Conductive pads for generating tumor treatment fields and methods of making and using same - Patents.com

Abstract

Systems and methods for delivering TT fields are described herein. The system includes an electric field generator, the electric field generator generating a signal having a frequency of 50 kHz to 500 kHz, and coupled to a first lead and a second lead. A first pad is coupled to the first lead and includes a conductive foam and a first conductive gel. The conductive foam receives the signal from the first conductive lead and includes a solid continuous phase material including at least a conductive material. A plurality of pockets are interspersed throughout the conductive foam. The first conductive gel is attached, absorbed, or adsorbed to the conductive foam. A second lead is coupled to the electric field generator, and a second pad is coupled to the second lead. The second pad has a second electrode element connected to a second conductive gel element and receives the signal from the second conductive lead.

Description

[Technical field]

[0001] [CROSS REFERENCE TO RELATED APPLICATIONS / INCORPORATION BY REFERENCE] This non-provisional application claims the benefit of U.S. Provisional Application No. 63 / 224,241, filed June 21, 2021, the entire contents of which are expressly incorporated herein by reference in their entirety. [Background technology]

[0002] Tumor Treating Fields (TTFields or TTFs) are low intensity (e.g., 1-3 V / cm) alternating electric fields in the mid-frequency range (e.g., 50 kHz-1 MHz, e.g., 50-500 kHz, etc.) that target solid tumors by disrupting mitosis. This non-invasive treatment targets solid tumors and is described, for example, in U.S. Pat. No. 5,393,436; U.S. Pat. No. 5,493,663; U.S. Pat. No. 5,523,366; U.S. Pat. No. 5,639,136; U.S. Pat. No. 5,711,633; U.S. Pat. No. 5,711,633; and U.S. Pat. No. 5,711,633. TTFields are typically delivered through two pairs of transducer arrays that generate perpendicular fields in the tumor being treated. The transducer arrays that make up each of these pairs are positioned on either side of the body part being treated. More specifically, for the OPTUNE® system, one pair of electrodes of the transducer array is positioned left and right (LR) of the tumor, and the other pair of electrodes of the transducer array is positioned anterior and posterior (AP) of the tumor. TT Fields have been approved for the treatment of glioblastoma multiforme (GBM) and can be delivered, for example, via the OPTUNE® system (Novocure Limited, St. Helier, Jersey), which includes a transducer array placed on the patient's shaved head. More recently, TT Fields therapy has been approved as a combination therapy with chemotherapy for malignant pleural mesothelioma (MPM) and may also be utilized in the treatment of tumors in other parts of the body.

[0003] Each transducer array used for delivery of TT Fields in the OPTUNE® device includes a set of non-conductive ceramic disk electrodes that are coupled to the patient's skin (such as, but not limited to, the patient's shaved head for treatment of GBM) through a layer of conductive medical gel. To form the ceramic disk electrodes, a conductive layer is formed on the top surface of the non-conductive ceramic material. The bottom surface of the non-conductive ceramic material is coupled to the conductive medical gel. The non-conductive ceramic material is a safety feature to ensure that DC signals are blocked from being accidentally and unintentionally transmitted to the patient.

[0004] By interposing a non-conductive ceramic material between the conductive layer and the conductive medical gel, the prior art systems were thought to ensure that the patient would remain protected. The purpose of the medical gel is to conform to the contours of the body and to provide good electrical contact between the array and the skin. As such, the gel interface creates a bridge with the skin, reducing interference. The device is intended to be worn continuously by the patient for 2-4 days, after which it is removed for hygienic care and re-shaving (if necessary), followed by reapplication of a new set of arrays. As such, the medical gel remains in substantially continuous contact with an area of ​​the patient's skin for periods of 2-4 days at a time, with only a short period of time during which that area of ​​skin is uncovered and exposed to the environment before more medical gel is applied to it.

[0005] One approach to applying TT fields in different directions is to apply the field between a first set of electrodes for a predetermined period of time, then apply the field between a second set of electrodes for a predetermined period of time, and then repeat the cycle for an extended duration (e.g., over a period of days or weeks).

[0006] To generate a TT field, an electric current is applied to each electrode of the transducer array. The application of the electric current for a period of time causes each electrode to warm up and eventually become hot, thus becoming uncomfortable or painful for the patient. To maintain the desired temperature of the transducer array, the applied current is reduced, resulting in a weaker TT field, or the transducer array is powered off, thus shortening the duration of the treatment. Additionally, the prior art teaches electrodes made of rigid and / or non-flexible materials (e.g., ceramics, etc.), which do not contour to the patient.

[0007] Due to this heating of the transducer array, new and improved array assemblies that reduce the temperature of the transducer array while generating stronger TT fields are desired, and it is to such assemblies and methods of producing and using them that the present disclosure relates. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent No. 7016725 [Patent Document 2] U.S. Patent No. 7,089,054 [Patent Document 3] U.S. Patent No. 7,333,852 [Patent Document 4] U.S. Patent No. 7,565,205 [Patent Document 5] U.S. Patent No. 8,244,345 [Patent Document 6] U.S. Patent No. 8,715,203 [Patent Document 7] U.S. Patent No. 8,764,675 [Patent Document 8] U.S. Patent No. 10,188,851 [Patent Document 9] U.S. Patent No. 10,441,776 [Patent Document 10] U.S. Patent No. 7,805,201 [Patent Document 11] U.S. Patent Application No. 17 / 313114 [Non-patent literature]

[0009] [Non-Patent Document 1] Eilon D. Kirson et al., Disruption of Cancer Cell Replication by Alternating Electric Fields, Cancer Res. 2004 64:3288-3295 Summary of the Invention [Means for solving the problem]

[0010] The challenge of reducing the temperature of a transducer array while generating stronger TT fields is addressed by a system for delivering TT fields to a body of a subject, the system including: an electric field generator configured to generate an electrical signal having an alternating current waveform at a frequency in the range of 50 kHz to 500 kHz; a first conductive lead electrically coupled to the electric field generator, the first conductive lead configured to transmit the electrical signal; and a first pad coupled to the first conductive lead, the first pad having a conductive foam and a first conductive gel element, the conductive foam receiving the electrical signal from the first conductive lead, the conductive foam having a solid continuous phase material, the solid continuous phase material being constructed from or attached to a conductive material. and a conductive foam having at least one of a conductive material attached, absorbed, or adsorbed thereon, the conductive foam defining a plurality of pockets interspersed throughout the solid continuous phase material, the first conductive gel element being attached, absorbed, or adsorbed to the conductive foam; a second conductive lead electrically coupled to the electric field generator, the second conductive lead being configured to transmit an electrical signal; and a second pad coupled to the second conductive lead, the second pad having a second electrode element and receiving the electrical signal from the second conductive lead, the second electrode element being connected to the second conductive gel element.

[0011] The extra surface area of ​​the conductive foam, both in terms of the planar area that may extend beyond the edges of the electrode element and in terms of the additional surface area provided by the porous cell structure of the foam, provides a mechanism for dissipating heat from the area of ​​the electrode element, thereby reducing the problem of uncomfortable heat on the patient's skin, which in turn allows for the use of more powerful TT-FIELDS while staying within a selected thermal comfort threshold.

[0012] The details of one or more implementations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other aspects, features, and advantages of the subject matter will become apparent from the description, drawings, and claims.

[0013] 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 certain features and certain perspectives of the figures may be exaggerated, shown to scale, or shown diagrammatically for clarity and conciseness. Not all components may be labeled in every drawing. Like reference numbers among the figures may represent and refer to the same or similar elements or functions. [Brief description of the drawings]

[0014] [Figure 1] FIG. 1 shows an exemplary embodiment of a schematic diagram of an electrode as applied to living tissue. [Diagram 2] FIG. 1 illustrates an exemplary embodiment of an electronic device configured to generate a TT field constructed in accordance with the present disclosure. [Diagram 3] FIG. 1 is a block diagram of an exemplary embodiment of a pad constructed in accordance with the present disclosure. [Figure 4] FIG. 2 is a block diagram of another exemplary embodiment of a pad constructed in accordance with the present disclosure. [Diagram 5] FIG. 1 illustrates a cross-section of an exemplary embodiment of an array assembly constructed in accordance with the present disclosure. [Figure 6] 1 is a cross-sectional view of an exemplary embodiment of an electrode element constructed in accordance with the present disclosure. [Figure 7] 1 is a top view of an exemplary embodiment of a fabric layer constructed in accordance with the present disclosure. [Figure 8]1 is a cross-sectional diagram of an exemplary embodiment of a foam layer constructed in accordance with the present disclosure. [Figure 9] FIG. 13 illustrates a cross-section of another exemplary embodiment of an array assembly constructed in accordance with the present disclosure. [Figure 10] 1 is a cross-sectional diagram of an exemplary embodiment of a pad constructed in accordance with the present disclosure. [Figure 11] FIG. 1 is a top view of an exemplary embodiment of a pad constructed in accordance with the present disclosure. [Figure 12] 1 is a process flow diagram of an exemplary embodiment of a process for using an electronic device to apply TT Fields to a patient. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] Before describing at least one embodiment of the inventive concept in detail by way of exemplary language and results, it should be understood that the inventive concept is not limited in its application to the details of construction and the arrangement of components set forth in the following description. The inventive concept is capable of other embodiments or of being practiced or carried out in various ways. As such, the language used herein is intended to be given the broadest possible scope and meaning, and the embodiments are meant to be illustrative (not exhaustive). It should also be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0016] Headings are provided for convenience only and should not be construed as limiting the invention in any manner. An embodiment 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 in other parts of this disclosure. Any combination of the elements described herein in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or clearly contradicted by context.

[0017] Unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular.

[0018] All patents, published patent applications, and non-patent publications referenced in any part of this application are expressly incorporated by reference in their entirety herein to the same extent as if each individual patent or publication was specifically and individually indicated to be incorporated by reference.

[0019] All of the compositions, assemblies, systems, kits, and / or methods disclosed herein can be made and executed without undue experimentation in light of the present disclosure. If a method claim does not specifically recite in the claims or specification that the steps are to be limited to a particular order, no order is intended to be inferred in any respect, including matters of logic regarding the arrangement or operational flow of the steps, the plain meaning derived from grammatical organization or punctuation, or any possible non-express basis of interpretation, including the number or type of embodiments described herein.

[0020] As utilized in accordance with the present disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings:

[0021] The use of the terms "a" or "an," when used in conjunction with the term "comprising" in the claims and / or specification, may mean "one," but is also consistent with the meanings of "one or more," "at least one," and "one or more." The term "plurality" refers to "two or more."

[0022] Additionally, 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. Use of ordinal terminology (e.g., "first," "second," "third," "fourth," etc.) is for the purpose of distinguishing between two or more items only and is not meant to imply, for example, any sequence or order or importance of one item relative to another, or any additional ordering.

[0023] Use of the term "or" in the claims is used to mean an inclusive "and / or" unless expressly stated to refer to alternatives only or unless the alternatives are mutually exclusive.

[0024] As used herein, the term TT Fields (TTFields or TTF(s)) refers to a medium frequency (about 50 kHz to 1 MHz, more preferably about 50 kHz to 500 kHz), low intensity (e.g., 1-4 V / cm) alternating electric field that, when applied via electrodes to a conductive medium (e.g., the human body) may be used, for example, to treat tumors, as described in U.S. Pat. Nos. 5,993, 6,133, 6,141, 6,151, 6,163, 6,171, 6,182, 6,213, 6,226, 6,233, 6,246, 6,251, 6,252, 6,262, 6,271, 6,272, 6,281, 6,313, 6,313, 6,313, 6,271, 6,313, 6,281, 6,297, 7,32 ...

[0025] As used herein, the term TT 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 fields described above. TT signals are often AC electrical signals.

[0026] As used herein, the term "pad" refers to one or more conductive materials configured to be placed over a portion of a subject's body to generate a TT field upon receiving a TT signal from a field generator.

[0027] Turning now to the inventive concepts, certain non-limiting embodiments thereof include a system and a method of implementing the system, the system including: an electric field generator configured to generate an electrical signal having an alternating current waveform at a frequency in the range of 50 kHz to 500 kHz; and a first conductive lead electrically coupled to the electric field generator, the first conductive lead configured to convey the electrical signal to a pad and / or a transducer array electrically coupled to the first conductive lead. Various aspects of the disclosure are provided in detail below.

[0028] Referring now to the drawings, and in particular to FIG. 1, there is shown an exemplary embodiment of a dividing cell 10 under the influence of an external TT field (e.g., an alternating field in the frequency range of about 100 kHz to about 300 kHz), generally indicated by a line 14, generated by a first electrode 18a with a negative charge and a second electrode 18b with a positive charge. Also shown are microtubules 22, which are known to have a very strong dipole moment. This strong polarization makes the microtubules 22 as well as other polar macromolecules (and especially those that have a specific orientation in the cell 10 or its surroundings) susceptible to electric fields. The positive charges of the microtubules 22 are located at the two centrioles 26, while two sets of negative poles are located at the center 30 of the dividing cell 10 and at the points of attachment 34 of the microtubules 22 to the cell membrane. The locations of the charges form a set of double dipoles and are therefore susceptible to electric fields of different directions. In one embodiment, cells undergo electroporation, ie, DNA or chromosomes are introduced into the cells using a pulse of electricity to briefly open pores in the cell membrane.

[0029] Turning now to FIG. 2, the TT fields described above, which have been found to advantageously destroy tumor cells, can be generated by an electronic device 50. FIG. 2 is a simplified schematic diagram of the electronic device 50, showing its major components. The 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. The first conductive lead 58a includes a first end 62a and a second end 66a. The second conductive lead 58b includes a first end 62b 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 62b of the second conductive lead 58b is conductively attached to the electric field generator 54. The electric field generator 54 generates as an output a desired electrical signal (TT signal) in the form of a waveform or train of pulses. The second end 66a of the first conductive lead 58a is connected to a pad 70a, and the second end 66b of the second conductive lead 58b is connected to a pad 70b. Both pads 70a and 70b are activated by an electrical signal (e.g., a TT signal, a waveform). Pads 70a and 70b activated by an electrical signal cause a current to flow between pads 70a and 70b. The current generates an electric field (i.e., a TT field), the electric field having a predetermined frequency and amplitude, which is generated between pads 70a and 70b.

[0030] Although the electronic device 50 shown in FIG. 2 includes only two pads 70 (pad 70a and pad 70b), in some embodiments, the electronic device 50 may include three or more pads 70.

[0031] The electric field generator 54 generates an alternating voltage waveform (i.e., a TT field) at a frequency in the range of about 50 kHz to about 500 kHz (preferably about 100 kHz to about 300 kHz). The required voltage is such that the electric field strength in the tissue in the treatment area is in the range of about 0.1 V / cm to about 10 V / cm. To achieve this field, the potential difference between the two conductors 18 (e.g., conductors 188 in FIG. 6 or electrode layer 162, described in detail below in FIG. 5) in each of pads 70a or 70b is determined by the relative impedances of the system components, e.g., the percentage of the electric field on each component is given by the impedance of that component divided by the total circuit impedance.

[0032] In certain (but non-limiting) embodiments, pads 70a and 70b generate an alternating current and field in a target area of ​​a patient. The target area typically includes at least one tumor, and the generation of the alternating current and field selectively destroys or inhibits the growth of the tumor. The alternating current and field can be generated at any frequency (such as, for example, at any frequency of a TT field) that selectively destroys or inhibits the growth of the tumor.

[0033] In certain (but non-limiting) embodiments, the alternating currents and fields may be imposed at two or more different frequencies. When more than one frequency is present, each frequency is selected from any of the values ​​above, or a range from any of the values ​​above, or a combination of two integers between two of the values ​​above. As used herein, the alternating electric field may be referred to as an electric field or a TT field.

[0034] To optimize the electric field (i.e., TT field) distribution, pads 70a and 70b (pair of pads) can be configured differently depending on the application for which the pair of pads 70a and 70b will be used. As described herein, the pair of pads 70a and 70b are applied externally to the patient, i.e., generally to the patient's skin, to apply an electric current and an electric field (TT field), thereby generating an electric current in the patient's tissue. Generally, the pair of pads 70a and 70b are placed by a user on the patient's skin, such that an electric field is generated across the patient's tissue in the treatment area. The externally applied TT field can be of a localized type or a widely distributed type, for example, for treating skin tumors and lesions near the skin surface.

[0035] In one embodiment, the user may be a medical professional, such as a doctor, nurse, therapist, or other person acting under the instruction of a doctor, nurse, or therapist, etc. In another embodiment, the user may be a patient, i.e., the patient (and / or a helper) may place pads 70a and 70b over their treatment area.

[0036] Optionally, and in accordance with another exemplary embodiment, electronic device 50 includes a control box 74 and a temperature sensor 78 coupled to control box 74, which are included to control the amplitude of the electric field so as not to cause excessive heating in the treatment area.

[0037] When the control box 74 is included, the control box 74 may, for example, control the output of the electric field generator 54, causing the output to remain constant at a value preset by the user. Alternatively, the control box 74 may set the output to a maximum value that does not cause excessive heating of the treatment area. In any of the above cases, the control box 74 may issue an alarm or the like when the temperature of the treatment area (as sensed by the temperature sensor 78) exceeds a preset limit value. The temperature sensor 78 may be mechanically connected and / or otherwise associated with the pad 70a or pad 70b to sense the temperature of the treatment area at either or both of the pads 70a or pad 70b. In one embodiment, the control box 74 may turn off or reduce the power of the TT signal generated by the electric field generator 54 if the temperature sensed by the temperature sensor 78 meets or exceeds a comfort threshold. In one embodiment, the comfort threshold is a temperature at which the patient will become uncomfortable while using the pads 70a and pad 70b. In one embodiment, the comfort threshold is a temperature at or about 40 degrees Celsius. In one embodiment, the comfort threshold is a temperature between about 39 degrees Celsius and 42 degrees Celsius, or a particular selected temperature between about 39 degrees Celsius and 42 degrees Celsius.

[0038] Conductive lead 58 is a standard isolated conductor with a flexible metal shield, preferably grounded, to prevent spreading of any electric field generated by conductive lead 58. Pads 70a and 70b can have a specific shape and positioning to generate a TT field of a desired configuration, direction, and strength in the treatment area, and only in the treatment area to focus the treatment.

[0039] The specifications of the electronic device 50 as a whole and its individual components are heavily influenced by the fact that at TT field frequencies, biological systems behave according to their "Ohm's law" properties rather than their dielectric properties.

[0040] In one embodiment, to protect the patient from any current due to DC voltage or DC offset voltage passing through the patient, the leads 58a and 58b can include DC blocking components (such as, for example, blocking capacitors 82a and 82b) to prevent DC current from passing to the pads 70a and 70b. Without being bound by theory, the inventors believe herein that the DC blocking components are important for safety reasons, but do not need to be located at the patient interface (i.e., in the electrodes of the transducer array) or, for that matter, be the non-conductive ceramic disks described above. The blocking capacitors 82a and 82b pass the AC voltage to the pads 70a and 70b and also prevent any DC voltage or DC offset generated by the electric field generator 54 or otherwise present in the electrical signal from passing to or through the patient. DC voltages, when applied to a patient, can have undesirable consequences, such as electrolysis or excessive heating of pads 70a and 70b, without the benefit of contributing to the power of the TT field. Thus, blocking capacitors 82a and 82b can prevent electrolysis caused by DC offsets or DC voltages. In one embodiment, blocking capacitors 82a and 82b are non-polarized capacitors. In one embodiment, blocking capacitors 82a and 82b have a capacitance of about 1 μF. In one embodiment, blocking capacitors are leaded non-polarized ceramic capacitors, "Goldmax, 300 Series, Conformally Coated, X7R Dielectric, 25-250VDC (Commercial Grade)" by KEMET Electronics Corporation (Fort Lauderdale, FL, USA).

[0041] Electrical isolation of the patient from the electric field generator 54 can be very important, therefore providing blocking capacitor 82a and / or blocking capacitor 82b outside of the electric field generator 54 enhances patient safety. Blocking capacitor 82a and blocking capacitor 82b can be components of the leads 58a and 58b, or in other embodiments, can be additional components at any location between the conductor 188 (see FIG. 6) or electrode element 136 (see FIG. 9) and the electric field generator 54. For example, blocking capacitor 82a and 82b can be intermediate the first end 62a (or 62b) of lead 58a (or 58b) and the electric field generator 54, or intermediate the second end 66a (or 66b) of lead 58a (or 58b) and the pad 70a (or 70b). The inventors contemplate that blocking capacitors 82a and 82b may be provided remotely from pads 70a and 70b and still provide patient safety. In other embodiments, blocking capacitors 82a and 82b may be located on the non-patient side of conductor 188 or electrode element 136.

[0042] In other embodiments, blocking capacitors 82a and 82b can be components of electric field generator 54, i.e., blocking capacitors 82a and 82b can be integrated into electric field generator 54 such that the electrical signal passes through blocking capacitors 82a and 82b, respectively, before being passed into leads 58a and 58b. Alternatively, blocking capacitors 82a and 82b can be components of pads 70a and 70b, components of leads 58a and 58b, or additional components at any location between gel layer 158 (see FIG. 10) and electric field generator 54.

[0043] Referring now to FIG. 3, a diagram of an exemplary embodiment of a pad 70 constructed in accordance with the present disclosure is now shown. The pad 70 includes one or more electrode elements 104. As shown in FIG. 3, each pad 70 is configured as a set of one or more electrode elements 104. The pad 70 may utilize capacitively coupled electrode elements 104. In the example shown in FIG. 3, the pad 70 is configured as a plurality of electrode elements 104 (e.g., approximately 2 cm in diameter) interconnected via flex wires 108 (and connected to a field generator via conductive leads 58). Each electrode element 104 may include a ceramic disk and an electrode layer (described below with respect to FIG. 6). In one embodiment, the pad 70 includes an outer peripheral edge 132.

[0044] Alternative constructions for the pad 70 may be used, including, for example, disc-shaped ceramic elements, non-disc-shaped ceramic elements, and non-ceramic dielectric materials positioned between the electrode layer and the skin-facing surface of the pad 70 over the plurality of flat conductors 188 (see FIG. 6). Examples of non-ceramic dielectric materials positioned over the plurality of flat conductors include a polymer film disposed over a pad of a printed circuit board or a polymer film disposed over a flat piece of metal. Pads 70 that utilize electrode elements 104 that are not capacitively coupled may also be used. In this situation, each electrode element 104 of the transducer array would be implemented using a region of conductive material that is configured to be placed against a person's body, with no insulating dielectric layer disposed between the electrode element 104 and the body. Examples of conductive materials include conductive films, conductive fabrics (e.g., fabric layer 150, see FIG. 5), and conductive foams (e.g., foam layer 154, see FIG. 5). Other alternative constructions for implementing pad 70 may also be used, so long as they are capable of delivering TT-Fields to the person's body. Optionally, a gel layer 158 may be disposed between pad 70 and the person's body in any of the embodiments described herein (see FIG. 6).

[0045] 4, a top view of an exemplary embodiment of pad 70c is now shown. Pad 70c is an exemplary embodiment of pad 70a or pad 70b. Pad 70c may be provided with a top surface 124, a bottom surface 128 (shown in FIG. 10 for pad 70d), an outer peripheral edge 132, and an electrode element 136 bounded by the outer peripheral edge 132. As shown, pad 70c is connected to the second end 66 of conductive lead 58. Pad 70c is constructed to be sufficiently flexible so that it can accommodate a portion of a patient (e.g., a portion of the patient's head, the patient's knee, or the patient's elbow, etc.). Pad 70c may also be constructed such that electrode element 136 is continuous and extends to outer peripheral edge 132. In the illustrated example, pad 70c is provided with a rectangular shape or a substantially rectangular shape with rounded apexes. However, it should be understood that pad 70c may be provided with any type of shape (e.g., polygonal, circular, or odd shapes, etc.) Additionally, pad 70c may be constructed to be cut and / or shaped at the point of use to custom fit particular parts of a particular patient.

[0046] In one embodiment, the pad 70c is provided with a durable topcoat layer 140 as the upper surface 124. The durable topcoat layer 140 can be a non-woven, non-conductive fabric. The durable topcoat layer 140 provides a safe handling surface for the pad 70c and electrically isolates the electrode elements 136 from the upper surface 124 of the pad 70c. In some embodiments, the durable topcoat layer 140 is colored to match or approximate the color of the patient's skin.

[0047] In one embodiment, durable topcoat layer 140 can be "breathable," i.e., durable topcoat layer 140 includes one or more perforations or the like extending from top surface 124 to bottom surface 128 to allow air flow to other layers of pad 70c, as described below. The one or more perforations can have the same or different dimensions as the one or more other perforations, and similarly can have the same or different shape as the one or more other perforations.

[0048] 5, a cross-section of an exemplary embodiment of an array assembly 144 constructed in accordance with the present disclosure is now shown. The array assembly 144 generally includes one or more layers, including a fabric layer 150, a foam layer 154, a gel layer 158, an electrode layer 162, a durable topcoat layer 140, and a compressible layer 170. In one embodiment, the foam layer 154, the gel layer 158, the electrode layer 162, and the durable topcoat layer 140 may be combined and referred to as a pad 70. In one embodiment, the fabric layer 150 is a conductive fabric (such as, for example, the fabric layer 150 shown in FIG. 7 and discussed in more detail below). In some embodiments, the array assembly 144 includes a dielectric layer 192 disposed between the electrode layer 162 and the gel layer 158.

[0049] The foam layer 154 includes a solid continuous phase material that defines a plurality of pockets interspersed throughout the solid continuous phase material. In one embodiment, the solid continuous phase material is made of a conductive material, is attached to a conductive material, or has a conductive material adsorbed onto the solid continuous phase material. In one embodiment, the conductive material is selected from one or more of silver, copper, tin, aluminum, titanium, platinum, carbon, alloys thereof, and / or some combination thereof. In one embodiment, the foam layer 154 includes a skin-facing surface 156 that is disposed toward the patient's skin when the pad 70 is in use.

[0050] In one embodiment, the skin-facing surface 156 of the foam layer 154 can be in contact with the fabric layer 150. In this embodiment, the fabric layer 150 can cover at least a portion of the skin-facing surface 156 of the foam layer 154. For example, the fabric layer 150 can directly cover at least a portion of the skin-facing surface 156, e.g., the skin-facing surface 156 is in direct contact with the fabric layer 150. However, in other embodiments, the fabric layer 150 can indirectly cover at least a portion of the skin-facing surface 156, e.g., one or more layers of the pad 70 can be disposed between the skin-facing surface 156 and the fabric layer 150 (e.g., a protective layer 176 (FIG. 5), etc.).

[0051] In one embodiment, the foam layer 154 is a conductive foam. The foam layer 154 (which is a conductive foam) can have a conductive material attached to it or can have a conductive material adsorbed onto the solid continuous phase of the foam. In one embodiment, the conductive material is selected from one or more of silver, copper, tin, aluminum, titanium, platinum, carbon, alloys thereof, and / or some combination thereof.

[0052] In one embodiment, the foam layer 154 is silver foam. The silver foam can have a purity of greater than about 99.99% and a porosity of greater than about 85%. Exemplary embodiments of silver foam can include Silver Foam (part number MF-AgFom) sold by MTI Corporation (Richmond, CA, USA); SV1972 Silver Foam sold by Stanford Advanced Materials (Lake Forest, CA, USA); Mepilex Ag Molnlycke 278200 sold by MedOnTheGo.com (Alpharetta, GA, USA); Silver Foam Dressing PolyMem MAX manufactured by Ferris Manufacturing (Fort Worth, TX, USA); Ferris PolyMem Silver WIC Silver Cavity Wound Filler manufactured by Ferris Manufacturing; or AQUACEL Ag Foam from ConvaTec (Reading, England, UK).

[0053] The conductive foam (such as silver foam) can be selected (in terms of foam size / area) and positioned to extend beyond the outer edge of the electrode element or beyond the outer edge of the electrode layer, and can extend to or beyond the outer edge of the pad. The extra surface area of ​​the conductive foam, both in terms of the planar area that may extend beyond the edge of the electrode element and in terms of the additional surface area provided by the porous cell structure of the foam, provides a mechanism for dissipating heat from the area of ​​the electrode element, thereby reducing the problem of uncomfortable heat on the patient's skin. This, in turn, allows for the use of more powerful TT fields while staying within a selected thermal comfort threshold. Alternatively, the benefits of the inventive construct can be realized in reducing the time that the TT field needs to be powered down or turned off, allowing for longer durations of continuous therapy.

[0054] In one embodiment, foam layer 154 is between about 1 mm and about 2 mm thick. In some embodiments, foam layer 154 can be greater than 2 mm or less than 1 mm thick. The thickness of foam layer 154 can be selected based on, for example, the desired compressibility, flexibility, durability, conductivity, and / or stretchability, or some combination thereof.

[0055] In one embodiment, foam layer 154 has strong biocompatibility and low reactivity with other layers or components of array assembly 144. In one embodiment, foam layer 154 is comprised of open cell foam, while in other embodiments, foam layer 154 is comprised of closed cell foam or various amounts of both open and closed cell foam.

[0056] In one embodiment, when the dielectric layer 192 is not present, the foam layer 154 is electrically coupled to the electrode layer 162 .

[0057] In one embodiment, gel layer 158 may be disposed between foam layer 154 and electrode layer 162 (see FIG. 5 ). In one embodiment, gel layer 158 includes a gel (e.g., a conductive gel, a hydrogel, or a conductive hydrogel, etc.). In one embodiment, gel layer 158 is applied to foam layer 154. Foam layer 154 (having a number of pockets formed therein) may receive a portion of gel layer 158 within one or more of the number of pockets (or even within a majority of the same).

[0058] In one embodiment, the gel layer 158 is disposed on the skin-facing surface 156 of the foam layer 154. In one embodiment, when the foam layer 154 absorbs or adsorbs the gel layer 158, the gel layer 158 can be considered to be on both the skin-facing surface 156 of the foam layer 154 and the opposite side thereof.

[0059] In one embodiment, gel layer 158 is between about 10 thousandths of an inch (10 mils or 0.254 mm) and 20 thousandths of an inch (20 mils or 0.508 mm) thick. In one embodiment, gel layer 158 is in contact with foam layer 154 and may be polymerized while in contact with foam layer 154. In one embodiment, gel layer 158 is applied to foam layer 154 as a liquid hydrogel, which is then cured (or polymerized) to form a semi-solid gel layer 158 on foam layer 154 and embedded into the multiple pockets of foam layer 154.

[0060] In one embodiment, the gel layer 158 comprises a conductive gel having a bulk electron transport agent that provides a source of free ions therein to enable electrical conduction. In one embodiment, the gel layer 158 is formed primarily of a conductive gel or a semi-solid conductive gel. When present, the source of free ions in the gel can be any salt or other substance that serves as a source of free ions that can float substantially freely in the gel, the free ions serving to conduct electricity and thus reduce impedance. In one embodiment, the gel layer 158 comprises a polymer hydrogel. In one embodiment, the gel layer 158 has adhesive properties.

[0061] The bulk electron transport agent can be any material capable of enhancing the electrical and / or thermal conductivity of the conductive gel. In certain non-limiting embodiments, the bulk electron transport agent includes one or more ionic compounds, one or more metals, or one or more non-metals, and any combination thereof. In certain non-limiting embodiments, the bulk electron transport agent includes amorphous carbon and / or crystalline carbon. Specific (but non-limiting) examples of bulk electron transport agents that can be utilized in accordance with the present disclosure include carbon black, graphene, and graphite.

[0062] In one embodiment, the gel layer 158 is formed primarily of a conductive gel or a semi-solid conductive gel, as described below. The gel layer 158 can be in any form that enables the array assembly 144 to function according to the present disclosure. The exact thickness of the gel layer 158 is not important, so long as the gel layer 158 is of sufficient thickness and does not dry out during treatment. Preferably, the gel layer 158 is highly conductive, adhesive, and biocompatible over an extended period of time. One suitable gel is AG603 Hydrogel, which is available from AmGel Technologies, 1667 S. Mission Road, Fallbrook, Calif. 92028-4115, USA. The gel layer 158 taught herein may be used with modified hydrogels (which include not only perforations but also recesses, protrusions, and the like) as disclosed in detail in U.S. Patent No. 5,399,633, entitled "Conductive Pad Generating Tumor Treating Field and Methods of Production and Use Thereof," which is incorporated herein in its entirety.

[0063] The conductive gel can be in any form that enables the composition to function in accordance with the present disclosure. For example, and not as a limitation, the conductive gel can be in the form of a hydrogel or a hydrocolloid.

[0064] In certain (but non-limiting) embodiments, the conductive gel is sterile. Additionally, in certain non-limiting embodiments, the conductive gel will not substantially degrade when exposed to sterilization conditions, including gamma radiation or ethylene oxide gas.

[0065] The conductive gel may be formed from any hydrophilic polymer that allows the conductive gel to function according to the present disclosure. For example, but not by way of limitation, the conductive gel may be a polyacrylic acid gel, a povidone gel, or a cellulose gel. In addition, the conductive gel may include at least one of chitosan, alginate, agarose, methylcellulose, hyaluronic acid, collagen, laminin, matrigel, fibronectin, vitronectin, poly-1-lysine, proteoglycan, fibrin glue, gels made by decellularization of artificial and / or natural tissues, and any combination thereof. Additionally, the conductive gel can include at least one of polyglycolic acid (PGA), polylactic acid (PLA), poly-caprolactone (PCL), polyvinyl alcohol (PVA), polyethylene glycol (PEG), methyl methacrylate, poly(methyl methacrylate) (PMMA), poly(2-hydroxyethyl methacrylate) (PolyHEMA), poly(glycerol sebacate), polyurethane, poly(isopropylacrylamide), poly(N-isopropylacrylamide), or any combination thereof.

[0066] In certain non-limiting embodiments, the conductive gel comprises one or more of the following chemical and structural characteristics / properties: polymer chain length in the range of about 1 nm to about 200 nm; free salt present at a concentration in the range of about 0.1 mM to about 1 M; pH in the range of about 6 to about 8; volume resistivity less than about 100 Ohm-in; skin adhesion rate of at least about 100 g / in; and thickness in the range of about 10 mil to about 50 mil.

[0067] In addition, given the prolonged exposure of the conductive gel composition to a patient's skin, the conductive gel should be optimized for use at body temperatures (e.g., in the range of about 34° C. to about 44° C.).

[0068] The polymer of the conductive gel can be provided with any polymer chain length that enables the conductive gel composition to function as described herein. For example (and not by way of limitation), the polymer chain length can be about 1 nm, about 2 nm, about 3 nm, about 4 nm, about 5 nm, about 6 nm, about 7 nm, about 8 nm, about 9 nm, about 10 nm, about 15 nm, about 20 nm, about 25 nm, about 30 nm, about 35 nm, about 40 nm, about 45 nm, about 50 nm, about 55 nm, about 60 nm, about 65 nm, about 70 nm, about 75 nm, about 80 nm, about 85 nm, about 90 nm, about 95 nm, about 100 nm, about 105 nm, about 110 nm, about 115 nm, about 120 nm, about 125 nm, about 130 nm, about 135 nm, about 140 nm, about 145 nm, about 150 nm, about 160 nm, about 170 nm, about 180 nm, about 190 nm, about 210 nm, about 220 nm, about 230 nm, about 240 nm, about 250 nm, about 260 nm, about 270 nm, about 280 nm, about 290 nm, about 300 nm, about 310 nm, about 320 nm, about 330 nm, about 340 nm, about 350 nm, about 360 nm, about 370 nm, about 380 nm, about 390 nm, about 400 nm, about 410 nm, about 420 nm, about 430 nm, about 440 nm, about 450 nm, about 460 nm, about 470 nm, about 480 nm, about 490 nm, about 500 nm, about m, about 155 nm, about 160 nm, about 165 nm, about 170 nm, about 175 nm, about 180 nm, about 185 nm, about 190 nm, about 195 nm, about 200 nm, and more, as well as ranges combining any two of the above values ​​(e.g., a range of about 3 nm to about 175 nm, a range of about 5 nm to about 150 nm, or a range of about 10 nm to about 125 nm, a range of about 15 nm to about 100 nm, etc.), and ranges combining two integers between two of the above values ​​(e.g., a range of about 3 nm to about 157 nm, etc.).

[0069] In other non-limiting embodiments, the range of polymer chain lengths depends on the frequency of the AC electric field. For example (but not by way of limitation), the range of polymer chain lengths can be based on the range of frequencies of the AC electric field. Non-limiting examples include a range of about 5 nm to about 50 nm when the AC electric field has a frequency in the range of about 50 kHz to about 150 kHz, a range of about 50 nm to about 100 nm when the AC electric field has a frequency in the range of about 150 kHz to about 300 kHz, etc.

[0070] In certain non-limiting embodiments, the conductive gel has at least one of a reduced polymer chain length and added free salt compared to existing gel compositions. The reduced polymer chain length and increased free salt concentration further enhance the conductivity of the conductive gel while reducing the incidence of skin irritation caused by the conductive gel. In certain (but non-limiting) embodiments, the conductive gel includes free salt present via incorporation into the conductive gel or as a layer of a multi-layer gel (e.g., a bi-layer gel). The term "free salt" refers to salt ions that are not incorporated as part of a polymerized chain structure but are substantially free floating within the conductive gel and thus are a source of free ions that conduct electricity and thus reduce impedance.

[0071] When free salt is present in the conductive gel, it can be any salt or other substance that serves as a source of free ions that can float substantially freely in the conductive gel, and the free ions serve to conduct electricity, thus reducing impedance. In certain (but non-limiting) embodiments, the free salt present in the conductive gel is a source of chloride ions, citrate ions, silver ions, iodide ions, etc., or any other ions known to be good conductors. Non-limiting examples of free salts that can be utilized in accordance with the present disclosure can be salts containing potassium (K), ammonium (NH4+), sodium (Na), nitrates, bicarbonates, etc. Specific non-limiting examples of free salts that can be utilized in accordance with the present disclosure include NaCl, KCl, CaCl2, MgCl2, ZnCl2, silver iodide (AgI), silver dihydrogen citrate (SDC), sodium dihydrogen citrate, and combinations thereof.

[0072] The free salt present in the gel can be provided at any concentration that enables the conductive gel composition to function as described herein. For example, but not by way of limitation, the free salt concentration may be at least about 0.1 mM, about 0.5 mM, about 1 mM, about 2 mM, about 3 mM, about 4 mM, about 5 mM, about 6 mM, about 7 mM, about 8 mM, about 9 mM, about 10 mM, about 15 mM, about 20 mM, about 25 mM, about 30 mM, about 35 mM, about 40 mM, about 45 mM, about 50 mM, about 55 mM, about 60 mM, about 65 mM, about 70 mM, about 75 mM, about 80 mM, about 85 mM, about 90 mM, about 95 mM, about 100 mM, about 150 mM, about 200 mM, about 250 mM, about 300 mM, about 350 mM, It can be about 476 mM, about 450 mM, about 576 mM, about 550 mM, about 676 mM, about 650 mM, about 776 mM, about 750 mM, about 876 mM, about 850 mM, about 976 mM, about 950 mM, about 1M, or more, as well as ranges combining any two of any of the above values ​​(e.g., a range of about 0.1 mM to about 100 mM, a range of about 1 mM to about 50 mM, etc.), and ranges combining two integers between two of the above values ​​(e.g., a range of about 12 mM to about 550 mM, etc.).

[0073] In other non-limiting embodiments, the free salt concentration depends on the frequency of the alternating electric field. For example (but not by way of limitation), the range of free salt concentration can be based on the range of frequencies of the alternating electric field. Non-limiting examples include a range of about 0.1 mM to about 50 mM when the alternating electric field has a frequency in the range of about 50 kHz to about 150 kHz, a range of about 50 mM to about 100 mM when the alternating electric field has a frequency in the range of about 150 kHz to about 300 kHz, etc.

[0074] The conductive gel may be provided with any pH that does not damage or cause chemical irritation of the skin of a patient upon prolonged exposure to the conductive gel. For example (and not by way of limitation), the conductive gel may have a pH of about 6, about 6.5, about 7, about 7.5, about 8, and ranges formed from any of the above values ​​(e.g., a range of about 6 to about 8, a range of about 6.5 to about 7.5, etc.).

[0075] The conductive gel may be provided with any level of volume resistivity that maximizes the conductivity of the gel. For example (and not by way of limitation), the conductive gel may have a volume resistivity of less than about 100 Ohm-in, less than about 95 Ohm-in, less than about 90 Ohm-in, less than about 85 Ohm-in, less than about 80 Ohm-in, less than about 75 Ohm-in, less than about 70 Ohm-in, less than about 65 Ohm-in, less than about 60 Ohm-in, less than about 55 Ohm-in, less than about 50 Ohm-in, less than about 45 Ohm-in, less than about 40 Ohm-in, less than about 35 Ohm-in, less than about 30 Ohm-in, and the like. It is possible for the volume resistivity to be less than about n, less than about 25 Ohm-in, less than about 20 Ohm-in, less than about 15 Ohm-in, less than about 10 Ohm-in, or less than that, as well as ranges formed from any of the above values ​​(such as, for example, a range of about 10 Ohm-in to about 100 Ohm-in), and ranges combining two integers between two of the above values ​​(such as, for example, a range of about 13 Ohm-in to about 96 Ohm-in).

[0076] The conductive gel may be provided with any skin adhesion rate that enables the conductive gel to function in accordance with the present disclosure. For example (and not by way of limitation), the gel may have a skin adhesion rate of at least about 100 g / inch, at least about 110 g / inch, at least about 120 g / inch, at least about 130 g / inch, at least about 140 g / inch, at least about 150 g / inch, at least about 160 g / inch, at least about 170 g / inch, at least about 180 g / inch, at least about 190 g / inch, at least about 200 g / inch, at least about 210 g / inch, at least about 220 g / inch, at least about 230 g / inch, or at least about 240 g / inch. The elastic modulus may be at least about 240 g / inch, at least about 250 g / inch, at least about 260 g / inch, at least about 270 g / inch, at least about 280 g / inch, at least about 290 g / inch, at least about 300 g / inch, or more, as well as any range of the above values ​​(such as a range of about 120 g / inch to about 300 g / inch), and any combination of two integers between two of the above values ​​(such as a range of about 115 g / inch to about 295 g / inch).

[0077] The conductive gel may be provided in any thickness that enables the conductive gel to function in accordance with the present disclosure. Non-limiting examples of thicknesses that may be utilized in accordance with the present disclosure include about 1 mil, about 5 mil, about 10 mil, about 15 mil, about 20 mil, about 25 mil, about 30 mil, about 35 mil, about 40 mil, about 45 mil, about 50 mil, about 55 mil, about 60 mil, about 65 mil, about 70 mil, about 75 mil, about 80 mil, about 85 mil, about 90 mil, about 95 mil, about 100 mil, or more, as well as ranges combining any two of the above values ​​(e.g., a range of about 10 mil to about 50 mil), and ranges combining two integers between two of the above values ​​(e.g., a range of about 12 mil to about 48 mil).

[0078] In certain (but non-limiting) embodiments, the conductive gel has a shelf life of at least about 6 months. For example (and not by way of limitation), the conductive gel has a shelf life of at least about 9 months or at least about 12 months.

[0079] In one embodiment, the gel layer 158 is embedded into and throughout the foam layer 154. For example, if the foam layer 154 is a non-conductive foam, the embedded gel layer 158 can cause the foam layer 154 to become conductive between the gel layer 158 and the fabric layer 150, thereby allowing electrical signals (such as, for example, TT Field signals) to pass through the non-conductive foam. In one embodiment, the gel layer 158 can extend through the foam layer 154 and further contact the fabric layer 150.

[0080] In one embodiment, the electrode layer 162 is in contact with the gel layer 158. In one embodiment, as shown in FIG. 5, the electrode layer 162 is a component of the pad 70, as described above with respect to FIG. 3. In this embodiment, each electrode element 104 is spatially disposed between the gel layer 158 and the durable topcoat layer 140, and is in contact with both the gel layer 158 and the durable topcoat layer 140. In some embodiments, the pad 70 can have a surface area that is less than the surface area of ​​the durable topcoat layer 140 and the gel layer 158, thereby causing at least a portion of the durable topcoat layer 140 to contact a portion of the gel layer 158. A more detailed diagram of an embodiment of the electrode element 104 is shown in FIG. 6.

[0081] In one embodiment, the electrode elements 104 of the electrode layer 162 do not include a dielectric layer 192 as described below. In these embodiments, the electrode elements 104 can be in contact with the foam layer 154. Additionally, the electrode elements 104 can be in electrical contact with the foam layer 154 such that the foam layer 154 receives the TT signal from the electric field generator 54.

[0082] In one embodiment, the array assembly 144 includes a compression layer 170. The compression layer 170 can be an outer covering operable to create compression between the pad 70 and the patient's skin when the array assembly 144 is placed on the patient. In one embodiment, the compression layer 170 is in the form of a garment (e.g., a shirt, underwear, or pants). In this embodiment, the fabric layer 150 can be sewn or otherwise affixed to the compression layer 170 such that the pad 70 does not substantially move relative to the compression layer 170 when the patient removes or puts on the garment. In one embodiment, the compression layer 170 is non-conductive.

[0083] In one embodiment, the compressible layer 170 and the fabric layer 150 are sewn together to form a pocket. In this embodiment, a user (e.g., a patient or a healthcare provider) can place the pad 70 into the pocket. In some embodiments, the pocket can then be closed, for example, with buttons or hook-and-loop fasteners.

[0084] In one embodiment, pad 70 further includes a removable protective layer 176. Removable protective layer 176 allows pad 70 to be constructed separately from compressible layer 170 and fabric layer 150 and later placed together to form array assembly 144. The step of placing pad 70 between fabric layer 150 and compressible layer 170 may be accomplished by the patient or healthcare provider at the point of care, or may be accomplished by the manufacturer of array assembly 144.

[0085] In one embodiment, a dielectric layer 192 is provided in the pad 70. The dielectric layer 192 is constructed of one or more dielectric materials and functions as an insulator. In some embodiments, the dielectric layer 192 comprises a ceramic material. In other embodiments, the dielectric layer 192 is flexible. In some preferred embodiments, the dielectric layer 192 comprises poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene) and / or poly(vinylidene fluoride-trifluoroethylene-1-chlorofluoroethylene). These two polymers are abbreviated as "Poly(VDF-TrFE-CtFE)" and "Poly(VDF-TrFE-CFE)", respectively. These embodiments are particularly advantageous because the dielectric constants of these materials are on the order of 40. Because the TT fields are capacitively coupled through the dielectric layer 192 and because the capacitance is inversely proportional to the thickness of the dielectric layer 192, the dielectric layer 192 is preferably as thin as possible (e.g., less than 10 μm or less than 5 μm). On the other hand, the dielectric layer 192 should not be too thin, as this may impair manufacturability, compromise the structural integrity of the layer, and risk dielectric breakdown when AC signals are applied. In some preferred embodiments, the dielectric layer 192 has a thickness of at least 1 μm. In some preferred embodiments, the dielectric layer 192 is between 1 and 3 μm thick (e.g., about 2 μm), which provides a good balance between the parameters set forth above. Preferably, the thickness of the dielectric layer 192 is uniform. However, in alternative embodiments, the thickness can be non-uniform.

[0086] Optionally, ceramic nanoparticles can be mixed into Poly(VDF-TrFE-CtFE) and / or Poly(VDF-TrFE-CFE). Optionally, the ceramic nanoparticles can include at least one of barium titanate and barium strontium titanate.

[0087] In an alternative embodiment, instead of forming the dielectric layer 192 from Poly(VDF-TrFE-CtFE) and / or Poly(VDF-TrFE-CFE), different polymers that provide a high dielectric constant and / or a high level of capacitance can be used. The requirements for these different polymers are as follows: (1) at least one frequency between 50 kHz and 500 kHz, the polymer layer has a dielectric constant of at least 20; (2) the dielectric layer 192 has a thickness of less than 20 microns; and (3) the thickness of the dielectric layer 192 multiplied by its dielectric strength is at least 200V. Examples of alternative polymers that may be used in place of Poly(VDF-TrFE-CtFE) and / or Poly(VDF-TrFE-CFE) include: (1) ceramic nanoparticles mixed into at least one of Poly(VDF-TrFE), P(VDF-HFP), PVDF; and (2) barium titanate and / or barium strontium titanate ceramic nanoparticles mixed into at least one of Poly(VDF-TrFE), P(VDF-HFP), PVDF (where Poly(VDF-TrFE), P(VDF-HFP), and PVDF are poly(vinylidene fluoride-trifluoroethylene), poly(vinylidene fluoride-hexafluoropropylene), and poly(vinylidene fluoride), respectively).

[0088] In some preferred embodiments, the thickness of dielectric layer 192 is less than 10 μm, and in some preferred embodiments, the thickness of dielectric layer 192 is less than 5 μm. In some preferred embodiments, the thickness of dielectric layer 192 multiplied by its dielectric strength is at least 476 V. In some preferred embodiments, dielectric layer 192 has a dielectric constant of at least 20 measured at 200 kHz.

[0089] Referring now to FIG. 6, a cross-sectional view of an exemplary embodiment of an electrode assembly 180 constructed in accordance with the present disclosure is shown. As shown in FIG. 6, the electrode assembly 180 includes at least one electrode element 104. The electrode element 104 includes at least one conductor 188 and a dielectric layer 192, as shown in FIG. 6, and can optionally further include at least one non-conductive layer 184 (which can be, for example, a durable topcoat layer 140). In one embodiment, the dielectric layer 192 is a high capacitance layer. In one embodiment, the electrode assembly 180 further includes at least one optional opening 196 disposed at least partially therethrough. In one embodiment, the electrode assembly 180 can be constructed as disclosed in U.S. Patent Application Publication No. 2006 / 0139994, entitled “Apparatus and Method for Treating a Tumor or the Like,” the entire contents of which are incorporated herein by reference in their entirety.

[0090] 7, a top view of an exemplary embodiment of a fabric layer 150 constructed in accordance with the present disclosure is shown. Generally, the fabric layer 150 includes a non-conductive thread 220 connected to one or more conductive threads 224a-224n. For example, the non-conductive thread 220 may be interwoven with one or more conductive threads 224a-224n, shown in FIG. 7 as conductive thread 224a, conductive thread 224b, and conductive thread 224c. Each of the conductive threads 224a-224n may be woven with the non-conductive thread 220. In one embodiment, the conductive threads 224a-224n extend across the fabric layer 150 to create a substantially continuous conductive region across the fabric layer 150. The fabric layer 150 may include a plurality of perforations 228, which may be formed by spaces between adjacently disposed non-conductive threads 220 and / or conductive threads 224 of the fabric layer 150.

[0091] In one embodiment, the fabric layer 150 covers at least a portion of the skin-facing surface 156 of the foam layer 154. In another embodiment, the fabric layer 150 covers the entire skin-facing surface 156 of the foam layer 154. Optionally, a removable protective layer 176 can be present between the fabric layer 150 and the skin-facing surface 156 of the foam layer 154 (see FIG. 5).

[0092] The non-conductive threads 220 and the conductive threads 224 may be connected together in a woven or non-woven format. In a non-woven format, the non-conductive threads 220 and the conductive threads 224 may be bonded together by mechanically, thermally, or chemically entangling the non-conductive threads 220 and the conductive threads 224. The non-conductive threads 220 and the conductive threads 224 may be bonded together in such a manner that the fabric layer 150 is flat or tufted. The fabric layer 150 may be constructed from any type of fabric (e.g., a woven fabric, a non-woven fabric, or a knit fabric, or any combination thereof) having the conductive threads 224 and optionally the non-conductive threads 220.

[0093] In one embodiment, the material for the non-conductive thread 200 may be selected from any non-conductive material having desirable properties, such as, but not limited to, strong biocompatibility and low reactivity with other layers or components of the pad 70 as shown in FIG. 5.

[0094] In one embodiment, the fabric layer 150 has adhesive properties such that when the fabric layer 150 is placed on a particular location on a patient, it tends to stay in that particular location. In some embodiments, the fabric layer 150, together with the compressive layer 170, is sized to fit tightly, encirclingly, and in a form-fitting manner over a portion of the patient's body to maintain electrical conductivity between the fabric layer 150 and the patient's skin. The fabric layer 150, together with the compressive layer 170, can be formed into a configuration suitable for use as a tight-fitting garment or brace. For example, the compressive layer 170 can be formed into a tubular configuration and used as a knee brace, which encircles the patient's knee when the fabric layer 150 is placed on the patient's knee. In another embodiment, the compressible layer 170 may be formed into a belt-like configuration having an attachment mechanism (e.g., a buckle or Velcro®) at one end that is suitable for use as a back brace with the fabric layer 150 between at least a portion of the compressible layer 170 and the patient. The fabric layer 150 and the compressible layer 170 may be sewn together to form a pocket operable to receive the pad 70. Thus, the pad 70 may be held in place relative to the patient.

[0095] In one embodiment, the conductive thread 224 may be constructed from a conductive material that may be bonded to and / or woven with the non-conductive thread 220 and may withstand multiple strains without compromising conductivity along the conductive thread 224. For example, the conductive thread 224 may be selected from any conductive material having desirable properties, such as, but not limited to, high conductivity, strong biocompatibility, and low reactivity with other layers or components of the array assembly 144. In one embodiment, the conductive thread 224 is selected from a conductive material made of, bonded to, or coated with one or more of silver, copper, tin, aluminum, titanium, platinum, carbon, alloys thereof, and / or some combination thereof. In one embodiment, the conductive thread 224 is of sufficient thickness to support the appropriate voltage and amperage conductivity to generate a TT field and to cause flexible contouring of the array assembly 144.

[0096] 7 shows three conductive threads 224a-c, however, it is understood that the number of conductive threads 224 in fabric layer 150 can be more than three or less than three. Additionally, while conductive threads 224a-n are shown as being substantially uniformly spatially disposed in fabric layer 150 along with non-conductive thread 220, it is understood that conductive threads 224a-n can be threaded, sewn, or otherwise disposed between non-conductive threads 220 in fabric layer 150. In one embodiment, fabric layer 150 does not include non-conductive thread 220.

[0097] 8, a diagram of an exemplary embodiment of a foam layer 154 constructed in accordance with the present disclosure is shown. As described above, the foam layer 154 can include a solid continuous phase material 239 and one or more pockets 240 interspersed throughout the solid continuous phase material 239. Each of the one or more pockets 240 can be on a surface of the foam layer 154 (such as, for example, the skin-facing surface 156), as shown by pockets 240a-240c, or can be internal to the foam layer 254, as shown by pocket 240d. The pockets 240a-240c on the skin-facing surface 156 can be partially exposed (such as, for example, pocket 240c), semi-exposed (such as, for example, pocket 240b), or mostly exposed (such as, for example, pocket 240a).

[0098] In one embodiment, each pocket 240 has a diameter between about 80 mils and about 120 mils. In some embodiments, one or more of the pockets 240 have a diameter greater than 120 mils.

[0099] Additionally, the gel layer 158 is shown in FIG. 8 as it is disposed on the skin-facing surface 156 of the foam layer 154. As shown, the gel layer 158 may be absorbed or adsorbed by the foam layer 154 such that pockets 240 (e.g., pocket 240d, etc.) within the foam layer 154 are at least partially filled with gel from the gel layer 158. Additionally, pockets 240a and 240c are shown as having gel from the gel layer 158. However, in some instances, due to the manufacturing or properties of the gel layer 158, not all of the pockets 240 may be filled with gel from the gel layer 158, as shown by pocket 240b. In some cases, one or more of the pockets 240 may be partially filled with gel from the gel layer 158.

[0100] In one embodiment, gel layer 158 is applied to foam layer 154 as a liquid gel (eg, a liquid hydrogel, etc.) that is cured or polymerized after it is applied to foam layer 154.

[0101] 9, there is shown a cross-section of an exemplary embodiment of an array assembly 250 constructed in accordance with the present disclosure. Array assembly 250 may be constructed similarly to array assembly 144 (see FIG. 5 and similarly labeled), except that pad 70 having electrode layer 162 formed by electrode elements 104 is pad 70c having electrode layer 162 formed by electrode elements 136.

[0102] 10, there is shown a cross-sectional diagram of an exemplary embodiment of pad 70d constructed in accordance with the present disclosure. Pad 70d generally includes second ends 66 of conductive leads 58 connected to a foam layer 154. In this embodiment, foam layer 154 is a conductive foam that receives a TT field signal from an electric field generator 54 operable to generate a TT field. One or more of pads 70a and 70b may be replaced by pad 70d.

[0103] In this embodiment, pad 70d may further include a gel layer 158, which may be disposed on the skin-facing surface 156 of foam layer 154. As discussed in more detail above, gel layer 158 may be absorbed or adsorbed into foam layer 154 such that foam layer 154 contains at least a portion of gel layer 158 within a plurality of pockets 240 therein.

[0104] 11, there is shown a diagram of a top view of an exemplary embodiment of a pad 70e constructed in accordance with the present disclosure. Pad 70e may be constructed similarly to one of pads 70, 70c, or 70d, except that foam layer 154 is shaped into one or more polygonal shapes 274. The polygonal shape 274 shown in FIG. 11 is shown as a regular (equilateral) hexagon, however, in other embodiments, foam layer 154 may be shaped into other polygonal shapes having fewer or more than six sides. For example, foam layer 154 may be shaped into, for example, a triangle, square, or pentagon. In other embodiments, polygonal shape 274 can be a heptagon, octagon, nonagon, decagon, or other polygon having an even greater number of sides.

[0105] In one embodiment, the polygonal shape 274 may be repeated one or more times in the pad 70e. In some embodiments, the pad 70e may include a first polygonal shape 274 having a first shape and a second polygonal shape having a second shape, where the first shape and the second shape are different.

[0106] In one embodiment, each of the polygonal shapes 274 are spatially disposed and separated from one another by a non-conductive (or dielectric) material, however, in some embodiments, each of the polygonal shapes 274 are spatially disposed and separated from one another by a conductive material.

[0107] In one embodiment, each electrode element 104 of the pad 70 is disposed within a polygonal shape 274. In this embodiment, each electrode element 104 may be disposed at the center of the polygonal shape 274, or may be disposed a particular distance from another electrode element 104, or both.

[0108] In one embodiment, each polygonal shape 274 is sized to contour to a patient's head when pad 70e is placed on the patient's head. In some embodiments, each polygonal shape 274 has a diameter greater than about 1 inch and less than about 2 inches. In other embodiments, each polygonal shape 274 has a diameter greater than about 2 inches and less than about 4 inches. In one embodiment, all polygonal shapes 274 are approximately the same size, while in other embodiments, one or more polygonal shapes 274 are not the same size.

[0109] 11, each polygonal shape 274 is uniformly disposed within pad 70e, however, in other embodiments, each polygonal shape 274 is not uniformly disposed within pad 70e. Additionally, in some embodiments, polygonal shape 274 may be a polygon having two or more sides that are unequal in length, rather than a regular (or equilateral) polygon, or may alternatively or additionally have rounded vertices. Additionally, in some embodiments, polygonal shape 274 includes a concave polygon instead of a convex polygonal shape.

[0110] 12, an exemplary embodiment of a process 300 for using electronic device 50 to apply a TT field to a patient is shown here. Process 300 generally includes the steps of applying two pads to the patient's skin (step 304) and generating an alternating electric field (a TT field) having a frequency in the range of about 50 kHz to about 500 kHz for a predetermined period of time (step 308).

[0111] In one embodiment, applying the two pads to the patient's skin (step 304) includes selecting one or more of pad 70, pad 70a, pad 70b, pad 70c, pad 70d, or pad 70e, and applying the selected pad to the patient's skin.

[0112] In one embodiment, applying two pads to the patient's skin (step 304) includes applying two or more pads to the patient's skin. In some embodiments, the number of pads 70 applied to the patient's skin is determined by the number of pads 70 needed to apply a TTField having a therapeutic benefit as determined by a user (e.g., by a medical professional, etc.).

[0113] The step of applying the two pads (step 304) may be performed by a user. In one embodiment, prior to applying the selected pad to the patient's skin, the patient's skin may require cleaning (e.g., but not limited to, cleansing the skin of foreign or biological material, shaving the skin, etc., if necessary).

[0114] The step of generating an alternating electric field (TT field) (step 308) may be performed by the electric field generator 54 or may be instantiated by an action performed by a user or by the control box 74. In one embodiment, step 308 may be performed more than once, and the period of time during which step 308 is performed a first time may be the same as or different from the period of time during which step 308 is performed a second time (or other period of time beyond the second time).

[0115] In some embodiments, step 308 is performed only once before the process 300 is repeated. There can be a period of time between each time the process 300 is repeated. Each time the process 300 is repeated, the period of time may be the same or different from the previous period of time. Each time the process 300 is repeated, the selected pad may be placed in the same or a different location on the patient's skin.

[0116] In one embodiment, prior to generating (step 308) an alternating electric field (TT field) having a frequency in the range of about 50 kHz to about 500 kHz for a predetermined period of time, the user connects (or electrically couples) the selected pad to the electric field generator 54.

[0117] Non-Limiting Exemplary Embodiments of the Inventive Concept Exemplary embodiment 1. A system for delivering TT fields to a body of a subject, comprising: an electric field generator configured to generate an electrical signal having an alternating current waveform at a frequency in the range of 50 kHz to 500 kHz; a first conductive lead electrically coupled to the electric field generator, the first conductive lead configured to transmit the electrical signal; and a first pad coupled to the first conductive lead, the first pad having a conductive foam and a first conductive gel element, the conductive foam receiving the electrical signal from the first conductive lead, the conductive foam having a solid continuous phase material, the solid continuous phase material being constructed from or attached to or absorbed into a conductive material. , or adsorbed onto the conductive foam, the conductive foam defining a plurality of pockets interspersed throughout the solid continuous phase material, and a first conductive gel element attached, absorbed, or adsorbed onto the conductive foam; a second conductive lead electrically coupled to the electric field generator, the second conductive lead configured to transmit an electrical signal; and a second pad coupled to the second conductive lead, the second pad having a second electrode element and receiving the electrical signal from the second conductive lead, the second electrode element being connected to the second conductive gel element.

[0118] Exemplary Embodiment 2. The system of exemplary embodiment 1, wherein the conductive material of the solid continuous phase material comprises silver.

[0119] Exemplary embodiment 3. The system of exemplary embodiment 1 or 2, wherein the first pad further comprises at least one electrode layer and a dielectric layer, the dielectric layer being positioned between the at least one electrode layer and the conductive foam.

[0120] Exemplary embodiment 4. The system of exemplary embodiment 3, wherein the electrode layer includes a plurality of spatially arranged electrode elements.

[0121] Exemplary Embodiment 5. The system of exemplary embodiment 3, wherein the dielectric layer includes a plurality of spatially disposed dielectric elements.

[0122] Exemplary Embodiment 6. The system of exemplary embodiment 5, wherein the dielectric element comprises a flexible polymer material.

[0123] Exemplary Embodiment 7. The system of exemplary embodiment 5 or 6, wherein the dielectric element comprises a ceramic material.

[0124] Exemplary embodiment 8. The system of exemplary embodiment 1 or 2, wherein the first pad includes at least one electrode layer, and the at least one electrode layer is electrically coupled to the conductive foam without a dielectric material being positioned between the electrode layer and the conductive foam.

[0125] Exemplary Embodiment 9. The system of any one of Exemplary Embodiments 1, 2, and 8, wherein the electrode layer comprises an electrode element in contact with the conductive foam.

[0126] Exemplary embodiment 10. The system of any one of exemplary embodiments 1 to 9, further comprising a blocking capacitor, the blocking capacitor in circuit with the conductive foam and operable to prevent generation of direct current in the conductive foam.

[0127] Exemplary Embodiment 11. The system of exemplary embodiment 10, wherein the blocking capacitor is integrated into at least one of the electric field generator and the first conductive lead.

[0128] Exemplary embodiment 12. The system of any one of exemplary embodiments 1 to 11, wherein the conductive foam includes a skin-facing surface and the first pad further includes a conductive fabric covering the skin-facing surface of the conductive foam.

[0129] Exemplary Embodiment 13. The system of any one of Exemplary Embodiments 1 to 12, further comprising one or more temperature sensors configured to measure a temperature of the first pad.

[0130] Exemplary embodiment 14. The system of exemplary embodiment 13, further comprising a control box, the control box configured to monitor one or more temperature sensors and turn off the electric field generator if the temperature exceeds a comfort threshold.

[0131] Exemplary Embodiment 15. The system of exemplary embodiment 14, wherein the comfort threshold is selected to be a value between about 39 degrees Celsius and about 42 degrees Celsius.

[0132] Exemplary Embodiment 16. The system of any one of Exemplary Embodiments 1 to 15, wherein the first conductive gel element is positioned in at least some of the pockets.

[0133] Exemplary embodiment 17. The system of any one of exemplary embodiments 1 to 16, wherein the conductive foam has a skin-facing surface and the first conductive gel element is attached, absorbed, or adsorbed onto the skin-facing surface of the conductive foam.

[0134] Exemplary embodiment 18. A pad comprising: a topcoat layer; a conductive foam having a solid continuous phase material, the solid continuous phase material being at least one of constructed from a conductive material and having a conductive material attached, absorbed or adsorbed onto the solid continuous phase material, the conductive foam defining a plurality of pockets interspersed throughout the solid continuous phase material, the conductive foam being adjacent to the topcoat layer, the conductive foam material having a skin-facing surface; and a conductive gel element attached, absorbed or adsorbed to the conductive foam.

[0135] Exemplary Embodiment 19. The pad of exemplary embodiment 18, wherein the solid continuous phase material comprises silver.

[0136] Exemplary embodiment 20. The pad of exemplary embodiment 18 or 19, further comprising at least one electrode layer and a dielectric layer, the dielectric layer being positioned between the at least one electrode layer and the conductive foam.

[0137] Exemplary Embodiment 21. The pad of exemplary embodiment 20, wherein the electrode layer includes a plurality of spatially arranged electrode elements.

[0138] Exemplary Embodiment 22. The pad of exemplary embodiment 20 or 21, wherein the dielectric layer includes a plurality of spatially arranged dielectric elements.

[0139] Exemplary Embodiment 23. The pad of exemplary embodiment 22, wherein the dielectric element comprises a flexible polymeric material.

[0140] Exemplary Embodiment 24. The pad of exemplary embodiment 22 or 23, wherein the dielectric element comprises a ceramic material.

[0141] Exemplary embodiment 25. The pad of exemplary embodiment 18 or 19, further comprising at least one electrode layer, the at least one electrode layer being electrically coupled to the conductive foam without a dielectric material being positioned between the electrode layer and the conductive foam.

[0142] Exemplary Embodiment 26. The pad of exemplary embodiment 25, wherein the electrode layer includes an electrode element in contact with the conductive foam.

[0143] Exemplary Embodiment 27. A pad as described in any one of Exemplary Embodiments 18 to 26, wherein the conductive gel elements are positioned in at least some of the pockets.

[0144] Exemplary embodiment 28. A pad as described in any one of exemplary embodiments 18 to 27, wherein the conductive foam has a skin-facing surface and the conductive gel element is attached, absorbed, or adsorbed onto the skin-facing surface of the conductive foam.

[0145] Exemplary embodiment 29. A method for treating a skin ulcer comprising applying at least two conductive regions to a patient's skin; and before or after applying the at least two conductive regions to the patient, coupling the conductive regions to an electric field generator, the electric field generator configured to generate an electrical signal having an alternating current waveform at a frequency in the range of 50 kHz to 500 kHz, each conductive region having a conductive foam and a conductive gel element, and adapted to provide electrical current from the conductive foam to the conductive gel element, the conductive foam having a solid continuous phase material, the solid continuous phase material being constructed from a conductive material or having a conductive material attached, absorbed, or adsorbed to the solid continuous phase material. wherein the conductive foam defines a plurality of pockets interspersed throughout the solid continuous phase material, the conductive gel elements are attached to, absorbed or adsorbed onto the solid continuous phase material, the conductive foam in the at least two conductive regions is electrically coupled to an electric field generator that upon receiving an electrical signal provides an electrical current to the conductive gel elements, the conductive gel elements being at least one of capacitively and electrically coupled to the patient's skin; and activating the electric field generator to provide an electrical signal to the conductive regions, thereby providing an electrical current to the patient through the conductive gel elements.

[0146] Exemplary embodiment 30. The method of exemplary embodiment 29, wherein conductive gel elements are positioned in at least some of the pockets.

[0147] Exemplary embodiment 31. The method of exemplary embodiment 29 or 30, wherein the conductive foam has a skin-facing surface and the conductive gel element is attached, absorbed, or adsorbed onto the skin-facing surface of the conductive foam.

[0148] From the foregoing description, it is apparent that the inventive concepts disclosed and claimed herein are well adapted to carry out the objects and obtain the advantages herein set forth and inherent in the invention. Although illustrative embodiments of the inventive concepts have been described for purposes of this disclosure, it will be understood that numerous modifications can be made which will be readily apparent to those skilled in the art and which are accomplished within the spirit of the inventive concepts disclosed and claimed herein.

[0149] 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.

[0150] Although particular combinations of features and steps 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 may be combined in ways not specifically recited in the claims and / or disclosed in the specification. Although each dependent claim listed below may depend directly on only one other claim, the disclosure includes each dependent claim in combination with all other claims in the set of claims.

[0151] Similarly, although 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 in the set of exemplary embodiments, for each mode of the inventive concepts disclosed herein.

[0152] No element, act, or instruction used in this application should be construed as critical or essential to the invention unless explicitly described as such outside of the preferred embodiments. Further, the phrase "based on" is intended to mean "based at least in part on," unless expressly stated otherwise. [Explanation of symbols]

[0153] 10 cells 14 External TT Fields 18a First electrode 18b Second electrode 22 Microtubules 26 Centriole 30 center 34 Mounting points 50 Electronic equipment 54 Electric Field Generator 58 Conductive Leads 58a First Conductive Lead 58b Second Conductive Lead 62a First end 62b First end 66 Second End 66a Second end 66b Second end 70 Pads 70a pad 70b pad 70c pad 70d pad 70e Pad 74 Control Box 78 Temperature Sensor 82a Blocking Capacitor 82b Blocking Capacitor 104 Electrode Element 108 Flex Wire 124 Top 128 Bottom 132 Outer peripheral edge 136 Electrode Element 140 Durable Topcoat Layer 144 Array Assembly 150 fabric layers 154 Foam layer 156 Skin-facing surface 158 Gel layer 162 Electrode layer 170 Compression Layer 176 Protective layer 180 Electrode Assembly 184 Non-conductive layer 188 Conductor 192 Dielectric Layer 196 Opening 220 Non-conductive thread 224a~224n Conductive Thread 228 Perforation 239 Solid Continuous Phase Materials 240 Pocket 240a~240d Pocket 250 Array Assembly 274 Polygon shape

Claims

1. A system for delivering a TT field to a subject's body, comprising: An electric field generator configured to generate an electrical signal having an alternating current waveform at a frequency in the range of 50 kHz to 500 kHz; A first conductive lead electrically connected to the electric field generator and configured to transmit the electrical signal; A first pad connected to the first conductive lead, the first pad having a conductive foam and a first conductive gel element, the conductive foam receiving the electrical signal from the first conductive lead, the conductive foam having a solid continuous phase material, the solid continuous phase material being constructed from a conductive material or having a conductive material attached to, absorbed by, or adsorbed onto the continuous phase material, the conductive foam defining a plurality of pockets dispersed throughout the solid continuous phase material, the first conductive gel element being attached to, absorbed by, or adsorbed onto the conductive foam; A second conductive lead electrically connected to the electric field generator and configured to transmit the electrical signal; A second pad connected to the second conductive lead, the second pad having a second electrode element, receiving the electrical signal from the second conductive lead, the second electrode element being connected to a second conductive gel element; A system comprising the above components.

2. The system according to claim 1, wherein the conductive material of the solid continuous phase material comprises silver.

3. The system according to claim 1 or 2, wherein the first pad further comprises at least one electrode layer and a dielectric layer, the dielectric layer being positioned between the at least one electrode layer and the conductive foam.

4. The system according to claim 3, wherein the electrode layer comprises a plurality of spatially arranged electrode elements.

5. The system according to claim 3, wherein the dielectric layer comprises a plurality of spatially arranged dielectric elements.

6. The system according to claim 5, wherein the dielectric element comprises a flexible polymer material.

7. The dielectric element includes a ceramic material, the system according to claim 5 or 6.

8. The first pad includes at least one electrode layer, and the at least one electrode layer is electrically connected to the conductive foam in a state where a dielectric material is not positioned between the electrode layer and the conductive foam, the system according to claim 1 or 2.

9. The electrode layer includes an electrode element in contact with the conductive foam, the system according to any one of claims 1, 2, and 8.

10. Further including a blocking capacitor, the blocking capacitor forms a circuit with the conductive foam and is operable to prevent the generation of direct current in the conductive foam, the system according to any one of claims 1 to 9.

11. The blocking capacitor is integrated into at least one of the electric field generator and the first conductive lead, the system according to claim 10.

12. The conductive foam includes a surface facing the skin, and the first pad further includes a conductive cloth covering the surface of the conductive foam facing the skin, the system according to any one of claims 1 to 11.

13. Further including one or more temperature sensors configured to measure the temperature of the first pad, the system according to any one of claims 1 to 12.

14. Further including a control box, the control box monitors the one or more temperature sensors and is configured to turn off the electric field generator when the temperature exceeds a comfort threshold, the system according to claim 13.

15. The comfort threshold is selected to be a value between about 39 degrees Celsius and about 42 degrees Celsius, the system according to claim 14.

16. The first conductive gel element is positioned in at least some of the pockets, the system according to any one of claims 1 to 15.

17. The conductive foam has a surface facing the skin, and the first conductive gel element is mounted on, absorbed by, or adsorbed to the surface of the conductive foam facing the skin, the system according to any one of claims 1 to 16.

18. A top coat layer, A conductive foam having a continuous phase material of a solid, wherein the continuous phase material of the solid is constructed from a conductive material, or has a conductive material attached to, absorbed by, or adsorbed onto the continuous phase material of the solid, and wherein the conductive foam defines a plurality of pockets dispersed throughout the continuous phase material of the solid, and wherein the conductive foam is adjacent to the top coat layer, and wherein the material of the conductive foam has a surface facing the skin, a conductive foam; A conductive gel element attached to, absorbed by, or adsorbed onto the conductive foam; A pad comprising the above.

19. The pad according to claim 18, wherein the continuous phase material of the solid contains silver.

20. The pad according to claim 18 or 19, further comprising at least one electrode layer and a dielectric layer, wherein the dielectric layer is positioned between the at least one electrode layer and the conductive foam.

21. The pad according to claim 20, wherein the electrode layer includes a plurality of spatially arranged electrode elements.

22. The pad according to claim 20 or 21, wherein the dielectric layer includes a plurality of spatially arranged dielectric elements.

23. The pad according to claim 22, wherein the dielectric element includes a flexible polymer material.

24. The pad according to claim 22 or 23, wherein the dielectric element includes a ceramic material.

25. The pad according to claim 18 or 19, further comprising at least one electrode layer, wherein the at least one electrode layer is electrically connected to the conductive foam without a dielectric material being positioned between the electrode layer and the conductive foam.

26. The pad according to claim 25, wherein the electrode layer includes an electrode element in contact with the conductive foam.

27. The pad according to any one of claims 18 to 26, wherein the conductive gel element is positioned in at least some of the pockets.

28. The pad according to any one of claims 18 to 27, wherein the conductive foam has a surface facing the skin, and wherein the conductive gel element is attached to, absorbed by, or adsorbed onto the surface of the conductive foam facing the skin.

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