Preparation of a needle sensor for a body monitoring system

Abstract

The present invention relates to a sensor preparation assembly (30) for a body monitoring system, the sensor (30) comprising at least one needle, the preparation assembly comprising: a pouch (26) containing a volume of a preparation solution, the pouch (26) being configured to be positioned under the sensor (30) and being piercable by the needle (32), a receptacle (28) on which the pouch (26) is disposed, support means (24) movable relative to the receptacle (28) to a support position, the support means (24) in the support position being configured to cause the sensor (30) to pierce the pouch (26). The invention further relates to a sensor preparation method, comprising placing the sensor (30) in a position interposed between the support means (24) and the pouch (26), the needle (32) of the sensor (30) piercing the pouch (26). Figure for the abstract: Fig. 1a

Description

Description Title of the invention: Preparation of a needle sensor of a body monitoring system FIELD OF INVENTION

[0001] — The present invention belongs to the technical field of ready-to-wear devices or "wearables" used in body monitoring systems, for example for the recording and monitoring of biochemical parameters of the human body.

[0002] …— The invention relates to an assembly for preparing a needle sensor of a body monitoring system, as well as a sensor kit including such together. The invention further relates to a method for preparing a sensor at needle. The invention is particularly advantageous for the calibration of a needle sensor, preferably before its integration into a ready-to-wear device. STATE OF THE ART

[0003] The monitoring of many known chronic diseases in humans requires a daily record of biochemical parameters. A concentration level of a body analyte in a body fluid of the organism, for example in the plasma blood or in the interstitial fluid of the body's cells, can be detected.

[0004] As a common example, monitoring diabetes in a patient requires a detection precise daily blood glucose readings of the patient.

[0005] A common solution for monitoring diabetes is to perform a puncture, for example at the fingertip, to draw out a drop of blood, then to to perform a daily blood glucose measurement in the drop of blood thus obtained.

[0006] Monitoring systems have been proposed to eliminate the need for a blood draw manual, so as to make blood glucose measurement less laborious and less invasive. These are called CGM systems, for "Continuous Glucose Monitoring". Some of these CGM systems perform blood glucose measurements at regular intervals at the level of the Interstitial fluid between skin cells. The blood glucose level of the interstitial fluid is very close to blood plasma glucose levels. Measurements at the level of the intra- fluid Interstitial devices allow for simple and minimally invasive monitoring of patients' blood glucose levels; these Measurements can be taken using needle sensors, transcutaneously, or by non-invasive methods, such as iontophoresis or implantable devices with a measurement by cheo-fluorescence.

[0007] — The international application published under number WO 2018 / 104647 describes a body monitoring system, usable in particular for blood glucose monitoring. This monitoring system includes an electronic watch that can be attached to the wrist. with the help of a bracelet. The watch has a case into which a capsule is inserted. Removable, interchangeable device containing a microneedle sensor. The sensor is automatically controlled by the device's electronics to perform a transcutaneous measurement. Blood glucose measurement by the sensor is an electrochemical measurement. The body monitoring system described in the above-mentioned document has the significant advantage of providing autonomous calibration measurement by measuring a reference concentration of a body analyte in the user. The number of steps the user needs to take to obtain their daily measurements is significantly reduced. Specifically, the user needs to perform very few manual punctures (for example, a single weekly puncture), or even none at all. Another advantage of this system is its low hygiene risk, as the sensor needles are not in contact with the external environment once inserted into the skin. Furthermore, maintenance of the aforementioned system is simple, because to replace a faulty sensor, one simply needs to remove the removable capsule and insert a new one. However, a significant amount of time—for example, several months—can elapse between the production of the removable capsule containing the microneedle sensor and its insertion into a wearable device. It has been observed that the quality of the blood glucose measurement provided by the sensor deteriorates during such a long period of non-use. The deterioration in the measurement performance of the needle sensor is due to electrochemical drift over time. This drift can be caused by unsuitable ambient temperatures in the storage areas of the removable capsules containing the needle sensors. In particular, excessively high temperatures are detrimental to the integrity of the measurement system. Sudden and significant temperature fluctuations in the sensor further exacerbate the electrochemical drift. One known method to address this drift is a "factory" calibration performed on an entire batch of needle sensors after the batch has been produced. An alphanumeric code is then printed on the packaging of the removable capsule containing the sensor, or is stored in the sensor's electronic memory. The wearable device has a chart in which each alphanumeric code is associated with a reference value. When the capsule is inserted into the wearable device, the alphanumeric code is read, and the calibration can be performed. This factory calibration, known to be state-of-the-art and based on the use of nomograms, is nevertheless not entirely satisfactory. Drifts in the electrochemical measurement provided by the sensor are still observed. A second known calibration method, sometimes used in combination with the first, involves calibration measurements (manual blood glucose readings) performed regularly by the user while wearing the wearable device. These calibration measurements are taken manually by the user, for example, daily or weekly. To perform the manual calibration, the user may be required to enter a capillary blood glucose reading on the wearable device. - In this second method, which can be used in conjunction with the first, the user is responsible for the proper calibration of their own wearable device. Regular manual operation is required, which contradicts one of the objectives of an autonomous body monitoring system, namely to limit the discomfort experienced by the user. In light of the above considerations, the state of the art is unsatisfactory regarding the preparation of needle sensors for wearable devices, such as electronic watches. Some known systems do not ensure sustained accuracy of electrochemical measurement, and other known systems require regular calibrations that must be performed by the user. The current state of the art is also unsatisfactory regarding the speed of commissioning needle sensors when using a new sensor. The convergence of the electrochemical measurement provided by the sensor after needle insertion into human interstitial fluid—that is, the achievement of equilibrium between the sensor's chemical species enabling the measurement and the surrounding environment—is currently quite slow. The convergence time for known sensors, for example, is several hours. During this commissioning period, the measurement provided is unreliable, and the user is at risk because they are not informed of fluctuations in their biochemical parameters. GENERAL DESCRIPTION OF THE INVENTION One objective of the invention is to provide improvements for a body monitoring system including a needle sensor, so that the measurement provided by this sensor remains reliable and accurate over time. Specifically, a solution is being sought to easily calibrate this sensor while minimizing any inconvenience to the user. The goal is to eliminate the need for daily manual punctures and reduce them to at least weekly, or even eliminate them altogether. Consequently, it is desired that the user of the body monitoring system not be responsible for the proper calibration of the sensor during the system's lifespan. The aim is to avoid the need for regular finger pricks to perform daily sensor calibration. The solution sought must remain very simple to use, in order to ensure a pleasant user experience. A secondary objective is to enable the rapid deployment of a new needle sensor after its insertion into a ready-to-wear device. This requires accelerating the convergence of the electrochemical measurement between the sensor's chemical compounds and the medium into which the sensor needle is inserted, typically human interstitial fluid. Furthermore, the aim is to maintain a simple body monitoring system with a low production cost, compatible with large-scale industrialization. In this respect, the invention relates, according to a first aspect, to a sensor preparation assembly for a body monitoring system, the sensor comprising at least one needle, the preparation assembly comprising: - a pouch containing a volume of a preparation solution, the pouch being configured to be positioned under the sensor and being piercable by the needle, - a receptacle on which the pouch is placed, - mobile support means relative to the receptacle towards a support position, the support means in the support position being configured to cause the sensor to pierce the pocket. In a sensor preparation kit according to the invention, the preparation solution contained in the pouch allows for easy and rapid preparation of the needle sensor. A user of the body monitoring system wishing to prepare the sensor does not need to prick their finger or directly manipulate the sensor needles in any way. The preparation assembly of the invention is used, for example, when putting the needle sensor into service. During the first use of a ready-to-wear device incorporating the sensor, or when putting a new sensor into service, the user can easily prepare the sensor themselves by using the support means to pierce the pocket with the sensor needle. Sensor preparation, for example, involves pre-calibrating the sensor to correct for potential drift in an electrochemical measurement provided by the sensor. This operation can be called "pre-calibration" because it occurs at the beginning of the sensor's operating cycle. Sensor preparation can also be performed, either as an alternative to or in combination with pre-calibration, as pre-wetting the sensor needle(s). The sensor preparation assembly according to the first aspect of the invention may optionally and without limitation have the following technical characteristics taken alone or in any of the technically possible combinations: - the preparation solution is a calibration solution with a volume concentration of a body analyte equal to a predetermined reference value, - the body analyte is glucose, - the predetermined reference value is between 2 millimoles of glucose per liter and 20 millimoles of glucose per liter, preferably between 6 millimoles of glucose per liter and 10 millimoles of glucose per liter, - the preparation solution is a pre-wetting solution, - in the support position, the support means cover the sensor, - the preparation kit further includes an electronic device, the electronic device preferably being configured to control a measurement of the concentration of a body analyte via the sensor, and / or being configured to generate an electric current, - the electronic device includes a ready-to-wear device, preferably an electronic watch or bracelet or tracker, - The electronic device includes a processing unit and memory, configured to record and manage recalibration information for a measurement of body analyte concentration, - a part of the electronic device forms part of the support means or is part of the support means, - the support means include a cover, the cover preferably being configured to completely cover the support means, - The preparation kit includes a box, with at least some of the support means integrated into the box. - The pouch and the receptacle are received in the box, - the box includes at least one housing configured to stably hold the receptacle in the box, and / or configured to stably hold a ready-to-wear device in the box, - the support means include at least one mechanical clip configured to provide Z-shaped support on the sensor, or on a part of an electronic device, - the preparation kit further includes a peelable film, the peelable film preferably forming with the receptacle an enclosure which contains the pouch and / or which contains the sensor, - The preparation unit also includes a preparation station configured to receive the bag, - The preparation station includes an indicator to inform a user of the duration for which the support position must be maintained. - The electronic device includes an indicator to inform a user of the duration for which the support position has been maintained. - The preparation station is configured to charge a battery from an electronic device included in the preparation set, - the preparation station further includes at least one support cover and / or includes two mechanical clips movable relative to each other in a direction of separation, - at least one mechanical clip includes an electrical charging contact. According to a second aspect, the invention relates to a sensor kit including a preparation set as defined above, the sensor kit further including a sensor comprising at least one needle, the sensor being configured so that, in the support position of the support means, the needle is partially or totally immersed in the preparation solution. Optionally and without limitation, the sensor also includes a memory configured to record recalibration information for a body analyte concentration measurement. In the latter case, one advantage is that the need to record the recalibration information in a device separate from the sensor is eliminated during calibration. According to a third aspect, the invention relates to a method for preparing a sensor for a body monitoring system, the method being implemented using a sensor kit as defined above, the method comprising a step of placing the sensor in a position interposed between the support means and the pocket, the support means being placed in a support position so that the sensor needle pierces the pocket. The preparation process according to the third aspect of the invention may optionally and without limitation have the following technical characteristics taken alone or in any of the technically possible combinations: - the support means are integrated into an electronic device which also includes a processing unit, - the processing unit is used to control the needle sensor so that the needle sensor acquires a concentration measurement of a body analyte, and / or the processing unit is used to generate an electrical current in the sensor, - The process includes additional steps of: acquisition by the sensor of a concentration measurement of a body analyte in the bag preparation solution; transmission of the measurement to the processing unit; and calculation of a recalibration signal based on the measurement, in order to calibrate the sensor, - a ready-to-wear device is inserted between the support means and the sensor, - the support means include a cover that presses against the ready-to-wear device, - the support means are maintained in the support position for a period of between 10 seconds and 2 hours, in order to press the sensor, - after the sensor preparation, the bag is discarded, and a new bag is used when preparing a separate sensor. GENERAL DESCRIPTION OF THE FIGURES Other features, purposes and advantages of the invention will become apparent from the following description, which is purely illustrative and not limiting, and which should be read in conjunction with the accompanying drawings, among which: [fig.1a] Figure 1a is a schematic illustration of the different elements of a sensor kit, the sensor kit including an electronic watch. [fig.1b] Figure lb is a schematic front view of the electronic watch shown in Figure la. [fig.2] Figure 2 is a top perspective view of a needle sensor as an example. This sensor can be used in conjunction with any of the sensor preparation assemblies illustrated in the accompanying figures. [fig.3] Figure 3 represents a sensor preparation assembly according to a first embodiment, comprising a box. [fig.4] Figure 4 represents a charging station for an electronic watch, said charging station being able to be integrated into a sensor preparation set according to a second embodiment. [fig.5a] Figure Sa is a cross-sectional view of the loading station in Figure 4, with the clips of the loading station in a close position. [fig.5b] Figure 5b is a cross-sectional view of the loading station of Figure 4, with the clips of the loading station in the spread-apart position. [fig.6] Figure 6 illustrates steps in a sensor preparation process. DETAILED DESCRIPTION OF METHODS OF IMPLEMENTING THE INVENTION The following description relates to the development of a needle sensor integrated into an electronic watch. The sensor is designed to measure glucose concentration in the wearer's interstitial fluid. The electronic watch, together with the sensor, forms a body monitoring system. By "body monitoring," we mean the verification of biochemical constants of the wearer of the monitoring system, typically the concentration of the wearer's interstitial fluid of a protein, hormone, biomarker, oxygen, nutrients, etc. A person skilled in the art will readily understand that other physical quantities can be monitored by the system, such as lactate concentration, hydration, etc. Throughout this series, the biochemical constant to monitor is the concentration of Glucose (or blood glucose) within the interstitial fluid of the skin. The blood glucose level in the interstitial fluid is considered representative of the blood plasma glucose level. It will be understood that the sensor preparation kit described below can be used, with the same advantages, to prepare a sensor intended to measure another biochemical parameter. Furthermore, the sensor needle(s) could be designed to be inserted into a body fluid other than interstitial fluid, for example, into blood. Furthermore, the wearable device, as described below, is an electronic watch configured to display information to its wearer. However, the sensor preparation kit described below can be used, with the same advantages, in conjunction with any other type of wearable device: bracelet, tracker, etc. Throughout all the attached figures and the description below, similar elements bear identical numerical references. hi led'. ble di ion de Figure 1a schematically represents a sensor kit 1 as an example. Kit 1 includes a sensor 30 intended for the routine monitoring of an individual's blood glucose. The sensor 30 is designed to provide an electrical current measurement within the interstitial fluid. Kit 1 also includes a sensor preparation kit. In this example, the preparation kit includes, among other things, an electronic watch, intended to be worn on the wearer's wrist. The preparation set includes support means 24, a pocket 26 and a receptacle 28, examples of whose structure will be described below. Pocket 26 contains a volume of a sensor preparation solution. In this example, the preparation solution is a calibration solution, exhibiting a volume concentration of a body analyte equal to a predetermined reference value. It is recalled that, in this example, the body analyte to be analyzed is glucose, and the measurement provided by sensor 30 is representative of blood glucose. Thus, the solution contained in bag 26 has a precisely known glucose concentration. This concentration is advantageously between 2 millimoles of glucose per liter and 20 millimoles of glucose per liter, more preferably between 6 millimoles of glucose per liter and 10 millimoles of glucose per liter. Alternatively, the preparation solution contained in pocket 26 can be a pre-wetting solution, i.e., a solution that replicates the chemical nature of the body fluid into which the sensor 30 is intended to be inserted (namely (the interstitial fluid here). Pre-wetting involves moistening a portion of the chemical or biochemical materials (such as active enzymatic elements) that enable electrochemical measurement, contained, for example, on the upper layers of needles 32. These chemical elements typically include active enzymatic elements. Pre-wetting accelerates the subsequent transfer of electrical elements between all the chemical layers and the human body fluid (e.g., the interstitial fluid) once the needle sensor is in place. One advantage of pre-wetting sensor 30 during sensor preparation is that it accelerates the convergence of subsequent sensor measurements in the body fluid. This allows the sensor to reach an operational state more quickly. The preparation solution is here in the form of a gel. Alternatively, the preparation solution can be a liquid solution. It should be noted that pocket 26 can contain a solution which serves, among other possible uses, as a calibration solution and a pre-wetting solution. Whatever form is chosen for the preparation solution contained in bag 26, the bag preferably also includes a cover that surrounds the volume of preparation solution, to allow transport and handling of bag 26. The pocket 26 is perforable, so that a needle 32 from the sensor 30 can reach the preparation solution. If a casing is present, it is at least partially perforable. The pouch 26 is positioned on a surface of the receptacle 28. The surface on which the pouch 26 is positioned is preferably quite rigid, so as to offer resistance to penetration by a needle. Thus, a needle pressed towards the receptacle 28 can pierce the pouch 26. For example, pocket 26 is arranged on a flat surface of receptacle 28. The receptacle 28, for example, has a dome shape, with a flat surface for receiving the pocket 26 and one or more edges for gripping the dome. The pouch 26 can here be separated from the receptacle 28. However, the receptacle 28 can alternatively be joined to the pouch 26. In addition, the sensor preparation set included in kit 1 includes support means 24 which are used to press the sensor 30, so that the sensor 30 pierces the pocket 26. The needles 32 of the sensor 30 are at least partially immersed in the volume of preparation solution. In this example, the support means 24 include the watch 10 and a cover that presses against the electronic watch. Thus, in Figure 1a, the electronic watch case is interposed between the cover and the sensor. It should be noted that the support means could include only a cover, configured to press the sensor 30 against the receptacle 28. Alternatively, the means of support could consist solely of the watch. The support means 24 are movable relative to the receptacle 28, from a relaxed position to a support position, along a direction A. In the relaxed position, the sensor area which carries the needle 32 is distant from the pocket 26. The needle 32 does not pierce the pocket 26 in the relaxed position of the support means. In the support position of the support means, the sensor area which carries the needle 32 is closer to the pocket 26, so that the needle 32 pierces the pocket 26. The support means 24 in the support position preferably cover the sensor 30. To be brought from their relaxed position to their support position, the support means 24 can be manipulated by the user, for example with the hand, and / or be actuated by an additional device which may be an electronic device. The support means in the supported position can then be returned to the released position. The pressure of the sensor 30 on the pocket 26 is then released. Advantageously, the support means can be actuated in a direction opposite to direction A by means of return. Figure 1a schematically illustrates a state of kit 1 in which the support means are in the relaxed position. The needles 32 are distant from the pocket 26. In Figure 1a, the relaxed position corresponds to a high position of the support means and the sensor. Depending on the orientation of this figure, a support position of the support means 24 corresponds to a lower position of the support means and the sensor. The support means 24 are preferably separate from the receptacle 28 and the pouch 26. Furthermore, if the support means 24 have a cover as in kit 1 of Figure 1a, said cover and the receptacle 28 preferably have complementary shapes. Thus, when the cover is pressed against the receptacle, the sensor 30 easily pierces the pouch 26 without the need for additional manipulation. In one possible embodiment, the sensor preparation assembly includes a film that covers the pocket 26 and / or that covers the sensor 30. The film is preferably disposed on the receptacle 28, and is typically attached to edges of the receptacle 28. The film can thus delimit, with the receptacle 28, a package or "sterile pack" containing the pouch 26 and / or the sensor 30. Such a film is not shown in Figure 1a. An advantage of this design is that the pouch 26 and the sensor 30 are separated from the external environment until use, and are easily stored and transported. The film in question is preferably a peelable film. Thus, the user wishing to prepare the sensor 30 can easily remove the peelable film to expose the pocket 26, and then prepare the sensor 30. Optionally, sensor kit 1 also includes a base. The receptacle 28 is itself placed in the base. Here, the base has dimensions close to those of the lid. The base and lid together thus form a box. It should be noted that, in one possible variant, kit 1 does not include any means specifically dedicated to supporting the sensor. The user then uses their hand directly to bring the needles 32 into the pocket 26, by pressing in the direction A: Electronic watch Figure 1b schematically represents a watch 10 as an example. The watch 10 includes, in particular, a case 12, a strap 13, and a display 16. The watch 10 is a ready-to-wear device, thanks to the strap 13 which allows it to be attached to the user's wrist. The strap 13 is preferably adjustable. The watch 10 is an electronic watch. The case 12 houses the electronics necessary for the watch's operation, in particular for controlling operations related to monitoring the user's blood glucose levels. As such, the watch 10 includes a processing unit 14. The processing unit 14 includes, for example, one or more processors contained within the case 12, and allows, in particular, the management of data acquisition for the measurement of the concentration of the body analyte. The processing unit 14 is intended to be connected to the sensor 30, once the sensor 30 is inserted into the watch 10. Computer code instructions for controlling the sensor 30 are pre-recorded in the processing unit 14. The watch 10 is thus configured to acquire a glucose concentration measurement using the sensor 30. The watch 10 preferably also includes a memory configured to save the glucose concentration measurements thus acquired. The processing unit 14 is further configured to control the display of information on the screen 16. The information displayed preferably includes time information and / or blood glucose monitoring information. The watch 10 may, in particular, have a structure conforming to the watch described in document WO 2018 / 104647.Such a watch comprises two modules that can be separated from each other; the first module includes the case body attached to the strap and the control electronics, and the second module is formed by an interchangeable removable capsule containing the hand sensor. The two modules have complementary shapes and are connected by a preferably separable mechanical link. As an alternative to an electronic watch such as the Watch 10, a body monitoring system may include, as a wearable device, a watch without a screen (commonly referred to as a "tracker"), or an electronic bracelet with or without electronic display elements. A tracker typically provides sports data and / or vertical positioning data (e.g., for the elderly) and / or GPS positioning data (e.g., for monitoring young children) and / or data for analyzing medical variables. More generally, a body monitoring system can include any ready-to-wear device that can be positioned in regular contact with the skin. Advantageously, the watch 10 also includes a wireless communication interface, for example via a 3G and / or 4G and / or 5G and / or Wi-Fi and / or Bluetooth and / or NFC and / or DECT type telecommunications network. Advantageously, the watch may include a light indicator such as an LED, which can be used to signal the end of a sensor preparation operation. A ready-to-wear device such as the 10 watch, equipped with a 30 sensor, is an example of a body monitoring system that allows monitoring of an individual's blood glucose levels. Here with micro-needle Figure 2 illustrates a 30 sensor usable within kit 1, as an example. Sensor 30 is a needle sensor designed to provide an electrical current measurement within the interstitial fluid of the wearer of watch 10. The needles 32 are advantageously "micro-needles". Sensor 30 preferably comprises between four and fifty micro-needles. It should be noted that a needle sensor in a body monitoring system can have any number of needles, starting from a single needle. A "microneedle" is defined as a needle of short length, preferably between 10 micrometers and 1 millimeter, and more preferably between 300 micrometers and 800 micrometers. In the following text, microneedles are referred to simply as "needles" for ease of reading. However, needles other than microneedles may also be used as alternatives. The length of the hands 32 is thus reduced to avoid contact with a nerve of the user, to limit the pain caused by wearing the watch 10. Each needle here has a pyramidal shape. The 32 needles are arranged to form a network of needles. In this example, each needle 32 comprises on its surface at least one chemical or biochemical material capable of reacting with the bodily analyte from which one wishes to obtain a measurement (i.e., in this case, glucose). A material capable of reacting with the body analyte is, for example, an enzyme capable of oxidizing the body analyte. In an alternative example, each needle 32 includes an internal cavity located at the rear of the tip, and the chemical or biochemical material suitable for reacting with the analyte is located in this internal cavity. In another alternative example, the sensor 30 may include cavities located at the rear of the needles 32, and / or within the needles 32. For example, one or more needles 32 may include an open channel. The cavities contain the chemical or biochemical material capable of reacting with the analyte. The needles 32 are then capable of conveying the body fluid to said cavities. The sensor 30 illustrated in Figure 2 comprises, in addition to the needles 32, a substrate 34 having a plurality of metallic tracks 340, a working conductivity electrode 360, a reference conductivity electrode 362 and a central opening 38. During the use of the sensor 30 to perform a measurement, a voltage is generated between several needles. At least some of the needles 32 of the sensor 30 are at least partially immersed in the interstitial fluid. The chemical or biochemical material present on the surface of the needles 32 reacts with the glucose in the interstitial fluid. The sensor 30 thus provides an electrical current measurement, representative of the glucose concentration in the interstitial fluid. The substrate 34 and the needles 32 are preferentially arranged on a single face of the sensor 30, which is the face directed upwards according to the orientation of Figure 2. This upper face is intended to be positioned facing the user's skin. Each needle extends from the upper face in a Z direction, from its base to its tip. The Z direction is preferably orthogonal to a plane of the upper face. When the sensor 30 is placed under the support means 24 for preparation, this upper face is positioned facing the pocket 26. A movement of the support means towards the support position causes the pocket 26 to be pierced by the needles 32. The central aperture 38 is circular in shape. The sensor 30 thus has, in this example, a generally annular shape. For a detailed example of the structure of sensor 30, reference may be made to the international application published under number WO 2020 / 025822 and in particular to the description relating to Figures 1 and 2 of this document. Preferably, the sensor 30 is integrated into a removable capsule. The removable capsule is designed to be accepted into the ready-to-wear device, here in the case 12 of the watch 10. The capsule can be coupled to the case 12 by mechanical coupling. The capsule is inserted into the back of the case 12. The case 12 and the capsule can to present complementary shapes, which limits the effort required for proper insertion of the capsule against the casing. A support for the sensor 30 (for example, the removable capsule) preferably includes a patch (not shown) that attaches to the user's skin. The patch has an adhesive layer or is itself made of an adhesive material. The patch thus allows the capsule to be attached to the wearer's skin and helps retain the needles 32 in the interstitial fluid. The patch may, for example, have an annular shape and cover the capsule. The 30 sensor is intended to be controlled by the 14 processing unit of the 10 watch. In one possible variant, the sensor 30 includes a memory, configured among other things to store recalibration information. The recalibration information can then be stored in the sensor 30 after transmission by a processing unit integrated into the watch 10, during a calibration process of the sensor 30. Example l = Di-ion box According to a first embodiment, at least part of the support means 24 of the sensor preparation assembly is integrated into a box. Figure 3 illustrates a sensor preparation assembly according to this first embodiment, comprising a box 20. The box 20 includes a lid 240 forming the upper face (according to the orientation of Figure 3), and includes side faces 22 and a lower face 242. The box 20 is generally parallelepiped in shape. Preferably, the pouch 26 and the receptacle 28 are received in an internal space formed inside the box 20. When the sensor 30 is placed opposite the pouch 26 for preparation, the sensor 30 is also received in the internal space of the box 20. The receptacle 28 is either disposed against the lower face 242 or fixed to said face. In either case, the receptacle 28 is preferably received in a central part of the internal space of the box 20. The cover 240 is integrated into the support means 24. In a simple embodiment, one attachment edge of the cover 240 is fixed to a side face 22. The other edges are free, to allow the cover 240 to pivot in the direction R. In one possible variant, at least one side face 22 includes, on an upper edge left free by the cover 240, a recess 200 for the placement of a ready-to-wear device. The recess 200 is, for example, a concavity formed by material removal. Part of the ready-to-wear device—for example, the watch case 12 10—can then be stably interposed between the cover 240 and the pocket 26. If the desired ready-to-wear device is a watch, it is particularly advantageous for housing 200 to be complementary to the watch strap 13. The strap 13 is placed inside housing 200, in a transverse position relative to the plane of housing 200. Preferably, the case 20 comprises two compartments 200 placed opposite each other on two opposing lateral faces 22, these faces being located on the sides of the attachment edge of the cover 240. One advantage is that it stabilizes the bracelet 13 on either side of the case 12 The housing can also be provided to stabilize the receptacle 28 on which the pocket 26 is placed. A wedge (not shown) can be provided in the internal space of box 20, and / or in the internal space of housing 200, for example to ensure that the ready-to-wear device remains in place after its insertion into the box. The cover 240 advantageously includes a window 241. The window 241 is made of a transparent or semi-transparent material. The window 241 advantageously has dimensions similar to or slightly larger than the dimensions of the screen 16, and extends in front of the screen 16 when the watch 10 is received in the box 20. Thus, information displayed on screen 16 remains visible when the watch 10 is placed in the closed box 20. In another possible variant, the 200 housings can be omitted. Indeed, it is not necessary to use a watch part 10 or any other ready-made device as a support. It is possible to bring the hands 32 and the pocket 26 into contact by directly pressing the cover 24 against the sensor 30. The lower face 242 is preferably fixed and flat. The box 20 can thus be easily positioned on a flat surface. The box 20 is preferably made of a lightweight and easily formable material, such as a polymer. The sensor preparation assembly shown in Figure 3 is very easy and quick to use. The user does not need to directly manipulate the hands 32 of the sensor 30. For example, they remove the watch 10 and place the sensor to be prepared inside the watch 10, then close the cover 240 over the watch 10 and the sensor. There is no risk of injury to the user. Another advantage of the sensor preparation assembly in Figure 3 is that box 20 does not require a power supply. In the example shown, box 20 does not contain any electronic components. In one possible variant, however, box 20 can be powered by electrical current, for example if box 20 includes a light indicator such as a diode to inform the user of the duration of the support position. In addition, the 20 box forms a packaging device which is easy to store and transport. In one possible variation, the lid 240 of box 20 can be omitted. This results in a box open at the top. Supporting means can then be used either a part of a ready-to-wear device, a mechanical actuator of the ready-to-wear device, the user's own hand, or any other means. Example 2 — Electronic watch charging station According to a second embodiment, at least part of the support means for the sensor preparation assembly is integrated into a loading station. A loading station 40 usable for preparing a needle sensor, for example for preparing sensor 30, is illustrated in Figure 4, Figure Sa and Figure 5b. Figure 4 is a top view of the charging station 40 into which the case 12 of the watch 10 is inserted. Figures Sa and 5b are sectional views along the section plane CC of Figure 4. In these figures, the housing 12 is coupled with a sensor 30. The station 40 constitutes a complementary "dock" with the housing 12. A housing reception space is formed on top of a central area of ​​the station 40. Preferably, the housing reception space is formed between two mechanical clips 44 of the station 40. Here, the housing reception space is adapted to receive the housing 12. Station 40 further includes at least one mechanical clip for pressing housing 12, here two lateral mechanical clips 44. Housing 12, in conjunction with the mechanical clips 44, provides support for sensor 30 against pocket 26. The mechanical clips 44 are movable between a spread-open and a close-closed position. The position shown in Figure 4 and Figure Sa is a close-closed position. The position shown in Figure Sb is a spread-open position. Depending on whether the mechanical clips 44 are in a close or spread-open position, the housing 12 either presses or does not press the sensor 30 towards the pocket 26. Thus, station 40 acts as a preparation station for sensor 30. Station 40 is designed to receive receptacle 28 below housing 12, and pocket 26 below sensor 30. For readability of the figures, the receiving area of ​​receptacle 28 and pocket 26 is not shown in Figures 4, 5a and 5b. The receptacle 28 and the pouch 26 are removable from the station 40. Alternatively, the receptacle 28 is fixed to the station 40. Alternatively still, a surface of the station 40 acts as a receptacle; thus, the pouch 26 is directly located on station 40 and is not supported by a structural element separate from the station. Alternatively, the mechanical clips 44 can be omitted. A cover can be used to support the housing 12 against the sensor 30, or the user can be asked to directly support the housing. It may be required that the user position the housing 12 in the receiving space, and press on the housing 12 to press the sensor. In cases where sensor preparation includes pre-wetting and pre-calibration, the needles 32 can be pressed into the pocket 26 for a period of 1 to 120 minutes to perform the pre-wetting. The indicator 42, or alternatively, an indicator on the wearable device, can be activated to notify the user when pre-wetting is complete. Following pre-wetting, the sensor 30 is pre-calibrated. Alternatively, the pre-calibration is performed before the needles are pre-wetting. In both cases, the time required for pre-calibration (for example between 10 seconds and 2 minutes) is generally much shorter than the time required for pre-wetting (for example between 1 minute and 120 minutes). Returning to Figure 4, the mechanical clips 44 and the housing 12 are aligned on a median plane of the station 40. A longitudinal axis L of the station 40, shown as a dashed line in Figure 4, is orthogonal to the median plane. Preferably, the lateral edges of each of the mechanical clips 44 are aligned with the lateral edges of the housing 12. In their close position, each of the mechanical clips 44 is positioned longitudinally between two blocks 48 of the station 40. The mechanical clips 44 are mobile relative to the blocks 48, so as to move closer together or further apart. Preferably, a channel is provided in the volume of the blocks 48 (here along the longitudinal axis L) to allow the user to easily insert and grasp the housing 12 when the mechanical clips 44 are in a spread position. Station 40 advantageously includes an actuator (not shown), preferably electric, for controlling the spacing or bringing together of the mechanical clips 44. The actuator is, for example, a push button that the user can operate to switch the position of the mechanical clips 44 between the close and spread positions. According to another option, the mechanical clips 44 are switched between the closed and open positions by slight pressure from the user. The mechanical clips 44 may emit a "click" and change position. Preferably, station 40 also includes an indicator 42 to inform a user of the duration for which the support position of the housing 12 and the clips must be maintained. Mechanics 44. The indicator 42 is placed on a top surface of the station 40. The indicator 42 is here a diode. Figures Sa and 5b further illustrate respectively the close and distant position of the mechanical clips 44. As can be seen in Figures Sa and 5b, a height of each of the mechanical clips 44 is equal to a cumulative height of the housing 12 and a lower portion 480 of the station 40. Each mechanical clip 44 is mounted to pivot about its own axis 45. Here, the two axes 45 extend orthogonally to the cutting plane CC. Thus, the mechanical clips 44 are free to rotate along the cutting plane CC. Preferably, the two mechanical clips 44 are symmetrical with respect to a longitudinal plane of the loading station, i.e. here with respect to the plane orthogonal to the cutting plane CC passing through the longitudinal axis L. Each mechanical clip 44 has, on one upper end, a concavity adapted to receive one side of the housing 12. In this example, each mechanical clip 44 comprises a tip 442 at a distal position and a tooth 440 at a medial position, with the tip 442 and tooth 440 extending inwards. A receiving concavity is formed between the tip 442 and the tooth 440. In the close-up position shown in Figure 5a, the two mechanical clips 44 are in contact with the housing 12 and exert a Z-shaped pressure on the housing 12. The sensor 30, located under the housing 12, is pressed towards the pocket 26 positioned below the sensor. The prongs 442 prevent accidental removal of the housing 12. In an alternative embodiment, the mechanical clips can be configured to provide Z-axis support directly on the sensor 30 itself. In this case, it is not necessary to insert the ready-to-wear device into the station 40 during pre-calibration of the sensor 30. In the extended position of Figure 5b, the two mechanical clips 44 are not in contact with the housing 12. The housing 12 can be extracted from the station 40. Optionally and advantageously, at least one mechanical clip 44 (here the right-hand mechanical clip) includes an electrical contact 46, disposed on a contact surface with the housing 12. Preferably, the electrical contact 46 is disposed on a lateral contact surface with the housing. The electrical contact 46 is here disposed on the tooth 440. Station 40 is configured to supply electrical current to a battery (not shown) of the watch 10, via electrical contact 46. The watch 10 includes, for this purpose, a watch contact 18 designed to cooperate with electrical contact 46. In the close-up position shown in Figure 5a, the watch contact 18 is against the electrical contact 46 of station 40. Furthermore, sensor contacts 15 are provided in the housing 12, in order to electrically connect the electronics of the housing 12 and the sensor 30. The sensor contacts 15 allow the housing 12 not only to supply electrical current to the sensor 30, but also to exchange data with the sensor 30. It should be noted that, alternatively or in combination, the housing 12 and the sensor 30 can each include a wireless communication interface, such as an NFC interface. Alternatively, separate and mechanically independent electrical contacts from the mechanical clips 44 are provided in the charging station, for charging the battery. Station 40 is itself powered by current, preferably by a power cord 482, one end of which includes an electrical plug and the other end of which is fixed to the lower portion 480. Station 40 is therefore preferably both a sensor preparation station and a watch electrical charging station. The screen 16 of the watch 10 is directed outwards from the station 40. Thus, indicative information about battery charging and / or sensor preparation operations can be displayed on the screen 16 during the use of the station 40. Station 40 has a U-shaped appearance when viewed from above. Alternatively, station 40 has a parallelepiped shape, or any other shape. The functions of electrically charging a battery of the wearable device on the one hand, and of preparing the needle sensor of the wearable device (in particular of calibrating said sensor) on the other hand, can thus be fulfilled by the same station 40. This reduces the number of equipment that the user has to group and keep together to operate the body monitoring system. Alternatively, station 40 prepares sensor 30 completely autonomously, without involving the watch 10. Station 40 then incorporates the necessary electronics to perform, for example, a pre-calibration measurement and recalibration as described below. One possible option is to directly press the hands 32 inside the pocket 26 by pressing on sensor 30 via the mechanical clips 44, or via any other mechanical actuator. In an alternative example (not shown in the accompanying figures), the sensor preparation assembly includes a receptacle itself equipped with some of the support means. For example, the sensor support means include the housing 12 and lateral clipping edges of the receptacle 28, suitable for locking the housing 12 in the position of support against the sensor 30. One advantage of this last example is that it omits the need for an additional component. a container, such as a box or a preparation station. Furthermore, since the shape of the housing 12 is simple, it is easy to manufacture a receptacle with complementary clip edges to the housing. Sensor preparation process — Example of sensor pre-calibration Figure 6 illustrates the steps of a 50 process for preparing a needle sensor for a body monitoring system, according to an example in which sensor preparation includes a "pre-calibration" of the sensor. "Pre-calibration" refers to a calibration operation of the measurement provided by the needle sensor, which takes place at the beginning of the sensor's usage cycle. The sensor pre-calibration corrects for any drift in the electrical current measurement provided by the sensor needles 32. The needles 32 are immersed in a volume of calibration solution contained in the pouch 26. Since the concentration of the body analyte (here, glucose) in the calibration solution is known, the expected electrical current measurement value is also known. A correction to the electrical current measurement, or "drift correction," is thus performed based on the expected electrical current measurement value. Pre-calibration is advantageously performed immediately before inserting the sensor (preferably new) into a ready-to-wear device. In this example, sensor 30 undergoes pre-calibration before being inserted into watch 10. Sensor 30 may or may not have undergone a "factory calibration" prior to pre-calibration. It should be noted that a factory calibration, performed after the production of a batch of needle sensors, involves either inscribing an alphanumeric code on the sensor packaging or integrating a string of characters representing said code into the sensor's memory. The alphanumeric code can be recognized by an electronic device equipped with a nomogram, where the alphanumeric code is associated with a reference value for the concentration of a body analyte. It should be noted that a needle sensor preparation process does not necessarily involve calibrating a measurement provided by the sensor. Sensor preparation may simply involve wetting the needle, specifically a "pre-wetting" to accelerate the subsequent convergence of the measurement provided by the sensor. Sensor preparation may also include, in combination, pre-wetting and pre-calibration. One advantage of the sensor preparation assemblies described above is that they allow simultaneous wetting and calibration, by means of immersing at least one needle 32 in the volume of the pocket 26. At an optional step 100, the peelable film, if present on the receptacle 28, is removed. The pouch 26 received in the receptacle is then exposed to the air. In the Insofar as the receptacle 28 preferably also includes the sensor 30 before removal of the peelable film, the sensor 30 is preferably also exposed to the air after removal of the film. Step 100 can be carried out while the receptacle 28 is already positioned facing the support means 24, or beforehand. Next, the sensor 30 is placed at step 200 in a position between the support means 24 and the pouch 26. In the sensor example in Figure 2, the upper face bearing the needles is positioned opposite the pouch containing the preparation solution. The needles 32 then face the pouch 26. In a preferred case, the sensor 30 is integrated into a removable, interchangeable capsule. The removable capsule is placed in the ready-to-wear device, here on the back of the housing 12, prior to step 200. As examples, the sensor placement can be done as follows: - if the sensor preparation assembly conforms to Figure 3, the cover 24 is opened and the sensor 30 is placed above the receptacle 28 in the box 20; - if the sensor preparation assembly conforms to Figure 4, the mechanical clips 44 are placed in the spread position, the receptacle 28 is placed in the receiving space and the sensor 30 is placed above the receptacle 28. Next, the support means are placed in the support position so that at least one needle, preferably a plurality of needles 32, pierce the pocket 26 and are at least partially immersed in the calibration solution. Preferably, the needles are totally immersed in the solution. It is recalled that the support means are for example formed of the cover 24 in combination or not with the watch case, or of the mechanical clips 44 in combination or not with the watch case. Preferably, the support means are maintained in their support position for a period of between 10 seconds and 2 hours. The immersion time of the needles 32 is thus sufficient to carry out a pre-calibration measurement and recalibration, according to steps 300 and 410 described below, and / or to carry out pre-wetting of the needles 32. The duration for which the support means are held in the support position is preferably between 1 and 120 minutes, particularly in the case of pre-wetting. Alternatively, the duration for which the support means are held is advantageously between 10 seconds and 2 minutes in the case of pre-calibration performed alone. It should be noted that the watch 10 is not necessarily used for steps 200 and 300. For example, a sensor preparation assembly as shown in Figure 3 may include a cover 24 capable of pressing the hands 32 into the pocket 26, without the watch 10. Thus, even if the holding time of the support means is long, The user can continue normal use of the watch 10 during sensor preparation. To perform the pre-calibration of sensor 30, process 50 includes additional steps 300 to 410. At step 300, sensor 30 is commanded to acquire a measurement of the concentration of a body analyte, here the concentration of glucose, of the preparation solution contained in bag 26. The sensor 30 is preferably controlled by the processing unit 14 contained in the case 12 of the watch 10. Alternatively, the sensor 30 is controlled by a processing unit of another electronic device, for example a processing unit of a calibration station (such as the station 40 described above). The measurement acquired can be described as a "pre-calibration measurement". At step 400, the pre-calibration measurement is transmitted to the processing unit of the electronic device. In this example, the sensor 30 is already in place on the housing 12 and can exchange data with the housing 12 during the measurement. Alternatively, the pre-calibration measurement can be saved in an electronic memory embedded in the sensor 30, for later reading by the wearable device. Alternatively still, the pre-calibration measurement is saved in the memory of another device (for example, the memory of the station 40), and then transmitted to the wearable device via wired or wireless communication. In step 410, a recalibration signal is calculated. The recalibration signal is preferably obtained from the pre-calibration measurement and from the reference value of the body analyte concentration in the calibration solution. For example, if the reference value for glucose concentration is 10 millimoles per liter, and if the electrical current measurement acquired by sensor 30 at step 300 corresponds to a concentration of 9 millimoles per liter, then the recalibration signal includes code instructions for rectifying the measurement until it matches 10 millimoles per liter. In other words, the glucose concentration in the calibration solution of bag 26 is used as a reference to recalibrate the measurement provided by sensor 30. The recalibration signal is saved, so that recalibration is carried out automatically during subsequent measurements supplied by sensor 30. Preferably, the recalibration signal is recorded in a memory of the watch 10, in association with a reference of the capsule containing the sensor 30. The capsule reference is, for example, an alphanumeric code assigned to the capsule, at the end of the capsule production. Once the recalibration signal has been calculated and saved by the watch, an indicator The watch's display can be illuminated to indicate the end of the pre-calibration operation. In particular, the preparation kit illustrated in Figure 3 includes a transparent or semi-transparent window 241 that allows the user to see the end of the pre-calibration operation when the cover 24 is closed. Alternatively, the recalibration signal is stored in a sensor memory. At the end of step 410, the support position of the support means is released and the sensor 30 is freed. The sensor 30 can then be moved and integrated into a ready-to-wear device during an optional step 500, if its integration into the ready-to-wear device has not already been carried out previously. After sensor preparation (including, for example, pre-calibration and / or pre-wetting), bag 26 is preferably discarded. A new bag 26 is preferably used for each subsequent iteration of the sensor preparation process 50 to ensure complete sterility of sensor 30. Such a pre-calibration process is particularly useful when replacing the interchangeable removable capsule containing the sensor. A new removable capsule containing a non-pre-calibrated sensor 30 is, for example, inserted into the back of the case 12. Then, a sensor preparation kit, according to one of the examples described above, is used to, among other things, pre-moisten and pre-calibrate the sensor 30. One advantage is that the new removable capsule is already inserted into the watch 10 after the sensor preparation. Method 50 thus makes it possible to correct the potential drift of the electrochemical measurement provided by a needle sensor in a body monitoring system. Recalibrating the sensor measurement is simple, quick, and reliable. It is advantageous to perform the measurement recalibration and the pre-wetting of the sensor needles simultaneously or sequentially, which is made possible by the sensor preparation kits described above. Furthermore, the sensor measurement recalibration can be carried out simultaneously with the charging of a battery of the ready-to-wear device, as seen above. Pre-calibrating the sensor increases the reliability of the measurement provided by the sensor. In this example, pre-calibrating the sensor, possibly combined with a factory calibration at the end of production, ensures satisfactory accuracy of blood glucose measurements throughout the wearable device's usage cycle.

Claims

Demands

1. Sensor preparation assembly (30) DC monitoring system bodily, the sensor (30) comprising at least one needle (32), The preparation kit includes: - a bag (26) containing a volume of a preparation solution, the pocket (26) being configured to be positioned under the sensor (30) and being piercable by the needle (32), - a receptacle (28) on which the pouch (26) is placed, - means (24) of mobile support relative to the receptacle (28) towards a support position, the means (24) of support in the support position being configured to cause the sensor (30) to pierce the pocket (26).

2. Assembly according to claim 1, wherein the pre- solution paration is a calibration solution with a concentration volume in a body analyte equal to a predetermined reference value Done.

3. The set according to claim 2, wherein the body analyte is from glucose, and in which the predetermined reference value is between 2 millimoles of glucose per liter and 20 millimoles of glucose per liter, preferably between 6 millimoles of glucose per liter and 10 millimoles of glucose per liter.

4. Assembly according to claim 1, wherein the pre- solution paration is a pre-wetting solution.

5. Assembly according to any one of claims 1 to 4, comprising in addition an electronic device (10), the electronic device (10) being preferably configured to control a concentration measurement in a body analyte via the sensor (30) and / or configured to generate an electric current.

6. Assembly according to claim 5, wherein the electronic device includes a ready-to-wear device, preferably a watch or a electronic bracelet or tracker.

7. Assembly according to any one of claims 5 or 6, in which the electronic device (10) comprises at least one processing unit (14) and a memory, configured to record and manage an in- formation of a calibration curve for an analyte concentration measurement bodily.

8. Together according to any one of claims 5 to 7, in which a part of the electronic device (10) forms the support means (24) or is part of the support measures.

9. Assembly according to any one of claims 1 to 8, in which The support means include a cover.

10. | Together according to any one of claims 1 to 9, comprising a box (20), at least part of the support means (24) being integrated into the box (20), the pocket (26) and the receptacle (28) being preference received in the box (20).

11. Assembly according to claim 10, wherein the box (20) comprises at least one dwelling (200) configured to have stable the receptacle (28) or a ready-to-wear device in the box (20).

12. | Assembly according to any one of claims 1 to 11, in which the support means include at least one mechanical clip (44) configured to perform a Z-shaped press on the sensor (30) or on a part of an electronic device (10).

13. Assembly according to any one of claims 1 to 12, comprising in addition a peelable film, the peelable film forming with the receptacle (28) an enclosure which contains the pocket (26) and / or the sensor.

14. Assembly according to any one of claims 1 to 13, comprising in addition a preparation station (40) configured to receive the pocket (26), the preparation station (40) preferably comprising a indicator (42) to inform a user of a maintenance time of the support position.

15. Assembly according to claim 14, wherein the pre- station (40) The assembly also includes a support cover and / or at least two mechanical clips (44) movable relative to each other in one direction spacing.

16. Sensor kit including a sensor preparation set according to any one of claims 1 to 15, the sensor kit including in in addition to a sensor (30) comprising at least one needle (32), the sensor (30) being configured so that, in the support position of the means (24) of support, the needle (32) either partially or totally immersed in the preparation solution.

17. Kit according to claim 16, wherein the sensor comprises a unit processing and memory, configured to record and manage a information on recalibrating an analyte concentration measurement bodily.

18. Method for preparing a sensor (30) for a monitoring system bodily, the process being implemented using a sensor kit according to any one of claims 16 or 17, the process including a step of placing (200) the sensor (30) in a positioned between the means (24) of support and the pocket (26), the support means (24) being placed in a support position such that the needle (32) of the sensor (30) pierces the pocket (26).

19. A preparation method according to claim 18, wherein the support means (24) are integrated into an electronic device (10) which includes in addition a processing unit (14).

20. | Preparation process according to claim 19, the process comprising additional steps of: - acquisition (300) by the sensor (30) of a concentration measurement in a body analyte in the bag preparation solution (26), - transmission (400) of the measurement to the processing unit (14), - calculation (410) of a recalibration signal as a function of the measurement, so to calibrate the sensor (30).

21. A preparation method according to any one of claims 18 to 20, in which a ready-to-wear device is inserted between the means support (24) and the sensor (30), the support means (24) comprising preferably a lid that presses on the ready-to-wear device.

22. Preparation method according to any one of claims 18 to 21, in which the support means (24) are maintained in the position pressing the button for a period of between 10 seconds and 2 hours, in order to to press the sensor (30).