WO2024165947A1

WO2024165947A1 - Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient

Info

Publication number: WO2024165947A1
Application number: PCT/IB2024/050908
Authority: WO
Inventors: Paolo Giorgi; Paolo Marini; Gianluca Testa; Marco URSITTI
Original assignee: Advanced Electronic Biosystem Srl
Priority date: 2023-02-08
Filing date: 2024-02-01
Publication date: 2024-08-15

Abstract

"Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient" Flexible and sensor-equipped adhesive device for the continuous and remote monitoring of the physiological parameters of a patient. The device, preferably made of polyamide, thin, flexible and invisible, on which a processing board is miniaturized that is based on a microprocessor and a series of electrodes and sensors, is capable of detecting, without any invasiveness, the physical parameters directly from the body of the patient without the aid of further external devices; the electrodes and the sensors able to measure, and the processing board able to derive, a plurality of physiological parameters such as, by way of a non-limiting example, heart rate, pressure, oximetry, presence of liquids in the lung, respiratory rate, position of the body, temperature and nocturnal apnea; the data is then sent to a processing and remote display device for the doctor evaluation.

Description

“Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient”

Description

Field of the art

The present invention has application in medical and pharmaceutical fields. This generally refers to a system of digital electronic detection of clinical body parameters for medical use. More particularly, this is a flexible, adhesive, conductive and sensor-equipped device for medical use, which allows instantaneously measuring the clinical body values.

Prior art

Following the aging of the population, with the increase of incidence of degenerative and transmissible chronic diseases, one observes a growing need - in accordance with the guidelines for managing specific pathologies - for detection and monitoring of parameters referable to the health state. Such information, presently, can be periodically acquired through the direct detection by a health worker and by the patient himself/herself.

Nevertheless, the possibility of acquiring such parameters, even if quite widespread, in order to be useful from the medical standpoint, must be reliable and remains tied to three fundamental variables: 1) it is dependent on the availability of the instrumentation necessary for detection; 2) it is tied to the individual capacity to acquire the measurement; 3) it is limited to the time of acquisition of the measured parameter. Therefore, while several parameters referable to the health state can be detectable in the home context by the health worker or by the patient himself/herself (blood pressure, blood oxygen saturation, body temperature), others require being taken in a medical setting, hospital or otherwise, and only by health worker personal (electrocardiogram - cardiac biopotential, bio-impedance).

The availability of systems for reliable remote detection of the parameters that are the object of monitoring considerably increases (or would increase) the possibilities of control of the health state of patients who require frequent clinical and instrumental controls in order to maintain a state of compensation (equilibrium) of the diseases that are subjected to worsening. Over the last few years, also following the need to remote manage medical conditions, the field of telemedicine was introduced and defined. In particular, the National Health Care System has recently officially included several services that can be done remotely, such as the “televisit”, the “teleconsult”, the “teleconsultancy” and the “teleassistance”, by means of which it is possible to be remotely assisted by health care personnel. Nevertheless, even in these circumstances, the recording and monitoring of parameters referable to the health state of an individual still remain constrained to the execution of specific additional instrumental exams or to direct detection and subjected to the limitations described above.

Telemonitoring consists of the remote detection of the parameters referable to the health state of an individual so as to correct, in a timely manner, the management of specific medical conditions or to identify new medical conditions that have not yet clinically manifested. This is a mode of delivering medical services, provided for in the field of telemedicine, that would allow considerably modifying the management of medical conditions, even complex ones. Indeed, telemonitoring, when attained by means of wearable devices that are not overly cumbersome for the monitored subject, hence not interfering with the quality of life and the detections carried out, could be employed in many health contexts, allowing the facilitation of both the transition of the patient from recovery setting to hospital setting, which would mark the need to increase the intensity of the treatments to be delivered following the worsening of a specific condition.

The remote detection of the information referable to the health state, if carried out by means of devices that are technologically reliable and not very cumbersome for the subject who must use it, will become an essential practice and will be made possible due to the technological innovations introduced by telemedicine, allowing the revolution of the clinical management protocols of numerous medical conditions.

In the prior art, there are alternative miniaturized solutions for the acquisition of instrumental parameters, such as cardiac biopotential, mono or bi-electrode, which have however various evident limits: 1) they are adapted to measuring cardiac biopotential with a precision lower than a conventional electrocardiograph recording; 2) they do not allow the acquisition of other parameters, even derived, referable to the health state, leaving unchanged to need to execute conventional instrumental examinations that can be executed in a health care environment and by health care personnel, with all of the corresponding inconveniences. In addition, given their necessarily reduced shape, they are able to reach the objective of use practicality by the subject wears them but they are unable to maximize the electric field by measuring the biopotential through the thorax, nor to calculate a pulmonary bio-impedance, which is useful for the detection of the respiratory rate and of its derived parameters referable to the health state.

Object of the present industrial patent application is therefore that of proposing a new and alternative solution to all these limits of the present technology, through a flexible and sensor- equipped adhesive device for the continuous and remote monitoring of the parameters referable to the health state of a subject, which is able to optimize the extension of the electric field through the thorax, reaching a measurement precision and a detectable quantity of physiological parameters that is much greater than that of the prior art. The present device, preferably made of polyamide, is thin, flexible and invisible, and can be comfortably worn, reducing the invasiveness to a minimum, not obstructing the performance of daily life activities. A processing board is miniaturized thereon, based on a microprocessor; it has, in contact with the skin, a series of electrodes and sensors capable of detecting the physical parameters directly from the body surface of the subject who wears it without the aid of further external instruments; the electrodes and the sensors able to measure, and the processing board able to derive, a plurality of parameters referable to the health state such as, by way of a nonlimiting example: the recording of the cardiac biopotential (electrocardiogram), the heart rate, the blood pressure, the oxygen saturation of the arterial blood, the liquid content of the thorax, the respiratory rate, the position of the body, the body temperature; the data is then sent to a remote display device for the doctor evaluation. Description of the invention

With the present industrial invention patent application, it is intended to describe and claim a device provided with at least a new solution that is an alternative to the solutions known up to now and/or meet one or more needs felt in the art and in particular inferable from that stated above. In order to accomplish this task, the inventors have implemented a flexible, elastic and sensor-equipped adhesive device for the continuous and remote monitoring of the physiological parameters of a patient at least adapted for the detection of the following physical parameters: cardiac biopotential;

- bio-impedance; pace detection;

- body temperature; quantity of oxygen present in the arterial blood (oximetry); position and movement of the body.

The device consists of electrodes and sensors connected together by a flexible rigid circuit, preferably printed on polyamide, a rubbery plastic polymer that is soft and twistable, i.e. on silicon paper which has an even greater extensibility, and is characterized by a particular crescent form that allows it to cross the surface of the human body, preferably but not necessary from the armpit to the heart. The internal layer of the device, that in contact with the skin, is coated by a special adhesive having specific zones with high electric conductivity at the electrodes, such that it is not necessary to use a conductive hydrogel.

For the present description, reference is made to one end of the device with the name “end”, i.e. the terminal part in contact with the armpit; to the other end with the name “head”, which is in contact with the area of the sternum in proximity to the heart and houses several sensors and the processing board; and to its median component as “median segment”.

The end is the terminal part of the flexible circuit in contact with the armpit, is composed of an external layer preferably made of polyamide, of an adhesive internal layer having a conductive zone, and houses at least: - an oximeter composed of an LED for phototransmission, at least a photoreceiver LED for the reception of the light variation and a lens designed so as to allow the correct focusing of the beams from the phototransmitter LED to the photoreceiver LED;

- a sensor for the body temperature;

- an electrode for detecting the cardiac biopotential and the detection of the bioimpedance.

The median segment is placed between the head and the end, houses at least a median electrode adapted for the detection of only the cardiac biopotential, the bio-impedance and is connected both to the head and to the end through the connection that runs along the flexible body of the device; a conductive zone of said adhesive being placed at the electrode.

The head of the device, in contact with the area of the sternum in proximity to the heart, is composed of an external layer preferably made of polyamide that houses at least:

- a processing board described hereinbelow;

- an electrode for detecting the cardiac biopotential and the bio-impedance; and by an internal layer, in contact with the skin, constituted by a conductive zone of said adhesive. Said adhesive being non-conductive in the adherence zones not close to said sensors and electrodes.

The head of the device also comprises a processing board composed of a flexible rigid miniaturized circuit preferably printed on polyamide having at least a microprocessor, a Bluetooth module, a battery preferably flat circular and contained within a suitable small carriage protected against accidental opening, an accelerometer, a system for detecting the GPS position and an antenna; said antenna being specifically developed for being used in proximity to the biological tissues without causing absorption or damage, through a particular geometry that allows directing the irradiation lobe outward; and said small carriage for the battery able to be thrust outward by means of the two first lateral elements adapted to apply a leverage when both are simultaneously pressed and having two second non-deformable rubber elements adapted to report the two first elements in initial position after the opening. Optionally, it is possible to insert an altimeter in the processing board, such altimeter adapted to establish the altimetric height at which the measurement of the physiological parameters is carried out, such information being useful for the clinical evaluation of the cardiac health.

A functionally characterizing element of the device, object of the present industrial patent application, is the presence of at least three electrodes capable of measuring the electric voltage and positioned in three different points of the thoracic cage, which allows a precise measurement both of the cardiac biopotential and of the bio-impedance: indeed, with regard to the biopotential, the electrodes at the two ends of the device measure the voltage generated by the heart by comparing it with the reference measurement detected by the median electrode; while, in the measurement of the bio-impedance, the two electrodes placed at the two ends (under the armpit and in proximity to the sternum) can generate an electric voltage in response to the injection of a current imposed in the two electrodes and obtain a transverse measurement that maximizes the value of the biopotential measured in the lung crossing zone, so as to be able to calculate also the respiratory rate, the possible presence of liquid in the lung and the possible nocturnal apnea.

The presence of the electrodes in three points also allows calibrating the electric detection specifically on the artificial biopotential emitted by a possible pacemaker, with the object of detecting the presence thereof and the possible malfunctioning.

Once correctly positioned on the human body, the device in its entirety is therefore able to detect the direct measurement of the cardiac biopotential, the presence and the correct operation of a pacemaker, the measurements of the bio-impedance, of the body temperature, of the oxygen level in the arteries, of the position and of the movement of the body of the patient.

These direct measurements can then be communicated to said processing board present on the head of the device for the determination of further derived clinical parameters. In this manner, the device is overall able to correctly measure a wide set of physiological parameters such as, by way of a non-binding example:

- heart rate;

- variability of the heart rate; - pressure value;

- oximetry;

- presence of liquid in the lung;

- cardiac output

- respiratory rate;

- position of the body and movement;

- pedometer;

- value of the body temperature;

- nocturnal apnea.

Among the derived parameters, that of the blood pressure is calculated by relating the oximetric parameter with the cardiac trace; the presence of liquid in the lungs is derived from the known values of the electrical resistance of the liquids: the presence of a liquid in the lung in fact increases the detected impedance; the respiratory rate is derived from the variation of the impedance relative to the greater/smaller presence of air in the lung; and the nocturnal apnea emerge from the observation of the respiratory rate, which in the case of stop simply indicates the temporary absence of breathing.

The presence of the accelerometer provides further information that is useful for the evaluation of the overall clinical picture, by showing the position of the patient and his/her physical activity, i.e. if he/she is lying down or standing, if still, walking or running. A specific cardiac trace, together with the general clinical picture, can in fact be more or less worrying if the patient is at rest or moving.

The oximeter and the thermometer, both positioned on the end of the device, finally accompany all the evaluations by making direct and programmed measurements of the body temperature and of the blood oxygenation.

Once all the measurements have been detected by the instruments equipping the device, the Bluetooth module present on the head and power supplied by said battery, sends, through the antenna, all the information to a remote device, such as, by way of a non-binding example, a cell phone or a remote computer, which carries out the residual processing and proceeds with the graphical display of all the results through a digital screen. Said remote device being able, in case the set clinical parameters are exceeded, to send an alarm to the user or to the connected doctor.

Said graphical displays of the clinical parameters detected able to be sent to a dedicated application for cell phones, so as to allow a continuous monitoring for the user or doctor, and said alarm for the exceeding of the parameter thresholds also able to be received on said application.

In one version of said device, the terminal portion, comprising the median electrode and the end, can be substituted; in this case, said portion can be connected to the head through a flat miniature grip of male/female type and substituted with a new terminal portion, e.g. in case of malfunctioning or for use with a new patient.

According to one embodiment of the invention, the flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters is also capable of detecting the biopotential generated by the heart rate of a fetus, so as to allow the monitoring thereof without having to do an ultrasound or an electronic fetal monitor. In this manner, it becomes possible to execute the end-of-pregnancy clinical monitoring even from home.

Optionally, the flexible, adhesive and sensor-equipped device for the detection and the display of clinical body parameters is integrated with a meter, i.e. a material that releases a pre- established dose of drug if stimulated by the sensor-equipped device or by the remote control and display system controlled by the doctor.

In another version, the adhesive layer that runs along the entire device, placing a conductive zone in contact with the electrodes and the sensors, is substitutable for use with another patient. In another version of the device, the head has a button only for turning on, the turning off only being possible by remote application.

In a further version, the external layer on which the sensors and the electrodes are printed is made with a support of silicon paper type, i.e. silicone printed with conductive ink, adapted to ensure the extensibility and the adaptability to any complex surface, such as that of the human body. In a further version, the head of the device comprises a sensor of “analog front end” type adapted to separate the wave spectrum and to cancel the noise due to the conducted noisiness, to the vicinity with other electronic apparatuses and disturbance sources.

Finally, it should be specified that the device can be attained for professional clinical purposes and be provided to the doctor, but it can also be attained in a commercial version designed specifically for athletes, gyms and all those who wish to keep their own physiological parameters under control.

The advantages offered by the present invention are evident in light of the description set forth up to now and will be even clearer due to the enclosed figures and to the relative detailed description.

Description of the figures

The preceding advantages, as well as other advantages and characteristics of the present invention, will be illustrated with reference to the enclosed drawings, which are to be considered merely illustrative and non-limiting or non-binding for the purposes of the present patent application, in which:

- FIGURE 1 shows the upper surface of a possible device 100, where the following are visible: the head 10, the median segment 20 and the end 30.

- FIGURE 2 illustrates the lower surface of a possible device 100, that in contact with the skin of the patient, where the following are visible: the electrodes 11, 21 and 31, the various described sensors, the processing board 12 with several of its components and connections 110 between the parts.

- FIGURE 3 shows the upper layer 200 on which the circuits and the sensors are printed, and the lower layer, composed of the particular adhesive 300 having conductive zones 310 at electrodes and sensors.

- FIGURE 4 shows the head 10 of the device 100 where the system is visible for expelling a small carriage 18 containing the battery 16 and having first expulsion elements 18a and second non-deformable rubber elements 18b. Detailed description of the invention

It will be immediately obvious that innumerable variations and modifications can be made to that described (e.g. related to shape, size, arrangements and parts with equivalent functions) without diverging from the field of protection of the invention as set forth in the enclosed claims.

With reference to Figures 1 and 2, a possible embodiment of the device 100 is represented that is composed of a lower adhesive layer 300 having zones with high conductivity 310 at electrodes and sensors described hereinbelow; and of an upper layer of plastic polymer 200, preferably polyamide, having a thickness of 0.14 mm and comprising:

- a head 10, comprising a processing board 12, at least an electrode 11 and an accelerometer 13. Said processing board 12 comprising in turn at least a microprocessor 14, a Bluetooth device 15, a 3V battery 16 preferably of flat type capable of power supplying the device for an approximate time of 40 days and inserted within a small carriage 18 protected against accidental opening, a system for detecting the GPS position, a special antenna 17 optimized for the outward irradiation and a button 19 for turning on; said button 19 being prevented from the function of turning off, possible only by remote device;

- a median segment 20, comprising at least an electrode 21;

- an end 30, comprising at least an electrode 31, an oximeter 32 and a temperature sensor 33;

- said head 10, median segment 20 and end 30 being connected to each other by at least an electric connection 110.

Said end 30 being intended to adhere, by means of the special adhesive 300, under the armpit of the patient; said head 10 being intended to adhere, by means of the same adhesive 300, on the sternum in proximity to the heart; and said median portion 20 adhering in an intermediate position on the thorax of the patient who wears the device 100.

Two said electrodes 11 and 31 being adapted for the measurement of the cardiac biopotential by means of the aid of a reference value provided by said electrode 21, positioned in contact with the body of the patient in a median position; two said electrodes 11 and 31 also being adapted for the measurement of the pulmonary bio-impedance since they are able to generate an electric voltage and obtain a transverse measurement that maximizes the bio-impedance measured through the thorax, so as to be able to calculate the respiratory rate together with the possible presence of liquid in the lung and the possible nocturnal apnea. Said accelerometer 13 being adapted for the detection of the position and of the movement of the body of the patient; said oximeter 32 being adapted for the detection of the quantity of oxygen present in the arteries; said temperature sensor 33 being adapted for the detection of the body temperature.

Said Bluetooth device 15 being adapted to transmit the physiological parameters detected directly on the body of the patient towards a remote device adapted to process the further derived physiological parameters such as, by way of a non-binding example:

- heart rate;

- variability of the heart rate;

- pressure value;

- oximetry;

- presence of liquid in the lung;

- cardiac output;

- respiratory rate;

- position of the body and movement;

- pedometer;

- value of the body temperature;

- nocturnal apnea.

Said information, aggregated and suitably graphed, finally being displaced on a remote device such as by way of example a cell phone and/or a computer and/or a tablet, provided with dedicated software; said remote device then able to send a visual alarm and/or sound alarm when the detected parameters exceed certain preset thresholds or in all the cases in which the doctor or the supervisor user has set the need to receive an alarm on the basis of the variation of the detected physiological data.

It is clear that modifications, additions or variations that are obvious for the man skilled in the art can be made to the invention described up to now, without departing from the protective scope that is provided by the enclosed claims.

Claims

1. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient comprising a lower adhesive layer (300) having zones with high conductivity (310) and an upper layer made of plastic polymer (200), characterized in that it comprises: a functionally separate head (10), comprising: a processing board (12), at least an electrode (11) and an accelerometer (13); said processing board (12) in turn comprising at least a microprocessor (14), a Bluetooth device (15), a device for detecting GPS position, a battery (16) preferably with button, an antenna (17) and a turn-on button (19) which is prevented from the turning off function; a functionally separate median segment (20), comprising at least an electrode (21); a functionally separate end (30), comprising at least an electrode (31), a oximeter (32) and a temperature sensor (33); said head (10), median segment (20) and end (30) being connected to each other by at least an electric connection (110); said end (30) being adapted to adhere, by means of the special adhesive (300), under the armpit of the patient; said head (10) being adapted to adhere, by means of the same adhesive (300), on the sternum in proximity to the heart; and said median portion (20) adhering in an intermediate position on the thorax of the patient who wears the device (100).

2. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to the preceding claim, characterized in that two said electrodes (11 and 31), respectively positioned on the sternum in proximity to the heart and under the armpit, are adapted to measuring the cardiac biopotential by means of the aid of a reference value provided by said electrode (21), positioned in contact with the body of the patient in a median position.

3. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to the preceding claim, characterized in that said measurement regarding the cardiac biopotential, is transferred through said Bluetooth module (15) present on said processing board (12), towards a remote processing device on which it is used for deriving at least the value of the heart rate, of the variability of the heart rate and the possible presence and the correct operation of a possible cardiac electro-stimulator present in the body of the patient; the heart rate being a direct function of the biopotential and of the variation thereof; the presence and the operation of a pacemaker being detectable through the listening calibration of the artificial biopotential emitted specifically by the pacemaker.

4. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that two said electrodes (11 and 31), respectively positioned on the sternum in proximity to the heart and under the armpit, are adapted to measuring the bioimpedance, generating an electric voltage and obtaining a transverse measurement that maximizes the bio-impedance parameter in the lung crossing zone.

5. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to the preceding claim, characterized in that said measurement regarding the bio-impedance is transferred through said Bluetooth module (15) present on said processing board (12), towards a remote processing device on which it is used for deriving at least the value of the respiratory rate, the possible presence of liquid in the lung and possible nocturnal apnea; the respiratory rate being derived from the value of the impedance which varies upon varying the air in the lung; the presence of the liquid in the lung being derived from varying the impedance which varies as a function of the presence of a liquid; the nocturnal apnea being a function of the temporary stopping of the respiratory rate.

6. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, at least according to claims 1, 2 and 3, characterized in that the detection of the measurement of the oxygen in the arterial blood carried out by said oximeter (32) is used in combination with the trace of the heart rate obtained according to claims 2 and 3, in order to derive the value of the current blood pressure; said derivation being calculated on said remote device following the reception of the direct measurements obtained by means of said Bluetooth device (15).

7. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that it measures the position of the body and the motion state of the patient by means of said accelerometer (13); said measurement indicating if the patient is lying down or standing, if he/she is walking and how many steps he/she is completing, if he/she is running, if he/she is under stress/exerting himself/herself, in which position he/she is sleeping and more; said information being interfaceable with the data relative to the heart trace and other direct and derived parameters that are available.

8. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that it measures the current body temperature of the patient by means of said temperature sensor (33); said information being useful when integrated in the evaluation of all the available direct and derived parameters.

9. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that said antenna (17) present on said processing board (12) is provided with a geometry configured for directing the irradiation lobe outward, preventing absorption or damage to the biological tissues.

10. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that said battery (16) present in the head (10) of the device, is inserted within a specific small carriage (18) protected against accidental opening; said small carriage (18) able to be thrust outward by means of two first lateral elements (18a) adapted to apply a leverage when both are simultaneously pressed and arranging second two non- deformable rubber elements (18b) adapted to report the two first elements in initial position after the opening.

11. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that it comprises an altimeter, positioned in said processing board (12) and adapted to establish the altimetric height at which the measurement of the physiological parameters is carried out, such information being useful for the clinical evaluation of cardiac health.

12. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that the terminal portion of said device (100), comprising the median segment (20) and the end (30), can be entirely substituted with a new equivalent one; said portion being easily connectable to/disconnectable from the head (10) through a miniature grip adapted to continue said electric connection (110); said device (100) thus being substitutable in case of malfunctioning and reusable on different patients.

13. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that it detects the biopotential generated by the heart rate of a fetus, so as to allow the clinical monitoring of a pregnancy.

14. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that it comprises a material, i.e. a meter adapted to release a pre- established dose of drug when stimulated by the sensor-equipped device or by a display and remote control system controlled by the doctor.

15. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that the adhesive (300) having conductive zones (310) at electrodes and sensors, is entirely removable and substitutable with a new equivalent and dedicated adhesive, so as to render the device (100) reusable on a new patient.

16. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that the external layer (200) on which the sensors and the electrodes are printed is made of flexible polyamide, so as to ensure a greater adaptability to the human body.

17. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that the external layer (200) on which the sensors are printed is attained with support of silicon paper type, i.e. silicone printed with conductive ink, adapted to ensure the extensibility and adaptability to any complex surface, such as that of the human body.

18. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that it integrates a sensor of “analog front end” type on said processing board (12), said sensor being adapted to separate the spectrum of the waves and to cancel the noise due to the noisiness conducted, close to other electronic devices and to disturbance sources.

19. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that it is adapted to monitor sports performances.

20. Flexible, elastic and sensor-equipped adhesive device for the remote monitoring of the physiological parameters of a patient, according to any one of the preceding claims, characterized in that all the measurements directly detected by the electrodes and by the sensors on the body of the patient are sent, by means of said Bluetooth device (15), to said remote processing device, such as, by way of example, a cell phone, a tablet or a computer, and such remote device, by means of a dedicated software, graphically displays them on a digital screen; said remote processing device being adapted to display at least the following overall physiological parameters: heart rate; variability of the heart rate; pressure value; oximetry; presence of liquid in the lung; respiratory rate; position of the body and movement; pedometer; value of the body temperature; nocturnal apnea; said remote processing device providing a command for turning off said device (100); said remote processing device able to be configured by the user for sending visual alarms, sound alarms and alarms of another nature to the attention of the user himself/herself or of the doctor, if one or more detected physiological parameters exceed the set reference values.