Polymer composite dry electrode for electrical stimulation and method of use therefor

Abstract

Electrodes known in the art and used with functional electrical stimulation degrade after multiple uses and require a certain level of wetting or skin interface layer to remain comfortable. The reusable, convenient, and comfortable dry electrode disclosed herein comprises a conductive material comprising a fluoropolymer matrix and conductive carbon nanoparticles dispersed in the matrix, as well as a conductor configured to contact the material from a stimulator and deliver electrical pulses, wherein the dry tissue contact surface of the material is configured to deliver electrical stimulation directly to the tissue. The disclosure also relates to the use of reusable dry electrodes, dry electrode garments and devices, and methods for manufacturing the same and their use.

Description

[Technical Field]

[0001] This Patent Cooperation Treaty application claims the benefit of priority of U.S. Provisional Application No. 63 / 454,498, filed on 24 March 2023, and U.S. Application No. 63 / 619,703, filed on 10 January 2024 (each of which is incorporated herein by reference as a whole).

[0002] field This disclosure relates to reusable dry electrodes. This disclosure also relates to methods for manufacturing washable dry electrode articles or garments. This disclosure also relates to dry electrode apparatus. This disclosure also relates to the use of reusable dry electrodes and dry electrode articles, garments and apparatus. [Background technology]

[0003] Functional electrical stimulation (FES) is a rehabilitation technique that enables functional improvement in patients with motor control disorders, and consists of delivering low-energy electrical pulses through peripheral nerves in the affected limb to activate target muscles[5] and generate muscle contractions, which can be used for the rehabilitation of people with upper motor neuron injuries, such as stroke and spinal cord injuries (which often result in paralysis)[1][3][6][7]]. These pulses are delivered via electrodes, which serve as the primary interface between the stimulator and the patient. To deliver the stimulation, the minimum setup requirements are a stimulator and at least one pair of electrodes. The electrodes can be placed on the surface of the skin (i.e., transcutaneous), through the skin (i.e., percutenious), directly on the nerve (i.e., the rotator cuff), or directly on the muscle adjacent to the nerve (i.e., the epimysium)[1][2]. These charge transfers can be influenced by many factors, such as placement, tissue-electrode interface, electrode material, and the stimulator used, which can ultimately affect motion generation and comfort during stimulation[4][8,9]. These factors can also play a role in the user experience, whether patient or therapist.

[0004] A stimulator is a device that provides electrical pulses. Pulses can have different shapes, widths, and amplitudes and can be delivered at specific frequencies. Electrodes are the interface between the stimulator and the body. They can be classified as invasive or non-invasive depending on whether they are placed directly on nerves, via the skin, or on the surface of the skin. Invasive electrodes require a surgical procedure for implantation and deliver stimulation directly to specific nerves or in close proximity to motor neurons. Non-invasive electrodes are placed on the skin (i.e., percutaneous) and electrical impulses are delivered via the surface of the skin [1], [2]. Within the percutaneous electrode category, the current FES standard is self-adhesive hydrogel electrodes. These are multilayer electrodes with an adhesive hydrogel that comes into contact with the skin [5]. They are easy to use but tend to lose their adhesive properties in the short term and are therefore not ideal for reuse.

[0005] Transcutaneous electrodes have the advantages of being non-invasive and easy to apply and remove. Types of transcutaneous electrodes used to date include sponge electrodes, carbon rubber electrodes, hydrogel electrodes, and textile electrodes.[5]

[0006] One of the most commonly used types of transcutaneous electrodes is the self-adhesive hydrogel electrode. Given their non-invasiveness and ease of application, their widespread use is understandable. They consist of a multilayer material which contains an adhesive gel that allows them to adhere directly to the skin.[5] However, these types of electrodes have the disadvantage that they degrade after multiple uses and their adhesive properties are quickly lost. To keep the electrode in place, an elastic bandage or other additional support can be wrapped around the electrode. This prevents the electrode from falling due to body movement, pulling on the cable connecting the electrode to the stimulator, or the weight of the cable connecting the electrode to the stimulator. Hydrogel electrodes are also not reusable, which makes the cost of use higher if multiple sessions are required.

[0007] The typical method of delivering stimulation is cumbersome, as it requires at least two hydrogel electrodes for each muscle being stimulated, which are connected to the stimulator using long cables [10,11]. This is not a major issue for stimulating one or two muscles, but to accomplish more complex tasks, such as reaching, grasping, and walking, 6 to 12 pairs of stimulating electrodes are required, and the use of hydrogel electrodes and individual cables becomes significantly cumbersome. Consequently, more advanced forms of FES therapy must be delivered in clinical settings, as they require knowledgeable therapists to deliver the treatment. Therefore, novel methods for delivering FES therapy are needed.

[0008] To address this problem, various groups have begun development with the aim of using dry electrodes as reusable stimulating electrodes

[12] . One of the advantages of dry electrodes is that they are reusable and can be used without the need for conductive gels. A wide range of materials can be used to fabricate dry electrodes

[13] , making them easily adaptable to FES applications [22, 23, 29]. However, one of the fundamental problems with dry electrodes, such as metal plates or carbon rubber, is that they are uncomfortable and individuals using them experience pain and discomfort during stimulation

[17] . In fact, due to their high conductivity, metal plate electrodes can cause severe skin burns and need to be associated with a wetting medium to distribute the current evenly. Similarly, carbon rubber electrodes, another type of non-adhesive transcutaneous electrode made from carbon and elastomers, such as silicone (which has low conductivity), require a gel or water as a skin interface and need to be repeatedly wetted and require the use of additional straps, tapes or bandages to hold them in place [5], which makes them difficult to use for long-term applications.

[0009] In recent years, textile electrodes have been proposed as a solution to some of the limitations of hydrogel electrodes, however, they require a certain level of moisture or a skin interface layer to maintain comfort when used with electrical stimulation or functional electrical stimulation, and for this reason, they are less convenient to use than hydrogel electrodes [5],

[16] -

[21] . For example, embroidered electrode pads made of plasma-coated metallized yarn [5] have been used with electrical stimulation, however, at higher currents (8 mA or more), they could not be used comfortably without a skin interface layer due to poor electrical properties (e.g., impedance) and an ineffective skin-electrode interface. Hot-melt carbon composites made from thermoplastic polymers (e.g., polyolefins or polyamides) have been used as an interface between textile electrodes and skin to reduce the intensity of stimulation from high current delivery [5]. In such situations, the hot-melt carbon composite acts as an interface layer between the stimulating electrode and the skin, improving impedance matching and not acting as the electrode itself which requires an interface layer between the electrode and the skin, ensuring efficient and comfortable stimulation [5].

[0010] The level of comfort can influence the user's tolerance and adherence to stimulation; therefore, a higher level of comfort would potentially allow for longer-term use of FES or the generation of stronger muscle contractions. Current transcutaneous electrode options require the use of a moist interface to improve performance and increase comfort, as the constant addition of gel or water can be impractical and uncomfortable for the user.

[0011] Clothing (e.g., shirts, pants) knitted with conductive Ag-AgCl and LYCRA-coated nylon yarn has been used with functional electrical stimulation, however, they required the fabric electrodes to be kept constantly moist for comfortable and reliable use.[8]

[0012] Conductive polymer composites are robust structures fabricated from a combination of thermoplastic polymers and conductive nanofillers, offering unique properties along with high mechanical flexibility and durability.

[22] Conductive polymer films containing conductive carbon nanoparticles dispersed in a fluoropolymer matrix have been used as force sensors designed to wrap around neurosurgical instruments. For example, a 200 μm thick tube was wrapped in a conductive polymer film and interfaced with silicon-based simulated nerve tissue, then coated with comb electrodes and a laminated layer to receive pressure signals from there.

[23] Conductive carbon nanotube composites, consisting of carbon nanotubes (CNTs) dispersed in thermoplastic polyurethane (TPU), ethylene-vinyl acetate (EVA), and styrene-butadiene-styrene (SBS), have been used to acquire electrical signals from cardiac tissue during electrocardiograms (ECGs).

[22]

[0013] Different wearable devices have been proposed to make FES more convenient [20, 24]. Advances in printing technology have made it possible to develop printed electrodes on textile substrates

[25] . However, the porosity of textile materials makes it difficult to control the amount of ink and thus the electrode properties

[26] . On the other hand, knitting technology has made it possible to integrate textile conductive yarn to create textile electrodes in specific locations and develop clothing, such as sleeves or tights

[18] . However, the developed textile electrodes are not suitable for FES application due to their discomfort. Regardless of better performance in terms of flexibility or stretchability, they also require to be wet, at least before stimulation

[20] . Moreover, conventional textile materials and processes produce rough electrode surfaces, which do not match the roughness and impedance of skin

[27] . The same applies to embroidery technology, except that the electrodes are sewn onto the substrate after manufacturing

[28] .

[0014] A dry electrode for use with electrical stimulation that is convenient, comfortable, and / or reusable, as well as a wearable device for FES that addresses any of the above challenges, namely (i) reusability, (ii) minimization of pain and discomfort, (iii) ease of attachment and removal, and / or (iv) simplification of connection to a stimulator for electrical pulse transmission, is desirable. [Overview of the Initiative]

[0015] This disclosure relates to reusable dry electrodes and their use, methods for manufacturing washable dry electrode articles or garments, and the use of dry electrode articles, garments and apparatus.

[0016] This disclosure also relates to the use of dry polymer composite electrodes based on, for example, polyvinylidene fluoride (PVDF) thermoplastics and carbon nanotube (CNT) conductive fillers for FES on a knitted substrate to provide smart clothing. The electrodes and stimulators are integrated and linked via a textile conductive matrix made of sewn or embroidered textile conductive threads. Thus, the described method for manufacturing reusable dry electrodes can be applied to produce smart FES clothing for a wide range of muscles, which are wearable and suitable for long-term application, such as FES therapy.

[0017] In one embodiment, a reusable dry electrode comprises a conductive material comprising a fluoropolymer matrix and conductive carbon nanoparticles dispersed in the matrix, and a conductor configured to contact the material from a stimulator and deliver electrical pulses, wherein the dry tissue contact surface of the material is configured to deliver electrical stimulation directly to the tissue, for example, without passing through an intervening layer placed between the tissue contact surface and the tissue. The conductive material is, for example, nonmetallic (e.g., the conductive material does not use metal for electrical conductivity).

[0018] In another embodiment, the fluoropolymer matrix is ​​polyvinylidene fluoride (PVDF).

[0019] In another embodiment, the nanoparticles are carbon nanotubes (CNTs).

[0020] In another embodiment, the nanoparticles are dispersed in the fluoropolymer matrix at about 5 to about 10 wt% of the matrix.

[0021] In another embodiment, the nanoparticles have an aspect ratio of about 1 to about 600.

[0022] In another embodiment, the aspect ratio of the nanoparticles is about 130 to about 160.

[0023] In another embodiment, the nanoparticles are interconnected.

[0024] In another embodiment, the impedance of the conductive material is about 1,000 to about 10,000 Ω, and / or the sheet resistivity of the conductive material is at least 50 Ω·cm or about 50 to about 500 Ω·cm.

[0025] In another embodiment, the impedance of the conductive material is about 2,100 to about 2,800 Ω, and / or the sheet resistivity of the conductive material is about 100 to about 300 Ω·cm. ​​​​​​​​​​​​​​​​​​​​​​In another embodiment, the electrical stimulation is functional electrical stimulation.

[0032] In another embodiment, the dry electrode is placed on an article or garment.

[0033] In another embodiment, the dry electrode is positioned on the inner surface of an article or garment, with the dry tissue contact surface of the electrode parallel to the tissue.

[0034] In another embodiment, the dry electrode is fixed to an article or garment using an adhesive.

[0035] In another embodiment, the dry electrode is used in conjunction with a high-voltage regulated stimulator, and the electrode is configured to deliver electrical pulses.

[0036] In another embodiment, the pulse used in the dry electrode is a symmetrical or asymmetrical biphasic electrical pulse.

[0037] In another embodiment, the pulse rise time is approximately 10 to 40 ns.

[0038] In another embodiment, the pulse has a total width of approximately 8 to approximately 2,000 μs.

[0039] In another embodiment, the pulse width is approximately 100 to approximately 1,000 μs.

[0040] In another embodiment, the width is approximately 300 to 500 μs.

[0041] In another embodiment, the pulses are asymmetric and include a first phase pulse having a first amplitude and a first width, and a second phase pulse having a second amplitude and a second width.

[0042] In another embodiment, the first amplitude of the pulse is approximately -0.04 to approximately -160 mA, and / or the second amplitude of the pulse is approximately 0.01 to approximately 40 mA.

[0043] In another embodiment, the first amplitude of the pulse is approximately -0.4 to approximately -120 mA, and / or the second amplitude of the pulse is approximately 0.1 to approximately 30 mA.

[0044] In another embodiment, the width of the first pulse is approximately 200 to approximately 500 μs, and / or the width of the second pulse is approximately 800 to approximately 2,000 μs.

[0045] In another embodiment, the amplitudes of the first and second pulses are not equal.

[0046] In another embodiment, the widths of the first and second pulses are not equal.

[0047] In another embodiment, a washable dry electrode article or garment includes a dry electrode as disclosed herein.

[0048] In another embodiment, the dry electrode is positioned on the inner surface of an article or garment, with the tissue-contact surface of the conductive material parallel to the tissue.

[0049] In another embodiment, the dry electrode is fixed to an article or garment using an adhesive.

[0050] In another embodiment, the conductor includes an electrode contact segment configured to contact a dry electrode, the electrode contact segment including at least one conductive yarn integrated into a woven textile substrate.

[0051] In another embodiment, at least one conductive thread is integrated into the textile substrate by sewing or embroidery.

[0052] In another embodiment, the conductor comprises at least two conductive threads, some of which are integrated into a textile substrate to form a pattern containing multiple non-intersecting lines.

[0053] In another embodiment, the conductor further includes a cable segment comprising one or more unintegrated portions of conductive threads configured to deliver electrical stimulation from a stimulator to a conductive electrode contact segment, and optionally the cable segment is fixed to a textile substrate by mounting means.

[0054] In another embodiment, at least two lengths of a plurality of non-intersecting lines are arranged substantially parallel to each other within the electrode contact segment.

[0055] In another embodiment, the textile base material is or includes a polyester jersey material.

[0056] In another embodiment, one or more conductive threads are silver-plated threads, or include such threads, and / or have a linear resistance of at least 1 Ω / m or about 1 to about 1000 Ω / m.

[0057] In another embodiment, a protective layer is placed on a non-skin contact surface of an article or garment and covers the exposed portions of one or more conductive threads.

[0058] In another embodiment, the protective layer is a fabric layer or a liquid silicone layer.

[0059] In another embodiment, a dry electrode device for delivering electrical stimulation to a user includes a dry electrode article or garment disclosed herein, a high-voltage regulated stimulator, and a connector for connecting the conductor and the stimulator.

[0060] In another embodiment, the dry electrode is fixed to an article or clothing using an adhesive.

[0061] In another embodiment, the connector for the dry electrode is placed on an article or garment.

[0062] In another embodiment, the stimulator used with a dry electrode, article, clothing, or device is portable.

[0063] In another embodiment, the stimulator is configured to be placed within a part of an article or clothing.

[0064] In another embodiment, the dry electrodes or dry electrode articles, clothing, or devices disclosed herein are used to treat motor disorders in a user.

[0065] In another embodiment, the use of a dry electrode or dry electrode article, garment or device disclosed herein includes placing the article, garment or at least two dry electrodes directly on the user's tissue in close proximity to a selected muscle or muscle group, connecting the conductor of the article, garment or at least two dry electrodes to a stimulator, and delivering electrical stimulation from the stimulator to the conductor of the article or garment or at least two dry electrodes, the stimulation inducing contraction of the muscle or muscle group, thereby treating a motor disorder.

[0066] In another embodiment, the motor impairment is paralysis.

[0067] In another embodiment, a method for delivering electrical stimulation to a subject disclosed herein includes: placing a dry electrode article or garment or at least two dry electrodes directly on the subject's tissue in close proximity to a selected muscle or muscle group; connecting the article, garment conductor or at least two dry electrodes to a high-voltage regulated stimulator; and delivering electrical pulses from the stimulator to the article or garment conductor or to at least two dry electrodes, the stimulation inducing contraction of the muscle or muscle group.

[0068] In another embodiment, the pulse is a symmetrical or asymmetrical biphasic electrical pulse.

[0069] In another embodiment, the pulse rise time is approximately 10 to 40 ns.

[0070] In another embodiment, the pulse has a total width of approximately 8 to approximately 2,000 μs.

[0071] In another embodiment, the pulse width is approximately 100 to approximately 1,000 μs.

[0072] In another embodiment, the pulse width is approximately 300 to 500 μs.

[0073] In another embodiment, the pulses are asymmetric and include a first phase pulse having a first amplitude and a first width, and a second phase pulse having a second amplitude and a second width.

[0074] In another embodiment, the first amplitude of the pulse is approximately -0.04 to approximately -160 mA, and / or the second amplitude of the pulse is approximately 0.01 to approximately 40 mA.

[0075] In another embodiment, the first amplitude of the pulse is approximately -0.4 to approximately -120 mA, and / or the second amplitude of the pulse is approximately 0.1 to approximately 30 mA.

[0076] In another embodiment, the width of the first pulse is approximately 200 to approximately 500 μs, and / or the width of the second pulse is approximately 800 to approximately 2,000 μs.

[0077] In another embodiment, the amplitudes of the first and second pulses are not equal.

[0078] In another embodiment, the widths of the first and second pulses are not equal.

[0079] In another embodiment, the pulse is delivered at a frequency of approximately 1 to approximately 100 Hz.

[0080] In another embodiment, the pulse frequency is approximately 20 to approximately 40 Hz.

[0081] In another embodiment, the method of delivering electrical stimulation disclosed herein is used to treat a motor disorder in a subject.

[0082] In another embodiment, a method for manufacturing a washable dry electrode article or garment comprises A) manufacturing a dry electrode as disclosed herein, the steps of i) dispersing conductive carbon nanoparticles in a polymer solvent to obtain a dispersion, ii) dissolving a fluoropolymer matrix in the dispersion to obtain a blend, iii) casting the blend, iv) drying the cast blend, v) compressing the blend, vi) cooling the blend to obtain a conductive material, vii) cleaning the material, and viiii) placing a conductor on or inside the conductive material, the conductor being configured to contact the material from a stimulator and deliver electrical pulses; and further, B) placing the dry electrode of (A) on or inside an article or garment, the electrode being placed on the inner surface of the article or garment, the tissue contact surface of the electrode being parallel to the tissue, and not passing through an intervening layer, for example, placed between the tissue contact surface and the tissue.

[0083] In another embodiment, casting and / or compression includes transferring the blend to a mold.

[0084] In another embodiment, the solvent is dimethylformamide (DMF).

[0085] In another embodiment, dispersion is performed by ultrasonic treatment.

[0086] In another embodiment, melting, casting and / or drying further includes heating the blend.

[0087] In another embodiment, heating is carried out within a range of approximately 80 to 200°C.

[0088] In another embodiment, cleaning is performed using water and / or ethanol.

[0089] In another embodiment, arranging the conductor on the material according to (viii) includes integrating at least one conductive thread into a woven textile base material.

[0090] In another embodiment, the integration includes sewing or embroidery.

[0091] In another embodiment, arranging the dry electrode according to (B) further includes i) placing a thermal adhesive on the textile substrate before integrating at least one conductive yarn, ii) placing the dry electrode on the thermal adhesive, and iii) using thermal compression to bond the thermal adhesive to the dry electrode and the textile substrate, the thermal compression integrating a portion of at least one conductive yarn into the dry electrode conductive material.

[0092] In another embodiment, thermal compression includes heating the dry electrode to a temperature of at least 180°C, optionally in the range of 180°C to 230°C.

[0093] In another embodiment, thermal compression includes applying a pressure in the range of 1 to 10 tons to a textile substrate, optionally applying a pressure of about 1 ton to the textile substrate, followed by a pressure of about 5 tons.

[0094] In another embodiment, pressure is applied for a period of time ranging from 5 to 10 minutes.

[0095] In another embodiment, a pressure of about 1 ton is applied for about 5 minutes, and a pressure of about 5 tons is applied for about 5 to 7 minutes.

[0096] In another embodiment, the textile base material is or includes a polyester jersey material.

[0097] In another embodiment, at least one conductive thread is a silver-plated thread, or includes one, and / or has a resistance of at least 1 Ω·m or about 1 to about 1000 Ω·m.

[0098] In another embodiment, the protective layer is placed on a non-skin contact surface of an article or garment and covers the exposed portion of at least one conductive thread.

[0099] In another embodiment, the protective layer is a fabric layer or a liquid silicone layer.

[0100] In another embodiment, a dry electrode article or garment manufactured by the method disclosed herein is used to treat a motor disorder in a user.

[0101] In another embodiment, the motor impairment is paralysis.

[0102] Other features and advantages of this disclosure will become apparent from the detailed description below. However, it should be understood that the detailed description and specific examples, while illustrating preferred embodiments of this disclosure, are provided only as examples, for various changes and modifications within the spirit and scope of this disclosure will become apparent to those skilled in the art from this detailed description.

[0103] Embodiments of this disclosure are described below with reference to the drawings. [Brief explanation of the drawing]

[0104] [Figure 1] This specification shows a reusable dry electrode. [Figure 2] This specification describes the manufacturing process for reusable dry electrodes. [Figure 3a-3b] The TGA curves under two different environments are shown: Figure 3a shows air, and Figure 3b shows nitrogen. Figure 3c shows the tensile stress-strain curves for the dry electrode polymer nanocomposite and the raw polymer. [Figure 4] The impedance amplitude (top) and phase response (bottom) of hydrogel, dry polymer nanocomposite, and dry carbon rubber electrodes on the human forearm are shown. [Figure 5]Examples of asymmetric biphasic pulses delivered using three different stimulators are shown: a portable battery-powered stimulator (left: EV-906, Everyway Medical Instruments), a MyndSearch stimulator (center: MyndTec, Canada), and a Compex Motion stimulator (right: Compex, Switzerland). [Figure 6] The experimental setup, visual analog comfort rating scale, and different electrode types used (from left to right): hydrogel, dry polymer nanocomposite, and carbon rubber, as well as the stimulators used with their individual electrode shapes (from left to right): EV-906, MyndSearch, and Compex Motion. [Figure 7] The average stimulation intensity used for each electrode and stimulator type is shown. In each box plot, the horizontal line represents the median, and the circle represents the mean. [Figure 8] This shows the average percentage of stimulation intensity used, based on the maximum possible output of each stimulator. In each box plot, the horizontal line represents the median, and the circle represents the average. [Figure 9] For each intensity level, the reported average comfort rating is shown, with 0 being the most comfortable and 10 being the most uncomfortable. [Figure 10] This shows each participant's comfort rating for each electrode-stimulator combination. 0 = most comfortable and 10 = most uncomfortable. Darker colors indicate higher comfort. [Figure 11] For each electrode-stimulator combination, the average comfort rating versus the stimulation intensity used is shown. [Figure 12] This shows the average normalized muscle torque generated at different stimulus intensities. [Figure 13] This chart shows the normalized torque for each individual participant for each electrode-stimulator combination. Darker colors indicate higher torque. [Figure 14] For each electrode-stimulator combination, the average normalized generated torque versus the stimulation intensity used is shown. [Figure 15] This shows the average level of sensations reported during stimulation. [Figure 16] This chart shows the reported sensations of each individual participant for each electrode-stimulator combination. Darker colors indicate a stronger perceived sensation. [Figure 17] This shows the total sensory scores for each electrode type and stimulator used, categorized by skin (superficial), muscle (deep), and general classification. [Figure 18] This shows the average amount of normalized torque generated in relation to the perceived comfort level. [Figure 19] A 3D plot is shown showing the average amount of torque generated versus comfort rating versus stimulation intensity at each intensity level. [Figure 20] This specification shows a conductive material attached to the inner surface of a dry electrode garment. [Figure 21] This specification shows the experimental setup used during the electrical stimulation test of dry electrode garments. [Figures 22A-22B] Figure 22B shows the average comfort ratings obtained using the experimental setup, and Figure 22A shows the comfort rating scales for low (left), medium (center), and high (right) stimulation intensities using three different stimulators (EV-906, MyndSearch, and Compex Motion). A rating of 0 is very comfortable, and 10 is very uncomfortable. [Figure 23] This shows the textile stitching pattern for a dry electrode article or garment sleeve. [Figures 24a-24b] Figure 24a shows the sewn conductive matrix and nonwoven thermal adhesive on a textile substrate. Figure 24a shows the inside of the conductive matrix (facing the skin), and Figure 24b shows the outside of the conductive matrix that does not face the skin. [Figures 25a-25c]The process of attaching dry electrodes to a textile substrate is shown. Figure 25a shows conductive threads woven into a nonwoven thermal adhesive, and then the dry electrodes are fixed to the thermal adhesive using thermal compression. Figure 25b shows the outer, non-skin-facing side of the integrated thread before the dry electrodes are attached, and Figure 25c shows the inner, skin-facing side of the integrated thread after the dry electrodes are attached. [Figures 26a-26c] Figure 26a shows a dry electrode article or clothing sleeve for the biceps muscle. Figure 26a shows the inner side of the sleeve facing the skin, Figure 26b shows the outer side of the sleeve not facing the skin, and Figure 26c shows the sleeve fitted by the user and connected to the stimulator. [Figure 27] This indicates the average perceived comfort rating, where 0 = most comfortable and 10 = most uncomfortable. [Figure 28] This shows the average normalized torque induced by stimulation using a hydrogel electrode versus a wearable dry electrode sleeve, which incorporates a dry electrode into the clothing. [Figure 29] The average stimulation intensity values ​​used for all participants are shown, using hydrogel electrodes versus wearable dry electrodes integrated into a sleeve garment. [Figure 30] This shows the average reported sensation after stimulation with a hydrogel electrode versus a wearable dry electrode sleeve, where the dry electrode is integrated into the clothing. [Figure 31a] Figure 31a shows the fabric pattern of the forearm dry electrode garment sleeve for functional electrical stimulation (FES), Figure 31b shows the forearm dry electrode garment sleeve indicating the dry electrode position, Figure 31c shows the zipper that allows the sleeve to be closed, and Figure 31d shows the sleeve attached to the forearm by the user. [Figures 32a-32b] The embroidery conductor matrix on the woven textile base material is shown. Figure 32a shows the side of the garment facing the skin, and Figure 32b shows the opposite side of the garment. [Figure 33] The image shows a carbon-based dry electrode fixed to a textile substrate by heat compression molding, with the conductor positioned between the dry electrode and the textile substrate (only the cable segment is shown). [Figures 34a-34c] The image shows a textile-based functional electrical stimulation dry electrode garment sleeve for the forearm: Figure 34a shows the forearm sleeve and zipper closure, Figure 34b shows the outer surface of the forearm sleeve, and Figure 34c shows the forearm sleeve connected to a system for delivering electrical stimulation to the dry electrode within the forearm sleeve. [Figures 35a-35b] The experimental setup for using a dry electrode clothing forearm sleeve during functional electrical stimulation is shown, with Figure 35a showing no stimulation (resting) and Figure 35b showing stimulation (wrist extension). [Modes for carrying out the invention]

[0105] Conventional transcutaneous stimulation electrodes currently available (e.g., hydrogels) are often not reusable, cannot be washed, and cannot be conveniently embedded in wearable clothing. Available dry electrodes (e.g., textiles, carbon rubber, and metals) frequently cause pain to the wearer during electrical stimulation and require moistening or an intervening layer, such as a gel layer, to make them comfortable during use. While available hydrogel electrodes are comfortable to use, they dry out and degrade over time or with repeated use, thus requiring frequent replacement.

[0106] This specification describes a completely dry transcutaneous electrode 2 intended for stimulation, which does not require a wet interface to operate effectively. The electrode is a thin film made from a polymer nanocomposite blend (e.g., PVDF+CNT), which is durable, flexible, and can have, for example, a smooth, non-adhesive surface.

[0107] Conductive polymer composites are robust structures fabricated from a combination of thermoplastic polymers and conductive nanofillers, offering unique properties along with high mechanical flexibility and durability [4]. As shown in the examples, when combined with the appropriate components, they become conductive and biocompatible, and the inventors have found that they can be used as thin-film electrodes for different electrical stimulation applications [4]. The inventors have further discovered that the stable chemical structure of conductive polymer composites allows for re-cleaning and reuse without inducing changes in composition. These features make electrodes fabricated from conductive polymer composites superior to conventional gel electrodes or those used with permanent conductive chemical adhesives that cannot be reused after several hours of use.

[0108] As detailed in the examples, the inventors further found that the carbon-based dry electrode 2 can be integrated into the textile substrate 12 by a heat compression molding process on an embroidered conductive matrix. This matrix consists of textile silver-plated conductive threads 10 and is connected to the stimulator 8. In addition to ensuring electrical connectivity, the matrix improves fixation between the textile substrate 12 and the dry electrode 2. Stimulation intensity, perceived comfort, and muscle torque generated by the smart FES sleeve 4 were compared to those with a hydrogel electrode.

[0109] This disclosure relates in one aspect to a reusable dry electrode 2 comprising a conductive material made from conductive carbon nanoparticles dispersed in a non-reactive and / or chemically stable fluoropolymer matrix, and a conductive element configured to contact the conductive material. When connected to a stimulator 8, electrical pulses delivered via the conductor 10 to the conductive material in contact with the tissue are delivered directly and comfortably to the underlying tissue without the need for wetting or passing through an intervening layer (e.g., interface material or hydrogel).

[0110] Conductive materials are, for example, nonmetals.

[0111] In another embodiment, the present disclosure relates to a reusable dry electrode 2 incorporated into a washable article or garment 4 that can be worn, can be used comfortably with electrical stimulation, and does not require wetting or an interface layer.

[0112] The disclosure also relates in further embodiments to a method for manufacturing a washable dry electrode article or garment 4, which includes manufacturing a reusable dry electrode 2 as disclosed herein, and incorporating the dry electrode 2 into an article or garment 4 that is worn, used comfortably with electrical stimulation, and does not require wetting or an interface layer.

[0113] In yet another embodiment, the disclosure relates to a dry electrode device assembled with a dry electrode article or garment 4, which includes a reusable dry electrode 2 and a stimulator 8 connected to a conductive element that contacts the conductive material of the dry electrode 2. In some embodiments, a connector 6 connected to the portable stimulator 8 is also incorporated into the article or garment 4. In these embodiments, the portable stimulator 8 can be conveniently carried in or on the article or garment 4, for example, in a pocket.

[0114] In another embodiment, the disclosure relates to the use of a reusable dry electrode 2, and an article or garment 4 and / or device containing the reusable dry electrode 2, for treating motor impairments in users in need of treatment, for example, manufactured using the manufacturing methods described herein. In some embodiments, the treatment of motor impairment using the reusable dry electrode 2 and article or garment 4 and / or device disclosed herein involves placing the dry electrode 2, or the article or garment 4 containing it, in close proximity to a selected muscle or muscle group on the user's tissue, and then delivering electrical stimulation via a conductor 10 to comfortably induce contraction of one or more muscles. In some embodiments, the motor impairment to be treated is a form of paralysis.

[0115] definition In this specification, the term "Ω" means ohm.

[0116] In this specification, the term "Ω·cm" means ohm-centimeter.

[0117] In this specification, the term "Ω·m" means ohm-meter.

[0118] In this specification, the term "Ω / cm" means ohms per centimeter.

[0119] In this specification, the term "Ω / m" means ohms per meter.

[0120] In this specification, the term "μs" means microsecond.

[0121] In this specification, the term "μm" means micrometer.

[0122] In this specification, the term "GPa" means gigapascal.

[0123] In this specification, the term "Hz" means Hertz.

[0124] In this specification, the term "kHz" means kilohertz.

[0125] In this specification, the term "mA" means milliampere.

[0126] In this specification, the term "mm" means millimeter.

[0127] In this specification, the term "ms" means milliseconds.

[0128] In this specification, the term "MPa" means megapascal.

[0129] In this specification, the term "wt%" means weight percentage.

[0130] In this specification, the term "aspect ratio" refers to the ratio of length to diameter.

[0131] In this specification, “Article” means any item that can come into direct contact with and / or conform to a user’s body parts. Examples include non-wearable items that can come into direct contact with a user’s body parts, such as bedding, shoe insoles, rugs, mats, carpets, and furniture covers or upholstery that can be placed on, for example, chairs, stools, etc., as well as other similar items and their derivatives.

[0132] The term "conductor" as used herein and as is well understood in the art means any material that is inherently or intrinsically capable of conducting electric current. Examples include metallic materials such as silver-coated yarn, copper-coated yarn, yarn containing silver fibers, yarn containing copper fibers, carbon fibers, and yarns.

[0133] In this specification, the term “direct” and its derivatives mean passing from one point to another without interacting with any intervening components. For example, delivering an electrical stimulus “directly” to tissue from an electrode should be interpreted as meaning that the stimulus is delivered to the tissue without first interacting with any intervening components, such as an interface (e.g., a hydrogel), placed between the electrode and the tissue.

[0134] In this specification, “to position,” “to place on,” “placed,” “placed on,” and derived terms refer to any means of bringing one component together with another component, so that the two components are in contact with each other, reversibly or irreversibly, and include, for example, pasting, attaching, embedding, joining, connecting, associating, linking, incorporating, integrating and / or merging the two components.

[0135] In this specification, “dry” means substantially lacking moisture, humidity, or dampness from a non-biological tissue source. For example, a “dry” electrode should be interpreted as substantially lacking moisture during use, such as moisture resulting from immersion in water or the addition of a hydrogel interface layer, but not as an electrode that becomes wet or damp during use as a result of such use, such as use that causes sweating in the user (leading to wetting of the electrode during use).

[0136] In this specification, the term “clothing” means any item that is wearable on and / or fitted to and in direct contact with a part of the user’s body. Examples include wearable items such as clothing, shirts, pants, socks, shawls, cuffs, sleeves, gloves, boots, orthotics, suits, helmets, costumes and other similar items and their derivatives.

[0137] As used herein and as is commonly understood in the art, the term “impedance” means the amount of impedance (i.e., combination of resistance and capacitance) that a component provides to a current flowing through a circuit at a given frequency, and is measured in ohms (Ω).

[0138] In this specification, the term “improved comfort” means an increase in the perceived comfort level of the electrode (e.g., one or more parameters reported by the user) compared to the perceived comfort level when using different types of electrodes, e.g., conventional electrodes known in the art (e.g., sponge, carbon rubber, hydrogel, and textile transcutaneous electrodes). For example, the perceived comfort level of an electrode user can be assessed using a comfort evaluation tool known in the art, for example, by obtaining an oral report on how comfortable the stimulation felt using a visual numerical rating scale of 0 to 10 presented to the user, where a comfort level of 0 indicates “very comfortable” and a comfort level of 10 indicates “very uncomfortable”. In this context, “improved comfort” should be interpreted as a relatively high level of reported comfort when using an electrode with electrical stimulation compared to the comfort level reported when using a different type of electrode with electrical stimulation delivered by the same type of stimulator using consistent stimulation pulse parameters (e.g., uniform pulse frequency and pulse width). For example, “improved comfort” may indicate a relatively high level of reported comfort (e.g., a lower mean comfort level score for one or more parameters) when used with the dry polymer nanocomposite electrode disclosed herein, used with a specific pulse, e.g., having a frequency of 40 Hz and a width of 300 μs, at high or maximum tolerable intensity, and delivered by a specific stimulator, e.g., the MyndSearch stimulator, compared to the reported comfort level when used with a conventional hydrogel electrode, e.g., having a frequency of 40 Hz and a width of 300 μs, and delivered by a MyndSearch stimulator at high or maximum tolerable intensity. Improved comfort can be said in relation to the dry polymer nanocomposite electrode disclosed herein in comparison to different electrodes, and the comparison is made without an interface layer, e.g., hydrogel or wetting.

[0139] In this specification, "interconnected" means that individual components are in physical contact with one another. For example, interconnected nanoparticle units in a polymer matrix are in contact with each other (e.g., because they are physically entangled), and a conductive network of nanoparticle units is created.

[0140] In this specification, “motor impairment” means any disability or condition that limits motor function in any area or part of the body. Examples of disabilities or conditions that limit motor function include, but are not limited to, congenital anomalies, e.g., spina bifida; central nervous system injuries resulting from head trauma, e.g., spinal cord injury resulting from physical trauma or accident; paralysis or partial paralysis; diseases, e.g., muscular dystrophy, multiple sclerosis, cerebral palsy, injuries resulting from stroke; and brachial plexus injury.

[0141] In this specification, "portable" means that it can be carried, moved, or transported.

[0142] In this specification, “reusable” means that an item can be reused multiple times (e.g., more than two- or three times) under normal use conditions without significant change in the physical integrity and / or performance of the item. For example, the reusable dry electrodes described herein can be reused more than two- or three times, e.g., 10, 100, or 1000 times, and the dry electrodes provide the user with substantially consistent stimulation each time they are used (e.g., when used with a stimulator that delivers pulses of substantially similar characteristics, it provides consistent muscle torque).

[0143] In this specification, "rise time" with respect to a pulse refers to the time required for the pulse to reach a final stimulation intensity level (e.g., 25 mA) from an initial stimulation intensity level (e.g., 0 mA) within a single pulse.

[0144] In this specification, “linear resistance” refers to a measure of how well a conductive component resists the flow of electric current, measured in ohms per centimeter (Ω / cm) or ohms per meter (Ω / m).

[0145] In this specification, "sheet resistivity" is a measure of how well a component resists the flow of electric current in a thin sheet or film, measured in ohms-centimeters (Ω·cm) or ohms-meters (Ω·m), and can be used to determine the electrical conductivity of a film component.

[0146] In this specification, “tissue” means any living tissue that can be subjected to electrical stimulation. Examples include skin, skeletal muscle, cardiac muscle, smooth muscle, and nervous system tissue, such as the brain, spinal cord, peripheral nerves, auditory nerves, or optic nerves.

[0147] In this specification, “washable” means a component that can be repeatedly washed, rewashed or cleaned over a specified period of time without damaging or otherwise impairing the physical integrity and / or functionality of the component.

[0148] As used in this specification, including the attached claims, unless expressly otherwise specified, the singular forms "a, an" and "the" include references to the plural. Thus, for example, "one electrode" includes two or more electrodes.

[0149] As used in this specification, including the attached claims, the term “or” is used generally to mean “and / or” unless expressly otherwise specified.

[0150] In this specification, the terms “about,” “substantially,” and “approximately” mean a reasonable amount of deviation from the modified term so as not to significantly alter the final result. If the deviation does not negate the meaning of the word it modifies, the term “deviation” should be interpreted as including a deviation of at least ±5%, or at least ±10%, from the modified term.

[0151] As used in this specification, including the attached claims, the words “contains” and its derivatives, e.g., “contains” and “has,” are intended to be unrestricted terms that specify that the described features, elements, components, groups, integers, and / or steps do not exclude the existence of other undescribed features, elements, components, groups, integers, and / or steps.

[0152] Definitions and embodiments described in special sections are intended to be applicable to other embodiments described herein that will be understood to be preferred by those skilled in the art. For example, different embodiments are described in more detail in the following sections. Each of the embodiments described herein may be combined with any other one or more embodiments unless expressly indicated otherwise. In particular, any feature indicated as preferred or advantageous may be combined with any other one or more features indicated as preferred or advantageous.

[0153] Dry electrode A first aspect provided herein relates to a reusable, transcutaneous dry electrode 2 comprising i) a conductive material further comprising conductive carbon nanoparticles dispersed in a fluoropolymer matrix, and ii) a conductor 10 configured to contact the conductive material and deliver electrical pulses from a stimulator. The conductive material may be, for example, nonmetallic. The dry surface of the conductive material is configured to contact tissue so as to comfortably deliver transcutaneous electrical pulses directly to the tissue without wetting the electrode 2 or using an intervening layer (e.g., a hydrogel) configured to interface between the electrode and the tissue. The disclosed reusable dry electrode 2 can provide the user with comparable or improved comfort compared to conventional electrodes known in the art under similar electrical stimulation conditions (e.g., at high or maximum stimulation intensity).

[0154] The dry electrode 2 disclosed herein is configured, for example, to deliver rather than receive electrical stimulation.

[0155] The reusable transcutaneous dry electrodes 2 described herein may generally have a smooth surface (e.g., having uniform and consistent surface characteristics) and / or a non-adhesive surface (e.g., a surface that does not adhere to or stick to other surfaces or objects), and do not require surface modification (e.g., physical or chemical surface modification) for effective delivery of transcutaneous electrical pulses to tissue.

[0156] Due to the compositional properties of the conductive material, the reusable dry electrodes 2 described herein are generally robust, long-lasting, durable, and highly mechanically flexible, conforming to parts of the human body, such as limbs, and sterilizable. In some embodiments, sterilization of the dry electrodes 2 described herein can be carried out using known methods, for example, by exposing the material to suitable sterilizing chemicals or gases, radiation, high temperatures (e.g., as high as 125–350°C), or high-pressure and / or high-temperature steam (e.g., as high as 125–350°C). In preferred embodiments, the dry electrodes 2 disclosed herein can be used with electrical stimulation or functional electrical stimulation (FES) for at least 10 hours or longer while maintaining their electrical and mechanical properties.

[0157] The reusable dry electrodes 2 described herein can be comfortably worn by the user for extended periods (e.g., 10 hours or more, or 16–24 hours) because they do not require the use of a wetting agent (e.g., water) or hydrogel and are thermally stable.

[0158] In some embodiments, the dry electrode 2 is a long-term use electrode that can be comfortably worn for extended periods (e.g., 10 hours or more, or 16-24 hours).

[0159] In a preferred embodiment, the fluoropolymer matrix is ​​polyvinylidene fluoride (PVDF).

[0160] In some embodiments, the conductive nanoparticles may include carbon black, graphene nanoplatelets, or single-walled carbon nanotubes (CNTs). In preferred embodiments, the conductive nanoparticles are multi-walled CNTs, which are commercially available, for example, from Nanocyl or Sigma-Aldrich. In some embodiments, the conductive nanoparticles are preferably dispersed in a substrate at about 5-10 wt% of the substrate. In some embodiments, the nanoparticles have an aspect ratio of about 1:10,000. In other embodiments, the nanoparticles have an aspect ratio of about 1:600. In preferred embodiments, the nanoparticles have an aspect ratio of about 130:160. In some embodiments, the nanoparticles are interconnected. For example, multi-walled carbon nanotubes (CNT-NC7000) from Nanocyl® (Belgium), cPD15L1-5 multi-walled carbon nanotubes - hollow structure from NanoLab®, or graphene nanotubes (single-walled carbon nanotubes) from Tuball® can be used.

[0161] In some embodiments, the stiffness of the conductive material, as expressed by its elastic modulus, is approximately 1.2 to 0.8 gigapascals (GPa). In other preferred embodiments, the strength of the conductive material, as expressed by its yield strength, is approximately 16 to 10 megapascals (MPa).

[0162] In some embodiments, the conductive material has an impedance of approximately 10 to 100,000 Ω. In other embodiments, the conductive material has an impedance of approximately 100 to 10,000 Ω. In yet another embodiment, the conductive material has an impedance of approximately 1,000 to 10,000 Ω. In yet another embodiment, the conductive material has an impedance of approximately 1,000 to 5,000 Ω. In a preferred embodiment, the conductive material has an impedance of approximately 2,100 to 2,800 Ω.

[0163] In some embodiments, the conductive material has a sheet resistivity of 50 to 500 Ω·cm. In preferred embodiments, the conductive material has a sheet resistivity of 100 to 300 Ω·cm.

[0164] In a preferred embodiment, the conductive material has an impedance of about 1,000 to about 10,000 Ω and a sheet resistivity of about 50 to about 500 Ω·cm.

[0165] In a preferred embodiment, the conductive material has an impedance of about 2,100 to about 2,800 Ω and a sheet resistivity of about 100 to about 300 Ω·cm.

[0166] In some embodiments, the conductive material is formed as a film-like layer and / or has a width of about 50 to 200 μm. In preferred embodiments, the conductive material has a width of about 50 to 100 μm.

[0167] In some embodiments, the tissue is human tissue. In preferred embodiments, the tissue is skin. In other preferred embodiments, the tissue is human skin.

[0168] In some embodiments, the dry electrode 2 is fitted onto the skin so as to be positioned in close proximity to a selected muscle or muscle group. In preferred embodiments, electrical stimulation induces contraction of the muscle or muscle group.

[0169] In some embodiments, the dry electrode 2 is used in conjunction with electrical stimulation. In preferred embodiments, the electrical stimulation used or to be used with the dry electrode 2 described herein is functional electrical stimulation.

[0170] In some embodiments, the dry electrode 2 described herein provides improved comfort to the user. For example, as shown herein, at high or maximum stimulation intensities, the dry electrode 2 described herein, used with a high-voltage adjustable stimulator 8, such as the MyndSearch stimulator, provides improved comfort to the user compared to a conventional electrode used with the MyndSearch stimulator using substantially similar stimulation parameters, for example, with an overall mean comfort rating of approximately 1 to 6 on a self-reported comfort scale of 1 to 10 (1 being the most comfortable). As shown herein, higher stimulation intensities can be comfortably used with the dry electrode 2 described herein in conjunction with the EV-906 and MyndSearch stimulator. For example, stimulation intensities up to approximately 20% higher can be comfortably used with the dry electrode described herein and the EV-906 or MyndSearch stimulator compared to the use of the dry electrode with the Compex stimulator.

[0171] In some embodiments, the electrode 2 is positioned on, incorporated into, or integrated with a dry electrode article or garment 4, which can be wearable or non-wearable. In other embodiments, the electrode 2 is integrated into or manufactured integrally with the article or garment, for example, by casting the electrode 2 directly onto the surface of the garment using compression molding. In other embodiments, the garment is a garment that can be worn on a daily basis. In preferred embodiments, the electrode 2 is positioned on the inner surface of the article or garment 4, with the dry tissue contact surface of the electrode 2 parallel to the tissue. In some embodiments, the electrode 2 is positioned on, or attached to or bonded to, the article or garment 4, for example, by sewing, overlocking, embroidery, and other known bonding or bonding means. In embodiments, the electrode 2 is fixed to the article or garment 4 using an adhesive. In other embodiments, preferred adhesives used with the invention are of a type known in the art that is suitable for use with textiles, for example, adhesives, fabric adhesives, adhesive tapes, rivets, etc. In preferred embodiments, the dry electrode 2 is integrated into the article or garment 4 using thermal compression, as further described below.

[0172] Dry electrode articles or clothing and manufacturing methods Another embodiment relates to a washable dry electrode article or garment 4, which includes a reusable dry electrode 2 as described herein.

[0173] In some embodiments, dry electrodes can be placed on, incorporated into, or integrated with articles or clothing 4, such as everyday wear, facilitating the delivery of electrical stimulation or functional electrical stimulation (FES) therapy to a broad patient population outside of clinical settings.

[0174] In some embodiments, the article or garment 4 includes the dry electrode 2, for example, as an integrated layer or as a layer placed on the inner surface of the article or garment, with the tissue contact surface of the conductive material parallel to the tissue.

[0175] In some embodiments, the article or garment 4 and the dry electrode 2 are attached using, for example, joining, sewing, overcasting, embroidery, compression molding, and other known means of combining or bonding. In other embodiments, the article or garment 4 is fixed to the dry electrode 2 using an adhesive. In other embodiments, a suitable adhesive to be used with the invention is of a type known in the art that is suitable for use with textiles, such as adhesives, fabric adhesives, adhesive tapes, rivets, etc.

[0176] In other embodiments, the conductor 10 includes an electrode contact segment 14 that contacts a dry electrode 2 placed on an article or garment 4 textile substrate 12. Within the electrode contact segment 14, the conductor 10 is integrated into the textile substrate 12. In these embodiments, the conductor 10 may be one or more conductive yarns 100, or may include them. The conductive yarns 100 can be integrated into the textile substrate 12 (and / or any other layer, e.g., a thermal adhesive) by any means known in the art, e.g., sewing, embroidery, knitting or weaving.

[0177] In the embodiment, the article or garment 4 is wearable and is formed of a single layer of a non-conductive knitted textile base material 12, for example, a knitted compressed fabric, which is flexible and conformable to the shape of a body part, such as an arm, leg, or torso, and can be worn in close contact with the skin. Examples of wearable dry electrode articles or garments 4 include face masks, neck collars, gloves, shirts, sleeves, pants, etc., which contain dry electrodes 2 and can be attached to and stimulate muscles on any part of the body, such as the pectoral muscles, deltoid muscles, or trapezius muscles. In the preferred embodiment, the textile base material is a polyester jersey material, for example, PET (polyethylene terephthalate) jersey, or may include this.

[0178] In the embodiments, a portion of the conductive yarn 100 is integrated into the textile substrate 12 in the electrode contact segment to form a pattern including multiple lines that do not interact with each other and contact a dry electrode 2 placed on an article or garment 4. In these embodiments, each line is formed by one conductive yarn 100. If lines made of separate conductive yarns 100 are integrated to intersect or contact each other, the delivery of stimuli to the dry electrode 2 placed on the textile substrate may become less effective due to short circuits between the individual conductive yarns 10. At least two lengths of the multiple non-intersecting lines can be arranged substantially parallel to each other within the electrode contact segment 14, or the lengths of the non-intersecting lines can be substantially non-parallel or spread out within the electrode contact segment 14, for example, forming a fan pattern with substantially coincident central nodes where an unintegrated cable segment 16 of conductors begins, which includes a converging, unintegrated portion of the conductive yarn 100.

[0179] In one embodiment, the electrode contact segment 14 includes more than two non-crossing lines that are substantially parallel to each other.

[0180] In one embodiment, the electrode contact segment 14 includes seven lines that are substantially parallel to one another.

[0181] In the embodiment, the integration pattern of the conductive electrode contact segment 14 can be formed to resemble any shape that maintains lines in a non-crossing path, such as a series of non-crossing zigzags, waves, or helical paths. Any such integration pattern can be used with a dry electrode 2 of any desired shape (e.g., square, circle, rectangle, etc.).

[0182] In a preferred embodiment, the lines form a pattern resembling a candelabra, with at least one centerline extending in a straight line toward the cable segment, dividing the electrode contact segment 14 into two approximately equal regions. The remaining non-centerlines extend toward each other and substantially parallel to the centerline in the portion of the electrode contact segment opposite the cable segment 16, and in the portion adjacent to the cable segment 16, they make a rotation of approximately 90° so as to extend perpendicularly toward the centerline without intersecting each other (for example, they continue to extend substantially parallel to each other). Thus, the centerline positioned at the center of the electrode contact segment forms a dividing centerline, and approximately mirror images, differently sized "L" and "J" paths are nested on either side of the dividing centerline relative to each other.

[0183] In this embodiment, the wire can be integrated into the textile substrate 12 and cover an area substantially corresponding to the shape of the dry electrode 2 placed on the textile substrate 12, for example, a circular or square shape.

[0184] In other embodiments, the conductor 10 further includes a cable segment 16. In embodiments in which the conductor is one or more conductive threads 100, the cable segment 16 includes an unintegrated portion of the conductive thread 100. The unintegrated portion is configured to deliver electrical stimulation to a conductor electrode contact segment 14, for example, by contacting a connector 6 that connects the conductor 10 to a stimulator 8. The conductor cable segment 16 can be fixed to the textile substrate 12 by any adhesive means known in the art, for example, by sewing the cable segment to the textile substrate 12 using non-conductive sewing thread, by bonding the cable segment to the textile substrate 12, or by fastening the cable segment to the textile substrate 12 using a fastener.

[0185] In this embodiment, the conductor cable segment 16 includes one or more conductive threads 100 that are crimped, woven, or otherwise bonded together.

[0186] In the embodiment, the conductive thread 100 is or includes a silver-plated thread. Any stimulator 8 known in the art can be connected to the conductive thread 100 and stimuli can be delivered thereto. In a preferred embodiment, the MyndSearch stimulator is connected to the conductive thread 100 via a connector 6 known in the art, such as a detachable connector.

[0187] In this embodiment, the conductive thread 100 has a linear resistance of at least 1 Ω / m or about 1 to about 1000 Ω / m.

[0188] In other embodiments, the protective layer 20 is placed on the non-skin contact surface of the article or garment 4 and covers the exposed portion of the conductive yarn 100. In these embodiments, the protective layer 20 shields the exposed portion of the conductive yarn 100 from contact with other conductive objects (which could lead to short circuits and less effective delivery of stimuli to the dry electrode 2 placed on the article or garment 4). The protective layer 20 can also provide protection to the conductive portion of the dry electrode article or garment 4 from mechanical and chemical stresses experienced during the wash cycle. The protective layer 20 can be, for example, a fabric layer attached to the article or garment 4, a liquid silicone layer spread over the dry electrode 2, or a covering embroidery or polyurethane film that covers the dry electrode 2 placed on the article or garment 4.

[0189] The wearable dry electrode articles or garments 4 disclosed herein may be at least as comfortable for the patient (if not more so) and easier for the patient and healthcare professionals to use compared to other wearable stimulators known in the art, such as those incorporating hydrogel electrodes known in the art. Furthermore, the dry electrode articles or garments 4 disclosed herein do not require the use of a gel layer, as required with hydrogel electrodes (which can lead to discomfort and cause the hydrogel electrodes to shift during use).

[0190] Another embodiment relates to a method for manufacturing a washable dry electrode article or garment 4, comprising: i) dispersing conductive carbon nanoparticles in a polymer solvent to obtain a dispersion; ii) dissolving a fluoropolymer matrix in the dispersion to obtain a blend; iii) casting the blend; v) drying the cast blend; vi) compressing the blend; vii) cooling the blend to obtain a conductive material; viiii) cleaning the material; and ix) arranging a conductor 10 on the material to produce a dry electrode 2 as described herein, wherein the conductor 10 is configured to contact the material and deliver electrical pulses from a stimulator 8; and further comprising incorporating the manufactured dry electrode into an article or garment, wherein the electrode 2 is positioned on the inner surface of the article or garment, the tissue contact surface of the electrode is parallel to the tissue, and electrical stimulation is delivered thereto directly, for example, without passing through an intervening layer placed between the tissue contact surface and the tissue.

[0191] In preferred embodiments, casting and / or compression involves transferring the blend to a mold or dish. The mold or dish used to form the conductive material can be made from durable materials known in the art, such as aluminum or steel, and can be custom-made, allowing the conductive material to be formed into any desired shape, for example, any shape or size based on standard commercially available electrode dimensions used with electrical stimulation or functional electrical stimulation (FES) applications, or into circular, square and / or rectangular shapes. In other embodiments, the conductive material is custom-formed to fit a specific body part or to fit a specific body part of an individual. In some embodiments, the conductive material is formed into a circular shape with a diameter of 25 mm and / or a square shape with a side length of 50 mm.

[0192] In preferred embodiments of the manufacturing methods disclosed herein, the polymer solvent is dimethylformamide (DMF).

[0193] In a preferred embodiment, dispersion is performed by ultrasonic treatment.

[0194] In some embodiments, melting, casting, and / or drying further include heating the blend. In preferred embodiments, heating is carried out within approximately 80–220°C.

[0195] In some embodiments, compression is performed using a commercially available forming press system, such as the Bench Top Auto Press available from Carver, Inc. In preferred embodiments, the applied compressive force is approximately 5 to 10 tons.

[0196] In some embodiments, cleaning is performed using water and / or ethanol.

[0197] In other embodiments, arranging the conductor 10 on the material in accordance with (viii) above includes integrating at least one conductive yarn 100 via a knitted textile substrate 12, for example, a textile substrate 12 configured to fit a body part. Integration can be carried out using any method known in the art, such as sewing or embroidery.

[0198] In other embodiments, arranging the dry electrode 2 according to (B) above further includes i) arranging a thermal adhesive 18 on the textile substrate 12 and then integrating one or more conductive threads 100 via both the textile substrate 12 and the thermal adhesive 18; ii) arranging the dry electrode 2 on the thermal adhesive; and iii) bonding the thermal adhesive to the dry electrode 2 and the textile substrate 12 using thermal compression. Thermal compression involves applying sufficient heat to melt at least a portion of the conductive material of the dry electrode 2, while simultaneously applying pressure to bring at least a portion of one or more conductive threads 100 into contact with the molten portion of the dry electrode 2 material and integrate them. The thermal adhesive 18 is manufactured from a woven or nonwoven substrate or fabric configured to be placed between the dry electrode 2 and the textile substrate 12. Thermal compression can melt a portion of the thermal adhesive material, resulting in adhesion between the layers. Thermal compression should be carried out at a temperature sufficient to melt the dry electrode 2 material, for example, at least 180°C or about 180°C to 230°C, and at a pressure sufficient to integrate the conductive yarn 100 into the molten dry electrode 2 material. For example, a pressure of about 1 to 10 tons may be applied for a period of time, for example, in the range of 5 to 10 minutes, for example, a pressure of about 1 ton applied to the dry electrode 2 and textile substrate 12 for at least 5 minutes. Subsequently, a pressure of about 5 tons may be applied to the molten dry electrode 2 material and textile substrate 12 for at least about 5 minutes, or up to about 7 minutes.

[0199] In a preferred embodiment, the thermal adhesive material 18 is made of a nonwoven material configured to maximize adhesion between the dry electrode 2 and the textile substrate 12, for example, a nonwoven thermal adhesive material provides adhesion to the dry electrode 2 under heat and compression.

[0200] Dry electrode device and method of use Another embodiment relates to a dry electrode device for delivering electrical stimulation to a subject, comprising i) a dry electrode article or garment 4 as described herein, ii) a stimulator 8, and iii) a connector 6 connecting a conductor 10 or 100 as described herein and the stimulator 8.

[0201] In some embodiments, the dry electrode 2 is integrated into or manufactured integrally with the article or garment, for example, by casting the electrode 2 directly onto the surface of the article or garment, for example, using compression molding. In preferred embodiments, the garment is everyday wear. In some embodiments, the electrode 2 is positioned on the inner surface of the article or garment, with the dry tissue contact surface of the electrode parallel to the user's tissue. In some embodiments, the electrode 2 is attached to the article or garment using other known means, such as joining, sewing, overcasting, embroidery, and adhesion. In some embodiments, the electrode 2 is fixed to the article or garment using an adhesive. In other embodiments, a preferred adhesive used with the invention is of a type known in the art that is suitable for use with textiles, such as adhesives, fabric adhesives, adhesive tapes, rivets, etc. In preferred embodiments, the dry electrode 2 is integrated into the dry electrode article or garment 4.

[0202] The dry electrode 2 described herein is lighter than conventional electrodes known in the art (e.g., carbon rubber electrodes) and is therefore suitable for use in articles or clothing. When integrated into an article or clothing 4, the dry electrode 2 has minimal impact on its shape and can contribute to providing increased comfort to the wearer compared to clothing containing conventional electrodes.

[0203] In some embodiments, the connector 6 connecting the conductor 10 or 100 and the stimulator 8 has been of a type known in the art, such as copper wire, silver-coated yarn, and carbon fiber and yarn. In some embodiments, the connector 6 is placed on an article or garment 4. In preferred embodiments, the connector 6 is incorporated into or integrated with the article or garment 4.

[0204] In some embodiments, the stimulator 8 is non-portable. In preferred embodiments, the stimulator 8 is portable, rechargeable, and / or battery-powered. In a more preferred embodiment, the battery-powered stimulator 8 functions without battery replacement or the need to charge for at least 10 hours. In other preferred embodiments, the portable stimulator 8 is configured to be placed in an article or part of clothing 4, for example, in a pocket placed on clothing.

[0205] In another embodiment, a dry electrode article or garment 4 and / or a dry electrode device and / or a dry electrode 2 manufactured by a manufacturing method described herein is used to treat a motor disorder in a user.

[0206] In another embodiment, the dry electrode 2 described herein is manufactured by the manufacturing method described herein and / or used in a user to treat a motor disorder, such as paralysis.

[0207] In some embodiments, the dry electrode articles or garments 4 and / or dry electrode devices described herein are used to treat motor disorders, such as paralysis, in a user.

[0208] In another embodiment, dry electrode articles or garments 2 and / or dry electrode devices and / or dry electrodes 2 manufactured by the manufacturing methods described herein are used for muscle strengthening, muscle relaxation and massage-like interventions in athletes, healthy individuals and individuals with various types of neuromuscular disorders.

[0209] In another embodiment, a dry electrode article or garment 4 and / or dry electrode device and / or a dry electrode 2 manufactured by a manufacturing method described herein is used to treat pain using an electrical stimulation-based technique, such as transcutaneous electrical nerve stimulation (TENS) or other similar techniques.

[0210] In another embodiment, dry electrodes manufactured by the dry electrode article or garment 2 and / or dry electrode apparatus and / or manufacturing method described herein are used to provide sensory stimulation to patients with impaired sensory function, such as amputees and individuals with peripheral nervous system damage.

[0211] In a preferred embodiment, the use of the dry electrode 2 or dry electrode article or garment 4 described herein includes: i) placing the dry electrode article or garment 4 or at least two dry electrodes 2 directly on the user's tissue in close proximity to a selected muscle or muscle group; ii) connecting the conductor 10 or 100 of the article or garment, or at least two dry electrodes 2, to a stimulator; and iii) delivering electrical stimulation from the stimulator 8 to the conductor 10 or 100 of the article or garment 4 or at least two dry electrodes 2, the stimulation inducing contraction of the muscle or muscle group, thereby treating a motor disorder.

[0212] In some embodiments, use in the treatment of movement disorders involves electrically stimulating or inducing muscle contractions to cause movement generation in the user, such as standing up, walking, grasping an object, or making a facial expression. In other embodiments, a specific or selected sequence of electrical stimulations causes muscle contractions and movement, for example, by varying the timing of electrical stimulation delivered to a specific muscle, or by simultaneously delivering electrical stimulation to a selected set of muscles via the use of multiple dry electrodes 2.

[0213] In another embodiment, a method of delivering electrical stimulation to a subject using the dry electrode 2 or dry electrode article or garment 4 described herein includes: i) placing the article or garment 4 or at least two dry electrodes 2 directly on the subject's tissue in close proximity to a selected muscle or muscle group; ii) connecting the conductor 10 or 100 of the article, garment 4 or the dry electrode 2 to a high-voltage regulated stimulator 8; and iii) delivering electrical pulses from the stimulator 8 to the conductor 10 or 100 of the article or garment 4 or the dry electrode 2, the stimulation inducing contraction of the muscle or muscle group.

[0214] In some embodiments, the dry electrode 2 is configured for use with a high-voltage regulated stimulator 8, and the electrode 2 is configured to deliver electrical pulses, for example, single-phase or two-phase electrical pulses. In some embodiments, the pulses are monopolar. In other embodiments, the pulses are bipolar. In preferred embodiments, suitable stimulators 8 for use with the dry electrode 2 described herein are high-voltage regulated stimulators, e.g., EV-906 (Everyway Medical Instruments, Taiwan) and MyndSearch stimulators (MyndTec, Canada). In preferred embodiments, the dry electrode 2 is used with, or intended for use with, a stimulator 8, e.g., MyndSearch stimulator (MyndTec, Canada), which can deliver pulses having a rise time of less than 40 ns or, for example, about 10 to 40 ns. In other preferred embodiments, the dry electrode 2 is used with functional electrical stimulation systems or devices described in U.S. Patents 8,880,178 and 9,440,077.

[0215] In some embodiments, the pulse configured to be used with the dry electrode 2 has a total width of approximately 8 to 2,000 μs (i.e., from the start to the end of the pulse). In other embodiments, the pulse has a total width of approximately 10 to 1,500 μs. In yet another embodiment, the pulse has a total width of approximately 100 to 1,000 μs. In a preferred embodiment, the total pulse width is approximately 200 to 500 μs.

[0216] In some embodiments, pulses are delivered at a frequency of approximately 1 to 100 Hz. In other embodiments, pulses are delivered at a frequency of approximately 16 to 100 Hz. In preferred embodiments, pulses are delivered at a frequency of approximately 20 to 40 Hz. In other preferred embodiments, pulses have an amplitude of approximately 0.5 to 120 mA.

[0217] In some embodiments, the pulses are balanced and / or symmetrical. In preferred embodiments, the pulses are two-phase and / or symmetrical or asymmetrical, comprising a first phase pulse and a second phase pulse. In preferred embodiments, the rise time of the pulses is about 10 to about 40 ns. In some embodiments, the first phase pulse has an amplitude of about -0.04 to -160 mA. In preferred embodiments, the first phase pulse has an amplitude of about -0.4 to -120 mA and / or a width of about 200 to 500 μs. In some embodiments, the second phase pulse has an amplitude of about 0.1 to 30 mA. In other embodiments, the second phase pulse has an amplitude of about 0.4 to about 120 mA and / or a width of about 200 to about 500 μs. In preferred embodiments, the second phase pulse has an amplitude of about 0.01 to 40 mA and / or a width of about 800 to 2,000 μs.

[0218] In some embodiments, the pulses are symmetrical and / or the amplitude of the first phase pulse and the amplitude of the second phase pulse are equal and / or the width of the first phase pulse and the width of the second phase pulse are equal. In other embodiments, the amplitude of the first phase pulse is approximately -0.04 to approximately -160 mA, and the amplitude of the second phase pulse is approximately 0.04 to approximately 160 mA. In other embodiments, the amplitude of the first phase pulse is approximately -0.4 to approximately -120 mA, and the amplitude of the second phase pulse is approximately 0.4 to approximately 120 mA. In yet another embodiment, the width of the first phase pulse is approximately 200 to approximately 500 μs, and the width of the second phase pulse is approximately 200 to approximately 500 μs.

[0219] In a preferred embodiment, the pulses are asymmetric, and / or the amplitudes of the first phase pulse and the second phase pulse are not equal, and / or the widths of the first phase pulse and the second phase pulse are not equal. In a preferred embodiment, the first phase pulse has an amplitude of about -0.4 to -120 mA and / or a width of about 200 to 500 μs, and the second phase pulse has an amplitude of about 0.1 to 30 mA and / or a width of about 800 to 2,000 μs.

[0220] The dry electrode articles or garments 4 and / or apparatus described herein can be used in conjunction with any wireless communication means and / or any brain-controlled neuromodulation means known in the art, in which the input of a stimulator 8 to the dry electrode 2 is controlled.

[0221] The following non-limiting examples illustrate preferred embodiments of the invention and are merely illustrative of the invention disclosed herein.

[0222] Examples Example 1: Dry electrode conductive material As shown in Figure 1, dry electrodes in this and the non-limiting embodiments of the invention described herein were fabricated from flexible thin-film conductive polymer composites. The use of PVDF as the polymer matrix and CNTs as conductive fillers has been shown to provide suitable electrical and mechanical properties for producing conductive thermoplastic polymer composites having the characteristics required for stimulus delivery

[12] ,

[13] . The use of PVDF as the polymer matrix and CNTs as conductive fillers provided suitable electrical and mechanical properties for polymer composites [6]. The high conductivity of CNTs and their uniform dispersion in the PVDF polymer matrix provided the desired conductivity of the polymer composite, as well as the biocompatibility, robustness, and chemical stability of the selected polymer and the complete entanglement of CNTs into the matrix, providing a durable, flexible, washable thin-film layer for electrode design that functions as an interface between the skin and the stimulator connector.

[0223] The selected conductive nanodoppel is multi-walled carbon nanotube (CNT-NC7000), which is obtained from Nanocyl (Belgium). The carbon nanotube is in powder form, with an average diameter of 9.5 nm, an average length of 1.5 μm, and 25-300 m. 2 It has a surface area of ​​10⁻⁴ Ω·cm and a volume resistivity of 10⁻⁴ Ω·cm. The selected polymer solvent was dimethylformamide (DMF) purchased from Sigma-Aldrich (USA). The main polymer matrix was made of polyvinylidene fluoride (PVDF) polymer, with PVDF pellets (Kynar™ 740) supplied by Arkema (Canada). Ethanol was purchased from Toronto Chem Stores University (Canada) for washing the samples. The aluminum molds for forming the dry electrodes were fabricated in the machine shop of the Department of Mechanical and Industrial Engineering at the University of Toronto. All materials were used without further purification. Deionized (DI) water was used for all experiments.

[0224] Example 2: Manufacturing and assembly of dry electrodes using a solution casting process As shown in Figure 2, the conductive polymer composite dry electrodes described in Example 1 were prepared using a solution casting process

[12] ,

[13] . First, the conductive filler (i.e., 5-10 wt% of the polymer CNTs) was dispersed in the polymer solvent (i.e., 93 wt% of the total solution DMF) using a sonication process at 60 watts for 1 hour. Next, the selected thermoplastic polymer pellets (i.e., PVDF) were added to the dispersion and mixed at 80°C for 4 hours using a magnetic stirrer. After complete dissolution of the polymer, the solution was poured into a petri dish and dried on a hot plate at 120°C for 12 hours. The resulting dry PVDF-CNT blend was then transferred to a compression molding setup and heated at 180°C-220°C for 6 minutes, and then compressed in a custom aluminum or steel mold for 3-5 minutes to obtain thin film layers (50-100 μm) of desired dimensions, including circular or square shapes. The circular electrodes had a diameter of 25 mm, and the square electrodes had a side length of 50 mm. Both the shape and corresponding size were based on the dimensions of standard commercially available electrodes used for FES applications. The samples were then cooled in a water bath for 5 minutes and then removed from the mold. Finally, the resulting electrode conductive materials were washed with water and ethanol, respectively, to obtain dry electrodes ready for stimulation application.

[0225] The dry electrodes prepared as described above were then attached to a conductive cable or wire. The other end of the cable or wire was attached to a connector, which was then connected directly to an electrical stimulator or a cable system commonly used with stimulators and connected to conventional hydrogel electrodes.

[0226] Example 3: Thermal and mechanical characterization of dry electrodes Since dry, reusable transcutaneous electrodes can be used in wearable applications, they may be exposed to high temperatures, such as those from a clothes dryer or potentially ironing. Therefore, we studied the thermal stability behavior of the material at elevated temperatures.

[0227] To investigate the properties of dry electrode materials and the effects of conductive nanofillers (i.e., CNTs), the thermal and mechanical properties of polymer nanocomposite electrode materials were investigated and compared with unprocessed PVDF polymers without additives. The thermal decomposition behavior of polymer composites and unprocessed polymers was tested by thermogravimetric analysis (TGA, Q50, TA Instruments, USA). The mechanical properties of dry electrode and unprocessed polymer film samples were tested and compared with each other, demonstrating the mechanical stiffness and strength of the developed electrodes. For this purpose, the tensile stress-strain behavior of the three film samples was obtained using a dynamic mechanical analyzer (DMA, Q800, TA Instruments, USA) with a force velocity of 1 N / min.

[0228] The thermal behavior of polymer nanocomposites and raw polymers, obtained by thermogravimetric analysis (TGA) in an air environment, is shown in Figure 3(a). The initial decomposition temperatures of the PVDF samples were approximately 436±2°C and 383±2°C for the raw polymer and CNT nanocomposites, respectively. Both samples were thermally stable up to 350°C, which implies that the electrodes are safe for daily use from a thermal decomposition standpoint, and that these electrodes could be embedded in clothing and withstand the temperatures of washing, drying, and ironing processes. The samples exhibited relatively high initial decomposition temperatures, and the slight differences may be attributable to the dispersion of CNTs in the polymer matrix, similar to the results reported by

[14] . Following the non-restrictive theory, the reduction in the onset temperature is assumed to be due to the CNTs acting as defects between the polymer matrix and interface sites that initiate decomposition, thus reducing the initial onset decomposition temperature

[14] . Above 700°C, all samples decomposed completely, with the final weight approaching 0%. For comparison, the thermal stability from standard TGA tests under a nitrogen environment is also shown in Figure 3(b), where initial decomposition temperatures of approximately 445±2°C and 429±2°C were found for the raw polymer and polymer nanocomposites, respectively.

[0229] Stress-strain curves for the dry electrode and raw polymer samples after mechanical testing are shown in Figure 3(c). The addition of a small percentage of CNTs (which exhibit higher stiffness and strength) to the polymer matrix resulted in increased modulus and yield strength of the polymer composite film compared to the raw polymer film. The high tensile and yield strength of the dry polymer nanocomposite electrodes could contribute to the durability of these electrodes in wearable applications. The stiffness, expressed by the modulus, was found to be approximately 1.19±0.04 Gpa and 0.92±0.05 Gpa for the polymer composite film and the raw polymer film, respectively. The strength of the samples, expressed by the yield strength, was approximately 16.3±0.1 MPa and 12.7±0.1 MPa for the polymer composite and the raw polymer, respectively. The elongation of the raw polymer at lower stresses was relatively higher than that of the polymer composite due to its higher stiffness. Overall, the increase in stiffness and strength of the dry electrode film material due to the addition of a small percentage of CNTs remains within a reasonable range compared to thermoplastic PVDF polymers, and its application for electrical stimulation purposes is possible, possessing suitable flexibility and durability.

[0230] Example 4: Electrical Characterization of Dry Electrodes To investigate the functionality of the dry electrodes fabricated as described in Example 2, the interfacial impedance of a conductive composite material (circular with a thickness of 100 μm and a diameter of 25 mm) was measured to ensure the desired conductivity of the layer for signal delivery to the skin. The electrical properties of three types of electrodes were determined, and the impedance of each electrode (hydrogel, dry polymer nanocomposite as described herein, and dry carbon rubber) was measured using electrochemical impedance spectroscopy (EIS) with an electrochemical analyzer (Model CHI6054E, CH Instruments, USA). The experimental setup consisted of a 3-electrode configuration, with one sample connected to the working electrode, a second sample to the counter electrode, and a third sample to the reference electrode, placed on the forearm of a single subject (female, age 30). The parameters used were sinusoidal, with a peak amplitude of 0.01 V and a frequency in the range of 1 Hz to 1 MHz. For comparison, this procedure was performed on a sample with a 5 × 5 cm square design. In addition, the average surface resistivity of the samples was measured using a digital multimeter (34401A Multimeter, Agilent, USA). From electrical testing, the average impedance of the hydrogel electrode over the tested frequency range was 36.06 ± 77.70 kΩ, the average impedance of the dry polymer nanocomposite sample was 401.19 ± 664.63 kΩ, and the average impedance of the dry carbon rubber electrode was 970.51 ± 1933.12 kΩ. The impedance and phase results are shown in Figure 4. In addition, the average surface resistivity of the measured samples was 1.46 ± 2.06 MΩ for the hydrogel electrode, 261.66 ± 85.42 Ω for the dry polymer nanocomposite electrode, and 628.33 ± 198.74 kΩ for the dry carbon rubber electrode.

[0231] Based on non-restrictive theory, it is hypothesized that relatively small differences between samples may be due to non-identical mixing processes occurring during sonication. The impedance and phase results shown in Figure 4 indicate that the samples possessed desirable properties for a range of target applications [5]. The high impedance of the dry polymer nanocomposite can prevent high current concentrations on the skin, potentially reducing discomfort. Therefore, PVDF-CNT conductive polymer dry electrode films may be useful as interface electrodes between stimulator connectors and skin for electrical stimulation or FES delivery.

[0232] Example 4: Functional Electrical Stimulation (FES) Test To investigate the functionality and efficiency of the dry electrodes prepared as described in Example 2 for FES purposes, 13 healthy individuals were stimulated in their upper arms using different electrode types and stimulator combinations, during which muscle torque and perceived comfort or discomfort levels were measured. The subjects consisted of 5 males and 8 females, the demographics of which can be seen in Table 1. All participants were informed of the protocol to be used prior to the study and signed an informed consent form approved by the University Health Network's Research Ethics Board (ID#21-5298). [Table 1]

[0233] Three different electrode types were used: a standard self-adhesive hydrogel (ValuTrode 5×5cm, Axelgaard Manufacturing, Denmark), a carbon rubber without electrolyte (i.e., gel or water) (5×5cm, AMG Medical Inc, Canada), and a dry polymer nanocomposite electrode as described herein. Each electrode type was tested using each of the following three stimulators: a portable battery-powered stimulator (EV-906, Everyway Medical Instruments, Taiwan), a MyndSearch stimulator (MyndTec Inc, Canada), and a Compex Motion stimulator (Compex SA, Switzerland). The three stimulator parameters were set to a pulse frequency of 40 Hz, a pulse width of 300 μs, and a pulse amplitude (e.g., 3.5–28 mA) that depended on each participant. Each stimulator had a specific pulse shape as shown in Figure 5. The EV-906 stimulator generated voltage-regulated pulses, MyndSearch generated stimulation pulses that were both voltage-regulated and current-regulated (voltage regulation was controlled by the inner loop of the closed-loop control device, and current regulation was controlled by the outer loop), and Compex Motion generated current-regulated stimulation pulses.

[0234] As shown in Figure 6, a pair of electrodes were placed on the right biceps brachii muscle of each subject, with the anode at the proximal end of the muscle and the cathode at the distal end of the muscle belly. After testing the first electrode type, the outline of the electrode placement was marked to ensure that all other electrode types were placed in the same area. The carbon rubber electrodes and dry polymer nanocomposite electrodes were secured to the skin using medical tape along the sides. All electrode types, such as self-adhesive hydrogel electrodes, were wrapped in self-adhesive wrap to maintain their position.

[0235] For each individual electrode-stimulator combination, the sensory threshold (i.e., the amplitude at which the person begins to feel sensation from the stimulus), the minimum contraction threshold (i.e., mCT, the amplitude at which the person's muscle begins to spasm or contract), and the maximum tolerable contraction threshold (i.e., MTC, the amplitude at which the person can no longer tolerate further increases in stimulus intensity) were determined in a random order.

[0236] Next, muscle torque generated during isometric elbow flexion was measured using a Biodex dynamometer (System3, Biodex Medical Systems, USA). Each participant sat on the Biodex dynamometer chair, with a strap around their torso to maintain their posture, their arms resting supine on the chair's armrests, their hands gripping the handles of the arm attachments, and self-adhesive bandages wrapped around their hands to maintain their position. The experimental setup is shown in Figure 6. Based on each individual stimulation threshold, three different intensity levels (low, medium, and high) for testing each electrode-stimulator combination were determined using the following formula: Low=mCT+0.25 * (MTC-mCT) Medium=mCT+0.50 * (MTC-mCT) High=mCT+0.75 * (MTC-mCT)

[0237] Before stimulating at a predetermined intensity level, participants performed three voluntary contractions using maximum effort, holding each for 5 seconds. The average of the three maximum voluntary contractions was used to normalize the stimulation-induced torque record for each individual. The order of electrode type and stimulator testing was randomized for each individual. Each electrode type was tested with all three stimulators before changing the electrode type. Using each combination, each subject was stimulated once to the previously established maximum tolerance level, and then stimulated three times at each intensity level (low, medium, and high) in a random order. The stimulation was held for 5 seconds after reaching the desired intensity level. After each stimulation round, participants rated their comfort level using a visual analog scale from 0 to 10 displayed in front of them. As shown in Figure 6, 0 is very comfortable and 10 is very uncomfortable. After all rounds of stimulation using electrode-stimulator combinations, 10 participants were asked to complete a revised, shortened McGill Pain Questionnaire, which was used for electrical stimulation and is shown in Table 2 below. This questionnaire had 14 sensory options: "throbbing," "stinging," "prickling," "stabbing," "sharp," "cramping," "biting," "pulsating," "burning," "tingling," "needle-like," "throbbing," "painful to the touch," and "snapping." Each sensation was rated on a scale of 0 to 3, depending on how much the participant felt about it (0=none, 1=mild, 2=moderate, and 3=severe). [Table 2]

[0238] Torque data was recorded from the Biodex analog output at a sampling rate of 1 kHz using data acquisition system software (LabChart, PowerLab, AD Instruments, USA). All data was then analyzed using MATLAB (v.2021a, Mathworks, USA). The Kruskal-Wallis test was used for statistical analysis of generated torque and comfort evaluation.

[0239] Stimulus intensity Since different stimulation intensities were used for each electrode-stimulator combination, the average current amplitude was compared for each individual at each intensity level, as shown in Figure 7. Overall, higher intensities were usable with the EV-906 and with the MyndSearch stimulator using the dry polymer nanocomposite electrode. In Compex Motion, all electrode types used similar intensities on average. However, it should be noted that each stimulator has an established pulse intensity limit, and each of the four reached this limit using several electrode-stimulator combinations. One participant reached maximum output from the MyndSearch stimulator using only the dry polymer nanocomposite electrode, one participant reached maximum output from both the EV-906 and MyndSearch stimulators using only the dry polymer nanocomposite electrode, one participant reached maximum output from the EV-906 stimulator using hydrogel, dry polymer nanocomposite, and carbon rubber electrodes, and one participant reached maximum MyndSearch stimulator output using only the carbon rubber electrode. The EV-906 device limit was 100 mA, the MyndSearch limit was 20 mA, and the Compex Motion limit was 125 mA. When each intensity is expressed as a percentage of the maximum possible output of each stimulator, as shown in Figure 8, the dry polymer nanocomposite electrode and the dry carbon rubber electrode allowed for the use of higher intensities in combination with MyndSearch, considering the device limits.

[0240] Perceived comfort rating Figure 9 shows the average perceived comfort ratings among all individuals for each electrode-stimulator combination. Based on the average from the visual analog scale, the MyndSearch stimulator was the most comfortable across all intensity levels compared to the other two stimulators. At low intensity, MyndSearch with hydrogel electrodes was the most comfortable combination, with an overall average comfort rating of 3.38 ± 2.27. At medium intensity, MyndSearch with hydrogel electrodes was the most comfortable combination, with an overall average comfort rating of 4.51 ± 2.42. At high intensity, MyndSearch with dry polymer nanocomposite electrodes was the most comfortable combination, with an overall average comfort rating of 5.26 ± 2.28. At the maximum tolerable intensity level, the most comfortable combination was the MyndSearch stimulator with dry polymer nanocomposite electrodes, with an overall average comfort rating of 6.38 ± 2.50. Individual comfort ratings for each combination can be found in Figure 10. After statistical analysis, no statistically significant differences (p<0.05) were found in the comfort rating among the three electrode types or three different stimulators used. The p-values ​​for each electrode or stimulator tested can be found in Table 3. [Table 3]

[0241] A comparison between the applied stimulation intensity and comfort levels can also be seen in Figure 11. The EV-906 stimulator showed the greatest difference between intensities depending on the electrode type used, but the comfort levels were very similar among them. The MyndSearch stimulator required a higher intensity when using dry electrodes than when using hydrogels, but both dry polymer nanocomposite electrodes and dry carbon rubber electrodes were more comfortable at the maximum tolerable intensity level. The Compex Motion stimulator used similar intensities for all electrode types, but the carbon rubber electrode was the most uncomfortable at all levels, while the dry polymer nanocomposite was more comfortable at the maximum tolerable level.

[0242] Most transdermal electrode types require the addition of gel or water to improve the interface with the skin, thereby reducing discomfort. However, the use of the fully dry polymer nanocomposite electrodes disclosed herein can achieve performance comparable to standard self-adhesive hydrogel electrodes intended for irritation.

[0243] stimulation-induced muscle torque The recorded stimulus-induced torque values ​​were used to compare the average steady-state torques of each individual. Steady-state torque was defined as the average torque within the last second of stimulation at the intensity level being tested. The torque was normalized for each individual using the average of the three maximum spontaneous contractions. The stimulus-induced normalized torques are shown in Figure 12. At low intensity levels, the dry polymer nanocomposite electrode, in combination with the EV-906 stimulator, produced the strongest contraction on average at 0.086 ± 0.116. At medium intensity, the dry polymer nanocomposite electrode, in combination with the EV-906 stimulator, produced the strongest contraction on average at 0.127 ± 0.105. At high intensity, the hydrogel electrode, in combination with the EV-906 stimulator, produced the strongest contraction at 0.171 ± 0.121. At maximum tolerable intensity, the hydrogel electrode, in combination with the EV-906 stimulator, produced the strongest contraction at 0.267 ± 0.181. The torques generated by each individual participant for each combination can be seen in Figure 13. After performing a statistical analysis to determine whether there were significant differences in the generated torque depending on the electrode type or stimulator used, no statistically significant differences (p<0.05) were found, as shown in the p-values ​​in Table 4. [Table 4]

[0244] Comparing the applied stimulation intensity to the average amount of torque generated, as shown in Figure 14, the hydrogel electrodes produced the highest amount of torque with lower intensity than the dry electrode type for the EV-906 and MyndSearch stimulators at high and maximum allowable levels. On the other hand, the Compex Motion stimulator could be used with hydrogel electrodes at slightly higher intensities, but the amount of torque was also higher.

[0245] Although the difference was not statistically significant, the combination that generated the highest torque and was rated as the most comfortable at the maximum tolerable stimulation level was the dry polymer nanocomposite electrode using the MyndSearch stimulator.

[0246] Reported sensations The average reported sensations from the given questionnaire are shown in Figure 15. "Prickling" was the most frequently reported sensation across all possible combinations, with very similar scores ranging from 1.5 to 1.8 on a 3-point scale. The reported sensations of each individual participant can also be found in Figure 16.

[0247] The described sensations can be divided into three distinct categories, as they relate to the level of activated nerve fibers: skin (superficial), muscle (deep), and whole-body. Skin sensations include "prickling," "stinging," "sharp," "burning," and "needle-like." In particular, "prickling" and "needle-like" were associated with the activation of Aδ fibers, while "stinging," "sharp," and "burning" were associated with C fibers. Muscle sensations include "muscle spasm," "biting," "pulling," and "throbbing." These are all associated with the activation of deep nociceptors and muscle pain. Whole-body sensations include "throbbing," "tingling," "prickling," "painful to the touch," and "snapping," all of which are associated with the stimulation of mechanoreceptors. The summation score for all sensations in each category can be found in Figure 17. All electrode types, along with all stimulators, reported more skin sensations than deep sensations. In particular, dry carbon rubber electrodes, along with Compex Motion, most frequently reported sensations as "prickling," "sharp," and "needle-like." Within the deep tissue category, "muscle spasm" and "pulling" were the most frequently reported sensations across all electrode and stimulator types.

[0248] Figure 18 shows the average amount of normalized torque generated in relation to the perceived comfort level.

[0249] Figure 19 shows a 3D plot illustrating the average amount of torque generated versus comfort rating versus stimulation intensity at each intensity level.

[0250] Overall, the dry polymer nanocomposite electrode exhibited high yield strength and sufficient flexibility, as well as high impedance. It had a smooth surface and did not require the addition of gel or water to achieve performance comparable to currently available self-adhesive hydrogel electrodes.

[0251] Example 5: Manufacturing of dry electrode articles or clothing The dry polymer nanocomposite electrodes described herein can be integrated into clothing for stimulation, for example, due to their reusable properties and smooth, non-adhesive surface, potentially enabling a more user-friendly form for delivering FES. When integrated into clothing, it may also facilitate the use of stimulation in non-clinic settings.

[0252] Figure 20 shows the attachment of a dry electrode to the inside of a stretchable fabric garment for interface with the skin. In this configuration, the sleeve was designed to apply electrical stimulation via the forearm. The dry electrode position was selected based on the anatomy of the target muscle. Dry electrode attachment was performed by applying a commercially available adhesive between the garment and the back of the electrode, or by using a compression molding setup, heating the electrode placed on the garment to 180-200°C for 4-8 minutes while simultaneously compressing the film layer onto the garment under a force of 2-6 tons. Before attachment, one end of the conductor was held between the garment and the back of the dry electrode and secured to the electrode via adhesion to the garment. The other end of the conductor was connected to the stimulator.

[0253] Figure 21 shows the outside of garment 4 shown in Figure 20, where the sleeve was fitted by the participant so that the dry electrodes were in direct contact with the desired location on the wearer's arm, and the conductor ends were connected to a stimulator to apply electrical pulses. The stretchy garment allowed for adjustment and proper placement of the electrodes in close proximity to the target muscle.

[0254] Example 6: Use of a dry electrode device The dry electrodes described in Example 5 were arranged on the participant so as to be close to the target muscles responsible for performing a specific movement, such as bringing something to the mouth. To perform the movement of the left hand bringing something to the mouth, electrode pairs were placed on the anterior deltoid, biceps, and triceps muscles of the left arm. By stimulating the anterior deltoid and biceps simultaneously, the arm flexed relative to the elbow (contraction of the biceps), and the arm was gently twisted inward, thus allowing the arm to reach the mouth (contraction of the anterior deltoid). To move the arm away from the mouth and extend it to the side of the body, stimulation was stopped at the anterior deltoid and biceps, and elbow extension was produced by stimulating the triceps. All electrodes responsible for stimulating these three muscles were embedded in elastic clothing resembling a sleeve that covered all of the muscles. Persons skilled in the art of functional electrical stimulation (FES) are proficient in the technique of positioning electrodes to generate movements, such as opening and closing the hand, extending it, standing up, walking, and sitting down. Elastic dry electrode garments covering body areas including the target muscle, such as those shown in Figures 20 and 21, facilitate the desired electrode placement required to stimulate the target muscle by positioning on the target muscle.

[0255] Example 7: Functional Electrical Stimulation (FES) Test To determine the functionality of a dry electrode containing a conductive composite material during FES (described in Example 3), stimulation was tested on the upper limbs of two healthy participants (one male and one female) with a mean age of 38.5 ± 13.4 years. Comfort levels were compared using a standard self-adhesive hydrogel electrode (ValuTrode 5 × 5 cm, Axelgaard Manufacturing, Denmark), a commercially available dry carbon rubber electrode (5 × 5 cm, AMG Medical, Canada), and the control dry electrode. As shown in Figure 6, participants sat supine in a Biodex chair with the backrest straightened and one hand holding the handle of the arm attachment. A self-adhesive bandage was wrapped around the hand and held in place. The armrest height was adjusted for each participant so that the shoulder was in a comfortable, neutral, straight position. The rotation axis of the dynamometer was aligned with each individual elbow. Two straps were placed around each participant's torso to maintain position.

[0256] To determine the participants' sensory thresholds, a pair of electrodes was placed on the right upper arm biceps of each participant. The anode was placed on the proximal end of the muscle (i.e., on the upper part of the long and short heads of the upper arm), while the cathode was placed on the distal end of the muscle belly. The dry electrodes described herein were placed directly against the participants' skin. The outline of the electrode placement was marked on the skin to ensure that all the electrode types tested were placed in the same position. The electrodes were wrapped with self-adhesive bandages and fixed in place on the upper arm at a predetermined position when placed on the arm.

[0257] Three different stimulation devices with asymmetric biphasic pulses were used: a portable battery-powered stimulation device (EV-906, Everyway Medical Instruments, Taiwan - voltage-adjustable stimulation device), a MyndSearch stimulation device (MyndTec, Canada - voltage and current-adjustable stimulation device), and a Compex Motion stimulation device (Compex, Switzerland - current-adjustable stimulation device). Examples of the pulses delivered using these stimulation devices are shown in Figure 5. The stimulation devices were used to represent all the adjustment modes for an electrical stimulator. The stimulation device parameters were set at a pulse frequency of 40 Hz, a pulse width of 300 μs, and a pulse amplitude (3.5 - 28 mA) depending on each participant and the stimulation device used.

[0258] The individual sensory thresholds (i.e., the amplitude at which the participant began to feel the stimulation), the minimum contraction threshold (i.e., mCT, the amplitude at which the selected muscle first began to contract or twitch), and the maximum tolerable contraction threshold (i.e., MTC, the amplitude at which the stimulation was too uncomfortable for the participant) were determined. These thresholds were determined using a standard hydrogel electrode in combination with each of the three stimulation devices to test the same intensity level using all three electrode types. Based on these thresholds, three different intensities (low, medium, and high) were calculated and used to stimulate each participant as follows: Low: mCT + 0.25 * (MTC - mCT) Medium: mCT + 0.50 * (MTC - mCT) High: mCT + 0.75 * (MTC - mCT)

[0259] The electrode type, stimulator, and intensity order were randomized. Participants performed three initial spontaneous contractions with maximum effort, holding each for 5 seconds. Participants were then stimulated three times at each intensity using one type of electrode. The stimulation amplitude was increased by 0.25–1 mA at a time until the desired intensity was reached, and then held for 5 seconds. After each stimulation round, participants verbally reported the comfort level of the stimulation using a visual numerical rating scale of 0 to 10 displayed in front of them, where 0 was very comfortable and 10 was very uncomfortable. Each electrode type was tested with three different stimulators, and after testing one type of electrode at all intensities, the electrode type was switched and the same stimulation procedure described above was repeated.

[0260] Data was recorded using a data acquisition system and software (PowerLab, LabChart, AD Instruments, USA). Torque was recorded at a sampling rate of 1 kHz, while stimulation pulses were recorded at 200 kHz. All data was collected and stored for further analysis on a computer.

[0261] After data collection, the data was filtered and analyzed using MATLAB (v.2021a, Mathworks, USA).

[0262] Comfort rating As shown in Figure 22, across all intensity levels, dry electrodes were perceived as most comfortable with the MyndSearch and EV-906 stimulators, while hydrogel electrodes were most comfortable with the Compex Motion stimulator. The most uncomfortable combination was dry electrodes and dry carbon rubber electrodes with the Compex Motion stimulator.

[0263] At the end of all stimulation tests, both participants reported the MyndSearch and dry electrode combination as the most comfortable of all, which is consistent with the assessment shown in Figure 22.

[0264] Example 8: Functional electrical stimulation biceps sleeve based on textile-embedded dry electrodes This embodiment presents a method for designing and prototyping a smart biceps sleeve for FES application, and explains how to integrate a carbon-based dry electrode into a textile structure and establish an electrical connection between the electrode and the stimulator for effective FES delivery.

[0265] material and method Dry electrode The dry electrodes used to develop the Smart FES clothing were manufactured as described above. In short, they were made from polyvinylidene fluoride (PVDF) mixed with 5 wt% carbon nanotubes (CNTs). The polymer was then molded into a thin, flexible, conductive film, which can be easily adjusted to the desired size.

[0266] Textile conductive yarn While sewn or embroidered conductive textile threads have been widely used to create conductive tracks on textile substrates [30-32], prior art methods have not used a sewn conductive matrix as a contact power support for dry electrodes for the FES garment described herein. As shown in Figure 1, the conductive matrix of the smart FES garment consists of seven parallel stitch lines produced using two “Silver-Tech HC12” threads (front and back) from Madeira Company

[33] . This thread exhibits a linear resistivity of approximately 100 Ω·m⁻¹

[34] . The use of conductive sewing threads for the front and back threads allows for electrical connection between both sides of the 42easuree, thus enabling connection of both the electrodes inside the sleeve and the stimuli outside the sleeve.

[0267] Textile base material We developed a smart FES sleeve using a blend of polyester (80%), viscose (15%), and elastane (5%). As support, the textile sleeve had to ensure accurate electrode placement and good adhesion, and it had to withstand the electrode fixation process (including heat compression molding at 190°C). This structure was chosen because it provides elasticity and ensures a good skin-electrode interface.

[0268] Textile sleeve pattern The woven base material was cut according to a specific pattern and formed into a sleeve. The textile sleeve pattern is a two-dimensional representation of the sleeve before assembly, as shown in Figure 23. It was created based on the patient's biceps measurements and electrode placement, with the aim of stimulating the biceps brachii muscle responsible for elbow flexion. Three different sizes (S, M, L) were developed, and their dimensions are shown in Table 1. The pattern was designed using Inkscape® software. [Table 5]

[0269] Textile electrode conductive interface Textile conductive threads created an electrical connection between the dry electrode and the stimulator. They formed a conductive matrix and were fixed onto a knitted substrate by sewing or embroidery. Figure 24 shows a sample of a conductive matrix embroidered on a knitted substrate, both front and back sides. The textile conductive threads constituting the matrix were extended to the crimp connector, thereby enabling the transport of current from the stimulator to the electrode. In addition, the use of sewn textile conductive threads provided a larger surface area, improving mechanical and chemical fixation. Furthermore, the roughness of the matrix allowed the electrode polymer to fill a new volume under thermal compression, enhancing mechanical fixation.

[0270] The matrix was composed of seven parallel textile conductive threads. This shape ensured a uniform current distribution within the matrix, and consequently, within the electrodes.

[0271] Dry electrode fixation As soon as the textile conductive matrix was formed, the carbon-based dry electrode was fixed to the substrate via a thermal compression process using a CARVER compression press, as shown in Figure 25(a). The machine applied a temperature of 190°C only from above. From below, a pressure of 1 ton was applied for 5 minutes, followed by a pressure of 5 tons for 5-7 minutes. The compression press area was 15 × 15 cm square. To increase surface smoothness, two Teflon sheets were placed on a steel plate, sandwiching the textile substrate and electrode. After thermal compression, the sample was removed as soon as it cooled to room temperature. Photographs of both sides of the dry electrode fixed on the woven substrate are shown in Figures 25(b) and 25(c).

[0272] adjustment The final step of the manufacturing process consisted of adjusting the pattern, shaping it into a sleeve, and integrating the connector. The remaining textile conductive threads protruding from the conductive matrix were twisted and then inserted into a circular crimp connector, which was then passed through a heat shrink tube. The resulting cable was secured to the base material using cord stitching. Finally, the textile structure (plane) was closed and the sleeve was formed with straight stitching. A prototype of the smart FES sleeve for the biceps is shown in Figure 26.

[0273] Experimental protocol for smart FES sleeve characterization The purpose of the smart FES sleeve for the biceps was to provide elbow flexion without causing pain through electrical stimulation of the brachialis biceps. The stimulation was delivered to the right arm using a MyndSearch stimulator (MyndTec Inc.), with a pulse frequency of 40 Hz, a pulse width of 300 μs, and the pulse amplitude determined individually for each. A smart FES sleeve with implanted dry electrodes was compared to a conventional self - adhesive hydrogel electrode (ValuTrode 5×5 cm, Axelgaard Manufacturing Co.) from the perspectives of muscle torque and perceived comfort. Electrical intensity, perceived comfort, and muscle torque were evaluated for three levels of stimulation intensity for both the hydrogel electrode and the smart FES sleeve using five participants according to the protocol outlined in Example 4 above. Torque was measured using a Biodex dynamometer (System 3, Biodex Medical Systems), and comfort was evaluated using a visual analog scale of 1 - 10 presented to the participants and a sensation questionnaire. All participants were informed of the protocol and signed a consent form approved by the Research Ethics Review Board of the University Health Network (ID#21 - 5298). The three levels of stimulation intensity used to conduct the measurements were defined as follows: Low = mCT + 0.25 * (MTC - mCT) Medium = mCT + 0.5 * (MTC - mCT) High = mCT + 0.75 * (MTC - mCT))

[0274] mCT is the minimum contraction threshold, and MTC is the maximum tolerable contraction threshold.

[0275] Participant demographics The smart FES sleeve was tested on five participants (3 females and 2 males, mean age 28.6 ± 2.7 years) as presented in Table 2.

Table 6

[0276] result Stimulating comfort In the reported comfort ratings, participants rated the sleeve with the dry electrode as at least as comfortable as the hydrogel electrode, on average, for all intensity levels, as shown in Figure 27. At maximum tolerable intensity, the mean discomfort was 6.40±2.88 for the sleeve and 7.20±3.35 for the hydrogel electrode. At high intensity, the mean discomfort rating was 5.07±1.48 for the sleeve and 6.20±2.75 for the hydrogel electrode. At moderate intensity, the mean discomfort was 3.93±1.04 for the sleeve and 4.87±2.62 for the hydrogel electrode. At low intensity, the mean discomfort rating was 3.00±0.88 for the sleeve and 3.93±2.58 for the hydrogel electrode.

[0277] stimulation-induced muscle torque The average muscle torque generated by stimulation did not show any significant difference across electrode types or intensity levels, as shown in Figure 28. At maximum tolerable stimulation intensity, the average normalized torque generated was 0.241±0.180 with the sleeve and 0.164±0.213 with the hydrogel electrode. At high intensity, the average torque was 0.156±0.158 with the sleeve and 0.153±0.172 with the hydrogel electrode. At moderate intensity, the average torque was 0.140±0.161 with the sleeve and 0.113±0.169 with the hydrogel electrode. At low intensity, the average torque was 0.111±0.138 with the sleeve and 0.089±0.141 with the hydrogel electrode.

[0278] Stimulation intensity used As shown in Figure 29, the stimulation intensity used for all five participants was, on average, higher with the dry electrode in the sleeve than with the hydrogel electrode. At the maximum tolerance level, the average stimulation used was 9.90±5.77mA with the sleeve and 7.58±2.60mA with the hydrogel electrode. At the high level, the average intensity was 8.50±5.27mA with the sleeve and 6.36±1.99mA with the hydrogel electrode. At the medium level, the average intensity was 7.13±4.82mA with the sleeve and 5.14±1.49mA with the hydrogel electrode. At the low level, the average intensity was 5.76±4.33mA with the sleeve and 3.90±1.20mA with the hydrogel electrode.

[0279] Reported sensations The average reported sensations after stimulation are shown in Figure 30. On average, the most reported sensation for both electrode types was "tingling," with individuals rating the intensity on average at 1.80 ± 1.10 for the sleeve and 2.00 ± 0.71 for the hydrogel electrode. Other reported sensations for the sleeve were "prickling," "throbbing," and "muscle spasm," while for the hydrogel electrode they were "prickling," "tingling," "sharp," "muscle spasm," and "throbbing." The average assessed sensory intensity was 0.40±0.55 with the sleeve and 1.00±1.00 with the hydrogel electrode for "prickling," 0.40±0.55 with both the sleeve and hydrogel electrode for "throbbing," 0.20±0.45 with the sleeve and 0.40±0.89 with the hydrogel electrode for "muscle spasm," 0.60±1.34 with the hydrogel electrode for "throbbing," and 0.40±0.89 for "sharp."

[0280] Example 9: Functional electrical stimulation forearm sleeve based on textile-embedded dry electrodes This embodiment presents a design and prototyping method for a smart forearm sleeve for FES application.

[0281] material and method Dry electrodes, textile conductive yarns, and textile substrates were manufactured as described in Example 8.

[0282] Textile sleeve pattern As soon as the electrodes were fixed onto the substrate, the knitted PET jersey was cut according to a specific pattern to form the sleeve. The textile sleeve pattern was a two-dimensional representation of the sleeve before assembly, as shown in Figure 31(a). This was fabricated based on the patient's forearm measurements and electrode placement. The sewing process took place last, as shown in Figure 31(bd), and the pattern was assembled. The pattern was designed using Inkscape® software.

[0283] Due to the difference in diameter between the distal (wrist) and proximal parts of the forearm, it could be difficult to slip the sleeve onto the forearm, especially for patients with motor impairments. Therefore, the stitching on the lower part of the forearm can be replaced with a zipper, as shown in Figure 31(c).

[0284] Textile electrode conductive interface An electrical connection between the dry electrode and the stimulator was fabricated using textile conductive threads. These formed a conductive matrix and were fixed to a knitted substrate by embroidery. Figure 32 shows a sample of the embroidered conductive matrix on the knitted substrate, both the front and back sides. The textile conductive threads constituting the matrix were extended to the crimp connector, thereby allowing them to transport current from the stimulator to the electrode. In addition, the use of embroidered textile conductive threads provided a larger contact surface, improving chemical fixation. Furthermore, the roughness of the matrix allowed the electrode polymer to fill this new volume under thermal compression, enhancing mechanical fixation.

[0285] As soon as the textile conductive matrix was formed, a carbon-based dry electrode was immobilized onto the substrate via the thermal compression process described in Example 8. A photograph of the immobilized dry electrode on the woven substrate is shown in Figure 33.

[0286] adjustment The final step of the manufacturing process consisted of adjusting the pattern, shaping it into a sleeve, and integrating the connector. Excess textile conductive yarn protruding from the conductive matrix was woven in and inserted into a circular crimp connector, which was then passed through a heat-shrink tube. The resulting cable was secured to the base material using cord stitching. A zipper was sewn onto two-thirds of the pattern, starting from the wrist area, to facilitate attachment. The remaining one-third was sewn on with straight stitching. A prototype of the textile functional electrical stimulation sleeve prototype is shown in Figure 34.

[0287] Experimental protocol The objective is to provide a smart sleeve for functional electrical stimulation, which provides wrist extension via electrical stimulation without causing pain. The stimulation is delivered using a MyndSearch® stimulator. Figure 35 shows the experimental setup for both resting and extended wrists. The study focused on the presence or absence of wrist flexion before pain occurred. It was conducted on a group of healthy individuals.

[0288] result Pain-free wrist flexion was observed in a subset of participants, which was comparable to the results achieved with dry electrodes alone (i.e., not integrated into the textile solution) as detailed in Example 4 above. The dry electrode manufacturing process and electrode integration into clothing did not alter the stimulation properties of the dry stimulation electrodes. Thus, the forearm FES sleeve ensured a good skin / electrode interface, and the textile conductive matrix allowed for a uniform current distribution within the dry electrodes upon delivery to the skin.

[0289] It should be understood that this application is not limited to the embodiments disclosed. Conversely, this application is intended to encompass various modifications and equivalent arrangements that fall within the spirit and scope of the appended claims.

[0290] All publications, patents, and patent applications mentioned herein are incorporated by reference in their entirety to the same extent that each individual publication, patent, and patent application is specifically and individually incorporated by reference as a whole.

[0291] The claims should not be limited by preferred embodiments and examples, but should be given the broadest possible interpretation consistent with the overall description.

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Claims

1. A reusable, transdermal dry electrode, i) A conductive material comprising a fluoropolymer matrix and conductive carbon nanoparticles dispersed in the matrix, and ii) A conductor configured to come into contact with the material from the stimulator and deliver electrical pulses. Includes, The dry tissue contact surface of the material is configured to deliver electrical stimulation directly to the tissue, forming a dry electrode.

2. The electrode according to claim 1, wherein the conductive material is nonmetallic.

3. The electrode according to claim 1 or 2, wherein the fluoropolymer matrix is ​​polyvinylidene fluoride (PVDF) and / or the nanoparticles are carbon nanotubes (CNTs).

4. The electrode according to any one of claims 1 to 3, wherein the nanoparticles are dispersed in the fluoropolymer matrix at an amount of about 5 to about 10 wt% of the matrix.

5. The electrode according to any one of claims 1 to 4, wherein the nanoparticles have an aspect ratio of approximately 1 to approximately 600.

6. The electrode according to claim 5, wherein the aspect ratio is approximately 130 to approximately 160.

7. The electrode according to any one of claims 1 to 6, wherein the nanoparticles are interconnected.

8. The electrode according to any one of claims 1 to 7, wherein the impedance of the conductive material is approximately 1,000 to approximately 10,000 Ω, and / or the sheet resistivity of the conductive material is at least 50 Ω·cm or approximately 50 to approximately 500 Ω·cm.

9. The electrode according to claim 8, wherein the impedance is approximately 2,100 to approximately 2,800 Ω, and / or the sheet resistivity is approximately 100 to approximately 300 Ω·cm.

10. The electrode according to any one of claims 1 to 9, wherein the conductive material has a width of about 50 to about 200 μm.

11. The electrode according to claim 10, wherein the width is approximately 50 to approximately 100 μm.

12. The electrode according to any one of claims 1 to 11, wherein the tissue is skin.

13. The electrode according to claim 12, wherein the electrode is adapted to be positioned on the skin in close proximity to a selected muscle or muscle group.

14. The electrode according to claim 13, wherein the electrical stimulation induces contraction of the muscle or muscle group.

15. The electrode according to any one of claims 1 to 14, wherein the electrical stimulation is functional electrical stimulation.

16. The electrode according to any one of claims 1 to 15, wherein the electrode is placed on an article or clothing.

17. The electrode according to claim 16, wherein the electrode is positioned on the inner surface of the article or clothing, and the dry tissue contact surface of the electrode is in parallel with the tissue.

18. The electrode according to claim 16 or 17, wherein the electrode is fixed to the article or clothing using an adhesive.

19. An electrode according to any one of claims 1 to 18 for use with a high-voltage adjustable stimulator, wherein the electrode is configured to deliver electrical pulses.

20. The electrode according to claim 19, wherein the pulse is a symmetrical or asymmetrical biphasic electrical pulse.

21. The electrode according to claim 19 or 20, wherein the rise time of the pulse is approximately 10 to approximately 40 ns.

22. The electrode according to any one of claims 19 to 21, wherein the pulse has a total width of approximately 8 to approximately 2,000 μs.

23. The electrode according to claim 22, wherein the width is approximately 100 to approximately 1,000 μs.

24. The electrode according to claim 23, wherein the width is approximately 300 to approximately 500 μs.

25. The electrode according to any one of claims 20 to 24, wherein the pulse is asymmetric and includes a first phase pulse having a first amplitude and a first width, and a second phase pulse having a second amplitude and a second width.

26. The electrode according to claim 25, wherein the first amplitude is approximately -0.04 to approximately -160 mA, and / or the second amplitude is approximately 0.01 to approximately 40 mA.

27. The electrode according to claim 26, wherein the first amplitude is approximately -0.4 to approximately -120 mA, and / or the second amplitude is approximately 0.1 to approximately 30 mA.

28. The electrode according to any one of claims 25 to 27, wherein the first width is approximately 200 to approximately 500 μs, and / or the second width is approximately 800 to approximately 2,000 μs.

29. The electrode according to any one of claims 25 to 28, wherein the first and second amplitudes are not equal.

30. The electrode according to any one of claims 25 to 29, wherein the first and second widths are not equal.

31. A washable dry electrode article or garment comprising the electrode described in any one of claims 1 to 30.

32. The article or garment according to claim 31, wherein the electrode is positioned on a portion of the inner surface of the article or garment, and the tissue contact surface of the conductive material is in parallel with the tissue.

33. The article or garment according to claim 32, wherein the electrode is fixed to the part of the article or garment using an adhesive.

34. The article or garment according to claim 31 or 32, wherein the conductor includes an electrode contact segment configured to contact the dry electrode, and the electrode contact segment includes at least one conductive yarn integrated into a knitted textile base material.

35. The article or garment according to claim 34, wherein the at least one conductive thread is integrated into the textile base material by sewing or embroidery.

36. An article or garment according to claim 34 or 35, comprising at least two conductive threads, wherein a portion of the at least two conductive threads is integrated into the textile base material to form a pattern comprising a plurality of non-intersecting lines.

37. The article or garment according to any one of claims 34 to 36, wherein the conductor further includes a cable segment comprising at least one or two unintegrated portions of conductive threads configured to deliver electrical stimulation from a stimulator to the conductive electrode contact segment, and optionally the cable segment is fixed to the textile substrate by attachment means.

38. The article or garment according to claim 36 or 37, wherein at least two lengths of the plurality of non-intersecting lines are arranged substantially parallel to each other within the electrode contact segment.

39. The article or garment according to any one of claims 34 to 38, wherein the textile base material is a polyester jersey material or comprises the same.

40. The article or garment according to any one of claims 34 to 39, wherein the at least one or two conductive threads are silver-plated threads and / or have a linear resistance of at least 1 Ω / m or about 1 to about 1000 Ω / m.

41. The article or garment according to any one of claims 34 to 40, wherein the protective layer is placed on the non-skin contact surface of the article or garment and covers the exposed portions of the at least one or two conductive threads.

42. The article or garment according to claim 41, wherein the protective layer is a fabric layer or a liquid silicone layer.

43. A dry electrode device for delivering electrical stimulation to a user, i) Article or clothing as described in any one of claims 31 to 42, ii) High-voltage adjustable stimulator, and iii) Connector connecting the conductor and the stimulator A dry electrode apparatus, including a dry electrode device.

44. The apparatus according to claim 43, wherein the dry electrode is fixed to the article or clothing using an adhesive.

45. The apparatus according to claim 43 or 44, wherein the connector is positioned on the article or clothing.

46. The apparatus according to any one of claims 43 to 45, wherein the stimulator is portable.

47. The apparatus according to claim 46, wherein the stimulator is configured to be placed within a part of the article or clothing.

48. Use of a dry electrode according to any one of claims 1 to 30, an article or clothing according to any one of claims 31 to 42, or an apparatus according to any one of claims 43 to 47 for treating a motor disorder in the user.

49. i) Placing the article, clothing, or at least two dry electrodes directly on the user's tissue, in close proximity to the selected muscle or muscle group. ii) Connecting the conductor of the article, clothing or the at least two dry electrodes to the stimulator, and iii) Delivering electrical stimulation from the stimulator to the conductor of the article or clothing, or to the at least two dry electrodes. Includes, The use according to claim 48, wherein the stimulus induces contraction of the muscle or muscle group to treat the motor disorder.

50. The use according to claim 48 or 49, wherein the motor impairment is paralysis.

51. A method for delivering electrical stimulation to a subject, i) Placing the article or garment according to any one of claims 31 to 42, or at least two dry electrodes according to any one of claims 1 to 30, directly onto the subject's tissue in close proximity to a selected muscle or muscle group. ii) Connecting the conductor of the article, clothing, or the at least two dry electrodes to a high-voltage adjustable stimulator, iii) Delivering electrical pulses from the stimulator to the conductor of the article or clothing, or to the at least two dry electrodes. Includes, A method by which the aforementioned stimulus induces contraction of a muscle or group of muscles.

52. The method according to claim 51, wherein the pulse is a symmetrical or asymmetrical biphasic electrical pulse.

53. The method according to claim 51 or 52, wherein the rise time of the pulse is approximately 10 to approximately 40 ns.

54. The method according to any one of claims 51 to 53, wherein the pulse has a total width of approximately 8 to approximately 2,000 μs.

55. The method according to claim 54, wherein the width is approximately 100 to approximately 1,000 μs.

56. The method according to claim 55, wherein the width is approximately 300 to approximately 500 μs.

57. The method according to any one of claims 51 to 56, wherein the pulse is asymmetric and includes a first phase pulse having a first amplitude and a first width, and a second phase pulse having a second amplitude and a second width.

58. The method according to claim 57, wherein the first amplitude is approximately -0.04 to approximately -160 mA, and / or the second amplitude is approximately 0.01 to approximately 40 mA.

59. The method according to claim 58, wherein the first amplitude is approximately -0.4 to approximately -120 mA, and / or the second amplitude is approximately 0.1 to approximately 30 mA.

60. The method according to any one of claims 57 to 59, wherein the first width is about 200 to about 500 μs, and / or the second width is about 800 to about 2,000 μs.

61. The method according to any one of claims 57 to 60, wherein the first and second amplitudes are not equal.

62. The method according to any one of claims 57 to 61, wherein the first and second widths are not equal.

63. The method according to any one of claims 51 to 62, wherein the pulse is delivered at a frequency of approximately 1 to approximately 100 Hz.

64. The method according to claim 63, wherein the frequency is approximately 20 to approximately 40 Hz.

65. Use of the method according to any one of claims 51 to 64 for treating a motor disorder in the aforementioned subject.

66. A method for manufacturing washable dry electrode articles or clothing, A) Manufacturing a dry electrode according to any one of claims 1 to 30, the steps comprising: i) Dispersing conductive carbon nanoparticles in a polymer solvent to obtain a dispersion, ii) Dissolve the fluoropolymer matrix in the dispersion to obtain a blend. iii) Casting the aforementioned blend, iv) Dry the casting blend, v) Compressing the blend, vi) Cool the blend to obtain a conductive material. vii) Cleaning the material, and viiii) Placing a conductor on or within the conductive material, wherein the conductor is configured to contact the material and deliver electrical pulses from a stimulator. B) Placing the dry electrode of (A) on or inside the article or clothing. Includes, A method wherein the electrodes are placed on the inner surface of the article or clothing, and the tissue contact surfaces of the electrodes are aligned with the tissue.

67. The method according to claim 66, wherein the casting and / or compression includes transferring the blend to a mold.

68. The method according to claim 66 or 67, wherein the solvent is dimethylformamide (DMF).

69. The method according to any one of claims 66 to 68, wherein the dispersion is performed by ultrasonic treatment.

70. The method according to any one of claims 66 to 69, further comprising heating the blend as described above.

71. The method according to claim 70, wherein the heating is carried out in a temperature range of approximately 80 to approximately 200°C.

72. The method according to any one of claims 66 to 71, wherein the cleaning is carried out using water and / or ethanol.

73. The method according to claim 66, wherein arranging the conductor on the material in accordance with (viiii) includes integrating at least one conductive yarn into a woven textile base material.

74. The method according to claim 73, wherein the integration includes sewing or embroidery.

75. Arranging the dry electrode according to (B) means i) Before integrating the at least one conductive thread, place the heat adhesive on the textile substrate. ii) Placing the dry electrode on the thermal adhesive, and iii) Applying the thermal adhesive to the dry electrode and textile substrate using thermal compression, It further includes, The method according to claim 73 or 74, wherein the thermal compression integrates a portion of the at least one conductive thread into the dry electrode conductive material.

76. The method according to claim 75, wherein the thermal compression includes heating the dry electrode to a temperature of at least 180°C, optionally in the range of 180°C to 230°C.

77. The method according to claim 76, wherein the thermal compression comprises applying a pressure in the range of 1 to 10 tons to the textile substrate, optionally applying a pressure of about 1 ton to the textile substrate, and subsequently applying a pressure of about 5 tons.

78. The method according to claim 77, wherein the pressure is applied for a period of time ranging from 5 to 10 minutes, and optionally, the pressure of approximately 1 ton is applied for approximately 5 minutes, and the pressure of approximately 5 tons is applied for approximately 5 to 7 minutes.

79. The method according to any one of claims 73 to 78, wherein the textile base material is a polyester jersey material or includes the same.

80. The method according to any one of claims 73 to 79, wherein the at least one conductive thread is a silver-plated thread, or includes one, and / or has a resistance of at least 1 Ω·m or about 1 to about 1000 Ω·m.

81. The method according to any one of claims 73 to 80, wherein the protective layer is placed on a non-skin contact surface of the article or clothing and covers the exposed portion of the at least one conductive thread.

82. The method according to claim 81, wherein the protective layer is a fabric layer or a liquid silicone layer.

83. Use of a dry electrode article or garment manufactured by the method of any one of claims 66 to 82 for treating a motor disorder in the user.

84. The use according to claim 83, wherein the motor impairment is paralysis.

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