Patent Description:
Each transducer array used for the delivery of TTFields in the OPTUNE® device comprises a set of non-conductive ceramic disk electrodes, which 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 a top surface of nonconductive ceramic material. A bottom surface of the nonconductive ceramic material is coupled to the conductive medical gel. The nonconductive ceramic material is a safety feature to ensure that direct-current signals are blocked from unintentionally being transmitted to the patient by mistake.

By interposing a nonconductive ceramic material between the conductive layer and the conductive medical gel, the prior art system was thought to ensure the patient remains protected. The purpose of the medical gel is to deform to match the body's contours and to provide good electrical contact between the arrays and the skin; as such, the gel interface bridges the skin and reduces interference. The device is intended to be continuously worn by the patient for <NUM>-<NUM> days before removal for hygienic care and re-shaving (if necessary), followed by reapplication with a new set of arrays. As such, the medical gel remains in substantially continuous contact with an area of the patient's skin for a period of <NUM>-<NUM> days at a time, and there is only a brief period of time in which the area of skin is uncovered and exposed to the environment before more medical gel is applied thereto.

One approach to applying the TTField in different directions is to apply the field between a first set of electrodes for a period of time, then applying a field between a second set of electrodes for a period of time, then repeating that cycle for an extended duration (e.g., over a period of days or weeks).

In order to generate the TTFields, current is applied to each electrode of the transducer array. The application of current over a period of time causes each electrode to warm and eventually become hot, and thus uncomfortable or painful to the patient. In order to maintain the desired temperature of the transducer array, the current applied is lowered, resulting in a weaker TTField, or the transducer array is powered off, thus shortening the duration of treatment. Additionally, the prior art teaches electrodes made from rigid and/or inflexible materials, such as ceramics, which do not contour to the patient.

Because of this heating of the transducer array, new and improved array assemblies that reduce the temperature of the transducer array while generating a more powerful TTField are desired. It is to such assemblies and methods of producing and using the same, that the present disclosure is directed.

<CIT> discloses an electrode of a monitoring and/or therapy unit which is provided at and/or around the skin interface by a porous material, such as a foam polymer, that is impregnated with conductive gel.

<CIT> discloses transducer assemblies which include a plurality of capacitively-coupled electrode elements mounted on a support, with the electrode elements being configured for placement against a subject's body, preferably with a layer of hydrogel disposed on the surface of the electrode elements that faces the subject's body, and the support holds the electrode elements against the subject's body.

The problem of reducing the temperature of the transducer array while generating a more powerful TTField is solved by a system for delivering TTFields to a body of a subject according to claim <NUM>.

Other aspects, features and advantages of the subject matter will become apparent from the description, the drawings, and the claims.

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 views of the figures may be shown exaggerated, to scale or in schematic in the interest of clarity and conciseness. Not every component may be labeled in every drawing. Like reference numerals in the figures may represent and refer to the same or similar element or function. In the drawings:.

Before explaining at least one embodiment of the inventive concept(s) in detail by way of exemplary language and results, it is to be understood that the inventive concept(s) is not limited in its application to the details of construction and the arrangement of the components set forth in the following description. The inventive concept(s) 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 exemplary - not exhaustive.

Headings are provided for convenience only and are not to be construed to limit the invention in any manner. Embodiments illustrated under any heading or in any portion of the disclosure may be combined with embodiments illustrated under the same or any other heading or other portion of the disclosure. Any combination of the elements described herein in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

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

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. Where a method claim does not specifically state in the claims or description that the steps are to be limited to a specific order, it is no way intended that an order be inferred, in any respect. This holds for any possible non-express basis for interpretation, including matters of logic with respect to arrangement of steps or operational flow, plain meaning derived from grammatical organization or punctuation, or the number or type of embodiments described in the specification.

As utilized in accordance with the present disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings:
The use of the term "a" or "an" when used in conjunction with the term "comprising" in the claims and/or the specification may mean "one," but it is also consistent with the meaning of "one or more," "at least one," and "one or more than one. " The term "plurality" refers to "two or more.

In addition, the use of the term "at least one of X, Y, and Z" will be understood to include X alone, Y alone, and Z alone, as well as any combination of X, Y, and Z. The use of ordinal number terminology (e.g., "first," "second," "third," "fourth," etc.) is solely for the purpose of differentiating between two or more items and is not meant to imply any sequence or order or importance to one item over another or any order of addition, for example.

The use of the term "or" in the claims is used to mean an inclusive "and/or" unless explicitly indicated to refer to alternatives only or unless the alternatives are mutually exclusive.

As used herein, the term TTField (TTFields, or TTF(s)) refers to low intensity (e.g., <NUM>-<NUM> V/cm) alternating electric fields of medium frequencies (about <NUM> - <NUM>, and more preferably from about <NUM> - <NUM>) that when applied to a conductive medium, such as a human body, via electrodes may be used, for example, to treat tumors as described in <CIT>, <CIT>, <CIT>,<CIT>,<CIT>, and <CIT>and in a publication by Kirson (see <NPL>). TTFields have been shown to have the capability to specifically affect cancer cells and serve, among other uses, for treating cancer. TTFields therapy is an approved mono-treatment for recurrent glioblastoma (GBM), and an approved combination therapy with chemotherapy for newly diagnosed GBM patients.

As used herein, the term TT Signal is an electrical signal that, when received by electrodes applied to a conductive medium, such as a human body, causes the electrodes to generate the TTField described above. The TT Signal is often an AC electrical signal.

As used herein, the term "pad" refers to one or more conductive materials that is/ are configured to be placed over a part of a body of a subject to generate a TTField upon receiving TT signals from an electric field generator.

Turning now to the inventive concept(s), certain non-limiting embodiments thereof include a system and method of implementing the system, the system comprising an electric field generator configured to generate an electrical signal having an alternating current waveform at a frequency in a range from <NUM> to <NUM>; a first conductive lead electrically coupled to the electric field generator, the first conductive lead configured to carry the electrical signal to a pad and/or transducer array electrically coupled to the first conductive lead. Various aspects of the present disclosure are provided in detail below.

Referring now to the drawings and in particular to <FIG>, shown therein is an exemplary embodiment of a dividing cell <NUM>, under the influence of external TTFields (e.g., alternating fields in the frequency range of about <NUM> to about <NUM>), generally indicated as lines <NUM>, generated by a first electrode 18a having a negative charge and a second electrode 18b having a positive charge. Further shown are microtubules <NUM> that are known to have a very strong dipole moment. This strong polarization makes the microtubules <NUM>, as well as other polar macromolecules and especially those that have a specific orientation within the cell <NUM> or its surroundings, susceptible to electric fields. The microtubules <NUM> positive charges are located at two centrioles <NUM> while two sets of negative poles are at a center <NUM> of the dividing cell <NUM> and point of attachment <NUM> of the microtubules <NUM> to the cell membrane. The locations of the charges form sets of double dipoles and therefore are susceptible to electric fields of differing directions. In one embodiment, the cells go through electroporation, that is, DNA or chromosomes are introduced into the cells using a pulse of electricity to briefly open pores in the cell membranes.

Turning now to <FIG>, the TTFields described above that have been found to advantageously destroy tumor cells may be generated by an electronic apparatus <NUM>. <FIG> is a simple schematic diagram of the electronic apparatus <NUM> illustrating major components thereof. The electronic apparatus <NUM> includes an electric field generator <NUM> and a pair of conductive leads <NUM>, including first conductive lead 58a and 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 <NUM> and the first end 62b of the second conductive lead 58b is conductively attached to the electric field generator <NUM>. The electric field generator <NUM> generates desirable electric signals (TT signals) in the shape of waveforms or trains of pulses as an output. 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 of the pad 70a and the pad 70b are activated by the electric signals (e.g., TT signals, wave forms). The pad 70a and the pad 70b, being activated by the electric signals, causes an electrical current to flow between the pad 70a and the pad 70b. The electrical current generates an electric field (i.e., TTField), having a frequency and an amplitude, to be generated between the pad 70a and the pad 70b.

While the electronic apparatus <NUM> shown in <FIG> comprises only two pads <NUM> (the pad 70a and the pad 70b), in some embodiments, the electronic apparatus <NUM> may comprise more than two pads <NUM>.

The electric field generator <NUM> generates an alternating voltage wave form at frequencies in the range from about <NUM> to about <NUM> (preferably from about <NUM> to about <NUM>) (i.e., the TTFields). The required voltages are such that an electric field intensity in tissue within the treatment area is in the range of about <NUM> V/cm to about 10V/cm. To achieve this field, the potential difference between the two conductors <NUM> (e.g., the conductor <NUM> in <FIG>, or the electrode layer <NUM> described in detail below, <FIG>) in each of the pad 70a or the pad 70b is determined by the relative impedances of the system components, e.g., a fraction of the electric field on each component is given by that component's impedance divided by a total circuit impedance.

In certain particular (but non-limiting) embodiments, the pad 70a and the pad 70b generate an alternating electric current and field within a target region of a patient. The target region typically comprises at least one tumor, and the generation of the alternating electric current and field selectively destroys or inhibits growth of the tumor. The alternating electric current and field may be generated at any frequency that selectively destroys or inhibits growth of the tumor, such as at any frequency of a TTField.

In certain particular (but non-limiting) embodiments, the alternating electric current and field may be imposed at two or more different frequencies. When two or more frequencies are present, each frequency is selected from any of the above-referenced values, or a range formed from any of the above-referenced values, or a range that combines two integers that fall between two of the above-referenced values. As used herein, the alternating electric field may be referred to as the electric field or as the TTField.

In order to optimize the electric field (i.e., TTField) distribution, the pad 70a and the pad 70b (pair of pads) may be configured differently depending upon the application in which the pair of pads 70a and 70b are to be used. The pair of pads 70a and 70b, as described herein, are externally applied to a patient, that is, are generally applied to the patient's skin, in order to apply the electric current, and electric field (TTField) thereby generating current within the patient's tissue. Generally, the pair of pads 70a and 70b are placed on the patient's skin by a user such that the electric field is generated across patient tissue within a treatment area. TTFields that are applied externally can be of a local type or widely distributed type, for example, the treatment of skin tumors and treatment of lesions close to the skin surface.

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. In another embodiment, the user may be the patient, that is, the patient (and/or a helper) may place the pad 70a and the pad 70b on their treatment area.

Optionally, and according to another exemplary embodiment, the electronic apparatus <NUM> includes a control box <NUM> and a temperature sensor <NUM> coupled to the control box <NUM>, which are included to control the amplitude of the electric field so as not to generate excessive heating in the treatment area.

When the control box <NUM> is included, the control box <NUM> controls the output of the electric field generator <NUM>, for example, causing the output to remain constant at a value preset by the user. Alternatively, the control box <NUM> sets the output at the maximal value that does not cause excessive heating of the treatment area. In either of the above cases, the control box <NUM> may issue a warning, or the like, when a temperature of the treatment area (as sensed by temperature sensor <NUM>) exceeds a preset limit. The temperature sensor <NUM> may be mechanically connected to and/or otherwise associated with the pad 70a or the pad 70b so as to sense the temperature of the treatment area at either one or both of the pad 70a or the pad 70b. In one embodiment, the control box <NUM> may turn off, or decrease power of the TT Signal generated by the electrical field generator <NUM>, if a temperature sensed by the temperature sensor <NUM> meets or exceeds a comfortability threshold. In one embodiment, the comfortability threshold is the temperature at which a patient would be made uncomfortable while using the pad 70a and the pad 70b. In one embodiment, the comfortability threshold is a temperature at or about <NUM> degrees Celsius. In one embodiment, the comfortability threshold is a temperature of between about <NUM> degrees Celsius and <NUM> degrees Celsius, or a specific selected temperature between about <NUM> degrees Celsius and <NUM> degrees Celsius.

The conductive leads <NUM> are standard isolated conductors with a flexible metal shield, preferably grounded thereby preventing spread of any electric field generated by the conductive leads <NUM>. The pad 70a and the pad 70b may have specific shapes and positioning so as to generate the TTField of a desired configuration, direction, and intensity at the treatment area and only at that treatment area so as to focus the treatment.

The specifications of the electronic apparatus <NUM> as a whole and its individual components are largely influenced by the fact that at the frequency of the TTFields, living systems behave according to their "Ohmic", rather than their dielectric properties.

In one embodiment, to protect the patient from any current due to DC voltage or DC offset voltage passing through the patient, leads 58a and 58b may include a DC blocking component, such as blocking capacitor 82a and blocking capacitor 82b, to block DC current from passing to the pad 70a and the pad 70b. Without being bound by theory, the inventor now believes that the DC blocking component, while important for safety reasons, does not have to be located at the patient interface, i.e., within an electrode of the transducer array, or for that matter, be the non-conductive ceramic disk described above. The blocking capacitors 82a and 82b pass AC voltage to the pad 70a and the pad 70b, and also prevent any DC voltage or DC offset generated by the electric field generator <NUM> or otherwise present in the electrical signal from passing to or through the patient. DC voltage, when applied to a patient, may have undesirable consequences, such as electrolysis or excessive heating of the pad 70a and pad 70b without the benefit of contributing to the power of the TTField. Thus, the blocking capacitors 82a and 82b can prevent electrolysis due to DC offsets or DC voltage. In one embodiment, the blocking capacitors 82a and 82b are non-polarized capacitors. In one embodiment, the blocking capacitors 82a and 82b have a capacitance of about 1µF. In one embodiment, the blocking capacitor is a "Goldmax, <NUM> Series, Conformally Coated, X7R Dielectric, <NUM>-<NUM> VDC (Commercial Grade)" leaded non-polarized ceramic capacitor by KEMET Electronics Corporation (Fort Lauderdale, FL, USA).

Electrically isolating the patient from the electric field generator <NUM> may be very important, and so providing the blocking capacitor 82a and/or the blocking capacitor 82b outside of the electric field generator <NUM> enhances the safety of the patient. The blocking capacitor 82a and the blocking capacitor 82b may be a component of the leads 58a and 58b, or in other embodiments, an additional component at any position between the conductor <NUM> (see <FIG>) or electrode element <NUM> (see <FIG>) and the electric field generator <NUM>. For example, the blocking capacitors 82a and 82b may be intermediate the first end 62a (or 62b) of the lead 58a (or 58b) and the electric field generator <NUM>, or intermediate the second end 66a (or 66b) of the lead 58a (or 58b) and the pad 70a (or 70b). The inventor believes that the blocking capacitor 82a and 82b can be provided remote from the pad 70a and the pad 70b and still provide for safety of the patient. In other embodiments, the blocking capacitor 82a and the blocking capacitor 82b can be located on a non-patient side of the conductor <NUM> or electrode element <NUM>.

In other embodiments, the blocking capacitor 82a and the blocking capacitor 82b may be components of the electric field generator <NUM>, that is, the blocking capacitor 82a and the blocking capacitor 82b may be integrated into the electric field generator <NUM> such that prior to the electrical signal being passed into the leads 58a and 58b, the electrical signal passes through the blocking capacitors 82a and 82b, respectively. Alternatively, the blocking capacitors 82a and 82b may be a component of the pad 70a and the pad 70b, the leads 58a and 58b, or an additional component at any position between a gel layer <NUM> (see <FIG>) and the electric field generator <NUM>.

Referring now to <FIG>, shown therein is a diagram of an exemplary embodiment of the pad <NUM> constructed in accordance with the present disclosure. The pad <NUM> includes one or more electrode element <NUM>. As shown in <FIG>, each pad <NUM> is configured as a set of one or more electrode elements <NUM>. Pads <NUM> may utilize electrode elements <NUM> that are capacitively coupled. In the example shown in <FIG>, the pad <NUM> is configured as multiple electrode elements <NUM> (for example, about <NUM> in diameter) that are interconnected via flex wires <NUM> (and connected to the electric field generator via the conductive lead <NUM>). Each electrode element <NUM> may include a ceramic disk and an electrode layer (described below with respect to <FIG>). In one embodiment, the pad <NUM> includes an outer peripheral edge <NUM>.

Alternative constructions for the pad <NUM> may be used, including, for example ceramic elements that are disc-shaped, ceramic elements that are not disc-shaped, and non-ceramic dielectric materials positioned between the electrode layer and a skin-facing surface of the pads <NUM> over a plurality of flat conductors <NUM> (see <FIG>). Examples of non-ceramic dielectric materials positioned over a plurality of flat conductors include: polymer films disposed over pads on a printed circuit board or over flat pieces of metal. Pads <NUM> that utilize electrode elements <NUM> that are not capacitively coupled may also be used. In this situation, each electrode element <NUM> of the transducer array would be implemented using a region of a conductive material that is configured for placement against a person's body, with no insulating dielectric layer disposed between the electrode elements <NUM> and the body. Examples of the conductive material include a conductive film, a conductive fabric (e.g., fabric layer <NUM>, see <FIG>), and a conductive foam (e.g., foam layer <NUM>, see <FIG>). Other alternative constructions for implementing the pads <NUM> may also be used, as long as they are capable of delivering TTFields to the person's body. Optionally, a gel layer <NUM> may be disposed between the pad <NUM> and the person's body in any of the embodiments described herein (see <FIG>).

Referring now to <FIG>, shown therein is a top plan view of an exemplary embodiment of a pad 70c. The pad 70c is an exemplary embodiment of the pad 70a or the pad 70b. The pad 70c may be provided with a top <NUM>, a bottom <NUM> (shown in <FIG> for the pad 70d), an outer peripheral edge <NUM>, and an electrode element <NUM> bounded by the outer peripheral edge <NUM>. As shown, the pad 70c is connected to the second end <NUM> of the conductive lead <NUM>. The pad 70c is constructed so as to have sufficient flexibility and to be able to conform to a portion of the patient, such as a portion of the patient's head, the patient's knee, the patient's elbow, or the like. The pad 70c may also be constructed such that the electrode element <NUM> is continuous, and extends to the outer peripheral edge <NUM>. In the example shown, the pad 70c is provided with a rectangular shape, or substantially rectangular shape having rounded vertices. However, it should be understood that the pad 70c can be provided with any type of shape such as a polygon, circle, or fanciful shape. Further, the pad 70c may be constructed such as to be cut and/or shaped at a point of use so as to be custom fitted for a particular part of a particular patient.

In one embodiment, the pad 70c is provided with a durable topcoat layer <NUM> as the top <NUM>. The durable topcoat layer <NUM> may be a non-woven, non-conductive fabric. The durable topcoat layer <NUM> provides a safe handling surface for the pad 70c to electrically isolate the electrode element <NUM> from the top <NUM> of the pad 70c. In some embodiments, the durable topcoat layer <NUM> is colored to match or approximate the skin color of the patient.

In one embodiment, the durable topcoat layer <NUM> may be "breathable", that is, the durable topcoat layer <NUM> includes one or more perforation or the like extending from the top <NUM> to the bottom <NUM> to enable air-flow to other layers of the pad 70c as described below. The one or more perforation may have the same or different dimension(s) as one or more other perforation, as well as the same or different shape as one or more other perforation.

Referring now to <FIG>, shown therein is a cross section of an exemplary embodiment of an array assembly <NUM> constructed in accordance with the present disclosure. The array assembly <NUM> generally comprises one or more layer, including a fabric layer <NUM>, a foam layer <NUM>, a gel layer <NUM>, an electrode layer <NUM>, the durable topcoat layer <NUM>, and a compression layer <NUM>. In one embodiment, the foam layer <NUM>, the gel layer <NUM>, the electrode layer <NUM>, and the durable topcoat layer <NUM> may, in combination, be referred to as the pad <NUM>. In one embodiment, the fabric layer <NUM> is a conductive fabric, such as the fabric layer <NUM> shown in <FIG> and discussed in more detail below. In some embodiments, the array assembly <NUM> includes a dielectric layer <NUM> disposed between the electrode layer <NUM> and the gel layer <NUM>.

The foam layer <NUM> comprises a solid continuous phase material defining 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, an alloy thereof, and/or some combination thereof. In one embodiment, the foam layer <NUM> includes a skin-facing surface <NUM> disposed towards the patient's skin when the pad <NUM> is in use.

In one embodiment, the skin-facing surface <NUM> of the foam layer <NUM> may be in contact with the fabric layer <NUM>. In this embodiment, the fabric layer <NUM> may cover at least a portion of the skin-facing surface <NUM> of the foam layer <NUM>. For example, the fabric layer <NUM> may directly cover at least a portion of the skin-facing surface <NUM>, e.g., the skin-facing surface <NUM> is in direct contact with the fabric layer <NUM>; however, in other embodiments, the fabric layer <NUM> may indirectly cover at least a portion of the skin-facing surface <NUM>, e.g., one or more layer of the pad <NUM> may be disposed between the skin-facing surface <NUM> and the fabric layer <NUM>, such as, for example, protective layer <NUM> (<FIG>).

In one embodiment, the foam layer <NUM> is a conductive foam. The foam layer <NUM>, being the conductive foam, may have a conductive material attached to the foam layer <NUM> or have the 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, an alloy thereof, and/or some combination thereof.

In one embodiment, the foam layer <NUM> is a silver foam. The silver foam may have a purity of greater than about <NUM>% and a porosity of more than about <NUM>%. Exemplary embodiments of the silver foam may include: silver foam, item 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 <NUM> 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, U.

The conductive foam, such as the silver foam, may be selected (in terms of size/area of the foam) and positioned to extend past the outer edges of the electrode elements or past the outer edges of the electrode layer, and may extend to the outer edge of the pad, or beyond. The extra surface area of the conductive foam, both in terms of the planar area that may extend beyond the edges of the electrode elements and in terms of the additional surface area provided by the porous cell structure of the foam, provides a mechanism to dissipate heat from the area of the electrode elements, and thereby reduce the problem of uncomfortable heat on the patient's skin. This in turn allows the use of more powerful TTFields while remaining within the selected temperature comfortability threshold. Alternatively, the advantage of the inventive construct may be realized in reduced time that the TTFields need to be powered down or turned off, and may allow for longer durations of continuous treatment.

In one embodiment, the foam layer <NUM> is between about <NUM> and about <NUM> thick. In some embodiments, the foam layer <NUM> may be greater than <NUM> or lesser than <NUM>. The thickness of the foam layer <NUM> may be selected, for example, based on a desired compressability, flexibility, durability, conductivity, and/or stretchability, or some combination thereof.

In one embodiment, the foam layer <NUM> has a strong biocompatibility and low reactivity with other layers or components of the array assembly <NUM>. In one embodiment, the foam layer <NUM> is comprised of an open-cell foam, whereas, in other embodiments, the foam layer <NUM> is comprised of a closed-cell foam, or varying amounts of both of open-cell foam and closed-cell foam.

In one embodiment, where the dielectric layer <NUM> is not present, the foam layer <NUM> is electrically coupled to the electrode layer <NUM>.

In one embodiment, the gel layer <NUM> may be disposed between the foam layer <NUM> and the electrode layer <NUM> (see <FIG>). In one embodiment, the gel layer <NUM> includes a gel, such as a conductive gel, a hydrogel, or a conductive hydrogel. In one embodiment, the gel layer <NUM> is applied to the foam layer <NUM>. The foam layer <NUM>, having the plurality of pockets formed therein, may receive a portion of the gel layer <NUM> within one or more, or even the majority, of the plurality of the pockets.

In one embodiment, the gel layer <NUM> is disposed on the skin-facing surface <NUM> of the foam layer <NUM>. In one embodiment, when the foam layer <NUM> absorbs or adsorbs the gel layer <NUM>, the gel layer <NUM> may be considered to be on both the skin-facing surface <NUM> and the opposite side of the foam layer <NUM>.

In one embodiment, the gel layer <NUM> is between about <NUM> thousandths of an inch (<NUM> mils or <NUM>) and <NUM> thousandths of an inch (<NUM> mils or <NUM>) thick. In one embodiment, the gel layer <NUM> is in contact with the foam layer <NUM> and may be polymerized while in contact with the foam layer <NUM>. In one embodiment, the gel layer <NUM> is applied to the foam layer <NUM> as a liquid hydrogel, which is then cured, or polymerized, to form a semi-solid gel layer <NUM> on the foam layer <NUM> and embedded into the plurality of pockets of the foam layer <NUM>.

In one embodiment, the gel layer <NUM> includes a conductive gel having a bulk electron transport agent providing a source of free ions therein to enable electrical conductivity. In one embodiment, the gel layer <NUM> is formed primarily of a conductive gel or a semi-solid conductive gel. When present, the source of free ions in the gel may be any salt or other substance that serves as a source of free ions that are capable of floating substantially freely within the gel, wherein the free ions serve to conduct electricity and thus reduce impedance. In one embodiment, the gel layer <NUM> includes a polymeric hydrogel. In one embodiment, the gel layer <NUM> has adhesive properties.

The bulk electron transport agent(s) may be any substance that is capable of enhancing the electrical and/or thermal conductivity of the conductive gel. In certain non-limiting embodiments, the bulk electron transport agent(s) includes one or more ionic compounds, one or more metals, or one or more non-metals, as well as any combinations thereof. In certain non-limiting embodiments, the bulk electron transport agent comprises an amorphous carbon and/or a crystalline carbon. Particular (but non-limiting) examples of bulk electron transport agents that may be utilized in accordance with the present disclosure include carbon black, graphene, and graphite.

In one embodiment, the gel layer <NUM> is formed primarily of a conductive gel or semi-solid conductive gel such as described below. The gel layer <NUM> may be in any form that allows the array assembly <NUM> to function in accordance with the present disclosure. The exact thickness of the gel layer <NUM> is not important so long as the gel layer <NUM> is of sufficient thickness that the gel layer <NUM> does not dry out during the treatment. Preferably, the gel layer <NUM> has high conductivity, is tacky, and is biocompatible for extended periods of time. One suitable gel is AG603 Hydrogel, which is available from AmGel Technologies, <NUM>. Mission Road, Fallbrook, Calif. <NUM>-<NUM>, USA. The gel layer <NUM> taught herein may be used with modified hydrogels (which includes not only perforations but also recesses, protrusions, etc.) as disclosed in detail in <CIT> entitled "Conductive Pad Generating Tumor Treating Field and Methods of Production and Use Thereof".

The conductive gel may be in any form that allows the composition to function in accordance with the present disclosure. For example (but not by way of limitation), the conductive gel may be in the form of a hydrogel or a hydrocolloid.

In certain particular (but non-limiting) embodiments, the conductive gel is sterile. In addition, in certain non-limiting embodiments, the conductive gel will not substantially degrade upon exposure to sterilization conditions that include gamma rays or ethylene oxide gas.

The conductive gel may be formed of any hydrophilic polymer that allows the conductive gel to function in accordance with 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 comprise at least one of chitosan, alginate, agarose, methylcellulose, hyaluronan, collagen, laminin, matrigel, fibronectin, vitronectin, poly-<NUM>-lysine, proteoglycans, fibrin glue, gels made by decellularization of engineered and/or natural tissues, as well as any combinations thereof. Further, the conductive gel may comprise 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(<NUM>-hydroxyethyl methacrylate) (PolyHEMA), poly(glycerol sebacate), polyurethanes, poly(isopropylacrylamide), poly(N-isopropylacrylamide), or any combination thereof.

In certain non-limiting embodiments, the conductive gel comprises one or more of the following chemical and structural features/properties: a polymer chain length in a range of from about <NUM> to about <NUM>; a free salt present at a concentration in a range of from about <NUM> to about <NUM>; a pH in a range of from about <NUM> to about <NUM>; a volume resistivity of less than about <NUM> Ohm-in; a skin adhesion rate of at least about <NUM>/inch; and a thickness in a range of from about <NUM> mil to about <NUM> mil.

In addition, given the prolonged exposure of the conductive gel composition to the patient's skin, the conductive gel should be optimized for use at body temperature (e.g., in a range of from about <NUM> to about <NUM>).

The polymer(s) of the conductive gel may be provided with any polymer chain length that allows the conductive gel composition(s) to function as described herein. For example (but not by way of limitation), the polymer chain length may be about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, and above, as well as a range that combines any two of the above-referenced values (e.g., a range of from about <NUM> to about <NUM>, a range of from about <NUM> to about <NUM>, or a range of from about <NUM> to about <NUM>, a range of from about <NUM> to about <NUM>, etc.), and a range that combines two integers that fall between two of the above-referenced values (e.g., a range of from about <NUM> to about <NUM>, etc.).

In other non-limiting embodiments, the range of the polymer chain length is dependent upon the frequency(ies) of the alternating electric field. For example (but not by way of limitation), the range of the polymer chain length may be based upon a range of frequencies of the alternating electric field. Non-limiting examples include a range of from about <NUM> to about <NUM> when the alternating electric field has a frequency in a range of from about <NUM> to about <NUM>, a range of from about <NUM> to about <NUM> when the alternating electric field has a frequency in a range of from about <NUM> to about <NUM>, etc..

In certain non-limiting embodiments, the conductive gel has at least one of a decreased polymer chain length and an added free salt when compared to existing gel compositions; the decrease in polymer chain length and increase in free salt concentration further enhances the conductivity of the conductive gel while reducing the occurrence of skin irritation caused by the conductive gel. In a particular (but non-limiting) embodiment, the conductive gel comprises a free salt present via incorporation within the conductive gel or as one layer of a multi-layered gel (e.g., a bilayered gel). The term "free salt" refers to salt ions that are not incorporated as part of the polymerized chain structure but rather are floating substantially freely within the conductive gel and thus are a source of free ions that conduct electricity and thus reduce impedance.

When free salt is present in the conductive gel, the free salt may be any salt or other substance that serves as a source of free ions that are capable of floating substantially freely within the conductive gel, wherein the free ions serve to conduct electricity and thus reduce impedance. In certain particular (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 that are known to be good conductors. Non-limiting examples of free salts that may be utilized in accordance with the present disclosure are salts that contain potassium (K), ammonium (NH4+), sodium (Na), nitrate, bicarbonate, and the like. Particular non-limiting examples of free salts that may be utilized in accordance with the present disclosure are NaCl, KCl, CaCl2, MgCl2, ZnCl2, silver iodide (Agl), silver dihydrogen citrate (SDC), sodium dihydrogen citrate, combinations thereof, and the like.

The free salt present in the gel may be provided with any concentration that allows the conductive gel compositions to function as described herein. For example (but not by way of limitation), the free salt concentration may be at least about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or higher, as well as any range that combines any two of the above-referenced values (e.g., a range of from about <NUM> to about <NUM>, a range of from about <NUM> to about <NUM>, etc.), and a range that combines two integers that fall between two of the above-referenced values (e.g., a range of from about <NUM> to about <NUM>, etc.).

In other non-limiting embodiments, the free salt concentration is dependent upon the frequency(ies) of the alternating electric field. For example (but not by way of limitation), the range of the free salt concentration may be based upon a range of frequencies of the alternating electric field. Non-limiting examples include a range of from about <NUM> to about <NUM> when the alternating electric field has a frequency in a range of from about <NUM> to about <NUM>, a range of from about <NUM> to about <NUM> when the alternating electric field has a frequency in a range of from about <NUM> to about <NUM>, etc..

The conductive gel may be provided with any pH that does not damage the skin of a patient or cause chemical irritation of the skin upon prolonged exposure to the conductive gel. For example (but not by way of limitation), the conductive gel may have a pH of about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, as well as a range formed from any of the above values (e.g., a range of from about <NUM> to about <NUM>, a range of from about <NUM> to about <NUM>, etc.).

The conductive gel may be provided with any level of volume resistivity that maximizes the conductivity of the gel. For example (but not by way of limitation), the conductive gel may have a volume resistivity of less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, less than about <NUM> Ohm-in, or lower, as well as a range formed of any of the above values (e.g., a range of from about <NUM> Ohm-in to about <NUM> Ohm-in, etc.) and a range that combines two integers that fall between two of the above-referenced values (e.g., a range of from about <NUM> Ohm-in to about <NUM> Ohm-in, etc.).

The conductive gel may be provided with any skin adhesion rate that allows the conductive gel to function in accordance with the present disclosure. For example (but not by way of limitation), the skin adhesion rate of the gel may be at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, at least about <NUM>/inch, or higher, as well as a range of any of the above values (a range of from about <NUM>/inch to about <NUM>/inch, etc.), and a range that combines two integers that fall between two of the above-referenced values (e.g., a range of from about <NUM>/inch to about <NUM>/inch, etc.).

The conductive gel may be provided with any thickness that allows 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 <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, about <NUM> mil, or higher, as well as a range that combines any two of the above-referenced values (e.g., a range of from about <NUM> mil to about <NUM> mil, etc.), and a range that combines two integers that fall between two of the above-referenced values (e.g., a range of from about <NUM> mil to about <NUM> mil, etc.).

In certain particular (but non-limiting) embodiments, the conductive gel has a shelf life of at least about six months. For example (but not by way of limitation), the conductive gel has a shelf life of at least about <NUM> months or at least about <NUM> months.

In one embodiment, gel layer <NUM> is embedded into and throughout the foam layer <NUM>. For example, if the foam layer <NUM> is a non-conductive foam, the embedded gel layer <NUM> may cause the foam layer <NUM> to be conductive between the gel layer <NUM> and the fabric layer <NUM>, thereby allowing an electric signal, such as the TTField signal, to pass through the non-conductive foam. In one embodiment, the gel layer <NUM> may extend through the foam layer <NUM> to further contact the fabric layer <NUM>.

In one embodiment, the electrode layer <NUM> is in contact with the gel layer <NUM>. In one embodiment, as shown in <FIG>, the electrode layer <NUM> is a constituent in the pad <NUM> such as described above with respect to <FIG>. In this embodiment, each electrode element <NUM> is spatially disposed from each other and disposed between, and in contact with, both of the gel layer <NUM> and the durable topcoat layer <NUM>. In some embodiments, the pad <NUM> may have a surface area less than that of the durable topcoat layer <NUM> and the gel layer <NUM>, thereby causing at least a portion of the durable topcoat layer <NUM> to be in contact with a portion of the gel layer <NUM>. A more detailed diagram of an embodiment of the electrode element <NUM> is shown in <FIG>.

In one embodiment, the electrode elements <NUM> of the electrode layer <NUM> do not include a dielectric layer <NUM> as described below. In these embodiments, the electrode elements <NUM> may be in contact with the foam layer <NUM>. Further, the electrode elements <NUM> may be in electrical contact with the foam layer <NUM> such that the foam layer <NUM> receives the TT Signal from the electric field generator <NUM>.

In one embodiment, the array assembly <NUM> includes the compression layer <NUM>. The compression layer <NUM> may be an exterior covering operable to cause a compression between the pad <NUM> and the patient's skin when the array assembly <NUM> is placed on the patient. In one embodiment, the compression layer <NUM> is a form of clothing, for example, a shirt, an undergarment, or a pants. In this embodiment, the fabric layer <NUM> may be sewn or otherwise affixed to the compression layer <NUM> such that, when the patient takes off or puts on clothing, the pad <NUM> does not substantially move relative to the compression layer <NUM>. In one embodiment, the compression layer <NUM> is non-conductive.

In one embodiment, the compression layer <NUM> and the fabric layer <NUM> are sewn together to form a pocket. In this embodiment, the user, such as the patient or the healthcare provider, may place the pad <NUM> into the pocket. In some embodiments, the pocket may then be closed, such as by a button or hook and loop fastener, for example.

In one embodiment, the pad <NUM> further includes a removeable protection layer <NUM>. The removeable protection layer <NUM> permits the pad <NUM> to be constructed separately from the compression layer <NUM> and the fabric layer <NUM> and placed together at a later time to form the array assembly <NUM>. The step of placing the pad <NUM> between the fabric layer <NUM> and the compression layer <NUM> can be accomplished by the patient or healthcare provider at a point of care, or by a manufacturer of the array assembly <NUM>.

In one embodiment, the dielectric layer <NUM> is provided within the pad <NUM>. The dielectric layer <NUM> is constructed of one or more dielectric material and functions as an insulator. In some embodiments, the dielectric layer <NUM> includes a ceramic material. In other embodiments, the dielectric layer <NUM> is flexible. In some preferred embodiment, the dielectric layer <NUM> comprises poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene) and/or poly(vinylidene fluoride-trifluoroethylene-<NUM>-chlorofluoroethylene). Those two polymers are abbreviated herein as "Poly(VDF-TrFE-CtFE)" and "Poly(VDF-TrFE-CFE)", respectively. These embodiments are particularly advantageous because the dielectric constant of these materials is on the order of <NUM>. Because the TTFields are capacitively coupled through the dielectric layer <NUM>, and because capacitance is inversely proportional to the thickness of the dielectric layer <NUM>, the dielectric layer <NUM> is preferably as thin as possible (e.g., less than <NUM> or less than <NUM>). On the other hand, the dielectric layer <NUM> should not be too thin because that could impair manufacturability, compromise the layer's structural integrity, and risk dielectric breakdown when the AC signals are applied. In some preferred embodiments, the dielectric layer <NUM> has a thickness that is at least <NUM>. In some preferred embodiments the dielectric layer <NUM> is between <NUM>-<NUM> thick (e.g., about <NUM>), which provides a good balance between the parameters noted above. Preferably, the thickness of the dielectric layer <NUM> is uniform. But in alternative embodiments, the thickness could be non-uniform.

Optionally, ceramic nanoparticles may be mixed into the Poly(VDF-TrFE-CtFE) and/or Poly(VDF-TrFE-CFE). Optionally, these ceramic nanoparticles may comprise at least one of barium titanate and barium strontium titanate.

In alternative embodiments, instead of forming the dielectric layer <NUM> from Poly(VDF-TrFE-CtFE) and/or Poly(VDF-TrFE-CFE), a different polymer that provides a high dielectric constant, and/or a high level of capacitance may be used. The requirements for these different polymers are as follows: (<NUM>) at least one frequency between <NUM> and <NUM>, the polymer layer has a dielectric constant of at least <NUM>; (<NUM>) the dielectric layer <NUM> has a thickness of less than <NUM> microns; and (<NUM>) the thickness of the dielectric layer <NUM> multiplied by its dielectric strength is at least <NUM> V. Example of alternative polymers that may be used in place of Poly(VDF-TrFE-CtFE) and/or Poly(VDF-TrFE-CFE) include the following: (<NUM>) ceramic nanoparticles mixed into at least one of Poly(VDF-TrFE), P(VDF-HFP), PVDF; and (<NUM>) 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, respectively poly(vinylidene fluoride-trifluoroethylene), poly(vinylidene fluoride-hexafluoropropylene) and poly(vinylidene fluoride)).

In some preferred embodiments, the thickness of the dielectric layer <NUM> is less than <NUM>, and in some preferred embodiments, the thickness of the dielectric layer <NUM> is less than <NUM>. In some preferred embodiments, the thickness of the dielectric layer <NUM> multiplied by its dielectric strength is at least <NUM> V. In some preferred embodiments, the dielectric layer <NUM> has a dielectric constant of at least <NUM> measured at <NUM>.

Referring now to <FIG>, shown therein is a cross-sectional view of an exemplary embodiment of an electrode assembly <NUM> constructed in accordance with the present disclosure. As shown in <FIG>, the electrode assembly <NUM> comprises at least one electrode element <NUM>. The electrode element <NUM> comprises at least one conductor <NUM>, and the dielectric layer <NUM>, and, optionally, may further comprise at least one non-conducting layer <NUM> (which, for example, may be the durable topcoat layer, <NUM>), as shown in <FIG>. In one embodiment, the dielectric layer <NUM> is a high capacitance layer. In one embodiment, the electrode assembly <NUM> further includes at least one optional opening <NUM> disposed at least partially therethrough. In one embodiment, the electrode assembly <NUM> may be constructed as disclosed in <CIT> entitled "Apparatus and Method for Treating a Tumor or the Like".

Referring now to <FIG>, shown therein is a top view of an exemplary embodiment of a fabric layer <NUM> constructed in accordance with the present disclosure. Generally, the fabric layer <NUM> comprises nonconductive threads <NUM> connected to one or more conductive thread 224a-n. For example, the nonconductive threads <NUM> can be interwoven with the one or more conductive thread 224a-n shown in <FIG> as conductive thread 224a, conductive thread 224b, and conductive thread 224c. Each of the conductive threads 224a-n can be woven with the nonconductive threads <NUM>. In one embodiment, the conductive threads 224a-n extend across the fabric layer <NUM> so as to create a substantially continuous conductive region across the fabric layer <NUM>. The fabric layer <NUM> may include a plurality of perforations <NUM>, which may be formed by a space between adjacently disposed nonconductive threads <NUM> and/or conductive threads <NUM> of the fabric layer <NUM>.

In one embodiment, the fabric layer <NUM> covers at least a portion of the skin-facing surface <NUM> of the foam layer <NUM>. In other embodiments, the fabric layer <NUM> covers the entirety of the skin-facing surface <NUM> of the foam layer <NUM>. Optionally, the removable protection layer <NUM> may reside between the fabric layer <NUM> and the skin-facing surface <NUM> of the foam layer <NUM> (see <FIG>).

The nonconductive threads <NUM> and the conductive threads <NUM> can be connected together in a woven format or a non-woven format. In the non-woven format, the nonconductive threads <NUM> and the conductive threads <NUM> can be bonded together by entangling the nonconductive threads <NUM> and the conductive threads <NUM> mechanically, thermally or chemically. The nonconductive threads <NUM> and the conductive threads <NUM> may be bonded together in a manner so that the fabric layer <NUM> is flat or tufted. The fabric layer <NUM> may be constructed of any type of fabric having conductive threads <NUM> and optionally nonconductive threads <NUM>, such as woven fabric, non-woven fabric, or knit fabric, or any combination thereof.

In one embodiment, material for the nonconductive threads <NUM> 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 <NUM> as shown in <FIG>.

In one embodiment, the fabric layer <NUM> has an adhesive property such that the fabric layer <NUM> has a propensity to, when placed at a particular location on a patient, stay at that particular location. In some embodiments, the fabric layer <NUM>, in conjunction with the compression layer <NUM>, is sized to fit tightly and in an encircling, and form fitting manner onto a portion of the patient's body so as to maintain electrical conductivity between the fabric layer <NUM> and the patient's skin. The fabric layer <NUM>, in conjunction with the compression layer <NUM>, can be formed into a configuration suitable for use as a tight-fitting garment or a brace. For example, the compression layer <NUM> can be formed into a tubular configuration and used as a knee brace which surrounds the patient's knee when the fabric layer <NUM> is placed onto the patient's knee. In another embodiment, the compression layer <NUM> can be formed into a beltlike configuration having an attachment mechanism on one end, (e.g., buckle, hook and loop (Velcro) or the like), suitable for use as a back brace with the fabric layer <NUM> between at least a portion of the compression layer <NUM> and the patient. The fabric layer <NUM> and the compression layer <NUM> may be sewn together forming a pocket operable to receive the pad <NUM>. The pad <NUM> may thus be held in place against the patient.

In one embodiment, the conductive thread <NUM> may be constructed of a conductive material able to be bonded to and/or woven with the nonconductive threads <NUM> and able to withstand multiple distortions without compromising conductivity along the conductive thread <NUM>. For example, the conductive thread <NUM> 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 <NUM>. In one embodiment, the conductive thread <NUM> is selected from a conductive material made from, bonded with, or coated with one or more of silver, copper, tin, aluminum, titanium, platinum, carbon, an alloy thereof, and/or some combination thereof. In one embodiment, the conductive thread <NUM> is of a thickness sufficient to support conductivity of a voltage and an amperage suitable to generate TTFields and sufficient to cause flexible contouring of the array assembly <NUM>.

<FIG> depicts three conductive threads 224a-c; however, it is understood that the number of conductive threads <NUM> within the fabric layer <NUM> could be greater than or lesser than three. Further, while the conductive threads 224a-n are shown as being substantially evenly, spatially disposed within the fabric layer <NUM> along with nonconductive threads <NUM>, it is understood that the conductive threads 224a-n may be threaded, sewn, or otherwise disposed between nonconductive threads <NUM> of the fabric layer <NUM>. In one embodiment, the fabric layer <NUM> does not include the nonconductive threads <NUM>.

Referring now to <FIG>, shown therein is a diagram of an exemplary embodiment of the foam layer <NUM> constructed in accordance with the present disclosure. As described above, the foam layer <NUM> may include a solid continuous phase material <NUM> and one or more pocket <NUM> interspersed throughout the solid continuous phase material <NUM>. Each of the one or more pocket <NUM> may be on a surface of the foam layer <NUM> such as the skin-facing surface <NUM> as shown by pockets 240a-c, or internal to the foam layer <NUM> as shown by pocket 240d. The pockets 240a-c on the skin-facing surface <NUM> may be partially exposed, such as the pocket 240c, semi-exposed, such as the pocket 240b, or mostly exposed, such as the pocket 240a.

In one embodiment, each pocket <NUM> has a diameter of between about <NUM> mils and about <NUM> mil. In some embodiments, one or more pocket <NUM> has a diameter greater than <NUM> mil.

Further shown in <FIG> is the gel layer <NUM> when the gel layer <NUM> is disposed on the skin-facing surface <NUM> of the foam layer <NUM>. As shown the gel layer <NUM> may be absorbed or adsorbed by the foam layer <NUM> such that pockets <NUM> internal to the foam layer <NUM>, such as the pocket 240d, is at least partially filled with gel from the gel layer <NUM>. Additionally, the pocket 240a and the pocket 240c are shown as having gel from the gel layer <NUM>. However, in some instances, due to manufacturing or properties of the gel layer <NUM>, not all pockets <NUM> may be filled with the gel from the gel layer <NUM> as shown by the pocket 240b. In some cases, one or more pocket <NUM> may be partially filled by gel from the gel layer <NUM>.

In one embodiment, the gel layer <NUM> is applied to the foam layer <NUM> as a liquid gel, such as a liquid hydrogel, and is cured, or polymerized, after it has been applied to the foam layer <NUM>.

Referring now to <FIG>, shown therein is a cross section of an exemplary embodiment of an array assembly <NUM> constructed in accordance with the present disclosure. The array assembly <NUM> may be constructed similar to the array assembly <NUM> (see <FIG>, and with similar labelling) with the exception that the pad <NUM> having the electrode layer <NUM> formed by the electrode elements <NUM> is a pad 70c having the electrode layer <NUM> formed by the electrode element <NUM>.

Referring now to <FIG>, shown therein is a cross-sectional diagram of an exemplary embodiment of a pad 70d constructed in accordance with the present disclosure. The pad 70d generally comprises the second end <NUM> of the conductive lead <NUM> connected to the foam layer <NUM>. In this embodiment, the foam layer <NUM> is a conductive foam that receives the TTField signals from the electric field generator <NUM> which is operable to generate the TTFields. One or more of the pad 70a and the pad 70b may be substituted with the pad 70d.

In this embodiment, the pad 70d may further include the gel layer <NUM>, which may be disposed on the skin-facing surface <NUM> of the foam layer <NUM>. As discussed in more detail above, the gel layer <NUM> may be absorbed or adsorbed into the foam layer <NUM> such that the foam layer <NUM> includes at least a portion of the gel layer <NUM> in the plurality of pockets <NUM> within the foam layer <NUM>.

Referring now to <FIG>, shown therein is diagram of a top view of an exemplary embodiment of a pad 70e constructed in accordance with the present disclosure. The pad 70e may be constructed similar to one of the pad <NUM>, pad 70c, or pad 70d with the exception that the foam layer <NUM> is shaped into one or more polygon shape <NUM>. The polygon shape <NUM> shown in <FIG> is shown as a regular, equilateral hexagon, however, in other embodiments, the foam layer <NUM> may be shaped into other polygons with a fewer or a greater number of sides than six sides. For example, the foam layer <NUM> may be shaped into a triangle, square, or pentagon, for example. In other embodiments, the polygon shape <NUM> may be a heptagon, octagon, nonagon, decagon, or other polygon with an even greater number of sides.

In one embodiment, the polygon shape <NUM> may be repeated one or more times within the pad70e. In some embodiments, the pad 70e may include a first polygon shape <NUM> having a first shape and a second polygon shape having a second shape, where the first shape and the second shape are different.

In one embodiment, each polygon shape <NUM> is spatially disposed and separated from each other by a non-conductive, or dielectric, material. In some embodiments, however, each polygon shape <NUM> is spatially disposed and separated from each other by a conductive material.

In one embodiment, each electrode element <NUM> of the pad <NUM> is disposed within a polygon shape <NUM>. In this embodiment, each electrode element <NUM> may be disposed at a center of the polygon shape <NUM> or may be disposed a particular distance from another electrode element <NUM>, or both.

In one embodiment, each polygon shape <NUM> is sized such that the pad 70e, when placed on a patient's head, contours to that patient's head. In some embodiments, each polygon shape <NUM> has a diameter greater than about <NUM> inch and lesser than about <NUM> inches. In other embodiments, each polygon shape has a diameter greater than about <NUM> inches and lesser than about <NUM> inches. In one embodiment, all polygon shapes <NUM> are about the same size, whereas in other embodiments, one or more polygon shape <NUM> are not the same size.

In one embodiment, shown in <FIG>, each polygon shape <NUM> is disposed evenly within the pad 70e, however, in other embodiments, each polygon shape <NUM> is not disposed evenly within the pad 70e. Additionally, in some embodiments, the polygon shape <NUM> is not a regular, or equilateral, polygon, but may be a polygon where two or more sides are unequal in length, or, alternatively or additionally, may have rounded vertices. Additionally, in some embodiments, the polygon shape <NUM> includes a concave polygon instead of a convex polygon shape.

Referring now to <FIG>, shown therein is an exemplary embodiment of a process <NUM> of using the electronic apparatus <NUM> to apply a TTField to a patient. The process <NUM> generally comprises the steps of: applying two pads to the patient's skin (step <NUM>) and generating an alternating electric field (TTField) having a frequency in a range of from about <NUM> to about <NUM> for a period of time (step <NUM>).

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

In one embodiment, the step of applying two pads to the patient's skin (step <NUM>) includes applying two or more pads to the patient's skin. In some embodiments, the number of pads <NUM> applied to a patient's skin is determined by a number of pads <NUM> needed to apply a TTField having a therapeutic benefit as determined by the user, such as by a medical professional.

The step of applying two pads (step <NUM>) may be performed by the user. In one embodiment, before applying the selected pads to the patient's skin, the patient's skin may need to be cleaned (e.g., such as but not limited to, cleansing of the skin of foreign matter or biological matter and shaving of the skin, if necessary).

The step of generating an alternating electric field (TTField) (step <NUM>) may be performed by the electric field generator <NUM> and may be instantiated by an operation performed by the user or the control box <NUM>. In one embodiment, step <NUM> may be performed more than one time and the period of time for which the step <NUM> is performed a first time may be the same as or different from the period of time for which the step <NUM> is performed a second time (or other period(s) of time beyond the second time).

In some embodiments, step <NUM> is only performed once before the process <NUM> is repeated. There may be a time period between each time the process <NUM> is repeated. Each time the process <NUM> is repeated, the time period may be the same as or different from the previous time period. Each time the process <NUM> is repeated, the selected pads may be placed in the same or a different position on the patient's skin.

In one embodiment, prior to generating an alternating electric field (TTField) having a frequency in a range of from about <NUM> to about <NUM> for a period of time (step <NUM>), the user connects, or electrically couples, the selected pads to the electric field generator <NUM>.

From the above description, it is clear that the inventive concepts disclosed and claimed herein are well adapted to carry out the objects and to attain the advantages mentioned herein, as well as those inherent in the invention. While exemplary embodiments of the inventive concepts have been described for purposes of this disclosure, it will be understood that numerous changes may be made which will readily suggest themselves to those skilled in the art and which are accomplished within the scope of the appended claims.

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 set forth in the present disclosure.

Similarly, although each illustrative embodiment listed above may directly depend on only one other illustrative embodiment, the disclosure includes each illustrative embodiment in combination with every other illustrative embodiment in the set of illustrative embodiments for each mode of the inventive concepts disclosed herein.

Claim 1:
A system for delivering tumor treating fields, TTFields, to a body of a subject, the system comprising:
an electric field generator (<NUM>) configured to generate an electrical signal having an alternating current waveform at a frequency in a range from <NUM> to <NUM>;
a first conductive lead (<NUM>; 58a) electrically coupled to the electric field generator (<NUM>), the first conductive lead (<NUM>; 58a) being configured to carry the electrical signal;
a first pad (<NUM>; 70a; 70c; 70d; 70e) coupled to the first conductive lead (<NUM>; 58a), the first pad (<NUM>; 70a; 70c; 70d; 70e) having a foam (<NUM>) and a first conductive gel element (<NUM>);
a second conductive lead (<NUM>; 58b) electrically coupled to the electric field generator (<NUM>), the second conductive lead (<NUM>; 58b) being configured to carry the electrical signal; and
a second pad (<NUM>; 70b; 70c; 70d; 70e) coupled to the second conductive lead (<NUM>; 58b), the second pad (<NUM>; 70b; 70c; 70d; 70e) having an electrode element (<NUM>; <NUM>) and receiving the electrical signal from the second conductive lead (<NUM>; 58b), the electrode element (<NUM>; <NUM>) being connected to a second conductive gel element (<NUM>);
characterised by:
the foam (<NUM>) being a conductive foam (<NUM>) and receiving the electrical signal from the first conductive lead (<NUM>; 58a);
the conductive foam (<NUM>) having a solid continuous phase material (<NUM>) being at least one of constructed of a conductive material or having a conductive material attached, absorbed or adsorbed to the solid continuous phase material (<NUM>) and defining a plurality of pockets (<NUM>; 240a-d) interspersed throughout the solid continuous phase material (<NUM>); and
the first conductive gel element (<NUM>) being attached, absorbed or adsorbed to the conductive foam (<NUM>).