MULTI-INPUT BODY MONITORING METHOD

Abstract

The present invention relates to a method for determining a body quantity, preferably physiological, of a user, the method comprising the steps of providing a body monitoring device, receiving, by a control and processing unit, data from a sensor of a body analyte concentration, receiving, by the control and processing unit, data representative of the body quantity measured by a module for measuring a body quantity different from the analyte concentration, and determining a value representative of at least one body quantity chosen from stress, muscle fatigue, and a rectified concentration of the analyte in the interstitial fluid. Figure for abstract: Fig. 2

Description

Title of the invention: MULTI-INPUT BODY MONITORING METHOD FIELD OF THE INVENTION

[0001] The present invention relates to a method of body monitoring. More specifically, it relates to a method of body monitoring by analyzing body fluid, typically interstitial. STATE OF THE ART

[0002] Certain pathologies such as diabetes require daily monitoring of physiological quantities of the human body, in particular concentrations of certain compounds (blood sugar in the example of glucose).

[0003] To do this, it is common to prick a point on the skin so as to cause a drop of blood to appear, and to analyze this drop either reactively (for example with a strip), or electronically (for example by at least one analytical sensor), so as to estimate the target quantity(ies).

[0004] Today, less invasive systems are known, which simply analyze the interstitial fluid, that is to say the fluid which fills the space between the blood capillaries and the cells. Indeed, the interstitial fluid has an ionic composition close to that of blood plasma.

[0005] Such systems thus make it possible to monitor the desired physiological quantities transcutaneously, without having to regularly pierce the skin.

[0006] In particular, a wrist-worn device called GlucoWatch was proposed, implementing a phenomenon known as iontophoresis (or iontophoresis) in which an electric field allows interstitial fluid to be attracted through the skin to a sensor on the wall of the device. However, this concept was quickly abandoned because only 6% of patients tolerated the pain caused by electrical extraction. In addition, the measurement results were unreliable.

[0007] Alternatively, transcutaneous probes have been proposed in the form of a self-adhesive patch placing a “microneedle sensor” just under the skin, so as to put the sensor in permanent fluid communication with the interstitial fluid, for continuous monitoring. Some of these patch-type transcutaneous probes include wireless communication means for sending measurements on the interstitial fluid to a mobile terminal, for storage and / or processing of the measurements (verification of thresholds and variations, production of statistics, triggering of alerts if necessary, etc.). Examples include the sugarBEAT™ or FreeStyle Libre systems.

[0008] However, the values ​​of a glucose concentration in the interstitial fluid of a user measured by known devices may present variations or anomalies capable of significantly modifying, or even distorting, the measurement of the glucose concentration. Statement of the invention

[0009] An aim of the invention is to propose a solution for measuring bodily quantities, such as blood sugar, a user's stress, and / or a user's muscular fatigue, with more precision than with known methods.

[0010] This aim is achieved within the framework of the present invention by means of a method for determining a body size, preferably physiological, of a user, the method comprising the steps of: (a) providing a body monitoring device, the device comprising - a sensor of a concentration of the body analyte in an interstitial fluid, - at least one module for measuring a body quantity of the user, the body quantity being a quantity different from the concentration of the analyte measurable by the sensor, - a housing comprising a control and data processing unit configured to receive data from the sensor and data from the measurement module, (b) receipt, by the control and processing unit, of data from the sensor, the data from the sensor being representative of the concentration of the analyte in the interstitial fluid of the user, c) reception, by the control and processing unit, of data representative of the body size from the measurement module, d) determining a value representative of at least one bodily quantity of the user from the data from the sensor received during step b) and the data from the module received during step c).

[0011] The invention is advantageously supplemented by the following characteristics, taken individually or in any of their technically possible combinations:

[0012] - the body size determined during step d) is chosen from a stress, muscle fatigue, and a rectified concentration of the analyte in the interstitial fluid,

[0013] - the body size is determined by implementing the steps of: e) commanding a first series of measurements implemented by the sensor, each measurement being associated with the data supplied to the control unit during step b), the measurements being implemented at a first regular time interval, f) control of a second series of measurements implemented by the module, each measurement being associated with the data supplied to the control unit during step c), the measurements being implemented at a second regular time interval, the determination of the representative value during step d) being implemented periodically, from data coming from the sensor and from data coming from the module measured during the same third time interval, the third time interval being equal to twice the longest time interval of the first time interval and the second time interval, the third time interval preferably being less than three minutes,

[0014] - step b) also comprises a determination by the control unit and processing a representative value of the concentration of the analyte from the data received from the sensor,

[0015] - during step d), the representative value of the rectified concentration is determined of the analyte in the interstitial fluid, and step d) comprises a sub-step of correction or deletion, by the control and processing unit, of the representative value of the concentration of the analyte determined during step b) from the values ​​of the data representative of the body size received during step c),

[0016] - the sensor comprises a plurality of microneedles adapted to be inserted into the user's dermis, and a plurality of electrodes, each electrode comprising a metallic active surface arranged on the surface of one of the microneedles and also comprising biomolecules covering the active surface, each electrode being adapted to measure a concentration of the analyte in the user's interstitial fluid by an electrochemical reaction between the biomolecules and the analyte,

[0017] - the module for measuring a body size of the user's body is a accelerometer and / or a movement detector, and, during step d), the representative value of at least one body quantity is determined by correcting and / or deleting the representative value of the concentration of the analyte measured during step b) from the result of a comparison between, on the one hand, a predetermined threshold and / or a predetermined time profile representative of an acceleration and / or a movement of the device and, on the other hand, a value of the measurement of the body quantity and / or a time profile of a value of the measurement of the body quantity,

[0018] - the module for measuring a body size of the user's body is configured to measure an impedance at the surface and / or in the user's skin,

[0019] - during step d), the representative value of at least one is determined body size, by correcting and / or deleting the representative value of the concentration of the analyte measured during step b) from the result of a comparison between, on the one hand, a predetermined threshold and / or a profile over time predetermined representative) of a humidity level at the surface of the skin, and on the other hand, a value of the measurement of the body size and / or a profile over time of a value of the measurement of the body size,

[0020] - the module for measuring a body size of the user's body is a heart rate monitor configured to measure the user's heart rate,

[0021] - during step d), the representative value of at least one is determined body size, by correcting and / or deleting the representative value of the concentration of the analyte measured during step b) from the result of a comparison between, on the one hand, a predetermined threshold and / or a predetermined time profile representative of a heart rate, and on the other hand, a value of the measurement of the body size and / or a time profile of a value of the measurement of the body size,

[0022] - the module for measuring a body size of the user's body is a pH sensor configured to measure the pH on the user's skin and / or in the user's interstitial fluid,

[0023] - the representative value of at least one bodily quantity is determined, in correcting and / or deleting the representative value of the concentration of the analyte measured during step b) from the result of a comparison between, on the one hand, a predetermined threshold and / or a predetermined time profile representative of the pH on the user's skin and / or in the user's interstitial fluid, and on the other hand, a value of the measurement of the body size and / or a time profile of a value of the measurement of the body size.

[0024] - the housing also comprises means for attachment to the user's body,

[0025] - during step d), the determined value is representative of muscular fatigue, the method further comprising a step of transmitting a signal to the user when the value representative of muscular fatigue exceeds a predetermined value representative of muscular fatigue.

[0026] Another aspect of the invention is a body monitoring device, the device comprising - a sensor of a concentration of the bodily analyte in an interstitial fluid, - at least one module for measuring a body quantity of the user, the body quantity being a quantity different from the concentration of the analyte measurable by the sensor, - a housing comprising a control and data processing unit configured to receive data from the sensor and data from the measurement module, the device being configured to: - that the control and processing unit receives data from the sensor, the data from the sensor being representative of the concentration of the analyte in the user's interstitial fluid, - that the control and processing unit receives data representative of the body size measured by the measurement module, - determine a representative value of at least one bodily quantity, preferably chosen from stress, muscular fatigue, and a rectified concentration of the analyte in the interstitial fluid, from the data received from the sensor and the data received from the module.

[0027] Advantageously, the sensor and / or the module are mounted fixed to the housing, preferably in a removable manner. DESCRIPTION OF FIGURES

[0028] Other characteristics, aims and advantages of the invention will emerge from the following description, which is purely illustrative and non-limiting, and which must be read in conjunction with the appended drawings in which:

[0029] [Fig.l] - [Fig.l] schematically illustrates a body monitoring device according to one embodiment of the invention,

[0030] [Fig.2] - [Fig.2] schematically illustrates a method according to one embodiment of the invention.

[0031] Throughout the figures, similar elements bear identical references. DEFINITIONS

[0032] The term "electrode" means a conductive device for sensing variations in electrical potential in a living organism. An electrode comprises at least two ends, or terminals, between which an electrical potential or an electrical current is transmitted. An electrode may preferably have at least three ends, at least two of the ends being intended to penetrate the body of a living organism. In this case, it will be noted that the electrode is unique, even if several ends are intended to penetrate the body of a living organism.

[0033] The term “body quantity” means any physical, chemical and / or biological quantity representative of a state of the user’s body.

[0034] The term “physiological quantity” means any physical, chemical and / or biological quantity representative of a physiological state of the user’s body.

[0035] “Stress” means a non-specific response of the user’s body to any demand. Smets et al. have shown, in the document “Smets, E., Velâzquez, ER, Schiavone, G., Chakroun, L, D’Hondt, E., De Raedt, VF, ... & Van Diest, I. (2018). Earge-scale wearable data reveal digital phenotypes for daily-life stress detection. NPJ digital medicine, 1(1), 1-10 », that stress is reliably characterized by various physiological signals from the user, which gives it a technical character. For example, it is known to measure a user's stress using skin conductance, an electrocardiogram, an electromyogram, blood pressure, or skin temperature (with reference to the document "Sharma, N. & Gedeon, T. Objective measures, sensors and computational techniques for stress recognition and classification: a survey. Comput. Methods Prog. Biomed. 108, 1287-1301 (2012)").

[0036] "Muscle fatigue" is understood to mean a bodily quantity quantified as a decrease in the maximum strength or power capacity of the muscle (with reference to the document "Enoka, RM, & Duchateau, J. (2008). Muscle fatigue: what, why and how it influences muscle function. The Journal of physiology, 586(1), 11-23)"). It is known to measure muscle fatigue by measuring, for example, an accumulation of metabolites in the fibers of a muscle, or by an electromyogram. DETAILED DESCRIPTION OF THE INVENTION

[0037] With reference to [Fig.l], a body monitoring device 2 according to one embodiment of the invention comprises a sensor 3 of a concentration of a body analyte in an interstitial fluid of the user. The sensor 3 preferably comprises a plurality of microneedles 8 adapted to be inserted into the dermis of the user, a plurality of electrodes 9, each electrode 9 comprising a metallic active surface 10 arranged on the surface of one of the microneedles 8 and also comprising biomolecules covering the active surface 10. Each electrode 9 is adapted to measure a concentration of the analyte in the interstitial fluid of the user by an electrochemical reaction between the biomolecule and the analyte.Thus, it is possible to measure the concentration of the analyte in the interstitial fluid of the user without causing pain to the user, unlike, for example, when using a centimeter needle in known devices. It is possible to choose the analyte detected by the electrodes 9 by choosing a biomolecule suitable for recognizing this analyte, preferably by electrochemistry. Preferably, the analytes detected are glucose and / or lactate. The electrode 9 preferably comprises a coating, the coating comprising the biomolecules, the coating being configured to allow an electrochemical measurement of a concentration of the analyte in the interstitial fluid within a predetermined concentration range of the analyte.

[0038] The sensor 3 and / or the module 4 can be mounted fixedly in the housing 5, preferably in a removable manner. Thus, the data measured by the sensor 3 and by the module 4 can be representative of the same organ of the user. In addition, it is thus possible to integrate in the same device the display of the determined body size, and the measurements carried out by the sensor 3 and by the module 4.

[0039] The device 2 also comprises at least one module 4 for measuring a bodily quantity of the user, the bodily quantity being a quantity different from the concentration of the analyte measurable by the sensor 3. The measured bodily quantity may preferably be at least chosen from the movement of an organ of the user, the acceleration of an organ of the user, the muscular fatigue of the user (or its corollary: the muscular form of the user), the stress of the user, the concentration of an analyte in the body of a user, the heart rate of the user or the frequency of the heartbeats of the user, an impedance at the surface and / or in the skin of the user, the pH on the skin of the user, and / or the pH of the interstitial fluid of the user.Preferably, the body quantity does not include the acceleration of an organ of the user in space, nor the detection of the movement of the organ of the user in space. Considering that the detection of the movement in space of an organ of the user and the acceleration of an organ of the user are not physiological quantities, the measured body quantity is preferably a physiological quantity, and perhaps preferably at least chosen from the muscular fatigue of the user (or its corollary: the muscular fitness of the user), the stress of the user, the concentration of an analyte in the body of a user, and / or the heart rate of the user or the frequency of the heartbeats of the user, an impedance at the surface and / or in the skin of the user, the pH on the skin of the user, and / or the pH of the interstitial fluid of the user.

[0040] The device 2 also comprises a housing 5 comprising a data control and processing unit 7, the unit 7 being configured to receive data from the sensor 3 and data from the measurement module 4. The data can be transmitted from the sensor 3 to the control and processing unit 7 electrically, preferably by transmission of an electrical signal in electrodes connecting the sensor 3 to the unit 7. The data can also be transmitted by electromagnetic waves, when the sensor 3 is provided with an electromagnetic wave transmitter and the unit 7 is provided with an electromagnetic wave receiver. The housing 5 can also comprise a display unit, and / or other means for transmitting information or signals to the user.In particular, the display unit allows the user to know in real time the measured body quantity, and preferably the measured physiological quantity.

[0041] In the case where the module 4 is configured to measure a concentration of an analyte different from the concentration of another analyte measured by the sensor 3, the module 4 may also comprise a plurality of microneedles 8 adapted to be inserted into the dermis of the user, a plurality of electrodes 9, each electrode 9 comprising a metallic active surface 10 arranged on the surface of one of the microneedles 8 and also comprising biomolecules covering the active surface 10, each electrode 9 being adapted to measure a concentration of the analyte in the interstitial fluid of the user by an electrochemical reaction between the biomolecule and the analyte. Thus, it is possible to measure the concentration of the analyte in the interstitial fluid of the user without causing pain to the user, unlike a measurement of such a concentration using a centimeter needle. It is possible to choose the analyte detected by the electrodes 9 by choosing a biomolecule adapted to the recognition of this analyte, preferably by electrochemistry.Preferably, the detected analytes are glucose and / or lactate. Indeed, a measurement of the concentration of lactate in the user's body makes it possible to determine, at least in part, muscular fatigue of the user. The electrode preferably comprises a coating, the coating comprising the biomolecules, the coating being configured to allow an electrochemical measurement of a concentration of the analyte in the interstitial fluid in a predetermined concentration range of the analyte.

[0042] The housing 5 preferably comprises means 6 for attachment to the user's body. Thus, it is possible to simplify the measurement of the body quantity, preferably the physiological quantity, by integrating in a single device the means for measuring the body quantity and the means for communicating this measurement to the user. In addition, in the case where the sensor 3 comprises microneedles 8, the means 6 for attachment to the user's body allow one of the faces to exert pressure on the skin. Thus, the microneedles 8 can be inserted to a predetermined depth, so as to detect the analyte in the user's interstitial fluid.

[0043] With reference to [Fig.2], one aspect of the invention is a method 1 for determining a body quantity, preferably physiological.

[0044] The method 1 comprises a step 201 of providing a body monitoring device 2.

[0045] The method 1 comprises a step 202 of receiving, by the control and processing unit 7, data from the sensor 3, the data from the sensor 3 being representative of the concentration of the analyte in the interstitial liquid of the user. Preferably, the step 202 also comprises a determination by the control and processing unit 7 of a value representative of the concentration of the analyte from the data received from the sensor 3.

[0046] The method 1 comprises a step 203 of reception, by the control and processing unit 7, of data representative of the body quantity measured by the measurement module 4. Preferably, the step 203 also comprises a determination by the control and processing unit 7 of a value representative of the body quantity from the data received from the module 4.

[0047] The method 1 comprises a step 204 of determining a value representative of at least one bodily quantity of the user. Preferably, the bodily quantity is chosen from stress, muscular fatigue, and a rectified concentration of the analyte in the interstitial liquid from the data from the sensor 3 received during step 202 and the data from the module 4 received during step 203.

[0048] Indeed, certain bodily quantities, preferably physiological, cannot be detected or measured precisely using one or more sensors making it possible to measure a single bodily quantity. The inventors have discovered that the measurement of different distinct bodily quantities of the user allows the continuous measurement of another bodily quantity, and / or makes it possible to precisely measure one of the bodily quantities initially measured. Thus, it is possible to measure the stress of a user. In addition, it is possible to precisely measure muscular fatigue and / or the concentration of an analyte in the user's body.

[0049] The body size can be determined by further implementing the steps of: - control of a first series of measurements implemented by the sensor 3, each measurement being associated with the data supplied to the control unit 7 during step 202, the measurements being implemented at a first regular time interval, - control of a second series of measurements implemented by the module 4, each measurement being associated with the data supplied to the control unit during step 203, the measurements being implemented at a second regular time interval, the determination of the representative value during step 204 being implemented periodically, from data coming from the sensor 3 and from data coming from the module 4 measured during the same third time interval, the third time interval being equal to twice the longest time interval of the first time interval and the second time interval, the third time interval preferably being less than three minutes. Thus, it is possible to determine the body size continuously over time, for example to monitor it or to allow an interaction with the user to be initiated.The determination of the body size during step 204 can in fact be carried out from measurements of the sensor 3 and the module 4 carried out simultaneously.

[0050] In the case where the representative value of the rectified concentration of the analyte in the interstitial liquid is determined, step 204 preferably comprises a sub-step of correction of deletion by the control and processing unit 7, of the representative value of the concentration of the analyte determined during step 202 from the values ​​of the data representative of the body size received during step 203. Thus, the concentration of bodily analyte can be determined more precisely so as to take into account other bodily parameters, and preferably physiological parameters, of the user's body.

[0051] In the case where the module 4 is an accelerometer and / or a motion detector, the representative value of at least one bodily quantity is preferably determined during step 204 by correcting and / or deleting the representative value of the concentration of the analyte measured during step 202 from the result of a comparison between, on the one hand, a predetermined threshold and / or a predetermined time profile representative of an acceleration and / or a movement of the device and, on the other hand, a value of the measurement of the bodily quantity and / or a time profile of a value of the measurement of the body quantity. Indeed, the movements of the user can cause movements of the microneedles in the user's skin, and thus cause measurement errors.Thus, it is possible to eliminate measurements that correspond to artifacts and / or series of measurements that correspond to artifacts or series that cannot be used to measure a concentration of the body analyte.

[0052] The module 4 may be a module configured to measure an impedance at the surface and / or in the skin of the user. Indeed, a difference in impedance on and / or in the skin of the user may be correlated with variations in the concentration of the analyte to be measured. Thus, it is possible to take into account these variations in impedance to correct or eliminate values ​​which would not be relevant in measuring the concentration of the analyte.

[0053] During step 204, it is preferentially possible to determine the representative value of at least one bodily quantity, by correcting and / or deleting the representative value of the concentration of the analyte measured during step 202 from the result of a comparison between, on the one hand, a predetermined threshold and / or a predetermined time profile representative of a humidity level at the surface of the skin, and on the other hand, a value of the measurement of the bodily quantity and / or a time profile of a value of the measurement of the bodily quantity. Thus, it is possible to take into account in the measurement of the bodily quantity determined in step 204 the humidity at the surface of the skin.

[0054] During step 204, it is preferentially possible to determine the representative value of at least one bodily quantity, by correcting and / or deleting the value representative of the concentration of the analyte measured during step 202 from the result of a comparison between, on the one hand, a predetermined threshold and / or a predetermined time profile representative) of a heart rate, and on the other hand, a value of the measurement of the body size and / or a time profile of a value of the measurement of the body size. Thus, it is possible to take into account the user's heart rate dependence of the measured body size.

[0055] During step 204, it is preferentially possible to determine the representative value of at least one body quantity, by correcting and / or deleting the representative value of the concentration of the analyte measured during step 202 from the result of a comparison between, on the one hand, a predetermined threshold and / or a predetermined time profile representative of the pH on the skin of the user and / or in the interstitial fluid of the user, and on the other hand, a value of the measurement of the body quantity and / or a time profile of a value of the measurement of the body quantity. Thus, it is possible to take into account the dependence of the measured body quantity on the pH.

[0056] The method 1 preferably comprises a step of transmitting a signal to the user when the value representative of muscular fatigue exceeds a predetermined value representative of muscular fatigue. Thus, it is possible for the user to base his training on objective criteria of muscular fatigue rather than basing his training on his impression during training.

[0057] Another aspect of the invention is a body monitoring device 2 configured to implement the steps of at least one of the embodiments of the invention.

Claims

1. Claims Body monitoring device (2), comprising - a sensor (3) of a concentration of the body analyte in an interstitial liquid, - at least one module (4) for measuring a body quantity of the user, the body quantity being a quantity different from the concentration of the analyte measurable by the sensor (3), - a housing (5) comprising a data control and processing unit (7) configured to receive data from the sensor (3) and data from the measurement module (4), the control and processing unit (7) being configured to implement the steps of: b) receiving data from the sensor (3), the data from the sensor (3) being representative of the concentration of the analyte in the interstitial fluid of the user, c) receiving data representative of the body size from the measurement module (4), d) determining a value representative of at least one bodily quantity of the user from the data from the sensor (3) received during step b) and the data from the module (4) received during step c), the bodily quantity is determined by implementing the steps of: e) controlling a first series of measurements implemented by the sensor (3), each measurement being associated with the data received during step b), the measurements being implemented at a first regular time interval, f) commanding a second series of measurements implemented by the module (4), each measurement being associated with the data received during step c), the measurements being implemented at a second regular time interval, the determination of the representative value during step d) being implemented periodically, from data coming from the sensor (3) and from data coming from the module (4) measured during the same third time interval, the third time interval is equal to twice the longest time interval of the first time interval and of the second time interval.

2. Device according to the preceding claim, in which the body size determined during step d) is chosen from stress, muscular fatigue, and a rectified concentration of the analyte in the interstitial fluid.

3. Device according to one of the preceding claims, in which the third time interval is less than three minutes.

4. Device according to one of the preceding claims, in which step b) also comprises a determination by the control and processing unit (7) of a value representative of the concentration of the analyte from the data received from the sensor (3).

5. Device according to the preceding claim, in which, during step d), the representative value of the rectified concentration of the analyte in the interstitial liquid is determined, and in which step d) comprises a sub-step of correction or deletion, by the control and processing unit (7), of the representative value of the concentration of the analyte determined during step b) from the values ​​of the data representative of the body size received during step c).

6. Device according to one of the preceding claims, in which the sensor (3) comprises: - a plurality of microneedles (8) adapted to be inserted into the dermis of the user, - a plurality of electrodes (9), each electrode (9) comprising a metallic active surface (10) arranged on the surface of one of the microneedles (8) and also comprising biomolecules covering the active surface (10), each electrode (9) being adapted to measure a concentration of the analyte in the interstitial fluid of the user by an electrochemical reaction between the biomolecule and the analyte.

7. Device according to one of claims 4 to 6, in which: - the module (4) for measuring a bodily quantity of the user's body is an accelerometer and / or a movement detector, - during step d), the representative value of at least one bodily quantity is determined by correcting and / or deleting the representative value of the concentration of the analyte measured during step b) from the result of a comparison between, on the one hand, a predetermined threshold and / or a predetermined time profile representative) of an acceleration and / or a movement of the device and on the other hand a value of the measurement of the body quantity and / or a profile over time of a value of the measurement of the body quantity.

8. Device according to one of the preceding claims, in which the module (4) for measuring a body quantity of the user's body is configured to measure an impedance at the surface and / or in the skin of the user.

9. Device according to the preceding claim, in which, during step d), the representative value of at least one bodily quantity is determined, by correcting and / or deleting the representative value of the concentration of the analyte measured during step b) from the result of a comparison between, on the one hand, a predetermined threshold and / or a predetermined time profile representative of a humidity level at the surface of the skin, and on the other hand, a value of the measurement of the bodily quantity and / or a time profile of a value of the measurement of the body quantity.

10. Device according to one of the preceding claims, in which the module (4) for measuring a bodily quantity of the user's body is a heart rate monitor configured to measure a heartbeat frequency of the user.

11. Device according to one of the preceding claims, in which the module (4) for measuring a body quantity of the user's body is a pH sensor configured to measure the pH on the user's skin and / or in the user's interstitial fluid.

12. Device according to one of the preceding claims, in which the housing (5) also comprises means (6) for attachment to the user's body.

13. Device according to one of the preceding claims, in which the sensor (3) and / or the module (4) are mounted fixed to the housing (5), preferably in a removable manner.

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