An ingestible implantable device for measuring internal TT field strength

Abstract

Described herein are devices and methods for determining characteristics of an electric field, the device including a housing having a biocompatible exterior surface, a plurality of electrodes supported by the housing, and a controller supported within the housing, the controller including a processor, a communication device, and a non-transitory computer-readable medium storing processor-executable code that, when executed, causes the processor to measure a potential difference between a first electrode and a second electrode of the plurality of electrodes, the first electrode and the second electrode being spaced apart by a predetermined distance, and transmit data indicative of the potential difference via the communication device.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This patent application claims priority to U.S. Patent Application No. 63 / 377,256, filed September 27, 2022, the entire contents of which are incorporated herein by reference.

[0002] [Statement Regarding Federally Sponsored Research or Development] Not applicable. [Background technology]

[0003] Tumor treating fields (TT fields or TTFs) are low-intensity (e.g., 1-3 V / cm) alternating electric fields in the mid-frequency range (50 kHz-1 MHz, e.g., 100-500 kHz) that target solid tumors by inhibiting mitosis. This non-invasive treatment is targeted to solid tumors and is described, for example, in U.S. Patent Nos. 7,016,725, 7,089,054, 7,333,852, 7,565,205, 8,244,345, 8,715,203, 8,764,675, 10,188,851, and 10,441,776. TT fields are typically delivered through two pairs of transducer arrays, each pair positioned on opposite sides of the body to be treated, that generate perpendicular magnetic fields within the tumor. TT fields are approved for the treatment of glioblastoma multiforme (GBM) and can be delivered, for example, via the OPTUNE® system (Novocure Limited, St. Helier, Jersey), which includes a transducer array placed on the patient's shaved head.

[0004] Each transducer array used to deliver TT fields in the OPTUNE® device includes a set of non-conductive ceramic disc electrodes that are coupled to a patient's skin (such as a patient's shaved head for the treatment of GBM) via a layer of conductive medical gel. To form the ceramic disc electrodes, a conductive layer is formed on the top surface of the non-conductive ceramic material. The bottom surface of the non-conductive ceramic material is coupled to the conductive medical gel.

[0005] One way to apply TT fields in different directions is to apply the field between a first set of electrodes in a first direction for a period of time, then apply the field between a second set of electrodes in a second direction for a period of time, and then repeat the cycle for an extended period of time (e.g., days, weeks, or months).To generate the TT field, a current is applied to each electrode of the transducer array. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 7,016,725 [Patent Document 2] U.S. Patent No. 7,089,054 [Patent Document 3] U.S. Patent No. 7,333,852 [Patent Document 4] U.S. Patent No. 7,565,205 [Patent Document 5] U.S. Patent No. 8,244,345 [Patent Document 6] U.S. Patent No. 8,715,203 [Patent Document 7] U.S. Patent No. 8,764,675 [Patent Document 8] U.S. Patent No. 10,188,851 [Patent Document 9] U.S. Patent No. 10,441,776 Summary of the Invention [Problem to be solved by the invention]

[0007] The TT field interacts with the patient and one or more of the patient's organs based on the electrical impedance, resistance, resistivity, or conductivity of each of the patient's organs. As the TT field interacts with the patient, the shape of the field may change based on the electrical impedance, resistance, resistivity, or conductivity and the relative position of each of the patient's organs. Because the electrical conductivity of each of the patient's organs changes the shape of the TT field, and a specific TT field shape may be required to effectively target the tumor, it is important to be able to determine how the applied TT field will be formed within the patient's body.

[0008] To date, there has been no way to measure a patient's actual TT field shape without computer simulation, but computer simulation and other models rely on programming techniques and assumptions and cannot represent a patient's expected actual TT field shape. [Means for solving the problem]

[0009] Because the electrical impedance, resistance, resistivity, or conductivity of each organ in a patient affects the shape of the TT field, and a specific TT field shape may be required to effectively target a tumor, new and improved assemblies and methods for determining the magnitude and direction of the TT field are needed. The present disclosure relates to such assemblies, as well as methods for making and using the same. The problem of determining the magnitude and / or direction of a TT field is solved by a device, system, and method, including a housing having a biocompatible outer surface, a plurality of electrodes supported by the housing, and a controller supported within the housing, the controller including a processor, a communication device, and a non-transitory computer-readable medium storing processor-executable code, which, when executed, causes the processor to measure a potential difference between a first electrode and a second electrode of the plurality of electrodes, space the first electrode and the second electrode a predetermined distance apart, and transmit data indicative of the potential difference via the communication device.

[0010] The problem of determining the magnitude and / or direction of a TT field is further solved by a method including the steps of measuring a potential difference between a first electrode and a second electrode spaced a predetermined distance apart among a plurality of electrodes supported by a housing having a biocompatible outer surface, and determining characteristics of the electric field based at least in part on the potential difference and the predetermined distance.

[0011] The problem of determining the magnitude and / or direction of a TT field is further solved by a system including a probe device and a computer system, wherein the probe device includes a housing having a biocompatible outer surface, a plurality of electrodes supported by the housing, and a controller supported within the housing, the controller including a first processor, a first communication device, and a first non-transitory computer-readable medium storing first processor-executable code, which when executed causes the first processor to measure a potential difference between a first electrode and a second electrode of the plurality of electrodes, the first electrode and the second electrode being spaced apart by a predetermined distance, and to transmit first data indicative of the potential difference using the first communication device, and the computer system includes a second processor, a second communication device, and a second non-transitory computer-readable medium storing second processor-executable code, and in response to receipt of the first data by the second communication device, the second processor stores second data indicative of a characteristic of the electric field based at least in part on the first data and the predetermined distance.

[0012] The details of one or more implementations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other aspects, features, and advantages of the subject matter will become apparent from the description, drawings, and claims. [Brief explanation of the drawings]

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more implementations described herein and, together with the description, explain these implementations. The drawings are not intended to be drawn to scale, and for clarity and conciseness, certain features and certain views of the figures may be exaggerated, drawn to scale, or shown in schematic form. Not every component is labeled in every drawing. Like reference numbers in the figures may represent and refer to the same or similar elements or functions.

[0014] [Figure 1] 1 is a schematic diagram of an exemplary embodiment of an electrode applied to a field target, such as biological tissue, with a probe device implanted within the field target; [Figure 2] 1 is a schematic diagram of an exemplary embodiment of an electronic device configured to generate a TT field. [Figure 3] 1 is a schematic diagram of an exemplary embodiment of a transducer array. [Figure 4] 1 is a schematic diagram of an exemplary embodiment of a probing device. [Figure 5] FIG. 2 is a block diagram of an exemplary embodiment of a controller. [Figure 6] FIG. 1 is a block diagram of an exemplary embodiment of a computer system. [Figure 7] FIG. 1 is a process flow diagram of an exemplary embodiment of a method for determining a property of an electric field. [Figure 8] FIG. 1 is a process flow diagram of an exemplary embodiment of a method for determining a transducer array placement. DETAILED DESCRIPTION OF THE INVENTION

[0015] Before describing in detail at least one embodiment of the inventive concepts in illustrative terms and results, it should be understood that application of the inventive concepts is not limited to the details of construction and the arrangement of components set forth in the following description. The inventive concepts are capable of other embodiments or of being practiced or carried out in various ways. Accordingly, the terms used herein are intended to be accorded the broadest possible scope and meaning, and the embodiments are intended to be illustrative and not exhaustive. It should also be understood that the phraseology and terminology used herein are for the purpose of description and not limitation.

[0016] Headings are provided for convenience only and should not be construed as limiting the invention in any way. Embodiments described under any heading or in any portion of this disclosure may be combined with embodiments described under the same heading or other headings or other portions of this disclosure. Unless otherwise indicated herein or clearly contradicted by context, any combination of elements described herein in all possible variations is encompassed by the invention.

[0017] Unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular, except that as used herein the word "plural" does not include the singular.

[0018] All patents or published patent applications referenced in any part of this application are expressly incorporated by reference in their entirety to the same extent as if each individual patent or publication was specifically and individually indicated to be incorporated by reference.

[0019] All of the assemblies, systems, kits, and / or methods disclosed herein can be made and executed without undue experimentation in light of the present disclosure. In method claims, unless the claims or description specifically state that the steps are limited to a particular order, no order is intended to be inferred in any respect. This does not apply to any possible implicit basis for interpretation, such as questions of logic regarding the arrangement of steps or operational flow, the apparent meaning derived from grammatical construction or punctuation, or the number or type of embodiments described in the specification.

[0020] As used in accordance with the present disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings:

[0021] The use of the terms "a" or "an" in the claims and / or specification when used in conjunction with the term "comprising" may mean "one," but is also consistent with the meaning of "one or more," "at least one," or "one or more than one." The term "plurality" refers to "two or more."

[0022] Use of the term "at least one" is understood to include quantities greater than 1, not just 1. Additionally, use of the term "at least one of X, Y, Z" is understood to include X only, Y only, Z only, and any combination of X, Y, and Z.

[0023] The use of ordinal terminology (e.g., "first," "second," "third," "fourth," etc.) is intended only to distinguish between two or more items and does not indicate superiority of one item over another, or any order or importance, such as additive order.

[0024] Use of the term "or" in the claims is used to mean an inclusive "and / or" unless expressly indicated to refer only to alternatives or unless the alternatives are mutually exclusive.

[0025] As used herein, the term "patient" includes human and veterinary subjects. For purposes of treatment, "mammal" refers to any animal classified as a mammal, including, but not limited to, humans, domestic animals, farm animals, non-human primates, and other animals with mammary tissue.

[0026] As used herein, a circuit may be analog and / or digital components, or hardware and software in association with one or more appropriately programmed processors (e.g., microprocessors), or hardwired logic. Also, a "component" may perform one or more functions. The term "component" may include hardware such as a processor (e.g., a microprocessor), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or a combination of hardware and software. As used herein, the term "processor" refers to a single processor or multiple processors acting independently or jointly to perform a task jointly.

[0027] As used herein, the term "TT field" (TT field, or TTF(s)) refers to a tumor treatment field. A TT field is a medium-frequency (about 50 kHz to 1 MHz, more preferably about 50 kHz to 500 kHz), low-intensity (e.g., 1 to 4 V / cm) alternating electric field that, when applied via electrodes to a conductive medium such as the human body, can be used to treat tumors, for example, as described in U.S. Pat. Nos. 7,016,725, 7,089,054, 7,333,852, 7,565,205, 7,805,201, and 8,244,345 by Palti (each incorporated herein by reference) and in publications by Kirson (see Eilon D. Kirson, et al., "Disruption of Cancer Cell Replication by Alternating Electric Fields," Cancer Res. 2004 64:3288-3295). TT fields have the ability to specifically act on cancer cells and have been shown to be useful in cancer treatment. TT field therapy is an approved monotherapy for recurrent glioblastoma (GBM) and an approved combination therapy with chemotherapy for newly diagnosed GBM patients.

[0028] As used herein, the term TT signal(s) refers to electrical signals that, when received by electrodes applied to a conductive medium such as the human body, cause the electrodes to generate the TT field described above. TT signals are often alternating current electrical signals.

[0029] As used herein, the term "transducer array" can refer to a conductive transducer array or a non-conductive transducer array. Exemplary transducer arrays can include, for example, those disclosed in either U.S. Patent Publication No. 2021 / 0346693, entitled "Conductive Pads for Generating Tumor Treatment Fields, and Methods of Making and Using the Same," or U.S. Patent Publication No. 2022 / 0193404A1, entitled "Optimization of Composite Electrodes," each of which is incorporated herein in its entirety.

[0030] The term "resistance" refers to the degree to which a substance or device, or component of a device, resists the passage of electric current and dissipates energy. "Resistivity" is a fundamental property of a substance or material that refers to the degree to which a substance or material resists the passage of electric current and dissipates energy, normalized to resistance per unit length and unit cross-sectional area at a specified temperature.

[0031] The term "impedance" refers to the effective resistance of an electrical circuit or component to alternating current, resulting from the combined effects of ohmic resistance and reactance.

[0032] The term "electrical conductivity" refers to the degree to which a particular material conducts electricity and is calculated as the ratio of the current density in the material to the electric field that causes the current to flow. The "conductivity" of a material is the reciprocal of the material's resistivity.

[0033] Referring now to the drawings, and particularly to FIG. 1 , there is shown a diagram of an exemplary embodiment of a dividing cell 10 under the influence of an external TT field, generally shown as line 14, generated by a negatively charged first electrode 18a and a positively charged second electrode 18b. Also shown are microtubules 22, which are known to have a very strong dipole moment. This strong polarization makes the microtubules 22, as well as other polar macromolecules, particularly those with specific orientations within or around the cell 10, susceptible to the electric field. The positive charges on the microtubules 22 are located at the two centrioles 26, and two sets of negative poles are located at the center 30 of the dividing cell 10 and at the attachment points 34 of the microtubules 22 to the cell membrane. The locations of the charges form a set of double dipoles, making them susceptible to electric fields of different directions. In one embodiment, the cells are treated by electroporation, i.e., using an electric pulse to briefly open pores in the cell membrane and introduce DNA or chromosomes into the cells.

[0034] Referring now to FIG. 2, the TT fields described above, which have been shown to effectively destroy tumor cells, can be generated by an electronic device 50. FIG. 2 is a simplified schematic diagram illustrating the major components of electronic device 50. Electronic device 50 includes an electric field generator 54 and a pair of conductive leads 58, including a first conductive lead 58a and a second conductive lead 58b. First conductive lead 58a includes a first end 62a and a second end 62b. Second conductive lead 58b includes a first end 66a and a second end 66b. First end 62a of first conductive lead 58a is conductively connected to electric field generator 54, and first end 66a of second conductive lead 58b is conductively connected to electric field generator 54.

[0035] The electric field generator 54 generates as an output a desired electrical signal (TT signal) in the form of a waveform or pulse train. The second end 62b of the first conductive lead 58a is connected to a first transducer array 70a, and the second end 66b of the second conductive lead 58b is connected to a second transducer array 70b to provide the electrical signal (e.g., waveform).

[0036] Each of the first transducer array 70a and the second transducer array 70b is in contact with or associated with a field target 74 (see FIG. 1), such as biological tissue (e.g., a patient) or a phantom made of material(s) with similar conductive properties to biological tissue. The electrical signal generates an electric field (i.e., a TT field) that is capacitively coupled to the field target 74, the TT field having a frequency and amplitude that is generated between the first transducer array 70a and the second transducer array 70b within the field target 74. In one embodiment, the field target 74 is a phantom that typically includes two or more conductive elements.

[0037] Each of the first and second transducer arrays 70a, 70b includes one or more conductive electrode elements that can be capacitively coupled to a field target 74 by a non-conductive layer. Alternative constructions of the first and second transducer arrays 70a, 70b are also possible, including, for example, transducer arrays that use non-conductive layers formed of disk-shaped or non-disk-shaped ceramic elements, and / or non-conductive layer(s) that use a non-ceramic dielectric material disposed on a plurality of flat conductors. Examples of the latter include a polymer film disposed on electrical contacts on a printed circuit board or on a flat metal strip.

[0038] In some embodiments, the first transducer array 70a and the second transducer array 70b may also include electrode elements that are not capacitively coupled to the field target 74. In this case, each of the first transducer array 70a and the second transducer array 70b may be implemented using an area of ​​conductive material configured for placement against the human body without an insulating dielectric layer between the conductive elements and the human body. Examples of conductive materials include, but are not limited to, conductive films, conductive fabrics, and / or conductive foams. Other alternative configurations for implementing the first transducer array 70a and the second transducer array 70b may also be used, as long as they are capable of transmitting the TT field to the field target 74. If desired, in any of the embodiments described herein, a skin-contact layer may be disposed between the first transducer array 70a and the field target 74 and between the second transducer array 70b and the field target 74. The skin-contacting layer serves to adhere / secure the first and second transducer arrays 70a and 70b to the field target 74, provides a conductive path for the electric field to pass between the first and second transducer arrays 70a and 70b and the field target 74 through an intervening non-conductive or conductive layer, and is biocompatible. Examples of skin-contacting layers include hydrogels and carbon-conductive adhesive composites. The latter adhesives may include conductive particles such as carbon black powder or carbon fibers.

[0039] Although the electronic device 50 shown in FIG. 2 includes only two transducer arrays 70 (first transducer array 70a and second transducer array 70b), in some embodiments, the electronic device 50 may include more than two transducer arrays 70.

[0040] The electric field generator 54 generates an AC voltage waveform (i.e., a TT field) at a frequency ranging from about 50 kHz to about 1 MHz (preferably from about 100 kHz to about 500 kHz, or from about 100 kHz to about 300 kHz). The required voltage is such that the electric field strength in the tissue within the treatment region is in the range of about 0.1 V / cm to about 10 V / cm, e.g., 1 to 4 V / cm. To achieve this electric field, the potential difference between the two conductors 18 (not shown) of the first and second transducer arrays 70a and 70b is determined by the relative impedances of the system components; that is, the proportion of the electric field in each component is determined by the impedance of that component divided by the overall circuit impedance.

[0041] To optimize the electric field (i.e., TT field) distribution, the first and second transducer arrays 70a and 70b (the pair of transducer arrays 70) can be configured or oriented differently depending on the application for which the pair of transducer arrays 70a and 70b is being used. As described herein, the pair of transducer arrays 70a and 70b is externally applied to a field target 74. When the field target 74 is a patient, the pair of transducer arrays 70 can be applied to the patient's skin to apply an electric current and an electric field (TT field), thereby generating currents in the patient's tissue. Typically, the pair of transducer arrays 70 is positioned on the patient's skin by a user (or a helper), generating an electric field throughout the patient's tissue within the treatment area. Externally applied TT fields can be localized or widely distributed and are used, for example, to treat skin tumors, lesions close to the skin surface, or tumors deeper within the body.

[0042] In one embodiment, the user may be a medical professional, such as a doctor, nurse, therapist, or other person acting under the direction of a doctor, nurse, therapist, etc. In another embodiment, the user may be a patient, i.e., the patient (and / or a helper) may position transducer arrays 70a and 70b at the treatment site.

[0043] Optionally, according to another exemplary embodiment, electronic device 50 includes a control box 86 and a temperature sensor 90 connected to control box 86, which are included to control the amplitude of the electric field so that excessive heating does not occur in the treatment area.

[0044] If included, the control box 86 controls the output of the electric field generator 54, for example, ensuring that the output is constant at a value preset by the user. Alternatively, the control box 86 sets the output to a maximum value that does not cause excessive heating of the treatment site. In either case, the control box 86 may issue an alert or the like if the temperature of the treatment area (as sensed by the temperature sensor 90) exceeds a preset limit. The temperature sensor 90 may be mechanically connected to and / or otherwise associated with the first transducer array 70a or the second transducer array 70b so as to enable sensing of the temperature of the field target 74 by either or both of the first transducer array 70a or the second transducer array 70b.

[0045] In one embodiment, if the temperature sensed by temperature sensor 90 meets or exceeds a comfort threshold, control box 86 may turn off or reduce the power of the TT signal generated by electric field generator 54. In one embodiment, the comfort threshold is the temperature at which the patient feels uncomfortable while using transducer array 70a and transducer array 70b. In one embodiment, the comfort threshold is a temperature at or about 40 degrees Celsius. In one embodiment, the comfort threshold is a temperature between about 39°C and 42°C, or a specific selected temperature between about 39°C and 42°C, such as 41°C.

[0046] Conductive leads 58 are standard insulated conductors that include a flexible metal shield, preferably grounded, to prevent diffusion of the electric field generated by conductive leads 58. Transducer arrays 70a and 70b may have specific shapes and arrangements to generate TT fields of a desired configuration, direction, and intensity in the treatment area, and only in the treatment area to focus the treatment.

[0047] The specifications of the electronic device 50 as a whole and its individual components are heavily influenced by the fact that at the frequencies of the TT field, biological systems behave according to their "ohmic" rather than dielectric properties.

[0048] Referring now to FIG. 3, a diagram of an exemplary embodiment of a transducer array 70a constructed in accordance with the present disclosure is shown. Transducer array 70b may be similar in structure and function to transducer array 70a. Therefore, for brevity, only transducer array 70a will be described herein. Transducer array 70a includes one or more electrode elements 104. As shown in FIG. 3, each transducer array 70a is configured as a set of one or more electrode elements 104. Transducer array 70a may utilize capacitively coupled electrode elements 104. In the example shown in FIG. 3, transducer array 70a is configured as multiple electrode elements 104 (e.g., approximately 2 cm in diameter) interconnected via flex wires 108. Each electrode element 104 may include a ceramic disc and an electrode layer. In one embodiment, transducer array 70a includes an outer periphery 112.

[0049] Alternative structures for the transducer array 70a can also be used, including, for example, disc-shaped ceramic elements, non-disc-shaped ceramic elements, and non-ceramic dielectric materials disposed between the electrode layer on the plurality of flat conductors and the skin-facing surface of the transducer array 70a. Examples of non-ceramic dielectric materials disposed on the plurality of flat conductors include a polymer film disposed on electrodes on a printed circuit board or on a flat metal piece.

[0050] In one embodiment, the transducer array 70a may utilize electrode elements 104 that are not capacitively coupled. In this case, each electrode element 104 of the transducer array 70a is implemented using an area of ​​conductive material configured to be placed against the human body, with no insulating dielectric layer disposed between the electrode element 104 and the human body. Other alternative structures for implementing the transducer array 70a may also be used, as long as they are capable of delivering a TT field to the human body, including examples of conductive materials such as conductive films, conductive fabrics, and conductive foams. If desired, a gel layer may be disposed between the transducer array 70a and the human body in any of the embodiments described herein.

[0051] In one embodiment, the transducer array 70a may be constructed in accordance with any of the transducer arrays or pads disclosed in U.S. Patent Application No. 17 / 813,837, filed July 20, 2022, entitled "Conductive Pads for Generating Tumor Treatment Fields, and Methods of Making and Using the Same," the entire contents of which are incorporated herein by reference. In some embodiments, the electric field generator 54 uses a control process to control the voltage and / or current supplied to the transducer array 70a without obtaining or requiring feedback regarding the temperature of the transducer array 70a. In these embodiments, the transducer array 70a may be free of a temperature sensor. Furthermore, in these embodiments, the leads 58a and / or 58b include wiring associated with powering the electrode elements 104, but do not include wiring used for temperature measurement. This has the added benefit of reducing the total number of wires extending from the electric field generator 54 to the patient, thereby improving patient comfort and reducing the circuitry level compared to conventional methods that require temperature measurement(s) to prevent overheating of the transducer array or pad.

[0052] Referring now to FIG. 4, a schematic diagram of an exemplary embodiment of a probe device 116 constructed in accordance with the present disclosure is shown. As shown in FIG. 1, the probe device 116 may be implanted within the field target 74. Generally, the probe device 116 includes a housing 120, a plurality of electrodes 124a-n (collectively "electrodes 124") supported by the housing 120, and a controller 128 supported within the housing 120. The housing 120 may have a biocompatible outer surface 129, meaning that the housing 120 may be configured to be ingestible by a patient and / or implantable within a patient (i.e., surgically implantable within a patient). While FIG. 4 shows the probe device 116 as spherical, it will be understood by those skilled in the art that the probe device 116 may be any shape that can be ingested by a patient or implanted within the field target 74 or a patient. 4, the probe device 116 is shown as including six electrodes 124a-f, however, those skilled in the art will appreciate that the probe device 116 may include more than six electrodes 124, such as eight, ten, or twelve electrodes. As described in more detail below, each electrode 124 may be connected to a controller 128 for communicating data between the electrode 124 and the controller 128.

[0053] In certain embodiments, the electrodes 124 are grouped into pairs of electrodes 124. That is, the electrodes 124 may include a first electrode pair 124a-b, a second electrode pair 124c-d, and a third electrode pair 124e-f. In each electrode pair 124, e.g., the first electrode pair 124a-b, the first electrode 124a and the second electrode 124b may be supported by the outer surface 129 of the housing 120 at opposite points along the first axis 130a. Similarly, the third electrode 124c and the fourth electrode 124d may be supported by the outer surface 129 of the housing 120 at opposite points along the second axis 130b, and the fifth electrode 124e and the sixth electrode 124f may be supported by the outer surface 129 of the housing 120 at opposite points along the third axis 130c. The first axis 130a, the second axis 130b, and the third axis 130c may be orthogonal to one another.

[0054] Referring to FIG. 5, a block diagram of an exemplary embodiment of a controller 128 constructed in accordance with the present disclosure is shown. The controller 128 generally includes one or more processors 132 (hereinafter, “controller processors 132”), one or more communication devices 136 (hereinafter, “controller communication devices 136”), and one or more non-transitory computer-readable media 140 (hereinafter, “controller memory 140”). The controller communication devices 136 may be configured to communicate using a wireless communication protocol, such as, for example, WiFi, Bluetooth, and / or a wireless communication protocol that complies with the requirements of other wireless communication standards created and / or maintained by the Institute of Electrical and Electronics Engineers (IEEE). As described in more detail below, the controller processor 132 may use the controller communication devices 136 to communicate data with, for example, a computer system 172. The controller memory 140 may store, for example, processor executable code 144 (hereinafter, “controller program logic 144”) and / or one or more data stores 148 (hereinafter, “controller data stores 148”) for storing, for example, data received from the electrodes 124. As described in more detail below, when the controller program logic 144 is executed, the controller processor 132 may perform one or more steps of the methods described herein to determine characteristics of an electric field.

[0055] The controller 128 may include an analog-to-digital converter 152 electrically connected to one or more amplifiers 156 (hereinafter, “amplifiers 156”). In certain embodiments, each pair of electrodes 124 is electrically coupled to one of the amplifiers 156. Each amplifier 156 may be configured to amplify the electrical signals received from the electrodes 124, and the analog-to-digital converter 152 may be configured to convert the amplified electrical signals received from each amplifier 156 into digital signals for transmission to the controller processor 132.

[0056] The controller 128 may include one or more power sources 160 (hereinafter “power sources 160”), such as, for example, batteries. The power sources 160 may be configured to provide power to one or more components of the controller 128 described herein. In certain embodiments, the controller 128 further includes one or more orientation sensors 168 (hereinafter “orientation sensors 168”) configured to measure the orientation of the probing device 116. The orientation sensors 168 may be implemented, for example, as an accelerometer, a gyroscope, a magnetometer, and / or combinations thereof. In other embodiments, the orientation sensors 168 are separate from the controller 128 and are supported at a known position within the housing 120.

[0057] Generally, when the controller program logic 144 is executed, the controller processor 132 measures a first potential difference between the first electrode 124a and the second electrode 124b, the first electrode 124a and the second electrode 124b being separated by a first predetermined distance, and transmits, using the controller communication device 136, at least one of first data indicative of the first potential difference and second data indicative of a first characteristic of the electric field based at least in part on the first potential difference (i.e., the first data) and the first predetermined distance. In certain embodiments, the second data indicative of the magnitude of the electric field is based at least in part on a quotient determined by dividing the first potential difference (i.e., the first data) by the first predetermined distance. In certain embodiments, when the controller program logic 144 is executed, the controller processor 132 stores at least one of the first data and the second data in the controller data store 148.

[0058] In certain embodiments, execution of the controller program logic 144 further causes the controller processor 132 to measure a second potential difference between the third electrode 124c and the fourth electrode 124d, wherein the third electrode 124c and the fourth electrode 124d are separated by a second predetermined distance; measure a third potential difference between the fifth electrode 124e and the sixth electrode 124f, wherein the fifth electrode 124e and the sixth electrode 124f are separated by a third predetermined distance; and transmit, using the controller communication device 136, at least one of third data indicative of the second potential difference, fourth data indicative of the third potential difference, and fifth data indicative of a second electric field characteristic based at least in part on the first data, the third data, the fourth data, the first predetermined distance, the second predetermined distance, and the third predetermined distance. In certain embodiments, execution of the controller program logic 144 causes the controller processor 132 to store at least one of the third data, the fourth data, and the fifth data in the controller data store 148.

[0059] In some embodiments, the controller 128 also includes a switching device 157 connected to the controller processor 132, the electrodes 124a-124f, and the input of the amplifier 156. The switching device 157, under the control of the controller program logic 144 executed by the controller processor 132, allows any of the electrodes 124a-124f to be connected to the input of any of the amplifiers 156, thereby allowing potential differences in different directions to be detected. For example, one skilled in the art will understand that by sending a control signal to the switching device 157 to connect any two electrodes 124 to the input of a particular amplifier 156, first, second, and third potential differences and first, second, and third predetermined distances, respectively, may be measured between any two electrodes 124. For example, a first potential difference may be measured between the first electrode 124a and the fourth electrode 124d, with the first predetermined distance being the distance between the first electrode 124a and the fourth electrode 124d, a second potential difference may be measured between the second electrode 124b and the fifth electrode 124e, with the second predetermined distance being the distance between the second electrode 124b and the fifth electrode 124e, and a third potential difference may be measured between the third electrode 124c and the sixth electrode 124f, with the third predetermined distance being the distance between the third electrode 124c and the sixth electrode 124f. The predetermined distances between any two electrodes 124 can be stored in the controller memory 140.

[0060] In certain embodiments, execution of the controller program logic 144 further causes the controller processor 132 to measure the orientation of the orientation sensors 168 using at least one of the orientation sensors 168 and transmit sixth data indicative of the orientation using the controller communication device 136. In certain embodiments, execution of the controller program logic 144 further causes the controller processor 132 to store the sixth data in the controller data store 148. The electrode pairs 124 can be fixed in known positions / orientations relative to the orientation sensors 168, allowing the direction of the electric field between the electrode pairs 124 to be determined.

[0061] 6, a block diagram of an exemplary embodiment of a computer system 172 constructed in accordance with the present disclosure is shown. The computer system 172 generally includes one or more processors 176 (hereinafter “computer processors 176”), one or more communication devices 180 (hereinafter “computer communication devices 180”), and one or more non-transitory computer-readable media 184 (hereinafter “computer memory 184”). The computer communication devices 180 may be configured to communicate using a wireless communication protocol, such as, for example, WiFi, Bluetooth, and / or a wireless communication protocol that conforms to the requirements of other wireless communication standards created and / or maintained by the Institute of Electrical and Electronics Engineers (IEEE). As described in more detail below, the computer processor 176 may communicate data with the controller 128, for example, using the computer communication devices 180. The computer memory 184 may store, for example, processor executable code 188 (hereinafter “computer program logic 188”) and one or more data stores 192 (hereinafter “computer data stores 192”) for storing, for example, data received from the controller 128. As described in more detail below, when executed, the computer program logic 188 may cause the computer processor 176 to perform one or more steps of the methods described herein for determining characteristics of an electric field.

[0062] The computer system 172 may include one or more input devices 196 (hereinafter “input device(s) 196”) and one or more output devices 200 (hereinafter “output device(s) 200”). The input device(s) 196 may be implemented as, for example, a keyboard, a touchscreen, a mouse, a trackball, a microphone, a fingerprint reader, an infrared port, a mobile phone, a personal digital assistant (PDA), a controller, a network interface, a voice recognition system, a gesture recognition system, an eye-tracking system, a brain-computer interface system, and / or a combination thereof. The output device(s) 200 may be implemented as, for example, a computer monitor, a screen, a touchscreen, a speaker, a website, a television, an augmented reality system, a smartphone, a personal digital assistant (PDA), a mobile phone, a fax machine, a printer, a laptop computer, an optical head-mounted display (OHMD), a hologram, and / or a combination thereof. The computer system 172 may be implemented as, for example, a desktop computer, a laptop computer, a smartphone, a computer tablet, a computer kiosk, or other computing device.

[0063] When the computer program logic 188 is executed, the computer processor 176 receives data (i.e., first data indicative of the first potential difference, second data indicative of the first characteristic of the electric field, third data indicative of the second potential difference, fourth data indicative of the third potential difference, fifth data indicative of the second characteristic of the electric field, and / or sixth data indicative of the orientation) from the controller 128 via the computer communication device 180, stores the data in the computer data store 192, analyzes the data, and / or renders the information on one or more output devices 200 for viewing by an operator.

[0064] 7, a process flow diagram of an exemplary embodiment of a method 204 for determining characteristics of an electric field disclosed herein is shown. The method 204 generally includes: xThe potential difference V between the first electrode 124a and the second electrode 124b, which are spaced apart by X (step 208) and measuring the potential difference V X and a predetermined distance d x and determining a characteristic of the electric field based at least in part on the potential difference V (step 212). X is measured in volts, for example. x may be measured in centimeters, for example. In certain embodiments, method 204 further includes positioning probe device 116 on field target 74 or on the patient prior to measuring the potential difference (step 208). In certain embodiments, method 204 further includes measuring the orientation of at least one of orientation sensors 168.

[0065] In certain embodiments, determining the characteristics of the electric field (step 212) includes determining the potential difference V X at a predetermined distance d x (i.e., E=V X / d x ) ) The magnitude E may be measured, for example, in volts / centimeter.

[0066] In certain embodiments, the potential difference V X is the first potential difference V1, and the predetermined distance d x is a first predetermined distance d1, and method 204 further includes measuring a second potential difference V2 between third electrode 124c and fourth electrode 124d, which are spaced a second predetermined distance d2 apart, and measuring a third potential difference V3 between fifth electrode 124e and sixth electrode 124f, which are spaced a third predetermined distance d3 apart. In such an embodiment, determining the characteristics of the electric field (step 212) may be further defined as determining the characteristics of the electric field based at least in part on the first potential difference V1, the second potential difference V2, the third potential difference V3, the first predetermined distance d1, the second predetermined distance d2, and the third predetermined distance d3.

[0067] In certain embodiments, determining the characteristic of the electric field (step 212) includes determining a first component E based at least in part on the first potential difference V and the first predetermined distance d. x , a second component E based at least in part on the second potential difference V2 and the second predetermined distance d2. y and a third component E based at least in part on the third potential difference V3 and the third predetermined distance d3. z A vector with

number

[0068] 8, an exemplary embodiment of a method 216 for determining placement of transducer arrays 70a and 70b is shown. Method 216 generally includes providing a recommended placement for applying at least two conductive electrode elements (i.e., transducer arrays 70a and 70b) to a patient (step 220) before measuring potential differences (step 208), generating an electrical signal having an alternating waveform at a frequency ranging from 50 kHz to 1 MHz (step 224), and providing an updated placement for applying at least two conductive electrode elements (i.e., transducer arrays 70a and 70b) to the patient (step 228) after determining characteristics of the electric field using probing device 216 (the updated placement is based at least in part on the characteristics of the electric field). The recommended placement may be based at least in part on estimates of TT field strengths in various regions of the patient's body, for example.

[0069] 5 , the controller program logic 144 may transition the controller processor 132 between standby mode and measurement mode upon receiving instructions from the computer system 172 via the controller communication device 136. While the controller processor 132 is in standby mode, the controller program logic 144 causes the controller processor 132 to hold instructions and, in some embodiments, idle in a low power state. Upon receiving an initial instruction to transition to measurement mode via the controller communication device 136, the controller program logic 144 may transition the controller processor 132 to measurement mode. While the controller processor 132 is in measurement mode, the controller program logic 144 may cause the controller processor 132 to perform one or more steps of the methods described herein to determine characteristics of an electric field. In certain embodiments, the controller program logic 144 may transition the controller processor 132 to standby mode. However, as described in more detail below, in other embodiments, the controller program logic 144 may cause the controller processor 132 to transition to the standby mode in response to receiving a second instruction to transition to the standby mode at the controller's communication device 136.

[0070] 6 , while controller processor 132 is in standby mode, computer program logic 188 may cause computer processor 176 to send an initial instruction to transition to measurement mode using computer communication device 180. Computer program logic 188 may, for example, cause computer processor 176 to send the first instruction in response to user input. While controller processor 132 is in measurement mode, computer program logic 188 may cause computer processor 176 to wait for receipt of data by computer communication device 180 (i.e., first data indicative of the first potential difference, second data indicative of the first characteristic of the electric field, third data indicative of the second potential difference, fourth data indicative of the third potential difference, fifth data indicative of the second characteristic of the electric field, and / or sixth data indicative of orientation). In certain embodiments, in response to receiving such data, computer program logic 188 may cause computer processor 176 to send a second instruction to transition to standby mode.

[0071] Illustrative Embodiments

[0072] The following is a non-limiting list of exemplary embodiments of the inventive concepts disclosed herein.

[0073] Exemplary Embodiment 1. A device comprising: a housing having a biocompatible outer surface; a plurality of electrodes supported by the housing; a controller supported within a housing, the controller including a processor, a communication device, and a non-transitory computer readable medium storing processor executable code that, when executed, causes the processor to perform the following operations: A potential difference is measured between a first electrode and a second electrode that are separated by a predetermined distance from each other among the plurality of electrodes, and A communications device is used to transmit data indicative of the potential difference.

[0074] Exemplary Embodiment 2. The device of exemplary embodiment 1, wherein the housing is configured to be ingestible by or implantable in a patient.

[0075] Exemplary Embodiment 3. The device of exemplary embodiment 1, wherein the processor further stores data when the processor-executable code is executed.

[0076] Exemplary Embodiment 4. The device of exemplary embodiment 1, wherein the communication device is configured to communicate using a wireless communication protocol.

[0077] Exemplary Embodiment 5. The device of exemplary embodiment 1, wherein the data is first data, and wherein when the processor-executable code is executed, the processor transmits, using the communications device, at least one of the first data and second data, the second data indicating a characteristic of the electric field based at least in part on the first data and the predetermined distance.

[0078] Exemplary Embodiment 6. The device of exemplary embodiment 5, wherein when the processor-executable code is executed, the processor further stores at least one of the first data and the second data.

[0079] Exemplary Embodiment 7. The device of embodiment 5, wherein the first electrode and the second electrode are supported by the biocompatible outer surface at antipodal points of the housing, and wherein the step of transmitting at least one of the first data and the second data is further defined as transmitting at least one of the first data and the second data, the second data indicating the magnitude of the electric field based at least in part on a quotient determined by dividing the first data by a predetermined distance.

[0080] Exemplary Embodiment 8. The device of exemplary embodiment 1, wherein the data is first data, the potential difference is a first potential difference, and the predetermined distance is a first predetermined distance, and when the processor-executable code is executed, the processor further: a second potential difference between a third electrode and a fourth electrode of the plurality of electrodes is measured, the third electrode and the fourth electrode being spaced apart by a second predetermined distance; a third potential difference between a fifth electrode and a sixth electrode among the plurality of electrodes is measured, the fifth electrode and the sixth electrode being spaced apart by a third predetermined distance; Using the communication device, at least one of second data indicative of the second potential difference and third data indicative of the third potential difference is transmitted.

[0081] Exemplary Embodiment 9. The device of exemplary embodiment 8, wherein when the processor-executable code is executed, the processor further stores at least one of the first data, the second data, and the third data.

[0082] Exemplary Embodiment 10. The device of exemplary embodiment 8, wherein when the processor executable code is executed, the processor, together with the communication device, further transmits fourth data indicative of a characteristic of the electric field based at least in part on the first data, the second data, the third data, the first predetermined distance, the second predetermined distance, and the third predetermined distance.

[0083] Exemplary Embodiment 11. The device of exemplary embodiment 10, wherein when the processor-executable code is executed, the processor further stores at least one of the first data, the second data, the third data, and the fourth data.

[0084] Exemplary Embodiment 12. The device of exemplary embodiment 8, wherein the first and second electrodes are supported by the biocompatible outer surface along a first axis of the housing, the third and fourth electrodes are supported by the biocompatible outer surface along a second axis of the housing, and the fifth and sixth electrodes are supported by the biocompatible outer surface along a third axis of the housing, wherein the first axis, the second axis, and the third axis are orthogonal to one another.

[0085] Exemplary Embodiment 13. The device of exemplary embodiment 1, further including one or more orientation sensors supported at known positions within the housing, wherein the data is the first data, and wherein the processor-executable code, when executed, causes the processor to further: measuring the orientation of the orientation sensor using at least one of the one or more orientation sensors; and Using the communication device, second data indicative of the orientation is transmitted.

[0086] Exemplary Embodiment 14. The device of exemplary embodiment 13, wherein when the processor-executable code is executed, the processor further stores second data.

[0087] Exemplary embodiment 15. A method comprising: measuring a potential difference between a first electrode and a second electrode of a plurality of electrodes supported by a housing having a biocompatible outer surface, the first electrode and the second electrode being spaced apart by a predetermined distance; and determining a characteristic of the electric field based at least in part on the potential difference and the predetermined distance.

[0088] Exemplary Embodiment 16 The method of exemplary embodiment 15, wherein the housing is configured to be ingestible by or implantable in the patient, and the method further comprises the step of placing the housing in the patient.

[0089] Exemplary Embodiment 17. The method of exemplary embodiment 15, wherein the first electrode and the second electrode are supported at antipodal points on the housing, and wherein determining the characteristic of the electric field is further defined as determining a magnitude of the electric field based at least in part on a quotient determined by dividing the potential difference by a predetermined distance.

[0090] Exemplary Embodiment 18. The method of exemplary embodiment 15, wherein the potential difference is a first potential difference and the predetermined distance is a first predetermined distance, and the method further comprises: measuring a second potential difference between a third electrode and a fourth electrode of the plurality of electrodes, the third electrode and the fourth electrode being spaced apart by a second predetermined distance; measuring a third potential difference between a fifth electrode and a sixth electrode of the plurality of electrodes, the fifth electrode and the sixth electrode being spaced apart by a third predetermined distance; Determining the characteristics of the electric field is further defined as determining the characteristics of the electric field based at least in part on the first potential difference, the second potential difference, the third potential difference, the first predetermined distance, the second predetermined distance, and the third predetermined distance.

[0091] Exemplary Embodiment 19. The method of exemplary embodiment 18, wherein the first and second electrodes are supported along a first axis, the third and fourth electrodes are supported by the biocompatible outer surface along a second axis, and the fifth and sixth electrodes are supported by the biocompatible outer surface along a third axis, wherein the first, second, and third axes are orthogonal to one another, and wherein determining a characteristic of the electric field is further defined as determining a direction of the electric field based at least in part on a vector having a first component based at least in part on the first potential difference and the first predetermined distance, a second component based at least in part on the second potential difference and the second predetermined distance, and a third component based at least in part on the third potential difference and the third predetermined distance.

[0092] Exemplary Embodiment 20. The method of exemplary embodiment 15, further comprising measuring the orientation of at least one of the one or more orientation sensors supported by the housing.

[0093] Exemplary Embodiment 21 The method of exemplary embodiment 15, further comprising, before measuring the potential difference between the first electrode and the second electrode: providing a recommended placement for applying at least two conductive electrode elements to a patient; supplying an electrical signal having an AC waveform with a frequency in the range of 50 kHz to 1 MHz to each conductive electrode element; and after determining a characteristic of the electric field based at least in part on the potential difference and the predetermined distance, providing an updated configuration for applying the at least two conductive electrode elements to the patient based at least in part on the characteristic of the electric field.

[0094] Exemplary embodiment 22. A system comprising: a probe device and a computer system, The probe device includes a housing having a biocompatible outer surface; a plurality of electrodes supported by the housing; a controller supported within a housing, the controller including a first processor, a first communication device, and a first non-transitory computer readable medium storing first processor executable code, the first processor executable code, when executed, causing the first processor to: A potential difference between a first electrode and a second electrode, which are separated by a predetermined distance, is measured. transmitting, using the first communication device, first data indicative of the potential difference; The computer system includes a second processor, a second communication device, and a second non-transitory computer-readable medium storing second processor executable code, the second processor executable code, when executed, causing the second processor to: In response to receiving the first data by the second communication device, second data indicative of a characteristic of the electric field based at least in part on the first data and the predetermined distance is stored.

[0095] Exemplary Embodiment 23. The system of exemplary embodiment 22, wherein the housing is configured to be ingestible by or implantable in a patient.

[0096] Exemplary Embodiment 24. The system of exemplary embodiment 22, wherein the first communication device and the second communication device are configured to communicate using a wireless communication protocol.

[0097] Exemplary Embodiment 25. The system of exemplary embodiment 22, wherein the first electrode and the second electrode are supported by the biocompatible outer surface at opposite points on the housing, and wherein storing the second data is further defined as storing the second data indicative of the magnitude of the electric field based at least in part on a quotient determined by dividing the potential difference by a predetermined distance.

[0098] Exemplary Embodiment 26. The system of exemplary embodiment 22, wherein the potential difference is a first potential difference, the predetermined distance is a first predetermined distance, and when the first processor executable code is executed, the first processor further: a second potential difference between a third electrode and a fourth electrode among the plurality of electrodes is measured, the third electrode and the fourth electrode being spaced apart by a second predetermined distance; transmitting third data indicating the second potential difference; a third potential difference between a fifth electrode and a sixth electrode among the plurality of electrodes is measured, the fifth electrode and the sixth electrode being spaced apart by a third predetermined distance; transmitting fourth data indicating the third potential difference; The step of storing the second data is further defined as storing the second data indicative of a characteristic of the electric field based at least in part on the first data, the third data, the fourth data, the first predetermined distance, the second predetermined distance, and the third predetermined distance.

[0099] Exemplary Embodiment 27. The system of Exemplary Embodiment 26, wherein the first electrode and the second electrode are supported by the housing along a first axis, the third electrode and the fourth electrode are supported by the housing along a second axis, and the fifth electrode and the sixth electrode are supported by the housing along a third axis, wherein the first axis, the second axis, and the third axis are orthogonal to one another, and wherein storing the second data is further defined as storing the second data indicative of an orientation of the electric field based at least in part on a vector having a first component based at least in part on the first data and the first predetermined distance, a second component based at least in part on the third data and the second predetermined distance, and a third component based at least in part on the fourth data and the third predetermined distance.

[0100] Exemplary Embodiment 28. The system of exemplary embodiment 22, wherein the probe device further includes one or more orientation sensors, and wherein when the first processor executable code is executed, the first processor further: measuring an orientation of at least a portion of the probe device using at least one of the one or more orientation sensors; and Using the first communication device, transmit third data indicating a direction; When the second processor executable code is executed, the second processor stores the third data in response to receipt of the third data by the second communication device.

[0101] Exemplary Embodiment 29. The system of exemplary embodiment 22, wherein when the second processor executable code is executed, the second processor further: Using a second communication device, send an instruction to cause the probe device to enter a measurement mode; When the first processor executable code is executed, the first processor further the steps of transitioning the probe device to a measurement mode in response to receiving the instruction by the first communication device, measuring the potential difference, and transmitting the first data are performed when the probe device is in the measurement mode; The probe device is put into standby mode.

[0102] Exemplary Embodiment 30. The system of exemplary embodiment 29, wherein the instructions are the first instructions, and wherein the second processor, upon execution of the second processor executable code, further comprises: using a second communication device to send a second instruction to cause the probe device to transition to a standby mode; and Transitioning the probe device into a standby mode is further defined as transitioning the probe device into the standby mode in response to receiving the second instruction.

[0103] From the foregoing, it is apparent that the inventive concepts disclosed and claimed herein are well adapted to carry out the objects and attain the advantages set forth herein, as well as those inherent therein. While exemplary embodiments of the inventive concepts have been set forth for purposes of this disclosure, it will be understood that numerous modifications, which will readily occur to those skilled in the art, are possible which are within the spirit of the inventive concepts disclosed and claimed herein. [Explanation of symbols]

[0104] 10 dividing cells 14 lines 18a 1st electrode 18b 2nd electrode 22 Microtubules 26 Centriole 30 center 34 Attachment point 50 Electronic Devices 54 Electric Field Generator 58a First Conductive Lead 58b Second Conductive Lead 62a First end 62b Second end 66a First end 66b Second end 70a First transducer array 70b Second transducer array 74 Field Target 86 Control Box 90 Temperature Sensor 104 Electrode Element 108 Flex Wire 112 outer edge 116 Probe Device 120 Housing 124 electrodes 128 Controller 129 Biocompatible Outer Surface 130a 1st axis 130b Second axis 130c 3rd axis 132 Controller Processor 136 Communication Devices 140 controller memory 144 Controller Program Logic 148 Controller Data Store 156 Amplifier 157 Switching Devices 160 Power supply 168 Orientation Sensor 172 Computer Systems 176 processors 180 Communication Devices 184 Computer Memory 188 Computer Program Logic 192 Computer Data Store 196 Input Devices 200 output devices 216 Probing Devices

Claims

1. A device, a housing having a biocompatible outer surface; a plurality of electrodes supported by the housing; a controller supported within the housing, the controller including a processor, a communication device, and a non-transitory computer-readable medium storing processor-executable code, the processor-executable code, when executed, causing the processor to: measuring a potential difference between a first electrode and a second electrode that are spaced apart by a predetermined distance from each other among the plurality of electrodes; transmitting data indicative of the potential difference using the communication device; a controller that causes the 1. A device comprising:

2. The device of claim 1 , wherein the housing is configured to be ingestible by or implantable in a patient.

3. 2. The device of claim 1, wherein the data is first data, and wherein the processor executable code, when executed, causes the processor to transmit, with the communication device, at least one of the first data and second data, the second data indicating a characteristic of an electric field based at least in part on the first data and the predetermined distance.

4. 4. The device of claim 3, wherein the first electrode and the second electrode are supported by a biocompatible outer surface at antipodal points of the housing, and wherein the step of transmitting at least one of the first data and the second data is further defined as transmitting at least one of the first data and the second data, the second data indicating a magnitude of an electric field based at least in part on a quotient determined by dividing the first data by a predetermined distance.

5. the data is first data, the potential difference is a first potential difference, and the predetermined distance is a first predetermined distance, and when the processor executable code is executed, the processor further a second potential difference between a third electrode and a fourth electrode of the plurality of electrodes is measured, the third electrode and the fourth electrode being spaced apart by a second predetermined distance; a third potential difference between a fifth electrode and a sixth electrode of the plurality of electrodes is measured, the fifth electrode and the sixth electrode being spaced apart by a third predetermined distance; The device of claim 1 , wherein the communication device is used to transmit at least one of second data indicative of the second potential difference and third data indicative of the third potential difference.

6. 6. The device of claim 5, wherein when the processor executable code is executed, the processor further transmits, with the communication device, fourth data indicative of a characteristic of an electric field based at least in part on the first data, the second data, the third data, the first predetermined distance, the second predetermined distance, and the third predetermined distance.

7. 6. The device of claim 5, wherein the first electrode and the second electrode are supported by the biocompatible outer surface along a first axis of the housing, the third electrode and the fourth electrode are supported by the biocompatible outer surface along a second axis of the housing, and the fifth electrode and the sixth electrode are supported by the biocompatible outer surface along a third axis of the housing, the first axis, the second axis, and the third axis being orthogonal to one another.

8. and one or more orientation sensors supported at known positions within the housing, the data being first data, and the processor, when executed, further comprising: measuring the orientation of the orientation sensor using at least one of the one or more orientation sensors; transmitting second data indicating a bearing using the communication device; The device of claim 1 .

9. 1. A system comprising: a probe device; a computer system; Including, The probe device comprises: a housing having a biocompatible outer surface; a plurality of electrodes supported by the housing; a controller supported within the housing, the controller including a first processor, a first communication device, and a first non-transitory computer readable medium storing first processor executable code, the first processor, when executed, causing the first processor to: measuring a potential difference between a first electrode and a second electrode that are separated by a predetermined distance from one another among the plurality of electrodes; the controller using a first communication device to transmit first data indicative of the potential difference; Including, the computer system includes a second processor, a second communication device, and a second non-transitory computer-readable medium storing second processor executable code; When the second processor executable code is executed, the second processor: responsive to receiving the first data by the second communication device, storing second data indicative of a characteristic of an electric field based at least in part on the first data and a predetermined distance; system.

10. The system of claim 9 , wherein the housing is configured to be ingestible by or implantable in a patient.

11. 10. The system of claim 9, wherein the first electrode and the second electrode are supported by a biocompatible outer surface at antipodal points on the housing, and wherein storing the second data is further defined as storing second data indicative of an electric field magnitude based at least in part on a quotient determined by dividing a potential difference by a predetermined distance.

12. the potential difference is a first potential difference, the predetermined distance is a first predetermined distance, and when the first processor executable code is executed, the first processor further a second potential difference between a third electrode and a fourth electrode of the plurality of electrodes is measured, the third electrode and the fourth electrode being spaced apart by a second predetermined distance; transmitting third data indicating the second potential difference; a third potential difference between a fifth electrode and a sixth electrode of the plurality of electrodes is measured, the fifth electrode and the sixth electrode being spaced apart by a third predetermined distance; transmitting fourth data indicating the third potential difference; wherein storing the second data is further defined as storing second data indicative of a characteristic of an electric field based at least in part on the first data, the third data, the fourth data, the first predetermined distance, the second predetermined distance, and the third predetermined distance. The system of claim 9.

13. The probe device further includes one or more orientation sensors, and when the first processor executable code is executed, the first processor further: measuring an orientation of at least a portion of the probe device using at least one of the one or more orientation sensors; transmitting third data indicating a direction using the first communication device; When the second processor executable code is executed, the second processor stores the third data in response to receipt of the third data by the second communication device. The system of claim 9.

14. When the second processor executable code is executed, the second processor further Using the second communication device, send an instruction to cause the probe device to transition to a measurement mode; When the first processor executable code is executed, the first processor further the steps of transitioning the probe device to a measurement mode in response to receiving an instruction by the first communication device, measuring the potential difference, and transmitting first data are performed when the probe device is in the measurement mode; The system of claim 9 , further comprising: placing the probe device in a standby mode.

15. the instructions are first instructions, and the second processor, when executed, further comprises: Using the second communication device, send a second instruction to cause the probe device to transition to a standby mode; The step of transitioning the probe device to a standby mode is further defined as transitioning the probe device to a standby mode in response to receiving a second instruction. The system of claim 14.

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