DEVICES, SYSTEMS AND METHODS FOR APPLYING TUMOR TREATMENT FIELDS - Patent application

Abstract

An assembly for delivering a tumor treatment field to a patient's body can include an electrode subassembly and one or more replaceable adhesive subassemblies. Each adhesive subassembly can have a support layer having a first side and a second side. The support layer can define at least one opening. Each electrode of the electrode subassembly can be received within a respective opening of the at least one opening. A first adhesive can be disposed on the first side of the support layer, and the support layer can be bonded to an inner side of the cover layer of the electrode subassembly at an attachment surface of the cover layer. A biocompatible conductive adhesive can be disposed on the second side of the support layer.

Description

[Technical field]

[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of priority and the filing date of U.S. Provisional Patent Application No. 63 / 284,357, filed November 30, 2022, the entirety of which is incorporated herein by reference for all purposes.

[0002] The present disclosure relates to devices, systems, and methods for providing a tumor treatment field, and in particular to devices, systems, and methods for providing an electrode assembly having a replaceable adhesive subassembly for securing the electrode subassembly to a subject's body. [Background technology]

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

[0004] Provided herein, in various aspects, is an assembly for delivering a tumor treatment field to a patient's body. The assembly may include an electrode subassembly including a circuit layer having a skin-facing inner side and an outer side. A plurality of electrodes may be disposed on the inner side of the circuit layer and electrically coupled to the circuit layer. Each electrode of the plurality of electrodes may have an electrode edge. The cover layer may have an inner side and an outer side. The inner side of the cover layer may be disposed on the outer side of the circuit layer. A portion of the inner side of the cover layer may define at least one mounting surface beyond the circuit layer and beyond the edge of each electrode. The assembly may include at least one replaceable adhesive subassembly including a support layer having a first side and a second side. The support layer may define at least one opening. Each electrode of the plurality of electrodes 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 bond the support layer to the inner side of the cover layer of the electrode subassembly at the at least one mounting surface of the cover layer. A biocompatible conductive adhesive may be disposed 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 obvious from the description, or may be learned by the practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood, however, that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not intended to limit the scope of the invention as claimed.

[0006] These and other features of embodiments of the present invention will become more apparent in the following detailed description taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0007] [Figure 1] FIG. 1 is an exploded view of an assembly for delivering a tumor treatment field to a patient's body. [Diagram 2] FIG. 2 is an exploded view of a replaceable adhesive subassembly of the assembly of FIG. 1. [Diagram 3]FIG. 3 is a schematic cross-sectional view of the replaceable adhesive subassembly of FIG. 2 taken along plane 3-3. [Figure 4A] FIG. 4 is a perspective view of a second release liner being removed from a replaceable adhesive subassembly such as that of FIG. 3. [Figure 4B] FIG. 2 is a perspective view of a replaceable adhesive subassembly that is applied to an electrode subassembly to provide an assembly as in FIG. 1. [Figure 4C] FIG. 13 is a perspective view of a first release liner being removed from the replaceable adhesive subassembly to expose the biocompatible conductive adhesive. [Figure 4D] FIG. 2 is a perspective view of the assembly applied to the main body by a user. [Figure 4E] FIG. 13 is a perspective view showing application of a vest onto the assembly. [Figure 4F] FIG. 13 is a perspective view of a user removing the replaceable adhesive subassembly from the electrode subassembly. [Diagram 5] FIG. 2 is a block diagram of an apparatus for distributing a TT field according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Tumor Treating Fields (TTFs) can be used to treat various types of cancer. For example, the TTFs can be applied to a portion of a subject via one or more electrode / transducer arrays. Typically, the electrode array is coupled to a signal generator that generates the TTF in the transducer array. Traditionally, the skin-facing portion of the electrode is provided with a hydrogel to transmit the electrical signal to the subject's body. However, the hydrogel may have a short lifespan, after which the electrode array must be discarded. What is needed is a way to refresh, replenish, or replace the adhesive layer without discarding the electrode along with the entire electrode array, which is costly. The present invention addresses this and other important challenges.

[0009] The present invention will now be described in more detail with reference to the drawings, which show some, but not all, of the embodiments of the present invention. Indeed, the present invention may be implemented in various forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout. It should be understood that the present invention is not limited to the specific methodology and protocols described, which may therefore be modified. It should also be understood that the terms used herein are for the purpose of describing specific embodiments, and are not intended to limit the scope of the present invention.

[0010] Modifications and other embodiments of the invention will come to mind to one skilled in the art to which this invention pertains having the benefit of the teachings set forth in this description and the associated drawings. It is understood, therefore, that the invention is not to be limited to the specific embodiments disclosed, but that modifications and the like are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

[0011] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, an "electrode" or a "replaceable adhesive subassembly" may refer to one or more of those electrodes or replaceable adhesive subassemblies.

[0012] 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 belongs unless clearly indicated otherwise.

[0013] As used herein, ranges may be expressed as from "about" one particular value and / or to "about" another particular value. When such a range is expressed, other aspects are included within the one particular value and / or the other particular value. Similarly, when values ​​are expressed as approximations using the antecedent "about," it is understood that the particular value forms another aspect. It is further understood that the endpoints of each range are significant both in relation to the other endpoint and independently of the other endpoint. Optionally, in some embodiments, when values ​​are approximated using the aforementioned "about," it is contemplated that values ​​within up to 15%, up to 10%, up to 5%, or up to 1% (more or less) of the specifically stated value may be included within the scope of these embodiments. Similarly, in some optional embodiments, when values ​​are approximated using the terms "substantially" or "generally," it is contemplated that values ​​within up to 15%, up to 10%, up to 5%, or up to 1% (more or less) of the specifically stated value may be included within the scope of these embodiments. When used with respect to a specified characteristic or circumstance, "substantially" or "generally" can refer to a degree of deviation that is small enough so as not to measurably detract from the specified characteristic or circumstance, and the precise degree of permissible deviation may, in some cases, depend on the particular context.

[0014] As used herein, the terms "optional" or "optionally" mean that the event or circumstance described thereafter may or may not occur, and that the description includes both the occurrence and non-occurrence of said event or circumstance.

[0015] As used herein, the term "at least one" is intended to be synonymous with "one or more." For example, "at least one of A, B, C" explicitly includes A only, B only, C only, and each combination.

[0016] As used herein, the term "or" means any one member of a particular list, and unless otherwise indicated, in alternative embodiments, it can also include any combination of members of that list.

[0017] It should be understood that unless expressly stated otherwise, the methods described herein are never intended to be construed as requiring that the steps be performed in a particular order. Thus, if a method claim does not actually recite the order in which its steps are to be followed, or if the claim or description does not specifically state that the steps are limited to a particular order, no order is ever intended to be inferred in any respect. This applies to any non-express basis of interpretation, including questions of logic regarding the placement or operational flow of steps, the simple meaning derived from grammatical construction or punctuation, and the number or type of aspects described in the specification.

[0018] Headings are provided for convenience only and should not be construed as limiting the invention in any way. An embodiment shown under any heading or in any portion of this disclosure may be combined with an embodiment shown under the same or any other heading or portion of this disclosure.

[0019] Any combination of the elements described herein and possible variations thereof is encompassed by the invention unless otherwise indicated herein or clearly contradicted by context.

[0020] FIG. 5 illustrates an exemplary apparatus 100 for electrical therapy. In general, apparatus 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. Apparatus 100 may include an electric field generator 112 and one or more electrode (e.g., transducer) arrays (e.g., assemblies 10) including a plurality of electrodes 20. Apparatus 100 may be configured to generate and deliver Tumor Treating Fields (TTFields) at frequencies ranging from 50 kHz to 1 MHz via electric field generator 112, e.g., at frequencies between 50 kHz and 500 kHz (e.g., 150 kHz for one tumor cell type and / or 300 kHz for a different tumor cell type) to regions within the body via one or more electrode arrays 10. Electric field generator 112 may be a battery and / or power operated device.

[0021] The electric field generator 112 may include a processor 116 in communication with a signal generator 118. The electric field generator 112 may include control software 120 that controls the performance of the processor 116 and the signal generator 118.

[0022] The signal generator 118 may generate one or more electrical signals in the form of a waveform or a pulse train. The signal generator 118 may be configured to generate an alternating voltage waveform at a frequency (e.g., TTFields) in the range of, for example, 50 kHz to 500 kHz (preferably 100 kHz to 300 kHz). The voltage is such that the electric field strength in the tissue to be treated typically ranges from about 0.1 V / cm to about 10 V / cm.

[0023] One or more outputs 124 of the electric field generator 112 may be coupled to one or more conductive leads 122 attached at one end to a signal generator 118. Both ends of the conductive leads 122 are connected to one or more electrode arrays 10 that are actuated by an electrical signal (e.g., a waveform). The conductive leads 122 may be made of standard insulated conductors with a flexible metal shield and may be grounded to prevent diffusion of the electric field generated by the conductive leads 122. The one or more outputs 124 may be operated sequentially. Output parameters of the signal generator 118 may include, for example, the strength of the electric field, the frequency of the wave (e.g., the processing frequency), and the maximum allowable temperature of the one or more electrode arrays 10. The output parameters may be set and / or determined by the control software 120 in conjunction with the processor 116. After determining a desired (e.g., optimal) processing frequency, the control software 120 may cause the processor 116 to send a control signal to the signal generator 118, causing the signal generator 118 to output the desired processing frequency to the one or more electrode arrays 10. Additionally, it is contemplated that the control software 120 may cause the processor 116 to shift or change the direction of the TT field, or adjust the characteristics of the TT field, in manners further disclosed herein.

[0024] Disclosed herein, in various embodiments, and with reference to Figures 1-3, is an assembly 10 for delivering a tumor treatment field to a patient's body. The assembly 10 may include an electrode subassembly 12 with a circuit layer 14 having a skin-facing inner side 16 and an outer side 18 (Figure 1). The circuit layer 14 may include, for example, a flexible circuit that allows the circuit layer 14 to contour to the patient's body. Optionally, the circuit layer 14 may include a printed circuit board (PCB).

[0025] A plurality of electrodes 20 may be disposed on the interior side 16 of the circuit layer 14 and electrically coupled to the circuit layer. Each electrode 20 of the plurality of electrodes may have an electrode edge 22. The electrode edge 22 may, for example, track the perimeter of the electrode 20.

[0026] 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 bonded to the outer side 18 of the circuit layer 14. For example, the cover layer 24 may be located (e.g., disposed on) all or a portion of the circuit layer 14, with the outer side 18 of the circuit layer 14 facing the inner side 26 of the cover layer 24. In some optional aspects, an adhesive may bond the inner cover layer 24 and the circuit layer. A portion of the inner side 26 of the cover layer 24 may define at least one mounting surface 30 beyond (e.g., from the outside) the circuit layer 14 and beyond (e.g., from the outside) the electrode edge 22 of each electrode 20.

[0027] The assembly 10 for delivering a tumor treatment field may further include one or more replaceable adhesive subassemblies 32 (FIGS. 1-3). The replaceable adhesive subassembly 32 may include a support layer 34 (FIGS. 2-3) having a first side 36 and a second side 38 (FIG. 3). The support layer 34 may define at least one opening 40 therethrough. Each electrode 20 of the plurality of electrodes may be received within a respective opening 40. The support layer may, in various embodiments, define 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more openings 40 for receiving each electrode 20.

[0028] A first adhesive 42 (FIGS. 2-3) may be disposed on a first side 36 of the support layer 34 of the adhesive subassembly 32 and bond the support layer 34 of the adhesive subassembly 32 to the inner side 26 of the cover layer 24 of the electrode subassembly 12 at at least one mounting surface 30 of the cover layer 24 of the electrode subassembly 12 (FIG. 1). Alternatively, if not bonded to the electrode subassembly 12, the first adhesive 42 may be covered by a release liner 74 (FIGS. 2-3), described below (referred to as a second release liner).

[0029] In some embodiments, the first adhesive 42 may be a non-permanent adhesive configured to be peelable from at least one mounting surface of the cover layer 24 of the electrode subassembly 12. In some embodiments, the first adhesive 42 may form a stronger bond with the backing layer 34 than with the cover layer 24. For example, the first adhesive 42 may form a stronger bond with a peel strength (e.g., as measured by ASTM D3330 / D3330M) at the interface between the first adhesive 42 and the backing layer 34 than at the interface between the first adhesive 42 and the cover layer 24. This allows the replaceable adhesive subassembly 32 to be removed from the electrode subassembly 12 and the electrode subassembly 12 to be reused by replacing the replaceable adhesive subassembly. In various embodiments, the first adhesive may be an acrylic adhesive known in the art, a homopolymer polybutyl acrylate (pBA) or homopolymer polyethylhexyl acrylate (pEHA), or a copolymer containing polymerized units of either or both BA or EHA together, in each case polymerized with or without other monomers which may or may not be acrylic monomers.Acrylic monomers in the present invention refer to esters of acrylic acid, methacrylic acid, itaconic acid, and the like, and further refer to acrylic acid monomers (acrylic acid, methacrylic acid, itaconic acid, and the like) in the present invention.

[0030] A biocompatible conductive adhesive 44 may be disposed on the second side 38 of the support layer 34. The biocompatible conductive adhesive 44 may extend across each of the openings 40 of the one or more openings in the support layer, thereby applying the biocompatible conductive adhesive 44 to the electrodes 20 received within the openings 40 of the support layer 34. The biocompatible conductive adhesive 44 may be, for example, a hydrogel. One suitable hydrogel is AG603 hydrogel available from Amgel Technologies, Inc., Fallbrook, California, USA. The hydrogel layer may be a modified hydrogel (e.g., having holes, recesses, protrusions, etc., or combinations thereof) as disclosed in detail in U.S. Patent Application Serial No. 17 / 313,114, entitled "CONDUCTIVE PAD GENERATING TUMOR TREATMENT FIELDS AND METHODS OF MAKING AND USING THEREOF," which is incorporated herein in its entirety.

[0031] In further aspects, the biocompatible conductive adhesive 44 may be or may contain a conductive adhesive composite. In an exemplary embodiment, the conductive adhesive composite may include a dielectric material and conductive particles dispersed within the dielectric material. In some embodiments, at least a portion of the conductive particles may define a conductive path through the thickness of the conductive adhesive composite. It is believed that the conductive particles may be aligned in response to application of an electric field such that the conductive particles undergo electrophoretic movement. In some aspects, the dielectric material of the conductive adhesive composite may be a polymer adhesive. Optionally, the polymer adhesive may be an acrylic adhesive as described above. In some aspects, the conductive particles may include carbon. Optionally, in these aspects, the conductive particles may include graphite powder. Alternatively or additionally, the conductive particles may include carbon flakes. Alternatively or additionally, the conductive particles may include carbon particles. Alternatively or additionally, the conductive particles may include carbon fibers. Alternatively or additionally, the conductive particles may include carbon nanowires. Alternatively or additionally, the conductive particles may include carbon black powder. Alternatively or additionally, the conductive particles may include carbon microcoils. In a further embodiment, the non-hydrogel conductive adhesive layer further includes 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 composites and methods for making such conductive adhesive composites are disclosed in U.S. Pat. Nos. 8,673,184 and 9,947,432, which are incorporated herein by reference for all purposes. In an exemplary embodiment, 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). Other conductive adhesive composites may also be suitable, such as, for example, the ARcare® 8006 conductive adhesive composition manufactured and sold by Adhesives Research, Inc. (Glen Rock, PA, USA).These adhesives are also suitable as the first adhesive 42 (FIG. 3) described above.

[0032] In some optional embodiments, the replaceable adhesive subassembly 32 may include a second adhesive 46 disposed on the second side 38 of the support layer 34. The second adhesive 46 may adhere the biocompatible conductive adhesive 44 to the support layer 34. Additionally, in some optional embodiments, the second adhesive 46 may be omitted.

[0033] In some exemplary aspects, the support layer 34 may be constructed from a foam (e.g., a polymer foam) or other suitable flexible material, such as an elastomer or rubber, having a sufficient thickness to receive the electrodes 20. This allows the support layer 34 to be flexible while still providing a sufficient thickness to receive the electrodes 20. The thickness of the support layer 34 can be greater than or less than the thickness of the electrodes 20, but in some embodiments has the same or approximately the same thickness.

[0034] The biocompatible conductive adhesive 44 may have a first side 50 facing the backing layer 34 (facing the second adhesive 46, if present) and an opposing second side 52. In some optional embodiments, a first release liner 54 may be disposed on the opposing second side 52 of the biocompatible conductive adhesive 44.

[0035] In some optional embodiments, the 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. The plurality of branches 60 may have a distal end 62 connected to the trunk structure 56 and an opposing proximal end 64 spaced outwardly from the trunk structure.

[0036] In some embodiments, one or more (optionally all) of the electrodes 20 may be reusable ceramic electrodes. In further embodiments, one or more (optionally all) of the electrodes 20 may be reusable high dielectric polymer electrodes.

[0037] The cover layer 24 of the electrode subassembly 12 may define a first peripheral contour. The support layer 34 may define a second peripheral contour. At least a portion of the first peripheral contour of the cover layer 24 corresponds to at least a portion of the second peripheral contour of the support layer 34. For example, the arc length of the second peripheral contour may have an arc length corresponding to 50% or more, 60% or more, 70% or more, 80% or more, 90% or more, or substantially all or all of the arc length of the first peripheral contour. Here, "arc length" refers to the length of a curve or perimeter that tracks the peripheral contour of a given element. Thus, the arc length of the first peripheral contour refers to the length of a curve or perimeter that tracks the first peripheral contour, and the arc length of the second peripheral contour refers to the length of a curve or perimeter that tracks the second peripheral contour.

[0038] Optionally, the assembly 10 may include a plurality of replaceable adhesive subassemblies 32 covering each portion of the cover layer 24. For example, the adhesive 10 may be comprised of two, three, four, five, six, seven, eight, or more replaceable adhesive subassemblies 32 forming a set of replaceable adhesive subassemblies. A set 72 of replaceable adhesive subassemblies 32 may receive and / or provide a biocompatible conductive adhesive 44 to cover each electrode 20 of the electrode subassembly 12. That is, the set 72 of replaceable adhesive subassemblies 32 may cooperate with the electrode subassembly 12 to form the assembly 10. Optionally, two or more of the plurality of replaceable adhesive subassemblies 32 of the set 72 may be substantially similar or identical to one another. For example, as shown in FIG. 1, the set 72 of the plurality of replaceable adhesive subassemblies 32 may include two of a first replaceable adhesive subassembly 32a and three of a second replaceable adhesive subassembly 32b that is different from the first replaceable adhesive subassembly. The different replaceable adhesive subassemblies 32 may differ in peripheral contour, number of openings 40 for receiving electrodes 20, etc. For example, a first replaceable adhesive subassembly 32a may be configured to receive and / or provide a biocompatible conductive adhesive to cover two electrodes, and a second replaceable adhesive subassembly 32b may be configured to receive and / or provide a biocompatible conductive adhesive to cover three electrodes. In some embodiments (not shown), a replaceable adhesive subassembly 32 may be configured to receive and / or provide a biocompatible conductive adhesive to cover a single electrode. In further aspects, the replaceable adhesive subassemblies 32 of an assembly 10 may all be identical. In further optional aspects, an assembly 10 may include a single replaceable adhesive subassembly 32. Thus, in some optional aspects, a set 72 may have only one replaceable adhesive subassembly 32.

[0039] The system 70 (FIG. 1) may include the electrode subassembly 12 disclosed herein and at least one replaceable adhesive subassembly 32. In some embodiments, the system 70 may include a plurality of replaceable adhesive subassemblies 32. In some optional embodiments, the 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 replacement adhesive subassemblies may have a similar structure and may have the same structure as the replaceable adhesive subassemblies 32 described herein. For example, it is contemplated that the replacement adhesive subassembly may have a support layer having a first side and a second side, the support layer defining at least one opening configured to receive a respective electrode of an electrode subassembly therein. A first adhesive may be disposed on a first side of the support layer of the replacement adhesive subassembly and configured to bond the support layer to a 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.

[0040] As described above, since multiple replaceable adhesive subassemblies 32 can cover each portion of the cover layer 24, it is contemplated that a set 72 can receive and / or provide a biocompatible conductive adhesive to cover each electrode 20 of the electrode subassembly 12. For example, as shown in FIG. 1, a set can include two sets of replaceable adhesive subassemblies 32a and three sets of replaceable adhesive subassemblies 32b. The system 70 can include multiple sets 72 of replaceable adhesive subassemblies 32, each configured to receive and / or provide a biocompatible conductive adhesive to cover each electrode 20 of the electrode subassembly 12. In some embodiments, the system 70 can include a plurality of replacement adhesive subassemblies (e.g., 10, 20, 30, 40 or more). For example, the system 70 can include one or more sets of replaceable adhesive subassemblies 72 for use as replacement adhesive subassemblies. The number of replaceable adhesive subassemblies 32 and the number of sets of replacement adhesive subassemblies 72 can vary depending on how often replacement is required and the expected duration of treatment. The adhesive subassembly may need to be replaced daily or every 2-3 days.

[0041] The first adhesive 42 may have a first side 43 facing the backing layer 34 and an opposite second side 45 (FIG. 3). In some embodiments, a second release liner 74 may be disposed on (e.g., facing) the opposite second side 45 of the first adhesive 42. In some embodiments, at least a portion of the second release liner 74 may extend outwardly from the second peripheral contour of the backing 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 outwardly from the second peripheral contour of the backing layer 34 to provide a tab 78 (FIG. 2) for removing the first release liner from the remaining replaceable adhesive subassembly 32.

[0042] Also included may be a method of applying the assembly 10 to a patient's body, with reference to Figure 4. The electrode subassembly 12 may be used to deliver a tumor treating field to the patient. For example, as described herein, the electrode subassembly 12 of the assembly 10 may be in electrical communication with an electric field generator 112, which may generate a TT field between the electrodes.

[0043] In some embodiments, the assembly 10 can be provided preassembled with the replaceable adhesive subassembly (or subassemblies) 32 attached to the electrode subassembly 12. In further embodiments, the assembly 10 can be provided. For example, as shown in FIG. 4A, the second release liner 74 can be removed from the first adhesive 42 of the replaceable adhesive subassembly 32 to expose the first adhesive 42. Referring to FIG. 4B, the replaceable adhesive subassembly 32 (without the second release liner 74) can be applied to the electrode subassembly 12 to receive the electrode therein within the opening 40. The first adhesive 42 can releasably affix the replaceable adhesive subassembly 32 to the mounting surface 30 of the electrode subassembly 12 so that the replaceable adhesive subassembly 32 can then be removed from the electrode subassembly. The application of the replaceable adhesive subassembly 32 can be repeated until the replaceable adhesive subassembly 72 covers each electrode 20 to provide the adhesive subassembly 10. With reference to Figure 4C, the first release liner 54 can be removed from the biocompatible conductive adhesive 44 of the assembly 10 to expose the biocompatible conductive adhesive. With reference to Figure 4D, the assembly 10 (without the first release liner 54) can be applied to a patient's body with the biocompatible conductive adhesive 44 located on the patient's skin. With reference to Figure 4E, optionally, a vest 80 can be placed over the assembly 10. The vest 80 can resiliently and elastically expand to receive at least a portion of the patient's body (e.g., the torso) and compress the assembly 10 against the patient.

[0044] The assembly 10 can be removed from the patient's body (e.g., after a period of tumor treatment field treatment using the assembly 10). With reference to FIG. 4F, the replaceable adhesive subassembly 32 can be removed and, following the process as described above, one or more replacement adhesive subassemblies can replace the removed replaceable adhesive subassembly 32 to provide another electrode subassembly 10 that is reusable. The above assembly 10 (with the replaceable adhesive subassembly) can be used with the same patient or a different patient to provide a TT field.

[0045] As discussed above, a system for delivering a tumor treatment field to a patient's body may include an assembly, such as an assembly of a combination of an electrode subassembly / subassembly described herein and a replaceable adhesive subassembly / subassembly described herein. In some embodiments, the system may include or take the form of a kit including such subassemblies and / or replacement subassemblies or any number of components. For example, the kit may include a plurality of one or more such components, such as, for example, a replacement adhesive subassembly configured to cover any number or all of the electrodes of the electrode subassembly. For example, in various embodiments, the replacement adhesive subassembly may be configured to cover one electrode, two electrodes, three electrodes, or more electrodes. In some optional embodiments, a single replacement adhesive subassembly may be configured to cover all of the electrodes of the electrode subassembly. In some embodiments, the kit need not include an electrode subassembly. In some embodiments, the kit may include only a plurality of adhesive subassemblies, such as, for example, as disclosed herein. Illustrative Embodiments

[0046] In view of the described products, systems, and methods and variations thereof, certain more detailed embodiments of the present invention are described herein below, however, these specifically recited embodiments should not be construed as having any limiting effect on the different claims that include different or more general teachings set forth herein, or as being limited in any way other than in the inherent meaning of the language in which the "specific" embodiment is literally used.

[0047] Aspect 1: An assembly for delivering a tumor treating field to a patient's body, said assembly comprising: an electrode assembly and at least one replaceable adhesive subassembly, the electrode assembly comprising: a circuit layer having a skin-facing inner side and an outer side; a plurality of electrodes disposed inside the circuit layer and electrically coupled to the circuit layer, each electrode of the plurality of electrodes having an electrode edge; a cover layer having an inner side and an outer side, the inner side being disposed on an outer side of the circuit layer, a portion of the cover layer extending beyond the circuit layer and beyond an electrode edge of each of the electrodes to define at least one mounting surface; Including, The at least one replaceable adhesive subassembly comprises: a support layer having a first side and a second side, the support layer defining at least one opening configured to receive a respective electrode of the plurality of electrodes therein; a first adhesive disposed on the first side of the support layer, the first adhesive configured to bond the support layer to an inner side of the cover layer of the electrode subassembly at at least one mounting surface of the cover layer; a biocompatible conductive adhesive disposed on the second side of the support layer.

[0048] Aspect 2: The adhesive of Aspect 1, wherein the replaceable adhesive subassembly includes a second adhesive disposed on a second side of the support layer and adhering the biocompatible conductive adhesive to the support layer.

[0049] Embodiment 3: The assembly of embodiment 1 or embodiment 2, wherein the support layer of the replaceable adhesive subassembly comprises foam.

[0050] Aspect 4: An assembly described in any of the preceding aspects, wherein the first adhesive is a non-permanent adhesive configured to be releasable from the at least one mounting surface of the cover layer.

[0051] Aspect 5: An assembly according to any one of the preceding aspects, wherein the first adhesive has stronger adhesion to the support layer than to the cover layer.

[0052] Aspect 6: An assembly described in any preceding aspect, wherein the biocompatible conductive adhesive has a first side facing the support layer and an opposite second side, and the replaceable adhesive subassembly includes a first release liner disposed on the opposite second side of the biocompatible conductive adhesive.

[0053] Aspect 7: An assembly described in any one of the above aspects, wherein the biocompatible conductive adhesive comprises a hydrogel.

[0054] Example 8: An assembly described in any of Examples 1 to 6, wherein the biocompatible conductive adhesive comprises a conductive adhesive composite.

[0055] Aspect 9: An assembly described in any preceding aspect, wherein the circuit layer has a longitudinally extending trunk structure and a plurality of branches extending laterally from the trunk structure, each of the plurality of branches having a distal end connected to the trunk structure and an opposite proximal end spaced outwardly from the trunk structure.

[0056] Example 10: An assembly described in any preceding example, wherein the plurality of electrodes includes at least one reusable ceramic electrode.

[0057] Example 11: An assembly described in any of the preceding examples, wherein the plurality of electrodes comprises at least one reusable high dielectric polymer electrode.

[0058] Aspect 12: An assembly described in any of the preceding aspects, wherein the covering layer of the electrode subassembly defines a first peripheral contour and the support layer has a second peripheral contour, and at least a portion of the first peripheral contour of the covering layer corresponds to at least a portion of the second peripheral contour of the support layer.

[0059] Aspect 13: A system for delivering a tumor treating field to a patient's body, comprising: an electrode assembly and at least one replaceable adhesive subassembly, the electrode assembly comprising: a circuit layer having a skin-facing inner side and an outer side; a plurality of electrodes disposed inside the circuit layer and electrically coupled to the circuit layer, each electrode of the plurality of electrodes having an electrode edge; a cover layer having an inner side and an outer side, the inner side being disposed on an outer side of the circuit layer, a portion of the cover layer extending beyond the circuit layer and beyond an electrode edge of each of the electrodes to define at least one mounting surface; Including, The at least one replaceable adhesive subassembly comprises: a support layer having a first side and a second side, the support layer defining at least one opening configured to receive a respective electrode of the plurality of electrodes therein; a first adhesive disposed on the first side of the support layer, the first adhesive configured to bond the support layer to an inner side of the cover layer of the electrode subassembly at at least one mounting surface of the cover layer; a biocompatible conductive adhesive disposed on a second side of the support layer.

[0060] Aspect 14: The system described in Aspect 13, wherein the at least one replaceable adhesive subassembly includes a second adhesive disposed on a second side of the support layer and adhering the biocompatible conductive adhesive to the support layer.

[0061] Example 15: The system described in Example 13 or Example 14, wherein the support layer of at least one replaceable adhesive subassembly comprises foam.

[0062] Aspect 16: The system described in any of Aspects 13 to 15, wherein the first adhesive is a non-permanent adhesive configured to be peelable from the at least one mounting surface of the covering layer.

[0063] Aspect 17: The system of any of aspects 13-16, wherein the first adhesive is configured to provide stronger adhesion to the support layer than to the covering layer.

[0064] Aspect 18: A system described in any of aspects 13 to 17, wherein the biocompatible conductive adhesive of the at least one replaceable adhesive subassembly has a first side facing the support layer and an opposite second side, and the at least one replaceable adhesive subassembly includes a first release liner disposed on the opposite second side of the biocompatible conductive adhesive.

[0065] Aspect 19: A system described in any of aspects 13 to 18, wherein the biocompatible conductive adhesive comprises a hydrogel.

[0066] Aspect 20: The system described in any of aspects 13 to 18, wherein the biocompatible conductive adhesive comprises a conductive adhesive composite.

[0067] Aspect 21: A system described in any of aspects 13 to 20, wherein the circuit layer has a longitudinally extending trunk structure and a plurality of branches extending laterally from the trunk structure, each of the plurality of branches having a distal end connected to the trunk region and an opposite proximal end spaced outwardly from the trunk structure.

[0068] Aspect 22: A system described in any of aspects 13 to 21, wherein the plurality of electrodes includes at least one reusable ceramic electrode.

[0069] Aspect 23: A system described in any of aspects 13 to 22, wherein the plurality of electrodes includes at least one reusable high dielectric polymer electrode.

[0070] Aspect 24: A system described in any of aspects 13 to 23, wherein the covering layer of the electrode subassembly defines a first peripheral contour and the support layer has a second peripheral contour, and at least a portion of the first peripheral contour of the covering layer corresponds to at least a portion of the second peripheral contour of the support layer.

[0071] Aspect 25: A system described in any of aspects 13 to 24, wherein the first adhesive has a first side facing the support layer and an opposite second side, and the at least one replaceable adhesive subassembly further includes a second release liner located on the opposite second side of the first adhesive.

[0072] Embodiment 26: The system described in any of embodiments 13-25, wherein the at least one replaceable adhesive subassembly includes a plurality of replaceable adhesive subassemblies.

[0073] Embodiment 27: One or more of the plurality of replaceable adhesive subassemblies comprises a plurality of replacement adhesive subassemblies, one replacement adhesive subassembly comprising: a support layer having a first side and a second side, the support layer defining at least one opening configured to receive a respective electrode of the electrode subassembly therein; a first adhesive disposed on the first side of the support layer and configured to bond the support layer to the cover layer of the electrode subassembly at at least one mounting surface of the cover layer; A biocompatible conductive adhesive disposed on the second side of the support layer.

[0074] Aspect 28: The system of any of aspects 13-27, wherein the electrode subassembly further includes a vest configured to extend around an individual's torso with the electrode subassembly disposed between the torso and the vest.

[0075] Aspect 29: A replaceable adhesive subassembly for use with an electrode subassembly having a plurality of electrodes and a cover layer defining at least one mounting surface, comprising: a support layer having a first side and a second side, the support layer defining at least one opening for receiving therein a respective electrode of the plurality of electrodes of the electrode subassembly; a first adhesive disposed on the first side of the support layer and configured to bond the support layer to the cover layer of the electrode subassembly at at least one mounting surface of the cover layer; and a biocompatible conductive adhesive disposed on the second side of the support layer.

[0076] Aspect 30: A replaceable adhesive subassembly as described in aspect 29, including a second adhesive disposed on a second side of the support layer and adhering the biocompatible conductive adhesive to the support layer.

[0077] Aspect 31: A replaceable adhesive subassembly described in any of aspects 29 to 30, wherein the biocompatible conductive adhesive has a first side facing the support layer and an opposite second side, and the replaceable adhesive subassembly includes a first release liner disposed on the opposite second side of the biocompatible conductive adhesive.

[0078] Aspect 32: A replaceable adhesive subassembly described in any of aspects 29 to 31, wherein the first adhesive has a first side facing the support layer and an opposite second side, and further includes a second release liner positioned on the opposite second side of the first adhesive.

[0079] Aspect 33: A method comprising: applying the assembly to a patient, the assembly comprising: an electrode assembly and at least one replaceable adhesive subassembly, the electrode assembly comprising: a circuit layer having a skin-facing inner side and an outer side; a plurality of electrodes disposed inside the circuit layer and electrically coupled to the circuit layer, each electrode of the plurality of electrodes having an electrode edge; a cover layer having an inner side and an outer side, the inner side being disposed on an outer side of the circuit layer, a portion of the cover layer extending beyond the circuit layer and beyond an electrode edge of each of the electrodes to define at least one mounting surface; Including, The at least one replaceable adhesive subassembly comprises: a support layer having a first side and a second side, the support layer defining at least one opening configured to receive a respective electrode of the plurality of electrodes therein; a first adhesive disposed on the first side of the support layer, the adhesive configured to bond the support layer to an inside of the cover layer of the electrode subassembly at at least one mounting surface of the cover layer; and a biocompatible conductive adhesive disposed on the second side of the support layer.

[0080] Embodiment 34: The method according to embodiment 33, comprising: Optionally, upon removing the assembly from the patient, removing one or more of the replaceable adhesive subassemblies from the electrode subassembly; applying one or more replacement adhesive subassemblies to the electrode subassembly, each replacement adhesive subassembly of the one or more replacement adhesive subassemblies comprising: a support layer having a first side and a second side, the support layer defining at least one opening configured to receive a respective electrode of the electrode subassembly therein; a first adhesive disposed on the first side of the support layer and configured to bond the support layer to the cover layer of the electrode subassembly at at least one mounting surface of the cover layer; and a biocompatible conductive adhesive disposed on the second side of the support layer.

[0081] Aspect 35: The method of aspect 34, further comprising the step of applying to the patient one or more replacement adhesives having the electrode subassembly attached thereto when the adhesive is removed from the patient.

[0082] Aspect 36: A biocompatible conductive adhesive of each replacement adhesive subassembly of the one or more replacement adhesive subassemblies has a first side facing the support layer and an opposite second side, and a first release liner is disposed opposite the second side of the biocompatible conductive adhesive of the replacement adhesive subassembly, a first adhesive of each replacement adhesive subassembly has a first side disposed opposite the support layer and an opposite second side, and a second release liner is disposed opposite the second side of the first adhesive, and the method further comprises: removing the second release liner prior to applying the replacement adhesive subassembly to the electrode subassembly; A method according to aspect 36, comprising the step of removing the first release liner prior to applying the one or more replacement adhesive subassemblies having the electrode subassembly attached to the patient.

[0083] Aspect 37: The method of any of aspects 33-36, further comprising the step of delivering the tumor treatment field to a patient using the electrode subassembly.

[0084] Embodiment 38: A kit comprising a plurality of replaceable adhesive subassemblies according to any of embodiments 29-32.

[0085] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, certain changes and modifications can be practiced within the scope of the appended claims.

Claims

1. 1. A system for delivering a tumor treating field to a patient's body, comprising: an electrode subassembly and at least one replaceable adhesive subassembly, the electrode subassembly comprising: a circuit layer having a skin-facing inner side and an outer side; a plurality of electrodes disposed on the skin-facing inner side of the circuit layer and electrically coupled to the circuit layer, each electrode of the plurality of electrodes having an electrode edge; a cover layer having an inner side and an outer side, the inner side being disposed on the outer side of the circuit layer, a portion of the cover layer extending beyond the circuit layer and beyond the electrode edge of each of the electrodes to define at least one mounting surface; Including, The at least one replaceable adhesive subassembly comprises: a support layer having a first side and a second side, the support layer defining at least one opening configured to receive a respective electrode of the plurality of electrodes therein; a first adhesive disposed on the first side of the support layer, the first adhesive configured to bond the support layer to the inner side of the cover layer of the electrode subassembly at the at least one mounting surface of the cover layer; a biocompatible conductive adhesive disposed on the second side of the support layer.

2. 10. The system of claim 1, wherein the at least one replaceable adhesive subassembly includes a second adhesive disposed on the second side of the support layer and 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 be releasable from the at least one mounting surface of the cover layer.

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

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

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

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

11. The at least one replaceable adhesive subassembly includes a plurality of replaceable adhesive subassemblies, one or more of the plurality of replaceable adhesive subassemblies including a plurality of replacement adhesive subassemblies, one replacement adhesive subassembly comprising: 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 disposed on the first side of the support layer and configured to bond the support layer to the cover layer of the electrode subassembly at the at least one mounting surface of the cover layer; a biocompatible conductive adhesive disposed on the second side of the support layer.

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

13. The replaceable adhesive subassembly of claim 12 including a second adhesive disposed on the second side of the support layer and adhering the biocompatible conductive adhesive to the support layer.

14. 13. 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, and the replaceable adhesive subassembly includes a first release liner disposed on the opposite second side of the biocompatible conductive adhesive.

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

16. 1. A method comprising: applying an assembly to a patient, said assembly comprising: an electrode subassembly and at least one replaceable adhesive subassembly, the electrode subassembly comprising: 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, each electrode of the plurality of electrodes having an electrode edge; a cover layer having an inner side and an outer side, the inner side being disposed on the outer side of the circuit layer, a portion of the inner side of the cover layer extending beyond the circuit layer and beyond the electrode edge of each of the electrodes to define at least one mounting surface; Including, The at least one replaceable adhesive subassembly comprises: a support layer having a first side and a second side, the support layer defining at least one opening, each electrode of the plurality of electrodes being received within a respective opening of the at least one opening; a first adhesive disposed on the first side of the support layer, the first adhesive bonding the support layer to the inner side of the cover layer of the electrode subassembly at the at least one mounting surface of the cover layer; a biocompatible conductive adhesive disposed on the second side of the support layer.

17. removing one or more of the at least one replaceable adhesive subassembly from the electrode subassembly; applying one or more replacement adhesive subassemblies to the electrode subassembly, wherein each replacement adhesive subassembly of the one or more replacement adhesive subassemblies comprises: a support layer having a first side and a second side, the support layer defining at least one opening configured to receive a respective electrode of the plurality of electrodes therein; a first adhesive disposed on the first side of the support layer, the first adhesive configured to bond the support layer to the inner side of the cover layer of the electrode subassembly at the at least one mounting surface of the cover layer; a biocompatible conductive adhesive disposed on the second side of the support layer.

18. removing the electrode subassembly from the patient before removing one or more of the at least one replaceable adhesive subassembly from the electrode subassembly; 20. The method of claim 17, further comprising the step of: applying the one or more replacement adhesive subassemblies with the electrode subassemblies attached to the patient.

19. the biocompatible conductive adhesive of each replacement adhesive subassembly of the one or more replacement adhesive subassemblies has a first side facing the backing layer and an opposite second side, a first release liner disposed opposite the second side of the biocompatible conductive adhesive of the replacement adhesive subassembly, the first adhesive of each replacement adhesive subassembly has a first side disposed opposite the backing layer and an opposite second side, a second release liner disposed opposite the second side of the first adhesive, and the method further comprises: removing the second release liner prior to applying the replacement adhesive subassembly to the electrode subassembly; 20. The method of claim 18, further comprising removing the first release liner prior to applying the one or more replacement adhesive subassemblies with the electrode subassemblies attached to the patient.

Images