Device for sampling surface electrophysiological signals, particularly surface electromyographic signals

Abstract

The Device (1) for sampling surface electrophysiological signals, particularly surface electromyographic signals, comprises: one flexible backing film (2), made of polymeric material, and provided with one backing face (3) arranged, in use, substantially in contact with the skin of a patient (4); a plurality of sampling elements (5), made on the backing face (3) and adapted to sample at least one high-density surface electromyographic signal, the sampling elements (5) being arranged, in use, substantially in contact with the skin of the patient (4) to sample at least one surface electromyographic signal; wherein the sampling elements (5) are made of conductive ink.

Description

[0001] DEVICE FOR SAMPLING SURFACE ELECTROPHYSIOLOGICAL SIGNALS, PARTICULARLY SURFACE ELECTROMYOGRAPHIC SIGNALS

[0002] Technical Field

[0003] The present invention relates to a device for sampling surface electrophysiological signals.

[0004] Background Art

[0005] A number of devices for sampling surface electrophysiological signals are known to be used to detect some physiological signals, relating e.g. to the electrical activity underlying muscle contraction (surface electromyographic signals - sEMG, or high-density electrode surface electromyographic signals - HD-sEMG) and / or nerve excitation, the cardiac cycle (electrocardiographic signal - ECG) or the activity of cortical neurons (electroencephalographic signal - EEG).

[0006] For this purpose, the devices of known type make use of a plurality of electrodes which can be applied to the skin of a patient to sample one or more electrophysiological signals in a simple and non-invasive maimer.

[0007] In particular, it is known to arrange one-dimensional (arrays) or two-dimensional (grids or matrices) sequences of electrodes on a special backing device that can be applied to the skin. In such a case, this consists in sampling high-density electrode surface electrophysiological or electromyographic signals.

[0008] More specifically in the application of high-density electrode sampling, electrodes are directly made on a partly flexible printed circuit board which can partly adapt to the body conformation at the point of application of the device. Other examples of known devices employ arrays or grids of electrodes mounted on textile backing devices, made of silicone, or made directly on the skin in the form of tattoos.

[0009] In this way, a large amount of surface electrophysiological signals can be acquired through a single backing device which can be applied onto the skin.

[0010] This type of device for sampling surface electrophysiological signals does have however some drawbacks.

[0011] In particular, despite partial flexibility, known devices are unlikely to adapt to the irregularities of the body at the point of application and this often prevents all electrodes from adhering perfectly to the skin.

[0012] This drawback tends to limit the number of electrodes generally mounted on the backing device and significantly complicates the application of known devices at areas of the body that are particularly large, irregular and / or subject to anatomical deformation during movement.

[0013] In addition, the more flexible known devices (silicone and tattoo) that partly fix this problem do, however, have problems with connection reliability and miniaturization difficulties, especially with regard to connections to the signal amplification and conditioning systems.

[0014] The aforementioned problems significantly increase as the number of electrodes used increases, leading to a considerable increase in experimental timelines and a reduction in the quality and information content of the signals taken.

[0015] In addition, the limited flexibility and overall dimensions of known devices make them very uncomfortable and annoying on the skin, limiting the patient’s movements or reducing the time they can be used.

[0016] To reduce the effects of some of these drawbacks, some devices employ a biadhesive layer of varying thickness and a conductive gel or paste applied between the electrodes and the skin, so as to promote the adherence of the electrodes to the skin and to make an ionic bridge that improves the quality of the signal sampled.

[0017] This solution, however, has limited benefits at the expense of greatly increasing the complexity of use and cost of this type of device.

[0018] In addition, known devices do not integrate or integrate only partly with other technologies.

[0019] For example, known devices are characterized by limited echo transparency that prevents simultaneous detection of ultrasound images from the narrow anatomical district of interest of the sampling device.

[0020] In addition, known devices are very sensitive to water and therefore difficult to be used in the presence of moisture and / or liquids, e.g. for underwater electrophysiological evaluations, in sports / rehabilitation settings and / or microgravity environments.

[0021] In addition, known devices have substantial costs related to the study and development of the electrode layout that prevent such devices from coping with the need for very customizable solutions which can adapt to the great anatomical heterogeneity of the human body.

[0022] These drawbacks make known devices very inconvenient, expensive and difficult to use, thus limiting their deployment and use.

[0023] Description of the Invention

[0024] The main aim of the present invention is to devise a device for sampling surface electrophysiological signals which allows improving the adherence of the electrodes to the skin.

[0025] A further object of the present invention is to devise a device for sampling surface electrophysiological signals which can adapt to the conformation of the skin without compromising the adhesion of the electrodes to the body, both under static and dynamic conditions.

[0026] An additional object of the present invention is to devise a device for sampling surface electrophysiological signals which can be applied in a simple, easy and quick maimer.

[0027] Still one object of the present invention is to devise a device for sampling surface electrophysiological signals which is unobtrusive and more comfortable on the skin.

[0028] An additional object of the present invention is to devise a device for sampling surface electrophysiological signals which may be easy and affordable to make.

[0029] A further object of the present invention is to devise a device for sampling surface electrophysiological signals of echo-transparent surface to the acoustic signals for ultrasound imaging.

[0030] Another object of the present invention is to devise a device for sampling surface electrophysiological signals which allows the aforementioned drawbacks of the prior art to be overcome within the framework of a simple, rational, easy and effective to use as well as affordable solution.

[0031] The aforementioned objects are achieved by this device having the characteristics of claim 1.

[0032] The aforementioned objects are achieved by this process having the characteristics of claim 15.

[0033] Other characteristics and advantages of the present invention will become more apparent from the description of a preferred, but not exclusive, embodiment of a device for sampling surface electrophysiological signals, illustrated by way of an indicative, yet non-limiting example in the accompanying tables of drawings in which:

[0034] Figure 1 is an exploded schematic view of the device according to the invention; Figure 2 is a schematic view of the device according to the invention;

[0035] Figure 3 is another schematic view of the device according to the invention;

[0036] Figure 4 is a schematic view of the device applied to the skin of a patient according to the invention.

[0037] Embodiments of the Invention

[0038] With particular reference to these figures, reference numeral 1 globally relates to a device for sampling surface electrophysiological signals.

[0039] The device 1 for sampling surface electrophysiological signals comprises at least one flexible backing film 2, made of polymeric material and provided with at least one backing face 3 arranged, in use, substantially in contact with the skin of a patient 4.

[0040] Conveniently, the backing film 2 can be creased, crumpled and / or irregularly handled.

[0041] In this way, in use, the backing film 2 conforms to irregular application surfaces, e.g. having irregular radii of curvature.

[0042] In particular, the backing film 2 can be creased and / or crumpled by hand.

[0043] More specifically, the backing film 2 is thick enough to crease, crumple and / or bend unevenly as a result of gravity.

[0044] Conveniently, the backing film 2 has a thickness of less than 50 micrometers, preferably of less than 20 micrometers.

[0045] Advantageously, the backing film 2 has a thickness of 15 micrometers or less. Preferably, Young’s modulus of the backing film 2 is less than 0.4 megapascals. It cannot be ruled out that the Young’s modulus of the backing film 2 may be greater than 0.25 megapascals.

[0046] Conveniently, the backing film 2 has a radius of curvature of less than 14.5 millimeters, preferably when subjected to a pressure of 40 mmHg.

[0047] It cannot be ruled out that the backing film 2 may have a radius of curvature greater than or equal to 3.5 millimeters, preferably when subjected to a pressure of 40 mmHg.

[0048] Preferably, the radius of curvature of the backing film 2 determines the degree to which it can be creased and / or crumpled.

[0049] Conveniently, the backing film 2 is the removable film of a decal sheet, e.g., of the water slide type, i.e., removable from its backing as a result of wetting thereof. According to a possible, but not exclusive, embodiment of the device 1, the backing film 2 is of the type of a printable film, such as those used in decal water slide transfer paper.

[0050] Advantageously, the backing film 2 is substantially echo-transparent.

[0051] According to the invention, the device 1 comprises a plurality of sampling elements 5, made on the backing face 3 and adapted to sample at least one surface electrophysiological signal.

[0052] Preferably, the term “surface electrophysiological signal” means any electrical signal which can be sampled superficially, e.g. surface electromyographic signals (sEMG), high-density electrode surface electromyography signals (HD-sEMG), electrocardiography signals (ECG) and the like.

[0053] Specifically, the sampling elements 5 comprise at least one electrode 6 configured to acquire at least one surface electrophysiological signal.

[0054] For example, the electrode has a substantially circular conformation with a diameter less than 5 millimeters, e.g., 2 millimeters.

[0055] Appropriately, the electrodes 6 are arranged, in use, substantially in contact with the skin of the patient 4.

[0056] In particular, one or more sampling elements 5 comprise at least one or more connecting portions 7 to a conductor, e.g. to transmit the electromyographic signal (sampled from the electrode 6) outside the device.

[0057] More specifically, at least one or more sampling elements 5 comprise at least one connecting track 8 that runs along the backing face 3 and connects the electrode 6 to the connecting portion 7.

[0058] Conveniently, the connecting track 8 has a thickness of less than 0.5 millimeters, e.g., 0.1 millimeters.

[0059] According to the invention, the sampling elements 5 are made of conductive ink. Preferably, the term “conductive ink” means any liquid comprising particles or nano-particles of electrically conductive material within it, such as silver, copper or the like.

[0060] For example, the ink preferably comprises particles or nano-particles of silver (Ag), chlorinated silver (AgCl) or gold (Au).

[0061] It cannot, however, be ruled out that the ink may comprise copper (Cu) particles or nano-particles.

[0062] In particular, the electrodes 6 are arranged in a two-dimensional grid or array.

[0063] In other words, the electrodes 6 can be distributed along a plurality of rows and along a plurality of columns, wherein the rows and columns extend substantially transverse, preferably orthogonal, to each other, e.g., with a customizable interelectrode spacing, e.g., of less than 20 millimeters, preferably of 10, 5, or 3 millimeters.

[0064] The figures show a non-limiting example of a two-dimensional grid or array, wherein the electrodes 6 are arranged in a 4 x 8 matrix, that is, 32 electrodes 6 distributed along 4 rows and 8 columns.

[0065] It cannot, however, be ruled out that the electrodes 6 may be distributed along a single row or along a single column.

[0066] It cannot also be ruled out that the electrodes 6 may only be two, e.g., for sampling applications of electrophysiological signals in bipolar mode instead of high electrode density.

[0067] In particular, the arrangement of the electrodes 6 in a two-dimensional grid or array is particularly suitable for the sampling of high-density surface electromyographic signals. Advantageously, the backing film 2 is made of a printable material, such as by inkjet printing, laser printing, screen print and the like.

[0068] Conveniently, the device 1 comprises separating means 9 made of electrically insulating / non-conductive ink positioned between the sampling elements 5, keeping them separate from each other.

[0069] In other words, the separating means 9 and the sampling elements 5 define on the backing film 2 two at least partly complementary regions.

[0070] In this way, the separating means 9 prevent the sampling elements 5 from coming into contact with each other, e.g. by forming short circuits both during the application phase on the skin and during the manufacturing process of the device 1.

[0071] Preferably, the separating means 9 are made of electrically insulating / non- conductive ink.

[0072] Conveniently, the device 1 comprises at least one flexible base layer 10 associated overlapping the backing film 2, keeping it substantially stretched to prevent it from creasing.

[0073] Preferably, the base layer 10 is made of a different material than the backing film 2.

[0074] Specifically, the base layer 10 is associated with the backing film 2 on the opposite face to the backing face 3.

[0075] Preferably, the base layer 10 is waterproof.

[0076] In this way, when the device 1 is applied to the skin of the patient 4, the base layer 10 coats the device itself and makes it substantially waterproof to any external liquids with which the patient 4 may come into contact.

[0077] Preferably, the base layer 10 has characteristics that make it compliant and usable for medical use.

[0078] More in detail, the face of the base layer 10 opposite the face of the same base layer which adheres to the backing film 2 is waterproof.

[0079] Preferably, the backing film 2, the sampling elements 5, the separating means 9 and / or the base layer 10, are echo-transparent, that is, transparent to acoustic signals for ultrasound imaging. In other words, the acoustic signals used for ultrasound imaging cross, preferably without particular distortion, reflection and / or attenuation, the backing film 2, the sampling elements 5, the separating means 9 and / or the base layer 10.

[0080] Conveniently, the device 1 comprises attachment means 11, 12 to be attached to the skin of the patient 4 in a removable manner.

[0081] Specifically, the attachment means 11, 12 attach, in use, the backing face 3 in contact with the skin of the patient 4.

[0082] In more detail, the attachment means 11, 12 comprise: an adhesive face 11 made on the base layer 10 and arranged to frame, at least partly, the backing face 3; and / or at least one adhesive layer 12 made on the backing face 3, on the sampling elements 5 and / or on the separating means 9 and adapted, in use, to adhere to the skin of the patient 4.

[0083] Preferably, the adhesive layer is made of medical-grade adhesive glue.

[0084] Conveniently, the adhesive layer 12 also serves as a protective layer of the sampling elements 5, interposing itself, in use, between the latter and the skin. Preferably, the base layer 10 comprises the adhesive face 11.

[0085] In more detail, the base layer 10, in use, is attached to the skin of the patient by interposition of the adhesive face 11 and coats, preferably completely, the backing film 2 by retaining it with the backing face 3 resting on the skin itself.

[0086] In other words, in use, the backing film 2 is retained between the skin of the patient 4 and the base layer 10.

[0087] Conveniently, the adhesive layer 12 adheres, in use, to the skin of the patient 4 while keeping the backing film 2 and the sampling elements 5 in contact with the same skin.

[0088] It cannot be ruled out that the adhesive layer 12 may be applied only on the separating means 9 and / or on the backing face 2 free from the sampling elements 5 and / or from the separating means 9.

[0089] In addition, it cannot be ruled out that the adhesive layer 12 may comprise one or more different components, e.g. an electrically conductive component applied on the sampling elements 5 and an electrically non-conductive component to be applied on the separating means 9 and / or on the backing face 2 free from the sampling elements 5 and / or from the separating means 9.

[0090] In this way, the sampling elements 5 are kept perfectly adhered to the skin of the patient 4 by interposition of the adhesive layer 12.

[0091] In fact, in use, the adhesive layer 12 is placed at least between the sampling elements 5 and the skin of the patient 4.

[0092] Conveniently, the device 1 comprises at least one protective body 13 applied, in a removable maimer, onto at least one of either the adhesive face 11 or the adhesive layer 12 coating at least one of the latter.

[0093] Specifically, the protective body 13 is a removable layer the purpose of which is to preserve the integrity and functionality of the adhesive face 11 and / or of the adhesive layer 12 before the device is applied onto the skin of the patient 4.

[0094] In fact, before applying the device 1 to the skin of the patient 4 it is necessary to remove the protective body 13 to free the adhesive face 11 and / or the adhesive layer 12 and allow it to be applied to the same skin.

[0095] Conveniently, the device 1 is devoid of additional interstitial bodies, such as biadhesive foams and electrolytic or conductive pastes and / or gels placed, in use, between the skin of the patient 4 and the backing face and / or the adhesive layer 12.

[0096] Conveniently, the device 1 comprises electrical connecting means 15, 16 of the sampling elements 5 to handling means 14 of surface electrophysiological signals.

[0097] Preferably, the handling means 14 are configured to allow the processing, recording and / or display of the surface electrophysiological signals sampled by the device 1.

[0098] In particular, the connecting means 15, 16 comprise at least one flexible backing body 15 and a plurality of electric conductive bodies 16 made on the backing body 15 and electrically connected to the sampling elements 5.

[0099] In addition, the conductive bodies 16 are adapted, in use, to transmit to the handling means 14 at least one surface electrophysiological signal sampled by the sampling elements 5. Specifically, the backing body 15 extends cantilevered from the backing film 2 and / or from the base layer 10. In this way, the backing body 15 remains externally accessible even following the application of the device 1 on the skin of the patient

[0100] 4.

[0101] In more detail, the backing body 15 comprises at least a first portion 17, arranged overlapping the backing face 3, so as to connect the sampling elements 5 to the conductive bodies 16, and a second portion 18, connected to the first portion 17 and extending cantilevered from the backing film 2 and / or from the base layer 10. Conveniently, the conductive bodies 16 extend along the backing body 15 between the first portion 17 and the second portion 18. In this way, the conductive bodies 16 are accessible and connectable to the handling means 14 through the second portion 18.

[0102] Advantageously, the device 1 comprises at least one electrically conductive adhesive placed between the connecting means 15, 16 and the sampling elements

[0103] 5.

[0104] Specifically, the electrically conductive adhesive is placed between the sampling elements 5 and the conductive bodies 16, so that each sampling element 5 is mechanically and electrically connected to a corresponding conductive body 16. Preferably, in the present disclosure, the term “electrically conductive adhesive” also means any adhesive element or body, e.g. glues, resins and the like.

[0105] Conveniently, the device 1 comprises at least one electrically insulating layer 19 that at least partly coats the backing body 15 at the point of connection between the sampling elements 5 and the conductive bodies 16.

[0106] In particular, the electrically insulating layer 19 substantially coats the first portion 17.

[0107] More specifically, the electrically insulating layer 19 is arranged, in use, between the backing body 15 and the skin of the patient 4.

[0108] It cannot also be ruled out that the electrically insulating layer 19 may comprise an adhesive portion that allows the insulating layer itself to be attached to the backing body 15.

[0109] In addition, it cannot be ruled out that the adhesive portion may also partly coat the backing face 3 and / or the base layer 10, so as to contribute to the attachment of the connecting means 15, 16 to the backing face 3 and / or the base layer 10.

[0110] Advantageously, the backing body 15 is made of a different material than the backing film 2.

[0111] Preferably, the backing body 15 and the conductive bodies 16 are made as a flexible printed circuit board.

[0112] Specifically, the backing body 15 is made of kapton, thinflex or mylar and the conductive bodies 16 are preferably made of copper, silver or gold.

[0113] It cannot be ruled out that the device 1 may comprise the handling means 14 electrically connected to the device 1, preferably by interposition of the connecting means 15, 16, to receive and / or to process the surface electrophysiological signal sampled by the device itself.

[0114] In addition, it cannot be ruled out that the device 1 may comprise electronic acquisition means 20 electrically connected to the device 1, preferably by interposition of the connecting means 15, 16, to amplify the surface electrophysiological signal sampled by the device itself.

[0115] Preferably, the acquisition means 20 comprise at least a single- or multi-channel biopotential amplifier.

[0116] In fact, it cannot be ruled out that the acquisition means 20 may be electrically connected between the device 1 and the handling means 14.

[0117] Preferably, the handling means 14 receive the signals acquired and transmitted by the acquisition means 20 via a wireless connection.

[0118] According to a further aspect, the present invention relates to an acquisition system 22 of surface electrophysiological signals comprising the device 1 and at least one of either the handling means 14 or the acquisition means 20.

[0119] According to another aspect, the present invention relates to a manufacturing process of a device 1 for sampling surface electrophysiological signals, particularly high-density surface electromyographic signals, characterized by the fact that it comprises at least the phases of: supplying at least one flexible backing film 2 made of a polymeric material and provided with at least one backing face 3 to be arranged, in use, substantially in contact with the skin of a patient 4; printing of a plurality of sampling elements 5 on the backing film 2, the printing being carried out with electrically conductive ink.

[0120] Preferably, one or more of the characteristics of one or more of the components of the device 1 described above are also to be considered valid for the same components described with reference to the process and vice versa.

[0121] Advantageously, the process comprises at least one phase of printing the separating means 9 positioned between the sampling elements 5 to keep the latter spaced apart from each other.

[0122] In addition, the phase of printing the separating means 9 is carried out with electrically insulating / non-conductive ink.

[0123] Preferably, the phase of printing is done through an inkjet printer, a laser printer, a screen printer or the like.

[0124] Preferably, the printing of the sampling elements 5 and the printing of the separating means 9 occurs simultaneously during a single phase of printing.

[0125] Advantageously, the phase of supplying comprises at least one supply step of at least one printable sheet provided with the backing film 2 and with at least one load-bearing layer on which the backing film 2 is overlaid.

[0126] Specifically, the backing film 2 is coupled to the load-bearing layer in a removable maimer.

[0127] Preferably, the load-bearing layer is made of a flexible material, e.g. paper or water-soluble paper.

[0128] Conveniently, the load-bearing layer imparts more rigidity to the backing film 2 making the latter easily handled and usable for printing processes.

[0129] This expedient allows using a backing film 2 with very thin thicknesses that would not allow it to be handled and / or printed without being creased or damaged. More specifically, the printable sheet is a decal sheet, such as a decal water slide transfer paper.

[0130] Conveniently, the process comprises at least one phase of heating the backing film 2 to attach the electrically conductive ink and / or the insulating / non- conductive ink to the backing face 3. Appropriately, the phase of heating is carried out after printing to further attach the electrically conductive ink and / or the insulating / non-conductive ink onto the backing face 3.

[0131] Specifically, the phase of heating is carried out at about 150 °C for about 20 minutes.

[0132] In this way, the ink remains in place on the film without being displaced and / or smudged, which could impair the functionality of the device 1, for example, by creating interruptions (open circuits) along the body of the sampling elements 5. Advantageously, the process comprises at least one phase of activating the electrically conductive ink.

[0133] Specifically, the activation phase comprises at least one step of gliding the sampling elements 5 with at least one activation body made of metallic or organic material.

[0134] In more detail, the sampling elements 5 are made electrically conductive as a result of the gliding thereof with the activation body.

[0135] Specifically, the activation phase comprises the execution of a chemicalmechanical sintering process carried out as a result of gliding and of the material used to carry out this operation.

[0136] Conveniently, the activation body is a body which can be manually used by an operator to carry out the activation phase.

[0137] Preferably, the activation body is made of stainless steel, aluminum or other similar materials.

[0138] Specifically, the activation body is provided with a substantially flat activation surface which is rubbed in contact with one or more sampling elements 5 during the rubbing step, so as to reduce the risk of damage to them as a result of rubbing. Preferably, the activation body is made of sheet.

[0139] It cannot, however, be ruled out that the activation phase may comprise a rolling step.

[0140] Conveniently, the activation phase is carried out as a result of the heating phase. Appropriately, the process comprises at least one phase of separating the backing film 2 from the load-bearing layer. Conveniently, the separating phase is carried out subsequently to the printing phase.

[0141] In particular, the separating phase is carried out subsequently to the heating and / or activation phase.

[0142] Specifically, the separating phase comprises a wetting step of the load-bearing layer.

[0143] More in detail, the wetting step comprises applying water or another liquid substance (e.g., isopropyl alcohol) that is equivalently solvent to the load-bearing layer.

[0144] In fact, the load-bearing layer is made of a material that is substantially porous to water. Thus, water passes through the load-bearing layer until it seeps at the interface between the load-bearing layer and the backing film 2, allowing the film itself to separate.

[0145] Advantageously, the process comprises at least one step of providing at least one flexible base layer 10 and at least one phase of coupling the base layer 10 by overlapping with the backing film 2, keeping it substantially stretched to prevent it from creasing.

[0146] Preferably, the coupling phase is carried out as a result of the separation phase.

[0147] In other words, the backing film 2 is separated from the load-bearing layer to be coupled to the base layer 10.

[0148] In this way, the base layer 10 keeps the backing film 2 stretched out.

[0149] In addition, the base layer 10 is waterproof, so that the device 1 is made waterproof when applied to the skin of the patient 4 as described above with reference to the device 1.

[0150] Therefore, the coupling phase of the base layer 10 substantially coincides with a waterproofing phase of the backing film 2.

[0151] Specifically, the base layer 10 comprises at least one adhesive face 11, and the coupling phase comprises a step of applying the backing film 2 onto the adhesive face 11, so as to free at least one portion of the adhesive face, substantially framing, at least partly, the backing face 3.

[0152] Conveniently, the process comprises at least one phase of applying at least one adhesive layer 12 onto the backing face 3, the sampling elements 5 and / or the separating means 9.

[0153] Conveniently, the phase of applying the adhesive layer 12 comprises the application of an adhesive glue or other medical-grade adhesive material onto the backing face 3.

[0154] Advantageously, the process comprises at least one phase of coating at least one of either the adhesive face 11 or the adhesive layer 12 with at least one removable protective body 13.

[0155] Appropriately, the process comprises: at least one phase of supplying electrical connecting means 15, 16 to at least handling means 14 of surface electrophysiological signals; at least one phase of linking the connecting means 15,16 to the sampling elements 5.

[0156] Specifically, the linking phase comprises: at least one step of applying at least one electrically conductive adhesive onto the connecting means 15, 16 and / or the sampling elements 5; at least one step of overlapping the connecting means 15, 16 to a portion of the sampling elements 5, the overlapping step electrically connecting the connecting means 15, 16 to the sampling elements 5 to enable the transmission to the handling means 14 of at least one surface electrophysiological signal acquired from the sampling elements 5.

[0157] Conveniently, the connecting phase comprises at least one step of covering the connecting means 15, 16 with at least one electrically insulating layer 19.

[0158] Specifically, the step of covering provides for covering the connecting means 15, 16 at the point of connection with the sampling elements 5, e.g. at the connecting portions 7.

[0159] More specifically, the step of covering is carried out subsequently to the step of overlapping.

[0160] Preferably, the phase of linking is carried out prior to the phase of coating.

[0161] It has in practice been ascertained that the described invention achieves the intended objects. In particular, the backing film and the electrodes made of conductive ink allow for improved adhesion of the electrodes to the skin.

[0162] In addition, the attachment means allow the device to be applied to the skin easily, smoothly and quickly. Moreover, the backing film 2 and the electrodes made of conductive ink allow the device to be smaller and more comfortable on the skin.

[0163] In addition, the backing film 2 and the electrodes made of conductive ink make the device easy and affordable to manufacture.

[0164] In addition, the device’s components make it echo-transparent to ultrasound acoustic signals.

[0165] Again, the base layer allows the device to be made waterproof.

Claims

CLAIMS1) Device (1) for sampling surface electrophysiological signals, particularly surface electromyographic signals, comprising: at least one flexible backing film (2), made of polymeric material, and provided with at least one backing face (3) arranged, in use, substantially in contact with the skin of a patient (4); a plurality of sampling elements (5), made on said backing face (3) and adapted to sample at least one high-density surface electromyographic signal, said sampling elements (5) being arranged, in use, substantially in contact with the skin of the patient (4) to sample at least one surface electromyographic signal; characterized by the fact that said sampling elements (5) are made of conductive ink.2) Device (1) according to claim 1, characterized by the fact that it comprises separating means (9), made of electrically insulating / non-conductive ink positioned between said sampling elements (5), keeping them separated from each other.3) Device (1) according to one or more of the preceding claims, characterized by the fact that said separating means (9) and said sampling elements (5) define on said backing film (2) two at least partly complementary regions.4) Device (1) according to one or more of the preceding claims, characterized by the fact that said backing film (2) can be creased, crumpled and / or irregularly handled.5) Device (1) according to one or more of the preceding claims, characterized by the fact that said backing film (2) has a thickness of less than 50 micrometers.6) Device (1) according to one or more of the preceding claims, characterized by the fact that the Young’s modulus of said backing film (2) is less than 0.4 megapascals.7) Device (1) according to one or more of the preceding claims, characterized by the fact that said backing film (2) has a radius of curvature of less than 14.5 millimeters.8) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises at least one flexible base layer (10), associated overlapping said backing film (2), keeping it substantially stretched to prevent it from creasing.9) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises attachment means (11, 12) to be attached to the skin of the patient (4) in a removable maimer, said attachment means (11, 12) attaching, in use, said backing face (3) in contact with the skin of the patient (4).10) Device (1) according to one or more of the preceding claims, characterized by the fact that said attachment means (11, 12) comprise: at least one adhesive face (11) made on said base layer (10) and arranged to frame, at least partly, said backing face (3), said adhesive face (11) being adapted, in use, to adhere to the skin of the patient (4); and / or at least one adhesive layer (12) made on said backing face (3), on said sampling elements (5) and / or on said separating means (9) and adapted, in use, to adhere to the skin of the patient (4).11) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises at least one protective body (13) applied, in a removable manner, onto at least one of either said adhesive face (11) or said adhesive layer (12) coating at least one of the latter.12) Device (1) according to one or more of the preceding claims, characterized by the fact that it comprises electrical connecting means (15, 16) of said sampling elements (5) to at least handling means (14) of surface electrophysiological signals.13) Device (1) according to one or more of the preceding claims, characterized by the fact that said connecting means (15, 16) comprise at least one flexible backing body (15) and a plurality of electrical conductive bodies (16), made on said backing body (15) and electrically connected to said sampling elements (5), said conductive bodies (16) being adapted, in use, to transmit to the handling means (14) at least one surface electrophysiological signal sampled by said sampling elements (5).14) Device (1) according to one or more of the preceding claims, characterized by the fact that said backing body (15) is made of a different material than said backing film (2).15) Manufacturing process of a device (1) for sampling surface electrophysiological signals, particularly surface electromyographic signals, characterized by the fact that it comprises at least the phases of: supplying at least one flexible backing film (2) made of a polymeric material and provided with at least one backing face (3) to be arranged, in use, substantially in contact with the skin of a patient (4); printing a plurality of sampling elements (5) on said backing film (2), said printing being carried out with electrically conductive ink.16) Process according to claim 15, characterized by the fact that it comprises at least one phase of printing separating means (9) positioned between said sampling elements (5) to keep the latter spaced apart from each other, said printing phase being carried out with electrically insulating / non-conductive ink.17) Process according to one or more of claims 15 to 16, characterized by the fact that said phase of supplying comprises at least one supply step of at least one printable sheet provided with said backing film (2) and with at least one loadbearing layer on which said backing film (2) is overlaid.18) Process according to one or more of claims 15 to 17, characterized by the fact that it comprises at least one phase of heating said backing film (2) to attach said electrically conductive ink and / or said insulating / non-conductive ink to said backing face (3).19) Process according to one or more of claims 15 to 18, characterized by the fact that it comprises at least one phase of activating said electrically conductive ink, said activating phase comprising at least one step of gliding said sampling elements (5) with at least one activation body made of metallic or organic material, said sampling elements (5) being made electrically conductive as a result of the gliding thereof with said activation body.20) Process according to one or more of claims 15 to 19, characterized by the fact that it comprises at least one phase of separating said backing film (2) from saidload-bearing layer.21) Process according to one or more of claims 15 to 20, characterized by the fact that it comprises at least one phase of providing at least one flexible base layer (10) and at least one phase of coupling said base layer (10) by overlapping with said backing film (2), keeping it substantially stretched to prevent it from creasing.22) Process according to one or more of claims 15 to 21, characterized by the fact that said base layer (10) comprises at least one adhesive face (11) and by the fact that said coupling phase comprises a step of applying said backing film (2) onto said adhesive face (11), so as to leave at least one portion of said adhesive face free, substantially framing, at least partly, said backing face (3).23) Process according to one or more of claims 15 to 22, characterized by the fact that it comprises at least one phase of applying at least one adhesive layer (12) onto said backing face (3), said sampling elements (5) and / or said separating means (9).24) Process according to one or more of claims 15 to 23, characterized by the fact that it comprises at least one phase of coating at least one of either said adhesive face (11) or said adhesive layer (12) with at least one removable protective body (13).25) Process according to one or more of claims 15 to 24, characterized by the fact that it comprises: at least one phase of supplying electrical connecting means (15, 16) to at least handling means (14) of surface electrophysiological signals; at least one phase of linking said connecting means (15, 16) to said sampling elements (5).26) Process according to one or more of claims 15 to 25, characterized by the fact that said linking phase comprises: at least one step of applying at least one electrically conductive adhesive onto said connecting means (15, 16) and / or said sampling elements (5) at least one step of overlapping said connecting means (15, 16) to a portion of said sampling elements (5), said overlapping step electrically connectingsaid connecting means (15, 16) to said sampling elements (5) to enable the transmission to the handling means (14) of at least one surface electrophysiological signal acquired from said sampling elements (5).27) Process according to one or more of claims 15 to 26, characterized by the fact that said connecting phase comprises at least one step of covering said connecting means (15, 16) with at least one electrically insulating layer (19).

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