Treatment of tissues using electrical stimulation

Abstract

The device for electrically stimulating tissue includes a first pair of electrodes and a second pair of electrodes. The first pair of electrodes is configured to contact a person and pass a first alternating current (AC current) through the person's tissue between the electrodes. The second pair of electrodes is configured to contact a person and pass a second AC current through the person's tissue between the electrodes. The first pair of electrodes and the second pair of electrodes are configured to be arranged such that the first AC current and the second AC current flow through the person's target tissue simultaneously. The first AC current and the second AC current are configured to stimulate the target tissue.

Description

Technical Field

[0001] Cross - References to Related Applications This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 348,986, filed on June 3, 2022, U.S. Provisional Patent Application No. 63 / 349,003, filed on June 3, 2022, and European Patent Application EP21306447.0, filed on July 15, 2021. The entire contents of each of the above - mentioned applications are incorporated herein by reference.

[0002] The present disclosure generally relates to the electrical stimulation of tissues, and more specifically, to the treatment of diseases by electrical stimulation.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Due to disorders related to the airway, the airway volume decreases, the air flow is restricted, and proper breathing is hindered. These disorders can occur in diseases such as obstructive sleep apnea (OSA), but can also occur in other situations, such as when the patient is under sedation. Partial obstruction by the tongue can reduce the air flow through the patient's airway. OSA may present as a symptom of repeated airway collapse during sleep due to relaxation of the upper airway dilator muscles. In patients with OSA, the tension of the tongue muscles is lost and relaxed, the tongue drops backward in the mouth, and the pharynx becomes narrow. OSA contributes to upper airway obstruction, loss of respiratory control, and reduced oxygenation and gas exchange, which can lead to intermittent hypoxemia. Existing treatments for OSA focus on opening the airway and increasing air flow or require surgical implants. Continuous positive airway pressure (CPAP) is a treatment method that forces air flow through a mask while the patient is sleeping. CPAP and surgical implants are invasive and uncomfortable treatment methods with many deficiencies. OSA is just one example of many diseases that have great room for improvement in treatment methods.

Means for Solving the Problems

[0004] The present disclosure relates to the use of electric current for stimulating tissue.

[0005] According to an aspect of the present disclosure, an apparatus for electrically stimulating tissue includes a first pair of electrodes configured to contact a person and pass a first alternating current (AC) through the person's tissue between the pair of electrodes, and a second pair of electrodes configured to contact the person and pass a second AC current through the person's tissue between the pair of electrodes. The first pair of electrodes and the second pair of electrodes are configured to be disposed on the human body such that the first AC current and the second AC current flow through the person's target tissue simultaneously. The first AC current and the second AC current are configured to stimulate the target tissue.

[0006] In an embodiment of the apparatus, the first AC current has a first frequency, the second AC current has a second frequency, and both the first frequency and the second frequency are higher than 1000 Hz.

[0007] In an embodiment of the apparatus, the current flowing through the target tissue has a frequency different from both the first frequency and the second frequency.

[0008] In an embodiment of the apparatus, the current flowing through the target tissue has a frequency corresponding to the frequency difference between the first frequency and the second frequency. In an embodiment of the apparatus, the frequency difference is less than 200 Hz.

[0009] In an embodiment of the apparatus, the first pair of electrodes and the second pair of electrodes are one of an interleaved configuration, a nested configuration, or a nearest neighbor configuration.

[0010] In an embodiment of the apparatus, the apparatus includes a first battery configured to supply power to the first pair of electrodes and a second battery configured to supply power to the second pair of electrodes. The first battery does not supply power to the second pair of electrodes, and the second battery does not supply power to the first pair of electrodes.

[0011] In an embodiment of the device, the device includes a controller configured to set parameters of a first AC current and a second AC current. The parameters include a first frequency of the first AC current and a second frequency of the second AC current.

[0012] In an embodiment of the device, the controller sets the first frequency and the second frequency to base frequency values, and in response to a determination that an event has occurred, within a first time after the event, sets the first frequency to a different frequency value different from the base frequency value, maintains the first frequency at the different frequency value and the second frequency at the base frequency value over a second time after the first time, and within a third time after the second time, sets the first frequency back to the base frequency value, thereby configuring to set parameters of the first AC current and the second AC current.

[0013] In an embodiment of the device, the device includes a first electrode array and a second electrode array. The first electrode array includes a first pair of electrodes, and the second electrode array includes a second pair of electrodes.

[0014] In an embodiment of the device, the controller is further configured to determine a subset of the first electrode array and a subset of the second electrode array that stimulate the target tissue during operation, and activate a subset of the first electrode array including the first pair of electrodes without activating all the electrodes of the first electrode array, and activate a subset of the second electrode array including the second pair of electrodes without activating all the electrodes of the second electrode array.

[0015] In an embodiment of the device, the device includes an electromyogram (EMG) sensor configured to provide sensor data. The controller is further configured to determine at least one of muscle tension or confirmation of tissue stimulation based on the EMG sensor data. The controller sets parameters of the first AC current and the second AC current based on at least one of muscle tension or confirmation of tissue stimulation.

[0016] In an embodiment of the device, the device includes an electroencephalogram (EEG) sensor configured to provide sensor data. The controller is further configured to determine a person's sleep state based on the EEG sensor data. The controller sets parameters of a first AC current and a second AC current based on the person's sleep state.

[0017] In an embodiment of the device, the device includes a photoplethysmography (PPG) sensor configured to provide sensor data. The controller is further configured to determine a person's respiratory rate based on the PPG sensor data. The controller sets parameters of a first AC current and a second AC current based on the respiratory rate.

[0018] In an embodiment of the device, the device includes a housing. The controller is disposed inside the housing, and a first electrode pair and a second electrode pair are disposed on the surface of the housing.

[0019] In an embodiment of the device, the device includes at least one patch configured to adhere to a person's skin, and the at least one patch includes a first electrode pair and a second electrode pair, at least one battery, and at least one electrical connection configured to electrically couple the at least one battery to the at least one patch.

[0020] In an embodiment of the device, the tissue within at least a portion of the path of the first AC current is not stimulated by the first AC current, and the tissue within at least a portion of the path of the second AC current is not stimulated by the first AC current.

[0021] In an embodiment of the device, the device includes a third electrode pair configured to contact a person and pass a third AC current through the person's tissue between the electrode pair, and a fourth electrode pair configured to contact a person and pass a fourth AC current through the person's tissue between the electrode pair. The first electrode pair, the second electrode pair, the third electrode pair, and the fourth electrode pair are configured to be arranged on the human body such that the first AC current, the second AC current, the third AC current, and the fourth AC current flow through the person's target tissue simultaneously and stimulate the target tissue.

[0022] In an embodiment of the device, the tissue within at least a portion of the path of the third AC current is not stimulated by the third AC current, and the tissue within at least a portion of the path of the fourth AC current is not stimulated by the fourth AC current.

[0023] In an embodiment of the device, the target tissue includes the person's hypoglossal nerve.

[0024] According to an aspect of the present disclosure, a method for electrically stimulating tissue by a first electrode pair contacting a person and a second electrode pair contacting a person is disclosed. The method includes simultaneously passing a first AC current through the person's tissue between the first electrode pair and passing a second AC current through the person's tissue between the second electrode pair. The first AC current and the second AC current flow through the person's target tissue simultaneously based on the arrangement of the first electrode pair and the second electrode pair on the human body. The first AC current and the second AC current are configured to stimulate the target tissue.

[0025] In an embodiment of the method, the first AC current has a first frequency, the second AC current has a second frequency, and both the first frequency and the second frequency are higher than 1000 Hz.

[0026] In an embodiment of the method, the current flowing through the target tissue has a frequency different from both the first frequency and the second frequency.

[0027] In an embodiment of the method, the current flowing through the target tissue has a frequency corresponding to the frequency difference between a first frequency and a second frequency. In an embodiment of the method, the frequency difference is less than 200 Hz.

[0028] In an embodiment of the method, the method includes setting parameters of a first AC current and a second AC current. The parameters include a first frequency of the first AC current and a second frequency of the second AC current.

[0029] In an embodiment of the method, setting the parameters of the first AC current and the second AC current includes setting the first frequency and the second frequency to a fundamental frequency value, and in response to a determination that an event has occurred, within a first time after the event, setting the first frequency to a different frequency value different from the fundamental frequency value, maintaining the first frequency at the different frequency value and the second frequency at the fundamental frequency value over a second time after the first time, and within a third time after the second time, returning the first frequency to the fundamental frequency value.

[0030] In an embodiment of the method, the first electrode pair is in a first electrode array and the second electrode pair is in a second electrode array.

[0031] In an embodiment of the method, the method includes determining a subset of the first electrode array and a subset of the second electrode array that stimulate the target tissue during operation, activating a subset of the first electrode array including the first electrode pair without activating all the electrodes of the first electrode array, and activating a subset of the second electrode array including the second electrode pair without activating all the electrodes of the second electrode array.

[0032] In an embodiment of the method, setting the parameters of the first AC current and the second AC current includes determining at least one of muscle tension or tissue stimulation confirmation based on sensor data from an electromyogram (EMG) sensor, and setting the parameters of the first AC current and the second AC current based on at least one of muscle tension or tissue stimulation confirmation.

[0033] In an embodiment of the method, setting the parameters of the first AC current and the second AC current includes determining a person's sleep state based on sensor data from an electroencephalogram (EEG) sensor and setting the parameters of the first AC current and the second AC current based on the person's sleep state.

[0034] In an embodiment of the method, setting the parameters of the first AC current and the second AC current includes determining a person's respiratory rate based on sensor data from a photoplethysmography (PPG) sensor and setting the parameters of the first AC current and the second AC current based on the respiratory rate.

[0035] In an embodiment of the method, the tissue within at least a portion of the path of the first AC current is not stimulated by the first AC current, and the tissue within at least a portion of the path of the second AC current is not stimulated by the first AC current.

[0036] In an embodiment of the method, the method includes simultaneously passing a third AC current through a person's tissue between a third pair of electrodes and passing a fourth AC current through the person's tissue between a fourth pair of electrodes. The first AC current, the second AC current, the third AC current, and the fourth AC current flow simultaneously to the target tissue based on the arrangement of the third pair of electrodes and the fourth pair of electrodes on the human body.

[0037] In an embodiment of the method, the tissue within at least a portion of the path of the third AC current is not stimulated by the third AC current, and the tissue within at least a portion of the path of the fourth AC current is not stimulated by the fourth AC current.

[0038] In an embodiment of the method, the target tissue includes a person's hypoglossal nerve.

[0039] According to aspects of the present disclosure, an apparatus for electrically stimulating tissue includes a housing configured to be attached to human tissue, a first battery and a second battery disposed within the housing, a first electrode pair electrically coupled to the first battery, a second electrode pair electrically coupled to the second battery, and an attachment mechanism configured to attach the housing or at least one of the first and second electrode pairs to human tissue such that the first and second electrode pairs contact the human tissue. The first battery does not supply power to the second electrode pair, and the second battery does not supply power to the first electrode pair.

[0040] In an embodiment of the apparatus, the first electrode pair and the second electrode pair are disposed on a surface of the housing.

[0041] In an embodiment of the apparatus, the apparatus includes at least one patch configured to adhere to human skin, the at least one patch including the first electrode pair and the second electrode pair and at least one electrical connection configured to couple the first battery and the second battery to the at least one patch.

[0042] In an embodiment of the apparatus, the at least one patch includes a first patch and a second patch. The first patch includes the first electrode pair, and the second patch includes the second electrode pair.

[0043] In an embodiment of the apparatus, the at least one patch includes a first patch including a first electrode of the first electrode pair, a second patch including a second electrode of the first electrode pair, a third patch including a first electrode of the second electrode pair, and a fourth patch including a second electrode of the second electrode pair.

[0044] In an embodiment of the apparatus, the housing is disposed within a human oral cavity and configured to be removable from the oral cavity. In an embodiment of the apparatus, the housing has a shape that follows the gingival margin of a human oral cavity.

[0045] In an embodiment of the device, the housing is configured to be attached to the skin under a person's chin. In an embodiment of the device, the housing has a shape along the line of a person's jaw.

[0046] In an embodiment of the device, the device includes a charging pin disposed on the surface of the housing. The charging pin is electrically coupled to a first battery and a second battery. The charging pin is configured to transfer power for recharging the first battery and the second battery.

[0047] In an embodiment of the device, the device includes a wireless communication device disposed within the housing, and the wireless communication device is configured to provide a wireless communication function for communicating with a central system.

[0048] In an embodiment of the device, the device includes a controller disposed within the housing. The wireless communication device is configured to communicate a firmware update to the controller. The firmware update is provided by the central system.

[0049] In an embodiment of the device, the device includes at least one sensor configured to provide sensor data. The wireless communication device is configured to communicate the sensor data for delivery to the central system.

[0050] According to an aspect of the present disclosure, a method for electrically stimulating the hypoglossal nerve includes passing a first AC current through a person's tissue between a first pair of electrodes, passing a second AC current through the person's tissue between a second pair of electrodes, and stimulating the person's hypoglossal nerve with the first AC current and the second AC current, wherein the person's tongue moves by stimulating the hypoglossal nerve.

[0051] In an embodiment of the method, the first AC current has a first frequency and the second AC current has a second frequency. Both the first frequency and the second frequency are higher than 1000 Hz.

[0052] In an embodiment of the method, the current flowing through the hypoglossal nerve has a frequency different from both the first frequency and the second frequency.

[0053] In an embodiment of the method, the current flowing through the hypoglossal nerve has a frequency corresponding to the frequency difference between the first frequency and the second frequency. In an embodiment of the method, the frequency difference is less than 200 Hz.

[0054] According to an aspect of the present disclosure, a method for electrically stimulating neurons to treat a disease includes passing a first current through human tissue between a first pair of electrodes, passing a second current through human tissue between a second pair of electrodes, and stimulating human neurons with the first current and the second current, and treating the disease is provided by stimulating the neurons.

[0055] In an embodiment of the method, the first alternating current has a first frequency and the second alternating current has a second frequency.

[0056] In an embodiment of the method, the current flowing through the neurons has a frequency different from both the first frequency and the second frequency.

[0057] In an embodiment of the method, the current flowing through the neurons has a frequency corresponding to the frequency difference between the first frequency and the second frequency.

[0058] In an embodiment of the method, the disease includes at least one of an inflammatory disease, lymphatic stasis, and incontinence.

[0059] Further details and exemplary aspects of the present disclosure will be described in more detail below with reference to the accompanying drawings. Any aspect of the present disclosure can be combined with other aspects without departing from the scope of the present disclosure.

[0060] A better understanding of the features and advantages of the disclosed technology will be obtained by referring to the following detailed description which illustrates exemplary aspects in which the principles of this technology are used.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0062] The present disclosure relates to the use of electric current for stimulating tissue. Aspects of the present disclosure use electrical stimulation to treat diseases (such as obstructive sleep apnea and other diseases) in a non-invasive manner without surgery or surgical implants. As described below, an electric current is passed through the tissue between the electrodes, and the plurality of electric currents from the plurality of electrodes are electrically and spatially configured to stimulate the target tissue or provide treatment for the target tissue. As used herein, tissue is "stimulated" when an electric current flowing through the tissue causes muscle movement such as muscle contraction and / or depolarization of a nerve. When an electric current flowing through the tissue does not cause muscle movement or nerve depolarization, the tissue is not stimulated. When the target tissue includes motor neurons, for example, electrical stimulation of the motor neurons can cause the associated muscle fibers to react in a desired manner, thereby achieving treatment of the disease.

[0063] As used herein, the term "exemplary" is intended to mean "an example" and is not intended to mean "preferred". Unless otherwise indicated, the terms "apparatus" and "system" are used interchangeably and are not intended to mean or imply a particular structure. For example, an apparatus or system disclosed herein may be embodied in a variety of structures, such as being embodied within a single housing or within more than one housing.

[0064] In the following detailed description, specific details are set forth in order to provide an understanding of aspects of the present disclosure and to provide various examples. It will be understood by those skilled in the art that aspects of the present disclosure may be practiced without the exact details described herein and may be practiced in ways not specifically described herein. In various examples, well-known methods, procedures, and / or components are not described in detail so as not to obscure the present disclosure. Unless the context indicates otherwise, any or all of the aspects, embodiments, and examples detailed herein may be used in combination with any or all of the other aspects or embodiments detailed herein.

[0065] FIG. 1 shows a block diagram of exemplary components of a system or apparatus for electrically stimulating tissue. For convenience, the term "system" is used in the description of FIG. 1, but descriptions using the term "system" are intended to be considered as if the term "apparatus" were used in the same description. In the embodiment shown in FIG. 1, the components include a controller 110, various sensors 120, 122, a battery 130 for the controller 110, and a plurality of electrical stimulators 140-170 for generating electrical stimulation. The controller 110 can be or can include any computing device, including, among other computing devices, a microcontroller, a microprocessor, a digital signal processor, a central processing unit (CPU), a graphics processing unit (GPU), an application specific integrated circuit (ASIC), a programmable logic device (PLD), and / or a field programmable gate array (FPGA). The controller 110 is powered by the battery 130, which can be a rechargeable battery or a non-rechargeable battery. The controller 110 includes input and / or output ("I / O") connections to the sensors 120, 122. The I / O connections can be analog I / O connections or digital I / O connections. The illustrated sensors include a photoplethysmography (PPG) sensor 120 and an accelerometer / gyroscope sensor 122. However, the illustrated sensors are merely examples, and the sensors connected to the controller 110 can include any type and any number of sensors supported by the controller 110.

[0066] Controller 110 includes I / O connections to electrical stimulators 140-170. The I / O connections can be analog I / O connections or digital I / O connections. In the illustrated embodiment, each electrical stimulator 140-170 includes a battery, a frequency generator, and an amplifier. In some embodiments, the frequency generator of each stimulator 140-170 can be a voltage-controlled oscillator controlled by an analog I / O connection of the controller 110. The amplifier of each electrical stimulator 140-170 can be any type of amplifier known to those skilled in the art. The battery of each electrical stimulator 140-170 can be a rechargeable battery or a non-rechargeable battery. Each electrical stimulator 140-170 also includes electrodes (not shown) that can be arranged in various manners, and such electrodes and arrangements will be described later in this specification.

[0067] According to aspects of the present disclosure, the controller 110 can independently drive each of the electrical stimulators 140-170 to provide a desired electrical output, such as a desired voltage, a desired current, and / or a desired frequency, among other electrical outputs. For example, the controller 110 can independently drive each of the electrical stimulation blocks 140-170 to provide an AC current within a desired frequency or a desired frequency range, such as the exemplary frequency / range shown in FIG. 1. Since each electrical stimulator 140-170 has a dedicated battery, the electrical output of each electrical stimulation 140-170 can be more accurately controlled by the controller 110. The effects of the electrical stimulators 140-170 can depend on the characteristics of their electrical outputs (e.g., frequency) and / or the physical locations where their electrodes are placed on the human body. Examples of such electrical characteristics and physical locations will be described later.

[0068] According to aspects of the present disclosure, the controller 110 can control the electrical stimulators 140-170 in various manners based on the outputs of the sensors 120, 122. For example, the controller 110 can drive one or more of the electrical stimulators 140-170 to provide an electrical output based on the output of one or both of the sensors 120, 122.

[0069] The system shown in FIG. 1 is exemplary, and various variations are possible within the scope of the present disclosure. In some embodiments, the number of electrical stimulators may be more or less than four. In some embodiments, the stimulation of the tissue can be made continuous and constant, or can be cycled on and off. When turned on and off, the stimulation can be regular, random, variable, or event-based. Various events, including respiratory events, apnea events, and / or user-defined events such as the passage of time, can be configured to trigger the activation of the stimulation. In some embodiments, the main trigger can be a respiratory event. The respiratory event can be the detection of the occurrence of breathing, or can be defined by an algorithm. The algorithmic event can include various variables such as oxygen level, respiratory rate, and fatigue due to excessive use of muscles. In some embodiments, sensors including a chest accelerometer, a microphone, an electrical activity sensor, and a pressure transducer can be configured to detect respiratory events.

[0070] For example, in some embodiments, a chest accelerometer can measure body movement. In some embodiments, a microphone can detect breathing sounds. In some embodiments, recordings of the electrical activity of the phrenic nerve that controls the diaphragm during breathing can be analyzed to detect breathing. In some embodiments, a pressure transducer implanted in the chest can sense changes in pressure associated with respiratory events. In some embodiments, the respiratory rate can be determined from a plethysmograph trace.

[0071] In some embodiments, tissue stimulation can be activated in response to an algorithm that detects respiratory events in real time. In some embodiments, tissue stimulation can be activated based on an algorithm that predicts respiratory events, such as a moving average of previously measured respiratory events. In some embodiments, the tissue can be stimulated without detection of respiratory events, such as with regular periodic stimulation or semi-random stimulation. The frequency and current of the stimulation are adjustable, can be modulated between periodic stimulations, or the frequency can be swept from an "off" frequency to an "on" frequency, which will be described in more detail in connection with FIGS. 4 and 7.

[0072] Those skilled in the art will understand that, among other components, a memory, data, and / or machine-readable instructions stored in the memory, and certain components not shown in FIG. 1, such as a communication circuit, can be included in the system of FIG. 1. Such variations and other variations are considered to be within the scope of the present disclosure.

[0073] FIG. 2 is a diagram of exemplary electrical outputs of two electrical stimulators. The illustrated system includes a controller 210, a respiratory sensor 220, a first electrical stimulator 240 having electrodes 242, 244, and a second electrical stimulator 250 having electrodes 252, 254. The electrical stimulators 240, 250 can include the components of the electrical stimulator shown in FIG. 1. The controller 210 can control the two electrical stimulators 240, 250 to provide electrical outputs having different frequencies, such as the frequencies shown in FIG. 2. For example, both electrical stimulators 240, 250 can provide electrical outputs having frequencies above 1 kHz. One electrical stimulator (e.g., 250) can provide an electrical output having a slightly higher frequency, such as only 1 Hz to 200 Hz higher. The frequencies are exemplary, and other frequencies are considered to be within the scope of the present disclosure.

[0074] An electric current flows between the electrodes of each electric stimulator. A corresponding current 246 flows between the electrodes 242 and 244 of the first electric stimulator 240, and a corresponding current 256 may flow between the electrodes 252 and 254 of the second electric stimulator 250. As shown in FIG. 2, the illustrated paths of the currents 246 and 256 intersect at two positions. The illustrated paths are provided for illustrative purposes, and the actual current paths may not have the illustrated shape. In some embodiments, the paths of the currents 246 and 256 may intersect at one position or at more than two positions.

[0075] According to aspects of the present disclosure, the currents 246 and 256 flowing between the electrodes of the electric stimulators 240 and 250 can simultaneously flow to the target tissue 280 and stimulate the target tissue 280. The effects of the currents 246 and 256 on the target tissue 280 will be described in more detail in connection with FIG. 4. The controller 210 can control the timing and / or electrical characteristics (e.g., frequency, amplitude, etc.) of the currents 246 and 256 to achieve a desired effect on the target tissue 280. For example, in some embodiments, when the target tissue 280 includes motor neurons, the effects of the currents 246 and 256 can activate the muscle fibers associated with the motor neurons, whereby the muscles of the human body can contract. In some embodiments, the neurons of the target tissue 280 may include the hypoglossal nerve. When the respiration sensor 220 indicates a decrease or cessation of respiration, the controller 210 can control the electric stimulators 240 and 250 to stimulate the hypoglossal nerve of the target tissue 280 to move the tongue. Other types of target tissues and other effects by applying an electrical output to the target tissue are considered to be within the scope of the present disclosure.

[0076] Figure 3 is another diagram of exemplary electrical outputs of two electrical stimulators. With the first stimulator 340, a current 346 flows between its electrodes 342, 344, and with the second stimulator 350, a current 356 flows between its electrodes 352, 354. The electrical stimulators 340, 350 may include the components of the electrical stimulator shown in FIG. 1. Electrodes 342, 344, 352, 354 are physically placed on the human body at positions where the current paths 346, 356 will cross. The illustrated current paths 346, 356 are shown for illustrative purposes, and the actual current paths may have various shapes. In some embodiments, the current paths 346, 356 may cross at more than one position. In some embodiments, the current paths 346, 356 cross in the target tissue, stimulating the target tissue or affecting the treatment of the target tissue. For example, the currents 346, 356 may have the frequencies shown in FIG. 3 and provide treatment to the target tissue. The frequencies shown in FIG. 3 are exemplary, and other frequencies are considered to be within the scope of the present disclosure.

[0077] The systems described in connection with FIGS. 1-3 can be used to stimulate neurons and muscle fibers. As described above, tissue is "stimulated" when the current flowing through the tissue causes muscle movement such as muscle contraction and / or depolarization of nerves. When the current flowing through the tissue does not cause muscle movement or nerve depolarization, the tissue is not stimulated. Neurons and muscle fibers can be stimulated by currents with frequencies less than 1 kilohertz. At frequencies above 1 kHz, neurons may not respond and muscle fibers may not move.

[0078] At a certain electrical level, each electrode pair generates an electric field, and the current flowing between the electrodes of the electrode pair is based on the electric field. When multiple electrode pairs output electric fields, the respective electric fields can interfere with each other. When the individual electric fields have different frequencies, such interference between the electric fields can result in a region where the electric field has a frequency that is the difference between the frequencies of the individual electric fields. For example, as shown in FIG. 4, one electric field 410 may have a frequency of 2.1 kHz, and another electric field 420 may have a frequency of 2 kHz. Due to the interference between these electric fields, a region of an electric field 430 having a frequency of 100 Hz, which is the difference between the frequencies of the individual electric fields 410, 420, may occur. Such a region is referred to herein as an "activation region". However, outside the activation region, the individual electric fields 410, 420 may each have their respective frequencies.

[0079] The current flowing between the electrodes is based on the electric field generated by the electrodes. Outside the activation region, the current may have a frequency corresponding to the frequency of the electric field through which the current flows. When such a frequency exceeds 1000 Hz, there is a possibility that the tissue through which the current flows will not be stimulated. For the target tissue within the activation region, the target tissue can be exposed to a current having a frequency of less than 1000 Hz and a greater average current than that experienced in non-target tissue, as described in relation to FIG. 4. When the target tissue includes the muscles of the tongue or the hypoglossal nerve that controls the tongue, the tongue can be moved. When the target tissue is the genioglossus muscle, the tongue can be moved forward away from the airway. In contrast, non-target tissue is not exposed to frequencies that cause muscle contraction or nerve stimulation.

[0080] The current sufficient to induce stimulation can vary depending on the type of target tissue. For example, as the frequency increases, an increased current can be supplied to stimulate neurons. In some embodiments, the stimulation of the target tissue is also achieved by modulating the current, and different ratios of current can provide stimulation at various depths. For example, unilateral stimulation of various regions including the motor cortex can be achieved using a current ratio of ipsilateral:contralateral electrodes in the range of 1:8 to 8:1, for example, 50 uA:12.5 uA. In some embodiments, since the increase in temperature is very small, there is no concern of burns.

[0081] FIG. 4 is exemplary, and for the electric field and current, other frequencies, waveforms, and / or number of waveforms are considered to be within the scope of the present disclosure. For example, in some embodiments, the waveforms of the electric field and current can be modulated, such as by amplitude modulation. In some embodiments, the waveforms of the electric field and current may be square waves or other types of pulse waves, and the pulse width of the pulse wave can be modulated. In some embodiments, the waveforms of the electric field and current can be modulated in the Fourier domain.

[0082] Referring back to FIGS. 1-3, the disclosed system can apply the techniques described in connection with FIG. 4. That is, the individual electrical stimulators and electrode pairs can provide an electrical output at a frequency that does not stimulate the tissue. In the case of neurons, such a frequency may be greater than 1 kHz. The electrodes can be configured and / or arranged at positions such that an activation region is created in the target tissue by the synergistic effect of the electric fields generated by the electrodes. As described above, the current flowing through the activation region can have a frequency that stimulates the target tissue. In the case of neurons, such a frequency can be less than 1 kHz. In some embodiments, in the systems of FIGS. 1-3, the electrical stimulator can provide an electrical output at a frequency greater than 1 kHz, such as 3000 Hz, 4000 Hz, and / or 10 kHz, among other frequencies. The frequency difference between the frequencies generated by two different electrode pairs can be from 1 Hz to 1000 Hz, for example, from 1 Hz to 200 Hz. The frequency values are exemplary, and other frequency values are considered to be within the scope of the present disclosure.

[0083] Referring to FIG. 5, various configurations of electrode pairs are shown, including an interleaved electrode configuration 510, a nested electrode configuration 520, and a nearest neighbor electrode configuration 530. The electrode configurations of FIG. 5 can be used in conjunction with any aspect of the systems, devices, and techniques described in connection with FIGS. 1-4. The electrical stimulators (represented by I x and I y shown) are illustrated to show individual electrical stimulators for each electrode pair. The illustrated electrical stimulators are not intended to indicate a particular arrangement or location of the electrical stimulators.

[0084] In the "interleaved" electrode configuration 510, electrode pairs E1 and E2 are arranged on the surface S such that the electrodes from E1 are between the electrodes of E2 and the electrodes of E2 are between the electrodes of E1. The current paths in the interleaved electrode configuration 510 can intersect as shown in FIG. 3, for example, at one location. In the "nested" electrode configuration 520, electrode pairs E1 and E2 are arranged on the surface S such that electrode E2 is between the electrodes of E1 or electrode E1 is between the electrodes of E2. In such a configuration 520, the current paths can intersect in various manners depending on how the electrical output of the stimulator is configured, for example, at one location or two locations. In the "adjacent" electrode configuration 530, electrode pairs E1 and E2 are arranged on the surface S such that electrode E1 is arranged adjacent to electrode E2. The current in the adjacent electrode configuration 530 can intersect as shown in FIG. 2, for example, at two locations. This figure is illustrative and various variations are conceivable within the scope of the present disclosure. In some embodiments, there may be no individual electrical stimulator for each electrode pair.

[0085] In some embodiments, the electrodes can be configured and / or controlled taking into account different anatomical differences among humans in order to ensure proper treatment of target tissue such as the movement of a muscle (e.g., a tongue muscle). For example, if the electrodes are not properly arranged or controlled, the muscles of a part of the body (e.g., the tongue) may not contract due to the current generated by the electrical stimulator. In some embodiments, an array of electrodes can be incorporated.

[0086] FIG. 6 shows an exemplary configuration of electrode arrays 610, 620 including four electrode pairs and four electrical stimulators. The electrode configuration of FIG. 6 can be used in conjunction with any aspect of the systems, devices, and methods described in connection with FIGS. 1-4. In electrode array 610, electrode pairs E1 and E2 are arranged in a nested configuration, and electrode pairs E3 and E4 are also arranged in a nested configuration. The portions of the two nested configurations can be separated from each other by different distances. For example, one portion of the two nested configurations is separated by a distance d A and another portion of the two nested configurations is separated by a distance dB can only be separated. In the electrode array 620, the electrodes are arranged in the configuration shown in FIG. 3, and some of the electrodes are separated by a distance d A only, while another portion of the electrodes can be separated by a distance d B only. The illustrated electrical stimulators (I x1 , I x2 , I y1 , and I y2 ) are provided to show that each electrode pair has an individual electrical stimulator and is not intended to indicate a particular arrangement or location of the electrical stimulators. This figure is exemplary, and in some embodiments, there may be no individual electrical stimulator for each electrode pair.

[0087] According to aspects of the present disclosure, the controller can selectively activate some of the electrode pairs in the electrode arrays 610, 620 or can activate all of the electrode pairs in the electrode arrays 610, 620. By the function of the controller to selectively activate some or all of the electrode pairs and adjust the electrical output characteristics by the electrode pairs, the controller can customize the electrical output according to the human anatomical structure and enable treatment of the human target tissue in the most effective manner.

[0088] In some embodiments, in an array of electrodes, more than two electrode pairs can be used to create an electric field interference region, but that region can still have a current at a frequency that does not stimulate tissue (e.g., a frequency above 1000 Hz in the case of neurons). Further electric fields of one or more other electrode pairs of the array can cause further interference to create an activation region having a current at a frequency that stimulates tissue (e.g., a frequency below 1000 Hz in the case of neurons). The electrodes can be configured and / or arranged such that an activation region is created within the target tissue.

[0089] The embodiments of FIGS. 5 and 6 are exemplary. Other electrode configurations and other numbers of electrodes are considered to be within the scope of the present disclosure.

[0090] FIG. 7 shows an operation for controlling the electrical output of an electrode. Stimulation can be activated by changing the frequency of the current. The operation of FIG. 7 can be applied to any of the systems, devices, and configurations described in relation to FIGS. 1-3, 5, and 7, or variations of such systems, devices, and configurations. In some embodiments, the frequency of the current changes from a basic state in which electrode pairs E1 and E2 provide currents 710, 720 at the same frequency to a second state in which the frequency of the current between at least one of the electrode pairs is shifted such that the current in the activation region has a frequency (e.g., the difference between frequencies f1 and f2) that provides stimulation of the target tissue. When currents 710, 720 are operating at the same frequency, there may be no perceptible stimulation of the target tissue. For example, current 710 between electrodes E1 may have frequency f1 and current 720 between electrodes E2 may have frequency f2. Frequencies f1 and f2 may be equal, in phase, or out of phase. Detection, initiation, or measurement of an “event” 730 (e.g., by a sensor) can cause frequency f1 or frequency f2 to be shifted to a new frequency f3. The shift can be performed within time t1. The new frequency f3 is held for a time t2 and then can be shifted back to the starting frequency within time t3. Detection, initiation, or measurement of the next “event” 740 can repeat the operation. Although only two electrode pairs are shown in FIG. 7, this operation can be scaled to apply to more than two electrode pairs as applied to the configuration of FIG. 6 or any other configuration.

[0091] Various configurations and operations have been described above. Such variations of the configurations and operations are considered to be within the scope of the present disclosure. Various additional electrode and electronic device configurations may be used with the disclosed systems and devices. In some embodiments, the electrodes generate biphasic bipolar pulses and the electrodes may include an anode and a cathode. In some embodiments, the intensity and duty cycle of the electric field and / or current are adjustable. In some embodiments, the electronic device driving two electrode pairs may be separated and electronically insulated so as not to lose the integrity of the electric field. This may be achieved through measures such as an individual power source (shown in FIG. 1) or an optically driven circuit. In some embodiments, the stimulating current is driven by optoelectronics and the current can be driven by the application of light. In some embodiments, the stimulator circuit may be powered by electromagnetic induction. The disclosed system or device may be powered by an additional power source including a battery power source. In some embodiments, the power source may be rechargeable or non-rechargeable. Such variations and other variations are considered to be within the scope of the present disclosure.

[0092] The disclosed configurations and operations can be used to stimulate or treat various parts of the body. While various uses are considered to be within the scope of the present disclosure, a system or device that stimulates tissue to move the tongue to improve air flow will be described below. For example, this system or device can stimulate the tongue muscles to increase muscle tone and treat snoring and mild sleep apnea. Unless otherwise indicated, the aspects of the following description are intended to be generally applicable for stimulating or treating any tissue.

[0093] According to aspects of the present disclosure, as shown in FIGS. 8-11, an exemplary embodiment of an apparatus for electrical stimulation may include a curved housing. In some embodiments, the curved housing may have a size and shape generally following the curvature of a person's mandible or a person's teeth. In some embodiments, the curved housing can be made in different sizes and / or curvatures, and a person can use the particular size and / or curvature that best fits that person. The curved housing has an attachment mechanism for fixing the housing to a person, such as an adhesive (e.g., tape or glue), a strap, and / or a magnet, or other mechanism for attaching the housing to a person.

[0094] FIG. 8 is a diagram of an exemplary curved housing 810. The curved housing 810 includes electrodes 820. The configuration of the electrodes 820 may be any of the configurations described above (e.g., of FIG. 5 or FIG. 6), or may be a different configuration. The positions of the electrodes 820 are exemplary, and the electrodes 820 may be disposed at other positions on the curved housing 810. In some embodiments, the curved housing 820 may have a different number of electrodes than shown in FIG. 8. The curvature shown in FIG. 8 is exemplary, and other curvatures of the curved housing are considered to be within the scope of the present disclosure. As described above, in some embodiments, the curved housing may have a size and shape generally following the curvature of a person's mandible, jaw line, teeth, or gum line.

[0095] In some embodiments, some or all of the components shown in FIG. 1 can be disposed inside a curved housing 810 that includes the battery shown in FIG. 1. In some embodiments, the battery can be rechargeable. FIG. 9 is a diagram of the curved housing 810 that includes a charging pin 930 for charging the battery within the curved housing 810. The charging pin 930 can be disposed on a side of the curved housing 810 different from the side that includes the electrodes (820 in FIG. 8). The shape, number, and position of the pins in FIG. 9 are exemplary, and other shapes, numbers, and positions are considered to be within the scope of the present disclosure.

[0096] FIG. 10 is a diagram of an exemplary docking device 1010 that receives the curved housing 810 and charges the battery within the curved housing 810. The docking device 1010 is provided with a recess 1015 that is shaped similarly to the curved housing 810 such that the curved housing 810 fits within the recess 1015. The docking device 1010 also includes a charging cable that can be plugged into a power port (e.g., a wall outlet, a USB port, etc.) to transmit power for charging the battery within the curved housing 810. The power is transmitted to the curved housing 810 by pins 1030 on the docking device 1010. The pins 1030 are arranged to couple with the charging pins 930 on the curved housing 810 when the curved housing 810 is docked to the docking device 1010.

[0097] In some embodiments, the curved housing 810 and the docking device 1010 may be provided with one or more data pins (not shown) that enable communication of data therebetween. In some embodiments, the data pins may be used, among other uses, to update firmware and / or communicate usage data and / or sensor data (e.g., sensors 120, 122 of FIG. 1). In some embodiments, a controller (not shown) within the curved housing 810 may be programmed using a wired data connection that is directly connected to a connector (not shown) of the curved housing 810. The wired data connection may include a USB, lightning, micro-USB, or USB-C connection. After programming, the wired data connection hardware can be removed from the curved housing 810. In some embodiments, port-based connectors may be designed to be easily removable, such as by a pre-cut connection or a sufficiently long connection wire that is easily severed. In some embodiments, the ports may be designed to be able to re-establish the connection, such as by re-establishing electrical conduction between the wires. In some embodiments, the connection is magnetically held and can be connected and disconnected without using tools. In further embodiments, the connection can be established and stabilized by a physical clip.

[0098] FIG. 11 is a diagram of exemplary components of an embodiment having an electrode array and various sensors. The illustrated components include a curved housing 1110, two electrode arrays 1120, 1122, and various sensors 1130-1138. The electrode arrays 1120, 1122 can be disposed on the curved housing 1110. In some embodiments, some or all of the sensors 1130-1138 can be disposed on the curved housing 1110. In some embodiments, some or all of the sensors 1130-1138 can be disposed within the curved housing 1110.

[0099] The electrode arrays 1120, 1122 can be configured in the manner described in connection with FIG. 6. For example, a particular electrode pair can be configured such that both electrodes of the pair are in the electrode array 1120 or both electrodes of the pair are in the electrode array 1122. A particular electrode pair can be configured such that one electrode of the pair is in the electrode array 1120 and the other electrode of the pair is in the electrode array 1122. Combinations of such configurations are intended to be within the scope of the present disclosure. In some embodiments, a controller (not shown) can selectively activate a particular electrode pair or activate all of the electrode pairs of the electrode arrays 1120, 1122. As described above, with the function of the controller to activate a particular electrode pair, the controller can determine and / or implement the configuration of the electrodes according to the human anatomical structure.

[0100] Continuing to refer to FIG. 11, the illustrated sensor includes electromyogram (EMG) sensors 1130, 1132, an EMG reference sensor (1134), an accelerometer 1136, and a PPG sensor 1138. The controller can use the sensor data of the EMG sensors 1130 - 1134 to evaluate the electrical activity of a person resulting from the electrical output provided by some or all of the electrodes in the electrode arrays 1120, 1122. Such EMG sensor data can be used to determine the configuration of the electrodes that provide an effective stimulus or treatment to the person from among the electrode arrays 1120, 1125. For example, the device is applied to a person, and the controller of the device can activate a plurality of predetermined combinations of the electrodes in the electrode arrays 1120, 1122. The controller can evaluate data from the EMG sensors 1130, 1132, the accelerometer 1136, and / or the PPG sensor 1138 among other possible sensors. One or more electrode combinations that result in sensor data meeting a predetermined criterion are selected by the controller for use by the person.

[0101] In some embodiments, sensor data from the accelerometer 1136 and / or the PPG sensor 1138 can be used to determine when to provide the electrical output from the electrode arrays 1120, 1122. For example, in some embodiments, if the sensor data from the accelerometer 1136 indicates movement or a sufficient degree of movement, the electrode arrays 1120, 1122 can be activated. As another example, in some embodiments, if the sensor data from the accelerometer 1136 indicates no movement or a sufficiently low degree of movement, the electrode arrays 1120, 1122 can be activated in that situation. In some embodiments, if the sensor data from the PPG sensor 1138 indicates no respiration or a sufficiently low degree of respiration, the electrode arrays 1120, 1122 can be activated in that situation. The accelerometer 1136 and the PPG sensor 1138 are merely examples. Other types of sensors and their sensor data can be used to determine when to activate the electrodes to provide the electrical output.

[0102] FIG. 12 shows various portions of the tongue muscles including the tongue 1257, the styloglossus muscle 1258, the hyoglossus muscle 1259, the mandible and teeth 1260, and the genioglossus muscle 1261. According to aspects of the present disclosure, electrical stimulation can be applied to the tongue muscles using any of the systems, devices, configurations, and operations described above. In some embodiments, current passes through the tissue and flows into the activation region of the tongue muscles, stimulating the tongue muscles and the hypoglossal muscles to move the tongue out of the airway. In some embodiments, the electrodes can be arranged parallel to the hypoglossal nerve. The electrodes can be configured as shown in either the configuration of FIG. 5 or FIG. 6, or can have other configurations not shown herein. In some embodiments, a single electrode pair can be used to induce a current, such as neuromuscular electrical stimulation, in the hypoglossal muscles to cause them to contract during respiration. In some embodiments, the stimulation of other nerves can assist in opening the airway. For example, the stimulation of the cervical nerve loop can stimulate the sternohyoid muscle, the sternothyroid muscle, and / or the omohyoid muscle, potentially improving the airway and thus can be a target of the device during treatment.

[0103] In some embodiments, to move the jaw forward to open the airway, stimulation of other muscles of the jaw (not shown) can be used. These muscles include the lateral pterygoid muscle innervated by the lateral pterygoid branch of the mandibular nerve, the masseter muscle innervated by the masseteric nerve and / or a branch of the mandibular nerve, and the medial pterygoid muscle innervated by the medial pterygoid branch of the mandibular nerve.

[0104] In some embodiments, the stimulation can be bilateral or unilateral. In embodiments of bilateral stimulation, each of the two sides can be stimulated using different frequencies. For example, in the case of stimulating two hypoglossal nerve branches, using the same frequency can result in unintended phase cancellation and potentially painful stimulation across the entire jaw.

[0105] According to aspects of the present disclosure, moving the tongue can be beneficial in many procedures. For example, moving the tongue can potentially improve the airway of a patient under the influence of anesthesia or opioids, or a patient recovering from anesthesia or opioids. In some embodiments, moving the tongue can make access during imaging, including intubation, dental treatment, upper airway-related surgery, or endoscopy, placement of a feeding tube, or gastric surgery, easier. Any of the systems, devices, and operations disclosed herein can be applied to such procedures and other procedures to result in beneficial tongue movement.

[0106] Referring to FIG. 13, according to an aspect of the present disclosure, the anatomical structure of FIG. 12 can be electrically stimulated by an apparatus 1310 disposed under a person's lower jaw. The apparatus 1310 can include any aspect of the systems and / or apparatuses described in connection with FIGS. 1-11. For example, the shape of the curved housing can be configured to conform to the shape of a person's anatomical structure (e.g., the lower jaw, jaw line, neck, and / or other facial features). In some embodiments, the apparatus 1310 can be fixed to a person's skin with a removable adhesive, or the apparatus 1310 can be fixed to a person's head with a strap or band (not shown), among other mechanisms. The adhesive can contain agents that reduce skin inflammation and redness, including moisturizers, anti-inflammatory agents, NSAIDs, anesthetics, analgesics, antihistamines, niacinamide, aloe vera, witch hazel, seabuckthorn oil, palmitoleic acid, calendula, chamomile, tiger grass, tubocurarine, hyaluronic acid, vitamin E, squalane, glycerin, and / or cannabidiol. The adhesive or a portion thereof can contain conductive substances such as salts and conductive metals such as gold, zinc, colloidal silver, copper, and selenium.

[0107] Referring to FIGS. 14 and 15, according to an aspect of the present disclosure, the anatomical structure of FIG. 12 can be electrically stimulated by an apparatus 1410. The apparatus 1410 includes electrodes 1420 and can be disposed in the oral cavity, such as under or on a person's tongue. The apparatus 1410 can include any aspect of the systems and / or apparatuses described in connection with FIGS. 1-11. For example, the shape of the curved housing can be configured to conform to the shape of a person's anatomical structure (e.g., teeth, gum line, and / or other facial features). In some embodiments, the apparatus 1410 can be substantially flat, although other configurations are considered to be within the scope of the present disclosure. The electrodes 1420 can be fixed to the housing and disposed in the oral cavity behind the teeth and the mandible.

[0108] The housing of device 1410 can include various materials. In some embodiments, the housing can have a thermoplastic component that contacts a portion of a human tooth and a rigid acrylic component that contacts a portion of the human palate. In some embodiments, only the thermoplastic component can contact the human tooth.

[0109] In some embodiments, device 1410 can include an orthodontic component (not shown). The orthodontic component can include a tooth-encircling component having a lingual side and a labial side. The tooth-encircling component can partially or fully overlap a human tooth and palate. The orthodontic component can also include a rigid component fused along the entire length of the lingual side that overlaps a portion of the patient's palate. In some embodiments, the orthodontic component can further include a rigid acrylic component welded to the thermoplastic tooth-encircling component.

[0110] The rigid acrylic component can extend from the entire length of the lingual side of the thermoplastic tooth-encircling component toward the patient's palate. The rigid acrylic component can partially or fully cover the human tooth and palate. In some embodiments, only the thermoplastic tooth-encircling component fully overlaps the human tooth, and the rigid acrylic component can also overlap all portions of the palate where the thermoplastic tooth-encircling component overlaps. In some embodiments, the rigid acrylic component can have a higher rigidity than the thermoplastic tooth-encircling component. The rigid acrylic component can also increase the rigidity of the entire arch defined by the thermoplastic tooth-encircling component without fully overlapping the human tooth. In some embodiments, a mouthpiece that fits can be fabricated using the mold of a human mandible and palate. The mold can incorporate various components for placing electrodes to contact the floor of the mouth.

[0111] The devices of FIGS. 14 and 15 can be used to electrically stimulate the tongue muscles. Without electrical stimulation, the tongue may approach the airway and obstruct the air flow. With electrical stimulation, as shown in FIG. 16, the tongue muscles move forward, widening the airway, and the person's air flow can be improved. In some embodiments, the electrical stimulator can provide an electrical output at a frequency of about 10 kHz. An activation region having a current with a frequency of 1 Hz to 200 Hz can be used to induce involuntary forward flexion of the tongue. In some embodiments, other frequency values can be used. The above description regarding FIGS. 14 to 16 is exemplary, and various variations are conceivable within the scope of the present disclosure. For example, the device in the oral cavity can be sized and arranged in other manners not illustrated and described herein.

[0112] Referring to FIG. 17, an example of an electrode patch is shown. The electrode patches 1710, 1720 include electrodes 1730, and the patches 1710, 1720 can be attached to a person at the positions shown in FIG. 17 (for example, one patch 1710 on the right cheek and one patch 1720 on the left cheek), or at other positions. In some embodiments, the electrode patches 1710, 1720 can include a removable adhesive that adheres to a person's skin. The electrodes 1730 contact the person's skin and can be held in place by the adhesive. The adhesive can contain an agent that reduces skin inflammation and redness, as described above in connection with FIG. 13. The adhesive or a portion thereof can contain a conductive substance such as a salt, and / or a conductive metal such as gold, zinc, colloidal silver, copper, and / or selenium. In some embodiments, other mechanisms for attaching the electrode patch to a person, such as a strap or a band, are contemplated.

[0113] In some embodiments, an electrical circuit (not shown) may be incorporated into the electrode patches 1710, 1720. In some embodiments, electrical conductors (not shown) can connect the electrodes 1730 of the electrode patches 1710, 1720 to a separate system or device that provides control and electrical output, such as the system of FIG. 1. In some embodiments, a particular electrical circuit may be incorporated into the electrode patches 1710, 1720, the particular electrical circuit may be present in a separate system or device, and may be connected to the electrode patches 1710, 1720 by electrical conductors.

[0114] FIG. 17 is illustrative, and various variations are possible within the scope of the present disclosure. In some embodiments, as shown in FIG. 18, a single electrode patch can be used, which can be fixed under a person's chin and / or on a person's neck. The single electrode patch 1810 may include a plurality of electrodes 1830 and may include one or more electrode arrays.

[0115] In some embodiments, more than two electrode patches can be used, for example, as shown in FIGS. 19 and 20. In some embodiments, the patches may be circular patches, such as the circular patch 1930 shown in FIG. 19 and the circular patch 2030 shown in FIG. 20, and may have a diameter of 2 inches or another size. In some embodiments, each circular patch may include a single electrode. As shown in FIGS. 18 and 19, one patch can be fixed along the line of the left jaw, one patch can be fixed along the line of the right jaw, and the patches may be disposed above and / or below the line of the jaw.

[0116] In some embodiments, the electrode patch may have a shape and size different from those shown in FIGS. 17-20. In some embodiments, the electrode patch can be placed in various locations, including any location or any combination of locations shown in FIGS. 17-20, or a location different from those shown in FIGS. 17-20. For example, the electrode patch can be placed on a body part other than the face or neck, such as an arm, a leg, the back, or any other part of the body. Such variations and other variations are considered to be within the scope of the present disclosure.

[0117] Accordingly, the above are systems, devices, and modes of operation for electrically stimulating tissue. In some embodiments, any of the systems, devices, and operations disclosed herein can be used while a person is asleep or awake. The components of the system and device can include various materials and can have various durabilities. In some embodiments, the system and device can include one or more disposable components and one or more durable reusable components. In some embodiments, the disposable components can include, among others, electrodes, sensors, and / or wires for sensors. In some embodiments, the durable components can include, among others, electronic devices, sensors, stimulation circuits, Bluetooth and wireless communication circuits, and / or processing circuits. For example, the electrodes can be disposable, while the electronic device is durable and reusable. In some embodiments, the electrodes, electronic devices, and sensors can all be durable, and a removable adhesive sheet can be configured such that the electrodes are electrically conductive with the patient's skin. After use, the removable adhesive sheet can be removed and discarded. In some embodiments, the electrodes can be flexible such that they maintain electrical connection while being comfortable for the patient.

[0118] FIG. 21 is a block diagram of exemplary sensors and operations of the systems and devices disclosed herein. Any of the systems and devices disclosed herein may include various sensors for obtaining patient information, including, among other sensors, an electromyogram (EMG) sensor 2110, an electroencephalogram sensor 2120, a photoplethysmography sensor 2130a, an accelerometer 2130b, and / or a microphone (not shown). In some embodiments, a therapist or healthcare provider may have access to the information provided by the sensors. For example, the information provided by the sensors may be downloaded via a docking device such as the docking device of FIG. 10. In some embodiments, for systems and devices that include a wireless communication function, the information provided by the sensors may be wirelessly uploaded to a central system (not shown). A physician or healthcare provider may then access such information from the central system.

[0119] In some embodiments, the central system can be used to generate a compliance report using the information obtained from the sensors. The compliance report can be used to review treatment details, including actual use, effectiveness, sleep quality, and / or the number of apnea or hypopnea events. For example, the sleep state can be monitored, including parameters such as respiratory rate, blood oxygen level, pulse, and / or muscle tension, and the stimulation parameters can be adjusted accordingly (e.g., increased in intensity, modified according to the respiratory pattern).

[0120] Continuing to refer to FIG. 21, the operation at block 2140 includes operating the disclosed system or apparatus, which may include performing a power-on and startup routine and startup diagnostics. At block 2150, the operation includes generating a confirmation signal that the operation of the system was successful. The operation at block 2160 includes controlling the operation based on sensor data from sensors 2110 - 2130a / b, among other possible sensors (not shown), and may be performed by a controller (e.g., 110 of FIG. 1). At block 2170, the information from sensors 2110 - 2130a / b can be used to detect breathing. If the information from the sensors indicates that breathing has stopped or a predetermined criterion has been met, the operation at block 2180 can activate the electrodes to stimulate the activation zone and move the tongue to open the airway.

[0121] In some embodiments, the data from one or more EMG sensors 2110 can be used to confirm stimulation and provide additional patient information. For example, a signal corresponding to the stimulation signal can be detectable by the EMG sensor 2110 and used to confirm stimulation, electrode placement, or parameter selection in control operation 2160. In some embodiments, muscle tension can be used as an indicator of sleep stages such as N1, N2, N3, REM, and deep sleep. The information from the EMG sensor 2110 can be used to estimate the sleep stage in control operation 2160. This data can also be used to automatically adjust parameters such as the electrical output parameters of the electrical stimulator among other parameters in control operation 2160. In some embodiments, a peripheral arterial tone monitor can provide similar patient information. The EMG sensor 2110 may be part of a disposable component such as a patch including electrodes, or may be part of a durable reusable component.

[0122] In some embodiments, the data from the electroencephalogram 2120 can be used to determine sleep stages such as N1, N2, N3, REM, and deep sleep in the control operation 2160. These stages can correspond to various relaxation levels of the muscles, including the state of general paralysis during REM sleep. This information can be used in the control operation 2160 to change the level of stimulation based on the specific muscle tension at the current stage.

[0123] In some embodiments, the photoplethysmography sensor 2130a can provide information on the heart rate and blood oxygen level. The photoplethysmography sensor 2130a can also include a pulse oximeter or digital holography. The data from this sensor 2130a can also provide an estimate of the respiratory rate and can be used in the control operation 2160 to automatically adjust parameters to improve the function of the system and device.

[0124] In some embodiments, the accelerometer 2130b can also provide information on the respiratory rate, movement, and / or sleep posture. This data can further be used in the control operation 2160 to automatically adjust parameters such as the electrical output parameters of the electrical stimulator among other parameters.

[0125] The level of effort required to move the tongue varies depending on the sleep posture. For example, more effort is required when sleeping on the back. In some embodiments, the stimulation parameters can also be changed depending on the sleep posture. Furthermore, the movement of the jaw can be analyzed to determine apnea events. The data from the EMG 2110, photoplethysmography 2130a, and / or accelerometer 2130b sensors can provide a sleep score, provide information for a sleep study, and / or assist in creating a compliance report.

[0126] In some embodiments, a microphone can be used to detect snoring and breathing-related sounds to calculate the respiratory rate. A nasal cannula can also be used to measure air flow and changes in nasal pressure. This information can be used to calculate the respiratory rate and can indicate apnea events.

[0127] Control operation 2160 can be configured to adjust the stimulation current over time. For example, a lower current can be used during an adaptation period, and the current can be increased over several days or weeks thereafter. This can assist in using the disclosed systems and devices as transition devices. Additionally, the stimulation current can be modulated by control operation 2160 based on the sleep stage. During some sleep stages, particularly during REM sleep, muscle tension further decreases, so increasing the current may improve patient outcomes.

[0128] Referring now to FIG. 22, a flow diagram of an exemplary operation for stimulating the hypoglossal nerve is shown. The operations of FIG. 22 can be performed by any of the systems and devices disclosed herein. At block 2210, the operation includes passing a first AC current through a person's tissue between a first pair of electrodes. At block 2220, the operation includes passing a second AC current through the person's tissue between a second pair of electrodes. At block 2230, the operation includes stimulating the person's hypoglossal nerve with the first AC current and the second AC current, and stimulating the hypoglossal nerve causes the person's tongue to move.

[0129] Referring now to FIG. 23, a flow diagram of an exemplary operation for stimulating a neuron is shown. The operations of FIG. 23 can be performed by any of the systems and devices disclosed herein. At block 2310, the operation includes passing a first AC current through a person's tissue between a first pair of electrodes. At block 2320, the operation includes passing a second AC current through the person's tissue between a second pair of electrodes. At block 2330, the operation includes stimulating the person's neuron with the first AC current and the second AC current, and stimulating the neuron provides treatment for a disease.

[0130] According to aspects of the present disclosure, the systems and devices disclosed herein can be used in combination with a host of an external device (not shown). For example, the systems and devices can be communicatively connected to a telephone, a wristwatch, a remote control, and / or a tablet. The external device can store various patient data. For example, the data can be used to find the relationship between the application of electrical stimulation to a patient and the patient's respiratory response to such electrical stimulation, among other additional information. The relational data of multiple patients can be aggregated and then used to identify the trends or common elements of OSA across various demographic groups. The storage device can be a local storage device or a remote storage device (e.g., accessible via one or more means and / or networks including, but not limited to, wide area network (WAN), wireless local area network (WLAN), virtual private network (VPN), and the Internet). The data can be made available and operable locally or remotely and can be saved for immediate use and / or later utilization and / or for the device. In some embodiments, a vibration motor or a speaker can be used in conjunction with any of the systems and devices disclosed herein to provide feedback and warnings to the user or to be used as an alarm or notification.

[0131] In some embodiments, the electrical stimulators and sensors of the disclosed systems and devices can communicate with a mobile device or computer via a wired or wireless connection, and the mobile device or computer can collect and analyze data and control stimulation parameters based on the analyzed data. This computer can communicate with one or more central systems (e.g., cloud systems). These central systems can be connected to a company's computer or a physician's computer. A physician can provide inputs, control stimulation parameters, review sensor data, and generate compliance reports through these computers. In some embodiments, the mobile device or computer can receive patient feedback through an app (e.g., tapping to trigger an accelerometer) or through the patient pressing a button. For example, the feedback can include data indicating that the tongue has moved appropriately. In one embodiment, the sensor can also be used to confirm that the tongue or other tissue has moved.

[0132] In some embodiments, the systems and devices disclosed herein can include both user-worn components (e.g., 1310 of FIG. 13) and desktop components (e.g., 1010 of FIG. 10) that communicate with each other either wired or wirelessly. The desktop component may be battery-powered or may be connected to a wall outlet. The desktop component can supply power to a rechargeable battery incorporated in the user-worn component wirelessly or through a wired connection. In some embodiments, the desktop component can include processing hardware.

[0133] The systems, devices, and operations disclosed herein are contemplated to be used to stimulate various tissues and / or treat symptoms. For example, the flow of lymph can be modulated by nerve stimulation of lymph nodes. This treatment results in various effects including the isolation of infectious bacteria, the limitation of the colonization of malignant tumor cells, the increase in the production of antibodies against vaccines, and the increase in class switching to IgG antibodies such as during allergy desensitization. In one embodiment, lymph nodes and the nerves that innervate them, including the axillary and supraclavicular lymph nodes of the armpit and neck, the inguinal and popliteal lymph nodes of the legs, and nerves such as the sciatic nerve, can be the subject of electrical stimulation.

[0134] In some embodiments, the systems and devices disclosed herein can be used to target branches of the vagus nerve. Stimulation of the vagus nerve is known to be effective for various diseases and symptoms. For example, in relation to traumatic bleeding events or the risk thereof, stimulation of the vagus nerve or splenic nerve can be used as a treatment to reduce bleeding time, total blood loss, and the risk of postoperative bleeding. In some embodiments, the stimulation can be applied prophylactically (e.g., before surgery, or before activities with a risk of trauma such as participation in sports or the military, or during or after a traumatic event) to address bleeding. When used in relation to surgery, the stimulation can be applied for several days after surgery to further reduce the risk of postoperative bleeding. Further, stimulation of the vagus nerve is known to treat inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. In some embodiments, regular stimulation of the vagus nerve can be employed to treat these diseases. Stimulation of the vagus nerve can further be used to enhance sensory perception and treat migraine, epilepsy, or depression.

[0135] The systems and devices disclosed herein can stimulate a variety of other nerves. For example, pain can be alleviated by stimulating peripheral nerves and sensory spinal nerves. Incontinence and overactive bladder syndrome can be controlled by stimulating the sacral nerves that control the bladder. Similar to deep brain stimulators, regions of the brain can be stimulated to target the area where seizures originate or to prevent the spread of seizures. The phrenic nerve can be stimulated to control the contraction of the diaphragm, which improves muscle tone and enables weaning from a ventilator during the use of a ventilator. To control muscle contraction, motor nerves that drive muscle movement can be stimulated. For example, in some embodiments, various tissues of the extremities can be mapped and stimulated with a grid of various electric fields to control gross and fine motor movements of the arm, wrist, and hand.

[0136] According to aspects of the present disclosure, the systems and devices disclosed herein can be used to supply operating power to in vivo devices such as in vivo batteries or implantable devices. As shown in FIG. 24, electrode pairs can be controlled to provide an electrical output to a human and to a battery or device 2430 within the human body. A particular electrical output 2410 targets one terminal 2420 of the battery or device 2430, and another electrical output 2415 targets another terminal 2425 of the battery or device 2430, thereby generating a differential current between points 2420 and 2425. Periodic signals f1 and f2 2410 from electrodes E1 and E2 can create a potential under the surface S of the battery terminal T2 120. Similarly, periodic signals f1' and f2' 2415 from electrodes E1' and E2' can create a potential under the surface S' of the battery terminal T' 2425. The potentials at T 2420 and T' 2425 can be controlled so that the battery or device 2430 enters a charged state. Such charging can also supply power to the implantable stimulator 2430 or charge the battery for the stimulator or other implantable device 2430.

[0137] Certain aspects of the present disclosure may include some, all, or none of the above advantages, and / or one or more other advantages that will be readily apparent to those skilled in the art from the drawings, description, and claims contained herein. Further, although specific advantages are listed above, various aspects of the present disclosure may include all, some, or none of the enumerated advantages and / or other advantages not specifically listed above.

[0138] The aspects disclosed herein are examples of the present disclosure and may be embodied in various forms. For example, although specific aspects are described herein as separate aspects, each aspect herein may be combined with one or more of the other aspects herein. The specific details of the structures and functions disclosed herein should not be construed as limiting, but rather as a basis for the claims and as a representative basis for teaching those skilled in the art how to make various uses of the present disclosure with virtually any appropriately detailed structure. Like reference numerals may refer to like or identical elements throughout the description of the drawings.

[0139] The phrases "in one aspect," "in some aspects," "in various aspects," "in some embodiments," or "in other embodiments" may each refer to one or more of the same or different aspects of the present disclosure. The phrase in the form of "A or B" means "(A), (B), or (A and B)". The phrase in the form of "at least one of A, B, or C" means "(A), (B), (C), (A and B), (A and C), (B and C), or (A, B, and C)".

[0140] Any method, program, algorithm, or code described herein can be converted to or expressed in a programming language or computer program. As used herein, the terms "programming language" and "computer program" each include any language used to specify instructions to a computer, including the following languages and their derivatives: assembler, Basic, batch file, BCPL, C, C+, C++, Delphi, Fortran, Java, JavaScript, machine code, operating system command language, Pascal, Perl, PL1, script language, Visual Basic, a meta-language that itself specifies a program, and all generations of computer languages of the first, second, third, fourth, fifth, or later generations (including, but not limited to, these). Also included are databases and other data schemas, and any other meta-language. There is no distinction between languages that use an interpreted, compiled, or both compiled and interpreted approach. There is no distinction between the compiled and source versions of a program. Thus, references to a program that can exist in more than one programming language state (such as source, compiled, object, or linked) are references to any and all such states. References to a program can include the actual instructions and / or the intent of those instructions.

[0141] It should be understood that the above description is only illustrative of the present disclosure. Those skilled in the art will be able to devise various alternatives and modifications without departing from the present disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications, and variations. The aspects described with reference to the drawings are presented only to illustrate specific examples of the present disclosure. It is intended that other aspects, elements, steps, methods, and techniques that are substantially different from those described above and / or recited in the appended claims are also within the scope of the present disclosure.

Claims

1. An apparatus for electrically stimulating tissue, a first pair of electrodes configured to contact a human and pass a first AC current through the human tissue between the pair of electrodes, a second pair of electrodes configured to contact a human and pass a second AC current through the human tissue between the pair of electrodes, comprising, wherein the first pair of electrodes and the second pair of electrodes are configured to be disposed on the human body such that the first AC current and the second AC current flow through the human target tissue simultaneously, and the first AC current and the second AC current are configured to stimulate the target tissue, Apparatus.

2. The apparatus according to claim 1, wherein the first AC current has a first frequency, the second AC current has a second frequency, and both the first frequency and the second frequency are higher than 1000 Hz.

3. The apparatus according to claim 2, wherein the current flowing through the target tissue has a frequency different from both the first frequency and the second frequency.

4. The apparatus according to claim 3, wherein the current flowing through the target tissue has a frequency corresponding to the frequency difference between the first frequency and the second frequency.

5. The apparatus according to claim 4, wherein the frequency difference is less than 200 Hz.

6. The apparatus according to claim 1, wherein the first pair of electrodes and the second pair of electrodes are one of an interleaved configuration, a nested configuration, or a nearest neighbor configuration.

7. a first battery configured to supply power to the first pair of electrodes, a second battery configured to supply power to the second pair of electrodes, further comprising, the first battery does not supply power to the second pair of electrodes, the second battery does not supply power to the first pair of electrodes, The apparatus according to claim 1.

8. The apparatus according to claim 1, further comprising a controller configured to set parameters of the first AC current and the second AC current, the parameters including the first frequency of the first AC current and the second frequency of the second AC current.

9. The controller, sets the first frequency and the second frequency to a fundamental frequency value, in response to a determination that an event has occurred, within a first time after the event, sets the first frequency to a different frequency value different from the fundamental frequency value, maintains the first frequency at the different frequency value and the second frequency at the fundamental frequency value for a second time after the first time, Within a third time period after the second time period, return the first frequency to the fundamental frequency value, The apparatus according to claim 8, configured to set parameters of the first AC current and the second AC current thereby.

10. Further comprising a first electrode array and a second electrode array, The first electrode array includes a first pair of electrodes, The second electrode array includes a second pair of electrodes, The apparatus according to claim 8.

11. The controller further, Determines a subset of the first electrode array and a subset of the second electrode array that stimulate the target tissue during operation, Without activating all the electrodes of the first electrode array, activates a subset of the first electrode array including the first pair of electrodes, Without activating all the electrodes of the second electrode array, activates a subset of the second electrode array including the second pair of electrodes, The apparatus according to claim 10, configured as such.

12. Further comprising an electromyogram (EMG) sensor configured to provide sensor data, The controller is further configured to determine at least one of muscle tension or tissue stimulation confirmation based on the EMG sensor data, The controller sets parameters of the first AC current and the second AC current based on at least one of the muscle tension or tissue stimulation confirmation, the apparatus according to claim 8.

13. Further comprising an electroencephalogram (EEG) sensor configured to provide sensor data, The controller is further configured to determine a person's sleep state based on the EEG sensor data, The controller sets parameters of the first AC current and the second AC current based on the person's sleep state, The apparatus according to claim 8.

14. Further comprising a photoplethysmography (PPG) sensor configured to provide sensor data, The controller is further configured to determine a person's respiratory rate based on the PPG sensor data, The controller sets parameters of the first AC current and the second AC current based on the respiratory rate, The apparatus according to claim 8.

15. Further comprising a housing, The controller is disposed inside the housing, The first pair of electrodes and the second pair of electrodes are disposed on the surface of the housing, The apparatus according to claim 8.

16. further comprising at least one patch configured to adhere to human skin, said at least one patch comprising a first pair of electrodes and a second pair of electrodes, at least one battery, and at least one electrical connection configured to electrically couple said at least one battery to said at least one patch, The apparatus according to claim 1.

17. Tissue within at least a portion of the path of said first AC current is not stimulated by said first AC current, Tissue within at least a portion of the path of said second AC current is not stimulated by said first AC current, The apparatus according to claim 1.

18. a third pair of electrodes configured to contact a human and pass a third AC current through human tissue between its pairs of electrodes; a fourth pair of electrodes configured to contact a human and pass a fourth AC current through human tissue between its pairs of electrodes; further comprising, wherein said first pair of electrodes, said second pair of electrodes, said third pair of electrodes, and said fourth pair of electrodes are configured to be arranged on the human body such that said first AC current, second AC current, third AC current, and fourth AC current flow through human target tissue simultaneously and stimulate the target tissue. The apparatus according to claim 1.

19. Tissue within at least a portion of the path of said third AC current is not stimulated by said third AC current, Tissue within at least a portion of the path of said fourth AC current is not stimulated by said fourth AC current, The apparatus according to claim 18.

20. The apparatus according to claim 1, wherein said target tissue includes the human hypoglossal nerve.

21. A method for electrically stimulating tissue by a first pair of electrodes contacting a human and a second pair of electrodes contacting a human, comprising: simultaneously, passing a first AC current through human tissue between said first pair of electrodes; passing a second AC current through human tissue between said second pair of electrodes; including wherein said first AC current and second AC current flow through human target tissue simultaneously based on the arrangement of said first pair of electrodes and second pair of electrodes on the human body, and said first AC current and second AC current are configured to stimulate the target tissue. A method.

22. The method according to claim 21, wherein said first AC current has a first frequency and said second AC current has a second frequency, and both said first frequency and said second frequency are higher than 1000 Hz.

23. The method according to claim 22, wherein the current flowing through the target tissue has a frequency different from both the first frequency and the second frequency. **Claim 24** The method according to claim 23, wherein the current flowing through the target tissue has a frequency corresponding to the frequency difference between the first frequency and the second frequency. **Claim 25** The method according to claim 24, wherein the frequency difference is less than 200 Hz. **Claim 26** The method according to claim 21, further comprising setting parameters of a first AC current and a second AC current, the parameters including a first frequency of the first AC current and a second frequency of the second AC current. **Claim 27** Setting the parameters of the first AC current and the second AC current includes setting the first frequency and the second frequency to basic frequency values, in response to a determination that an event has occurred, setting the first frequency to a different frequency value different from the basic frequency value within a first time after the event, maintaining the first frequency at the different frequency value and the second frequency at the basic frequency value over a second time after the first time, and returning the first frequency to the basic frequency value within a third time after the second time. The method according to claim 26. **Claim 28** The method according to claim 26, wherein the first electrode pair is in a first electrode array and the second electrode pair is in a second electrode array. **Claim 29** determining a subset of a first electrode array and a subset of a second electrode array that stimulate the target tissue during operation, activating a subset of the first electrode array including the first electrode pair without activating all electrodes of the first electrode array, activating a subset of the second electrode array including the second electrode pair without activating all electrodes of the second electrode array. The method according to claim 28, further comprising. **Claim 30** Setting the parameters of the first AC current and the second AC current includes determining at least one of muscle tension or tissue stimulation confirmation based on sensor data from an electromyogram (EMG) sensor, and setting the parameters of the first AC current and the second AC current based on at least one of the muscle tension or tissue stimulation confirmation. The method according to claim 26. **Claim 31** Setting the parameters of the first AC current and the second AC current Determining a person's sleep state based on sensor data from an electroencephalogram (EEG) sensor, Setting parameters of a first AC current and a second AC current based on the sleep state of the person, The method according to claim 26, comprising:

32. Setting the parameters of the first AC current and the second AC current comprises: Determining a person's respiratory rate based on sensor data from a photoplethysmography (PPG) sensor, Setting parameters of the first AC current and the second AC current based on the respiratory rate, The method according to claim 26, comprising:

33. Tissue within at least a portion of the path of the first AC current is not stimulated by the first AC current, Tissue within at least a portion of the path of the second AC current is not stimulated by the first AC current, the method according to claim 21.

34. Simultaneously, Passing a third AC current through a person's tissue between a third pair of electrodes, Passing a fourth AC current through a person's tissue between a fourth pair of electrodes, The method according to claim 21, further comprising: the first AC current, the second AC current, the third AC current, and the fourth AC current flow simultaneously to a target tissue based on the arrangement of the third pair of electrodes and the fourth pair of electrodes on the human body.

35. Tissue within at least a portion of the path of the third AC current is not stimulated by the third AC current, Tissue within at least a portion of the path of the fourth AC current is not stimulated by the fourth AC current, the method according to claim 34.

36. The target tissue includes a person's hypoglossal nerve, the method according to claim 21.

37. An apparatus for electrically stimulating tissue, comprising: A housing configured to be attached to a person's tissue, A first battery and a second battery disposed within the housing, A first pair of electrodes electrically coupled to the first battery, A second pair of electrodes electrically coupled to the second battery, An attachment mechanism configured to attach the housing or at least one of the first and second pairs of electrodes to a person's tissue such that the first and second pairs of electrodes contact the person's tissue, Comprising: The first battery does not supply power to the second pair of electrodes, The second battery does not supply power to the first pair of electrodes, Apparatus.

38. The first pair of electrodes and the second pair of electrodes are disposed on a surface of the housing, the apparatus according to claim 37.

39. further comprising at least one patch configured to adhere to human skin, wherein the at least one patch a first pair of electrodes and a second pair of electrodes; at least one electrical connection configured to couple a first battery and a second battery to the at least one patch; The device according to claim 37, comprising.

40. The at least one patch includes a first patch and a second patch, The first patch includes a first pair of electrodes, The second patch includes a second pair of electrodes, The device according to claim 39.

41. The at least one patch a first patch comprising a first electrode of the first pair of electrodes; a second patch comprising a second electrode of the first pair of electrodes; a third patch comprising a first electrode of the second pair of electrodes; a fourth patch comprising a second electrode of the second pair of electrodes; The device according to claim 39, comprising.

42. The housing is disposed within a human oral cavity and configured to be removable from the oral cavity. The device according to claim 37.

43. The housing has a shape along the gum line of a human oral cavity. The device according to claim 42.

44. The housing is configured to be attached to the skin under a human mandible. The device according to claim 37.

45. The housing has a shape along the jaw line of a human. The device according to claim 44.

46. further comprising a charging pin disposed on a surface of the housing, the charging pin being electrically coupled to the first battery and the second battery, The charging pin is configured to transmit power for recharging the first battery and the second battery. The device according to claim 37.

47. further comprising a wireless communication device disposed within the housing, the wireless communication device being configured to provide a wireless communication function for communicating with a central system. The device according to claim 37.

48. further comprising a controller disposed within the housing, the wireless communication device being configured to communicate a firmware update to the controller, the firmware update being provided by a central system. The device according to claim 47.

49. The apparatus according to claim 47, further comprising at least one sensor configured to provide sensor data, wherein the wireless communication device is configured to communicate the sensor data for delivery to a central system.

50. A method for electrically stimulating the hypoglossal nerve, comprising: passing a first AC current through human tissue between a first pair of electrodes; passing a second AC current through human tissue between a second pair of electrodes; stimulating the human hypoglossal nerve with the first AC current and the second AC current; wherein stimulating the hypoglossal nerve causes the human tongue to move. Method.

51. The method according to claim 50, wherein the first AC current has a first frequency, the second AC current has a second frequency, and both the first frequency and the second frequency are higher than 1000 Hz.

52. The method according to claim 51, wherein the current flowing through the hypoglossal nerve has a frequency different from both the first frequency and the second frequency.

53. The method according to claim 52, wherein the current flowing through the hypoglossal nerve has a frequency corresponding to the frequency difference between the first frequency and the second frequency.

54. The method according to claim 53, wherein the frequency difference is less than 200 Hz.

55. A method for electrically stimulating neurons to treat a disease, comprising: passing a first AC current through human tissue between a first pair of electrodes; passing a second AC current through human tissue between a second pair of electrodes; stimulating the human neurons with the first AC current and the second AC current; wherein stimulating the neurons provides treatment of the disease.

56. The method according to claim 55, wherein the first AC current has a first frequency and the second AC current has a second frequency.

57. The method according to claim 56, wherein the current flowing through the neurons has a frequency different from both the first frequency and the second frequency.

58. The method according to claim 57, wherein the current flowing through the neurons has a frequency corresponding to the frequency difference between the first frequency and the second frequency.

59. The method according to claim 55, wherein the disease includes at least one of an inflammatory disease, lymphatic stasis, and incontinence.

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