Priority of us provisional application No. 62/842,674 filed on 3.5.2019 and us application No. 16/866,417 filed on 4.5.2020, both of which are incorporated herein by reference in their entireties.
Detailed Description
Before the present methods and systems are disclosed and described, it is to be understood that the methods and systems are not limited to specific methods, specific components, or to particular implementations. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.
As used in the specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" one particular value, and/or to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
"optional" or "optionally" means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.
Throughout the description and claims of this specification, the word "comprise", and variations of the word, such as "comprises" and "comprising", means "including but not limited to", and is not intended to exclude, for example, other components, integers or steps. "exemplary" means "an example of … …," and is not intended to convey an indication of a preferred or desired embodiment. "such as" is not used in a limiting sense, but is for explanatory purposes.
Components are disclosed that can be used to perform the disclosed methods and systems. These and other components are disclosed herein, and it is understood that when combinations, subsets, interactions, groups, etc. of these components are disclosed that while specific reference of each various individual and collective combinations and permutation of these may not be explicitly disclosed, each is specifically contemplated and described herein for all methods and systems. This applies to all aspects of the present application including, but not limited to, steps in the disclosed methods. Thus, if there are a variety of additional steps that can be performed it is understood that each of these additional steps can be performed with any specific embodiment or combination of embodiments of the disclosed methods.
The present method and system may be understood more readily by reference to the following detailed description of preferred embodiments and the examples included therein and the figures and their previous and following description.
As will be appreciated by those skilled in the art, the methods and systems may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining 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 in the storage medium. More particularly, the present methods and systems may take the form of network-implemented computer software. Any suitable computer readable storage medium may be utilized including hard disks, CD-ROMs, optical storage devices, or magnetic storage devices.
Embodiments of the methods and systems are described below with reference to block diagrams and flowchart illustrations of methods, systems, apparatus, and computer program products. It will be understood that each block of the block diagrams and flowchart illustrations, and combinations of blocks in the block diagrams and flowchart illustrations, respectively, can be implemented by computer program instructions. These computer program instructions may be loaded onto a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create means for implementing the functions specified in the flowchart block(s).
These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including computer-readable instructions for implementing the function specified in the flowchart block(s). The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart block(s).
Accordingly, blocks of the block diagrams and flowchart illustrations support combinations of means for performing the specified functions, combinations of steps for performing the specified functions and program instruction means for performing the specified functions. It will also be understood that each block of the block diagrams and flowchart illustrations, and combinations of blocks in the block diagrams and flowchart illustrations, can be implemented by special purpose hardware-based computer systems that perform the specified functions or steps, or combinations of special purpose hardware and computer instructions.
TTFields (also referred to herein as alternating electric fields) are established as anti-mitotic cancer therapies because they interfere with proper microtubule assembly during metaphase and ultimately destroy cells during telophase and cytokinesis. The efficacy increased with increasing field strength, and the optimal frequency was dependent on the cancer cell line, with 200kHz being the frequency at which inhibition of glioma cell growth by TTFields is highest. For cancer therapy, non-invasive devices with capacitively coupled transducers were developed, which are placed directly at the skin area close to the tumor, e.g. for patients with glioblastoma multiforme (GBM), the most common primary malignant brain tumor in humans.
Because the effects of TTFields are directional, in which cells that divide parallel to the field are affected more than cells that divide in other directions, and because cells divide in all directions, TTFields are typically delivered by two pairs of transducer arrays that generate a perpendicular field within the treated tumor. More specifically, one pair of transducer arrays may be located on the left and right side of the tumor (LR) while another pair of transducer arrays may be located on the anterior and posterior of the tumor (AP). Cycling the field between these two directions (i.e., LR and AP) ensures that the maximum range of cell orientation is targeted. Other locations of the transducer array are envisioned beyond the vertical field. In an embodiment, an asymmetric positioning of three transducer arrays is envisaged, wherein one pair of the three transducer arrays may deliver an alternating electric field and then another pair of the three transducer arrays may deliver an alternating electric field, while the remaining pair of the three transducer arrays may deliver an alternating electric field.
In vivo and in vitro studies show that the efficacy of TTFields therapy increases with increasing field strength. Therefore, optimizing array placement on the patient's scalp to increase intensity in brain lesions is standard practice for the opture system. Array placement optimization may be performed by "rule of thumb" (e.g., placing the array on the scalp as close as possible to the tumor) measurements that describe the geometry of the patient's head, the tumor size, and/or the tumor location. The measurements used as input may be derived from imaging data. Imaging data is intended to include any type of visual data, such as, for example, Single Photon Emission Computed Tomography (SPECT) image data, x-ray computed tomography (x-ray CT) data, Magnetic Resonance Imaging (MRI) data, Positron Emission Tomography (PET) data, data that may be captured by an optical instrument (e.g., a photographic camera, a charge-coupled device (CCD) camera, an infrared camera, etc.), and the like. In certain implementations, the image data may include 3D data (e.g., point cloud data) obtained from or generated by a 3D scanner. Optimization may rely on an understanding of how the electric field is distributed within the head as a function of array position, and in some aspects, takes into account variations in the distribution of electrical properties within different patient heads. A plurality of transducer array maps may be determined that indicate optimal positioning of the transducer arrays on the patient's body that satisfy various criteria (e.g., provide minimum and/or maximum strength of an electric field within a region of interest (ROI), power density within the ROI, etc.).
Since the positioning of the transducer array on the patient's scalp (and/or other body parts) affects the electric field strength in the ROI and/or target region, a transducer array map can be determined that enables the positioning of the transducer array to be changed while maintaining the target strength of the electric field in the ROI and/or target region.
FIG. 1 shows an example apparatus 100 for electrotherapy therapy. In general, the apparatus 100 may be a portable battery or power-operated device that generates an alternating electric field within the body by means of a non-invasive surface transducer array. The apparatus 100 may include an electric field generator 102 and one or more transducer arrays 104. The apparatus 100 may be configured to generate tumor therapy fields (TTFields) (e.g., at 150 kHz) via an electric field generator 102 and deliver 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 an embodiment, one or more transducer arrays 104 are uniformly shaped. In an embodiment, one or more transducer arrays 104 are not uniformly shaped.
The electric field generator 102 may include a processor 106 in communication with a signal generator 108. The electric field generator 102 may include control software 110 configured to control the performance of the processor 106 and the signal generator 108.
The signal generator 108 may generate one or more electrical signals in the shape of a waveform or pulse train. The signal generator 108 may be configured to generate an alternating current voltage waveform (e.g., TTFields) at a frequency ranging from about 50KHz to about 500KHz, preferably from about 100KHz to about 300 KHz. The voltage is such that the electric field strength in the tissue to be treated is in the range of about 0.1V/cm to about 10V/cm.
One or more outputs 114 of the electric field generator 102 may be coupled to one or more conductive leads 112, the conductive leads 112 being attached at one end thereof to the signal generator 108. The opposite ends of the conductive leads 112 are connected to one or more transducer arrays 104 that are activated by electrical signals (e.g., waveforms). The conductive leads 112 may include standard isolated conductors with flexible metal shields and may be grounded to prevent the electric field generated by the conductive leads 112 from spreading. The one or more outputs 114 may operate sequentially. The output parameters of the signal generator 108 may include, for example, field strength, frequency of the wave (e.g., treatment frequency), and maximum allowable temperature of the one or more transducer arrays 104. The output parameters may be set and/or determined by the control software 110 in conjunction with the processor 106. After determining the desired (e.g., optimal) treatment frequency, the control software 110 may cause the processor 106 to send control signals to the signal generator 108 that cause the signal generator 108 to output the desired treatment frequency to the one or more transducer arrays 104.
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 at a target volume to focus therapy. One or more transducer arrays 104 may be configured to deliver two perpendicular field directions through a volume of interest.
One or more arrays of transducer arrays 104 may include one or more electrodes 116. The one or more electrodes 116 may be made of any material having a high dielectric constant. The one or more electrodes 116 may comprise, for example, one or more insulating ceramic disks. The electrodes 116 may be biocompatible and coupled to a flexible circuit board 118. The electrodes 116 may be configured so as not to be in direct contact with the skin, as the electrodes 116 are separated from the skin (similar to that found on an ecg pad) by a layer of conductive hydrogel (not shown).
The electrodes 116, hydrogel and flexible circuit board 118 may be attached to a hypoallergenic medical adhesive bandage 120 to hold the one or more transducer arrays 104 in place on the body and in continuous direct contact with the skin. Each transducer array 104 may include one or more thermistors (not shown), for example 8 thermistors (accuracy ± 1 ℃), to measure the skin temperature beneath the transducer array 104. The thermistor may be configured to measure the skin temperature periodically (e.g., every second). The thermistor can be read by the control software 110 when no TTFields are delivered in order to avoid any interference with the temperature measurement.
If, between two subsequent measurements, the measured temperature is below a preset maximum temperature (Tmax), e.g., 38.5-40.0 ℃ ± 0.3 ℃, the control software 110 may increase the current until the current reaches a maximum treatment current (e.g., 4 amps peak-to-peak). If the temperature reaches Tmax +0.3 deg.C and continues to rise, control software 110 may decrease the current. If the temperature rises to 41 ℃, the control software 110 may turn off TTFields therapy and may trigger an overheat alarm.
One or more transducer arrays 104 may vary in size and may include varying numbers of electrodes 116 based on patient body size and/or different therapy treatments. For example, in the context of a patient's chest, the small transducer arrays may each include 13 electrodes, and the large transducer arrays may each include 20 electrodes, with the electrodes interconnected in series in each array. For example, as shown in fig. 2, in the context of a patient's head, each transducer array may include 9 electrodes each, with the electrodes interconnected in series in each array.
The status of the apparatus 100 and the monitored parameters may be stored in a memory (not shown) and may be transmitted to the 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, therapy on, alarm, and low battery.
Fig. 3A and 3B illustrate an example application of the apparatus 100. Transducer array 104a and transducer array 104b are shown, each incorporated into hypoallergenic medical adhesive bandages 120a and 120b, respectively. Hypoallergenic medical adhesive bandages 120a and 120b are applied to skin surface 302. Tumor 304 is located beneath skin surface 302 and bone tissue 306, and within brain tissue 308. The electric field generator 102 causes the transducer array 104a and the transducer array 104b to generate an alternating electric field 310 within the brain tissue 308, the alternating electric field 310 disrupting the rapid cell division exhibited by the cancerous cells of the tumor 304. The alternating electric field 310 has been shown in non-clinical experiments to prevent tumor cell proliferation and/or destroy tumor cells. The use of an alternating electric field 310 takes advantage of the particular characteristics, geometry and rate at which cancer cells divide, making them susceptible to the influence of the alternating electric field 310. The alternating electric field 310 alters their 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., 150kHz for MPM). Alternating electric field 310 has been shown to disrupt mitotic spindle microtubule assembly and cause dielectrophoretic dislocation of intracellular macromolecules and organelles during cytokinesis. These processes result in physical disruption of the cell membrane and programmed cell death (apoptosis).
Because the effect of the alternating electric field 310 is directional, in that cells that divide parallel to the field are affected more than cells that divide in other directions, and because cells divide in all directions, the alternating electric field 310 can be delivered by two pairs of transducer arrays 104 that generate a vertical field within the treated tumor. More specifically, one pair of transducer arrays 104 may be located on the left and right sides (LR) of the tumor, while another pair of transducer arrays 104 may be located on the Anterior and Posterior (AP) of the tumor. Cycling the alternating electric field 310 between these two directions (e.g., IR and AP) ensures that the maximum range of cell orientation is targeted. In an embodiment, the alternating electric field 310 may be delivered according to a symmetrical arrangement of the transducer arrays 104 (e.g., four transducer arrays 104 in total, two matching pairs). In another embodiment, the alternating electric field 310 may be delivered according to an asymmetric arrangement of the transducer array 104 (e.g., a total of three transducer arrays 104). The asymmetric arrangement of the transducer arrays 104 may engage two of the three transducer arrays 104 to deliver the alternating electric field 310 and then switch to the other two of the three transducer arrays 104 to deliver the alternating electric field 310 and so on.
In vivo and in vitro studies show that the efficacy of TTFields therapy increases with increasing field strength. The described methods, systems, and devices are configured for optimizing array placement on a patient's scalp to increase intensity in brain lesion areas.
As shown in fig. 4A, the transducer array 104 may be placed on the head of a patient. As shown in fig. 4B, the transducer array 104 may be placed on the abdomen of a patient. As shown in fig. 5A, the transducer array 104 may be placed on the torso of a patient. As shown in fig. 5B, the transducer array 104 may be placed on the pelvis of a patient. It is specifically contemplated that the transducer array 104 may be placed on other parts of the patient's body (e.g., arms, legs, etc.).
Fig. 6 is a block diagram depicting a non-limiting example of a system 600 including a patient support system 602. The patient support system 602 may include one or more computers configured to operate and/or store an Electric Field Generator (EFG) configuration application 606, a patient modeling application 608, and/or imaging data 610. The patient support system 602 may include, 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.
The patient modeling application 608 may be configured to generate a three-dimensional model of a portion of a patient's body (e.g., a patient model) from the imaging data 610. The imaging data 610 may include any type of visual data, such as, for example, Single Photon Emission Computed Tomography (SPECT) image data, x-ray computed tomography (x-ray CT) data, Magnetic Resonance Imaging (MRI) data, Positron Emission Tomography (PET) data, data that may be captured by an optical instrument (e.g., a photographic camera, a charge-coupled device (CCD) camera, an infrared camera, etc.), and the like. In certain implementations, the image data may include 3D data (e.g., point cloud data) obtained from or generated by a 3D scanner. The patient modeling application 608 may also be configured to generate a three-dimensional array layout based on the patient model and one or more electric field simulations.
To properly optimize array placement on a portion of a patient's body, imaging data 610 (such as MRI imaging data) can be analyzed by patient modeling application 608 to identify regions of interest including tumors. In the context of a patient's head, to characterize how the electric field behaves and distributes within the human head, a modeling framework based on an anatomical head model can be used, which is simulated using a Finite Element Method (FEM). These simulations generate a true head model based on Magnetic Resonance Imaging (MRI) measurements and classify tissue types within the head, such as skull, white matter, gray matter, and cerebrospinal fluid (CSF). Dielectric properties of relative conductivity and permittivity may be assigned to each tissue type, and simulations may be run whereby different transducer array configurations are applied to the surface of the model in order to understand how an externally applied electric field of a preset frequency will be distributed throughout any part of the patient's body (e.g. the brain). These simulation results with paired array configuration, constant current and preset frequency of 200kHz have shown that the electric field distribution is relatively non-uniform throughout the brain and generates electric field strengths in excess of 1V/cm in most tissue compartments except CSF. These results were obtained assuming that the total current at the transducer array-scalp interface had a peak-to-peak value of 1800 milliamps (mA). This threshold electric field strength is sufficient to prevent cell proliferation in glioblastoma cell lines. Furthermore, by manipulating the configuration of the paired transducer arrays, it is possible to achieve almost three times the electric field strength of a particular region of the brain as shown in fig. 7. FIG. 7 illustrates the electric field amplitude and distribution (in V/cm) shown in a coronal view from a finite element method simulation model. The simulation employs a left-right paired transducer array configuration.
In one aspect, 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, using axial and coronal views, initial morphometric head size measurements can be determined from T1 sequences of brain MRI. Post-contrast axial and coronal MRI slices can be selected to indicate the maximum diameter of the enhanced lesion. Using a measure of head size and distance from the predetermined fiducial markers to the tumor margin, the varying permutations and combinations of the paired array layouts can be evaluated to generate a configuration that delivers maximum electric field strength to the tumor site. As shown in fig. 8A, the output may be a three-dimensional array layout 800. The patient and/or caregiver can use the three-dimensional array layout 800 (e.g., transducer array layout) to place the array on the scalp during a normal TTFields therapy procedure as shown in fig. 8B.
In one aspect, the patient modeling application 608 may be configured to determine a three-dimensional array layout of a patient. MRI measurements of a portion of the patient to receive the transducer array may be determined. As an 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 by means of artificial intelligence techniques, or may be performed manually, for example by means of a physician.
Manual MRI measurement determination may include receiving and/or providing MRI data via a DICOM viewer. The MRI data may include a scan of a portion of the patient containing the tumor. As an example, in the context of a patient's head, the MRI data may include a scan of the head including one or more of a right frontotemporal tumor, a left parietal occipital tumor, and/or a multifocal midline tumor. Fig. 9A, 9B, 9C, and 9D illustrate example MRI data showing a scan of a patient's head. Fig. 9A shows an axial T1 series slice containing the topmost image, including a trajectory for measuring head size. Fig. 9B shows a coronal T1 sequence slice selected for measuring an image at the ear canal level of head size. Fig. 9C shows a post-contrast T1 axial image showing the maximum enhanced tumor diameter used to measure the tumor location. Fig. 9D shows a post-contrast T1 coronal image showing the maximum enhanced tumor diameter used to measure the tumor location. MRI measurements may begin with fiducial markers at the periphery of the scalp and extend tangentially from right, front, and upper starting points. The morphometric head size may be estimated from an axial T1 MRI sequence that selects the topmost image that still includes the trajectory (or the image directly above the upper edge of the trajectory).
In one aspect, the MRI measurements may include, for example, one or more of head size measurements and/or tumor measurements. In one aspect, one or more MRI measurements may be rounded to the nearest millimeter and may be provided to a transducer array placement module (e.g., software) for analysis. The MRI measurements may then be used to generate a three-dimensional array layout (e.g., three-dimensional array layout 800).
MRI measurements may include one or more head size measurements, such as: maximum anterior-posterior (a-P) head size, measured from the outer edge of the scalp; maximum width of head measured perpendicular to a-P: right-to-left lateral distance; and/or the distance from the rightmost edge of the scalp to the anatomical midline.
The MRI measurements may include one or more head size measurements, such as coronal view head size measurements. Coronal view head size measurements may be obtained on a T1 MRI sequence that selects images at the ear canal level (fig. 9B). Coronal view head size measurements may include one or more of: a perpendicular measurement from the apex of the scalp to an orthogonal line delineating the inferior border of the temporal lobe; maximum right-to-left lateral head width; and/or the distance from the rightmost edge of the scalp to the anatomical midline.
The MRI measurements may include one or more tumor measurements, such as tumor location measurements. Tumor location measurements can be made using T1 post-contrast MRI sequences, first indicating the maximum enhanced tumor diameter on the axial images (fig. 9C). Tumor location measurements may include one or more of the following: maximum a-P head size excluding nose; a maximum right-to-left lateral diameter measured perpendicular to the A-P distance; 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 lateral distance and perpendicular to the a-P measurement; the distance from the right edge of the scalp to the farthest tumor edge measured parallel to the right-left lateral distance, perpendicular to the a-P measurement; measuring the distance from the front of the head to the nearest tumor margin measured parallel to the a-P; and/or the distance from the leading edge of the head to the farthest tumor margin measured parallel to the a-P measurements.
The one or more tumor measurements may include a coronal view tumor measurement. Coronal view tumor measurements may include identifying post-contrast T1 MRI slices characterized by the maximum diameter of tumor enhancement (fig. 9D). Coronal view tumor measurements may include one or more of the following: the maximum distance from the apex of the scalp to the lower edge of the brain. In the anterior slice, this will be marked by a horizontal line drawn at the lower margin of the frontal or temporal lobe, and the posterior, which will extend to the lowest level of the visual curtain; maximum right-to-left 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 lateral distance; the distance from the right edge of the scalp to the farthest tumor edge measured parallel to the right-left lateral distance; distance from the apex of the head to the nearest tumor margin measured parallel to the upper apex to the lower brain line; and/or the distance from the apex of the head to the farthest tumor margin measured parallel to the superior apex to the inferior brain line.
Other MRI measurements may be used, particularly when the tumor is present in another part of the patient's body.
The patient modeling application 608 may use MRI measurements to generate a patient model. The patient model may then be used to determine a three-dimensional array layout (e.g., three-dimensional array layout 800). Continuing with the example of a tumor within the patient's head, a healthy head model may be generated, which serves as a deformable template from which a patient model may 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). The segmented MRI data identifies tissue types in each voxel, and electrical attributes may be assigned to each tissue type based on empirical data. Table 1 shows the standard electrical properties of an organization that may be used for simulation. The tumor region in the patient MRI data may be masked and a non-rigid registration algorithm may be used to register the remaining region of the patient's head onto the 3D discrete image of the deformable template representing the healthy head model. The process produces a non-rigid transformation that maps healthy portions of the patient's head into template space, and an inverse transformation that maps the template into patient space. The inverse transform is applied to the 3D deformable template to produce an approximation of the patient's head in the absence of a tumor. Finally, the tumor, called the region of interest (ROI), is implanted back into the deformed template to generate a complete patient model. The patient model may be a digital representation in three-dimensional space of a body part of the patient, including internal structures such as tissues, organs, tumors, etc.
Patient modeling application 608 may then use the patient model to simulate delivery of TTFields. Simulated electric field distributions, Dosimetry and Simulation-based Analysis are described in U.S. patent publication No. 20190117956A 1 and the publication "Correlation of machining Fields dose to overview Outcommunications in New Diamond diagnostic Glaiblastoma: A Large-Scale Numerical Simulation-based Analysis of Data from the Phase 3 EF-14 calibrated Trial" by Ballo et al (2019), which are incorporated herein by reference in their entirety.
To ensure systematic localization of the transducer array relative to the tumor location, a reference coordinate system may be defined. For example, the transverse plane may be initially 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 may be defined as the y-axis, and the fore-aft direction orthogonal to the xy-plane may be defined as the z-axis.
After defining the coordinate system, the transducer array may be virtually placed on the patient model with the center and longitudinal axis of the transducer array in the xy plane. A pair of transducer arrays may be systematically rotated around the z-axis of the head phantom (i.e., from 0 to 180 degrees in the xy-plane) to cover (by symmetry) the entire circumference of the head. The rotational interval may be, for example, 15 degrees, corresponding to approximately 2cm of translation, giving a total of 12 different positions within a 180 degree range. Other rotational intervals are contemplated. Electric field distribution calculations may be performed for each transducer array position relative to tumor coordinates.
The electric field distribution in the patient model may be determined by the
patient modeling application 608 using a Finite Element (FE) approximation of the electric potential. In general, the amount of time-varying electromagnetic field is defined by complex maxwell's equations. However, in biological tissue and at TTFields (f = 200 kHz) down to medium frequencies, the electromagnetic wavelength is much larger than the size of the head, and the dielectric constant ∈ is negligible compared to the real-valued conductivity σ, i.e. where
Is the angular frequency. This implies that electromagnetic propagation effects and capacitive effects in tissue are negligible, so scalar potentials can well be represented by the static Laplace equation

To approximate, there are appropriate boundary conditions at the electrodes and the skin. Thus, the complex impedance is considered to be resistive (i.e. negligible reactance) and thus the current flowing within the bulk conductor is predominantly free (ohmic) current. The FE approximation of the laplace equation can be calculated using software such as SimNIBS software (SimNIBS. Residual error requirement of computation and conjugate gradient solver based on Galerkin method<lE-9. A dirichlet boundary condition is used in which the potential is set to a (arbitrarily chosen) fixed value at each electrode array set. The electric (vector) field can be calculated as a numerical gradient of the electric potential and the current density (vector field) can be calculated from the electric field using ohm's law. The potential difference of the electric field value and the current density can be linearly scaled to ensure that the total peak-to-peak amplitude of each 1.8A array pair is calculated as the (numerical) surface integral of the normal current density component over all triangular surface elements on the active electrode disk. The "dose" of TTFields can be calculated as the intensity of the field vector (L2 norm). It may be assumed that the modeled currents are provided by two separate and sequentially activated sources, each source connected to a pair of 3 x 3 transducer arrays. In the simulation, the left and back arrays may be defined as sources, while the right and front arrays are corresponding sinks, respectively.However, because TTfields use alternating fields, this choice is arbitrary and does not affect the results.
The average electric field strength generated by the transducer array placed at multiple locations on the patient may be determined by the patient modeling application 608 for one or more tissue types. In one aspect, the transducer array location corresponding to the highest average electric field strength in the tumor tissue type(s) may be selected as the patient's desired (e.g., optimal) transducer array location.
In some cases, transducer array placement positions may be determined, such as optimized transducer array placement positions for effective and/or optimized TTFields treatment and/or therapy. For example, one or more users (e.g., doctors, nurses, assistants, staff members, physicists, dosimeters, etc.) may use a user interface to determine and/or generate a transducer array layout (e.g., a three-dimensional array layout, etc.) for positioning a transducer array on the body (e.g., head, torso, etc.) of a person (e.g., patient, subject, etc.), which will optimize TTFields therapy and/or therapy while avoiding and/or limiting skin toxicity. For example, a plurality of sets (e.g., groups, assemblies, etc.) of transducer array layouts may be determined to each include a transducer array layout that satisfies the criterion (es). The criteria may include potential amplitudes of electric fields distributed within a region of interest (ROI) associated with a person (e.g., patient, subject, etc.), potential power densities associated with electric fields distributed within the ROI, and an estimate of skin toxicity associated with a portion of the body of the person (e.g., head, torso, etc.), and/or any other criteria. A set of transducer array layouts of the plurality of sets of transducer array layouts may be determined, including two or more transducer array layouts including non-overlapping locations for transducer array placement. The plurality of sets of transducer array layouts may be displayed, for example, to a user and/or may be selectable, for example, via a user interface. The user interface may be used to select a transducer array layout and, based on the selection, be presented with a set of transducer array layouts of a plurality of sets of transducer array layouts associated with the selected transducer array layout (e.g., based on a criterion, based on a non-overlapping location, an overlapping location, etc.).
An example method may include presenting a plurality of images of an anatomical volume to at least one user, and accepting from the at least one user a selection of which images of the anatomical volume should be used to generate a plurality of transducer array layouts. The method may include generating a model (3D model) of electrical characteristics of the anatomical volume based on the selected images and determining a plurality of transducer array layouts. Then, based on the created model, it is evaluated which of the determined transducer array layouts satisfies at least one criterion. The method may include presenting a plurality of transducer array layouts satisfying at least one criterion to at least one user, and accepting from the at least one user a selection of one of the transducer array layouts presented to the at least one user. A report may be generated describing the selected transducer array layout. In some instances, the model may also be based on at least one additional image. In some instances, generating the model may include performing segmentation based on input received from at least one user. In some instances, the at least one user may include a first user and a second user. The method may further include accepting input from the first user identifying the region of interest and outputting data describing the region of interest to the second user. In some instances, generating the model may include performing the segmentation based on input received from the second user. In some instances, the method may include accepting input from a first user identifying a coarse segmentation, and outputting data describing the coarse segmentation to a second user. In some instances, generating the model may include performing the segmentation based on input received from the second user. In some instances, the method may include accepting at least one note from a first user and outputting the at least one note to a second user. In some instances, generating the model may include performing the segmentation based on input received from the second user. In some instances, the method may include accepting an input from a first user identifying an avoidance region and outputting data describing the avoidance region to a second user. In some instances, generating the model may include performing the segmentation based on input received from the second user.
FIG. 10 is a block diagram depicting an example system 1000 for managing transducer array placement. In some instances, components of system 1000 may be implemented as a single device and/or the like. In some instances, components of system 1000 may be implemented as separate devices/components and/or communicate collectively. System 1000 and/or components of system 1000 may be implemented as hardware, software, or a combination of both hardware and software. In one aspect, some or all of the steps of any of the methods described herein may be performed on and/or via components of system 1000. The system 1000 may be used to determine the location at which a transducer array is placed on a body of a person (e.g., patient, subject, etc.). The location (position) of the transducer array placement may be indicated by one or more transducer array layouts. A user (e.g., a physician, nurse, assistant, staff member, physicist, dosimeter, etc.) may use the system 1000 to generate and/or evaluate a plurality of transducer array layouts. The system 1000 enables a user, who may be a higher cost and/or highly skilled person (e.g., a physician, etc.), to provide guidance and/or instructions for lower cost persons (e.g., a dosimeter, a physicist, etc.) to determine and/or generate a transducer array layout. For example, image data (e.g., one or more images associated with CT, MRI, ultrasound, SPECT, x-ray CT, PET, etc.) may be segmented via a user device, and the segmented image data may be transmitted to another user device for analysis, for generating a three-dimensional (3D) model, and/or for generating a plurality of transducer array layouts. The determined and/or generated transducer array layouts may be reviewed and/or selected to generate reports that may be used for effective TTFields treatments and/or therapies.
The system 1000 may include a patient support module 1001. The patient support module 1001 may include a processor 1008. The processor 1008 may be a hardware device for executing software, particularly software stored in the memory 1010. The processor 1008 may 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 chip set), or generally any device for executing software instructions. When the patient support module 1001 is operational, the processor 1008 may be configured to execute software stored in the memory 1010, to transfer data to and from the memory 1010, and to generally control operation of the patient support module 1001 in accordance with the software.
I/O interface 1012 may be used to receive user input from and/or provide system output to one or more devices or components, such as user devices 1020 and 1030. User input may be provided via, for example, a keyboard, a mouse, a data/information communication interface, and/or the like. I/O interface 1012 may include, for example, a serial port, a parallel port, a Small Computer System Interface (SCSI), an IR interface, an RF interface, and/or a Universal Serial Bus (USB) interface.
The network interface 1014 may be used to send 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. Network interface 1014 may include address, control, and/or data connections to enable appropriate communications.
The memory 1010 (memory system) can include any one or combination of volatile memory elements (e.g., random access memory (RAM, such as DRAM, SRAM, SDRAM, etc.)) and nonvolatile memory elements (e.g., ROM, hard drive, tape, CDROM, DVDROM, etc.). Further, the memory 1010 may incorporate electronic, magnetic, optical, and/or other types of storage media. In some instances, the memory system 1010 may have a distributed architecture, where various components are located remotely from each other, but may be accessed by the processor 1008.
The memory 1010 may include one or more software programs, each of which comprises an ordered listing of executable instructions for implementing logical functions. For example, memory 1010 may include an EFG configuration application 606, a patient modeling application 608, imaging data 610 (as described in FIG. 6), and a suitable operating system (O/S) 1018. Operating system 1018 can essentially control the execution of other computer programs, and provide scheduling, input-output control, file and data management, memory management, and communication control and related services.
For purposes of illustration, application programs and other executable program components, such as the operating system 1018, are illustrated herein as discrete blocks, although it is recognized that such programs and components may reside at various times in different storage components of the patient support system 104. Implementations of the EFG configuration application 606, the patient modeling application 608, the imaging data 610, and/or the control software 110 may be stored on or transmitted across some form of computer readable media. Any of the disclosed methods can be performed by computer readable instructions embodied on a computer readable medium. Computer readable media can be any available media that can be accessed by a computer. By way of example, and not limitation, computer readable media may comprise "computer storage media" and "communication media". "computer storage media" may include volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information, such as computer readable instructions, data structures, program modules or other data. Exemplary computer storage media can include RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, Digital Versatile Disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by a computer.
System 1000 may include user devices 1020 and 1030. The user devices 1020 and 1030 may be electronic devices, such as computers, smart phones, laptops, tablets, and/or the like, capable of communicating with the patient support module 1001. Although only user devices 1020 and 1030, system 1000 may include multiple devices.
The user devices 1020 and 1030 may include an interface module 1022. The interface module 1022 may provide an interface for a user to interact with the user devices 1020 and 1030 and/or the patient support module 1001. The interface module 1022 may include one or more input devices/interfaces such as a keyboard, pointing device (e.g., computer mouse, remote control), microphone, joystick, scanner, tactile sensing and/or tactile input device, and/or the like.
The interface module 1022 may include one or more interfaces for presenting and/or receiving information, such as user feedback, to/from a user (e.g., doctor, nurse, assistant, staff member, physicist, dosimeter, etc.). The interface module 1022 may include any software, hardware, and/or interface for providing communication between a user and one or more of the user devices 1020 and 1030, the patient support module 1001, and/or any other component of the system 1000 and/or any other component associated therewith. The interface module 1022 may include one or more displays (e.g., a monitor, a heads-up display, a head-mounted display, a liquid crystal display, an organic light emitting diode display, an active matrix organic light emitting diode display, a stereoscopic display, etc.) for displaying/presenting information to a user. Interface module 1022 may include one or more audio devices (e.g., stereo, speakers, microphones, etc.) for capturing/obtaining audio information and communicating audio information, such as audio information captured/obtained from and/or communicated to a user. The interface module 1022 may comprise a Graphical User Interface (GUI), a web browser (e.g., Internet Explorer @, Mozilla Firefox @, Google Chrome @, Safari @, or the like), applications/APIs. The interface module 1022 may request and/or query various files from local and/or remote sources, such as the patient support module 1001.
The interface module 1022 can transmit/send data/information to local and/or remote devices/components of the system 1000, such as the patient support module 1001 and/or another user device (e.g., user device 1020, user device 1030, etc.). The user devices 1020 and 1030 may include a communication module 1023. The communication module 1023 may enable the user devices 1020 and 1030 to communicate with components of the system 1000 (such as the patient support module 1001 and/or another user device) via wired and/or wireless communication techniques. For example, the communication module 1023 may utilize any suitable wired communication technology, such as ethernet, coaxial cable, fiber optics, and/or the like. The communication module 1023 may utilize any suitable telecommunications technology, such as WiFi (IEEE 802.11), BLUETOOTH, cellular, satellite, infrared, and/or the like. The communication module 1023 may utilize any suitable short range communication technology, such as BLUETOOTH ®, near field communications, infrared, and the like.
As described, the system 1000 can be used to determine the location (position) at which a transducer array is placed on the body of a person (e.g., patient, subject, etc.). The location (position) of the transducer array placement may be indicated by one or more transducer array layouts. A user (e.g., a physician, nurse, assistant, staff member, physicist, dosimeter, etc.) may use the system 1000 to generate and/or evaluate a plurality of transducer array layouts. The system 1000 enables a user, who may be a higher cost and/or highly skilled person (e.g., a physician, etc.), to provide guidance and/or instructions for lower cost persons (e.g., a dosimeter, a physicist, etc.) to determine and/or generate a transducer array layout. For example, higher cost and/or highly skilled personnel may use the user device 1020 to provide guidance and/or instructions for determining and/or generating a transducer array layout to lower cost personnel (e.g., a dosimeter, a physicist, etc.), which may be users of the user device 1030.
11A-11D illustrate screens of example interfaces (e.g., interface module 1022, etc.) for managing transducer array placement. For example, one or more images of a portion of the body of a subject/patient (e.g., head, torso, anatomical volume, etc.) from image data 610 may be segmented and used to generate a three-dimensional (3D) model. Fig. 11A shows an example screen 1101 of a user interface 1100. Screen 1101 may include subject/patient identification information 1102. The identification information 1102 may identify a subject/patient associated with one or more images used to generate the 3D model. Progression through the user interface 1100 can be enabled and/or indicated by an interactive element 1103 (e.g., a tag, etc.). As indicated by interactive element 1103, screen 1101 may be used for segmentation of image data.
Screen 1101 enables a user (e.g., a user of user devices 1020 and 1030, etc.) to import and examine one or more images of a body part (e.g., head, torso, anatomical volume, etc.) of a subject/patient and determine whether the imaged should be used to generate a 3D model. By interacting with the interaction element 1104 (e.g., buttons, etc.), images may be imported, for example, from the patient support module 1001. Interaction with the interactive element 1104 may cause a menu to open that enables the user to search for related images and/or upload related images. After the image has been imported, for example from the image data 610, a representation of the image may be shown in the panel 1105. FIG. 11B shows an example screen 1101 of the user interface 1100 when an image has been imported and represented by the image 1106 in the panel 1105. The user may view and examine the imported images 1106, e.g., by using an interactive element (e.g., a mouse, small touchpad, etc.), to drag one or more images 1106 to one or more windows 1107 of the screen 1101. The user may identify the image(s) (e.g., one or more images, a set of images, etc.) that best fits the TTFields treatment plan. As shown in fig. 11B, one or more images 1106 are represented in window 1107.
After viewing/examining the images 1106, the user may select an image or set of images to segment and use to generate a 3D model. In some instances, a user of the user device 1020 may select an image or set of images, and the user device 1020 may transmit the selected image or set of images (e.g., information associated with the selected image or set of images, etc.) to the user device 1030 for segmentation and 3D model generation. In some instances, a user of the user device 1030 may select an image or set of images, and the user device 1030 may transmit the selected image or set of images (e.g., information associated with the selected image or set of images, etc.) to the user device 1020 for segmentation and 3D model generation. When an image or set of images is selected, the image may be labeled with an element 1108, such as an "anchor" icon indicating that the image is the primary ("anchor") image to be used to generate the computed 3D model and/or transducer array layout. The other images may be labeled "auxiliary images" to indicate that the user has optionally selected an image to assist in generating the 3D model and/or the transducer array layout. The auxiliary image may be registered with the main image to improve the accuracy of the 3D model. In some instances, the quality of the 3D model and/or transducer array layout may be proportional to the number of images used to generate the 3D model and/or transducer array layout.
The user may select the images represented in one or more windows 1107. After the image has been selected, the image may be segmented to identify/determine/select features and/or regions of interest within the image, such as a represented tumor and/or abnormal tissue structure. The user interface 1100 may be configured with segmentation tools (e.g., semi-automatic segmentation tools, manual segmentation tools, etc.) and/or algorithms that enable a user to mark features, structures, and/or regions of interest within an image (ROl). For example, the segmentation tool may enable a user to mark image regions as enhanced tumors, necrotic cores, resection cavities, craniotomies, and/or the like. Region 1109 of screen 1101 shows examples of structures in the image that may be defined by the user, such as tissue type, ROI, and avoidance structures/regions. The avoidance structure/region may be any region on the surface of the subject/patient's body where the transducer array should not be placed, such as a region of scar tissue, medical device implantation, and/or the like.
As described, a user may assign a tissue type to an image used to generate a 3D model and/or a transducer array layout. When a user assigns a tissue type to a particular voxel of an image, the corresponding voxel in the 3D model is assigned the same tissue type dielectric and/or electrical properties associated with the tissue type. Each ROI determined and/or selected by the user may be assigned a unique label. The user interface 1100 enables any determined and/or selected ROI to be optionally marked on the images used to generate the 3D model and/or transducer array layout. In some examples, the electric field distribution simulation and/or optimization algorithm may use any determined and/or selected ROI to generate the transducer array layout. In some instances, the ROI may be imported into the system 1000 from an external source (e.g., third-party software for planning radiation therapy, etc.). After the user has completed the segmentation editing of the image, the interactive element 1110 may be interacted with and/or selected to generate a 3D model 1110.
FIG. 11C shows an example screen 1111 of the user interface 1100. Screen 1111 may be a progressive screen of screen 1101. As shown, the interactive element 1103 is set to a "model" to indicate the progress of the user interface 1100. Screen 1111 may display any abnormal tissue indicated on screen 1101 and any normal body tissue within the image (e.g., gray matter, white matter, skull, scalp, and CSF). The user interface 1100 may be configured to automatically add and/or include any normal body tissue when generating the 3D model.
The generated 3D model may model any electrical characteristics at each point in space within a portion of the body of the subject/patient (e.g., head, torso, anatomical volume, etc.). For example, system 1000 may map electrical characteristics to a 3D model. Mapping the electrical characteristics to the 3D model may be based on diffusion tensor imaging MRI Data (DTI), hydroelectric property tomography (wupt), machine learning, and/or any other method/technique for correlating electrical characteristics to tissue types based on image data. Once the 3D model is generated, the user interface 1100 enables a user to position the analog transducer array at various locations on the 3D model, application of analog AC voltages to the analog transducer array, and perform simulations that determine the resulting electric field distribution and/or power density at each point within the body part (e.g., head, torso, anatomical volume, etc.) of the subject/patient represented by the 3D model. The 3D model may be displayed to a user. If the user is not satisfied with the displayed model, the interactive element 1112 "view segmentation" may be used, for example, to return to a previous screen, such as the segmentation input screen of the user interface 1100. If the user is satisfied with the displayed model, for example, the interactive element 1113 "Create plan" may be used to advance to the next screen of the user interface 1100.
FIG. 11D shows an example screen 1114 of the user interface 1100. The user may "plan" to interact with the interactive element 1103, e.g., to progress to screen 1114. For example, screen 1114 may be used to analyze, evaluate, and/or select TTfields treatment plans. For example, after generating a 3D model and determining a plurality of simulated electric field distributions based on the 3D model, a plurality of transducer array layouts may be generated. In some instances, the system 1000 may determine a plurality of transducer array layouts, for example, from a library, record, corpus, and/or the like of standard transducer array layouts. In some instances, the system 1000 may determine a multiple transducer array layout, for example, enabling a user to vary the position of one or more arrays using the user interface 1100 to converge on a transducer array layout that provides a desired and/or optimal (e.g., best suited to meet criteria, etc.) result. Based on varying the position of one or more arrays as described, the system 1000 may determine one or more of a plurality of transducer array layouts (e.g., a set of transducer array layouts, etc.) that optimize the electric field distribution within the target ROI while also satisfying constraints associated with transducer array placement imposed by the avoidance structure. For example, one or more sets of transducer array layouts may be determined (e.g., automatically, manually selected, etc.) from a plurality of transducer array layouts, each transducer array layout representing at least two transducer array layouts having non-overlapping locations and/or meeting criteria. As described, the criteria can include an amplitude of the simulated electric field distribution within the ROI associated with the 3D model, a power density associated with the simulated electric field distribution within the ROI, and/or the like. In some instances, the criteria may be based on an estimate of skin toxicity associated with the portion of the subject/patient's body where the transducer array is to be placed and/or the avoidance zone.
An optimal transducer array layout for a desired TTFields treatment plan may be determined to generate composite data (e.g., reports, plans, summaries, etc.). For example, the composite data may include information associated with the transducer array layout and an associated simulated electric field distribution. The composite data may be displayed, for example, via user interface 1100. Returning to fig. 11D, the screen 1114 may display an electric field distribution (e.g., represented as one or more color maps, etc.) associated with each of the plurality of transducer array layouts. For example, the interactive elements 1115 may be used to view the electric field distribution of each transducer array layout by interacting with corresponding TAL elements (e.g., TAL 1 through TAL 5). As shown, TAL 1 of the interactive elements 1115 is selected and a color map of the electric field distribution and associated transducer array layout are displayed in regions 1116 and 1117, respectively. A table summarizing the electric field dose delivered to the target ROI for each of the plurality of transducer array layouts may be displayed to enable the user to select a TTFields treatment plan. In some instances, an aggregate score for each of a plurality of transducer array layouts and/or a set of transducer array layouts may be determined and displayed. The score may represent how satisfactory the associated transducer array layout is with respect to the criterion(s). The scores may be color-coded (e.g., green for the highest score, yellow for the medium score, and red for the low score). The multiple transducer array layouts and/or the set of transducer array layouts in the multiple transducer array layouts may be ordered according to any method, algorithm, and/or criteria, and the ordering may be displayed to a user.
The user interface 1100 enables a plurality and/or set of transducer array layouts to be evaluated by a user, for example. The evaluation of the transducer array layout is based on and/or determines the quality of the 3D model used to generate the transducer array layout (e.g., TTFields treatment plan, etc.). The user may evaluate and select one or more of the plurality of transducer array layouts and/or the set of transducer array layouts.
FIG. 12 shows a flow diagram of a method 1200 for managing transducer array placement. One or more of the apparatus 100, patient support system 602, patient modeling application 608, system 1000, and/or any other device/component described herein may be configured to perform a method 1200, the method 1200 including generating a three-dimensional (3D) model of a portion of a body of a subject at 1210. Generating the 3D model may be based on image data from any imaging modality, such as one or more images associated with CT, MRI, ultrasound, SPECT, x-ray CT, PET, combinations thereof, and/or the like. In some examples, one or more user devices may display multiple images of a body part of a subject. A selection of one or more of the plurality of images may be received based on a region of interest (ROI), and a 3D model may be generated based on the one or more images. For example, the ROI may be based on features and/or structures within one or more images, such as enhanced tumors, necrotic cores, resection cavities, craniotomies, and/or the like. In some instances, the received information associated with the ROI may be received from a first user device of the one or more user devices, and the selection of the one or more images may be received from a second user device of the one or more user devices.
At 1220, a plurality of transducer array layouts are determined based on the 3D model and the plurality of simulated electric field distributions. Determining the plurality of transducer array layouts may include determining a plurality of pairs of positions for transducer array placement based on the 3D model. In some instances, pairs of locations for transducer array placement may be determined from a library, record, corpus, and/or the like of standard transducer array layouts. In some instances, pairs of locations for transducer array placement may be determined and/or selected to avoid one or more regions within the 3D model (e.g., avoidance regions, etc.), and/or the like. For each of the plurality of pairs of positions, a simulated electric field distribution of the plurality of simulated electric field distributions may be determined. Determining the simulated electric field distribution for each of the plurality of pairs of positions may include simulating a first electric field generated by the first transducer array at a first position of the pair of positions and simulating a second electric field generated by the second transducer array at a second position of the pair of positions. The second position may be opposite the first position. In some examples, a third electric field generated by the first transducer array may be simulated at a third location and a fourth electric field generated by the second transducer array may be simulated at a fourth location opposite the third location, and based on the third and fourth electric fields, a simulated electric field distribution may be determined. The simulated electric field distribution may be determined based on the first and second electric fields and/or the third and fourth electric fields. A plurality of transducer array layouts may be determined based on the plurality of simulated electric field distributions.
At 1230, one or more sets of transducer array layouts are determined from the plurality of transducer array layouts, wherein each set of transducer array layouts represents at least two transducer array layouts having non-overlapping locations of the plurality of pairs of locations for transducer array placement, wherein the at least two transducer array layouts satisfy a criterion. The criteria can include an amplitude of a simulated electric field distribution of a plurality of simulated electric field distributions within a region of interest (ROI) associated with the 3D model, a power density associated with the simulated electric field distribution of the plurality of simulated electric field distributions within the ROI, and an estimate of skin toxicity associated with the body part of the subject.
At 1240, a set of one or more transducer array layouts is caused to be displayed. The set of one or more transducer array layouts may be displayed by an interface of one or more user devices. A selection of a set of transducer array layouts of the one or more sets of transducer array layouts may be received, for example, via an interface of the one or more user devices. Composite data (e.g., reports, plans, summaries, etc.) may be generated based on the selected set of transducer array layout images. The composite data may include information associated with the selected set of transducer array layouts and a simulated electric field distribution of a plurality of simulated electric field distributions associated with the selected set of transducer array layouts. The composite data may be transmitted to one or more user devices.
FIG. 13 shows a flow diagram of a method 1300 for managing transducer array placement. One or more of the apparatus 100, the patient support system 602, the patient modeling application 608, the system 1000, and/or any other device/component described herein may be configured to perform a method 1300, the method 1300 including generating a three-dimensional (3D) model of a portion of a body of a subject at 1310. Generating the 3D model may be based on image data from any imaging modality, such as one or more images associated with CT, MRI, ultrasound, SPECT, x-ray CT, PET, combinations thereof, and/or the like. In some examples, one or more user devices may display multiple images of a body part of a subject. A selection of one or more of the plurality of images may be received based on a region of interest (ROI), and a 3D model may be generated based on the one or more images. For example, the ROI may be based on features and/or structures within one or more images, such as enhanced tumors, necrotic cores, resection cavities, craniotomies, and/or the like. In some instances, the received information associated with the ROI may be received from a first user device of the one or more user devices, and the selection of the one or more images may be received from a second user device of the one or more user devices.
At 1320, a plurality of transducer array layouts are determined based on the 3D model and the plurality of simulated electric field distributions. Determining the plurality of transducer array layouts may include determining a plurality of pairs of positions for transducer array placement based on the 3D model. In some instances, pairs of locations for transducer array placement may be determined from a library, record, corpus, and/or the like of standard transducer array layouts. In some instances, pairs of locations for transducer array placement may be determined and/or selected to avoid one or more regions within the 3D model (e.g., avoidance regions, etc.), and/or the like. For each of the plurality of pairs of positions, a simulated electric field distribution of the plurality of simulated electric field distributions may be determined. Determining the simulated electric field distribution for each of the plurality of pairs of positions may include simulating a first electric field generated by the first transducer array at a first position of the pair of positions and simulating a second electric field generated by the second transducer array at a second position of the pair of positions. The second position may be opposite the first position. In some examples, a third electric field generated by the first transducer array may be simulated at a third location and a fourth electric field generated by the second transducer array may be simulated at a fourth location opposite the third location, and based on the third and fourth electric fields, a simulated electric field distribution may be determined. The simulated electric field distribution may be determined based on the first and second electric fields and/or the third and fourth electric fields. A plurality of transducer array layouts may be determined based on the plurality of simulated electric field distributions.
At 1330, a selection of a first transducer array layout of a plurality of transducer array layouts is received, wherein the first transducer array layout satisfies a criterion. A selection of a first transducer array layout may be received from one or more user devices. The criteria can include an amplitude of a simulated electric field distribution of a plurality of simulated electric field distributions within a region of interest (ROI) associated with the 3D model, a power density associated with the simulated electric field distribution of the plurality of simulated electric field distributions within the ROI, and an estimate of skin toxicity associated with the body part of the subject.
At 1340, one or more associated transducer array layouts are determined from the plurality of transducer array layouts. Each associated transducer array layout may include a location for transducer array placement that does not overlap with a location for transducer array placement of the first transducer array layout. In some instances, each associated transducer array layout may satisfy a criterion.
At 1350, a selection of a second transducer array layout is received from one or more associated transducer array layouts.
At 1360, a first transducer array layout and a second transducer array layout are displayed. In some examples, composite data (e.g., a report, a plan, a summary, etc.) may be generated based on the first transducer array layout and the second transducer array layout. The composite data may include, for example, information associated with the first transducer array layout and the second transducer array layout and a simulated electric field distribution of the plurality of simulated electric field distributions associated with the first transducer array layout and the second transducer array layout.
FIG. 14 shows a flow diagram of a method 1400 for managing transducer array placement. One or more of the apparatus 100, the patient support system 602, the patient modeling application 608, the system 1000, and/or any other device/component described herein may be configured to perform a method 1300, the method 1300 comprising generating a three-dimensional (3D) model of a portion of a body of a subject at 1410. Generating the 3D model may be based on image data from any imaging modality, such as one or more images associated with CT, MRI, ultrasound, SPECT, x-ray CT, PET, combinations thereof, and/or the like. In some examples, one or more user devices may display multiple images of a body part of a subject. A selection of one or more of the plurality of images may be received based on a region of interest (ROI), and a 3D model may be generated based on the one or more images. For example, the ROI may be based on features and/or structures within one or more images, such as enhanced tumors, necrotic cores, resection cavities, craniotomies, and/or the like. In some instances, the received information associated with the ROI may be received from a first user device of the one or more user devices, and the selection of the one or more images may be received from a second user device of the one or more user devices.
At 1420, a plurality of transducer array layouts are determined based on the 3D model and the plurality of simulated electric field distributions. Determining the plurality of transducer array layouts may include determining a plurality of pairs of positions for transducer array placement based on the 3D model. In some instances, pairs of locations for transducer array placement may be determined from a library, record, corpus, and/or the like of standard transducer array layouts. In some instances, pairs of locations for transducer array placement may be determined and/or selected to avoid one or more regions within the 3D model (e.g., avoidance regions, etc.), and/or the like. For each of the plurality of pairs of positions, a simulated electric field distribution of the plurality of simulated electric field distributions may be determined. Determining the simulated electric field distribution for each of the plurality of pairs of positions may include simulating a first electric field generated by the first transducer array at a first position of the pair of positions and simulating a second electric field generated by the second transducer array at a second position of the pair of positions. The second position may be opposite the first position. In some examples, a third electric field generated by the first transducer array may be simulated at a third location and a fourth electric field generated by the second transducer array may be simulated at a fourth location opposite the third location, and based on the third and fourth electric fields, a simulated electric field distribution may be determined. The simulated electric field distribution may be determined based on the first and second electric fields and/or the third and fourth electric fields. A plurality of transducer array layouts may be determined based on the plurality of simulated electric field distributions.
At 1430, a selection of a first transducer array layout and a second transducer array layout of a plurality of transducer array layouts is received. The selection of the first transducer array layout and the second transducer array layout may be received via an interface of one or more user devices.
At 1430, an overlap condition is determined based on the first transducer array layout and the second transducer array layout. Each of the plurality of transducer array layouts may include one or more of a plurality of pairs of positions for transducer array placement. The overlap condition may indicate that the first transducer array layout includes one or more of the plurality of pairs of positions that overlap with one or more of the plurality of pairs of positions associated with the second transducer array layout. For example, the first transducer array layout may include locations of the transducer arrays at the same locations indicated on the 3D model (e.g., overlapping, etc.) or locations at locations indicated on the 3D model that satisfy a distance threshold and/or are within a tolerance positioning range with respect to each other (e.g., substantially overlapping, etc.).
At 1430, an overlap condition is caused to be displayed. One or more user devices may be caused to display the overlap condition, for example, via an interface, display, and/or the like. In some instances, the overlap condition may be indicated by an audible sound and/or notification.
In view of the described apparatus, systems, and methods, as well as variations thereof, certain more particularly described embodiments of the invention are described below. These specifically described embodiments should not, however, be construed as having any limiting effect on any of the various claims containing the different or more general teachings described herein, or that a "particular" embodiment is limited in some way other than by the inherent meaning of the language in which it is literally used.
Example 1: a method, comprising: generating a three-dimensional (3D) model of a portion of a subject's body; determining a plurality of transducer array layouts based on the 3D model and the plurality of simulated electric field distributions; determining one or more sets of transducer array layouts from the plurality of transducer array layouts, wherein each set of transducer array layouts represents at least two transducer array layouts having non-overlapping locations of the plurality of pairs of locations for transducer array placement, wherein the at least two transducer array layouts satisfy a criterion; and causing display of the set of one or more transducer array layouts.
Example 2: the embodiment of any of the preceding embodiments, wherein the criteria include an amplitude of a simulated electric field distribution of the plurality of simulated electric field distributions within a region of interest (ROI) associated with the 3D model, a power density associated with the simulated electric field distribution of the plurality of simulated electric field distributions within the ROI, and an estimate of skin toxicity associated with the body part of the subject.
Example 3: an embodiment as in any one of the preceding embodiments, further comprising receiving a selection of a set of transducer array layouts of the one or more sets of transducer array layouts.
Example 4: as in embodiment 3, further comprising generating composite data based on the selected set of transducer array layouts.
Example 5: the embodiment as in embodiment 4 wherein the composite data comprises information associated with the selected set of transducer array layouts and a simulated electric field distribution of a plurality of simulated electric field distributions associated with the selected set of transducer array layouts.
Example 6: the embodiment as in embodiment 4 further comprising sending the composite data to the user equipment.
Example 7: an embodiment as in any one of the preceding embodiments, wherein generating the 3D model comprises: causing one or more user devices to display a plurality of images of a body part of a subject; receiving a selection of one or more of the plurality of images based on a region of interest (ROI); and generating a 3D model based on the one or more images.
Example 8: the embodiment as in embodiment 7 further comprising receiving information associated with the ROI from a first user device of the one or more user devices, and wherein receiving the selection of the one or more images comprises receiving the selection of the one or more images from a second user device of the one or more user devices.
Example 9: an embodiment as in any one of the preceding embodiments, wherein determining a plurality of transducer array layouts comprises: determining pairs of positions for transducer array placement based on the 3D model; for each of a plurality of pairs of positions, determining a simulated electric field distribution of a plurality of simulated electric field distributions; and determining a plurality of transducer array layouts based on the plurality of simulated electric field distributions.
Example 10: the embodiment as in embodiment 9, wherein determining the simulated electric field distribution for each of the plurality of pairs of positions comprises: simulating a first electric field generated by a first transducer array at a first one of the pair of locations; simulating a second electric field generated by a second transducer array at a second location of the pair, wherein the second location is opposite the first location; and determining a simulated electric field distribution based on the first electric field and the second electric field.
Example 11: a method, comprising: generating a three-dimensional (3D) model of a portion of a subject's body; determining a plurality of transducer array layouts based on the 3D model and the plurality of simulated electric field distributions; receiving a selection of a first transducer array layout of a plurality of transducer array layouts, wherein the first transducer array layout satisfies a criterion; determining one or more associated transducer array layouts from the plurality of transducer array layouts, wherein each associated transducer array layout includes a location for transducer array placement that does not overlap with a location for transducer array placement of the first transducer array layout, wherein each associated transducer array layout satisfies a criterion; receiving a selection of a second transducer array layout from the one or more associated transducer array layouts; and causing display of a first transducer array layout and a second transducer array layout.
Example 12: embodiment as in embodiment 11 wherein the criteria comprises an amplitude of a simulated electric field distribution of the plurality of simulated electric field distributions within a region of interest (ROI) associated with the 3D model, a power density associated with the simulated electric field distribution of the plurality of simulated electric field distributions within the ROI, and an estimate of skin toxicity associated with the body part of the subject.
Example 13: the embodiment as in any one of embodiments 11-12 further comprising generating composite data based on the first transducer array layout and the second transducer array layout.
Example 14: the embodiment as in embodiment 13 wherein the composite data comprises information associated with the first transducer array layout and the second transducer array layout and a simulated electric field distribution of the plurality of simulated electric field distributions associated with the first transducer array layout and the second transducer array layout.
Example 15: an embodiment as in any of embodiments 11-14, wherein generating the 3D model comprises: causing one or more user devices to display a plurality of images of a body part of a subject; receiving a selection of one or more of the plurality of images based on a region of interest (ROI); and generating a 3D model based on the one or more images.
Example 16: the embodiment as in embodiment 15 further comprising receiving information associated with the ROI from a first user device of the one or more user devices, and wherein receiving the selection of the one or more images comprises receiving the selection of the one or more images from a second user device of the one or more user devices.
Example 17: an embodiment as in any of embodiments 11-16, wherein determining a plurality of transducer array layouts comprises: determining pairs of positions for transducer array placement based on the 3D model; determining a simulated electric field distribution of a plurality of simulated electric field distributions for each of a plurality of pairs of positions; and determining a plurality of transducer array layouts based on the plurality of simulated electric field distributions.
Example 18: the embodiment as in embodiment 17, wherein determining the simulated electric field distribution for each of the plurality of pairs of positions comprises: simulating a first electric field generated by a first transducer array at a first position of the pair of positions; simulating a second electric field generated by a second transducer array at a second location of the pair of locations, wherein the second location is opposite the first location; and determining a simulated electric field distribution based on the first electric field and the second electric field.
Example 19: a method, comprising: generating a three-dimensional (3D) model of a portion of a subject's body; determining a plurality of transducer array layouts based on the 3D model and the plurality of simulated electric field distributions; receiving a selection of a first transducer array layout and a second transducer array layout of a plurality of transducer array layouts; determining an overlap condition based on the first transducer array layout and the second transducer array layout; and causes the display of the overlapping condition.
Example 20: the embodiment as in embodiment 19, wherein each transducer array layout of the plurality of transducer array layouts comprises one or more of a plurality of pairs of positions for transducer array placement, wherein the overlap condition indicates that the first transducer array layout comprises one or more of the plurality of pairs of positions that overlap with one or more of the plurality of pairs of positions associated with the second transducer array layout.
Example 21: a method, comprising: presenting a plurality of images of an anatomical volume to at least one user; accepting from the at least one user a selection of which images of the anatomical volume should be used to generate the transducer array layout; creating an electrical property model of the anatomical volume based on the selected images; determining a plurality of transducer array layouts; evaluating which of the determined transducer array layouts satisfies at least one criterion based on the created model; presenting to the at least one user a plurality of transducer array layouts satisfying the at least one criterion; accepting from the at least one user a selection of one of the transducer array layouts presented to the at least one user; and generating a report describing the selected transducer array layout.
Example 22: an embodiment as in embodiment 21, wherein the model of the electrical properties of the anatomical volume is also based on the at least one additional image.
Example 23: an embodiment as in any one of embodiments 21-22, wherein creating a model comprises performing segmentation based on input received from the at least one user.
Example 24: the embodiment as in any one of embodiments 21-23 wherein the at least one user comprises a first user and a second user, wherein the method further comprises (a) accepting input from the first user identifying the region of interest, and (b) outputting data descriptive of the region of interest to the second user.
Example 25: the embodiment as in embodiment 24 wherein creating the model comprises performing the segmentation based on input received from the second user.
Example 26: an embodiment as in any of embodiments 21-25, wherein the at least one user comprises a first user and a second user, wherein the method further comprises: accepting input from a first user identifying a total split; and outputting data describing the total split to a second user.
Example 27: the embodiment as in embodiment 26 wherein creating the model comprises performing the segmentation based on input received from the second user.
Example 28: an embodiment as in any of embodiments 21-27 wherein the at least one user comprises a first user and a second user, wherein the method further comprises (a) accepting at least one note from the first user, and (b) outputting the at least one note to the second user.
Example 29: the embodiment as in embodiment 28 wherein creating the model comprises performing the segmentation based on input received from the second user.
Example 30: an embodiment as in any one of embodiments 21-29 wherein the at least one user comprises a first user and a second user, wherein the method further comprises (a) accepting input from the first user identifying the avoidance area, and (b) outputting data describing the avoidance area to the second user.
Example 31: the embodiment as in embodiment 30 wherein creating the model comprises performing the segmentation based on input received from the second user.
Unless explicitly stated otherwise, it is in no way intended that any method set forth herein be construed as requiring that its steps be performed in a specific order. Accordingly, where a method claim does not actually recite an order to be followed by its steps or it is not otherwise specifically stated in the claims or descriptions that the steps are to be limited to a specific order, it is no way intended that an order be inferred, in any respect. This applies to any possible basis for non-explicit interpretation, including: logic issues regarding step placement or operational flow; simple meaning derived from grammatical organization or punctuation; the number or type of embodiments described in the specification.
While the methods and systems have been described in connection with preferred embodiments and specific examples, it is not intended that the scope be limited to the specific embodiments set forth, as the embodiments herein are intended in all respects to be illustrative rather than restrictive.
Unless explicitly stated otherwise, it is in no way intended that any method set forth herein be construed as requiring that its steps be performed in a specific order. Accordingly, where a method claim does not actually recite an order to be followed by its steps or it is not otherwise specifically stated in the claims or descriptions that the steps are to be limited to a specific order, it is no way intended that an order be inferred, in any respect. This applies to any possible basis for non-explicit interpretation, including: logic issues regarding step placement or operational flow; simple meaning derived from grammatical organization or punctuation; the number or type of embodiments described in the specification.
It will be apparent to those skilled in the art that various modifications and variations can be made without departing from the scope or spirit thereof. Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the disclosure disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit being indicated by the following claims.