Transducer array with temperature sensor insulation layer between the temperature sensor and the external environment

Abstract

The present invention discloses a transducer array, tumor treatment field system, and method, including an electrode having a first side and a second side, a transport layer covering the first side of the electrode and transporting a TT field to a patient, a temperature sensor in contact with the second side of the at least one electrode, and an insulating layer covering the temperature sensor and at least a portion of the at least one electrode such that the temperature sensor is disposed between the insulating layer and the second side of the electrode, the insulating layer resisting at least one of heat flow and fluid flow through the insulating layer.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] Not applicable [Background technology]

[0002] A tumor treating field (TT field or TTF) is a low-intensity (e.g., 1-3 V / cm) alternating electric field in the mid-frequency range (e.g., 50-1 MHz, such as 50-500 kHz) that targets solid tumors by disrupting mitosis. This non-invasive treatment targets 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 pair positioned on opposite sides of the body to generate perpendicular fields within the tumor being treated. More specifically, in the case of the OPTUNE® system, one pair of electrodes of the transducer array is placed on the left and right (LR) sides of the tumor, and another pair of electrodes of the transducer array is placed on the anterior-posterior (AP) sides of the tumor. TT fields have been approved for the treatment of multiforme neuroblastoma (GBM) and are delivered, for example, via the OPTUNE® system (Novocure Limited, St. Helier, Jersey), which includes a transducer array placed on the patient's shaved head. Recently, TT field therapy has been approved as a combination therapy with chemotherapy for malignant pleural mesothelioma (MPM), and may also be used to treat tumors in other parts of the body.

[0003] The device is intended for patients to wear continuously for 2-4 days, then remove for hygiene and reshaving (if necessary), after which a new set of arrays is reapplied. As patients use the device to perform daily activities, prolonged use of the device can cause the transducer array to become active and heat up. To ensure patient comfort while wearing the transducer array, a temperature sensor is placed within the array to monitor the temperature of the transducer array and skin interface. Summary of the Invention [Problem to be solved by the invention]

[0004] Traditionally, temperature sensors have been placed within a cavity in a transfer layer, or dielectric layer, between the electrodes of a transducer array and the patient's skin to measure temperature near the surface of the patient's skin. However, advances in transducer array construction have resulted in thinner and lighter transfer layers, but they are less likely to form an air gap for placing a temperature sensor. Positioning the temperature sensor farther from the surface of the patient's skin can introduce errors due to differences in environmental temperature. Construction of these types of arrays requires placing the temperature sensor farther than desired from the transducer array / skin interface (e.g., where the electrodes are positioned between the temperature sensor and the patient's skin), resulting in inaccuracies in the temperature sensor's temperature measurements due to interactions with the external environment.

[0005] Therefore, what is desired is a new and improved system for improving the accuracy of temperature measurements when electrode elements are placed between a temperature sensor and a patient's skin. The present disclosure is directed to such a system and methods of making and using the same.

[0006] The problem of inaccurate temperature measurements due to differences in environmental temperature is addressed by a transducer array, a tumor treatment field system, and a method for delivering a TT field to a subject's body. In one embodiment, the transducer array includes an electrode having a first side and a second side, a transport layer covering the first side of the electrode and transporting a TT field to a patient, a temperature sensor in contact with the second side of the electrode, and an insulating layer covering the temperature sensor and at least a portion of the electrode such that the temperature sensor is disposed between the insulating layer and the second side of the electrode, the insulating layer being composed of a non-epoxy material that resists at least one of heat flow and fluid flow through the insulating layer.

[0007] In one embodiment, the tumor treatment field system includes an electric field generator generating an electric signal having an alternating current waveform at a frequency in the range of 50 kHz to 1 MHz, a first conductive lead electrically coupled to the electric field generator and carrying the electric signal, a second conductive lead coupled to the first conductive lead and electrically connected to the electric field generator, and a second transducer array coupled to the second conductive lead and receiving the electric signal from the second conductive lead and cooperating with the first conductive lead to form a tumor treatment field. The first transducer array includes at least one electrode layer having the first surface, a second surface, and a periphery, a transfer layer contacting the first surface of the electrode layer, a temperature sensor contacting the second surface of the electrode layer, and an insulating layer disposed over the temperature sensor and at least a portion of the second surface of the electrode layer, the insulating layer being composed of a non-epoxy material that resists at least one of heat flow and fluid flow through the insulating layer.

[0008] The details of one or more embodiments of the subject matter described herein are set forth in the drawings and the description below. Other aspects, features, and advantages of the subject matter will become apparent from the description, drawings, and claims.

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more implementations described herein and, together with the description, explain these implementations. The drawings are not intended to be drawn to scale, and for clarity and conciseness, certain features and certain views of the drawings may be shown to scale or exaggerated in schematic form. Not every component is labeled in every drawing. Like numerals in the figures may represent and refer to the same or similar elements or functions. In the drawings, [Brief explanation of the drawings]

[0010] [Figure 1] 1 is an exemplary embodiment of a schematic diagram of electrodes applied to biological tissue. [Figure 2] 1 is an exemplary embodiment of an electronic device configured to generate a TT field constructed in accordance with the present disclosure. [Figure 3] FIG. 1 is a block diagram of an exemplary embodiment of a transducer array constructed in accordance with the present disclosure. [Figure 4] 4 is a cross-sectional view of an electrode element of the transducer array shown in FIG. 3 taken along line 4-4 of FIG. 3. [Figure 5] FIG. 1 is a flow diagram of an exemplary embodiment for providing a TT field to a patient in accordance with the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0011] Before describing at least one embodiment of the inventive concept(s) in detail using exemplary language and results, it should be understood that the inventive concept(s) are not limited to the details of construction and arrangement of components set forth in the following description. The inventive concept(s) may be embodied in other embodiments or may be practiced or carried out in various ways. Therefore, the language used herein is intended to be given the broadest possible scope and meaning. Also, the embodiments are intended to be illustrative, not exhaustive. It should also be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0012] Names are provided for convenience only and should not be construed as limiting the invention in any manner. Embodiments shown under any heading or in any portion of this disclosure may be combined with embodiments shown under the same or any other heading or portion of this disclosure. Unless otherwise indicated herein or clearly contradicted by context, all possible combinations of the elements described herein in all possible variations are included in this disclosure.

[0013] Unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular.

[0014] All compositions, assemblies, systems, kits, and / or methods disclosed herein can be made and performed without undue experimentation in light of this disclosure. Thus, unless a method claim specifically recites in the claim or description 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 aspects set forth in the specification.

[0015] In the claims and / or specification, the use of the terms "a" or "an," when used in conjunction with the term "comprising," can mean "one," but is consistent with the meanings of "one or more," "at least one," and "one or more." "Plurality" can refer to "two or more."

[0016] Furthermore, use of the term "at least one of X, Y, and Z" is understood to include X alone, Y alone, and Z alone, as well as any combination of X, Y, and Z. Use of sequential terminology (e.g., "first," "second," "third," "fourth," etc.) is for the purpose of distinguishing between two or more items only and does not imply, for example, any order or priority or importance of one item over another or any order of additional items.

[0017] Use of the term "or" in the claims is used to mean an inclusive "and / or" unless expressly indicated to refer to alternatives only or unless the alternatives are mutually exclusive.

[0018] 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 operating independently or together to perform a task.

[0019] As used herein, unless the context clearly dictates otherwise, all numerical values ​​or ranges include values ​​within such ranges and fractional integers within such ranges. Numerical ranges specified herein include endpoints, all values, subranges of values ​​within the ranges, and values ​​and fractional integers within said ranges. Thus, for example, any two values ​​within the range of 1 mm to 10 m can be used to define the lower and upper limits of a range according to embodiments of the present disclosure.

[0020] As used herein, TT field (TT field, or TTF(s)) refers to a medium-frequency (approximately 50 kHz to 1 MHz, more preferably approximately 50 kHz to 500 kHz), low-intensity (e.g., 1 to 4 V / cm) alternating electric field that, when applied via electrodes to a conductive medium such as the human body, can be used to treat tumors, as described, for example, in U.S. Patent Nos. 7,016,725, 7,089,054, 7,333,852, 7,565,205, 7,805,201, and 8,244,345. TT fields have been shown to have the ability to specifically affect cancer cells, making them particularly useful in cancer treatment. TT field therapy is an approved monotherapy for recurrent glioblastoma (GBM) and an approved combination therapy with chemotherapy for newly diagnosed GBM patients.

[0021] As used herein, the term TTS signal is an electrical signal that, when received by electrodes applied to a conductive medium such as the human body, causes the electrodes to generate the TT field described above. TT signals are often alternating current electrical signals.

[0022] Illustrated here is an exemplary embodiment of a dividing cell 10 under the influence of an external TTF field, generally shown as line 14, generated by a negatively charged first electrode 18a and a positively charged second electrode 18b. Also shown are microtubules 22, known to have a very strong dipole moment. This strong polarization makes the microtubules 22, as well as other polar macromolecules, particularly those with a specific orientation within the cell 10 or its surroundings, susceptible to the effects of the electric field. The positive charges on the microtubules 22 are located at the two centrioles 26, and two sets of negative poles are located at the center 30 of the dividing cell 10 and at the attachment points 34 of the microtubules 22 to the cell membrane. The locations of the charges form a double dipole assembly, making them susceptible to the effects of electric fields of different directions. In one embodiment, the cells are electroporated, i.e., DNA or chromosomes are introduced into the cells using an electric pulse, temporarily opening pores in the cell membrane.

[0023] Returning to FIG. 2, the beneficial TT field for destroying tumor cells described above may be generated by electronic device 50. FIG. 2 is a simplified schematic diagram illustrating the major components of electronic device 50. Electronic device 50 includes an electric field generator 54 and a pair of conductive leads 58, including a first conductive lead 58a and a second conductive lead 58b. First conductive lead 58a includes a first end 62a and a second end 62b. Second conductive lead 58b includes a first end 66a and a second end 66b. First end 62a of first conductive lead 58a is conductively attached to electric field generator 54, and first end 66a of second conductive lead 58b is conductively attached to electric field generator 54.

[0024] The electric field generator 54 is configured to provide power and generate as an output a desired electrical signal (TTS signal) in the form of a waveform or pulse train. The second end 62b of the first conductive lead 58a is connected to the transducer array 70a, and the second end 66b of the second conductive lead 58b is connected to the transducer array 70b. Both the transducer array 70a and the transducer array 70b are supplied with an electrical signal (e.g., a TT signal, waveform). When supplied with the electrical signal, the transducer array 70a and the transducer array 70b pass a current between the transducer array 70a and the transducer array 70b. This current generates an electric field (TT field) of a certain frequency and amplitude that is generated between the transducer array 70a and the transducer array 70b.

[0025] Although the electronic device 50 shown in FIG. 2 includes only two transducer arrays 70 (i.e., transducer array 70a and transducer array 70b), in some embodiments, the electronic device 50 may include three or more transducer arrays 70.

[0026] The electric field generator 54 generates an AC voltage waveform (i.e., a TT signal) at a frequency ranging from about 50 kHz to about 1 MHz (preferably from about 100 kHz to about 500 kHz). The required voltage is such that the electric field strength in the tissue within the treatment region ranges from about 0.1 V / cm to about 10 V / cm. To achieve this electric field strength, the potential difference between the two conductors 18 (e.g., electrode elements 78 in FIG. 3) in each transducer array 70a or transducer array 70b depends on the relative impedances of the system components; for example, the fraction of the electric field on each component is determined by the impedance of that component divided by the impedance of the overall circuit.

[0027] In certain (but non-limiting) embodiments, transducer arrays 70a and 70b generate alternating currents and fields within a target region of a patient. The target region typically includes at least one tumor, and the generation of the alternating currents and fields selectively destroys and / or inhibits tumor growth. The alternating currents and fields may be generated at any frequency that selectively destroys or inhibits tumor growth, such as any frequency of a TT field.

[0028] In certain (but not limiting) embodiments, the alternating current and magnetic field may be applied at two or more different frequencies, where two or more frequencies are present, each frequency being selected from a range consisting of any of the values ​​listed above or a range combining two integers between any of the values ​​listed above.

[0029] To optimize the electric field (TT Field) distribution, transducer array 70a and transducer array 70b (paired transducer array 70) may be configured differently depending on the application for which the paired transducer array 70 is being used. As described herein, the paired transducer array 70 is applied externally to a patient, i.e., typically to the patient's skin, to apply electrical currents and electric fields (TTFields), thereby generating currents within the patient's tissue. Typically, the paired transducer array 70 is placed on the patient's skin by a user to generate an electric field across the patient's tissue within a treatment area. The externally applied TT Fields may be of a localized type or a widely distributed type (e.g., for treating skin tumors or lesions close to the skin surface).

[0030] 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, or therapist. In another embodiment, the user may be a patient, i.e., the patient (and / or a helper) may position transducer arrays 70a and 70b over the patient's treatment area.

[0031] According to another exemplary embodiment, electronic device 50 includes controller 74. In one embodiment, controller 74 includes circuitry configured to control the output of electric field generator 54, e.g., to set the output to a maximum value that does not cause excessive heating of the treatment region. Controller 74 may issue an alert, or the like, if the temperature of the treatment region (as sensed by one or more of multiple temperature sensors 104, described in more detail below) exceeds a preset limit. Temperature sensors may be mechanically connected and / or associated with either or both of transducer array 70a and / or transducer array 70b to more closely detect the temperature of the treatment region, as described below.

[0032] In one embodiment, controller 74 may turn off or reduce the power of the TTS signal generated by electric field generator 54 if the temperature sensed by temperature sensor 104 meets or exceeds a comfort threshold. In one embodiment, the comfort threshold is the temperature at which the patient becomes uncomfortable when using transducer array 70a and transducer array 70b. For example, the comfort threshold may be a temperature of 40°C or approximately 40°C. In one embodiment, the comfort threshold is a temperature between approximately 39°C and 42°C, or a specific selected temperature between approximately 39°C and 42°C.

[0033] Conductive leads 58 are preferably insulated conductors that include a flexible metal shield and are grounded to prevent diffusion of the electric field generated by conductive leads 58. Transducer arrays 70a and 70b may have specific shapes and arrangements to generate TT fields of a desired configuration, direction, and intensity at, and only, the treatment area to focus the treatment.

[0034] The specifications of the electronic device 50 as a whole and its individual components are heavily influenced by the fact that at the frequencies of the TT field, biological systems behave according to their "ohmic" rather than dielectric properties.

[0035] Referring now to FIG. 3, there is shown a diagram of an exemplary embodiment of a transducer array 70 constructed in accordance with the present disclosure. The transducer array 70 includes one or more electrode elements 78. As shown in FIG. 3, each transducer array 70 is configured as a collection of one or more electrode elements 78. In the illustrated example, the transducer array 70 includes nine electrode elements 78. The transducer array 70 may utilize capacitively coupled electrode elements 78. In the example shown in FIG. 3, the transducer array 70 is configured with multiple electrode elements 78 (e.g., approximately 2 cm in diameter) connected via flexible wires 90 (connected to the electric field generator 54 via conductive leads 58). Each electrode element 78 is described in detail below in FIG. 4. In one embodiment, the transducer array 70 includes a perimeter 84.

[0036] 4, there is shown a cross-sectional view of an exemplary embodiment of one of the electrode elements 78 of FIG. 3 constructed in accordance with the present disclosure. The electrode element 78 generally includes an electrode 100, a temperature sensor 104, an insulating layer 108, and a transfer layer 112. In some embodiments, the electrode element 78 further includes a patient interface member 116 and / or a topcoat layer 120.

[0037] Electrode 100 includes and / or consists of at least one conductive element and / or compound, including, by way of example only, elemental silver. In some embodiments, electrode 100 further includes a conductive support layer electrically coupled to electrode 100. Electrode 100 may be selected from any conductive material having desirable properties, such as, but not limited to, high electrical conductivity, strong biocompatibility, and low reactivity with other layers or components of transducer array 70. If present, the conductive support layer may be formed of a conductive carbon film or conductive fabric configured to support electrode 100. In one embodiment, the conductive support layer may be electroplated or otherwise coupled to electrode 100.

[0038] In one embodiment, electrode 100 is electrically conductive and comprises, at least in part, a material selected from one or more of silver, tin, aluminum, titanium, platinum, alloys thereof, and / or some combination thereof.

[0039] The electrode 100 further includes a first surface 124 and a second surface 128. The temperature sensor 104 may be supported in contact with the second surface 128 of the electrode 100 to detect and / or respond to a temperature experienced by a patient on which the electrode 100 is placed. In some embodiments, the first surface 124 of the electrode 100 is in contact with the transfer layer 112, if present.

[0040] In one embodiment, the temperature sensor 104 may include an exterior surface 132, and the environment or atmosphere in contact with the exterior surface 132 of the temperature sensor 104 affects the temperature of the temperature sensor 104. The exterior surface 132 of the temperature sensor 104 may be considered to have at least two surface portions, for example, a contact portion 136 of the exterior surface 132 that contacts the second side 128 of the electrode 100, an exposed portion 140 of the exterior surface 132 that does not contact the second side 128 of the electrode 100, and a surface of the exterior surface 132 that does not contact the second side 128 of the electrode 100.

[0041] In some embodiments, the temperature sensor 104 includes a thermistor, and the temperature of the thermistor may be determined by passing a known current through the thermistor and measuring the voltage that appears across the thermistor. In one embodiment, the temperature sensor 104 is mechanically connected to and / or associated with a particular electrode element 78 of the transducer array 70 so as to estimate the temperature of the treatment region at the location of the particular electrode element or elements 78.

[0042] In one embodiment, the insulating layer 108 has a first surface 144 and a second surface 148 and includes an insulator operative to resist the transfer of heat through the insulator and / or a water-resistant material operative to resist the transfer of fluids, such as gases or liquids, through the water-resistant material. For example, the insulating layer 108 is more resistant to heat transfer from the temperature sensor to the environment than a standard bandage. In one embodiment, the insulating layer 108 resists heat flow and fluid flow and is comprised of an insulating matrix material, such as an insulating foam or epoxy material, or a liquid-resistant matrix material. The insulating matrix material may be a hydrophobic, insulating matrix material, or epoxy material. The fluid flow may be a liquid flow and / or a gas flow. An example of a gas flow is air flow containing water vapor. In some embodiments, the insulating layer 108 may be comprised of a non-epoxy material that resists at least one of heat flow and fluid flow through the insulating layer 108. The non-epoxy material may be insulating and may be in the form of a foam material as described herein, a waterproof sealant (e.g., a silicone waterproof sealant, liquid rubber, etc.), a waterproof fabric such as a synthetic rubber that may be made by polymerizing chloroprene (e.g., neoprene), etc.

[0043] Exemplary insulating and hydrophobic foam materials include closed-cell foams, such as closed-cell polyethylene foam, which may be coated with a pressure-sensitive adhesive to adhere the insulating layer 108 to the electrode 100. In some embodiments, the insulating layer 108 has a thickness of 0.9 mm. In some embodiments, the insulating layer 108 may be composed of medical foam tape, identified as Model 1773, available from 3M Company, St. Paul, Minnesota, USA.

[0044] Exemplary epoxy materials can include two-part epoxy resins. The epoxy material may be an epoxy, a polyester resin, and / or an epoxy acrylate. Prior to polymerization / polymer crosslinking, one or more components of the epoxy may be combined with an insulating component to impart desired insulating properties to the polymerized epoxy and / or with a water-resistant component to impart desired hydrophobic properties to the epoxy.

[0045] In one embodiment, the insulating layer 108 is air impermeable to prevent, limit, and / or minimize exposure of the temperature sensor 104 to the environment or atmosphere. That is, the insulating layer 108 prevents, limits, and / or minimizes air movement between the second side 148 of the insulating layer 108 and the first side 144 of the insulating layer 108.

[0046] In one embodiment, when placed on the temperature sensor 104 such that the first surface 144 substantially covers the exposed portion 140 of the outer surface 132, it resists heat and liquid flow between the temperature sensor 104 and the environment or atmosphere of the second surface 148 of the insulating layer 108.

[0047] In one embodiment, the first surface 144 of the insulating layer 108 substantially surrounds and contacts the outer surface 132 of the temperature sensor 104, except for the exposed portion 140 of the outer surface 132, e.g., the contact portion 136 of the outer surface 132 that contacts the electrode 100. By substantially surrounding and contacting the exposed portion 140, the insulating layer 108 thermally insulates the temperature sensor 104 from the environment or atmosphere that is in contact with the second surface 148 of the insulating layer 108.

[0048] In one embodiment, the insulating layer 108 is composed of multiple insulating materials. For example, the insulating layer 108 may be composed of a first insulating material that contacts the temperature sensor 104 and a second insulating material that is positioned opposite the first insulating material and is exposed to the environment or air. In some embodiments, the first insulating material and the second insulating material may be composed of the same insulating material but with different insulating properties, or the first insulating material and the second insulating material may be composed of different insulating materials but with similar insulating properties, or a combination thereof. For example, the first insulating material may be an insulating foam material having a first insulating value, and the second insulating material may be an insulating epoxy material having a second insulating value that is the same as the first insulating value. Alternatively, the first insulating material may be an insulating epoxy material having a first insulating value, and the second insulating material may be an insulating epoxy material having a second insulating value that is different from the first insulating value.

[0049] In one embodiment, the insulating layer 108 may be composed of multiple materials with different properties. For example, the insulating layer 108 may be composed of a first insulating material that is thermally insulating (resists heat transfer through the insulating layer 108) and a second insulating material that is water-repellent and / or hydrophobic (resists liquid / fluid transfer through the insulating layer 108). The first and second insulating materials may be layered over the temperature sensor 104 and, in some embodiments, underneath the topcoat layer 120.

[0050] In one embodiment, the insulating layer 108 covers the temperature sensor and only a portion of the second side 128 of the electrode 100, e.g., the insulating layer 108 does not extend across the entire second side 128 of the electrode 100. In some embodiments, the first surface area of ​​the first side 144 of the insulating layer 108 is less than two times the second surface area of ​​the exposed portion 140 of the outer surface 132 of the temperature sensor 104. In another embodiment, the first surface area of ​​the first side 144 of the insulating layer 108 is less than 20% of the surface area of ​​the second side 128 of the electrode 100. In another embodiment, the first surface area of ​​the first side 144 of the insulating layer 108 is less than 50% of the surface area of ​​the second side 128 of the electrode 100.

[0051] In one embodiment, the thickness 152 of the insulating layer 108 is between 0.9 mm and 1 cm, typically between 0.9 mm and 5 mm. In one embodiment, the topcoat layer 120 may have a thickness between 0.3 mm and 0.4 mm. In one embodiment, the insulating layer 108 is at least twice as thick as the topcoat layer 120. In another embodiment, the insulating layer 108 is between twice the thickness of the topcoat layer 120 and six times the thickness of the topcoat layer 120. In another embodiment, the insulating layer 108 is four to six times as thick as the topcoat layer 120. In some embodiments, the topcoat layer 120 may be a non-conductive topcoat layer.

[0052] In one embodiment, the insulating layer 108 is not conductive, e.g., non-conductive, to limit and / or prevent shorting of the insulating layer 108 and / or the electrode 100. The insulating layer 108 being non-conductive can enhance the safety of the electrode element 78 by preventing a patient or other user from coming into contact with the thermistor during operation of the transducer array 70 and electronic device 50.

[0053] In one embodiment, the insulating layer 108 is hydrophobic, i.e., resists the flow of fluids, e.g., liquids and / or gases, through the insulating layer 108. The insulating layer 108 may be constructed of a water-impermeable material, a hydrophobic material, a water-resistant material, and / or a water-repellent material. In one embodiment, the insulating layer 108 limits moisture in the environment from contacting the temperature sensor 104. In some embodiments, the insulating layer 108 does not include perforations, channels, or other openings through which liquids may pass.

[0054] In one embodiment, the insulating layer 108 is air impermeable, that is, the insulating layer 108 restricts the movement of air therethrough so as to restrict air from the environment from contacting the temperature sensor 104. In some embodiments, the insulating layer 108 does not include perforations, channels, or other openings through which air may pass.

[0055] In one embodiment, when an insulating layer 108 is applied to a transducer array 70 having a plurality of electrode elements 78 with electrodes 100, the insulating layer 108 includes a plurality of insulating sections, at least some of which separate the plurality of insulating sections overlying the temperature sensor 104 from the second surface 128 of each electrode 100 of the plurality of electrode elements 78. In some embodiments, if one or more particular electrodes 100 of the plurality of electrode elements 78 are not in contact with a temperature sensor 104, the insulating layer 108 may be omitted from that particular electrode 100 or may be placed on the second surface 128 of the electrode 100 without the temperature sensor 104.

[0056] In one embodiment, the transfer layer 112 covers the first surface 124 of the electrode 100 and is configured to transfer the TT field to the patient. In some embodiments, the transfer layer 112 is non-conductive. For example, the transfer layer 112 may include a dielectric layer, such as a ceramic disc and / or a highly dielectric or non-conductive thin-film polymer layer.

[0057] For example, alternative structures for the transfer layer 112 may be used, including disk-shaped ceramic elements, non-disk-shaped ceramic elements, and non-ceramic dielectric materials disposed adjacent the first surface 124 of the electrode 100. In some embodiments, the transfer layer 112 extends beyond the electrode 100 to the outer periphery 84 of the transducer array 70. Exemplary non-ceramic dielectric materials disposed on the plurality of electrodes 100 include polymer films, such as non-conductive thin-film highly dielectric polymer films.

[0058] In some embodiments, the transducer array 70 includes one or more electrode elements 78 that are not capacitively coupled to the patient. In this case, each electrode element 78 of the transducer array 70 may be implemented using a transfer layer 112 comprising a conductive material placed on the body without an insulating dielectric layer between the electrode element 78 and the transfer layer 112. The conductive material may include, for example, a conductive film, a conductive foam, and / or a conductive fabric. Other alternative configurations for implementing the transducer array 70 may also be used as long as they are capable of delivering a TT field to the patient's body.

[0059] In one embodiment, the patient interface member 116 is optional, i.e., some embodiments of the transducer array 70 do not include a patient interface member 116. If present, the patient interface member 116 may be disposed between the transfer layer 112 and the patient's body in any of the embodiments described herein.

[0060] In one embodiment, the patient interface member 116 is electrically conductive and biocompatible with extended use. The patient interface member 116 is a gel or hydrogel layer constructed in accordance with the gel / hydrogel layer described in U.S. Patent Publication No. 2021 / 0346693 A1, published November 11, 2021, entitled "Conductive Pad-Generating Tumor Treatment Field, Methods of Making and Using the Same," and U.S. Patent No. 11,458,298, published October 4, 2022, entitled "Assemblies Comprising Two Conductive Gel Compositions, and Methods of Making and Using the Same."

[0061] In one embodiment, the patient interface member 116 comprises one or more layers of a material that is electrically conductive, biocompatible when in prolonged contact with the patient's skin, flexible so as not to interfere with patient movement while the transducer array 70 is in place, and able to withstand movement on the patient's skin as the patient goes about their daily lives.

[0062] In one embodiment, the patient interface member 116 is constructed from one or more layers of conductive carbon adhesive and graphite / anisotropic material. An example patient interface member 116 may be constructed in accordance with U.S. patent application Ser. No. 17 / 899,220, filed Aug. 30, 2022, and entitled "Electrode Assembly Having a Skin-Contacting Layer Comprising a Conductive Adhesive Composite, and System and Method for Applying a Tumor Treatment Field Using the Same."

[0063] In some embodiments, the patient interface member 116 extends to the electrode 100 , while in other embodiments, it extends to at least the outer periphery 84 of the transducer array 70 or more.

[0064] In one embodiment, the topcoat layer 120 may enhance the safety of the transducer array 70 and / or electrode elements 78 by preventing or limiting contact with the electrodes 100 to prevent accidental electric shock when the electrode elements 78 are activated. The topcoat layer 120 may be composed of a durable, non-conductive material, such as a non-conductive fabric. In some embodiments, the non-conductive fabric may have a plurality of holes. In one embodiment, the topcoat layer has a thickness of less than 1 mm, typically about 0.5 mm.

[0065] In one embodiment, the topcoat layer 120 may extend into or beyond the outer periphery 84 of the transducer array 70 and may have an extent similar to that of the patient interface member 116. In some embodiments, the topcoat layer 120 extends to cover the second surface 128 of the electrode 100. In one embodiment, the topcoat layer 120 may have an adhesive on its surface to adhere to the patient's skin beyond other components of the topcoat layer 120 and adhere to the surface of the topcoat layer 120 to prevent movement of the topcoat layer 120 and / or the electrode elements 78 relative to the patient's skin after being placed on the patient.

[0066] In one embodiment, the topcoat layer 120 has an insulation value that is less than the insulation value of the insulating layer 108. The insulation value of the topcoat layer 120 may be in the range of 1 / 2 to 1 / 4 of the insulation value of the insulating layer 108.

[0067] 5, one embodiment of a process 200 for applying a TT field to a patient using electronic device 50 and transducer array 70 according to the present disclosure is shown. Process 200 generally includes applying transducer array 70a and transducer array 70b to the patient to generate an AC electric field (step 208) with a frequency in the range of approximately 50 kHz to 1 MHz for a period of time.

[0068] The step of applying transducer array 70a and transducer array 70b to the patient (step 204) may be performed by a user. In one embodiment, prior to applying transducer array 70a to the patient's skin, the patient's skin needs to be cleansed (e.g., without limitation, cleaning the skin of any foreign or biological material and shaving the skin, if necessary) in order to adhere transducer array 70a to the patient's skin.

[0069] The step of generating an alternating electric field (TT field) (step 208) may be performed by electric field generator 54 or may be instantiated by an action performed by a user or controller 74. In one embodiment, step 208 is performed multiple times, and the time at which step 208 is performed the first time may be the same as or different from the time at which step 208 is performed the second time (or any other time thereafter). In some embodiments, step 208 is performed only once before process 200 is repeated. There may be a fixed period of time between each repetition of process 200. Each time process 200 is repeated, the period of time may be the same as or different from the previous period. Each time process 200 is repeated, first conductive pad 100a and second conductive pad 100b may be placed in the same or different positions on the patient's skin.

[0070] The step of generating an alternating electric field (TT field) (step 208) may be performed by generating an alternating current and field at two or more different frequencies within the range of 50 kHz to 1 MHz. When two or more frequencies are present, each frequency is selected from a range consisting of any of the values ​​listed above or a range combining two integers within the range listed above.

[0071] In one embodiment, generating an alternating current electric field (TT field) (step 208) may be performed by supplying a first alternating current and electric field to a first pair of transducer arrays 70 for a first time period and supplying a second alternating current electric field to a second pair of transducer arrays 70 for a second time period. In one embodiment, the first time period may be of a similar duration to the second time period, while in other embodiments, the first time period may be of a different duration than the second time period. Additionally, the first time period may or may not overlap with the second time period.

[0072] Illustrative Embodiments Below is a list of exemplary embodiments of the inventive concept.

[0073] 1. A transducer array comprising: an electrode having a first side and a second side; a transport layer covering the first side of the electrode and transporting a TT field to a patient; a temperature sensor in contact with the second side of the electrode; an insulating layer covering the temperature sensor and at least a portion of the electrode such that the temperature sensor is disposed between the insulating layer and the second side of the electrode, the insulating layer being composed of a non-epoxy material that resists at least one of heat flow and fluid flow through the insulating layer.

[0074] 2. A transducer array as described in exemplary embodiment 1, further comprising a topcoat layer disposed over the insulating layer and the exposed portion of the second side of the electrode that is not in contact with the temperature sensor and the insulating layer, the topcoat layer having a first thickness that is less than a second thickness of the insulating layer.

[0075] 3. The transducer array of exemplary embodiment 2, wherein the insulating layer has a second thickness in the range of 2 to 6 times greater than the first thickness of the topcoat layer.

[0076] 4. The transducer array according to any one of exemplary embodiments 1 to 3, wherein the insulating layer is a thermal insulator.

[0077] 5. A transducer array as described in exemplary embodiment 2, wherein the insulating layer comprises a thermally insulating matrix material configured to resist heat flow from the temperature sensor to the atmosphere outside the insulating layer more than the topcoat layer.

[0078] 6. A transducer array described in any one of exemplary embodiments 1 to 5, wherein the insulating layer includes a liquid-resistant matrix material, and the liquid-resistant matrix material is configured to resist liquid flow through the insulating layer.

[0079] 7. The transducer array of exemplary embodiment 6, wherein the insulating layer is hydrophobic.

[0080] 8. The transducer array of any one of exemplary embodiments 1 to 7, wherein the insulating layer covers only the temperature sensor and a portion of the second side of the electrode.

[0081] 9. The transducer array of exemplary embodiment 8, wherein the insulating layer covers the temperature sensor and contacts less than 20% of the second side of the electrode.

[0082] 10. The transducer array of any one of exemplary embodiments 1-9, wherein the insulating layer includes at least one of a thermally insulating foam material and a hydrophobic material.

[0083] 11. The transducer array of any one of exemplary embodiments 1-9, wherein the insulating layer is non-conductive.

[0084] 12. The transducer array of any one of exemplary embodiments 1-12, wherein the transfer layer is a non-conductive thin film polymer layer.

[0085] 13. The transducer array of any one of exemplary embodiments 1-12, wherein the temperature sensor is a thermistor.

[0086] 14. A transducer array as described in any one of exemplary embodiments 1-13, wherein the insulating layer has a first insulating value, and the first transducer array further includes a non-conductive topcoat layer disposed on the insulating layer, the non-conductive topcoat layer extending within and beyond the outer periphery of the electrode layer, and the non-conductive topcoat layer having a second insulating value less than the first insulating value.

[0087] 15. A transducer array as described in any one of exemplary embodiments 1 to 14, wherein the transfer layer further includes a patient interface member covering the transfer layer so as to be positioned between the patient interface member and the first side of the electrode, and the patient interface member is configured to be positioned between the transfer layer and the patient's skin.

[0088] 16. An oncology treatment field system comprising: an electric field generator that generates an electric signal having an AC waveform at a frequency of 50 kHz to 1 MHz; a first conductive lead electrically coupled to the electric field generator and carrying the electrical signal; a first transducer array coupled to the first conductive lead, the first transducer array including at least one electrode layer having the first side, a second side, and an outer periphery, a transfer layer in contact with the first side of the electrode layer, a temperature sensor in contact with the second side of the electrode layer, and an insulating layer disposed over the temperature sensor and at least a portion of the second side of the electrode layer, the insulating layer being composed of a non-epoxy material that resists at least one of heat flow and fluid flow through the insulating layer; a second conductive lead electrically coupled to the electric field generator; a second transducer array coupled to the second conductive lead, the second transducer array receiving electrical signals from the second conductive lead and cooperating with the first conductive lead to form a tumor treatment field.

[0089] 17. A tumor treatment field system as described in exemplary embodiment 16, wherein the first transducer array further includes a topcoat layer disposed over the insulating layer and the exposed portion of the second surface of the electrode layer that is not in contact with the temperature sensor and the insulating layer, the topcoat layer having a first thickness that is less than a second thickness of the insulating layer.

[0090] 18. A tumor treatment field system as described in any one of exemplary embodiments 16-17, wherein the insulating layer has a first insulating value, and the first transducer array further includes a non-conductive topcoat layer disposed on the insulating layer, the non-conductive topcoat layer extending within and beyond the outer periphery of the electrode layer, and the non-conductive topcoat layer having a second insulating value less than the first insulating value.

[0091] 19. The tumor treatment field system of any one of exemplary embodiments 16-18, wherein the transfer layer is a non-conductive thin film polymer layer.

[0092] 20. A tumor treatment field system as described in any one of exemplary embodiments 16 to 19, wherein the electrode layer of the first transducer array includes a plurality of electrodes, each electrode having a first surface and a second surface and a temperature sensor in contact with the first surface, and the insulating layer includes a plurality of insulating sections, at least some of which are positioned over the temperature sensor and at least a portion of the first surface of each electrode.

[0093] 21. A tumor treatment field system described in any one of exemplary embodiments 16-20, wherein the insulating layer comprises an insulating matrix material, and the insulating matrix material is configured to resist heat flow from the temperature sensor to the atmosphere outside the insulating layer more than the topcoat layer.

[0094] 22. A tumor treatment field system described in any one of exemplary embodiments 16-21, wherein the insulating layer comprises a liquid-resistant matrix material, and the liquid-resistant matrix material is configured to resist the flow of liquid through the insulating layer.

[0095] 23. The tumor treatment field system of any one of exemplary embodiments 16-22, wherein the insulating layer is non-conductive.

[0096] 24. The tumor treatment field system of any one of exemplary embodiments 16-23, wherein the transfer layer comprises a highly dielectric polymeric film.

[0097] 25. The tumor treatment field system of any one of exemplary embodiments 16-24, wherein the temperature sensor is a thermistor.

[0098] 26. A transducer array comprising: an electrode having a first side and a second side; a transport layer covering the first side of the electrode and transporting a TT field to a patient; a temperature sensor in contact with the second side of the electrode; an insulating layer covering the temperature sensor and at least a portion of the electrode such that the temperature sensor is disposed between the insulating layer and the second side of the electrode, the insulating layer resisting at least one of heat flow and fluid flow through the insulating layer.

[0099] 27. The transducer array of exemplary embodiment 26, further comprising a topcoat layer disposed over the insulating layer and the exposed portion of the second side of the electrode that is not in contact with the temperature sensor and the insulating layer, the topcoat layer having a first thickness that is less than a second thickness of the insulating layer.

[0100] 28. The transducer array of exemplary embodiment 27, wherein the insulating layer has a second thickness in the range of 2 to 6 times greater than the first thickness of the topcoat layer.

[0101] 29. The transducer array of any one of exemplary embodiments 26-28, wherein the insulating layer is a thermal insulator.

[0102] 30. A transducer array as described in exemplary embodiment 27, wherein the insulating layer includes a thermally insulating matrix material configured to resist heat flow from the temperature sensor to the atmosphere outside the insulating layer more than the topcoat layer.

[0103] 31. A transducer array described in any one of exemplary embodiments 26-30, wherein the insulating layer includes a liquid-resistant matrix material, and the liquid-resistant matrix material is configured to resist liquid flow through the insulating layer.

[0104] 32. The transducer array of exemplary embodiment 31, wherein the insulating layer is hydrophobic.

[0105] 33. The transducer array of any one of exemplary embodiments 26-32, wherein the insulating layer covers only the temperature sensor and a portion of the second side of the electrode.

[0106] 34. The transducer array of exemplary embodiment 33, wherein the insulating layer covers the temperature sensor and contacts less than 20% of the second side of the electrode.

[0107] 35. The transducer array of any one of exemplary embodiments 26-34, wherein the insulating layer includes at least one of an epoxy material, a thermal insulating foam material, and a hydrophobic material.

[0108] 36. The transducer array of any one of exemplary embodiments 26-34, wherein the insulating layer is non-conductive.

[0109] 37. The transducer array of any one of exemplary embodiments 26-36, wherein the transfer layer is a non-conductive thin film polymer layer.

[0110] 38. The transducer array of any one of exemplary embodiments 26-37, wherein the temperature sensor is a thermistor.

[0111] 39. A transducer array as described in any one of exemplary embodiments 26-38, wherein the insulating layer has a first insulating value, and the first transducer array further includes a non-conductive topcoat layer disposed on the insulating layer, the non-conductive topcoat layer extending within and beyond the outer periphery of the electrode layer, and the non-conductive topcoat layer having a second insulating value less than the first insulating value.

[0112] 40. The transducer array of any one of exemplary embodiments 26-39, further comprising a patient interface member covering the transfer layer such that the transfer layer is positioned between the patient interface member and the first side of the electrode, the patient interface member configured to be positioned between the transfer layer and the patient's skin.

[0113] 41. A tumor treatment field system, comprising: an electric field generator that generates an electric signal having an AC waveform at a frequency of 50 kHz to 1 MHz; a first conductive lead electrically coupled to the electric field generator and carrying the electrical signal; a first transducer array coupled to the first conductive lead, the first transducer array including at least one electrode layer having the first side, a second side, and an outer periphery, a transfer layer in contact with the first side of the electrode layer, a temperature sensor in contact with the second side of the electrode layer, and an insulating layer disposed over the temperature sensor and at least a portion of the second side of the electrode layer, the insulating layer resisting at least one of heat flow and fluid flow through the insulating layer; a second conductive lead electrically coupled to the electric field generator; a second transducer array coupled to the second conductive lead, the second transducer array receiving electrical signals from the second conductive lead and cooperating with the first conductive lead to form a tumor treatment field.

[0114] 42. A tumor treatment field system as described in exemplary embodiment 41, wherein the first transducer array further includes a topcoat layer disposed over the insulating layer and the exposed portion of the second surface of the electrode layer that is not in contact with the temperature sensor and the insulating layer, and the topcoat layer has a first thickness that is less than a second thickness of the insulating layer.

[0115] 43. A tumor treatment field system as described in any one of exemplary embodiments 41-42, wherein the insulating layer has a first insulating value, and the first transducer array further includes a non-conductive topcoat layer disposed on the insulating layer, the non-conductive topcoat layer extending within and beyond the outer periphery of the electrode layer, and the non-conductive topcoat layer having a second insulating value less than the first insulating value.

[0116] 44. The tumor treatment field system of any one of exemplary embodiments 41-43, wherein the transfer layer is a non-conductive thin film polymer layer.

[0117] 45. A tumor treatment field system as described in any one of exemplary embodiments 41 to 44, wherein the electrode layer of the first transducer array includes a plurality of electrodes, each electrode having a first surface and a second surface and a temperature sensor in contact with the first surface, and the insulating layer includes a plurality of insulating sections, at least some of which are positioned over the temperature sensor and at least a portion of the first surface of each electrode.

[0118] 46. ​​A tumor treatment field system described in any one of exemplary embodiments 41 to 45, wherein the insulating layer includes a thermally insulating matrix material, and the thermally insulating matrix material is configured to resist heat flow from the temperature sensor to the atmosphere outside the insulating layer more than the topcoat layer.

[0119] 47. A tumor treatment field system described in any one of exemplary embodiments 41-46, wherein the insulating layer comprises a liquid-resistant matrix material, and the liquid-resistant matrix material is configured to resist the flow of liquid through the insulating layer.

[0120] 48. The tumor treatment field system of any one of exemplary embodiments 41-47, wherein the insulating layer is non-conductive.

[0121] 49. The tumor treatment field system of any one of exemplary embodiments 41-48, wherein the transfer layer comprises a highly dielectric polymeric film.

[0122] 50. The tumor treatment field system of any one of exemplary embodiments 41-49, wherein the temperature sensor is a thermistor.

[0123] From the foregoing, it will be apparent that the inventive concepts described herein are adapted to achieve the features described in the present invention as well as those described in the present invention. While exemplary embodiments of the inventive concepts have been described for purposes of this disclosure, it will be understood that many modifications may be made which will readily suggest themselves to those skilled in the art and which are accomplished within the spirit of the inventive concepts disclosed and claimed herein.

[0124] The foregoing description provides illustration and description, but is not intended to be exhaustive or to limit the inventive concepts to the precise form disclosed. Modifications and variations are possible in light of the above teachings or may be acquired from practice of the methodologies described in the present disclosure.

[0125] Although particular combinations of features are recited in the claims and / or disclosed in the specification, these combinations are not intended to limit the disclosure. Indeed, many of these features and steps can be combined in ways not specifically recited in the claims and / or disclosed in the specification. Although each dependent claim listed below may directly depend on only one other claim, the disclosure includes each dependent claim in combination with every other claim in the claim set.

[0126] Similarly, while each exemplary embodiment listed above may depend directly on only one other exemplary embodiment, the present disclosure includes each exemplary embodiment in combination with all other exemplary embodiments within the set of exemplary embodiments for each mode of the inventive concepts disclosed herein.

[0127] No element, act, or instruction used herein should be construed as critical or essential to the present disclosure unless explicitly described outside of the preferred embodiments. Further, the phrase "based on" is intended to mean "based at least in part on," unless explicitly stated otherwise.

Claims

1. 1. A transducer array comprising: an electrode having a first side and a second side; a transport layer covering the first side of the electrode and transporting a TT field to a patient; a temperature sensor in contact with the second side of the electrode; an insulating layer covering the temperature sensor and at least a portion of the electrode such that the temperature sensor is disposed between the insulating layer and the second side of the electrode; the insulating layer being comprised of a non-epoxy material that resists at least one of heat flow and fluid flow through the insulating layer.

2. a topcoat layer disposed on the insulating layer and on the temperature sensor and an exposed portion of the second side of the electrode that is not in contact with the insulating layer; The transducer array of claim 1 , wherein the topcoat layer has a first thickness that is less than a second thickness of the insulating layer.

3. The transducer array of claim 2 , wherein the insulating layer has the second thickness in a range of 2 to 6 times greater than the first thickness of the topcoat layer.

4. The transducer array of claim 1 , wherein the insulating layer is a thermal insulator.

5. the insulating layer comprises a thermally insulating matrix material; The transducer array of claim 1 , wherein the thermally insulating matrix material is configured to resist heat flow from the temperature sensor to an atmosphere outside the insulating layer beyond a topcoat layer.

6. the insulating layer comprises a liquid-resistant matrix material; The transducer array of claim 1 , wherein the liquid-resistant matrix material is configured to resist liquid flow through the insulating layer.

7. The transducer array of claim 1 , wherein the insulating layer covers only the temperature sensor and a portion of the second side of the electrode.

8. The transducer array of claim 7 , wherein the insulating layer covers the temperature sensor and contacts less than 20% of the second side of the electrode.

9. 1. An oncology treatment field system, comprising: an electric field generator that generates an electric signal having an AC waveform at a frequency between 50 kHz and 1 MHz; a first conductive lead electrically coupled to the electric field generator and carrying the electrical signal; a first transducer array coupled to the first conductive lead, The first transducer array comprises: at least one electrode layer having a first surface, a second surface, and an outer periphery; a transfer layer contacting the first surface of the electrode layer; a temperature sensor in contact with the second surface of the electrode layer; an insulating layer disposed on the temperature sensor and at least a portion of the second surface of the electrode layer; the insulating layer is constructed of a non-epoxy material that resists at least one of heat flow and fluid flow through the insulating layer; a second conductive lead electrically coupled to the electric field generator; a second transducer array coupled to the second conductive lead, a second transducer array that receives electrical signals from the second conductive lead and cooperates with the first conductive lead to form a tumor treatment field.

10. the first transducer array further includes a topcoat layer disposed over the insulating layer and the temperature sensors and exposed portions of the second surface of the electrode layer that are not in contact with the insulating layer; 10. The tumor treatment field system of claim 9, wherein the topcoat layer has a first thickness that is less than a second thickness of the insulating layer.

11. the insulating layer has a first insulating value; the first transducer array further includes a non-conductive topcoat layer disposed over the insulating layer; the non-conductive topcoat layer extends into and beyond the periphery of the electrode layer; 11. The tumor treatment field system of claim 9 or 10, wherein the non-conductive topcoat layer has a second insulation value less than the first insulation value.

12. the electrode layer of the first transducer array includes a plurality of electrodes; each of the electrodes having a first surface and a second surface and a temperature sensor in contact with the first surface; the insulating layer includes a plurality of insulating sections; 12. The tumor treatment field system of claim 9, wherein at least some of the insulating sections are disposed over the temperature sensor and at least a portion of the first surface of each of the electrodes.

13. the insulating layer comprises a thermally insulating matrix material; 13. The tumor treatment field system of claim 12, wherein the thermally insulating matrix material is configured to resist heat flow from the temperature sensor to the atmosphere outside the insulating layer beyond the topcoat layer.

14. the insulating layer comprises a liquid-resistant matrix material; 10. The tumor treatment field system of claim 9, wherein the liquid-resistant matrix material is configured to resist the flow of liquid through the insulating layer.

15. 10. The tumor treatment field system of claim 9, wherein said insulating layer is non-conductive.

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