Apparatus having electrode array subassemblies integrally coupled by flexible bonding

Abstract

An electrode array assembly providing a tumor treatment site includes first and second electrode array subassemblies, each of which includes at least one electrode. The electrode array assembly further includes a flexible coupling extending between the first and second electrode array subassemblies and coupled to them. This flexible coupling provides a spacing between the first and second electrode array subassemblies measured along the surface of the electrode array assembly.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the priority and benefit of the filing date of U.S. Provisional Patent Application No. 63 / 511,507, filed on June 30, 2023, the entire content of which is incorporated herein by reference.

[0002] This application relates to an apparatus for delivering tumor treatment fields.

Background Art

[0003] Tumor treatment field (TTField) therapy is a proven approach for treating tumors using an alternating current electric field at a frequency of 100 - 500 KHz. The alternating current electric field is induced by an electrode assembly (e.g., an array of capacitive coupling electrodes, also referred to as a transducer array) placed on opposite sides of the target location within the subject's body. When an AC voltage is applied between the opposing electrode assemblies, an AC current flows through the electrode assemblies and into the subject's body.

[0004] The proper placement of the electrode arrays relative to each other and the target area (e.g., the tumor) can affect the performance of the treatment. However, proper placement is difficult, especially when the subject is placing the electrode arrays on themselves. Thus, this difficulty can reduce the subject's independence and require another person (a helper) to place the electrode arrays for the subject. Therefore, a method for assisting the subject in properly placing one or more electrode arrays is desired.

[0005] Furthermore, treatment often requires the use of multiple electrode arrays. Conventionally, each array requires its own cable, which may not be desirable for many reasons. For example, multiple cables can cause discomfort due to cable entanglement and / or, in some cases, complex problems such as pulling or detachment of the arrays.

Summary of the Invention

[0006] In one aspect of this specification, an electrode array assembly is disclosed, comprising first and second electrode array subassemblies, each comprising at least one electrode. The electrode array assembly further comprises a flexible coupling extending between the first and second electrode array subassemblies and coupled thereto. This flexible coupling provides a spacing between the first and second electrode array subassemblies measured along the surface of the electrode array assembly.

[0007] Furthermore, this specification discloses a system comprising a plurality of electrode array assemblies, each comprising at least a first electrode assembly and a second electrode assembly, wherein each of the plurality of electrode array assemblies comprises at least a first electrode array subassembly and a second electrode array subassembly, and a flexible coupling extending between and coupled to the first and second electrode array subassemblies. The system further comprises at least one additional strap extending between the first electrode array subassembly of the first electrode assembly and the first electrode array subassembly of the second electrode assembly. Each of the first and second electrode array subassemblies comprises at least one electrode. The flexible coupling provides a spacing between the first and second electrode array subassemblies measured along the surface of the electrode array assembly.

[0008] In a further embodiment, a method for positioning an electrode array assembly is disclosed. For example, the method includes positioning an electrode array assembly, which includes a plurality of electrode array subassemblies, on the body of a patient, wherein the plurality of electrode array subassemblies include at least a first electrode array subassembly and a second electrode array subassembly. Each electrode array subassembly of the plurality of electrode array subassemblies includes at least one electrode. A flexible coupling extends between the first and second electrode array subassemblies and connects them. This flexible coupling provides a distance between the first and second electrode array subassemblies measured along the surface of the electrode array assemblies. In a further embodiment, the method may further include applying an electric field between at least one electrode of the first electrode array subassembly and at least one electrode of the second electrode array subassembly. [Brief explanation of the drawing]

[0009] [Figure 1] This is a schematic top view of an exemplary electrode array assembly supplying a TT field as disclosed herein. [Figure 2] This is a schematic top view of another exemplary electrode array assembly supplying a TT field as disclosed herein. [Figure 3] This is an exemplary cross-sectional view of an electrode array assembly in Figure 1 along line A-A', showing an exemplary electrode array subassembly. [Figure 4] This is another exemplary cross-sectional view of the assembly in Figure 1 along line A-A', showing one exemplary electrode array subassembly. [Figure 5] This is yet another exemplary cross-sectional view of the assembly in Figure 1 along line A-A', showing one exemplary electrode array subassembly. [Figure 6] This is an illustrative cross-sectional view of the assembly in Figure 2 along line B-B'. [Figure 7] This is yet another exemplary cross-sectional view of the assembly in Figure 1 along line A-A', showing one exemplary electrode array subassembly. [Figure 8]This is yet another exemplary cross-sectional view of the assembly in Figure 1 along line A-A', showing one exemplary electrode array subassembly. [Figure 9] This is a block diagram of a system using the electrode array assembly disclosed herein. [Figure 10] This is a schematic front view of a system including an electrode array assembly with additional straps, according to an embodiment disclosed herein. [Figure 11] This is a schematic rear view of a system including an electrode array assembly with additional straps, according to an embodiment disclosed herein. [Figure 12] This is a schematic front view of a system including a pair of electrode array assemblies with additional straps, according to an embodiment disclosed herein. [Figure 13] This is a schematic rear view of a system including a pair of electrode array assemblies with additional straps, according to an embodiment disclosed herein. [Figure 14] This is a schematic front view of a system including a pair of electrode array assemblies with additional straps, according to an embodiment disclosed herein. [Figure 15] This is a schematic rear view of a system including a pair of electrode array assemblies with additional straps, according to an embodiment disclosed herein.

[0010] Various embodiments will be described in detail below with reference to the attached drawings. In the drawings, similar reference numerals represent similar elements. [Modes for carrying out the invention]

[0011] This application describes, for example, a device (e.g., an exemplary electrode array assembly and / or therapeutic assembly) that can be used to deliver a TT field to the body of a subject and treat one or more cancers or tumors located in the body of the subject.

[0012] 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.

[0013] 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 other parts of this disclosure.

[0014] Unless otherwise specified herein, or unless the context clearly indicates otherwise, all combinations of elements described herein are encompassed in the present invention in all possible variations thereof. For example, an embodiment described in dependent claims with respect to a given embodiment (e.g., a given embodiment described in independent claims) may be combined with other embodiments (described in independent or dependent claims). overview

[0015] Electrode arrays are placeable on a patient, with a target area between them, to provide TT field therapy. For convenience, separate electrode arrays are placed individually. However, electrode placement can be difficult, especially on the back of the torso. Improper placement may lead to reduced effectiveness. Therefore, placement difficulties can lead to a loss of patient independence, requiring another individual, such as a healthcare professional or caregiver, to place the electrode arrays. Furthermore, each electrode array is conventionally associated with its own cable. Therefore, multiple arrays result in multiple cables, which can be undesirable for aesthetic, comfort, and performance reasons.

[0016] FIG. 9 schematically shows an exemplary system 200 for delivering a tumor treatment field using an electrode array assembly disclosed herein, which is further described herein. The electrode array assembly, which includes two electrode sub-assemblies, can be coupled by a flexible coupling such that the distance therebetween is controllable and determined. In this way, the position of one electrode array sub-assembly can at least partially control the position of the other electrode array sub-assembly. Thus, for example, in order to properly position the second electrode array sub-assembly relative to the first electrode array sub-assembly, the first electrode array sub-assembly can be positioned at a location more accessible to the patient (e.g., the front of the patient's torso) using the length of the flexible coupling, and the second electrode array sub-assembly can be positioned at a location less accessible to the patient (e.g., the back of the patient's torso). Electrode array assembly

[0017] As shown herein, referring to FIGS. 1-2, an electrode array assembly 100 is disclosed that includes first and second electrode array sub-assemblies 10a, b, each of which includes at least one electrode 70. A flexible coupling 110 extends between and is coupled to the first and second electrode array sub-assemblies 10a, b. This flexible coupling 110 provides an interval S measured along the surface of the electrode array assembly between the first and second electrode array sub-assemblies, as further discussed herein.

[0018] In an exemplary aspect, each electrode 70 can include a metal pad. In some optional aspects, each electrode array sub-assembly 10 can include a plurality of electrodes 70. For example, in some aspects, the plurality of electrodes 70 can be arranged in respective patterns. In other aspects, either or both of the first and second electrode array sub-assemblies 10a, b can have a single electrode 70.

[0019] In exemplary embodiments, the flexible coupling 110 can provide a fixed, non-adjustable interval between the first and second electrode array subassemblies, measured along the surface of the electrode array assembly. Optionally, in these embodiments, the fixed, non-adjustable interval may be a patient-specific interval. For example, when determining the patient-specific interval, the patient's physique may be taken into consideration.

[0020] In some embodiments, where a fixed, non-adjustable interval is patient-specific, the electrode array assembly is pre-fitted to the patient, and the couplings are specially fitted and adjusted for appropriate sizing and measurement, allowing the first and second electrode array subassemblies 10a, b to be positioned at first and second preferred locations within or on the patient, respectively. The first and second preferred locations may correspond to two distinct target locations (e.g., two distinct tumors within the body). In further embodiments, the fixed, non-adjustable interval may be patient-specific, positioning the first and second electrode array subassemblies across opposite sides of the same target site (e.g., a tumor) within or on the patient. For example, referring further to Figures 10 and 11, the target site may be located in the torso (e.g., within one lung). In some embodiments, a single electrode array assembly 100 is positioned on the patient. In such embodiments, the first electrode array subassembly 10a can be positioned on the patient's chest, and the second electrode array subassembly 10b can be positioned on the patient's back. Figure 10 shows the front view of the patient (and the patient's chest), and Figure 11 shows the back view of the patient (and the patient's back). Thus, Figures 10 and 11 show an electrode array assembly 100 positioned on the patient, with two electrode array subassemblies (10a positioned on the front and 10b positioned on the back) separated by a flexible coupling 110. The flexible coupling 110 can provide length such that, when the first electrode array subassembly 10a is properly positioned on the patient's chest, the flexible coupling extends along the patient's shoulder without slack, so that the second electrode array subassembly 10b is positioned at the appropriate height on the patient's back.

[0021] Referring to Figures 12 and 13, the target site may be located in the torso (e.g., within both lungs). In some embodiments, multiple electrode array assemblies 100 (e.g., two electrode array assemblies 100, as shown in Figures 12 and 13) are positioned on the patient. Figure 12 shows the front of the patient (and the patient's chest), and Figure 13 shows the back of the patient (and the patient's back). In Figures 12 and 13, two electrode array assemblies 100 are positioned on the patient, each having two electrode array subassemblies (10a positioned on the front and 10b positioned on the back), and in each case, the two electrode array assemblies 10a and 10b are separated by a flexible coupling 110. As described above, the flexible coupling 110 can provide a length for each electrode array assembly 100 such that, when the first electrode array subassembly 10a is properly positioned on the patient's chest, the flexible coupling extends along the patient's shoulder without slack, and the second electrode array subassembly 10b is positioned at an appropriate height on the patient's back. Thus, in this embodiment, each electrode array assembly 100 can position the first and second electrode array subassemblies across opposite sides of a target site (e.g., a tumor), in which case each electrode array assembly 100 targets different sites (e.g., two tumors, one in each lung). In some arbitrary embodiments, the flexible coupling 110 allows for adjustment of the spacing between the first and second electrode array subassemblies 110a,b, measured along the surface of the electrode array assembly 100. In some exemplary embodiments, the flexible coupling 110 may include an adjustable strap. For example, the flexible coupling 110 may include an adjustable slide strap adjustment device 112, or at least one of a hook material on a first portion of the flexible coupling and a loop material on a second portion of the flexible coupling. An example hook-and-loop fastener is the Velcro® hook-and-loop fastener (available from Velcro Companies in Manchester, New Hampshire).In some embodiments, the flexible coupling 110 may have a length that allows for the simultaneous placement of the first electrode array subassembly on the front of the patient's torso and the second electrode array subassembly on the back of the patient's torso. Thus, for a given patient, the adjustable flexible coupling 110 can be repeatedly used by that patient after being initially adjusted to the appropriate length without further adjustment.

[0022] In some embodiments, the distance S between the first and second electrode array subassemblies 10a and b, measured along the surface of the electrode array assembly 100, is the shortest distance between any one electrode of at least one electrode of the first electrode array subassembly and any one electrode of at least one electrode of the second electrode array subassembly, measured along the surface of the electrode array assembly (for example, the distance between the nearest electrodes 70 of each electrode array subassembly 10a and b, as shown in Figure 1). In some embodiments, the distance S between the first and second electrode array subassemblies 10a and b, measured along the surface of the electrode array assembly 100, is the shortest distance between the outer circumference of the first electrode array subassembly and the outer circumference of the second electrode array subassembly, measured along the surface of the electrode array assembly. In some embodiments, where the electrode array assembly 100 includes a layer of anisotropic material 30 (Figures 3-6, 8), the distance S between the first and second electrode array subassemblies 10a, b, measured along the surface of the electrode array assembly 100, is the shortest distance between the outer circumference of the area footprint of the anisotropic material layer of the first electrode array subassembly and the outer circumference of the area footprint of the anisotropic material layer of the second electrode array subassembly, measured along the surface of the electrode array assembly. In various embodiments, the distance between the first and second electrode array subassemblies 10a, b, measured along the surface of the electrode array assembly, can be about 0.05 m to about 1.5 m. In exemplary embodiments, the distance can be at least 0.3 m. In further exemplary embodiments, the distance can be at least 0.5 m, or at least 0.75 m, or at least 1 m, or about 0.5 m to 1.5 m.

[0023] Referring to Figure 1, in some embodiments, the electrode array assembly 100 may include a first electrical lead wire 80a and a second electrical lead wire 80b, where each electrode 70 of the first electrode array subassembly 10a is electrically communicable with the first electrical lead wire 80a, and each electrode of the second electrode array subassembly 10b is communicable with the second electrical lead wire 80b.

[0024] Referring to Figure 2, in some arbitrary embodiments, the electrode array assembly 100 may include only a single cable 80. For example, electrical leads supplying current to both the first and second electrode array subassemblies 10a, b may extend through the cable 80. Thus, in some embodiments, at least one electrical lead 81 extends between the first and second electrode array subassemblies 10a, b so that the single cable 80 can supply current to both the first and second electrode array subassemblies 10a, b. In other embodiments (not shown), the single cable 80 may branch and extend to both the first and second electrode array subassemblies 10a, b. In this way, the cables required to provide treatment can be significantly reduced. This is in contrast to conventional systems, which require their own cable for each electrode array, potentially leading to complex problems resulting from cable entanglement and / or discomfort due to the pulling or detachment of the arrays.

[0025] Furthermore, referring to Figure 3, each electrode array subassembly 10 may include a flexible circuit 60 (e.g., a flex circuit or printed circuit board) extending between each electrode 70 of the electrode array subassembly. In a further embodiment, the electrode array subassembly 10 may include a printed circuit board (PCB).

[0026] Referring to Figures 2 and 6, in some embodiments, the flexible coupling 110 may include a cover material 92 that extends across the outward-facing sides 94 of each electrode array subassembly 10 (e.g., the first and second electrode array subassemblies 10a, b).

[0027] In other embodiments, referring to Figure 1, the flexible coupling 110 may include a strap. The strap may have a thickness and a width greater than its thickness. For example, the width of the strap may be at least five times the thickness of the strap. The width of the strap may be at least 1 centimeter, or at least 2 centimeters, or at least 5 centimeters. A strap having such a width is intended to suppress unwanted twisting of the flexible coupling, which may affect the spacing between the first and second electrode array subassemblies 10a, b. Furthermore, a strap having sufficient width can suppress angular offset of the first and second electrode array subassemblies 10a, b (e.g., offset around an axis extending off-page in Figure 1). For example, rather than attachment points to the first and second electrode array subassemblies 10a, b that allow angular pivoting, the strap may have an extended region (e.g., a line) of attachments to the strap that extends perpendicular to the length of the strap, thereby minimizing angular pivoting of the first and second electrode array subassemblies.

[0028] Referring to Figures 10 and 11 (see also Figures 12-15), in some arbitrary embodiments, at least one additional strap 120 can assist in the positioning and securing of the electrode array subassemblies 10a, b. The additional strap 120 can extend between the first and second electrode array subassemblies 10a, b in a single electrode array assembly 100 on the patient (Figures 10, 11). For example, in some embodiments, at least one additional strap 120 can be configured to extend around the patient's torso (e.g., horizontally in Figures 10, 11). At least one additional strap 120 can further confirm the proper positioning of the first and second electrode array subassemblies 10a, b. Furthermore, at least one additional strap 120 can secure the first and second electrode array subassemblies 10a, b in place on the patient.

[0029] In some embodiments, at least one additional strap may include a single strap. In some embodiments, a single (horizontal) additional strap 120 extending around the torso may help position and secure a single electrode array assembly 100 to the patient. The single additional strap may be coupled to the upper, lower, or (as shown in Figures 10 and 11) central portion of the first and second electrode array subassemblies 10a, b. Alternatively, in some embodiments, multiple additional straps 120 may extend around the torso and similarly help position and secure a single electrode array assembly 100 to the patient.

[0030] In some embodiments, a single (horizontal) additional strap 120 extending from the torso may help position and secure the two electrode array assemblies 100 to the patient. For example, a single additional strap 120 may be coupled to the bottom of the first and second electrode array subassemblies 10a, b for the two electrode array assemblies 100. In other embodiments, multiple additional straps 120 (e.g., pairs) can be coupled to the two electrode array assemblies 100 (Figures 12, 13). For example, a first strap can be coupled to the top of the first and second electrode array subassemblies 10a, b of the two electrode array assemblies 100, and a second strap can be coupled to the bottom of the first and second electrode array subassemblies 10a, b of the two electrode array assemblies 100.

[0031] In some embodiments, at least one additional strap 120 can be integrally formed with the electrode array assembly 100 (e.g., by welding, molding, or suturing). In other embodiments, at least one additional strap 120 may be a separate element detachably bonded to the electrode array assembly 100. For example, at least one additional strap 120 may include a corresponding hook or loop fastener of the electrode array assembly 100, or a hook or loop fastener configured to bond, for example, to the nonwoven backing of the electrode array assembly. In other embodiments, at least one additional strap 120 can be integrally formed with the electrode array assembly 100 by adhesive.

[0032] In yet another embodiment, at least one additional strap 120 may extend across the electrode array assembly 100 (e.g., horizontally) to compressively hold the electrode array assembly against the patient. In yet another embodiment, at least one strap may be elastic and bondable to itself (e.g., via adhesive or fastener) so as to form a loop that wraps around the patient and presses the electrode array assembly against the patient. For example, at least one additional strap 120 may include a self-adhesive bandage such as Coban® bandage, provided by 3M, headquartered in Minneapolis, Minnesota. In yet another embodiment, the electrode array assembly 100 may define at least one opening (e.g., a slot) through which at least one additional strap 120 may be received. In this case as well, the compression strap may position and secure a single electrode array assembly to the patient or two electrode array assemblies to the patient. One or more (e.g., two) compression straps may be used in a manner similar to that described above.

[0033] As discussed above, in some embodiments, the treatment system may include a plurality of (e.g., pairs) electrode array assemblies 100. Optionally, the pairs of electrode array assemblies 100 may be separate elements. In other embodiments, the pairs of electrode array assemblies 100 may be coupled together. Optionally, electrical leads may supply power to both electrode array assemblies 100. For example, the electrode array assemblies may be linked via a hub so that an AC voltage or AC current generator can generate an electric field for the plurality of electrode array assemblies. For example, the hub may include an input port electrically connected to the AC voltage or AC current generator. The hub may further include a plurality of output ports electrically coupled to each electrode array assembly (or electrode array subassembly) to provide electrical communication between the AC voltage or AC current generator and the coupled electrode array assemblies (or electrode array subassemblies). The hub enables the AC voltage or AC current generator to generate an electric field in each electrode array assembly. In exemplary embodiments, the hub further allows an AC voltage or AC current generator to selectively generate an electric field between one or more electrodes of at least two electrode array subassemblies of any electrode array assembly coupled to the hub. In further embodiments, the hub allows an AC voltage or AC current generator to selectively generate an electric field between at least two electrodes of a single electrode array subassembly. Optionally, in these embodiments, an electric field can be applied between the first and second electrode array subassemblies 10a,b in the single electrode array assembly 100. In other embodiments, an electric field can be applied between the first electrode array subassembly 10a of the first electrode array assembly and the second electrode array subassembly 10b of the second electrode array subassembly (for example, between the left chest and the right back, or between the right chest and the left back).

[0034] In some embodiments, each strap of at least one additional strap 120 may extend to (and optionally connect to) each of a plurality of electrode array assemblies 100. In other embodiments, referring to Figures 14 and 15, at least one additional strap 120 may extend only between the first and second electrode array subassemblies 10a, b of a single electrode array assembly 100. In this embodiment, each additional strap 120 does not completely encircle the torso, but simply links from the chest to the back, centered on one side. In these embodiments, the additional straps 120 may be supplied with an adhesive for bonding the additional straps 120 to the main body.

[0035] This specification discloses an exemplary electrode array subassembly 10, showing further embodiments of the disclosed electrode array assembly 100 with reference to Figures 2-6. The electrode array subassembly 10 may include an outer adhesive layer 20. The outer adhesive layer 20 may include a conductive gel or conductive adhesive 22. The electrode array subassembly 10 may further include at least one layer 30 of anisotropic material, a dielectric material layer 40, and a skin contact layer 50. By including a dielectric material layer, a capacitive structure can be formed. The skin contact layer 50 may include a conductive gel or conductive adhesive 52. The anisotropic material layer 30 may be a nonmetallic anisotropic material layer.

[0036] In some embodiments, the dielectric material layer 40 can be positioned between the electrode and the outer adhesive layer 20. In some embodiments, at least one layer 30 of anisotropic material and the dielectric material layer 40 can be positioned between the outer adhesive layer 20 and the skin contact layer 50.

[0037] The circuit board 60 can be electrically connected to the outer adhesive layer 20. In some arbitrary embodiments, the circuit board 60 can be electrically connected to the outer adhesive layer 20 through one or more conductive elements (e.g., metal pads 70) that are in electrical contact with the circuit board 60. Two electrodes 70 are shown in Figures 3-6, but each electrode array subassembly 10 may include additional electrode elements.

[0038] In some embodiments, the anisotropic material layer 30 may include a sheet 32 ​​of the anisotropic material having a rear surface 34 and a front surface 36 (with the front surface facing the subject's skin). The sheet 32 ​​of the anisotropic material has a first thermal conductivity in a direction perpendicular to the front surface 36. In some embodiments, the thermal conductivity of the sheet in a direction parallel to the front surface may be more than twice the first thermal conductivity. In other embodiments, the sheet 32 ​​of the anisotropic material may have a first resistance in a direction perpendicular to the front surface, and the resistance of the sheet in a direction parallel to the front surface may be less than half the first resistance.

[0039] In some arbitrary embodiments, the first layer 30a of the anisotropic material may include graphite.

[0040] Optionally, the first layer 30a of the anisotropic material may contain synthetic graphite.

[0041] Furthermore, in any embodiment, the first layer 30a of the anisotropic material may include pyrolysis graphite or a graphitized polymer film.

[0042] Furthermore, in any embodiment, the first layer 30a of the anisotropic material may include graphite foil. For example, optionally, the first layer of the anisotropic material may include graphite foil made from compressed, high-purity exfoliated mineral graphite.

[0043] The dielectric material layer 40 has a skin-facing surface 42 and an outward-facing surface 44 on the opposite side. The first layer 30a of the anisotropic material has a skin-facing surface 38a and an outward-facing surface 39a on the opposite side. In some embodiments, as shown in Figure 3, the outward-facing surface 44 of the dielectric material layer 40 can contact the skin-facing surface 38a of the first layer 30a of the anisotropic material. In some embodiments, as shown in Figure 3, the outward-facing surface 39a of the first layer 30a of the anisotropic material can contact the outer adhesive layer 20. In another embodiment, as shown in Figure 3, the skin-facing surface 42 of the dielectric material layer 40 can contact the skin contact layer 50.

[0044] In some embodiments, the outward-facing surface 44 of the dielectric material 40 can be in direct contact with at least one electrode 70 (e.g., Figure 7). In other embodiments, an outer adhesive layer 20 may be present between the dielectric material 40 and at least one electrode 70. In these embodiments, the outward-facing surface 44 of the dielectric material 40 can be in direct contact with the outer adhesive layer 20 (e.g., Figure 4). In some embodiments, as seen in Figure 4, the skin-facing surface 42 of the dielectric material 40 can be in contact with the outward-facing surface 39a of the first layer 30a of the anisotropic material. In some embodiments, the skin-facing surface 38a of the first layer 30a of the anisotropic material can be in contact with the skin-contact layer 50. The embodiment in Figure 4 shows that, compared to the embodiment in Figure 3, the relative arrangement of the anisotropic material layer 30a and the dielectric material layer 40 is reversed between the outer adhesive layer 20 and the skin-contact layer 50. In such embodiments as Figure 4, the relative arrangement of other components in the electrode array subassembly 10, such as the circuit board 60 and the electrodes 70, may not need to be changed.

[0045] Referring to Figure 5, in some arbitrary embodiments, at least one layer 30 of the anisotropic material may include a second layer 30b of the anisotropic material. The dielectric material layer 40 can be positioned between the first and second layers 30a,b of the anisotropic material. The second layer of the anisotropic material 30b may have a skin-facing surface 38b and an opposing outward-facing surface 39b. In some embodiments, the outward-facing surface 39a of the first layer 30a of the anisotropic material may be in contact with the outer adhesive layer 20. In further embodiments, the skin-facing surface 42 of the dielectric material layer 40 may be in contact with the outward-facing surface 39b of the second layer 30b of the anisotropic material. In even further embodiments, the skin-facing surface 38b of the second layer 38b of the anisotropic material may be in contact with the skin contact layer 50.

[0046] In some arbitrary embodiments, the dielectric material layer 40 is positioned between the first layer 30a and the second layer 30b of the anisotropic material and can be in contact with both of them (Figure 5). In these embodiments, the relative arrangement of other components of the electrode array subassembly 10, such as the circuit board 60 and the metal pads 70, does not need to be changed, except for the three-layer sandwich structure (first layer 30a of anisotropic material - dielectric material layer 40 - second layer 30b of anisotropic material).

[0047] In some optional embodiments, the electrode array subassembly 10 may include wires 80 (Figure 2) electrically connected to the outer adhesive layer 20. Optionally, in these embodiments, the electrode array subassembly 10 does not include a circuit board 60 or flexible circuit. Optionally, the wires 80 may be bonded to the outer adhesive layer 20 via one or more electrodes 70 or metal layers. Optionally, or alternatively, the electrode array subassembly 10 does not include metal pads 70 or metal layers. Optionally, the wires 80 may be bonded to the outer adhesive layer 20 via a circuit board 60 or flexible circuit. Such embodiments may exist for each of the embodiments described herein.

[0048] Referring to Figure 6, the electrode array subassembly 10 may include at least one layer 30 of an anisotropic material and a layer 40 of a dielectric material. The dielectric material layer 40 may be in contact with at least the first layer 30a of the at least one layer 30 of the anisotropic material.

[0049] At least one layer 30 of anisotropic material and a layer 40 of dielectric material can be placed between opposing layers of conductive material (e.g., between the outer adhesive layer 20 and the skin contact layer 50). In various embodiments, the conductive material may optionally include a conductive gel or a conductive adhesive. In further embodiments, the conductive material may include a conductive grease. In some embodiments, one of the outer adhesive layer 20 and the skin contact layer 50 may contain conductive grease, and the other of the outer adhesive layer 20 and the skin contact layer 50 may contain a conductive gel or a conductive adhesive. In these embodiments, a cover 92 (e.g., a bandage, adhesive bandage, or other cover structure) can hold the subassembly 10 in a laminated arrangement against the patient's skin. Optionally, a bandage or other cover 92 may be used in any embodiment described herein. Except for replacing the conductive gel or conductive adhesive of the outer adhesive layer with conductive grease and adding a bandage or cover 92 as necessary, the embodiment in Figure 6 is similar to the embodiment in Figure 4, and the relative arrangement of other components of the electrode array subassembly 10, such as the circuit board 60 and electrodes 70 (e.g., metal pads), does not need to be changed. In fact, replacing the conductive gel or conductive adhesive of the outer adhesive layer with conductive grease and / or adding a bandage or cover 92 as necessary can be adopted as an additional embodiment for any and all of the other embodiments described herein. Furthermore, replacing the conductive gel or conductive adhesive of the skin contact layer with conductive grease and / or adding a bandage or cover 92 as necessary can be adopted as an additional embodiment for any and all of the other embodiments described herein.

[0050] In exemplary embodiments disclosed herein, a sheet of material having anisotropic thermal properties and / or anisotropic electrical properties (also referred to herein as the anisotropic material layer 30) is incorporated into the electrode array subassembly 10. If the sheet of material has anisotropic thermal properties (e.g., greater in-plane thermal conductivity than perpendicular to the surface), the sheet distributes heat more uniformly over a larger surface area. If the sheet of material has anisotropic electrical properties (e.g., greater in-plane conductivity than perpendicular to the surface, or conversely, lower in-plane resistance than perpendicular to the surface), the sheet distributes current more uniformly over a larger surface area. In either case, this results in a decrease in the temperature of hot spots and an increase in the temperature of cold regions when a given AC voltage is applied to the electrode array subassembly. Thus, the current can be increased (and consequently, the therapeutic effect can be increased) without exceeding a safe temperature threshold at any point on the subject's skin.

[0051] In some embodiments, the anisotropic material is anisotropic with respect to its electrical conductivity. In some embodiments, the anisotropic material is anisotropic with respect to its thermal conductivity. In some embodiments, the anisotropic material is anisotropic with respect to both its electrical conductivity and its thermal conductivity.

[0052] Anisotropic thermal properties include directional thermal properties. Specifically, the sheet has a first thermal conductivity in the direction perpendicular to its front surface. Furthermore, the thermal conductivity of the sheet in the direction parallel to the front surface is more than twice that of the first thermal conductivity. In some preferred embodiments, the thermal conductivity in the parallel direction is more than 10 times higher than that of the first thermal conductivity. For example, the thermal conductivity of the sheet in the direction parallel to the front surface may be 1.5 times, 2 times, 3 times, 5 times, 10 times, 20 times, 100 times, 200 times, or even more than 1,000 times that of the first thermal conductivity.

[0053] Anisotropic electrical properties include directional electrical properties. Specifically, a sheet has a first resistance in a direction perpendicular to its surface. Furthermore, the resistance of the sheet in a direction parallel to the front surface is lower than the first resistance. In some preferred embodiments, the resistance in the parallel direction is less than half of the first resistance, or less than 10% of the first resistance. For example, the resistance of sheet 70 in a direction parallel to the front surface may be less than 75%, 50%, 40%, 30%, 20%, 10%, 5%, 1%, 0.5%, or 0.1% of the first resistance.

[0054] In some embodiments (for example, when the anisotropic material sheet is a pyrolytic graphite sheet), the anisotropic material sheet has both anisotropic electrical properties and anisotropic thermal properties.

[0055] The use of nonmetallic anisotropic materials is particularly advantageous in situations where it is desirable to prevent the movement of ions into the subject's body. Specifically, the use of metal sheets may allow ions to enter the subject's body. For all embodiments of this specification, alternative embodiments exist that do not involve sheets of anisotropic material.

[0056] In some embodiments, the dielectric material layer 40 may have a dielectric constant of at least 10. In some arbitrary embodiments, the dielectric material layer 40 may include a high dielectric constant polymer (dielectric constant of at least 10). In an alternative embodiment, the dielectric material 40 may be a ceramic material. In an alternative embodiment, the dielectric material 40 may be a metal oxide, for example Al2O3, which can optionally be coated onto a substrate by chemical vapor deposition (CVD) and have sufficient flexibility as a thin film.

[0057] In various arbitrary embodiments, the dielectric material layer 40 can have a dielectric constant in the range of 10 to 50,000.

[0058] In some preferred embodiments, the high dielectric constant polymer material 40 comprises poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene) and / or poly(vinylidene fluoride-trifluoroethylene-1-chlorofluoroethylene). These two polymers are abbreviated herein as "poly(VDF-TrFE-CTFE)" and "poly(VDF-TrFE-CFE)," respectively. These embodiments are particularly advantageous because the dielectric constant of these materials is about 40. In some embodiments, the polymer layer can be poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene-chlorofluoroethylene) or "poly(VDF-TrFE-CTFE-CFE)."

[0059] In some embodiments, the terpolymer used in the insulating polymer layer may contain VDF, TrFE, CFE, and / or CTFE in any preferred molar ratio. A preferred terpolymer, for example, has 30-80 mol% VDF, 5-60 mol% TrFE, and CFE and / or CTFE making up the remainder of the terpolymer's molar percentage.

[0060] Figure 7 illustrates another embodiment of the electrode array subassembly 10 according to the embodiments disclosed herein. In some embodiments, one or both of the electrode array subassemblies 10 may include respective ceramic materials arranged across each electrode 70 and functioning as dielectric material 40. In any further embodiment, the skin contact layer 50 may include a hydrogel. Optionally, each skin contact layer (e.g., hydrogel or conductive gel / adhesive) can be associated with each electrode 70. For example, in the exemplary embodiment, the sheet 30 of anisotropic material is optional.

[0061] Furthermore, various embodiments can be combined to provide further embodiments of the present disclosure. For example, embodiments and components of the embodiments described with reference to Figures 3-6 can be added to or replaced with the elements shown in Figure 7. For example, in other embodiments, the electrode array subassembly 10 may include a ceramic material as the dielectric material 40 and a conductive adhesive / gel 50. Optionally, in these embodiments, each ceramic material may be arranged across each electrode 70. In yet another embodiment, the electrode array subassembly 10 may omit (not include) the dielectric material, as illustrated in Figure 8. Optionally, the embodiment in Figure 8 may have other components outlined herein. How to use an electrode array assembly

[0062] The method may include positioning the electrode array assembly 100 described in any of the preceding claims on the patient's body. A first electrode array subassembly can be applied to a first location on the patient's body, and a second electrode array subassembly can be applied to a second location on the patient's body, spaced apart along the surface of the body by a distance S measured along the surface of the electrode array assembly between the first and second electrode subassemblies. In some embodiments, when the second electrode subassembly is applied, the flexible coupling contacts the patient's body along the substantial length of the flexible coupling. In various embodiments, the electrode array assembly 100 can be positioned such that a target area (e.g., a tumor) is located between the first and second electrode array subassemblies 10a, b. For example, the first location may be on the front of the torso of the patient's body, and the second location may be on the back of the torso of the patient's body. In another embodiment, the first location may be located on the skin on the right side of the subject's head, and the second location may be located on the skin on the left side of the subject's head.

[0063] In embodiments where the flexible connection includes an adjustable strap, the length of the adjustable strap is adjustable. In some embodiments, the strap can be adjusted by a medical professional. In other embodiments, the strap can be adjusted by the patient or caregiver.

[0064] Figure 9 illustrates an exemplary system 200 for applying an electric field using an electrode array assembly 100. Using the electrode array assembly 100, an electric field can be applied between at least one electrode of a first electrode array subassembly 10a and at least one electrode of a second electrode array subassembly 10b. An AC voltage or AC current generator 210 can communicate with each electrode array subassembly 10. The AC voltage or AC current generator 210 can be configured to generate alternating electric fields through a target region (e.g., a tumor).

[0065] In some arbitrary embodiments, applying an electric field may include applying an alternating electric field having an alternating waveform in the frequency range of about 50 kHz to about 1 MHz. Optionally, in these embodiments, applying an alternating electric field can generate an electric field having an electric field strength in the range of about 0.1 V / cm to about 10 V / cm.

[0066] In some embodiments, the frequency of the AC voltage is 50 kHz to 1 MHz, or 100 kHz to 500 kHz. In some embodiments, the AC voltage generator may be controlled by a controller. The controller can use temperature measurements to control the amplitude of the current to be delivered through the electrode array subassembly 10 in order to maintain a temperature below a safety threshold (e.g., 41°C). This can be achieved, for example, by measuring a first temperature of a first electrode element, measuring a second temperature of a second electrode element, and controlling the application of the AC voltage based on the first and second temperatures, as described below.

[0067] More specifically, a temperature sensor (e.g., a thermistor) can be positioned in thermal contact with each electrode element in each of the electrode array subassemblies 10. The temperature sensor can measure the respective first and second temperatures (e.g., at the first and second electrode elements in the first and second electrode array subassemblies 10a and 10b, respectively), and the controller can control the output of the AC voltage generator based on these temperatures. By using additional temperature sensors at the locations of additional electrode elements, the temperatures of multiple electrode elements in the transducer array can be measured, and the controller can control the current applied to each electrode element according to the delta temperature compared to a threshold temperature (e.g., 41°C), thereby balancing temperature hotspots on the array.

[0068] As discussed above, the flexible coupling 110 extends between the first and second electrode array subassemblies 10a and b and can be coupled to them (Figure 9). This flexible coupling 110 can provide a gap S measured along the surface of the electrode array assembly between the first and second electrode array subassemblies. Electrode array subassembly having a layer containing conductive adhesive composite material

[0069] Optionally, the outer adhesive layer 20 and / or the skin contact layer 50 may contain a hydrogel. It is further intended that the outer adhesive layer 20 and / or the skin contact layer 50 may contain a conductive adhesive composite (described further below) instead of a hydrogel.

[0070] 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 define conductive paths through the thickness of the conductive adhesive composite. In some embodiments, the dielectric material 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. Additionally or alternatively, the conductive particles may include carbon granules. Additionally or alternatively, the conductive particles may include carbon nanotubes. Additionally or alternatively, the conductive particles may include carbon nanowires. Alternatively or additionally, the conductive particles may include carbon fibers. Additionally or alternatively, the conductive particles may include carbon black powder. In another embodiment, the conductive adhesive composite further includes a polar material (e.g., a polar salt). Examples of polar salts include quaternary ammonium salts such as tetraalkylammonium salts. Exemplary conductive adhesive composites and methods for manufacturing such conductive adhesive composites are disclosed in U.S. Patents 8,673,184 and 9,947,432, which are incorporated herein by reference for all purposes. In exemplary embodiments, the conductive adhesive composite may be a dry carbon / salt adhesive such as the OMNI-WAVE adhesive composition manufactured and sold by FLEXcon (Spencer, Massachusetts, USA). In other exemplary embodiments, the conductive adhesive composite may be the ARcare® 8006 conductive adhesive composition manufactured and sold by Adhesives Research, Inc. (Glenrock, Pennsylvania, USA).

[0071] In exemplary embodiments, the outer adhesive layer 20 and / or the skin contact layer 50 do not contain hydrogel.

[0072] In yet another embodiment, the conductive adhesive composite layer has a thickness in the range of approximately 30 μm to approximately 2000 μm, for example, 30 μm to approximately 200 μm. Optionally, the conductive adhesive composite layer of the outer adhesive layer may have a thickness in the range of approximately 30 μm to approximately 2000 μm, approximately 50 μm to approximately 1000 μm, approximately 50 μm to approximately 200 μm, or approximately 70 μm to approximately 150 μm. Optionally, the conductive adhesive composite layer of the skin contact layer may have a thickness in the range of approximately 30 μm to approximately 100 μm, approximately 30 μm to approximately 70 μm, approximately 40 μm to approximately 60 μm, or approximately 45 μm to approximately 55 μm.

[0073] In yet another embodiment, the conductive adhesive composite does not contain water.

[0074] Optionally, in exemplary embodiments, the electrode array subassembly may further include a release liner covering the skin contact layer. In these embodiments, the release liner may be provided on the electrode array subassembly to ensure that the skin contact layer does not adhere to undesirable surfaces or locations before use. Immediately before use, the release liner may be removed, and the skin contact layer may be placed in contact with the patient's skin.

[0075] Embodiments including a sheet of anisotropic material are further intended to help avoid or reduce electrode overheating and the resulting skin discomfort by dissipating both electric current and heat laterally (in a plane) rather than concentrating them directly through the layer (in a direction perpendicular to the plane of the skin contact layer). In some embodiments, the layer of anisotropic material may exist as a laminate having a layer of conductive adhesive, a layer of anisotropic material, and a layer of conductive adhesive, or may include such a laminate. Exemplary embodiments

[0076] More specifically described embodiments of the present invention will be described below in view of the products, systems, methods and variations thereof described herein. However, these particularly enumerated embodiments should not be construed as having any limiting effect on different claims, including different or more general teachings, as described herein, nor should it be construed as limiting in any way or in any way other than the inherent meaning of the language in which they are literally used.

[0077] Embodiment 1: An electrode array assembly, A first and second electrode array subassembly, each comprising at least one electrode, An electrode array assembly comprising a flexible coupling extending between and coupled to the first and second electrode array subassemblies, the flexible coupling providing a gap between the first and second electrode array subassemblies measured along the surface of the electrode array assembly.

[0078] Embodiment 2: The electrode array assembly according to Embodiment 1, wherein at least one electrode in each of the first and second electrode array subassemblies includes a plurality of electrodes.

[0079] Embodiment 3: The electrode array assembly according to Embodiment 1 or Embodiment 2, wherein the flexible coupling provides a fixed, non-adjustable gap between the first and second electrode array subassemblies, measured along the surface of the electrode array assembly.

[0080] Embodiment 4: The electrode array assembly according to Embodiment 3, wherein the fixed, non-adjustable interval is a patient-specific interval.

[0081] Embodiment 5: The electrode array assembly according to Embodiment 3, wherein the fixed, non-adjustable spacing is a patient-specific spacing that positions the first and second electrode array subassemblies across the first and second target locations in or on the patient, or across opposite sides of the same target locations in or on the patient.

[0082] Embodiment 6: The electrode array assembly according to Embodiment 1 or Embodiment 2, wherein the flexible coupling allows for adjustment of the distance between the first and second electrode array subassemblies, as measured along the surface of the electrode array assembly.

[0083] Embodiment 7: The electrode array assembly according to Embodiment 6, wherein the flexible coupling includes an adjustable strap.

[0084] Embodiment 8: The above flexible bond is, Adjustable slide strap adjustment device, or The electrode array assembly according to embodiment 7, comprising at least one of a hook material on a first portion of the flexible bond and a loop material on a second portion of the flexible bond.

[0085] Embodiment 9: The electrode array assembly according to any one of the preceding embodiments, wherein the flexible coupling has a length that allows the first electrode array subassembly to be positioned on the front of the patient's torso and the second electrode array subassembly to be positioned on the back of the patient's torso at the same time.

[0086] Embodiment 10: An electrode array assembly according to any one of the preceding embodiments, wherein the distance between the first and second electrode array subassemblies, measured along the surface of the electrode array assembly, is approximately 0.05 m to approximately 1.5 m.

[0087] Embodiment 11: An electrode array assembly according to any one of the prior embodiments, further comprising a first electrical lead wire and a second electrical lead wire, wherein each electrode of at least one electrode of the first electrode array subassembly communicates electrically with the first electrical lead wire, and each electrode of at least one electrode of the second electrode array subassembly communicates electrically with the second electrical lead wire.

[0088] Embodiment 12: An electrode array assembly according to any one of the prior embodiments, wherein each of the first and second electrode array subassemblies includes a flexible circuit extending between each electrode of the at least one electrode of the electrode array subassembly.

[0089] Embodiment 13: The electrode array assembly according to any one of the prior embodiments, wherein the flexible bond includes a cover material that extends across the outward-facing sides of each of the first and second electrode array subassemblies.

[0090] Embodiment 14: The electrode array assembly according to any one of the preceding embodiments, wherein the distance between the first and second electrode array subassemblies, measured along the surface of the electrode array assembly, is the shortest distance between any one of the at least one electrodes of the first electrode array subassembly and any one of the at least one electrodes of the second electrode array subassembly, measured along the surface of the electrode array assembly.

[0091] Embodiment 15: An electrode array assembly according to any one of the preceding embodiments, wherein each of the first and second electrode array subassemblies includes a skin contact layer configured to be positioned between at least one electrode of the respective array subassembly and the patient's skin.

[0092] Embodiment 16: The electrode array assembly according to Embodiment 15, wherein the skin contact layer of each of the first and second electrode array subassemblies comprises a conductive gel or conductive adhesive.

[0093] Embodiment 17: The electrode array assembly according to Embodiment 15, wherein the skin contact layer of each of the first and second electrode array subassemblies comprises a conductive adhesive.

[0094] Embodiment 18: An electrode array assembly according to any one of embodiments 15 to 17, wherein each of the first and second electrode array subassemblies includes a dielectric material disposed between the electrode and the skin contact layer.

[0095] Embodiment 19: The electrode array assembly according to Embodiment 18, wherein the dielectric material comprises a polymer.

[0096] Embodiment 20: The electrode array assembly according to Embodiment 18, wherein the dielectric material includes ceramic.

[0097] Embodiment 21: An electrode array assembly according to any one of Embodiments 1 to 17, wherein at least one of the first and second electrode array subassemblies does not contain a dielectric material between the electrode and the skin contact layer.

[0098] Embodiment 22: Each of the first and second electrode array subassemblies is: A layer of an anisotropic material having a skin-facing surface and an opposing outward-facing surface, A skin contact layer, The above at least one electrode is in electrical contact with the above outward-facing surface of the anisotropic material layer. The electrode array assembly according to any one of the preceding embodiments, wherein the skin contact layer is disposed on the skin-facing side of the anisotropic material layer.

[0099] Embodiment 23: The electrode array assembly according to Embodiment 22, wherein the layer of anisotropic material is synthetic graphite.

[0100] Embodiment 24: The electrode array assembly according to any one of Embodiments 22 to 23, wherein the layer of the anisotropic material is a sheet of pyrolytic graphite.

[0101] Embodiment 25: The electrode array assembly according to any one of Embodiments 22 to 24, wherein the layer of the anisotropic material is a graphitized polymer film or graphite foil manufactured from compressed high-purity exfoliated mineral graphite.

[0102] Embodiment 26: The anisotropic material layer is a first layer of anisotropic material, and each of the first and second electrode array subassemblies is The second layer of anisotropic material, An electrode array assembly according to any one of embodiments 22 to 25, comprising a dielectric between the first and second layers of anisotropic material.

[0103] Embodiment 27: The electrode array assembly according to any one of Embodiments 22 to 26, wherein the layer of the anisotropic material has a first thermal conductivity in a direction perpendicular to the plane of the layer, and the thermal conductivity of the layer in a direction parallel to the plane of the layer is twice or more than 10 times higher than the first thermal conductivity.

[0104] Embodiment 28: The electrode array assembly according to any one of Embodiments 22 to 27, wherein the layer of anisotropic material has a first resistance in a direction perpendicular to the plane of the layer, and the resistance of the layer in a direction parallel to the plane of the layer is less than half or less than 10% of the first resistance.

[0105] Embodiment 29: The electrode array assembly according to any one of Embodiments 22 to 28, wherein the skin contact layer is arranged on the skin-facing surface of the anisotropic material layer.

[0106] Embodiment 30: The electrode array assembly according to any one of the preceding embodiments, further comprising an upper adhesive layer containing a conductive adhesive composite, wherein the upper adhesive layer is positioned on the outward side of the layer of anisotropic material.

[0107] Embodiment 31: The electrode array assembly according to any one of the prior embodiments, further comprising at least one additional strap extending between the first and second electrode array subassemblies.

[0108] Embodiment 32: The electrode array subassembly according to Embodiment 31, wherein the at least one additional strap is coupled to the first and second electrode array subassemblies.

[0109] Embodiment 33: The electrode array subassembly according to Embodiment 31, wherein the at least one additional strap compressively holds the first and second electrode array subassemblies to the patient.

[0110] Embodiment 34: A system, A plurality of electrode array assemblies comprising at least a first electrode assembly and a second electrode assembly, wherein each of the plurality of electrode array assemblies comprises at least a first electrode array subassembly and a second electrode array subassembly, and a flexible coupling extending between the first and second electrode array subassemblies and coupled thereto, The present electrode assembly includes at least one additional strap extending between the first electrode array subassembly of the first electrode assembly and the first electrode array subassembly of the second electrode assembly, The system wherein each of the first and second electrode array subassemblies includes at least one electrode, and the flexible coupling provides a distance between the first and second electrode array subassemblies measured along the surface of the electrode array assembly.

[0111] Embodiment 35: The system according to Embodiment 34, wherein the at least one additional strap compressively extends from the patient's torso and holds at least the first electrode array subassembly of the first electrode assembly and the first electrode array subassembly of the second electrode assembly to the patient's torso.

[0112] Embodiment 36: A method, A method comprising placing the electrode array assembly described in any one of the preceding claims on the body of a patient.

[0113] Embodiment 37: Arranging the electrode array assembly is Applying the above-mentioned first electrode array subassembly to a first location on the patient's body, The method according to embodiment 36, further comprising applying the second electrode array subassembly described above to a second location on the patient's body, spaced apart along the surface of the body by an amount measured along the surface of the electrode array assembly between the first and second electrode subassemblies.

[0114] Embodiment 38: The method according to Embodiment 37, wherein, when the second electrode assembly is applied, the flexible coupling contacts the patient's body along substantially the entire length of the flexible coupling.

[0115] Embodiment 39: The method according to Embodiment 37 or 38, wherein the first position is located on the front of the torso of the patient's body, and the second position is located on the back of the torso of the patient's body.

[0116] Embodiment 40: The method according to any one of Embodiments 36 to 39, wherein the flexible coupling includes an adjustable strap, and the method further includes adjusting the length of the adjustable strap.

[0117] Embodiment 41: The method according to any one of embodiments 36 to 40, further comprising applying an electric field between the at least one electrode of the first electrode array subassembly and the at least one electrode of the second electrode array subassembly.

[0118] Embodiment 42: The method according to Embodiment 41, wherein applying the above-mentioned electric field includes applying an AC electric field having an AC waveform in the frequency range of about 50 kHz to about 1 MHz, and generating an electric field having an electric field strength in the range of about 0.1 V / cm to about 10 V / cm.

[0119] Embodiment 43: An electrode array assembly, A plurality of electrode array subassemblies, wherein each of the plurality of electrode array subassemblies includes at least a first electrode array subassembly and a second electrode array subassembly, and each electrode array subassembly of the plurality of electrode array subassemblies includes at least one electrode, An electrode array assembly comprising a flexible coupling extending between and coupled to the first and second electrode array subassemblies, the flexible coupling providing a gap between the first and second electrode array subassemblies measured along the surface of the electrode array assembly.

[0120] Appearance 44: A method, The electrode array assembly, which includes placing the electrode array assembly on the patient's body, A plurality of electrode array subassemblies, wherein each of the plurality of electrode array subassemblies includes at least a first electrode array subassembly and a second electrode array subassembly, and each electrode array subassembly of the plurality of electrode array subassemblies includes at least one electrode, and the plurality of electrode array assemblies A method comprising a flexible coupling extending between and coupled to the first and second electrode array subassemblies, wherein the flexible coupling provides a gap between the first and second electrode array subassemblies measured along the surface of the electrode array assemblies.

[0121] Embodiment 45: Arranging the electrode array assembly is Applying the above-mentioned first electrode array subassembly to a first location on the patient's body, The method according to embodiment 44, further comprising applying the second electrode array subassembly described above to a second location on the patient's body, spaced apart along the surface of the body by an amount measured along the surface of the electrode array assembly between the first and second electrode subassemblies.

[0122] Embodiment 46: The method of Embodiment 45, wherein, when the second electrode assembly is applied, the flexible coupling contacts the patient's body along substantially the entire length of the flexible coupling.

[0123] Embodiment 47: The method according to Embodiment 45 or 46, wherein the first position is located on the front of the torso of the patient's body, and the second position is located on the back of the torso of the patient's body.

[0124] Embodiment 48: The method according to any one of Embodiments 45 to 47, wherein the flexible coupling includes an adjustable strap, and the method further includes adjusting the length of the adjustable strap.

[0125] Embodiment 49: The method according to any one of embodiments 45 to 48, further comprising applying an electric field between the at least one electrode of the first electrode array subassembly and the at least one electrode of the second electrode array subassembly.

[0126] Embodiment 50: The method according to Embodiment 49, wherein applying the above-mentioned electric field includes applying an AC electric field having an AC waveform in the frequency range of approximately 50 kHz to approximately 1 MHz.

[0127] 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 present invention is not limited to the described embodiments and is intended to encompass the entire scope defined by the following claims and their equivalents.

Claims

1. An electrode array assembly, A first and second electrode array subassembly, each comprising at least one electrode, An electrode array assembly comprising a flexible coupling extending between and coupled to the first and second electrode array subassemblies, the flexible coupling providing a gap between the first and second electrode array subassemblies measured along the surface of the electrode array assembly.

2. The electrode array assembly according to claim 1, wherein the at least one electrode in each of the first and second electrode array subassemblies comprises a plurality of electrodes.

3. The electrode array assembly according to claim 1, wherein the flexible coupling provides a fixed, non-adjustable gap between the first and second electrode array subassemblies, measured along the surface of the electrode array assembly.

4. The electrode array assembly according to claim 3, wherein the fixed, non-adjustable interval is a subject-specific interval.

5. The electrode array assembly according to claim 3, wherein the fixed, non-adjustable spacing is a subject-specific spacing that positions the first and second electrode array subassemblies across first and second target positions in or on the subject, or across opposite sides of the same target positions in or on the subject.

6. The electrode array assembly according to claim 1, wherein the flexible coupling allows for adjustment of the distance between the first and second electrode array subassemblies, as measured along the surface of the electrode array assembly.

7. The electrode array assembly according to claim 6, wherein the flexible coupling includes an adjustable strap.

8. The aforementioned flexible bond is Adjustable slide strap adjustment device, or The electrode array assembly according to claim 7, comprising at least one of a hook material on a first portion of the flexible bond and a loop material on a second portion of the flexible bond.

9. The electrode array assembly according to claim 1, wherein the flexible coupling has a length that allows the first electrode array subassembly to be positioned at the front of the torso of a subject and the second electrode array subassembly to be positioned at the back of the torso of the subject.

10. The electrode array assembly according to claim 1, wherein the distance between the first and second electrode array subassemblies, measured along the surface of the electrode array assembly, is approximately 0.05 m to approximately 1.5 m.

11. The electrode array assembly according to claim 1, further comprising at least one additional strap extending between the first and second electrode array subassemblies.

12. The electrode array assembly according to claim 11, wherein the at least one additional strap is coupled to the first and second electrode array subassemblies.

13. The electrode array assembly according to claim 11, wherein the at least one additional strap compressively holds the first and second electrode array subassemblies to the subject.

14. It is a system, A plurality of electrode array assemblies comprising at least a first electrode assembly and a second electrode assembly, wherein each of the plurality of electrode array assemblies comprises at least a first electrode array subassembly and a second electrode array subassembly, and a flexible coupling extending between the first and second electrode array subassemblies and coupled thereto, The present invention includes at least one additional strap extending between the first electrode array subassembly of the first electrode assembly and the first electrode array subassembly of the second electrode assembly, A system in which each of the first and second electrode array subassemblies includes at least one electrode, and the flexible coupling provides a distance between the first and second electrode array subassemblies measured along the surface of the electrode array assembly.

15. The system according to claim 14, wherein the at least one additional strap compressively extends around the torso of the subject and holds at least the first electrode array subassembly of the first electrode assembly and the first electrode array subassembly of the second electrode assembly to the torso of the subject.

16. It is a method, This includes placing an electrode array assembly on the body of a subject, wherein the electrode array assembly is A plurality of electrode array subassemblies, wherein the plurality of electrode array subassemblies include at least a first electrode array subassembly and a second electrode array subassembly, and each electrode array subassembly of the plurality of electrode array subassemblies includes at least one electrode, A method comprising a flexible coupling extending between and coupled to the first and second electrode array subassemblies, wherein the flexible coupling provides a distance between the first and second electrode array subassemblies measured along the surface of the electrode array assemblies.

17. The electrode array assembly is positioned as follows: Applying the first electrode array subassembly to the first position on the subject's body, The method according to claim 16, further comprising applying the second electrode array subassembly to a second location on the body of the subject, spaced apart along the surface of the body by an amount measured along the surface of the electrode array assembly between the first and second electrode subassemblies.

18. The method according to claim 17, wherein, when the second electrode assembly is applied, the flexible coupling contacts the subject's body along substantially the entire length of the flexible coupling.

19. The method according to claim 17, wherein the first position is located on the front of the torso of the subject's body, and the second position is located on the back of the torso of the subject's body.

20. The method according to claim 16, wherein the flexible coupling includes an adjustable strap, and the method further includes adjusting the length of the adjustable strap.

Images