate the movement. Figure 8 illustrates one embodiment using a screw-nut connection. The displacement actuator 620 can be a displacement motor 620, for example, an electric motor, which drives a rod 622 in rotation. The rod 622 mechanically cooperates with a nut 800 fixed to the injector 604, so that the rotational movement of the rod around the first axis T1 is transformed into a translation of the nut 800 at the first axis TL. The rod 622 and the nut 800 each have a thread that cooperates with each other.Due to the curvature of the injector 604, the dimensions of the displacement actuator 620, the rod 622, and the other components enabling a functional injector are offset into a free area of the housing 204, next to the mechanical coupler 604 of the station 200, while the proximal end 700 of the injector 604 can move along the second axis T2, which is in a radial or substantially radial direction. The nut 800 is said to be a captive nut, in that it cannot rotate on its own axis.
[0177] The screw-nut connection allows for good motion conversion, without step skipping, discrepancies between the setpoint and the result, or even loss of connection in the event of a fall of station 200. Furthermore, given the masses of the components, friction and the need for lubrication are low. For example, lubrication during assembly is sufficient.
[0178] The nut 800 can be made in the form of a threaded insert or by tapping a hole.
[0179] Alternatively, the displacement actuator 620 can be a linear motor, or even a linear actuator (cylinder, etc.), which produces a translational movement directly.
[0180] To improve accuracy, the injector 604 can be fixed to a guide 802 (or slide) in translation at the level of the first axis TL. The guide 802 can include a circular orifice which cooperates with a fixed rod 804 fixed to the housing 204. The guide 802, when in the form of a circular orifice, cannot detach from the fixed rod 804, which ensures good robustness (for example in case of a fall of the station 200).
[0181] The injector 604 can be mounted on a carriage 900, shown alone in [Fig. 9] and visible in the housing in [Fig. 10]. The carriage 900 has a curved shape that can accommodate the injector 604. The force transfer from the displacement actuator 620 can be applied to the carriage 900 rather than directly to the injector 604, thus protecting the latter from any mechanical stress. Indeed, the offset due to the curvature of the injector 604 and the reaction force of the orifice 511 when it is pierced by the injector 604 can create a parasitic torque. The carriage 900 allows for greater System robustness. For example, at a proximal end 902 of the carriage 900 is the nut 800, which couples with the rod 622. At a distal end 904 is the guide 802, in the form of a circular opening. The offset between the two openings of the nut 800 and the guide 802 can correspond to the offset between the first translational axis T1 and the second translational axis T2 (in a plane orthogonal to the axis of rotation A). The carriage 900 may include retaining clips 906 to hold the injector 604 in position.
[0182] The displacement actuator 620 allows the injector 604 to be moved into the three positions mentioned above: the withdrawal position PR, the injection position PI, and the purge position PP. Activating the displacement actuator 620 allows these movements to be performed between the three positions PPI, PI, and PP.
[0183] Other types of motors and / or mechanical links allow the injector 604 to be moved in translation.
[0184] The distal end 700 can also be configured to pierce the operculum 511 of the cartridge 202. A bevel can be provided to facilitate insertion.
[0185] The needle 704 may have a diameter of approximately 0.5 mm. The proximal end 702 and the intermediate portion 710 may be one piece (for example, made by 3D printing), and the needle 704 is inserted into the intermediate portion, which includes an orifice provided for this purpose. The needle 704 may be made of metal.
[0186] The injection zone ZI, which corresponds to the window or angular range (around the axis of rotation) for positioning a strip 501 for proper urine injection by the injector 604, typically comprises a few degrees at most (less than 5°, or even less than 2°). In the case of a stepper drive actuator (in the form of a stepper motor 600, for example), this injection window corresponds to a few steps (the number depending on the drive motor 600 itself and the gear train 608).
[0187] The injector 604 can inject a controlled volume of urine onto a test strip, for example between 2.5 microliters and 3.5 microliters. The injector injects a sufficient volume of urine onto a test strip to perform a conclusive analysis without risking urine overflow from the housing.
[0188] The injector 604 can inject a controlled volume of urine onto the test strip 56 in two stages. For example, the injector 604 can inject twice between 2.5 microliters and 3.5 microliters. This solution allows for the reaction and migration time of the urine on the test strip 501 to be taken into account.
[0189] Position sensor and injector
[0190] A position sensor 624 may be provided in the housing 204 to obtain the position of the cartridge 202 and / or the strips 501 relative to the housing 204 and more specifically relative to the injector 604 and / or the analyzer 1200. This allows to improve accuracy since the displacement actuator 620 can be controlled by position commands using data from the position sensor 624 (feedback loop).
[0191] In order for the injector 604 to inject the urine correctly onto the chosen strip 501, it is important to know the position of the strips 501 in the annular housing 212. In particular, due to the structure of the cartridge 202, assembly inaccuracies are possible, so that the strips 501 are not regularly positioned (small offsets, but in view of the distances involved, which can generate bad analyses).
[0192] In one embodiment, the analysis station 200 therefore includes a position sensor 624 (visible in Figures 6 or 11). For space-saving reasons, the position sensor 624 can be positioned, at least partially, within the housing 204, radially outside the annular housing 212. The position sensor 624 makes it possible to identify the position of a marker on the cartridge 202 when said marker is located in the control zone ZC. There are typically at least as many markers as there are strips 501, so that each strip 501 can be located by a marker. As previously stated, injector 604 is configured to inject urine into an injection zone ZI of annular housing 212 and position sensor 624 is configured to obtain the position of a marker associated with strip 501 in a control zone ZC of annular housing 212.
[0193] In one embodiment, the injection zone ZI and the control zone ZC are coincident or close to each other. In other words, the position sensor 624 makes it possible to measure the position of a marker associated with a strip 501 when said marker is positioned in the injection zone ZI or in a zone close to the injection zone ZI (the measurement is made on this marker, and not by deduction from a measurement on a marker outside or at a distance from the injection zone ZI). This means that the position sensor 624 allows the position of a strip of interest 501 to be known precisely in the injection zone ZI and therefore to inject the urine correctly onto the strip of interest 501. The position inaccuracies of the strips 501, due to the positioning of the strips in the separator 508 and of the separator 508 itself in the cartridge 202 (which is flexible), are generally small from one housing to the other.Therefore, by measuring the position of a marker in a proximity zone to the injection zone ZI, and thus near the strip of interest 501, a fairly precise measurement of the position of strip 501 within that injection zone ZI is obtained. A proximity zone is defined as within 30° on either side of the injection zone, or even less than 20°, less than 10°, or less than 5°. The closer the position sensor 624 measures a marker to strip 501, the better the accuracy for that strip. 501. Conversely, the further the position sensor 624 measures the position of a marker from the injection zone ZI, the more positioning inaccuracies can accumulate, so that the strip of interest may in fact not be correctly located in the injection zone ZI.
[0194] In one embodiment, the marker is the strip 501 directly, which maximizes accuracy. A detailed description will be given later. Alternatively, the marker is a locatable element located on the cylindrical portion 504 of the cartridge 202 or on the separator 508.
[0195] For example, as illustrated in [Fig. 11], the position sensor 624 is a mechanical sensor, for example in the form of a follower 1100, mounted in the housing 204, which cooperates with a lobed cam 1102 of the cartridge 202 (of the cylindrical portion 504, for example). The marker is then the top 1104 or the bottom 1106 of the lobed cam that is closest to a strip. Thus, by measuring the position of the marker, which is near the strip, the position of the strip can be determined and the latter can be correctly positioned in the injection zone ZI.
[0196] For example, the position sensor 624 may include an electromagnetic sensor, such as a Hall effect sensor, and the marker may be a magnetic element on the cartridge. A magnetic element may be mounted on the rotating support opposite or just beside each housing 510.
[0197] In one embodiment, the position sensor 624 is radially aligned (once projected into a plane orthogonal to the axis of rotation) with the distal end of the injector (same angular location around the axis of rotation A), but offset along the axis of rotation. In this way, the measurement obtained is relevant for the injection.
[0198] In one embodiment, the position sensor 624 is an optical sensor that locates the marker by analyzing a received light signal. More specifically, the position sensor 624 can be the analyzer 606 itself. This allows for increased compactness and accuracy, since the marker is very close to the strip (or is even the strip).
[0199] Analysis and injection
[0200] Figure 12 illustrates in detail one embodiment of the analyzer 606, referenced herein as 1200. The analyzer 606 can perform colorimetric analysis on test strips. "Colorimetric analysis" refers to a measurement of absorbance or fluorescence under predetermined illumination, in transmission or reflection. The analyzer 606 can then determine one or more analytical results.
[0201] The analyzer 606 may be an optical analyzer 1200, comprising at least one light source 1202 (for example, one or more light-emitting diodes), 1204 and a sensor 1206 (for example, a CCD photodiode, “Charged Coupled Device”, or CMOS (“Complementary Metal Oxide Semiconductor”) The light source may include two separate sources 12O2, 12O4 (e.g., two different wavelengths)
[0202] The analyzer 1200 is typically located on either side of the annular housing 212, so that the light emitted by the light source 1202, 1204 can pass through the transparent cylindrical portion 504, then the orifices 512 of the separator, then the strip, to finally reach the optical sensor 1206. An optical separator 1208 helps to guide the two light sources 1202, 1204 to prevent light leakage from one optical path to the other.
[0203] As previously stated, the 1200 analyzer works in the ZA analysis area.
[0204] In one embodiment, the analyzer 1200 comprises several LEDs with wavelengths specific to the different reagents contained in different types of test strips. Thus, the urine analysis device can perform different analyses with precision.
[0205] For example, each light source 1202, 1204 may each comprise a white LED and an ultraviolet LED. A vertical separator (not visible in [Fig. 12]) may be provided to prevent the activation of the white LED from exciting the ultraviolet LED.
[0206] Alternatively, the 1200 analyzer may include a single LED. For example, the LED may be white. In this case, the LED can cover the entire visible spectrum. This configuration reduces the complexity of the analyzer.
[0207] The 1200 analyzer may also include a collimator. The collimator allows the illumination of the LED(s) to be directed towards the test strip.
[0208] The 1208 sensor can measure the absorbance or fluorescence of the test strip reagent, in particular by transmission or reflection, to establish the result(s) of analysis.
[0209] The 1208 sensor can be fitted with a filter. The filter increases the sensitivity of the optical sensor to specific wavelengths. The accuracy of an analysis is then very satisfactory.
[0210] As illustrated in [Fig. 12], the analyzer 1200 is arranged here on either side of the annular housing 212 (and therefore on either side of the cylindrical portion 504 when the cartridge 202 is inserted into the station). A first part of the analyzer 1200 (for example, the light source 1202, 1204) is radially external to the annular housing 212, and a second part of the analyzer 1200 (for example, the optical sensor 1206) is radially internal to the annular housing 212. The analyzer 1200 operates by transmitting light from the first part to the second part.
[0211] The first part includes the light source 1202, 1204, for example in the form of a pair of LEDs 1202, 1204. When aligned, the light is guided through the orifices 512 to illuminate the test strips 501. A first LED 1202 of the pair can be white to cover the entire visible spectrum and determine color changes in the test strip 501. A second LED 1204 of the pair can be monochromatic, for example ultraviolet, to excite fluorophores and allow observation of their emission wavelength.
[0212] The second part comprises the optical sensor 1206. The optical sensor 1206 is of the spectral type. It includes several photodiodes surmounted by filters, enabling the measurement of light intensity at different wavelengths distributed across the visible spectrum. The sensor 1206 is compatible with optical measurements by absorbance and fluorescence.
[0213] The sensor 1206 can be used for different types of test strips. For example, the test strip 501 is of the immunochromatographic type and has a test area and a control area aligned respectively with the orifices 512, the color change of which provides a result. In another example, the test strip 501 can be a colorimetric strip and have two separate test areas (for example, to simultaneously test the pH and specific gravity of the urine) aligned respectively with the orifices 512.
[0214] Alternatively, the 1200 analyzer can be mounted on a linear motor. In this way, the analyzer can be brought closer to a test strip to perform a more precise analysis.
[0215] In one embodiment, the analysis zone ZA of the analyzer 1200 coincides with the injection zone ZI of the injector 604. In other words, the drive actuator 600 does not need to be activated and rotate the cartridge 202 between the injection of urine by the injector 604 and the analysis of the strip 501 by the analyzer 1200. The injector 604 and the analyzer 606, 1200 are arranged to operate at the same angle and can interact with the same strip (without rotation of the cartridge 202). The advantages are numerous. One of the advantages is the kinematics: the analysis can start just before (for example at most two seconds or at most one second), at the same time or just after the injection, so that the kinetics of the chemical reaction (for example the rate of color change) of the 501 strip once in contact with the urine can be observed.Another advantage is precision: a good position for injection means a good position for analysis. Regarding space requirements, as shown in [Fig. 12], the optical sensor 1206 can be offset, along the axis of rotation A, from the injector 604 (in particular from the needle 704). This makes it possible to obtain a specific configuration. allowing the same strip to be injected and analyzed without rotating the cartridge (and therefore without activating the drive actuator 600).
[0216] In one embodiment, the analysis zone ZA of the analyzer 1200 coincides with the control zone ZC of the position sensor 624. This ensures that the strip 501 is correctly positioned for measurement by the analyzer 1200, thus obtaining a high-quality measurement. In particular, the optical sensor 624 can be the analyzer 1200 itself.
[0217] In one embodiment, the analysis zone ZA, the injection zone ZI, and the control zone ZC are combined. This means that the position sensor 624 determines that a strip 501 is correctly positioned using a marker located in a proximity zone to said strip 501. Then the injection and analysis take place without the cartridge 202 being rotated.
[0218] Direct measurement of the position of the test support (e.g., the strip).
[0219] In an embodiment already mentioned above, the marker for the position sensor 624 is the strip itself. In this way, the position sensor 624 is configured to directly measure the position of a strip relative to the housing 204. This eliminates the positioning uncertainties of the strip in the separator 508 or the uncertainties related to the position of the separator 508 in the rotating support 500.
[0220] Figure 13 schematically illustrates examples of inaccuracies, using a partial view of a separator 508 shown lying flat and not wound on the rotating support. Five slots 510a, 510b, 510c, 510d, 510e are shown, with a respective strip 501a, 501b, 501c, 501d, 501e. Due to the flexibility of the separator 508, the distance d1, d2, d3, d4 between two slots can vary during its installation. Due to the flexibility of the strips and their insertion into the slots, the position e1, e2, e3, e4, e5 of the strips in their slots can also vary. It is therefore clear that a marker positioned on the rotating support 500 cannot account for these irregularities and thus only provides the position of the strip to which it is attached, taking into account these irregularities. The position sensor 624, when it directly measures the position of the strip, completely eliminates these irregularities.
[0221] In particular, the position sensor 624 is an optical sensor, without contact with the cartridge 202. In [Fig. 12], the position sensor 624 is the analyzer 1200 itself (the control zone ZC and the analysis zone ZA are therefore combined). This results in increased compactness and precision, as previously mentioned.
[0222] When the cartridge 202 is rotating and the strips 501 pass in front of the position sensor 624, the position sensor 624 (which may be the analyzer 1200 itself, as previously stated) receives a variation in light that corresponds light passing through the orifices 512 of the separator 508 and on either side of the strip 501 or through the strip 501. Consequently, the detected signal depends directly on the position of the strip 501 in the annular housing 212, independently of the position of the strip 501 relative to the separator 508 or the rotating support 500. The control of the drive motor 600 can therefore be done independently of the position of the rotating support 500 or the separator 508.
[0223] A process using this feature will be described later.
[0224] Obtaining data directly from the strip also allows characterize the test strips. For example, depending on their nature, the strips may have different extrema. Therefore, the station can use the extremum value and a table stored within the station to determine the nature of the strip present in the control zone (and thus in the injection and analysis zones).
[0225] Additional Information
[0226] As previously stated, in one embodiment, the position sensor 624 determines whether a strip is within the control zone (local position) but does not directly determine the absolute position of the strip within the cartridge (in other words, which strip in the cartridge is within the control zone ZC). To do this, the ECU can count the number of strips that have passed since zero (zero being the orifice through 514, which is easily identifiable by a higher signal value than the others – since light only passes through air or transparent or nearly transparent components). By combining this count with a table stored in the ECU's memory, the station can identify the strip. The table can map, for a given cartridge model, the type of strip to a strip number (the numbering being unique within each cartridge).Identification 516 allows station 200 to obtain the cartridge model and therefore know which table to use.
[0227] In one embodiment, the device 100 includes a urine presence sensor. The urine presence sensor can be located near the collection port. The urine presence sensor then detects when urine is present in the vicinity of the collection port. The urine presence sensor can be a temperature sensor, for example, a thermistor. The temperature sensor makes it possible to distinguish between urine and water from the toilet. In addition, the temperature sensor can also be used to measure the temperature of the urine. Urine temperature makes it possible, in particular, to detect periods of fertility by comparison to one or more reference curves. The use of a temperature sensor thus reduces the number of components used by the test assembly to perform an analysis. The complexity and costs associated with the The manufacturing costs of the urine analysis device are reduced. Alternatively, the urine presence sensor can be any type of liquid detector, for example, a capacitive or resistive sensor.
[0228] Figure 14 shows a schematic view of an analysis environment 1400 comprising the urine analysis device and its surroundings. The station 200 is controlled by an electronic control unit (ECU) 1402. The ECU 1402 is housed inside the enclosure 204. The ECU 1402 controls the components of the test assembly to perform a urine analysis using test strips 501 and obtain one or more analysis results. In particular, the ECU 1402 manages the drive actuator 600, the displacement actuator 620, the position sensor 624, the analyzer 1200, and the pump 614.
[0229] The ECU 1402 typically includes a processor 1404 and a memory 1406 capable of storing instructions that the processor 1404 executes. In particular, the processes described in the description are stored as instruction lines in the memory 1406. In order to be able to communicate directly or indirectly with the mobile terminal 114, the server 116 and / or, where applicable, the external activator 118, the station 200 includes a communication module 1408, typically wireless, for example Bluetooth, WiFi and / or cellular (GSM, 3G, 4G, 5G, 4G-LTE). A battery 1410 provides power to the various components of station 200. To identify the cartridge 202 in station 200 (via identification 516), station 200 may include a reader 1412, for example a contactless proximity reader, such as an RFID reader.
[0230] The mobile terminal 114 includes in particular a processor 1414 and a memory 1416, which allow for example to run an application which serves as a user interface for the device 100. The server 116 also includes a processor 1418 and a memory 1420, to process and store data generated in particular by the device 100.
[0231] The device 100, the mobile terminal 114 and the server 116 communicate with each other via a telecommunications network 1422. The telecommunications network 1422 may be hybrid, including a WiFi or Bluetooth network and a cellular network, the roles of which have been explained previously.
[0232] Piloting method
[0233] In connection with the urine analysis device 100 presented previously, various processes will now be described. The described steps may all be implemented during an analysis, or only some of them may be implemented. In particular, these steps are executable from instructions stored in memory 1305 of the ECU 1402.
[0234] A global method of using device 100 will be described in relation to [Fig.15].
[0235] Step E0 consists of holding the urine analysis device 100 in a purge position. The ECU controls the drive actuator 600 to move the purge opening 514 of the cartridge 202 into the injection zone ZI (i.e., aligned with the injector 604). To this end, the ECU uses position data obtained by the position sensor 624, which can detect the opening 512 (for example, by a stronger light signal because there is no strip between the light source and the photodiode). Before rotating the cartridge, the ECU drives the displacement actuator 620 to move the injector to the retracted position PR. Once the purge opening 514 is aligned with the injector, the ECU drives the displacement actuator 620 to move the injector 604 to the purge position PP. Device 100 can thus be rinsed of water or urine residue.Thus, urine or water received from the toilet in the collection pipe 612 can reach the drain port 310.
[0236] In a step El (“urine collection”), the ECU activates the pump 614 to deliver urine from the collection port 218 to the injector 604. The injector 604 is always in the PP priming position, and urine may flow out through the drain port. This step cleans the injector and ensures it is properly filled with urine. Step El may also include a pre-charge step to bring a controlled amount of urine to the distal end 700 of the injector 604.
[0237] Step E2 (“strip selection”) consists of positioning the urine analysis device 100 in a selection position, placing the desired strip 501 opposite the injector 604. The ECU activates the displacement actuator 620 to move the injector 604 from the priming position PP to the retraction position PR. The ECU then drives the drive actuator 600 to rotate the cartridge 202 and place the selected strip 501 into the injection zone ZI. The selection of the strip 501 may depend on the desired analysis (if different types of strips are placed in the cartridge 202) by the user or may be done automatically (strips used sequentially according to a pre-established program). The ECU retrieves the position sensor 624 data again to ensure that the desired strip is correctly positioned.The absolute position of the test strip can be determined using the position sensor (see above and below in the description). The exact positioning of the strip is achieved using the position sensor as described. A specific procedure will be described later. Step E2 may take a few seconds. However, since the urine was already collected in step E1, there is no risk of missing the user's urination.
[0238] Step E3 (“urine injection”) subsequently consists of positioning the urine analysis device in an injection position and injecting urine. The pilot ECU The displacement actuator 620 moves the injector to the injection position (PI). The distal end 700 then pierces the seal 511 of the cartridge 202. The ECU then controls the pump 614 to inject urine onto a test strip. The injected urine can then react with the reagents on the test strip. After the injection, the injector 604 can be retracted to the withdrawal position (PR).
[0239] Step E4 (“measurement”) is a measurement step that consists of obtaining data on the desired test strip with the 606, 1200 analyzer. To this end, the ECU controls the 606, 1200 analyzer to generate data on the test strips. Step E4 can be performed in parallel with step E3, slightly before step E3, or slightly after (specifically with respect to the injection of the first drop of urine). Obtaining data as soon as the first drop is injected allows for the acquisition of reaction kinetic data. Alternatively, only static data (when the reaction of the test strips has stabilized) are used. When the ZA analysis zone and the ZI injection zone of the annular housing are coincident (i.e., when analyzer 606, 1200 is positioned radially in the same location as injector 604), the ECU does not need to rotate cartridge 202.
[0240] Step E5 (“purge”) consists of purging the urine analyzer. The ECU drives the drive actuator 600 to align the bleed port 514 with the injector 604, then drives the displacement actuator 620 to move the injector to the bleed position PP, and then activates the pump 614 to push air through. Urine is then expelled from the urine analyzer via the bleed channel and through the drain port 310. The urine analyzer 100 is thus in the same position as in step E0. Prior to aligning the bleed port 514 with the injector 604, the injector 604 can be returned to the retraction position PR by driving the displacement actuator 620, if this was not done at the end of step E3.
[0241] Activation of step El may involve the ECU receiving a request for a urine analysis. The analysis request may originate from the remote activator. The analysis request may also be initiated from the smartphone 114. The analysis request may also be performed automatically when the user is near a toilet.
[0242] Similarly, activation of step El may involve the ECU detecting urine near the collection port 218. If no urine stream is received within a specified time, then the urine analysis device returns to step E0. If, on the other hand, a urine stream is detected, step El is implemented.
[0243] The urine injection in step E2 can be done in two stages. For example, the automated syringe 80 can inject twice, with between 2.5 microliters and 3.5 microliters. This solution allows for the reaction and migration time of the urine on the test strip 501.
[0244] The analyzer performs a colorimetric analysis on the test strip. The urine analysis device then derives the analysis result(s). The analysis performed depends on the type of test strip. The analysis performed may also depend on a user selection. The analysis performed may also be selected based on the identified user.
[0245] A data processing and result transmission step E6 can be implemented. The ECU processes the data received by the analyzer 606 and instructs a transmitter to send the result(s), for example, directly to the user's mobile terminal 114. The result(s) can also be sent to the server 116. The user can, for example, view and use the result(s) on the smartphone application 114, or on a website. The result(s) can also be sent to a healthcare professional. Step E6 can be performed at any time after step E4.
[0246] It should be noted that steps E2 to E4 can be repeated several times. Thus, several test strips receive urine and are analyzed. Therefore, several analyses can be performed from a single urine aspirate in step EL.
[0247] Step E0 consists of maintaining the urine analysis device in the purge position, by placing the injector 604 in the PP purge position.
[0248] The positioning of the strip will now be described in more detail. As mentioned previously, the position sensor 624 can receive a signal (for example, a light signal) whose intensity varies according to the elements passing in front of said position sensor 624. In particular, the signal reaches an extremum when a strip is in the control zone ZC, that is, radially opposite the position sensor 624. In the case of a stepper motor 600, a signal value is determined for each step. Graph 1600 in [Fig. 16] shows three curves: the signal 1602 obtained by the position sensor 624, the filtered signal 1604 (typically an average of several values), and the value 1606 of the last extremum. The ordinate is a unit of optical signal intensity and the abscissa is a number of steps of the drive motor 600.The highest intensities correspond to an alignment of the orifices 512 of the separator 508 with the position sensor 624, and the lowest intensities correspond to the separator 508 blocking the light.
[0249] In a step FL, the ECU sets the strips 501 in motion in a given direction, which pass in front of the position sensor 624. For example, the ECU can drive the motor 600 in one direction. The strips 501 can pass in front of the position sensor 624 in two opposite directions. One direction is chosen in step FL
[0250] In a step F2, generally concomitant with step Fl, the ECU receives and analyzes the evolution of the feedback signal during scrolling. A measurement can be obtained at each step of the 600 drive motor or at regular time intervals (e.g. every 0.1 seconds), for example if the motor is continuous displacement.
[0251] In an F3 step, the ECU identifies a local extremum of the signal. This means that the ECU has detected that the signal value has begun to decrease after a peak (up to the sign). In this respect, the ECU needs to detect at least three signal values, corresponding to three different cartridge positions, for which the intermediate value is the highest (up to the sign) of the three values. These three values are detectable over three successive steps, for example.
[0252] More generally (in the case of a stepper motor), if we assume that there is an extremum at step N (time t1 or t2, for the filtered signal, in [Fig. 16]), the ECU observes a window of ± k measurements (i.e., 2xk + l steps), and if value[N] = max(value[Nk;N+k]), the ECU determines that value[N] is an extremum (time t3 in [Fig. 16]). However, the cartridge is then in position N+k, meaning that the extremum of position N has been exceeded by k steps at that moment. One solution is therefore to reverse the movement by k steps. However, because the drive chain has backlash, the ECU cannot simply count k steps in the other direction: the ECU tries to find the extremum value (modulo a margin), which means that the cartridge is in the desired position. Steps F4 and F5 describe this in detail.
[0253] In a step F4, in response to step F3, the ECU sets the strips in motion in the opposite direction to that of step Fl. For example, the ECU can drive the motor 600 in the opposite direction or, cause a reversal of the direction of rotation in the gear chain 608 (by disengaging or engaging a gear).
[0254] In a step F5, the ECU positions the strip that generated the extremum. In other words, the ECU stops the drive actuator 600 to position the strip at the desired location, which in this case is the injection zone ZI or the analysis zone ZA (which may coincide, as explained previously). In particular, when the control zone ZC coincides with the injection zone ZI and / or the analysis zone ZA, the desired location is the control zone ZC, i.e., the area opposite the position sensor 624. Step F5 may include a substep F51 in which the ECU identifies a signal value close to the value of the first local extremum and a substep F52 in which the strip stops scrolling in the opposite direction. By "close" is understood to mean a value that is identical or similar within a predetermined range (defined, for example, during testing).Identifying a close value allows the scrolling to stop at the position exactly corresponding to the extremum. If the ECU were to determine a new extremum, the reverse scrolling would have had to go beyond the position corresponding to the original extremum.
[0255] In reverse scrolling (step F4), that is, when the ECU seeks to find the position of the cartridge corresponding to the extremum, the scrolling can be done at the same speed as in the direction of step Fl, in order to have the same acquisition conditions as in steps Fl and F2. For this, step-by-step movement is particularly suitable.
[0256] When the ECU detects an extremum, cartridge 202 has been rotated only a few degrees, so that no further strip has yet passed in front of position sensor 624 or, at the very least, no further extremum can be identified.
[0257] Such a positioning method offers several advantages: firstly, measuring the position of the strip directly eliminates inaccuracies caused by backlash in the mechanical chain (for example, play between the gear train sprockets 608 when the direction of rotation changes) and by the position of the strip itself (see [Fig. 13]). Furthermore, identifying an extremum eliminates variations in signal values between strips. As illustrated in Figure 1600, the values of the extrema can vary. Two successive extrema (associated with two successive strips) can therefore have different values without the method failing.The extreme values can be affected by irregularities in the positioning of the strips or by the nature of the strips themselves (a 202 cartridge can contain different types of strips, which do not exhibit the same response to the optical sensor, all other parameters being equal). Secondly, the process allows for managing the data processing latency of the electronics (position sensor and ECU): the fact that the peak is not known in real time is compensated for by the reverse movement. The onboard electronics can therefore be less energy-intensive, less expensive, and more robust.
[0258] It is noted here that this process can be implemented independently of the annular shape of the housing 212. However, the rotational movement of the cartridge 202 in the station 200 is particularly suited to this type of process, and this for all the strips of the cartridge (due to the symmetry of revolution).
[0259] With reference to counting the strips to identify the strip that is in the control zone, the ECU can count the extremities that the position sensor has seen. For example, if the ECU determines that strip number 54 (out of 90, for example) should be used, the ECU can count 90 extremities from zero.
[0260] Additional information on test media
[0261] The test supports comprise a reagent that reacts upon contact with urine. In one embodiment, the reagent is a dry reagent. In particular, the test supports are test strips, which will be described in more detail below.
[0262] Test strips 501 may be of the lateral or vertical flow immunoassay type. In this case, test strips 501 consist of a sampling buffer and an absorption buffer O2. A nitrocellulose membrane extends between the sampling buffer and the absorption buffer. When a urine sample is introduced onto the sampling buffer, it migrates by capillary action to the absorption buffer, passing through a conjugate buffer, one or more test lines, and a control line. The conjugate buffer, the test line(s), and the control line contain reagents.
[0263] The conjugated buffer contains, in particular, detection antibodies sensitive to compounds found in urine. If the compounds are present when the urine sample passes through the conjugated buffer, the antibodies bind to the compounds to form markers. The markers migrate to a test line. The test line contains, in particular, test antibodies. The test antibodies bind to the markers and retain them on the test line. A colored line then forms, and the density of the line varies according to the concentration of markers present. The remaining sample migrates to a control line. The control line contains control antibodies, indicating that the sample has passed through the nitrocellulose membrane.
[0264] For example, the test strips may be ELISA-type strips. This type of test strip allows for the detection of the pregnancy hormone hCG in urine. The detection antibody may be mouse monoclonal beta hCG, the test antibody may be goat polyclonal anti-mouse IgG, and the control antibody may be rabbit polyclonal anti-mouse IgG.
[0265] Test strips may be of the conventional colorimetric type. Each test strip contains at least one buffer containing one or more reagents sensitive to one or more compounds present in the urine sample. For example, the compound(s) may be: LH hormone, HCG hormone, leukocytes / nitrites, urobilinogen / bilirubin, proteins, pH, specific gravity, and / or glucose.
[0266] Other types of reactions may use reagents or compounds designed to detect the presence of a particular analyte (e.g., molecularly imprinted polymers, or MIPs), including a drug active ingredient or a drug active ingredient metabolite in urine. In this case, the device may be used to monitor a user's adherence to a medication regimen, including verifying that they are taking their medication or alerting them when they have missed a dose.
[0267] Each test strip is generally rectangular. The width of each test strip can be between 0.5 mm and 3 mm, for example, about 1 mm. The length of each test strip can be between 10 and 15 mm, for example, 12 mm or about 12 mm. Alternatively, each test strip can have any shape, for example, square or circular. The shape and dimensions of the test strips allow a significant number of test strips to be stored in the urine analysis device (at least 50 strips, or even at least 100 strips). In fact, it appears possible to store up to 120 test strips, which corresponds to 4 months of testing when a user performs one test per day.
[0268] The test result(s) may be one or more indicators revealing one or more of the following: a fertile period, pregnancy, urinary tract infections, liver problems, kidney failure, uric acid stones, dehydration, heart disease, and / or diabetes. The result(s) may also be an indicator of medication adherence.
Claims
Demands
1. Station (200) for a urine analysis device (100), the station comprising: - a housing (204), intended to be positioned inside a toilet bowl (106) (102), - an annular housing (212) about an axis of rotation, positioned in the housing, the annular housing (212) being configured to at least partially receive a cartridge (202) mounted for rotation about the axis of rotation in the station and comprising a plurality of test supports (501), - an analyzer (606, 1200), mounted in the housing (204), and configured to obtain information relating to the test support after urine injection, when the test support is in an analysis zone (AZ) of the annular housing (212), - an injector (604), mounted in the housing (204), and configured to inject a controlled volume of urine onto a test support, when the The test support is located in an injection zone (IZ) of the annular housing.in which the analysis zone (AZ) and the injection zone (IZ) are the same.
2. Station according to claim 1, wherein the analyzer and injector are located angularly at the same place around the axis of rotation (A).
3. Station according to any one of claims 1 to 2, further comprising a position sensor (624), configured to obtain the position of a marker associated with a test holder of the cartridge, when said marker is positioned in the analysis zone (AZ) or in a zone near the analysis zone.
4. Station claim 3, wherein the proximity zone of the analysis zone (AZ) corresponds to an angular sector of less than 30° on either side of the injection zone, or even 20°, or even 10°, or
5. J. Station according to any one of claims 1 to 4, wherein the injector is mounted movable in translation within the housing.
6. A station according to any one of claims 1 to 5, comprising a memory (1406) and a processor (1404), said memory including instructions configured to implement the following steps: - (E3) injection of urine onto a test support by the injector (604), - (E4) measurement on a test support by the analyzer (606, 1200).
7. Station (200) according to claim 6, wherein the instructions do not include rotating the cartridge between the injection step (E3) and the analysis step (E4).
8. Station (200) according to claim 6 or 7, wherein the instructions include that the measurement step (E4) starts before the end of the injection step (E3), for example two seconds before the end or as soon as the first drop of urine is injected, or even before the first drop of urine is injected.
9. Station (200) according to any one of claims 1 to 8, wherein the housing (204) has a diameter, measured in the direction normal to the axis of rotation (A), of between 50 mm and 150 mm.
10. Station (200) according to any one of claims 1 to 9, wherein the housing (204) is arranged in the toilet bowl (106) in a removable manner.
11. Urine analysis device (100) comprising a station (200) according to any one of the preceding claims and a cartridge (202), the cartridge being configured to be at least partially received in the annular housing of the casing.
12. Device according to claim 11, wherein the analysis zone (AZ) corresponds to an angular sector including a single test support.
13. Urine analysis device according to claim 12, wherein the cartridge (202) comprises a rotating support (500) configured to be driven in rotation by the station 200, the cartridge (202) comprising test strips (501) attached and integral with the rotating support (500), the strips (501) being arranged parallel to each other.
14. Method of urine analysis utilizing the urine analysis device according to claim 12 or claim 13, comprising the following steps, implemented by the device: - (E3) injection of urine onto the test support by the injector, - (E4) measurement on the test support by the analyzer, wherein the cartridge is not rotated between the injection step and the analysis step.