Apparatus, system, and method for removing and replacing subassemblies of electrode assemblies

Abstract

Apparatus for use in applying a TT field is disclosed. The apparatus includes a subassembly comprising at least one electrode element having a skin-facing side and a skin-facing surface. The apparatus further includes a skin-contact subassembly comprising a skin-contact conductive adhesive or gel configured to contact the skin of a subject. One of the electrode subassembly or the skin-contact subassembly comprises a conductive polymer layer, and the other of the electrode subassembly or the skin-contact subassembly comprises a second conductive adhesive or gel. The conductive polymer layer is positioned relative to the second conductive adhesive or gel and removably bonded thereto, thereby removably bonding the electrode subassembly to the skin-contact subassembly such that the skin-contact conductive adhesive or gel is electrically bonded to at least one electrode element.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of priority and filing dates of U.S. Provisional Patent Application No. 63 / 493,561, filed on March 31, 2023, and U.S. Provisional Patent Application No. 63 / 548,656, filed on February 1, 2024, each of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Tumor treating electric fields (TTFields) therapy is a proven approach for treating tumors using alternating electric fields at frequencies of 50 kHz to 1 MHz, more typically 100 kHz to 500 kHz. The alternating electric fields are induced by electrode assemblies (e.g., arrays of capacitive coupling electrodes, also called transducer arrays) placed on either side of a target location within the body of a subject. When an alternating voltage is applied between opposing electrode assemblies, an alternating current flows through the electrode assemblies and into the body of the subject. And higher currents are strongly correlated with higher treatment efficacy.

[0003] The electrode assemblies used during the application of TTFields typically include a conductive hydrogel layer that functions as a skin - contact layer that adheres to the skin of the subject. Conductive hydrogels typically have a shorter lifespan than other electrode assemblies. For example, through use, the skin - contact layer can degrade, for example, by collecting oils and dirt, thereby reducing the effectiveness of the conductive hydrogel layer. Hydrogels are typically integrally formed within the electrode assembly. Thus, when the hydrogel expires or becomes contaminated, the entire electrode assembly needs to be discarded and replaced.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

[0005] This specification discloses apparatuses and kits for applying a TT field in various embodiments.

[0006] In one embodiment, the device includes an electrode subassembly having a skin-facing side and a skin-facing surface. The electrode subassembly includes a subassembly comprising at least one electrode element having a skin-facing side and a skin-facing surface. The device further includes a skin contact subassembly comprising a skin-contact conductive adhesive or gel configured to come into contact with the skin of a subject. One of the electrode subassembly or the skin contact subassembly comprises a conductive polymer layer, and the other of the electrode subassembly or the skin contact subassembly comprises a conductive adhesive or gel layer. The skin contact subassembly is removably bonded to the electrode subassembly by adhesion between the conductive polymer layer and the conductive adhesive or gel layer. The skin-contact conductive adhesive or gel is electrically bonded to at least one electrode element when the skin contact subassembly is positioned relative to the skin-facing surface of the electrode subassembly.

[0007] In one embodiment, the kit includes an electrode subassembly. The electrode subassembly includes at least one electrode element having a skin-facing side and a skin-facing surface, and a non-adhesive conductive polymer layer on the skin-facing side of at least one electrode element. The non-adhesive conductive polymer layer has a skin-facing surface that defines the skin-facing surface of the electrode subassembly. The kit further includes a plurality of skin-contact subassemblies, each skin-contact subassembly configured to bond to the electrode subassembly as a removable unit. Each skin-contact subassembly includes a skin-contact conductive adhesive or gel configured to contact the skin of a subject. When the skin-contact subassembly is positioned relative to the non-adhesive conductive polymer layer of the electrode subassembly, the skin-contact conductive adhesive or gel of the skin-contact subassembly is configured to electrically bond to at least one electrode element.

[0008] In one embodiment, the method includes the step of using an apparatus, the apparatus including an electrode subassembly having a skin-facing side and a skin-facing surface. The electrode subassembly includes a subassembly comprising at least one electrode element having a skin-facing side and a skin-facing surface. The apparatus further includes a skin contact subassembly comprising a skin-contact conductive adhesive or gel configured to come into contact with the skin of a subject. One of the electrode subassembly or the skin contact subassembly comprises a conductive polymer layer, and the other of the electrode subassembly or the skin contact subassembly comprises a conductive adhesive or gel layer. The skin contact subassembly is removably bonded to the electrode subassembly by adhesion between the conductive polymer layer and the conductive adhesive or gel layer. The skin-contact conductive adhesive or gel is electrically bonded to at least one electrode element when the skin contact subassembly is positioned relative to the skin-facing surface of the electrode subassembly. The method further includes removing the skin contact subassembly from the electrode subassembly.

[0009] In one embodiment, the device includes a subassembly comprising at least one electrode element having a skin-facing side and a skin-facing surface. The electrode subassembly further comprises a conductive polymer layer on the skin-facing side of at least one electrode element. The conductive polymer layer has a skin-facing surface that defines the skin-facing surface of the electrode subassembly. The device further comprises a skin-contact subassembly detachably coupled to the electrode subassembly. The skin-contact subassembly comprises a skin-contact conductive adhesive or gel configured to contact the skin of a subject. The skin-contact conductive adhesive or gel is electrically coupled to the at least one electrode element when the skin-contact subassembly is positioned relative to the skin-facing surface of the conductive polymer layer of the electrode subassembly.

[0010] In one embodiment, the kit includes a subassembly comprising at least one electrode element having a skin-facing side and a skin-facing surface. The electrode subassembly further comprises a conductive polymer layer on the skin-facing side of at least one electrode element. The conductive polymer layer has a skin-facing surface that defines the skin-facing surface of the electrode subassembly. The kit further comprises a plurality of skin-contact subassemblies. Each skin-contact subassembly is configured to bond to the electrode subassembly as a removable unit. Each skin-contact subassembly comprises a skin-contact conductive adhesive or gel configured to contact the skin of a subject. When the skin-contact subassembly is positioned relative to the conductive polymer layer of the electrode subassembly, the skin-contact conductive adhesive or gel of the skin-contact subassembly is configured to electrically bond to at least one electrode element.

[0011] In one embodiment, the device includes a subassembly comprising at least one electrode element having a skin-facing side and a skin-facing surface. The electrode subassembly further comprises a first conductive adhesive or gel on the skin-facing side of at least one electrode element. The first conductive adhesive or gel has a skin-facing surface that defines the skin-facing surface of the electrode subassembly. The device further comprises a skin-contact subassembly detachably coupled to the electrode subassembly. The skin-contact subassembly comprises a conductive polymer layer configured to be detachably coupled to the skin-facing surface of the electrode subassembly. The skin-contact subassembly further comprises a skin-contact conductive adhesive or gel configured to be in contact with the skin of a subject. The skin-contact conductive adhesive or gel is electrically coupled to at least one electrode element when the conductive polymer layer of the skin-contact subassembly is positioned relative to the skin-facing surface of the electrode subassembly.

[0012] In one embodiment, the kit includes a subassembly comprising at least one electrode element having a skin-facing side and a skin-facing surface. The electrode subassembly further comprises a first conductive adhesive or gel on the skin-facing side of at least one electrode element. The first conductive adhesive or gel has a skin-facing surface that defines the skin-facing surface of the electrode subassembly. The kit further comprises a plurality of skin-contact subassemblies. Each skin-contact subassembly is configured to be coupled to the electrode subassembly as a removable unit. Each skin-contact subassembly comprises a conductive polymer layer configured to be removably coupled to the skin-facing surface of the electrode subassembly, and a skin-contact conductive adhesive or gel configured to be in contact with the skin of a subject. When the conductive polymer layer of the skin-contact subassembly is positioned relative to the skin-facing surface of the electrode subassembly, the skin-contact conductive adhesive or gel of the skin-contact subassembly is electrically coupled to at least one electrode element.

[0013] In one embodiment, the apparatus includes a subassembly comprising at least one electrode element having a skin-facing side and a skin-facing surface. The apparatus further includes a skin-contact subassembly comprising a skin-contact conductive adhesive or gel configured to come into contact with the skin of a subject. One of the electrode subassembly or the skin-contact subassembly comprises a conductive polymer layer, and the other of the electrode subassembly or the skin-contact subassembly comprises a second conductive adhesive or gel. The conductive polymer layer is positioned relative to the second conductive adhesive or gel and is removably bonded thereto, thereby removably bonding the electrode subassembly to the skin-contact subassembly such that the skin-contact conductive adhesive or gel is electrically bonded to at least one electrode element.

[0014] In one embodiment, the device includes a subassembly comprising at least one electrode element having a skin-facing side and a skin-facing surface. The device further includes a skin-contact subassembly comprising a skin-contact conductive adhesive or gel. The skin-contact conductive adhesive or gel is configured to be electrically coupled to at least one electrode element and to be in contact with the subject's skin. One of the electrode subassembly or the skin-contact subassembly comprises a conductive polymer layer. The skin-contact subassembly is removably bonded to the electrode subassembly by adhesion between the conductive polymer layer and the conductive adhesive layer of the other of the electrode subassembly or the skin-contact subassembly.

[0015] Systems and methods for using the disclosed devices and kits (e.g., therapeutic assemblies) are also disclosed. [Brief explanation of the drawing]

[0016] [Figure 1] This is a schematic top view of an exemplary therapeutic assembly disclosed herein. [Figure 2] This is a schematic cross-sectional view of an exemplary therapeutic assembly disclosed herein, along plane 2-2' of Figure 1, according to various non-limiting embodiments. [Figure 3] This is a schematic cross-sectional view of an exemplary therapeutic assembly disclosed herein, along plane 2-2' of Figure 1, according to various non-limiting embodiments. [Figure 4] This is a schematic cross-sectional view of an exemplary therapeutic assembly disclosed herein, along plane 2-2' of Figure 1, according to various non-limiting embodiments. [Figure 5] This is a schematic cross-sectional view of an exemplary therapeutic assembly disclosed herein, along plane 2-2' of Figure 1, according to various non-limiting embodiments. [Figure 6] This is a schematic cross-sectional view of an exemplary therapeutic assembly disclosed herein, along plane 2-2' of Figure 1, according to various non-limiting embodiments. [Figure 7]A schematic cross-sectional view of an exemplary therapeutic assembly disclosed herein along the plane 2-2' of FIG. 1, according to various non-limiting embodiments. [Figure 8] A schematic cross-sectional view of an exemplary therapeutic assembly disclosed herein along the plane 2-2' of FIG. 1, according to various non-limiting embodiments. [Figure 9] A schematic cross-sectional view of an exemplary therapeutic assembly disclosed herein along the plane 2-2' of FIG. 1, according to various non-limiting embodiments. [Figure 10] A schematic cross-sectional view of an exemplary therapeutic assembly disclosed herein along the plane 2-2' of FIG. 1, according to various non-limiting embodiments. [Figure 11] A schematic diagram of an exemplary system for aligning the electrode sub-assembly and the skin contact sub-assembly of the therapeutic assembly of FIG. 1, according to various non-limiting embodiments. [Figure 12] A schematic diagram of an exemplary system for aligning the electrode sub-assembly and the skin contact sub-assembly of the therapeutic assembly of FIG. 1, according to various non-limiting embodiments. [Figure 13] A schematic diagram of an exemplary system for aligning the electrode sub-assembly and the skin contact sub-assembly of the therapeutic assembly of FIG. 1, according to various non-limiting embodiments. [Figure 14] A schematic cross-sectional view of an exemplary conductive adhesive structure including a substrate having opposing conductive adhesive or gel layers. [Figure 15] A schematic cross-sectional view of an exemplary therapeutic assembly disclosed herein along the plane 2-2' of FIG. 1, according to various non-limiting embodiments. [Figure 16] A schematic cross-sectional view of an exemplary therapeutic assembly disclosed herein along the plane 2-2' of FIG. 1, according to various non-limiting embodiments. [Figure 17] A schematic cross-sectional view of an exemplary therapeutic assembly disclosed herein along the plane 2-2' of FIG. 1, according to various non-limiting embodiments. [Modes for carrying out the invention]

[0017] Various embodiments are described in detail below with reference to the attached drawings. Here, the same reference numerals represent the same elements.

[0018] This application describes an example of an exemplary electrode assembly that can be used, for example, to deliver a TT field to a subject's body and treat one or more cancers or tumors located in the subject's body.

[0019] The present invention can be more readily understood by referring to the following detailed description, examples, drawings, and claims, as well as the preceding and following descriptions thereof. However, it should be understood that the present invention is not limited to the specific apparatus, devices, systems, and / or methods disclosed unless otherwise specified, and is therefore necessarily subject to change.

[0020] The headings are provided for convenience only and should not be construed as limiting the invention. Embodiments shown under any heading or any part of this disclosure may be combined with embodiments shown under the same or other headings or parts of this disclosure.

[0021] Unless otherwise specified herein, or unless the context clearly contradicts it, all combinations of elements described herein, in all possible variations thereof, are incorporated into the present invention.

[0022] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include multiple referents unless the context clearly indicates otherwise. Therefore, the disclosure of a singular form of an element is intended to support not only embodiments in which only one such element is provided, but also embodiments in which multiple such elements are provided.

[0023] As used herein, the term “conductive adhesive or gel” should be understood to mean “conductive adhesive or conductive gel.” Furthermore, the term “conductive gel” should be understood to include hydrogels.

[0024] As used herein, the term “front” refers to the skin-facing side of the element, and “back” refers to the outward-facing side opposite the skin-facing side of the element.

[0025] Existing electrode assemblies for providing a TT field are constructed as a single unit, comprising one or more electrode elements and one skin contact layer. As described above, if the skin contact layer becomes contaminated or decomposes, the entire structure needs to be replaced. Disclosed herein is an electrode assembly (i.e., a two-part array including an electrode subassembly and a skin contact subassembly) that allows for the replacement of the skin contact layer and the reuse of subsequent electrode assemblies.

[0026] Figure 1 shows a schematic top view of an apparatus 10 for providing a TT field, showing two electrode elements 30 (however, the apparatus may have one, two, or three or more electrode elements 30). In some arbitrary embodiments, the apparatus 10 may include a plurality of electrode elements 30. In these embodiments, the electrode elements 30 may be wired together (for example, using wires or traces on a printed circuit board 94 which may optionally be a flex circuit, etc.). As further described herein, the apparatus 10 may have an operating conductive region. For example, as shown in Figure 1, the operating conductive region 90 may be defined by the outer periphery surrounding all electrodes of at least one electrode (e.g., the area footprint of at least one electrode element). Also, as described herein, in an alternative embodiment (e.g., Figure 2) in which the apparatus includes an anisotropic conductive material layer 70, the operating conductive region 90' may be defined by the outer periphery of the anisotropic material. Referring also to Figure 2, which shows a schematic cross-sectional view of the apparatus 10 along plane 2-2', the apparatus 10 may include an electrode subassembly 20, which includes at least one electrode element 30 having a skin-facing side 32 and a skin-facing surface 34. The electrode subassembly 20 may further include a polymer layer on the skin-facing side 32 of at least one electrode element 30, and the polymer layer is conductive, and even if the polymer itself is not conductive, it is referred to herein as a conductive polymer layer 40. The conductive polymer layer 40 may have a skin-facing surface 42 defining the skin-facing surface 22 of the electrode subassembly 20. In some embodiments, the conductive polymer layer 40 is a non-adhesive conductive polymer layer.

[0027] The apparatus 10 may further include a skin contact subassembly 50 detachably coupled to the electrode subassembly 20. The skin contact subassembly 50 may include a skin contact conductive adhesive or gel 52 configured to contact the subject's skin 300 (e.g., Figures 2 and 4). Generally, as used herein, the skin-facing side of the skin contact conductive adhesive or gel 52 defines the skin-facing side of the skin contact subassembly 50. The skin contact conductive adhesive or gel 52 may be electrically coupled to at least one electrode element 30 when the skin contact subassembly 50 is positioned against the skin-facing side of the conductive polymer layer 40 of the electrode subassembly 20. In any exemplary embodiment, as shown in Figures 3 and 5, the skin contact conductive adhesive or gel 52 may include a hydrogel 53. For example, Figure 3 shows an embodiment similar to (and using the same display scheme as) shown in Figure 2, where the skin contact conductive adhesive or gel is shown as a hydrogel 53.

[0028] In some embodiments, the conductive polymer layer 40 of the electrode subassembly 20 is a non-adhesive conductive polymer layer. In some embodiments, the conductive polymer layer 40 of the electrode subassembly 20 may include rubber or elastomer. In some exemplary embodiments, the conductive polymer layer 40 of the electrode subassembly 20 may include adhesive or sealant. In some embodiments, the conductive polymer layer of the electrode subassembly may include silicone polymer. In some embodiments, the conductive polymer layer of the electrode subassembly may include polydimethylsiloxane (PDMS). In various embodiments, the conductive polymer layer of the electrode subassembly may include, but is not limited to, one or more of the following: silicone rubber, silicone elastomer, natural rubber, polycis-isoprene, polyisobutylene, polychloroprene, cis-polybutadiene, styrene-butadiene polymer, styrene-acrylonitrile-butadiene polymer, polyurethane, ethylene propylene diene monomer (EPDM) polymer, acrylic ethylene copolymer (AEM) polymer, ethylene-vinyl acetate (EVA) polymer, fluoropolymer, and perfluoropolymer. In some embodiments, the conductive polymer layer 40 of the electrode subassembly 20 may contain polyetherimide, polyetherketone, polyethersulfone, polyetheretherketone, or polyaryletherketone.

[0029] In some embodiments, the conductive polymer layer 40 of the electrode subassembly 20 may include a composite material in which conductive particles are dispersed. For example, the conductive particles may include carbon. In exemplary embodiments, the conductive particles may include one or more of the following: graphite powder, carbon flakes, carbon fibers, carbon granules, carbon nanotubes, carbon nanowires, carbon black powder, or carbon microcoils. In some embodiments, the conductive particles may include metals. In exemplary embodiments, the composite material may include a polymer (e.g., a silicone polymer) in which conductive particles are dispersed. As used herein, the conductive species may, in some embodiments, optionally refer to a composite material comprising a species in which conductive particles are dispersed.

[0030] The conductive polymer layer 40 of the electrode subassembly 20 may have an outward-facing surface 44 that faces at least one electrode 30. The electrode subassembly 20 may further include an electrode subassembly conductive adhesive or gel layer 60 positioned against the outward-facing surface 44 of the conductive polymer layer 40.

[0031] In some exemplary embodiments, the electrode subassembly 20 may further include a dielectric layer 36 between at least one electrode element 30 and the conductive polymer layer 40 of the electrode subassembly 20. In exemplary embodiments where the electrode subassembly 20 includes an electrode subassembly conductive adhesive or gel layer 60, the dielectric layer 36 can be positioned between at least one electrode element 30 and the electrode subassembly conductive adhesive or gel layer 60. In some exemplary embodiments, the dielectric layer 36 can be positioned in front of the at least one electrode element 30, in contact with it.

[0032] In some embodiments, the dielectric layer 36 may include a ceramic. In some embodiments, the dielectric layer 36 may include a dielectric polymer. In exemplary embodiments, the dielectric layer 36 may have a dielectric constant greater than 10 or greater than 20. Although shown in the figure as separate discrete (discontinuous) layers on the surface of each electrode, in some embodiments, the dielectric layer 36 may be a single (continuous) layer covering multiple electrode elements or covering all of the electrode elements. In some embodiments, referring to Figure 10, the electrode subassembly 20 does not include the dielectric layer 36.

[0033] Optionally, in further embodiments, referring to Figure 9, the conductive adhesive 60 for the electrode subassembly can be omitted. For example, in some embodiments, the conductive polymer 40 (e.g., conductive silicone rubber) can be deposited (e.g., deposited from solution) directly onto the dielectric layer 36 (or directly onto electrode element(s) 30 where the dielectric layer is omitted), thereby establishing a stable interface between the conductive polymer 40 and the dielectric layer 36 or electrode element(s) 30 (e.g., an interface where the conductive polymer 40 covers the entire surface of the dielectric layer 36, is mechanically stable (not removable), and has low contact resistance) without requiring additional adhesive. Optionally, in these embodiments, the dielectric layer 36 is intended to include a ceramic material, as further disclosed herein.

[0034] In some embodiments, the apparatus 10 does not include (i.e., does not have) an additional adhesive (e.g., structural adhesive) between the skin contact subassembly 50 and the conductive polymer layer 40 of the electrode subassembly 20. For example, the conductive polymer layer 40 of the electrode subassembly 20 and the skin contact subassembly 50 can be removably bonded by physical non-chemical adhesion. The conductive polymer layer 40 of the electrode subassembly 20 and the skin contact subassembly 50 can be removably bonded by van der Waals forces. In some embodiments, weak van der Waals forces may be supplemented. For example, weak van der Waals forces may be supplemented by additional attractive forces around the periphery, such as the positioning of a fastener, such as one or more pairs of magnets (i.e., one of the pair on the electrode subassembly and the other of the pair on the skin contact subassembly), or a hook and / or loop fastener (i.e., one of the hook or loop material on the electrode subassembly and the other of the hook or loop material on the skin contact subassembly).

[0035] In some embodiments, the skin-facing surface 42 of the conductive polymer layer 40 of the electrode subassembly 20 can be smooth. In some arbitrary embodiments, the conductive polymer layer 40 of the electrode subassembly 20 is not tacky.

[0036] In some embodiments, as shown in Figures 2 to 10 and Figures 16 to 17, the skin contact subassembly 50 may optionally further include an anisotropic conductive material layer 70 having a skin-facing side 72 with a skin-facing surface 74 and an opposite outward-facing surface 76. The anisotropic conductive material layer 70 may be positioned in contact with the skin contact conductive adhesive or gel 52. At least one electrode element 30 may be in electrical contact with the outward-facing surface 76 of the anisotropic conductive material layer 70 when the electrode subassembly is in contact with the skin contact subassembly.

[0037] In some arbitrary embodiments, the skin-contact conductive adhesive or gel 52 may include a conductive adhesive composite (as further described herein). The conductive adhesive composite may include dispersed conductive particles. For example, the conductive particles may include carbon. In exemplary embodiments, the conductive particles may include one or more of graphite powder, carbon flakes, carbon fibers, carbon granules, carbon nanotubes, carbon nanowires, carbon black powder, or carbon microcoils. In some embodiments, the conductive particles may include metals.

[0038] In exemplary embodiments, as shown in Figures 2–10 and 16–17, the skin contact subassembly 50 may include a three-layer unit comprising a skin contact conductive adhesive or gel 52 (or hydrogel 53), an anisotropic conductive material layer 70 (further described herein), and a second conductive adhesive or gel layer 78. In some embodiments, the three-layer unit may further include edges that cover the peripheral edges of the three layers and optionally seal non-conductive boundaries, such as strips of tape that adhere to the top and bottom surfaces of the three-layer unit. The anisotropic conductive material layer 70 may have a skin-facing side 72 with a skin-facing surface 74 and an opposite outward-facing surface 76. The skin-facing side 74 of the anisotropic conductive material layer 70 may be in contact with the skin contact conductive adhesive or gel 52. Optionally, the skin contact conductive adhesive or gel 52 may include a hydrogel 53 (e.g., Figures 3 and 5). The outward-facing side 76 of the anisotropic conductive material layer 70 may be in contact with the second conductive adhesive or gel layer 78. In any further embodiment, the skin contact subassembly 50 may further include an additional skin-side conductive adhesive or gel between the anisotropic conductive material layer 70 and the skin-contact conductive adhesive or gel 52 (for example, optionally one of the layers may be a hydrogel 53). For example, the additional skin-side conductive adhesive or gel may be a conductive adhesive composite, and the skin-contact conductive adhesive or gel may be a hydrogel.

[0039] Referring to Figures 4-5 (also shown in Figures 6-8, 10, 15 and 17), the electrode subassembly 20 may include a three-layer unit comprising a first conductive adhesive or gel 130, an anisotropic conductive material layer 70, and an upper conductive adhesive or gel 140. The anisotropic conductive material layer 70 may have a skin-facing side 72 with a skin-facing surface 74 and an opposite outward-facing surface 76. The skin-facing surface 74 of the anisotropic conductive material layer 70 may be in contact with the first conductive adhesive or gel 130, and the outward-facing surface 76 of the anisotropic conductive material layer 70 may be in contact with the upper conductive adhesive or gel 140.

[0040] In some embodiments, each of the electrode subassembly 20 and the skin contact subassembly 50 may include an anisotropic conductive material layer 70 (see, for example, Figures 4-8, 10, and 17).

[0041] In some exemplary embodiments, referring to Figure 6, the conductive polymer layer 40 of the electrode subassembly 20 may include conductive silicone rubber 120 (e.g., silicone rubber with dispersed conductive particles), and the second conductive adhesive or gel layer 78 may include conductive acrylic adhesive 122 (e.g., acrylic adhesive with dispersed conductive particles). In other exemplary embodiments, referring to Figure 7, the conductive polymer layer 40 of the electrode subassembly 20 may include conductive acrylic AEM rubber 124, and the second conductive adhesive or gel layer 78 may include conductive silicone adhesive 126. In an additional exemplary embodiment, referring to Figure 8, the conductive polymer layer 40 of the electrode subassembly 20 may include conductive silicone adhesive 126, and the second conductive adhesive or gel layer 78 may include conductive acrylic adhesive 122, or vice versa.

[0042] In some embodiments, the skin-contact subassembly 50 may include an acrylic adhesive. For example, in some embodiments, the second conductive adhesive or gel layer 78 that contacts the conductive polymer layer 40 of the electrode subassembly 20 may include an acrylic adhesive. Furthermore, in some embodiments, the skin-contact conductive adhesive or gel 52 may include an acrylic adhesive.

[0043] A method of using the apparatus 10 may include the step of removing the skin contact subassembly 50 from the conductive polymer layer 40 of the electrode subassembly 20. For example, the removed skin contact subassembly 50 may be a used or otherwise soiled skin contact subassembly 50. The new skin contact subassembly 50 can be positioned relative to the conductive polymer layer 40 of the electrode subassembly 20 so that the new skin contact subassembly 50 is removably bonded to the electrode subassembly. In this way, the electrode subassembly 20 can be reused. Optionally, the conductive polymer layer 40 of the electrode subassembly 20 may be cleaned before positioning the new skin contact subassembly 50 relative to the conductive polymer layer 40 of the electrode subassembly 20.

[0044] In embodiments in which the skin contact subassembly 50 (or electrode subassembly 20) includes at least one alignment feature that provides indication of a desired position of the electrode subassembly 20 relative to the skin contact subassembly 50, the at least one alignment feature can be used to orient the electrode subassembly 20 relative to the skin contact subassembly 50. The alignment features are described further below with reference to Figures 11 to 13.

[0045] The first kit may include an electrode subassembly 20 comprising at least one electrode element 30 having a skin-facing side 32 and a skin-facing surface 34. A conductive polymer layer 40 may be positioned on the skin-facing side 32 of at least one electrode element 30. The conductive polymer layer 40 may have a skin-facing surface 42 defining the skin-facing surface 22 of the electrode subassembly 20. Optionally, the electrode subassembly 20 may include a three-layer unit comprising an anisotropic conductive material layer 70, as described herein. The kit may further include a plurality of skin-contact subassemblies 50. Each skin-contact subassembly 50 may include a skin-contact conductive adhesive or gel 52. The skin-contact conductive adhesive or gel 52 of each skin-contact subassembly 50 may be configured to contact the subject's skin 300. Any exposed adhesive or gel surfaces may be protected within the kit by covering the adhesive / gel surfaces with a release liner. For example, in some embodiments, one or both sides of the skin contact subassembly 50 may have a release liner, each of which may be removed when the adhesive / gel surface is ready for use (e.g., when the two subassemblies are combined or when the skin contact conductive adhesive or gel 52 is bonded to the subject's skin). When the skin contact subassembly 50 is positioned relative to the conductive polymer layer 40 of the electrode subassembly 20, the skin contact conductive adhesive or gel 52 can be configured to electrically bond to at least one electrode element 30, and the skin contact subassembly 50 can be configured to bond to the electrode subassembly as a removable unit.

[0046] In some embodiments, each skin-contact subassembly 50 of the first kit may include a three-layer unit comprising a skin-contact conductive adhesive or gel 52, an anisotropic conductive material layer 70, and a second conductive adhesive or gel layer 78. In some embodiments, the three-layer unit may further include edges that cover the peripheral edges of the three layers and optionally seal non-conductive boundaries, such as strips of tape that adhere to the top and bottom surfaces of the three-layer unit. The anisotropic conductive material layer 70 may have a skin-facing side 72 with a skin-facing surface 74 and an opposite outward-facing surface 76. The skin-facing side 74 of the anisotropic conductive material layer may be in contact with the skin-contact conductive adhesive or gel 52 (optionally, a hydrogel 53). The outward-facing surface 76 of the anisotropic conductive material layer 70 may be in contact with the second conductive adhesive or gel layer 78. In other respects, the components of the kit (e.g., electrode subassemblies 20 and skin-contact subassemblies 50), the structure of the components, and the method of using the components of the kit may be as described above.

[0047] Referring to Figure 14, in some embodiments, one or more of the electrode subassembly conductive adhesive or gel 60, the skin-contact conductive adhesive or gel 52, and the second conductive adhesive or gel 78 (e.g., Figure 2) may include a substrate layer 80, a skin-facing substrate-related conductive adhesive or gel layer 82, and an outward-facing substrate-related conductive adhesive or gel layer 84. In some embodiments, the substrate layer 80 may have a continuous, uninterrupted structure, and the substrate layer may be conductive. In other embodiments, the substrate layer 80 may have at least a partially open structure configured to allow contact between the adhesive layers 82, 84 from both sides of the substrate layer. In exemplary embodiments, the substrate 80 may include a mesh or scrim.

[0048] In some embodiments, the electrode subassembly may include a three-layer structure comprising a substrate layer 80, a skin-facing substrate-related conductive adhesive or gel layer 82, and an outward-facing substrate-related conductive adhesive or gel layer 84 (a double layer of conductive adhesive or gel separated by the substrate layer, as shown in Figure 14). In some embodiments, the skin-contact subassembly may include a three-layer structure comprising a substrate layer 80, a skin-facing substrate-related conductive adhesive or gel layer 82, and an outward-facing substrate-related conductive adhesive or gel layer 84 (a double layer of conductive adhesive or gel separated by the substrate layer, as shown in Figure 14).

[0049] In some embodiments, a double layer of conductive adhesive or gel separated by a substrate layer (e.g., a three-layer structure including a substrate layer 80, a skin-facing substrate-related conductive adhesive or gel layer 82, and an outward-facing substrate-related conductive adhesive or gel layer 84, as shown in Figure 14) can function as a skin-contact subassembly that can be removably bonded to an electrode subassembly. This same structure can also be used as a skin-contact subassembly in the kit described herein, and optionally, the exposed adhesive / gel surface(s) may be protected by a release liner(s). In each of these embodiments, either the skin-facing substrate-related conductive adhesive or gel layer 82 or the outward-facing substrate-related conductive adhesive or gel layer 84, or both, may be a conductive adhesive such as a conductive adhesive composite (as described herein). Furthermore, in each of these embodiments, the skin-facing substrate-related conductive adhesive or gel layer 82 or the outward-facing substrate-related conductive adhesive or gel layer 84, or both, may be a hydrogel.

[0050] In various embodiments, one or more of the electrode subassembly conductive adhesive or gel 60, the skin contact conductive adhesive or gel 52, the second conductive adhesive or gel 78, the skin-facing substrate-related conductive adhesive or gel layer 82, or the outward-facing substrate-related conductive adhesive or gel layer 84 may be a hydrogel. In various embodiments, one or more of the electrode subassembly conductive adhesive or gel 60, the skin contact conductive adhesive or gel 52, the second conductive adhesive or gel 78, the skin-facing substrate-related conductive adhesive or gel layer 82, or the outward-facing substrate-related conductive adhesive or gel layer 84 may be a conductive adhesive composite. The conductive adhesive composite may include a dielectric material and dispersed conductive particles. For example, the conductive particles may include carbon. In exemplary embodiments, the conductive particles may include one or more of graphite powder, carbon flakes, carbon fibers, carbon granules, carbon nanotubes, carbon nanowires, carbon black powder, or carbon microcoils. In some embodiments, the conductive particles may include metals. The dielectric material may be, for example, an acrylic polymer (e.g., acrylic adhesive). In some embodiments, the dielectric material may be, for example, a silicone polymer (e.g., a silicone adhesive).

[0051] In exemplary embodiments, the electrode subassembly conductive adhesive or gel 60 and the conductive polymer layer 40 can cooperate to have a thickness of about 40 μm to about 2000 μm, for example, about 300 μm to about 700 μm. In exemplary embodiments, the skin contact subassembly 50 can have a thickness of about 100 μm to about 400 μm, for example, 200 μm to 250 μm.

[0052] Referring to Figure 15, in another embodiment, the device 10' may include an electrode subassembly 20' comprising at least one electrode element 30 having a skin-facing side 32 and a skin-facing surface 34. The electrode subassembly 20' may further include a first conductive adhesive or gel 130 on the skin-facing side of at least one electrode element 30. The first conductive adhesive or gel 130 may have a skin-facing surface 132 defining the skin-facing surface 22' of the electrode subassembly 20'. The device 10' may further include a skin-contact subassembly 50' removably bonded to the electrode subassembly 20'. The skin-contact subassembly 50' may include a conductive polymer layer 40 configured to removably bond to the skin-facing surface 22' of the electrode subassembly 20'. The skin-contact subassembly 50' may further include a skin-contact conductive adhesive or gel 52 configured to contact the subject's skin 300. The skin-contact conductive adhesive or gel 52 can be electrically coupled to at least one electrode element 30 when the conductive polymer layer 40 of the skin-contact subassembly 50' is positioned against the skin-facing surface 22' of the electrode subassembly 20'.

[0053] In some embodiments, the conductive polymer layer 40 of the skin contact subassembly 50' can be a non-adhesive conductive polymer layer. In some embodiments, the conductive polymer layer 40 of the skin contact subassembly 50' can include rubber or elastomer. In some embodiments, the conductive polymer layer 40 of the skin contact subassembly 50' can include adhesive or sealant. In some embodiments, the conductive polymer layer 40 of the skin contact subassembly 50' can include silicone polymer. In some embodiments, the conductive polymer layer of the skin contact subassembly can include polydimethylsiloxane (PDMS). In some embodiments, the conductive polymer layer 40 of the skin contact subassembly 50' can include, but is not limited to, one or more of the following: silicone rubber, silicone elastomer, natural rubber, polycis-isoprene, polyisobutylene, polychloroprene, cis-polybutadiene, styrene-butadiene polymer, styrene-acrylonitrile-butadiene polymer, polyurethane, EPDM polymer, AEM polymer, EVA polymer, fluoropolymer, and perfluoropolymer. In some embodiments, the conductive polymer layer 40 of the skin contact subassembly 50' may contain polyetherimide, polyetherketone, polyethersulfone, polyetheretherketone, or polyaryletherketone.

[0054] In some embodiments, the conductive polymer layer 40 of the skin contact subassembly 50' may include a composite material in which conductive particles are dispersed. For example, the conductive particles may include carbon. In exemplary embodiments, the conductive particles may include one or more of graphite powder, carbon flakes, carbon fibers, carbon granules, carbon nanotubes, carbon nanowires, carbon black powder, or carbon microcoils. In some embodiments, the conductive particles may include metals.

[0055] In some embodiments, the electrode subassembly 20' may further include a dielectric layer 36 between at least one electrode element 30 and the conductive polymer layer 40 of the skin contact subassembly 50'. The dielectric layer 36 of the electrode subassembly 20' can be positioned between at least one electrode element 30 and the first conductive adhesive 130. For example, the dielectric layer 36 of the electrode subassembly 20' can be positioned between at least one electrode element 30 and the upper conductive adhesive layer 140.

[0056] In some embodiments, the dielectric layer 36 may include a ceramic or a dielectric polymer. In embodiments where the dielectric layer 36 includes a dielectric polymer, the dielectric polymer has a dielectric constant greater than 10 or greater than 20. In some embodiments, the electrode subassembly 20' does not include the dielectric layer 36.

[0057] In some embodiments, the apparatus 10' does not include any additional adhesive (e.g., structural adhesive) between the skin contact subassembly 50' and the first conductive adhesive or gel 130 of the electrode subassembly 20'. The first conductive adhesive or gel 130 of the electrode subassembly 20' and the skin contact subassembly 50' can be removably bonded by physical non-chemical adhesion. For example, the first conductive adhesive or gel 130 of the electrode subassembly 20' and the skin contact subassembly 50' can be removably bonded by van der Waals forces (e.g., weak van der Waals forces). In some embodiments, weak van der Waals forces may be supplemented, as further described herein.

[0058] In some embodiments, the outward-facing surface 46 of the conductive polymer layer 40 of the skin-contact subassembly 50' can be smooth.

[0059] In exemplary embodiments, the conductive polymer layer 40 of the skin contact subassembly 50' is not tacky.

[0060] In some embodiments, the skin-contact subassembly 50' may include an acrylic adhesive. For example, the skin-contact conductive adhesive or gel 52 may include an acrylic adhesive.

[0061] In some embodiments, the electrode subassembly 20' may further include an anisotropic conductive material layer 70 having a skin-facing side 72 with a skin-facing surface 74 and an opposite outward-facing surface 76. The anisotropic conductive material layer 70 may be positioned in contact with the first conductive adhesive or gel 130.

[0062] In some arbitrary embodiments, the electrode subassembly 20' may include a three-layer unit comprising a first conductive adhesive or gel 130, an anisotropic conductive material layer 70, and an upper conductive adhesive or gel 140. The anisotropic conductive material layer 70 may have a skin-facing side 72 with a skin-facing surface 74 and an opposite outward-facing surface 76. The skin-facing surface 74 of the anisotropic conductive material layer 70 may be in contact with the first conductive adhesive or gel 130, and the outward-facing surface 76 of the anisotropic conductive material layer 70 may be in contact with the upper conductive adhesive or gel 140.

[0063] In other embodiments, referring to Figure 16, the electrode subassembly 20' does not include the anisotropic conductive material layer 70. In such cases, the skin-facing surface 22' of the electrode subassembly 20' can be provided by the electrode subassembly conductive adhesive 60. In other respects, the electrode subassembly 20' of Figure 16 may be similar to that described for the electrode subassembly 20' of Figure 15.

[0064] Referring to Figures 16-17 (and following the labeling scheme described above), in some embodiments, the skin contact subassembly 50' may include an anisotropic conductive material layer 70. For example, the skin contact subassembly 50' may include a second conductive adhesive layer 78 between the anisotropic conductive material layer 70 and the conductive polymer layer 40. The skin contact subassembly 50' may further include a skin contact conductive adhesive or gel 52 on the skin side of the anisotropic conductive material layer 70 opposite the second conductive adhesive layer 78. Optionally, the skin contact conductive adhesive or gel 52 may include a hydrogel 53 (see, for example, Figures 16-17). In further embodiments, the skin contact subassembly 50' may further include a skin-side conductive adhesive or gel between the anisotropic conductive material layer 70 and the skin contact conductive adhesive or gel 52 (for example, optionally, a hydrogel 53). For example, the additional skin-side conductive adhesive or gel may be a conductive adhesive composite, and the skin contact conductive adhesive or gel may be a hydrogel. In other embodiments, as shown in Figures 16-17, the skin-side conductive adhesive or gel can be omitted.

[0065] In some embodiments, as shown in Figure 17, each of the electrode subassemblies 20' and the skin contact subassemblies 50' may include an anisotropic conductive material layer 70. In other embodiments, referring to Figure 16, the anisotropic conductive material layer 70 may be provided only within the skin contact subassembly 50. In other respects, the structures shown in Figures 16 and 17 may be similar to those described in the embodiments of Figure 15 (and follow the same labeling scheme).

[0066] A method of using the apparatus 10' may include the step of removing the skin contact subassembly 50' from the first conductive adhesive or gel 130 (Figures 15 and 17) of the electrode subassembly 20' or the electrode subassembly conductive adhesive 60 (Figure 16) of the electrode subassembly 20'. The new skin contact subassembly 50' can be positioned relative to the first conductive adhesive or gel 130 (Figures 15 and 17) or the electrode subassembly conductive adhesive 60 (Figure 16) of the electrode subassembly 20' so that the new skin contact subassembly 50' is removably bonded to the electrode subassembly 20'. The first conductive adhesive or gel 130 (or electrode subassembly conductive adhesive 60) of the electrode subassembly 20' can be cleaned before positioning the new skin contact subassembly 50' relative to the first conductive adhesive or gel 130 (or electrode subassembly conductive adhesive 60) of the electrode subassembly 20'.

[0067] In embodiments where the skin contact subassembly 50' (or electrode subassembly 20') includes at least one alignment feature that provides indication of a desired position of the electrode subassembly relative to the skin contact subassembly, the at least one alignment feature can be used to orient the electrode subassembly relative to the skin contact subassembly (see Figures 11–13).

[0068] The second kit may include an electrode subassembly 20' comprising at least one electrode element 30 having a skin-facing side 32 and a skin-facing surface 34. The electrode subassembly 20' may further include a first conductive adhesive or gel 130 (Figures 15 and 17) or an electrode subassembly conductive adhesive 60 (Figure 16) on the skin-facing side of at least one electrode element 30. The first conductive adhesive or gel 130' may have a skin-facing surface (e.g., surface 132 in Figures 15 and 17, or surface 22' in Figure 16) that defines the skin-facing surface 22' of the electrode subassembly 20'.

[0069] A second kit may further include a plurality of skin-contact subassemblies 50', each skin-contact subassembly comprising a conductive polymer layer 40 configured to be placed on the skin-facing surface 22' of an electrode subassembly 20', and a skin-contact conductive adhesive or gel 52 (optionally, a hydrogel 53). The skin-contact conductive adhesive or gel 52 of each skin-contact subassembly 50' can be configured to contact the subject's skin 300. Optionally, the skin-contact subassembly 50' may include a three-layer unit comprising an anisotropic conductive material layer 70 as described herein. As described above, any exposed adhesive or gel surface may be protected within the kit by covering the adhesive / gel surface with a release liner. The release liner(s) may be removed when the adhesive / gel surface is ready for use (e.g., when two subassemblies are combined or when the skin-contact conductive adhesive or gel is bonded to the subject's skin). When the skin contact subassembly 50' is positioned against the skin-facing surface 22' of the electrode subassembly 20', the skin contact conductive adhesive or gel 52 can be configured to electrically bond to at least one electrode element 30, and the skin contact subassembly 50' is configured to bond to the electrode subassembly 20' as a removable unit.

[0070] In some embodiments, the electrode subassembly 20' may include a three-layer unit comprising a first conductive adhesive or gel 130, an anisotropic conductive material layer 70, and a top conductive adhesive or gel 140. The anisotropic conductive material layer 70 may have a skin-facing side 72 with a skin-facing surface 74 and an opposite outward-facing surface 76. The skin-facing surface 74 of the anisotropic conductive material layer 70 may be in contact with the first conductive adhesive or gel 130, and the outward-facing surface 76 of the anisotropic conductive material layer 70 may be in contact with the top conductive adhesive or gel 140. In other respects, the components of the kit (e.g., the electrode subassembly and the skin-contact subassembly), the structure of the components, and the method of using the components of the kit may be as described above.

[0071] Exemplary embodiments of the disclosed apparatus, kits, and methods As described above with respect to the embodiment in Figure 2, any of the conductive adhesive or gel components of the embodiments in Figures 2 to 10 or Figures 15 to 17 may also exist as a three-layer structure in Figure 14 and be configured in the same manner as described above with respect to Figure 14. That is, any layer of the conductive adhesive or gel described herein (including adhesive layers 52, 60, 78, 130 and 140) may be in the form of a double layer of conductive adhesive or gel separated by a substrate layer as described above, and the double layer of conductive adhesive or gel may be the same conductive adhesive or gel on both sides of the substrate or different conductive adhesives or gels. For example, referring to Figures 14 and 15, in some embodiments, one or more of the skin-contact conductive adhesive or gel 52, the first conductive adhesive or gel 130, or the upper conductive adhesive or gel 140 may include a substrate layer 80, a skin-facing substrate-related conductive adhesive or gel layer 82, and an outward-facing substrate-related conductive adhesive or gel layer 84. In some embodiments, the substrate layer 80 may have a continuous, uninterrupted structure, and the substrate layer may be conductive. In other embodiments, the substrate layer 80 may have at least a partially open structure configured to allow contact between the adhesive layers 82, 84 from both sides of the substrate layer. In exemplary embodiments, the substrate 80 may include a mesh or scrim.

[0072] In various embodiments, including those in Figures 2 to 10 and Figures 14 to 17, one or more of the electrode subassembly conductive adhesive or gel 60, the second conductive adhesive or gel 78, the skin contact conductive adhesive or gel 52, the skin-facing substrate-related conductive adhesive or gel layer 82, or the outward-facing substrate-related conductive adhesive or gel layer 84 can be hydrogels. Similarly, the first conductive adhesive or gel 130 and / or the top conductive adhesive or gel layer 140 can be hydrogels. In various embodiments, including those in Figures 2 to 10 and Figures 14 to 17, one or more of the electrode subassembly conductive adhesive or gel 60, the second conductive adhesive or gel 78, the skin contact conductive adhesive or gel 52, the skin-facing substrate-related conductive adhesive or gel layer 82, or the outward-facing substrate-related conductive adhesive or gel layer 84 can be conductive adhesive composites. Similarly, the first conductive adhesive or gel 130 and / or the top conductive adhesive or gel layer 140 can be conductive adhesive composites. A conductive adhesive composite may include a dielectric material and dispersed conductive particles. For example, the conductive particles may include carbon. In exemplary embodiments, the conductive particles may include one or more of graphite powder, carbon flakes, carbon fibers, carbon granules, carbon nanotubes, carbon nanowires, carbon black powder, or carbon microcoils. In some embodiments, the conductive particles may include metals. The dielectric material may be, for example, an acrylic polymer (e.g., an acrylic adhesive). In some embodiments, the dielectric material may be, for example, a silicone polymer (e.g., a silicone adhesive).

[0073] In various embodiments, as further described herein, the conductive adhesives disclosed herein may include conductive adhesive composites, hydrogels, or other suitable conductive materials. For example, in some embodiments, one or more of the conductive adhesives 52, 60, 78, 82, 84, 130, and 140 may include hydrogels.

[0074] Furthermore, as described above, it is intended that one or more of the conductive adhesive layers 52, 60, 78, 82, 84, 130, and 140 disclosed herein may include a conductive adhesive composite (as further described below) rather than a hydrogel. In exemplary embodiments, the conductive adhesive composite may include a dielectric material and conductive particles dispersed within the dielectric material. In some embodiments, at least a portion of the conductive particles may define conductive paths through the thickness of the conductive adhesive composite. In some embodiments, it is intended that the conductive particles are positioned in response to the application of an electric field so that they undergo electrophoresis. In some embodiments, the dielectric material of the conductive adhesive composite is a polymer adhesive. Optionally, in these embodiments, the polymer adhesive may be an acrylic adhesive. In some embodiments, the conductive particles may include carbon. Optionally, in these embodiments, the conductive particles may include graphite powder. Additionally or alternatively, the conductive particles may include carbon flakes. Furthermore, or instead, the conductive particles may include carbon granules. Furthermore, or instead, the conductive particles may include carbon nanotubes. Additionally or alternatively, the conductive particles may include carbon black powder. Alternatively or additionally, the conductive particles may include carbon microcoils. In further embodiments, the conductive adhesive composite further comprises a polar material (e.g., a polar salt). Examples of polar salts include quaternary ammonium salts such as tetraalkylammonium salts. Exemplary conductive adhesive composites, as well as methods for producing such conductive adhesive composites, are disclosed in Patent Documents 1 and 2, which are incorporated herein by reference for all purposes. Conductive adhesive composites include, for example, Flexcon (登録商標) OMNI-WAVE (manufactured and sold by Spencer, Massachusetts, USA) (商標)The conductive adhesive composite may be a dry carbon / salt adhesive such as an adhesive composition, or ARcare® 8006 conductive adhesive composition manufactured and sold by Adhesives Research, Inc. (Glenrock, Pennsylvania, USA). In a further exemplary embodiment, the conductive adhesive composite may be, for example, conductive adhesive transfer tape 9712 or conductive adhesive transfer tape 9713 (both from 3M). (商標)It is intended that the conductive adhesive layer may include the use of (by removing the transfer film layer) etc. (manufactured by St. Paul, MN, USA). As an example, the three-layer skin-contact subassembly 50 shown in Figure 2 may include an anisotropic material layer 70 (as described above, for example, a sheet of pyrolytic graphite) sandwiched between two layers of conductive adhesive composites which may be the same or different. For example, one layer of the conductive adhesive composite may contain an acrylic adhesive, the other layer of the conductive adhesive composite may contain a silicone adhesive, or both layers may contain an acrylic adhesive, or both layers may contain a silicone adhesive. For example, the skin-contact conductive adhesive or gel 52 may be an acrylic adhesive filled with carbon fibers, the second conductive adhesive layer 78 may be an acrylic adhesive filled with carbon powder, or vice versa, or both acrylic adhesives may utilize the same type of filler particles. In any case, the two acrylic adhesives may be the same or different. Alternatively, in some embodiments, the skin-contact conductive adhesive or gel 52 may be a silicone adhesive filled with carbon fibers, and the second conductive adhesive layer 78 may be a silicone adhesive filled with carbon powder, or vice versa, or both silicone adhesives may utilize the same type of filler particles. In any case, the two silicone adhesives may be the same or different. Furthermore, in some embodiments, one adhesive layer may be an acrylic adhesive and the other a silicone adhesive (or vice versa), and each adhesive may (individually) have conductive particles (e.g., either carbon fibers or carbon powder as conductive fillers) which may be the same or different in the two adhesives. Further options may be considered for using other adhesive compositions and other conductive particle fillers. In other embodiments using a three-layer unit including an anisotropic material layer 70 sandwiched between two layers of conductive adhesive in either the skin-contact subassemblies 50, 50' or the electrode subassemblies 20, 20', the same options for the conductive adhesive layer exist.

[0075] In some embodiments, either or both of the electrode subassemblies (20, 20') or the skin contact subassemblies (50, 50') may include an anisotropic conductive material layer 70. In some embodiments, the anisotropic conductive material layer 70 may be or include synthetic graphite. In additional embodiments, the anisotropic conductive material layer 70 may be or include a layer of pyrolysis graphite, graphitized polymer film, or graphite foil made from compressed high-purity exfoliated mineral graphite. In other embodiments, other anisotropic materials may be suitable as the anisotropic conductive material layer 70.

[0076] The anisotropic conductive material layer 70 may have a first thermal conductivity in the direction perpendicular to the skin-facing surface. In some arbitrary embodiments, the thermal conductivity of the sheet in the direction parallel to the skin-facing surface can be more than twice as great as the first thermal conductivity. For example, the thermal conductivity of the sheet in the direction parallel to the skin-facing surface may be 1.5 times, 2 times, 3 times, 5 times, 10 times, 20 times, 30 times, 100 times, 200 times, or even more than 1,000 times greater than the first thermal conductivity. In some embodiments, the thermal conductivity of the anisotropic material sheet in the direction parallel to the skin-facing surface is 1.5 to 1,000 times greater than the first thermal conductivity, for example, 5 to 30 times greater. The anisotropic conductive material layer 70 may further have a first resistance in the direction perpendicular to the skin-facing surface. In some arbitrary embodiments, the resistance of the sheet in the direction parallel to the skin-facing surface can be less than half of the first resistance. For example, the resistance of sheet 70 in the direction parallel to the skin-facing surface may be 75%, 75%, 50%, 40%, 30%, 20%, 10%, 5%, 1%, 0.5%, 0.1%, or even less than 0.05% of the first resistance. In some embodiments, the resistance of the anisotropic material sheet in the direction parallel to the skin-facing surface is 0.05% to 75% of the first resistance, for example, 0.05% to 10% of the first resistance. In some embodiments, either or both of the electrode subassemblies (20, 20') or the skin contact subassemblies (50, 50') do not include the anisotropic conductive material layer 70.

[0077] The electrode subassembly 20 or 20' may have an operating conductive region. For example, in embodiments where the electrode subassembly 20 (or 20') does not include an anisotropic conductive material layer 70, as shown in Figure 1, the operating conductive region 90 may be defined by the outer circumference surrounding all electrodes of at least one electrode (e.g., the area footprint of at least one electrode element). In embodiments where the electrode subassembly 20 (or 20') includes an anisotropic conductive material layer 70, the operating conductive region 90' may be defined by the outer circumference of the anisotropic material. In some embodiments, the skin contact subassembly 50 may cover the entire operating conductive region (90 or 90'). In further embodiments, the skin contact subassembly 50 may extend beyond the operating conductive region (90 or 90'). For example, the skin contact subassembly 50 may extend beyond the operating conductive region (90 or 90') by at least 1 mm, or at least 2 mm, or at least 5 mm, or at least 10 mm or more. In a further embodiment, the skin contact subassembly 50 can be fitted into the operating conductive region (90 or 90').

[0078] Referring to Figures 11 to 13, the skin contact subassemblies 50, 50' may include at least one alignment feature 100 that provides indication of the desired position of the electrode subassemblies 20, 20' relative to the skin contact subassemblies 50, 50', so that the electrode subassemblies 20, 20' are positioned within the outer periphery of the skin contact subassemblies 50, 50' (conversely, the skin contact subassemblies 50, 50' cover the entire operating conductive area 90 or 90' (shown in Figure 1)). For example, as shown in Figure 11, the alignment feature 100 on the skin contact subassemblies 50, 50' may include the contour of at least a portion of the area around the electrode subassemblies 20, 20'. In other embodiments, referring to Figure 12, the electrode subassemblies 20, 20' may define at least one opening 102 through which they pass. The alignment feature 100 may be an opening 102, and the skin contact subassemblies 50, 50' may include corresponding markings 104 on the skin contact subassemblies 50, 50' that are visible through each opening 102 of at least one opening through the electrode subassemblies 20, 20' when the electrode subassemblies are in a desired position relative to the skin contact subassemblies.

[0079] In further embodiments, the skin contact subassemblies 50, 50' may have a larger footprint than the electrode subassemblies 20, 20' such that the entire electrode subassembly covers the skin contact subassembly within the footprint of the skin contact subassembly (for example, so that part or all of the outer circumference of the skin contact subassembly extends outward beyond the outer circumference of the electrode subassembly). Such an arrangement facilitates the attachment and detachment of the skin contact subassemblies 50, 50' and the electrode subassemblies 20, 20' and is intended to allow the outer circumference of the skin contact subassembly to be visible around the edges of the electrode subassemblies. In embodiments including an anisotropic conductive material layer within the skin contact subassembly, the larger area footprint of the skin contact subassembly also allows for the lateral diffusion of heat and current over a larger area of ​​skin, thereby helping to avoid the formation of hot spots under the electrodes. However, in other embodiments, the electrode subassemblies 20, 20' may have a larger footprint than the skin contact subassemblies 50, 50' such that the entire skin contact subassembly is within the footprint of the electrode subassembly. In other embodiments, the electrode subassemblies 20, 20' and the skin contact subassemblies 50, 50' may have the same or substantially the same footprint.

[0080] In some embodiments, referring to Figure 13, the skin contact subassemblies 50, 50' may define at least one opening 112 through them. The alignment feature 100 may include at least one opening. The electrode subassemblies 20, 20' may include corresponding markings 114 visible through each of the at least one opening 112 through the skin contact subassemblies 50, 50' when the skin contact subassemblies are in a desired position relative to the electrode subassemblies 20, 20'.

[0081] In some arbitrary embodiments, the devices 10, 10' may include multiple electrode elements 30. In these embodiments, the electrode elements 30 may be wired together (for example, using wires or traces on a printed circuit board 94 which can optionally be a flexible circuit). Optionally, the electrodes may be held in place using cover tape or bandages on the electrode subassemblies. In other embodiments, the devices 10, 10' may have only one single electrode element; that is, the devices 10, 10' have only one electrode.

[0082] In some embodiments, the periphery of either or both of the electrode subassemblies 20, 20' or the skin contact subassemblies 50, 50' may optionally include additionally fixed reversible fasteners such as hook-and-loop fastener materials, snap fasteners such as fastener materials based on a flexible projection body and a widened (e.g., mushroom-shaped) head designed to interlock with a similar opposite fastener material of a similar shape (e.g., mushroom-shaped), or magnets, any of which can help support the adjacency of the electrode subassemblies 20, 20' and the skin contact subassemblies 50, 50'. An example of hook-and-loop material is Velcro® fastener (Velcro USA, Inc., Manchester, NH, USA), and an example of fasteners based on an interlocking mushroom head is DUAL-LOCK® re-closable fastener (3M®, St. Paul, MN, USA). Alternatively, the area around either or both of the electrode subassemblies 20, 20' or the skin contact subassemblies 50, 50' may additionally include adhesive or adhesive tape, or one or more buttons and associated buttonholes, or a zipper mechanism.

[0083] Exemplary aspects More specifically described embodiments of the present invention will be described below in view of the products, systems, methods and their variations. However, these particularly enumerated embodiments should not be construed as having any limiting effect on different claims, including different or more general teachings set forth herein, nor should it be construed as limiting in any way other than the inherent meaning of the language in which they are literally used.

[0084] Embodiment 1: An electrode assembly, At least one electrode element having a skin-facing side and a skin-facing surface, An electrode subassembly comprising: a conductive polymer layer on the skin-facing side of at least one electrode element, wherein the conductive polymer layer has a skin-facing surface defining the skin-facing surface of the electrode subassembly; A device comprising a skin contact subassembly detachably coupled to the electrode subassembly, the skin contact subassembly comprising a skin contact conductive adhesive or gel configured to contact the skin of a subject, wherein the skin contact conductive adhesive or gel is electrically coupled to the at least one electrode element when the skin contact subassembly is positioned relative to the skin-facing surface of the conductive polymer layer of the electrode subassembly.

[0085] Embodiment 2: The apparatus according to Embodiment 1, wherein the conductive polymer layer of the electrode subassembly comprises rubber or elastomer.

[0086] Embodiment 3: The apparatus according to Embodiment 1, wherein the conductive polymer layer of the electrode subassembly comprises an adhesive or sealant.

[0087] Embodiment 4: The apparatus according to any one of Embodiments 1 to 3, wherein the conductive polymer layer of the electrode subassembly comprises a silicone polymer.

[0088] Embodiment 5: The apparatus according to Embodiment 1, wherein the conductive polymer layer of the electrode subassembly is silicone rubber, silicone elastomer, natural rubber, polycis-isoprene, polyisobutylene, polychloroprene, cis-polybutadiene, styrene-butadiene, styrene-acrylonitrile-butadiene, polyurethane, EPDM, EVA polymer, AEM polymer, fluoropolymer, or perfluoropolymer, or a combination thereof, or comprising thereof.

[0089] Embodiment 6: The apparatus according to any one of Embodiments 1 to 5, wherein the conductive polymer layer of the electrode subassembly comprises a composite material in which conductive particles are dispersed.

[0090] Embodiment 7: The apparatus according to Embodiment 6, wherein the conductive particles contain carbon.

[0091] Embodiment 8: The apparatus according to Embodiment 7, wherein the conductive particles include one or more of graphite powder, carbon flakes, carbon fibers, carbon granules, carbon nanotubes, carbon nanowires, carbon black powder, or carbon microcoils.

[0092] Embodiment 9: The apparatus according to Embodiment 6, wherein the conductive particles include a metal.

[0093] Embodiment 10: The apparatus according to any one of Embodiments 1 to 9, wherein the conductive polymer layer of the electrode subassembly has an outward-facing surface facing the at least one electrode element, and the electrode subassembly further comprises an electrode subassembly conductive adhesive or gel layer positioned relative to the outward-facing surface of the conductive polymer layer.

[0094] Embodiment 11: The apparatus according to any one of Embodiments 1 to 10, wherein the electrode subassembly further includes a dielectric layer between the at least one electrode element of the electrode subassembly and the conductive polymer layer.

[0095] Embodiment 12: The apparatus according to any one of Embodiments 1 to 11, wherein the electrode subassembly further includes a dielectric layer between the at least one electrode element and the conductive adhesive or gel layer of the electrode subassembly.

[0096] Embodiment 13: The apparatus according to Embodiment 11 or Embodiment 12, wherein the dielectric layer comprises a ceramic or dielectric polymer.

[0097] Embodiment 14: The apparatus according to Embodiment 13, wherein the dielectric layer comprises a dielectric polymer, and the dielectric polymer has a dielectric constant greater than 10.

[0098] Embodiment 15: The apparatus according to any one of Embodiments 1 to 14, wherein the apparatus does not include an additional adhesive between the skin contact subassembly and the conductive polymer layer of the electrode subassembly.

[0099] Embodiment 16: The apparatus according to any one of Embodiments 1 to 15, wherein the conductive polymer layer of the electrode subassembly and the skin contact subassembly are removably bonded by physical non-chemical adhesion.

[0100] Embodiment 17: The apparatus according to any one of Embodiments 1 to 16, wherein the conductive polymer layer of the electrode subassembly and the skin contact subassembly are removably bonded by van der Waals forces.

[0101] Embodiment 18: The apparatus according to any one of Embodiments 1 to 17, wherein the skin-facing surface of the conductive polymer layer of the electrode subassembly is smooth.

[0102] Embodiment 19: The apparatus according to any one of Embodiments 1 to 18, wherein the conductive polymer layer of the electrode subassembly is not adhesive.

[0103] Embodiment 20: The apparatus according to any one of Embodiments 1 to 19, wherein the skin contact subassembly further comprises an anisotropic conductive material layer.

[0104] Embodiment 21: The apparatus according to any one of Embodiments 1 to 20, wherein the skin contact subassembly further comprises an anisotropic conductive material layer having a skin-facing side with a skin-facing surface and an outward-facing side opposite to the skin-facing side, the anisotropic conductive material layer being disposed in contact with the skin contact conductive adhesive or gel, and the at least one electrode element electrically contacts the outward-facing surface of the anisotropic conductive material layer when the electrode subassembly is in contact with the skin contact subassembly.

[0105] Embodiment 22: The apparatus according to any one of Embodiments 1 to 21, wherein the skin-contact conductive adhesive or gel comprises a conductive adhesive composite.

[0106] Embodiment 23: The apparatus according to Embodiment 22, wherein the conductive adhesive composite comprises dispersed conductive particles.

[0107] Embodiment 24: The apparatus according to Embodiment 23, wherein the conductive particles contain carbon.

[0108] Embodiment 25: The apparatus according to Embodiment 24, wherein the conductive particles include one or more of graphite powder, carbon flakes, carbon fibers, carbon granules, carbon nanotubes, carbon nanowires, carbon black powder, or carbon microcoils.

[0109] Embodiment 26: The apparatus according to Embodiment 23, wherein the conductive particles include a metal.

[0110] Embodiment 27: The apparatus according to any one of Embodiments 1 to 26, wherein the skin contact subassembly further comprises an anisotropic conductive material layer.

[0111] Embodiment 28: The apparatus according to any one of Embodiments 1 to 27, wherein the skin contact subassembly comprises a three-layer unit including the skin contact conductive adhesive or gel, an anisotropic conductive material layer, and a second conductive adhesive or gel layer, the anisotropic conductive material layer having a skin-facing side with a skin-facing surface and an outward-facing side opposite to the skin-facing surface of the anisotropic conductive material layer in contact with the skin contact conductive adhesive or gel, and the outward-facing surface of the anisotropic conductive material layer in contact with the second conductive adhesive or gel layer.

[0112] Embodiment 29: One or both of the skin-contact conductive adhesive or gel and the second conductive adhesive or gel layer are, The substrate layer, Conductive adhesive or gel layer related to skin-facing substrates, The apparatus according to embodiment 28, comprising a conductive adhesive or gel layer related to an outward-facing substrate.

[0113] Embodiment 30: The apparatus according to Embodiment 29, wherein the substrate layer has a continuous and uninterrupted structure, and the substrate layer is conductive.

[0114] Embodiment 31: The apparatus according to Embodiment 29, wherein the substrate layer has at least a partially open structure configured to allow contact of the adhesive layer from both sides of the substrate layer.

[0115] Embodiment 32: The apparatus according to Embodiment 31, wherein the substrate includes a mesh or scrim.

[0116] Embodiment 33: The apparatus according to Embodiment 29, wherein one or more of the second conductive adhesive or gel, the conductive adhesive or gel layer related to the skin-facing substrate, or the conductive adhesive or gel layer related to the outward-facing substrate is a conductive adhesive composite.

[0117] Embodiment 34: The apparatus according to Embodiment 33, wherein the conductive adhesive composite comprises dispersed conductive particles.

[0118] Embodiment 35: The apparatus according to Embodiment 34, wherein the conductive particles contain carbon.

[0119] Embodiment 36: The apparatus according to Embodiment 35, wherein the conductive particles include one or more of graphite powder, carbon flakes, carbon fibers, carbon granules, carbon nanotubes, carbon nanowires, carbon black powder, or carbon microcoils.

[0120] Embodiment 37: The apparatus according to Embodiment 34, wherein the conductive particles include a metal.

[0121] Embodiment 38: The apparatus according to any one of Embodiments 1 to 37, wherein the skin contact subassembly includes an acrylic adhesive.

[0122] Embodiment 39: The apparatus according to Embodiments 20, 21, 27, or 28, wherein the anisotropic conductive material layer is or contains synthetic graphite.

[0123] Embodiment 40: The apparatus according to Embodiment 21 or Embodiment 28, wherein the anisotropic conductive material layer is a layer of pyrolysis graphite, graphitized polymer film, or graphite foil made from compressed high-purity exfoliated mineral graphite, or includes the same.

[0124] Embodiment 41: The apparatus according to Embodiment 21 or Embodiment 28, wherein the anisotropic conductive material layer has a first thermal conductivity in a direction perpendicular to the skin-facing surface, and the thermal conductivity of the sheet in a direction parallel to the skin-facing surface is more than twice as great as the first thermal conductivity.

[0125] Embodiment 42: The apparatus according to Embodiment 21 or Embodiment 28, wherein the anisotropic conductive material layer has a first resistance in a direction perpendicular to the skin-facing surface, and the resistance of the sheet in a direction parallel to the skin-facing surface is less than half of the first resistance.

[0126] Embodiment 43: The apparatus according to any one of Embodiments 1 to 42, wherein the electrode subassembly has an operating conductive region, and the skin contact subassembly has an area footprint that covers the entire operating conductive region.

[0127] Embodiment 44: The apparatus according to any one of Embodiments 1 to 43, wherein the electrode subassembly has a working conductive region, the skin contact subassembly has an area footprint covering the entire working conductive region, and the skin contact subassembly includes at least one alignment feature that provides indication of a desired position of the electrode subassembly relative to the skin contact subassembly.

[0128] Embodiment 45: The apparatus according to Embodiment 44, wherein the alignment feature includes the contour of at least a portion of the periphery of the electrode subassembly.

[0129] Embodiment 46: The apparatus according to Embodiment 44, wherein the electrode subassembly defines at least one opening through it, and the alignment feature includes corresponding markings on the skin contact subassembly that are visible through each of the at least one openings through the electrode subassembly when the electrode subassembly is in the desired position relative to the skin contact subassembly.

[0130] Embodiment 47: The apparatus according to Embodiment 4, wherein the skin contact subassembly defines at least one opening through it, the alignment feature includes at least one opening, and the electrode subassembly includes corresponding markings visible through each of the at least one openings when the skin contact subassembly is in the desired position relative to the electrode subassembly.

[0131] Embodiment 48: A method using the apparatus described in any one of Embodiments 1 to 47, wherein the method is A method comprising the step of removing the skin contact subassembly from the conductive polymer layer of the electrode subassembly.

[0132] Embodiment 49: The method according to Embodiment 48, further comprising the step of positioning the new skin contact subassembly relative to the conductive polymer layer of the electrode subassembly so that the new skin contact subassembly is removably coupled to the electrode subassembly.

[0133] Embodiment 50: The method according to Embodiment 49, further comprising the step of cleaning the conductive polymer layer of the electrode subassembly before positioning the new skin contact subassembly relative to the conductive polymer layer of the electrode subassembly.

[0134] Embodiment 51: The method according to Embodiment 49, wherein the skin contact subassembly includes at least one alignment feature that provides indication of a desired position of the electrode subassembly relative to the skin contact subassembly, and the method includes the step of oriented the electrode subassembly relative to the skin contact subassembly using the at least one alignment feature, or the electrode subassembly includes at least one alignment feature that provides indication of a desired position of the skin contact subassembly relative to the electrode subassembly, and the method includes the step of oriented the skin contact subassembly relative to the electrode subassembly using the at least one alignment feature.

[0135] Embodiment 52: An electrode subassembly, At least one electrode element having a skin-facing side and a skin-facing surface, An electrode subassembly comprising: a conductive polymer layer on the skin-facing side of at least one electrode element, wherein the conductive polymer layer has a skin-facing surface defining the skin-facing surface of the electrode subassembly; A kit comprising a plurality of skin contact subassemblies, each skin contact subassembly configured to be coupled to the electrode subassembly as a removable unit, each skin contact subassembly comprising a skin contact conductive adhesive or gel configured to come into contact with the skin of a subject, and the skin contact conductive adhesive or gel of the skin contact subassembly being electrically coupled to the at least one electrode element when the skin contact subassembly is positioned relative to the conductive polymer layer of the electrode subassembly.

[0136] Embodiment 53: The kit according to Embodiment 52, wherein each skin-contact subassembly comprises a three-layer unit comprising the skin-contact conductive adhesive or gel, an anisotropic conductive material layer, and a second conductive adhesive or gel layer, the anisotropic conductive material having a skin-facing side with a skin-facing surface and an outward-facing side opposite to the skin-facing side of the anisotropic conductive material layer in contact with the skin-contact conductive adhesive or gel, and the outward-facing side of the anisotropic conductive material layer in contact with the second conductive adhesive or gel layer.

[0137] Embodiment 54: One or both of the skin-contact conductive adhesive or gel and the second conductive adhesive or gel are The substrate layer, Conductive adhesive or gel layer related to skin-facing substrates, The apparatus according to embodiment 53, comprising a conductive adhesive or gel layer related to an outward-facing substrate.

[0138] Embodiment 55: The kit according to Embodiment 54, wherein the substrate layer has a continuous and uninterrupted structure, and the substrate layer is conductive.

[0139] Embodiment 56: The kit according to Embodiment 54, wherein the substrate layer has at least a partially open structure configured to allow contact of the adhesive layer from both sides of the substrate layer.

[0140] Embodiment 57: The kit according to Embodiment 56, wherein the substrate includes a mesh or scrim.

[0141] Embodiment 58: The kit according to any one of Embodiments 53 to 57, wherein the anisotropic conductive material layer is or contains synthetic graphite.

[0142] Embodiment 59: The kit according to any one of Embodiments 53 to 57, wherein the anisotropic conductive material layer is a layer of pyrolysis graphite, a graphitized polymer film, or a graphite foil made from compressed high-purity exfoliated mineral graphite, or includes the same.

[0143] Embodiment 60: The kit according to any one of Embodiments 53 to 59, wherein the anisotropic conductive material layer has a first thermal conductivity in a direction perpendicular to the skin-facing surface, and the thermal conductivity of the sheet in a direction parallel to the skin-facing surface is more than twice as great as the first thermal conductivity.

[0144] Embodiment 61: The kit according to any one of Embodiments 53 to 60, wherein the anisotropic conductive material layer has a first resistance in a direction perpendicular to the skin-facing surface, and the resistance of the sheet in a direction parallel to the skin-facing surface is less than half of the first resistance.

[0145] Embodiment 62: An electrode subassembly, At least one electrode element having a skin-facing side and a skin-facing surface, An electrode subassembly comprising: a first conductive adhesive or gel on the skin-facing side of at least one electrode element, wherein the first conductive adhesive or gel has a skin-facing surface defining the skin-facing surface of the electrode subassembly; A skin contact subassembly is detachably coupled to the electrode subassembly, wherein the skin contact subassembly is A conductive polymer layer configured to be removably bonded to the electrode subassembly, A device comprising a skin-contact subassembly, the skin-contact conductive adhesive or gel configured to come into contact with the skin of a subject, wherein the skin-contact conductive adhesive or gel is electrically coupled to at least one electrode element when the conductive polymer layer of the skin-contact subassembly is positioned relative to the skin-facing surface of the electrode subassembly.

[0146] Embodiment 63: The apparatus according to Embodiment 62, wherein the conductive polymer layer of the skin contact subassembly comprises rubber or elastomer.

[0147] Embodiment 64: The apparatus according to Embodiment 62, wherein the conductive polymer layer of the skin contact subassembly comprises an adhesive or sealant.

[0148] Embodiment 65: The apparatus according to any one of Embodiments 62 to 64, wherein the conductive polymer layer of the skin contact subassembly comprises a silicone polymer.

[0149] Embodiment 66: The apparatus according to Embodiment 62, wherein the conductive polymer layer of the skin contact subassembly is silicone rubber, silicone elastomer, natural rubber, polycis-isoprene, polyisobutylene, polychloroprene, cis-polybutadiene, styrene-butadiene, styrene-acrylonitrile-butadiene, polyurethane, EPDM, EVA polymer, AEM polymer, fluoropolymer, or perfluoropolymer, or a combination thereof, or comprising thereof.

[0150] Embodiment 67: The apparatus according to any one of Embodiments 62 to 66, wherein the conductive polymer layer of the skin contact subassembly comprises a composite material in which conductive particles are dispersed.

[0151] Embodiment 68: The apparatus according to Embodiment 67, wherein the conductive particles contain carbon.

[0152] Embodiment 69: The apparatus according to Embodiment 68, wherein the conductive particles include one or more of graphite powder, carbon flakes, carbon fibers, carbon granules, carbon nanotubes, carbon nanowires, carbon black powder, or carbon microcoils.

[0153] Embodiment 70: The apparatus according to Embodiment 69, wherein the conductive particles include a metal.

[0154] Embodiment 71: The apparatus according to any one of embodiments 62 to 70, wherein the electrode subassembly further includes a dielectric layer between the at least one electrode element of the skin contact subassembly and the conductive polymer layer.

[0155] Embodiment 72: The apparatus according to any one of Embodiments 1 to 71, wherein the electrode subassembly further comprises a dielectric layer between the at least one electrode element of the electrode subassembly and the first conductive adhesive or gel.

[0156] Embodiment 73: The apparatus according to Embodiment 71 or Embodiment 72, wherein the dielectric layer comprises a ceramic or dielectric polymer.

[0157] Embodiment 74: The apparatus according to Embodiment 73, wherein the dielectric layer comprises a dielectric polymer, and the dielectric polymer has a dielectric constant greater than 10.

[0158] Embodiment 75: The apparatus according to any one of embodiments 62 to 74, wherein the apparatus does not include an additional adhesive between the skin contact subassembly of the electrode subassembly and the first conductive adhesive or gel.

[0159] Embodiment 76: The apparatus according to any one of embodiments 62 to 75, wherein the first conductive adhesive or gel of the electrode subassembly and the skin contact subassembly are removably bonded by physical non-chemical adhesion.

[0160] Embodiment 77: The apparatus according to any one of Embodiments 62 to 76, wherein the first conductive adhesive or gel of the electrode subassembly and the skin contact subassembly are removably bonded by van der Waals forces.

[0161] Embodiment 78: The apparatus according to any one of embodiments 62 to 77, wherein the conductive polymer layer of the skin contact subassembly has a smooth surface that is removably bonded to the electrode subassembly.

[0162] Embodiment 79: The apparatus according to any one of Embodiments 62 to 78, wherein the conductive polymer layer of the skin contact subassembly is not adhesive.

[0163] Embodiment 80: The apparatus according to any one of Embodiments 62 to 79, wherein the skin contact subassembly further comprises an anisotropic conductive material layer having a skin-facing side having a skin-facing surface and an outward-facing side having the opposite side, the anisotropic conductive material layer being disposed in contact with the skin contact conductive adhesive or gel.

[0164] Embodiment 81: The apparatus according to any one of Embodiments 62 to 80, wherein the skin-contact conductive adhesive or gel comprises a conductive adhesive composite.

[0165] Embodiment 82: The apparatus according to Embodiment 81, wherein the conductive adhesive composite comprises dispersed conductive particles.

[0166] Embodiment 83: The apparatus according to Embodiment 82, wherein the conductive particles contain carbon.

[0167] Embodiment 86: The apparatus according to Embodiment 83, wherein the conductive particles include one or more of graphite powder, carbon flakes, carbon fibers, carbon granules, carbon nanotubes, carbon nanowires, carbon black powder, or carbon microcoils.

[0168] Embodiment 85: The apparatus according to Embodiment 82, wherein the conductive particles include a metal.

[0169] Embodiment 86: The apparatus according to any one of Embodiments 1 to 85, wherein the skin contact subassembly further comprises an anisotropic conductive material layer.

[0170] Embodiment 87: The apparatus according to any one of embodiments 62 to 86, wherein the electrode subassembly comprises a three-layer unit comprising the first conductive adhesive or gel, an anisotropic conductive material layer and an upper conductive adhesive or gel, the anisotropic conductive material layer having a skin-facing side with a skin-facing surface and an opposite outward-facing surface, the skin-facing surface of the anisotropic conductive material layer in contact with the first conductive adhesive or gel, and the outward-facing surface of the anisotropic conductive material layer in contact with the upper conductive adhesive or gel.

[0171] Embodiment 88: One or both of the first conductive adhesive or gel and the upper conductive adhesive or gel are The substrate layer, Conductive adhesive or gel layer related to skin-facing substrates, The apparatus according to embodiment 87, comprising a conductive adhesive or gel layer related to an outward-facing substrate.

[0172] Embodiment 89: The apparatus according to Embodiment 88, wherein the substrate layer has a continuous and uninterrupted structure, and the substrate layer is conductive.

[0173] Embodiment 90: The apparatus according to Embodiment 88, wherein the substrate layer has at least a partially open structure configured to allow contact of the adhesive layer from both sides of the substrate layer.

[0174] Embodiment 91: The apparatus according to Embodiment 90, wherein the substrate includes a mesh or scrim.

[0175] Embodiment 92: The apparatus according to Embodiment 91, wherein one or more of the skin-contact conductive adhesive or gel, the skin-facing substrate-related conductive adhesive or gel layer, or the outward-facing substrate-related conductive adhesive or gel layer is a conductive adhesive composite.

[0176] Embodiment 93: The apparatus according to Embodiment 92, wherein the conductive adhesive composite comprises dispersed conductive particles.

[0177] Embodiment 94: The apparatus according to Embodiment 93, wherein the conductive particles contain carbon.

[0178] Embodiment 95: The apparatus according to Embodiment 94, wherein the conductive particles include one or more of graphite powder, carbon flakes, carbon fibers, carbon granules, carbon nanotubes, carbon nanowires, carbon black powder, or carbon microcoils.

[0179] Embodiment 96: The apparatus according to Embodiment 93, wherein the conductive particles include a metal.

[0180] Embodiment 97: The apparatus according to any one of Embodiments 62 to 96, wherein the skin contact subassembly includes an acrylic adhesive.

[0181] Embodiment 98: The apparatus according to Embodiment 96 or Embodiment 97, wherein the anisotropic conductive material layer is or contains synthetic graphite.

[0182] Apparatus 99: The apparatus according to Apparatus 80 or 87, wherein the anisotropic conductive material layer is a layer of pyrolysis graphite, graphitized polymer film, or graphite foil made from compressed high-purity exfoliated mineral graphite, or includes the same.

[0183] Embodiment 100: The apparatus according to Embodiment 80 or Embodiment 87, wherein the anisotropic conductive material layer has a first thermal conductivity in a direction perpendicular to the skin-facing surface, and the thermal conductivity of the sheet in a direction parallel to the skin-facing surface is more than twice as great as the first thermal conductivity.

[0184] Embodiment 101: The apparatus according to Embodiment 80 or Embodiment 87, wherein the anisotropic conductive material layer has a first resistance in a direction perpendicular to the skin-facing surface, and the resistance of the sheet in a direction parallel to the skin-facing surface is less than half of the first resistance.

[0185] Embodiment 102: The apparatus according to any one of Embodiments 62 to 101, wherein the electrode subassembly has an operating conductive region, and the skin contact subassembly has an area footprint that covers the entire operating conductive region.

[0186] Embodiment 103: The apparatus according to any one of Embodiments 62 to 102, wherein the electrode subassembly has a working conductive region, the skin contact subassembly has an area footprint covering the entire working conductive region, and the skin contact subassembly includes at least one alignment feature that provides indication of a desired position of the electrode subassembly relative to the skin contact subassembly.

[0187] Embodiment 104: The apparatus according to Embodiment 103, wherein the alignment feature includes the contour of at least a portion of the periphery of the skin contact subassembly.

[0188] Embodiment 105: The apparatus according to Embodiment 103, wherein the electrode subassembly defines at least one opening through it, and the alignment feature includes corresponding markings on the skin contact subassembly that are visible through each of the at least one openings through the electrode subassembly when the electrode subassembly is in the desired position relative to the skin contact subassembly.

[0189] Embodiment 106: The apparatus according to Embodiment 103, wherein the skin contact subassembly defines at least one opening through it, the alignment feature includes at least one opening, and the electrode subassembly includes corresponding markings visible through each of the at least one openings when the skin contact subassembly is in the desired position relative to the electrode subassembly.

[0190] Embodiment 107: A method using the apparatus described in any one of Embodiments 62 to 106, wherein the method is A method comprising the step of removing the skin contact subassembly from the first conductive adhesive or gel of the electrode subassembly.

[0191] Embodiment 108: The method according to Embodiment 107, further comprising the step of positioning the new skin contact subassembly relative to the first conductive adhesive or gel of the electrode subassembly so that the new skin contact subassembly is removably bonded to the electrode subassembly.

[0192] Embodiment 109: The method according to Embodiment 108, further comprising the step of cleaning the first conductive adhesive or gel of the electrode subassembly before positioning the new skin contact subassembly relative to the first conductive adhesive or gel of the electrode subassembly.

[0193] Embodiment 110: The method according to Embodiment 108, wherein the electrode subassembly includes at least one alignment feature that provides indication of a desired position of the skin contact subassembly relative to the electrode subassembly, and the method includes the step of oriented the skin contact subassembly relative to the electrode subassembly using the at least one alignment feature.

[0194] Embodiment 111: An electrode subassembly, At least one electrode element having a skin-facing side and a skin-facing surface, An electrode subassembly comprising: a first conductive adhesive or gel on the skin-facing side of at least one electrode element, wherein the first conductive adhesive or gel has a skin-facing surface defining the skin-facing surface of the electrode subassembly; A plurality of skin contact subassemblies, each skin contact subassembly is configured to be coupled to the electrode subassembly as a removable unit, and each skin contact subassembly is A conductive polymer layer configured to be removably bonded to the skin-facing surface of the electrode subassembly, A plurality of skin-contact subassemblies comprising a skin-contact conductive adhesive or gel configured to come into contact with the skin of a subject, When the conductive polymer layer of the skin contact subassembly is positioned relative to the skin-facing surface of the electrode subassembly, the skin-contact conductive adhesive or gel of the skin contact subassembly is electrically coupled to the at least one electrode element, in a kit.

[0195] Embodiment 112: The kit according to Embodiment 111, wherein the electrode subassembly comprises a three-layer unit comprising the first conductive adhesive or gel, an anisotropic conductive material layer and an upper conductive adhesive or gel, the anisotropic conductive material layer having a skin-facing side with a skin-facing surface and an opposite outward-facing surface, the skin-facing surface of the anisotropic conductive material layer in contact with the first conductive adhesive or gel, and the outward-facing surface of the anisotropic conductive material layer in contact with the upper conductive adhesive or gel.

[0196] Embodiment 113: The first conductive adhesive or gel or the upper conductive adhesive or gel, one or both of these, The substrate layer, Conductive adhesive or gel layer related to skin-facing substrates, The apparatus according to embodiment 112, comprising a conductive adhesive or gel layer related to an outward-facing substrate.

[0197] Embodiment 114: The kit according to Embodiment 113, wherein the substrate layer has a continuous and uninterrupted structure, and the substrate layer is conductive.

[0198] Embodiment 115: The kit according to Embodiment 113, wherein the substrate layer has at least a partially open structure configured to allow contact of the adhesive layer from both sides of the substrate layer.

[0199] Embodiment 116: The kit according to Embodiment 115, wherein the substrate includes a mesh or scrim.

[0200] Embodiment 117: The kit according to any one of Embodiments 111 to 116, wherein the anisotropic conductive material layer is or contains synthetic graphite.

[0201] Embodiment 118: The kit according to any one of Embodiments 111 to 117, wherein the anisotropic conductive material layer is a layer of pyrolysis graphite, a graphitized polymer film, or a graphite foil made from compressed high-purity exfoliated mineral graphite, or includes the same.

[0202] Embodiment 119: The kit according to any one of Embodiments 112 to 118, wherein the anisotropic conductive material layer has a first thermal conductivity in a direction perpendicular to the skin-facing surface, and the thermal conductivity of the sheet in a direction parallel to the skin-facing surface is more than twice as great as the first thermal conductivity.

[0203] Embodiment 120: The kit according to any one of Embodiments 12 to 119, wherein the anisotropic conductive material layer has a first resistance in a direction perpendicular to the skin-facing surface, and the resistance of the sheet in a direction parallel to the skin-facing surface is less than half of the first resistance.

[0204] Embodiment 121: An electrode assembly, An electrode assembly including at least one electrode element having a skin-facing side and a skin-facing surface, A skin contact subassembly comprising a skin contact conductive adhesive or gel configured to come into contact with the skin of a subject, An apparatus wherein one of the electrode subassembly or the skin contact subassembly includes a conductive polymer layer, and the other of the electrode subassembly or the skin contact subassembly includes a second conductive adhesive or gel, the conductive polymer layer being positioned relative to the second conductive adhesive or gel and removably bonded thereto, thereby removably bonding the electrode subassembly to the skin contact subassembly such that the skin contact conductive adhesive or gel is electrically bonded to the at least one electrode element.

[0205] Embodiment 122: An electrode subassembly including at least one electrode element having a skin-facing side and a skin-facing surface, A skin contact subassembly comprising a skin contact conductive adhesive or gel configured to come into contact with the skin of a subject, One of the electrode subassembly or the skin contact subassembly includes a conductive polymer layer, The other of the electrode subassembly or the skin contact subassembly includes a conductive adhesive or gel layer. The device wherein the skin-contact subassembly is removably bonded to the electrode subassembly by adhesion between the conductive polymer layer and the conductive adhesive or gel layer, and the skin-contact conductive adhesive or gel is electrically bonded to the at least one electrode element when the skin-contact subassembly is positioned relative to the skin-facing surface of the electrode subassembly.

[0206] Embodiment 123: The apparatus according to Embodiment 122, wherein the electrode subassembly includes the conductive polymer layer, the conductive polymer layer being a non-adhesive conductive polymer layer positioned on the skin-facing side of the at least one electrode element, and the non-adhesive conductive polymer layer having a skin-facing surface defining the skin-facing surface of the electrode subassembly.

[0207] Embodiment 124: The apparatus according to Embodiment 122, wherein the conductive polymer layer is bonded to the skin-contact conductive adhesive or gel of the skin-contact subassembly.

[0208] Embodiment 125: The apparatus according to Embodiment 123, wherein the skin contact subassembly comprises at least one additional layer of conductive adhesive or gel, and the non-adhesive conductive polymer layer of the electrode subassembly is removably bonded to the at least one additional layer of conductive adhesive or gel of the skin contact subassembly.

[0209] Embodiment 126: The apparatus according to Embodiment 123, wherein the non-adhesive conductive polymer layer is silicone rubber or silicone elastomer, or comprises the same.

[0210] Embodiment 127: The apparatus according to any one of Embodiments 122 to 126, wherein the conductive polymer layer is silicone rubber, silicone elastomer, natural rubber, polycis-isoprene, polyisobutylene, polychloroprene, cis-polybutadiene, styrene-butadiene, styrene-acrylonitrile-butadiene, polyurethane, EPDM, EVA polymer, AEM polymer, fluoropolymer, perfluoropolymer, polyetherimide, polyetherketone, polyethersulfone, polyetheretherketone, or polyaryletherketone, or a combination thereof, or comprising thereof.

[0211] Embodiment 128: The apparatus according to any one of Embodiments 122 to 126, wherein the conductive polymer layer is silicone rubber, silicone elastomer, natural rubber, polycis-isoprene, polyisobutylene, polychloroprene, cis-polybutadiene, styrene-butadiene, styrene-acrylonitrile-butadiene, polyurethane, EPDM, EVA polymer, AEM polymer, fluoropolymer, or perfluoropolymer, or a combination thereof, or comprising thereof.

[0212] Embodiment 129: The apparatus according to any one of Embodiments 122 to 127, wherein the conductive polymer layer comprises a composite material in which conductive particles are dispersed.

[0213] Embodiment 130: The apparatus according to Embodiment 129, wherein the conductive particles include carbon particles.

[0214] Embodiment 131: The apparatus according to any one of Embodiments 123 to 130, wherein the non-adhesive conductive polymer layer of the electrode subassembly has an outward-facing surface facing the at least one electrode element, and the electrode subassembly further comprises an electrode subassembly conductive adhesive or gel layer positioned relative to the outward-facing surface of the non-adhesive conductive polymer layer.

[0215] Embodiment 132: The apparatus according to any one of Embodiments 123 to 131, wherein the electrode subassembly further includes a dielectric layer between the at least one electrode element of the electrode subassembly and the non-adhesive conductive polymer layer.

[0216] Embodiment 133: The apparatus according to any one of Embodiments 122 to 132, wherein the electrode subassembly has an operating conductive region, and the skin contact subassembly has an area footprint that covers the entire operating conductive region.

[0217] Embodiment 134: The apparatus according to any one of Embodiments 122 to 133, wherein one or both of the skin contact subassembly or the electrode subassembly further comprises an anisotropic conductive material layer.

[0218] Embodiment 135: The apparatus according to Embodiment 134, wherein the anisotropic conductive material layer is sandwiched between individual layers of conductive adhesive or gel on each individual surface of the anisotropic conductive material layer and in contact with them.

[0219] Embodiment 136: The apparatus according to Embodiment 134, wherein the skin contact subassembly includes the anisotropic conductive material layer, the anisotropic conductive material layer having a skin-facing side with a skin-facing surface and an outward-facing side opposite to the skin-facing surface, the anisotropic conductive material layer is disposed in contact with the skin-contact conductive adhesive or gel, and the at least one electrode element is in electrical contact with the outward-facing surface of the anisotropic conductive material layer when the electrode subassembly is in contact with the skin contact subassembly.

[0220] Embodiment 137: The apparatus according to any one of Embodiments 122 to 136, wherein the skin contact subassembly comprises a three-layer unit including an anisotropic conductive material layer having a skin-facing side having a skin-facing surface and an opposite outward-facing surface, the skin-facing surface of the anisotropic conductive material layer in contact with the skin-contact conductive adhesive or gel, and the outward-facing surface of the anisotropic conductive material layer in contact with a second conductive adhesive or gel layer.

[0221] Embodiment 138: The apparatus according to any one of Embodiments 133 to 137, wherein the anisotropic conductive material layer is or contains synthetic graphite.

[0222] Embodiment 139: The apparatus according to any one of Embodiments 123 to 138, wherein the non-adhesive conductive polymer layer of the electrode subassembly and the skin contact subassembly are removably bonded by van der Waals forces.

[0223] Embodiment 140: The attractive force between the electrode subassembly and the skin contact subassembly is compensated by an additional attractive force around the electrode subassembly and the skin contact subassembly, and the additional attractive force is i) Placing one of the hook material or loop material on the electrode subassembly and positioning the other of the hook material or loop material on the skin contact subassembly, ii) Placing one of a pair of magnets on the electrode subassembly and positioning the other of the pair of magnets on the skin contact subassembly, or iii) Using adhesive or adhesive tape to bond the peripheral region of the electrode subassembly to the skin contact subassembly, or vice versa, iv) Using buttons and buttonhole fasteners or snap fasteners to join the peripheral region of the electrode subassembly to the skin contact subassembly, or vice versa, v) The apparatus according to any one of embodiments 122 to 139, provided by a combination thereof.

[0224] Embodiment 141: The apparatus according to any one of Embodiments 123 to 140, wherein the apparatus does not have a layer of electrode subassembly conductive adhesive or gel between the at least one electrode and the non-adhesive conductive polymer layer.

[0225] Embodiment 142: The apparatus according to any one of Embodiments 122 to 141, wherein the conductive polymer layer comprises a conductive adhesive or gel or a conductive sealant.

[0226] Embodiment 143: The apparatus according to Embodiment 122, wherein the skin contact subassembly comprises the conductive polymer layer, the conductive polymer layer being a non-adhesive conductive polymer layer, the electrode subassembly comprises at least one layer of electrode subassembly conductive adhesive or gel, and the skin contact subassembly is removably bonded to the electrode subassembly by adhesion between the conductive polymer layer of the skin contact subassembly and at least one layer of electrode subassembly conductive adhesive or gel.

[0227] Embodiment 144: The apparatus according to Embodiment 143, wherein the skin contact subassembly comprises a skin contact adhesive or gel defining the skin-facing surface of the skin contact subassembly, and one or both of the skin contact subassembly or the electrode subassembly further comprises an anisotropic conductive material layer.

[0228] Embodiment 145: The apparatus according to any one of embodiments 1 to 9, 16 to 47, or 121 to 144, wherein the apparatus has no additional layer of electrode subassembly conductive adhesive or gel between the at least one electrode and the conductive polymer layer.

[0229] Embodiment 146: The apparatus according to Embodiment 145, wherein the electrode subassembly includes a dielectric layer between the at least one electrode and the conductive polymer layer, and the conductive polymer layer of the skin contact subassembly is deposited on the dielectric layer.

[0230] Embodiment 147: The apparatus according to Embodiment 146, wherein the skin contact subassembly comprises the conductive polymer layer, the conductive polymer layer being a non-adhesive conductive polymer layer, the electrode subassembly comprises at least one layer of electrode subassembly conductive adhesive or gel, and the skin contact subassembly is removably bonded to the electrode subassembly by adhesion between the conductive polymer layer of the skin contact subassembly and at least one layer of electrode subassembly conductive adhesive or gel.

[0231] Embodiment 148: The apparatus according to Embodiment 147, wherein the skin contact subassembly comprises a skin contact adhesive or gel defining the skin-facing surface of the skin contact subassembly, and one or both of the skin contact subassembly or the electrode subassembly further comprises an anisotropic conductive material layer.

[0232] Embodiment 149: An electrode subassembly, At least one electrode element having a skin-facing side and a skin-facing surface, An electrode subassembly comprising: a non-adhesive conductive polymer layer on the skin-facing side of at least one electrode element, wherein the non-adhesive conductive polymer layer has a skin-facing surface defining the skin-facing surface of the electrode subassembly; A kit comprising a plurality of skin contact subassemblies, each skin contact subassembly configured to be coupled to the electrode subassembly as a removable unit, each skin contact subassembly comprising a skin contact conductive adhesive or gel configured to come into contact with the skin of a subject, and the skin contact conductive adhesive or gel of the skin contact subassembly being electrically coupled to the at least one electrode element when the skin contact subassembly is positioned relative to the non-adhesive conductive polymer layer of the electrode subassembly.

[0233] Embodiment 150: A step of using the apparatus described in any one of Embodiments 121 to 148, A method comprising the step of removing the skin contact subassembly from the electrode subassembly.

[0234] While the present invention is disclosed with reference to specific embodiments, numerous modifications, changes, and variations are possible to the described embodiments without departing from the scope and scope of the invention, as defined in the appended claims. Therefore, the invention is not limited to the described embodiments and is intended to have the entire scope defined by the following claims and their equivalents. For example, various combinations of layer arrangements are disclosed with reference to the exemplary embodiments. Logical combinations and omissions of different layers are contemplated. As another example, various skin contact subassemblies are shown in combination with different electrode subassemblies. It should be understood that the electrode subassemblies and skin contact subassemblies are logically interchangeable within the spirit and scope of this disclosure. For example, Figure 2 shows an embodiment in which the skin contact subassembly includes an anisotropic material layer, but the electrode subassembly does not, and Figure 15 shows an embodiment in which the electrode subassembly includes an anisotropic material layer, but the skin contact subassembly does not. Furthermore, Figure 4 shows an embodiment in which both the electrode subassembly and the skin contact subassembly each include an anisotropic material layer.

[0235] Embodiments shown in any heading or portion of this disclosure may be combined with embodiments shown in the same or other headings or portions of this disclosure, unless otherwise stated herein or unless the context expressly contradicts the description. For example, an embodiment described in dependent claim form to a given embodiment (e.g., a given embodiment described in independent claim form) may be combined with other embodiments (described in independent or dependent claim form).

Claims

1. An electrode subassembly including at least one electrode element having a skin-facing side and a skin-facing surface, A skin contact subassembly comprising a skin contact conductive adhesive or gel configured to come into contact with the skin of a subject, One of the electrode subassembly or the skin contact subassembly includes a conductive polymer layer, The other of the electrode subassembly or the skin contact subassembly includes a conductive adhesive or gel layer. The apparatus wherein the skin-contact subassembly is removably bonded to the electrode subassembly by adhesion between the conductive polymer layer and the conductive adhesive or gel layer, and the skin-contact conductive adhesive or gel is electrically bonded to the at least one electrode element when the skin-contact subassembly is positioned relative to the skin-facing surface of the electrode subassembly.

2. The apparatus according to claim 1, wherein the electrode subassembly includes the conductive polymer layer, the conductive polymer layer is a non-adhesive conductive polymer layer positioned on the skin-facing side of the at least one electrode element, and the non-adhesive conductive polymer layer has a skin-facing surface that defines the skin-facing surface of the electrode subassembly.

3. The apparatus according to claim 2, wherein the skin contact subassembly comprises at least one additional layer of conductive adhesive or gel, and the non-adhesive conductive polymer layer of the electrode subassembly is removably bonded to the at least one additional layer of conductive adhesive or gel of the skin contact subassembly.

4. The apparatus according to claim 1, wherein the conductive polymer layer is silicone rubber, silicone elastomer, natural rubber, polycis-isoprene, polyisobutylene, polychloroprene, cis-polybutadiene, styrene-butadiene, styrene-acrylonitrile-butadiene, polyurethane, EPDM, EVA polymer, AEM polymer, fluoropolymer, perfluoropolymer, polyetherimide, polyetherketone, polyethersulfone, polyetheretherketone, or polyaryletherketone, or a combination thereof, or comprising thereof.

5. The apparatus according to claim 2, wherein the non-adhesive conductive polymer layer is a silicone rubber or a silicone elastomer, or comprises the same.

6. The apparatus according to claim 1, wherein the conductive polymer layer comprises a composite material in which conductive particles are dispersed.

7. The apparatus according to claim 6, wherein the conductive particles include carbon particles.

8. The apparatus according to claim 2, wherein the non-adhesive conductive polymer layer of the electrode subassembly has an outward-facing surface facing the at least one electrode element, and the electrode subassembly further comprises an electrode subassembly conductive adhesive or gel layer disposed against the outward-facing surface of the non-adhesive conductive polymer layer.

9. The apparatus according to claim 2, wherein the electrode subassembly further includes a dielectric layer between the at least one electrode element of the electrode subassembly and the non-adhesive conductive polymer layer.

10. The apparatus according to claim 1, wherein the electrode subassembly has an operating conductive region, and the skin contact subassembly has an area footprint that covers the entire operating conductive region.

11. The apparatus according to claim 1, wherein one or both of the skin contact subassembly or the electrode subassembly further comprises an anisotropic conductive material layer.

12. The apparatus according to claim 11, wherein the anisotropic conductive material layer is sandwiched between individual layers of conductive adhesive or gel on each individual surface of the anisotropic conductive material layer and in contact with them.

13. The apparatus according to claim 11, wherein the skin contact subassembly includes the anisotropic conductive material layer, the anisotropic conductive material layer having a skin-facing side with a skin-facing surface and an outward-facing side opposite to the skin-facing surface, the anisotropic conductive material layer is disposed in contact with the skin-contact conductive adhesive or gel, and the at least one electrode element is in electrical contact with the outward-facing surface of the anisotropic conductive material layer when the electrode subassembly is in contact with the skin contact subassembly.

14. The apparatus according to claim 2, wherein the skin contact subassembly comprises a three-layer unit including an anisotropic conductive material layer having a skin-facing side having a skin-facing surface and an opposite outward-facing surface, the skin-facing surface of the anisotropic conductive material layer is in contact with the skin-contact conductive adhesive or gel, and the outward-facing surface of the anisotropic conductive material layer is in contact with a second conductive adhesive or gel layer.

15. The apparatus according to claim 11, wherein the anisotropic conductive material layer is synthetic graphite or comprises synthetic graphite.

16. The apparatus according to claim 2, wherein the non-adhesive conductive polymer layer of the electrode subassembly and the skin contact subassembly are removably bonded by van der Waals forces.

17. The attractive force between the electrode subassembly and the skin contact subassembly is compensated for by an additional attractive force around the electrode subassembly and the skin contact subassembly, and the additional attractive force is i) Placing one of the hook material or loop material on the electrode subassembly and positioning the other of the hook material or loop material on the skin contact subassembly, ii) Placing one of a pair of magnets on the electrode subassembly and positioning the other of the pair of magnets on the skin contact subassembly, or iii) Using adhesive or adhesive tape to bond the peripheral region of the electrode subassembly to the skin contact subassembly, or vice versa, iv) Using buttons and buttonhole fasteners or snap fasteners to join the peripheral region of the electrode subassembly to the skin contact subassembly, or vice versa, v) The apparatus according to claim 1, provided by a combination thereof.

18. The apparatus according to claim 2, wherein the apparatus does not have a layer of electrode subassembly conductive adhesive or gel between the at least one electrode and the non-adhesive conductive polymer layer.

19. The apparatus according to claim 1, wherein the conductive polymer layer comprises a conductive adhesive, gel, or conductive sealant.

20. The apparatus according to claim 1, wherein the skin contact subassembly comprises the conductive polymer layer, the conductive polymer layer being a non-adhesive conductive polymer layer, the electrode subassembly comprises at least one layer of electrode subassembly conductive adhesive or gel, and the skin contact subassembly is removably bonded to the electrode subassembly by adhesion between the conductive polymer layer of the skin contact subassembly and at least one layer of electrode subassembly conductive adhesive or gel.

21. The apparatus according to claim 20, wherein the skin contact subassembly comprises a skin contact adhesive or gel defining the skin-facing surface of the skin contact subassembly, and one or both of the skin contact subassembly or the electrode subassembly further comprises an anisotropic conductive material layer.

22. An electrode subassembly, At least one electrode element having a skin-facing side and a skin-facing surface, An electrode subassembly comprising: a non-adhesive conductive polymer layer on the skin-facing side of at least one electrode element, wherein the non-adhesive conductive polymer layer has a skin-facing surface that defines the skin-facing surface of the electrode subassembly; A kit comprising a plurality of skin contact subassemblies, each skin contact subassembly configured to be coupled to the electrode subassembly as a removable unit, each skin contact subassembly comprising a skin contact conductive adhesive or gel configured to come into contact with the skin of a subject, and the skin contact conductive adhesive or gel of the skin contact subassembly being electrically coupled to the at least one electrode element when the skin contact subassembly is positioned relative to the non-adhesive conductive polymer layer of the electrode subassembly.

23. An electrode subassembly including at least one electrode element having a skin-facing side and a skin-facing surface, A step of using an apparatus comprising: a skin contact subassembly comprising a skin contact conductive adhesive or gel configured to come into contact with the skin of a subject, wherein one of the electrode subassembly or the skin contact subassembly comprises a non-adhesive conductive polymer layer, the skin contact subassembly is removably bonded to the electrode subassembly by adhesion between the non-adhesive conductive polymer layer and the conductive adhesive or gel layer of the other of the electrode subassembly or the skin contact subassembly, and the skin contact conductive adhesive or gel is electrically bonded to the at least one electrode element when the skin contact subassembly is positioned relative to the skin-facing surface of the electrode subassembly; A method comprising the step of removing the skin contact subassembly from the electrode subassembly.

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