Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
  • A61B5/1495—Calibrating or testing of in-vivo probes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
  • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
  • A61B5/1451—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
  • A61B5/14514—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
  • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
  • A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
  • A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/6802—Sensor mounted on worn items
  • A61B5/681—Wristwatch-type devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
  • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
  • A61B5/685—Microneedles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
  • A61B2560/02—Operational features
  • A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
  • A61B2560/0228—Operational features of calibration, e.g. protocols for calibrating sensors using calibration standards
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
  • A61B2560/02—Operational features
  • A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
  • A61B2560/0238—Means for recording calibration data
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
  • A61B2560/04—Constructional details of apparatus
  • A61B2560/0456—Apparatus provided with a docking unit
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
  • A61B2560/06—Accessories for medical measuring apparatus

Definitions

• the present invention belongs to the technical field of ready-to-wear or “wearable” devices used in body monitoring systems, for example for recording and monitoring biochemical parameters of the human body.
• the invention relates to an assembly for preparing a needle sensor of a body monitoring system, as well as a sensor kit comprising such an assembly.
• the invention further relates to a method of preparing a needle sensor.
• the invention is particularly of advantageous application for the calibration of a needle sensor, preferably before its integration into a ready-to-wear device.
• a concentration level of a bodily analyte in a bodily fluid of the organism for example in blood plasma or in the interstitial fluid of cells of the organism, can be noted.
• monitoring a patient's diabetes requires an accurate daily reading of the patient's blood sugar.
• a widespread solution for carrying out the monitoring of diabetes consists in carrying out a puncture, for example at the end of the finger, to make a drop of blood bead, then to carry out a daily measurement of glycemia in the drop of blood thus obtained.
• CGM systems Continuous Glucose Monitoring systems
• Some of these CGM systems measure blood glucose at regular intervals in the interstitial fluid between skin cells.
• the glycemia of interstitial fluid is very close to the glycemia of blood plasma.
• Measurements at the level of interstitial fluid allow simple and minimally invasive monitoring of patients' blood sugar levels; these measurements can be carried out using needle sensors, transcutaneously, or non-invasively, such as for example iontophoresis or implantable with a measurement by chemofluorescence.
• the international application published under the number WO 2018/104647 describes a body monitoring system, which can be used in particular for monitoring blood sugar.
• This monitoring system includes an electronic watch that can be attached to the wrist using a bracelet.
• the watch has a case, into which is inserted an interchangeable removable capsule containing a micro-needle sensor.
• the sensor is automatically controlled by the electronics of the box, in order to carry out a transcutaneous measurement.
• the blood glucose measurement by the sensor is an electrochemical measurement.
• the body monitoring system described in the aforementioned document has the significant advantage of providing an autonomous calibration measurement by measuring a reference concentration of a body analyte in the user.
• the number of operations that the user has to perform to obtain his daily measurements is greatly reduced.
• the user needs to perform few manual punctures (for example a simple weekly puncture), or even no manual puncture anymore.
• Another advantage of this system is its low hygienic risk, since the needles of the sensor are not in contact with the external environment, once these needles are inserted into the skin.
• the deterioration in the measurement performance of the needle sensor is explained by a drift in the electrochemical measurement over time.
• This drift may be due to an unsuitable ambient temperature in the storage areas for removable capsules including needle sensors.
• too hot temperatures are detrimental to the integrity of the measuring system. If sudden and large changes in the temperature of the sensor occur, this worsens the drift of the electrochemical measurement.
• a first known method to overcome this drift is a "factory" calibration carried out on the scale of an entire batch of needle sensors, after production of the batch.
• An alphanumeric code is then written on a packaging of the removable capsule containing the sensor, or is integrated into an electronic memory of the sensor.
• the ready-to-wear device has an abacus in which each alphanumeric code is associated with a reference value. When inserting the capsule into the ready-to-wear device, the alphanumeric code is read and calibration can be performed.
• a second known calibration method sometimes used in combination with the first, consists of calibration measurements (manual punctures) carried out regularly by the user while he is wearing the ready-to-wear device.
• the calibration measurements are carried out manually by the user, for example on a daily or weekly basis.
• the user may need to enter a capillary blood glucose value on the ready-to-wear device.
• the state of the art is not satisfactory either with regard to the speed with which needle sensors are put into service when a new sensor is used.
• the convergence of the electrochemical measurement provided by the sensor after insertion of the needle into the human interstitial fluid that is to say the achievement of a balance between the chemical species of the sensor allowing the measurement and the medium, is currently quite slow.
• the convergence time of known sensors is for example several hours. During this commissioning time, the measurement provided is unreliable, and the user is at risk because he is not informed of fluctuations in his biochemical parameters.
• An objective of the invention is to provide improvements for a body monitoring system comprising a needle sensor, so that the measurement provided by this sensor remains reliable and precise over time.
• the aim is to eliminate the need for daily manual punctures and to switch to weekly manual punctures at a minimum, or even to eliminate the need for manual punctures.
• the user of the body monitoring system is not responsible for the correct calibration of said sensor, during the life cycle of the monitoring system.
• the desired solution must remain very easy to use, in order to ensure a pleasant user experience.
• a secondary objective is to allow the rapid commissioning of a new needle sensor, after insertion of this sensor in a ready-to-wear device. To do this, it is necessary to accelerate the convergence of the electrochemical measurement between the chemical compounds of the sensor and the medium in which the needle of the sensor is inserted, typically human interstitial fluid. Furthermore, it is desired to keep a simple body surveillance system, with a low cost price, compatible with large-scale industrialization.
• the invention relates, according to a first aspect, to a body monitoring system sensor preparation assembly, the sensor comprising at least one needle, the preparation assembly comprising:
• a bag comprising a volume of a preparation solution, the bag being configured to be positioned under the sensor and being configured to be pierced by the needle,
• Support means movable 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.
• the preparation solution contained in the bag makes it possible to easily and quickly prepare the needle sensor. It is not necessary for a user of the body monitoring system wishing to prepare the sensor to perform a finger puncture or directly manipulate the needles of the sensor in any way.
• the preparation assembly of the invention is used, for example, when the needle sensor is put into service.
• the user can easily prepare the sensor himself by using the means of press to pierce the pocket with the sensor needle.
• the preparation of the sensor is for example a pre-calibration of the sensor, in order to correct a possible drift of an electrochemical measurement provided by the sensor. This operation can be qualified as "pre-calibration" because it occurs at the start of the sensor's cycle of use.
• the preparation of the sensor is, as an alternative to the pre-calibration or in combination, a pre-wetting of the needle (s) of the sensor.
• the sensor preparation assembly according to the first aspect of the invention can have, in an optional and non-limiting manner, the following technical characteristics taken alone or in any one of the technically possible combinations: - the preparation solution is a calibration solution having 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
• the support means cover the sensor
• the preparation assembly further comprises an electronic device, the electronic device preferably being configured to control a measurement of a 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 a tracker,
• the electronic device comprises a processing unit and a memory, configured to record and manage information on the registration of a measurement of the concentration of body analyte,
• the support means comprise a cover, the cover preferably being configured to completely cover the support means
• the preparation set includes a box, at least part of the support means being integrated into the box,
• the box comprises at least one housing configured to stably place the receptacle in the box, and / or configured to stably place a ready-to-wear device in the box,
• the support means comprise at least one mechanical clip configured to perform a Z-shaped support on the sensor, or on a part of an electronic device,
• the preparation assembly further comprises a peelable film, the peelable film preferably forming with the receptacle an enclosure which encloses the pocket and / or which encloses the sensor,
• the preparation set also includes a preparation station configured to receive the bag
• the preparation station includes an indicator to inform a user of a duration of maintenance of the support position
• the electronic device comprises an indicator to inform a user of a duration of maintenance of the support position
• the preparation station is configured to charge a battery of an electronic device included in the preparation set
• the preparation station further comprises at least one support cover and / or comprises two mechanical clips movable relative to each other in a direction of separation,
• - at least one mechanical clip includes an electrical charging contact.
• the invention relates to a sensor kit including a preparation assembly as defined above, the sensor kit further including a sensor comprising at least one needle, the sensor being configured so that, in the position support means, the needle is partially or totally immersed in the preparation solution.
• the senor further comprises a memory configured to record information on the registration of a measurement of the concentration of bodily analyte.
• an advantage is that it eliminates the need to record the registration information in a device separate from the sensor, during a calibration.
• 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 the support position so that the needle of the sensor pierces the pocket.
• the preparation process according to the third aspect of the invention may have, in an optional and non-limiting manner, 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 measurement of a concentration of a body analyte, and / or the processing unit is used to generate an electric current in the body. sensor,
• the method comprises additional steps of: acquisition by the sensor of a concentration measurement of a body analyte in the preparation solution of the bag; transmission of the measurement to the processing unit; and calculation of a resetting signal as a function of the measurement, so as to calibrate the sensor,
• a ready-to-wear device is interposed between the support means and the sensor, - the support means comprise a cover which presses on 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,
• the bag is discarded, and a new bag is used during the preparation of a separate sensor.
• Figure 1a is a schematic illustration of the different elements of a sensor kit, the sensor kit including an electronic watch.
• Figure 1b is a schematic front view of the electronic watch shown in Figure 1a.
• FIG. 2 is a top perspective view of a needle sensor according to an example. This sensor can be used in conjunction with any of the sensor preparation sets shown in the accompanying figures.
• Figure 3 shows a sensor preparation assembly according to a first embodiment, comprising a box.
• Figure 4 shows a charging station of an electronic watch, said charging station being able to be integrated into a sensor preparation assembly according to a second embodiment.
• Figure 5a is a cross-sectional view of the loading station of Figure 4 with the clips of the loading station in the close position.
• Figure 5b is a cross-sectional view of the loading station of Figure 4 with the clips of the loading station in the spread position.
• Figure 6 illustrates steps in a sensor preparation process.
• the following description relates to the preparation of a needle sensor (s) integrated into an electronic watch.
• the sensor is designed to provide a measurement of glucose concentration within a carrier's interstitial fluid.
• the electronic watch, together with the sensor, constitutes a body monitoring system.
• body monitoring is meant the verification of biochemical constants of the carrier of the monitoring system, typically the concentration of the carrier's interstitial fluid in a protein, hormone, biomarker, oxygen, nutrients, and the like.
• concentration of the carrier's interstitial fluid in a protein typically the concentration of the carrier's interstitial fluid in a protein, hormone, biomarker, oxygen, nutrients, and the like.
• Other physical quantities can be monitored by the monitoring system, such as, for example, lactate concentration, hydration, etc.
• the biochemical constant to watch is the glucose (or blood sugar) concentration in the interstitial fluid of the skin.
• the glycemia of interstitial fluid is considered representative of the glycemia of the blood plasma.
• the sensor preparation set described below can be used, with the same advantages, to prepare a sensor for measuring another biochemical parameter.
• the needle or needles of the sensor could be intended to be inserted into a body fluid other than the interstitial fluid, for example in blood.
• the ready-to-wear device is, throughout the following description, an electronic watch configured to display information to the attention of its wearer.
• the sensor preparation set described below can be used, with the same advantages, in association with any other type of ready-to-wear device: bracelet, tracker, etc.
• Kit 1 includes a sensor 30 intended for the regular monitoring of an individual's blood sugar.
• the sensor 30 is intended to provide a measurement of electric current within the interstitial liquid.
• Kit 1 also includes a sensor preparation set.
• the preparation assembly comprises in particular an electronic watch, intended to be worn on the wrist of the wearer.
• the preparation assembly comprises support means 24, a pocket 26 and a receptacle 28, structural examples of which will be described below.
• Bag 26 includes a volume of a sensor preparation solution.
• the preparation solution is a calibration solution, having a volume concentration of a body analyte equal to a predetermined reference value.
• the body analyte to be analyzed is glucose
• the measurement provided by the sensor 30 is representative of the glycemia.
• the solution contained in the bag 26 here 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.
• the preparation solution contained in the bag 26 can be a pre-wetting solution, that is to say a solution which reproduces the chemical nature of the body fluid in which the sensor 30 is intended to be inserted ( namely the interstitial fluid here).
• the pre-wetting consists in humidifying a part of the chemical or biochemical materials (such as active enzymatic elements) which allow the electrochemical measurement, contained for example on the upper layers of the needles 32.
• These chemical elements typically comprise active enzymatic elements.
• Pre-wetting accelerates the subsequent passage of electrical elements between all of the chemical layers and human body fluid (eg, interstitial fluid), once the needle sensor is in place.
• An advantage of pre-wetting the sensor 30, during preparation of the sensor 30, is to accelerate the convergence of subsequent sensor measurements in the body fluid.
• the sensor thus quickly reaches an operational state.
• the preparation solution is here produced in the form of a gel.
• the preparation solution can be a liquid solution.
• the bag 26 may contain a solution which serves both, among other possible uses, as a calibration solution and as a pre-wetting solution.
• the bag preferably further comprises an envelope which surrounds the volume of preparation solution, to allow the transport and handling of the bag 26.
• the pocket 26 is pierceable, so that a needle 32 of the sensor 30 can reach the preparation solution. If an envelope is present, it is at least partly pierceable.
• the pocket 26 is disposed on a surface of the receptacle 28.
• the surface on which the pocket 26 is disposed is preferably quite rigid, so as to oppose a resistance force to penetration by a needle.
• a needle pressed in the direction of the receptacle 28 can pierce the pocket 26.
• the pocket 26 is placed on a flat surface of the receptacle 28.
• the receptacle 28 has, for example, the shape of a dome, with a flat surface for receiving the pocket 26 and one or more edges making it possible to grip the dome.
• the pocket 26 can here be separated from the receptacle 28.
• the receptacle 28 can alternatively be secured to the pocket 26.
• the sensor preparation assembly included in kit 1 includes bearing means 24 which are used to squeeze sensor 30, so that sensor 30 pierces pocket 26. Needles 32 of sensor 30 are at the center. less partially immersed in the volume of preparation solution.
• the support means 24 comprise the watch 10 and comprise a cover which presses on the electronic watch.
• the case of the electronic watch is interposed between the cover and the sensor.
• the support means could only comprise a cover, configured to press the sensor 30 against the receptacle 28.
• the means of support could include only the watch.
• the support means 24 are movable relative to the receptacle 28, from a relaxed position towards a support position, in a direction A.
• the sensor area which carries the needle 32 is remote from the pocket 26.
• the needle 32 does not pierce the pocket 26 in the released position of the support means.
• the sensor zone 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 pocket 26. support position preferably cover the sensor 30.
• the support means 24 can be manipulated by the user, for example with the hand, and / or be actuated by an additional device which can be an electronic device.
• the support means in the support position can then be returned to the released position.
• the pressure of the sensor 30 on the bag 26 is then released.
• the support means can be urged in a direction opposite to direction A by return means.
• Figure 1a schematically illustrates a state of the kit 1 in which the support means are in the released position.
• the needles 32 are distant from the pocket 26.
• the released position corresponds to a high position of the support means and of the sensor.
• a support position of the support means 24 corresponds to a lower position of the support means and of the sensor.
• the support means 24 are preferably separate from the receptacle 28 and the pocket 26.
• the support means 24 comprise a cover as in kit 1 of FIG. 1a, said cover and the receptacle 28 have preferably complementary shapes.
• the sensor preparation assembly comprises a film which covers the pocket 26 and / or which covers the sensor 30.
• the film is preferably disposed on the receptacle 28, and is typically attached to edges of the pocket. receptacle 28.
• the film can thus define, with the receptacle 28, a sterile packaging or pack which contains the bag 26 and / or the sensor 30.
• a sterile packaging or pack which contains the bag 26 and / or the sensor 30.
• Such a film is not illustrated in Figure 1a.
• An advantage of this construction is that the bag 26 and the sensor 30 are separated from the outside environment until their use, and are easily stored and transported.
• the sensor kit 1 further comprises a base.
• the receptacle 28 is itself disposed in the base.
• the base has dimensions close to those of the cover. The base and the cover therefore together form a box.
• the kit 1 does not include means specifically dedicated to supporting the sensor. The user then uses his hand directly to bring the needles 32 inside the pocket 26, by pressure in direction A.
• FIG. 1b schematically shows a watch 10 according to an example.
• Watch 10 comprises in particular a case 12, a bracelet 13 and a screen 16.
• Watch 10 constitutes a ready-to-wear device, thanks to bracelet 13 which allows it to be hung on the user's wrist.
• the bracelet 13 is preferably adjustable.
• Watch 10 is an electronic watch.
• the box 12 carries the electronics necessary for the operation of the watch, in particular for the control of operations relating to the monitoring of the blood sugar of the user of the watch.
• the watch 10 comprises a processing unit 14.
• the processing unit 14 comprises for example one or more processors contained in the housing 12, and makes it possible in particular to manage the acquisition information of the measurement of the concentration of analyte. bodily.
• the processing unit 14 is intended to be connected to the sensor 30, once the sensor 30 has been 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 further preferably comprises 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 displayed information preferably includes time information and / or blood glucose monitoring information.
• Watch 10 may in particular have a structure conforming to the watch described in document WO 2018/104647.
• a watch has two modules which can be separated from one another; a first module comprises the housing body attached to the bracelet and the control electronics, and a second module is formed by an interchangeable removable capsule comprising the needle sensor.
• the two modules have complementary shapes, and are connected by a mechanical link which is preferably separable.
• a body monitoring system can comprise, as a ready-to-wear device, a watch without a screen (the term “tracker” is then commonly used), or even a bracelet.
• a tracker typically provides data sports and / or vertical positioning data (eg for the elderly) and / or GPS positioning data (eg for monitoring young children) and / or analysis data of medical variables.
• a body monitoring system can include any ready-to-wear device that can be positioned in regular contact with the skin.
• the watch 10 further comprises a wireless communication interface, for example via a telecommunications network of 3G and / or 4G and / or 5G type and / or Wi-Fi and / or Bluetooth and / or NFC and / or DECT.
• a wireless communication interface for example via a telecommunications network of 3G and / or 4G and / or 5G type and / or Wi-Fi and / or Bluetooth and / or NFC and / or DECT.
• the watch can include a light indicator such as a diode, which can be used to signal the end of a sensor preparation operation.
• a light indicator such as a diode
• a ready-to-wear device such as watch 10, equipped with a sensor 30, is an example of a body monitoring system for monitoring the evolution of an individual's blood sugar.
• FIG. 2 illustrates a sensor 30 which can be used within the kit 1, according to an example.
• the sensor 30 is a needle sensor intended to provide a measurement of electric current within the interstitial liquid of the wearer of the watch 10.
• the hands 32 are advantageously “micro-needles”.
• the sensor 30 preferably comprises between four and fifty micro needles. Note that a needle sensor of a body monitoring system can have any number of needles from a single needle.
• micro-needle is understood to mean a needle having a short length, preferably between 10 micrometers and 1 millimeter, more preferably between 300 micrometers and 800 micrometers. In the following, the microneedles are referred to as “needles” to facilitate reading. However, needles other than microneedles can also be used as an alternative.
• the length of the hands 32 is thus sufficiently reduced to avoid contact with a user's nerve, to limit the pain caused by wearing the watch 10.
• Each needle here has a pyramidal shape.
• the needles 32 are arranged to form a network of needles.
• each needle 32 comprises on its surface at least one chemical or biochemical material capable of reacting with the body analyte of which it is desired to obtain a measurement (that is to say here glucose).
• a material capable of reacting with the body analyte is, for example, an enzyme capable of oxidizing the body analyte.
• each needle 32 comprises an internal cavity located behind the tip, and the chemical or biochemical material capable of reacting with the analyte is located in this internal cavity.
• the sensor 30 can include cavities located behind the needles 32, and / or inside the needles 32.
• one or more needles 32 can include an open channel. The cavities include the chemical or biochemical material capable of reacting with the analyte. The needles 32 are then able to bring the body fluid up to said cavities.
• the sensor 30 illustrated in Figure 2 comprises, in addition to the needles 32, a substrate 34 provided with a plurality of metal tracks 340, a working conductivity electrode 360, a reference conductivity electrode 362 and a central opening 38.
• a voltage is generated between several needles. At least part of the needles 32 of the sensor 30 are at least partially immersed in the interstitial liquid. 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 a measurement of electric current, representative of the glucose concentration in the interstitial fluid.
• the substrate 34 and the needles 32 are preferably placed on a single face of the sensor 30, which is the face directed upwards according to the orientation of FIG. 2. This upper face is intended to be placed opposite the skin of the. user.
• Each needle extends from the top face in a Z direction, from its base to its point.
• the Z direction is preferably orthogonal to a plane of the upper face.
• the central opening 38 is here circular.
• the sensor 30 thus has, in the present example, a generally annular shape.
• the senor 30 is integrated into a removable capsule.
• the removable capsule is designed to be admitted into the ready-to-wear device, here in the case 12 of the watch 10.
• the capsule can be coupled to the housing 12, by mechanical coupling.
• the capsule is inserted into the back of the housing 12.
• the housing 12 and the capsule may have complementary shapes, which limits the effort required for the correct insertion of the capsule against the housing.
• a support for the sensor 30 preferably comprises a patch (not shown) attachable to the skin of the user.
• the patch has an adhesive layer, or is itself formed of an adhesive material. The patch therefore allows the capsule to be attached to the skin of the wearer, and promotes the retention of the needles 32 in the interstitial fluid.
• the patch has for example an annular shape, and covers the capsule.
• the sensor 30 is here provided to be controlled by the processing unit 14 of the watch 10.
• the sensor 30 comprises a memory, configured among other things to record a resetting information. The readjustment information can then be recorded in the sensor 30 after transmission by a processing unit integrated into the watch 10, during a process for calibrating the sensor 30.
• Figure 3 illustrates a sensor preparation assembly according to this first example, comprising a box 20.
• the box 20 includes a cover 240 forming the top face (according to the orientation of Figure 3), and includes side faces 22 and a bottom face 242.
• the box 20 is here of generally parallelepipedal shape.
• the bag 26 and the receptacle 28 are received in an internal space formed inside the box 20.
• the sensor 30 is placed in front of the bag 26 for its preparation, the sensor 30 is also received in the box. 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, receptacle 28 is preferably received in a central part of the internal space of box 20.
• the cover 240 is integrated into the support means 24.
• an attachment edge of the cover 240 is fixed to a side face 22.
• the other edges are free, to allow pivoting of the cover 240 according to the position. direction R.
• At least one side face 22 comprises, on an upper edge left free by the cover 240, a housing 200 for the placement of a ready-to-wear device.
• the housing 200 is for example a concavity formed by removing material. A part of the ready-to-wear device - for example the case 12 of the watch 10 - can then be stably interposed between the cover 240 and the pocket 26.
• the housing 200 is particularly advantageous for the housing 200 to be complementary with the strap 13 of the watch.
• the bracelet 13 is placed inside the housing 200, in a transverse position with respect to the plane of the housing 200.
• the box 20 comprises two housings 200 placed face to face on two opposite side faces 22, these faces being located on the sides of the attachment edge of the cover 240.
• One advantage is to stabilize 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 the box 20, and / or in the internal space of the housing 200, for example to ensure that the ready-to-wear device remains in place after its insertion into the housing. the box.
• the cover 240 advantageously comprises a window 241.
• Window 241 is formed from a transparent or semi-transparent material.
• Window 241 advantageously has dimensions similar to or slightly larger than the dimensions of screen 16, and extends opposite screen 16 when watch 10 is received in box 20.
• the housings 200 can be omitted. Indeed, it is not necessary to use as support means a part of a watch 10 or a part of any other ready-to-wear device. It is possible to bring the needles 32 into contact with the pocket 26, by directly pressing the cover 24 on the sensor 30.
• the lower face 242 is, for its part, preferably fixed and planar.
• the box 20 is thus easily positioned on a flat surface.
• the box 20 is preferably formed of a light and easy to shape material, such as a polymer.
• the sensor preparation set 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, he removes the watch 10 and places inside the watch 10 the sensor which must be prepared, then he closes the cover 240 on. watch 10 and on the sensor. The user is not at risk of injury.
• box 20 does not need to be supplied with electrical current.
• box 20 does not carry any electronic component.
• the box 20 can however be supplied with electric current, for example if the box 20 includes a light indicator such as a diode to inform the user of a duration of maintaining the support position.
• a light indicator such as a diode
• the box 20 forms a packaging device which is easy to store and transport.
• the cover 240 of the box 20 can be omitted. An open top box is thus obtained. It is then possible to use as support means either part of a ready-to-wear device, or a mechanical actuator of the ready-to-wear device, or the hand of the user himself, or all other way.
• Example 2 Electronic watch charging station
• At least part of the support means of the sensor preparation assembly is integrated into a loading station.
• a loading station 40 usable for the preparation of a needle sensor, for example for the preparation of the sensor 30, is illustrated in Figure 4, Figure 5a and Figure 5b.
• Figure 4 is a top view of the loading station 40 in which is inserted the case 12 of the watch 10.
• Figures 5a and 5b are sectional views along the sectional plane C-C of Figure 4.
• the box 12 is coupled with a sensor 30.
• the station 40 constitutes a complementary “dock” with the box 12.
• a housing receiving space is formed on top of a central area of the station 40.
• the housing receiving space is formed between two mechanical clips 44 of the station 40.
• the receiving space housing is adapted to receive the housing 12.
• the station 40 further comprises at least one mechanical clip for pressing the housing 12, here two lateral mechanical clips 44.
• the housing 12 here constitutes, in conjunction with the mechanical clips 44, means for supporting the sensor 30 against the pocket 26.
• the mechanical clips 44 are movable between a separated position and a close position.
• the position shown in Figure 4 and Figure 5a is a close-together position.
• the position illustrated in Figure 5b is a spread position.
• the housing 12 presses or does not press the sensor 30 in the direction of the pocket 26.
• the station 40 acts as a preparation station for the sensor 30.
• the station 40 is designed to receive the receptacle 28 below the housing 12, and the pocket 26 below the sensor 30.
• the reception area of the receptacle 28 and the pocket 26 is not not shown in Figures 4, 5a and 5b.
• the receptacle 28 and the pocket 26 are removable with respect to the station 40.
• the receptacle 28 is fixed on the station 40.
• a surface of the station 40 acts as a receptacle; thus, the bag 26 is directly disposed on the station 40 and is not carried by a structural element separate from the station.
• 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 requested to directly support the housing.
• the user may be required to position housing 12 in the receiving space, and press housing 12 to squeeze the sensor.
• the needles 32 can be pressed inside the pocket 26 for a period of between 1 minute and 120 minutes to perform the pre-wetting.
• the indicator 42 or, alternatively, an indicator present on the ready-to-wear device, can be activated to notify the end of the pre-wetting to the user.
• the pre-calibration of the sensor 30 is carried out.
• the pre-calibration is carried out before the pre-wetting of the needles. In either case, 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).
• mechanical clips 44 and housing 12 are aligned with a midplane of station 40.
• a longitudinal axis L of station 40 shown in dotted lines in Figure 4, is orthogonal to the midplane.
• the side edges of each of the mechanical clips 44 are aligned with the side edges of the housing 12.
• each of the mechanical clips 44 is positioned longitudinally between two blocks 48 of the station 40.
• the mechanical clips 44 are movable relative to the blocks 48, so as to approach or move apart.
• a channel is formed in the volume of the blocks 48 (here along the longitudinal axis L) to allow the user to easily insert and grip the housing 12 when the mechanical clips 44 are in a separated position. .
• the station 40 advantageously comprises an actuator (not illustrated), preferably electric, to control a spacing or an approach of the mechanical clips 44.
• the actuator is for example a push button that the user can actuate to switch the position. mechanical clips 44 between the close and spread positions.
• the mechanical clips 44 are switched between the close position and the spread position by light pressure from the user. Mechanical clips 44 can "click” and change position.
• the station 40 further comprises an indicator 42 to inform a user of a duration of maintenance of the supporting position of the housing 12 and of the mechanical clips 44.
• the indicator 42 is placed on an upper surface of the station. 40.
• the indicator 42 is here a diode.
• Figures 5a and 5b further illustrate respectively the close position and the spread position of the mechanical clips 44.
• a height of each of the mechanical clips 44 is equal to a cumulative height of the housing 12 and of a lower portion 480 of the station 40.
• Each mechanical clip 44 is pivotally mounted on it. even, around a respective axis 45.
• the two axes 45 extend orthogonally to the C-C section plane.
• the mechanical clips 44 are movable in rotation along the section plane C-C.
• the two mechanical clips 44 are symmetrical with respect to a longitudinal plane of the loading station, that is to say here with respect to the plane orthogonal to the section plane C - C passing through the longitudinal axis L.
• Each mechanical clip 44 has, on an upper end, a concavity adapted to receive one side of the housing 12.
• each mechanical clip 44 includes a tip 442 at a distal position and includes a tooth 440 at a medial position, with tip 442 and tooth 440 extending inwardly.
• a receiving concavity is formed between tip 442 and tooth 440.
• the two mechanical clips 44 are in contact with the housing 12 and perform a Z-shaped support on the housing 12.
• the sensor 30, placed under the housing 12, is pressed towards the pocket 26 positioned below the sensor. Spikes 442 prevent untimely extraction from housing 12.
• the mechanical clips can be configured to provide a Z 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 a pre-calibration of the sensor 30.
• At least one mechanical clip 44 (here the straight mechanical clip) comprises an electrical contact 46, arranged on a contact surface with the housing 12.
• the electrical contact 46 is arranged on a contact surface. side with the housing.
• the electrical contact 46 is here arranged on the tooth 440.
• the station 40 is configured to supply electric current to a battery (not shown) of the watch 10, via the electric contact 46.
• the watch 10 comprises, as such, a watch contact 18 intended to cooperate with the watch. electrical contact 46. In the close position of Figure 5a, watch contact 18 is against electrical contact 46 of station 40.
• 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 electric current to the sensor 30, but also to exchange data with the sensor 30.
• the box 12 and the sensor 30 can each comprise a wireless communication interface, such as an NFC interface.
• the station 40 is itself supplied with current, preferably by a power cord 482, a first end of which includes an electrical outlet and a second end of which is attached to the lower portion 480.
• Station 40 is thus preferably both a sensor preparation station and an electric watch charging station.
• the screen 16 of the watch 10 is directed towards the outside of the station 40.
• information indicative of the charging of the battery and / or of the sensor preparation operations can be displayed on the screen 16 during the process. use of station 40.
• Station 40 here has a U-shape when the station is viewed from above.
• the station 40 has a parallelepipedal shape, or any other shape.
• the functions of electrically charging a battery of the ready-to-wear device on the one hand, and of preparing the needle sensor of the ready-to-wear device (in particular for calibrating said sensor) on the other hand, can thus be fulfilled by the same station 40.
• the number of items of equipment that the user must group together and keep in order to operate the body monitoring system is thus reduced.
• the station 40 performs the preparation of the sensor 30 in a completely autonomous manner, without requesting the watch 10.
• the station 40 then embeds the electronics necessary to implement, for example, a pre-calibration measurement and a resetting. as described below.
• One possible option is to directly press the needles 32 inside the pocket 26 by pressing the sensor 30 via the mechanical clips 44, or via any other mechanical actuator.
• the sensor preparation assembly comprises a receptacle itself equipped with part of the support means.
• the sensor support means comprise the housing 12 as well as lateral clipping edges of the receptacle 28, capable of locking the housing 12 in the position of support against the sensor 30.
• An advantage of the latter example is to omit the need for an additional component, such as a box or a prep station.
• the shape of the housing 12 being simple, it is easy to manufacture a receptacle comprising complementary clipping edges with the housing.
• Figure 6 illustrates the steps of a method 50 for preparing a needle sensor of a body monitoring system, according to an example in which the preparation of the sensor includes a "pre-calibration" of the sensor.
• pre-calibration is meant a calibration operation of the measurement supplied by the needle sensor, which occurs at the start of the sensor's cycle of use.
• the pre-calibration of the sensor corrects any drift in the electric current measurement supplied by needles 32 of the sensor.
• the needles 32 are immersed in a volume of a calibration solution contained in the bag 26.
• the concentration of body analyte (here in glucose) of the calibration solution being known, the value of the expected electric current measurement is also known. .
• a correction of the electric current measurement, or “Drift correction” is thus performed as a function of the value of the expected electrical current measurement.
• the pre-calibration is advantageously carried out immediately before the insertion of the sensor (preferably new) in a ready-to-wear device.
• the sensor 30 is subjected to a pre-calibration before its insertion into the watch 10.
• the sensor 30 may or may not have been the subject of a "factory calibration" prior to the pre-calibration. It is recalled that a factory calibration includes, at the end of the production of a batch of needle sensors, the inscription of an alphanumeric code on a packaging of the sensor or the integration of a chain of characters representative of said code in a memory of the sensor.
• the alphanumeric code can be recognized by an electronic device having an abacus, where the alphanumeric code is associated with a reference value of body analyte concentration.
• a method for preparing the needle sensor does not necessarily include a calibration of a measurement provided by the sensor.
• the preparation of the sensor may only involve wetting of the needle, in particular a "pre-wetting" to accelerate the subsequent convergence of the measurement provided by the sensor.
• the preparation of the sensor can also include, in combination, a pre-wetting and a pre-calibration.
• An advantage of the sensor preparation assemblies described above is that they allow simultaneous wetting and calibration, via the immersion of at least one needle 32 in the volume of pocket 26.
• step 100 the peelable film possibly present on the receptacle 28 is removed.
• the pocket 26 received in the receptacle is vented.
• the receptacle 28 preferably also comprises the sensor 30 before removal of the peelable film
• the sensor 30 is preferably also in the open air after removal of the film.
• Step 100 can be implemented while the receptacle 28 is already positioned facing the support means 24, or beforehand.
• the senor 30 is placed in a step 200 in a position interposed between the support means 24 and the pocket 26.
• the upper face carrying the needles is placed opposite the bag containing the preparation solution.
• the needles 32 then face the pocket 26.
• the senor 30 is integrated into an interchangeable removable capsule.
• the removable capsule is placed in the ready-to-wear device, here on the back of the case 12, prior to step 200.
• the placement of the sensor can be carried out as follows:
• the cover 24 is open and the sensor 30 is placed above the receptacle 28 in the box 20;
• the mechanical clips 44 are placed in the separated position, the receptacle 28 is placed in the receiving space and the sensor 30 is placed above the receptacle 28.
• 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. .
• the needles are completely immersed in the solution.
• the support means are for example formed by the cover 24 in combination or not with the watch case, or mechanical clips 44 in combination or not with the watch case.
• the support means are maintained in their support position for a period of between 10 seconds and 2 hours.
• the duration of immersion of the needles 32 is thus sufficient to carry out a pre-calibration measurement and a resetting, according to steps 300 and 410 described below, and / or to carry out a pre-wetting of the needles 32. .
• the duration of maintaining the support means in the support position is even more preferably between 1 minute and 120 minutes, especially in the case of pre-wetting.
• the duration of maintenance of the support means is advantageously between 10 seconds and 2 minutes in the case of a pre-calibration carried out alone.
• a sensor preparation assembly may include a cover 24 able to press hands 32 inside the watch. pocket 26, without watch 10.
• a cover 24 able to press hands 32 inside the watch. pocket 26, without watch 10.
• the method 50 comprises additional steps 300 to 410.
• step 300 the sensor 30 is controlled to acquire a measurement of the concentration of a body analyte, here the glucose concentration, of the preparation solution contained in the bag 26.
• the sensor 30 is preferably controlled by the processing unit 14 contained in the housing
• the senor 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 qualified as a “pre-calibration measurement”.
• step 400 the pre-calibration measurement is transmitted to the processing unit of the electronic device.
• the sensor 30 is already in place on the housing 12 and can exchange data with the housing 12 during the measurement.
• the pre-calibration measurement can be saved in an electronic memory on board the sensor 30, for later reading by the ready-to-use device. carry.
• the precalibration measurement is saved in a memory of another device (for example a memory of the station 40), then transmitted to the ready-to-wear device by wired or wireless communication.
• a registration signal is calculated.
• the readjustment signal is preferably obtained from the pre-calibration measurement, and from the reference value of the concentration of body analyte in the calibration solution.
• the readjustment signal includes code instructions for rectifying the measurement to make it correspond to 10 millimoles per liter.
• the glucose concentration in the calibration solution of the bag 26 is used as a reference to reset the measurement supplied by the sensor 30.
• the readjustment signal is saved, so that the readjustment is carried out automatically during the subsequent measurements supplied by the sensor 30.
• the reset signal is recorded in a memory of watch 10, in association with a reference of the capsule containing the sensor 30.
• the reference of the capsule is for example an alphanumeric code assigned to the capsule, to the from the production of the capsule.
• a visual indicator on the watch can be turned on to indicate the end of the pre-calibration operation.
• the preparation assembly illustrated in Figure 3 includes a transparent or semi-transparent window 241 which allows the user to observe the end of the pre-calibration operation while the cover 24 is closed.
• the resetting signal is recorded in a memory of the sensor.
• step 410 the support position of the support means is released and the sensor 30 is released.
• 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 beforehand.
• the bag 26 is preferably discarded.
• a new bag 26 is preferably used for any new iteration of the sensor preparation process 50, to ensure perfect sterility of the sensor 30.
• Such a pre-calibration method is particularly useful when replacing the interchangeable removable capsule containing the sensor.
• a new removable capsule comprising a non-pre-calibrated sensor 30 is for example inserted into the back of the housing 12. Then, a sensor preparation assembly according to any one of the examples described above is used for. in particular pre-wet and pre-calibrate the sensor 30.
• One advantage is that the new removable capsule is already inserted into the watch 10 after the preparation of the sensor.
• the method 50 thus makes it possible to correct the possible drift of the electrochemical measurement supplied by a needle sensor of a body monitoring system.
• the readjustment of the sensor measurement is carried out in a simple, fast and reliable manner. It is advantageous to carry out, simultaneously or sequentially, the readjustment of the measurement and the pre-wetting of the needles of the sensor, which is made possible by the sensor preparation assemblies described above. Furthermore, the readjustment of the sensor measurement can be carried out simultaneously with the charging of a battery of the ready-to-wear device, as seen above.
• the pre-calibration of the sensor increases the reliability of the measurement provided by the sensor. In the present example, the pre-calibration of the sensor, possibly associated with a “factory calibration” at the end of production, ensures satisfactory accuracy of the blood glucose measurement throughout the cycle of use of the ready-to-use device. carry.

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• 2020
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