Transducer arrays with alternative array materials

Abstract

A transducer array, electronic device, and method are described. The transducer array includes an electrode assembly including an electrode layer and a non-hydrogel skin interface material transducer array. The electrode layer includes one or more electrodes. The non-hydrogel skin interface material is for placement between a surface of the electrode layer and a patient's skin, the non-hydrogel skin interface material configured to contact the patient's skin and conform to the contours and / or irregularities of the patient's skin. The method includes applying the non-hydrogel skin interface material to the patient's skin. The non-hydrogel skin interface material is configured to contact the patient's skin and conform to the contours and / or irregularities of the patient's skin. The electrode assembly is then placed on the surface of the non-hydrogel skin interface material.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to the provisional patent application identified in U.S. Patent Application No. 63 / 385,540, filed November 30, 2022, the contents of which are expressly incorporated herein by reference in their entirety.

[0002] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable. [Background technology]

[0003] Tumor treating fields (TT fields or TTFs) are low-intensity (e.g., 1-10 V / cm) alternating electric fields in the mid-frequency range (50 kHz-1 MHz, e.g., 100-500 kHz) that target solid tumors by inhibiting mitosis. This non-invasive treatment is directed at solid tumors and is described, for example, in U.S. Patent Nos. 7,016,725, 7,089,054, 7,333,852, 7,565,205, 8,244,345, 8,715,203, 8,764,675, 10,188,851, and 10,441,776. TT fields are typically delivered through two pairs of transducer arrays, each of which is positioned on opposite sides of the body part being treated, to generate perpendicular fields within the tumor being treated. TT electric fields are approved for the treatment of glioblastoma multiforme (GBM) and may be generated, for example, via the OPTUNE® system (Novocure Limited, St. Helier, Jersey), which includes a transducer array placed on the patient's shaved head.

[0004] Each transducer array used to generate a TT electric field in the OPTUNE® device includes a set of non-conductive ceramic disc electrodes that are coupled to a patient's skin (e.g., but not limited to, a patient's shaved head for the treatment of GBM) via a layer of conductive medical gel, such as hydrogel. To form the ceramic disc electrodes, a conductive layer is formed on the upper (outward-facing) surface of the non-conductive ceramic material. The lower (skin-contacting) surface of the non-conductive ceramic material is coupled to the conductive medical gel.

[0005] One way to apply TT fields in different directions is to apply the field between a first set of electrodes in a first direction for a period of time, then apply the field between a second set of electrodes in a second direction for a period of time, and then repeat the cycle for an extended period of time (e.g., days, weeks, or months).To generate the TT fields, a current is applied to each electrode of the transducer array. Summary of the Invention [Problem to be solved by the invention]

[0006] The ceramic discs used in conventional systems have a rough surface, similar to the patient's skin, meaning that the disc cannot be directly applied to the skin without a hydrogel because the contact area is incomplete. The use of hydrogels has many drawbacks, including the problem of the hydrogel drying out and cracking (which also creates incomplete contact areas), its conductive properties that change depending on the water content in the hydrogel (which changes over time), and the need for humidity / moisture-controlled packaging of the hydrogel before use. Furthermore, some patients suffer from skin irritation caused by the hydrogel. Furthermore, some patients suffer from skin irritation when adhesives are used as skin contact layers. A skin contact layer between the device and the skin is necessary without the need for a hydrogel. In some cases, a skin contact layer between the device and the skin is necessary without the need for a hydrogel or adhesive. The present invention avoids the need for a ceramic disc and a hydrogel or adhesive layer and instead utilizes a non-hydrogel skin interface material that can replace both components. [Means for solving the problem]

[0007] In one aspect, the present disclosure describes a method that includes applying a non-hydrogel skin interface material to a patient's skin, where the non-hydrogel skin interface material is configured to contact the patient's skin and conform to the contours and / or irregularities of the patient's skin, and placing an electrode assembly on a surface of the non-hydrogel skin interface material.

[0008] In another aspect, the present disclosure describes a transducer array including an electrode layer including one or more electrodes and a non-hydrogel skin interface material for placement between a surface of the electrode layer and a patient's skin, the non-hydrogel skin interface material configured to contact the patient's skin and conform to the contours and / or irregularities of the patient's skin.

[0009] In the embodiments described herein, the non-hydrogel skin interface material can be an adhesive-free non-hydrogel skin interface material.

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more embodiments described herein and, together with this specification, explain these embodiments. The drawings are not intended to be drawn to scale, and certain features and certain views of the figures may be emphasized and shown to scale or in schematic form for clarity and conciseness. Not all components may be labeled in all figures. Like reference numbers in the figures may represent and refer to the same or similar elements or functions. [Brief explanation of the drawings]

[0011] [Figure 1] 1 is a schematic diagram of an exemplary electrode for applying an electric field to a target such as biological tissue. [Figure 2] FIG. 1 is a schematic diagram of an exemplary electronic device configured to generate a TT electric field. [Figure 3] FIG. 1 is a schematic diagram of an exemplary transducer array. [Figure 4A] 4 is an exploded cross-sectional view of the transducer array shown in FIG. 3 taken along line A-A' in the direction of the arrows (shown relative to the patient's skin). [Figure 4B] FIG. 4B is an assembled cross-sectional view of the transducer array shown in FIG. 4A. [Figure 5] FIG. 1 is a process flow diagram of an exemplary method for applying a TT electric field to a patient using a transducer array. DETAILED DESCRIPTION OF THE INVENTION

[0012] Before describing at least one embodiment of the inventive concept(s) in detail using illustrative terms and results, it is understood that the inventive concept(s) are not limited to the details of construction and the arrangement of components set forth in the following description. The inventive concept(s) are capable of other embodiments or of being practiced or carried out in various ways. Therefore, the terminology used herein is intended to be accorded the broadest possible scope and meaning, and the embodiments are meant to be illustrative rather than exhaustive. It is also understood that the terminology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0013] Headings are provided for convenience only and should not be construed as limiting the invention in any way. Embodiments shown under any heading or in any portion of this disclosure may be combined with embodiments shown under the same heading or in other headings or portions of this disclosure. Unless otherwise specified herein or clearly contradicted by context, any combination of elements described herein in all possible variations is encompassed by the invention.

[0014] Unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular, except that as used herein the word "plural" does not include the singular.

[0015] All patents or published patent applications referenced in any part of this application are expressly incorporated by reference in their entirety to the same extent as if each individual patent or publication was specifically and individually indicated to be incorporated by reference.

[0016] All of the assemblies, systems, kits, and / or methods disclosed herein can be made and executed without undue experimentation in light of the present disclosure. In method claims, unless the claim or the specification specifically recites that the steps are limited to a particular order, no order is intended to be inferred in any respect. This applies to any implied basis of interpretation, including questions of logic regarding the arrangement of steps or operational flow, the simple meaning derived from grammatical construction or punctuation, and the number or type of examples set forth in the specification.

[0017] As used in accordance with the present disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings:

[0018] The use of the terms "a" or "an" in the claims and / or specification when used in conjunction with the term "comprising" may mean "one," but is also consistent with the meaning of "one or more," "at least one," or "one or more." The term "plurality" refers to "two or more."

[0019] Use of the term "at least one" is understood to include one as well as more than one. Additionally, use of the term "at least one of X, Y, Z" is understood to include X only, Y only, Z only, and any combination of X, Y, and Z.

[0020] The use of ordinal terminology (e.g., "first," "second," "third," "fourth," etc.) is intended only to distinguish between two or more items and does not indicate superiority of one item over another, or any order or importance, such as additive order.

[0021] Use of the term "or" in the claims is used to mean an inclusive "and / or" unless expressly indicated to refer to only alternatives or unless the alternatives are mutually exclusive.

[0022] As used herein, the term "patient" includes human and veterinary subjects, including mammals, and for purposes of treatment, "mammal" refers to any animal classified as a mammal, including, but not limited to, humans, domestic animals, farm animals, non-human primates, and other animals with mammary tissue.

[0023] As used herein, a circuit may be analog and / or digital components, or one or more appropriately programmed processors (e.g., microprocessors) and associated hardware and software, or hardwired logic. Also, a "component" may perform one or more functions. A "component" may include hardware such as a processor (e.g., microprocessor), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or a combination of hardware and software. As used herein, the term "processor" refers to a single processor or multiple processors acting independently or jointly to perform a task jointly.

[0024] As used herein, the term "TT field" (plural TT field, or TTF(s)) refers to a tumor treating field. TT electric fields are medium frequency (about 50 kHz to 1 MHz, more preferably about 150 kHz to 500 kHz), low intensity (e.g., 1 to 10 V / cm, e.g., 1 to 4 V / cm) alternating electric fields that, when applied to a conductive medium such as the human body via electrodes, can be used, for example, to treat tumors, as described in U.S. Pat. Nos. 7,016,725, 7,089,054, 7,333,852, 7,565,205, 7,805,201, and 8,244,345 by Palti (each of which is incorporated herein by reference) and in a publication by Kirson (see Eilon D. Kirson, et al., "Disruption of Cancer Cell Replication by Alternating Electric Fields," Cancer Res. 2004 64:3288-3295). TT electric fields have the ability to specifically affect cancer cells, making them useful for cancer treatment, among other uses. TT electric field therapy is an approved monotherapy for recurrent glioblastoma (GBM) and an approved combination therapy with chemotherapy for newly diagnosed GBM patients.

[0025] As used herein, the term TT signal(s) refers to an electrical signal that, when received by an electrode applied to a conductive medium such as the human body, causes the electrode to generate the TT electric field described above. TT signals are often AC electrical signals having an alternating current waveform.

[0026] As used herein, the term "transducer array" can refer to a conductive transducer array or a non-conductive transducer array, such as those disclosed in U.S. Patent Publication No. 2021 / 0346693, entitled "CONDUCTIVE PAD GENERATING TUMOR TREATING FIELD AND METHODS OF PRODUCTION AND USE THEREOF," and U.S. Patent Publication No. 2022 / 0193404A1, entitled "OPTIMIZATION OF COMPOSITE ELECTRODE," both of which are incorporated herein in their entireties.

[0027] Referring now to the drawings, and particularly to FIG. 1 , an exemplary embodiment of an electric field target 100 (i.e., a divided cell) is shown under the influence of an external electric field, generally shown as lines 104, generated by a negatively charged first electrode 108a and a positively charged second electrode 108b. Also shown are microtubules 112, which are known to have very strong dipole moments. This strong polarization makes the microtubules 112, as well as other polar macromolecules, particularly molecules with specific orientations within or around the electric field target 100, susceptible to the electric field. The positive charges on the microtubules 112 are located at two central poles 116, while two sets of negative poles are located at the center 120 of the electric field target 100 and at the attachment point 124 of the microtubules 112 to the cell membrane. The location of the charges forms a set of double dipoles, making them susceptible to electric fields of different directions.

[0028] Referring now to FIG. 2, the above-described TT electric fields, which have been shown to effectively destroy tumor cells, can be generated by an electronic device 200. FIG. 2 is a simplified schematic diagram of the electronic device 200, illustrating its major components. The electronic device 200 comprises an electric field generator 204 and a pair of conductive leads 208, including a first conductive lead 208a and a second conductive lead 208b. The first conductive lead 208a has a first end 212a and a second end 212b. The second conductive lead 208b has a first end 216a and a second end 216b. The first end 212a of the first conductive lead 208a is conductively attached to the electric field generator 204, and the first end 216a of the second conductive lead 208b is conductively attached to the electric field generator 204.

[0029] The electronic device 200 may also include a first transducer array 220a and a second transducer array 220b. The electric field generator 204 generates as an output a desired electrical signal (TT signal) in the form of a waveform or pulse train. The second end 212b of the first conductive lead 208a is connected to the first transducer array 220a, and the second end 216b of the second conductive lead 208b is connected to the second transducer array 220b to provide the electrical signal (e.g., waveform).

[0030] Each of the first transducer array 220a and the second transducer array 220b is in contact with or associated with an electric field target 100 (see FIG. 1), such as biological tissue (e.g., a patient) or a phantom made of material(s) with similar conductive properties to biological tissue. The electrical signal generates an electric field (i.e., a TT electric field) that may be capacitively coupled to the electric field target 100, the TT electric field having a frequency and amplitude that is generated between the first transducer array 220a and the second transducer array 220b within the electric field target 100.

[0031] Each of the first and second transducer arrays 220a, 220b includes one or more conductive electrodes 300 (FIG. 3) that can be capacitively coupled to the electric field target 100 by a non-conductive layer. Alternative configurations of the first and second transducer arrays 220a, 220b can also be used, including, for example, transducer arrays that use non-conductive layers formed of disk-shaped or non-disk-shaped ceramic elements, and / or non-conductive layer(s) that use non-ceramic dielectric materials disposed on a plurality of flat conductors, such as a polymer film disposed on electrical contacts on a printed circuit board or on a flat metal piece.

[0032] In some implementations, the first transducer array 220a and the second transducer array 220b may include electrodes 300 that are not capacitively coupled to the electric field target 100. In this case, each of the first transducer array 220a and the second transducer array 220b may be implemented using an area of ​​conductive material configured for placement against the human body without an insulating dielectric layer between the conductive elements and the human body. Examples of conductive materials include, but are not limited to, conductive films, conductive fabrics, and / or conductive foams. Other alternative configurations for implementing the first transducer array 220a and the second transducer array 220b may also be used, as long as they are capable of transmitting the TT electric field to the electric field target 100.

[0033] Although the electronic device 200 shown in FIG. 2 includes only two transducer arrays 220 (first transducer array 220a and second transducer array 220b), in some embodiments, the electronic device 200 may include more than two transducer arrays 220.

[0034] The electric field generator 204 generates an AC waveform (i.e., a TT electric field) at a frequency ranging from about 50 kHz to about 1 MHz (e.g., about 100 kHz to about 200 kHz, or about 100 kHz to about 120 kHz). The required voltage is such that the electric field strength in the tissue within the treatment area is in the range of about 0.1 V / cm to about 100 V / cm, e.g., 1 to 4 V / cm. To achieve this electric field, the potential difference between the two conductors (not shown) of the first transducer array 220a and the second transducer array 220b is determined by the relative impedances of the system components; i.e., the proportion of the electric field in each component is determined by the impedance of that component divided by the overall circuit impedance.

[0035] To optimize the electric field (i.e., TT electric field) distribution, the first and second transducer arrays 220a and 220b (the pair of transducer arrays 220) may be configured or oriented differently depending on the application for which the pair of transducer arrays 220 is used. As described herein, the pair of transducer arrays 220 is positioned externally to the electric field target 100. When the electric field target 100 is a patient, the pair of transducer arrays 220 is positioned on the patient's skin to apply an electric current and an electric field (TT electric field), thereby generating currents in the patient's tissue. Typically, the pair of transducer arrays 220 is positioned on the patient's skin by a user (or a helper) so that an electric field is generated across the patient's tissue within the treatment area. The externally applied TT electric field can be of a localized or widely distributed type and is used, for example, to treat skin tumors and lesions close to the skin surface or tumors located deeper within the body.

[0036] In one embodiment, the user may be a medical professional such as a doctor, nurse, therapist, or other person acting under the direction of a doctor, nurse, therapist, etc. In another embodiment, the user may be a patient, i.e., the patient (and / or a helper) may position a pair of transducer arrays 220 over their treatment area.

[0037] Optionally, according to another exemplary embodiment, electronic device 200 includes a control box 224 and a temperature sensor 228 coupled to control box 224, which are included to control the amplitude of the electric field so that excessive heating does not occur in the treatment area.

[0038] If included, the control box 224 controls the output of the electric field generator 204, for example, ensuring that the output is constant at a value predetermined by a user. Alternatively, the control box 224 sets the output to a maximum value that does not cause excessive heating of the treatment region. In either case, the control box 224 may issue a warning or the like if the temperature of the treatment region (as sensed by the temperature sensor 228) exceeds a predetermined limit. The temperature sensor 228 may be mechanically connected to and / or otherwise associated with the first transducer array 220a and / or the second transducer array 220b so that either or both of the first transducer array 220a and / or the second transducer array 220b can sense the temperature of the electric field target 100.

[0039] In one embodiment, if the temperature sensed by temperature sensor 228 reaches or exceeds a comfort threshold, control box 224 may power off or reduce the TT signal generated by electric field generator 204. In one embodiment, the comfort threshold is the temperature at which a patient feels uncomfortable while using transducer array 220. In one embodiment, the comfort threshold is a temperature at or near 40° C. In one embodiment, the comfort threshold is a temperature between about 39° C. and 42° C., or a specific temperature between about 39° C. and 42° C., for example, 41° C.

[0040] The conductive leads 208 are standard insulated conductors with a flexible metal shield and are preferably grounded, thereby preventing the diffusion of any electric fields generated by the conductive leads 208. The transducer array 220 may have a particular shape and configuration to generate TT electric fields of a desired configuration, direction, and strength at, and only at, the treatment area to focus the treatment.

[0041] The specifications of the electronic device 200 as a whole and its individual components are greatly influenced by the fact that at the frequencies of the TT electric field, biological systems behave according to their "ohmic properties" rather than their dielectric properties.

[0042] Referring now to FIG. 3, a diagram of an exemplary embodiment of a first transducer array 220a constructed in accordance with the present disclosure is shown. The second transducer array 220b may have a structure and function similar to the first transducer array 220a. Therefore, for brevity, only the first transducer array 220a will be described herein. As described in more detail below, the first transducer array 220a includes one or more electrodes 300. As shown in FIG. 3, the first transducer array 220a is configured as a set of one or more electrodes 300. The first transducer array 220a may utilize electrodes 300 configured to be capacitively coupled with the patient. In the example shown in FIG. 3, the first transducer array 220a is configured as a plurality of electrodes 300 (each of the electrodes 300 is, for example, approximately 2 cm in diameter) interconnected via flex wires 304. Each electrode 300 may include a ceramic disc and a conductive electrode layer. In one embodiment, the first transducer array 220 a includes a perimeter edge 308 .

[0043] Alternative structures for the first transducer array 220a may be used, including, for example, disc-shaped ceramic elements, non-disc-shaped ceramic elements, and non-ceramic dielectric materials disposed on a plurality of flat conductors between the conductive electrode layer and the skin-contacting surface of the transducer array 220a, such as a polymer film disposed on electrodes on a printed circuit board or on a flat metal piece.

[0044] In one embodiment, the first transducer array 220a may utilize electrodes 300 that are not capacitively coupled. In this case, each electrode 300 of the first transducer array 220a is implemented using an area of ​​conductive material configured for placement against the human body, without an insulating dielectric layer disposed between the electrode 300 and the human body. Examples of conductive materials include conductive films, conductive fabrics, and conductive foams. Other alternative structures for implementing the first transducer array 220a may also be used, so long as they are capable of delivering a TT electric field to the human body.

[0045] In one embodiment, the transducer array 220a may be constructed in accordance with any transducer array or pad disclosed in U.S. patent application Ser. No. 17 / 813,837, filed July 20, 2022, entitled "CONDUCTIVE PAD GENERATING TUMOR TREATING FIELD AND METHODS OF PRODUCTION AND USE THEREOF," the contents of which are incorporated herein in their entirety.

[0046] 4A and 4B, which illustrate cross-sectional views of a portion of the first transducer array 220a shown in FIG. 3, taken along line A-A' in the direction (and in the plane) of the arrows. FIG. 4A illustrates an exploded cross-sectional view of a portion of the first transducer array 220a (shown in relation to the patient's skin 412), and FIG. 4B illustrates an assembled cross-sectional view of a portion of the first transducer array 220a (again shown in relation to the patient's skin 412). As shown in FIGS. 4A and 4B, the first transducer array 220a may include an electrode assembly 400 and a non-hydrogel skin interface material 404 for placement between a skin-contacting surface 408 of the electrode assembly 400 and the patient's skin 412. In embodiments described herein, the non-hydrogel skin interface material may be an adhesive-free non-hydrogel skin interface material. The electrode assembly 400 may include an electrode layer 416 including one or more electrodes 300 and, optionally, an intermediate layer 420 disposed on a skin-contacting surface 424 of the electrode layer 416. The intermediate layer 420 may be composed of a dielectric material (e.g., ceramic, polymer, etc.) or a conductive material. The electrode assembly 400 may further include a cover layer 428 disposed on an outward-facing surface 432 of the electrode layer 416.

[0047] The non-hydrogel skin interface material 404 may be configured to contact the patient's skin and conform to the contours and / or irregularities 436 of the patient's skin 412. The contours and / or irregularities 436 of the patient's skin 412 may include at least one of protrusions, impressions, ridges, or valleys. In some embodiments, the non-hydrogel skin interface material 404 is optionally configured to encapsulate at least a portion of the hairs 440 extending from the patient's skin 412.

[0048] In some embodiments, the non-hydrogel skin interface material 404 serves to adhere / anchor the first transducer array 220a and the second transducer array 220b to the patient's skin 412, provides a conductive path for the electric field to pass between the one or more electrodes 300 and the electric field target 100 (FIG. 1) through intervening non-conductive or conductive layers, and is biocompatible.

[0049] In some embodiments, the non-hydrogel skin interface material 404 may be applied to the patient's skin 412 as a liquid non-hydrogel skin interface material 404. In some embodiments, the non-hydrogel skin interface material 404 may be applied to the patient's skin 412 as an adhesive-free non-hydrogel skin interface material, such as a dielectric grease suspension. The liquid non-hydrogel skin interface material 404 may be sprayed onto the patient's skin 412 (i.e., the treatment area). The liquid non-hydrogel skin interface material 404 may be configured to change to a non-liquid state upon application. More specifically, the liquid non-hydrogel skin interface material 404 may be configured to change to a non-liquid, i.e., solid, state without exposure to ultraviolet light. That is, the liquid non-hydrogel skin interface material 404 may be configured to change to a non-liquid, i.e., solid, state after waiting a sufficient period of time.

[0050] In some embodiments, non-hydrogel skin interface material 404 is a viscoelastic material. In some embodiments, non-hydrogel skin interface material 404 comprises a silicone polymer. In such embodiments, the silicone polymer may optionally be crosslinked. In some embodiments, non-hydrogel skin interface material 404 is or comprises polydimethylsiloxane (PDMS), which may optionally be crosslinked.

[0051] In some embodiments, non-hydrogel skin interface material 404 is an adhesive-free non-hydrogel skin interface material, such as a dielectric material. In some such embodiments, non-hydrogel skin interface material 404 is or includes a dielectric (or silicone) grease. In such embodiments, the dielectric (or silicone) grease includes a polydimethylsiloxane (PDMS) polymer, which may optionally be crosslinked.

[0052] In some embodiments, the non-hydrogel skin interface material 404 may be configured to be disposed between the electrode assembly 400 and the patient's skin 412 such that the skin-contacting surface 408 of the intermediate layer 420, e.g., at least a portion of the intermediate layer 420, contacts at least a portion of the non-hydrogel skin interface material 404.

[0053] In some embodiments, the non-hydrogel skin interface material 404 is an electrically conductive material. In some such embodiments, the electrode assembly 400 further includes one or more DC blocking capacitors 444 (see FIG. 2 ) in series with one or more electrodes 300 to prevent DC signals from reaching the first transducer array 220 a or the second transducer array 220 b ( FIG. 2 ). In other embodiments, the non-hydrogel skin interface material 404 is a non-conductive material having a conductive material suspended therein. For example, the non-hydrogel skin interface material 404 may be a skin mask (e.g., a cosmetic facial mask) containing conductive particles. The conductive particles may include metal particles such as gold, silver, or copper particles, or carbon particles such as carbon flakes, carbon granules, carbon fibers, carbon nanotubes, single-walled carbon nanotubes, multi-walled carbon nanotubes, carbon black powder, graphite powder, carbon nanowires, and carbon microcoils.

[0054] Those skilled in the art will appreciate that the DC blocking capacitor 444 may be one or more components of the electric field generator 204, any of the pair of conductive leads 208 (i.e., first conductive lead 208a and / or second conductive lead 208b) (as shown in FIG. 2), and / or any of the transducer arrays 220 (i.e., first transducer array 220a, second transducer array group 220b, etc.).

[0055] Covering layer 428 may extend laterally beyond at least a portion of the periphery of electrode layer 416. More specifically, covering layer 428 may extend laterally beyond at least a portion of the periphery of electrode layer 416, and may also extend laterally beyond at least a portion of the outer periphery 308 ( FIG. 3 ) of transducer array 220 a such that at least a portion of covering layer 428 contacts non-hydrogel skin interface material 404 and / or the patient's skin 412. In some embodiments, for example, when non-hydrogel skin interface material 404 is an adhesive-free non-hydrogel skin interface material, covering layer 428 is an adhesive tape or bandage that operates to secure electrode layer 416 to the patient's skin 412.

[0056] Referring now to FIG. 5, an exemplary method 500 for applying a TT electric field to a patient using a transducer array 220 is shown, and the exemplary method 500 generally includes applying a first non-hydrogel skin interface material 404 to the patient's skin 412 (step 504); placing a first electrode assembly 400 on a first region of the surface of the first non-hydrogel skin interface material 404 (step 508); and placing a second electrode assembly 400 on a second region of the surface of the first non-hydrogel skin interface material 404, or applying a second electrode assembly 400 on a second region of the surface of the first non-hydrogel skin interface material 404 (step 509). The method includes placing the electrode assembly 400 on a surface of a second non-hydrogel skin interface material 404 applied to the patient's skin 412 (the second non-hydrogel skin interface material 404 is preferably separate from the first non-hydrogel skin interface material 404) (step 512), and activating a generator (i.e., electric field generator 204) to supply an electrical signal having an alternating current waveform at a frequency in the range of about 50 kHz to about 1 MHz to the first electrode assembly 400 and the second electrode assembly 400 (step 516).

[0057] First non-hydrogel skin interface material 404 may be configured to contact the patient's skin and conform to the contours and / or irregularities 436 of the patient's skin 412. In some embodiments, applying first non-hydrogel skin interface material 404 to the patient's skin 412 (Step 504) is further defined as applying first non-hydrogel skin interface material 404 to a first area on the surface of first non-hydrogel skin interface material 404. In some embodiments, first non-hydrogel skin interface material 404 may be applied to the patient's skin 412 as a first liquid non-hydrogel skin interface material 404. Alternatively, first non-hydrogel skin interface material 404 may be applied to the patient's skin 412 as a grease suspension.

[0058] In some implementations, the step of applying the first non-hydrogel skin interface material 404 to the patient's skin 412 (step 504) is further defined as spraying the first non-hydrogel skin interface material 404 onto the patient's skin 412. The first liquid non-hydrogel skin interface material 404 may be configured to convert to a non-liquid, i.e., solid, state upon application. In some embodiments, the first liquid non-hydrogel skin interface material 404 may be configured to change to a non-liquid, i.e., solid, state without exposure to ultraviolet light. That is, the first liquid non-hydrogel skin interface material 404 may be configured to change to a non-liquid, i.e., solid, state after waiting a sufficient period of time.

[0059] In some embodiments, the step of placing the first electrode assembly 400 on a first region of the surface of the first non-hydrogel skin interface material 404 (Step 508) is further defined as waiting a sufficient time for the first liquid non-hydrogel skin interface material 404 to change to a non-liquid state, and placing the first electrode assembly 400 on the first region of the surface of the non-liquid first non-hydrogel skin interface material 404. The first electrode assembly 400 may include an electrode layer 416 that includes one or more electrodes 300. The first electrode assembly 400 may further include a cover layer 428 that extends laterally beyond at least a portion of the perimeter of the electrode layer 416, and may extend laterally beyond at least a portion of the outer perimeter edge 308 of the transducer array 220a.

[0060] In some embodiments, the step of placing the first electrode assembly 400 on the first region on the surface of the first non-hydrogel skin interface material 404 (Step 508) is further defined as placing the first electrode assembly 400 on the first region on the surface of the first non-hydrogel skin interface material 404 such that at least a portion of the covering layer 428 contacts the first non-hydrogel skin interface material 404 or the patient's skin 412. At least a portion of the covering layer 428 may have an adhesive material, e.g., an adhesive layer (not shown), on at least a portion of the skin-contacting surface (not shown) of the covering layer 428 to assist in securing the first electrode assembly 400 to the patient's skin 412. The covering layer 428 may be an adhesive tape or a bandage.

[0061] In some embodiments, first non-hydrogel skin interface material 404 is a dielectric material. In such embodiments, first electrode assembly 400 may further include an intermediate layer 420 that is a conductive material, and the step of disposing first electrode assembly 400 on a first region of a surface of first non-hydrogel skin interface material 404 (Step 508) is further defined as disposing first electrode assembly 400 on the first region of a surface of first non-hydrogel skin interface material 404 such that at least a portion of intermediate layer 420 contacts at least a portion of first non-hydrogel skin interface material 404.

[0062] In some embodiments, first non-hydrogel skin interface material 404 is a viscoelastic material. In some embodiments, first non-hydrogel skin interface material 404 comprises a silicone polymer. In such embodiments, the silicone polymer may optionally be crosslinked. In some embodiments, first non-hydrogel skin interface material 404 is or comprises polydimethylsiloxane (PDMS), which may optionally be crosslinked.

[0063] In some embodiments, first non-hydrogel skin interface material 404 is a dielectric material. In some embodiments, non-hydrogel skin interface material 404 is or includes a dielectric (or silicone) grease. In some embodiments, the dielectric (or silicone) grease includes a polydimethylsiloxane (PDMS) polymer, which may optionally be crosslinked.

[0064] In some embodiments, the first non-hydrogel skin interface material 404 is electrically conductive. In some embodiments, the step of disposing the first electrode assembly 400 on a first region of the surface of the first non-hydrogel skin interface material 404 (Step 508) is further defined as disposing the first electrode assembly 400 on the first region of the surface of the first non-hydrogel skin interface material 404 such that at least a portion of the electrode layer 416 is electrically coupled to at least a portion of the first non-hydrogel skin interface material 404. In some embodiments, the first electrode assembly 400 may further include a DC blocking capacitor 444 in series with the one or more electrodes 300. In some embodiments, the first non-hydrogel skin interface material 404 is a skin mask (e.g., a cosmetic facial mask) that includes electrically conductive particles (e.g., metal particles or carbon particles).

[0065] Second non-hydrogel skin interface material 404 may be configured to contact the patient's skin and conform to the contours and / or irregularities 436 of the patient's skin 412. In some embodiments, second non-hydrogel skin interface material 404 may be applied to the patient's skin 412 as a second liquid non-hydrogel skin interface material 404. Alternatively, second non-hydrogel skin interface material 404 may be applied to the patient's skin 412 as a grease suspension.

[0066] The second liquid non-hydrogel skin interface material 404 may be configured to convert to a non-liquid, i.e., solid, state upon application. More specifically, the second liquid non-hydrogel skin interface material 404 may be configured to convert to a non-liquid state without exposure to ultraviolet light. That is, the second liquid non-hydrogel skin interface material 404 may be configured to convert to a non-liquid state after waiting a sufficient period of time.

[0067] In some embodiments, the step of placing the second electrode assembly 400 on a second region of the surface of the first non-hydrogel skin interface material 404 or placing the second electrode assembly 400 on the surface of the second non-hydrogel skin interface material 404 applied to the patient's skin 412 (Step 512) is further defined as waiting a sufficient time for at least one of the first liquid non-hydrogel skin interface material 404 and the second liquid non-hydrogel skin interface material 404 to change to a non-liquid state, and placing the second electrode assembly 400 on the second region of the surface of the first non-hydrogel skin interface material 404 or placing the second electrode assembly 400 on the surface of the second non-hydrogel skin interface material 404. The second electrode assembly 400 may include an electrode layer 416 including one or more electrodes 300. The second electrode assembly 400 may further include a cover layer 428 that extends laterally beyond at least a portion of the periphery of the electrode layer 416 and may extend laterally beyond at least a portion of the outer periphery 308 of the transducer array 220a.

[0068] In some embodiments, the step of placing the second electrode assembly 400 on a second region of the surface of the first non-hydrogel skin interface material 404 or the step of placing the second electrode assembly 400 on the surface of the second non-hydrogel skin interface material 404 applied to the patient's skin 412 (step 512) is further defined as placing the second electrode assembly 400 on a second region of the surface of the first non-hydrogel skin interface material 404 such that at least a portion of the covering layer 428 contacts the first non-hydrogel skin interface material 404 or the patient's skin 412, or placing the second electrode assembly 400 on the surface of the second non-hydrogel skin interface material 404 applied to the patient's skin 412 such that at least a portion of the covering layer 428 contacts the second non-hydrogel skin interface material 404 or the patient's skin 412. At least a portion of the covering layer 428 may have an adhesive layer (not shown) on at least a portion of the skin-contacting surface (not shown) of the covering layer 428 to assist in securing the second electrode assembly 400 to the patient's skin 412. The covering layer 428 may be an adhesive tape or a bandage.

[0069] In some embodiments, the second non-hydrogel skin interface material 404 is a dielectric material. In some embodiments, the second electrode assembly 400 may further include an intermediate layer 420, and the step of disposing the second electrode assembly 400 on a second region of the surface of the first non-hydrogel skin interface material 404 or on the surface of the second non-hydrogel skin interface material 404 applied to the patient's skin 412 (Step 512) is further defined as disposing the second electrode assembly 400 on the second region of the surface of the first non-hydrogel skin interface material 404 such that at least a portion of the intermediate layer 420 contacts at least a portion of the first non-hydrogel skin interface material 404, or disposing the second electrode assembly 400 on the surface of the second non-hydrogel skin interface material 404 applied to the patient's skin 412 such that at least a portion of the intermediate layer 420 contacts at least a portion of the second non-hydrogel skin interface material 404.

[0070] In some embodiments, second non-hydrogel skin interface material 404 is a viscoelastic material. In some embodiments, second non-hydrogel skin interface material 404 comprises a silicone polymer. In such embodiments, the silicone polymer may optionally be crosslinked. In some embodiments, second non-hydrogel skin interface material 404 is or comprises polydimethylsiloxane (PDMS), which may optionally be crosslinked.

[0071] In some embodiments, second non-hydrogel skin interface material 404 is a dielectric material. In some embodiments, second non-hydrogel skin interface material 404 is or includes a dielectric (or silicone) grease. In some embodiments, the dielectric (or silicone) grease includes a polydimethylsiloxane (PDMS) polymer, which may optionally be crosslinked.

[0072] In some embodiments, the second non-hydrogel skin interface material 404 is electrically conductive. In some embodiments, the step of placing the second electrode assembly 400 on a second region of the surface of the first non-hydrogel skin interface material 404, or placing the second electrode assembly 400 on the surface of the second non-hydrogel skin interface material 404 applied to the patient's skin 412 (Step 512) is further defined as placing the second electrode assembly 400 on the second region of the surface of the first non-hydrogel skin interface material 404 such that at least a portion of the electrode layer 416 is electrically coupled to at least a portion of the first non-hydrogel skin interface material 404, or placing the second electrode assembly 400 on the surface of the second non-hydrogel skin interface material 404 applied to the patient's skin 412 such that at least a portion of the electrode layer 416 is electrically coupled to at least a portion of the second non-hydrogel skin interface material 404. In some embodiments, the second electrode assembly 400 may further include a DC blocking capacitor 444 in series with one or more electrodes 300. In some embodiments, the second non-hydrogel skin interface material 404 is a skin mask (e.g., a cosmetic facial mask) that includes conductive particles.

[0073] In some embodiments, the step of activating the electric field generator 204 to supply an electrical signal having an alternating current frequency in the range of about 50 kHz to about 1 MHz (step 516) is further defined as activating the electric field generator 204 to supply an electrical signal to the first electrode assembly 400 and the second electrode assembly 400, thereby generating an electric field (i.e., a TT electric field) for a period of time, wherein the electrical signal has an alternating current waveform at a frequency in the range of about 50 kHz to about 1 MHz.

[0074] Below is a list of exemplary embodiments of the inventive concept.

[0075]

[0023] Exemplary Embodiment 1. A method, comprising: applying a non-hydrogel skin interface material to the patient's skin, the non-hydrogel skin interface material configured to contact the patient's skin and conform to the contours and / or irregularities of the patient's skin; and placing an electrode assembly on the surface of the non-hydrogel skin interface material.

[0076] [Illustrative Embodiment 2] The method of illustrative embodiment 1, wherein placing the electrode assembly on the surface of the non-hydrogel skin interface material is further defined as placing the electrode assembly on the surface of the non-hydrogel skin interface material so that an alternating current waveform may be applied to the patient through the non-hydrogel skin interface material.

[0077] [Exemplary Embodiment 3] The method of exemplary embodiment 1, wherein the non-hydrogel skin interface material is applied as a liquid non-hydrogel skin interface material or a grease suspension.

[0078] [Exemplary Embodiment 4] A method according to any one of exemplary embodiments 1 to 3, wherein the step of applying the non-hydrogel skin interface material to the patient's skin is further defined as spraying the non-hydrogel skin interface material onto the patient's skin.

[0079]

[0023] [Illustrative Embodiment 5] The step of applying the non-hydrogel skin interface material to the patient's skin is further defined as applying a liquid non-hydrogel skin interface material to the patient's skin, and the step of placing the electrode assembly on the surface of the non-hydrogel skin interface material further comprises: waiting a sufficient time for the liquid non-hydrogel skin interface material to change to a non-liquid state; 2. The method of Exemplary Embodiment 1, defined as: placing the electrode assembly on the surface of the non-liquid non-hydrogel skin interface material.

[0080] [Illustrative Embodiment 6] The method described in illustrative embodiment 5, wherein the non-hydrogel skin interface material is configured to change to a non-liquid state without exposure to ultraviolet light, and the step of placing the electrode assembly on the surface of the non-hydrogel skin interface material includes waiting a sufficient time for the liquid non-hydrogel skin interface material to change to the non-liquid state before placing the electrode assembly on the surface of the hydrogel skin interface material.

[0081] [Exemplary Embodiment 7] The method of any one of exemplary embodiments 1 to 6, wherein the electrode assembly comprises an electrode layer including one or more electrodes and a covering layer disposed on the outward surface of the electrode layer, the covering layer extending laterally beyond at least a portion of the periphery of the electrode layer, and the step of disposing the electrode assembly on the surface of the non-hydrogel skin interface material is further defined as disposing the electrode assembly on the surface of the non-hydrogel skin interface material so that at least a portion of the covering layer contacts the non-hydrogel skin interface material, the patient's skin, or both.

[0082] [Illustrative Embodiment 8] The method described in illustrative embodiment 7, wherein at least the portion of the covering layer that contacts the non-hydrogel skin interface material or the patient's skin, or both, has an adhesive layer on at least a portion of the skin-contacting surface of the covering layer to help secure the electrode assembly to the patient's skin.

[0083] [Exemplary embodiment 9] The method of exemplary embodiment 7, wherein the covering layer is an adhesive tape or a bandage.

[0084] [Exemplary Embodiment 10] A method according to any one of exemplary embodiments 1 to 9, wherein the non-hydrogel skin interface material is a dielectric, the electrode assembly comprises an electrode layer including one or more electrodes and a conductive layer disposed on the skin-contacting surface of the electrode layer, and the step of disposing the electrode assembly on the surface of the non-hydrogel skin interface material is further defined as disposing the electrode assembly on the surface of the non-hydrogel skin interface material so that at least a portion of the conductive layer contacts at least a portion of the non-hydrogel skin interface material.

[0085] [Exemplary embodiment 11] The method of exemplary embodiment 10, wherein the non-hydrogel skin interface material is or includes a silicone polymer, which may optionally be crosslinked.

[0086] [Exemplary embodiment 12] The method of exemplary embodiment 10, wherein the non-hydrogel skin interface material is or includes a polydimethylsiloxane polymer, which may optionally be crosslinked.

[0087]

[0033] ...

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[0032] ...

[0089] [Exemplary embodiment 15] The method described in exemplary embodiment 10, wherein the non-hydrogel skin interface material is a viscoelastic material.

[0090]

[0042] [Illustrative Embodiment 16] The electrode assembly is a first electrode assembly, the non-hydrogel skin interface material is a first non-hydrogel skin interface material, the step of disposing the first electrode assembly on the surface of the first non-hydrogel skin interface material is further defined as disposing the first electrode assembly on a first region of the surface of the first non-hydrogel skin interface material, and the method further comprises: placing a second electrode assembly on a second region of the surface of the first non-hydrogel skin interface material or placing the second electrode assembly on a surface of a second non-hydrogel skin interface material applied to the patient's skin; 16. The method of any one of exemplary embodiments 1-15, comprising: activating a generator to supply an electrical signal comprising an alternating current waveform to the first electrode assembly and the second electrode assembly, thereby generating an electric field within the patient for a period of time.

[0091] [Exemplary Embodiment 17] The method described in Exemplary Embodiment 16, wherein the step of operating the generator is further defined as operating the generator to supply the electrical signal having an alternating current waveform at a frequency in the range of about 50 kHz to about 1 MHz.

[0092] [Exemplary Embodiment 18] A method according to any one of exemplary embodiments 1 to 17, wherein the non-hydrogel skin interface material is a conductor, the electrode assembly includes an electrode layer including one or more electrodes, and the step of disposing the electrode assembly on the surface of the non-hydrogel skin interface material is further defined as disposing the electrode assembly on the surface of the non-hydrogel skin interface material so that at least a portion of the electrode layer is electrically coupled to at least a portion of the non-hydrogel skin interface material.

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[0094] [Exemplary embodiment 20] The method described in exemplary embodiment 18, wherein the non-hydrogel skin interface material is a skin mask containing conductive particles.

[0095] [Exemplary embodiment 21] A method according to any one of exemplary embodiments 1 to 20, wherein the non-hydrogel skin interface material is an adhesive-free non-hydrogel skin interface material.

[0096] Exemplary Embodiment 22. A transducer array, comprising: an electrode assembly including an electrode layer including one or more electrodes; a non-hydrogel skin interface material for placement between a surface of the electrode layer and the patient's skin, the non-hydrogel skin interface material configured to contact the patient's skin and conform to the contours and / or irregularities of the patient's skin.

[0097] [Example 23] A transducer array as described in Example 22, wherein the contours and / or irregularities comprise at least one of protrusions, impressions, ridges, or valleys.

[0098] [Illustrative Embodiment 24] A transducer array described in any one of illustrative embodiments 22 to 23, wherein the non-hydrogel skin interface material is a liquid non-hydrogel skin interface material or a grease suspension.

[0099] [Illustrative embodiment 25] A transducer array as described in illustrative embodiment 24, wherein the non-hydrogel skin interface material is a liquid non-hydrogel skin interface material configured to change to a non-liquid state without exposure to ultraviolet light.

[0100] [Illustrative embodiment 26] A transducer array as described in illustrative embodiment 22, wherein the non-hydrogel skin interface material is a viscoelastic material.

[0101] [Illustrative Embodiment 27] A transducer array as described in illustrative embodiment 22, wherein the non-hydrogel skin interface material is a dielectric material and the electrode assembly further comprises a conductive material disposed between the surface of the electrode layer and the non-hydrogel skin interface material.

[0102] [Illustrative Embodiment 28] A transducer array as described in illustrative embodiment 22, wherein the non-hydrogel skin interface material is or includes a silicone polymer, which may optionally be crosslinked.

[0103] [Illustrative Embodiment 29] A transducer array as described in illustrative embodiment 22, wherein the non-hydrogel skin interface material is or includes polydimethylsiloxane (PDMS), which may optionally be crosslinked.

[0104] [Example 30] A transducer array as described in Example 22, wherein the non-hydrogel skin interface material is or includes a dielectric grease.

[0105] [Example 31] A transducer array as described in Example 30, wherein the dielectric grease comprises polydimethylsiloxane (PDMS) and may optionally be crosslinked.

[0106] [Illustrative Embodiment 32] A transducer array described in any one of illustrative embodiments 22 to 31, further comprising a cover layer disposed on the outward surface of the electrode layer, the cover layer extending laterally beyond at least a portion of the periphery of the electrode layer so that at least a portion of the cover layer contacts the non-hydrogel skin interface material or the patient's skin.

[0107] [Example 33] A transducer array as described in Example 32, wherein the covering layer is an adhesive tape or a bandage.

[0108] [Illustrative embodiment 34] A transducer array described in any one of illustrative embodiments 22 to 33, wherein the non-hydrogel skin interface material is a conductive material.

[0109] [Illustrative Embodiment 35] A transducer array as described in illustrative embodiment 34, wherein the electrode assembly further comprises a DC blocking capacitor connected in series with one or more electrodes.

[0110] [Illustrative embodiment 36] A transducer array described in any one of illustrative embodiments 22 to 33, wherein the non-hydrogel skin interface material is a non-conductive material having a conductive material suspended therein.

[0111] [Illustrative Embodiment 37] A transducer array as described in illustrative embodiment 36, wherein the non-conductive material is a skin mask and the conductive material is conductive particles.

[0112] [Illustrative embodiment 38] A transducer array described in any one of illustrative embodiments 22 to 37, wherein the non-hydrogel skin interface material is a non-hydrogel skin interface material that does not contain an adhesive.

[0113]

[0047] Exemplary embodiment 39 is an electronic device, an electric field generator including circuitry configured to generate an alternating current electrical signal having an alternating current waveform; a first conductive lead connected to the electric field generator to receive the alternating current electrical signal; a second conductive lead connected to the electric field generator to receive the alternating current electrical signal; a first transducer array connected to the first conductive lead; a second transducer array connected to the second conductive lead, The first transducer array includes: an electrode layer including one or more electrodes; a non-hydrogel skin interface material for placement between a surface of the electrode layer and the patient's skin, the non-hydrogel skin interface material configured to contact the patient's skin and conform to the contours and / or irregularities of the patient's skin.

[0114] [Illustrative embodiment 40] The electronic device described in illustrative embodiment 39, wherein the non-hydrogel skin interface material is a conductive material and further comprises a DC blocking capacitor connected in series with the first conductive lead.

[0115] [Illustrative Embodiment 41] An electronic device as described in illustrative embodiment 40, wherein the DC blocking capacitor is a first DC blocking capacitor and further comprises a second DC blocking capacitor connected in series with the second conductive lead.

[0116] [Illustrative embodiment 42] An electronic device as described in illustrative embodiment 39, wherein the non-hydrogel skin interface material is a non-conductive material having a conductive material suspended therein.

[0117] [Exemplary embodiment 43] An electronic device described in any one of exemplary embodiments 39 to 42, wherein the non-hydrogel skin interface material is a non-hydrogel skin interface material that does not contain an adhesive.

[0118]

[0082] Exemplary embodiment 44. A method, comprising: applying the adhesive-free non-hydrogel skin interface material to the patient's skin, wherein the adhesive-free non-hydrogel skin interface material is configured to contact the patient's skin and conform to the contours and / or irregularities of the patient's skin; placing an electrode assembly on the surface of the adhesive-free non-hydrogel skin interface material.

[0119] [Illustrative Embodiment 45] The method described in illustrative embodiment 44, wherein placing the electrode assembly on the surface of the adhesive-free non-hydrogel skin interface material is further defined as placing the electrode assembly on the surface of the adhesive-free non-hydrogel skin interface material so that an alternating current waveform may be applied to the patient through the adhesive-free non-hydrogel skin interface material.

[0120] [Exemplary embodiment 46] The method described in exemplary embodiment 44, wherein the adhesive-free non-hydrogel skin interface material is applied as an adhesive-free liquid non-hydrogel skin interface material or a grease suspension.

[0121] [Exemplary embodiment 47] A method according to any one of exemplary embodiments 44 to 46, wherein the step of applying the adhesive-free non-hydrogel skin interface material to the patient's skin is further defined as spraying the adhesive-free non-hydrogel skin interface material onto the patient's skin.

[0122] [Exemplary Embodiment 48] The step of applying the adhesive-free non-hydrogel skin interface material to the patient's skin is further defined as applying the adhesive-free liquid non-hydrogel skin interface material to the patient's skin, and the step of placing the electrode assembly on the surface of the adhesive-free non-hydrogel skin interface material further comprises: waiting a sufficient time for the adhesive-free, liquid non-hydrogel skin interface material to change to a non-liquid state; 45. The method of exemplary embodiment 44, defined as placing the electrode assembly on the surface of the non-liquid, non-hydrogel skin interface material that does not contain the adhesive.

[0123] [Illustrative Embodiment 49] The method described in illustrative embodiment 48, wherein the adhesive-free non-hydrogel skin interface material is configured to change to a non-liquid state without exposure to ultraviolet light, and the step of placing the electrode assembly on the surface of the adhesive-free non-hydrogel skin interface material includes waiting a sufficient amount of time for the adhesive-free, liquid non-hydrogel skin interface material to change to a non-liquid state before placing the electrode assembly on the surface of the adhesive-free non-hydrogel skin interface material.

[0124] [Exemplary Embodiment 50] A method according to any one of exemplary embodiments 44 to 49, wherein the electrode assembly comprises an electrode layer including one or more electrodes and a covering layer disposed on the outward surface of the electrode layer, the covering layer extending laterally beyond at least a portion of the periphery of the electrode layer, and the step of disposing the electrode assembly on the surface of the adhesive-free non-hydrogel skin interface material is further defined as disposing the electrode assembly on the surface of the adhesive-free non-hydrogel skin interface material so that at least a portion of the covering layer contacts the adhesive-free non-hydrogel skin interface material, the patient's skin, or both.

[0125] [Illustrative embodiment 51] The method described in illustrative embodiment 50, wherein at least a portion of the covering layer that contacts the adhesive-free non-hydrogel skin interface material or the patient's skin, or both, has an adhesive layer on at least a portion of the skin-contacting surface of the covering layer to help secure the electrode assembly to the patient's skin.

[0126] [Exemplary embodiment 52] The method of exemplary embodiment 50, wherein the covering layer is an adhesive tape or a bandage.

[0127] [Exemplary Embodiment 53] A method according to any one of exemplary embodiments 44 to 52, wherein the adhesive-free non-hydrogel skin interface material is a dielectric, the electrode assembly comprises an electrode layer including one or more electrodes and a conductive layer disposed on the skin-contacting surface of the electrode layer, and the step of disposing the electrode assembly on the surface of the adhesive-free non-hydrogel skin interface material is further defined as disposing the electrode assembly on the surface of the adhesive-free non-hydrogel skin interface material so that at least a portion of the conductive layer contacts at least a portion of the adhesive-free non-hydrogel skin interface material.

[0128] [Exemplary embodiment 54] The method described in exemplary embodiment 53, wherein the adhesive-free non-hydrogel skin interface material is or includes a silicone polymer, which may optionally be crosslinked.

[0129] [Exemplary embodiment 55] The method described in exemplary embodiment 53, wherein the non-hydrogel skin is or includes a silicone polymer, optionally an interface material, which may be crosslinked.

[0130] [Exemplary embodiment 56] The method described in exemplary embodiment 53, wherein the adhesive-free non-hydrogel skin interface material is or includes a dielectric grease.

[0131]

[0072] ...

[0132] [Exemplary embodiment 58] The method described in exemplary embodiment 53, wherein the adhesive-free non-hydrogel skin interface material is a viscoelastic material.

[0133] [Illustrative Embodiment 59] The electrode assembly is a first electrode assembly, the adhesive-free non-hydrogel skin interface material is a first adhesive-free non-hydrogel skin interface material, the step of disposing the first electrode assembly on the surface of the first adhesive-free non-hydrogel skin interface material is further defined as disposing the first electrode assembly on a first region of the surface of the first adhesive-free non-hydrogel skin interface material, and the method further comprises: placing a second electrode assembly on a second region of the surface of the first adhesive-free non-hydrogel skin interface material or placing the second electrode assembly on a surface of a second adhesive-free non-hydrogel skin interface material applied to the patient's skin; 16. The method of any one of exemplary embodiments 1-15, comprising: activating a generator to supply an electrical signal comprising an alternating current waveform to the first electrode assembly and the second electrode assembly, thereby generating an electric field within the patient for a period of time.

[0134] [Illustrative Embodiment 60] The method described in illustrative embodiment 59, wherein the step of operating the generator is further defined as operating the generator to supply the electrical signal having an alternating current waveform at a frequency in the range of about 50 kHz to about 1 MHz.

[0135] [Exemplary Embodiment 61] A method according to any one of exemplary embodiments 44 to 60, wherein the adhesive-free non-hydrogel skin interface material is a conductor, the electrode assembly includes an electrode layer including one or more electrodes, and the step of placing the electrode assembly on the surface of the adhesive-free non-hydrogel skin interface material is further defined as placing the electrode assembly on the surface of the adhesive-free non-hydrogel skin interface material so that at least a portion of the electrode layer is electrically coupled to at least a portion of the adhesive-free non-hydrogel skin interface material.

[0136] [Example 62] The method of Example 61, wherein the electrode assembly further comprises a DC blocking capacitor connected in series with one or more electrodes.

[0137] [Exemplary embodiment 63] The method described in exemplary embodiment 61, wherein the adhesive-free non-hydrogel skin interface material is a skin mask containing conductive particles.

[0138] Exemplary Embodiment 64. A transducer array, comprising: an electrode assembly including an electrode layer including one or more electrodes; the transducer array comprising: an adhesive-free, non-hydrogel skin interface material for placement between a surface of the electrode layer and the patient's skin, the adhesive-free, non-hydrogel skin interface material configured to contact the patient's skin and conform to the contours and / or irregularities of the patient's skin.

[0139] [Illustrative Embodiment 65] A transducer array as described in illustrative embodiment 64, wherein the contours and / or irregularities comprise at least one of protrusions, impressions, ridges, or valleys.

[0140] [Illustrative embodiment 66] A transducer array as described in illustrative embodiment 64 or 65, wherein the adhesive-free non-hydrogel skin interface material is an adhesive-free liquid non-hydrogel skin interface material or a grease suspension.

[0141] [Illustrative embodiment 67] A transducer array as described in illustrative embodiment 66, wherein the adhesive-free non-hydrogel skin interface material is an adhesive-free liquid non-hydrogel skin interface material configured to change to a non-liquid state without exposure to ultraviolet light.

[0142] [Illustrative embodiment 68] A transducer array as described in illustrative embodiment 64, wherein the adhesive-free non-hydrogel skin interface material is a viscoelastic material.

[0143] [Illustrative Embodiment 69] A transducer array as described in illustrative embodiment 64, wherein the adhesive-free non-hydrogel skin interface material is a dielectric material, and the electrode assembly further comprises a conductive material disposed between the surface of the electrode layer and the adhesive-free non-hydrogel skin interface material.

[0144] [Illustrative embodiment 70] A transducer array as described in illustrative embodiment 64, wherein the adhesive-free non-hydrogel skin interface material is or includes a silicone polymer, which may optionally be crosslinked.

[0145] [Illustrative Embodiment 71] A transducer array as described in illustrative embodiment 64, wherein the adhesive-free non-hydrogel skin interface material is or includes polydimethylsiloxane (PDMS), which may optionally be crosslinked.

[0146] [Illustrative Embodiment 72] A transducer array as described in illustrative embodiment 64, wherein the adhesive-free non-hydrogel skin interface material is or includes a dielectric grease.

[0147] [Illustrative Embodiment 73] A transducer array as described in illustrative embodiment 72, wherein the dielectric grease comprises polydimethylsiloxane (PDMS) and may optionally be crosslinked.

[0148] [Illustrative Embodiment 74] A transducer array described in any one of illustrative embodiments 64 to 73, further comprising a cover layer disposed on the outward surface of the electrode layer, the cover layer extending laterally beyond at least a portion of the periphery of the electrode layer so that at least a portion of the cover layer contacts the adhesive-free non-hydrogel skin interface material or the patient's skin.

[0149] [Illustrative Embodiment 75] A transducer array as described in illustrative embodiment 74, wherein the covering layer is an adhesive tape or bandage.

[0150] [Illustrative embodiment 76] A transducer array described in any one of illustrative embodiments 64 to 75, wherein the non-hydrogel skin interface material is a conductive material.

[0151] [Illustrative Embodiment 77] A transducer array as described in illustrative embodiment 76, wherein the electrode assembly further comprises a DC blocking capacitor connected in series with one or more electrodes.

[0152] [Illustrative embodiment 78] A transducer array described in any one of illustrative embodiments 64 to 75, wherein the adhesive-free non-hydrogel skin interface material is a non-conductive material having a conductive material suspended therein.

[0153] [Illustrative Embodiment 79] A transducer array as described in illustrative embodiment 78, wherein the non-conductive material is a skin mask and the conductive material is conductive particles.

[0154]

[0077] [Illustrative Embodiment 80] An electronic device, an electric field generator including circuitry configured to generate an alternating current electrical signal having an alternating current waveform; a first conductive lead connected to the electric field generator to receive the alternating current electrical signal; a second conductive lead connected to the electric field generator to receive the alternating current electrical signal; a first transducer array connected to the first conductive lead; a second transducer array connected to the second conductive lead, The first transducer array includes: an electrode layer including one or more electrodes; the transducer array comprising: an adhesive-free, non-hydrogel skin interface material for placement between a surface of the electrode layer and the patient's skin, the adhesive-free, non-hydrogel skin interface material configured to contact the patient's skin and conform to the contours and / or irregularities of the patient's skin.

[0155] [Illustrative embodiment 81] An electronic device as described in illustrative embodiment 80, wherein the adhesive-free non-hydrogel skin interface material is a conductive material and further comprises a DC blocking capacitor connected in series with the first conductive lead.

[0156] [Illustrative Embodiment 82] An electronic device as described in illustrative embodiment 81, wherein the DC blocking capacitor is a first DC blocking capacitor and further includes a second DC blocking capacitor connected in series with the second conductive lead.

[0157] [Illustrative embodiment 83] An electronic device as described in illustrative embodiment 80, wherein the adhesive-free non-hydrogel skin interface material is a non-conductive material having a conductive material suspended therein.

[0158] From the foregoing, it is apparent that the inventive concepts disclosed and claimed herein are well adapted to carry out the objects and attain the advantages set forth herein, as well as those inherent therein. While exemplary embodiments of the inventive concepts have been set forth for purposes of this disclosure, it will be understood that numerous modifications, which will readily occur to those skilled in the art, are possible which are within the spirit of the inventive concepts disclosed and claimed herein. [Explanation of symbols]

[0159] 100 Electric Field Target 104 line 108a 1st electrode 108b 2nd electrode 112 Microtubules 116 Center pole 120 center 124 attachment points 200 Electronic equipment 204 Electric Field Generator 208 Conductive Lead 208a First conductive lead 208b Second conductive lead 212a, 216a first end 212b, 216b 2nd end 220 Transducer Array 220a First transducer array 220b Second transducer array 224 Control Box 444 DC blocking capacitor

Claims

1. 1. A transducer array comprising: an electrode assembly including an electrode layer including one or more electrodes; a non-hydrogel skin interface material for placement between the skin contacting surface of the electrode layer and the patient's skin, the non-hydrogel skin interface material configured to contact the patient's skin and conform to the contours and / or irregularities of the patient's skin.

2. A transducer array as described in claim 1, wherein the non-hydrogel skin interface material is a non-hydrogel skin interface material that does not contain an adhesive.

3. 3. The transducer array of claim 1 or 2, wherein the non-hydrogel skin interface material is (i) a liquid or grease suspension, or (ii) a liquid configured to change to a non-liquid state without exposure to ultraviolet light.

4. The transducer array of claim 1 or 2, wherein the non-hydrogel skin interface material is a viscoelastic material.

5. The transducer array of claim 1 or 2, wherein the non-hydrogel skin interface material comprises a silicone polymer.

6. The transducer array of claim 1 or 2, wherein the non-hydrogel skin interface material is a conductive material.

7. A transducer array as described in claim 6, wherein no insulating dielectric layer is disposed between the one or more electrodes and the patient's skin.

8. The transducer array of claim 7 , wherein the electrode assembly further comprises a DC blocking capacitor connected in series with one or more electrodes.

9. 3. The transducer array of claim 1, wherein the non-hydrogel skin interface material is a non-conductive material having a conductive material suspended therein.

10. 10. The transducer array of claim 9, wherein the non-conductive material is a skin mask and the conductive material is conductive particles.

11. A transducer array as described in claim 1 or 2, wherein the non-hydrogel skin interface material comprises a silicone polymer having conductive carbon particles suspended therein.

12. A transducer array as described in claim 1 or 2, further comprising an intermediate layer between the electrode layer and the non-hydrogel skin interface material, the intermediate layer being a conductive material.

13. A transducer array as described in claim 1 or 2, further comprising a cover layer disposed on an outwardly facing surface of the electrode layer, the cover layer extending laterally beyond at least a portion of the periphery of the electrode layer such that at least a portion of the cover layer contacts the non-hydrogel skin interface material and / or the patient's skin.

14. A transducer array as described in claim 1 or 2, wherein the non-hydrogel skin interface material is a dielectric material, and the electrode assembly further comprises a conductive material disposed between the skin contact surface of the electrode layer and the non-hydrogel skin interface material.

15. 1. An electronic device comprising: an electric field generator including circuitry configured to generate an alternating current electrical signal having an alternating current waveform; a first conductive lead connected to the electric field generator to receive the alternating current electrical signal; a second conductive lead connected to the electric field generator to receive the alternating current electrical signal; a transducer array according to claim 2 connected to the first conductive lead; a further transducer array connected to the second conductive lead.

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