Array for longitudinal transmission of tumor-treating electric fields to the body
Longitudinal electrode arrays address the impracticality and discomfort of conventional A/P and R/L arrays by generating effective tumor-treating electric fields that conform to body contours, enhancing treatment efficacy and comfort.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- NOVOCURE GMBH CH
- Filing Date
- 2024-08-05
- Publication Date
- 2026-06-08
AI Technical Summary
Conventional A/P and R/L electrode arrays for tumor-treating electric fields are impractical or uncomfortable for certain body parts due to pain, ulcers, or anatomical constraints, limiting their effectiveness and patient comfort.
A device and method using a set of capacitively coupled electrodes arranged in a longitudinal configuration around the body, with alternating AC voltages applied between electrode pairs to generate a longitudinal electric field, enhancing treatment efficacy and comfort by adapting to body contours and allowing multiple field directions.
The longitudinal electrode arrays provide effective tumor treatment with higher electric field intensity and improved patient comfort by conforming to body shapes, offering enhanced therapeutic outcomes and flexibility in electrode layouts.
Smart Images

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Abstract
Description
Technical Field
[0001] "Cross - References to Related Applications" This application claims the benefit of U.S. Provisional Patent Application No. 62 / 356,986, filed on June 30, 2016, which is hereby incorporated by reference in its entirety.
Background Art
[0002] Tumor treating fields (TTFields) are low - intensity alternating electric fields (e.g., 1 - 3 V / cm) in an intermediate frequency range (e.g., 125 - 250 kHz, or in some cases 100 - 500 kHz) that target solid tumors by interrupting cell division. Tumor treating fields are typically transmitted through two sets of electrode arrays. Each of these sets of electrode arrays is placed on opposite sides of the body part being treated. FIGS. 1A and 1B show conventional arrangements of electrode arrays on a subject's head and chest, respectively. In each of these examples, the first set of electrode arrays includes one electrode array at a front position 16 / 19 and a second electrode array at a rear position (not shown but located immediately behind the corresponding front position). When an AC voltage is applied between the front electrode array and the rear electrode array, the resulting electric field lines of force will generally extend between the front and the back of the object.
[0003] Each of the examples of FIG. 1A and FIG. 1B includes a second set of electrode arrays that includes a first electrode array at a right - hand position 14 / 17 and a second electrode array at a left - hand position 15 / 18. When an AC voltage is applied between the right - hand array and the left - hand array, the resulting electric field lines of force will generally extend between the left and the right of the object. The alternating voltage is applied in an alternating sequence between (i) the anterior - posterior (A / P) electrode arrays and (ii) the right - left (R / L) electrode arrays, whereby the direction of the electric field repeatedly switches between the two above - mentioned directions (e.g., every second).
Prior Art Documents
Patent Documents
[0004] [Patent Document 1] U.S. Patent No. 7,715,921 [Patent Document 2] U.S. Patent No. 8,715,203 [Overview of the Initiative] [Problems that the invention aims to solve]
[0005] While A / P and R / L electrode arrays are well-suited for applying electric fields in two nearly perpendicular directions to many parts of a subject's body, several situations can be anticipated where the use of A / P and R / L electrodes may be difficult or impossible. Examples include the subject having pain or ulcers in one of the commonly used sites for electrode array placement, as well as the use of both A / P and R / L electrodes being uncomfortable and / or impractical (e.g., the subject's neck, elbows, knees, etc.). [Means for solving the problem]
[0006] One aspect of the present invention relates to a first device for treating a target region within a subject's body using a tumor-treating electric field, wherein the target region is located in a part of the subject's body having a longitudinal axis. The device comprises a first set of one or more capacitively coupled electrodes and a first substrate configured to hold the first set of one or more electrodes against the subject's body, wherein the first set of one or more electrodes surrounds a first part of the subject's body at a longitudinal front position of the target region. The device also comprises a second set of one or more capacitively coupled electrodes and a second substrate configured to hold the second set of one or more electrodes against the subject's body, wherein the second set of one or more electrodes surrounds a second part of the subject's body at a longitudinal next position of the target region. The device also comprises a third set of one or more capacitively coupled electrodes and a third substrate configured to hold the third set of one or more electrodes on the first side of the target region relative to the subject's body at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes. The device also comprises a fourth set of one or more capacitively coupled electrodes and a fourth substrate, and is configured to hold the fourth set of one or more electrodes on the second side opposite the first side of the target area relative to the subject's body, at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes.
[0007] Some embodiments of the first apparatus further include an AC voltage generator configured to repeatedly and alternately generate, one after the other, (a) an AC voltage having a frequency of 100 to 500 kHz between a first set of one or more electrodes and a second set of one or more electrodes, and (b) an AC voltage having a frequency of 100 to 500 kHz between a third set of one or more electrodes and a fourth set of one or more electrodes.
[0008] Some embodiments of the first apparatus further include an AC voltage generator configured to repeatedly and alternately generate, one after the other, (a) an AC voltage having a frequency of 125 to 250 kHz between a first set of one or more electrodes and a second set of one or more electrodes, and (b) an AC voltage having a frequency of 125 to 250 kHz between a third set of one or more electrodes and a fourth set of one or more electrodes.
[0009] In some embodiments of the first apparatus, a first set of one or more electrodes comprises a first plurality of flat electrode elements, and a second set of one or more electrodes comprises a second plurality of flat electrode elements. In some of these embodiments, each of the first and second substrates is flexible.
[0010] In some embodiments of the first device, each of the first and second substrates is shaped and sized to fit around the torso of the subject. In some embodiments of the first device, the first substrate is shaped and sized to fit around the torso of the subject, and the second substrate is shaped and sized to fit around the neck of the subject. In some embodiments of the first device, the first substrate is shaped and sized to fit around the neck of the subject, and the second substrate is shaped and sized to fit around the head of the subject. In some embodiments of the first device, the first substrate is shaped and sized to fit around the neck of the subject, and the second substrate is shaped and sized to fit around the head of the subject. In some embodiments of the first device, each of the first and second substrates is shaped and sized to fit around the rim of the subject.
[0011] Some embodiments of the first apparatus include a fifth set of one or more capacitively coupled electrodes and a fifth substrate, configured to hold the fifth set of one or more electrodes on the third side of the target region relative to the subject's body at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes. These embodiments also include a sixth set of one or more capacitively coupled electrodes and a sixth substrate, configured to hold the sixth set of one or more electrodes on the fourth side opposite the third side of the target region relative to the subject's body at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes.
[0012] Another aspect of the present invention relates to a first method for treating a target region within a subject's body using a tumor-treating electric field, wherein the target region is located in a part of the subject's body having a longitudinal axis. The method includes attaching a first set of one or more electrodes to the subject's body so as to surround a first part of the subject's body at a position longitudinally forward of the target region, and attaching a second set of one or more electrodes to the subject's body so as to surround a second part of the subject's body at a position longitudinally following the target region. The method also includes applying a first AC voltage with a frequency of 100 to 500 kHz between the first set of one or more electrodes and the second set of one or more electrodes, thereby applying a first AC electric field having electric field lines that pass longitudinally through the target region, the first AC electric field having an electric field intensity of at least 1 V / cm in at least a portion of the target region.
[0013] In some embodiments of the first method, each of the first and second sets of one or more electrodes is capacitively coupled to the subject's body.
[0014] Some embodiments of the first method include attaching a third set of one or more electrodes to the subject's body on a first side of the target area at a longitudinal position between a first set of one or more electrodes and a second set of one or more electrodes, and further including attaching a fourth set of one or more electrodes to the subject's body on a second side, opposite to the first side of the target area, at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes. These methods also include applying a first AC voltage with a frequency of 100 to 500 kHz between the third set of one or more electrodes and the fourth set of one or more electrodes, applying a second AC electric field passing through the target area, the second AC electric field having an electric field strength of at least 1 V / cm in at least a portion of the target area. In some of these embodiments, each of the first, second, third, and fourth sets of one or more electrodes is capacitively coupled to the subject's body. In some of these embodiments, each of the first and second AC voltages has a frequency of 125 to 250 kHz. In some of these embodiments, the steps of applying a first AC voltage and applying a second AC voltage are repeated at least 10,000 times in an alternating order.
[0015] Some embodiments of the first method include attaching a fifth set of one or more electrodes to the subject's body on a third side of the target area at a longitudinal position between a first set of one or more electrodes and a second set of one or more electrodes, and further including attaching a sixth set of one or more electrodes to the subject's body on a fourth side, opposite to the third side of the target area, at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes. These methods also include applying a third AC voltage with a frequency of 100 to 500 kHz between the fifth set of one or more electrodes and the sixth set of one or more electrodes, applying a third AC electric field having lines of force passing longitudinally through the target area, and the third AC electric field having an electric field strength of at least 1 V / cm in at least a portion of the target area. In some of these embodiments, the steps of applying the first AC voltage, applying the second AC voltage, and applying the third AC voltage are repeated at least 10,000 times in an alternating order.
[0016] In some embodiments of the first method, a first set of one or more electrodes comprises a first plurality of flat electrode elements distributed around a first part of the subject's body, and a second set of one or more electrodes comprises a second plurality of flat electrode elements distributed around a second part of the subject's body.
[0017] In some embodiments of the first method, the target region is located within the torso of a subject, a first set of one or more electrodes is positioned around the subject's torso below the target region, and a second set of one or more electrodes is positioned around the subject's torso above the target region.
[0018] In some embodiments of the first method, the target area is located within the torso of the subject, a first set of one or more electrodes is located around the subject's torso below the target area, and a second set of one or more electrodes is located around the subject's neck.
[0019] In some embodiments of the first method, the target area is located in the subject's head, a first set of one or more electrodes is located around the subject's neck, and a second set of one or more electrodes is located around the subject's head.
[0020] In some embodiments of the first method, the target region is located at the limb of the subject. In these embodiments, the longitudinal axis extends through the limb from proximal to distal, and a first set of one or more electrodes is positioned around the limb near the target region, while a second set of one or more electrodes is positioned around the limb farther from the target region.
[0021] Another aspect of the present invention relates to a second apparatus for treating a target area in the rim of a subject's body using a tumor-treating electric field. This apparatus comprises a first set of one or more capacitively coupled electrodes and a first substrate configured to hold the first set of one or more electrodes relative to the subject's body such that the first set of one or more electrodes partially surrounds a first side of the rim at a position close to the target area. This apparatus also comprises a second set of one or more capacitively coupled electrodes and a second substrate configured to hold the second set of one or more electrodes relative to the subject's body such that the second set of one or more electrodes partially surrounds a second side of the rim at a position far from the target area. The second side of the rim is opposite to the first side of the rim. This apparatus also comprises a third set of one or more capacitively coupled electrodes and a third substrate configured to hold the third set of one or more electrodes relative to the subject's body such that the third set of one or more electrodes partially surrounds a second side of the rim at a position close to the target area. The apparatus also includes a fourth set of one or more capacitively coupled electrodes and a fourth substrate configured to hold the fourth set of one or more electrodes relative to the subject's body such that the fourth set of electrodes partially surrounds the first side of the rim at a position far from the target area.
[0022] Some embodiments of the second device are configured to repeatedly and alternately generate, from one to the next: (a) a first AC voltage having a frequency of 100 to 500 kHz between a first set of one or more electrodes and a second set of one or more electrodes; and (b) a second AC voltage having a frequency of 100 to 500 kHz between a third set of one or more electrodes and a fourth set of one or more electrodes. In some of these embodiments, each of the first and second AC voltages has a frequency of 125 to 250 kHz.
[0023] In some embodiments of the second device, each of the first, second, third, and fourth sets of one or more electrodes includes a plurality of flat electrode elements. In some of these embodiments, each of the first, second, third, and fourth substrates is flexible.
[0024] In some embodiments of the second device, the rim is an arm, and each of the first and third substrates is shaped and sized to fit on the arm proximal to the elbow, and each of the second and fourth substrates is shaped and sized to fit on the arm distal to the elbow. In some embodiments of the second device, the rim is a leg, and each of the first and third substrates is shaped and sized to fit on the leg proximal to the knee, and each of the second and fourth substrates is shaped and sized to fit on the leg distal to the knee.
[0025] Another aspect of the present invention relates to a second method of treating a target region within a rim of a subject's body using tumor treatment electric fields. The method includes attaching a first set of one or more electrodes to partially surround a first side of the rim at a location close to the target region, and attaching a second set of one or more electrodes to partially surround a second side of the rim at a location far from the target region, wherein the second side of the rim is opposite the first side of the rim. The method also includes attaching a third set of one or more electrodes to partially surround the second side of the rim at a location close to the target region, and attaching a fourth set of one or more electrodes to partially surround the first side of the rim at a location far from the target region. The method also includes applying a first AC voltage of a frequency between 100 and 500 kHz between the first set of one or more electrodes and the second set of one or more electrodes, applying a first AC electric field through the target region, and applying the first AC electric field such that the first AC electric field has an electric field intensity of at least 1 V / cm in at least a portion of the target region, and further applying a second AC voltage of a frequency between 100 and 500 kHz between the third set of one or more electrodes and the fourth set of one or more electrodes, applying a second AC electric field through the target region, and applying the second AC electric field such that the second AC electric field has an electric field intensity of at least 1 V / cm in at least a portion of the target region. In this method, the step of applying the first AC voltage and the step of applying the second AC voltage are repeatedly executed alternately, one after the other.
[0026] In some embodiments of the second method, each of the first, second, third, and fourth sets of one or more electrodes is capacitively coupled to the subject's body. In some of these embodiments, each of the first and second AC voltages has a frequency between 125 and 250 kHz.
[0027] In some embodiments of the second method, the step of applying the first AC voltage and the step of applying the second AC voltage are repeated at least 10,000 times in an alternating order.
[0028] In some embodiments of the second method, the limb is the arm, with a first set of one or more electrodes and a third set of one or more electrodes positioned proximal to the elbow, and a second set of one or more electrodes and a fourth set of one or more electrodes positioned distal to the elbow. In some embodiments of the second method, the limb is the leg, with a first set of one or more electrodes and a third set of one or more electrodes positioned proximal to the knee, and a second set of one or more electrodes and a fourth set of one or more electrodes positioned distal to the knee.
[0029] In some embodiments of the second method, each of the first, second, third, and fourth sets of one or more electrodes includes a plurality of flat electrode elements. [Brief explanation of the drawing]
[0030] [Figure 1A] This shows a conventional arrangement of electrode arrays on the head and chest of the subject. [Figure 1B] This shows a conventional arrangement of electrode arrays on the head and chest of the subject. [Figure 2] This is a schematic diagram showing how longitudinal pairs of electrodes are used to generate a longitudinal electric field within a cylindrical body. [Figure 3A] This shows the arrangement of longitudinal pairs of electrode arrays for transmitting an electric field to the chest or abdomen. [Figure 3B] This shows the longitudinal arrangement of electrode array pairs for transmitting an electric field to the abdomen. [Figure 3C] This shows the arrangement of longitudinally paired electrode arrays for transmitting an electric field to a portion of the arm. [Figure 3D] This shows the arrangement of longitudinally paired electrode arrays for transmitting an electric field to a portion of the leg. [Figure 3E] This shows the arrangement of longitudinally paired electrode arrays for transmitting electric fields to the ventral brain, brainstem, and neck. [Figure 3F] Another embodiment for transmitting an electric field to the ventral brain, brainstem, and neck is shown. [Figure 4A]This is a front view showing a pair of longitudinal arrays combined with a pair of anterior-posterior arrays for transmitting an electric field to the chest or abdomen. [Figure 4B] This is a rear view showing a pair of longitudinal arrays combined with a pair of anterior-posterior arrays for transmitting an electric field to the chest or abdomen. [Figure 4C] This is a front view showing a pair of longitudinal arrays combined with a pair of lateral arrays for transmitting an electric field to the chest or abdomen. [Figure 4D] This is a rear view showing a pair of longitudinal arrays combined with a pair of lateral arrays for transmitting an electric field to the chest or abdomen. [Figure 4E] This is a front view showing a pair of longitudinal arrays combined with a pair of diagonally positioned latitudinal arrays for transmitting an electric field to the chest. [Figure 4F] This is a rear view showing a pair of longitudinal arrays combined with a pair of diagonally positioned latitudinal arrays for transmitting an electric field to the chest. [Figure 4G] This is a rear view showing a pair of longitudinal arrays combined with a pair of left-right directional arrays for transmitting an electric field to the submammillary brain. [Figure 4H] This is a rear view of another embodiment combining a transverse array and a longitudinal array for use in the same anatomical position as Figure 4G. [Figure 5A] This is a front view showing pairs of longitudinal arrays, each consisting of a pair of anterior-posterior arrays and a pair of lateral arrays, respectively, for transmitting an electric field to the chest. [Figure 5B] This is a rear view showing pairs of longitudinal arrays, each consisting of a pair of anterior-posterior arrays and a pair of lateral arrays, respectively, for transmitting an electric field to the chest. [Figure 5C] This is a front view showing a pair of longitudinal arrays combined with two sets of diagonally positioned latitudinal arrays to transmit an electric field to the chest. [Figure 5D]This is a rear view showing a pair of longitudinal arrays combined with two sets of diagonally positioned latitudinal arrays to transmit an electric field to the chest. [Figure 6A] A first configuration suitable for fixing a strip-shaped or belt-shaped set of electrodes to a subject's body is shown. [Figure 6B] A second configuration suitable for fixing a panel-shaped set of electrodes to the subject's body is shown. [Figure 7A] A front view of the arrangement of multiple electrode elements in an example of a pair of longitudinal arrays is shown. [Figure 7B] A rear view of the arrangement of multiple electrode elements in an example of a pair of longitudinal arrays is shown. [Figure 7C] A front view of the arrangement of multiple electrode elements for an example of a pair of front-to-back arrays is shown. [Figure 7D] A rear view of the arrangement of multiple electrode elements for an example of a pair of front-to-back arrays is shown. [Figure 7E] A front view of the arrangement of multiple electrode elements in an example of a pair of left-right oriented arrays is shown. [Figure 7F] This shows a rear view of the arrangement of multiple electrode elements in an example of a pair of left-right oriented arrays. [Figure 8] The electric field strengths for six axial slices using the configuration shown in Figure 7A / B, calculated using finite element simulations, are shown. [Figure 9A] For the arrangement in Figure 7A / B, the directions of the longitudinal electric field lines passing through the body and lungs are shown. [Figure 9B] For the arrangement in Figure 7A / B, the directions of the longitudinal electric field lines passing through the body and lungs are shown. [Figure 10A] An inside view of an embodiment intended to transmit an electric field to the knee using two sets of longitudinal arrays is shown. [Figure 10B] An external view of an embodiment intended to transmit an electric field to the knee using two sets of longitudinal arrays is shown.
[0031] Various embodiments are described in detail below with reference to the attached drawings, where similar reference numerals represent similar elements. [Modes for carrying out the invention]
[0032] The embodiments described below overcome the aforementioned limitations of using A / P and R / L electrodes by including at least one pair of electrode arrays configured to generate a longitudinal electric field within a target area. Note the following as used herein: (1) With respect to the head and major parts of the body, the longitudinal axis is perpendicular to both the anterior-posterior axis and the lateral axis. (2) With respect to the legs or arms, the longitudinal axis is the mesiodistal axis. (3) The term “longitudinal electric field” refers to an electric field that extends substantially in the same direction as the longitudinal axis and is not limited to an electric field that is exactly parallel to the longitudinal axis. (4) An electrode array designed to generate a longitudinal electric field is called a “longitudinal array.” (5) Conventional electrode arrays generally designed to generate an electric field that extends between the left and right sides of a subject, or between the front and back of a subject, are called “latitude arrays.”
[0033] To generate a longitudinal electric field, a pair of ring-shaped or arc-shaped electrode arrays that fit around the subject's body may be used, with one array positioned on top of the other. In some embodiments, the arrays are designed as rings that completely enclose the body portion on which they are placed. In other embodiments, the arrays are designed as arcs (e.g., semicircles) that partially enclose the body portion on which they are placed. When a voltage is applied between the upper and lower electrode arrays, the electric field generated between them is oriented longitudinally.
[0034] Figure 2 is a schematic diagram showing a first-order estimation of how a longitudinal electric field can be generated within the body. In this example, we consider the electric field within a solid conductive cylindrical body 20 when an alternating voltage 25 is applied between thin ring-shaped electrode rings 21, 22 at both ends of the cylindrical body. As indicated by the electric field lines 26, the electric field within the cylinder 20 is directed substantially uniformly longitudinally along the cylinder and also penetrates into the interior of the cylinder 20. In some embodiments, a pair of electrode arrays for transmitting a tumor-treating electric field may be designed as two ring-shaped arrays that fit around the subject's body, with one array positioned on top of the other.
[0035] The use of longitudinal electric fields can offer significant advantages, as tumor-treating electric fields are more effective when the longitudinal electric field is parallel to the axis of cell division. Consequently, increasing the number of directions to which the electric field is applied can enhance effectiveness against the tumor being treated (which can alter the orientation of dividing cells). In particular, the use of longitudinal arrays creates new options for on-body array layouts, allowing for optimization of both electric field distribution and patient comfort.
[0036] Figures 3A–3D show four examples of longitudinal pairs of electrode arrays designed to transmit a tumor-treating electric field to different parts of the human body. In all of these embodiments, each electrode array includes one or more electrode elements mounted on a substrate configured to hold the electrode elements relative to the subject's body such that the electrode elements completely enclose each body part. In some preferred embodiments, the substrate is flexible to facilitate conformity with the subject's body. An example of a suitable technique for mounting individual electrode elements on a flexible substrate is described below in relation to Figures 6A and 6B.
[0037] For example, in the embodiment shown in Figure 3A, intended to transmit an electric field to the chest or abdomen, the first electrode array is positioned at position 31 around the torso (e.g., just above the subject's waist), and the second electrode array is positioned at position 32 around the subject's neck. For example, in the embodiment shown in Figure 3B, intended to transmit an electric field to the abdomen, the first electrode array is positioned at position 33 around the torso (e.g., just above the subject's waist), and the second electrode array is positioned at position 34 around the torso (e.g., at the top of the subject's abdomen). For example, in an alternative embodiment (not shown) for transmitting an electric field to the lungs, the first electrode array is positioned below the chest (similar to position 34 in Figure 3B), and the second electrode array is positioned around the subject's neck (similar to position 32 in Figure 3A).
[0038] For example, in the embodiment shown in Figure 3C, intended to transmit an electric field to a portion of the arm, a first electrode array is positioned at position 35 on the arm close to the target region, and a second electrode array is positioned at position 36 on the arm distal to the target region. The target region within the elbow can be accommodated by adjusting the positions of these positions 35 and 36. Similarly, in the embodiment shown in Figure 3D, intended to transmit an electric field to a portion of the leg, for example, a first electrode array is positioned at position 37 on the leg close to the target region, and a second electrode array is positioned at position 38 on the leg distal to the target region. The target region within the knee can be accommodated by adjusting the positions of these positions 37 and 38.
[0039] For example, in the embodiment shown in Figure 3E, which is intended to transmit a tumor-treating electric field to the pituitary gland, brainstem, and neck, the first electrode array is positioned at location 26 around the subject's neck, and the second electrode array is positioned at location 27 near the subject's crown. In the embodiment shown in Figure 3F, which is an alternative embodiment intended to transmit the electric field to these same anatomical locations, the first electrode array is positioned at location 28 around the subject's neck, and the second electrode array is positioned at location 29 above the subject's head.
[0040] Each embodiment shown in Figures 3A to 3E is used to carry out a method for treating a target area within a subject's body with a tumor-treating electric field, the method comprising the following steps: (1) Attaching a first set of one or more electrodes to the subject's body so as to surround a first portion of the subject's body at a position longitudinally in front of the target area; (2) Attaching a second set of one or more electrodes to the subject's body so as to surround a second portion of the subject's body at a position longitudinally following the target area; (3) Applying a first AC voltage with a frequency of 100 to 500 kHz between the first set of one or more electrodes and the second set of one or more electrodes, wherein the first AC electric field has an electric field that passes longitudinally through the target area, and the first AC voltage is applied such that the first AC electric field has an electric field strength of at least 1 V / cm in at least a portion of the target area. In some preferred embodiments, the first and second sets of one or more electrodes are capacitively coupled to the subject's body.
[0041] Depending on the anatomical location in which they are used, longitudinal arrays can offer one or more of the following advantages. Firstly, longitudinal arrays can allow for coverage of specific target areas with higher electric field intensity than transverse arrays. For example, when treating lung tumors using only conventional latitudinal arrays, the arrays on both sides of the subject must be placed under the armpits. As a result, the electric field intensity in the upper lobes of the lung is relatively low. In contrast, longitudinal arrays placed around the waist and neck (as shown in Figure 3A) can provide a more uniform high electric field intensity throughout the lung (as will be discussed later in relation to Figures 8 and 9A, 9B).
[0042] Secondly, in certain anatomical locations, longitudinal arrays may adhere better to the body's contours than latitudinal arrays. For example, when treating the chest, latitudinal arrays placed on the chest may not adhere well to the body's contours (e.g., in the case of a woman's breast), resulting in suboptimal electrical contact between the array and the body and reduced electric field strength within the tumor. In these situations, electrical coupling of the electric field to the body via longitudinal arrays can provide better coverage than electrical coupling of the electric field to the body via transverse arrays.
[0043] Thirdly, large latitudinal arrays placed on a subject's body may restrict movement or cause discomfort in certain anatomical locations. For example, when treating the chest, a large latitudinal array placed on the subject's chest (as shown, e.g., in Figures 4A and 4B) may cause discomfort or even restrict movement. In such cases, a longitudinal pair of arrays, one bypassing the neck and the other bypassing the upper abdomen or waist, can make the subject using them more comfortable, and thus can help improve comfort when transmitting electric fields using a well-designed pair of longitudinal arrays (as shown, e.g., in Figure 3A).
[0044] A fourth important advantage is that the electric field generated using a longitudinal array is nearly perpendicular to the electric field generated by a transverse array (i.e., a set of electrode arrays arranged in the anterior-posterior or lateral direction). Therefore, arrays designed to generate a longitudinal electric field (for example, as shown in Figures 3A-3D) can be combined with conventional arrays designed to generate a latitudinal electric field to treat a target area with electric fields in multiple different directions, thereby enhancing the therapeutic effect. The availability of longitudinal arrays also provides further flexibility in finding electrode layouts that optimize electric field distribution and patient comfort.
[0045] Figures 4A–4H show examples in which a pair of longitudinal arrays (similar to those described above in relation to Figures 3A–F, for example) are combined with a pair of latitudinal arrays. In each of these situations, after the electrodes are fixed in their respective positions, (a) an AC voltage is applied between the first and second electrode sets arranged longitudinally to impose a longitudinal electric field on the target region, and (b) an AC voltage is applied between the third and fourth sets of electrodes arranged latitudinally to impose a latitudinal electric field on the target region. These steps (a) and (b) are repeated in an alternating order during the treatment period to repeatedly switch the direction of the electric field being applied to the target region. In some embodiments, the switching speed is between 0.25 and 2 seconds. Since the treatment is preferably continued for several hours at a time, each of these steps (a) and (b) is preferably repeated at least 10,000 times. Preferably, the frequency of the AC voltage is between 100 and 500 kHz, and in some preferred embodiments, the frequency is between 125 and 250 kHz. In some preferred embodiments (for example, for treating pancreatic cancer and certain types of lung cancer), the frequency is between 140 and 160 kHz. In some preferred embodiments (for example, for treating ovarian cancer), the frequency is between 190 and 210 kHz. Preferably, each electric field applied to the target region has an electric field strength of at least 1 V / cm.
[0046] For example, in the embodiment shown in Figure 4A / B, which is intended to transmit an electric field to the chest, the longitudinal array is implemented by a first electrode array positioned 31 just above the subject's waist and a second electrode array positioned 32 around the subject's neck. Furthermore, the latitudinal array comprises a third electrode array positioned 41 on the subject's chest and a fourth electrode array positioned 42 on the subject's back. In this embodiment, the direction of the electric field lines of the latitudinal electric field extends from front to back.
[0047] For example, in the embodiment shown in Figure 4C / D, which is intended to transmit an electric field to the chest, the longitudinal array is implemented in the same way as in Figure 4A / 4B, but the latitudinal array is implemented by placing the third electrode array at position 43 on the right side of the subject and the fourth electrode array at position 44 on the left side of the subject. In this embodiment, the electric field line direction of the latitudinal electric field extends laterally.
[0048] For example, in the embodiment shown in Figure 4E / F, which is intended to transmit an electric field to the chest, the longitudinal array is implemented in the same way as in Figure 4A / 4B, but the latitudinal array is implemented by placing the third electrode array at position 45 on the left side of the subject's chest and the fourth electrode array at position 46 on the right side of the subject's back. In this embodiment, the direction of the electric field lines of the latitudinal electric field extends diagonally from front to back through the subject's chest.
[0049] For example, in the embodiment shown in Figure 4G, which is intended to transmit a tumor-treating electric field to the submammillary brain, the longitudinal array is implemented by a first electrode array positioned at position 26 around the subject's neck and a second electrode array positioned at position 27 near the crown of the subject's head. Furthermore, the latitudinal array comprises a third electrode array positioned at position 47 on the left side of the subject's head and a fourth electrode array positioned at position 48 on the right side of the subject's head. In this embodiment, the electric field line direction of the latitudinal electric field extends laterally. Alternatively, the latitudinal array may be implemented using third and fourth electrodes (not shown) positioned anterior-posteriorly on the subject's head.
[0050] The embodiment shown in Figure 4H is the same as the embodiment shown in Figure 4G, except that the first electrode array is positioned at location 28 around the subject's neck and the second electrode array is positioned at location 29 above the subject's head.
[0051] With reference to Figures 4A to 4H, in addition to the embodiments described above, a wide variety of alternative configurations combining a pair of arrays arranged longitudinally and a pair of arrays arranged latitudinally are readily conceivable for use in a wide range of anatomical structures and may be apparent to those skilled in the art.
[0052] Figures 5A to 5D show examples in which a pair of longitudinal arrays (similar to those described above in relation to, for example, Figures 3A to F) are combined with two pairs of latitudinal arrays. In each of these situations, (a) an AC voltage is applied between first and second electrode sets arranged longitudinally to impose a longitudinal electric field on the target region; (b) an AC voltage is applied between third and fourth electrode sets arranged latitudally to impose a first latitudinal electric field on the target region; and (c) an AC voltage is applied between fifth and sixth electrode sets arranged latitudally to impose a second latitudinal electric field on the target region. The angle between the first latitudinal electric field and the second latitudinal electric field is preferably between 60° and 120°, most preferably as close to 90° as possible. These steps (a), (b), and (c) are repeated in an alternating order during the treatment period to repeatedly switch the direction of the electric field imposed on the target region between each of the three directions. In some embodiments, the switching speed is between 0.25 and 2 seconds. Since the treatment is preferably continued for several hours at a time, each of these steps (a), (b), and (c) is preferably repeated at least 10,000 times.
[0053] For example, in the embodiment shown in Figure 5A / B, which is intended to transmit an electric field to the chest, the longitudinal array is implemented by a first electrode array positioned 31 just above the subject's waist and a second electrode array positioned 32 around the subject's neck. Furthermore, the first latitudinal array comprises a third electrode array positioned 41 on the subject's chest and a fourth electrode array positioned 42 on the subject's back to generate a first latitudinal electric field having electric field lines extending from front to back. Finally, the third latitudinal array comprises a fifth electrode array positioned 51 on the right side of the subject's body and a sixth electrode array positioned 52 on the left side of the subject's body to generate a second latitudinal electric field having electric field lines extending laterally.
[0054] The embodiment shown in Figure 5C / D is similar to the embodiment shown in Figure 5A / B, but differs in that the third and fourth electrode arrays are positioned at a frontal position 55 and a rearal position 56 of the subject, respectively, and the fifth and sixth electrode arrays are positioned at a frontal position 57 and a rearal position 58 of the subject, respectively. In this embodiment, the first latitudinal electric field has an electric field line extending from the front right to the rear left, and the second latitudinal electric field has an electric field line extending from the front left to the rear right. The angle between the first latitudinal electric field and the second latitudinal electric field is preferably between 60° and 120°, and most preferably as close to 90° as possible.
[0055] Here again, with reference to Figures 5A to 5D, in addition to the two embodiments described above, a wide variety of alternative configurations combining a pair of arrays arranged longitudinally with two pairs of arrays arranged latitudinally are readily conceivable for use in a wide range of anatomical locations and may be apparent to those skilled in the art.
[0056] The descriptions in Figures 3 to 5 above illustrate the positions where various pairs of electrodes are placed on the subject's body, but they do not describe the configuration of these electrode sets. Various configurations, including but not limited to those shown in Figures 6A and 6B, can be used to implement these electrode sets.
[0057] Figure 6A shows a first configuration suitable for fixing a set of electrodes 60 to a subject's body. In this embodiment, each set of electrodes 60 includes a plurality of individual electrode elements 61 mounted on a strip substrate 62. The strip substrate 62 is shaped and sized to fit the specific body part in which it is used. For example, in the case of the longitudinal array shown at position 31 in Figure 3A, the substrate 62 is a flexible substrate similar to a belt; in the case of the longitudinal array shown at position 32 in Figure 3A, the substrate 62 is a flexible substrate similar to a choker; and in the case of the longitudinal array shown at position 27 in Figure 3E, the substrate 62 is a flexible substrate similar to a headband. The role of the substrate 62 is to hold the individual electrode elements 61 against the subject's skin, thereby ensuring good contact between these elements and the skin. Optionally, a conductive gel may be applied between the electrode elements 61 and the subject's skin.
[0058] In some embodiments, each of the individual electrode elements 61 is a disk-shaped capacitively coupled electrode with a high dielectric constant, similar to the electrode elements used in conventional Novocure TTF-100L® transducer arrays. In alternative embodiments, instead of using multiple individual electrode elements 61, a single electrode element (not shown) may be used, in which case the single electrode element preferably has flexibility or a contour to fit a specific part of the body of the person it is used on.
[0059] The individual electrode elements 61 within each set of electrodes 60 are wired together using appropriate wiring 63. For example, the individual electrode elements 61 may be wired in parallel, in series, or in a parallel / series combination. If necessary, this wiring 63 may be terminated with a connector 64. This connector 64 is used to connect the set of electrodes 60 to an AC signal generator 65, which can apply a voltage between the two sets of electrodes.
[0060] Figure 6B shows a second configuration suitable for fixing a panel-shaped electrode set 60' to the subject's body. This configuration includes a plurality of individual electrode elements 61 mounted on a panel-shaped substrate 62'. The wiring 63 and connector 64 in this embodiment of Figure 6B are similar to the corresponding elements in Figure 6A. This embodiment of Figure 6B is best suited for placement at positions 41 to 58 (shown in Figures 4 to 5) and for generating the lateral electric field described above with reference to these embodiments.
[0061] Based on the anatomical positions where the electrode elements are placed, a wide variety of alternative substrate configurations for mounting multiple individual electrode elements will be apparent to those skilled in the art. Figures 7A to 7F show the arrangement of electrode elements in three such configurations. The substrate supporting the electrode elements for the longitudinal electrode sets 71 and 72 shown in Figures 7A / B (front and rear views, respectively) is similar to the strip configuration shown in Figure 6A, scaled to dimensions appropriate to the corresponding anatomical structure. The substrate supporting the electrode elements for the front / rear latitudinal electrode sets 73 / 74 shown in Figures 7C / D (front and rear views, respectively) and the electrode elements for the right / left latitudinal electrode sets 75 / 76 shown in Figures 7E / F (front and rear views, respectively) is similar to the panel configuration shown in Figure 6B, scaled and shaped to dimensions appropriate to the corresponding anatomical structure. By combining all three electrode configurations shown in Figures 7A / B, 7C / D, and 7E / F, and circulating the electric field between these three sets of electrodes to provide three different electric field directions, it is possible to create an excellent electric field range for the upper lobes of the lung while maintaining patient comfort.
[0062] Finite element calculations revealed that longitudinal arrays can provide effective penetration into corresponding anatomical structures. In one example, as shown in Figure 7A / B, multiple ceramic disc-shaped electrode elements are distributed to a first position 71 corresponding to the lumbar region and a second position 72 corresponding to the neck region in a realistic computational phantom.
[0063] Figure 8 shows the electric field strength for this example of axial slices 81-86 separated at regular vertical intervals through the lung, calculated using finite element simulation. This simulation reveals that it is possible to obtain electric field strengths between 1 and 4 V / cm through most of the lung using a longitudinal array. Figures 9A / B show the direction of the electric field lines 91 of the longitudinal electric field through the body and lung, respectively, for this simulation. These figures illustrate the longitudinal characteristics of these electric field lines.
[0064] In some cases, using a tumor-treating electric field may only be a practical method of treating tumors by using at least one pair of longitudinal arrays. For example, if the tumor is located in a joint such as the knee or elbow, using only a lateral electrode set may significantly impair the patient's mobility.
[0065] Figures 10A and 10B show the inside and outside, respectively, of an embodiment intended to transmit an electric field to the knee using two sets of longitudinal arrays to overcome this mobility problem. In this embodiment, a first substrate holds a first set of one or more electrodes to the leg so as to partially surround the front of the leg at a position 101 close to the knee; a second substrate holds a second set of one or more electrodes to the leg so as to partially surround the back of the leg at a position 102 distal to the knee; a third substrate holds a third set of one or more electrodes to the leg so as to partially surround the back of the leg at a position 103 close to the knee; and a fourth substrate holds a fourth set of one or more electrodes to the leg so as to partially surround the front of the leg at a position 104 distal to the knee.
[0066] The electrodes in each set of positions 101-104 are preferably shaped like an open arc that matches the contour of the leg. This arc shape can be achieved using a flexible substrate on which multiple individual electrode elements are mounted, as described above in relation to Figure 6A. Alternatively, the arc shape can also be achieved using a rigid substrate on which one or more electrode elements are mounted. When an open arc configuration is used for an electrode array, it is important that any given pair of arrays is positioned on opposite sides of the body portion being used so that the electric field is sure to penetrate the body, because if both arcs of a given electrode pair are positioned on the same side of the body, the significant electric field may only be generated in the superficial region of the body.
[0067] In this embodiment, a first AC voltage is applied between a set of electrodes fixed at position 101 and a set of electrodes fixed at position 102, creating an electric field having electric field lines extending in the general direction of the dashed line 106. Next, a second AC voltage is applied between a set of electrodes fixed at position 103 and a set of electrodes fixed at position 104, resulting in an electric field having electric field lines extending in the general direction of the dotted line 107. This configuration results in two electric fields forming an X shape through the joint. The directions of these two electric fields (106, 107) may not be perpendicular, but the angle between them will be large enough to produce an improved result compared to a unidirectional electric field. Preferably, the frequencies of the first and second AC voltages are between 100 and 500 kHz. In some preferred embodiments, this frequency is between 125 and 250 kHz. The strength of the two electric fields is preferably at least 1 V / cm in at least a portion of the target area.
[0068] In another embodiment, the knee can be treated by combining a pair of longitudinal arrays located above and below the joint with a pair of latitudinal arrays located outside the joint. In these embodiments, the longitudinal arrays can completely enclose the leg (as seen, for example, in Figure 3D) or partially enclose the leg (as described above, for example, in relation to Figure 10).
[0069] It should be noted that, provided that appropriate changes are made to the corresponding dimensions, the same concepts described above in the context of the knee in relation to Figure 10 can also be applied in the context of the elbow or other joints.
[0070] In some cases (for example, the embodiments in Figures 3A-3F), the arrays are designed to completely avoid the body parts in which they are placed, while in other cases (for example, the embodiments in Figures 10A-B), the arrays are designed not to completely avoid the body parts in which they are placed. However, in both of these array configurations, each array must be positioned at a different location along the longitudinal axis.
[0071] The tumor treatment electric field may be transmitted through an electrode array that capacitively couples the electric field generated by an electric field generator into the body. For example, the array design structure described in U.S. Patent No. 7,715,921 (Patent Document 1) can be incorporated into the design of a longitudinal array. The electrode array may also be designed as a composite electrode including multiple ceramic elements designed to be positioned against the skin of a subject, as described in U.S. Patent No. 8,715,203 (Patent Document 2).
[0072] In some embodiments, the array is designed as a set of ceramic discs having a high dielectric constant, connected to the body via a thin conductive gel. The discs of each array are electrically interconnected via flexible wires, and adhesive tape is placed on the discs to ensure that the array adheres securely to the subject's body. The components for creating a longitudinal array may be similar to those currently used to transmit tumor-treating electric fields to the head using Optune®, as well as to transmit tumor-treating electric fields to the torso using NovoTTF-100L®. The ceramic elements may be wired in parallel, in series, or any combination of parallel and series (e.g., three groups wired in parallel, each group containing three discs wired in series).
[0073] Optionally, the design of the array layout can be performed with the help of finite element simulations, which can be used to calculate the expected electric field distribution that any particular design of the longitudinal array will result in. Such a design can be optimized to transfer the maximum electric field intensity to the target region.
[0074] Optionally, the disks within each array may be connected in a way that allows them to fit objects of different sizes (for example, each array may contain several connection patches with a small number of disks, or the disks may be connected with flexible connectors).
[0075] Although the embodiments described above are for human subjects, they can also be used for other animals (e.g., dogs, horses, etc.) with appropriate modifications, which will be apparent to those skilled in the art.
[0076] While the present invention has been disclosed with reference to specific embodiments, numerous modifications, revisions, and changes are possible to the embodiments described without departing from the scope and scope of the invention, as defined in the appended claims. Therefore, the present invention is not limited to the embodiments described and is intended to encompass the entire scope defined by the language of the claims and their equivalents.
[0077] [Section 1] A device for treating a target region within a subject's body with a tumor treatment electric field, wherein the device positions the target region on a part of the subject's body having a longitudinal axis, A first set of one or more capacitively coupled electrodes, A first substrate configured to hold the first set of one or more electrodes against the body of a subject, wherein the first set of one or more electrodes surrounds a first portion of the body of the subject in the longitudinal direction, in front of the target region, A second set of one or more capacitively coupled electrodes, A second substrate configured to hold the second set of one or more electrodes against the body of a subject, wherein the second set of one or more electrodes surrounds a second portion of the body of the subject at a position in the longitudinal direction following the target region, A third set of one or more capacitively coupled electrodes, A third substrate for holding the third set of one or more electrodes, wherein the third substrate holds the third set of one or more electrodes on the first side of the target region relative to the subject's body at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes, A fourth set of one or more capacitively coupled electrodes, A fourth substrate for holding the fourth set of one or more electrodes, wherein the fourth set of one or more electrodes is held on the second side of the target region opposite to the first side relative to the subject's body, at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes, An apparatus characterized by comprising: [Section 2] The apparatus according to claim 1, further comprising an AC voltage generator configured to repeatedly and alternately generate (a) an AC voltage having a frequency of 100 to 500 kHz between a first set and a second set of one or more electrodes, and (b) an AC voltage having a frequency of 100 to 500 kHz between a third set and a fourth set of one or more electrodes. [Section 3] The apparatus according to claim 1, further comprising: (a) an AC voltage generator configured to generate an AC voltage with a frequency of 125 to 250 kHz between a first set and a second set of one or more electrodes; and (b) an AC voltage generator configured to repeatedly and alternately generate, one after the other, an AC voltage having a frequency of 125 to 250 kHz between a third set and a fourth set of one or more electrodes. [Section 4] The apparatus according to the first claim, characterized in that the first set of one or more electrodes includes a first plurality of flat electrode elements, and the second set of one or more electrodes includes a second plurality of flat electrode elements. [Section 5] The apparatus according to paragraph 4, characterized in that each of the first substrate and the second substrate is flexible. [Section 6] The apparatus according to paragraph 1, characterized in that each of the first substrate and the second substrate has a shape and dimensions such that it fits around the torso of the subject's body. [Section 7] The apparatus according to paragraph 1, characterized in that the first substrate has a shape and dimensions such that it fits around the torso of the subject's body, and the second substrate has a shape and dimensions such that it fits around the neck of the subject's body. [Section 8] The apparatus according to paragraph 1, characterized in that the first substrate has a shape and dimensions such that it fits around the neck of the subject's body, and the second substrate has a shape and dimensions such that it fits around the head of the subject's body. [Section 9] The apparatus according to paragraph 1, characterized in that the first substrate has a shape and dimensions such that it fits around the neck of the subject's body, and the second substrate has a shape and dimensions such that it fits around the head of the subject's body. [Section 10] The apparatus according to paragraph 1, characterized in that each of the first substrate and the second substrate has a shape and dimensions such that it fits around the rim of the subject's body. [Section 11] A fifth set of one or more capacitively coupled electrodes, A fifth substrate for holding the fifth set of one or more electrodes, wherein the fifth substrate holds the fifth set of one or more electrodes on the third side of the target region relative to the subject's body at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes, A sixth set of one or more capacitively coupled electrodes, A sixth substrate for holding the sixth set of one or more electrodes, wherein the sixth set of one or more electrodes is held on the fourth side of the target region opposite to the third side of the subject's body at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes, The apparatus according to paragraph 1, further comprising the following: [Section 12] A method for treating a target region within a subject's body with a tumor treatment electric field, wherein the target region is positioned on a portion of the subject's body having a longitudinal axis, The steps include: attaching one or more electrodes to the subject's body at a position in front of the longitudinal direction of the target region, so as to surround a first part of the subject's body; The steps include: attaching one or more sets of electrodes to the subject's body so as to surround a second portion of the subject's body at a position that extends longitudinally along the target region; A step of applying a first AC voltage having a frequency of 100 to 500 kHz between a first set of one or more electrodes and a second set of one or more electrodes, wherein a first AC electric field having electric field lines passing longitudinally through the target region is applied, and the first AC electric field has an electric field strength of at least 1 V / cm in at least a portion of the target region, A method characterized by comprising [a certain element]. [Section 13] The method according to claim 12, characterized in that each of the first set and the second set of one or more electrodes is capacitively coupled to the body of the subject. [Section 14] The steps include: attaching a third set of one or more electrodes to the subject's body on the first side of the target region at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes; The steps include attaching a fourth set of one or more electrodes to the subject's body on the second side, which is opposite to the first side of the target region, at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes, A step of applying a second AC voltage having a frequency of 100 to 500 kHz between the third set of one or more electrodes and the fourth set of one or more electrodes, wherein a second AC electric field passing through the target region is applied, and the second AC voltage is applied such that the second AC electric field has an electric field strength of at least 1 V / cm in at least a portion of the target region. The method according to paragraph 12, further comprising the following: [Section 15] The method according to claim 14, characterized in that each of the first set, second set, third set, and fourth set of the one or more electrodes is capacitively coupled to the body of the subject. [Section 16] The method according to claim 15, characterized in that each of the first AC voltage and the second AC voltage has a frequency of 125 to 250 kHz. [Section 17] The method according to claim 16, characterized in that the step of applying the first AC voltage and the step of applying the second AC voltage are repeated alternately at least 10,000 times. [Section 18] The steps include: attaching a fifth set of one or more electrodes to the subject's body on the third side of the target region at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes; The steps include attaching a sixth set of one or more electrodes to the subject's body on the fourth side, opposite to the third side of the target region, at a longitudinal position between the first set of one or more electrodes and the second set of one or more electrodes, A step of applying a third AC voltage at a frequency of 100 to 500 kHz between a fifth set of one or more electrodes and a sixth set of one or more electrodes, wherein the third AC electric field passing through the target region is applied, and the third AC voltage is applied such that the third AC electric field has an electric field strength of at least 1 V / cm in at least a portion of the target region. The method according to paragraph 14, further comprising the following: [Section 19] The method according to claim 18, characterized in that the steps of applying the first AC voltage, applying the second AC voltage, and applying the third AC voltage are repeated alternately at least 10,000 times. [Section 20] The method according to claim 12, characterized in that the first set of one or more electrodes includes a first plurality of flat electrode elements distributed around a first part of the subject's body, and the second set of one or more electrodes includes a second plurality of flat electrode elements distributed around a second part of the subject's body. [Section 21] The method according to claim 12, characterized in that the target region is located inside the torso of the subject's body, the first set of one or more electrodes is located below the target region and around the subject's torso, and the second set of one or more electrodes is located above the target region and around the subject's torso. [Section 22] The method according to claim 12, characterized in that the subject has a neck, the target area is located within the torso of the subject's body, the first set of one or more electrodes is located below the target area and around the torso of the subject, and the second set of one or more electrodes is located around the neck of the subject. [Section 23] The method according to claim 12, characterized in that the subject has a head and a neck, the target region is located within the head of the subject, the first set of one or more electrodes is located around the neck of the subject, and the second set of one or more electrodes is located around the head of the subject. [Section 24] The method according to claim 12, characterized in that the target region is located on the rim of the subject's body, the longitudinal axis extends through the rim from proximal to distal, a first set of one or more electrodes is located around the rim at a position close to the target region, and a second set of one or more electrodes is located around the rim at a position far from the target region. [Section 25] A device for treating a target area within the limb of a subject's body with a tumor treatment electric field, A first set of one or more capacitively coupled electrodes, A first substrate configured to hold the first set of one or more electrodes against the body of a subject, wherein the first set of one or more electrodes partially surrounds the first side of the rim at a position close to the target region, A second set of one or more capacitively coupled electrodes, A second substrate configured to hold the second set of one or more electrodes against the body of a subject, wherein the second set of one or more electrodes partially surrounds the second side of the rim at a position far from the target area, and the second side of the rim is opposite to the first side of the rim, A third set of one or more capacitively coupled electrodes, A third substrate for holding the third set of one or more electrodes against the subject's body, wherein the third set of one or more electrodes partially surrounds the second side of the rim at a position close to the target region, A fourth set of one or more capacitively coupled electrodes, A fourth substrate for holding the fourth set of one or more electrodes against the subject's body, wherein the third set of one or more electrodes partially surrounds the first side of the rim at a position far from the target region, An apparatus characterized by comprising: [Section 26] The apparatus according to claim 25, further comprising an AC voltage generator configured to repeatedly and alternately generate, one after the other, a first AC voltage having a frequency of 100 to 500 kHz between a first set and a second set of one or more electrodes, and a second AC voltage having a frequency of 100 to 500 kHz between a third set and a fourth set of one or more electrodes. [Section 27] The apparatus according to paragraph 26, characterized in that each of the first AC voltage and the second AC voltage has a frequency of 125 to 250 kHz. [Section 28] The apparatus according to paragraph 25, characterized in that each of the first set, second set, third set, and fourth set of one or more electrodes includes a plurality of flat electrode elements. [Section 29] The apparatus according to paragraph 28, characterized in that each of the first substrate, the second substrate, the third substrate, and the fourth substrate is flexible. [Section 30] The aforementioned limb is an arm having an elbow, Each of the first and third substrates has a shape and dimensions that fit the arm proximal to the elbow, The apparatus according to paragraph 25, characterized in that each of the second substrate and the fourth substrate has a shape and dimensions that fit the arm distal to the elbow. [Section 31] The aforementioned limb is a leg having a knee, Each of the first and third substrates has a shape and dimensions such that it fits the leg proximal to the knee, The apparatus according to paragraph 25, characterized in that each of the second substrate and the fourth substrate has a shape and dimensions that fit the leg distal to the knee. [Section 32] A method for treating a target region within the limb of a subject's body with a tumor treatment electric field, The steps include: attaching a first set of one or more electrodes in a position close to the target region, so as to partially surround the first side of the rim; The steps include mounting a second set of one or more electrodes at a position far from the target region, partially surrounding the second side of the rim, such that the second side of the rim is opposite to the first side of the rim, The steps include attaching one or more third sets of electrodes in a position close to the target region and partially surrounding the second side of the rim, The steps include: attaching one or more sets of electrodes to a position far from the target region, so as to partially surround the first side of the rim; A step of applying a first AC voltage having a frequency of 100 to 500 kHz between a first set of one or more electrodes and a second set of one or more electrodes, wherein a first AC electric field passing through the target region is applied, and the first AC electric field has an electric field strength of at least 1 V / cm in at least a portion of the target region, A step of applying a second AC voltage having a frequency of 100 to 500 kHz between the third set of one or more electrodes and the fourth set of one or more electrodes, wherein a second AC electric field passing through the target region is applied, and the second AC voltage is applied such that the second AC electric field has an electric field strength of at least 1 V / cm in at least a portion of the target region. A method comprising the steps of applying the first AC voltage and applying the second AC voltage, characterized in that these steps are repeatedly and alternately performed one after the other. [Section 33] The method according to claim 32, characterized in that each of the first set, second set, third set, and fourth set of one or more electrodes is capacitively coupled to the body of the subject. [Section 34] The method according to claim 33, characterized in that each of the first AC voltage and the second AC voltage has a frequency of 125 to 250 kHz. [Section 35] The method according to paragraph 32, characterized in that the step of applying the first AC voltage and the step of applying the second AC voltage are repeated alternately at least 10,000 times. [Section 36] The method according to claim 32, characterized in that the rim is an arm having an elbow, the first set of one or more electrodes and the third set of one or more electrodes are positioned proximal to the elbow, and the second set of one or more electrodes and the fourth set of one or more electrodes are positioned distal to the elbow. [Section 37] The method according to claim 32, characterized in that the rim is a leg having a knee, the first set of one or more electrodes and the third set of one or more electrodes are positioned proximal to the knee, and the second set of one or more electrodes and the fourth set of one or more electrodes are positioned distal to the knee. [Section 38] The method according to claim 32, characterized in that each of the first set, second set, third set, and fourth set of one or more electrodes includes a plurality of flat electrode elements. [Explanation of symbols]
[0078] 20 Main body, cylinder 21, 22 Electrode rings 25 Voltage 26~29 position 31~38 position 41~48 position 51~58 position 60, 60´ electrode 61 Electrode Elements 62, 62' circuit board 63 Wiring 64 connectors 65 AC signal generator Electrode Set 71-76 81-86 Axis slice 91 directions 101~104 position 106, 107 direction
Claims
1. A device for treating a target area of a subject's elbow or knee with a tumor treatment electric field, A first set of one or more electrodes, A first substrate configured to hold the first set of one or more electrodes against the arm or leg of a subject, wherein the first set of one or more electrodes partially surrounds the first side of the arm or leg at a position close to the target region, A second set of one or more electrodes, A second substrate configured to hold the second set of one or more electrodes against the arm or leg of a subject, wherein the second set of one or more electrodes partially surrounds the second side of the arm or leg at a position far from the target area, and the second side of the arm or leg is opposite to the first side of the arm or leg, A third set of one or more electrodes, A third substrate configured to hold the third set of one or more electrodes against the arm or leg of a subject, wherein the third set of one or more electrodes partially surrounds the second side of the arm or leg at a position close to the target area, A fourth set of one or more electrodes, A fourth substrate configured to hold the fourth set of one or more electrodes against the arm or leg of a subject, wherein the fourth set of one or more electrodes partially surrounds the first side of the arm or leg at a position far from the target area, An AC voltage generator configured to repeatedly and alternately generate, one after the other, a first AC voltage having a frequency of 100 to 500 kHz between a first set and a second set of one or more electrodes, and a second AC voltage having a frequency of 100 to 500 kHz between a third set and a fourth set of one or more electrodes, It includes, The apparatus is characterized in that the first set, second set, third set, and fourth set of one or more electrodes are configured to produce two electric fields that form an X shape through the target region.
2. The apparatus according to claim 1, characterized in that each of the first AC voltage and the second AC voltage has a frequency of 125 to 250 kHz.
3. The apparatus according to claim 1, characterized in that each of the first set, second set, third set, and fourth set of one or more electrodes includes a plurality of flat electrode elements.
4. The apparatus according to claim 3, characterized in that each of the first substrate, the second substrate, the third substrate, and the fourth substrate is flexible.
5. Each of the first substrate and the third substrate has a shape and dimensions that match the contour of the arm or knee proximal to the elbow or knee, The apparatus according to claim 1, characterized in that each of the second substrate and the fourth substrate has a shape and dimensions that match the contour of the arm or knee distal to the elbow or knee.