Adhesive electrode patch and devices containing the electrode patch

Abstract

An adhesive electrode patch comprising a matrix, wherein the matrix comprises a polymeric matrix material that is adhesive to keratinaceous substrates, at least 3 dry electrodes (S1), (S2), (S3) in the matrix having a quick connection system for coupling to an electronic module, wherein the 3 dry electrodes (S1), (S2), (S3) are positioned to form an angle.

Description

ADHESIVE ELECTRODE PATCH AND DEVICES CONTAINING THE ELECTRODE PATCHCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority under 35 U.S.C. § 365 to U.S. Provisional application No. 63 / 594,628, filed on October 31. 2023 which is incorporated herein by reference in its entirety.FIELD OF THE INVENTION

[0002] The present invention relates, generally, to adhesive electrode patches and devices comprising the adhesive electrode patches for monitoring and / or recording the electrical activity of a heart.BACKGROUND OF THE INVENTION

[0003] Monitoring the electrical activity of the human heart is critical and essential to diagnose and monitor patients with cardiac deficiencies and cardiovascular diseases. According to the CDC someone in the US dies from cardiac disease every 34 seconds. Electrocardiography (ECG) is a non-invasive method for monitoring heart-related problems based on measurements of the electrical activity of the heart by electrodes attached to the skin surface. Depending on whether the occurrence and intensity of the cardiac problem is chronic or intermittent, different ECG instruments will be used by cardiologists. High frequency problems are evaluated with ambulatory 12-lead Holter monitor which can continuously monitor the heart function for 24 hours to 72 hours. Sporadic or less frequent problems occurring in a time frame of weeks or longer requires the use of continuous wearable cardiac monitoring devices which increase the probability of detecting arrhythmic events or other pathological cardiac problems. The longer the patient can wear the device the more likely infrequent or rare cardiac events will be detected and addressed by the physician.

[0004] However current wearable cardiac monitoring devices suffer from patient discomfort due to inflammatory responses of the skin over time which negatively impacts the patient adherence to the therapeutic procedure (up to 20% of patients terminate the monitoring because they remove the patch due to discomfort or the patch peels off and cannot be reapplied). In addition, the signal quality degrades over time due to poor skin contact, higher skin impedance, and less resistance to motion artifacts.

[0005] Therefore, there exists a need for wearable adhesive electrode patches and cardiac monitoring devices comprising adhesive electrode patches that provide improved patientcomfort, improved signal integrity over time, and improved skin impedance, and improved resistance to motion artifacts.BRIEF SUMMARY OF THE INVENTION

[0006] The present invention is directed to an adhesive electrode patch, comprising: a matrix, wherein the matrix comprises a polymeric matrix material that is adhesive to keratinaceous substrates; at least 3 dry electrodes (S1), (S2), (S3) in the matrix having a quick connection system for coupling to an electronic module; wherein the 3 dry electrodes (S1), (S2), (S3) are positioned to form an angle.

[0007] The present invention is further directed to a device for monitoring electrical signals from a body, comprising the adhesive electrode patch.

[0008] The adhesive electrode patch and devices comprising the electrode patch provides improved patient comfort, improved signal integrity over time, improved skin impedance, and improved resistance to motion artifacts.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 is a perspective view of the outer side of an example of the adhesive electrode patch.

[0010] Figure 2 is a perspective view of the skin-facing side of an example of the adhesive electrode patch.

[0011] Figure 3 is a top view of an example of the adhesive electrode patch.

[0012] Figure 4 is a bottom view of an example of the adhesive electrode patch.

[0013] Figure 5 is a graph of electrode-skin impedance for Example 1 .

[0014] Figure 6 is a graph of contact Impedance from on ITO coated glass substrate over time for Example 2.DETAILED DESCRIPTION OF THE INVENTION

[0015] The terms “comprises,” “comprising,” “includes,” “including,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a method, article, or apparatus that comprises a list of features is not necessarily limited only to those features but may include other features not expressly listed or inherent to such method, article, or apparatus. Further, unless expressly stated to the contrary, “or” refers to an inclusive-or and not to an exclusive-or. For example, a condition A or B is satisfied by any one of the following: A is true (or present), and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).

[0016] The use of “a” or “an” is employed to describe elements and components described herein. This is done merely for convenience and to give a general sense of the scope of theinvention. This description should be read to include one, at least one, or the singular as also including the plural, or vice versa, unless it is clear that it is meant otherwise. For example, when a single embodiment is described herein, more than one embodiment may be used in place of a single embodiment. Similarly, where more than one embodiment is described herein, a single embodiment may be substituted for that more than one embodiment.

[0017] One aspect of the invention relates to an adhesive electrode patch, comprising:(a) a matrix, wherein the matrix comprises a polymeric matrix material that is adhesive to keratinaceous substrates; and(b) at least 3 dry electrodes (S1), (S2) and (S3), in the matrix having a quick connection system for coupling to an electronic module; wherein the 3 dry electrodes (S1), (S2) and (S3) are positioned to form an angle.

[0018] The matrix material is adhesive to keratinaceous substrates. Examples of keratinaceous substrates include, but are not limited to, human skin, hair, and mucosal tissue. The matrix material may be any polymeric material typically used as an adhesive to adhere patches or devices to keratinaceous materials in medical applications. In one embodiment, the matrix material is a siloxane-containing material. Alternatively, the matrix material comprises a polysiloxane, alternatively a silicone rubber, alternatively a polysiloxane and is a hydrogel, an anhydrous gel, a thermoset, or thermoplastic, alternatively a thermoset or thermoplastic, alternatively a thermoset or thermoplastic elastomer. In one embodiment, the matrix material is a non-aqueous siloxane-based material. As used herein, “nonaqueous” means substantially free of water, alternatively free of water, alternatively has less than 0.1% (w / w) water.

[0019] In one embodiment, the matrix material has a rheology that ranges from viscoelastic to rubber. One skilled in the art would know how to select a matrix material and what constitutes a visco-elastic and a rubber rheology. Many of materials that may be used as the dielectric polymer matrix material are available commercially.

[0020] The adhesive electrode patch comprises at least three dry electrode. The dry electrodes may comprise the same or different material as the matrix material. In one embodiment, the dry electrodes comprise a polymeric material as described from the matrix material. One skilled in the art would know how to make a dry electrode.

[0021] In one embodiment, the polymeric material comprising the matrix, the polymeric material comprising the dry electrodes, or both the matrix and the dry electrode are dielectric.

[0022] The dry electrodes form an angle, alternatively an angle from 60 to 120 degrees, alternatively from 70 degrees to 110 degrees, alternatively from 80 degrees to 100 degrees,alternatively from 85 degrees to 95 degrees, alternatively about 90 degrees, alternatively 90 degrees. One skilled in the art would know how to position the dry electrodes in an adhesive patch.

[0023] In one embodiment, the dry electrode comprises carbon nanotubes. The carbon nanotubes may be Multi-Walled Carbon Nanotube (MWCNT). The MWCNT consist of multiple rolled layers of graphene rolled around each other (the smaller diameter in the center and then the diameter becomes bigger and bigger). The tubes are so imbricated in each other. The diameter of MWCNT is typically in the range of 5 nanometers (nm) to 100 nm. The interlayer distance in MWCNT is close to the distance between graphene layers in graphite.

[0024] In one embodiment, the carbon nanotubes are single-wall carbon nanotube (SWCNT). the SWCNT is a one-layer thick MWCNT. The SWCNT is a rolled layer of graphene with a diameter close to 1.3 nm, alternatively from 0.5 nm to 3 nm, alternatively from 1 nm to 1 .5 nm, and a tube length that can be up to 15 pm (micrometers), alternatively up to 10 pm, alternatively from 5 to 10 pm. SWCNT are very often capped at the end and have only one cylindrical carbon wall. In one embodiment, the SWCNT have a maximum particle size diameter, alternatively a particle size diameter up to 5 nm, alternatively up to 3 nm, alternatively up to 1 .5 nm. One skilled in the art would know how to measure particle size diameter and tube length. For example, particle size diameter and tube length may be measured using commercial particle size analyzers, alternatively particle size and tube length may be measure using microscopic techniques known the art.

[0025] The SWCNT useful in the invention is available commercially. For example, SWCNT may be purchased from the OCSiAl company based in Luxembourg. The SWCNT may be produced in a specific reactor called “Graphetron” using free metal catalyst nanoparticles. This process is based on a catalytic decomposition of hydrocarbon gas on metal nanoparticles and growth of carbon-based nanostructures. A process for producing SWCNT according to the invention is described in US Pat. No. 8137653, the disclosure of which is hereby incorporated herein for the method of making the SWCNT disclosed in the patent. In general, the process for making the SWCNT disclosed uses production in gas phase compared to a well-known and common process consisting of growing SWCNT on a catalytic surface.

[0026] The SWCNT may be size reduced by methods known in the art. For example, the SWCNT may be ground in known grinding equipment such as a ball mill or a basket mill, alternatively the SWCNT may be size reduced by treatment of a dispersion of the SWCNT ina dispersion with a blade or paddle mixer. One skilled in the art would know how to size reduce a SWCNT.

[0027] In one embodiment, the SWCNTs are supplied as an agglomeration of SWCNTs and the agglomerated SWCNTs are processed to reduce agglomeration prior to making the electrically conductive composition of the invention. The SWCNT agglomerations may be treated to reduce the agglomeration by methods known in the art as described for reducing the particle size of the SWCNT. One skilled in the art would know how to reduce the size of the agglomerations of SWCNTs.

[0028] The polymeric material comprising the dry electrode is capable of having the carbon nanotube dispersed in the dry electrode material to form a homogeneous dispersion.

[0029] Examples of the polymeric matrix and material comprising the dry electode material include, but are not limited to, styrenic resins, such as acrylonitrile butadiene styrene (ABS), acrylonitrile styrene acrylate (ASA), polystyrene (PS), Styrene acrylonitrile (SAN), Styrenebutane copolymers (SBC), styrene-ethylene-butylene-styrene copolymers (SEBS), styrenebutadiene rubber (SBR), styrene-butadiene block co-polymers (SBS), styrene-isoprene block copolymers (SIS), and styrene maleic anhydride (SMA); acetal resins such as polyoxymethylene (POM); polymers and copolymers derived from acrylic acid, acrylate, methacrylic acid or methacrylate compounds, such as alkyl acrylate copolymer (ACM), poly (acrylic acid) (PAA), polyacrylic acid sodium salt (PAAS), polyacrylamide (PAM), polyacrylonitrile (PAN), polyhydroxyethylmethacrylate (PHEMA), polymethylacrylate (PMA), and polymethylmethacrylate (PMMA); polyolefins, such as polyethylene (PE), polypropylene (PP), polymethylpentene (PMP), polybutene-1 (PB-1), polyolefin elastomers (POE), polyisobutylene (PIB), ethylene propylene rubber (EPR), and ethylene propylene diene monomer rubber (EPDM); polyvinylidene chloride (PVDC); polyvinylidene difluoride (PVDF); vinyl resins and copolymers, such as polyvinylalcohol (PVA), polyvinylacetate (PVAc), polyvinylchloride (PVC), and polyethylenevinylacetate (EVA); cyanoacrylates; aliphatic or semi-aromatic polyamides, such as polyamide Nylon-type (PA), polyphthalamide (PPA), polyamideimide (PAI), and aramid; aliphatic or aromatic polyimides such as polyimide (PI); polycarbonates, such as allyldiglycolcarbonate (ADC) and polycarbonate (PC); polyaryletherketones, such as polyaryletherketone (PAEK) and polyetherether ketone (PEEK); polyesters, such as poly-4-hydroxybutyrate (P4HB), polybutylene succinate (PBS), polybutylene terephthalate (PBT), polycaprolactone (PCL), polyethyleneadipate (PEA), polyethylene naphthalate (PEN), polyethylene terephthalate (PET), polyethylene terephthalate glycol-modified (PETG), polyglycolic acid (PGA), polyhydroxyalkanoates(PHAs), polyhydroxybutyrate (PHB), poly(3-hydroxybutyrate-co-3-hydroxyvalerate (PHBV),polyhydroxyhexenoate (PHH), polyhydroxyoctanoate (PHO), polyhydroxyvalerate (PHV), polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), and polytrimethylene terephthalate (PTT); alkyd resins; diallyl-phthalate (DAP); polyethers such as poly(p-phenylene ether) (PPE); phenolic resins such as (polyoxybenzylmethyleneglycolanhydride); formaldehyde resins, such as melamine formaldehyde and urea-formaldehyde (UF); epoxy resins; polybenzoxazines; furan resins; polysulfones, such as poly(arylene sulfone) (PAS), polyethersulfone (PES), poly(bisphenol-A sulfone) (PSF), polyphenylene sulfone (PPSU), and polysulfone (PSD); fluoropolymers, such as fluorinated ethylene propylene (FEP), perfluoroalkoxy alkane (PFA), polytetrafluoroethylene (PTFE); polyurethanes and polyureas sicu as thermoplastic polyurethane (TPU); polysaccharides, such as chitosan, chitin, pectin, starch, cellulose, hemicellulose based materials and derivatives; bioplastics and their blends and their copolymers; polysiloxane, such as liquid silicone rubber, silicone resin, silicone polymer, a mixture of silicone resin and silicone polymer and silicone hydrogel. Most of these materials are available commercially.

[0030] In one embodiment, each of the matrix material and / or the material comprising the dry electrode independently are a siloxane-containing material, alternatively a liquid silicone rubber. One skilled in the art would know how to select a liquid silicone rubber useful as the matrix material in the electrically conductive composition. The liquid silicone rubber may be formed from a one-part or two-part system, which is combined to form the liquid silicone rubber matrix material. The two-part system may comprise a first part comprising an organopolysiloxane containing two or more alkenyl groups bonded to silicon atoms per molecule and a second part comprising an organopolysiloxane comprising two or more hydrogen atoms bonded to silicon atom per molecule and a catalyst, typically a platinumbased catalyst, in the first part. One skilled in the art would know how to make or select a commercially available liquid silicone rubber suitable as the polymer matrix material.Methods of making the silicone rubber are known in the art. For example, patent application no. PCT / US2017 / 018687, which is hereby incorporated herein by reference for its description of making liquid silicone rubber, includes a description of such a method.

[0031] The siloxane-containing material may be a siloxane-grafted organic polymer, a siloxane and organic monomer block polymer, or an organic polymer grafted polysiloxane, alternatively a combination of polysiloxane materials such as a mixture of polysiloxane resin and polysiloxane polymer, where the polysiloxane resin comprises “Q” units (i.e., SiC> / 2) and may contain one or more of T (i.e., RSiOsc), D (i.e., F^SiChc), and M (i.e., RaSiO ) units, where each R is independently a C1-C4 hydrocarybyl or hydrogen, and the polysiloxane polymer typically contains primarily D and M units but may contain some T units, where D,M, and T units are as described above. As used herein with respect to the polysiloxane, mixture includes physical mixtures and where the polysiloxane resin is chemically bonded to the polysiloxane polymer.

[0032] The matrix material and the dry electrode independently may be a polysiloxane hydrogel. Polysiloxane hydrogels are available commercially. One skilled in the art would know how to select a polysiloxane hydrogel to use as the dielectric matrix material. Methods of making polysiloxane hydrogels are known in the art.

[0033] The matrix material and dry electrode may independently comprise additional materials typically found in liquid silicone rubbers such as adhesion promoters, inhibitors, and fillers. One skilled in the art would know how to select adhesion promoters, inhibitors, and fillers, which are available commercially.

[0034] The conductive filler can be made of intrinsically conductive polymers, ionic polymers and their salts thereof. The conductivity of the polymer is achieved through conjugated double bonds, which allow free mobility of charge carriers in the doped state or through ionic functionality. The conductive polymers include for example polyacetylene or polyethyne, polypyrrole (PPY), polythiophene, polyaniline (PANi) including the emeraldine form, poly(3,4-ethylenedioxythiophene) (PEDOT), poly(3,4- ethylenedioxythiophene):polystyrenesulfonate (PEDOT:PSS), perfluorosulfonic acid or perfluorocarboxylic acid polymers, and ormolytes such as siloxane-polypropyleneoxide. The conductive fillers can be doped to enhance their conductivity according to their chemical structures with p-type dopants including Br2, l2, Cl2, and AsF5, with n-type dopants including lithium, sodium and potassium, with acidic dopants like HBr, d,l-camphorsulfonic acid (CSA) or dodecyl benzene sulfonic acid (DBSA), with counter anions like tosylate (Tso) or trifluoromethanesulfonate (OTf), and with specific treatment with solvents, such as cresol, dimethyl sulfoxide, dimethylformamide, ethylene glycol, glycerol, sorbitol, salts, zwitterions, acids, alcohols, glycols and fluoro-compounds. Methods of making the conductive fillers, dopants, and solvents are known in the art and available commercially.

[0035] The matrix and dry electrode may comprise additional materials commonly included in electrically conductive materials. In one embodiment, the dry electrode or matrix independently further comprises a filler, alternatively metallized particles obtained by coating non-metallic particles with metal material. The particles can be tube, fiber, spheres, beads, spheroid powders or any kind of particles in the size domain ranging from nanometer to micrometer. Their surfaces are metallized to enhance their electrical conductivity. The metallic coating can be any kind of metal such as silver, copper, platinum, iron, aluminum and their alloys. The particle material can be glass, silica, carbon black powder, graphene,carbon nanotube, carbon fiber, plastic or rubber particles. Methods of making metallized particles are known in the art. Many metallized particles are available commercially.

[0036] In another embodiment, the dry electrode or matrix independently further comprises a filler, alternatively metallic particles. The particles can be tube, fiber, spheres, beads, plates, needles, or nano or micro wires, spheroid powders or any kind of particles in the size domain ranging from nanometer to micrometer. The particle material can be gold, silver, or copper. Methods of making metallic particles are known in the art. Many metallic particles are available commercially, for example, silver nanowire from C3Nano Incorporated.

[0037] In another embodiment, the dry electrode or matrix independently further comprises a web obtained by weaving, knitting, spinning, or assembling fiber or yarn. The web can be in a form of textile, non-woven fabric, or fluffy staple fiber. The web can be made of metal e.g., stainless steel, gold, silver, copper, aluminum, or alloys, metallized natural or polymeric fiber, electrically conductive polymers to cite some examples of many materials that someone skilled in the art would know.

[0038] The conductive adhesive patch may further comprise a system for connecting the electrodes to a circuit board or device. The connection system can be any connection system known the art for connecting an electrode to a device or circuit board. Examples of quick connects include snaps, clips, zero insertion force connectors, tapes, micro-needles and electrically conductive adhesives to cite some examples of many connecting systems that someone skilled in the art would know.. One skilled in the art would know how to employ a connection, alternative a quick connection, system for an adhesive patch.

[0039] The adhesive patch comprises three dry electrodes. The three electrodes are arranged to form an angle, alternatively an angle from 60 degrees to 120 degrees, alternatively 80 degrees to 110 degrees, alternatively around 90 degrees, alternatively 90 degrees. The positioning of the electrodes allows for the optimized collection of electrical signals from the heart.

[0040] The electrodes form an “L-shape” or “V-shape.” The vertex electrode is independently 1 centimeter to 8 centimeters, alternatively 1.5 centimeters to 7 centimeters, alternatively from 3 centimeters to 6 centimeters, from each of the other two dry electrodes.

[0041] The method of making a conductive composition comprises the step of: combining 0.1%-5% (w / w) single wall carbon nanotubes with a dielectric matrix material to form a homogeneous dispersion of the single wall carbon nanotubes in the dielectric matrix material and to reduce the size of the agglomerates of the single wall carbon nanotubes.

[0042] The single wall carbon nanotubes and the dielectric matrix material are as described above.

[0043] The single wall carbon nanotubes and dielectric matrix material are combined to form a homogeneous dispersion. The combination may be done according to methods known in the art that will form a homogeneous dispersion. For example, the single walled carbon nanotubes and the dielectric matrix material may be combined using ultrasonification, mixing in a homogenizer, or mixing with a paddle mixer. One skilled in the art would know how to combine the dielectric matrix material and the single walled carbon nanotubes.

[0044] The method of making a conductive composition may further comprise one or more of the additional steps of heating, casting, molding, and shaping.

[0045] One skilled in the art would know how to make the dry electrode and the electrode patch from the materials described. One skilled in the art would also know how to incorporate the quick connect system into the adhesive electrode patch for connecting to a device or circuit board.

[0046] The electrically conductive composition of the invention is adhesive to keratinaceous substrates such as skin, and may be used as an adhesive in medical applications requiring the measurement of biological electrical signals such as veterinary, consumer, pharmaceutical, or medical electronic devices.

[0047] Another aspect of the invention is a device for monitoring electrical signals from a body, comprising the adhesive electrode patch disclosed above.

[0048] The adhesive electrode patch is connectable to an electronic module, alternatively a flexible or flex hybrid circuit board or device.

[0049] Aspect 1. An adhesive electrode patch, comprising: a matrix, wherein the matrix comprises a polymeric matrix material that is adhesive to keratinaceous substrates; at least 3 dry electrodes (S1), (S2), (S3) in the matrix having a quick connection system for coupling to an electronic module; wherein the 3 dry electrodes (S1), (S2), (S3) are positioned to form an angle.The adhesive electrode patch is adhesive to keratinaceous substrates. “Adhesive” means its is adhesive to substrates as known in the art. For example, “adhesive” means that after applied to a substrate, it will take some force greater that normal forces of gravity to remove it from the substrate. One skilled in the art would understand what “adhesive” in the context of an adhesive patch means. “Keratinaceous substrates” are those traditionally known in theart as keratinaceous substrates. Examples of Keratinaceous substrates include, but are not limited to, human skin, hair, and mucosal tissue.Aspect 2. An adhesive electrode patch according to aspect 1 , wherein the matrix material comprises a siloxane-containing polymer.Aspect 3. An adhesive electrode patch according to aspect 1 , wherein the dry electrodes comprise a siloxane-containing polymer.Aspect 4. An adhesive electrode patch according to any one of the preceding aspects, wherein the dry electrodes further comprise up to 5% (w / w) of carbon nanotubes.Aspect 5. An adhesive electrode patch according to any one of the preceding aspects, wherein the angle is from 60° to 130°.Aspect 6. An adhesive electrode patch according to any one of the preceding aspects, wherein the adhesive electrode patch is anhydrous. “Anhydrous” means having less than 10% (w / w), alternatively less than 0.25% (w / w), alternatively less than 0.05% (w / w), alternatively substantially free of, water.Aspect 7. An adhesive electrode patch according to any one of the preceding aspects, wherein the adhesive electrode patch collects stable and high quality biopotential signals over long wear times through keratinocyte structures when connected to a signal collection device.Aspect 8. An adhesive electrode patch according to any one of the preceding aspects, wherein the patch has an electrode to electrode impedance of less than 2 kiloohms (kohms), preferably less than 1 kohm, more preferably <300 ohms.Aspect 9. An adhesive electrode patch according to any one of the preceding aspects, where the patch has a skin impedance of less than 200 kohms at 31 Hertz (Hz), alternatively less than 100 kohms at 31 Hz, alternatively less than 10 kohms at 31 Hz.Aspect 10. The adhesive electrode patch according to any one of the preceding aspects, wherein the anhydrous dry electrode diameter is less than 30 mm and preferably less than 20 mm and more preferably less than 10 mm.Aspect 11 . The adhesive electrode patch according to any one of the preceding aspects, wherein the patch has a resistive skin impedance less than 1 kohm.Aspect 12. The adhesive electrode patch according to any one of the preceding aspects, wherein the adhesive electrode patch has a resistive skin impedance settling time less than 30 seconds.Aspect 13. The adhesive electrode patch according to any one of the preceding aspects, wherein the electronic module is a circuit board or device.Aspect 14. A device for monitoring electrical signals from a body, comprising:the adhesive electrode patch according to any one of aspects 1-15. In one embodiment, the device further comprises a circuit or circuit board, and a processor and means for communicating signals between the components of the device such as leads or conductive wires.Aspect 15. The device according to aspect 14, wherein the electronic module includes a processor for biopotential signals collection, storage and transfer.Aspect 16. The device according to aspect 15, wherein the biopotential signals are used to monitor or diagnose Cardiac Arrhythmias.Aspect 17. The device according to aspect 16, wherein, the cardiac arrhythmia includes Atrial and ventricular Arrhythmias, Tachycardia, Bradycardia, heart rate variability, and atrial and ventricular fibrillationAspect 18. The device according to aspect 17, wherein the assembly of three electrodes settled to be a six lead ECG Holter.

[0050] The adhesive electrode patch and device comprising the adhesive electrode patch can be used to monitor and record electrical signals from the body, alternatively from a heart. EXAMPLES

[0051] The following examples are presented to better illustrate the method of the present invention, but are not to be considered as limiting the invention, which is delineated in the appended claims. Unless otherwise noted, all parts and percentages reported in the examples are by weight. The following table describes the abbreviations used in the examples:Table 1. List of abbreviations used in the examples.Example 1The patch prepared by Example 1 is described in Figures 1 - 4. Figure 1 is a perspective view of outer side (the side away from the body) of the patch, while Figure 2 is a perspective view of skin-facing side. The patch (1) used in the example includes three identical snap dry electrodes (11 , 12 and 13). In this Example, these electrodes are (S1), (S2), and (S3) of the invention. The snap dry electrodes were 43 mm x 29 mm rectangles with rounded corners. Their construction includes base film (21) made of PET printed with silver ink, silicone-based dry electrodes (31 , 32 and 33), a silicone-based skin adhesive (41) surrounding the dry electrode and covering the flat parts of metal snap connectors (51 , 52 and 53) as shown in Figures 1 - 4. Silicone-based dry electrodes (31 , 32 and 33) are located on the skin-facing side, but are not visible from the outer side because they are masked by the printed silver ink in keyhole shape which is visible as the base film (21) is transparent. The diameter of the dry electrode was 20 mm and its thickness was 150 pm. The metal snap connector (51) is punched through base film (21), silver ink (61), and silicone-based dry electrode (31) to make electrical contact. Ditto with the metal snap connectors (52) and (53).Skin Impedance at 31 Hz on a test subject over time.

[0052] Rinse subjects arm thoroughly with ultra-pure water. Apply two anhydrous dry electrodes and silicone-based adhesive to the anterior surface of the test subject’s forearm, one electrode serving as the working electrode, while the other acting as the reference electrode. Use a controlled slow rate of application and uniform pressure to ensure reproducible intimate contact between the electrode structure and the surface of the skin. Apply the ground electrode in the same manner. The ground electrode should be positioned away from the measurement site to ensure that it capture minimal electrical activity associated with the tissue of interest, in this case to the subject’s heel.

[0053] Using the OpenBCI system or equivalent, a low-intensity test signal is applied to the electrodes. This test signal can be either a small alternating current (AC) or a direct current (DC) signal. Skin Impedance measurements should be taken at 31 Hz for selected timeintervals from initial application of the anhydrous dry electrodes and silicone-based adhesive for up to three days. The test subject should go about their normal activities during the duration of the experiment. The test subject should be stationary and at rest for the data collection.

[0054] The data can be plotted as in Fig. 1 . The initial skin impedance may be slightly higher but will stabilize at a lower value over time. The Skin impedance will depend on many factors including the age of the subject and the state of hydration. The stable value after the first few hours should be used.EXAMPLE 2Contact Impedance from on ITO coated glass substrate over time.

[0055] Apply the anhydrous dry electrode to the flat ITO coated glass substrate. Use a controlled slow rate and a weighted roller for uniform application each time to ensure reproducible initial intimate contact between the electrode structure and the hard flat substrate. The substrate will be commercially available ITO coated glass (see below). Individual anhydrous dry electrode circles of various diameters will be used for this study. The data below was collected using 20 mm diameter dry electrodes.

[0056] After the weighted roller application, the samples will be exposed to equivalent lab environment over the duration of the experiment. Contact impedance spectroscopy will be conducted using the Analog Discovery instrument at selected time points from time 0 to at least 30 days. A drive voltage of 10 mV will be applied, and the frequency will sweep from 1 Hz to 1 MHz. Temperature and humidity will be monitored throughout the duration of the experiment. Plots will be created with data from 31 Hz (equivalent to skin Impedance measurements) using the Digilent Waveform software from initial application at time zero to 30 days. The data will be reported for the average of 5 electrodes.

[0057] The data can be plotted as in the Fig. 5. The initial contact impedance may be higher but will stabilize at a lower value over time. The stable value contact impedance after the first few hours should be used.

Claims

That which is claimed is:

1. An adhesive electrode patch, comprising: a matrix, wherein the matrix comprises a polymeric matrix material that is adhesive to keratinaceous substrates; at least 3 dry electrodes (S1), (S2), (S3) in the matrix having a quick connection system for coupling to an electronic module; wherein the 3 dry electrodes (S1), (S2), (S3) are positioned to form an angle.

2. An adhesive electrode patch according to claim 1 , wherein the matrix material comprises a siloxane-containing polymer.

3. An adhesive electrode patch according to claim 1 , wherein the dry electrodes comprise a siloxane-containing polymer.

4. An adhesive electrode patch according to any one of the preceding claims, wherein the dry electrodes further comprises up to 5% (w / w) of carbon nanotubes.

5. An adhesive electrode patch according to any one of the preceding claims, wherein the angle is from 60° to 130°.

6. An adhesive electrode patch according to any one of the preceding claims, wherein the adhesive electrode patch is anhydrous.

7. An adhesive electrode patch according to any one of the preceding claims, wherein the adhesive electrode patch collects stable and high quality biopotential signals over long wear times through keratinocyte structures when connected to a signal collection device.

8. An adhesive electrode patch according to any one of the preceding claims, wherein the patch has an electrode to electrode impedance of less than 2 kohms, preferably less than 1 kohm.

9. An adhesive electrode patch according to any one of the preceding claims, where the patch has a skin impedance of less than 200 kohms at 31 Hz.

10. The adhesive electrode patch according to any one of the preceding claims, wherein the anhydrous dry electrode diameter is less than 30 mm.11 . The adhesive electrode patch according to any one of the preceding claims, wherein the patch has a skin impedance less than 1 kohm.

12. The adhesive electrode patch according to any one of the preceding claims, wherein the adhesive electrode patch has a skin impedance settling time less than 30 seconds.

13. The adhesive electrode patch according to any one of the preceding claims, wherein the electronic module is a circuit board or device.

14. A device for monitoring electrical signals from a body, comprising: the adhesive electrode patch according to any one of claims 1-13.

15. The device according to claim 14, wherein the electronic module includes a processor for biopotential signals collection, storage and transfer.

16. The device according to claim 15, wherein the biopotential signals are used to monitor or diagnose Cardiac Arrhythmias.

17. The device according to claim 16, wherein, the cardiac arrhythmia includes Atrial and ventricular Arrhythmias, Tachycardia, Bradycardia, Heart Rate Variability and atrial and ventricular fibrillation.

Images