WO2017009879A1

WO2017009879A1 - Innovative wearable system for life parameter monitoring

Info

Publication number: WO2017009879A1
Application number: PCT/IT2016/000167
Authority: WO
Inventors: Franco BOLDI
Original assignee: XeosIt Srl
Current assignee: XeosIt Srl
Priority date: 2015-07-10
Filing date: 2016-07-06
Publication date: 2017-01-19
Anticipated expiration: 2018-01-10
Also published as: ITUB20152054A1

Abstract

A monitoring system of the health condition and/or of physical activity for an individual, including a garment, dry electrodes made of graphene or conductive silicone, integrated with the garment and configurated for the detection of ECG signals related to the electric activity of the heart. Moreover, on the garment are also placed an electric energy accumulator and an elaboration and control unit for the elaboration of the ECG signals, and for their transmission to a remote reception system.

Description

DESCRIPTION

INNOVATIVE WEARABLE SYSTEM FOR LIFE PARAMETER MONITORING .

The present invention, in general, can be placed in the health monitoring field. In particular, the invention refers to a wearable health monitoring system in order not to interfere with the individual daily life. Thanks to the nowadays technological progress, a monitoring system capable of controlling continuously the well being of a person who, although healthy, can be anyway at potential risk of occurring in a sudden health problem, is more and more necessary. However, there are no health monitoring system in the market yet, that are capable of monitoring health conditions in a sufficiently accurate way and with no limitations to the normal lifestyle of the person wearing it. A few wearable systems that monitor certain health parameters, such as heart rate wrist or belt sensors, or smartwatches are currently known, however, such systems records not so accurate signals or signals that are useful only for the subsequent offline analysis.

Currently, none of the known systems is capable of measuring parameters related to health, of analyzing

Such data in real time, while the user is living his daily routine, without being annoyed by such system. For instance, in clinical measurements related to heart activity (ECG) are commonly used electrodes firmly connected to the patient's body through suction cups or dedicated stickers. In such way, the electrode is connected to the body of the patient in a specific place during the whole measurement time. Typically, the doctor or a nurse is in charge of the placement of the electrodes in the specific places for an accurate ECG measurement . However, when a garment dedicated to the ECG recording is used, a few problems related to how to guarantee an effective adhesion of the electrode to the skin and how to prevent a change of place between electrode and skin, and also how to guarantee an adequate electric coupling for an effective signal conduction, may occur.

There have been many attempts until now to implement garments for the ECG monitoring, however, such garments are often bothersome to wear, or also, they don't measure ECG well enough for a correct analysis of the clinical condition.

The purpose of the present invention is that of realizing a system capable of detecting and monitoring continuously some health parameters of an individual, through a wearable garment that is perceived by the user as a normal daily life garment, for instance, underwear or sports garment, without being bothersome or bulky. According to the invention, such aim is solved by a health monitoring system based on claim 1. Preferable form of realization of the invention are explained in the depending claims .

The characteristics and advantages of the health monitoring system, according to the present invention, will be clear reading the following description, given as an example and not as a limitation, according to the attached figures, in which:

figure 1 shows a health monitoring system according to a realization form of the present invention .

- figure 2 shows a health monitoring system according to a realization form of the present invention, in which the garment is cuffed.

- figure 3 shows a dry electrode scheme, realized through a realization form of the present invention.

According to the attached figures, in figure 1 we generally showed a health monitoring system for a human or animal individual. The system includes a 2 garment, wearable by the individual and including detection areas 4, dedicated to be at least partially adherent to at least one body part of the individual. Such garment can be, for instance, an underwear shirt, or a sports t-shirt, or trousers and talk top, and also a bra or wristbands and ankle braces. On said detection areas 4, are integrated with the garment dry electrodes 6°, 6b, 6c, 6d dedicated to the adhesion to at least one body part. Such dry electrodes 6a, 6b, 6c, 6d are configurated for the detection of electrocardiographic signals related to the heart electric activity, such as standard leads signals of a clinical ECG. For clinical ECG we mean an ECG measured with a professionally and clinically accepted number of electrodes and with a sensitivity and specificity necessary for a correct evaluation by the majority of cardiologists, so that each cardiologist is able to detect an eventual presence of a suspect heart problem (such as arythmia, myocardial ischemia, heart insufficiency and similar) that can require an immediate intervention or further investigations. At the moment, the number of standard leads is at least 12 and preferably 15.

In the realization form showed through figure 1 and 2, 4 electrodes 6a, 6b, 6c, 6d are present, amongst those, one 6a electrode is placed in correspondence of the left clavicle, a second 6b electrode is place in correspondence of the right clavicle, a third 6c electrode is placed in correspondence of the left anterior superior iliac spine and a fourth 6d electrode is placed in correspondence of the right anterior superior iliac spine. In other realization forms the electrodes are placed also in correspondence of the classical precordial leads of a clinical ECG.

The system, according to the present invention, includes also an electric energy accumulator, such as a battery, and a elaboration and control S unit, configurated for the elaboration of ECG signals and for the transmission of said ECG signals and/or said ECG signals to a remote reception system such as a smartphone or a smartwatch or a device capable of dispatching such data to a further remote reception center, in which for example are present doctors capable of evaluating the received data.

Such elaboration and control 8 unit is electrically connected to the dry electrodes and to the electric energy accumulator, and it elaborates the signals and manages the communications with the remote reception system.

Both the elaboration and ECG signals transmission unit and the accumulator of electric energy are placed on the garment, for instance in a dedicated pocket 9 easily reachable by the user, or completely included in a garment fabric placement, in order not to be reachable by the user wearing the garment itself.

The dry electrodes are electrically connected with the elaboration and control unit 8 through conductive elements 10, integrated within the garment. Such conductive elements are made of the same material of the dry electrodes, in order to reduce at its minimum possible electric artifacts on the signal detected by the electrodes. Said artifacts are due to the junction of different materials. Furthermore, the conductive elements 10 are electrically isolated from the body of the individual by a layer of isolating material 11, for instance with a layer of polymeric material, flexible and isolating, fixe on the fabric of the garment, for example through gluing or sewing or heat-sealing or printing .

Preferably, the dry electrodes are realized at least partially with inox steel filaments and intertwined polyester filaments. Said intertwined filaments preferably form a conductive fabric that is sewed in correspondence of the detection areas .

In one realization form, the dry electrodes are subtle sheets made of conductive material. Such electrodes, preferably, are realized at least partially with subtle aluminum sheets, preferably between 50 and 150 micron.

In one realization form of the invention, each dry electrode has a first face 61, dedicated to be placed in contact with the skin, and a second face 62, opposite to the first one and directed to the fabric of the garment. The second face 62 is covered with a layer of flexible polymeric material 63, preferably silicone, said polymeric material 63 being suitable for preventing the transpiration of the underlying skin area. This way, there i san increase in the local transpiration between the electrode and the skin that allows to improve the coupling electrode-skin and thus the conduction of the electric signal.

Preferably, the dry electrodes 6a, 6b, 6c, 6d and/or the conductive elements are integrated (meaning united to form a unique body) to the garment through sewing or heat-sealing, or through printing on garment technique. In other words, with the term "integrated" we mean that the electrodes and /or the conductive elements are fixed on the garment in a non removable way, or removable also after an at least partial damage of the garment fabric, at least esthetically-wise . Preferably, in the garment some elastic bands are integrated, suitable for generating a compressive force neaerby the detecting area 4, in order to guarantee better adhesion of the electrode to the skin.

According to another aspect of the invention, around each of the dry electrodes 6a, 6b, 6c, 6d is placed a contact stripe, realized with a material with an adherence strip-skin bigger than that of the garment material or of the dry electrode, in order to increase the friction adhesion with the skin and to limit the mutual movement between skin and electrode.

Preferably, the material of the contact stripe 64, is a flexible polymeric material, for instance a material silicone-based .

In figure 3 is shown a scheme o fan example of realization of an electrode with the contact stripe all around. In such realization form, the electrode is not only surrounded by the contact stripe 64, but it is also covered by the polymeric material layer 63, for one whole face length. In other words, in such realization form, a multiplayer complex electrode is created. In this electrode the support layer is realized in flexible polymeric material, for instance in synthetic material such as silicone or pvc or polyester or similar, and one layer is made of a conductive material 65 suitable for the transmission of the signal, as previously described. In preferable realization, the same electrode is directly realized with material conductive silicone based .

The conductive silicones are amongst the elastomeric materials that, in the latest years have shown a higher level of usage. Amongst the advantages there is that of presenting both characteristics typical of organic materials and of inorganic ones, therefore offering a big number of advantages impossible to have with the organic rubbers. The silicone polymers present a skeleton called "polixiloxanic" , made of sequences - [-SiR2-0-] n-, in which with R we mean the general alkylic groups: it is the coexistence in the same compound of bonds Si-0 , typical of mineral compounds such as quartz or silica, and of organic groups that gives to the silicones a combination of properties coming from these two worlds.

As deducible, the standard silicones, more or less charged with mineral charges, are very good insulators, both in continuous power stream, both in alternate power stream, and in the whole temperature range of use. However, this does not prevent from formulating also compounds with opposite properties: adding black conduct ants we can reduce the specific resistivity down to 10-0.01 Q^em, thus obtaining products with antistatic or greatly conductive characteristics.

An aspect of discussion is the water resistance of silicone: it can be immersed in water from 0°C to 100°C for a very long time, with absorption less than 1% and without any deterioration of the mechanical or dielectric properties, and this makes it a great product for healthcare systems

Preferably, each of the conductive elements 10 forms with its own dry electrode 6a, 6b, 6c, 6d to which is connected a unique path of conduction realized with one conduction material only. This way it is possible to avoid sealing or possible junctions or couplings responsible of further artifacts and noises on the detected signal. Preferably, furthermore, the elaboration and control unit allows to obtain and elaborate the detected signals continuously, for a few hours or for a few dozen of hours.

Furthermore, the control unity s capable of elaborating the signal detected by the sensors and to send out a notification to the monitored person, and eventually, to external subjects, in case of identification of a dangerous situation such as arrhythmia or a myocardial ischemia. Such notification can for example be a noise or visual advice, or a message on the remote device, such as a SMS message or a data message on the GSM, GPRS, UMTS 3g or 4g net, towards a mobile phone or a smartphone or any other remote device suitable to receive a data message remotely .

In some variation of realization of the garment further sensors are integrated within the garment, therefore facilitating the individuation of a variety of anomalies related to the health state, such as temperature sensors or humidity or accelerometers.

The integration of such sensors in the garment allows to detect further signals related to the health state, such as pulmonary rate, pressure and transpiration.

Preferably, on the elaboration and control unit are present two temperature sensors, one sensor ditected to the skin of the individual and dedicated to the detection of the body temperature and a sensor relatively distant to the skin of the individual for the measurement of the environmental temperature. In one realization form, the control and elaboration unit has been configurated to detect the movement and position of the individual through the analysis of the signal o fan accelerometer and/or a gyroscope, and to elaborate the signals coming from the other sensors, in relation to the posture or the activity of the individual .

Preferably, the health monitoring system includes an adequate number of electrodes, such as 15 electrodes, in order to elaborate the signals obtained through the elaboration and control unit, in order to identify anomalies on the signals, chosen amongst the group including alteration of the synusal rhythm, elevation/depression of the ST trait, left bundle branch block. In one realization form of the invention, the same electrodes used for the detection of the heart activity are also used for the detection of the pulmonary frequency, through analysis of the biological impedance. For instance, the pulmonary rate is identified through an elaboration of the signal, detected by a couple of electrodes, for example the 60 and 6b electrodes. Preferably, such elaboration consists in implementing the difference between the electric signal detected on the 6 a electrode and the signal on the 6b electrode. Then, an analysis of the peaks of the Fourier transform is performed (ex. FFT o DFT) This way it is possible for instance to evaluate the number of pulmonary acts per minute. To calculate the pulmonary rate, a double analysis is performed, obtained by the ECG through the heart rate, and by the pulmonary graph obtained through the impedance analysis. On this, low pass filters on the Fourier transform are performed. Then, it is defined a threshold value, calculated on the basis of the minimum, maximum and medium values present. Once set the filter, an identification of the peaks is performed, considering only the values that overcome the threshold value. Then the values of the successive and previous peaks are calculated. At this point, it is calculated the number of breaths per minute. According to another aspect of the invention, the dry electrodes are realized at least partially in grapheme. With the term grapheme we mean a monoatomic layer of carbon atoms, organized in a compact hexagonal net. The graphene, in relation to the peculiar symmetry of its atoms and to the purity, shows a huge number of characteristics technologically relevant: a high electric and thermic conductivity, high mechanic reinforcement and barrier properties. Considering such characteristics, the graphene became object of study both of the academy and of the industries in different sectors that include electronics and polimeric compounds. With the term of "nano-plate" of graphene, we mean a pane particle of graphene with a thickness (z) of a few nanometers, typically inferior to 100 nm, and lateral dimension (x, y) superior than thickness. In particular, we refer to nano-plates of graphene, with a lateral dimension included between 0.5 and 50 pm and a thickness included between 0.34 and 30 nm, with a degree of purity explained by the ratio carbon/oxygen (C:0) ≥ 100:1. A high shape ratio (medium lateral dimension divided for the medium thickness) is an important characteristic in order to use low quantities of graphene, to obtain technologically relevant performances. This happens because the properties of interest, electric and thermic conductivity, are properties that develop on the graphenic plan (x,y), and not through it (z), therefore, considering very wide plans, it allows to reduce edges and the flaws generated at the edges that, as sources of scattering, oppose the conductive phenomenon. A high degree of purity means a higher crystalline quality of the material that, in turn, implies high intrinsic performances of the graphene, especially in terms of electric and thermic conductivity. There are several technological trajectories for the production of graphene-based material, such as both the "top-down" type, that elaborates the structure of the graphene to reduce it in a nanometric form, and "bottom-up" type, that from gas precursor synthesize sheets of graphene. Directa Plus S.p.A., that produces grippe based material and nano-plates of graphene with top-down method, is proprietor of the European license EP 2 038 209 Bl that describes and claims a production method of structures including layers of graphene, obtained through intercalation and subsequent expansion/exfoliation of graphite. The application of nano-plates of graphene, being them highly pure fabric nobilitation-wise, allows to incorporate the graphene itself within a series of polymeric matrix that work as a binder for the graphene itself, being the latter chemically inert, thus uncapable of adhering firmly to a substrate, in order for it to be applicable on fabrics according to traditional textile techniques such as printing, coating or lamination (coupling of membranes) . The concentration of graphene in the binder is generally included within 0.5 and 30 wt % and the superficial resistivity obtained is included in the range [104 - 10] Ω/D. In general, the binder is poliuretanic or acrylic based. Nano-plates of graphene, highly pure and with a high shape ratio are perfect to make conductive an insulating matrix to apply superficially for printing, coating or lamination on a textile substrate. This because, a highly pure material is available, and this is totally used, using therefore low concentrations of conductive charge and having a high shape ratio. We obtain therefore an alignment of the graphene nano-plate with the substrate place.

In this realization form with electrodes also made by graphene, for the realization of the garment intended to detect a signal, index of a physiologic or pathologic activity, such as a signal index for heart or pulmonary rate, we can predict the following phases: a) predict a garment that is wearable by the individual b) print on the fabric or couplet o the fabric of the garment detection areas containing graphene nano-plates intended to be at least partially adherent to at least one body part of the individual, in order to detect at least one signal index of at least one physiologic or pathologic activity c) Print on the fabric or couple to the fabric of the garment conduction paths containing graphene nano- plates for the electric connection of the detection areas with an elaboration unit of at least one said signal d) Cover the conduction paths with a payer of electrically insulating material, in order to insulate the conduction paths from the contact with the skin. Preferably the b) and c) phases are substantially realized at the same time.

Furthermore, preferably, the d) phase is realized through printing of an insulating material, such as a syntetic polymeric material. Preferably polyester or similar .

In one realization form of the method, the d) phase is realized through the sequence of the following phases : - masking the detection areas;

- printing a layer of insulating material above the conduction paths and the masking;

- removing the masking.

In one realization form of the method, with the term "printing" we mean a print with silkscreen technique.

The silkscreen allows the management of a huge number of work, guaranteeing good quality of the product in a short amount of time. In the printing form through silkscreen, in the b) and or in the c) phase of the method, the print on the fabric of the garment occurs through the placement above the fabric a matrix with a shape that can define the area of the fabric to print on and that is intended to receive the conductive material (including graphene) . Preferably, at the same time or before the deposition of the graphene or of the conductive material that includes the graphene in correspondence of the fabric to print, such fabric is ironed in order to allow the graphene or the conductive material to cover homogenously the area of fabric to print and also an efficient detection of the electric signal even in case the garment is undergoing ironing when wore (for instance in case of elastic fabric) . In another form of realization of the method, with the terms coating and lamination of membranes we mean those processes that, starting from a polymeric paste based of poliuretanic and solvent, obtain through coating and lamination a subtle film, already deposited on the final fabric substrate or free-standing and therefore able to be thermo-coupled to the final textile substrate. Incorporating the graphene within the polymeric paste before the deposition process, we will obtain an electrically conductive film. Innovatively, the health monitoring system, according to the present invention allows to drastically improve the detection of ECG signals from the electrodes integrated on the garment, thanks to the presence of a stripe made of flexible polymeric material that allows to maintain firm the electrode and sticking to the skin of the individual, independently from the activity performer by the individual himself. Such polymeric material stripe together with a polymeric layer covering the entire electrode allow to increase sensibly the transpiration and therefore the coupling skin-electrode, favoring the acguisition of the ECG signal. Fruitfully, the presence of one material only for the realization both of the electrodes and of the conductive elements of the signal detected by the electrodes to the elaboration and control unit allows to reduce at its minimum the junction artifacts between different conductors.

Moreover, the realization of the dry electrodes containing graphene allows a better and more efficient integration of the monitoring system with the garment, in particular thanks to the possibility of printing the electrodes directly on the garment. This way, we can improve the ergonomy of the user, eliminating any contact with sewing's or patching's. The entire system is also much more resistant and simple to realize in term of mass production.

It is clear that a technician of this field, in order to satisfy specific needs, can apply modification to the described invention, allow these modifications are included in the field of defense as described.

Claims

1. Monitoring system (1) of the health condition and/or physical activity for a human or an anumal, including. a) A garment (2) wearable by the individual and including detection areas (4) intended to be at least partially adherent to at least one body part of the individual. b) Dry electrodes (6°, 6b, 6c, 6d) , integrated with the garment (2) in correspondence of said detection areas (4) and intended to stick on at least one body part. Said dry electrodes (6a, 6b, 6c, 6d) are configurated for the detection of electrocardiographic signals related to the electric heart activity. c) An accumulator of electric energy such as a battery . d) An elaboration and control unit (8) configurated for the elaboration of ECG signals and for the transmission of said signals and/or said ecg signals elaborated by a remote reception system (30). Said elaboration and control unit (8) is electrically connected with the electrodes (6a, 6b, 6c, 6d) and with the accumulator of electric energy. e) In this, the accumulator of electric energy and the elaboration and transmission unit of ecg signals are placed on the garment (2) . f) In this, the dry electrodes (6a, 6b, 6c, 6d) are electrically connected with the elaboration and control unit (8) through conductive elements (10) integrated on the garment (2) g) Said dry electrodes (6a, 6b, 6c, 6d) are made of graphene entirely or at least partially. h) Said dry electrodes are realized at least partially with graphene nano-plates characterized by a side dimension included within 0.5 and 50 pm and a thickness included within 0.34 and 30 nm, with a purity degree described by the carbon-oxygen ratio (C:0) ≥ 100:1.

2. Health monitoring system according to the claim 1, in which the dry electrodes contain graphene nano-plates, in a percentage included between 0.5 and 30 wt %.

3. Monitoring system (1) according to claim 1, in which the dry electrodes are entirely made of conductive silicone.

4. Health monitoring system (1) according to claim 1 or 2, in which dry electrodes also include filaments of graphene and polyester, sintetic and/or artificial fibers, containing graphene nano-plates in a percentage 0.5 and 30 wt %.

5. Monitoring system (1) according to any of the previous claims, in which the dry electrodes (6a, 6b, 6c, 6d) and the conductive elements (10) are made of the same material.

6. Monitoring system (1) according to the previous claim, in which each of the conductive elements (10) form with its own dry electrode a unique path of conduction made piece by piece of one conductive material only.

7. Monitoring system (1) according to any of the previous claims, in which each electrode (6a, 6b, 6c, 6d) has a first face (61) intended to be placed in contact with the skin and a second face (62) opposite the first (61) and facing the fabric of the garment named second face (62) covered in a layer of flexible polymeric material, preferably silicone, named polymeric layer, being it suitable for preventing transpiration of the underlying skin region.

8. Monitoring system (1) according to any of the previous claims, in which surrounding each dry electrode (6a, 6b, 6c, 6d) there is a contact stripe (64) in flexible polymeric material, preferably silicone, to increase friction adhesion with the skin and to limit the mutual movement between skin and electrode.

9. Monitoring system (1) according to any of the claims in which the dry electrodes (6a, 6b, 6c, 6d) and the conductive elements (19) are connected to the garment through printing on fabric techniques and /or coupling of membrane on fabric .

10. Monitoring system (1) according to any of the previous claims, in which on the garment are integrated belts of elastic fabric, suitable to generate a compression near the detection areas, in order to guarantee a better of the electrode to the skin and/or coupling membrane/fabric.

11. Method of realization of a garment wearable by an individual, said indument is intended to detect a signal, index for a physiologic or pathologic activity such as a signal index for heart or pulmonary activity, including such phases : a. Predicting a garment that is wearable by the individual . b. Printing on the tissue and/or coupling on the fabric of the garment detection areas containing graphene nano-plates, characterized by a side dimension included between 0.5 and 50 m and a thickness included within 0.34 and 30 nm, with a degree of purity described with carbon-oxygen ratio (C:0) ≥ 100:1, in a percentage included within 0.5 and 30 wt %, intended to be at least partially adherent to at least one body part of the individual, to detect at least one signal, index of at least one physiologic and pathologic activity. c. Realizing through coupling with membrane on fabric of the garment, conduction paths containing graphene nano-plates for the electric connection of the detection areas with an elaboration unit of at least one said signals . d. Covering the conduction paths in one layer if electrically insulating material, to insulate the conduction paths from the contact with the skin.

12. Method according to claim 11, in which phases b) and c) are realized almost at the same time.

13. Method according to any of the claims from 11 to 12, in which phase d) is realized through printing of an insulating material.

14. Method according to any of the claims from 12 to 13 in which phase d) is realized through the sequence of the following phases: a. Masking of the detection areas. b. Printing on a layer of insulating material above the conduction paths and masking. c. Removing the masking.