EP3694395A1

EP3694395A1 - Cutaneous system for monitoring an individual

Info

Publication number: EP3694395A1
Application number: EP18783034.4A
Authority: EP
Inventors: Fabrice VAUSSENAT
Original assignee: Devinnova
Current assignee: Devinnova
Priority date: 2017-10-13
Filing date: 2018-10-12
Publication date: 2020-08-19
Also published as: CN111727007A; EA202091307A1; US20200397314A1; CA3084549A1; FR3072270A1; WO2019073061A1; FR3072270B1; JP2021509860A

Abstract

The invention relates to a cutaneous patch for monitoring the heart rate of an individual, as well as to a monitoring system comprising such a patch, and to an assembly that comprises a system of this type.

Description

Skin monitoring system of an individual

GENERAL TECHNICAL FIELD

The present invention provides a skin patch for collecting cardiac signals as well as other physiological parameters of an individual for obtaining parameters indicative of the cardiac activity of the patient individual. These parameters allow real-time monitoring of the individual's cardiac activity in ambulatory settings.

The invention also relates to a system for monitoring the cardiac activity of an individual comprising such a patch, the monitoring can be done remotely.

STATE OF THE ART

Monitoring ambulatory heart rate of individuals is used in many cases: suspected heart disease, effect of certain treatments, etc.

To do this, several monitoring devices are known. The most used are ECG Holter type devices that can record the ECG of the individual.

A problem is that this type of device is not practical because bulky. Another problem is that it only acquires a certain type of signal and does not allow real-time monitoring: the individual must wear the device for 24 hours and have the signals analyzed by a practitioner.

Yet another problem is that given the limited number of different signals acquired, the characteristic parameters of the individual's cardiac activity obtained are limited.

Consequently, there is a need to have a device for monitoring cardiac activity that can operate in real time, which is convenient for the individual to wear and which can contribute to obtaining several parameters characteristic of the patient. cardiac activity of the individual.

PRESENTATION OF THE INVENTION

The invention meets the above need and proposes, according to a first aspect, a cutaneous heart rate monitoring patch intended to be worn by an individual, the patch comprising, in a successive manner a bonding layer comprising a first adhesive face intended to be in contact with the skin of the individual and a second face;

a flexible printed circuit comprising

a first face supporting a plurality of sensors, said first face of said circuit being in contact with the second face of the bonding layer and said sensors comprising:

three electrodes configured to acquire signals representative of the cardiac activity of the individual, said electrodes being arranged according to an equilateral triangle,

a pressure sensor configured to measure the respiratory rate of the individual

a connector on which an electronic module is intended to be connected; said module being configured to control the sensors in order to acquire physiological parameters of the individual and, from said acquired parameters, to determine, in situ, parameters characteristic of the cardiac activity of the individual;

a second face opposite to the first face and supporting contacts coming from the sensors;

a shell covering the bonding layer and the flexible printed circuit, said shell comprising a lower part in contact with the second face of the flexible printed circuit and an upper part intended to be in the open air, said lower part comprising a housing intended to to house the electronic module;

the tie layer comprising a tongue having a shape adapted to cover the housing of the shell, said tongue to open or close the housing to allow the insertion or removal of the electronic module, the shell and the tongue together contributing to ensure the tightness of the housing so as to both withstand water and secondly to maintain a constant pressure in the housing.

The invention is advantageously completed by the following characteristics, taken alone or in any of their technically possible combination.

The printed circuit supports in addition: two temperature sensors configured to measure the cutaneous temperature of the individual;

a transmitter / receiver of an infra-red signal configured to measure the oxygen saturation of the individual;

an accelerometer configured to determine the posture of the individual.

The printed circuit further supports a piezoelectric sensor configured to measure tissue density by elastography.

The electrodes are equilaterally arranged and are spaced two by two by a distance of between 65 mm and 82 mm, typically 78 mm.

The infrared transmitter / receiver is configured to emit a signal having a wavelength of between 1420 mm and 1800 mm, typically between 1450 mm and 1700 mm.

The infrared transmitter / receiver is configured to emit a signal to the skin of the individual that is refracted by the skin at an angle of between 25 ° and 65 °, typically between 30 ° and 60 °.

The lower part of the shell comprises a space formed in said lower part so as to house a battery such as a button-type battery.

The upper part of the shell comprises a protective layer above the space intended to house the battery, said protective layer being configured to block electromagnetic waves coming from the battery during the operation of the patch, said protective layer preferably being polycarbonate.

The patch comprises hydrogel pellets disposed on each of the electrodes, the electrodes being in contact with the skin of the individual via said pellets.

The layer comprises three recesses of the size of the electrodes so as to allow contact of the electrodes with the skin of the individual.

The invention also relates to a skin monitoring system comprising a patch according to the invention and an electronic module electrically connected to the flexible printed circuit, said electronic module being configured to control the sensors and for information from the sensors to determine characteristic parameters. the cardiac activity of the individual. The invention also relates to a skin monitoring assembly comprising a surveillance system according to the preceding claim, a mobile terminal, the monitoring system being in wireless connection with the mobile terminal.

The advantages of the invention are manifold.

The structure of the patch comprising few layers is particularly advantageous insofar as its manufacture is simple and easily repeatable.

From the patch, it is possible to measure the electrical signals of the heart along three leads thus making it possible to have a morphological information (right heart, left heart) of the heart and to specify the origin of the disturbance of the rhythm.

Infrared (IR) measurement by reflection allows measurement of the heart rate thus making reliable the measurement from the ECG but also to measure the variation of the SP02.

The measurement of the temperature by two thermistor type temperature sensors also ensures the differential measurement of the temperature. This measurement allows us to track the temperature coefficient to find out if the patient is lowering or increasing their temperature.

The pressure sensor housed in a constant-pressure sealed chamber allows precise measurement of the pressure variation resulting from the costal movement with regard to the respiratory rate deduced from the ECG.

In addition, the measurement of the pressure by a dedicated sensor makes it possible to have a more precise measurement than when the pressure is deduced from the ECG.

Density measurement assesses ischemic necrosis and proposes an evaluation of unknown antecedents.

The combined information in specific algorithms makes it possible to measure indicators (physio-markers) thus enabling early detection of infarction, rhythm disorders, respiratory distress).

The lightness of the patch as well as the absence of wire allow the user to have total freedom with regard to his activity. Thus the problems of disconnection of the wires on the electrodes, the limit of use under stress conditions are limitations that are lifted and allow optimization of the support.

Indeed, the use of the patch with the effort is possible because it integrates the filtering of artefacts related to the myoelectric noise.

The invention enables real-time monitoring of an individual's cardiac activity. Indeed, the presence of an electronic module driving the sensors and performing the necessary treatments to obtain this information in real time.

The patch comprising several sensors can be used in particular for the detection of several cardiac disorders: bradycardia, tachycardia, atrial (or atrial) fibrillation, ventricular fibrillation, ventricular arrhythmias, extrasystoles (atrial or ventricular), cardiac conduction disorders, infarction.

PRESENTATION OF FIGURES

Other features, objects and advantages of the invention will emerge from the description which follows, which is purely illustrative and nonlimiting, and which should be read with reference to the appended drawings in which:

Figure 1 illustrates a monitoring assembly according to one embodiment of the invention;

FIG. 2 illustrates a front view of a cutaneous patch of a cutaneous monitoring system according to one embodiment of the invention;

Figure 3 illustrates an exploded view of a skin monitoring system according to one embodiment of the invention;

FIG. 4 illustrates a view of a printed circuit of a skin surveillance system according to the invention;

FIG. 5 schematically illustrates an electronic module of a skin surveillance system according to the invention.

In the set of figures, similar elements bear identical references.

DETAILED DESCRIPTION OF THE INVENTION

Figure 1 illustrates an individual 1 wearing a skin monitoring system 100 comprising a skin patch according to one embodiment.

The system 100 is intended to acquire, in addition to heart signals (known as ECG signals), several signals characteristic of physiological parameters of the individual: cutaneous temperature, posture, oxygen saturation, muscle mass density.

These signals make it possible to obtain characteristic parameters of the cardiac activity of the individual. The system 100 may advantageously be connected to a mobile terminal 2 (smartphone or tablet for example) via a wireless link of Bluetooth type.

The mobile terminal 2 embeds a mobile application that retrieves data from the system 100 to process, display or transmit to a remote server 3.

As such, the mobile terminal 2 can connect to the remote server 3 via a mobile network type Internet. The connection to this server is preferably secure. This server 3 allows the remote storage of data from the system 100 passing through the mobile terminal 2. This remote server 3 is connected via the mobile network to a remote terminal 4 comprising an interface (not shown) allowing a user, such as a doctor, to access the acquired data as well as the characteristic parameters of the activity. cardiac of the individual. Via this terminal 4, a doctor or other authorized person may receive alerts depending on the characteristic parameters of the cardiac activity obtained. This is particularly beneficial when it comes to remotely monitoring individuals at risk.

Patch 10

As mentioned, the system 100 is intended to be worn by an individual and comprises a patch 10 (visible in Figure 2) skin consisting of several layers (visible in Figure 3) and an electronic module 14 powered by a battery 18 such as a button-type battery.

The patch 10 advantageously comprises the following successive stacking: a layer 1 1 of binding comprising a first face 1 1 a adhesive in contact with the skin and a second side 1 1 b adhesive;

a flexible printed circuit 12;

a shell 13 covering the bonding layer and the printed circuit 12.

A layer 1 1 of binding with the skin ensures the binding of the patch 10 with the skin of the individual. The first side is therefore adhesive and supports a hypoallergenic adhesive to prevent possible allergic reactions. The first adhesive face 11a is preferably protected by a removable sheet (not shown) which withdraws before application of the patch 10 to the skin.

The second non-adhesive face 1 1b (that which is not intended to be in contact with the skin) supports a printed circuit 12 (shown in detail in FIG. 4) itself supporting a number of sensors that measure a number of signals representative of the cardiac activity of the individual.

The flexible printed circuit 12 includes a first face 12a supporting a plurality of sensors. The first face of the printed circuit 12 is in contact with the second face 11b of the connecting layer 11. The printed circuit 12 comprises three electrodes 121, 122, 123 in contact with the skin of the individual via three zones 11, 11, 11, 13 recessed in the layer 1 1 of connection. Additionally, hydrogel cushions (one for each electrode) make it possible to increase the contact area of the electrodes with the skin of the individual and to absorb water from the pores of the skin.

The circuit 12 printed comprises a connector 129 on which is connected an electronic module 14 electrically connected to the circuit 12 printed. In this way, it is possible to remove the electronic module 14 to reuse it with another patch or to perform updates.

The connector 129 is accessible from the first adhesive face 1 1a of the bonding layer via an opening 1 14 resealable by a tab 1 15. This tab 1 15 facilitates access to the electronic module 14 and makes it possible to seal of the zone in which the electronic module 14 is located.

The shell 13 comprises a lower portion 13a covering the second face 12a of the circuit 12 printed. This lower portion 13a comprises a first housing 133 in which the electronic module 14 is disposed. The lower part 13a also comprises a second housing 134 in which is housed a battery 18 (for example a battery). The first housing 133 is thus accessible from the first adhesive face 1 1a of the layer 1 1 of connection via the opening 1 14 and the tab 1 15.

The shell 13 also comprises an upper portion 13b which is in the open air and which seals the patch. This upper part 13b is preferably made of polyurethane. Thus the shell 13 is a protective layer of the components of the patch 10.

Advantageously, the portion covering the battery 18 comprises a polycarbonate foliage for blocking electromagnetic emissions from the battery which can disrupt the printed circuit 12 and the electronic module 14. This foliage also absorbs the moisture emitted by sweating when the patch is worn and absorb the heat emitted by the battery. In this way the patch can be worn 24 hours a day for a period of about seven days.

Printed circuit 12

The printed circuit 12 is illustrated in FIG. 4 and comprises several sensors among those described below (the simultaneous presence of the sensors is not limiting).

It is a printed circuit 12 made of flexible material in order to promote its integration into the patch 10 for application to the skin of the individual where the contact with the skin must be optimal.

As already mentioned, three electrodes 121, 122, 123 are arranged equilaterally (60 ° angle). These electrodes make it possible to acquire ECG signals from the heart of the individual. The electrodes are preferably spaced two by two from a distance of between 65 mm and 82 mm, typically 78 mm. Such a positioning makes it possible to limit the effects of overlapping of the electrical signals of the heart and to ensure a measurement "right heart", "left heart". These measures "right heart", "left heart" make it possible to obtain a morphological information of the heart. The electrodes are advantageously covered with a deposit of silver chloride to reduce the risk of oxidation.

Two temperature sensors 124, 125 positioned at 10 mm from the electrodes at an angle of 45 ° with respect to the center of the electrode, make it possible to measure the cutaneous temperature of the individual at two different locations. In this way, a temperature differential is measured. The differential is the guideline that indicates whether the temperature is increasing or decreasing. The measurement is the image of the derivative of the temperature which constitutes an essential element in the follow-up of the evolution of the vital parameters.

A transmitter / receiver 126 of an infra-red signal makes it possible to measure the oxygen saturation of the individual. In particular, the transmitter emits an infrared signal in a wavelength of between 1420 mm and 1800 mm, typically between 1450 mm and 1700 mm. In addition, the emitted signal is such that it has at the air / skin interface a reflection angle between 25 ° and 65 °, typically between 30 ° and 60 °. The angle of reflection ensures a decrease in the variability of the saturation by averaging the values measured on the diffusion surface.

A six-axis accelerometer 127 makes it possible to measure the posture of the individual, the speed of the individual, the distance traveled by the individual. These measurements from the accelerometer help to evaluate the acticity of the patient. A pressure sensor 128 makes it possible to measure the respiratory rate of the individual. Such a sensor 128 makes it possible to have a better measurement of the respiratory rate than when it is deduced from the ECG signals. To allow precise measurement of the respiratory rate by this sensor, the housing 133 of the electronic module 14 is at constant pressure thanks to the shell 13 and the tongue 1 15.

A piezoelectric sensor 130 makes it possible to measure the density of the fabrics by elastography. Indeed, the piezoelectric sensor 130 emits a mechanical wave and echo retrieves it. The ratio of the amplitudes of the transmitted and received wave makes it possible to deduce the density of the tissues. Such a measurement is useful for later detecting any cell necrosis.

Electronic module 14

The electronic module 14, diagrammatically illustrated in FIG. 5, is configured to control the sensors and, from the information coming from the sensors, to determine parameters characteristic of the cardiac activity of the individual. Advantageously, all the characteristic parameters are obtained in situ in the assembly 100.

In particular, the electronic module 14 comprises a processor 141 configured to implement different processing of the signals from the sensors, a memory 142 configured to store the acquired signals and a wireless communication interface 143 configured to be in communication with the terminal 2 or the server 3 (see Figure 1).

The processor 141 is notably configured to control the acquisition of the electrical signals from the heart via the three electrodes (three leads); These three derivations I, II and III give an indication of the origin of the rhythmic anomaly. The acquisition is preferably performed at the frequency 400 Hz on each of the electrodes is 1200 Hz in total considering the three electrodes.

The signals acquired for each of the electrodes are advantageously filtered by means of two analog filters (a high-pass filter and a low-pass filter) and by means of a wavelet-type digital filter. The wavelets used take their references in the Meyer coefficients but have undergone modifications to improve the detection of each of the vertices and intervals. The wavelet filtering makes it possible to extract particular elements of the acquired signals. In particular, it makes it possible to extract the P, Q, R, S, T and U waves of the ECG signals acquired by the electrodes. From these waves the following intervals are advantageously calculated: PR interval, PR segment, QRQ interval, ST segment, ST interval, RR interval.

Finally, these intervals, possibly coupled with one or more information from other sensors, allow to obtain parameters characteristic of the cardiac activity of the individual.

Claims

1. Patch (10) cutaneous heart rate monitoring intended to be worn by an individual, the patch comprising, in succession

- a layer (1 1) of connection comprising a first face (1 1 a) adhesive intended to be in contact with the skin of the individual and a second face (1 1 b);

a flexible printed circuit (12) comprising

a first face supporting a plurality of sensors, said first face of said circuit being in contact with the second face of the connecting layer and said sensors comprising:

three electrodes (121, 122, 123) configured to acquire signals representative of the cardiac activity of the individual, said electrodes being arranged according to an equilateral triangle,

a pressure sensor (128) configured to measure the respiratory rate of the individual

a connector (129) on which an electronic module (14) is intended to be connected; said module (14) being configured to control the sensors to acquire physiological parameters of the individual and from said acquired parameters to determine, in situ, parameters characteristic of the cardiac activity of the individual;

a second face (12b) opposite to the first face (12a) and supporting contacts coming from the sensors;

- a shell (13) covering the layer (1 1) of connection and the printed circuit (12) flexible, said shell (13) comprising a lower portion (13a) in contact with the second face of the flexible printed circuit and an upper portion (13b) intended to be in the open air, said lower part (13a) comprising a housing (133) intended to house the electronic module (14);

the layer (1 1) comprising a link (1 15) having a shape adapted to cover the housing (133) of the shell (13), said tongue (1 15) for opening or closing the housing (133) to allow the insertion or removal of the electronic module (14), the shell (13) and the tongue (1 15) contributing together to ensure sealing the housing (133) so as to both withstand water and secondly to maintain a constant pressure in the housing (1 15).

The patch of claim 1, wherein the printed circuit (12) further supports:

two temperature sensors (124, 125) configured to measure the cutaneous temperature of the individual;

a transmitter / receiver (126) of an infra-red signal configured to measure the oxygen saturation of the individual;

an accelerometer (127) configured to determine the posture of the individual;

3. Patch according to one of the preceding claims, wherein the printed circuit (12) further supports a piezoelectric sensor (130) configured to measure tissue density by elastography.

4. Patch according to one of the preceding claims, wherein the electrodes (121, 122, 123) are arranged equilaterally and are spaced apart by a distance of between 65 mm and 82 mm, typically 78 mm.

5. Patch according to one of the preceding claims, wherein the infrared transmitter / receiver (126) is configured to emit a signal having a wavelength of between 1420 mm and 1800 mm, typically between 1450 mm and 1700 mm. mm.

6. Patch according to one of the preceding claims, wherein the infrared transmitter / receiver (126) is configured to emit a signal to the skin of the individual which is refracted by the skin at an angle of between 25 ° and 65 °, typically between 30 ° and 60 °.

7. Patch according to one of the preceding claims, wherein the lower portion (13a) of the shell comprises a space (134) in said lower part.

(13b) to house a battery (18) such as a button-type battery.

8. Patch according to one of claims 6 to 7, wherein the upper part (13b) of the shell (13) comprises a layer (13c) of protection over space for accommodating the battery (18), said protective layer being configured to block electromagnetic waves from the battery during the operation of the patch, said protective layer being preferably polycarbonate.

9. Patch according to one of the preceding claims, comprising pellets (15) of hydrogel disposed on each of the electrodes, the electrodes being in contact with the skin of the individual through said pellets.

10. Patch according to one of the preceding claims, wherein the layer (1 1) comprises three recesses (1 1 1, 1 12, 1 13) of the size of the electrodes so as to allow the contact of the electrodes with the skin of the individual.

1 1. A skin monitoring system (100) comprising a patch (10) according to one of the preceding claims and an electronic module (14) electrically connected to the flexible printed circuit, said electronic module being configured to control the sensors and for information from sensors determine parameters characteristic of the cardiac activity of the individual.

12. A skin monitoring assembly comprising a surveillance system according to the preceding claim, a mobile terminal, the monitoring system being in wireless connection with the mobile terminal.