Transducer arrays with subarrays and methods of producing

Abstract

A transducer array is disclosed herein. The transducer array includes a hub and a transducer sub-array. The hub includes a housing having a housing peripheral edge having a boundary, and a hub port supported by the housing, with the hub port positioned within the boundary of the housing peripheral edge. The transducer sub-array includes an electrode, a sub-array port, and a support layer having a support layer peripheral edge and supporting the electrode and the sub-array port. The sub-array port couples the hub port with the electrode, and the electrode receives an alternating current waveform at a frequency in the range of 50 kHz-1 MHz from the hub via the sub-array port.

Description

Transducer arrays with subarrays and their manufacturing and usage methods

[0001] Reference to related applications This patent application claims priority to U.S. Provisional Patent Application No. 63 / 586,260, filed September 28, 2023, the entire contents of which are incorporated herein by reference. Background Technology

[0002] Tumor therapeutic electric fields (TTFields) are low-intensity (e.g., 1 V / cm to 3 V / cm) alternating electric fields in the mid-frequency range (e.g., 50 kHz to 1 MHz, such as 50 kHz to 500 kHz) that target solid tumors by interfering with mitosis. This non-invasive therapeutic targeting of solid tumors 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. TTField is typically delivered via two pairs of transducer arrays that generate a vertical electric field within the tumor being treated; each pair consists of transducer arrays positioned on opposite sides of the body site being treated. More specifically, for the OPTUNE® system, one pair of electrodes from the transducer array is positioned on the left and right sides of the tumor (LR), and the other pair is positioned on the anterior and posterior sides of the tumor (AP). TTField is approved for the treatment of glioblastoma multiforme (GBM) and can be delivered, for example, via the OPTUNE® system (Novocure Limited, St. Helier, Jersey), which comprises transducer arrays placed on the patient's laser head. Recently, TTField therapy has been approved as a concomitant therapy with chemotherapy for malignant pleural mesothelioma (MPM) and can be used to treat tumors in other parts of the body.

[0003] Typically, a transducer array with a hydrogel layer is placed on the patient's skin, on opposite sides of a target location (or multiple locations) determined to be of high therapeutic value for the patient. The device is designed to be worn continuously by the patient for a period of 2 to 4 days, then removed for hygiene care and shaving (if necessary), followed by reapplication of a new array.

[0004] As the person moves, the connecting cables may cause the array to shift away from the target location, thus reducing its therapeutic value. Furthermore, because the array must be worn for extended periods, current arrays may become uncomfortable due to their rigidity. When the target area is near avoidance areas (such as, for example, the chemotherapy site, nipple, etc.), conventional arrays may not be configurable for comfortable placement without interfering with or overlapping with the avoidance area. Summary of the Invention

[0005] Therefore, there is a need for a novel, improved transducer array configured to maintain position while improving patient comfort. This disclosure relates to such a system and methods of manufacturing and using such a system.

[0006] The transducer array, tumor therapy field system, and methods of manufacturing and using thereof, as described herein, address the problem of maintaining position while improving patient comfort. In one embodiment, the transducer array includes a hub and a transducer subarray. The hub includes a housing and a hub port supported by the housing, the housing having a peripheral edge having a boundary, wherein the hub port is positioned within the boundary of the peripheral edge. The transducer subarray includes an electrode, a subarray port, and a support layer having a peripheral edge and supporting the electrode and the subarray port. The subarray port couples the hub port to the electrode, and the electrode receives an alternating current waveform in the frequency range of 50 kHz–1 MHz from the hub via the subarray port.

[0007] In another embodiment, the transducer array includes a plurality of electrode elements, a first transducer subarray, a second transducer subarray, and a flexible cable. The plurality of electrode elements includes electrodes configured for placement on a patient's body and receiving an alternating current waveform. The first transducer subarray includes a first support layer having a first support layer peripheral edge and supporting a first subset of the plurality of electrode elements operable to receive the alternating current waveform. The second transducer subarray includes a second support layer having a second support layer peripheral edge and supporting a second subset of the plurality of electrode elements operable to receive the alternating current waveform, the second support layer peripheral edge being separately disposed from the first support layer peripheral edge. The flexible cable is electrically coupled to the first subset of the plurality of electrode elements and operable to transmit the alternating current waveform to the second subset of the plurality of electrode elements. Attached Figure Description

[0008] One or more specific embodiments described herein are illustrated in conjunction with the accompanying drawings, which form part of this specification. The drawings are not intended to be drawn to scale, and for clarity and simplicity, certain features and views may be shown to scale or as enlarged schematically. Not every component may be labeled in every drawing. Similar reference numerals in the figures may indicate and refer to the same or similar elements or functions, and unless otherwise specified, detailed descriptions of similar reference numerals that differ only in letter suffixes may be omitted for brevity. In the accompanying drawings: FIG1 is an exemplary embodiment of a schematic diagram of an electrode applied to living tissue; FIG2 is an exemplary embodiment of an electronic device configured to generate an alternating electric field according to the present disclosure; FIG3A is a diagram of an exemplary embodiment of a transducer array according to the present disclosure; FIG3B is a cross-sectional view along line 3B-3B' of an exemplary embodiment of the hub of FIG3A according to the present disclosure; FIG4 is a cross-sectional view along line 4-4' of an exemplary embodiment of the electrode elements of the first transducer subarray of FIG3A; FIG5 is a front view of an exemplary embodiment of the electronic device of FIG2 constructed and used according to the present disclosure; FIG6A is a perspective view of another embodiment of the transducer array constructed according to the present disclosure; FIG6B is a diagram of the transducer array of FIG6A constructed according to the present disclosure; and FIG7 is a process flowchart of an exemplary embodiment of the process of applying an alternating electric field to a patient using the electronic device and transducer array of FIG2 according to the present disclosure. Detailed Implementation

[0009] Before explaining in detail at least one embodiment of the inventive concept through exemplary language and results, it should be understood that the application of the inventive concept is not limited to the details of the construction and arrangement of the components set forth in the following description. The inventive concept can be other embodiments or can be practiced or performed in various ways. Therefore, the language used herein is intended to give the broadest possible scope and meaning; and these embodiments are intended to be exemplary rather than exhaustive. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting.

[0010] The headings are provided for convenience only and should not be construed as limiting this disclosure in any way. Embodiments illustrated under any heading or in any part of this disclosure may be combined with embodiments illustrated under the same or any other heading or other part of this disclosure. Unless otherwise stated herein or clearly contradicted by the context, this disclosure covers any combination of the elements described herein in all possible variations. Unless the context requires otherwise, singular terms shall include plural terms, and plural terms shall include singular terms.

[0011] All compositions, components, systems, kits, and / or methods disclosed herein can be prepared and performed without excessive experimentation. Where a method claim does not specifically state in the claims or specification that the steps are limited to a particular order, no inference is ever made in any respect of the order. This applies to any possible undefined basis of interpretation, including logical questions regarding the arrangement of steps or procedures, literal meanings derived from grammatical organization or punctuation, or the number or type of embodiments described in the specification.

[0012] When used in conjunction with the term "comprising" in the claims and / or description, the term "a" or "an" may mean "one," but is also consistent with "one or more," "at least one," and "one or more." The term "a plurality" means "two or more." The term "or" as used in the claims is used to mean inclusive "and / or," unless explicitly stated to refer only to alternatives, or unless the alternatives are mutually exclusive.

[0013] Furthermore, the use of the term "at least one of X, Y, and Z" will be understood to include X alone, Y alone, and Z alone, as well as any combination of X, Y, and Z. The use of ordinal terms (e.g., "first," "second," "third," "fourth," etc.) is solely for the purpose of distinguishing two or more items and does not imply any order or sequence or importance.

[0014] As used herein, a circuit may be an analog and / or digital component, or one or more appropriately programmed processors (e.g., microprocessors) and associated hardware and software, or hardwired logic. Furthermore, a “component” may perform one or more functions. The term “component” may include hardware such as processors (e.g., microprocessors), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), combinations of hardware and software, etc. As used herein, the term “processor” refers to a single processor or multiple processors that work individually or together to perform a task.

[0015] As used herein, the term TTField (or TTFields) refers to a low-intensity (e.g., 1 V / cm to 4 V / cm) alternating electric field of medium frequency (about 50 kHz to 1 MHz, and more preferably about 50 kHz to 500 kHz), which, when applied via electrodes to a conductive medium (such as the human body), can be used, for example, to treat tumors, as in Palti's U.S. Patents 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 (the entire contents of which are incorporated herein by reference), and Kirson's publication (see "Disruption of Cancer Cell Replication by Alternating Electric Fields" by Eilon D. Kirson et al., Cancer Research). As described in Res. (2004 64:3288-3295), TTField has been shown to have the ability to specifically affect cancer cells and is used, among other uses, to treat cancer. TTField therapy is an approved monotherapy for recurrent glioblastoma (GBM) and, together with chemotherapy, is an approved combination therapy for newly diagnosed GBM patients. Alternating electric fields can also be used to treat medical conditions other than oncology.

[0016] As used herein, the term TTSignal is an electrical signal that, when received by an electrode applied to a conductive medium (such as the human body), causes that electrode to produce the aforementioned TTField. TTSignal is typically an AC or alternating current electrical signal.

[0017] Referring now to the accompanying drawings, particularly Figure 1, an exemplary embodiment of a dividing cell 10 under the influence of an external TT Field (generally indicated by line 14) generated by a negatively charged first electrode 18a and a positively charged second electrode 18b is shown. Microtubules 22, known to have very strong dipole moments, are also shown. This strong polarization makes microtubules 22, as well as other polar macromolecules (and especially those polar macromolecules with specific orientations within or around the cell 10), susceptible to the influence of the electric field. The positive charge of the microtubules 22 is located at two centrosomes 26, while two sets of negative poles are located at the center 30 of the dividing cell 10 and at the attachment point 34 of the microtubules 22 to the cell membrane. The positions of the charges form multiple sets of bipolar poles and are therefore susceptible to the influence of electric fields in different directions.

[0018] Turning now to Figure 2, it has been found that the aforementioned TTField, which advantageously destroys tumor cells, can be generated by electronic device 50. Figure 2 is a simplified schematic diagram of electronic device 50, illustrating its main components. Electronic device 50 includes an electric field generator 54 and a pair of conductive leads 58, which include a first conductive lead 58a and a second conductive lead 58b. The first conductive lead 58a includes a first end 62a and a second end 62b. The second conductive lead 58b includes a first end 66a and a second end 66b. The first end 62a of the first conductive lead 58a is conductively attached to the electric field generator 54, and the first end 66a of the second conductive lead 58b is conductively attached to the electric field generator 54. The conductive leads 58 are insulating conductors with a flexible metal shielding layer (preferably grounded) to prevent any electric field generated by the conductive leads 58 from spreading.

[0019] An electric field generator 54 is configured to supply power and generate a desired electrical signal (TTSignal) of waveform or pulse train shape as output. The second end 62b of the first conductive lead 58a is connected to the first transducer array 70a, and the second end 66b of the second conductive lead 58b is connected to the second transducer array 70b. Both the first transducer array 70a and the second transducer array 70b are supplied with an electrical signal (e.g., TTSignal, waveform). The supply of electrical signals to the first transducer array 70a and the second transducer array 70b causes current to flow between them. The current generates an electric field (i.e., TTField) with frequency and amplitude between the first transducer array 70a and the second transducer array 70b.

[0020] Although the electronic device 50 shown in FIG2 includes only two transducer arrays 70 (i.e., the first transducer array 70a and the second transducer array 70b), in some embodiments, the electronic device 50 may include more than two transducer arrays 70.

[0021] The electric field generator 54 generates an alternating voltage waveform (i.e., TTSignal) with a frequency in the range of about 50 kHz to about 1 MHz (preferably about 100 kHz to about 500 kHz). The required voltage results in an electric field strength in the tissue within the treatment area in the range of about 0.1 V / cm to about 10 V / cm.

[0022] In certain specific (but not limiting) embodiments, the first transducer array 70a and the second transducer array 70b generate alternating current and an alternating electric field within a target region of the patient. The target region may include at least one tumor (or a region comprising a resection cavity after tumor removal), in which case the generation of the alternating current and alternating electric field selectively disrupts and / or inhibits the growth of the tumor (or cancer cells). The alternating current and alternating electric field may be generated at any frequency suitable for treating the patient, such as any frequency that selectively disrupts or inhibits the growth of the tumor (or cancer cells), such as any frequency of TTField.

[0023] To optimize the distribution of the electric field (e.g., TTField), the first transducer array 70a and the second transducer array 70b (a pair of transducer arrays 70) can be configured differently depending on the application of the pair of transducer arrays 70 to be used. As described herein, the pair of transducer arrays 70 are applied externally to the patient to apply a current and an electric field (TTField), thereby generating a current within the patient's tissue. Typically, the pair of transducer arrays 70 is placed on the patient's skin by the user, causing an electric field to be generated on the patient's tissue within the treatment area. The externally applied alternating electric field can be localized or widely distributed, for example, in the treatment of skin tumors and lesions near the skin surface.

[0024] In one embodiment, the user may be a medical professional, such as a doctor, nurse, therapist, or other person working under the guidance of a doctor, nurse, or therapist. In another embodiment, the user may be a patient, i.e., the patient (and / or assistant) may place the first transducer array 70a and the second transducer array 70b on the patient's treatment area.

[0025] According to another exemplary embodiment, the electronic device 50 includes a controller 74. In one embodiment, the controller 74 includes circuitry configured to control the output of the electric field generator 54, for example, to set the output to a maximum value that will not cause overheating of the treatment area. The controller 74 may issue a warning, etc., when the temperature of the treatment area exceeds a preset limit. A temperature sensor 76 may be mechanically connected to and / or otherwise associated with the first transducer array 70a and / or the second transducer array 70b to sense the temperature of the treatment area at one or both of the first transducer array 70a and the second transducer array 70b.

[0026] In some embodiments, the electric field generator 54 may be configured to wirelessly transmit TTSignal and / or TTField, thereby eliminating the need for conductive leads 58 to provide a direct electrical connection between the electric field generator 54 and the transducer array 70. Exemplary embodiments of the wireless connection may be constructed based on any of the embodiments disclosed in U.S. Provisional Application No. 63 / 387,113, filed December 13, 2022, entitled “Wireless Transducer Arrays Applying Tumor Treatment Fields and Systems and Methods of Use Thereof,” the entire contents of which are incorporated herein by reference.

[0027] Referring now in combination to Figures 3A and 3B, Figure 3A shows an exemplary embodiment of a transducer array 100 constructed according to the present disclosure, and Figure 3B is a cross-sectional view of the hub of the exemplary embodiment of Figure 3A along lines 3B-3B'. The transducer array 100 may be a specific embodiment of the transducer array 70 (Figure 2). The transducer array 100 generally includes a hub 104 and one or more transducer subarrays 108, shown as a first transducer subarray 108a, a second transducer subarray 108b, and a third transducer subarray 108c. While the transducer array 100 is shown having three transducer subarrays 108a to 108c, it should be understood that the transducer array 100 may include as few as one transducer subarray 108 or as many transducer subarrays 108 capable of providing therapeutic benefit or coupled to the hub 104.

[0028] In one embodiment, the hub 104 includes a housing 112 that supports a plurality of hub ports 116 (hereinafter referred to as hub ports 116, shown as hub ports 116a to 116f in FIG. 3A) and hub lead connector ports 117, which may be configured to receive at least one end of a conductive lead 58. The housing 112 includes a first surface 120 (shown in FIG. 3B) on a skin-facing side 132, a second surface 124 on an opposing outward-facing side 136, and a housing peripheral edge 128, thereby forming a boundary. In one embodiment, the housing 112 optionally includes a channel 152 extending from the first surface 120 to the second surface 124, thereby providing a path for airflow to the patient's skin when the hub 104 is applied to a patient, thus allowing air to cool the patient's skin and / or providing a path for sweat.

[0029] In one embodiment, a first number of n hub ports 116 supported by housing 112 may be positioned within the boundary of the housing peripheral edge 128. Typically, the hub ports 116 may be disposed between a first surface 120 and a second surface 124; however, it should be understood that in some embodiments, at least a portion of the hub ports 116 may extend into either the first surface 120 or the second surface 124. The hub ports 116 may be uniformly arranged around the boundary of the housing peripheral edge 128 (e.g., equidistant from each other, or approximately equidistant), as shown in the exemplary embodiment of FIG3A, or the hub ports 116 may be non-uniformly distributed around the housing peripheral edge 128. In one embodiment, n transducer subarrays are electrically coupled to all hub ports of the corresponding n hub ports 116 via corresponding subarray ports 164 (described below). In one embodiment, n-1 or n-2 transducer subarrays may be coupled to corresponding hub ports among the first number of n hub ports 116 via corresponding subarray ports 164.

[0030] In one embodiment, hub lead connector port 117 may be configured to receive at least one end of conductive lead 58. For example, hub lead connector port 117 may be configured to receive a second end 62b of conductive lead 58 (which is then connected to electric field generator 54 via a first end 62a of conductive lead 58), thereby supplying TTSignal to all hub ports of hub port 116. In one embodiment, the second end 62b may be permanently attached to hub lead connector port 117; alternatively, the second end 62b may be selectively attached to hub lead connector port 117. In one embodiment, the second end 62b of conductive lead 58 may include a second port operable to connect to and / or couple to hub lead connector port 117.

[0031] In one embodiment, hub port 116 may have port types such as a standardized port, a non-standardized port, or a combination of non-standardized and standardized ports. For example, hub port 116 (and optionally, hub lead connector port 117) may include, but is not limited to: USB Type-C, serial port, parallel port Type-USB, and combinations thereof. Exemplary embodiments of hub port 116 may be constructed based on any connector disclosed in U.S. Application No. 17 / 490,120, filed September 30, 2021, entitled “CONNECTOR FOR DETACHABLE ARRAY,” the entire contents of which are incorporated herein by reference.

[0032] In one embodiment, hub ports 116a to 116f include a first port type, and hub lead connector port 117 may include a second port type. The first port type and the second port type may be the same, or the first port type and the second port type may be different.

[0033] As shown in FIG3A, in one embodiment, one or more transducer subarrays 108 of transducer array 100 include a support layer 156, additional electrodes (i.e., one or more electrode elements 160), and subarray ports 164. The support layer 156 has a peripheral edge 168, from which the subarray ports 164 extend and are supported by the support layer 156. In one embodiment, the electrode elements 160 may be disposed within the peripheral edge 168 of the support layer and supported by the support layer 156.

[0034] In one embodiment, each of the one or more transducer subarrays 108 has a region dependent on the support layer 156. For example, the support layer 156 of the first transducer subarray 108a has a first region, the support layer 156 of the second transducer subarray 108b has a second region, and the support layer 156 of the third transducer subarray 108c has a third region. Although the first, second, and third regions are shown as different, in other embodiments, one or more of the first, second, and third regions may be the same. For example, the first region of the support layer 156 of the first transducer subarray 108a is shown as larger than the third region of the support layer 156 of the third transducer subarray 108c, while the first region of the support layer 156 of the first transducer subarray 108a is shown as smaller than the second region of the support layer 156 of the second transducer subarray 108b.

[0035] In one embodiment, each of the one or more transducer subarrays 108 has a shape dependent on the support layer 156. For example, the support layer 156 of the first transducer subarray 108a has a first shape, the support layer 156 of the second transducer subarray 108b has a second shape, and the support layer 156 of the third transducer subarray 108c has a third shape. While the first, second, and third shapes are shown as different, in other embodiments, one or more of the first, second, and third shapes may be consistent, for example, identical. In the example shown, one or more transducer subarrays 108 are configured with a generally triangular shape (or a truncated triangular shape), resembling a petal. However, it should be understood that one or more transducer subarrays 108 may be configured with a shape having any suitable geometry, including but not limited to: circles, ellipses, squares, rectangles, polygons, and odd shapes, or truncated forms of them, or combinations thereof.

[0036] In some embodiments, the support layer 156 of one or more transducer subarrays 108 may include a subarray neck 172 extending between the subarray port 164 and the electrode element 160, as shown in the subarray neck 172 of the second transducer subarray 108b. The subarray neck 172 may vary in length to allow a user to position the electrode elements 160 of one or more transducer subarrays 108 closer to or further away from the hub 104 as needed.

[0037] In one embodiment, the support layer 156 of one or more transducer subarrays 108 is constructed of a flexible material, enabling the one or more transducer subarrays 108 to operate to conform to the contours of a patient's body. For example, when the transducer subarrays 108 are placed on a patient's skin, the transducer subarrays 108 can operate to conform to (or fit) the contours of a target area.

[0038] In one embodiment, subarray port 164 may be constructed based on hub port 116 and complementary to the hub port (e.g., operable to couple to the hub port), as described above.

[0039] In one embodiment, one or more transducer subarrays 108 may be permanently attached to or selectively connected to hub 104 by coupling subarray ports 164 to specific hub ports 116 in the hub ports 116.

[0040] In one embodiment, subarray port 164 may be electrically coupled to one of the hub ports 116 and configured to receive TTSignal from hub port 116. In one embodiment, one or more transducer subarrays 108 include a flexible conductor 176 extending through a subarray neck 172 that electrically couples subarray port 164 to electrode element 160, thereby providing TTSignal to electrode element 160.

[0041] Referring now to FIG. 3B, a cross-sectional view of an exemplary embodiment of a hub 104 constructed according to the present disclosure is shown. A first surface 120 may include a first portion 140 and a second portion 144, which is different from the first portion 140. As shown, the first portion 140 includes a central surface region of the first surface 120, while the second portion 144 includes an outer surface region of the first surface 120. However, in other embodiments, the first portion 140 may include a first half of the surface region of the first surface 120, while the second portion 144 may include a second half of the surface region of the first surface 120. In one embodiment, the second portion 144 is discontinuous. In other words, the first portion 140 may be disposed within the second portion 144 such that a first region 144 of the second portion is not adjacent to a second region of the second portion 144.

[0042] In some embodiments, the hub 104 may include an adhesive layer 148 on a first surface 120. The adhesive layer 148 may be disposed on a first portion 140 of the first surface 120, a second portion 144 of the first surface 120, or both. The adhesive layer 148 may be biocompatible with the patient to reduce interaction between the adhesive layer 148 and the patient's skin. In one embodiment, the adhesive layer 148 is a tape operable to hold the hub 104 in place on the patient as they perform their daily activities.

[0043] In one embodiment, hub 104 may further include electrode element 160 (discussed in more detail below) disposed on or within a first portion 140 of a first surface 120 of housing 112. With electrode element 160 disposed on the first portion 140, adhesive layer 148 will be disposed only on a second portion 144 of the first surface 120. (In FIG. 3B, for clarity, adhesive layer 148 is shown only in one area of ​​the second portion 144, but in other embodiments, adhesive layer 148 may be located in a continuous area surrounding electrode element 160—i.e., shown on both sides of the first portion 140 in FIG. 3B). Electrode element 160 is electrically coupled to a hub port (e.g., hub port 116 or hub lead connector port 117) and is configured to receive TTSignal.

[0044] Referring now to FIG. 4, an exemplary embodiment of the electrode element 160 of the first transducer subarray 108a is shown as a cross-sectional view along line 4-4' of FIG. 3A. The electrode element 160 typically includes an electrode 180 and a skin interface layer 184, the electrode being electrically coupled to the subarray port 164 via a flexible wire 176 (shown in FIG. 3A). In one embodiment, the electrode element 160 further includes a non-conductive layer 188 configured such that the electrode 180 is inserted between the non-conductive layer 188 and the skin interface layer 184. In some embodiments, the electrode element 160 further (optionally) includes a dielectric layer 192 inserted between the electrode 180 and the skin interface layer 184.

[0045] In one embodiment, electrode 180 has a first electrode surface 196 (e.g., as a first skin-facing surface) on its skin-facing side 200 and a second electrode surface 204 on its opposite, outward-facing side 208. Electrode 180 may be made of any conductive material having desired properties, such as, but not limited to, high conductivity, strong biocompatibility, and low reactivity with other layers or components of electrode element 160. In one embodiment, the conductive material of electrode 180 is selected from one or more of the following: silver, gold, tin, aluminum, titanium, platinum, stainless steel, carbon, copper, alloys thereof, and / or some combination thereof.

[0046] The skin interface layer 184 may have a first interface surface 212 disposed on the skin-facing side 200 of the electrode 180 and may be electrically connected to the electrode 180 (i.e., electrically in communication with the electrode). The skin interface layer 184 may have a second interface surface 216 configured to contact the patient's skin.

[0047] In one embodiment, the skin interface layer 184 includes one or more materials configured to be conductive, biocompatible, and flexible when in prolonged contact with the patient's skin (e.g., for 3 hours to a week at a time) so as not to impede the patient's movement when the one or more transducer subarrays 108 are in place and to resist movement of the one or more transducer subarrays on the patient's skin when the patient is performing daily activities. In one embodiment, the skin interface layer 184 is a gel, hydrogel, conductive gel or hydrogel, polymeric gel or hydrogel, or conductive polymeric gel or hydrogel, constructed according to the gel / hydrogel layer described in U.S. Patent Publication No. 2021 / 0346693 A1, entitled “Conductive Pad Generating Tumor Treating Field and Methods of Production and Use Thereof,” published November 11, 2021, and U.S. Patent No. 11,458,298, entitled “Assemblies Continizing Two Conductive Gel Compositions and Methods of Production and Use Thereof,” published October 4, 2022, the entire contents of which are incorporated herein by reference. In another embodiment, the skin interface layer 184 is an adhesive or a conductive adhesive. In some embodiments, the skin interface layer 184 extends (laterally) to the location where the electrode 180 extends, while in other embodiments, the skin interface layer 184 extends at least to the peripheral edge 168 (FIG. 3A) of the support layer of the electrode element or extends beyond the peripheral edge of the support layer.

[0048] The non-conductive layer 188 may have a first layer surface 209 disposed on the opposite outward-facing side surface 208 of the electrode 180. The non-conductive layer 188 may have a second layer surface 210 opposite to the first layer surface 209. The non-conductive layer 188 may exist as a support layer 156 (FIG. 3A) of the transducer subarray 108, and the electrode element 160 may be fixedly attached to the support layer 156. In one embodiment, the non-conductive layer 188 may be constructed of a durable non-conductive material such as a non-conductive fabric. In some embodiments, the non-conductive fabric may have a plurality of perforations for heat dissipation from the electrode element 160.

[0049] In one embodiment, the non-conductive layer 188 may include an adhesive on the first layer surface 209 (constructed according to the adhesive layer 148 discussed above). Furthermore, the non-conductive layer 188 may be configured to cover and extend beyond the electrode element 160, such that the adhesive on the first layer surface 209 of the non-conductive layer 188 is accessible to the patient's skin to adhere the electrode element 160 and / or the transducer subarray 108 to the patient. For example, the non-conductive layer 188 may be tape or bandage and may extend laterally beyond the outer edges of the other layers.

[0050] In one embodiment, the dielectric layer 192 may be constructed of a dielectric material to capacitively couple the electrode 180 to the patient's skin. The dielectric material may be in the form of a ceramic material or a high-dielectric polymer. In one embodiment, the dielectric layer 192 may serve as a support layer 156. For example, in the absence of the dielectric layer 192, the first interface surface 212 of the skin interface layer 184 may contact the first electrode surface 196 on the skin-facing side 200 of the electrode 180.

[0051] In one embodiment, electrode 180 and / or dielectric layer 192 may (optionally) include a path 220 extending therethrough. Path 220 may be operable to allow moisture and / or air to move between the skin interface layer 184 and the air environment on the second layer surface 210 of the non-conductive layer 188.

[0052] Referring now to FIG. 5, a front view is shown of an exemplary embodiment of an electronic device 50 (FIG. 2) constructed and used according to the present disclosure. As shown in FIG. 5, a first transducer array 70a and a second transducer array 70b (shown as constructed according to transducer array 100 (FIG. 3A), but may be constructed according to transducer array 300 (FIG. 6A-6B, hereinafter)) are attached to the chest of a patient 224 and connected to an electric field generator 54 via a first conductive lead 58a and a second conductive lead 58b, respectively. In one embodiment, each component of the transducer array 70 (e.g., each component of the first transducer array 70a or the second transducer array 70b) is configured to conform to the shape of a target region to provide the desired TTField.

[0053] For example, the transducer array 70 may be configured to prevent overlap between the transducer array 70 and one or more avoidance areas 232 (e.g., shown as a first avoidance area 232a and a second avoidance area 232b) on the patient 224's body. For example, the first transducer array 70a is located on the right chest region and is configured such that the first transducer array 70b does not include the transducer subarray 108 connected to the hub port 116d so as not to interfere with and / or overlap with the first avoidance area 232a (i.e., the chemotherapy port) located toward the top of the patient's right chest. Similarly, the second transducer array 70b is located on the patient's left chest region and is configured such that the second transducer array 70b does not include the transducer subarray 108 connected to the hub port 116e to avoid the second avoidance area 232b on the patient's body, such as sensitive or highly innervated areas of the patient's body (such as the nipple).

[0054] As discussed above, transducer array 70 selectively includes one or more transducer subarrays 108 with different areas and shapes to create a customized transducer array that produces a desired TTField configuration while bypassing one or more avoidance areas 232 on the patient's body. In the example shown, the first transducer array 70a and the second transducer array 70b (constructed according to the transducer array 100 described above) each include five transducer subarrays from one or more transducer subarrays 108, wherein two transducer subarrays 108 have smaller areas and shorter subarray necks 172, one transducer subarray 108 has a larger area and shorter subarray necks 172, and two transducer subarrays 108 have larger areas and longer subarray necks 172. In one embodiment, if the size and shape of the third transducer subarray 108c (FIG. 3A) do not interfere with the first avoidance region 232a when coupled to the first transducer array 70a, the first transducer array 70a may include a transducer subarray 108 having a smaller size and area, for example, similar to the third transducer subarray 108c (FIG. 3A), and coupled to the hub port 116d.

[0055] Turning now to a combination of Figures 6A and 6B, Figure 6A shows a perspective view of an exemplary embodiment of the transducer array 300, and Figure 6B shows a diagram of another embodiment of the transducer array 300 constructed according to the present disclosure. The transducer array 300 may be a specific embodiment of the transducer array 70 (Figure 2). The transducer array 300 includes a plurality of electrode elements 302a to 302n and two or more transducer subarrays 304a to 304n, each transducer subarray including a subset of a plurality of antenna elements 302 and electrically coupled to at least one other transducer subarray among the n transducer subarrays via one or more flexible cables 308 (e.g., flexible cables 308a to 308c in Figure 6B), and electrically coupled to an electric field generator 54 (Figure 6B) via conductive leads 58.

[0056] Each of the multiple transducer subarrays 304a to 304n includes a subset of multiple electrode elements 302 and may include a support layer 312 having a peripheral edge 316 that supports the subset of electrode elements 302. Each electrode element 302 is constructed according to the electrode element 160 described above and shown in FIG. 4. The subset of multiple electrode elements 302 within a particular transducer subarray 304 is interconnected via flexible wires 324. The flexible wires 324 may be configured to distribute TTSignal to all electrode elements 302 of the subset of a particular transducer subarray 304 in a parallel circuit.

[0057] In one embodiment, the flexible conductor 324 may be configured to electrically couple each of a plurality of electrode elements 302 in a parallel circuit, a series circuit, or a combination thereof. While the transducer array 300 is shown as having each subset of transducer subarrays 304 having four electrode elements 302, it should be understood that each subset of transducer subarrays 304 may include as few as one electrode element 302 or as many as several electrode elements 302 required to provide the desired TTField or to be supported by the support layer 312. In one embodiment, the flexible conductor 324 is configured to electrically couple at least one electrode element 302 in parallel with at least one other electrode element 302. For example, a second electrode element 302b and a third electrode element 302c may be electrically coupled in series (as an electrode element pair), while a first electrode element 302a may be electrically coupled in parallel with the electrode element pair.

[0058] One or more flexible cables 308 may be used to electrically couple multiple transducer subarrays 304 together. Exemplary embodiments of the flexible cables 308 may be constructed according to any embodiment of the conductors disclosed in U.S. Application No. 17 / 490,120 cited above. Each flexible cable 308 may be configured to be fixedly or selectively attached to at least a portion of the flexible conductor 324, at least one electrode element of the plurality of electrode elements 302, another flexible cable of one or more flexible cables 308, or port 340. In one embodiment, the flexible cables 308 are constructed of a flexible conductive material such that the transducer array 300 is operable to conform to the contours of a patient's body. For example, when the transducer array 300 is placed on a patient's skin, the flexible cables 308 may be bent between each transducer subarray in the transducer subarray 304, thereby also enabling the transducer array 300 to conform to (or fit) the contours of a target region.

[0059] For example, in one embodiment, a first flexible cable 308a may be attached to the flexible conductor 324 of the first transducer subarray 304a and the flexible conductor 324 of the second transducer subarray 304. A second flexible cable 308b may be attached to a specific electrode element 302 of the first flexible cable 308a (or the flexible conductor 324 of the first transducer subarray 304a) and the third transducer subarray 304. In this configuration, the second transducer subarray 304b is electrically coupled in parallel with the third transducer subarray 304a. Furthermore, in one embodiment, at least one electrode element 302 (e.g., the first electrode element 302a) is electrically coupled in parallel with at least one other electrode element 302 (e.g., electrode elements 302b to 302d). In one embodiment, because the electrode element 302 is not electrically coupled in series with each of the other electrode elements 302, the flexible wire 324 and flexible cable 308 do not need to be configured to carry current or voltage for all electrode elements 302, thereby increasing the flexibility of the transducer array 300 and reducing the weight of the transducer array, thus improving patient comfort.

[0060] As described above, support layer 312 may be constructed and function according to support layer 156. In one embodiment, the area and shape of each of the plurality of transducer subarrays 304 304a to 304n will be determined by the number and arrangement of subsets of the plurality of electrode elements 302 contained within each transducer subarray 304.

[0061] In the example shown in Figure 6B, the transducer array 300 includes four transducer subarrays 304a to 304d, each transducer subarray 304 having a subset of multiple electrode elements 302, each subset having four electrode elements 302. Within each of the multiple transducer subarrays 304, the electrode elements 302 are interconnected via flexible wires 324. TTSignal is supplied to at least one of the transducer subarrays 304 via conductive leads 58 connected to the electric field generator 54. For example, the conductive leads 58 are attached to the flexible wires 324 connecting two electrode elements 302 (fifth electrode element 302e and sixth electrode element 302f) of the first transducer subarray 304a.

[0062] While the example shown in Figure 6B depicts each transducer subarray 304 as a square shape with four electrode elements 302, it should be understood that transducer subarray 304 may include other shapes and numbers of electrode elements 302. The shape and number of electrode elements 302 may vary between each transducer subarray 304 of transducer array 300. Specific shapes, sizes, and positioning of each transducer subarray 304 will be selected to generate an TTField with a desired configuration, orientation, and intensity at and only in the treatment area, thereby focusing treatment. In one embodiment, specific shapes and sizes of each transducer subarray 304 may be selected such that the size of transducer array 300 is approximately 200 cm². 2 .

[0063] Referring now to FIG7, a process flowchart illustrating an exemplary embodiment of process 350 using electronic device 50 (FIG. 2) and transducer array 70 (e.g., transducer array 100 and / or transducer array 300) according to the present disclosure is shown. Process 350 generally includes: providing a first transducer array 70a having at least one transducer subarray 108 or 304 (step 354); placing the first transducer array 70a at a designated location on a patient (step 358); applying a second transducer array 70b to the patient (step 362); and generating and supplying an electric field with a frequency in the range of 50 kHz to 1 MHz between the first transducer array 70a and the second transducer array 70b (step 366).

[0064] In one embodiment, providing a first transducer array 70a having at least one transducer subarray 108 or 304 (step 354) may include providing one of transducer array 100 or transducer array 300 as a first transducer array 70a having at least one transducer subarray 108 or 304. In one embodiment, providing a first transducer array 70a having at least one transducer subarray 108 or 304 includes providing a skin interface layer 184 on a patient or on a first electrode surface 196 on the skin-facing side 200 of electrode 180. In another embodiment, the skin interface layer 184 may be disposed on a patient or on the skin-facing surface of dielectric layer 192, thereby forming a first interface surface 212 between dielectric layer 192 and skin interface layer 184.

[0065] In one embodiment, placing the first transducer array 70a at a designated location on the patient (step 358) includes placing the first transducer array 70a having one or more transducer subarrays 108 or 304 at a designated location on the patient that is associated with providing therapeutic benefits for treating the patient at a target area.

[0066] In one embodiment, applying the second transducer array 70b to a patient (step 362) includes placing the second transducer array 70b, having one or more transducer subarrays 108 or 304, on the patient as described above with respect to the first transducer subarray 70a. In some embodiments, the second designated location may be a second location on the patient associated with providing therapeutic benefits for treating the patient at a target region.

[0067] In one embodiment, generating and supplying an electric field with a frequency in the range of 50 kHz to 1 MHz between the first transducer array 70a and the second transducer array 70b (the first pair of transducer arrays) (step 366) includes supplying a first alternating current waveform to the first transducer array 70a during a first time period and supplying a second alternating current waveform to the second transducer array 70b during a second time period. The first transducer array 70a and the second transducer array 70b are supplied with electrical signals, causing current to flow between them. The current generates an electric field (i.e., TTField) with a frequency and amplitude between the first transducer array 70a and the second transducer array 70b (the first pair of transducer arrays). In one embodiment, the second pair of transducer arrays may be positioned to similarly sense an electric field passing through the same target region but in a different direction (e.g., perpendicular to the direction of the first electric field between the first pair of transducer arrays). In one embodiment, generating and supplying an electric field with a frequency in the range of 50 kHz to 1 MHz to a target region includes generating an electric field through the target region between the first pair of transducer arrays 70 in a first time period, generating an electric field through the target region between the second pair of transducer arrays 70 in a second time period, and then repeating these two steps in a cycle.

[0068] In one embodiment, the first time period may have the same or similar duration as the second time period, while in other embodiments, the first time period may have a different duration than the second time period. Additionally, the first time period may overlap with or not overlap with the second time period.

[0069] Certain non-limiting embodiments of this disclosure relate to kits that include any of the components of the electronic device 50 described above, such as, but not limited to, one or more transducer arrays 70, 100, 300 in combination with one or more components, devices, and / or elements utilized according to this disclosure or otherwise contemplated herein. The kit may also optionally include one or more optional components of any of the optional components disclosed herein or otherwise contemplated. The kit may also optionally include one or more devices (or one or more components of devices) used in one or more additional therapeutic steps.

[0070] In one embodiment, the kit may also include instructions for performing any of the processes or methods disclosed herein or otherwise contemplated. For example (but not limited to), the kit may include instructions for applying one or more components of the electronic device 50 to a patient's skin, instructions for applying an alternating electric field to a patient, and / or instructions for when to activate and deactivate the alternating electric field associated with the application of the TTField.

[0071] In addition to the components described in detail above, the kit may also contain other components / reagents for performing any specific method of the particular method described herein or otherwise contemplated. For example (but not as a limitation), the kit may additionally include: (i) components for skin preparation (i.e., razors, cleaning compositions, or wipes / towels, etc.) prior to the application of the skin interface layer 184 and / or the transducer arrays 70, 100, 300 thereon; (ii) components for removing the skin interface layer / transducer array; (iii) components for cleaning the skin after removing the skin interface layer / transducer array; (iv) components for isolating cancer cell / tumor portions; (v) components for irradiating isolated and alternating electric field-treated cancer cell / tumor portions; and / or (vi) components for isolating irradiated and alternating electric field-treated cancer cells. The nature of these additional components / reagents will depend on the specific form of treatment, and their identification is entirely within the skill of a person skilled in the art; therefore, further description is not considered necessary. Furthermore, the components / reagents present in the kit may each be located in a separate container / compartment, or various components / reagents may be combined in one or more containers / compartments, depending on the sterility, cross-reactivity, and stability of the components / reagents.

[0072] The kit can be placed in any packaging that allows the components contained therein to function according to this disclosure. In some non-limiting embodiments, the kit also includes a sealed package in which the components are placed. In some specific (but non-limiting) embodiments, the sealed package is substantially airtight and / or substantially lighttight.

[0073] Furthermore, the kit may include a set of written instructions explaining how to use one or more components of the kit. Kits of this nature can be used in any of the methods described herein or otherwise conceived.

[0074] In some non-restrictive implementations, the kit has a shelf life of at least approximately six months, and between six months and 24 months.

[0075] Exemplary Embodiments The following is a non-limiting list of exemplary embodiments of the inventive concept disclosed herein: Exemplary Embodiment 1 A transducer array comprising: a hub including a housing and a hub port supported by the housing, the housing having a housing peripheral edge having a boundary, the hub port being positioned within the boundary of the housing peripheral edge; and a transducer subarray including electrodes, subarray ports, and a support layer, the support layer having a support layer peripheral edge and supporting the electrodes and the subarray ports, the subarray ports coupling the hub ports to the electrodes, the electrodes receiving alternating current waveforms in the frequency range of 50 kHz to 1 MHz from the hub via the subarray ports.

[0076] Exemplary Embodiment 2: According to the transducer array of Exemplary Embodiment 1, the hub further includes a hub lead connector port supported by the housing, and the transducer array further includes conductive leads electrically coupled to the hub lead connector port.

[0077] Exemplary Embodiment 3: According to the transducer array of Exemplary Embodiment 1, the subarray ports of the transducer subarray are at least partially disposed within the peripheral edge of the support layer.

[0078] Exemplary Embodiment 4: According to the transducer array of Exemplary Embodiment 1, wherein the electrode is a first electrode, the hub port is a first hub port, and wherein the hub further includes a second hub port supported by the housing, the second hub port being located within the boundary of the outer periphery of the housing, wherein the transducer subarray is a first transducer subarray, the subarray port is a first subarray port, the support layer is a first support layer, and the outer periphery of the support layer is the outer periphery of the first support layer, and the transducer array further includes a second transducer subarray, the second transducer subarray including a second electrode, a second subarray port, and a second support layer, the second support layer having a second support layer outer periphery and supporting the second electrode and the second subarray port, the second subarray port coupling the second hub port to the second electrode, the second electrode receiving the AC current waveform from the hub via the second subarray port.

[0079] Example 5: According to the transducer array of Example 4, the outer edge of the first support layer of the first transducer subarray has a first shape, and the outer edge of the second support layer of the second transducer subarray has a second shape different from the first shape.

[0080] Exemplary Embodiment 6: According to the transducer array of Exemplary Embodiment 4, the outer edge of the first support layer of the first transducer subarray has a first shape, and the outer edge of the second support layer of the second transducer subarray has a second shape consistent with the first shape.

[0081] Exemplary Embodiment 7: A transducer array according to Exemplary Embodiment 4, wherein the first support layer of the first transducer subarray has a first region, and the second support layer of the second transducer subarray has a second region different from the first region.

[0082] Exemplary Embodiment 8: A transducer array according to Exemplary Embodiment 4, wherein the first support layer of the first transducer subarray has a first region, and the second support layer of the second transducer subarray has a second region that coincides with the first region.

[0083] Exemplary Embodiment 9: A transducer array according to Exemplary Embodiment 2, wherein the conductive lead includes a first end and a second end, the second end of the conductive lead being operable to selectively couple to the hub lead connector port.

[0084] Exemplary Example 10: A transducer array according to Exemplary Example 1, wherein the transducer subarray includes more than one electrode, each electrode being configured to receive the alternating current waveform.

[0085] In an exemplary embodiment 11, according to the transducer array of exemplary embodiment 1, the housing of the hub further includes a first surface and a second surface, and the hub further includes an additional electrode disposed on at least a first portion of the first surface of the housing and configured to receive the alternating current waveform.

[0086] Exemplary embodiment 12: The transducer array according to exemplary embodiment 11, wherein the hub further includes an adhesive layer disposed on a second portion of the first surface of the housing, the second portion being different from the first portion.

[0087] In an exemplary embodiment 13, the transducer array according to the exemplary embodiment 1, wherein the housing of the hub further includes a first surface and a second surface, and the hub further includes an adhesive layer disposed on the first surface of the housing.

[0088] Exemplary Embodiment 14: According to the transducer array of Exemplary Embodiment 1, the electrode further includes a first skin-facing surface and a second surface opposite to the first skin-facing surface, and the transducer array further includes a skin interface layer disposed on the first skin-facing surface of the electrode.

[0089] Exemplary Embodiment 15: According to the transducer array of Exemplary Embodiment 14, the transducer array further includes a dielectric layer disposed between the skin interface layer and the electrode.

[0090] Exemplary Example 16: According to the transducer array of Exemplary Example 14, the transducer array further includes an anisotropic material layer disposed between the skin interface layer and the electrode.

[0091] Exemplary Embodiment 17: According to the transducer array of Exemplary Embodiment 15, the transducer array further includes an anisotropic material layer disposed between the skin interface layer and the dielectric layer.

[0092] Exemplary Embodiment 18: According to the transducer array of Exemplary Embodiment 1, a number of n hub ports are distributed equidistantly or approximately equidistantly around the outer edge of the housing, and n transducer subarrays are each coupled to a corresponding hub port among the n hub ports via a corresponding subarray port.

[0093] Exemplary Embodiment 19: According to the transducer array of Exemplary Embodiment 1, a number of n hub ports are distributed equidistantly or approximately equidistantly around the outer edge of the housing, and n-1 or n-2 transducer subarrays are each coupled to a corresponding hub port among the n hub ports via a corresponding subarray port.

[0094] Exemplary Embodiment 20: A transducer array comprising: a plurality of electrode elements, each electrode element including an electrode configured for placement on a patient's body and receiving an alternating current waveform; a first transducer subarray including a first support layer having a first support layer peripheral edge and supporting a first subset of the plurality of electrode elements operable to receive the alternating current waveform; a second transducer subarray including a second support layer having a second support layer peripheral edge and supporting a second subset of the plurality of electrode elements operable to receive the alternating current waveform, the second support layer peripheral edge being separately disposed from the first support layer peripheral edge; and a flexible cable electrically coupled to the first subset of the plurality of electrode elements and operable to transmit the alternating current waveform to the second subset of the plurality of electrode elements.

[0095] Exemplary Example 21: The transducer array according to Exemplary Example 20, wherein the frequency of the alternating current waveform is in the range of 50 kHz to 1 MHz.

[0096] Exemplary Example 22 is a transducer array according to Exemplary Example 20, wherein each electrode is configured to be placed on the patient’s body and receive the alternating current waveform in the frequency range of 50 kHz to 1 MHz.

[0097] Exemplary Embodiment 23: According to the transducer array of Exemplary Embodiment 20, the transducer array further includes conductive leads configured to receive the alternating current waveform in the frequency range of 50 kHz to 1 MHz and electrically coupled to the flexible cable.

[0098] Exemplary Embodiment 24: A transducer array according to Exemplary Embodiment 23, wherein the flexible cable is a first flexible cable, and the transducer array further includes: a third transducer subarray including a third support layer having a third support layer peripheral edge and supporting a third subset of the plurality of electrode elements; and a second flexible cable operable to electrically couple the first subset of the plurality of electrode elements to the third subset of the plurality of electrode elements.

[0099] Exemplary embodiment 25 is a transducer array according to exemplary embodiment 24, wherein the conductive leads are electrically coupled to the second flexible cable or electrically coupled to the first transducer subarray.

[0100] Exemplary embodiment 26 is a transducer array according to exemplary embodiment 24, wherein the conductive leads are electrically coupled to the first flexible cable.

[0101] Exemplary embodiment 27: The transducer array according to exemplary embodiment 20, wherein the first subset of the plurality of electrode elements includes at least two electrode elements.

[0102] Exemplary embodiment 28 is a transducer array according to exemplary embodiment 27, wherein the at least two electrode elements are electrically coupled to the flexible cable and are electrically connected in parallel with each other.

[0103] Exemplary Example 29: The transducer array according to Exemplary Example 24 includes four or more subarrays, each subarray being electrically connected to the conductive leads, and each subarray being electrically coupled to at least one other subarray via one or more flexible cables.

[0104] Example 30: A transducer array system comprising: an electric field generator operable to generate an electrical signal of an alternating current waveform in the frequency range of 50 kHz to 1 MHz; a plurality of electrode elements, each electrode element including an electrode configured for placement on a patient's body and receiving the alternating current waveform in the frequency range of 50 kHz to 1 MHz; a first transducer subarray including a first support layer having a first support layer peripheral edge and supporting a first subset of the plurality of electrode elements operable to receive the alternating current waveform; and a second transducer subarray including a second support layer having a second support layer peripheral edge and supporting a second subset of the plurality of electrode elements operable to receive the alternating current waveform; wherein the first support layer is different from the second support layer, and the first transducer subarray and the second transducer subarray are electrically connected in parallel.

[0105] According to the transducer array system of exemplary embodiment 30, the transducer array system further includes: a hub, the hub including a housing and a first port and a second port supported by the housing, the housing having a housing peripheral edge having a boundary, the first port and the second port being located within the boundary of the housing peripheral edge; wherein the first transducer subarray is coupled to the first port and the second transducer subarray is coupled to the second port.

[0106] Exemplary Embodiment 32: According to the transducer array system of Exemplary Embodiment 31, the transducer array system further includes one or more additional transducer subarrays, each additional transducer subarray including a corresponding support layer having a corresponding support layer peripheral edge and supporting an additional subset of the plurality of electrode elements operable to receive the alternating current waveform; and wherein each additional transducer subarray is coupled to a corresponding port supported by the housing of the hub.

[0107] Exemplary Embodiment 33: A transducer array system comprising: a conductive lead; a plurality of transducer subarrays, each of the plurality of subarrays including an electrode, one or more ports, and a support layer having a peripheral edge and supporting the electrode and the one or more ports, the electrode being configured to receive an alternating current waveform in the frequency range of 50 kHz to 1 MHz over a time period, the one or more ports being at least partially disposed within the peripheral edge of the support layer; and a plurality of flexible cables electrically coupled to the conductive lead, each flexible cable being operable to connect to at least one of the one or more ports and electrically coupling any two of the plurality of transducer subarrays; and wherein a first transducer subarray of the plurality of transducer subarrays is electrically coupled to the conductive lead and electrically disposed between at least two other transducer subarrays of the plurality of transducer subarrays.

[0108] Exemplary Embodiment 34: A transducer array system according to Exemplary Embodiment 33, wherein at least one of the one or more ports is configured to be selectively coupled to the conductive lead.

[0109] Exemplary Embodiment 35: A transducer array system according to Exemplary Embodiment 33, wherein the transducer array system further includes a hub, and the conductive leads are configured to selectively couple to the hub.

[0110] Exemplary embodiment 36: A kit comprising: a hub including a housing and a first port supported by the housing, the housing having a peripheral edge having a boundary, the first port being positioned within the boundary of the peripheral edge of the housing; and a transducer subarray including an electrode, a second port, and a support layer having a peripheral edge and supporting the electrode and the second port, the second port being operable to couple to the first port, the electrode receiving an alternating current waveform in the frequency range of 50 kHz to 1 MHz from the second port.

[0111] Exemplary embodiment 37: The kit according to exemplary embodiment 36 further includes a skin interface layer operable to be disposed between the transducer subarray and the patient's skin.

[0112] Exemplary embodiment 38: The kit according to exemplary embodiment 36, the kit further includes a written description of the explanatory process 350.

[0113] Exemplary Example 39: The kit according to Exemplary Example 36 further includes components for preparing the skin of a patient.

[0114] Although specific combinations of features and steps are listed in the claims, illustrative embodiments, and / or disclosed in the specification, these combinations are not intended to limit this disclosure. In fact, many of these features and steps can be combined in ways not specifically described in the claims, illustrative embodiments, and / or disclosed in the specification. While each dependent claim listed below may be directly dependent on only one other claim, this disclosure includes every dependent claim in combination with all other claims in the claim set.

[0115] Similarly, while each of the exemplary embodiments listed above may directly belong to only one other exemplary embodiment, this disclosure includes each exemplary embodiment in combination with all other exemplary embodiments in the set of exemplary embodiments for each mode of the inventive concept disclosed herein.

Claims

1. A transducer array, the transducer array comprising: A hub, the hub including a housing and a hub port supported by the housing, the housing having a housing periphery edge, the housing periphery edge having a boundary, and the hub port being positioned within the boundary of the housing periphery edge; The transducer subarray includes electrodes, subarray ports, and a support layer. The support layer has a peripheral edge and supports the electrodes and the subarray ports. The subarray ports couple the hub port to the electrodes. The electrodes receive AC current waveforms in the frequency range of 50kHz-1MHz from the hub via the subarray ports.

2. The transducer array of claim 1, wherein the hub further comprises a hub lead connector port supported by the housing, and the transducer array further comprises: A conductive lead, which is electrically coupled to the hub lead connector port.

3. The transducer array according to claim 1, wherein the subarray ports of the transducer subarray are at least partially disposed within the peripheral edge of the support layer.

4. The transducer array of claim 1, wherein the electrode is a first electrode, the hub port is a first hub port, and wherein the hub further comprises a second hub port supported by the housing, the second hub port being located within the boundary of the outer periphery of the housing, wherein the transducer subarray is a first transducer subarray, the subarray port is a first subarray port, the support layer is a first support layer, and the outer periphery of the support layer is the outer periphery of the first support layer, and the transducer array further comprises a second transducer subarray, the second transducer subarray comprising a second electrode, a second subarray port, and a second support layer, the second support layer having a second support layer outer periphery and supporting the second electrode and the second subarray port, the second subarray port coupling the second hub port to the second electrode, the second electrode receiving the AC current waveform from the hub via the second subarray port.

5. The transducer array according to claim 4, wherein the outer edge of the first support layer of the first transducer subarray has a first shape, and the outer edge of the second support layer of the second transducer subarray has a second shape different from the first shape.

6. The transducer array according to claim 4, wherein the outer edge of the first support layer of the first transducer subarray has a first shape, and the outer edge of the second support layer of the second transducer subarray has a second shape consistent with the first shape.

7. The transducer array of claim 4, wherein the first support layer of the first transducer subarray has a first region, and the second support layer of the second transducer subarray has a second region different from the first region.

8. The transducer array of claim 4, wherein the first support layer of the first transducer subarray has a first region, and the second support layer of the second transducer subarray has a second region consistent with the first region.

9. The transducer array of claim 1, wherein the housing of the hub further includes a first surface and a second surface, and the hub further includes an additional electrode disposed on at least a first portion of the first surface of the housing and configured to receive the alternating current waveform.

10. The transducer array of claim 1, wherein n hub ports are distributed equidistantly or approximately equidistantly around the outer edge of the housing, and n transducer subarrays are each coupled to a corresponding hub port among the n hub ports via a corresponding subarray port.

11. The transducer array of claim 1, wherein n hub ports are distributed equidistantly or approximately equidistantly around the outer edge of the housing, and n-1 or n-2 transducer subarrays are each coupled to a corresponding hub port among the n hub ports via a corresponding subarray port.

12. A transducer array, the transducer array comprising: Multiple electrode elements, each electrode element including an electrode, the electrode being configured to be placed on a patient's body and receive an alternating current waveform in the frequency range of 50 kHz to 1 MHz; A first transducer subarray, the first transducer subarray including a first support layer, the first support layer having a first support layer peripheral edge and supporting a first subset of the plurality of electrode elements operable to receive the alternating current waveform; The second transducer subarray includes a second support layer having a second support layer peripheral edge and supporting a second subset of the plurality of electrode elements operable to receive the alternating current waveform, the second support layer peripheral edge being separately disposed from the first support layer peripheral edge. And a flexible cable electrically coupled to a first subset of the plurality of electrode elements and operable to transmit the alternating current waveform to a second subset of the plurality of electrode elements.

13. The transducer array of claim 12, wherein the flexible cable is a first flexible cable, and the transducer array further comprises: The third transducer subarray includes a third support layer having a third support layer peripheral edge and supporting a third subset of the plurality of electrode elements; And a second flexible cable, which is operable to electrically couple the first subset of the plurality of electrode elements to the third subset of the plurality of electrode elements.

14. The transducer array of claim 13, further comprising conductive leads configured to receive the alternating current waveform, wherein the conductive leads are electrically coupled to the first flexible cable, the second flexible cable, or electrically coupled to the first transducer subarray, the second transducer subarray, or the third transducer subarray.

15. The transducer array of claim 12, wherein the first subset of the plurality of electrode elements comprises at least two electrode elements electrically connected in parallel with each other.

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