SYSTEM AND METHOD FOR MAINTAINING TT FIELD DURING BATTERY EXCHANGE - Patent application

Abstract

This application discloses an electronic device including an electric field generator that provides a first electrical signal having a first alternating current waveform at a frequency between 50 kHz and 1 MHz, and a controller in communication with the electric field generator, the controller including an input, a processor, and a memory, the memory having computer-executable instructions stored therein that cause the processor to perform the following steps: receiving an acceleration power-up program, a standard power-up program, and a generator power-down event via the input, detecting the generator power-down event, shutting down the electric field generator, storing operating parameters, determining an operating state based at least in part on the operating parameters, and, in response to the operating state being an acceleration state, operating the electric field generator using the acceleration power-up program to provide a second electrical signal, the second electrical signal having a second alternating current waveform at a frequency between 50 kHz and 1 MHz.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 377,642, entitled "System and Method for Maintaining a TT Field During a Battery Replacement," filed September 29, 2022, the entire contents of which are expressly incorporated herein by reference. [Background technology]

[0002] Tumor treating fields (TT fields or TTFs) are low-intensity (e.g., 1-3 V / cm) alternating electric fields within the mid-frequency range (e.g., 50 kHz-1 MHz, e.g., 50-500 kHz) that target solid tumors by inhibiting mitosis. This non-invasive treatment targets 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 that generate perpendicular magnetic fields within the tumor to be treated. The transducer arrays in each pair are positioned on opposite sides of the body part to be treated. Specifically, in the case of the OPTUNE® system, one pair of electrodes of the transducer array is placed on the left and right (LR) sides of the tumor, and another pair of electrodes of the transducer array is placed on the anterior-posterior (AP) side of the tumor. TT fields have been 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. Recently, TT field therapy has been approved as a combination therapy with chemotherapy for malignant pleural mesothelioma (MPM) and may also be used to treat tumors in other parts of the body.

[0003] The OPTUNE® device is designed for patients to wear it continuously for 2-4 days for hygiene and re-shaving (if necessary), after which a new set of arrays is reapplied. As patients use the device to perform daily activities, the device can be used for extended periods of time, even when the patient is not near a power source. For this reason, the device may contain batteries. Summary of the Invention

[0004] As explained above, the OPTUNE® device can be used for extended periods of time, even when the patient is not near a power source. Traditionally, replacing the batteries required shutting down the device and replacing the batteries. Because the system is shut down, the device must undergo a conventional initialization procedure, in which the TT field applied to the patient is initially delivered at a low power and slowly increased to operating power over approximately 30 minutes to ensure that the transducer array is properly applied to the patient and that no harm is done to the patient (e.g., a standard power-up process). However, delivering low power during the conventional initialization procedure reduces the amount of therapy the patient receives.

[0005] Therefore, new and improved systems (e.g., accelerated power-up processes) that preserve operating power, reduce re-initialization times, and more quickly provide a full-power TT field to the patient, especially during battery replacement, are desirable. The present disclosure relates to such systems and methods for making and using them.

[0006] The problem of reducing reinitialization time and providing a full-power TT field to a patient is solved by an electronic device for delivering a TT field to a subject's body, the device including an electric field generator and a controller. The electric field generator is configured to provide a first electrical signal having a first alternating current waveform at a frequency ranging from 50 kHz to 1 MHz. The controller is in communication with the electric field generator to control the output of the electric field generator. The controller includes an input, a processor, and a non-transitory computer-readable medium, the non-transitory computer-readable medium having stored thereon an accelerated power-up program, a standard power-up program, and computer-executable instructions, which, when executed by the processor, include receiving a generator power-down event via an input, the generator power-down event being a physical interaction with the input; detecting the generator power-down event; shutting down the electric field generator to stop supplying the first electrical signal; and shutting down the operation of the electric field generator or shutting down the operation of the electric field generator. determining an operating state based at least in part on the operating parameters, the operating state being one of an accelerating state and a standard state; and activating the electric field generator to: i) provide a second electrical signal using an acceleration power-up program in response to the operating state being the accelerating state, the second electrical signal having a second AC waveform at a frequency in the range of 50 kHz to 1 MHz; or ii) provide a third electrical signal with a standard power-up program in response to the operating state being the standard state, the third electrical signal having a third AC waveform at a frequency in the range of 50 kHz to 1 MHz.

[0007] 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]

[0008] 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 purposes of clarity and conciseness, certain features and certain views of the figures may be exaggerated, drawn to scale, or shown in schematic form. Not all components are labeled in every drawing. Like reference numbers in the figures may represent and refer to the same or similar elements or functions. In the drawings, [Figure 1] 1 is an exemplary embodiment of a schematic diagram of electrodes applied to biological tissue. [Figure 2] 1 is an exemplary embodiment of an electronic device configured to generate a TT field constructed in accordance with the present disclosure. [Figure 3] FIG. 1 is a block diagram of an exemplary embodiment of a transducer array constructed in accordance with the present disclosure. [Figure 4] FIG. 3 is a block diagram of an exemplary embodiment of the electric field generator of FIG. 2 constructed in accordance with the present disclosure. [Figure 5] FIG. 1 is a process flow diagram of an exemplary embodiment of a battery exchange process according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0009] Before describing in detail at least one embodiment of the inventive concepts by way of illustrative language 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 language used herein is 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 purposes of description and not limitation.

[0010] 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.

[0011] Unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular.

[0012] All compositions, 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 claim or description specifically states 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. Similarly, unless the claims or description specifically state that computer-executed events resulting from computer-executable instructions are limited to a particular order, no order is intended to be inferred in any respect.

[0013] The use of the words "a" or "an" in conjunction with the word "comprising" in the claims and / or specification may mean "one," but is also consistent with the meaning of "one or more," "at least one," or "one or more." The term "plurality" refers to "two or more."

[0014] Additionally, use of the term "at least one of X, Y, and Z" shall be understood to include X alone, Y alone, Z alone, and any combination of X, Y, and Z. 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 imply any order of superiority, importance, or additionality of one item over another.

[0015] 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.

[0016] As used herein, all numerical values ​​or ranges include endpoints, values ​​and fractions of integers within a range, and fractions of integers within a range, unless the context clearly dictates otherwise. Thus, by way of example, a reference to a numerical range such as 1 to 10 includes not only 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, but also 1.1, 1.2, 1.3, 1.4, 1.5, etc., as well as sub-ranges within the larger range of 1 to 10, such as 2 to 8.

[0017] As used herein, a circuit may be analog and / or digital components, or one or more appropriately programmed processors (e.g., microprocessors) and associated hardware and software, or hardwired logic. Also, a "component" may perform one or more functions. The term "component" may include hardware such as a processor (e.g., 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 cooperatively to jointly perform tasks.

[0018] A program or software may include one or more computer-executable instructions that, when executed by one or more components, such as a processor, cause the components to perform a particular function. It should be understood that the processes and / or algorithms described herein may be stored on one or more non-transitory computer-readable mediums. Examples of non-transitory computer-readable mediums may include random access memory, read-only memory, flash memory, etc. Such non-transitory computer-readable medium may be electrical-based, optical-based, magnetic-based, etc.

[0019] As used herein, the term TT field (TT field, or TTF(s)) refers to 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, as described, for example, 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, and in publications by Kirson (see, e.g., Eilon D. Kirson, et al., "Disruption of Cancer Cell Replication by Alternating Electric Fields," Cancer Res. 2004 64:3288-329). TT fields have been shown to be capable of specifically affecting cancer cells and are useful in cancer treatment, among other things. TT field therapy is an approved monotherapy for recurrent glioblastoma (GBM) and an approved combination therapy with chemotherapy for newly diagnosed GBM patients.

[0020] As used herein, the term TT signal refers to an electrical signal that, when received by electrodes applied to a conductive medium such as the human body, generates a TT field as described above by the electrodes. TT signals are often alternating current electrical signals.

[0021] Referring now to the drawings, and particularly to FIG. 1 , an exemplary embodiment of a dividing cell 10 is shown under the influence of an external TT field, generally indicated by lines 14, generated by a negatively charged first electrode 18a and a positively charged second electrode 18b. Also shown are microtubules 22, known to have a very strong dipole moment. This strong polarization makes microtubules 22 and other polar macromolecules, particularly those with specific orientations in or around the cell 10, susceptible to the effects of the electric field. The positive charges on microtubules 22 are located at two centrioles 26, while two sets of negative poles are located at the center 30 of the dividing cell 10 and at the point 34 where microtubules 22 attach to the cell membrane. The locations of the charges form a set of double dipoles, making them susceptible to the effects of electric fields of different directions. In one embodiment, 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 cell.

[0022] Referring 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 the electronic device 50. The 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. The first conductive lead 58a includes a first end 62a and a second end 62b. The second conductive lead 58b includes a first end 66a (86) and a second end 66b (88). The first end 62a of the first conductive lead 58a is conductively connected to a first electrode array port 90a of the electric field generator 54, and the first end 66a of the second conductive lead 58b is conductively connected to a second electrode array port 90b of the electric field generator 54.

[0023] The electric field generator 54 is configured to supply power to each electrode array port 90 and 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 the electrode array 70a, and the second end 66b of the second conductive lead 58b is connected to the electrode array 70b. Both the electrode arrays 70a and 70b are activated by an electrical signal (e.g., a TT signal, waveform). The electrode arrays 70a and 70b are activated by the electrical signal, which causes a current to flow between the electrode arrays 70a and 70b. The current generates an electric field (i.e., a TT field) having a desired frequency and amplitude between the electrode arrays 70a and 70b.

[0024] Although the electronic device 50 shown in FIG. 2 includes only two electrode arrays 70 (ie, electrode array 70a and electrode array 70b), in some embodiments, the electronic device 50 may include more than two electrode arrays 70.

[0025] The electric field generator 54 generates an AC voltage waveform (i.e., a TT signal) at a frequency ranging from about 50 kHz to about 1 MHz (preferably from about 100 kHz to about 500 kHz). The required voltage is such that the electric field strength in the tissue within the treatment area ranges from about 0.1 V / cm to about 10 V / cm. To achieve this electric field strength, the potential difference between two conductors (e.g., electrode elements 104 of FIG. 3) within each electrode array 70a or electrode array 70b is determined by the relative impedances of the system components; for example, the fraction of the electric field on each component is determined by the impedance of that component divided by the overall circuit impedance.

[0026] In certain (but non-limiting) embodiments, electrode arrays 70a and 70b generate alternating currents and electric fields within a target region of a patient. The target region typically includes at least one tumor, and the generation of the alternating currents and electric fields selectively destroys and / or inhibits tumor growth. The alternating currents and fields may be generated at any frequency that selectively destroys or inhibits tumor growth, such as any frequency of a TT field.

[0027] In certain (but non-limiting) embodiments, the alternating current and electric field may be applied at two or more different frequencies, where two or more frequencies are present, each frequency being selected from any of the values ​​above, or a range formed from any of the values ​​above, or a range combining two integers between the two values ​​above.

[0028] To optimize the electric field (i.e., TT field) distribution, the electrode arrays 70a and 70b (the pair of transducer arrays) can be configured differently depending on the application for which the pair of electrode arrays 70a and 70b is being used. The pair of electrode arrays 70a and 70b described herein is attached externally to the patient, i.e., typically to the patient's skin, and applies an electric current and an electric field (TT field) to generate currents in the patient's tissue. Typically, the pair of electrode arrays 70a and 70b is positioned on the patient's skin by the user so that an electric field is generated throughout the patient's tissue within the treatment area. The externally applied TT field can be localized or widely distributed and is used, for example, to treat skin tumors or lesions near the skin surface.

[0029] 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 place electrode arrays 70a and 70b at a treatment site on the patient.

[0030] According to another exemplary embodiment, electronic device 50 includes a controller 74 and, optionally, a temperature sensor 78 connected to controller 74 .

[0031] In one embodiment, the controller 74 includes circuitry configured to control the output of the electric field generator 54, for example, setting the output to a maximum value that does not cause excessive heating of the treatment site. The controller 74 can issue an alert, for example, if the temperature of the treatment area (as sensed by the temperature sensor 78) exceeds a preset limit. The temperature sensor 78 can be mechanically connected to and / or otherwise associated with the electrode array 70a and / or the electrode array 70b to sense the temperature of the treatment area at either or both of the electrode arrays 70a and 70b. In one embodiment, the controller 74 can turn off or reduce the power of the TT signal generated by the electric field generator 54 if the temperature sensed by the temperature sensor 78 meets or exceeds a comfort threshold. In one embodiment, the comfort threshold is the temperature at which the patient feels uncomfortable when using the electrode arrays 70a and 70b. In one embodiment, the comfort threshold is a temperature at or near 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, for example 41°C.

[0032] Conductive leads 58 are standard insulated conductors with a flexible metal shield, preferably grounded, to prevent diffusion of the electric field generated by conductive leads 58. Electrode arrays 70a and 70b can have specific shapes and configurations to generate a TT field of a desired configuration, direction, and strength in the treatment area, concentrating treatment only in that treatment area.

[0033] 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.

[0034] In one embodiment, the electric field generator 54 further includes one or more generator battery ports 82 (shown in FIG. 2 as 82a and 82b) for receiving or connecting generator batteries and electrically connecting the generator batteries to the electric field generator 54 to provide power to the electric field generator 54, as shown in more detail in FIG. 4.

[0035] Additionally, in some embodiments, the controller 74 includes one or more controller battery ports 86 (FIG. 4) that can accommodate or connect to a controller battery 158 (FIG. 4) and electrically connect the controller battery 158 to the controller 74, which is described in more detail below in connection with FIG. 4.

[0036] Referring now to FIG. 3 , a diagram of an exemplary embodiment of an electrode array 70 constructed in accordance with the present disclosure is shown. The electrode array 70 includes one or more electrode elements 104. As shown in FIG. 3 , each electrode array 70 is configured as a set of one or more electrode elements 104. The electrode array 70 may utilize capacitively coupled electrode elements 104. In the example shown in FIG. 3 , the electrode array 70 is configured as a plurality of electrode elements 104 (e.g., approximately 2 cm in diameter) interconnected via flex wires 108 (connected to an electric field generator via conductive leads 58). Each electrode element 104 may include a dielectric layer (such as a ceramic disc or a highly dielectric thin-film polymer layer) and an electrode layer. In one embodiment, the electrode array 70 includes a peripheral edge 132.

[0037] Alternative electrode array 70 structures may 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 and the skin-facing surface of the electrode array 70 on a plurality of flat conductors. Examples of non-ceramic dielectric materials disposed on a plurality of flat conductors include a polymer film disposed on electrical contacts on a printed circuit board or on a flat metal piece. Electrode arrays 70 using electrode elements 104 that are not capacitively coupled may also be used. In this case, each electrode element 104 of the transducer array is implemented using an area of ​​conductive material configured to be positioned against the patient's body, and no insulating dielectric layer is disposed between the electrode element 104 and the patient's body. Conductive materials include conductive films, conductive fabrics, conductive foams, etc. Other alternative structures for implementing the electrode array 70 may also be used, as long as they are capable of delivering a TT field to the patient's body. If desired, a gel layer, such as a conductive gel layer, or a conductive adhesive layer may be disposed between the electrode array 70 and the patient's body in any of the embodiments described herein.

[0038] Referring now to FIG. 4, a block diagram of an exemplary embodiment of the electronic device 50 of FIG. 2 constructed in accordance with the present disclosure is shown. As shown in FIG. 4, the electronic device 50 generally includes an electric field generator 54 supported by a housing 150. In some embodiments, the housing 150 may further support a controller 74. FIG. 4 also illustrates other features of FIG. 2, such as the first and second conductive leads 58a and 58b being conductively connected to the first and second electrode array ports 90a and 90b, respectively, of the electric field generator 54 via the first ends 62a and 62b of the first and second conductive leads 58a and 58b, respectively, as described with respect to FIG. 2.

[0039] In one embodiment, one or more generator battery ports 82 (e.g., 82a and 82b), which can accommodate generator batteries 154 (e.g., 154a and 154b), are supported by the housing 150 and are electrically coupled to the electric field generator 54. The generator battery ports 82 may be supported separately from the housing 150 or may be integrally and / or partially formed within the housing 150.

[0040] 4, the electronic device 50 includes a first generator battery port 82a (FIG. 480) and, optionally, a second generator battery port 82b (FIG. 481). In this embodiment, each of the first generator battery port 82a and the second generator battery port 82b may independently power the electric field generator 54. In some embodiments, the first generator battery port 82a may be associated with the first generator battery 154a and the second generator battery port 82b may be associated with the second generator battery 154b.

[0041] In one embodiment, the electronic device 50 includes a controller battery port 86 connected via circuitry to the processor 162, which provides power to the processor 162 and other components of the controller 74 (such as the memory 166) independently of the power provided to the first generator battery port 82a and / or optionally the second generator battery port 82b.

[0042] In one embodiment, the electronic device 50 further includes a controller charging circuit operable to charge the controller battery 158. In some embodiments, the controller battery 158 may be charged from one or more of the first generator battery 154a and the second generator battery 154b. In some embodiments, the controller battery 158 may be charged via the power port 88.

[0043] In one embodiment, electronic device 50f further includes a power port 88. Power port 88 may be supported by housing 150 or may be integrally and / or partially formed within housing 150. Power port 88 may be operable to supply power to electric field generator 54 and / or controller 74 independent of generator battery 154 and / or controller battery 158. In some embodiments, electronic device 50 may include circuitry operable to receive power from power port 88 and charge generator battery 154 and / or controller battery 158.

[0044] In one embodiment, controller 74 may further include circuitry for interfacing with generator battery port 82 and controller battery port 86. The circuitry may include, for example, a processor 162 in communication with a non-transitory computer-readable medium (e.g., memory 166). Memory 166 may store computer-executable instructions that, when executed by processor 162, cause processor 162 to perform one or more actions, for example, as described below. In one embodiment, controller 74 is integrated with electric field generator 54.

[0045] In some embodiments, the first generator battery 154a may be characterized as a primary battery, and the second generator battery 154b may be characterized as a backup battery. In these embodiments, the controller 74 is configured to maintain the TT field delivered to the patient during a battery change. In these embodiments, the first generator battery 154a has a much greater capacity than the second generator battery 154b. For example, the first generator battery 154a may be a 100 W, 30 V battery with a first charge capacity of approximately 3,000 mAh, and the second generator battery 154b (e.g., the backup battery) may be a 30 V battery with a second charge capacity of approximately 300 mAh. In some embodiments, the first generator battery 154a provides 20 Wh to 30 Wh of power to the electric field generator 54 for 3 to 4 hours.

[0046] In one embodiment, the first generator battery 154a is configured to continuously power the electric field generator 54 for a significant period of time, such as between 30 and 300 minutes. The second generator battery 154b is configured to continuously power the electric field generator 54 for a much shorter period of time, such as between 1 and 10 minutes. In these embodiments, the circuitry of the electronic device 50 can be configured to allow the first generator battery 154a to continuously provide power until the charge capacity of the first generator battery 154a falls below a predetermined power level. Upon determining that the first generator battery 154a is below the predetermined power level, the processor 162 provides a signal to the user to replace the first generator battery 154a and then provides a signal to the electric field generator 54 to begin drawing power from the second generator battery 154b. The second generator battery 154b powers the electric field generator 54 while the first generator battery 154a is disconnected from the first generator battery port 82a, i.e., being replaced, thereby providing continuous power to the electric field generator 54 and avoiding the conventional initialization procedure described above. Once the replacement first generator battery 154a is replaced and installed (i.e., the replacement has occurred and the replacement generator battery is connected to the first generator battery port 82a), a signal is provided to the electric field generator 54 to begin drawing power from the (replacement) first generator battery 154a and charging the second generator battery 154b in preparation for another future power change. In one embodiment, the second generator battery 154b has a charge capacity that is 1 / 3 to 1 / 300 of the charge capacity of the first generator battery 154a, and more preferably, has a charge capacity that is within the range of 1 / 5 to 1 / 300, e.g., 1 / 10, of the charge capacity of the first generator battery 154a. In one embodiment, the replacement first generator battery 154a may be referred to as a replacement battery or a replacement generator battery.

[0047] In one embodiment, the processor 162 may communicate with each of the first and second generator battery ports 82a, 82b to determine or detect the presence and / or current capacity of the first and / or second generator batteries 154a, 154b. Additionally, the processor 162 may communicate with the controller battery port 86 to determine or detect the presence and / or current capacity of the controller battery 158.

[0048] In one embodiment, a processor 162 in communication with each generator battery port 82 (e.g., the first generator battery port 82a and the second generator battery port 82b) may detect the insertion and / or new connection of a generator battery 154 to a generator battery port 82 and trigger a generator battery replacement event in response to the detection. For example, if a generator battery 154 is newly connected or inserted into the second generator battery port 82b, the processor 162 of the controller 74 detects the insertion of the generator battery 154 and triggers a generator battery replacement event in response.

[0049] In one embodiment, the processor 162 may communicate with each generator battery port 82 (e.g., the first generator battery port 82a and the second generator battery port 82b) to monitor and detect the removal and / or disconnection of the generator battery 154 from the generator battery port 82 and trigger a generator power-down event in response to the detection. For example, if the generator battery 154 is disconnected or removed from the first generator battery port 82a and / or the second generator battery port 82b, the processor 162 of the controller 74 may detect the removal of the generator battery 154 and trigger a generator power-down event in response. Alternatively, in one embodiment, the processor 162 of the controller 74 may be programmed to trigger a generator power-down event only if the first generator battery 154a is disconnected or removed from the first generator battery port 82a. In one embodiment, if only the second generator battery 154b is disconnected or removed from the second generator battery port 82b, the processor 162 of the controller 74 may be programmed to generate a warning signal indicating such an event.

[0050] In one embodiment, a processor 162 in communication with each generator battery port 82 (e.g., first generator battery port 82a and second generator battery port 82b) may detect the battery charge or charge capacity of the generator battery 154 connected to the generator battery port 82. The battery charge may be in terms of battery capacity, such as milliamp hours (mAh), or a percentage, such as the remaining battery charge. In some embodiments, the processor 162 may compare the charge capacity of the connected generator battery 154 to a minimum operating capacity, and if the charge capacity is less than (or approximately equal to) the minimum operating capacity, the processor 162 may generate a signal indicating that the generator battery charge capacity is less than the minimum operating capacity.

[0051] In one embodiment, the minimum operating capacity is the minimum charge capacity that a battery must have in order for the controller 74 to operate the electric field generator 54. For example, if the generator battery 154 connected to the generator battery port 82 does not have enough charge to power the electric field generator 54 for a predetermined period of time, the processor 162 may generate a signal indicating such. When a user is notified that the generator battery 154 does not have enough charge to power the electric field generator 54, the user may be instructed to, for example, replace the generator battery 154 or place the generator battery 154 in a charger.

[0052] The processor 162 may be in communication with the electric field generator 54. The processor 162 may activate the electric field generator 54, causing the electric field generator 54 to transmit a TT signal at a predetermined power for a predetermined period of time. For example, the processor 162 may cause the electric field generator 54 to transmit a TT signal at a first initial power and then increase the first initial power to an operating power over a predetermined period of time, e.g., a ramp-up period. The processor 162 may further cause the electric field generator 54 to transmit a TT signal at a first initial voltage or current and then increase the first initial voltage or current to an operating voltage or current over a predetermined period of time, e.g., a ramp-up period. The processor 162 may also deactivate the electric field generator 54, causing the electric field generator 54 to stop transmitting the TT signal.

[0053] The processor 162 is in communication with the electric field generator 54 and may store one or more operating parameters of the electric field generator 54 in the memory 166, for example, in response to a generator power-down event. The one or more operating parameters are data indicative of the operation of the electric field generator 54 or the cessation of operation of the electric field generator 54. For example, the operating parameters may be one or more of a calculated or measured output of the electric field generator 54, the power of the TT signal the electric field generator 54 is transmitting immediately before the electric field generator 54 is shut down, a timestamp indicating when the electric field generator 54 is activated and / or shut down, a duration of the shutdown, a circuit resistance, the voltage of the TT signal the electric field generator 54 is transmitting before the electric field generator 54 is shut down, the power of the TT signal the electric field generator 54 is transmitting before the electric field generator 54 is shut down, and / or the like.

[0054] Additionally, in some embodiments, the processor 162 may store in the memory 166 one or more operating parameters indicative of battery characteristics of each of the generator battery 154 and / or the controller battery 158. The one or more battery properties may include the battery charge level of each generator battery 154, the battery charge level of the controller battery 158, a timestamp indicating when the generator battery 154 was installed or fully charged, a timestamp indicating when the controller battery 158 was installed or fully charged, a cycle count of the generator battery 154 and / or the controller battery 158, etc. The processor may be configured to store such data (operating parameters) continuously both before and after a generator power-down event.

[0055] In one embodiment, controller 74 may store an accelerated power-up program 170 and a standard power-up program 174 in memory 166. When standard power-up program 174 is executed, processor 162 performs a standard initialization procedure in which the TT field delivered to the patient is initially low and then slowly increases over a relatively long period of time, such as 30 minutes. Accelerated power-up program 170 stored in memory 166 may include computer-executable instructions that, when executed by processor 162, cause processor 162 to perform an accelerated power-up process in which the TT field delivered to the patient is at or within 10% of the operating power, as described below. The standard power-up program 174 may be used to initiate the TT field delivered to the patient (as a safety measure) if one or more operating parameters provided to the processor 162 indicate that the electrode array 70 (FIG. 2) may have been tampered with or recently applied to the patient. The accelerated power-up program 170 may be used to initiate the TT field delivered to the patient at a higher power level to provide a higher level of therapy to the patient if one or more operating parameters provided to the processor 162 indicate that it is safe, e.g., if the one or more operating parameters indicate that the electrode array 70 has not been tampered with or newly applied.

[0056] In one embodiment, the electronic device 50 includes one or more inputs 176 integrated with and / or at least partially supported by the housing 150. The processor 162 may detect one or more interactions with the inputs 176 (i.e., inputs related to a battery change or a generator power-down event) and may trigger a generator power-down event upon detecting an interaction indicating an intent to turn off the electric field generator 54 or to change the generator battery 154. A generator power-down event is a physical interaction with the input 176 of the electronic device 50 indicating that the electric field generator 54 should be powered off. The intent to turn off the electric field generator 54 may be user-intentional or pre-programmed based on specific conditions provided to the input 176. The input 176 may be, for example, a button indicating an intent to perform a battery change, a power button on the electronic device 50, a sensor monitoring the disconnection of the pins on the generator battery port 82, a sensor monitoring the charge capacity of the generator battery 154, and / or a sensor monitoring another aspect of the electronic device 50 indicating that the electric field generator 54 should be powered off.

[0057] 5, a process flow diagram of an exemplary embodiment of a replacement process 300 according to the present disclosure is shown. Replacement process 300 generally includes storing operational parameters indicative of electric field generator operation or electric field generator inoperation (step 304), shutting down the electric field generator to stop providing the first electrical signal during an electric field generator power-down event (step 308), determining an operational state based at least in part on the operational parameters (step 312), and activating the electric field generator to either i) provide the second electrical signal in response to the operating state being an accelerating state (step 316) or ii) provide the third electrical signal in response to the operating state being a standard state (step 320). Generally, by storing operating parameters in response to a generator power-down event, the replacement process 300 determines whether one or more electrode arrays 70 have been tampered with and causes the processor 162 to execute the standard power-up program 174 if one or more electrode arrays 70 have been tampered with, or to execute the accelerated power-up program 170 if one or more electrode arrays 70 have not been tampered with.

[0058] In one embodiment, storing the operating parameters indicative of operation of the electric field generator or cessation of operation of the electric field generator (step 304) is performed in response to a generator power-down event and may include, for example, receiving the generator power-down event by processor 162 and storing one or more operating parameters in memory 166, for example.

[0059] In one embodiment, storing an operating parameter indicative of operation of the electric field generator or deactivation of the electric field generator (Step 304) includes storing the operating parameter, the operating parameter being data indicative of a circuit resistance. The operating parameter data may be determined prior to deactivating the electric field generator (Step 308). By storing data indicative of the circuit resistance, the circuit resistance may be compared to a second circuit resistance measured prior to activating the electric field generator to determine whether the electrode array 70 was tampered with during replacement of the generator battery 154.

[0060] In one embodiment, storing operating parameters indicative of operation of the electric field generator or cessation of operation of the electric field generator (step 304) includes storing operating parameters, where the operating parameters are data indicative of one or more electric field characteristics (i.e., TT field characteristics). For example, the operating parameters may indicate the current power of the first electrical signal (e.g., the power of the TT signal when the operating parameters are stored), the voltage of the first electrical signal, the frequency of the first electrical signal, and the current of the first electrical signal. Each of the operating parameter data may be determined before cessation of the electric field generator (step 308). The operating parameters indicative of the power, voltage, current, and / or frequency of the first AC waveform may be utilized by the accelerated power-up program 170 to determine a second initial power, a second initial voltage, a second initial current, and / or a second initial frequency of the second AC waveform (for the accelerated power-up process), as described in more detail below.

[0061] In one embodiment, the operational parameters are one or more of a first timestamp indicating when the generator battery 154 was removed from the generator battery port 82, a second timestamp indicating when the generator battery no longer has enough charge to operate the electric field generator 54, and / or the start of a replacement timer (a starting point for measuring the time the electric field generator 54 is in an inactive state). Each of the first timestamp, the second timestamp, and the replacement timer may be used by the processor 162 to measure a deactivation period of the electric field generator 54. By measuring the deactivation period, the processor 162 can determine whether tampering with one or more electrode arrays 70 may have occurred, resulting in a standard state, or whether tampering with one or more electrode arrays 70 has likely not occurred, resulting in an accelerated state of operation. That is, the standard state is an operational state indicative of a determination that a standard power-up program should be executed, and the accelerated state is an operational state indicative of a determination that an accelerated power-up program should be executed.

[0062] In one embodiment, storing the operating parameters in response to a generator power-down event (step 304) includes receiving, such as by processor 162, a generator power-down event triggered by, for example, one or more of: low battery capacity of the generator battery, removal of the generator battery, insertion of a second generator battery, disconnection of the electric field generator from the main power source, and / or the like.

[0063] For example, in one embodiment, the processor 162 may monitor one or more generator battery ports 82 to detect removal of a first generator battery, and upon detecting removal of the first generator battery, the processor 162 may trigger a generator power down event. Similarly, the processor 162 may monitor the power supply port 88 to detect removal of a power source connected to the power supply port 88, e.g., removal or disconnection of a mains power source or wall power source, and upon detecting removal of a power source connected to the power supply port 88, may trigger a generator power down event. In one embodiment, interaction with the input 176 may trigger a generator power down event.

[0064] In another example, the processor 162 monitors one or more generator battery ports 82 to detect the battery level of a first generator battery connected to the generator battery port 82 of the electric field generator 54. If the charge capacity of the first generator battery falls below a minimum operating capacity, the processor 162 generates a signal indicating that the charge capacity of the first generator battery falls below the minimum operating capacity. In one embodiment, the signal may include triggering a generator power-down event. The minimum operating capacity may be set, for example, to approximately 5-15% of the maximum charge of the first generator battery (e.g., generator battery 154). In one embodiment, the signal may be transmitted to a user, helper, or medical professional. The signal may activate, for example, a visual feedback device such as an LED or LCD, a tactile feedback device, an audio feedback device such as a speaker, a smartphone, an app, a website, an email, a text message (e.g., SMS, MMS), or the like. In one embodiment, the battery level may be the remaining charge percentage, the voltage of the battery (e.g., first generator battery), the available or remaining ampere-hours, etc.

[0065] In one embodiment, storing the operating parameters (step 304) includes monitoring one or more electric field characteristics (i.e., TT signal characteristics or TT field characteristics) and then storing data indicative of the operating parameters. Monitoring and storing the one or more electric field characteristics can be performed periodically or in response to a specific input, such as in response to a generator power-down event. The operating parameters are data indicative of the one or more electric field characteristics prior to the generator power-down event. For example, the operating parameters may indicate the power of the first electrical signal (e.g., the power of the TT signal prior to receiving the generator power-down event), the voltage of the first electrical signal, the frequency of the first electrical signal, and the current of the first electrical signal. Each of the operating parameter data may be determined prior to shutting down the electric field generator (step 308). The operating parameters indicative of the power, voltage, current, and / or frequency of the first AC waveform may be utilized by the accelerated power-up program 170 to determine a second initial power, a second initial voltage, a second initial current, and / or a second initial frequency of the second AC waveform (for the accelerated power-up process), as described in more detail below. Additionally, monitoring may be extended during the standard power-up process and / or the accelerated power-up process. For example, circuit resistance may be measured during the accelerated power-up process (or the standard power-up process), and if the user moves the array after the accelerated power-up process (or the standard power-up process) begins, the controller 74 stops the accelerated power-up process (or the standard power-up process) and returns to the beginning of the standard power-up process. In one embodiment, the processor 162 may periodically monitor one or more electric field characteristics, e.g., monitor one or more electric field characteristics a first time and monitor one or more electric field characteristics a second time after a waiting period. In some embodiments, the processor 162 may continuously monitor one or more electric field characteristics, e.g., the processor 162 may have a set of instructions for reading one or more electric fields that are repeated until interrupted.

[0066] In one embodiment, stopping the electric field generator and ceasing the supply of the first electrical signal during the electric field generator power-down event (step 308) includes, for example, sending a control signal from processor 162 to electric field generator 54 to cause electric field generator 54 to stop supplying the first electrical signal to each electrode array 70.

[0067] In one embodiment, determining the operating state based at least in part on the operating parameters (step 312) includes determining, by processor 164, the operating state to be either an accelerated state or a standard state. In some embodiments, the operating state is only one of an accelerated state and a standard state, while in other embodiments, the operating state may include one or more additional states. If potential tampering with the electrode array is detected, the operating state may be determined to be a standard state, while if potential tampering with the electrode array is not detected, the operating state may be determined to be an accelerated state.

[0068] In one embodiment, determining the operating state based at least in part on the operating parameters (Step 312) includes determining the operating state after detecting installation of a replacement first generator battery 154a before activating the electric field generator 54. Generally, when the first generator battery 154a is replaced with a replacement first generator battery operable to provide power to the electric field generator 54, the processor 162 determines the operating state to determine whether to execute the accelerated power-up program 170 if the operating state is an accelerated state or the standard power-up program 174 if the operating state is a standard state.

[0069] In one embodiment, determining the operating state based at least in part on the operating parameters (step 312) includes periodically or continuously determining the operating state between triggering a generator power-down event and activating the electric field generator to provide the second electrical signal (step 316). In one embodiment, the operating state may be determined multiple times per second before activating the electric field generator to provide the second electrical signal (step 316) or the third electrical signal (step 320). For example, processor 162 may communicate with electrode array port 90 to detect and monitor circuit resistance across electrode array 70 (e.g., as a monitored circuit resistance), and if the monitored circuit resistance exceeds a resistance threshold (e.g., above a predetermined resistance or below a predetermined resistance), processor 162 may determine that the operating state is normal.

[0070] In one embodiment, determining the operating state based at least in part on the operating parameters (step 312) includes processor 164 determining that the operating state is an accelerated state if the inactivation period is below a predetermined inactivation period threshold and determining that the operating state is a standard state if the inactivation period exceeds the predetermined inactivation period threshold. For example, if the operating parameters include a power-down event timestamp, such as the time at which processor 162 receives a generator power-down event, the inactivation period may be determined by comparing the current timestamp with the power-down event timestamp. The predetermined inactivation period threshold may be, for example, about 2 minutes (or about 120 seconds), or about 5 minutes, or in a range from about 2 minutes to about 5 minutes. Thus, in this example, determining the operating state based at least in part on the operating parameters (step 312) includes processor 164 determining that the operating state is an accelerated state if the inactivation period is less than 2 minutes (or less than 5 minutes) and determining that the operating state is a standard state if the inactivation period is greater than 2 minutes (or greater than 5 minutes). In some embodiments, the predetermined inactivation period threshold is set by the user (and / or helper) or medical professional, while in other embodiments, the predetermined inactivation period threshold is set by the manufacturer.

[0071] In one embodiment, determining the operating state based at least in part on the operating parameters (step 312) includes monitoring for disconnection of at least one electrode array 70 from the electrode array port 90, and determining the operating state to be a standard state upon detecting disconnection of any electrode array 70 from the electrode array port 90. In some embodiments, the operating state becomes a standard state when any electrode array 70 is disconnected, but the operating state does not necessarily become an accelerated state if all electrode arrays 70 are not disconnected.

[0072] In one embodiment, the operating state is assumed to be the accelerated state until the operating state is changed to the standard state. In other embodiments, the operating state is assumed to be the standard state until the operating state is changed to the accelerated state. In some embodiments, if the operating state is set to the accelerated state by default, changing the operating state to the standard state prevents the operating state from returning to the accelerated state until replacement process 300 is complete, but if the operating state is set to the standard state by default, changing the operating state to the accelerated state may return the operating state to the standard state. In other words, in some embodiments, any condition that results in the operating state being set to the standard state will cause processor 162 to execute standard power-up program 174.

[0073] In one embodiment, activating the electric field generator to provide the second electrical signal in response to the operating state being the acceleration state (Step 316) includes providing the second electrical signal having a second alternating current waveform at a frequency in the range of 50 kHz to 1 MHz. Processor 162 may execute acceleration power-up program 170 stored in memory 166 to thereby activate electric field generator 54 to provide the second electrical signal in response to the operating state being the acceleration state.

[0074] In one embodiment, activating the electric field generator to provide the second electrical signal in response to the operating state being the accelerated state (Step 316) includes activating the electric field generator to provide the second electrical signal having a second AC waveform at a second power greater than a third power of the third electrical signal. In other words, the second power of the second AC waveform resulting from execution of the accelerated power-up program is greater than the third power of the third AC waveform resulting from execution of the standard power-up program.

[0075] In one embodiment, activating the electric field generator to provide the second electrical signal in response to the operating state being an acceleration state (step 316) includes activating the electric field generator to provide the second electrical signal having a second alternating current waveform having a second initial power.

[0076] In one embodiment, activating the electric field generator to provide the second electrical signal in response to the operating state being the acceleration state (step 316) includes, for example, transmitting a control signal from processor 162 to electric field generator 54 to activate the electric field generator to provide the second electrical signal having a second AC waveform having a second initial power between the operating power and 95% of the operating power. The operating power may be determined, for example, by an operating parameter having data indicative of the power of the first AC waveform (i.e., the power of the TT signal before the generator power-down event).

[0077] In one embodiment, prior to activating the electric field generator to provide the second electrical signal in response to the operating state being an acceleration state (step 316), the charge of the first battery may be compared to the charge of the second battery, for example, by processor 162. In one embodiment, if the charge of the second battery is within 5-15% of the charge of the first battery, activating the electric field generator to provide the second electrical signal (step 316) may not be performed. In some embodiments, if the charge of the second battery is within 5-15% of the charge of the first battery, processor 162 may set the operating state to a warning state.

[0078] In one embodiment, activating the electric field generator to provide the second electrical signal in response to the operating state being an acceleration state (step 316) includes activating the electric field generator to provide the second electrical signal based on operating parameters having data indicative of either a voltage or a current of a first AC waveform, wherein either a second initial voltage of the second AC waveform or a second current of the second AC waveform is selected such that a second power of the second AC waveform is between a power of the first AC waveform and 95% of a power of the first AC waveform.

[0079] In one embodiment, activating the electric field generator to provide the second electrical signal in response to the accelerating operating state (step 316) includes providing a first ramp-up time that is shorter than a second ramp-up time provided by activating the electric field generator to provide the third electrical signal in response to the standard operating state. For example, in response to the accelerating operating state, the second electrical signal may have a second AC waveform in which a second initial voltage or a second initial current is set to the first initial voltage or the first initial current, and the second initial voltage and / or the second initial current may be increased to the operating voltage and / or the operating current in a shorter time than when activating the electric field generator to provide the third electrical signal in response to the standard operating state. In some embodiments, the first ramp-up time is between 10 minutes and 30 minutes.

[0080] In one embodiment, the ramp-up time is determined based on the position of the electrode array 70 on the patient. For example, the ramp-up time of an electrode array 70 positioned on the patient's head may be shorter than the ramp-up time of an electrode array 70 positioned on the patient's torso. In one embodiment, the ramp-up time may be calculated based on a first power, an operating power, and a ramp-up rate. For example, if the electric field applied to the patient's head has a first operating power and the electric field applied to the patient's torso has a second operating power that is lower than the first operating power, then for the same ramp-up rate, the ramp-up time of the electric field applied to the patient's head will be shorter than the ramp-up time of the electric field applied to the patient's torso.

[0081] In one embodiment, activating the electric field generator to provide a third electrical signal in response to the operating conditions being standard (Step 320) includes activating the electric field generator in response to the operating conditions being standard, the third electrical signal having a third alternating current waveform at a frequency in the range of 50 kHz to 1 MHz. Processor 162 may activate electric field generator 54 to provide the third electrical signal in response to the operating conditions being standard. In one embodiment, processor 162 may retrieve the operating conditions from memory 166.

[0082] In one embodiment, activating the electric field generator to provide a third electrical signal in response to the operating conditions being standard (Step 320) includes activating the electric field generator in response to the operating conditions being standard, the third electrical signal having a third initial power. In some embodiments, the third initial power is equal to the first initial power. In other embodiments, the third initial power is within 10% of the first initial power. Illustrative Embodiments

[0083] The following is a non-limiting list of exemplary embodiments of the inventive concepts disclosed herein.

[0084] Exemplary Embodiment 1. An electronic device comprising: an electric field generator configured to provide a first electrical signal having a first alternating waveform at a frequency in the range of 50 kHz to 1 MHz; A controller in communication with an electric field generator to control an output of the electric field generator, the controller including an input, a processor, and a temporary computer-readable medium, the temporary computer-readable medium having stored thereon an accelerated power-up program, a standard power-up program, and computer-executable instructions, the computer-executable instructions, when executed by the processor, receiving a generator power-down event via the input, the generator power-down event being a physical interaction with the input; detecting a generator power down event; deactivating the electric field generator to stop applying the first electric signal; storing an operating parameter indicative of operation of the electric field generator or cessation of operation of the electric field generator; determining an operating state based at least in part on the operating parameter, the operating state being one of an accelerating state and a standard state; Activate the electric field generator, i) providing a second electrical signal using an acceleration power-up program in response to the operating state being an acceleration state, the second electrical signal having a second AC waveform at a frequency in the range of 50 kHz to 1 MHz; or ii) providing a third electrical signal having a standard power-up program responsive to the operating condition being a standard condition, the third electrical signal having a third AC waveform at a frequency in the range of 50 kHz to 1 MHz.

[0085] Exemplary Embodiment 2. The electronic device of exemplary embodiment 1, wherein the electric field generator further comprises at least one electrode array port and is further configured to provide power to the at least one electrode array port.

[0086] Exemplary Embodiment 3. The electronic device of any of Exemplary Embodiments 1-2, wherein the generator power-down event includes a generator battery replacement event triggered by one or more of the removal of a first generator battery and the insertion of a second generator battery.

[0087] Exemplary Embodiment 4. The electronic device of any of embodiments 1-3, wherein the computer-executable instructions, when executed by a processor, further include instructions that cause the processor to perform the steps of detecting a battery level of a first generator battery connected to the electric field generator, and if the charge capacity of the first generator battery is below a minimum operating capacity, generating a signal indicating that the charge capacity of the first generator battery is below a minimum operating capacity.

[0088] Exemplary Embodiment 5. The electronic device of exemplary embodiment 4, wherein the processor includes computer-executable instructions that, when executed by the processor, cause the processor to perform the steps of receiving a signal indicating that the charge capacity of the first generator battery is below a minimum operating capacity and triggering a generator power-down event.

[0089] Exemplary Embodiment 6. The electronic device of any of embodiments 1-5, wherein the computer-executable instructions further include instructions that, when executed by the processor, cause the processor to store an operating parameter indicative of a deactivation period of the electric field generator, and wherein determining the operating state includes determining that the operating state is an acceleration state if the deactivation period is below a predetermined deactivation period threshold.

[0090] Exemplary Embodiment 7. The electronic device of exemplary embodiment 6, wherein the predetermined inactivity period threshold is 5 minutes.

[0091] Exemplary embodiment 8. The electronic device of any one of exemplary embodiments 1 to 7, The accelerated power-up program includes computer-executable instructions that, when executed by the processor, cause the processor to perform the steps of sending a first control signal to the electric field generator to cause the electric field generator to increase the power of the second alternating current waveform to an operating power over a first time period; and the standard power-up program includes computer-executable instructions that, when executed by the processor, cause the processor to perform the steps of sending a second control signal to the electric field generator to cause the electric field generator to increase the power of the third alternating current waveform to the operating power for a second time period; The first period is shorter than the second period.

[0092] Exemplary Embodiment 9. The electronic device of any of embodiments 1-8, wherein the standard power-up program includes computer-executable instructions that, when executed by the processor, cause the processor to perform the step of sending a control signal to the electric field generator to cause the electric field generator to set the initial power of the third alternating current waveform to less than 95% of the operating power.

[0093] Exemplary Embodiment 10. The electronic device of any of embodiments 1-9, wherein the accelerated power-up program includes computer-executable instructions that, when executed by the processor, cause the processor to perform the steps of sending a control signal to the electric field generator and causing the electric field generator to set the power of the second AC waveform from the operating power to 95% of the operating power.

[0094] Exemplary Embodiment 11. The electronic device of any of embodiments 1-10, wherein the electric field generator is connected to the first electrode array and the second electrode array, and the computer-executable instructions further include instructions that, when executed by a processor, cause the processor to perform a step of monitoring for disconnection of at least one of the first electrode array and the second electrode array, and when disconnection of at least one of the first electrode array and the second electrode array is detected, the operating state is set to a standard state.

[0095] Exemplary Embodiment 12. The electronic device of any of embodiments 1-11, wherein the electric field generator is connected to the first electrode array and the second electrode array, and the computer-executable instructions further include instructions that, when executed by the processor, cause the processor to perform the steps of monitoring for disconnection of at least one of the first electrode array and the second electrode array, and generating a warning signal indicative of disconnection of at least one of the first electrode array and the second electrode array.

[0096] Exemplary Embodiment 13. The electronic device of any one of exemplary embodiments 1 to 13, further comprising: a first electrode array; a second electrode array; The electric field generator is connected to the first electrode array and the second electrode array, and the computer-executable instructions, when executed by the processor, storing the measured circuit resistance as an operating parameter; and monitoring the circuit resistance during periods when the electric field generator is turned off.

[0097] Exemplary Embodiment 14. The electronic device of exemplary embodiment 13, wherein if the monitored circuit resistance differs from the circuit resistance stored as the operating parameter by more than a resistance threshold, the operating state is set to a standard state.

[0098] Exemplary Embodiment 15. The electronic device of any of embodiments 1-14, wherein the accelerated power-up program further includes computer-executable instructions that, when executed by the processor, cause the processor to perform the step of activating the electric field generator to provide a second electrical signal having a second alternating current waveform at a frequency of the first alternating current waveform.

[0099] Exemplary embodiment 16. An electronic device, comprising: an electric field generator having a housing and a first circuit disposed within the housing, the first circuit operable to generate an electrical signal having an alternating current waveform at a frequency in the range of 50 kHz to 1 MHz, the housing having a first generator battery port and a second generator battery port independent of the first generator battery port, the first generator battery port and the second generator battery port coupled to the first circuit and independently powering the first circuit; A controller in communication with the electric field generator to control the output of the electric field generator, the controller having a processor coupled to a battery port of the controller, the battery port of the controller coupled to the processor via a second circuit to provide power to the processor independently of power provided to the first generator battery port and the second generator battery port.

[0100] Exemplary embodiment 17. The electronic device of exemplary embodiment 16 further comprises: a first generator battery coupled to the first generator battery port, the first generator battery having a first charge; and a second generator battery coupled to the second generator battery port, the second generator battery having a second charge in the range of 1 / 3 to 1 / 300 of the first charge.

[0101] Exemplary embodiment 18. A method, comprising: storing an operating parameter, the operating parameter indicating operation of an electric field generator or cessation of operation of the electric field generator, the electric field generator being configured to provide a first electrical signal having a first alternating current waveform at a frequency in the range of 50 kHz to 1 MHz; deactivating the electric field generator to stop applying the first electric signal; determining an operating state based at least in part on the operating parameters, the operating state being one of an accelerating state and a standard state; Activate the electric field generator, i) providing a second electrical signal in response to the operating state being an acceleration state, the second electrical signal having a second AC waveform at a frequency in the range of 50 kHz to 1 MHz; or ii) providing a third electrical signal responsive to the operating condition being the standard condition, the third electrical signal having a third AC waveform at a frequency in the range of 50 kHz to 1 MHz.

[0102] Exemplary Embodiment 19. The method of Exemplary Embodiment 18, wherein activating the electric field generator to provide the second electrical signal further includes activating the electric field generator to provide the second electrical signal having a second alternating current waveform at a second power greater than a third power of the third electrical signal.

[0103] Exemplary Embodiment 20. The method of any of Exemplary Embodiments 18-19, further comprising detecting installation of the generator battery before determining the operating state.

[0104] Exemplary Embodiment 21. The method of any of embodiments 18-20, further comprising, before activating the electric field generator to provide the second electrical signal and before activating the electric field generator to provide the third electrical signal, comparing the charge of the first generator battery with the charge of the second generator battery, the second generator battery being a backup or replacement battery for the first generator battery.

[0105] Exemplary Embodiment 22. The method of exemplary embodiment 21, wherein determining the operating condition includes determining the operating condition to include a warning condition if the charge of the second generator battery is within 5% of the charge of the first generator battery, and further includes transmitting a signal indicating the warning condition.

[0106] Exemplary Embodiment 23. The method of any of Exemplary Embodiments 18-23, wherein the step of storing the operating parameters further includes storing data indicative of at least one of a circuit resistance, a voltage of the first AC waveform, and a current of the first AC waveform prior to shutting down the electric field generator.

[0107] Exemplary Embodiment 24.I The method of exemplary embodiment 23, wherein the step of activating the electric field generator to provide the second electrical signal is further defined as activating the electric field generator to provide the second electrical signal based on the operating parameters, wherein either the second initial voltage of the second AC waveform or the second current of the second AC waveform is selected such that the second power of the second AC waveform is between the power of the first AC waveform and 95% of the power of the first AC waveform.

[0108] Exemplary Embodiment 25. An electronic device comprising: an electric field generator providing a first electrical signal having a first alternating current waveform at a frequency between 50 kHz and 1 MHz; and a controller in communication with the electric field generator, the controller comprising an input, a processor, and a memory, the memory having stored therein an acceleration power-up program, a standard power-up program, and computer-executable instructions that cause the processor to perform the following steps: receiving a generator power-down event via the input; detecting the generator power-down event; stopping the electric field generator; storing an operating parameter indicative of whether the electric field generator is operating; determining an operating state based at least in part on the operating parameter; and responsive to the operating state being an acceleration state, operating the electric field generator to provide a second electrical signal using the acceleration power-up program, the second electrical signal having a second alternating current waveform at a frequency between 50 kHz and 1 MHz.

[0109] 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 illustrative embodiments of the inventive concepts have been described for purposes of this disclosure, it will be understood that numerous variations are possible which will readily occur to those skilled in the art and which are possible modifications and variations in light of the above teachings or which may be obtained from practice of the methodologies described in this disclosure.

[0110] Although particular combinations of features and steps are recited in the claims and disclosed in the specification, these combinations do not limit the disclosure. Indeed, many of these features and steps can be combined in ways not specifically recited in the claims and / or disclosed in the specification. Although each dependent claim set forth below may depend directly on only one other claim, the disclosure includes each dependent claim in combination with every other claim in the claim set.

[0111] No element, act, or instruction used herein should be construed as critical or essential to the invention unless explicitly described as such in other than the preferred embodiments. Further, the phrase "based on" means "based at least in part on," unless expressly specified otherwise.

Claims

1. 1. An electronic device, comprising: an electric field generator configured to provide a first electrical signal having a first alternating waveform at a frequency in the range of 50 kHz to 1 MHz; a controller in communication with the electric field generator to control an output of the electric field generator, the controller having an input, a processor, and a non-transitory computer readable medium, the non-transitory computer readable medium including an accelerated power-up program, a standard power-up program, and a program that, when executed by the processor, receiving a power down event of the generator via an input, the power down event of the generator being a physical interaction with the input; detecting a power down event of the generator; deactivating the electric field generator to stop applying the first electric signal; storing an operating parameter indicative of operation of the electric field generator or cessation of operation of the electric field generator; determining a motion state based at least in part on the motion parameter, the motion state being one of an accelerating state and a standard state; activating the electric field generator; i) providing a second electrical signal using the acceleration power-up program in response to the operating state being an acceleration state, the second electrical signal having a second AC waveform at a frequency in the range of 50 kHz to 1 MHz; or ii) in response to the operating condition being a standard condition, providing a third electrical signal with a standard power-up program, the third electrical signal having a third alternating current waveform at a frequency in the range of 50 kHz to 1 MHz.

2. 10. The electronic device of claim 1, wherein the generator power down event comprises a generator battery replacement event triggered by one or more of the removal of a first generator battery and the insertion of a second generator battery.

3. 3. The electronic device of claim 1, wherein the computer-executable instructions further include instructions that, when executed by a processor, cause the processor to store an operating parameter indicative of a deactivation period of the electric field generator, and wherein determining the operating state includes determining that the operating state is an acceleration state if the deactivation period is below a predetermined deactivation period threshold.

4. The acceleration power-up program the computer-executable instructions, when executed by the processor, cause the processor to send a first control signal to the electric field generator, causing the electric field generator to increase the power of the second alternating current waveform to an operating power over a first time period; the standard power-up program includes computer-executable instructions that, when executed by the processor, cause the processor to perform the step of sending a second control signal to the electric field generator to cause the electric field generator to increase the power of a third alternating current waveform to an operating power for a second time period; The electronic device according to any one of claims 1 to 3, wherein the first period is shorter than the second period.

5. 5. The electronic device of claim 1, wherein the standard power-up program comprises computer-executable instructions that, when executed by the processor, cause the processor to perform the step of sending a control signal to the electric field generator to cause the electric field generator to set an initial power of the third AC waveform to less than 95% of an operating power.

6. 6. The electronic device of claim 1, wherein the accelerated power-up program comprises computer-executable instructions that, when executed by the processor, cause the processor to perform the step of sending a control signal to the electric field generator to cause the electric field generator to set the power of a second AC waveform to between an operating power and 95% of the operating power.

7. 7. The electronic device of claim 1, wherein the electric field generator is connected to a first electrode array and a second electrode array, and the computer-executable instructions, when executed by the processor, further comprise instructions that cause the processor to perform the steps of monitoring for disconnection of at least one of the first electrode array and the second electrode array, and setting the operating state to the standard state when disconnection of at least one of the first electrode array and the second electrode array is detected.

8. moreover, a first electrode array; and a second electrode array; and the electric field generator is connected to the first electrode array and the second electrode array, and the computer-executable instructions, when executed by the processor, storing the measured circuit resistance as an operating parameter; 8. The electronic device of claim 1, further comprising instructions that cause the processor to perform the steps of: monitoring circuit resistance while the electric field generator is turned off.

9. 9. The electronic device of claim 8, wherein the operating state is set to the standard state if the monitored circuit resistance differs from a circuit resistance stored as an operating parameter by more than a resistance threshold.

10. 1. An electronic device comprising: an electric field generator having a housing and a first circuit disposed within the housing, the first circuit operable to generate an electrical signal having an alternating current waveform at a frequency in the range of 50 kHz to 1 MHz, the housing having a first generator battery port and a second generator battery port independent of the first generator battery port, the first generator battery port and the second generator battery port coupled to the first circuit and independently supplying power to the first circuit; a controller in communication with the electric field generator to control an output of the electric field generator, the controller having a processor coupled to a battery port of the controller, the battery port of the controller coupled to the processor through a second circuit to provide power to the processor independently of power provided to the first generator battery port and the second generator battery port.

11. moreover, a first generator battery coupled to the first generator battery port, the first generator battery having a first charge; 11. The electronic device of claim 10, comprising: a second generator battery coupled to said second generator battery port, said second generator battery having a second charge in a range of 1 / 3 to 1 / 300 of said first charge.

12. 1. A method comprising: storing operational parameters, the operational parameters indicative of operation of an electric field generator or cessation of operation of the electric field generator, the electric field generator being configured to provide a first electrical signal having a first alternating current waveform at a frequency in the range of 50 kHz to 1 MHz; deactivating the electric field generator to stop applying the first electric signal; determining an operating state based at least in part on the operating parameter, the operating state being one of an accelerating state and a standard state; activating the electric field generator; i) providing a second electrical signal responsive to the operating condition being an acceleration condition, the second electrical signal having a second alternating current waveform at a frequency in the range of 50 kHz to 1 MHz; or ii) providing a third electrical signal in response to the operating condition being a standard condition, the third electrical signal having a third alternating current waveform at a frequency in the range of 50 kHz to 1 MHz.

13. 13. The method of claim 12, wherein operating the electric field generator to supply a second electrical signal further comprises operating the electric field generator to supply a second electrical signal having a second alternating current waveform at a second power greater than a third power of a third electrical signal.

14. 14. The method of claim 12, wherein storing the operating parameters further comprises storing data indicative of at least one of a circuit resistance, a voltage of a first alternating current waveform, and a current of a first alternating current waveform before shutting down the electric field generator.

15. 15. The method of claim 14, wherein the step of operating the electric field generator to provide a second electrical signal is further defined as operating the electric field generator to provide a second electrical signal based on the operating parameters, wherein either a second initial voltage of the second AC waveform or a second current of the second AC waveform is selected such that a second power of the second AC waveform is between a power of the first AC waveform and 95% of a power of the first AC waveform.

Images