WO2016016468A1

WO2016016468A1 - Device for the medical monitoring of a patient, in particular a patient suffering from diabetes

Info

Publication number: WO2016016468A1
Application number: PCT/EP2015/067819
Authority: WO
Inventors: Pascal Barguirdjian
Original assignee: Tecknimedical
Priority date: 2014-08-01
Filing date: 2015-08-03
Publication date: 2016-02-04
Also published as: FR3024347A1; FR3024347B1

Abstract

The invention relates to a device (100) for the medical monitoring of a patient, in particular while the patient is sleeping, comprising a body temperature sensor (104), a body perspiration detector (103), and a means for emitting an alarm signal, intended to emit an alarm signal (106) when a perspiration state is detected by the body perspiration detector (103) and when the temperature, as measured by the temperature sensor (104), drops at a rate above pre-determined rate.

Description

Medical monitoring device of a particular patient suffering from diabetes.

The present invention is in the technical field of medical monitoring of a patient, in particular during his sleep.

When a patient is suffering from a pathology or is likely to suffer from a pathology, it may be necessary to monitor some of its physiological parameters.

For example, a sudden change in body temperature or excessive sweating may be symptoms of potentially serious conditions. Patients with type 1 or type 2 diabetes are frequently in a state of hypoglycemia, hyperglycemia or ketoacidosis. Among the physical manifestations related to these states, there is a sudden drop in temperature, excessive sweating and possibly a change in heart rate. When these states occur during the patient's sleep, without any supervision, the patient may enter a pre-comatose state.

Medical monitoring devices are known for controlling physiological parameters such as temperature, heart rate, humidity, respiration. As such? we can mention the patent document published under No. 2 039 289. This surveillance system is in the form of a coat of a jacket, tee-shirt or pajama type equipped with physical parameter sensors providing signals for measuring these parameters and provided with a device electronic processing device capable of processing these measurement signals and sending radio alarms to a third party device, such as a cellular telephone. A disadvantage of this device is that the clothes with sensors can not correctly detect the information of low temperature and sweating important due to a lack of close contact with the skin. It is likely to generate, moreover, nuisance alarms due to a contact break between the sensor and the skin. In addition, the corrosion created by perspiration of the human body oxidizes the electronic sensors integrated in the textile or in Velcro ribbons. On the other hand, the audible alarms awaken the patient but also other people near the patient with his equipment.

Other medical monitoring devices are also known which consist of electrically conductive tapes with passive humidity and temperature sensors but which can not be correctly applied to the skin, particularly on the surface of the armpit.

In addition, the prior art devices are generally programmed to compare the temperature data and the humidity data with reference values, and to trigger an alarm when one of its values only moves further away. or less than the threshold value. However, it may be advantageous to take into account the relationship or connections between different physiological parameters.

Moreover, these different monitoring systems do not allow to know the precise position of the patient when lying, either in the monitoring phase or in the alarm phase. However, it may be advantageous for the doctor to know whether the patient, at the moment preceding an abnormal measurement of a physiological parameter, for example before entering a pre-coma state of a diabetic patient, if he it was positioned on the right side, the left side, on the stomach or on the back. This is important to associate, for example, symptoms with respect to the position of the patient but also to have an average of the positions with respect to a beginning of alert.

An object of the present invention is to provide a device for solving the drawbacks mentioned above. In particular, one of the aims of the invention is to propose an effective device for medical surveillance of a patient especially during his sleep, which is able to trigger an alarm only in case of a worrying medical situation, ie an alarm based on disturbing physiological signs and which does not trigger nuisance alarms. Another object of the invention is to provide such a device that is able to inform the patient of a physiological condition requiring a reaction on his part avoiding the occurrence of a pre-coma.

For this purpose, the invention relates to a device for medical surveillance of a patient, in particular during his sleep, comprising a body temperature sensor, a body sweat detector, and a means for transmitting an alarm signal. provided to emit an alarm signal when a sweating state is detected by said body sweat detector and the temperature, as measured by said temperature sensor, has dropped at a higher rate than a predetermined speed.

Advantageously, the device further comprises a three-axis accelerometer. According to one embodiment, the means for transmitting an alarm signal comprises at least one of the following means: a means for transmitting a sound signal, a means for generating a vibration, a means for emission of a light signal.

According to one embodiment, the body perspiration sensor is a humidity sensor.

In another embodiment, the body sweat sensor is a pH sensor.

According to one embodiment, the device comprises a power-up or start-up means, which may include a push button or a touch key on which a manual pressure or a touch is to be made, or a means of detecting mechanical agitation of the device.

According to one embodiment, the body temperature sensor comprises a thermocelocimetric sensor.

According to one embodiment, the device is in the form of a housing equipped with straps or sticky patches.

According to one embodiment, the perspiration sensor is a means measuring the electrical conductivity of the skin.

According to another embodiment, the transpiration sensor is a capacitive detector comprising a pair of comb-tooth electrodes. According to one embodiment, the device comprises a means for supplying electrical energy.

According to one embodiment, the device comprises a means for recharging the electric power supply means comprising a means for converting the mechanical energy into electrical energy, a means for converting the light energy into electrical energy, or a means for converting thermal energy into electrical energy.

The invention also relates to a method of medical monitoring of a patient, in particular during his sleep, comprising the following steps:

a measurement step for detecting a state of body perspiration,

a step of measuring the body temperature,

a step of triggering the emission of an alarm signal when a state of body perspiration is detected and when the temperature as measured has dropped to a falling speed greater than a predetermined falling speed.

According to one embodiment, the method comprises:

a measurement step for detecting a state of body perspiration by measuring the level of body moisture,

a step of triggering the emission of an alarm signal when the measured humidity rate has reached 100% and when the temperature as measured has dropped to a falling speed greater than a predetermined falling speed.

Advantageously, the predetermined rate of drop in temperature is -0.5 ° C. in less than 45 minutes.

The invention also relates to a computer program comprising instructions for implementing, by a processor, the method as described above, when said program is executed by said processor.

The characteristics of the invention mentioned above, as well as others, will emerge more clearly on reading the following description of exemplary embodiments, said description being made in relation to the figures of which:

Fig. 1, in which is illustrated schematically an example of a hardware architecture of a device according to one embodiment of the invention,

Fig. 2, in which is illustrated a medical monitoring device arranged under the armpit of a patient according to one embodiment of the invention, Fig. 3, which shows a diagram of a computer system capable of implementing a medical monitoring method according to the present invention,

Fig. 4, in which is illustrated a diagram showing the different steps implemented by a medical monitoring method according to one embodiment of the invention,

Fig. 5 on which is illustrated a diagram showing the different steps implemented by a medical monitoring method according to another embodiment of the invention.

The internal components of a device 100 according to the invention are presented in connection with FIG. 1. The device 100 comprises an electrical power supply means 101, such as a rechargeable battery or batteries. If necessary, depending on the voltages useful for the operation of the various components of the device 100, several batteries may be provided.

The device 100 may advantageously comprise a charging means 109 of the power supply means 101, operating on a mains supply, or a means for converting the mechanical energy into electrical energy, a means of converting the light energy into electrical energy, or means for converting thermal energy into electrical energy. The light energy may for example come from a solar sensor or an artificial light sensor. The thermal energy will come from the heat dissipated by the carrier of the device and sensed by a thermal sensor described below. The mechanical energy will come from the energy captured via an accelerometer described in the following.

The device 100 also comprises a power-up means 102. The power-up in this embodiment is done by contact of a finger by pressure on the humidity sensor. This is a pressurized operating procedure. For example, a pressure exerted by a finger on the humidity sensor for a continuous period of 3 seconds allows the device to be powered up. The humidity sensor then detects a change in humidity due to the presence of the finger and triggering the power up follows.

Alternatively, the power-up means will comprise a touch key on which manual pressure or touching is to be performed, so as to control power-up to a microprocessor 108 described in the following. Turning off the power is done differently. It is done automatically when the device is no longer in contact with the patient by a detection by the temperature sensor described below which will turn off the device through a temperature detection below 32 ° C during a determined period.

The device 100 further includes a perspiration sensor which, in this embodiment, includes a humidity sensor 103. This is a capacitive sensor having a pair of comb-tooth electrodes. This type of humidity sensor is well known to those skilled in the art. It works on the principle of measuring the variation of the electrostatic capacitance of the capacitor. A capacitive type moisture detector is for example described in Japanese Patent No. JPH11-101 766A. The pair of comb-shaped electrodes is disposed on a semiconductor substrate, for example silicon or carbon.

The electrodes are in the same plane and face each other. This pair constitutes a capacitor. The pair of comb-shaped electrodes is covered by a moisture-sensitive film. The film is for example made of polyimide or cellulose acetate butyrate. When body sweating is absorbed by the moisture-sensitive film, the dielectric constant of the layer containing the film varies. The electrostatic capacitance of the capacitor changes as a function of the variation of the dielectric constant of the film. This variation indicates the humidity rate, that is, sweating or sweating.

The perspiration sensor may additionally include, in addition or as an alternative, a means for specifically identifying sweat, such as a pH measuring means, which evolves according to the sodium content. sweat, or electrical conductivity of the skin. Such an embodiment is advantageous because it makes it possible to prevent an unwanted alarm from being triggered when the device is not worn by the patient and is in contact with a liquid other than sweat, for example water in a humid room, and that the temperature measured by the device, for example the ambient temperature, has dropped.

A body temperature sensor 104 is provided for measuring temperature data. It is a thermovelocimetric detector. The temperature sensor 104 is, for example, arranged by a microcontroller, and provides characteristic electrical values of temperature to a microprocessor 105. The latter is designed to process the temperature data and detect an abnormal temperature drop that is characterized by a temperature drop rate high. More particularly, the microprocessor 105 compares the temperature drop as a function of time with a reference value according to the following formula 1:

Formula 1

≥Vref

In which :

dT °: temperature variation in degrees Celsius.

dt: variation of time in minutes

Vref: predetermined fall speed.

In a preferred embodiment, the predetermined rate of fall corresponds to a temperature drop of 0.5 ° C. in less than 45 minutes, ie 0.0FC / min.

The device 100 also comprises means for transmitting an alarm signal 106 designed to emit an alarm signal when the humidity level measured by the humidity sensor 103 has reached 100% and the temperature such as measured by the temperature sensor 104 has fallen at a speed above a predetermined speed, the moisture content representing a state of transpiration.

This means for transmitting an alarm signal 106 is capable of generating a sound as well as a vibration in parallel. It therefore includes a sound alarm, electromagnetic type, electronic or mechanical, and a vibrator. The emission of the alarm signal is sufficient to wake the patient carrying the device 100. It is recalled that one of the aims of the device according to the invention is to inform the patient of a physiological condition requiring on his part a reaction that avoids the coma state.

The device 100 also comprises a three-axis accelerometer 107. The three-axis accelerometer 107 is able to measure an acceleration in three orthogonal directions. It thus makes it possible to obtain information concerning the position of the patient carrying the device 100: lying on his back, lying on the right side, lying on the left side, lying on his stomach, standing up. The three-axis accelerometer 107 further enables the patient's respiratory rhythm to be detected and monitored.

The device 100 further comprises a microprocessor 108 which processes the physiological data of temperature, perspiration and body positioning measured by the humidity sensor 103, the temperature sensor 104 and the accelerometer 107 and determines, based on these data, whether the triggering of the means for transmitting an alarm signal 106 is appropriate.

It is advantageously provided a thermoelectric generator 109 which makes it possible to recover the calories from the body heat of a patient carrying the device 100 and to convert them into an electric current able to supply the battery 101 with electrical energy.

In FIG. 2, there is shown a device 100 placed on a patient P. Before falling asleep, the patient P fixed the device 100 under one of his armpits A, after putting it under electrical power. The device 100 is previously calibrated according to a normal body temperature and generally between 36.2 ° C and 36.7 ° C. The temperature and humidity sensors, not visible in FIG. 2, are in direct contact with the skin. The device 100 is held by means of one or more straps 110, 111 around the upper arm.

In FIG. 4 is a diagram illustrating a method of medical monitoring of a patient during sleep according to the invention which is advantageously implemented by means of a medical monitoring device, such as that shown in FIG. 1 or that shown in FIG. 2.

Step E10 is a step of detecting a state of perspiration, for example measuring a body moisture level using the body moisture sensor 103 described in Fig. 1. During this step , the humidity sensor 103 collects data concerning the body moisture content, and sends this data to the microprocessor 108 as illustrated in connection with FIG.

Step E20 is a step of measuring body temperature using the body thermobelocimetric temperature sensor 104. In this step, temperature sensor 104 collects data regarding body temperature. This data is processed by the microprocessor 105 as illustrated in connection with FIG. If a temperature drop occurs, the microprocessor 105 determines the rate of fall of this temperature and compares it to a predetermined fall speed value according to Formula 1 previously stated.

Step E30 is a step of triggering the emission of an alarm signal when a state of transpiration is detected, for example when the measured moisture content has reached 100%, and the temperature as measured. dropped at a fall rate greater than a predetermined fall rate. The transmission, as such, of an alarm signal is triggered in step E40. If no perspiration is detected, for example if the humidity level has not reached 100%, if no temperature drop is detected or if the falling speed is lower than the predetermined falling speed, no signal of alarm is issued and step E40 does not take place.

In one variant of the invention, the method comprises, after the step E10 of detecting a state of body transpiration, and if this state is detected, for example when the measured moisture content has reached 100%, a Step El 1 of triggering of the step E20 of measurement of the body temperature. The method according to this variant is continued in step E30 of triggering the emission of an alarm signal if a state of transpiration is detected, for example if the measured moisture content has reached 100%, and the The temperature as measured dropped to a falling speed greater than a predetermined falling speed. The emission of an alarm signal is triggered in step E40. Step E50 may be included in this variant.

In the process variants according to the invention presented below, the predetermined temperature drop rate is -0.5 ° C in 45 minutes.

In parallel with the steps E10 and E20, the method comprises, according to one embodiment, a step E50 for determining the position of the patient using accelerometer 107 and / or determining the cardiac rhythm. The collected data are transmitted to the microprocessor 108 and are such as to indicate whether the patient is lying on his back, stomach, right side, left side or still standing.

It may furthermore be provided in step E30 for the triggering of the emission of an alarm signal if a state of transpiration is detected, for example if the measured moisture content has reached 100%, if the The temperature as measured has dropped to a falling speed greater than a predetermined fall rate and the heart rate measured by the accelerometer is slowed or accelerated relative to a predetermined value. The emission of an alarm signal is triggered in step E40. Step E50 may be included in this variant.

The method may include additional steps of increasing intensity alarm triggering so as to alert the entourage that the patient is in a worrisome physiological condition when the patient has not responded.

These methods are implemented by means of a computer system such as that shown schematically in FIG. 3.

This computer system comprises a microprocessor 108 associated with a memory 1 12 in which are stored, on the one hand, the code of the instructions of a program executed by the microprocessor 108 and, on the other hand, data used to the execution of the program. It also includes a port 113 for interfacing with the humidity sensor 103 of FIG. 1, a port 114 for interfacing with the temperature sensor 104. The port 114 is connected by a bus 115 to the microprocessor 105. The computer system further comprises a port 116 for interfacing with accelerator 107, a port 117 for interfacing with the energizing means 102 and a port 121 for interfacing with the means for transmitting an alarm signal 106.

The microprocessor 108 and the ports 113, 114, 116, 118 and 121 are interconnected by means of a bus 119. The microprocessor 105 is connected to the microprocessor 108.

The microprocessor 108 is capable of executing instructions loaded into the memory 112, from, for example, an external memory (not shown), a storage medium, or a communication network. These instructions form a computer program causing the microprocessor 108 to implement all or some of the steps of the method of the invention which has been described in connection with FIG. 4 or FIG. 5.

The device according to the invention can also include means for displaying the data that have been stored in the memory 112 or another memory, or for transmitting this data to a third party device, such as a mobile phone or a computer, at any moment.

Thus, all or part of these steps can be implemented in software form by executing a set of instructions by a programmable machine, such as a DSP ("Digital Signal Processor" in English) or a microcontroller. All or part of these steps can also be implemented in hardware form by a machine or a dedicated component, such as an FPGA ("Field-Programmable Gaste Array" in English) or an ASIC ("Application-Specific Integrated Circuit"). ).

Claims

1) Device (100) for medical monitoring of a patient (P), in particular during his sleep, comprising a body temperature sensor (104), a body transpiration detector (103), and a transmission means of an alarm signal provided to emit an alarm signal (106) when a transpiration state is detected by said body transpiration detector (103) and the temperature as measured by said temperature sensor (104) has dropped at a speed above a predetermined speed.

2) Device (100) according to claim 1, characterized in that it comprises, in addition, a three-axis accelerometer (107).

3) Device (100) according to claim 1 or 2, characterized in that the means for transmitting an alarm signal (106) comprises at least one of the following means: a transmission means of a sound signal, means for generating vibrations, means for transmitting a light signal.

4) Device (100) according to one of the preceding claims, characterized in that the body perspiration sensor is a moisture sensor.

5) Device (100) according to claim 4, characterized in that the body moisture sensor (103) is a capacitive sensor having a pair of comb tooth electrodes.

6) Device (100) according to one of the preceding claims, characterized in that the body transpiration sensor is a pH sensor or means measuring the electrical conductivity of the skin.

7) Device (100) according to one of the preceding claims, characterized in that it comprises a power means (102) which can be a push button or a touch button on which a manual pressure or a touch must be performed, or a means for detecting the mechanical agitation of the device.

8) Device (100) according to one of the preceding claims, characterized in that the body temperature sensor (104) is a thermovelocimetric detector.

9) Device (100) according to one of the preceding claims, characterized in that it is in the form of a housing equipped with straps (110, 11 1) or sticky patches.

10) Device (100) according to one of the preceding claims, characterized in that it comprises a means for supplying electrical energy and a charging means (109) of the electric power supply means comprising a conversion means mechanical energy into electrical energy, means for converting light energy into electrical energy, or means for converting thermal energy into electrical energy.

11) A method of medical monitoring of a patient, comprising the steps of:

a step (E10) for detecting a state of body perspiration,

a step (E20) for measuring the body temperature,

a step (E30) for triggering the emission of a signal when a state of body transpiration is detected and when the temperature as measured has fallen at a falling speed greater than a predetermined falling speed.

12) Method according to claim 11, characterized in that it comprises:

a step of measuring a state of body transpiration (E10) by measuring the body moisture content,

a step of triggering the emission of an alarm signal (E30) when the measured humidity rate has reached 100% and when the temperature as measured has dropped to a falling speed greater than a falling speed predetermined. 13) Method according to claim 11 or 12, characterized in that the step (E20) for measuring the body temperature is performed only if a sweating state is detected. 14) Method according to one of claims 11 to 13, characterized in that said predetermined falling speed is -0.5 ° C in less than 45 minutes.

15) Computer program, characterized in that it comprises instructions for implementing, by a processor (108), a method according to one of claims 11 to 14, when said program is executed by said processor (108 ).