Applying an alternating electric field to multiple regions of interest within a body

Abstract

For certain types of cancer and / or in certain subjects, it can be the case that the cancer is not localized to a single well-positioned location. For example, a single subject can have two different tumor regions that are a few centimeters apart. When using an alternating electric field (e.g., TTFields) to treat such a tumor, it can be difficult to ensure that both tumors receive a sufficiently high electric field strength using prior art methods that rely only on four transducer arrays to induce the TTFields. The embodiments described herein employ one or more additional electrode assemblies to shape the path of the electric field within the subject's body such that the strength of the electric field is above a therapeutic threshold in all regions of interest (e.g., in both of the two different tumor regions).

Description

[0001] Cross-references to related applications This application claims the benefit of U.S. Provisional Application 63 / 571,535, filed March 29, 2024, the entire contents of which are incorporated herein by reference. Background Technology

[0002] Tumor therapeutic field (TTFields) therapy is a proven method of treating tumors using alternating electric fields with frequencies between 50 kHz and 1 MHz (e.g., 50-500 kHz, 75-300 kHz, or 150-250 kHz). Figure 1 The prior art Optune® system is described, which delivers 200 kHz TTFields to a patient via four electrode assemblies (also referred to as “transducer arrays”) placed on the patient’s skin near the tumor. These transducer arrays are arranged in two pairs (or “channels”), with one pair of transducer arrays 10L, 10R positioned to the left and right sides of the tumor, and another pair of transducer arrays 10A, 10P positioned to the front and rear of the tumor. Each transducer array is connected to an AC signal generator 20 via a multi-wire cable.

[0003] Optune's AC signal generator (a) sends an AC current to the transducer array for 1 second via the front / back (A / P) direction, which induces an electric field with a first direction through the tumor; then (b) sends an AC current to the array for 1 second via the left / right (L / R) direction, which induces an electric field with a second direction through the tumor; then steps (a) and (b) are repeated during the duration of the treatment. Summary of the Invention

[0004] One aspect of the invention relates to a first method of applying an alternating electric field to a first region of interest and a second region of interest within a subject's body. The first method includes (a) applying an alternating voltage between: (i) a first electrode assembly positioned at a first location on or within the subject's body; and (ii) a plurality of second electrode assemblies, each of the plurality of second electrode assemblies positioned at a corresponding second location on or within the subject's body. The first electrode assembly and a first of the second electrode assemblies are positioned on opposite sides of the first region of interest. The first electrode assembly and a second of the second electrode assemblies are positioned on opposite sides of the second region of interest. The first and second second electrode assemblies are spaced at least 5 cm apart from each other, and the alternating voltage has a frequency between 50 kHz and 1 MHz.

[0005] Some examples of the first method further include (b) applying an alternating voltage between a third electrode assembly positioned at a third location on or within the subject's body and a fourth electrode assembly positioned at a fourth location on or within the subject's body. In these examples, the third electrode assembly is positioned between the first electrode assembly and the first of the second electrode assemblies, and the fourth electrode assembly is positioned between the first electrode assembly and the second of the second electrode assemblies. Optionally, in these examples, steps (a) and (b) are repeated at least 100 times in an alternating sequence.

[0006] Some examples of the first method further include (b) applying an alternating voltage between a third electrode assembly positioned at a third location on or within the subject's body and a fourth electrode assembly positioned at a fourth location on or within the subject's body. In these examples, the third electrode assembly is radially positioned between the first electrode assembly and the first of the second electrode assemblies, and the fourth electrode assembly is radially positioned between the first electrode assembly and the second of the second electrode assemblies. Optionally, in these examples, steps (a) and (b) are repeated at least 100 times in an alternating sequence.

[0007] Some examples of the first method further include (b) applying an alternating voltage between (i) a third electrode assembly positioned at a third location on or within the subject's body and (ii) a plurality of fourth electrode assemblies, each of the plurality of fourth electrode assemblies positioned at a corresponding fourth location on or within the subject's body. In these examples, the third electrode assembly is positioned between the first of the second electrode assemblies and the second of the second electrode assemblies, and the fourth electrode assembly is positioned between the first of the fourth electrode assemblies and the second of the fourth electrode assemblies. Optionally, in these examples, steps (a) and (b) are repeated at least 100 times in an alternating sequence.

[0008] Some examples of the first method further include (b) applying an alternating voltage between (i) a third electrode assembly positioned at a third location on or within the subject's body and (ii) a plurality of fourth electrode assemblies, each of the plurality of fourth electrode assemblies positioned at a corresponding fourth location on or within the subject's body. In these examples, the third electrode assembly is radially positioned between the first and second of the second electrode assemblies, and the first electrode assembly is radially positioned between the first and second of the fourth electrode assemblies. Optionally, in these examples, steps (a) and (b) are repeated at least 100 times in an alternating sequence.

[0009] In some instances of this first method, the subject's body includes a third region of interest, the first electrode assembly and a third of these second electrode assemblies are positioned on opposite sides of the third region of interest, and all of these second electrode assemblies are spaced apart from each other by at least 5 cm or at least 8 cm.

[0010] In some instances of the first method, the first electrode assembly and the second electrode assembly of the second electrode assemblies are spaced far enough apart to create a low-intensity field region between the first region of interest and the second region of interest. In some instances of the first method, the first electrode assembly and the second electrode assembly of the second electrode assemblies are spaced at least 8 cm apart.

[0011] Some examples of the first method further include, prior to step (a): positioning the first electrode assembly on or in the subject's body at the first location; and positioning each of the plurality of second electrode assemblies on or in the subject's body at the corresponding second location.

[0012] In some instances of this first method, the alternating voltage has a frequency between 75 kHz and 300 kHz.

[0013] Another aspect of the invention relates to a first apparatus for applying an alternating electric field to both a first region of interest and a second region of interest within a subject's body. The first apparatus includes an AC signal generator, a first electrode assembly, and a plurality of second electrode assemblies. The AC signal generator operates at a frequency between 50 kHz and 1 MHz and applies a first output voltage across a first output pin and a second output pin. The first electrode assembly is configured to adhere to the subject's body and be connected to the first output pin via a first cable. Each of the plurality of second electrode assemblies is configured to adhere to the subject's body and be connected to the second output pin via a corresponding second cable. All of these second electrode assemblies are wired in parallel, and the plurality of second cables are configured such that the plurality of second electrode assemblies are spaced at least 5 cm apart from each other.

[0014] In some embodiments of the first device, the AC signal generator applies a second output voltage across a third output pin and a fourth output pin. In these embodiments, the device also includes a third electrode assembly and a fourth electrode assembly. The third electrode assembly is configured to adhere to the subject's body and be connected to the third output pin via a third cable, and the fourth electrode assembly is configured to adhere to the subject's body and be connected to the fourth output pin via a fourth cable. The AC signal generator is configured to (a) apply the first output voltage across the first output pin and the second output pin, and (b) apply the second output voltage across the third output pin and the fourth output pin, and repeat (a) and (b) in an alternating sequence at least 100 times.

[0015] In some embodiments of the first device, the AC signal generator applies a second output voltage across a third output pin and a fourth output pin. In these embodiments, the device also includes a third electrode assembly and a plurality of fourth electrode assemblies. The third electrode assembly is configured to adhere to the subject's body and be connected to the third output pin via a third cable. Each of the plurality of fourth electrode assemblies is configured to adhere to the subject's body and be connected to the fourth output pin via a corresponding fourth cable. All these fourth electrode assemblies are wired in parallel. The plurality of fourth cables are configured such that the plurality of fourth electrode assemblies can be spaced at least 5 cm apart from each other. The AC signal generator is configured to (a) apply the first output voltage across the first output pin and the second output pin, and (b) apply the second output voltage across the third output pin and the fourth output pin, and repeat (a) and (b) in an alternating sequence at least 100 times.

[0016] In some embodiments of the first device, the AC signal generator operates at a frequency between 75 kHz and 300 kHz. Attached Figure Description

[0017] Figure 1 A prior art device for performing tumor therapeutic field (TTFields) therapy is described.

[0018] Figure 2 This is a schematic diagram of a device for performing TTFields therapy in a portion of a subject's body that includes two regions of interest (ROIs).

[0019] Figure 3 This is a schematic diagram of another device used to perform TTFields therapy in a portion of the subject's body that includes two ROIs.

[0020] Figure 4 This is a schematic diagram of another device used to perform TTFields therapy in a portion of the subject's body that includes two ROIs.

[0021] Figure 5 This is a schematic diagram of another device used to perform TTFields therapy in a portion of two ROIs within the subject's body.

[0022] Figure 6A and Figure 6B Depicted respectively Figure 1 and Figure 5 The simulation results of the configuration.

[0023] Figure 7 This is a schematic diagram of another device used to perform TTFields therapy in a portion of the subject's body, which includes three ROIs.

[0024] Figure 8 This is a schematic diagram of another device used to perform TTFields therapy in a part of the subject's body, which includes two ROIs with an exclusion zone between them.

[0025] Figure 9 This is a flowchart of an example procedure for applying an alternating electric field to multiple regions of interest (ROIs) within a subject's body.

[0026] Various embodiments will now be described in detail with reference to the accompanying drawings, wherein the same reference numerals denote the same elements. Detailed Implementation

[0027] Existing transducer array configurations (where one pair of transducer arrays is positioned on the left and right sides of the tumor, and another pair is positioned on the front and rear of the tumor) are well-suited for treating tumors with a single, well-positioned location. However, for certain types of cancer and / or in certain subjects, the cancer may not be confined to a single well-positioned location. For example, a single subject may have two distinct tumor regions several centimeters apart. In such cases, existing methods relying on L / R and A / P transducer arrays may sometimes struggle to ensure that both tumors receive sufficiently high electric field strengths (e.g., >1 V / cm, such as 1–10 V / cm). This is because if the transducer arrays are positioned to optimize the field strength in one of the tumors, the field strength in the second tumor may fall below the treatment threshold (e.g., 1 V / cm). And if the transducer arrays are positioned to optimize the field strength in the second tumor, the field strength in the first tumor may fall below the treatment threshold.

[0028] The embodiments described herein employ one or more additional electrode assemblies to shape the path of the electric field within the subject's body such that the intensity of the electric field is above the treatment threshold in two or more regions of interest (e.g., both of these tumors in the example of the previous paragraph).

[0029] Figure 2 This is a schematic diagram of a device for performing TTFields therapy in a portion of the subject's body that includes two non-contiguous regions of interest (R1 and R2). Figure 2 Top-view and front perspective views showing the subject's body parts (with electrode components hidden in the views shown in dashed lines). Figure 2 In the example, five electrode assemblies are positioned around the portion of the subject's body that includes the two regions of interest, R1 and R2. A front electrode assembly 1 is paired with two separate rear electrode assemblies 2A and 2B, which are positioned a distance D2 apart from each other. Electrode assembly 1 and electrode assembly 2A are located on opposite sides of region of interest R1, and electrode assembly 2B and first electrode assembly 1 are located on opposite sides of region of interest R2. An electric field is induced in both regions of interest R1 and R2 when an alternating voltage is applied between: (i) the first electrode assembly 1 positioned at a frontal location on or within the subject's body, and (ii) a plurality of second electrode assemblies 2A and 2B, each of which is positioned at a corresponding rearal location on or within the subject's body. Therefore, through this positioning of the electrode assemblies, electrode assemblies 1, 2A, and 2B effectively define two separate paths that can be used to simultaneously apply an electric field to both regions of interest R1 and R2.

[0030] The positions of electrode assemblies 1, 2A, and 2B can be predetermined to cover all these regions of interest (e.g., all regions known to include tumors). The positioning of the electrode assemblies can be calculated based on these locations of the regions of interest and based on the type of electrode assembly used (in an arrangement where multiple electrode assemblies form paths with common / shared electrode assemblies). In some embodiments, these electrode assemblies can be placed relative to each other at specific, predetermined locations. For example, electrode assemblies 2A and 2B can be spaced at least 5 cm apart (denoted as...). Figure 2 (The distance D2 is depicted in the figure). This distance can induce a sufficiently strong electric field distribution within the regions of interest R1 and R2.

[0031] like Figure 2 As further shown, regions of interest R1 and R2 are also subjected to electric fields with a side-to-side orientation (e.g., left-right orientation) implemented by electrode assemblies 3 and 4. These electric fields can be applied in different directions in an alternating sequence as follows: firstly, (a) an alternating voltage is applied between (i) the first electrode assembly 1 and (ii) two second electrode assemblies 2A and 2B during a first time period (e.g., one second), which induces electric fields in the two regions of interest R1 and R2; secondly, an alternating voltage is applied between the third electrode assembly 3 and the fourth electrode assembly 4 during a second time period (e.g., one second), which induces electric fields in different directions in the two regions of interest; and (a) and (b) are repeated in an alternating sequence, for example, at least 100 times. This will induce alternating electric fields with repeatedly changing directions in the regions of interest R1 and R2.

[0032] A wide variety of electrode assemblies (or conventional electrodes) may be used in the embodiments described herein, including but not limited to those described in US 2023 / 0043071 entitled “Electrode Assembly for Applying Tumor Treating Fields (TTFields) that Include a Sheet of Graphite,” US 2021 / 0402179 entitled “Flexible Transducer Arrays with a Polymer Insulating Layer for Applying Tumor Treating Fields (TTFields),” and US Patent 8,715,203 entitled “Composite Electrode.” Each of these documents is incorporated herein by reference in its entirety. These electrode assemblies may be implemented in different sizes to meet specific needs in particular situations.

[0033] Figure 2 These electrode assemblies, as depicted in the other figures discussed below, can be attached to the skin using conductive adhesives, such as conductive hydrogel adhesives or conductive non-hydrogel polymer adhesives. For example, Figure 2 The electrode assemblies shown in the top view can be secured using an adhesive layer disposed on the contact surfaces of these electrode assemblies (i.e., the surfaces of these electrode assemblies facing the subject's skin). Alternatively or additionally, other electrode securing mechanisms can be used to secure these electrode assemblies to the subject's body (to maintain their position). For example, straps wrapped around these electrode assemblies can be used to secure them to the subject's body. Such straps can be made of stretchable / flexible materials that can be used with body parts of different sizes and contours, and can also be configured to operate to press these electrodes (or electrode assemblies) against the subject's body. Such stretchable / flexible materials can include breathable materials, such as cotton fabric, through which sweat can permeate. These stretchable / flexible straps can be reusable straps, in which case they can include fasteners (not shown), such as hook and loop fasteners (e.g., Velcro®), which are attached to opposite ends of these straps to allow adjustable tightening of these straps, thereby forming a closed loop surrounding body parts of different sizes. Other types of fastening mechanisms can be used, including various adhesive materials, buckle fasteners, etc. Alternatively, the bandage used to attach the electrode assembly to the patient's body can be a disposable bandage, such as a bandage (e.g., an adhesive bandage), whose front surface (the surface that contacts the subject's skin) is at least partially covered with an adhesive layer in order to attach the bandage to the body part.

[0034] Continue to refer to Figure 2 The device includes an AC signal generator 20, which is configured to generate AC signals and apply them to various electrode assemblies positioned on the subject's body. Note that although... Figure 2 Five electrode assemblies are depicted, but the number of deployed electrode assemblies can vary. The AC signal generator 20 is configured to apply an AC voltage with a frequency between 50 kHz and 1 MHz (e.g., 50-500 kHz, 75-300 kHz, or 150-250 kHz), the voltage level typically on the order of 50-150 VRMS. One method of implementing the AC signal generator 20 is described in U.S. Patent 9,910,453, the entire contents of which are incorporated herein by reference. Alternatively, various alternative methods for implementing the AC signal generator 20, which are obvious to those skilled in the art, may be used.

[0035] The AC signal generator 20 and the device as a whole are controlled by a controller 30 (e.g., a processor-based controller). In some embodiments, the controller 30 controls the operation of the AC signal generator 20 based on operating temperature measurements (e.g., measured by thermistors located on these electrode assemblies) to adjust the AC signal applied to these electrode assemblies so as to keep their temperature below a safe threshold (e.g., 39°C).

[0036] Therefore, in some embodiments, an apparatus is provided for applying an alternating electric field to both a first region of interest and a second region of interest within a subject's body. The apparatus includes an AC signal generator 20 and a set of electrode assemblies 1-4, the AC signal generator operating at a frequency between 50 kHz and 1 MHz (e.g., 50-500 kHz, 75-300 kHz, or 150-250 kHz). The AC signal generator 20 applies a first output voltage across a first output pin and a second output pin. The first electrode assembly 1 is connected to the first output pin via a first cable, and a plurality of second electrode assemblies 2A, 2B are connected to the second output pin via corresponding second cables (e.g., all of these second electrode assemblies are wired in parallel). The plurality of second cables are configured such that the plurality of second electrode assemblies can be spaced at least 5 cm apart from each other. When the AC signal generator 20 applies an AC voltage across the first and second output pins, the AC voltage is routed to the electrode assemblies 1-4 located on or within the subject's body. As a result, an electric field is induced through the subject's body. Note that these individual electrode assemblies within the plurality of second electrode assemblies do not necessarily have to be driven by the same AC signal. For example, the output of the AC signal generator 20 may be transformer-coupled, such that one of the second electrode assemblies 2A receives the entire output voltage of the AC signal generator, while another second electrode assembly 2B receives 75% of the entire output voltage.

[0037] In some embodiments, the AC signal generator 20 applies a second output voltage across the third and fourth output pins. In these embodiments, the third electrode assembly 3 is connected to the third output pin, and the fourth electrode assembly 4 is connected to the fourth output pin via a corresponding cable. Figure 2 In the example depicted, the third electrode assembly 3 is positioned between the first electrode assembly 1 and the first second electrode assembly 2A of the second electrode assembly, and the fourth electrode assembly 4 is positioned between the first electrode assembly 1 and the second second electrode assembly 2B of the second electrode assembly. The AC signal generator 20 is configured to (a) apply the first output voltage across the first output pin and the second output pin, (b) apply the second output voltage across the third output pin and the fourth output pin, and repeat (a) and (b) in an alternating sequence, for example, at least 100 times.

[0038] Note that these electrode assemblies do not need to be entirely located in a single planar region (e.g., a planar slice), but can be distributed throughout a three-dimensional volume, such as... Figure 3 Described in the text. Figure 3 The arrangement of electrode components in Figure 2 The arrangement described in the document is roughly similar, and as can be seen from the top view of the subject's body parts, electrode assemblies 1, 2A, 2B, 3, and 4 have the same... Figure 2 The electrode assemblies shown are positioned in a similar radial direction. However, Figure 3 In the embodiment, electrode assemblies 3 and 4 are positioned at different axial locations relative to assemblies 2A, 2B, and 1. Therefore, in a polar coordinate system with a radial angle θ for each electrode assembly, as shown... Figure 3 As indicated in the front perspective view, electrode assembly 3 is radially positioned between electrode assembly 1 and electrode assembly 2A (i.e., the angle θ of electrode assembly 3 is between the angles of electrode assembly 1 and electrode assembly 2A). Additionally, in Figure 3 In the example, electrode assembly 4 is radially positioned between electrode assembly 1 and electrode assembly 2B. Figure 3 The electrical connection between the electrode assembly and the AC signal generator 20 is similar to that of the other two. Figure 2 The electrical connections shown also apply to the timing used to excite these electrodes.

[0039] Figure 4 This is a diagram of another example apparatus for driving multiple electrode assemblies 1, 2A, 2B, 3, 4A, and 4B to induce alternating electric fields in different directions across more than one region of interest R1 and R2. When an AC voltage is applied between: (i) a first electrode assembly 1 positioned at a frontal location on or within the subject's body; and (ii) multiple second electrode assemblies 2A, 2B, each of which is positioned at a corresponding rearal location on or within the subject's body. This is similar to the combination described above. Figure 2 The situation described. Furthermore, when an AC voltage is applied between the following two, simultaneously in the regions of interest R1 and R2, the corresponding... different An electric field is induced in the following directions: (i) a third electrode assembly 3 located at a rear position on or within the subject's body, and (ii) a plurality of fourth electrode assemblies 4A, 4B located at corresponding front positions on or within the subject's body. This is similar to, but mirrored, the case described in this paragraph for the first electrode assembly 1 and the second electrode assemblies 2A, 2B.

[0040] The controller 30 controls the AC signal generator 20 to (a) apply an AC voltage between (i) the first electrode assembly 1 and (ii) a plurality of second electrode assemblies 2A, 2B, then (b) apply an AC voltage between (i) the third electrode assembly 3 and (ii) a plurality of fourth electrode assemblies 4A, 4B, and then (c) repeat steps (a) and (b) in an alternating sequence (e.g., at least 100 times). The final result of applying the AC voltage in this sequence is as follows: during step (a), an electric field will be induced simultaneously in both regions of interest R1 and R2 in the corresponding directions; during step (b), an electric field will be induced simultaneously in the corresponding... different An electric field is induced in both regions of interest R1 and R2 in the direction of the electric field; and these two steps will be repeated in an alternating order.

[0041] Note that Figure 4 These electrode assemblies in the embodiments do not need to be entirely located in a single planar region (e.g., a planar slice), but can be distributed throughout a three-dimensional volume. This is similar to the combination described above. Figure 3 The situation described. Therefore, in Figure 4 In the example depicted, the third electrode assembly 3 is radially positioned between the second electrode assemblies 2A and 2B, and the first electrode assembly 1 is radially positioned between the fourth electrode assemblies 4A and 4B.

[0042] Figure 5 It shows something similar to Figure 2 The arrangement of the electrode assemblies shown in the figure, except for... Figure 5 Excluding electrode assemblies 3 and 4. By applying an alternating voltage between (i) the first electrode assembly 1 and (ii) the second electrode assemblies 2A and 2B, an electric field is induced only in the regions of interest R1 and R2. As a result, the direction of the electric field in any given region of interest will not alternate between different directions, but will always remain consistent.

[0043] Figure 6A It is an intensity map, which shows... Figure 1 The electric field intensity at various points in a horizontal slice of a model subject's body depicting a prior art A / P electrode assembly configuration (which has a single centrally located front electrode assembly); and Figure 6B It is an intensity map, which shows... Figure 5 The electric field strength at various points in the same horizontal slice of the same model subject's body, depicting the electrode assembly configuration (which has two front electrode assemblies spaced approximately 10 cm apart). Figure 6A The review revealed that the electric field was quite strong directly below the surface of the center of the model subject's chest (i.e., at point C), and significantly weaker at both regions of interest R1 and R2. Therefore, Figure 1 The configuration of this A / P electrode assembly is suboptimal for treating tumors in the two regions of interest, R1 and R2.

[0044] In comparison, Figure 6B The review revealed that the electric field was very weak directly below the surface at the center of the chest of the model subject (i.e., at point Z), and that the electric field was significantly stronger in both regions of interest R1 and R2. Furthermore, Figure 6B The electric field in the region of interest is greater than that in both R1 and R2. Figure 6A The electric field is stronger in it. Therefore, it can be seen that... Figure 5 The configuration (which uses a single rear electrode assembly and two front electrode assemblies spaced approximately 10 cm apart) is far more suitable for treating tumors in these two regions of interest, R1 and R2.

[0045] Combined on the above Figures 2 to 5 In the described example, only two regions of interest (ROIs) R1 and R2 exist, and two rear electrode assemblies 2A and 2B are used to establish paths for the electric field traveling through these ROIs. However, the concepts described above in conjunction with these figures can be extended to cases where there are more than two ROIs (e.g., 3, 4, 5, or more). For example, Figure 7 An example with three regions of interest, R1, R2, and R3, is depicted. In this case, three rear electrode assemblies, 2A, 2B, and 2C, are used to establish three paths for the electric field traveling through all three regions of interest.

[0046] In the above embodiments, these individual electrode assemblies are arranged on or inside the subject's body to induce electric fields in multiple regions of interest within the subject's body. This may be useful, for example, in cases where two or more distinct tumors are present in the subject's body (e.g., spaced 5-10 cm apart).

[0047] In other cases, instead of striving to ensure that an electric field is induced in multiple regions of interest, it may be desirable to shape these electric fields to minimize the field strength in certain regions of the subject's body. For example, if a medical device is implanted in the subject's body, and if an alternating electric field might disrupt the operation of the medical device, it is desirable to shape the electric field to minimize the field strength in the immediate vicinity of the medical device.

[0048] Figure 8 An example of this situation is depicted, where Z represents the "exclusion zone" where the electric field should not be applied. This situation can be addressed by positioning electrode assemblies 1, 2A, and 2B such that the electric field strength is high enough to perform effective TTFields therapy on regions of interest R1 and R2, but low enough to prevent malfunction of the implanted device (in region Z). Figure 6B The electric field intensity simulation depicted in the figure confirms that spacing the electrode assemblies 2A and 2B apart from each other (e.g., about 10 cm) does indeed produce a low electric field intensity “exclusion zone” in region Z.

[0049] Figure 9 This is a flowchart of an example procedure 50 for applying an alternating electric field to both a first region of interest and a second region of interest within a subject's body. The method includes (a) applying an alternating voltage (at S52) between (i) a first electrode assembly positioned at a first location on or within the subject's body and (ii) a plurality of second electrode assemblies, each of which is positioned at a corresponding second location on or within the subject's body. The first electrode assembly and the first of the second electrode assemblies are positioned on opposite sides of the first region of interest. The second of the first electrode assembly and the second of the second electrode assemblies are positioned on opposite sides of the second region of interest. The first and second of the second electrode assemblies are spaced at least 5 cm apart from each other, and the alternating voltage has a frequency between 50 kHz and 1 MHz (e.g., 50-500 kHz, 75-300 kHz, or 150-250 kHz).

[0050] In some embodiments, procedure 50 may further include (b) applying an alternating voltage (at S54) between a third electrode assembly positioned at a third location on or within the subject's body and a fourth electrode assembly positioned at a fourth location on or within the subject's body. In such embodiments, the third electrode assembly may be positioned between the first electrode assembly and a first of the second electrode assemblies, and the fourth electrode assembly may be positioned between the first electrode assembly and a second of the second electrode assemblies. In such embodiments, the procedure may further include repeating steps (a) and (b) in an alternating sequence at least 100 times.

[0051] In some embodiments, the procedure may further include (b) applying an alternating voltage between a third electrode assembly positioned at a third location on or within the subject's body and a fourth electrode assembly positioned at a fourth location on or within the subject's body. The third electrode assembly may be radially positioned between the first electrode assembly and a first of the second electrode assemblies, and the fourth electrode assembly may be radially positioned between the first electrode assembly and a second of the second electrode assemblies. In such embodiments, the procedure may further include repeating steps (a) and (b) in an alternating sequence at least 100 times.

[0052] In some embodiments, the procedure may further include (b) applying an alternating voltage between (i) a third electrode assembly positioned at a third location on or within the subject's body and (ii) a plurality of fourth electrode assemblies, each of the plurality of fourth electrode assemblies positioned at a corresponding fourth location on or within the subject's body. The third electrode assembly may be positioned between a first of the second electrode assemblies and a second of the second electrode assemblies, and the first electrode assembly may be positioned between a first of the fourth electrode assemblies and a second of the fourth electrode assemblies. In such embodiments, the procedure may further include repeating steps (a) and (b) at least 100 times in an alternating sequence.

[0053] In some embodiments, the procedure may further include (b) applying an alternating voltage between (i) a third electrode assembly positioned at a third location on or within the subject's body and (ii) a plurality of fourth electrode assemblies, each of the plurality of fourth electrode assemblies positioned at a corresponding fourth location on or within the subject's body. The third electrode assembly may be radially positioned between a first second electrode assembly and a second second electrode assembly among the second electrode assemblies. The first electrode assembly may be radially positioned between a first fourth electrode assembly and a second fourth electrode assembly among the fourth electrode assemblies. In such embodiments, the procedure may further include repeating steps (a) and (b) in an alternating sequence at least 100 times.

[0054] In some embodiments, the subject's body may include a third region of interest. The first electrode assembly and a third of these second electrode assemblies may be positioned on the opposite side of the third region of interest. All of these second electrode assemblies (2A-C) may be spaced at least 5 cm apart from each other. In some examples, all of these second electrode assemblies may be spaced at least 8 cm apart from each other.

[0055] In some embodiments, the first electrode assembly and the second electrode assembly of these second electrode assemblies may be spaced far enough apart to create a low-intensity field region between the first region of interest and the second region of interest.

[0056] In some embodiments, the first second electrode assembly and the second second electrode assembly may be spaced at least 8 cm apart from each other.

[0057] In some embodiments, procedure 50 may further include, prior to step (a): positioning the first electrode assembly on or in the subject's body at the first location; and positioning each of the plurality of second electrode assemblies on or in the subject's body at the corresponding second location.

[0058] In some embodiments, the AC voltage may have a frequency between 75 kHz and 300 kHz.

[0059] Finally, it is important to note that the use of identifiers (a), (b), (c), (d), etc., in the appended claims does not imply a specific temporal order of the corresponding steps. While step (a) may certainly precede step (b) in time, different orders of these steps are also possible unless a particular order is inconsistent with the internal language of the individual steps or other language in the claims. For example, a step marked (b) may precede a step marked (a) in time. Two or more steps may also occur simultaneously or overlap to some extent, unless such simultaneous occurrence or overlap is inconsistent with the internal language of the individual steps or other language in the claims.

[0060] While the invention has been disclosed with reference to certain embodiments, various modifications, alterations, and changes can be made to the described embodiments without departing from the scope and domain of the invention as defined by the appended claims. Therefore, the invention is intended to be limited to the described embodiments, but rather to have the full scope defined by the language of the appended claims and their equivalents.

Claims

1. A method for applying an alternating electric field to both a first region of interest and a second region of interest within the body of a subject, the method comprising: (a) Applying an alternating voltage between: (i) a first electrode assembly positioned at a first location on or within the subject's body and (ii) a plurality of second electrode assemblies, each of the plurality of second electrode assemblies positioned at a corresponding second location on or within the subject's body. The first electrode assembly and the second electrode assembly are positioned on opposite sides of the first region of interest. The second electrode assembly of the first electrode assembly and the second electrode assembly are positioned on opposite sides of the second region of interest. The first second electrode assembly and the second electrode assembly in the second electrode assembly are spaced at least 5 cm apart from each other, and The AC voltage has a frequency between 50 kHz and 1 MHz.

2. The method according to claim 1, further comprising: (b) Applying an alternating voltage between: a third electrode assembly positioned at a third location on or within the subject's body and a fourth electrode assembly positioned at a fourth location on or within the subject's body. The third electrode assembly is positioned between the first electrode assembly and the first second electrode assembly in the second electrode assembly, and The fourth electrode assembly is positioned between the first electrode assembly and the second second electrode assembly.

3. The method according to claim 2, further comprising repeating steps (a) and (b) in an alternating order at least 100 times.

4. The method according to claim 1, further comprising: (b) Applying an alternating voltage between: a third electrode assembly positioned at a third location on or within the subject's body and a fourth electrode assembly positioned at a fourth location on or within the subject's body. The third electrode assembly is radially positioned between the first electrode assembly and the first second electrode assembly. The fourth electrode assembly is radially positioned between the first electrode assembly and the second second electrode assembly.

5. The method of claim 4, further comprising repeating steps (a) and (b) in an alternating order at least 100 times.

6. The method according to claim 1, further comprising: (b) Applying an alternating voltage between: (i) a third electrode assembly positioned at a third location on or within the subject's body and (ii) a plurality of fourth electrode assemblies, each of the plurality of fourth electrode assemblies positioned at a corresponding fourth location on or within the subject's body. The third electrode assembly is positioned between the first second electrode assembly and the second second electrode assembly in the second electrode assembly, and The first electrode assembly is positioned between the first fourth electrode assembly and the second fourth electrode assembly in the fourth electrode assembly.

7. The method of claim 6, further comprising repeating steps (a) and (b) in an alternating order at least 100 times.

8. The method according to claim 1, further comprising: (b) Applying an alternating voltage between: (i) a third electrode assembly positioned at a third location on or within the subject's body and (ii) a plurality of fourth electrode assemblies, each of the plurality of fourth electrode assemblies positioned at a corresponding fourth location on or within the subject's body. The third electrode assembly is radially positioned between the first second electrode assembly and the second second electrode assembly in the second electrode assembly, and The first electrode assembly is radially positioned between the first fourth electrode assembly and the second fourth electrode assembly in the fourth electrode assembly.

9. The method of claim 8, further comprising repeating steps (a) and (b) in an alternating order at least 100 times.

10. The method of claim 1, wherein the subject's body includes a third region of interest. The third second electrode assembly in the first and second electrode assemblies is positioned on opposite sides of the third region of interest, and All of the second electrode components are spaced at least 5 cm apart from each other.

11. The method of claim 10, wherein all the second electrode assemblies are spaced at least 8 cm apart from each other.

12. The method of claim 1, wherein the first electrode assembly in the second electrode assembly and the second electrode assembly in the second electrode assembly are spaced far enough apart to create a low-intensity field region between the first region of interest and the second region of interest.

13. The method of claim 1, wherein the first second electrode assembly and the second second electrode assembly are spaced at least 8 cm apart from each other.

14. The method of claim 1, further comprising, prior to step (a): The first electrode assembly is positioned on or within the subject's body at the first location; and Each of the plurality of second electrode assemblies is positioned on the subject's body or at the corresponding second location within the subject's body.

15. The method of claim 1, wherein the alternating voltage has a frequency between 75 kHz and 300 kHz.

16. An apparatus for applying an alternating electric field to both a first region of interest and a second region of interest within a subject's body, the apparatus comprising: An AC signal generator that operates at a frequency between 50 kHz and 1 MHz, wherein the AC signal generator applies a first output voltage across a first output pin and a second output pin; A first electrode assembly, configured to adhere to the subject's body and connected to the first output pin via a first cable; as well as Multiple second electrode assemblies, each configured to adhere to the subject's body and connected to the second output pin via a corresponding second cable from a plurality of second cables, wherein all second electrode assemblies are wired in parallel. The plurality of second cables are configured such that the plurality of second electrode assemblies are spaced apart from each other by at least 5 cm.

17. The apparatus of claim 16, wherein the AC signal generator applies a second output voltage across the third output pin and the fourth output pin, and wherein the apparatus further comprises: A third electrode assembly, the third electrode assembly being configured to adhere to the subject's body and connected to the third output pin via a third cable; as well as A fourth electrode assembly, configured to adhere to the subject's body and connected to the fourth output pin via a fourth cable; and The AC signal generator is configured to (a) apply the first output voltage across the first output pin and the second output pin, and (b) apply the second output voltage across the third output pin and the fourth output pin, and repeat (a) and (b) at least 100 times in an alternating sequence.

18. The apparatus of claim 16, wherein the AC signal generator applies a second output voltage across the third output pin and the fourth output pin, and wherein the apparatus further comprises: A third electrode assembly, the third electrode assembly being configured to adhere to the subject's body and connected to the third output pin via a third cable; as well as Multiple fourth electrode assemblies, each configured to adhere to the subject's body and connected to the fourth output pin via a corresponding fourth cable from a plurality of fourth cables, wherein all the fourth electrode assemblies are wired in parallel. The plurality of fourth cables are configured such that the plurality of fourth electrode assemblies are spaced at least 5 cm apart from each other, and The AC signal generator is configured to (a) apply the first output voltage across the first output pin and the second output pin, and (b) apply the second output voltage across the third output pin and the fourth output pin, and repeat (a) and (b) at least 100 times in an alternating sequence.

19. The apparatus of claim 16, wherein the AC signal generator operates at a frequency between 75 kHz and 300 kHz.

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