Kit for detecting and / or measuring an analyte and / or a physiological parameter in a biological fluid

Abstract

Kit (1) for the detection and / or measurement of an analyte and / or a physiological parameter in a fluid, - an analysis module (12) comprising a first face (16-1) provided with an analysis element (18, 20); - an electronic module (14) shaped to be connected to said analysis module (12) so as to form a sensor (10) of said analyte and / or said physiological parameter; - a cartridge (56) comprising a first housing (60); and - a gripping element (80); in which the gripping element (80) is shaped to be connected to said sensor (10) and to be movable between: - a first position in which said first face (16-1) of the analysis module (12) is in said first housing (60) covered at least partially by a protective film (62), and - a second position in which said first face (16-1) is separated from said protective film (62). Figure for the abridged version: Figure 11

Description

Title of the invention: Kit for detecting and / or measuring an analyte and / or a physiological parameter in a biological fluid. Technical field

[0001] This disclosure relates to a kit for detecting and / or measuring an analyte and / or a physiological parameter in a biological fluid, as well as an analysis module, an electronic module, a housing, and a gripping device for the kit. This disclosure also describes a charger for the electronic module of the kit. Finally, this disclosure relates to a method of using the kit. Prior art

[0002] Chronic kidney disease is a major public health problem, affecting approximately 10% of the world's population. If not managed at an early stage, these diseases can progress to conditions requiring renal replacement therapy, such as regular dialysis or kidney transplantation. These treatments are not only invasive to the body and the daily lives of patients, but also very costly for public health systems. Furthermore, the prospect of progression to an advanced stage of chronic kidney disease discourages physicians from prescribing certain medications, such as antihypertensives, which can cause hyperkalemia. It is therefore crucial to intervene early and ensure continuous patient monitoring to prevent the progression of chronic kidney disease.

[0003] To this end, several techniques are known for monitoring patients, but they rely on occasional, painful, and invasive blood draws. Currently, only patients' blood glucose levels can be recorded continuously, using devices worn on the arm or abdomen. These devices use flexible filaments approximately 1 cm long, placed under the skin's surface, which measure glucose concentration electrochemically. These sensors are used with an injector developed for placing the filament under the skin using a retractable needle. These injectors are for single use only and are systematically discarded after the sensor is placed on the user's skin, thus generating a significant amount of waste.Moreover, during the installation of the sensor in these injectors, there is a high risk of contamination and damage to the sensor, either through exposure to ambient air or through necessary handling by the user, which can distort the measurements obtained.

[0004] The invention aims to remedy these drawbacks. SUMMARY

[0005] To this end, a kit for detecting and / or measuring an analyte and / or a physiological parameter in a biological fluid is proposed, the kit comprising: - an analysis module comprising a first face equipped with an analysis organ capable of detecting and / or measuring said analyte and / or said physiological parameter; - an electronic module designed to be connected to said analysis module so as to form a sensor of said analyte and / or said physiological parameter; - a cartridge comprising a first housing; and - a gripping element; in which the analysis module is configured to be received in said first dwelling, and in which the gripping organ is shaped to be connected to said sensor and to be movable between: - a first position in which said first face of the analysis module is in said first housing, and - a second position in which said first face is extracted from the first housing and is ready to be connected to the skin of a user.

[0006] Since the first side of the analysis module is placed in the cartridge housing, the risk of contamination or damage to the analysis element before and when the grasping element is in the first position is very limited. Furthermore, the patient does not have to perform any direct manipulation of the first side of the analysis module to remove it from the housing, as the first side is removed by moving the grasping element, connected to the sensor, from the first position to the second position. This also limits the risk of damage to or contamination of the analysis element.

[0007] Furthermore, the kit is easy to use, which promotes user adoption and therefore better monitoring of analyte and / or physiological parameter variations in the biological fluid. The user simply connects the gripping device to the sensor, with the first side of the analysis module in the cartridge housing, and then moves the gripping device from the first position to the second position for the sensor to be ready for use.

[0008] Finally, the gripping organ allows for better gripping of the sensor for its positioning on the user's skin, thus limiting the risk of the sensor falling (and therefore, of damage and contamination) before its installation on the patient's skin.

[0009] In this text, "analyte" refers without limitation to a substance or chemical constituent in a biological fluid, in particular blood, interstitial fluid, etc. The analyte may be, for example, glucose, potassium, creatinine, etc.

[0010] In this text, the term "physiological parameter" refers without limitation to any chemical, biological, or physical measurement of the organism that remains within limits defined by self-regulation. This includes constants such as blood or interstitial fluid pH, impedance, heart rate, blood pressure, body temperature, etc.

[0011] “Measure” here means to quantify the analyte and / or the physiological parameter in the fluid. This measurement can be expressed by the total amount of analyte detected, its concentration and / or percentage, among other things, or by the value of the physiological parameter of interest. “Detect” here means to indicate the presence and / or absence of the analyte and / or the physiological parameter being sought.

[0012] It should also be noted that the use of the indefinite article "a" in this text means "at least one". For example, by way of non-limiting example, the kit housing comprises a plurality of first slots, each first slot being shaped to receive a respective analysis module.

[0013] Although the main application of the kit described in this text is the measurement and / or detection of an analyte and / or physiological parameter marker of the state of functioning of renal function, the kit could also be adapted for the measurement and / or detection of analytes and / or physiological parameters markers of the state of functioning of other organs.

[0014] It is also noted that the grasping organ can adopt any position between the first position and the second position mentioned above.

[0015] Depending on different aspects, it is possible to foresee one and / or the other of the characteristics below taken alone or in combination.

[0016] According to one feature, in said first position, the first face of the analysis module is covered at least partially by a protective film; and in said second position, the first face is separated from said protective film.

[0017] The protective film is, for example, attached to the bottom of the first housing, for example by adhesive. Advantageously, the film is adhered to the bottom of the housing only at one of its ends, to facilitate the separation of the first face of the analysis module when the gripping member moves from the first position to the second position. Advantageously, the separation of the first face of the analysis module from the protective film occurs gradually as the gripping member moves from the first position to the second position.

[0018] The protective film is for example made of polyester or any other plastic film.

[0019] In some cases, the protective film has a shape with a through hole. In such cases, the protective thread is arranged so as to cover the first face of the analysis module without covering the analysis element, the analysis element being inserted, or in Regarding the hole through the film. In other cases, the protective film has a shape without holes through it so as to also cover the analyzing organ.

[0020] As previously stated, the sensor comprises the analysis module and the electronic module connected to each other. As also stated, the sensor, via the first face of the analysis module, is advantageously configured to be installed on the user's skin, which allows for the in vivo detection and / or measurement of the analyte and / or the physiological parameter.

[0021] The analysis module and the electronic module may be made of the same material or of different materials. For example, the analysis module and the electronic module may be made at least partially of a non-conductive material. The exterior of the analysis module and the electronic module may, for instance, be made at least partially of a polymer, in particular an injectable polymer or one suitable for 3D printing, such as acrylonitrile butadiene styrene (ABS) or polycarbonate (PC).

[0022] The analytical device may include at least one needle intended to come into contact with the biological fluid. One tip of the needle is shaped to pierce the user's skin, so as to come into contact with the biological fluid in which the analyte and / or physiological parameter is to be measured and / or detected. This makes it possible to perform the measurement and / or detection in vivo, thus enabling real-time results to be obtained.

[0023] According to another example, the analytical instrument comprises at least two needles. When the analytical instrument comprises two needles, one needle acts as the reference electrode, and the other needle acts as the working electrode. The measurement and / or detection of the analyte and / or the physiological parameter is then performed between the two needles by measuring the voltage between the two electrodes. When the analytical instrument comprises more than two needles, they can be configured to operate in pairs, such that one needle in the pair acts as the reference electrode, and the other needle in the pair acts as the working electrode. The operation of each pair of needles is then the same as the operation explained above for the case where two needles are used.

[0024] According to another example, the analysis device comprises at least three needles configured to operate in a trio, such that one of the needles acts as a reference electrode, another needle as a working electrode, and the third as a counter electrode. In this configuration, the electric current between the working electrode and the counter electrode could be measured by applying a voltage to the working electrode.

[0025] Advantageously, the needle(s) of the analysis module are microneedles. The length of the microneedles between their tip, shaped to pierce the skin of the user and the first face of the analysis module is advantageously less than 1.5 mm.

[0026] The first face of the analysis module may include an adhesive suitable for fixing said analysis module to the skin of a kit user. Thus, it is possible to keep the sensor on the patient's skin while the analysis device detects and / or measures the analyte and / or the physiological parameter in vivo. The adhesive is advantageously a biocompatible adhesive to avoid any adverse reaction from the user's body.

[0027] The electronic module may include at least one of the following: a battery or a rechargeable battery with a charging circuit. The battery provides the electrical energy for the sensor's operation. The electronic module can thus be reused by changing the battery and / or recharging it. The electronic module may further include at least one of the following: a microcontroller, an antenna, a programming circuit, current measurement components, and / or voltage measurement components. The antenna allows the electronic module to be wirelessly connected to a device external to the sensor, for example, via Bluetooth or Bluetooth Low Energy (BLE). In this way, the electronic module can send the data collected by the analysis module to the external device for processing.The sensor can also communicate other information to the external device, such as the battery level of the electronic module. This can help the user decide when to recharge the electronic module's battery to ensure uninterrupted sensor operation.

[0028] The analysis module may include a coupling means for said electronic module, said coupling means being configured to cooperate with a complementary coupling means carried by said electronic module. The coupling means may include at least one protrusion and / or at least one recess, and the complementary coupling means may include at least one recess and / or at least one protrusion configured to cooperate with at least one protrusion and / or at least one recess of the coupling means.

[0029] According to one example, the electronic module can be configured to be connected to the analysis module by snapping it into place. The connection between the electronic module and the analysis module is thus removable, which allows, when the analysis module reaches the end of its useful life, for it to be replaced by a new analysis module, while retaining the same electronic module, which generally has a longer lifespan than the analysis module.

[0030] According to one feature, the kit may further include a charger configured to recharge said electronic module. In particular, the charger allows the The electronic module battery. The charger may include a compartment designed to receive the electronic module, thus allowing the electronic module to be charged while the sensor is worn by the user. Alternatively, the charger may not have a compartment designed to receive the electronic module, in which case charging can be performed by pressing one side of the charger against one side of the electronic module.

[0031] The charger can charge the electronic module wirelessly, for example by induction, although any other charging and / or power supply mechanism can also be used (for example, the electronic module and the charger could include complementary connectors configured to be connected to each other during charging).

[0032] According to one feature, the charger can be connected to a wearing element. The wearing element is advantageously designed to be connected to a part of the body, thus allowing the user to wear the charger attached to their body. Non-limiting examples of wearing elements include, for example, an armband, a wristband, or an ankle bracelet. In one example, the charger is permanently attached to the wearing element. In another embodiment, the charger is removably attached to the wearing element. The association of the charger with the wearing element allows the user to wear it easily, thus facilitating the recharging of the electronic module without interrupting the measurement and / or detection of the analyte or a physiological parameter in the biological fluid. In a first example, the wearing element and the charger are removably connected. In a second example, the wearing element and the charger are permanently connected.

[0033] According to one feature, the analysis module may include a first connector, and the electronic module may include a second connector, wherein the first connector is connected to said second connector when the electronic module is connected to the analysis module, wherein at least one of the first and second connectors comprises a spring and / or an elastomeric material. This allows the connector comprising the spring and / or the elastomeric material to deform to ensure contact between the first and second connectors even when the sensor 10 undergoes variations in the stress applied to it (for example, in the event of an impact or in the event of displacement of the electronic module 14 relative to the analysis module 12 during the use of the sensor 10).

[0034] At least one of the first connector and the second connector may be a spring finger connector, an elastomer connector, or a pogo pin.

[0035] The first connector can be the analyzing element of the analysis module. For example, each needle can protrude from a face of the analysis module which is in opposite the electronic module in the sensor. Alternatively, each needle can be flush with this face positioned opposite the electronic module. In one variant, the first connector can be a tab on the analyzer that allows the needle to be attached to the analyzer module. Using the analyzer as the first connector reduces the number of components in the sensor. Of course, the first connector could also be an additional component located within the analyzer module.

[0036] According to one feature, the gripping element can be shaped to be removably connected to the sensor. Thus, the gripping element can be separated from the sensor once the sensor is installed on the user's skin, reducing bulk and making the sensor more discreet. Furthermore, thanks to the removable connection between the gripping element and the sensor, the gripping element can be reused for placing other sensors on the skin. This reduces waste from using the kit.

[0037] According to one feature, the gripping member can be configured to be connected to the sensor's electronic module before being moved between said first position and said second position. According to a non-limiting sequence of kit use, the gripping member can be connected to the electronic module, and then the electronic module is connected to the analysis module, which is located in the respective housing. Alternatively, the electronic module is connected to the analysis module, which is located in the respective housing, and then the gripping member is formed into the sensor by the connection between the electronic module and the analysis module.

[0038] According to one feature, the gripping member may include a means for attaching to the housing, and the housing may include a complementary attachment means, said attachment means being configured to be connected to said complementary attachment means so as to allow the gripping member to be moved between said first position and said second position.

[0039] By way of example, the fastening means may be substantially in the shape of a hollow half-cylinder, while the complementary fastening means may be in the form of a cylinder with dimensions complementary to those of the fastening means of the gripping member. It is thus possible to form, between the gripping member and the housing, a pivot joint with an axis coinciding with the axis of revolution of the cylinder forming the complementary fastening means. The movement between the first and second positions of the gripping member then includes a rotation of the gripping member, in particular of the fastening means, around the axis of the complementary fastening means of the housing.

[0040] According to one characteristic, the grasping organ may comprise: - a base; and - a means of connecting to said sensor, said sensor comprising a complementary connecting means shaped to be connected to said connecting means, in which a width of the base is wider than a width of the sensor.

[0041] The base may be substantially flat, although this is not a limitation. The substantially flat base makes the gripping member very compact, which facilitates transport of the kit.

[0042] Since the base of the gripping member is wider than the sensor, it is possible to provide a small sensor while ensuring that the user of the kit can easily and correctly grasp the sensor for its installation on the body.

[0043] The connecting means extends, according to an example, from the base, substantially perpendicular to said base.

[0044] According to one feature, said connecting means may include a slide, said complementary connecting means then comprising an elongated groove adapted to cooperate with the slide of the connecting means. Alternatively, said connecting means may include an elongated groove, said complementary connecting means then comprising a slide adapted to cooperate with the elongated groove of the connecting means. The gripping member and the sensor can thus be attached to and detached from each other by simply sliding one over the other. Advantageously, the gripping member, and in particular its connecting means, is made of a material sufficiently flexible to allow the connection between the gripping member and the sensor to be made and maintained by snap-fit, by applying pressure from the gripping member to the sensor, or vice versa.In such a case, the fact that the connecting means or the complementary connecting means is a slide, while the complementary connecting means or the connecting means is an elongated groove, facilitates clipping since it does not need to be done in a very precise position, but can be done along the entire length of the slide and the elongated groove. Of course, even if the connection between the grasping element and the sensor is made by snapping, detachment can be made by sliding one over the other, as explained above, which reduces the stress applied to the sensor once installed on the user's skin, thus keeping it in a suitable position for the measurement and / or detection of the analyte and / or the physiological parameter.

[0045] Advantageously, the slide may have, at one end, a stop to prevent the gripping member from sliding relative to the sensor. In the present text, the slide comprises two rails, located opposite each other.

[0046] Of course, the connecting means and the complementary connecting means can take other forms, alternatively or additionally. For example, the means The connecting element and the complementary connecting means may include a complementary pin and / or hole to ensure the connection between the gripping element and the sensor.

[0047] According to one feature, the cartridge is shaped to be removably mounted in a housing. It is thus possible to replace the cartridge with another when all the analysis modules occupying their respective first slots have been used.

[0048] According to one feature, the housing may include: - an external body delimiting an internal space of the housing; and - said cartridge received in a removable manner in said internal space.

[0049] The external body of the case can thus be reused even if the cartridge is replaced by a new cartridge.

[0050] According to one example, the housing may further include a cover configured to be placed on the external body. The cover protects each analysis module located on the respective first slot of the cartridge, for example, during transport or when the kit is not in use.

[0051] According to one feature, the housing may further include a second compartment shaped to house said gripping member. It is thus possible to store the gripping member in the housing, along with the analysis module. In order to reduce the overall size of the housing, the second compartment may be contained within the housing lid, although this is not a limitation.

[0052] Advantageously, the gripping member can be housed in the second housing connected to the electronic module, so that the gripping member, the electronic module, and the analysis module can be stored in the same housing. Alternatively, the housing may include a third housing shaped to accommodate the electronic module.

[0053] According to another aspect, a gripping member for the kit described above is described, the gripping member being configured to be connected to a sensor of said kit and to be movable between: - a first position in which a first face of an analysis module of said sensor is in a first housing of a cartridge of the kit, said first face being equipped with an analysis element capable of detecting and / or measuring an analyte and / or a physiological parameter in a biological fluid, and - a second position in which said first is extracted from the first housing and is able to be connected to the skin of a user.

[0054] As explained previously, the gripping member may include a substantially flat base and a means of connecting the gripping member to said sensor extending from the base, substantially perpendicular to said base.

[0055] As also specified above, the gripping member may include a means for attaching it to the housing, said means being configured to allow the gripping member to be moved between said first position and said second position. The means may be configured to removably attach the gripping member to said housing. In particular, as already explained, said means may be configured to allow rotation about an axis of the gripping member relative to the housing.

[0056] It should be noted that all the details given in this text with regard to the gripping member and its components apply to the gripping member in this respect. For the sake of brevity, these details are not repeated.

[0057] According to another aspect, a cartridge for the kit described above is described, the cartridge comprising a first housing shaped to receive an analysis module of the kit comprising a first face equipped with an analysis element capable of detecting and / or measuring an analyte and / or a physiological parameter of a biological fluid, said first housing being shaped to: - to house said first face of said analysis module when a gripping element of the kit is in a first position, and - to allow the extraction of said first face of the housing when the grasping organ is moved into a second position so as to make said first face suitable for connection to the skin of a user.

[0058] It should be noted that all the details given in this text with regard to the cartridge and its components apply to the cartridge in this respect. For the sake of brevity, these details are not repeated.

[0059] According to another aspect, a housing for the kit described above is described, the housing comprising a first compartment shaped to receive an analysis module of the kit comprising a first face equipped with an analysis element capable of detecting and / or measuring said analyte and / or the physiological parameter, said first compartment being connected to a protective film such that: - said film covers at least partially said first face of said analysis module when said first face is in the housing and a gripping element of the kit is in a first position, and - said film is separated from said first face when the grasping organ is in a second position.

[0060] As explained previously, the housing may further include a second housing shaped to house said gripping member.

[0061] As also explained above, the housing may include an additional fastening means shaped to connect the housing to the gripping member, said additional fastening means being shaped to allow movement of the grasping member between said first position and said second position.

[0062] As already explained, the housing may include: - an external body delimiting an internal space of the casing; and - the cartridge received in a removable manner in said internal space.

[0063] It should be noted that all the details given in this text with regard to the housing and its components apply to the housing in this respect. For the sake of brevity, these details are not repeated.

[0064] According to another aspect, an analysis module for the kit described above is described, the analysis module comprising a first face equipped with an analysis organ capable of detecting and / or measuring an analyte and / or a physiological parameter in a biological fluid, the analysis module being shaped to be received in a first housing of a cartridge of the kit, said first face being housed in said first housing when a grasping organ of the kit is in a first position, said first face being extracted from the first housing and capable of being connected to the skin of a user when said grasping organ is in a second position.

[0065] As explained above, the analysis device includes at least one needle, preferably a micro-needle, intended to be in contact with said biological fluid.

[0066] As also explained above, said first face includes an adhesive suitable for fixing said analysis module to the skin of a user of the kit.

[0067] It should be noted that all the details given in this text with respect to the analysis module and its components apply to the analysis module in this respect. For the sake of brevity, these details are not repeated.

[0068] According to another aspect, an electronic module for the kit described above is described, the electronic module being configured to be connected to said analysis module so as to form a sensor of an analyte and / or a physiological parameter in a biological fluid, said sensor being configured to be connected to a grasping member of the kit configured to be movable between a first position in which a first face of said analysis module is in a first housing of a cartridge of the kit, and a second position in which said first face is extracted from the first housing and able to be connected to the skin of a user.

[0069] It should be noted that all the details given in this text with regard to the electronic module and its components apply to the electronic module in this respect. For the sake of brevity, these details are not repeated.

[0070] According to another aspect, a charger for the kit described above is described, the charger being configured to recharge the electronic module of the kit.

[0071] It should be noted that all the details given in this text with regard to the charger and its components apply to the charger in this respect. For the sake of brevity, these details are not repeated.

[0072] According to another aspect, a method for using the kit described above is described, the method comprising the steps: a) connect the gripping device to the electronic module; b) connect the electronic module to the analysis module; c) place the gripping member in said first position, said first face of the analysis module being in said first housing of the cartridge; d) move the grasping member from said first position to said second position so as to extract said first face from the housing and make it suitable for connection to the skin of a user, wherein step b) may be carried out before or after step a). Brief description of the drawings

[0073] Embodiments of the invention will be described below with reference to the drawings, briefly described below:

[0074] [Fig-1] represents a schematic perspective view of a sensor from the kit according to an example embodiment.

[0075] [Fig.2] represents a schematic side view of an example of a sensor analysis module of [Fig.1].

[0076] [Fig.3] represents a schematic perspective view of the analysis module of the [Fig.2],

[0077] [Fig.4] represents a schematic perspective view of an example of an electronic module of the sensor of [Fig.1].

[0078] [Fig.5] represents a schematic perspective view of an example charger for the electronic module of [Fig.4].

[0079] [Fig.6] represents a schematic perspective view of the charger of the [Fig.5] connected to a port element.

[0080] [Fig.7] represents a schematic perspective view of a kit box according to an example of embodiment.

[0081] [Fig.8] represents a schematic perspective view of a first face of a gripping member of the kit according to an example embodiment.

[0082] [Fig.9] represents a schematic perspective view of a second face of the grasping organ of [Fig.8].

[0083] [Fig. 10] represents a schematic perspective view of a first face of a gripping member of the kit according to another embodiment.

[0084] [Fig. 11] schematically represents the kit when the gripping member of figures 8 to 10 is in a first position.

[0085] [Fig. 12] schematically represents the kit when the gripping member of figures 8 to 10 is in a second position.

[0086] In the drawings, identical references designate identical or similar objects. Description of the implementation methods

[0087] An example of kit 1 for the detection and / or measurement of an analyte and / or a physiological parameter in a biological fluid will now be described. In particular, each of the components of kit 1 will be described with reference to the non-limiting embodiment examples shown in Figures 1 to 12.

[0088] Kit 1 includes a sensor 10, an example of which is shown in [Fig. 1]. The sensor 10 includes an analysis module 12 and an electronic module 14.

[0089] The analysis module 12 and the electronic module 14 are, for example, made, at least partially, of a polymer material, in particular an injectable polymer or one usable in 3D printing, such as acrylonitrile butadiene styrene (ABS) or polycarbonate (PC). Of course, the material of the analysis module 12 may be the same as or different from the material of the electronic module 14.

[0090] As will be detailed, the analysis module 12 and the electronic module are advantageously connected in a detachable manner.

[0091] The analysis module 12 will now be described with reference to Figures 2 and 3.

[0092] The analysis module 12 comprises a base 16. The base 16 comprises a first face 16-1 and a second face 16-2 opposite.

[0093] Base 16 is advantageously made of a non-conductive material. For example, base 16 is made of a polymer material, in particular an injectable or 3D printed polymer, without this being limiting.

[0094] The analysis module 12 further comprises an analysis element 18 intended to be brought into contact with the biological fluid in which the analyte and / or physiological parameter is measured and / or detected. As shown in [Fig. 2], the analysis element 18 is connected to the base 16.

[0095] In this example of [Fig. 2], the analysis device 18 comprises a plurality of needles 20 intended to be brought into contact with the body fluid in which the analyte and / or physiological parameter is measured and / or detected. More specifically, one tip of each needle 20 is shaped to penetrate the user's skin so as to come into contact with the body fluid and thus measure and / or detect the analyte and / or physiological parameter in vivo and in real time.

[0096] According to one example, the plurality of needles 20 can be configured so that the needles 20 operate in pairs, such that one of the needles 20 of each pair acts as the reference electrode, while the other needle 20 of the pair acts as the working electrode. The measurement and / or detection of the analyte and / or the physiological parameter is then performed between the two needles 20 of each pair, by measuring the voltage between the two corresponding electrodes.

[0097] According to another example, the analysis device comprises at least three needles 20 configured to operate in a trio, such that one of the needles acts as a reference electrode, another needle as a working electrode, and the third as a counter electrode. In this configuration, the electric current between the working electrode and the counter electrode could be measured by applying a voltage to the working electrode.

[0098] The needles 20 extend transversely across the base 16. As shown in Figures 2 and 3, the plurality of needles 20 pass through the base 16 between the first face 16-1 and the second face 16-2. By way of non-limiting example, the needles 20 are installed in the base 16 by overmolding or by press fitting. In some cases, the analyzing element 18 may additionally or alternatively include a paste for adhering each needle 20 to the base 16, this paste being arranged in contact with the second face 16-2 of the analyzing module 12.

[0099] It is apparent from [Fig. 2] that a first end of each needle 20, which includes the tip of the respective needle 20, protrudes from the first face 16-1, transversely to this first face 16-1. Each needle 20 can therefore be inserted into the user's body until the first face 16-1 of the analysis module 12 comes into contact with the user's skin. In order to hold the analysis module 12 against the skin, and thus the needles 20 inserted into the user's body, the first face 16-1 may include an adhesive. The adhesive may cover all or part of the first face 16-1 of the analysis module 12.

[0100] A second end of the needle 20 opposite the first end of this needle 20 may be flush with the second face 16-2, as in the example of Figures 2 or 3. According to an alternative not shown, the second end of each needle 20 may protrude from the second face 16-2, transversely with respect to this second face 16-2. As will be detailed, the second end of each needle 20 may serve as a connector to electrically connect the analysis module 12 to the electronic module 12.

[0101] Each needle 20 is preferably a microneedle. Advantageously, each needle is made from a metal plate (in particular stainless steel or titanium), preferably of medical grade. The metal plate can be functionalized by depositing one or more additional layer(s) by different methods. Each additional layer(s) can be, for example, a metallic or polymeric layer.

[0102] The analysis module 12 further includes coupling means 22 to the electronic module 14. The coupling means 22 extend, according to the example of figures 2 and 3, transversely to the base 16. In particular, the coupling means 22 protrude transversely from the second face 16-2 of the base 16. Advantageously, the coupling means 22 are made in one piece with the base 16, without this being limiting.

[0103] As can be seen in Figures 2 and 3, the coupling means 22 may include at least one recess 24 and / or at least one projection 26. As will be detailed later, each recess 24 is shaped to receive a projection arranged on the electronic module 14, while each projection 26 is shaped to be received in a recess of the electronic module 14.

[0104] Kit 1 further includes an electronic module 14 which will be described below with reference to [Fig.4].

[0105] The electronic module 14 comprises a body 28 including a front edge 28-1, a rear edge 28-2, and two side edges 28-3. In [Fig. 4], the front edge 28-1 and the rear edge 28-2 have different shapes. Although this is not limiting, since the front edge 28-1 and rear edge 28-2 could have the same shape, the difference in shape between the front edge 28-1 and the rear edge 28-2 has the advantage of serving as a guide for correctly positioning the electronic module 14 to a gripping member of the kit 1, which will be described later.

[0106] The electronic module 14 is intended to be installed opposite the second face 16-2 of the analysis module 12. In particular, the electronic module 14 is shaped to be removably connected to the analysis module 12, so as to form the sensor 10. For this purpose, the shape of the electronic module 14 is complementary to the shape of the analysis module 12.

[0107] By way of non-limiting example, the electronic module 14 can be connected to the analysis module 12 by snap-fitting. For this purpose, the electronic module 14 includes complementary coupling means 30 intended to cooperate with the coupling means 22 of the analysis module 12. Thus, as shown in [Fig. 4], the complementary coupling means 30 comprise at least one projection 32 and / or at least one recess 34. Each projection 32 is shaped to be received in a respective recess 24 of the analysis element 12, while each recess 34 is shaped to receive a respective projection 26 of the analysis element 12.

[0108] The electronic module 14 comprises a set of electronic elements used for the operation of the sensor 10. The set of electronic elements is advantageously housed inside the body 28. The electronic module 14 comprises advantageously at least one of the following: a battery or a rechargeable battery with a charging circuit (not shown in the figures). The battery provides the electrical power for the operation of sensor 10.

[0109] The electronic module 14 may further include at least one of the following: a microcontroller, an antenna, a programming circuit, current measurement components, and / or voltage measurement components. The antenna allows the electronic module 14 to be wirelessly connected to a device external to the sensor 10, for example, via Bluetooth or Bluetooth Low Energy (BLE). This enables the transmission and processing of data collected by the analysis module 12 between the electronic module 14 and the external device. The antenna can also communicate other information to the external device, such as the battery level of the electronic module.

[0110] In order to electrically connect the analysis module 12 to the electronic module 14, the analysis module 12 includes a first connector, and the electronic module 14 includes a second connector 36, which are connected together when the electronic module 14 is connected to the analysis module 12. As previously stated, the connector of the analysis module 12 is advantageously the end of each needle 20 that protrudes from or is flush with the second face 16-2 of the analysis module 12 or, alternatively, a pad disposed on the second face 16-2 to fix each needle 20 to the analysis module 12. The connector 36 of the electronic module 14 may include a spring and / or an elastomeric material. For example, the connector 36 may be a spring finger connector, an elastomeric connector, or a pogo pin.

[0111] As can be seen from [Fig. 4], at least one of the lateral edges 28-3 of the electronic module includes an elongated groove 38. Advantageously, both lateral edges 28-3 of the electronic module 14 each include an elongated groove 38. Each elongated groove 38 is shaped to cooperate with the gripping member of the kit 1, as will be detailed later. It should be noted that the elongated groove 38 can be extended by another groove 39 arranged on the analysis module 12 (see [Fig. 2]).

[0112] Kit 1 further includes a 40 magazine which will now be described with reference to figures 5 and 6.

[0113] The charger 40 comprises a casing 41 within which the entire electronic component set of the charger 40 is housed. A housing 42, shown in dashed line in [Fig. 6], can be arranged on a face of the charger 40 opposite to that shown in [Fig. 6]. The housing 42 is shaped to receive the electronic module 14. Alternatively, the charger 40 can be without the housing 42, in which case the recharge can be carried out by pressing one side of the charger 40 on one side of the electronic module 14.

[0114] The charger 40 is configured to recharge the battery of the electronic module 14. By way of non-limiting example, the charger 40 is configured to charge the electronic module 14 wirelessly, for example by induction. The charger 40 can, in particular, be plugged into the mains to be recharged, and then placed in contact with the electronic module 14 so as to transfer electrical energy from the charger 40 to the electronic module 14. Alternatively, the charger 40 can be plugged into the mains at the same time as it is placed in contact with the electronic module 14 to effect the transfer of electrical energy from the charger 40 to the electronic module.

[0115] The charger 40 may include a wearing element 43, visible in [Fig. 6]. The wearing element 43 may be an armband, a wristband, or an anklet, among other things. In the example shown in Figures 5 and 6, the housing 41 of the charger 40 includes two arms 44 for connecting the charger 40 to the wearing element 43. According to a first example, the wearing element 43 and the charger 40 are connected removably. According to a second example, the wearing element 43 and the charger 40 are connected permanently. Thanks to the wearing element 43, the user can easily wear the charger 40, for example, in a manner similar to a watch.

[0116] Kit 1 further includes a cartridge 56 which is described below. The cartridge 56 can be received in a case 50, described below with reference to [Fig. 7].

[0117] The housing 50 includes an outer body 52 that defines an internal space 54 of the housing 50. The internal space 54 removably receives a cartridge 56 that is shaped to be held in this space 54. In particular, the cartridge 56 can be shaped to bear against a wall of the outer body 52, thus preventing the cartridge 56 from being pushed into the internal space 54. Furthermore, the housing 50 can include a ring 58 shaped to rest on the cartridge 56. The ring thus prevents the cartridge 56 from being pulled out of the housing 50 when a force substantially transverse to the cartridge 56 is applied to the cartridge 56. The ring 58 is advantageously mounted on the cartridge 56 in a removable manner. For example, the ring 58 can be shaped to snap onto the outer body 52 of the housing 50.

[0118] As can be seen from [Fig.7], the cartridge 56 includes at least one first housing 60. In this case, three housings 60 are shown.

[0119] Each housing 60 is shaped to receive a respective analysis module 12. In particular, the analysis module 12 is received in its respective housing 60 so that the first face 16-1 is opposite the bottom of the housing 60.

[0120] As previously stated, the first face 16-1 includes an adhesive suitable for being stuck to the user's skin. In addition, the analysis organ 18 protrudes from the first face 16-1. In order to prevent the adhesive from wearing down and the analysis element 18 from being damaged or contaminated by the bottom of the housing 60, each housing 60 is fitted with a protective film 62, shown in Figures 11 and 12. The protective film 62 is in particular connected to the bottom of the housing 60, for example by glue 64. The first face 16-1 of the analysis module 12 is then in contact with the film 62.

[0121] As shown in Figures 11 and 12, the protective film includes a through hole 63. In such cases, the protective thread 62 is arranged to cover the first face of the analysis module without covering the analysis element 18, in this instance the needles 20. Indeed, as can be seen in Figures 11 and 12, the needles 20 are received in the hole 63. In this case, the protective film 62 prevents the adhesive on the first face 16-1 from sticking to the bottom of the housing, thus preventing wear on this adhesive before it is bonded to the user's skin. In a variant not shown, the film 62 can also cover the analysis element 18.

[0122] As will be detailed below, the protective film 62 is separated from the analysis module 12 before the sensor 10 is installed on the user's skin. In order to allow the separation of the film 62 from the face 16-1 to be gradual, the protective film 62 is advantageously adhered to the bottom of the housing 60 only at one of its ends, as shown in Figures 11 and 12, where adhesive 64 is provided only at one of these ends.

[0123] According to one example, the protective film 62 is made of polyester or any other plastic film. Advantageously, the film is made of a flexible material.

[0124] Since the cartridge 56 is mounted in the housing 50 in a removable manner, it is possible to replace it once all the analysis modules 12 housed in the slots 60 have been used. The risk of damage to or contamination of the analysis components 18 is therefore reduced, as each analysis module 18 can be pre-installed at the factory, and thus, user handling of the first face 16-1 is limited before the sensor 10 is installed on the skin.

[0125] In some cases, the housing 50 may include at least one additional fastening means 68 for a fastening means of a gripping member of the kit 1, which will be described below. Advantageously, the number of additional fastening means 68 is equal to the number of slots 60. In this case, the additional fastening means 68 is located on the ring 58, but other locations on the housing 50 may be considered.

[0126] In the non-limiting example of [Fig.7], each additional fastening means 68 has substantially the shape of a cylinder.

[0127] As seen in [Fig. 7], the housing 50 may further comprise a cover 66. The cover 66 is configured to be disposed on the external body 52. ​​The cover 66 protects each analysis module 18 disposed on the housing 60. relative to cartridge 56, for example in case of transport or non-use of kit 1.

[0128] As can be seen from [Fig. 7], the housing 50 can include a second housing 70 is arranged in the lid. The housing 70 is shaped to accommodate the gripping element of kit 1, which will be explained in detail later. Advantageously, the gripping element can be housed in the housing 70 connected to the electronic module, so that the gripping element, the electronic module 14, and the analysis module 12 can be stored in the same housing 50.

[0129] Kit 1 further includes a gripping member 80, which will be described below with reference to figures 8 to 10.

[0130] The grasping member 80 comprises a substantially flat base 82, which is substantially rectangular in the non-limiting examples of figures 8 and 9.

[0131] The gripping member 80 includes a means 84 for connecting the gripping member 80 to the sensor 10. The connecting means 84 extends from the base 82, in particular transversely to this base 82. The connecting means 84 allows, in particular, the gripping member 80 to be removably connected to the sensor 10. More specifically, the connecting means 84 can be shaped to be connected to the electronic module 14. For this purpose, the connecting means 84 includes a slide 86 which is shaped to fit into the groove 38 of the electronic module 14. The groove 38 thus forms a complementary connecting means to the connecting means 84. The gripping member 80 and the electronic module 14 can therefore slide relative to each other along the longitudinal direction of the slide 86 and the groove 38. This allows the gripping member to be attached to the electronic module 14, and detached from the electronic module 14, by simply moving the slide 86 along the groove 38.Advantageously, the slide 86 is made of a material sufficiently flexible to also allow the slide 86 to be inserted and held in the groove 38 by snapping (i.e., by applying pressure from the gripping member 80 on the electronic module 14, the pressure being applied transversely to the base 82).

[0132] As can be seen from [Fig.9], the slide 86 can terminate with a stop 88. The stop 88 is positioned so that one of the front edge 28-1 or the rear edge 28-2 of the electronic module 14 comes to rest against the stop 88 when the electronic module 14 is correctly linked to the gripping member 80.

[0133] As previously stated, the front edges 28-1 and rear edges 28-2 of the electronic module may have different shapes. The stop 88 sometimes has a shape complementary to the shape of the front edge 28-1 or rear edge 28-2 of the electronic module 14. In such a case, if the edge of the electronic module 14 opposite the stop 58 does not fully abut against the stop 88, the user may to realize that he did not place the electronic module 14 in the correct position in the slide 86, and therefore, to correct it.

[0134] The base 82 comprises two gripping edges 85 adapted to be grasped by the fingers of a user of the kit 1 when installing the sensor 10 on the body. In the non-limiting examples of Figures 8 to 10, the two gripping edges 85 have the same shape. In other words, in the examples of Figures 8 to 10, each edge 85 is the mirror image of the other edge 85. Moreover, in the examples of Figures 8 to 10, the two edges 85 are perfectly aligned, so that each point on one of the edges 85 is opposite the equivalent point on the other edge 85. A straight line joining two equivalent points (i.e., occupying the same position on their respective edges 85) is, in the case of the examples of Figures 8 to 10, substantially perpendicular to the slide 86.According to an unillustrated variant, each edge 85 could be offset from the other, so that a straight line joining two equivalent points (i.e., occupying the same position on their respective edges 85) would form an angle other than 90° with the slide 86. Advantageously, in such a case, the angle formed between the straight line joining the two equivalent points of the edges 85 and the slide 86 is equal to the angle formed between the hand and the longitudinal dimension of the sensor 10 when the user grasps the gripping element 80 connected to the sensor 10 to position the latter on the skin. In some cases, the edges 85 may not be mirror images of each other.In all cases (whether or not the edges 85 are mirror images of each other), a line, called the gripping line, connecting the points on each of the edges 85 where the maximum gripping force is exerted by the user, can be substantially perpendicular to the slide 86. Alternatively, the gripping line can form an angle other than 90° with the slide 86. Advantageously, in such a case, the angle formed between the gripping line and the slide 86 is equal to the angle formed between the hand and the longitudinal dimension of the sensor 10 when the user grasps the gripping element 80 connected to the sensor 10 to place the latter on the skin.

[0135] As shown in [Fig. 9], the gripping member 80 may also include at least one protrusion 90 extending transversely to the base 82. In this case, two protrusions 90 are provided, but any other number of protrusions 90 is possible. Each protrusion 90 guides the installation of the electronic module 14 in the slide 86 and limits the movement of the electronic module 14 transversely to the base 82.

[0136] As illustrated in Figures 9 and 10, the gripping member 50 comprises a means for attaching it to the housing 50. The means for attaching it 92 has, in particular, a shape complementary to the shape of the complementary means for attaching it 68 to the housing 50. In this case, the means for attaching it 92 is substantially in the shape of a half- hollow cylinder, with dimensions complementary to those of the cylinder forming the complementary fixing means 68 provided on the housing 50. It is thus possible to form, between the gripping member 80 and the housing 50, a pivot joint with axis coinciding with the axis of revolution of the cylinder forming the complementary fixing means 68. The gripping member 80 can thus move in rotation around the complementary fixing means 68 of the housing 50.

[0137] Advantageously, the gripping member 80 is dimensioned so that, when connected to the electronic module 14 via the slide 86, the gripping member 80 can be placed in a first position in which the electronic module 14 can be connected to the analysis module 12 installed in one of the slots 60. As previously stated, the connection between the analysis module 12 and the electronic module 14 can be made by snapping. In this first position of the gripping member 80, the first face 16-1 of the analysis module 12 is in contact with the film 62 in the corresponding slot 60. From this first position, the gripping member can be rotated around the additional fastening means 68 of the housing 50.During this rotation, the gripping element 80 causes a coordinated movement of the electronic module 14 and the analysis module 12, resulting in a progressive separation of face 16-1 from the film 62, until the gripping element 80 reaches a position in which face 16-1 is completely separated from the film 62. The adhesive and the analysis element 18 of the analysis module 12 are then exposed. The gripping element 80 can then be separated from the housing 50. Subsequently, the assembly formed by the sensor 10 and the gripping element 80 is placed on the user's body, with face 16-1 containing the adhesive in contact with the skin. Once the sensor 10 is correctly fixed to the skin, the gripping organ 80 can be removed by sliding the gripping organ 80 off the sensor 10, so that the user only keeps the sensor 10 on their body.With the sensor on its body, the set of needles 20 allows information to be obtained on the presence and / or quantity of the analyte and / or the physiological parameter as explained previously, and the data obtained can then be sent to an external device from the electronic module 14.

[0138] Figure 10 shows another embodiment of the gripping member 80. In this embodiment, the base 82 has an H-shape, with two lateral portions 82-1 connected by a central portion 82-1. Spaces 83 are therefore present between the two lateral portions 82-1, on either side of the central portion 82-1. In this case, the slide 86 extends along the lateral portions 82-1, so that when the sensor 10 is connected to the gripping member 80, the sensor 10 is positioned between the two lateral portions 82-1.

[0139] As in the previous embodiment, the gripping member 80 is movable between a first position, in which the first face 16-1 of the analysis module 12 is in the housing 60 corresponding to the contact of the film 62, and a second position, in which the first face 16-1 of the analysis module 12 is separated from the film 62. Unlike the embodiment of Figures 8 and 9, the gripping means 80 according to the embodiment of [Fig. 10] does not include any means of fixing the gripping member 80 to the housing 50. The movement from the first position to the second position is then carried out by withdrawing the gripping member 80 from the cartridge 56 of the housing 50, this withdrawal preferably taking the form of an angular displacement around an imaginary axis located for example at one of the ends of the lateral portions 82-1 of the gripping member 80.

[0140] The assembly formed by the gripping member 80 and the sensor 10 can then be placed on the user's skin as explained above with reference to the embodiments in Figures 8 and 9. Next, to separate the gripping member 80 from the sensor 10, the gripping member 80 can be slid along the sensor 10, as explained previously. Alternatively, to separate the gripping member 80 from the sensor 10, a force can be applied to the sensor 10 through the gaps 83 in the gripping member 80. This force is applied to the sensor 10 in a direction transverse to the base 82, so as to disengage the slide 86 from the groove 38.

[0141] According to another embodiment not illustrated, the gripping member 80 may have an O shape, the central space forming a through hole which allows, like the spaces 83 in the case of the H shape, to apply a transverse force to the base 82 of the gripping member 80 to disengage the slide 86 from the groove 38.

[0142] A method for using kit 1 described previously will now be described.

[0143] The method comprises step a) of connecting the gripping member 80 to the electronic module 14, and step b) of connecting the electronic module 14 to the analysis module 12. Step b) can be carried out before or after step a). Once steps a) and b) have been completed, the gripping member 80 is connected to the sensor 10 (formed, as previously stated, by the connection of the electronic module and the analysis module 12).

[0144] The method further comprises step c) of placing the gripping member in the first position, illustrated in [Fig. 11]. As already indicated, in the first position, the first face 16-1 of the analysis module 12 is in the housing covered by the protective film. Furthermore, it should be noted that in this first position, the base 82 of the gripping member is substantially parallel to the cartridge 56 of the housing, and the electronic module 14 exerts pressure on the analysis module. 12 located on the respective housing 60 of the cartridge 56. The electronic module 14 can thus be snapped onto the analysis module 12.

[0145] When the gripping member 80 is similar or identical to that described with reference to figures 8 and 9, the movement into the first position is advantageously carried out once the gripping member 80 is connected to the housing 50 via the fastening means 92 and the complementary fastening means 68.

[0146] The method further comprises step d) of moving the gripping member 80 from the first position to the second position ([Fig. 12]) so as to extract said first face 16-1 from the housing 60 and make it suitable for connection to the skin of a user (due to its separation from the protective film 62). This transition from the first position to the second position occurs once the analysis module 12 and the electronic module 14 are connected.

[0147] When the gripping member 80 is similar or identical to that described with reference to Figures 8 and 9, the gripping member 80 is moved in rotation around the additional fixing means 68 of the housing 50, in a direction which moves the gripping member 80 away from the cartridge 56.

[0148] When the gripping member 80 is similar or identical to that described with reference to [Fig. 10], the movement from the first to the second position is made by withdrawing the gripping member 80 from the cartridge 56 of the housing 50, this withdrawal preferably taking the form of an angular displacement around an imaginary axis located for example at one of the ends of the lateral portions 82-1 of the gripping member 80.

[0149] Moving the gripping element 80 from the first to the second position causes a corresponding movement of the sensor 10, formed by the analysis module 12 and the electronic module 14. This movement results in a progressive separation of the film 62 and the face 16-1 of the analysis module 12, until the film 62 is completely separated from the face 16-1. The adhesive and the analysis element 18 are then exposed, making it possible to place the assembly formed by the gripping element 80 and the sensor 10 on the user's body by positioning the face 16-1 against their skin. The measurement and / or detection of the analyte and / or the physiological parameter can then begin. In order to reduce the bulk on the user's body, the gripping member 80 can then be separated from the sensor 10 according to one of the methods explained above with reference to figures 8 to 10.

[0150] It is noted that once placed on the user's skin, the sensor 10 can be removed by pulling it away from the body. Once the sensor 10 is removed from the body, the analysis module 12 can be separated from the electronic module 14 by means of their removable linkage. The analysis module 12 is discarded, while the electronic module 14 can be reused to form a new sensor with a new analysis module 12.

[0151] It is noted that the process described in this text could be applied without installing the cartridge in the housing 56.

[0152] Apart from the advantages indicated above, kit 1 and its method of use provide the following advantages: - possibility of placing the sensor 10 on the skin without touching the analysis organ 18, so as to limit the risks of damage to the analysis organ 18 and the adhesive layer of the face 16-1, as well as the risks of injury to the user when the analysis organ 18 includes needles. - possibility of having a small sensor 10, but easy to grasp thanks to the gripping element 80, even when the user has little strength and dexterity. The gripping element serves to enlarge the gripping area. - ease of inserting the needles of the analysis organ 18 vertically into the skin - ease of sticking the adhesive of the first side 16-1 evenly onto the skin, and without touching it beforehand. - limiting the risk of dropping the sensor 10 (without the gripping organ 80, it would be necessary to grasp the sensor by its edges, which could cause the sensor 10 to fall, or by touching the adhesive of the first face 16-1, which would reduce the adhesion of the sensor 10 to the skin.

Claims

Demands

1. Kit (1) for detecting and / or measuring an analyte and / or a physiological parameter in a biological fluid, the kit comprising: - an analysis module (12) including a first face (16-1) provided with an analysis element (18, 20) capable of detecting and / or measuring said analyte and / or said physiological parameter; - an electronic module (14) shaped to be connected to said analysis module (12) so as to form a sensor (10) of said analyte and / or said physiological parameter; - a cartridge (56) including a first housing (60); and - a gripping element (80);in which the analysis module (12) is shaped to be received in said first housing (60), and in which the grasping member (80) is shaped to be connected to said sensor (10) and to be movable between: - a first position in which said first face (16-1) of the analysis module (12) is in said first housing (60), and - a second position in which said first face (16-1) is extracted from the first housing (60) and is able to be connected to the skin of a user.

2. Kit (1) according to claim 1, wherein: - in said first position, the first face (16-1) of the analysis module (12) is covered at least partially by a protective film (62); and - in said second position, the first face (16-1) is separated from said protective film (60).

3. Kit (1) according to any one of claims 1 or 2, wherein the gripping member (80) is shaped to be removably connected to the sensor (10).

4. Kit (1) according to any one of the preceding claims, further comprising a charger (40) configured to recharge said electronic module (14).

5. Kit (1) according to any one of the preceding claims, wherein the analysis module (12) comprises a first connector (20), and the electronic module (14) comprises a second connector (36), wherein the first connector (20) is connected to said second connector (36) when the electronic module (14) is connected to the analysis module (12), wherein at least one of the first connector (20) and the second connector (36) comprises a spring and / or an elastomeric material.

6. Kit (1) according to any one of the preceding claims, wherein the cartridge (56) is shaped to be removably mounted in a housing (50).

7. Kit (1) according to the preceding claim, wherein the gripping member (80) comprises a means for fixing (92) to the housing (50), and the housing (50) comprises a complementary fixing means (68), said fixing means (92) being configured to be connected to said complementary fixing means (68) so as to allow the gripping member (80) to be moved between said first position and said second position.

8. Kit (1) according to any one of the preceding claims, wherein the gripping member (80) comprises: - a base (82); and - a linking means (84, 86) to said sensor (10), said sensor (10) comprising a complementary linking means (38) shaped to be linked to said linking means (84, 86), wherein a width of the base (82) is wider than a width of the sensor (10).

9. Kit (1) according to any one of the preceding claims, wherein said analysis module (12) comprises a coupling means (22) to said electronic module (14), said coupling means (22) being configured to cooperate with a complementary coupling means (30) carried by said electronic module (14).

10. Gripping member (80) for the kit (1) according to any one of claims 1 to 9, the gripping member (80) being configured to be connected to a sensor (10) of said kit (1) and to be movable between: - a first position in which a first face (16-1) of an analysis module (12) of said sensor (10) is in a first housing (60) of a cartridge (56) of the kit (1), said first face (16-1) being provided with an analysis member (18) capable of detecting and / or measuring an analyte and / or a physiological parameter in a biological fluid, and - a second position in which said first face (16-1) is extracted from the first housing (60) and capable of being connected to the skin of a user.

11. Cartridge (56) for the kit (1) according to any one of claims 1 to 9, the cartridge (56) comprising a first housing (60) shaped to receive an analysis module (12) of the kit (1) comprising a first face (16-1) provided with an analysis element (18) capable of detecting and / or measuring an analyte and / or a physiological parameter of a biological fluid, said first housing (60) being shaped to: - house said first face (16-1) of said analysis module (12) when a gripping element (80) of the kit (1) is in a first position, and - allow the extraction of said first face (16-1) from the housing (60) when the gripping element (80) is moved into a second position so as to make said first face (16-1) capable of being connected to the skin of a user.

12. Analysis module (12) for the kit (1) according to any one of claims 1 to 9, the analysis module (12) comprising a first face (16-1) provided with an analysis element (18) capable of detecting and / or measuring an analyte and / or a physiological parameter in a biological fluid, the analysis module (12) being configured to be received in a first housing (60) of a cartridge (56) of the kit (1), said first face (16-1) being housed in said first housing (60) when a gripping element (80) of the kit (1) is in a first position, said first face (16-1) being extracted from the first housing (60) and capable of being connected to the skin of a user when said gripping element (80) is in a second position.

13. Electronic module (14) for the kit (1) according to any one of claims 1 to 9, the electronic module (14) being configured to be connected to said analysis module (12) so as to form a sensor (10) of an analyte and / or a physiological parameter in a biological fluid, said sensor (10) being configured to be connected to a gripping member (80) of the kit (1) configured to be movable between a first position in which a first face (16-1) of said analysis module (12) is in a first housing (60) of a cartridge (56) of the kit (1), and a second position in which said first face (16-1) is extracted from the first housing (60) and suitable for connection to the skin of a user.

14. A method of using the kit (1) according to any one of claims 1 to 9, the method comprising the steps: a) connect the gripping organ (80) to the electronic module (14); b) connect the electronic module (14) to the analysis module (12); (c) place the gripping member (80) in said first position, said first face (16-1) of the analysis module (12) being in said first housing (60) of the cartridge (56); d) move the grasping member (80) from said first position to said second position so as to extract said first face (16-1) from the housing (60) and make it suitable for connection to the skin of a user, in which step b) can be implemented before or after step a).

Images