Replaceable adhesive subassemblies, systems, and methods for applying tumortreating fields

Abstract

This invention provides an assembly for delivering a tumor therapeutic electric field to a patient's body, which may include an electrode subassembly and one or more replaceable adhesive subassemblies. Each adhesive subassembly may have a support layer having a first side and a second side. The support layer may define at least one opening. Each electrode of the electrode subassembly may be received within a respective opening of the at least one opening. A first adhesive may be disposed on the first side of the support layer and may couple the support layer to the inside of the cover layer of the electrode subassembly at an attachment surface of the cover layer. A biocompatible conductive adhesive may be disposed on the second side of the support layer.

Description

Technical Field

[0001] This disclosure relates to apparatus, systems, and methods for providing an electric field for tumor treatment, and more particularly to apparatus, systems, and methods for providing an electrode assembly and a replaceable adhesive subassembly to an individual's body, the replaceable adhesive subassembly being used to fix the electrode subassembly. [Cross-reference to related applications] []

[0002] This application claims priority and benefit on the filing date of U.S. Provisional Patent Application No. 63 / 284,357, filed November 30, 2022, the entire contents of which are incorporated herein by reference for all purposes. Prior Technology

[0003] Tumor-Treating Fields (TTFs) can be used to treat various types of cancer. For example, TTFs can be applied to a part of an individual's body via one or more electrode / transducer arrays. Typically, the electrode array is coupled to a signal generator that produces the TTF in the transducer array. Summary of the Invention

[0004] Among various embodiments, this document describes an assembly for delivering a tumor therapeutic electric field to a patient's body. The assembly may include an electrode subassembly comprising a circuit layer having inner and outer surfaces facing the skin. A plurality of electrodes may be disposed on the inner surface of the circuit layer and electrically coupled to the circuit layer. Each of the plurality of electrodes may have an electrode tip. A capping layer may have inner and outer surfaces. The inner surface of the capping layer may be disposed on the outer surface of the circuit layer. A portion of the inner surface of the capping layer may extend beyond the circuit layer and beyond the edges of each of the electrodes to define at least one attachment surface. The assembly may further include at least one replaceable adhesive subassembly comprising a support layer having a first side and a second side. The support layer may define at least one opening. Each of the plurality of electrodes may be received within a separate opening of the at least one opening. A first adhesive may be disposed on the first side of the support layer and may couple the support layer to the inner surface of the capping layer of the electrode subassembly at at least one attachment surface of the capping layer. A biocompatible conductive adhesive can be placed on the second side of the support layer.

[0005] Additional advantages of the invention will be set forth in part in the description which follows, and in part will be apparent from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and obtained by means of the essential elements and combinations specifically pointed out in the appended claims. As claimed, it should be understood that both the foregoing general description and the following detailed description are illustrative and explanatory only, and do not limit the invention. Simple Explanation of the Diagram

[0006] These and other features of the preferred embodiment of the present invention will become more apparent in the detailed description with reference to the accompanying drawings, in which:

[0007] [Figure 1] is an exploded view of the assembly used to deliver a tumor therapeutic electric field to a patient's body.

[0008] [Figure 2] is an exploded view of the replaceable adhesive subassembly of the assembly in Figure 1.

[0009] [Figure 3] is a schematic cross-sectional view of the replaceable adhesive subassembly taken along plane 3-3 of Figure 2.

[0010] [Figure 4A] is a perspective view of the second release liner removed from the replaceable adhesive subassembly as shown in Figure 3. [Figure 4B] is a perspective view of the replaceable adhesive subassembly applied to the electrode subassembly to provide the assembly as shown in Figure 1. [Figure 4C] is a perspective view of the first release liner removed from the replaceable adhesive subassembly to expose the biocompatible conductive adhesive. [Figure 4D] is a perspective view of the user applying the assembly to the body. [Figure 4E] is a perspective view showing the vest applied over the assembly. [Figure 4F] is a perspective view of the user removing the replaceable adhesive subassembly from the electrode subassembly.

[0011] [Figure 5] is a block diagram of a device for delivering TTField according to a specific example disclosed herein. Implementation

[0012] Tumor therapeutic electric fields (TTF) can be used to treat various types of cancer. For example, TTF can be applied to a part of an individual's body via one or more electrode / transducer arrays. Typically, the electrode array is coupled to a signal generator that produces the TTF within the transducer array. Conventionally, hydrogels are provided on the skin-facing portions of the electrodes to conduct electrical signals into the individual's body. However, hydrogels can have a short lifespan, after which the electrode array must be disposed of. The need to update, replenish, or replace the adhesive layer without discarding the electrodes and the entire electrode array is costly. The invention disclosed herein addresses this and other important issues.

[0013] The invention will now be described more fully below with reference to the accompanying drawings, which illustrate certain, but not all, specific examples of the invention. In fact, the invention may be embodied in many different forms and should not be construed as limited to the specific examples set forth herein; rather, these specific examples are provided so that this disclosure will satisfy applicable legal requirements. The same numerals throughout the text refer to the same elements. It should be understood that the invention is not limited to the specific methods and protocols described, as they are subject to variation. It should also be understood that the terminology used herein is for the purpose of describing specific examples only and is not intended to limit the scope of the invention.

[0014] Many modifications and other specific examples of the invention set forth herein will come to mind by those skilled in the art, which are beneficial to the teachings presented in the description and related drawings herein. Therefore, it should be understood that the invention is not limited to the specific examples disclosed, and that modifications and other specific examples are intended to be included within the scope of the appended claims. Although specific terminology is used herein, it is used in a general and descriptive sense only and not for limiting purposes.

[0015] Unless the context clearly specifies otherwise, as used herein, the singular forms “a,” “an,” and “the” include the plural of indicators. For example, the use of the terms “electrode” or “replaceable adhesive subassembly” may refer to one or more of the electrode or the replaceable adhesive subassembly.

[0016] Unless otherwise expressly indicated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0017] Ranges may be expressed herein as “about” a particular value and / or “about” another particular value. When such ranges are expressed, another state includes from one particular value and / or to another particular value. Similarly, when values ​​are expressed as approximations by using the prefix “about”, it should be understood that the particular value forms another state. It should be further understood that the endpoints of each range are important both relative to and independent of the other endpoint. Where necessary, in some states, when approximations are made by using the prefix “about”, it is expected that values ​​up to 15%, up to 10%, up to 5%, or up to 1% (above or below) of a particular stated value may be included within the range of those states. Similarly, in some states chosen where necessary, when approximations are made by using the terms “substantially” or “generally”, it is expected that values ​​up to 15%, up to 10%, up to 5%, or up to 1% (above or below) of a particular value may be included within the range of those states. When used in relation to the identified attribute or situation, "substantially" or "proportionately" may refer to a sufficiently small degree of deviation so as not to measurably diminish the identified attribute or situation, and in some cases, the permissible degree of accurate deviation may depend on the specific context.

[0018] As used herein, "optional" or "optionally" means that the event or situation described below may or may not occur, and the description includes both the occurrence of the event or situation and the absence of the event or situation.

[0019] As used herein, the term "at least one of" is intended to be synonymous with "one or more of". For example, "at least one of A, B and C" explicitly includes only A, only B, only C, and combinations thereof.

[0020] As used herein, the term "or" means any component of a particular list, and unless otherwise indicated, any combination of components of that list may also be included in an alternative sample.

[0021] It should be understood that, unless otherwise expressly stated, no method described herein is intended to be construed as requiring its steps to be performed in a specific order. Therefore, unless a method claim actually lists the order in which its steps will be followed or otherwise specifically states in the claims or description that such steps are limited to a specific order, no inference should be made in any way regarding the order. This does not constitute a basis for any possible ambiguity in interpretation, including: logical matters concerning the arrangement of steps or the flow of operations; general meanings derived from grammatical organization or punctuation; and the number or type of states described in the specification.

[0022] The headings are provided for convenience only and should not be construed as limiting the invention in any way. Specific examples illustrated under any heading or in any part of this disclosure may be combined with specific examples illustrated under the same or any other heading or in other parts of this disclosure.

[0023] Unless otherwise indicated herein or otherwise clearly contradicted by the context, this invention covers any combination of the elements described herein and all possible variations thereof.

[0024] Figure 5 illustrates an example device 100 for electrotherapy. Generally, device 100 may be a portable battery- or power-operated device that generates an alternating electric field within the body via a transducer array or other electrodes. Device 100 may include an electric field generator 112 and one or more electrode (e.g., transducer) arrays (e.g., assembly 10), each comprising a plurality of electrodes 20. Device 100 may be configured to generate a tumor treating electric field (TTField) via electric field generator 112, the frequency of which is, for example, in the range of about 50 kHz to about 1 MHz, such as 50 kHz to about 500 kHz (e.g., about 150 kHz for one tumor cell type, and / or about 300 kHz for different tumor cell types), and deliver the TTField to a region of the body via one or more electrode arrays 10. Electric field generator 112 may be a battery- and / or power-operated device.

[0025] The electric field generator 112 may include a processor 116 that communicates with the signal generator 118. The electric field generator 112 may include control software 120 configured to control the performance of the processor 116 and the signal generator 118.

[0026] Signal generator 118 can generate one or more electrical signals in the form of a waveform or a pulse train. Signal generator 118 can be configured to generate an AC voltage waveform (e.g., TTField) at frequencies ranging from about 50 kHz to about 500 kHz (preferably, from about 100 kHz to about 300 kHz). The voltage causes the electric field strength in the tissue to be treated to typically range from about 0.1 V / cm to about 10 V / cm.

[0027] One or more outputs 124 of the electric field generator 112 may be coupled to one or more conductive leads 122, which are attached at one end to a signal generator 118. The opposite ends of the conductive leads 122 are connected to one or more electrode arrays 10 activated by an electrical signal (e.g., a waveform). The conductive leads 122 may comprise standard insulated conductors with flexible metal sheaths and may be grounded to prevent the propagation of the electric field generated by the conductive leads 122. The one or more outputs 124 may operate sequentially. Output parameters of the signal generator 118 may include, for example, the intensity of the electric field, the frequency of the wave (e.g., a treatment frequency), and the maximum permissible temperature of one or more electrode arrays 10. The output parameters may be set and / or determined by control software 120 in conjunction with processor 116. After determining the desired (e.g., optimal) treatment frequency, the control software 120 may cause the processor 116 to send a control signal to the signal generator 118, which in turn causes the signal generator 118 to output the desired treatment frequency to one or more electrode arrays 10. Further consideration may be given to the control software 120 causing the processor 116 to shift or change the orientation of the TTField or otherwise adjust the properties of the TTField in a manner further disclosed herein.

[0028] Among various configurations, and referring to Figures 1 through 3, this document discloses an assembly 10 for delivering a tumor therapeutic electric field to a patient's body. The assembly 10 may include an electrode subassembly 12 containing a circuit layer 14 (Figure 1) having an inner side 16 and an outer side 18 facing the skin. The circuit layer 14 may include, for example, flexible circuitry that allows the outline of the circuit layer 14 to extend to the patient's body. If desired, the circuit layer 14 may include a printed circuit board (PCB).

[0029] A plurality of electrodes 20 may be disposed on the inner side 16 of the circuit layer 14 and electrically coupled to the circuit layer. Each of the plurality of electrodes 20 may have a terminal 22. For example, the terminal 22 may define the perimeter of the electrode 20.

[0030] The electrode subassembly 12 may further include a cover layer 24 having an inner side 26 and an outer side 28. The inner side 26 of the cover layer 24 may be coupled to the outer side 18 of the circuit layer 14. For example, the cover layer 24 may be positioned over (e.g., disposed on) all or part of the circuit layer 14, with the outer side 18 of the circuit layer 14 opposite to the inner side 26 of the cover layer 24. In some optional configurations, an adhesive may couple the inner cover layer 24 to the circuit layer. A portion of the inner side 26 of the cover layer 24 may extend beyond (e.g., outward) the circuit layer 14 and beyond (e.g., outward) the electrode terminals 22 of each of the electrodes 20 to define at least one attachment surface 30.

[0031] The assembly 10 for delivering a tumor therapeutic electric field may further include one or more replaceable adhesive subassemblies 32 (Figures 1 to 3). One or more replaceable adhesive subassemblies 32 may include a support layer 34 (Figures 2 to 3) having a first side 36 and a second side 38 (Figure 3). The support layer 34 may define at least one opening 40 extending therethrough. Each of the plurality of electrodes 20 may be received within a separate opening 40. In various configurations, the support layer may define 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more openings 40 for receiving individual electrodes 20.

[0032] The first adhesive 42 (Figures 2 and 3) may be disposed on the first side 36 of the support layer 34 of the adhesive subassembly 32, and the support layer 34 of the adhesive subassembly 32 may be coupled to the inner side 26 of the cover layer 24 of the electrode subassembly 12 at at least one attachment surface 30 of the cover layer 24 of the electrode subassembly 12. Alternatively, when not coupled to the electrode subassembly 12, the first adhesive 42 may be covered by a release liner 74 (Figures 2 and 3), discussed below (and referred to as the second release liner).

[0033] In some embodiments, the first adhesive 42 may be a non-permanent adhesive configured to allow release from at least one attachment surface of the cover layer 24 of the electrode subassembly 12. In some embodiments, the first adhesive 42 may have a stronger bond to the support layer 34 than to the cover layer 24. For example, the first adhesive may form a bond with stronger peel strength (e.g., as measured by ASTM D3330 / D3330M) at the interface between the first adhesive 42 and the cover layer 24 than at the interface between the first adhesive 42 and the support layer 34. In this way, the replaceable adhesive subassembly 32 can be removed from the electrode subassembly 12 to replace the replaceable adhesive subassembly and reuse the electrode subassembly 12. In various forms, the first adhesive may be an acrylic adhesive as known in the art, such as homopolymer polybutyl acrylate (pBA) or homopolymer polyethylhexyl acrylate (pEHA), or a copolymer containing polymeric units of BA or EHA or both, polymerized with or without other monomers that may or may not be acrylic monomers. As used in the art, the term acrylic monomer refers to esters of acrylic acid, methacrylic acid, icosinic acid, etc., and as used herein, also refers to acrylic monomers (acrylic acid, methacrylic acid, icosinic acid, etc.).

[0034] A biocompatible conductive adhesive 44 may be disposed on a second side 38 of the support layer 34. The biocompatible conductive adhesive 44 may extend across each of the openings 40 in one or more openings of the support layer. In this way, the biocompatible conductive adhesive 44 may be applied to an electrode 20 received within the openings 40 of the support layer 34. The biocompatible conductive adhesive 44 may be, for example, a hydrogel. A suitable hydrogel is AG603 hydrogel available from AmGel Technologies, Fallbrook, CA, USA. The hydrogel layer may be a modified hydrogel (e.g., having perforations, recesses, protrusions, or combinations thereof) as detailed in U.S. Patent Application No. 17 / 313,114 entitled "Conductive Pad Generating Tumor Treating Field and Methods of Production and Use Thereof," the entire contents of which are hereby incorporated.

[0035] In other samples, the biocompatible conductive adhesive 44 may be or comprise a conductive adhesive complex. In exemplary samples, the conductive adhesive complex may comprise a dielectric material and conductive particles dispersed within the dielectric material. In some specific instances, at least a portion of the conductive particles defines a conductive path through the thickness of the conductive adhesive complex. It is anticipated that the conductive particles may align in response to an applied electric field, causing the conductive particles to undergo electrophoresis. In some samples, the dielectric material of the conductive adhesive complex is a polymeric adhesive. If desired, in these samples, the polymeric adhesive may be an acrylic adhesive as described above. In some samples, the conductive particles may comprise carbon. If desired, in these samples, the conductive particles may comprise graphite powder. Alternatively or alternatively, the conductive particles may comprise carbon sheets. Alternatively or alternatively, the conductive particles may comprise carbon particles. Alternatively or alternatively, the conductive particles may comprise carbon nanotubes or carbon nanowires. Alternatively or alternatively, the conductive particles may comprise carbon black powder. Alternatively or concurrently, the conductive particles may comprise carbon microcoils. In another embodiment, the conductive adhesive compound further comprises a polar material (e.g., a polar salt). The polar salt may be a quaternary ammonium salt, such as a tetraalkylammonium salt. Exemplary conductive adhesive compounds and methods for preparing such conductive adhesive compounds are disclosed in U.S. Patent Nos. 8,673,184 and 9,947,432, which are incorporated herein by reference for all purposes. In the exemplary embodiment, the conductive adhesive compound may be an anhydrous carbon / salt adhesive, such as the OMNI-WAVE™ adhesive composition manufactured and sold by FLEXcon® (Spencer, MA, USA). Other conductive adhesive compounds may also be suitable, such as the ARcare® 8006 conductive adhesive composition manufactured and sold by Adhesives Research, Inc. (Glen Rock, PA, USA). Such similar adhesives may also be used as the first adhesive 42 discussed above (Figure 3). []

[0036] In some optional configurations, the replaceable adhesive subassembly 32 may include a second adhesive 46 disposed on a second side 38 of the support layer 34. The second adhesive 46 can adhere the biocompatible conductive adhesive 44 to the support layer 34. In other optional configurations, the second adhesive 46 may be omitted.

[0037] In some exemplary embodiments, the support layer 34 may comprise foam (e.g., polymer foam) or other suitable material that is flexible and provides sufficient thickness to accommodate the electrode, such as an elastomer or rubber. In this way, the support layer 34 can be flexible while providing sufficient thickness to accommodate the electrode 20. The support layer 34 may have a thickness greater than or less than that of the electrode 20, but in some exemplary embodiments, it has the same or substantially the same thickness.

[0038] The biocompatible conductive adhesive 44 may have a first side 50 positioned against the support layer 34 (or against the second adhesive 46, if present) and an opposing second side 52. In some optional configurations, a first release liner 54 may be disposed on the opposing second side 52 of the biocompatible conductive adhesive 44.

[0039] In some optional configurations, circuit layer 14 (FIG. 1) may include a trunk structure 56 extending along a longitudinal axis 58 and a plurality of branches 60 extending laterally from the trunk structure. Each of the plurality of branches 60 may have a proximal end 62 connected to the trunk structure 56 and a relatively distal end 64 spaced outward from the trunk structure.

[0040] In some embodiments, one or more of electrodes 20 (all, if necessary) may be reusable ceramic electrodes. In other embodiments, one or more of electrodes 20 (all, if necessary) may be reusable high-dielectric polymer electrodes.

[0041] The cover layer 24 of the electrode subassembly 12 defines a first peripheral profile. The support layer 34 defines a second peripheral profile. At least a portion of the first peripheral profile of the cover layer 24 corresponds to at least a portion of the second peripheral profile of the support layer 34. For example, the second peripheral profile may have an arc length corresponding to at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or substantially all or all of the arc length of the first peripheral profile. As used herein, the term "arc length" refers to the length of a curve or perimeter that traces the peripheral profile of a given element. Therefore, the arc length of the first peripheral profile refers to the length of a curve or perimeter that depicts the first peripheral profile, and the arc length of the second peripheral profile refers to the length of a curve or perimeter that depicts the second peripheral profile.

[0042] As needed, assembly 10 may include a plurality of replaceable adhesive subassemblies 32 covering individual portions of the cover layer 24. For example, assembly 10 may include 2, 3, 4, 5, 6, 7, 8 or more replaceable adhesive subassemblies 32 forming a set of replaceable adhesive subassemblies. The set 72 of replaceable adhesive subassemblies 32 may receive and / or provide a biocompatible conductive adhesive 44 to cover each of the electrodes 20 of the electrode subassembly 12. That is, the replaceable adhesive subassemblies 32 of a set 72 may cooperate with the electrode subassembly 12 to form assembly 10. As needed, two or more of the plurality of replaceable adhesive subassemblies 32 in set 72 may be substantially similar or identical to each other. For example, as shown in Figure 1, a collection 72 of a plurality of replaceable adhesive subassemblies 32 may include two of the first replaceable adhesive subassemblies 32a and three of the second replaceable adhesive subassemblies 32b, which are different from the first replaceable adhesive subassemblies. The different replaceable adhesive subassemblies 32 may differ in their peripheral contours, the number of openings 40 for receiving the electrodes 20, etc. For example, the first replaceable adhesive subassembly 32a may be configured to receive and / or provide a biocompatible conductive adhesive to cover two electrodes, and the second replaceable adhesive subassembly 32b may be configured to receive and / or provide a biocompatible conductive adhesive to cover three electrodes. In some specific instances (not shown in the figure), the replaceable adhesive subassemblies 32 may be configured to receive and / or provide a biocompatible conductive adhesive to cover a single electrode. In other configurations, all replaceable adhesive subassemblies 32 of assembly 10 may be identical. In other configurations selected as needed, assembly 10 may include a single replaceable adhesive subassembly 32. Therefore, in some configurations selected as needed, assembly 72 may have only one replaceable adhesive subassembly 32.

[0043] System 70 (FIG. 1) may include an electrode subassembly 12 as disclosed herein and at least one replaceable adhesive subassembly 32. In some embodiments, system 70 may include a plurality of replaceable adhesive subassemblies 32. In some optional embodiments, system 70 may include a first set 72 of replaceable adhesive subassemblies 32 and one or more sets of replaceable adhesive subassemblies that can be used as replacement adhesive subassemblies to replace used replaceable adhesive subassemblies. Thus, the replaceable adhesive subassemblies may be structurally similar to or identical to the replaceable adhesive subassemblies 32 described herein. For example, it is anticipated that the replaceable adhesive subassemblies may include a support layer having a first side and a second side, the support layer defining at least one opening configured to receive each electrode of the electrode subassembly therein. A first adhesive may be disposed on a first side of the support layer of the replacement adhesive subassembly and may be configured to couple the support layer to the cover layer of the electrode subassembly at at least one attachment surface of the cover layer. A biocompatible conductive adhesive may be disposed on a second side of the support layer.

[0044] As disclosed above, it is anticipated that a plurality of replaceable adhesive subassemblies 32 may cover individual portions of the cover layer 24, such that assembly 72 receives and / or provides a biocompatible conductive adhesive to cover each of the electrodes 20 of the electrode subassembly 12. For example, as illustrated in FIG1, the assembly may include two replaceable adhesive subassembly assemblies 32a and three replaceable adhesive subassembly assemblies 32b. It is anticipated that system 70 may include a plurality of assemblies 72 of replaceable adhesive subassemblies 32, wherein each assembly is configured to receive and / or provide a biocompatible conductive adhesive to cover each of the electrodes 20 of the electrode subassembly 12. In some embodiments, system 70 may include a plurality of (e.g., 10, 20, 30, 40 or more) replaceable adhesive subassemblies. For example, system 70 may include one or more assemblies of replaceable adhesive subassemblies 72 used as replaceable adhesive subassemblies. The number of replaceable adhesive subassemblies 32 or the number of sets 72 of replaceable adhesive subassemblies used to replace the adhesive subassemblies may vary depending on the frequency at which they may need to be replaced and the intended duration of treatment. Adhesive subassemblies may need to be replaced daily or every 2 to 3 days. []

[0045] The first adhesive 42 may have a first side 43 facing the support layer 34 and an opposite second side 45 (FIG. 3). In some embodiments, a second release liner 74 may be disposed on the opposite second side 45 of the first adhesive 42 (e.g., positioned against the opposite second side). In some embodiments, at least a portion of the second release liner 74 may extend outward from the second peripheral profile of the support layer 34 to provide a tab 76 (FIG. 2) for removing the second release liner from the replaceable adhesive subassembly 32. Similarly, at least a portion of the first release liner 54 may extend outward from the second periphery of the support layer 34 to provide a tab 78 (FIG. 2) for removing the first release liner from the remainder of the replaceable adhesive subassembly 32.

[0046] Referring also to Figures 4A to 4F and 5, the method may include applying assembly 10 to the patient's body. Using electrode subassemblies 12, a tumor therapeutic electric field can be delivered to the patient. For example, as described herein, the electrode subassemblies 12 of assembly 10 may be electrically connected to an electric field generator 112, and the electric field generator may cause the electrodes to generate an TTField therebetween.

[0047] In some embodiments, assembly 10 may be pre-assembled with a replaceable adhesive subassembly (or multiple subassemblies) 32 attached to electrode subassembly 12. In other embodiments, assembly 10 may be fabricated. For example, as shown in FIG4A, a second release liner 74 may be removed from the first adhesive 42 of the replaceable adhesive subassembly 32 to expose the first adhesive 42. Referring to FIG4B, the replaceable adhesive subassembly 32 may be applied to electrode subassembly 12 (without the second release liner 74) such that the electrode is received within opening 40. The first adhesive 42 may be removably attached to the attachment surface 30 of electrode subassembly 12 such that the replaceable adhesive subassembly 32 may subsequently be removed from electrode subassembly. The application of additional replaceable adhesive subassemblies 32 can be repeated until the assembly 72 of replaceable adhesive subassemblies covers each of the electrodes 20, thereby providing assembly 10. Referring to FIG. 4C, the first release liner 54 can be removed from the biocompatible conductive adhesive 44 of assembly 10 to expose the biocompatible conductive adhesive. Referring to FIG. 4D, assembly 10 can be applied to a patient's body (without the first release liner 54), wherein the biocompatible conductive adhesive 44 is positioned against the patient's skin. Referring to FIG. 4E, a vest 80 can be positioned above assembly 10 if necessary. Vest 80 can reversibly and elastically expand to accommodate at least a portion of the patient's body (e.g., torso) and abut against the patient to compress assembly 10.

[0048] Assembly 10 can be removed from the patient's body (e.g., after a treatment cycle using the tumor therapeutic electric field of assembly 10). Referring to Figure 4F, a removable replaceable adhesive subassembly 32 is available, and after the steps described above, one or more replaceable adhesive subassemblies can replace the removed replaceable adhesive subassembly 32 to provide another assembly 10 of the reusable electrode subassembly 12. This assembly 10 (with the replaced replaceable adhesive subassembly) can then be used on the same or different patients to deliver the TTField.

[0049] As discussed above, a system for delivering a tumor therapeutic electric field to a patient's body may include assemblies, such as assemblies resulting from combinations of the electrode subassemblies / multiple subassemblies discussed herein and the replaceable adhesive subassemblies / multiple subassemblies discussed herein. In some embodiments, the system may include or be in the form of a kit containing any number of such subassemblies and / or their replacement subassemblies or components. For example, a kit may contain or include a plurality of one or more such components, such as any number or all of the electrodes of the electrode subassembly configured to cover them. For example, in various embodiments, the replacement adhesive subassemblies may be configured to cover one, two, three, or more electrodes. In some embodiments selected as needed, a single replacement adhesive subassembly may be configured to cover all the electrodes of the electrode subassembly. In some embodiments, the kit may not contain electrode subassemblies. For example, in some configurations, the kit may consist of only a plurality of adhesive subassemblies as disclosed herein. [Exemplary form] []

[0050] In view of the products, systems, and methods described herein and their variations, certain specific descriptions of the invention are described below. However, such specific descriptions should not be construed as having any limiting effect on any different claims containing different or more general teachings described herein, or as limiting the “specific” descriptions in any way other than in the literal meaning of the language used herein.

[0051] Sample 1: An assembly for delivering a tumor therapeutic electric field to a patient's body, the assembly comprising: Electrode subassemblies, comprising: The circuit layer has an inner and outer surface facing the skin; A plurality of electrodes are disposed on the inner side of a circuit layer and electrically coupled to the circuit layer, wherein each of the plurality of electrodes has an electrode terminal; A capping layer having an inner side and an outer side, wherein the inner side is disposed on the outer side of the circuit layer, and wherein a portion of the inner side of the capping layer extends beyond the circuit layer and beyond the electrode terminals of each of the electrodes to define at least one attachment surface; and At least one replaceable adhesive subassembly comprising: A support layer having a first side and a second side, wherein the support layer defines at least one opening, wherein each of a plurality of electrodes is received within a separate opening of the at least one opening; A first adhesive, disposed on a first side of the support layer and coupling the support layer to the inner side of the cover layer of the electrode subassembly at at least one attachment surface of the cover layer; and A biocompatible conductive adhesive is placed on the second side of the support layer.

[0052] Version 2: Assembly as in Version 1, wherein the replaceable adhesive subassembly includes a second adhesive disposed on a second side of the support layer and for adhering a biocompatible conductive adhesive to the support layer.

[0053] Version 3: An assembly as in Version 1 or Version 2, wherein the support layer of the replaceable adhesive subassembly contains foam.

[0054] Sample 4: An assembly as described in any of the aforementioned samples, wherein the first adhesive is a non-permanent adhesive configured to allow release from at least one attachment surface of the cover layer.

[0055] Version 5: An assembly as described in any of the aforementioned versions, wherein the first adhesive has a stronger bond to the support layer compared to the bond to the cover layer.

[0056] Version 6: An assembly as described in any of the preceding versions, wherein the biocompatible conductive adhesive has a first side positioned against a support layer and an opposite second side, wherein the replaceable adhesive subassembly includes a first release liner disposed on the opposite second side of the biocompatible conductive adhesive.

[0057] Version 7: An assembly of any of the aforementioned versions, wherein the biocompatible conductive adhesive comprises a hydrogel.

[0058] State 8: An assembly of any one of States 1 to 6, wherein the biocompatible conductive adhesive comprises a conductive adhesive complex.

[0059] State 9: An assembly as described in any of the aforementioned states, wherein the circuit layer comprises a trunk structure extending in the longitudinal direction and a plurality of branches extending laterally from the trunk structure, each of the plurality of branches having a proximal end connected to the trunk structure and a relatively distal end spaced outward from the trunk structure.

[0060] Sample 10: An assembly as described in any of the aforementioned samples, wherein the plurality of electrodes includes at least one reusable ceramic electrode.

[0061] State 11: An assembly as described in any of the aforementioned states, wherein the plurality of electrodes comprises at least one reusable high-dielectric polymer electrode.

[0062] Version 12: An assembly as described in any of the preceding versions, wherein the cover layer of the electrode subassembly defines a first peripheral profile, wherein the support layer has a second peripheral profile, and wherein at least a portion of the first peripheral profile of the cover layer corresponds to at least a portion of the second peripheral profile of the support layer.

[0063] Sample 13: A system for delivering therapeutic electric fields to a patient's body, the system comprising: Electrode subassemblies, comprising: The circuit layer has an inner and outer surface facing the skin; A plurality of electrodes are disposed on the inner side of a circuit layer and electrically coupled to the circuit layer, wherein each of the plurality of electrodes has an electrode terminal; A capping layer having an inner side and an outer side, wherein the inner side is disposed on the outer side of the circuit layer, and wherein a portion of the capping layer extends beyond the circuit layer and beyond the electrode terminals of each of the electrodes to define at least one attachment surface; and At least one replaceable adhesive subassembly comprising: A support layer having a first side and a second side, wherein the support layer defines at least one opening configured to receive each of a plurality of electrodes therein; A first adhesive, disposed on a first side of the support layer, wherein the first adhesive is configured to couple the support layer to the inner side of the cover layer of the electrode subassembly at at least one attachment surface of the cover layer; and A biocompatible conductive adhesive is placed on the second side of the support layer.

[0064] Version 14: The system of Version 13, wherein at least one replaceable adhesive sub-assembly comprises a second adhesive disposed on a second side of the support layer and for adhering a biocompatible conductive adhesive to the support layer.

[0065] Version 15: A system like Version 13 or Version 14, wherein at least one of the support layers of the replaceable adhesive subassembly comprises foam.

[0066] State 16: A system of any one of States 13 to 15, wherein the first adhesive is a non-permanent adhesive configured to allow release from at least one attachment surface of the cover layer.

[0067] State 17: A system as in any of States 13 to 16, wherein the first adhesive is configured to form a stronger bond to the support layer compared to the bonding to the cover layer.

[0068] Version 18: A system of any one of Versions 13 to 17, wherein at least one replaceable adhesive sub-assembly of a biocompatible conductive adhesive has a first side facing the support layer and an opposite second side, wherein at least one replaceable adhesive sub-assembly includes a first release liner disposed on the opposite second side of the biocompatible conductive adhesive.

[0069] State 19: A system of any one of States 13 to 18, wherein the biocompatible conductive adhesive comprises a hydrogel.

[0070] State 20: A system of any one of States 13 to 18, wherein the biocompatible conductive adhesive comprises a conductive adhesive complex.

[0071] State 21: A system as described in any of States 13 to 20, wherein the circuit layer comprises a trunk structure extending in the longitudinal direction and a plurality of branches extending laterally from the trunk structure, each of the plurality of branches having a proximal end connected to the trunk region and a relatively distal end spaced outward from the trunk structure.

[0072] State 22: A system as described in any of States 13 to 21, wherein the plurality of electrodes comprises at least one reusable ceramic electrode.

[0073] State 23: A system of any one of States 13 to 22, wherein the plurality of electrodes comprises at least one reusable high-dielectric polymer electrode.

[0074] State 24: A system of any one of States 13 to 23, wherein a cover layer of an electrode subassembly defines a first peripheral profile, wherein a support layer has a second peripheral profile, and wherein at least a portion of the first peripheral profile of the cover layer corresponds to at least a portion of the second peripheral profile of the support layer.

[0075] Version 25, a system of any one of versions 13 to 24, wherein the first adhesive has a first side facing the support layer and an opposite second side, wherein at least one replaceable adhesive sub-assembly further includes a second release liner positioned against the opposite second side of the first adhesive.

[0076] Version 26, a system of any one of versions 13 to 25, wherein at least one replaceable adhesive sub-assembly comprises a plurality of replaceable adhesive sub-assemblies.

[0077] Version 27: The system of Version 26, wherein one or more of the plurality of replaceable adhesive sub-assemblies comprises a plurality of replaceable adhesive sub-assemblies, wherein the replaceable adhesive sub-assemblies comprise: A support layer having a first side and a second side, wherein the support layer defines at least one opening configured to receive each electrode of an electrode subassembly therein; A first adhesive, disposed on a first side of the support layer and configured to couple the support layer to the cover layer of the electrode subassembly at at least one attachment surface of the cover layer; and A biocompatible conductive adhesive is placed on the second side of the support layer.

[0078] State 28: A system of any of states 13 to 27, further comprising a vest configured to extend around the torso of an individual, wherein an electrode sub-assembly is disposed between the torso and the vest.

[0079] Sample 29: A replaceable adhesive subassembly for use with an electrode subassembly having a plurality of electrodes and a cover layer defining at least one attachment surface, the replaceable adhesive subassembly comprising: A support layer having a first side and a second side, wherein the support layer defines at least one opening for each of a plurality of electrodes of an electrode subassembly configured to receive therein; A first adhesive, disposed on a first side of the support layer and configured to couple the support layer to the cover layer of the electrode subassembly at at least one attachment surface of the cover layer; and A biocompatible conductive adhesive is placed on the second side of the support layer.

[0080] Version 30: A replaceable adhesive subassembly as in Version 29, comprising a second adhesive disposed on a second side of the support layer and for adhering a biocompatible conductive adhesive to the support layer.

[0081] Version 31: A replaceable adhesive sub-assembly of any of Versions 29 to 30, wherein the biocompatible conductive adhesive has a first side facing the support layer and an opposite second side, wherein the replaceable adhesive sub-assembly includes a first release liner disposed on the opposite second side of the biocompatible conductive adhesive.

[0082] Version 32, a replaceable adhesive sub-assembly of any of versions 29 to 31, wherein the first adhesive has a first side facing the support layer and an opposite second side, wherein the replaceable adhesive sub-assembly further includes a second release liner positioned against the opposite second side of the first adhesive.

[0083] State 33: A method, which includes: Apply a combination of the following to the patient: Electrode subassemblies, comprising: The circuit layer has an inner side and an outer side; A plurality of electrodes are disposed on the inner side of a circuit layer and electrically coupled to the circuit layer, wherein each of the plurality of electrodes has an electrode terminal; A capping layer having an inner side and an outer side, wherein the inner side is disposed on the outer side of the circuit layer, and wherein a portion of the inner side of the capping layer extends beyond the circuit layer and beyond the electrode terminals of each of the electrodes to define at least one attachment surface; and At least one replaceable adhesive subassembly comprising: A support layer having a first side and a second side, wherein the support layer defines at least one opening, wherein each of a plurality of electrodes is received within a separate opening of the at least one opening; A first adhesive, disposed on a first side of the support layer and coupling the support layer to the inner side of the cover layer of the electrode subassembly at at least one attachment surface of the cover layer; and A biocompatible conductive adhesive is placed on the second side of the support layer.

[0084] State 34: The method of state 33, further comprising: The assembly may need to be removed from the patient. Remove at least one or more of the replaceable adhesive subassemblies from the electrode subassembly; and Apply one or more replacement adhesive subassemblies to the electrode subassembly, wherein each of the one or more replacement adhesive subassemblies comprises: A support layer having a first side and a second side, wherein the support layer defines at least one opening configured to receive each of a plurality of electrodes therein; A first adhesive, disposed on a first side of the support layer, wherein the first adhesive is configured to couple the support layer to the inner side of the cover layer of the electrode subassembly at at least one attachment surface of the cover layer; and A biocompatible conductive adhesive is placed on the second side of the support layer.

[0085] Version 35: The method of Version 34, wherein the assembly is removed from the patient, the method further comprising applying one or more replacement adhesive subassemblies and electrode subassemblies attached thereto to the patient.

[0086] Version 36: The method of Version 35, wherein the biocompatible conductive adhesive of each of one or more alternative adhesive subassemblies has a first side facing the support layer and an opposite second side, and a first release liner is positioned against the opposite second side of the biocompatible conductive adhesive of the alternative adhesive subassembly, wherein the first adhesive of each alternative adhesive subassembly has a first side positioned against the support layer and an opposite second side, and a second release liner is disposed on the opposite second side of the first adhesive, and wherein the method further comprises: Remove the second release liner before applying the replacement adhesive subassembly to the electrode subassembly; and Before applying one or more replacement adhesive subassemblies and electrode subassemblies attached thereto to the patient, remove the first release liner.

[0087] Version 37: The method of any one of versions 33 to 36 further comprises delivering a tumor therapeutic electric field to a patient using an electrode sub-assembly.

[0088] Sample 38: A kit comprising a plurality of replaceable adhesive subassemblies as described in any one of Samples 29 to 32.

[0089] Although the invention has been described in considerable detail with the aid of illustrations and examples for the purpose of clear understanding, certain changes and modifications may be practiced within the scope of the appended patent application.

Claims

1. A system for delivering a tumor therapeutic electric field to a patient's body, the system comprising: an electrode subassembly including: a circuit layer having an inner side and an outer side facing the skin; a plurality of electrodes disposed on the inner side of the circuit layer and electrically coupled to the circuit layer, wherein each of the plurality of electrodes has an electrode terminal; a cover layer having an inner side and an outer side, wherein the inner side is disposed on the outer side of the circuit layer, wherein a portion of the cover layer extends beyond the circuit layer and beyond the electrode terminals of each of the electrodes to define at least one attachment surface; and at least one replaceable adhesive subassembly including: a support layer having a first side and a second side, wherein the support layer defines at least one opening configured to receive each of the plurality of electrodes therein; A first adhesive is disposed on a first side of the support layer, wherein the first adhesive is configured to couple the support layer to the inside of the cover layer of the electrode subassembly at at least one attachment surface of the cover layer; and a biocompatible conductive adhesive is disposed on a second side of the support layer.

2. The system of claim 1, wherein the at least one replaceable adhesive subassembly includes a second adhesive disposed on a second side of the support layer and for adhering the biocompatible conductive adhesive to the support layer.

3. The system of claim 1, wherein the support layer of the at least one replaceable adhesive subassembly comprises foam.

4. The system of claim 1, wherein the first adhesive is a non-permanent adhesive configured to allow release from at least one attachment surface of the cover layer.

5. The system of claim 1, wherein the biocompatible conductive adhesive of the at least one replaceable adhesive sub-assembly has a first side facing the support layer and an opposite second side, wherein the at least one replaceable adhesive sub-assembly includes a first release liner disposed on the opposite second side of the biocompatible conductive adhesive.

6. The system of claim 1, wherein the biocompatible conductive adhesive comprises a hydrogel.

7. The system of claim 1, wherein the biocompatible conductive adhesive comprises a conductive adhesive complex.

8. The system of claim 1, wherein the plurality of electrodes comprises at least one reusable ceramic electrode.

9. The system of claim 1, wherein the plurality of electrodes comprises at least one reusable high-dielectric polymer electrode.

10. The system of claim 1, wherein the first adhesive has a first side facing the support layer and an opposite second side, wherein the at least one replaceable adhesive sub-assembly further includes a second release liner positioned against the opposite second side of the first adhesive.

11. The system of claim 1, wherein the at least one replaceable adhesive subassembly comprises a plurality of replaceable adhesive subassemblies, wherein one or more of the plurality of replaceable adhesive subassemblies comprises a plurality of replaceable adhesive subassemblies, wherein the replaceable adhesive subassemblies comprise: a support layer having a first side and a second side, wherein the support layer defines at least one opening configured to receive each electrode of the electrode subassembly therein; a first adhesive disposed on the first side of the support layer and configured to couple the support layer to the cover layer of the electrode subassembly at at least one attachment surface of the cover layer; and a biocompatible conductive adhesive disposed on the second side of the support layer.

12. A replaceable adhesive subassembly for use with an electrode subassembly having a plurality of electrodes and a cover layer defining at least one attachment surface, the replaceable adhesive subassembly comprising: a support layer having a first side and a second side, wherein the support layer defines at least one opening configured to receive each of the plurality of electrodes of the electrode subassembly therein; a first adhesive disposed on the first side of the support layer and configured to couple the support layer to the cover layer of the electrode subassembly at at least one attachment surface of the cover layer; and a biocompatible conductive adhesive disposed on the second side of the support layer.

13. The alternative adhesive subassembly of claim 12, comprising a second adhesive disposed on a second side of the support layer and for adhering the biocompatible conductive adhesive to the support layer.

14. The replaceable adhesive subassembly of claim 12, wherein the biocompatible conductive adhesive has a first side facing the support layer and an opposite second side, wherein the replaceable adhesive subassembly includes a first release liner disposed on the opposite second side of the biocompatible conductive adhesive.

15. The replaceable adhesive sub-assembly of claim 12, wherein the first adhesive has a first side facing the support layer and an opposite second side, wherein the replaceable adhesive sub-assembly further includes a second release liner positioned against the opposite second side of the first adhesive.

16. A method of using an electrode assembly, the method comprising: applying to a patient an assembly comprising: an electrode subassembly including: a circuit layer having an inner side and an outer side; a plurality of electrodes disposed on the inner side of the circuit layer and electrically coupled to the circuit layer, wherein each of the plurality of electrodes has a terminal; a cover layer having an inner side and an outer side, wherein the inner side is disposed on the outer side of the circuit layer, wherein a portion of the inner side of the cover layer extends beyond the circuit layer and beyond the terminal of each of the electrodes to define at least one attachment surface; and at least one replaceable adhesive subassembly including: a support layer having a first side and a second side, wherein the support layer defines at least one opening, wherein each of the plurality of electrodes is received within a respective opening in the at least one opening; A first adhesive disposed on a first side of the support layer and coupling the support layer to the inner side of the cover layer of the electrode subassembly at at least one attachment surface of the cover layer; and a biocompatible conductive adhesive disposed on a second side of the support layer.

17. The method of claim 16, further comprising: removing one or more of the at least one replaceable adhesive subassemblies from the electrode subassembly; and applying one or more replaceable adhesive subassemblies to the electrode subassembly, wherein each of the one or more replaceable adhesive subassemblies comprises: a support layer having a first side and a second side, wherein the support layer defines at least one opening configured to receive each of the plurality of electrodes therein; a first adhesive disposed on the first side of the support layer, wherein the first adhesive is configured to couple the support layer to the inside of the cover layer of the electrode subassembly at at least one attachment surface of the cover layer; and a biocompatible conductive adhesive disposed on the second side of the support layer.

18. The method of claim 17, further comprising: removing the assembly from the patient before removing one or more of the at least one replaceable adhesive subassemblies from the electrode subassembly; and applying the one or more replaceable adhesive subassemblies and the electrode subassemblies attached thereto to the patient.

19. The method of claim 18, wherein the biocompatible conductive adhesive of each of the one or more alternative adhesive subassemblies has a first side facing the support layer and an opposite second side, and a first release liner is positioned against the opposite second side of the biocompatible conductive adhesive of the alternative adhesive subassembly, wherein the first adhesive of each alternative adhesive subassembly has a first side positioned against the support layer and an opposite second side, and a second release liner is disposed on the opposite second side of the first adhesive, and wherein the method further comprises: removing the second release liner before applying the alternative adhesive subassembly to the electrode subassembly; and removing the first release liner before applying the one or more alternative adhesive subassemblies and the electrode subassemblies attached thereto to the patient.

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