Method, system, and apparatus for inducing transducer placement in relation to a tumor treatment field.

Abstract

A method for assisting in transducer placement on a subject's body to apply a tumor treating field includes determining first image data based on one or more images associated with a portion of the subject's body, the first image data including one or more transducer placement locations; determining second image data based on the one or more images, the second image data including one or more recommended transducer placement locations; registering the second image data to the first image data; and generating composite data including the one or more transducer placement locations and the one or more recommended transducer array placement locations.

Description

Technical Field

[0001] This application relates to methods, systems, and devices for inducing transducer placement with respect to tumor treating fields.

[0002] Cross - reference to Related Applications This application claims priority to U.S. Patent Application No. 17 / 210,339, filed Mar. 23, 2021, U.S. Patent Application No. 63 / 002,937, filed Mar. 31, 2020, and U.S. Patent Application No. 63 / 056,262, filed Jul. 24, 2020, which are hereby incorporated by reference herein.

Background Art

[0003] Tumor Treating Fields, or TTFields, are low - intensity (e.g., 1 - 3 V / cm) alternating electric fields within the intermediate frequency range (100 - 300 kHz). This non - invasive treatment targets solid tumors and is described in U.S. Patent No. 7,565,205. TTFields inhibit cell division through physical interaction with key molecules during mitosis. TTFields therapy is an approved monotherapy for recurrent glioblastoma (GBM) and an approved combination therapy with chemotherapy for newly diagnosed patients. These electric fields are non - invasively induced by a transducer array (i.e., an arrangement of electrodes) placed directly on the patient's scalp. TTFields also appear to be beneficial for treating tumors in other parts of the body.

[0004] Patient-optimized transducer placement can increase and / or improve the amount of field irradiation delivered to the target area, such as a tumor, thereby improving the effectiveness of TTFields therapy. Ensuring proper placement of the transducer array on the patient's body is difficult because the visibility of the target area of ​​the user's body (e.g., head / scalp, torso, etc.) is very limited and / or nonexistent. Misaligned and / or improperly placed TAs reduce the effectiveness of TTFields therapy. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] U.S. Patent No. 7,565,205 [Patent Document 2] U.S. Patent Application Publication No. 20190117956 [Non-patent literature]

[0006] [Non-Patent Document 1] Ballo et al., “Correlation of Tumor treating Fields Dosimetry to Survival Outcomes in Newly Diagnosed Glioblastoma: A Large-Scale Numerical Simulation-Based Analysis of Data from the Phase 3 EF-14 Randomized Trial,” International Journal of Radiation Oncology, Biology, Physics, 2019, 104(5), pp. 1106–1113. [Overview of the project] [Means for solving the problem]

[0007] One aspect of the present invention relates to a method for assisting in the placement of transducers on a subject's body to apply a tumor treatment electric field. The method includes determining a first image data based on one or more images associated with a part of the subject's body, wherein the first image data includes one or more transducer placement locations; determining a second image data based on one or more images, wherein the second image data includes one or more recommended transducer placement locations; registering the first image data to the second image data; and generating composite data including one or more transducer placement locations and one or more recommended transducer array placement locations.

[0008] Another aspect of the present invention relates to another method for assisting in the placement of transducers on a subject's body to apply a tumor treatment electric field. The method includes generating a three-dimensional (3D) model of a portion of the subject's body based on first image data, the 3D model including the presentation of one or more recommended transducer placement locations; receiving a second image data of the portion of the subject's body; determining, based on the second image data, a representation of one or more placement locations for one or more transducers in three-dimensional (3D) space; comparing the representation of one or more placement locations for one or more transducers in 3D space with the presentation of one or more recommended transducer placement locations in the 3D model; and determining and outputting, based on the comparison result, the distribution of at least one of the one or more placement locations for one or more transducers from at least one of the one or more recommended transducer placement locations.

[0009] Another aspect of the present invention relates to a device that assists in the placement of transducers on a subject's body in order to apply a tumor treatment electric field. The device comprises one or more processors and a memory, the memory storing processor-executable instructions that, when executed by one or more processors, cause the device to: determine first image data based on one or more images associated with a part of a subject's body, wherein the first image data determines first image data including one or more transducer placement locations; determine second image data based on one or more images, wherein the second image data determines second image data including one or more recommended transducer placement locations; register the first image data to the second image data; and generate composite data including one or more transducer placement locations and one or more recommended transducer placement locations.

[0010] Additional advantages may be described in part in the following description or may be known in practice. These advantages are realized and achieved using the elements and combinations indicated in particular in the accompanying claims. It should be understood that both the general description above and the detailed description below are illustrative, explanatory, and not restrictive. [Brief explanation of the drawing]

[0011] [Figure 1] This is a diagram illustrating an exemplary apparatus for electrotherapy treatment. [Figure 2] This is a diagram illustrating an exemplary transducer array. [Figure 3A] This diagram illustrates an example of an application of a device for electrotherapy treatment. [Figure 3B] This diagram illustrates an example of an application of a device for electrotherapy treatment. [Figure 4A] This figure shows a transducer array placed on the patient's head. [Figure 4B] This figure shows a transducer array placed on the patient's abdomen. [Figure 5A] It is a diagram showing a transducer array placed on a patient's torso. [Figure 5B] It is a diagram showing a transducer array placed on a patient's pelvic region. [Figure 6] It is a block diagram showing an electric field generator and a patient support system. [Figure 7] It is a diagram exemplifying the electric field magnitude and distribution (unit: V / cm) shown in a coronal image from a finite element method simulation model. [Figure 8A] It is a diagram showing a three-dimensional array layout map 800. [Figure 8B] It is a diagram showing the placement of a transducer array on a patient's scalp. [Figure 9A] It is a diagram showing an axial T1 sequence slice including the most apical image including the orbit used to measure the head size. [Figure 9B] It is a diagram showing a coronal T1 sequence slice for selecting an image at the level of the external auditory canal used to measure the head size. [Figure 9C] It is a diagram showing a post-contrast T1 axial image showing the maximum enhanced tumor diameter used to measure the tumor site. [Figure 9D] It is a diagram showing a post-contrast T1 coronal image showing the maximum enhanced tumor diameter used to measure the tumor site. [Figure 10] It is a diagram showing an exemplary system for the placement of an induction transducer for TTFields. [Figure 11A] It is a diagram showing an example of generating a three-dimensional model associated with image data. [Figure 11B] It is a diagram showing an example of generating a three-dimensional model associated with image data. [Figure 12A] It is a diagram showing an example of generating composite data associated with image data. [Figure 12B] It is a diagram showing an example of generating composite data associated with image data. [Figure 12C] A diagram showing an example of generating composite data associated with image data. [Figure 12D] A diagram showing an example of generating composite data associated with image data. [Figure 13A] A diagram showing another example of the placement of an inductive transducer for TTFields. [Figure 13B] A diagram showing another example of the placement of an inductive transducer for TTFields. [Figure 13C] A diagram showing another example of the placement of an inductive transducer for TTFields. [Figure 13D] A diagram showing another example of the placement of an inductive transducer for TTFields. [Figure 14A] A diagram showing an example of visual notification for the placement of an inductive transducer array for TTFields. [Figure 14B] A diagram showing an example of visual notification for the placement of an inductive transducer array for TTFields. [Figure 14C] A diagram showing an example of visual notification for the placement of an inductive transducer array for TTFields. [Figure 15] A flowchart showing an example of the placement of an inductive transducer array for TTFields. [Figure 16] A flowchart showing another example of the placement of an inductive transducer array for TTFields. [Figure 17] A flowchart showing another example of the placement of an inductive transducer array. [Figure 18] A flowchart showing another example of the placement of an inductive transducer array. [Figure 19] A flowchart showing another example of the placement of an inductive transducer array. [Figure 20] A flowchart showing another example of the placement of an inductive transducer array. [Figure 21]This flowchart shows an example of generating distributed data. [Modes for carrying out the invention]

[0012] Various embodiments are described in detail below with reference to the attached drawings, and similar reference numbers represent similar elements.

[0013] Before the methods and systems of the present invention are disclosed and described, it should be understood that the methods and systems are not limited to any particular method, component, or implementation. It should also be understood that the terms used herein are intended to describe only specific embodiments and are not intended to be limiting.

[0014] When used herein and in the accompanying claims, the singular forms “a,” “an,” and “the” include the plural form unless the context clearly indicates otherwise. Ranges may be expressed herein using the word “about” as a range from one particular approximate value to and / or another particular approximate value. When such ranges are expressed, an alternative embodiment includes one particular value to and / or the other particular value. Similarly, when values ​​are expressed as approximations, the use of the antecedent “about” will be understood to mean that a particular value forms an alternative embodiment. Furthermore, it will be understood that each endpoint of a range is important both when it relates to other endpoints and when it does not relate to other endpoints.

[0015] "Optional" or "optional" means that the event or situation described thereafter may or may not occur, and that the description includes both cases in which the event or situation occurs and cases in which it does not occur.

[0016] Throughout this specification and the claims, the words “include,” “equip,” and their conjugations such as “include,” “equip,” etc., mean “to encompass, but not limit,” and are not intended to exclude, for example, other components, integers, or steps. “Exemplary” means “an example of,” and is not intended to convey that it refers to a preferred or ideal embodiment. “Etc.” is not used in a restrictive sense, but is used for illustrative purposes.

[0017] Disclosed are components that may be used to carry out the disclosed methods and systems. These and other components are disclosed herein, and while specific references to each of these various individual collective combinations and sortings may not be expressly disclosed when combinations, subsets, interactions, groups, etc., of these components are disclosed, each is understood to be particularly intended for and described herein for all methods and systems. This applies to all aspects of this application, including, but not limited to, the steps in the disclosed methods. Thus, where there are various additional steps that may be carried out, each of these additional steps may be carried out in any particular embodiment or combination of embodiments of the disclosed methods.

[0018] The methods and systems of the present invention can be more readily understood by referring to the following detailed description of preferred embodiments and the examples contained herein, as well as the figures and their preceding and succeeding descriptions.

[0019] As will be understood by those skilled in the art, the methods and systems may take the form of embodiments that are entirely hardware, entirely software, or a combination of software and hardware aspects. Furthermore, the methods and systems may take the form of a computer program product on a computer-readable storage medium having computer-readable program instructions (e.g., computer software) embodied within that storage medium. More specifically, the methods and systems may take the form of web-implemented computer software. Any suitable computer-readable storage medium may be used, including hard disks, CD-ROMs, optical storage devices, or magnetic storage devices.

[0020] Embodiments of the methods and systems are described below with reference to block diagrams and flowcharts of the methods, systems, apparatus, and computer program products. It will be understood that each block in the block diagrams and flowcharts, as well as combinations of blocks in the block diagrams and flowcharts, can be implemented by computer program instructions. These computer program instructions are loaded onto a general-purpose computer, a dedicated computer, or other programmable data processing device to create a machine, thereby creating means for instructions executed on the computer or other programmable data processing device to implement functions specified in one or more flowchart blocks.

[0021] These computer program instructions, which can direct a computer or other programmable data processing device to function in a particular way, may also be stored in computer-readable memory, thereby creating a product containing computer-readable instructions stored in computer-readable memory for implementing a function specified in one or more flowchart blocks. Furthermore, the computer program instructions may be loaded into a computer or other programmable data processing device so that the instructions are executed on the computer or other programmable device and provide steps for implementing a function specified in one or more flowchart blocks, thereby causing a series of operational steps to be executed on the computer or other programmable device to produce a computer implementation process.

[0022] Therefore, the blocks in block diagrams and flowcharts support combinations of means for performing a specified function, combinations of steps for performing a specified function, and means of program instructions for performing a specified function. It will also be understood that each block in block diagrams and flowcharts, as well as combinations of blocks in block diagrams and / or flowcharts, may be implemented by a dedicated hardware-based computer system that performs a specified function or step, or combination of dedicated hardware and computer instructions.

[0023] TTFields, also referred to herein as alternating electric fields, are established as an anti-mitotic carcinoma therapy because they disrupt proper microtubule polymerization during metaphase and ultimately destroy cells during telophase and cytokinesis. Their effectiveness increases with increasing electric field strength, and the optimal frequency depends on the cancer cell line; the frequency at which TTFields inhibit glioma cell growth most effectively was 200 kHz. For cancer treatment, non-invasive devices have been developed, for example, for patients with glioblastoma multiforme (GBM), the most common primary malignant brain tumor in humans, using capacitively coupled transducers that are directly placed in a skin area close to the tumor.

[0024] The effect of TTFields is directional, meaning that cells dividing parallel to the electric field are more affected than cells dividing in other directions. Since cells divide in all directions, TTFields are typically applied through two pairs of transducer arrays that generate an electric field perpendicular to the tumor being treated. More specifically, one pair of transducer arrays may be positioned on the left and right (LR) sides of the tumor, and the other pair on the front and back (AP) sides. Cycling the electric field between these two directions (i.e., LR and AP) ensures that the widest range of cell orientations is targeted. Other positions of the transducer arrays are intended for electric fields other than perpendicular ones. In one embodiment, asymmetric positioning of three transducer arrays is intended, where one pair of the three transducer arrays applies an alternating electric field, then another pair of the three transducer arrays applies the same alternating electric field, and the remaining pair of the three transducer arrays applies the same alternating electric field.

[0025] In vivo and in vitro studies have shown that the effectiveness of TTFields therapy increases with increasing field intensity. Therefore, optimizing array placement on the patient's scalp to increase intensity in the affected area of ​​the brain is a standard technique of the Optune system. Optimization of array placement can be performed by “rules of thumb” (e.g., placing the array on the scalp as close to the tumor as possible), measurements describing the geometric shape of the patient's head, tumor dimensions, and / or tumor location. Measurements used as input can be derived from image data. Image data is intended to include any type of visual data, such as single-photon emission tomography (SPECT) image data, X-ray computed tomography (X-ray CT) data, magnetic resonance imaging (MRI) data, positron emission tomography (PET) data, data that can be captured by optical instruments (e.g., photographic cameras, charge-coupled device (CCD) cameras, infrared cameras, etc.), and similar. In some implementations, image data may include 3D data (e.g., point cloud data) acquired from or generated by a 3D scanner. Optimization relies on an understanding of how the electric field is distributed as a function of the array's position, for example, within the head, and in some embodiments, may take into account variations in the electrical property distribution within the heads of different patients. The transducer array placement can be optimized to treat any part of the patient / subject's body (e.g., head, torso, etc.).

[0026] Optimized transducer array placement locations may be determined and recommended to the patient / subject, for example, when the patient / subject attempts to place one or more transducer arrays on / on the surface of any part of the patient / subject's body (e.g., head, torso, etc.). For example, transducer array placement guidance / support tools may be used to compare, in real time, image data (e.g., one or more images, videos, representations / avatars, etc.) of a part of the patient / subject's body (e.g., head, torso, etc.) showing the placement of one or more transducer arrays on the patient / subject's surface (skin) with a transducer array layout map that includes optimized and / or recommended areas for the placement of one or more transducer arrays on the patient / subject's surface (skin). Transducer array placement guidance / support tools may be used to guide / instruct the patient / subject on where / how to place and / or move the transducer arrays for optimal TTFields treatment.

[0027] Figure 1 shows an exemplary apparatus 100 for electrotherapy treatment. Generally, the apparatus 100 may be a portable, battery- or power-operated device that generates an alternating electric field in the body using a non-invasive surface transducer array. The apparatus 100 may comprise an electric field generator 102 and one or more transducer arrays 104. The apparatus 100 may be configured to generate tumor therapeutic electric fields (TTFields) (e.g., 150 kHz) via the electric field generator 102 and to apply the TTFields to a region of the body through one or more transducer arrays 104. The electric field generator 102 may be a battery and / or power-operated device. In one embodiment, one or more transducer arrays 104 have a uniform shape. In one embodiment, one or more transducer arrays 104 do not have a uniform shape.

[0028] The field generator 102 may include a processor 106 that communicates with the signal generator 108. The field generator 102 may also include control software 110 configured to control the execution of the processor 106 and the signal generator 108.

[0029] The signal generator 108 can generate one or more electrical signals in the form of a waveform or pulse train. The signal generator 108 may be configured to generate AC voltage waveforms with frequencies in the range of about 50 kHz to about 500 kHz (preferably about 100 kHz to about 300 kHz) (e.g., TTFields). These voltages are such that the electric field strength in the tissue to be treated is in the range of about 0.1 V / cm to about 10 V / cm.

[0030] One or more outputs 114 of the electric field generator 102 may be coupled to one or more conductive leads 112, one end of which is attached to the signal generator 108. The other end of the conductive leads 112 is connected to one or more transducer arrays 104 which are activated by an electrical signal (e.g., a waveform). The conductive leads 112 may consist of standard insulated conductors with a flexible metal shield and may be grounded to prevent the spread of the electric field generated by the conductive leads 112. One or more outputs 114 may be operated sequentially. Output parameters of the signal generator 108 may include, for example, the electric field strength, the frequency of the wave (e.g., a therapeutic frequency), and the maximum allowable temperature of the one or more transducer arrays 104. The output parameters may be set and / or determined by control software 110 in conjunction with the processor 106. After determining the desired (for example, optimal) treatment frequency, the control software 110 causes the processor 106 to send a control signal to the signal generator 108, causing the signal generator 108 to output the desired treatment frequency to one or more transducer arrays 104.

[0031] One or more transducer arrays 104 may be configured in various shapes and positions to generate an electric field of a desired configuration, direction, and intensity in a target volume, so as to be focused on treatment. One or more transducer arrays 104 may be configured to apply two perpendicular electric field directions through the volume of interest.

[0032] One or more transducer arrays 104 may comprise one or more electrodes 116. One or more electrodes 116 may be made from any material having a high dielectric constant. One or more electrodes 116 may comprise, for example, one or more insulating ceramic discs. The electrodes 116 may be biocompatible and bonded to a flexible circuit board 118. The electrodes 116 may be configured so as not to come into direct contact with the skin, as they are separated from the skin by a layer of conductive hydrogel (not shown) (similar to those found in electrocardiogram pads).

[0033] In an alternative embodiment, the transducer array 104 may comprise only a single electrode element 106. In one example, the single electrode element is a flexible organic material or flexible organic composite material positioned on a substrate. In another example, the transducer array 104 may include a flexible organic material or flexible organic composite material without a substrate.

[0034] The electrodes 116, hydrogel, and flexible circuit board 118 may be attached to a hypoallergenic medical bandage 120 to hold one or more transducer arrays 104 in place on the body and in continuous direct contact with the skin. Each transducer array 104 may be equipped with one or more thermistors (not shown) (accuracy ±1°C), for example, eight thermistors, to measure the skin temperature beneath the transducer array 104. The thermistors may be configured to measure the skin temperature periodically, for example, every second. The thermistors may be read by control software 110 when TTFields are not being delivered to avoid interference with the temperature measurement.

[0035] If the measured temperature falls below a preset maximum temperature (Tmax), e.g., 38.5–40.0°C ± 0.3°C, between two subsequent measurements, the control software 110 may increase the current until it reaches the maximum therapeutic current (e.g., 4 amperes peak-to-peak). If the temperature reaches Tmax + 0.3°C and continues to rise, the control software 110 may decrease the current. If the temperature rises to 41°C, the control software 110 may decide to stop the TTFields therapy, and an overheat alarm may be triggered.

[0036] One or more transducer arrays 104 may vary in size and / or number of electrodes 116, depending on the patient's body size and / or different treatment methods. For example, in the context of the patient's chest, a small transducer array may have 13 electrodes each, and a large transducer array may have 20 electrodes each, with the electrodes interconnected in series within each array. For example, in the context of the patient's head, as shown in Figure 2, each transducer array may have 9 electrodes each, with the electrodes interconnected in series within each array.

[0037] The status and monitoring parameters of the device 100 may be stored in memory (not shown) and transferred to a computing device via a wired or wireless connection. The device 100 may include a display (not shown) for displaying visual indicators such as power on, treatment on, alarms, and low battery.

[0038] Figures 3A and 3B illustrate application examples of the device 100. Transducer arrays 104a and 104b are shown, incorporated into hypoallergenic medical bandages 120a and 120b, respectively. The hypoallergenic medical bandages 120a and 120b are applied to the skin surface 302. The tumor 304 is located beneath the skin surface 302 and bone tissue 306, within the brain tissue 308. The field generator 102 causes transducer arrays 104a and 104b to generate an alternating electric field 310 within the brain tissue 308, disrupting the rapid cell division presented by the cancer cells of the tumor 304. The alternating electric field 310 has been shown in nonclinical experiments to halt the proliferation of tumor cells and / or destroy them. The use of alternating electric field 310 takes advantage of the specific properties, geometric shape, and division rate of cancer cells that make them susceptible to the effects of alternating electric field 310. Alternating electric field 310 changes its polarity at intermediate frequencies (on the order of 100–300 kHz). The frequency used for a particular treatment may be specific to the cell type being treated (e.g., 150 kHz for MPM). Alternating electric field 310 has been shown to disrupt mitotic spindle microtubule polymers, leading to dielectrophoretic transposition of intracellular macromolecules and organelles during cytokinesis. These processes result in physical disruption of the cell membrane and programmed cell death (apoptosis).

[0039] The effect of the alternating electric field 310 is directional, with cells dividing parallel to the electric field being more affected than cells dividing in other directions. Since cells divide in all directions, the alternating electric field 310 can be applied through two pairs of transducer arrays 104 that generate an electric field perpendicular to the tumor being treated. More specifically, one pair of transducer arrays 104 may be positioned on the left and right (LR) sides of the tumor, and the other pair of transducer arrays 104 may be positioned on the front and back (AP) sides of the tumor. Cycling the alternating electric field between these two directions (e.g., LR and AP) ensures that the widest range of cell orientations is targeted. In one embodiment, the alternating electric field 310 can be applied according to a symmetrical setup of transducer arrays 104 (e.g., four transducer arrays 104 in total, two matched pairs). In another embodiment, the alternating electric field 310 can be applied according to an asymmetrical setup of transducer arrays 104 (e.g., three transducer arrays 104 in total). An asymmetric setup of the transducer array 104 can be used to apply the alternating electric field 310, then switch to the other two of the three transducer arrays 104 to apply the alternating electric field 310, and so on.

[0040] In vivo and in vitro studies have shown that the effectiveness of TTFields therapy increases with increasing field intensity. The methods, systems, and apparatus described are configured to optimize array placement on the patient's scalp to increase intensity in the affected area of ​​the brain.

[0041] As shown in Figure 4A, the transducer array 104 may be placed on the patient's head. As shown in Figure 4B, the transducer array 104 may be placed on the patient's abdomen. As shown in Figure 5A, the transducer array 104 may be placed on the patient's torso. As shown in Figure 5B, the transducer array 104 may be placed on the patient's pelvis. Placement of the transducer array 104 on other parts of the patient's body (e.g., arms, legs, etc.) is also specifically intended.

[0042] Figure 6 is a block diagram showing a non-limiting example of system 600 including a patient support system 602. The patient support system 602 may comprise one or more computers configured to operate and / or store an EFG (Field Generator) configuration application 606, a patient modeling application 608, and / or image data 610. The patient support system 602 may comprise, for example, a computing device. The patient support system 602 may include, for example, a laptop computer, a desktop computer, a mobile phone (e.g., a smartphone), a tablet, and the like.

[0043] The patient modeling application 608 may be configured to generate a three-dimensional model (e.g., a patient model) of a portion of the patient's body according to image data 610. The image data 610 may include any type of visual data, such as single-photon emission tomography (SPECT) image data, X-ray computed tomography (X-ray CT) data, magnetic resonance imaging (MRI) data, positron emission tomography (PET) data, data that can be captured by optical instruments (e.g., photographic cameras, charge-coupled device (CCD) cameras, infrared cameras, etc.), and similar. In some implementations, the image data may also include 3D data (e.g., point cloud data) acquired from or generated by a 3D scanner. The patient modeling application 608 may also be configured to generate a three-dimensional array ray map based on the patient model and one or more electric field simulations.

[0044] To appropriately optimize array placement on a portion of the patient's body, image data 610, such as MRI image data, can be analyzed by a patient modeling application 608 to identify regions of interest, including tumors. In the context of a patient's head, a modeling framework based on an anatomical head model using finite element method (FEM) simulations can be used to characterize how electric fields behave and distribute within the human head. These simulations generate a realistic head model based on magnetic resonance imaging (MRI) measurements, separating tissue types within the head, such as the skull, white matter, gray matter, and cerebrospinal fluid (CSF). Each tissue type is assigned dielectric properties in terms of relative conductivity and relative permittivity, and simulations are performed in which different transducer array configurations are applied to the surface of the model, thereby understanding how an externally applied electric field at a preset frequency is distributed in any part of the patient's body, e.g., throughout the brain. Results from these simulations employing paired array configurations, constant current, and a preset frequency of 200 kHz demonstrate that the electric field distribution is relatively non-uniform throughout the brain, and that electric field strengths greater than 1 V / cm are generated in most tissue compartments except the CSF. These results are obtained assuming a total current with a peak-to-peak value of 1800 milliamperes (mA) at the transducer array interface with the scalp. This threshold of electric field strength is sufficient to halt cell proliferation in glioblastoma cell lines. In addition, by manipulating the configuration of the paired transducer arrays, it is possible to achieve nearly three times the electric field strength for specific regions of the brain, as shown in Figure 7. Figure 7 shows the electric field magnitude and distribution (in V / cm) as shown in coronal sections from a finite element method simulation model. This simulation employs a left-right paired transducer array configuration.

[0045] In one embodiment, the patient modeling application 608 may be configured to determine a desired (e.g., optimal) transducer array layout for the patient based on the location and extent of the tumor. For example, initial morphometric head size measurements may be determined from a T1 sequence of brain MRI using axial and coronal images. Post-contrast axial and coronal MRI slices may be selected to show the maximum diameter of the enhanced lesion. By employing measurements of head size and distance from a given reference marker to the tumor margin, various sortings and combinations of paired array layouts may be evaluated to generate a configuration that applies the maximum electric field intensity to the tumor site. As shown in Figure 8A, the output may be a three-dimensional array layout map 800. The three-dimensional array layout map 800 may be used by the patient and / or caregiver when positioning and configuring the array on the scalp during the normal course of TTFields therapy, as shown in Figure 8B.

[0046] In one embodiment, the patient modeling application 608 may be configured to determine a three-dimensional array layout map for the patient. MRI measurements of the parts of the patient that are to receive the transducer array may be determined. For example, the MRI measurements may be received via a standard Digital Imaging and Communications in Medicine (DICOM) viewer. The MRI measurement determination may be performed automatically, for example using artificial intelligence technology, or manually, for example by a physician.

[0047] Manual MRI measurement decisions may include receiving and / or providing MRI data via a DICOM viewer. MRI data may include scans of a portion of the patient containing a tumor. For example, in the context of a patient's head, MRI data may include scans of the head containing one or more of the following: a right frontotemporal tumor, a right parietal-temporal tumor, a left frontotemporal tumor, a left parietal-occipital tumor, and / or a multifocal midline tumor. Figures 9A, 9B, 9C, and 9D illustrate examples of MRI data showing scans of a patient's head. Figure 9A shows an axial T1 sequence slice including a apical image, including the orbit, used to measure head size. Figure 9B shows a coronal T1 sequence slice with an image selected at the level of the external auditory canal, used to measure head size. Figure 9C shows a post-contrast T1 axial image showing the maximum-weighted tumor diameter, used to measure tumor site. Figure 9D shows a post-contrast T1 coronal image showing the maximum-weighted tumor diameter, used to measure tumor site. MRI measurements may begin at a reference marker on the outer edge of the scalp and extend tangentially from the right, anterior, and superior origins. Morphometric head size can be estimated from an axial T1 MRI sequence, selecting the apex image (or image directly above the upper edge of the orbit) that still included the orbit.

[0048] In one embodiment, the MRI measurements may include, for example, one or more of head size measurements and / or tumor measurements. In one embodiment, one or more MRI measurements may be rounded to the nearest millimeter value and provided to a transducer array mounting module (e.g., software) for analysis. The MRI measurements may then be used to generate a three-dimensional array layout map (e.g., three-dimensional array layout map 800).

[0049] MRI measurements may include one or more head size measurements, such as the maximum anterior-posterior (AP) head size, starting from the outer edge of the scalp; the maximum head width perpendicular to the AP measurement, i.e., the lateral distance from right to left; and / or the distance from the rightmost edge of the scalp to the anatomical midline.

[0050] MRI measurements may include one or more head size measurements, such as coronal head size measurements. Coronal head size measurements can be obtained in a T1 MRI sequence that selects images at the level of the external auditory canal (Figure 9B). Coronal head size measurements may include one or more of the following: vertical measurement from the apex of the scalp to a line perpendicular to the lower edge of the temporal lobe, maximum left-right temporal width, and / or distance from the far right edge of the scalp to the anatomical midline.

[0051] MRI measurements may include one or more tumor measurements, such as tumor location measurements. Tumor location measurements may be performed first on an axial image showing the maximum-enhanced tumor diameter (Figure 9C) using a T1 contrast-enhanced MRI sequence. Tumor location measurements may include one or more of the following: maximum AP head size excluding the nose, maximum transverse diameter measured perpendicular to the AP distance, distance from the right edge of the scalp to the anatomical midline, distance from the right edge of the scalp to the nearest tumor edge measured parallel to the transverse distance and perpendicular to the AP measurement, distance from the right edge of the scalp to the furthest tumor edge measured parallel to the transverse distance and perpendicular to the AP measurement, distance from the frontal region to the nearest tumor edge measured parallel to the AP measurement, and / or distance from the frontal region to the furthest tumor edge measured parallel to the AP measurement.

[0052] One or more tumor measurements may include coronal tumor measurements. Coronal tumor measurements may include identifying a contrast-enhanced T1 MRI slice characterized by the maximum diameter of tumor enhancement (Figure 9D). Coronal tumor measurements may include one or more of the maximum distances from the apex of the scalp to the lower edge of the cerebrum. In anterior slices, this is demarcated by a horizontal line drawn at the lower edge of the frontal or temporal lobe, and posteriorly, it extends to the lowest level of the visible tent, i.e., the maximum left-right lateral head width, the distance from the right edge of the scalp to the anatomical midline, the distance from the right edge of the scalp to the nearest tumor edge measured parallel to the right-left transverse distance, the distance from the right edge of the scalp to the furthest tumor edge measured parallel to the right-left transverse distance, the distance from the vertex to the nearest tumor edge measured parallel to the inferior cerebral line, and / or the distance from the vertex to the furthest tumor edge measured parallel to the inferior cerebral line.

[0053] Other MRI measurements may be used, especially when the tumor is located in a different part of the patient's body.

[0054] MRI measurements may be used by patient modeling application 608 to generate a patient model. The patient model may then be used to determine a three-dimensional array layout map (e.g., three-dimensional array layout map 800). Continuing with the example of a tumor in the patient's head, a healthy head model may be generated that serves as a deformable template from which the patient model can be created. When creating the patient model, the tumor may be segmented from the patient's MRI data (e.g., one or more MRI measurements). Segmenting the MRI data allows for the identification of tissue types within each voxel, and based on empirical data, electrical properties may be assigned to each tissue type. Table 1 shows standard electrical properties of tissues that may be used in the simulation. The tumor region in the patient MRI data is masked, and a non-rigid registration algorithm may be used to align the remaining region of the patient's head onto a 3D discrete image representing a deformable template of the healthy head model. This process produces a non-rigid transformation that maps the healthy portion of the patient's head into template space, and then an inverse transformation that maps the template into patient space. This inverse transformation is applied to the 3D deformable template to generate an approximation of the patient's head as it would be without the tumor. Finally, the tumor (referred to as the region of interest (ROI)) is implanted back into the modified template to generate a complete patient model. The patient model may be a digital representation in three-dimensional space of parts of the patient's body, including internal structures such as tissues, organs, and tumors.

[0055] [Table 1]

[0056] Subsequently, the application of TTFields can be simulated using a patient model by patient modeling application 608. The simulated field distribution, dose measurements, and simulation-based analysis are described in U.S. Patent Application Publication 20190117956 and in "Correlation of Tumor treating Fields Dosimetry to Survival Outcomes in Newly Diagnosed Glioblastoma: A Large-Scale Numerical Simulation-Based Analysis of Data from the Phase 3 EF-14 Randomized Trial" by Ballo et al., International Journal of Radiation Oncology, Biology, Physics, 2019, 104(5), pp. 1106–1113.

[0057] A reference coordinate system may be defined to ensure the systematic positioning of the transducer array relative to the tumor location. For example, the transverse plane may first be defined by the conventional LR and anterior-posterior (AP) positioning of the transducer array. The left-right direction may be defined as the x-axis, the AP direction as the y-axis, and the craniocaudal direction, which is the normal direction to the xy-plane, as the z-axis.

[0058] After defining the coordinate system, the transducer array can be virtually placed on a patient model having its center and longitudinal axis on the xy-plane. Pairs of transducer arrays may be systematically rotated from 0 to 180 degrees around the z-axis of the head model, i.e., in the xy-plane, thereby covering the entire circumference of the head (due to symmetry). The rotation interval may be, for example, 15 degrees, corresponding to a translation of approximately 2 cm, which gives a total of 12 different positions within the 180-degree range. Other rotation intervals are also conceivable. Electric field distribution calculations may be performed for the position of each transducer array relative to the tumor coordinates.

[0059] The electric field distribution in a patient model can be determined by patient modeling application 608 using the finite element (FE) approximation method for electric potential. In general, quantities defining a time-varying electromagnetic field are given by the complex Maxwell equations. However, within biological tissue, at low to intermediate frequencies (f=200kHz) of TTFields, the wavelength of electromagnetic waves is considerably larger than the size of the head, and the dielectric constant ε is negligibly small compared to the real-valued electrical conductivity σ, i.e., ω=2πf is the angular frequency. This means that electromagnetic wave propagation and capacitance effects within the tissue are negligibly small, and therefore the scalar potential can be well approximated by the static Laplace equation ∇·(σ∇φ)=0 under appropriate boundary conditions at the electrodes and skin. Thus, the complex impedance is treated as resistive (i.e., reactance is negligible), and therefore the current flowing through a volume conductor is mainly free (ohmic) current. The FE approximation of Laplace's equation can be calculated using software such as SimNIBS software (simnibs.org). The calculation is based on the Galerkin method, requiring the residual of the conjugate gradient solver to be <1E-9. Dirichlet boundary conditions are used, and the potential is set to a (arbitrarily chosen) fixed value for each set of electrode arrays. The electric field (vector) is calculated as a numerical gradient of the potential, and the current density (vector field) can be calculated from the electric field using Ohm's law. The potential difference and current density of the electric field values ​​are linearly rescaled for each array pair so that the peak-to-peak total amplitude is 1.8A, and can be calculated as the (numerical) surface integral of the normal current density component across all triangular surface elements on the active electrode disk. The "dose" in TTFields can be calculated as the intensity (L2 norm) of the electric field vector. The modeled current can be assumed to be supplied by two separate, sequentially activated current sources, each connected to a pair of 3x3 transducer arrays. In the simulation, the left and rear arrays may be defined as sources, and the right and front arrays as corresponding sinks. However, since TTFields employs an alternating electric field, this choice is optional and does not affect the results.

[0060] The average strength of the electric field generated by transducer arrays placed at multiple locations on the patient can be determined by the patient modeling application 608 for one or more tissue types. In one embodiment, the transducer array location corresponding to the highest average electric field strength in a tumor tissue type can be selected as the desired (e.g., optimal) transducer array location for the patient. For example, a method for determining the optimal transducer array layout may include determining a region of interest (ROI) in a 3D model of a part of the subject's body. Based on the center of the ROI, a plane traversing the part of the subject's body may be determined, and the plane may include multiple pairs of locations along the contour of the plane. This method may include adjusting one or more of the multiple pairs of locations based on anatomical constraints to generate a modified plane. The anatomical constraints may be based on the anatomical features of the part of the subject's body. For example, a first electric field generated by a first transducer array may be simulated at a first position, a second electric field generated by a second transducer array may be simulated at a second position opposite to the first position, and a simulated electric field distribution may be determined based on the first and second electric fields. In some cases, a third electric field generated by a first transducer array may be simulated at a third position, a fourth electric field generated by a second transducer array may be simulated at a fourth position opposite to the third position, and a simulated electric field distribution may be determined based on the third and fourth electric fields. This method may include determining a simulated electric field distribution for each pair of positions among a plurality of pairs of positions on the modified plane, and determining a dose metric for each pair of positions among the plurality of pairs of positions based on the simulated electric field distribution. One or more sets of pairs of positions among a plurality of pairs of positions that satisfy the angular constraint conditions between pairs of transducer arrays may be determined. For example, the angle limit may be an orthogonal angle between multiple pairs of transducer arrays, and / or may indicate an orthogonal angle.The angular limit may be, for example, a range of angles between multiple pairs of transducer arrays, and / or may indicate a range of angles. One or more candidate transducer array layouts are mapped based on one or more sets of pairs of positions that satisfy the dose metric and angular limit conditions. A simulated orientation or simulated position for at least one transducer array may be adjusted at at least one position in one or more candidate transducer array layout maps. A final transducer array layout map may be determined based on the adjustment of the simulated orientation or simulated position for at least one transducer array.

[0061] The patient model may be modified, for example, to include indications for the desired transducer array positions based on the final transducer array layout map. The resulting patient model, including the indications for the desired transducer array positions, may be referred to as a three-dimensional array layout map (e.g., three-dimensional array layout map 800). Thus, the three-dimensional array layout map may include a digital representation in three-dimensional space of a portion of the patient's body, indications for tumor locations, indications for the placement of one or more transducer arrays, combinations thereof, and so on.

[0062] In one embodiment, a three-dimensional transducer array layout map having one or more recommended transducer placement positions may be generated and provided to the patient in digital and / or physical form. The patient, and / or the patient's caregiver, may use the three-dimensional transducer array layout map to attach one or more transducer arrays to relevant parts of the patient's body (e.g., head, torso, etc.).

[0063] In another embodiment, an augmented reality assisting tool may use a three-dimensional array layout map to assist a patient and / or caregiver in attaching one or more transducer arrays to relevant parts of the patient's body (e.g., head, torso, etc.). For example, transducer array placement locations, such as optimized transducer array placement positions, may be determined, and representations of the transducer array patches, disks, and / or similar objects may be presented on the surface of a patient / subject virtual model based on the determined locations. For example, an augmented reality assisting tool may be used to instruct a user (e.g., patient, patient caregiver, etc.) to capture images (e.g., photos, videos, etc.) of parts of the patient / subject's body (e.g., head, torso, etc.) for transducer array placement. Registration of images (e.g., photos, videos, etc.) to the virtual patient model may be performed, for example, in real time. After registration, representations of the transducer array patch, disk, additional landmarks, and / or similar may be virtually displayed (e.g., overlaid using augmented reality, etc.) with respect to an image and / or patient model, enabling the transducer array to be placed on the patient's surface (skin) with high precision (in an optimized position).

[0064] In some cases, transducer array placement guidance / assistance tools may be designed to guide / assist the patient / subject in positioning the transducer array on the patient / subject's surface. For example, when a patient / subject is placing one or more transducer arrays on / on the surface of any part of their body (e.g., head, torso, etc.), if one or more transducer arrays are not properly placed in a position that optimizes TTFields therapy / treatment, a three-dimensional array layout map may be used to recommend the correct movement and / or placement position for one or more transducer arrays.

[0065] In some cases, virtual reality assistance tools may be used to generate a 3D model with optimized transducer array placement positions and / or to guide / assist a patient / subject in placing one or more arrays in the optimized transducer array placement positions. For example, the virtual reality assistance tool may be a virtual reality headset, virtual reality goggles, etc. For example, a three-dimensional transducer array layout map may be provided to the patient through the virtual reality assistance tool. Furthermore, the virtual reality assistance tool may be used to provide feedback to the patient or caregiver regarding whether one or more transducer arrays are properly placed in the optimized positions.

[0066] The described method allows points in two-dimensional (2D) image data representing the actual transducer array placement on a patient / subject's body to be converted to points in three-dimensional (3D) space. The two-dimensional (2D) image data may include images captured by a user device (e.g., a smartphone, mobile device, computing device, etc.) that depicts the actual transducer array placement on a patient / subject's body. The 3D points / coordinates representing the actual transducer array placement on a patient / subject's body may be converted to 3D medical image coordinates, such as MRI coordinates, and / or registered to 3D medical image coordinates, based on the medical image data associated with the patient / subject. The actual transducer array placement may then be compared to one or more recommended transducer array placements previously determined from the medical image data, thereby determining whether the actual transducer array placement corresponds to one or more recommended transducer array placements.

[0067] For example, a patient / subject may use a user device (e.g., a smartphone, mobile device, computing device, etc.) to capture multiple images of a part of the patient / subject's body on which one or more transducer arrays are implanted for TTFields therapy / treatment, from different bandage points and / or viewpoints. The multiple images may capture the implantation locations of one or more transducer arrays. Object recognition and / or similar may be used to analyze the multiple images and determine the implantation locations of one or more transducer arrays. For example, object recognition and / or similar may be used to determine / detect one or more landmarks (e.g., anatomical landmarks, artificial landmarks, etc.) from the multiple images. One or more landmarks may be used to determine the implantation locations for one or more transducer arrays.

[0068] In some cases, a patient / subject's body may have one or more regions, such as the back of the patient's head, that lack landmarks that can be determined / detected by object recognition and used to determine the placement of one or more transducer arrays. Machine learning can be used, for example, to predict and / or estimate the placement of one or more transducer arrays in scenarios where one or more parts of one or more transducer arrays are not present and / or represented in multiple images. For example, a machine learning model can be trained to estimate the overall shape, configuration, and / or placement of a transducer array when only one or more parts of the transducer array are present and / or represented in multiple images. The estimated shape, configuration, and / or placement of one or more transducer arrays can be combined with the placement of one or more transducer arrays determined from object recognition to determine the overall shape, configuration, and / or placement of one or more transducer arrays. The machine learning model may assign estimated points / coordinates to the estimated shape, configuration, and / or placement of one or more transducer arrays.

[0069] Next, three-dimensional (3D) points (e.g., coordinates) representing and / or associated with the placement (and / or shape, configuration, etc.) of one or more transducer arrays may be determined / generated. The 3D points (e.g., coordinates) may be converted to 3D coordinates and / or used to determine three-dimensional coordinates within an anatomical coordinate system (e.g., patient coordinate system), such as 3D coordinates used in medical images incorporating anatomical planes (e.g., sagittal, coronal, transverse, etc.) (e.g., magnetic resonance imaging (MRI), X-ray computed tomography (X-ray CT) images, single-photon emission computed tomography (SPECT) images, positron emission tomography (PET) images, etc.). For example, the 3D points (e.g., coordinates) may be converted to 3D coordinates associated with one or more medical images associated with the patient / subject.

[0070] The placement / location of one or more transducer arrays, as determined and / or indicated by 3D coordinates associated with an anatomical coordinate system, can be compared to an optimized transducer array placement location indicated by a 3D transducer array layout map. The optimized transducer array placement location may be based on one or more TTFields treatment / therapy simulations performed on one or more medical images associated with the patient / subject. The optimized transducer array placement location may be recommended to the patient / subject, for example, to facilitate the optimal effect of the TTFields therapy / treatment. For example, the placement / location of one or more transducer arrays can be displayed (e.g., superimposed, overlaid, etc.) alongside the optimized (e.g., recommended, etc.) transducer array placement location. In some cases, the placement / location of one or more transducer arrays can be displayed (e.g., superimposed, overlaid, etc.) alongside representations of transducer array patches, disks, and / or similar objects at the optimized (e.g., recommended, etc.) transducer array placement location.

[0071] In another embodiment, the arrangement / position on which one or more transducer arrays are placed may be compared to and displayed (e.g., superimposed, overlaid, etc.) one or more recommended transducer array placement positions. In one example, one or more transducer placements and one or more recommended transducer placement positions may be displayed with actual images and / or realistic depictions of the patient / subject and / or parts of the patient / subject's body. In another example, one or more transducer placements and one or more recommended transducer placement positions may be displayed with surrogate images (e.g., avatars, etc.) of the patient / subject and / or parts of the patient / subject's body.

[0072] In one embodiment, the arrangement / position on which one or more transducer arrays are mounted may not coincide with one or more recommended transducer array mounting positions. For example, based on comparing 3D coordinates associated with anatomical coordinates with optimized transducer array mounting positions shown by a 3D transducer array layout map, the variance of at least one of the mounting positions for one or more transducer arrays from at least one of the recommended transducer mounting positions may be determined. To resolve the variance, any movement of the arrangement / position on which one or more transducer arrays are mounted (e.g., corrective movement) that causes the arrangement / position on which one or more transducer arrays are mounted to coincide with one or more recommended transducer mounting positions may be transmitted to the patient / subject, for example, as a notification. The notification may be a visual notification, an auditory notification, a text notification, and / or similar.

[0073] Figure 10 shows an exemplary system for inductive transducer mounting to TTFields. In some cases, the components of system 1000 may be implemented as a single device and / or similar. In some cases, the components of system 1000 may be implemented as separate devices / components communicating with each other collectively. In one embodiment, some or all steps of any described method may be performed on and / or via the components of system 1000.

[0074] System 1000 may include a user device 1020. User device 1020 may be an electronic device, such as a smartphone, mobile device, computing device, and / or similar, that can communicate with the patient support module 1001. User device 1020 may include an imaging module 1021. The imaging module 1021 may include one or more image capture devices, such as one or more video cameras, that determine / capture a first set of real-world-representing image data (e.g., video data, static / still images, dynamic / interactive images, etc.) for System 1000. In one example, user device 1020 may be used to determine one or more recommended transducer placement positions. In some cases, System 1000 may comprise multiple user devices (e.g., a second user device 1026) having imaging modules that share and / or exchange data / information, such as image data. The imaging module 1021 may capture image data that provides a real-time, real-world representation of the user (e.g., a patient, subject, etc.), such as a real-time, real-world representation of the user and / or a part of the user's body (e.g., head, torso, etc.). For example, the imaging module 1021 may be used to capture / photograph video images of a part of the user's body (related to the location) to which TTFields therapy should be administered, via one or more transducer arrays.

[0075] The user device 1020 may include an interface module 1022. The interface module 1022 may provide the user with an interface for interacting with the user device 1020 and / or the patient support module 1001. The interface module 1022 may include one or more input devices / interfaces, such as a keyboard, a pointing device (e.g., a computer mouse, a remote control), a microphone, a joystick, a scanner, a tactile sensing and / or tactile input device, and / or similar.

[0076] Interface module 1022 may include one or more interfaces for presenting and / or receiving information with the user, such as user feedback. Interface module 1022 may include any software, hardware, and / or interfaces used to provide communication between the user and one or more of the user device 1020, patient support module 1001, and / or other arbitrary components of system 1000. Interface module 1022 may include one or more audio devices (e.g., stereo, speakers, microphones, etc.) for capturing / acquiring and transmitting audio information, such as audio information captured / acquired from and / or transmitted to the user. Interface module 1022 may include a graphical user interface (GUI), a web browser (e.g., Internet Explorer®, Mozilla Firefox®, Google Chrome®, Safari®, etc.), and applications / APIs. Interface module 1022 may request and / or query various files from local sources and / or remote sources, such as patient support module 1001.

[0077] The interface module 1022 may transmit data to local or remote devices / components of system 1000, such as the patient support module 1001. The user device 1020 may include a communication module 1023. The communication module 1023 may enable the user device 1020 to communicate with components of system 1000, such as the patient support module 1001 and / or other user devices, via wired and / or wireless communication technologies. For example, the communication module 1023 may utilize any suitable wired communication technology, such as Ethernet, coaxial cable, optical fiber, and / or similar. The communication module 1023 may utilize any suitable long-range communication technology, such as Wi-Fi (IEEE 802.11), Bluetooth®, cellular, satellite, infrared, and / or similar. The communication module 1023 may utilize any suitable short-range communication technology, such as Bluetooth®, near-field communication, infrared, and similar.

[0078] The interface module 1022 may include one or more displays (e.g., monitors, head-up displays, head-mounted displays, liquid crystal displays, organic light-emitting diode displays, active-matrix organic light-emitting diode displays, stereo displays, virtual reality displays, etc.) for displaying / presenting information to a user (e.g., a patient, a subject, etc.), such as augmented reality and / or virtual images, mirrored images, superimposed images, and / or similar. For example, the interface module 1022 may display a representation of the user and / or a part of the user's body (e.g., head, torso, etc.) based on a first set of image data captured by the imaging module 1021. In some cases, the representation of the user and / or a part of the user's body (e.g., head, torso, etc.) may be an actual (e.g., mirrored) representation of the user and / or a part of the user's body (e.g., head, torso, etc.). In some cases, the representation of the user and / or a part of the user's body may represent the user and / or a part of the user's body from different viewpoints, angles / positions, fields of view, and / or similar. In some cases, representations of the user and / or parts of the user's body may include actual (e.g., mirrored) representations of the user and / or parts of the user's body, as well as representations of the user and / or parts of the user's body from different viewpoints, angles / positions, fields of view, and / or similar, such as split-view representations of the user and / or parts of the user's body. In some cases, representations of the user and / or parts of the user's body may include general / replica representations of the user and / or parts of the user's body, such as general images, duplicate images, wireframe / stick images, virtual images (e.g., avatars), and / or similar.To generate and / or display general / replica representations of the user and / or parts of the user's body, such as general images, replica images, wireframe / stick images, virtual images (e.g., avatars), and / or similar, the user device may transmit to the patient support module 1001 a first set of image data (e.g., video data, static / still images, dynamic / interactive images, etc.) associated with parts of the user's body (e.g., head, torso, etc.) captured by the imaging module 1021. In some cases, one or more user devices may transmit to the patient support module 1001 image data (e.g., compiled image data, image data taken from one or more viewpoints, etc.) associated with parts of the user's body (e.g., head, torso, etc.).

[0079] The patient support module 1001 may use image data (and / or compiled image data) from the user device 1020 to determine a patient model associated with the user and determine a transducer array mounting position, such as an optimized transducer array mounting position, on the patient model, where the transducer array (or associated equipment such as patches, disks, array mounting supports, and / or similar) may be represented as one or more images superimposed / overlaid with the image data.

[0080] System 1000 may include a second user device 1026. The second user device 1026 may be a different user device from user device 1020, or it may be the same user device as user device 1020. The second user device 1026 may be used to determine the actual placement of one or more transducers. User device 1026 may be an electronic device such as a smartphone, mobile device, computing device, virtual reality support tool, and / or similar, which can communicate with the patient support module 1001. The second user device 1026 may include an interface module 1028. The interface module 1028 may provide the user with an interface for interacting with the second user device 1026 and / or the patient support module 1001. The interface module 1028 may have a structure similar to and / or similar functionality to interface module 1022.

[0081] The interface module 1028 may transmit data to local or remote devices / components of system 1000, such as the patient support module 1001. The second user device 1026 may include a communication module 1029. The communication module 1029 may enable the second user device 1026 to communicate with components of system 1000, such as the patient support module 1001 and / or other user devices, via wired and / or wireless communication technology. The communication module 1029 may have a structure similar to and / or similar functionality to the communication module 1023.

[0082] The second user device 1026 may include an imaging module 1027. The imaging module 1027 may include one or more image capture devices, such as one or more cameras, that determine / capture a second set of image data (e.g., static / still images, dynamic / interactive images, video, etc.). The imaging module 1027 may capture image data that provides a real-time and / or real-world representation of the user (e.g., a patient, subject, etc.), such as a real-time and / or real-world representation of the user and / or a part of the user's body (e.g., head, torso, etc.). For example, the imaging module 1027 may be used to capture / photograph images and / or videos of a part of the user's body (related to the location) to which TTFields therapy should be administered via one or more transducer arrays.

[0083] To generate and / or display a representation of the user and / or a part of the user's body, the second user device 1026 may transmit image data (e.g., video data, static / still images, dynamic / interactive images, etc.) associated with a part of the user's body (e.g., head, torso, etc.) captured by the imaging module 1027 to the patient support module 1001. The second set of image data may include multiple images taken from multiple bandage points, viewpoints, and / or similar locations associated with a part of the user's body.

[0084] Image data may include data indicating and / or determined from one or more tracking points / landmarks, such as anatomical landmarks and / or visual / artificial landmarks. For example, anatomical landmarks may include body placements (e.g., head, bones / ligaments, joints, etc.) and / or facial expression points (e.g., eyes, nose, eyebrows, etc.). Visual / artificial landmarks may include one or more indicators (e.g., stickers, mark / removable tattoos, objects, etc.) placed on one or more placements / positions on the user and / or parts of the user's body.

[0085] The patient support module 1001 may include a processor 1008. The processor 1008 may be a hardware device for executing software, particularly stored in memory 1010. The processor 1008 can be any custom-made or commercially available processor, a central processing unit (CPU), an auxiliary processor among several processors associated with the patient support module 1001, a semiconductor-based microprocessor (in the form of a microchip or chipset), or any device for executing software instructions in general. When the patient support module 1001 is operating, the processor 1008 may be configured to execute software stored in memory 1010, communicate data with memory 1010, and generally control the operation of the patient support module 1001 according to the software.

[0086] The I / O interface 1012 may be used to receive user input from one or more devices or components, such as user device 1020 and / or a second user device 1026, and / or to provide system output to one or more devices or components. User input may be provided, for example, via a keyboard, mouse, data / information communication interface, and / or similar. The I / O interface 1012 may include, for example, a serial port, parallel port, Small Computer System Interface (SCSI), IR interface, RF interface, and / or Universal Serial Bus (USB) interface.

[0087] The network interface 1014 may be used to transmit and receive data / information from the patient support module 1001. The network interface 1014 may include, for example, a 10BaseT Ethernet adapter, a 100BaseT Ethernet adapter, a LAN PHY Ethernet adapter, a Token Ring adapter, a wireless network adapter (e.g., WiFi), or any other suitable network interface device. The network interface 1014 may include address, control, and / or data connections to enable appropriate communication.

[0088] The memory 1010 (memory system) may include any one or a combination of volatile memory elements (e.g., random access memory (RAM such as DRAM, SRAM, SDRAM, etc.)) and non-volatile memory elements (e.g., ROM, hard drives, tapes, CD-ROMs, DVD-ROMs, etc.). Furthermore, the memory 1010 may incorporate electronic, magnetic, optical, and / or other types of storage media. In some cases, the memory system 1010 may have a distributed architecture in which various components are located geographically separated from each other but can be accessed by the processor 1008.

[0089] Memory 1010 may contain one or more software programs, each containing an ordered listing of executable instructions for implementing logical functions. For example, memory 1010 may contain an EFG configuration application 606, a patient modeling application 608, image data 610, and a preferred operating system (O / S) 1018. The operating system 1018 essentially controls the execution of other computer programs and provides scheduling, input / output control, file and data management, memory management, and communication control and related services.

[0090] The patient support module 1001 may include an image processing module 1016. The image processing module 1016 may process image data from the user device 1020 and image data from the second user device 1026. In some cases, the image processing module 1016 may use artificial intelligence and / or machine learning, such as image recognition, to identify the user and / or parts of the user's body (e.g., head, torso, whole body, etc.). In some cases, the image processing module 1016 may use one or more object tracking algorithms and / or similar to determine / detect the arrangement of various tracking points on the user. For example, the tracking points may include body placement (e.g., head, bones / ligaments, joints, etc.) and / or facial expression points (e.g., eyes, nose, eyebrows, etc.). The arrangement of various tracking points may be provided to the avatar mapping and rendering module 1025. The avatar mapping and rendering module 1025 may use one or more mapping algorithms to map the user's tracked points to an avatar (e.g., a general image, a duplicate image, a wireframe / stick image, a virtual image, etc.). Mapping the user's tracked points to an avatar may allow one or more captured images of the user (e.g., image data) to be represented by the avatar. The patient support module 1001 (avatar mapping and rendering module 1025) may transmit the avatar (e.g., data / information representing the avatar, etc.) to the user device 1020 and / or a second user device 1026 for display.

[0091] In some cases, to assist the user in placing the transducer array, the image processing module 1016 may use facial recognition along with image data to identify the user. The image processing module 1016 may use object recognition along with image data to identify the user (e.g., identifying identification marks / scars on the user) and / or parts of the user's body represented by the image data (e.g., head, torso, whole body, etc.). In some cases, the image processing module 1016 may use object recognition along with image data to determine “sensitive areas” such as scar areas, blemish areas, genitals, and / or similar. The image processing module 1016 may modify the image to obscure, cover, and / or similarly obscure “sensitive areas” when the image data is displayed.

[0092] In some cases, the image processing module 1016 may determine one or more landmarks from image data. For example, the image processing module 1016 may be used to determine / detect anatomical landmarks from image data. In one example, the image processing module 1016 may determine one or more landmarks indicated by image data received from a user device 1020 and one or more landmarks indicated by image data received from a second user device 1026. Furthermore, the image processing module 1016 may determine that one or more landmarks indicated by image data received from user device 1020 correspond to one or more landmarks indicated by image data received from the second user device 1026. The image processing module 1016 may use artificial intelligence and / or machine learning, such as image / object recognition, to identify one or more landmarks (e.g., anatomical landmarks, artificial landmarks, etc.) depicted by one or more images among a plurality of images included with the image data. In some cases, the image processing module 1016 may use one or more object identification and / or tracking algorithms to determine / detect the location of one or more landmarks. In some cases, the image processing module 1016 may use object recognition along with image data to determine “sensitive areas” such as scars, blemishes, genitals, and / or similar areas. The image processing module 1016 may modify the image to obscure, cover, and / or similarly obscure “sensitive areas” when the image data is displayed.

[0093] The image processing module 1016 may be used to determine / detect objects depicted by image data, such as the actual (e.g., real-time) placement of one or more transducer arrays on the user and / or parts of the user's body.

[0094] In some cases, a portion of a user's body may have one or more regions, such as the back of the user's head, that lack landmarks that can be determined / detected by object recognition and used to determine the placement of one or more transducer arrays. The image processing module 1016 may use machine learning to predict and / or estimate the placement of one or more transducer arrays in scenarios where, for example, one or more portions of one or more transducer arrays are not present and / or represented in multiple images. The image processing module 1016 may include a trained machine learning model that can estimate / predict the overall shape, configuration, and / or placement of a transducer array when only one or more portions of the transducer array are present and / or represented in multiple images. The estimated shape, configuration, and / or placement of one or more transducer arrays may be combined with the placement of one or more transducer arrays determined from object recognition to determine the overall shape, configuration, and / or placement of one or more transducer arrays. The image processing module 1016 may assign the estimated points / coordinates to the estimated shape, configuration, and / or mounting position of one or more transducer arrays.

[0095] The image processing module 1016 may use the estimated shape, configuration, and placement of one or more transducer arrays, and / or one or more landmarks, as reference points for coordinate axes relative to a coordinate system (e.g., a 2D coordinate system, a 3D coordinate system, world coordinates, etc.). For example, one or more landmarks may define a spatial position (translation value) that can be used with transformation and / or projection matrices to determine a 3D point representing one or more landmarks in 3D space. A 4x4 matrix may be used to represent a coordinate system (e.g., a 2D coordinate system, a 3D coordinate system, etc.) and may be used to transform a 3D point from a coordinate system relating to a second user device 1026 (e.g., a 2D coordinate system, a 3D coordinate system, world coordinates, etc.) to a coordinate system relating to medical image data (e.g., 3D coordinates, etc.). For example, a 3D point (e.g., coordinates) may be transformed into and / or associated with 3D coordinates of one or more medical images. One or more medical images may be received from user device 1020.

[0096] Information / data identifying the user and / or a part of the user's body may be transmitted to the patient support module 1001 (image processing module 1016) along with the image data. After the user is identified, the image processing module 1016 may access / retrieve patient models associated with the user, such as the patient model created by the patient modeling application 608.

[0097] The patient support module 1001 may include an image registration module 1017. Image registration may involve registering image data to a three-dimensional transducer array map generated / output by the patient modeling application 608 (e.g., a patient model combined with a final transducer array layout map). For example, in some cases, the image registration module 1017 may determine the relationships between user coordinate systems, such as a coordinate system based on the bandage points of the user and / or user device 1020 (e.g., the bandage points of the imaging module 1021), a coordinate system of the object to which one or more transducer arrays should be applied (e.g., the user), and a coordinate system for the three-dimensional transducer array map. The image registration module 1017 may align, fix, and / or stabilize the three-dimensional transducer array map with respect to images of the object to which one or more transducer arrays should be applied, based on the center of the field of view associated with the bandage points of the user and / or user device 1020, and the principal axis relationships between the respective coordinate systems. In some cases, the image registration module 1017 may register image data to a three-dimensional transducer array map by associating landmarks included with the image data with landmarks shown on the three-dimensional transducer array map. Landmarks may include physical markers such as the user's nose, mouth, ears, arms, and / or similar. Landmarks may be determined by the image processing module 1016, for example, based on object recognition and / or similar, and provided to the image registration module 1017 for image registration. The image registration module 1017 may register image data to a three-dimensional transducer array map based on a surface analysis method in which an affine transformation method and / or one or more surface matching algorithms are applied to the rigid surfaces of the image data and one or more objects identified in the three-dimensional transducer array map.For example, a set of points (e.g., a point set) may be extracted from contours in image data, and a set of points (e.g., a point set) may be extracted from contours in a three-dimensional transducer array map. An iterative nearest neighbor algorithm and / or correspondence matching algorithm may be applied to both sets of points. The image registration module 1017 may register the image data to the three-dimensional transducer array map based on any method and / or technique.

[0098] In some cases, the three-dimensional transducer array map may include and / or associate geometric shape and / or dimensional information (e.g., shape, size, etc.) for one or more transducer arrays (and / or transducer array support devices such as patches, disks, and / or similar) that should be placed at user locations (optimized locations) based on the three-dimensional transducer array map. Registered image data (e.g., video images registered to the three-dimensional transducer array map) and geometric shape and / or dimensional information (e.g., shape, size, etc.) for one or more transducer arrays (and / or transducer array support devices such as patches, disks, and / or similar) may be provided to the graphics rendering module 1019 that generates a graphic guide along with the registered image data. The graphic guide may include a representation of one or more transducer arrays (and / or transducer array support devices such as patches, disks, and / or similar) shown at user locations (e.g., optimized locations) based on the three-dimensional transducer array map.

[0099] Registered image data and associated graphic guides may be provided to the image rendering module 1024. The image rendering module 1024 may use the registered image data and associated graphic guides to generate composite data. The composite data may include a three-dimensional transducer array map (and associated graphic guides) combined with the image data (e.g., superimposed, overlaid, etc.). In another example, the composite data may include the actual placement / location of one or more transducer arrays, as determined and / or indicated by three-dimensional coordinates associated with an anatomical coordinate system, as well as optimized (e.g., recommended, etc.) transducer array placement locations indicated by the 3D transducer array layout map. A second user device 1026 may trigger a display of the composite data (in real time), for example, via the interface module 1028. For example, the placement / location of one or more transducer arrays may be displayed together with the optimized (e.g., recommended, etc.) transducer array placement locations (e.g., superimposed, overlaid, etc.). In some cases, the arrangement / location on which one or more transducer arrays are mounted may be shown with representations of transducer array patches, disks, and / or similar elements at optimized (e.g., recommended, etc.) transducer array mounting locations (e.g., superimposed, overlaid, etc.).

[0100] Furthermore, the image registration module 1017 may register 3D coordinates (e.g., 3D points transformed from image data) associated with an anatomical coordinate system to a 3D transducer array layout map. For example, the image registration module 1017 may determine the coordinates of various landmarks indicated by image data transformed into an anatomical coordinate system. The image registration module 1017 may determine the coordinates of one or more landmarks indicated by the 3D transducer array layout map and / or the coordinates of one or more transducer arrays indicated by the 3D transducer array layout map. The image registration module 1017 may determine that the transformed coordinates (e.g., 3D points transformed from image data) of various landmarks indicated by image data correspond to the coordinates of one or more landmarks and / or transducer arrays indicated by the 3D transducer array layout map.

[0101] In some cases, the image registration module 1017 may determine the relationship between an anatomical coordinate system (e.g., 3D points transformed from image data) and a coordinate system for the 3D transducer array layout map. Based on the center of the field of view associated with the image of the bandage point / or viewpoint included with the image data, and the principal axis relationships between the respective coordinate systems, the image registration module 1017 may align, fix, and / or stabilize the 3D transducer array layout map with respect to the anatomical coordinate system (e.g., 3D points transformed from image data). In some cases, the image registration module 1017 may register 3D coordinates (e.g., 3D points transformed from image data) associated with an anatomical coordinate system to the 3D transducer array layout map based on a surface analysis method in which an affine transformation method and / or one or more surface matching algorithms are applied to the rigid surfaces of one or more objects identified in the image data and the 3D transducer array layout map. For example, a set of points (e.g., a point set) may be extracted from a contour in image data, and a set of points (e.g., a point set) may be extracted from a contour in a 3D transducer array layout map. An iterative nearest neighbor algorithm and / or correspondence matching algorithm may be applied to both sets of points. The image registration module 1017 may register 3D coordinates (e.g., 3D points converted from image data) associated with an anatomical coordinate system to the 3D transducer array layout map based on any method and / or technique.

[0102] For example, in some cases, the patient support module 1001 (e.g., image processing module 1016, image registration module 1017, etc.) may determine one or more landmarks indicated by medical image data associated with the user. A projection matrix may be used to determine the 2D representation of one or more landmarks indicated by the medical image data. The patient support module 1001 may, for example, use object recognition to determine one or more landmarks indicated by first image data received from user device 1020 and one or more landmarks indicated by second image data received from second user device 1026. The patient support module 1001 may determine that the 2D representation of one or more landmarks indicated by the first image data corresponds to one or more landmarks indicated by the second image data. Based on the correspondence between the 2D representation of one or more landmarks indicated by the first image data and one or more landmarks indicated by the second image data, the patient support module 1001 may determine the representation of one or more landmarks indicated by image data received from second user device 1026 in three-dimensional (3D) space. Subsequently, representations of one or more landmarks indicated by second image data received from a second user device 1026 in three-dimensional (3D) space are associated with a 3D transducer array layout map, which includes recommended placement positions for the transducer array, and / or may be registered to the 3D transducer array layout map.

[0103] As described, an avatar may be a general / replica representation of the user and / or a part of the user's body, such as a general image, a replica image, a wireframe / stick image, a virtual image, and / or similar. For example, user device 1020 via interface module 1022, and / or a second user device 1026 via interface module 1028, for example, may display an avatar. In some cases, an avatar may be displayed as a static (e.g., non-moving) image representing the user and / or a part of the user's body. In some cases, a tracked point of the user may be mapped to the avatar, and one or more kinetic algorithms may be used to mirror, represent, generalize, and / or have the avatar perform similar operations based on the image data.

[0104] Figure 11A illustrates exemplary image data (e.g., video) captured by a user device. Video images 1100 of a region (e.g., the user's head) associated with a transducer array placement on the user may be captured by one or more cameras and displayed to the user via the user device, for example, in real time. For example, in some cases, the video image 1100 may include image data captured by different cameras (imaging modules) associated with each of one or more user devices. Figure 11B shows an exemplary avatar 1101 that may be used for an assisted transducer array placement generated from the video image 1100. The avatar 1101 may be displayed as a static (e.g., non-moving) avatar representing the user and / or a part of the user's body. For example, the avatar 1101 represents the user's head as depicted by the video image 1100. In some cases, user-tracked points may be mapped to an avatar, and one or more kinetic algorithms may be used to mirror, represent, generalize, and / or cause the avatar to perform image-based user movements, such as movements and / or similar movements associated with transducer array placement.

[0105] Figure 12A shows exemplary image data (e.g., video) that may be used for assisted transducer array placement. Video images 1200 of the relevant region (e.g., the user's head) relative to the transducer array placement on the user (e.g., the user's head) may be captured by one or more cameras and displayed to the user via a user device, for example, in real time. Figure 12B shows an exemplary three-dimensional transducer array map 1201 that may be used for assisted transducer array placement. The three-dimensional transducer array map may include one or more graphic guides. The graphic guides may indicate the arrangement in which objects associated with TTFields treatment should be placed / positioned on the user. For example, graphic guide 1203 may be the contour of a transducer array patch placed in a predetermined position (optimized position) on the three-dimensional transducer array map 1201 for effective TTFields treatment. Graphic guides 1204 and 1205 may indicate the arrangement in which transducers should be placed on the user for effective TTFields treatment.

[0106] Figure 12C shows an example of composite data 1206 presented with actual images and / or realistic depictions of a patient / subject and / or a part of the patient / subject's body. The composite data 1206 may be displayed to the user, for example, in real time via a user device, to assist in user transducer array placement. In one example, the composite data includes one or more transducer placement locations overlaid on one or more recommended transducer placement locations. In a more specific example, the composite data includes a three-dimensional (3D) model showing one or more transducer placement locations and one or more recommended transducer placement locations.

[0107] Figure 12D shows another example of composite data 1207 presented with a surrogate image (e.g., an avatar) of a patient / subject and / or a part of the patient / subject's body. The composite data 1207 may be displayed to the user (e.g., via a second user device 1026) in real time to assist in user transducer array placement. The composite data 1207 may include a three-dimensional transducer array map 1201 superimposed / overlaid on the avatar 1101.

[0108] Object recognition and tracking (performed, for example, by the image processing module 1016) may be used to identify objects in image data represented by the graphic guide, such as transducer arrays, transducer array patches, and / or transducer array mounting components (e.g., disks, tapes, etc.), and / or similar. For example, object recognition and tracking may be used to track the user's movements when placing (or attempting to place) an object represented by the graphic guide onto a part of the user's body. In some cases, audible (voice) commands (via interface module 1028, etc.) may be provided to the user to guide their movements when placing (or attempting to place) an object represented by the graphic guide onto a part of the user's body. In Figure 12D, in some cases, the movements of the avatar 1101 may mirror the user's movements. For example, movements made by the user when placing a transducer array at one or more locations may be mirrored by the avatar 1101. In some cases, the avatar 1101 and / or composite data 1207 may remain entirely static (non-moving), and only one or more parts of the composite data 1207, such as the represented transducer array and / or graphic guide, mirror / represent user movements, such as the movement of the transducer array when the transducer array is placed in one or more positions.

[0109] Feedback and / or confirmation may be provided to the user via a second user device 1026 to indicate the placement of an object represented by the graphic guide onto the user (on the user's skin surface). For example, the placement (or attempt to place) a transducer array patch onto a location on the user indicated by graphic guide 1203, and / or the placement (or attempt to place) a transducer onto a location on the user indicated by graphic guides 1204 and 1205 may result in instructions being given to the user. In some cases, the graphic guide may be color-coded to indicate the placement of an object represented by the graphic guide onto the user. For example, the graphic guide may be represented in yellow. If the placement of the object represented by the graphic guide is correct, the graphic guide may transition to green; if the placement of the object is incorrect, the graphic guide may transition to red. In some cases, an audible indicator / notification may be provided to the user to indicate the correct and / or incorrect placement of an object represented by the graphic guide.

[0110] The appropriate and / or inappropriate placement of an object represented by a graphic guide may be based on one or more tolerance thresholds. In some cases, an object represented by a graphic guide, placed on the user at a location indicated by the graphic guide, may be determined to be within or outside the range of a target metric for the location indicated by the graphic guide, for example, by the correlation of object recognition and coordinate systems (e.g., the user's coordinate system, a coordinate system for a three-dimensional transducer array map, etc.). In some cases, one or more sensing components, such as accelerometers, gyroscopes, tactile sensors, global positioning sensors, and / or similar, configured with the object represented by the graphic guide (e.g., a transducer array patch), may be used to provide data / information that can be used to determine the placement / position of the object relative to the graphic guide. The placement / position of the object relative to the graphic guide may be compared to one or more placement / position thresholds to determine the appropriate and / or inappropriate placement of the object.

[0111] Figures 13A–13D illustrate an example of induction transducer placement for TTFields. Figure 13A shows an exemplary system 1300 for determining and / or capturing image data that may be used for induction transducer array placement. A second user device 1026 may capture multiple images of user 1301, such as images of the user's head and / or any other part of the user's body to be treated with TTFields. The transducer array may be placed at different locations on user 1301. For example, transducer arrays 1302 and 1303 may be placed on user 1301's head.

[0112] To determine whether transducer arrays 1302 and 1303 are positioned to promote the optimal effect of TTFields treatment, a second user device 1026 may capture multiple images of user 1301 depicting where transducer arrays 1302 and 1303 are positioned relative to user 1301. Multiple images may be taken for multiple bandage points, viewpoints, and / or similar. For example, the second user device 1026 may capture images from locations 1304, 1305, 1306, and 1307.

[0113] As described, image data associated with and / or showing multiple images may include data / information extracted from and / or associated with multiple images (e.g., features, data indicating one or more recognized objects, coordinate data / information, etc.). For example, image data may include data indicating one or more landmarks and / or tracking points, such as anatomical landmarks and / or visual / artificial landmarks. Anatomical landmarks may include body placements (e.g., head, bones / ligaments, joints, etc.) and / or facial expression points (e.g., eyes, nose, eyebrows, etc.). For example, anatomical landmark 1308 may include the nasal root of user 1301, and anatomical landmark 1309 may include ear hairs of user 1301. Visual / artificial landmarks may include one or more indicators (e.g., stickers, mark / removable tattoos, objects, etc.) placed on one or more placements / locations on the user and / or parts of the user's body. For example, landmark 1310 may include an indicator (e.g., a sticker, a mark / removable tattoo, an object, etc.) placed on the transducer array 1302 so that the transducer array 1302 can be determined / identified from the image data.

[0114] One or more landmarks may be used as reference points for coordinate axes relative to a coordinate system (e.g., a 2D coordinate system, a 3D coordinate system, etc.) relating to the second user device 1026. The coordinate system (e.g., a 2D coordinate system, a 3D coordinate system, etc.) relating to the user device 1026 may be used to generate and / or determine 3D points and / or coordinates that may be associated with additional image data associated with user 1301, such as medical image data. The medical image data may include volumetric and / or three-dimensional (3D) representations of user 1301 and / or parts of user 1301's body (e.g., the head, etc.) used to determine the transducer array layout map. The medical image data may include magnetic resonance imaging (MRI) data, X-ray computed tomography (X-ray CT) data, single-photon emission tomography (SPECT) image data, positron emission tomography (PET) data, and / or similar data associated with user 1301.

[0115] To associate 3D points derived from image data associated with a user with one or more medical images associated with the user, the second user device 1026 may generate and / or determine data / information associated with the image data, such as a device identifier, user identifier, user information, and / or similar. The device identifier, user identifier, user information, and / or similar are transmitted to the patient support module 1001 along with the image data and may be used to determine / identify additional image data associated with user 1301, such as medical image data. 3D points indicating one or more placement positions on one or more transducer arrays, derived from image data associated with the user, may be transmitted from the user device 1026 to the patient support module 1001. 3D points indicating one or more placement positions on one or more transducer arrays may be associated with medical image data. In some cases, image data and / or data / information associated with the image data may be transmitted to the patient support module 1001. The patient support module 1001 may determine 3D points indicating one or more placement positions on one or more transducer arrays and associate the 3D points with medical image data.

[0116] In one example, one or more landmarks from image data may be used as reference points for the coordinate axes of a coordinate system (e.g., a 2D coordinate system, a 3D coordinate system, etc.) relating to the user device 1026. The coordinate system (e.g., a 2D coordinate system, a 3D coordinate system, etc.) relating to the user device 1026 may be used to generate and / or determine 3D points and / or coordinates. The image processing module 1016 may use the shape, configuration, mounting position, and / or one or more landmarks of one or more transducer arrays as reference points for the coordinate axes of a coordinate system (e.g., a 2D coordinate system, a 3D coordinate system, a world coordinate system, etc.) relating to a second user device 1026.

[0117] One or more landmarks represented in 3D space may represent and / or be associated with the actual placement locations of one or more transducer arrays (e.g., transducer arrays 1302 and 1303). The actual placement locations of one or more transducer arrays (e.g., transducer arrays 1302 and 1303) may be compared to the optimized transducer array placement locations indicated by the 3D transducer array layout map.

[0118] The patient support module 1001 may use data / information associated with image data (e.g., device identifier, user identifier, user information, coordinate data / information, etc.) to determine a transducer array layout map including an optimized transducer array placement location associated with the user. The optimized transducer array placement location may be determined from one or more TTFields treatment / therapy simulations performed based on one or more medical images associated with the user. The optimized transducer array placement location may be recommended to the patient / subject, for example, to facilitate the optimal effect of the TTFields therapy / treatment. For example, the arrangement / location in which one or more transducer arrays are actually placed may be displayed (e.g., superimposed, overlaid, etc.) along with the optimized (e.g., recommended, etc.) transducer array placement location.

[0119] Figure 13B shows an exemplary representation 1320 of image data used to guide transducer array placement. Image data determined / captured by a second user device 1026 may be represented as static (e.g., non-moving, etc.) or dynamic images of user 1301 and / or parts of user 1301's body in Figure 13A. For example, avatar 1321 may represent user 1301. User 1301 may be represented by avatar 1321 to mitigate any privacy concerns and / or user resistance associated with transmitting image data depicting “sensitive areas” such as scar areas, blemish areas, genitals, and / or similar. Various landmarks (e.g., landmark 1310, anatomical landmark 1309, etc.), as well as transducer arrays 1302 and 1303, as illustrated, are represented in representation 1320.

[0120] Figures 13C and 13D show exemplary representations of surface-based registration. The image processing module 1016 may use image data of user 1301 depicting a part of the user's body, such as the head, to determine a plurality of points 1331 (e.g., a dataset) representing the facial skin surface of user 1301. Surface 1332 represents a skin surface extracted from medical image data associated with user 1301. Figure 13C shows, for example, the initial positions of the plurality of points 1331 determined by the image processing module 1316. Figure 13D shows the plurality of points 1331 after registration to surface 1332, for example, by the image registration module 1017. Registration may be performed using, for example, an iterative nearest neighbor algorithm and / or similar.

[0121] The patient support module 1001 may determine that the actual placement / position of one or more transducer arrays does not coincide with an optimized (e.g., recommended, etc.) transducer array placement position. For example, based on comparing 3D coordinates associated with anatomical coordinates with an optimized transducer array placement position indicated by a 3D transducer array layout map, the patient support module 1001 may determine the distribution of at least one of one or more placement positions for one or more transducer arrays from at least one of the optimized (e.g., recommended, etc.) transducer array placement positions.

[0122] Figures 14A–14C illustrate examples of resolving / correcting variance. Figure 14A is an example of a visual notification 1430 that may be used to guide transducer array placement. The placement / position where the transducer array electrodes are placed on the user, and the optimized (e.g., recommended, etc.) transducer array placement position may be displayed as a colored mesh on a volumetric representation 1400 of the user and / or part of the user's body, determined from medical imaging data (e.g., MRI data, etc.) associated with the user (e.g., user 1301, etc.). The placement / position where the transducer array electrodes are placed may be represented by a gray circle 1401, and the optimized (e.g., recommended, etc.) transducer array placement position may be represented by a black circle 1402. The notification may visually instruct the user to lower and pull the transducer array forward when placing it on the skin surface so that the placement / position of the transducer array electrodes matches the optimized (e.g., recommended, etc.) transducer array placement position.

[0123] Figure 14B is an example of a visual notification 1431 that may be used to guide transducer array placement. The placement / position where the transducer array electrodes are placed on the user, and the optimized (e.g., recommended, etc.) transducer array placement position may be displayed on a volumetric representation 1400 of the user and / or part of the user's body, determined from medical imaging data (e.g., MRI data, etc.) associated with the user (e.g., user 1301, etc.). The placement / position where the transducer array electrodes are placed may be represented by a gray circle 1401, and the movement of the transducer array required to cause the placement / position where the transducer array electrodes are placed to coincide with the optimized (e.g., recommended, etc.) transducer array placement position may be indicated by one or more directions, such as arrows 1403. Arrow 1403 may visually instruct the user to lower and pull the transducer array forward when placing it on the skin surface so that the arrangement / position of the transducer array electrodes matches the optimized (e.g., recommended, etc.) transducer array placement position.

[0124] Figure 14C shows an example of a notification 1432 that may be used to guide transducer array placement. The movement of the transducer array necessary to cause the placement / position of the transducer array electrodes to coincide with an optimized (e.g., recommended, etc.) transducer array placement position may be indicated by a text notification 1432. Notification 1432 may inform / instruct the user that the placement / position of the transducer array electrodes should be moved in one or more directions. For example, a text notification 1432 may include instructions relating to a transducer array (e.g., TA2) indicating "shift 2 cm to the bottom and 1 cm to the face." In some cases, notification 1432 may include additional data / text encouraging the user to follow instructions included with notification 1432 that present / explain the benefits, such as "moving the transducer array forward by 2 cm is expected to improve treatment by 10%."

[0125] Figure 15 is a flowchart of an exemplary method 1500 for inducing transducer array implantation. In 1510, a user device (such as a smartphone, mobile device, or computing device) may capture multiple images of a portion of the patient / subject's body where one or more transducer arrays are implanted for TTFields therapy / treatment, from different bandage points and / or viewpoints. The multiple images may capture the implantation locations of one or more transducer arrays.

[0126] Points and / or coordinates associated with a coordinate system (e.g., 2D coordinate system, 3D coordinate system, etc.) relating to multiple images captured by a user device can be converted to 3D points and / or coordinates (if they are not already 3D points and / or coordinates). A transformation / projection matrix can be used to convert points / coordinates in a 2D coordinate system relating to multiple images captured by a user device to 3D points / coordinates. For example, object recognition and / or similar applications can be used to determine / identify one or more anatomical landmarks represented by multiple images. Points and / or coordinates associated with one or more anatomical landmarks can be converted to 3D points / coordinates. In some cases, one or more transducer arrays may be used as one or more landmarks and / or may include one or more artificial landmarks. For example, one or more transducer arrays may include one or more or design attributes (e.g., grooves, depressions, ridges, etc.) that can be used as one or more landmarks (artificial landmarks). Points and / or coordinates associated with one or more landmarks associated with one or more transducer arrays can be converted to 3D points / coordinates. In some cases, multiple images may include one or more additional artificial landmarks, such as stickers and / or removable tattoos placed on the user. Points and / or coordinates associated with one or more artificial landmarks may be converted into 3D points / coordinates.

[0127] Data / information indicating 3D points / coordinates associated with one or more anatomical landmarks derived from a coordinate system of multiple images captured by the user device may be transmitted to a computing device and / or patient support system for analysis, such as the patient support module 1001.

[0128] Identification information (e.g., device identifier, user identifier, user information, etc.) included with data / information indicating 3D points / coordinates associated with one or more transducer arrays and / or one or more landmarks may also be transmitted to the computing device and / or system (e.g., patient support module 1001).

[0129] In 1520, a computing device and / or patient support system may use identification information to determine medical imaging data, such as MRI data, associated with a patient / subject. The MRI data is used for TTFields therapy / treatment planning for the patient / subject. The MRI data may include volumetric representations of body parts of the patient / subject. The MRI data may include 3D coordinates. Object recognition and / or similar may be used to determine anatomical landmarks in the MRI data that correspond to anatomical landmarks from multiple images. 3D points and / or coordinates associated with anatomical landmarks in the MRI data that correspond to anatomical landmarks from multiple images may be determined.

[0130] In 1530, point-based registration of anatomical landmarks from multiple images to corresponding anatomical landmarks in MRI data may be performed. Any method may be used to register 3D points and / or coordinates associated with anatomical landmarks from multiple images to 3D points and / or coordinates associated with anatomical landmarks in MRI.

[0131] In 1540, after registration of 3D points and / or coordinates associated with anatomical landmarks from multiple images to 3D points and / or coordinates associated with anatomical landmarks in MRI, all coordinates associated with the coordinate system for multiple images captured by the user device can be converted to coordinates of the MRI data. Such as any object contained within multiple images, such as one or more transducer arrays, can be represented along with the volumetric representation of a part of the patient / subject's body. Coordinates indicating the placement / position of one or more transducer arrays can be used to represent one or more transducer arrays along with the volumetric representation of a part of the patient / subject's body. Coordinates indicating the optimized (e.g., recommended, etc.) transducer array placement position determined from a prior analysis of the MRI data can be used to represent the optimized (e.g., recommended, etc.) transducer array placement position along with the volumetric representation of a part of the patient / subject's body.

[0132] In 1550, the placement / location of one or more transducer arrays may be compared to an optimized (e.g., recommended, etc.) transducer array placement location. For example, the placement / location of one or more transducer arrays may be displayed together with an optimized (e.g., recommended, etc.) transducer array placement location (e.g., superimposed, overlaid, etc.). In some cases, the placement / location of one or more transducer arrays may be displayed together with a representation of a transducer array patch, disk, and / or similar at an optimized (e.g., recommended, etc.) transducer array placement location (e.g., superimposed, overlaid, etc.).

[0133] Figure 16 is a flowchart illustrating another example of induction transducer array placement on TTFields. In 1620, the transducer array map is determined by determining the image data. In 1620, image data associated with parts of the subject's body (e.g., video data, static / still images, dynamic / interactive images, etc.) is determined. The subject (user) may use one or more cameras to capture video images of parts of the subject's body, such as video images of the subject's head, torso, and / or similar. In some cases, method 1600 may include determining an avatar based on the image data. The avatar may be a representation of the subject's body or one or more of the subject's body parts. In some cases, the avatar may be a static representation of the subject's body or one or more of the subject's body parts. In some cases, the avatar may be one or more dynamic (e.g., moving, mirrored movement, etc.) representations of the subject or parts of the subject's body.

[0134] In 1630, image data is registered to a three-dimensional (3D) model of a part of the subject's body, and the 3D model may include one or more locations indicated by a transducer array map. In some cases, the registration of image data to the 3D model may result in the registration of a corresponding part of an avatar representing the image data to the 3D model.

[0135] In 1640, generating composite data includes image data and one or more representations of transducer arrays associated with one or more locations indicated by a transducer array map. In some cases, the composite data may include an avatar and one or more representations of transducer arrays associated with one or more locations indicated by a transducer array map.

[0136] The composite data may include one or more representations of transducer arrays associated with one or more locations indicated by a transducer array map, overlaid on a video image (or avatar), such as a video image of a part of a subject's body. In some cases, Method 1600 may include causing a display of the composite data.

[0137] In some cases, Method 1600 may include determining that the positions of one or more transducer arrays and one or more positions indicated by the transducer array map meet an acceptable threshold. This determination may be based on one or more object recognition or object tracking. In some cases, Method 1600 may include, based on the meeting of the acceptable threshold condition, transmitting a notification indicating that the positions of one or more transducer arrays and one or more positions indicated by the transducer array map are aligned (e.g., the acceptable threshold condition is met) and / or that one or more transducer arrays are properly (e.g., accurately, effectively) placed on the subject. The notification may be an audible notification (e.g., a beep, chirp, or other sound) and / or a visual notification (e.g., displayed on a display along with composite data). In some cases, Method 1600 may include triggering a color change in one or more representations of the transducer arrays based on the meeting of the acceptable threshold condition. A change in color may indicate that the positions of one or more transducer arrays are aligned with the positions indicated by the transducer array map (e.g., that an acceptable threshold condition is met) and / or that one or more transducer arrays are properly (e.g., accurately, effectively, etc.) positioned on the subject.

[0138] Figure 17 is a flowchart of another example of induction transducer array placement. In 1710, a three-dimensional (3D) model of a portion of the subject's body is determined. In 1720, a transducer array map is determined based on the 3D model, and the transducer array map indicates one or more locations on the 3D model. In 1730, images of the portion of the subject's body are received. The subject (user) may use one or more cameras to capture images of parts of the subject's body, such as images of the subject's head, torso, and / or similar (e.g., video images, static / still images, dynamic / interactive images, etc.).

[0139] In 1740, it is determined that the image corresponds to a 3D model. In some cases, object recognition and / or face recognition may be used to identify a subject from the image. The identified subject may be associated with a given 3D model. In some cases, determining that the image corresponds to a 3D model may include determining one or more visual landmarks associated with the image, determining one or more visual landmarks associated with the 3D model, and determining that one or more visual landmarks associated with the image correspond to one or more visual landmarks associated with the 3D model. Determining that one or more visual landmarks associated with the image correspond to one or more visual landmarks associated with the 3D model may include determining that each of the one or more visual landmarks associated with the image and each of the one or more visual landmarks associated with the 3D model satisfy a correlation threshold.

[0140] In 1750, based on the determination that the image corresponds to a 3D model, a composite image is generated that includes the image, the 3D model, and one or more images of transducer arrays associated with one or more locations. In some cases, method 1600 may include causing a display of the composite image.

[0141] Figure 18 is a flowchart of another example of induction transducer array placement. In 1810, two-dimensional (2D) image data associated with a part of the subject's body is received, and the 2D image data indicates one or more placement locations on one or more transducer arrays. Receiving 2D image data may include receiving 2D image data from a user device (e.g., a smart device, a mobile device, an image capture device, a second user device 1026, etc.). The 2D image data may include and / or be derived from multiple images, each of which is associated with a different bandage point on a part of the subject's body. One or more placement locations on one or more transducer arrays may include one or more actual and / or real-time placement locations on one or more transducer arrays. In some cases, the image data may include an avatar associated with a part of the subject's body.

[0142] In 1820, a representation of one or more placement locations for one or more transducer arrays in three-dimensional (3D) space is determined based on 2D image data. Determining a representation of one or more placement locations for one or more transducer arrays in 3D space may include determining one or more landmarks indicated by 2D image data, determining a representation of one or more landmarks indicated by 2D image data in 3D space, determining one or more landmarks indicated by 3D image data, and determining that the representation of one or more landmarks indicated by 2D image data in 3D space corresponds to one or more landmarks indicated by 3D image data. One or more landmarks indicated by 2D image data and one or more landmarks indicated by 3D image data may include one or more anatomical landmarks or artificial landmarks. Artificial landmarks may include one or more stickers, removable tattoos, or design attributes of one or more transducer arrays.

[0143] Determining the representation of one or more placement positions for one or more transducer arrays in 3D space may include determining a plurality of coordinates indicated by 2D image data, wherein the plurality of coordinates represent a surface associated with a part of the subject's body; determining the representation of the surface in 3D space based on the plurality of coordinates; and determining that the representation of the surface in 3D space corresponds to the surface indicated by 3D image data.

[0144] Determining the representation of one or more placement positions for one or more transducer arrays in 3D space may include determining one or more landmarks indicated by 3D image data, determining the 2D representation of one or more landmarks indicated by 3D image data, determining one or more landmarks indicated by 2D image data, determining that the 2D representation of one or more landmarks indicated by 3D image data corresponds to one or more landmarks indicated by 2D image data, and determining the representation of one or more placement positions for one or more transducer arrays in three-dimensional (3D) space based on the correspondence between the 2D representation of one or more landmarks indicated by 3D image data and one or more landmarks indicated by 2D image data. Determining the representation of one or more placement positions for one or more transducer arrays in 3D space may include applying a projection matrix to one or more 2D coordinates associated with one or more placement positions for one or more transducer arrays. Determining the 2D representation of one or more landmarks indicated by 3D image data may include applying a projection matrix to one or more 3D coordinates associated with one or more landmarks indicated by 3D image data.

[0145] In 1830, a representation of one or more placement positions for one or more transducer arrays in 3D space is compared with one or more recommended placement positions for one or more transducer arrays shown by 3D image data. Comparing a representation of one or more placement positions for one or more transducer arrays in 3D space with one or more recommended placement positions for one or more transducer arrays shown by 3D image data may include displaying a representation of one or more placement positions for one or more transducer arrays in 3D space that is overlaid with one or more recommended placement positions for one or more transducer arrays shown by 3D image data.

[0146] In 1840, based on a comparison of representations of one or more placement locations for one or more transducer arrays in 3D space with one or more recommended placement locations for one or more transducer arrays indicated by 3D image data, the dispersion of at least one of the one or more recommended placement locations for one or more transducer arrays from at least one of the one or more recommended placement locations for one or more transducer arrays is determined. In some cases, method 1800 may include sending a notification based on the dispersion. The notification may include one or more instructions for correcting the dispersion. Correcting the dispersion may include associating new coordinates associated with one or more placement locations for one or more transducer arrays in 3D space with coordinates associated with one or more recommended placement locations for one or more transducer arrays indicated by 3D image data, based on the coordinates associated with the one or more placement locations for one or more transducer arrays in 3D space.

[0147] Figure 19 is a flowchart of another example of induction transducer array implantation. In 1910, first image data is determined based on one or more images associated with a part of the subject's body, where one or more images indicate one or more transducer array implantation locations. In 1920, second image data is determined associated with a part of the subject's body, where the second image data includes one or more recommended transducer array implantation locations.

[0148] In 1930, the first image data is registered to the second image data. Registering the first image data to the second image data may include determining one or more visual landmarks represented by the first image data, determining one or more visual landmarks represented by the second image data, and determining that one or more visual landmarks represented by the first image data correspond to one or more visual landmarks represented by the second image data.

[0149] Determining that one or more visual landmarks associated with the first image data correspond to one or more visual landmarks associated with the second image data includes determining that each of the one or more visual landmarks associated with the first image data satisfies a correlation threshold with each of the one or more visual landmarks associated with the second image data.

[0150] In method 1940, composite data is generated, which includes one or more transducer array placement locations and one or more recommended transducer array placement locations. The composite data may include a three-dimensional (3D) model showing one or more transducer array placement locations and one or more recommended transducer array placement locations. The composite data may include one or more transducer array placement locations overlaid on one or more recommended transducer array placement locations. In some cases, method 1900 may include displaying the composite data.

[0151] Figure 20 is a flowchart of another example of induction transducer array placement. In 2010, two-dimensional (2D) image data associated with a part of the subject's body is received, and the 2D image data indicates one or more placement locations on one or more transducer arrays. Receiving 2D image data may include receiving 2D image data from a user device (e.g., a smart device, mobile device, image capture device, user device 1020, second user device 1026, etc.). The 2D image data may include and / or be derived from multiple images, each of which is associated with a different bandage point on a part of the subject's body. One or more placement locations on one or more transducer arrays may include one or more actual and / or real-time placement locations on one or more transducer arrays. In some cases, the image data may include an avatar associated with a part of the subject's body.

[0152] In 2020, one or more three-dimensional (3D) coordinates representing one or more placement positions for one or more transducer arrays are determined based on 2D image data. Determining one or more three-dimensional (3D) coordinates may include applying a transformation / projection matrix to one or more points / coordinates associated with the 2D image data.

[0153] In step 2030, a representation of one or more placement locations for one or more transducer arrays in 3D space is determined based on the registered 3D coordinates and 3D image data. In step 2040, the representation of one or more placement locations for one or more transducer arrays in 3D space is compared with one or more recommended placement locations for one or more transducer arrays represented in 3D space. In step 2050, based on the comparison between one or more placement locations for one or more transducer arrays in 3D space and one or more recommended placement locations for one or more transducer arrays represented in 3D space, the distribution of at least one of the one or more placement locations for one or more transducer arrays from at least one of the one or more recommended placement locations for one or more transducer arrays is determined.

[0154] Figure 21 is a flowchart illustrating an example of generating variance data. In 2110, the variance between at least one of one or more recommended placement locations for one or more transducer arrays, indicated by three-dimensional (3D) image data, and at least one of one or more placement locations for one or more transducer arrays on a part of the subject's body, indicated by two-dimensional (2D) image data, is determined.

[0155] In 2120, distributed data is generated, which represents the distribution. In some cases, the distributed data may include a 3D representation of a part of the subject's body, where the 3D representation includes one or more recommended placement positions for one or more transducer arrays and one or more placement positions for one or more transducer arrays in overlaid 3D space. In some cases, the distributed data may include one or more images of a part of the subject's body, where these images represent one or more placement positions for one or more transducer arrays and one or more recommended placement positions for one or more transducer arrays. In some cases, the distributed data may include a representation of one or more recommended placement positions for one or more transducer arrays and overlaid real-time video data. The distributed data may include one or more instructions for correcting the distribution. In 2130, the distributed data is transmitted to the user device. The user device may display the distributed data.

[0156] Exemplary Embodiment 1. A device for assisting the placement of transducers on a subject's body to apply a tumor treatment electric field, the device comprising one or more processors and a memory, the memory storing processor-executable instructions that, when executed by one or more processors, cause the device to: determine first image data based on one or more images associated with a part of a subject's body, wherein the first image data determines first image data including one or more transducer placement locations; determine second image data based on one or more images, wherein the second image data determines second image data including one or more recommended transducer placement locations; register the first image data to the second image data; and generate composite data including one or more transducer placement locations and one or more recommended transducer placement locations.

[0157] Exemplary Embodiment 2. The apparatus according to Exemplary Embodiment 1, wherein a processor-executable instruction, when executed by one or more processors, causes the apparatus to further display composite data.

[0158] Exemplary Embodiment 3: The apparatus according to Exemplary Embodiment 1, wherein a processor-executable instruction, when executed by one or more processors, causes the apparatus to register first image data to second image data, further causes the apparatus to determine one or more visual landmarks indicated by the first image data, determine one or more visual landmarks indicated by the second image data, and determine that one or more visual landmarks indicated by the first image data correspond to one or more visual landmarks indicated by the second image data.

[0159] Exemplary Embodiment 4. The apparatus according to Exemplary Embodiment 1, wherein the composite data includes a three-dimensional (3D) model showing one or more transducer mounting positions and one or more recommended transducer mounting positions, and the composite data includes a distribution of at least one of one or more transducer mounting positions from at least one of the one or more recommended transducer mounting positions shown in the 3D model.

[0160] Exemplary Embodiment 5. The apparatus according to Exemplary Embodiment 4, wherein, when a processor-executable instruction is executed by one or more processors, the apparatus further causes the apparatus to send a distribution notification to a user device, the notification including one or more instructions for correcting the distribution.

[0161] While the present invention is disclosed with reference to several embodiments, numerous modifications, alterations, and changes are possible to the embodiments described without departing from the scope and realm of the invention, as defined in the accompanying claims. Therefore, the present invention should not be limited to the embodiments described, but is intended to encompass the entire scope defined by the following claims and their equivalents. [Explanation of Symbols]

[0162] 100 devices 102 Electric field generator 104 transducer array 104a Transducer Array 104b Transducer Array 106 Processors 108 Signal Generator 110 Control Software 112 Conductive Leads 114 Output 116 Electrode 118 Flexible circuit board 120 Hypoallergenic Medical Bandages 120a, 120b Hypoallergenic Medical Bandages 302 Skin surface 304 Tumor 306 Bone tissue 308 Brain tissue 310 Police Box Electric Field 600 System 602 Patient Support System 606 Field Generator (EFG) Configuration Applications 608 Patient Modeling Application 610 Image Data 800 Three-Dimensional Array Layout Map 1000 System 1001 Patient Support Module 1008 processor 1010 memory 1014 Network Interface 1016 Image Processing Module 1017 Image Registration Module 1018 Operating Systems (O / S) 1019 Graphics Rendering Module 1020 User Devices 1021 Imaging Module 1022 Interface Module 1023 Communication Module 1025 Avatar Mapping and Rendering Module 1026 Second User Device 1027 Imaging Module 1028 Interface Module 1029 Communication Module 1100 video images 1101 Avatar 1200 video images 1201 Three-Dimensional Transducer Array Map 1203 Graphic Guide 1204, 1205 Graphic Guide 1206 Composite Data 1207 Composite Data 1300 System 1301 users 1302, 1303 transducer array 1304, 1305, 1306, 1307 positions 1308 Anatomical Landmarks 1309 Anatomical Landmarks 1310 Landmark 1316 Image Processing Module 1320 expression 1321 Avatar 1331 points 1332 Surface 1400 Volume representation 1401 Gray circle 1402 Black Circle 1403 Arrow 1430 Visual notification 1431 Visual notification 1432 notifications 1500 ways 1600 methods 1800 methods 1900 method

Claims

1. A method performed by a device that assists in the placement of a transducer on the body of a subject in order to apply a tumor treatment electric field, A step in which the apparatus determines first image data based on one or more images associated with a part of a subject's body, wherein the first image data includes one or more transducer placement positions, A step in which the apparatus determines a second image data based on the one or more images, wherein the second image data includes one or more recommended transducer placement positions. The steps include: the apparatus registering the first image data to the second image data; A method comprising the step of generating composite data including the one or more transducer mounting positions and the one or more recommended transducer mounting positions.

2. The method according to claim 1, wherein the composite data includes the one or more transducer placement positions overlaid on the one or more recommended transducer placement positions.

3. The method according to claim 1, wherein the composite data includes a three-dimensional (3D) model showing the one or more transducer mounting positions and the one or more recommended transducer mounting positions.

4. The method according to claim 3, further comprising the step of causing the apparatus to display the composite data, which includes the 3D model showing the one or more transducer mounting positions and the one or more recommended transducer mounting positions, on a user device.

5. The method according to claim 1, wherein the one or more images include a plurality of video data, a plurality of images, an avatar, or a combination thereof.

6. The step of the apparatus registering the first image data to the second image data is: The apparatus includes the step of determining one or more visual landmarks indicated by the first image data, The apparatus includes the step of determining one or more visual landmarks indicated by the second image data, The method according to claim 1, comprising the step of determining that the one or more visual landmarks indicated by the first image data correspond to the one or more visual landmarks indicated by the second image data.

7. The method according to claim 6, wherein the one or more landmarks include at least one of anatomical landmarks or artificial landmarks.

8. The method according to claim 7, wherein the artificial landmark includes at least one of the following: a sticker, a removable tattoo, or a design attribute of the one or more transducers.

9. The method according to claim 1, further comprising the step of the device determining and outputting the distribution of at least one of the one or more recommended transducer placement positions from at least one of the one or more recommended transducer placement positions based on the composite data.

10. The method according to claim 9, further comprising the step of the device transmitting a notification regarding the distribution to a user device, the notification comprising one or more instructions for correcting the distribution.

11. The method according to claim 1, wherein the one or more transducer placement positions indicated by the first image data include one or more real-time placement positions for one or more transducers.

Images