Body monitoring device sensor preparation kit

Abstract

The invention relates to an assembly comprising a capsule (10) of a device (1) for monitoring a body analyte, the capsule (10) comprising a sensor (3) configured to provide a measurement of body analyte concentration, the sensor (3) comprising a sensor surface (31) and at least one needle (5) attached to the sensor (3) on the sensor surface (31), the capsule (10) further comprising a patch (4) supporting the sensor (3), the patch (4) covering at least part of the sensor surface (31), a portion of the patch (4) defining an opening (12) in which the needles (5) of the sensor (3) are arranged, the assembly being characterized in that it comprises: - at least one first compressible spacer (9), having a first face (91) opposite the patch (4) and a second face (92) opposite the first face (91), - a pierceable pocket (40) disposed at a distance and opposite the needle (5),The assembly is such that when the needle (5) is subjected to a thrust (F) towards the pocket (40), it pierces the pocket (40), the spacer (9) being compressed; the needle (5) returns to the opposite side and at a distance from the pocket (40) in the absence of any thrust (F), the spacer (9) being decompressed. Figure for the abbreviation: Figure 3a,

Description

Title of the invention: Assembly for preparing a sensor for a body monitoring device FIELD OF INVENTION

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

[0002] The invention relates in particular to a sensor preparation assembly comprising a capsule of a body analyte monitoring device, the capsule comprising a needle sensor(s) configured to provide a body analyte concentration measurement, and a patch on which the sensor is mounted, the assembly making it possible to prepare and optionally protect the sensor. STATE OF THE ART

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

[0004] As a common example, monitoring diabetes in a patient requires an accurate daily reading of the patient's blood glucose.

[0005] One solution for monitoring diabetes is to perform a puncture, for example at the tip of the finger, to draw a drop of blood, and then to perform a daily measurement of blood glucose in the drop of blood thus obtained.

[0006] Monitoring systems have been proposed to eliminate the need for manual blood glucose sampling, thereby making blood glucose measurement less laborious and less invasive. These are known as CGM systems, for "Continuous Glucose Monitoring".

[0007] Some of these CGM systems perform regular blood glucose measurements in the interstitial fluid between skin cells. The blood glucose level in the interstitial fluid is very close to that of blood plasma. Measurements in the interstitial fluid allow for simple and minimally invasive monitoring of patients' blood glucose levels; these measurements can be performed using needle sensors, transcutaneously, or non-invasively, such as by iontophoresis or implantable with chemofluorescence measurement.

[0008] 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 by means of a strap. 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. The blood glucose measurement by the sensor is an electrochemical measurement.

[0009] The body monitoring system described in the above-mentioned document has the significant advantage of providing an autonomous calibration measurement by measuring a reference concentration of a body analyte in the user.

[0010] The number of steps the user needs to take to obtain their daily measurements is greatly reduced. In particular, the user needs to perform few manual punctures (for example, a simple weekly puncture), or even none at all. Another advantage of this system is its low hygiene risk, since the sensor needles are not in contact with the external environment once inserted into the skin.

[0011] Moreover, maintenance of the aforementioned system is simple, because to replace a faulty sensor, it is enough to remove the removable capsule and insert a new one.

[0012] However, a significant amount of time—for example, several months—may elapse between the production of the removable capsule containing the microneedle sensor and the insertion of the removable capsule into a ready-to-wear device worn by the user. Furthermore, the quality of the blood glucose measurement provided by the sensor deteriorates during such a long period of non-use of the sensor between production and its use.

[0013] The deterioration in the measurement performance of the needle sensor is explained by a drift in the electrochemical measurement over time. This drift can be due to an unsuitable ambient temperature 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.

[0014] If sudden and significant variations in the sensor temperature occur, this worsens the drift of the electrochemical measurement.

[0015] A first known method for overcoming 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 integrated into 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.

[0016] This factory calibration is known from the prior art, based on the use However, the use of nomograms does not provide complete satisfaction. Discrepancies in the electrochemical measurement provided by the sensor are still observed.

[0017] A second known calibration method, sometimes used in combination with the first, consists of calibration measurements (manual blood glucose readings) performed regularly by the user while wearing the wearable device. The calibration measurements are performed 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.

[0018] In this second method, which can be combined with the first, the user is responsible for the correct calibration of their own ready-to-wear device. Regular manual operation is required, which runs counter to one of the objectives of an autonomous body monitoring system, namely to limit the discomfort experienced by the user.

[0019] In light of the above considerations, the prior art is unsatisfactory with regard to the preparation of needle sensors for ready-to-wear devices, such as electronic watches or needle-based patches. Some known systems do not ensure sustained accuracy of electrochemical measurement, and other known systems require regular calibrations that must be carried out by the user. Description of the invention

[0020] An objective of the invention is to provide improvements for a body monitoring device comprising a needle sensor(s), so that the measurement provided by this sensor remains reliable and accurate over time.

[0021] In particular, a solution is sought to easily calibrate this sensor while minimizing any inconvenience to the user. The objective is to eliminate the need for daily manual sampling and to reduce it to at least weekly manual sampling, or even to eliminate the need for manual sampling altogether.

[0022] Consequently, it is desired that the user of the body monitoring device not be responsible for the proper calibration of said sensor during the lifecycle of the monitoring system. The need to regularly prick the finger to perform daily calibration of the sensor is to be avoided.

[0023] The solution sought must remain very simple to use, in order to ensure a pleasant user experience.

[0024] Furthermore, all this must be able to be done under conditions such that the sensor remains protected until it reaches its final destination.

[0025] In this respect, the invention relates to an assembly comprising a capsule of a body analyte monitoring device, the capsule comprising a sensor configured to provide a measurement of body analyte concentration, the sensor comprising a sensor surface and at least one needle fixed to the sensor on the sensor surface, the capsule further comprising a patch supporting the sensor, the patch covering at least part of the sensor surface, a part of the patch defining an opening in which the sensor needles are arranged, the assembly being characterized in that it comprises: at least one first compressible spacer, having a first face opposite the patch and a second face opposite the first face, a pierceable pocket disposed at a distance and opposite the needle, the assembly being such that when the needle is pushed towards the pocket it pierces the pocket, the spacer being compressed, the needle returning opposite and at a distance from the pocket in the absence of any push, the spacer being decompressed.

[0026] The invention is advantageously complemented by the following features, taken alone or in any technically possible combination thereof.

[0027] The assembly includes a rigid membrane fixed to the second face of the spacer and extending away from and in front of the needle, said membrane being configured to close the opening in order to protect the needle.

[0028] The rigid membrane is made of an elastic or semi-elastic material.

[0029] The membrane is piercable by the needle, the pocket being disposed below the membrane, the whole being configured so that when the needle is subjected to a push towards the membrane it pierces, in addition to the pocket, the membrane and returns completely into the opening opposite and at a distance from the membrane in the absence of a push.

[0030] The pocket is arranged in the opening and rests on a surface of the membrane which opens into the opening.

[0031] The spacer in compressed or uncompressed position has a thickness greater than or equal to 0.1 millimeter and less than or equal to 2 millimeters.

[0032] The spacer comprises at least a first spacer part and a second spacer part opposite to the first part, the first part and the second part preferably being disjoint.

[0033] The patch includes a peelable film between the adhesive layer of the patch and the spacer, the first face of the spacer being fixedly glued to the peelable film, the peelable film being configured to allow the peelable film, the spacer, and optionally the membrane of an outer layer of the patch to be detached.

[0034] The assembly includes a receptacle, the sensor being movable relative to the receptacle between a first position in which the needle is at a distance and in front of the pocket, the spacer being then uncompressed, and a second position in which the pocket is pierced by the needle and in which the needle is in contact with a volume of the pocket, the spacer being then compressed.

[0035] The assembly comprises at least one first support element located opposite the spacer, the first support element being configured to facilitate the compression of the spacer and the piercing of the pocket by the needle.

[0036] The assembly includes at least one second support element located opposite the pocket, the second support element being configured to facilitate piercing the pocket.

[0037] The volume of the preparation bag includes a calibration solution having a glucose concentration equal to a reference value greater than or equal to two millimoles of glucose per liter and less than or equal to 20 millimoles of glucose per liter.

[0038] The volume of the preparation bag includes a wetting solution configured to moisten active elements of the needle.

[0039] The assembly includes support means mounted on the receptacle, the support means being configured to move the sensor relative to the receptacle from the first position to the second position, the support element then acting as a counter-support.

[0040] The assembly allows the needles to be pre-moistened and the sensor to be calibrated.

[0041] The membrane protects the needles in a sterile environment as long as it remains intact before use. The needles are thus protected from potential impacts, dust, etc., present during handling of the capsule once the needles are moistened.

[0042] In addition, once the sensor is calibrated, its commissioning is simple due to the presence of the peelable film which releases the needles for insertion into the user's skin. PRESENTATION OF THE FIGURES

[0043] Other features, objectives 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 on which:

[0044] - Fig. 1 illustrates an overview of an analyte monitoring device body

[0045] - [Fig.2] illustrates a schematic view of a needle sensor according to the invention;

[0046] - Figures [Fig. 3a] and [Fig. 3b] illustrate a sensor preparation assembly according to a first embodiment of the invention in a first position and in a second position;

[0047] - Figures [Fig. 4a] and [Fig. 4b] illustrate a sensor preparation assembly according to a second embodiment of the invention in a first position and in a second position.

[0048] Throughout the figures, similar elements bear identical references. DETAILED DESCRIPTION

[0049] The following description relates to the preparation of a needle sensor integrated into An electronic watch. The sensor is designed to provide a measurement of glucose concentration within the wearer's interstitial fluid. The electronic watch, together with the sensor, constitutes a body monitoring device.

[0050] 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, a hormone, a biomarker, oxygen, nutrients, etc. A person skilled in the art will readily understand that other physical quantities can be monitored by the monitoring system, such as lactate concentration, hydration, etc.

[0051] Throughout this text, the biochemical constant to be monitored is, for example, the glucose concentration (or blood glucose) in 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 assembly described below can be used, with the same advantages, to prepare a sensor intended to measure another biochemical parameter. Furthermore, the sensor needle or needles could be designed to be inserted into a body fluid other than interstitial fluid, for example, into blood.

[0052] Furthermore, the wearable device is, throughout the following description, an electronic watch configured to display information to its wearer. However, the sensor preparation assembly described below can be used, with the same advantages, in association with any other type of wearable device: bracelet, tracker, electronic patch, electronic radio reader, etc.

[0053] General architecture of a body monitoring device

[0054] Fig. 1 illustrates a body monitoring device 1 comprising a housing 2, a sensor 3 and an adhesive patch 4.

[0055] In this case, the sensor 3 is a needle sensor intended to provide an electrical current measurement within the interstitial fluid of the wearer of the device 1.

[0056] Needles 5 are advantageously arranged on an inner face 31 of the sensor 3. This inner face 31 is intended to be placed on the skin of the wearer.

[0057] The sensor 3 is assembled with the adhesive patch 4, together forming a capsule. The sensor 3 can also be removable from the patch 4. Such a capsule is advantageously mounted as removable with the housing 2. In particular, the capsule, and therefore the sensor 3, preferably engages in a cavity 21 of the housing 2 located on its face intended to be in contact with the skin. The sensor 3 comprises an outer face 32 opposite the inner face 31.

[0058] The housing 2 and the capsule may have complementary shapes, which limits the effort required for proper insertion of the capsule against the housing 2.

[0059] The patch 4 comprises an adhesive layer, or is itself formed from a material The patch is adhesive. It allows the capsule to attach to the wearer's skin and helps retain the needles in the interstitial fluid. Patch 4, for example, has a ring shape and covers the capsule.

[0060] The sensor 3 shown here is circular with a central opening 33, but it can take other shapes: rectangular, oblong, ellipsoidal, with or without a central opening. The central opening 33 allows the sensor 3 to be correctly positioned in the cavity 21 of the housing, which includes a central positioning pin (not shown).

[0061] The sensor 3 therefore includes elements which allow the liquid to be collected or the signals detected by each microneedle to be brought to the housing 2 for processing (not described here).

[0062] The sensor 3 can take the form of a plastic plate, a printed circuit board (rigid or flexible silicon), a non-conductive metal plate such as aluminium.

[0063] The adhesive patch 4 is designed to adhere to the skin and supports the sensor 3, allowing the housing 2 to be detached without removing the sensor 3, keeping it attached to the body. This configuration avoids removing the sensor for certain operations that only involve the housing: battery charging, repair, replacement, and data extraction to a computer.

[0064] The housing 2 is advantageously in the shape of a watch case and includes means 23 for attaching the device to a user's wrist. These include a strap adapted to encircle a user's wrist. The strap is preferably adjustable.

[0065] Housing 2 contains several elements for analyzing or extracting interstitial fluid. In this regard, reference may be made to document WO 2019 / 141743 in the name of the applicant, which describes in detail the measurement and detection of a physical quantity using microneedles in contact with a bodily fluid that may or may not be sampled.

[0066] Advantageously, the watch further 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.

[0067] Also, the watch may include a light indicator such as a diode, which can be used to signal the end of a sensor preparation operation.

[0068] The needles 5 are advantageously microneedles. The sensor 3 preferably comprises between four and fifty microneedles, or even four hundred microneedles. Of course, a different number can be considered without limiting the description of the invention given here.

[0069] A microneedle is defined as a needle with a small height, preferably between 10 µm and 1000 µm, and preferably between 0.3 mm and 0.8 mm. The height of the micro The needles are small enough to avoid contact with a nerve causing mechanical pain in the wearer when the device is worn.

[0070] The microneedles 5 allow for the measurement or collection of bodily fluid.

[0071] The microneedles 5 are hollow when it comes to collecting liquid or solid to directly analyze the fluid. When it comes to collecting the fluid, the microneedles allow the extraction of interstitial fluid from the dermis painlessly without blood beading and send it to a sensor housed in the casing 2. When it comes to analyzing the fluid, the microneedles do not collect any fluid and integrate the sensor on their surface in the form of a coating such as a biochemical material capable of reacting with the analysis to be performed on the fluid.

[0072] The length of the needles 5 is thus sufficiently reduced to avoid contact with a nerve of the user, to limit the pain caused by wearing the device 1.

[0073] Each needle, for example, has a pyramidal shape.

[0074] In the present example, each needle 5 comprises on its surface at least one chemical or biochemical material capable of reacting with the body analyte from which a measurement is to be obtained (i.e., here glucose). A material capable of reacting with the body analyte is, for example, an enzyme capable of oxidizing the body analyte.

[0075] In an alternative example, each needle 5 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.

[0076] In another alternative example, the sensor 3 may include cavities located at the rear of the needles 5, and / or within the needles 5. For example, one or more needles 5 may include an open channel. The cavities contain the chemical or biochemical material capable of reacting with the analyte. The needles 5 are then capable of conveying the body fluid to said cavities.

[0077] Advantageously, the sensor 3 comprises several microneedles forming a network of microneedles in that they are electrically connected to each other in groups. The microneedles pierce the skin to come into contact with the interstitial fluid when the sensor is in contact with the skin.

[0078] The sensor 3 illustrated in [Fig.2] comprises, in addition to the needles 5, a substrate 311 having a plurality of metallic tracks 312, a working conductivity electrode 313, a reference conductivity electrode 314.

[0079] During the use of the sensor 3 to perform a measurement, a voltage is generated between several needles. At least some of the needles 5 of the sensor 3 are at least partially immersed in the interstitial fluid. The chemical or biochemical material present on the surface of the needles 5 reacts with the glucose in the interstitial fluid.

[0080] The sensor 3 thus provides an electric current measurement, representative of the glucose concentration in the interstitial fluid.

[0081] The substrate 311 and the needles 5 are preferably arranged on a single face of the sensor 3, which is the face directed upwards according to the orientation of [Fig.2]. This upper face is intended to be positioned facing the user's skin.

[0082] 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.

[0083] The central aperture 33 is circular in shape. The sensor 3 thus has, in the present example, a generally annular shape.

[0084] For a detailed example of the structure of sensor 3, 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 that document.

[0085] A support for the sensor 3 (for example the removable capsule) preferably includes a patch (not shown) attachable to the user's skin.

[0086] The sensor 3 is here intended to be controlled by the processing unit 14 of the watch 10.

[0087] In one possible embodiment, the sensor 3 includes a memory, configured among other things to store recalibration information. The recalibration information can then be stored in the sensor 3 after transmission by a processing unit integrated into the watch 10, during a calibration process of the sensor 30.

[0088] Set: capsule and pouch

[0089] The following describes an assembly comprising a capsule and a pocket for "preparing" the sensor before its use and in particular its placement in the housing 2.

[0090] Figures 3a and 3b illustrate an assembly comprising a capsule 10 and a pocket 40 according to a first embodiment shown in a first position and a second position. Figures 4a and 4b illustrate an assembly comprising a capsule 10 and a pocket 40 according to a second embodiment shown in a first position and a second position.

[0091] In particular, and as already indicated, the capsule 10 comprises, in addition to the sensor 3, the patch 4 to which the sensor 3 is attached, the patch 4 covering at least part of the surface of the sensor 3. A portion, for example the central portion of the patch 4, defines an opening 12 in which the needles 5 of the sensor 3 are arranged. A surface of the sensor 5 is considered here to be the internal surface 31 of the sensor 5, which is directed towards the wearer's skin. In Figures 3a, 3b and 4a, 4b, the patch 4 is below the sensor 3; however, the patch 4 may be above the sensor 3.

[0092] The opening 12 preferably has, in a diametrical direction, a minimum dimension greater than or equal to 2 millimeters, preferably greater than or equal to 5 millimeters. The opening 12 therefore defines a free space in which the needles 5 are arranged. The opening 12 in which the needles are positioned therefore advantageously constitutes a cavity which makes it possible to protect the needles 5 in particular if they are to be handled in view of the installation of the sensor 3 in the housing 2.

[0093] The opening 12 is advantageously closed at its lower end by a rigid membrane 7a, 7b which can be perforated. We will return to this point later. The lower part of the opening 12 is the open part. The membrane 7a, 7b closes the open part of the opening 12 and thus protects the needles 5 within the enclosure formed by the opening 12 and the membrane 7a, 7b.

[0094] A membrane is understood to be a rigid layer of material(s) which has a thin thickness greater than or equal to 0.05 mm and less than or equal to 0.50 mm.

[0095] The rigid membrane 7a, 7b is formed of a layer of elastic or semi-elastic material. For example, the membrane is made of a mesh of fine wires, the average thickness of the mesh preferably being greater than or equal to 0.05 mm and less than or equal to 0.50 mm.

[0096] Alternatively, the membrane is made of rubber, artificial skin, metal, or paper. Of course, other materials or combinations of materials are possible.

[0097] At least one compressible spacer 9 having a first face 91 and a second face 92 opposite to the first face 91 is attached to the patch 4 at the opening 12.

[0098] In addition, a pierceable pocket 40 is disposed at a distance and opposite the needle(s) 5.

[0099] According to this configuration, when the needle(s) are subjected to a push towards the pocket 40 they can pierce the pocket 40 and conversely come out of the pocket in the absence of the push F (see figures 3b and 4b on which the pocket 40 is pierced).

[0100] In particular and in a complementary manner, the spacer 9 is configured to decompress once the thrust F is released, so that the needle 4 returns to a position away from the pocket in the opening 12.

[0101] It is the compressible nature of the spacer 9 (which can be compressed) that allows the needles to pierce the pocket 40.

[0102] The spacer 9 is therefore dimensioned and configured in particular to rest on a first support element 212 opposite and to compress on this first support element 212. This first support element 212 acts as a counter-support for the spacer 9.

[0103] Advantageously, the spacer 9 has an average thickness in compressed or uncompressed position which is greater than or equal to 0.1 millimeter and less than or equal to 2 millimeters.

[0104] In addition, the thickness of the spacer 9 is chosen according to the height of the needles 5 and the thickness of the patch 4.

[0105] Preferably, the spacer 9 is made of an elastic or semi-elastic material and is, for example, a foam having elastic properties. It may also be, for example, rubber or a spring blade.

[0106] Preferably, the spacer 9 comprises at least a first part of the spacer 9a and a second part of the spacer 9b, the spacer 9 being formed of several pieces. Alternatively, the first part 9a and the second part 9b may be disjoint. Conversely, the first and second parts may be one piece. However, when the spacer consists of disjoint parts, there may be 3, 4, or even more of these parts. In all cases, the spacer surrounds the hands 5 at the opening 12, as can be seen in Figures 3a, 3b, 4a, and 4b.

[0107] The force F required to pierce pocket 40 is greater than or equal to 10 Newtons and less than or equal to 50 Newtons, preferably equal to 10 Newtons. Since 10 Newtons corresponds to 1 kg of force, this is within the reach of an elderly person or a child. In other words, it covers a large number of users. The pocket 40 and spacer 9 are therefore configured in this way.

[0108] The patch 5 comprises several layers of adhesive 8 for attaching the sensor 3 to the outer layer 41 of the patch 4. Adhesive layers also allow the spacer 9 to be attached to a peelable film 11 and the membrane 7a, 7b to the spacer 9 on its other side 92. The idea here is to be able to easily detach the spacer 9 and the membrane 7a, 7b by removing the peelable film 11 from the outer layer 41 of the patch 4, the layer that will remain after the sensor 3, the spacer 9, and the membrane 7a, 7b have been installed. It should be noted that a peelable material is defined as a surface coating that can be detached dry and without breaking.

[0109] A receptacle 21 houses the above elements and includes, in particular, a receiving surface 210 on which the support element 212 is positioned opposite the spacer 9 to facilitate its compression. Such a support element 212 takes the form of a bump projecting from the receiving surface 210 of the receptacle 21, the bump 212 being positioned opposite the spacer 9. In the case where there are several spacers, there are as many bumps as there are spacers.

[0110] The receiving surface 210 is in the lower part 21a of the receptacle 21.

[0111] An upper part 21b of the receptacle forms a lid and can be removed Position the capsule in case 2.

[0112] The receptacle 21 comprising all the elements described above and constitutes a sterile storage enclosure for the capsule in order to prepare the sensor 3.

[0113] Thus, the receptacle 21 is generally parallelepiped in shape and takes the form of a box inside which are placed the sensor 3, the patch 4 and the pocket 40. Alternatively, receptacle 21 can be a charging dock, etc.

[0114] The membrane 7a, 7b therefore protects the needles of the sensor 3 against contamination and vibration while the sensor 3 is on the patch 4, and allows in combination with the preparation bag to calibrate or pre-wet the needles when the sensor is pushed towards the bag.

[0115] In operation, the sensor 3 is mobile relative to the receptacle 21 between a first position in which the needle 5 is at a distance and opposite the membrane 7a, 7b and the pocket 40, the spacer 9 being then uncompressed, and a second position in which the membrane 7a, 7b and the pocket 40 are pierced by the needle 5 and in which the needle 5 is in contact with a volume of the preparation pocket 40, the spacer 9 being then compressed.

[0116] As such, the assembly includes support means mounted on the receptacle 21, the support means being configured to move the sensor 2 relative to the receptacle 21 from the first position to the second position, the bump 212 acting as a counter-support for the spacer 9. The support means are the cover 21b of the receptacle 21 or the housing 2, the sensor 3 then being assembled to the housing 2.

[0117] Preparation pouch

[0118] The pouch 40 (or preparation pouch) includes a volume of a sensor preparation solution.

[0119] Here, the preparation solution is a calibration solution, having a volume concentration of a body analyte equal to a predetermined reference value.

[0120] It is recalled that, in the present example, the body analyte to be analyzed is glucose, and the measurement provided by sensor 3 is representative of blood glucose.

[0121] Thus, the solution contained in bag 40 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.

[0122] Alternatively, the preparation solution contained in the pouch 40 can be a pre-wetting solution, i.e., a solution that replicates the chemical nature of the body fluid into which the sensor 3 is intended to be inserted (namely, the interstitial fluid in this case). Pre-wetting consists of moistening some of the chemical or biochemical materials (such as active enzymatic elements) that enable the electrochemical measurement, contained, for example, on the upper layers of the needles 32. These chemical elements typically include active enzymatic elements. Pre-wetting accelerates the subsequent transfer of the electrical elements between all the chemical layers and the body fluid. human (e.g., in interstitial fluid), once the needle sensor is in place.

[0123] One advantage of pre-wetting the sensor 3 during its preparation is to accelerate the convergence of subsequent sensor measurements in the body fluid. The sensor 3 thus quickly reaches an operational state.

[0124] The preparation solution is here in the form of a gel.

[0125] Alternatively, the preparation solution may be a liquid solution.

[0126] It should be noted that pocket 40 can contain a solution which serves, among other things possible uses, calibration solution and pre-wetting solution.

[0127] Whatever form is chosen for the preparation solution contained in the bag 40, the bag preferably also includes an envelope which surrounds the volume of preparation solution, to allow the transport and handling of the bag 26.

[0128] The pocket 40 is piercable, so that a needle 5 from the sensor 3 can reach the preparation solution. If an envelope is present, it is at least partially piercable.

[0129] First embodiment: pocket on a receptacle

[0130] We return in detail to figures 3a and 3b which illustrate a set of preparations according to a first embodiment.

[0131] According to this first embodiment, the pouch 40 rests on the receiving surface 210. This receiving surface 210 must be sufficiently rigid to hold the pouch 40 in place. The pouch 40 is below the membrane 7a. Furthermore, this receiving surface 210 acts as a counter-support to allow the pouch 40 to be punctured.

[0132] Also, the assembly according to this first embodiment includes the membrane 7a which, in addition to being rigid, is here pierceable and is fixed on the second face 92 of the spacer 9 and extending at a distance and opposite the needles 5.

[0133] The membrane 7a is perforable and the assembly is such that when the needles 5 are subjected to a thrust F towards the membrane 7a they can pierce the membrane 7a. Conversely, when the needles 5 are not subjected to a thrust, the needles return to the opening 12 above the membrane 7.

[0134] It is specified that rigid means that the membrane allows a resistance force to be opposed to penetration by a needle, the membrane being able to be pierced when the thrust is greater than this resistance force.

[0135] The membrane 7a is therefore such that it ensures that the needles return to the opening 12 above the membrane 7a when no pressure is applied to the needles 5.

[0136] Advantageously, the membrane 7a must be such that it does not catch on the needle 5 in the absence of pressure to allow the needles to return properly to above membrane 7a.

[0137] Advantageously, to pierce the membrane 7a and the pocket 40, a thrust force required to pierce the membrane 7a is greater than or equal to 1 Newton and less than or equal to 50 Newtons, preferably equal to 10 Newtons. Here again, such a force can be exerted by a large number of users.

[0138] The membrane 7a is fixed here to the spacer 9 by means of an adhesive layer 8 and can be removed when the peelable film 11 is detached from the outer layer 41 of the patch 4.

[0139] In use, a user has the assembly as illustrated in [Fig.3a] and wishes to install a sensor 3 in the housing 2, the assembly being "new".

[0140] The user takes hold of the assembly and opens the upper part 21b of the receptacle. The capsule 10 is still in the receptacle 21 and the user brings the housing 2 to connect it to the sensor 3 via its external face 32.

[0141] Next, a force F is applied to the sensor 3 via the housing 2. This causes the needles to pierce the membrane 7 and the pocket 40, as shown in [Fig. 3b]. The membrane 7 deforms during this operation, and the spacer 9 is compressed onto the elements 212. The pre-calibration required at the start of the user cycle of the sensor 3 is thus performed, with the sensor 3 being powered via the housing 2 (not described in detail). In this respect, the pre-calibration corrects any drift in the measurement of the electrical current provided by the needles 5 of the sensor 3. The needles 5 are immersed in a volume of calibration solution contained in the pocket 40. Since the concentration of the body analyte (here, glucose) in the calibration solution is known, the expected value of the electrical current measurement is also known.A correction to the electrical current measurement or a correction to the delivered voltage is then performed based on the expected electrical current measurement value.

[0142] It should be noted that the preparation of sensor 3 does not necessarily involve calibration of a measurement provided by sensor 3. The preparation of sensor 3 may only involve wetting the needle(s), in particular pre-wetting to accelerate the subsequent convergence of the measurement provided by sensor 3.

[0143] The preparation of the sensor 3 may also include in combination a pre-wetting and a pre-calibration, the whole of the invention being able to allow both.

[0144] Once the needles have been thus dipped in the pocket, the pushing force is released and the needles come out of the pocket 40 and pass back through the membrane 7 to return to the opening 12. The assembly then returns to the position illustrated in [Fig.3a].

[0145] The user takes hold of the capsule 10 which includes the sensor 3 and the patch 4 and also the membrane 7a. The capsule is therefore at this moment in the open air.

[0146] Throughout this phase, the needles 5 are protected by the membrane 7a.

[0147] Next, the user positions the capsule 10 around his wrist and then removes the peelable film 11 which, during its removal, brings with it the membrane 7a, the spacer 9 and allows the user to adhere the patch 4 to his skin, the adhesive layer 8 directly in contact with the outer layer 41 of the patch 4 being released.

[0148] Second embodiment: membrane pocket

[0149] We return in detail to figures 4a and 4b which illustrate an assembly according to a second embodiment.

[0150] The assembly according to this second embodiment incorporates all the elements of the first embodiment, except that the pouch 40 is here arranged on the membrane 7b. This membrane 7b is not intended to be pierced by the needles, so only rigidity is required to support the pouch 40.

[0151] On the other hand, pocket 40 is piercable by needles 5.

[0152] According to this second embodiment, at least one second support element 213 is arranged below the pocket 40. As illustrated in [Fig.4a], these are two bumps 213 protruding from the receiving surface 210. These second support elements serve to facilitate the piercing of the pocket 40 by the needles since, in operation, the membrane and the pocket will come to rest on these support elements, the spacer 9 resting as on the first support elements 212 as described previously.

[0153] The operation of the assembly according to the second embodiment is similar to that of the first embodiment except that when the peelable film is removed the pouch is also removed.

[0154] Figure 4b illustrates the assembly according to the second embodiment with the pocket 40 pierced by the needles 5, the membrane 7 comes to be positioned on the support elements below, and the spacer 9 is compressed on the first support elements 212. In this way the calibration of the needles 5 can be carried out as described previously, the whole returning to the position of [Fig.4a] at the end of the operation.

Claims

Demands

1. An assembly comprising a capsule (10) of a ready-to-wear body analyte monitoring device (1), the capsule (10) comprising a sensor (3) configured to provide a body analyte concentration measurement, the sensor (3) comprising a sensor surface (31) and at least one needle (5) attached to the sensor (3) on the sensor surface (31), the capsule (10) further comprising a patch (4) supporting the sensor (3), the patch (4) covering at least part of the sensor surface (31), a portion of the patch (4) defining an opening (12) in which the needles (5) of the sensor (3) are arranged, the assembly being characterized in that it comprises: - at least one first compressible spacer (9), having a first face (91) opposite the patch (4) and a second face (92) opposite the first face (91), - a receptacle (21) comprising a reception area (210);- a perforable pocket (40) disposed on the receiving surface (210) at a distance and opposite the needle (5), the assembly being such that when the needle (5) is subjected to a push (F) towards the pocket (40), it pierces the pocket (40), the spacer (9) being compressed, the needle (5) returning opposite and at a distance from the pocket (40) in the absence of any push (F), the spacer (9) being decompressed, the sensor (3) being movable relative to the receptacle (21) between a first position in which the needle (5) is at a distance and opposite the pocket (40), the spacer (9) then being uncompressed, and a second position in which the pocket (40) is pierced by the needle (5) and in which the needle (5) is in contact with a volume of the pocket (40), the spacer (9) then being compressed, the pocket (40) comprising a volume of a sensor preparation solution (3).;

2. Assembly according to claim 1, comprising a rigid membrane (7a, 7b) fixed to the second face (91) of the spacer and extending away from and in front of the needle (5), said membrane (7a, 7b) being configured to close the opening (12) in order to protect the needle (5).

3. Assembly according to claim 2, wherein the rigid membrane (7a, 7b) is formed of an elastic or semi-elastic material.

4. Assembly according to any one of the preceding claims, wherein the membrane (7a) is piercable by the needle (5), the pocket (40) being disposed below the membrane (7a), the assembly being configured so that when the needle (5) undergoes a push (F) towards the membrane (7a) it pierces, in addition to the pocket (40), the membrane (7a) and returns completely into the opening (12) opposite and at a distance from the membrane (7a) in the absence of a push (F).

5. Assembly according to any one of claims 1 to 3, wherein the pocket (40) is disposed in the opening (12) and rests on a surface (7bl) of the membrane (7b) which opens into the opening (12).

6. Assembly according to any one of claims 1 to 5, wherein the spacer (9) in compressed or uncompressed position has a thickness greater than or equal to 0.1 millimeter and less than or equal to 2 millimeters.

7. Assembly according to any one of claims 1 to 6, wherein the spacer (9) comprises at least a first spacer part (9a) and a second spacer part (9b) opposite the first part (9a), the first part (9a) and the second part (9a) preferably being disjoint.

8. Assembly according to any one of claims 1 to 7 or claims 2 to 7, wherein the patch (4) comprises a peelable film (11) between an adhesive layer (8) of the patch (4) and the spacer (9), the first face (91) of the spacer (9) being fixedly bonded to the peelable film (11), the peelable film (11) being configured to permit the peelable film (11), the spacer (9), and optionally the membrane of an outer layer (41) of the patch (4) to be detached.

9. Assembly according to any one of claims 1 to 8, comprising at least a first support element (212) located opposite the spacer (9), the first support element being configured to facilitate compression of the spacer (9) and piercing of the pocket (40) by the needle (5).

10. Assembly according to any one of claims 1 to 8, comprising at least a second support element (210, 213) located opposite the pocket (40), the second support element being configured to facilitate drilling the pocket (40).

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