Treatment of tissue using electrical stimulation

Abstract

A 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 conduct a first AC current between the first pair of electrodes through tissue of the person. The second pair of electrodes is configured to contact the person and conduct a second AC current between the second pair of electrodes through tissue of the person. The first pair of electrodes and the second pair of electrodes are configured to be positioned such that the first AC current and the second AC current are conducted simultaneously through target tissue of a person. The first AC current and the second AC current are configured to stimulate target tissue.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to 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 No. EP21306447.0, filed on July 15, 2021. The entire contents of each of the foregoing applications are hereby incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to electrical stimulation of tissue, and more particularly to treating disease by electrical stimulation. Background Art

[0004] Conditions associated with the airway reduce airway volume, restrict airflow, and prevent adequate breathing. These conditions may occur in diseases such as obstructive sleep apnea (OSA), but may also occur in other situations, such as when the patient is sedated. Due to partial obstruction of the tongue, airflow through the patient's airway may be reduced. OSA may manifest as repeated collapse of the airway due to relaxation of the upper airway dilator muscles during sleep. In patients with OSA, their tongue muscles lose tension and relax, causing the tongue to slide back in the mouth and narrow the pharynx. OSA causes upper airway obstruction, loss of respiratory control, and loss of oxygenation and gas exchange, which may lead to intermittent hypoxia. Existing treatments for OSA focus on opening the airway and increasing airflow, or require surgical implants. Continuous positive airway pressure (CPAP) is a therapy that forces airflow through a mask while the patient is sleeping. CPAP and surgical implants are invasive and uncomfortable treatments, and there are many places to improve. OSA is just an example of many diseases, and there is a lot of room for improvement in the treatment of these diseases. Summary of the invention

[0005] The present disclosure relates to the use of electrical current to stimulate tissue.

[0006] According to various aspects of the present disclosure, a device for electrically stimulating tissue includes: a first pair of electrodes configured to contact a person and conduct a first AC current between the first pair of electrodes through the person's tissue; and a second pair of electrodes configured to contact the person and conduct a second AC current between the second pair of electrodes through the person's tissue. The first pair of electrodes and the second pair of electrodes are configured to be positioned on the person so that the first AC current and the second AC current are simultaneously conducted through the person's target tissue. The first AC current and the second AC current are configured to stimulate the target tissue.

[0007] In an embodiment of the device, the first AC current has a first frequency and the second AC current has a second frequency, and the first frequency and the second frequency are both greater than 1000 Hz.

[0008] In an embodiment of the device, the current conducted through the target tissue has a frequency that is different from the first frequency and different from the second frequency.

[0009] In an embodiment of the device, the current conducted through the target tissue has a frequency equal to the frequency difference between the first frequency and the second frequency. In an embodiment of the device, the frequency difference is less than 200 Hz.

[0010] In an embodiment of the device, the first pair of electrodes and the second pair of electrodes are in one of a staggered configuration, a nested configuration, or a nearest neighbor configuration.

[0011] In an embodiment of the device, the device comprises: 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.

[0012] In an embodiment of the device, the device comprises a controller configured to set parameters of the first AC current and the second AC current. The parameters comprise a first frequency of the first AC current and a second frequency of the second AC current.

[0013] In an embodiment of the device, the controller is configured to set parameters of the first AC current and the second AC current in the following manner: setting the first frequency and the second frequency to a base frequency value; in response to determining that an event has occurred, setting the first frequency to a different frequency value that is different from the base frequency value within a first time period after the event; maintaining the first frequency at the different frequency value and maintaining the second frequency at the base frequency value within a second time period after the first time period; and restoring the first frequency to the base frequency value within a third time period after the second time period.

[0014] In an embodiment of the device, the device comprises a first electrode array and a second electrode array. The first electrode array comprises a first pair of electrodes and the second electrode array comprises a second pair of electrodes.

[0015] In an embodiment of the device, the controller is also configured to: determine a subset of the first electrode array and a subset of the second electrode array, which subset causes stimulation to the target tissue when activated; activate the subset of the first electrode array without activating all electrodes of the first electrode array, wherein the subset of the first electrode array includes the first pair of electrodes; and activate the subset of the second electrode array without activating all electrodes of the second electrode array, wherein the subset of the second electrode array includes the second pair of electrodes.

[0016] In an embodiment of the device, the device includes an electromyography (EMG) sensor configured to provide sensor data. The controller is further configured to determine at least one of muscle tone 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 the confirmation of muscle tone or tissue stimulation.

[0017] 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 sleep state of the person based on the EEG sensor data. The controller sets parameters of the first AC current and the second AC current based on the sleep state of the person.

[0018] 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 respiration rate based on the PPG sensor data. The controller sets parameters of the first AC current and the second AC current based on the respiration rate.

[0019] In an embodiment of the device, the device comprises a housing, the controller is located within an interior of the housing, and the first pair of electrodes and the second pair of electrodes are located at a surface of the housing.

[0020] In an embodiment of the device, the device includes at least one patch configured to adhere to human skin, wherein the at least one patch includes 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 the at least one battery to the at least one patch.

[0021] In an embodiment of the device, tissue in at least a portion of the path of the first AC current is not stimulated by the first AC current, and tissue in at least a portion of the path of the second AC current is not stimulated by the first AC current.

[0022] In an embodiment of the device, the device comprises: a third pair of electrodes configured to contact a person and conduct a third AC current between the third pair of electrodes and through tissue of the person; and a fourth pair of electrodes configured to contact a person and conduct a fourth AC current between the fourth pair of electrodes and through tissue of the person. The first pair of electrodes, the second pair of electrodes, the third pair of electrodes and the fourth pair of electrodes are configured to be positioned on the person so that the first AC current, the second AC current, the third AC current and the fourth AC current are simultaneously conducted through target tissue of the person and stimulate the target tissue.

[0023] In an embodiment of the device, tissue in at least a portion of the path of the third AC current is not stimulated by the third AC current, and tissue in at least a portion of the path of the fourth AC current is not stimulated by the fourth AC current.

[0024] In an embodiment of the device, the target tissue comprises a human's hypoglossal nerve.

[0025] According to various aspects of the present disclosure, a method for electrically stimulating tissue by a first pair of electrodes in contact with a person and a second pair of electrodes in contact with the person is disclosed. The method includes, simultaneously: conducting a first AC current between the first pair of electrodes and through the tissue of the person, and conducting a second AC current between the second pair of electrodes and through the tissue of the person. Based on the positioning of the first pair of electrodes and the second pair of electrodes on the person, the first AC current and the second AC current are simultaneously conducted through the target tissue of the person. The first AC current and the second AC current are configured to stimulate the target tissue.

[0026] In an embodiment of the method, the first AC current has a first frequency and the second AC current has a second frequency, and the first frequency and the second frequency are both greater than 1000 Hz.

[0027] In an embodiment of the method, the current conducted through the target tissue has a frequency that is different from the first frequency and different from the second frequency.

[0028] In an embodiment of the method, the current conducted through the target tissue has a frequency equal 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.

[0029] In an embodiment of the method, the method comprises setting parameters of the first AC current and the second AC current. The parameters comprise a first frequency of the first AC current and a second frequency of the second AC current.

[0030] In an embodiment of the method, setting parameters of the first AC current and the second AC current includes: setting the first frequency and the second frequency to a base frequency value; in response to determining that an event has occurred, setting the first frequency to a different frequency value different from the base frequency value within a first time period after the event; maintaining the first frequency at the different frequency value and maintaining the second frequency at the base frequency value within a second time period after the first time period; and restoring the first frequency to the base frequency value within a third time period after the second time period.

[0031] In an embodiment of the method, the first pair of electrodes is in a first electrode array and the second pair of electrodes is in a second electrode array.

[0032] In an embodiment of the method, the method includes: determining a subset of a first electrode array and a subset of a second electrode array, which subset causes stimulation to a target tissue when activated; activating the subset of the first electrode array without activating all electrodes of the first electrode array, wherein the subset of the first electrode array includes a first pair of electrodes; and activating the subset of the second electrode array without activating all electrodes of the second electrode array, wherein the subset of the second electrode array includes a second pair of electrodes.

[0033] In an embodiment of the method, setting parameters of the first AC current and the second AC current includes: determining at least one of confirmation of muscle tone or tissue stimulation based on sensor data from an electromyography (EMG) sensor; and setting parameters of the first AC current and the second AC current based on at least one of confirmation of muscle tone or tissue stimulation.

[0034] In an embodiment of the method, setting parameters of the first AC current and the second AC current comprises: determining a sleep state of the person based on sensor data from an electroencephalogram (EEG) sensor; and setting parameters of the first AC current and the second AC current based on the sleep state of the person.

[0035] In an embodiment of the method, setting parameters of the first AC current and the second AC current comprises: determining a breathing rate of the person based on sensor data from a photoplethysmography (PPG) sensor; and setting parameters of the first AC current and the second AC current based on the breathing rate.

[0036] In an embodiment of the method, tissue in at least a portion of the path of the first AC current is not stimulated by the first AC current, and tissue in at least a portion of the path of the second AC current is not stimulated by the first AC current.

[0037] In an embodiment of the method, the method includes, simultaneously: conducting a third AC current between a third pair of electrodes and through tissue of the person, and conducting a fourth AC current between a fourth pair of electrodes and through tissue of the person. Based on the positioning of the third pair of electrodes and the fourth pair of electrodes on the person, the first AC current, the second AC current, the third AC current, and the fourth AC current are simultaneously conducted through the target tissue.

[0038] In an embodiment of the method, tissue in at least a portion of the path of the third AC current is not stimulated by the third AC current, and tissue in at least a portion of the path of the fourth AC current is not stimulated by the fourth AC current.

[0039] In an embodiment of the method, the target tissue comprises a human's hypoglossal nerve.

[0040] According to various aspects of the present disclosure, a device for electrically stimulating tissue includes: a housing configured to be attached to human tissue; a first battery and a second battery, the first battery and the second battery being located within the housing; a first pair of electrodes, the first pair of electrodes being electrically coupled to the first battery; a second pair of electrodes, the second pair of electrodes being electrically coupled to the second battery; and an attachment mechanism configured to attach the housing or at least one of the first pair of electrodes and the second pair of electrodes to human tissue so that the first pair of electrodes and the second pair of electrodes contact the human tissue. 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.

[0041] In an embodiment of the device, the first pair of electrodes and the second pair of electrodes are located at a surface of the housing.

[0042] In an embodiment of the device, the device includes: at least one patch, the at least one patch is configured to adhere to the skin of a person, wherein the at least one patch includes a first pair of electrodes and a second pair of electrodes; and at least one electrical connection, the at least one electrical connection is configured to couple the first battery and the second battery to the at least one patch.

[0043] In an embodiment of the device, the at least one patch comprises a first patch and a second patch. The first patch comprises a first pair of electrodes and the second patch comprises a second pair of electrodes.

[0044] In an embodiment of the device, at least one patch includes: a first patch, which includes a first electrode of a first pair of electrodes; a second patch, which includes a second electrode of the first pair of electrodes; a third patch, which includes a first electrode of the second pair of electrodes; and a fourth patch, which includes a second electrode of the second pair of electrodes.

[0045] In an embodiment of the device, the housing is configured to be placed in a person's oral cavity and to be removable from the oral cavity.In an embodiment of the device, the housing has a shape that tracks the gum line of a person's oral cavity.

[0046] In an embodiment of the device, the housing is configured to be attached to the skin of the person below the person's jaw.In an embodiment of the device, the housing has a shape that traces the person's jawline.

[0047] In an embodiment of the device, the device includes a charging pin located at a surface of the housing. The charging pin is electrically coupled to the first battery and the second battery. The charging pin is configured to conduct power to recharge the first battery and the second battery.

[0048] In an embodiment of the apparatus, the apparatus comprises a wireless communication device located within the housing, wherein the wireless communication device is configured to provide wireless communication capabilities to communicate with a central system.

[0049] In an embodiment of the device, the device comprises a controller located within the housing. The wireless communication device is configured to transmit a firmware update to the controller. The firmware update is provided by the central system.

[0050] In an embodiment of the device, the device comprises at least one sensor configured to provide sensor data. The wireless communication means is configured to transmit the sensor data for communication to the central system.

[0051] According to various embodiments of the present disclosure, a method for electrically stimulating the hypoglossal nerve includes: conducting a first AC current between a first pair of electrodes and through human tissue; conducting a second AC current between a second pair of electrodes and through human tissue; and stimulating the human hypoglossal nerve with the first AC current and the second AC current, wherein stimulation of the hypoglossal nerve causes movement of the human tongue.

[0052] In an embodiment of the method, the first AC current has a first frequency and the second AC current has a second frequency. The first frequency and the second frequency are both greater than 1000 Hz.

[0053] In an embodiment of the method, the current conducted through the hypoglossal nerve has a frequency that is different from the first frequency and different from the second frequency.

[0054] In an embodiment of the method, the current conducted through the hypoglossal nerve has a frequency equal 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.

[0055] According to various aspects of the present disclosure, a method for electrically stimulating neurons to treat a disease includes: conducting a first current between a first pair of electrodes and through human tissue; conducting a second current between a second pair of electrodes and through human tissue; and stimulating human neurons with the first current and the second current, wherein stimulating the neurons provides treatment for the disease.

[0056] In an embodiment of the method, the first AC current has a first frequency and the second AC current has a second frequency.

[0057] In an embodiment of the method, the current conducted through the neuron has a frequency that is different from the first frequency and different from the second frequency.

[0058] In an embodiment of the method, the current conducted through the neuron has a frequency equal to the frequency difference between the first frequency and the second frequency.

[0059] In an embodiment of the method, the disease comprises at least one of an inflammatory disease, restricted lymphatic flow, and incontinence.

[0060] Other details and exemplary schemes of the present disclosure are described in more detail below with reference to the accompanying drawings. Without departing from the scope of the present disclosure, any scheme of the present disclosure can be combined with other schemes. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] A better understanding of the features and advantages of the disclosed technology will be obtained by referring to the following detailed description which sets forth illustrative embodiments in which the principles of the technology are utilized, and in which:

[0062] Figure 1 is a block diagram of exemplary components of a system for electrically stimulating tissue according to various aspects of the present disclosure;

[0063] Figure 2 is a graph of exemplary electrical outputs of two electrical stimulators according to various aspects of the present disclosure;

[0064] Figure 3 is another graph of exemplary electrical outputs of two electrical stimulators according to various aspects of the present disclosure;

[0065] Figure 4 is a graph of exemplary electrical output frequencies of two electrical stimulators according to various aspects of the present disclosure;

[0066] Figure 5 is a diagram of an exemplary electrode configuration according to various aspects of the present disclosure;

[0067] Figure 6 is a diagram of an exemplary electrode array configuration according to various aspects of the present disclosure;

[0068] Figure 7 is a diagram of exemplary operations for controlling electrical output of an electrode according to various aspects of the present disclosure;

[0069] Figure 8 is a diagram of an exemplary curved housing with electrodes according to various aspects of the present disclosure;

[0070] Fig. 9 According to the various schemes of the present disclosure Figure 8 FIG. 1 is a diagram of exemplary charging pins on a curved housing;

[0071] Fig.10 is a diagram of an exemplary docking device according to various aspects of the present disclosure;

[0072] Fig.11 is a diagram of exemplary components of an apparatus according to various aspects of the present disclosure;

[0073] Fig.12 is a diagram of the tongue and associated tissues;

[0074] Fig.13is a diagram of an exemplary device placed beneath a person's jaw according to various aspects of the present disclosure;

[0075] Fig.14 and Fig.15 is a diagram of an exemplary device placed inside an oral cavity according to various aspects of the present disclosure;

[0076] Fig.16 is a diagram of tongue motion according to various aspects of the present disclosure;

[0077] Fig.17 is a diagram of an exemplary patch placed on a person according to various aspects of the present disclosure;

[0078] Fig.18 is a diagram of another exemplary patch placed under a person's chin in accordance with various aspects of the present disclosure;

[0079] Fig.19 is a diagram of exemplary placement of electrodes on a person according to various aspects of the present disclosure;

[0080] Fig. 20 is a diagram of another exemplary placement of electrodes on a person according to various aspects of the present disclosure;

[0081] Fig.21 is a block diagram of operations for electrically stimulating tissue according to various aspects of the present disclosure;

[0082] Fig. 22 is a flow chart of exemplary operations for electrically stimulating the hypoglossal nerve according to various aspects of the present disclosure;

[0083] Fig.23 is a flow chart of exemplary operations for electrically stimulating neurons according to various aspects of the present disclosure; and

[0084] Fig.24 is a diagram of example operations for providing power according to various aspects of the present disclosure. DETAILED DESCRIPTION

[0085] The present disclosure relates to using electric current to stimulate tissue. The various schemes of the present disclosure use electrical stimulation to treat diseases (such as obstructive sleep apnea and other diseases) in a non-invasive manner that does not involve surgery or surgical implants. As described below, the current is conducted through the tissue between the electrodes, and the multiple currents from the multiple electrodes are electrically and spatially configured to stimulate the target tissue or provide treatment to the target tissue. As used herein, the tissue is "stimulated" when the current flowing through the tissue causes muscle movement (such as muscle contraction) and / or causes nerve depolarization. When the current flowing through the tissue does not cause any muscle movement or nerve depolarization, the tissue will not be stimulated. For example, when the target tissue includes motor neurons, electrical stimulation of the motor neurons can cause the associated muscle fibers to react in a desired manner, and thereby achieve treatment of the disease.

[0086] As used herein, the term "exemplary" is intended to mean "example" and is not intended to mean "preferred". Unless otherwise indicated, the terms "device" and "system" may be used interchangeably, and each term is not intended to mean or imply any particular configuration. For example, the devices or systems disclosed herein may be implemented in a variety of configurations, such as in a single housing or in more than one housing.

[0087] In the following detailed description, specific details are set forth to provide an understanding of each scheme of the present disclosure and to provide various examples. It will be appreciated by those skilled in the art that each scheme of the present disclosure can be implemented without using the exact details described herein, and can be implemented in a manner not specifically described herein. In various cases, well-known methods, procedures and / or parts are not described in detail to avoid blurring the present disclosure. Unless otherwise indicated by the context, any one or all of the schemes, embodiments and examples described in detail herein can be used in combination with any one or all of the other aspects or embodiments described in detail herein.

[0088] Figure 1 A block diagram of exemplary components of a system or device for electrically stimulating tissue is shown. For convenience, the term "system" will be used to describe Figure 1 , however, it is intended that any description using the term "system" should be considered as if the same description also used the term "device". Figure 1In the illustrated embodiment of the present invention, 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 that generate electrical stimulation. The controller 110 may be or include any computing device, including 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), as well as other computing devices. The controller 110 is powered by a battery 130, which may 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 may be analog I / O connections or digital I / O connections. The illustrated sensors include a photoplethysmography (PPG) sensor 120 and an acceleration / gyro sensor 122. However, the illustrated sensors are merely examples, and the sensors connected to the controller 110 may include any type and any number of sensors supported by the controller 110.

[0089] The controller 110 includes an I / O connection to the electrical stimulators 140-170. The I / O connection can be an analog I / O connection or a digital I / O connection. In the illustrated embodiment, each electrical stimulator 140-170 includes a battery, a frequency generator, and an amplifier. In an embodiment, the frequency generator of each stimulator 140-170 can be a voltage-controlled oscillator controlled by the analog I / O connection of the controller 110. The amplifier of each electrical stimulator 140-170 can be any type of amplifier that will be recognized by 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 ways, and such electrodes and arrangements will be described later in this article.

[0090] According to various aspects of the present disclosure, the controller 110 can independently direct 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 direct each of the electrical stimulation blocks 140-170 to provide a desired frequency or a desired frequency range (such as Figure 1 The electrical output of each electrical stimulator 140-170 can be more precisely controlled by the controller 110 because each electrical stimulator 140-170 has a dedicated battery. The effect of the electrical stimulators 140-170 can depend on the properties of their electrical output (e.g., frequency) and / or the physical location where their electrodes are placed on the person. Examples of such electrical properties and physical locations are described below.

[0091] According to aspects of the present disclosure, controller 110 may control electrical stimulators 140-170 in various ways based on the output of sensors 120, 122. For example, controller 110 may direct one or more electrical stimulators 140-170 to provide electrical outputs based on the output of one or both of sensors 120, 122.

[0092] Figure 1 The system illustrated in is exemplary, and variations are contemplated within the scope of the present disclosure. In an embodiment, the number of electrical stimulators may be more than four or less than four. In an embodiment, the stimulation of the tissue may be continuous and constant, or turned on and off periodically. When turned on and off, the stimulation may be regular, random, variable, or event-based. Various events may be configured to trigger activation of the stimulation, including respiratory events, apnea events, and / or user-defined events (such as the passage of time). In an embodiment, the primary trigger may be a respiratory event. A respiratory event may be the detection of a breath, or may be defined by an algorithm. Algorithmic events may include various variables, such as oxygenation levels, breathing rate, and fatigue caused by overuse of muscles. In an embodiment, sensors may be configured to detect respiratory events, including chest-based accelerometers, sound level meters, electrical activity sensors, and pressure sensors.

[0093] For example, in an embodiment, a chest-based accelerometer can measure the movement of the body. In an embodiment, a sound level meter can detect breathing sounds. In an embodiment, a recording of the electrical activity of the phrenic nerve that controls the diaphragm during breathing can be analyzed to detect breathing. In an embodiment, a pressure sensor implanted in the chest can sense pressure changes associated with respiratory events. In an embodiment, the respiratory rate can be determined from plethysmography traces.

[0094] In embodiments, stimulation of tissue may be activated in response to an algorithm that detects respiratory events in real time. In embodiments, stimulation of tissue may be activated based on an algorithm that predicts respiratory events, such as a moving average of previously measured respiratory events. In embodiments, tissue may be stimulated without detecting respiratory events, such as regular periodic stimulation or semi-random stimulation. The frequency and current of stimulation may be adjustable and may be modulated between periodic stimulation, or the frequency may be swept from an "off" frequency to an "on" frequency, which would combine Figure 4 and Figure 7 Describe in more detail.

[0095] Those skilled in the art will understand that Figure 1 Certain components not shown may be included in Figure 1Such variations and other variations are contemplated to be within the scope of the present disclosure.

[0096] Figure 2 2 is a diagram of exemplary electrical outputs of two electrical stimulators. The illustrated system includes a controller 210, a respiration 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 may include Figure 1 The controller 210 can control the two electrical stimulators 240 and 250 to provide different frequencies (such as Figure 2 For example, both electrical stimulators 240, 250 can provide electrical outputs with frequencies greater than 1 kHz. For example, one electrical stimulator (e.g., 250) can provide a slightly higher electrical output frequency, such as 1 Hz to 200 Hz higher. The frequencies are exemplary, and other frequencies are also contemplated within the scope of the present disclosure.

[0097] The electrodes of each electrical stimulator cause an electric current to flow therebetween. The electrodes 242, 244 of the first electrical stimulator 240 cause a corresponding electric current 246 to flow therebetween, and the electrodes 252, 254 of the second electrical stimulator 250 cause a corresponding electric current 256 to flow therebetween. Figure 2 As shown, the illustrated paths of currents 246, 256 intersect at two locations. The illustrated paths are provided for explanation purposes, and actual current paths may not have the illustrated shapes. In embodiments, the paths of currents 246, 256 may intersect at one location, or may intersect at more than two locations.

[0098] According to various aspects of the present disclosure, the currents 246, 256 flowing between the electrodes of the electrical stimulators 240, 250 can simultaneously flow through the target tissue 280 and can stimulate the target tissue 280. Figure 4The effects of the currents 246, 256 in the target tissue 280 are described in more detail. The controller 210 can control the timing and / or electrical properties (e.g., frequency, amplitude, etc.) of the currents 246, 256 to provide the desired effect on the target tissue 280. For example, in an embodiment, if the target tissue 280 includes motor neurons, the effect of the currents 246, 256 can cause muscle fibers associated with the motor neurons to be activated, thereby causing muscles in the human body to contract. In an embodiment, the neurons of the target tissue 280 may include the hypoglossal nerve. If the breathing sensor 220 indicates that breathing is reduced or stopped, the controller 210 can control the electrical stimulators 240, 250 to stimulate the hypoglossal nerve of the target tissue 280 to move the tongue. Other types of target tissues and other effects of applying electrical outputs to target tissues are expected to be within the scope of the present disclosure.

[0099] Figure 3 340 causes a current 346 to flow between its electrodes 342, 344, and a second simulator 350 causes a current 356 to flow between its electrodes 352, 354. The electrical stimulators 340, 350 may include Figure 1 Components of an electrical stimulator are shown. Electrodes 342, 344, 352, 354 are physically located on the body such that currents 346, 356 intersect paths at a certain location. The illustrated current paths 346, 356 are shown for explanation purposes, and actual current paths may have different shapes. In embodiments, the paths of currents 346, 356 may intersect at more than one location. In embodiments, currents 346, 356 intersect paths at target tissue and stimulate or otherwise effect treatment of the target tissue. For example, currents 346, 356 may have Figure 3 The frequencies shown can provide treatment in the target tissue. Figure 3 The frequencies shown are exemplary and other frequencies are contemplated to be within the scope of the present disclosure.

[0100] Combination Figures 1 to 3 The described system 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 causes nerve depolarization. When the current flowing through the tissue does not cause any muscle movement or nerve depolarization, the tissue will not be stimulated. Sub-kilohertz frequency currents can stimulate neurons and muscle fibers. At frequencies above 1 kHz, neurons may not respond and, muscle fibers may not move.

[0101] At the electrical level, each electrode pair provides 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, their respective electric fields may interfere with each other. When the respective electric fields have different frequencies, such interference between the electric fields may produce such a region: the frequency of the electric field in this region is the difference between the frequencies of the respective electric fields. For example, Figure 4 As shown, one electric field 410 may have a frequency of 2.1 kHz and the other electric field 420 may have a frequency of 2 kHz. The interference between these electric fields may produce a region of electric field 430 having a frequency of 100 Hz, which is the difference between the frequencies of the individual electric fields 410, 420. Such a region will be referred to herein as an "activation region." However, outside the activation region, the individual electric fields 410, 420 may have their own frequencies.

[0102] The current flowing between the electrodes is based on the electric field provided by the electrodes. Outside the activation area, the current may have a frequency corresponding to the frequency of the electric field through which the current flows. When such a frequency is greater than 1000 Hz, the currents may not stimulate the tissue through which they flow. For target tissue within the activation area, the target tissue may be exposed to currents with a frequency less than 1000 Hz, such as in combination with Figure 4 The target tissue may be a muscle of the tongue or a hypoglossal nerve that controls the tongue, and the average current is greater than the current experienced in non-target tissue. When the target tissue includes the muscles of the tongue or the hypoglossal nerve that controls the tongue, the tongue may move. When the target tissue is the genioglossus muscle, the tongue may move forward away from the airway. Conversely, non-target tissue may not be exposed to frequencies that cause muscle contraction or nerve stimulation.

[0103] The current sufficient to cause stimulation can vary depending on the type of target tissue. For example, as the frequency increases, an increased current can be provided to stimulate neurons. In an embodiment, stimulation of the target tissue can also be achieved by modulation of the current, so that different ratios of current can provide stimulation at different depths. For example, a ratio of the ipsilateral electrode current to the contralateral electrode current in the range of (1:8) to (8:1) (e.g., 50uA:12.5uA) can be used to achieve unilateral stimulation of various areas including the motor cortex. In an embodiment, the temperature increase can be negligible, so that there is no concern about thermal burns.

[0104] Figure 4 are exemplary, and other frequencies, waveforms, and / or numbers of waveforms for the electric field and current are contemplated to be within the scope of the present disclosure. For example, in embodiments, the waveforms of the electric field and current may be modulated, such as by amplitude modulation. In embodiments, the waveforms of the electric field and current may be square waves or other types of pulsed waves, and the pulsed waves may be pulse width modulated. In embodiments, the waveforms of the electric field and current may be modulated in the Fourier domain.

[0105] Reference again Figures 1 to 3, the disclosed system can be applied in combination with Figure 4 That is, the individual electrical stimulators and electrode pairs may provide electrical outputs at frequencies that do not stimulate tissue. In the case of neurons, such frequencies may be above 1 kHz. The electrodes may be configured and / or placed in such a position that the combined effect of the electric fields provided by the electrodes produces an activation region at the target tissue. As described above, the current flowing through the activation region may have a frequency that stimulates the target tissue. In the case of neurons, such frequencies may be below 1 kHz. In an embodiment, Figures 1 to 3 In a system of the present invention, 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 provided by two different electrode pairs can be between 1 Hz and 1000 Hz, such as between 1 Hz and 200 Hz. The frequency values ​​are exemplary, and other frequency values ​​are also contemplated within the scope of the present disclosure.

[0106] refer to Figure 5 , various configurations of electrode pairs are shown, including a staggered electrode configuration 510, a nested electrode configuration 520, and a nearest neighbor electrode configuration 530. Figure 5 The electrode configuration can be combined with Figures 1 to 4 Any aspects of the described systems, devices, and methods may be used in combination. Figure 5 The electrical stimulator in x and I y ) are illustrated to show a separate electrostimulator for each pair of electrodes. The illustrated electrostimulators are not intended to show any particular placement or position of the electrostimulators.

[0107] In a "staggered" electrode configuration 510, a pair of electrodes E1 and a pair of electrodes E2 may be placed on a surface S such that electrodes from E1 may be between electrodes of E2, and electrodes of E2 may be between electrodes of E1. The current paths in the staggered electrode configuration 510 may be in the form of Figure 3 In a "nested" electrode configuration 520, a pair of electrodes E1 and a pair of electrodes E2 can be placed on a surface S such that electrode E2 is between electrodes of E1, or electrode E1 is between electrodes of E2. In such a configuration 520, the current paths can intersect in various ways, depending on how the electrical output of the stimulator is configured; for example, intersecting at one location or two locations. In a "nearest neighbor" electrode configuration 530, a pair of electrodes E1 and a pair of electrodes E2 can be placed on a surface S such that electrode E1 is placed next to electrode E2. The current of the nearest neighbor electrode configuration 530 can be in a Figure 2The electrodes may intersect in the manner shown; for example, intersecting at two locations. This illustration is exemplary, and variations are contemplated within the scope of the present disclosure. In embodiments, there may not be a separate electrical stimulator for each electrode pair.

[0108] In embodiments, electrodes may be configured and / or controlled to account for anatomical differences between individuals in order to ensure proper treatment of target tissue, such as movement of a muscle (e.g., tongue muscle). For example, without proper placement or control of the electrodes, the current generated by an electrical stimulator may not cause muscle contraction of a body part (e.g., tongue). In embodiments, an array of electrodes may be incorporated.

[0109] Figure 6 An exemplary configuration of electrode arrays 610, 620 including four pairs of electrodes and four electrical stimulators is shown. Figure 6 The electrode configuration can be combined with Figures 1 to 4 In the electrode array 610, the electrode pairs E1 and E2 are placed in a nested configuration, and the electrode pairs E3 and E4 are placed in a nested configuration. The portions of the two nested configurations can be separated from each other by different distances. For example, the portions of the two nested configurations can be separated by a distance d A , while the other part of the two nested configurations can be separated by a distance d B In the electrode array 620, the electrodes are Figure 3 The configuration shown is placed where a portion of the electrodes can be separated by a distance d A , while the other part of the electrode can be separated by a distance d B . Provide the electrical stimulator (I x1 ,I x2 ,I y1 and I y2 ) is to illustrate that each electrode pair has a separate electrostimulator, and is not intended to illustrate any specific placement or position of the electrostimulator. This illustration is exemplary, and in embodiments, there may not be a separate electrostimulator for each electrode pair.

[0110] According to various aspects of the present disclosure, the controller can selectively activate some electrode pairs in the electrode arrays 610, 620, or can activate all electrode pairs in the electrode arrays 610, 620. The ability of the controller to selectively activate some electrode pairs or activate all electrode pairs and adjust the electrical characteristics of the electrode pair output allows the controller to customize the electrical output to the human anatomy and treat the target tissue in the human body in the most effective manner.

[0111] In an embodiment, in an electrode array, more than two pairs of electrodes may be used to create an electric field interference region, but the region may still have current at a frequency that does not stimulate tissue (e.g., for neurons, frequencies above 1000 Hz). The additional electric fields of more than one other electrode pair of the array may provide further interference to create an activation region with current at a frequency that stimulates tissue (e.g., for neurons, frequencies below 1000 Hz). The electrodes may be configured and / or placed so that the activation region occurs in the target tissue.

[0112] Figure 5 and Figure 6 The embodiments are exemplary. Other electrode configurations and other numbers of electrodes are contemplated to be within the scope of the present disclosure.

[0113] Figure 7 Operations for controlling the electrical output of the electrodes are shown. Stimulation can be activated by varying the frequency of the current. Figure 7 The operation can be applied to combine Figures 1 to 3 , Figure 5 and Figure 7 Any of the systems, devices and configurations described herein, or variations of such systems, devices and configurations. In an embodiment, the frequency of the current can be obtained from the electrode pair E 1 and E 2 The base state of providing currents 710, 720 of the same frequency is changed to a second state in which the frequency of the current between at least one of the electrode pairs is shifted so that the current in the activation area has a frequency (e.g., frequency f) that provides stimulation to the target tissue. 1 and f 2 When the currents 710 and 720 operate at the same frequency, there may be no significant stimulation of the target tissue. 1 The current 710 between may have a frequency f 1 , and the electrode E 2 The current 720 between may have a frequency f 2 Frequency f 1 and f 2 can be equal, and can be in phase or out of phase. As an "event" 730 is detected, initiated, or measured (e.g., by a sensor), the frequency f 1 or frequency f 2 Can be shifted to a new frequency f 3 The shift can be in time period t 1 The new frequency f 3 Can maintain time period t 2 , and then in time period t 3 The operation can be repeated as the next "event" 740 is detected, started or measured. Figure 7Only two electrode pairs are shown in FIG. 1 , but the operation can be extended to apply to more than two pairs of electrodes, for example to Figure 6 configuration or any other configuration.

[0114] Various configurations and operations have been described above. Variations of such configurations and operations are contemplated to be within the scope of the present disclosure. The disclosed systems and devices may utilize various additional electrodes and electronic configurations. In embodiments, the electrodes may produce biphasic bipolar pulses, and the electrodes may include an anode and a cathode. In embodiments, the intensity and duty cycle of the electric field and / or current may be adjustable. In embodiments, the electronics driving the two pairs of electrodes may be separate and electrically isolated to avoid loss of electric field integrity. This may be accomplished by, for example, separate power supplies (e.g. Figure 1 In an embodiment, the stimulation current may be driven by optoelectronics, where the generation of the current may be driven by the application of light. In an embodiment, 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 an embodiment, the power source may be rechargeable or non-rechargeable. Such variations and other variations are contemplated to be within the scope of the present disclosure.

[0115] The disclosed configurations and operations can be used to stimulate or otherwise treat different parts of the body. Although various uses are contemplated within the scope of the present disclosure, the following will describe systems or devices that stimulate tissue to move the tongue to improve airflow. For example, the system or device can stimulate the tongue muscles to increase muscle tone for the treatment of snoring and mild sleep apnea. Unless otherwise noted, the various schemes described below are intended to be generally applicable to stimulating or treating any tissue.

[0116] According to each solution of the present disclosure, and as Figures 8 to 11 As shown, an exemplary embodiment of an apparatus for electrical stimulation may include a curved housing. In an embodiment, the curved housing may have a size and shape that generally follows the curvature of a person's jaw or a person's teeth. In an embodiment, the curved housing may be made in different sizes and / or curvatures, and a person may use a specific size and / or curvature that best suits the person. The curved housing has an attachment mechanism to secure the housing to the person, such as an adhesive (e.g., tape or glue), a strap, and / or a magnetic element, or other mechanism for attaching the housing to the person.

[0117] Figure 8 8 is a diagram of an exemplary curved housing 810. The curved housing 810 includes an electrode 820. The configuration of the electrode 820 can be any of the configurations described above (e.g., Figure 5 or Figure 6The location of the electrode 820 is exemplary, and the electrode 820 may be located at other locations on the curved shell 810. In an embodiment, the curved shell 820 may have a Figure 8 Different numbers of electrodes are shown. Figure 8 The illustrated curvatures are exemplary, and other curvatures of the curved shell are contemplated within the scope of the present disclosure.As described above, in embodiments, the curved shell may be sized and shaped to generally trace the curvature of a person's jaw, jawline, teeth, or gumline.

[0118] In an embodiment, Figure 1 Some or all of the components shown may be located inside the curved housing 810, including Figure 1 The battery shown. In embodiments, the battery may be rechargeable. Fig. 9 8 is a diagram of a curved housing 810, which includes a charging pin 930 for charging a battery inside the curved housing 810. The charging pin 930 may be located at a portion of the curved housing 810 that includes an electrode (820, Figure 8 ) on a different side. Fig. 9 The shapes of the pins, the number of pins, and the positions of the pins in are exemplary, and other shapes, numbers, and positions are also contemplated to be within the scope of the present disclosure.

[0119] Fig.10 is a diagram of an exemplary docking device 1010 that receives a curved housing 810 and charges a battery within the curved housing 810. The docking device 1010 includes a recess 1015 that is similar in shape to the curved housing 810 so that the curved housing 810 can be placed 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 deliver power for charging the battery within the curved housing 810. Power is delivered to the curved housing 810 through pins 1030 on the docking device 1010. When the curved housing 810 is docked on the docking device 1010, the pins 1030 are positioned to couple with the charging pins 930 on the curved housing 810.

[0120] In an embodiment, the curved housing 810 and the docking device 1010 may include one or more data pins (not shown) that allow data to be transferred between them. In an embodiment, the data pins may be used to update firmware and / or transfer usage data and / or sensor data (e.g., Figure 1Sensors 120, 122), etc. In an embodiment, a controller (not shown) in the curved housing 810 can be programmed using a wired data connection that is directly inserted into a connector (not shown) in 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 an embodiment, the port-based connector can be designed to be easily removed, such as by a pre-scored connection or a connection lead that is long enough to be easily cut. In an embodiment, the port can be designed so that the connection can be reestablished, including by reestablishing conductance between the leads. In an embodiment, the connection can be held together magnetically, allowing tool-free connection and disconnection. In an additional embodiment, the connection can be established and stabilized by a physical clip.

[0121] Fig.11 1 is a diagram of exemplary components of an embodiment with electrode arrays 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 positioned on the curved housing 1110. In an embodiment, some or all of the sensors 1130-1138 can be positioned on the curved housing 1110. In an embodiment, some or all of the sensors 1130-1138 can be positioned within the curved housing 1110.

[0122] The electrode arrays 1120, 1122 may be combined with Figure 6 1120, 1122. The controller may be configured in a manner described. For example, certain electrode pairs may be configured so that both electrodes of the pair are in electrode array 1120 or both electrodes are in electrode array 1122. Certain electrode pairs may be configured so that one electrode of the pair is in electrode array 1120 and the other electrode of the pair is in electrode array 1122. Combinations of such configurations are intended to be within the scope of the present disclosure. In an embodiment, a controller (not shown) may selectively activate certain electrode pairs, or may activate all of the electrode pairs of electrode arrays 1120, 1122. As described above, the ability of the controller to activate certain electrode pairs may allow the controller to determine and / or implement an electrode configuration suitable for the human anatomy.

[0123] Continue to refer Fig.11, the illustrated sensors include electromyography (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 in the human body caused by 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 electrodes from the electrode arrays 1120, 1125 that will provide effective stimulation or treatment to the person. For example, the device can be applied to a person, and the controller of the device can activate multiple predetermined combinations of 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, as well as other possible sensors. The controller can select one or more electrode combinations that produce sensor data that meets predetermined criteria for use with the person.

[0124] In an embodiment, sensor data from the accelerometer 1136 and / or the PPG sensor 1138 may be used to determine when to provide an electrical output from the electrode arrays 1120, 1122. For example, in an embodiment, if the sensor data from the accelerometer 1136 indicates motion or a sufficient degree of motion, the electrode arrays 1120, 1122 may be activated. As another example, in an embodiment, if the sensor data from the accelerometer 1136 indicates no motion or a sufficiently low degree of motion, the electrode arrays 1120, 1122 may be activated in such a case. In an embodiment, if the sensor data from the PPG sensor 1138 indicates no breathing or a sufficiently low degree of breathing, the electrode arrays 1120, 1122 may be activated in such a case. The accelerometer 1136 and the PPG sensor 1138 are merely examples. Other types of sensors and their sensor data may be used to determine when to activate the electrodes to provide an electrical output.

[0125] Fig.12 Various portions of the tongue musculature are illustrated, including the tongue 1257, the styloglossus 1258, the hyoglossus 1259, the mandible and teeth 1260, and the genioglossus 1261. According to various aspects of the present disclosure, electrical stimulation may be applied to the tongue musculature using any of the above-described systems, devices, configurations, and operations. In an embodiment, an electrical current may pass through the tissue and flow through an activation area in the tongue musculature that is stimulated to cause the tongue and hypoglossal muscles to move the tongue out of the airway. In an embodiment, the electrodes may be positioned parallel to the hypoglossal nerve. The electrodes may be configured such as Figure 5 or Figure 6The invention can be configured as shown in any of the configurations of, or configured into other configurations not shown herein. In an embodiment, a single pair of electrodes can be used to direct current through the hypoglossal muscle, such as neuromuscular electrical stimulation, thereby causing contraction during breathing. In an embodiment, stimulation of other nerves can help open the airway. For example, stimulation of the cervical cricoid nerve can innervate the sternohyoid muscle, sternothyroid muscle and / or omohyoid muscle, improve the airway, and therefore can be targeted by the device during treatment.

[0126] In an embodiment, stimulation of other muscles of the jaw (not shown) may be used to move the jaw forward to open the airway. These muscles include the lateral pterygoid muscle innervated by the lateral pterygoid branch of the mandibular nerve, the masseter muscle innervated by the masseter nerve and / or branches of the mandibular nerve, and the medial pterygoid muscle innervated by the medial pterygoid branch of the mandibular nerve.

[0127] In embodiments, stimulation may be bilateral or unilateral. In embodiments of bilateral stimulation, different frequencies may be used to stimulate each of the two sides. For example, in the case of stimulation of both hypoglossal nerve branches, using the same frequency may result in unintentional phase cancellation, thereby producing potentially painful stimulation throughout the jaw.

[0128] According to the various embodiments of the present disclosure, causing tongue movement may be beneficial in many procedures. For example, tongue movement may provide an improved airway in a patient under the influence of anesthesia or opioids, or during recovery from anesthesia or opioids. In an embodiment, tongue movement may allow easier access during intubation, dental surgery, surgical procedures involving the upper airway, or imaging (including endoscopy, feeding tube implantation, or gastric surgery). Any of the systems, devices, and operations disclosed herein may be applied to such procedures and other procedures to produce beneficial tongue movement.

[0129] refer to Fig.13 , and according to each solution of the present disclosure, Fig.12 The anatomical structure of the human body can be electrically stimulated by a device 1310 placed on the human body under the human jaw. The device 1310 may include a combination of Figures 1 to 11The invention relates to a method of any one of the systems and / or devices described herein. For example, the shape of the curved housing can be configured to follow the shape of a person's anatomical structure (e.g., the mandible, jawline, neck, and / or other facial features). In an embodiment, the device 1310 can be fixed to the person's skin by a removable adhesive, or the device 1310 can be fixed to the person's head by a strap or a belt (not shown), etc. The adhesive can contain agents that reduce skin irritation and redness, including moisturizers, anti-inflammatory agents, NSAIDs, anesthetics, analgesics, antihistamines, niacinamide, aloe, witch hazel, sea buckthorn oil, palmitoleic acid, calendula, chamomile, tiger grass, centella asiatica, hyaluronic acid, vitamin E, squalane, glycerin, and / or cannabidiol. The adhesive or a portion thereof can contain a conductive substance (such as a salt) and a conductive metal (such as gold, zinc, colloidal silver, copper, and selenium).

[0130] refer to Fig.14 and Fig.15 , and according to various schemes of the present disclosure, the device 1410 can be used to Fig.12 Device 1410 includes electrodes 1420 and can be placed in the oral cavity, such as under or on a person's tongue. Device 1410 can include electrodes 1420 in combination with Figures 1 to 11 Aspects of any of the described systems and devices. For example, the shape of the curved housing can be configured to follow the shape of a person's anatomy (e.g., teeth, gum line, and / or other facial features). In embodiments, the device 1410 can be substantially flat, but other configurations are also contemplated within the scope of the present disclosure. The electrode 1420 can be attached to the housing and can be positioned in the oral cavity behind the teeth and mandible.

[0131] The housing of device 1410 can include various materials. In an embodiment, the housing can have a thermoplastic component that contacts a portion of a person's teeth and a rigid acrylic component that contacts a portion of a person's upper palate. In an embodiment, only the thermoplastic component can contact a person's teeth.

[0132] In an embodiment, the device 1410 may include an orthodontic component (not shown). The orthodontic component may include a dental encasing component having a lingual surface and a labial surface. The dental encasing component may partially or completely cover a person's teeth and palate. The orthodontic component may also include a rigid component fused to the entire length of the lingual surface, which covers a portion of the patient's palate. In an embodiment, the orthodontic component may also include a rigid acrylic component fused to a thermoplastic dental encasing component.

[0133] The rigid acrylic component can extend from the entire length of the lingual surface of the thermoplastic tooth covering component to the patient's upper palate. The rigid acrylic component can partially or completely cover the person's teeth and upper palate. In an embodiment, only the thermoplastic tooth covering component can completely cover the person's teeth, and all parts of the upper palate covered by the thermoplastic tooth covering component can also be covered by the rigid acrylic component. In an embodiment, the rigid acrylic component can have a higher rigidity than the thermoplastic tooth covering component. The rigid acrylic component can also increase the rigidity of the entire arch defined by the thermoplastic tooth covering component without completely covering the person's teeth. In an embodiment, a model of the person's mandible and upper palate can be used to make a suitable mouthpiece. The model can be combined with various components to align the electrode to contact the base of the oral cavity.

[0134] Fig.14 and Fig.15 Devices can be used to electrically stimulate the tongue muscles. Without electrical stimulation, the tongue may position itself closer to the airway and obstruct airflow. Fig.16 As shown, electrical stimulation can move the tongue muscles forward to widen the airway and improve airflow in the human body. In an embodiment, the electrical stimulator can provide an electrical output with a frequency of about 10kHz. The activation area with current at a frequency between 1Hz and 200Hz can be used to induce involuntary forward tongue flexion. In an embodiment, other frequency values ​​can be used. Figures 14 to 16 The description is exemplary, and variations are contemplated within the scope of the present disclosure. For example, the device in the oral cavity may be sized and positioned in other ways not shown or described herein.

[0135] refer to Fig.17 , shows an example of an electrode patch. The electrode patch 1710, 1720 includes an electrode 1730, and the patch 1710, 1720 can be Fig.17 The electrode patches 1710, 1720 may be attached to the person at the locations shown (e.g., one patch 1710 on the right cheek and one patch 1720 on the left cheek) or at other locations. In embodiments, the electrode patches 1710, 1720 may include a removable adhesive that adheres to the person's skin. The electrodes 1730 may be in contact with the person's skin and may be held in place by the adhesive. The adhesive may contain an agent for reducing skin irritation and redness, such as the above-incorporated Fig.13 The adhesive or a portion thereof may contain a conductive substance (such as a salt) and / or a conductive metal (such as gold, zinc, colloidal silver, copper, and / or selenium). In embodiments, other mechanisms of attaching the electrode patch to a person are contemplated, such as a strap or a belt.

[0136] In embodiments, circuitry (not shown) may be incorporated into the electrode patches 1710, 1720. In embodiments, electrical leads (not shown) may connect the electrodes 1730 of the electrode patches 1710, 1720 to a separate system or device that provides control and electrical output, such as Figure 1 In embodiments, certain circuits may be incorporated into the electrode patches 1710, 1720, while certain circuits may be located in a separate system or device and may be connected to the electrode patches 1710, 1720 via electrical leads.

[0137] Fig.17 are exemplary, and variations are contemplated within the scope of the present disclosure. In an embodiment, a single electrode patch may be used, such as Fig.18 As shown, the patch can be attached under the person's jaw and / or the person's neck. A single electrode patch 1810 can include multiple electrodes 1830, and can include more than one electrode array.

[0138] In embodiments, more than two electrode patches may be used, e.g. Fig.19 and Fig. 20 In an embodiment, the patch may be a circular patch, such as Fig.19 The circular patch 1930 and Fig. 20 The circular patches 2030 shown may have a diameter of two inches or other sizes. In an embodiment, each circular patch may include a single electrode. Fig.18 and Fig.19 As shown, some patches may trace the left jawline attachment and some patches may trace the right jawline attachment, and the patches may be located above and / or below the jawline.

[0139] In an embodiment, the electrode patch may have Figures 17 to 20 The shapes and sizes shown are different shapes and sizes. In embodiments, the electrode patches can be placed in a variety of locations, including Figures 17 to 20 any of the positions shown or any combination of these positions, or with Figures 17 to 20 The positions shown are different than those shown. For example, the electrode patches can be placed on body parts other than the face or neck, such as arms, legs, back, or any other part of the body. Such variations and other variations are contemplated within the scope of the present disclosure.

[0140] Accordingly, the above describes various schemes for systems, devices and operations for electrically stimulating tissue. In an embodiment, any of the systems, devices and operations disclosed herein can be used when a person is asleep or awake. The components of the system and device can contain a variety of materials and can differ in durability. In an embodiment, the system and device can include more than one disposable component and more than one durable reusable component. In an embodiment, the disposable component can include electrodes, sensors and / or sensor leads, etc. In an embodiment, the durable component can include electronics, sensors, stimulation circuits, Bluetooth and wireless communication circuits and / or processing circuits, etc. For example, the electrode can be disposable, while the electronics are durable and reusable. In an embodiment, the electrode, the electronics and the sensor can all be durable, and the removable adhesive sheet can be configured to make the electrode conductive to the patient's skin. Once used, the removable adhesive sheet can be removed and discarded. In an embodiment, the electrode can also be flexible so that the electrode will remain electrically connected while keeping the patient comfortable.

[0141] Fig.21 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 an electromyogram (EMG) sensor 2110, an electroencephalogram 2120, an optical plethysmography sensor 2130a, an accelerometer 2130b, and / or a microphone (not shown), as well as other sensors. In an embodiment, the attending physician or medical provider may access the information provided by the sensors. For example, the information provided by the sensors may be communicated to the patient via a docking device such as a Fig.10 In an embodiment, for systems and devices that include wireless communication capabilities, the information provided by the sensors can be wirelessly uploaded to a central system (not shown). A doctor or medical provider can then access such information from the central system.

[0142] In an embodiment, the central system can be used to generate a compliance report using information obtained from the sensors. The compliance report can be used to confirm treatment details, including actual use, efficacy, sleep quality, and / or number of apnea or hypopnea events. For example, sleep state can be monitored, including parameters such as respiratory rate, blood oxygen level, pulse, and / or muscle tone, and stimulation parameters can be adjusted accordingly (e.g., increasing intensity, modifying based on breathing pattern).

[0143] Continue to refer Fig.21Operations at block 2140 involve activating the disclosed system or device, which may involve powering on and performing a startup routine and startup diagnostics. Operations at block 2150 involve generating a confirmation signal that the system activation was successful. Operations at block 2160 involve control operations based on sensor data from sensors 2110-2130a / b and other possible sensors (not shown), and may be controlled by a controller (e.g., Figure 1 At box 2170, information from sensors 2110-2130a / b can be used to detect breathing. If the information from the sensors indicates that breathing has stopped or meets predetermined criteria, the operation at box 2180 can activate the electrodes to stimulate the activation area and cause the tongue to move and open the airway.

[0144] In an embodiment, data from more than one EMG sensor 2110 can be used to confirm stimulation and provide additional patient information. For example, a signal corresponding to the stimulation signal can be detected by the EMG sensor 2110 and can be used by the control operation 2160 to confirm stimulation, electrode placement, or parameter selection. In an embodiment, muscle tension can be used as an indicator of sleep stages (such as N1, N2, N3, REM, and deep sleep). Information from the EMG sensor 2110 can be used by the control operation 2160 to estimate the sleep stage. The data can also be used by the control operation 2160 to automatically adjust parameters such as the electrical output parameters of the electrical stimulator and other parameters. In an embodiment, a peripheral artery tension monitor can provide similar patient information. The EMG sensor 2110 can be a part of a disposable component (such as a patch including an electrode), or can be a part of a durable and reusable component.

[0145] In an embodiment, data from the EEG 2120 may be used by the control operation 2160 to determine sleep stages, such as N1, N2, N3, REM, and deep sleep. These stages may correspond to varying degrees of muscle relaxation, including total paralysis during REM. This information may be used by the control operation 2160 to modify the level of stimulation based on the inherent muscle tone during the current stage.

[0146] In an embodiment, the optical plethysmographic sensor 2130a can provide information about pulse rate and blood oxygen levels. The optical plethysmographic sensor 2130a can also include a pulse oximeter or digital holography. Data from the sensor 2130a can also provide an estimate of the respiratory rate and can be used by the control operation 2160 to automatically adjust parameters to improve the function of the system and device.

[0147] In an embodiment, the accelerometer 2130b can provide information about breathing rate, movement and / or sleep position. This data can be further used by the control operation 2160 to automatically adjust parameters such as the electrical output parameters of the electrical stimulator and other parameters.

[0148] The degree of effort required to move the tongue may vary depending on the sleeping position. For example, when sleeping in a supine position, greater effort may be required. In an embodiment, the stimulation parameters may be changed based on the sleeping position. In addition, the movement of the mandible may be analyzed to determine apnea events. Data from EMG 2110, optical plethysmography 2130a, and / or accelerometer 2130b may provide sleep scoring, inform sleep studies, and / or assist in compliance reporting.

[0149] In an embodiment, a microphone can be used to detect sounds associated with snoring and breathing to calculate the respiratory rate. A nasal cannula can also be used to measure airflow and nasal pressure changes. This information can be used to calculate the respiratory rate and can indicate apnea events.

[0150] The 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 the next few days or weeks. This can help use the disclosed systems and devices as a transition device. In addition, the stimulation current can be modulated by the control operation 2160 based on the sleep stage. During some sleep stages, particularly during REM sleep, muscle tone may drop more, so that applying an increased current can improve the patient's treatment effect.

[0151] Reference now Fig. 22 , a flowchart showing an exemplary operation for simulating the hypoglossal nerve. Fig. 22 The operations may be performed by any of the systems and devices disclosed herein. At block 2210, the operations involve conducting a first AC current between a first pair of electrodes and through tissue of a person. At block 2220, the operations involve conducting a second AC current between a second pair of electrodes and through tissue of a person. At block 2230, the operations involve stimulating a hypoglossal nerve of the person with the first AC current and the second AC current, wherein stimulating the hypoglossal nerve causes movement of the person's tongue.

[0152] Reference now Fig.23 , a flowchart showing an exemplary operation for simulating a neuron is shown. Fig.23The operations may be performed by any of the systems and devices disclosed herein. At block 2310, the operations involve conducting a first AC current between a first pair of electrodes and through tissue of a person. At block 2320, the operations involve conducting a second AC current between a second pair of electrodes and through tissue of a person. At block 2330, the operations involve stimulating neurons of a person with the first AC current and the second AC current, wherein stimulating the neurons provides treatment for a disease.

[0153] According to various schemes of the present disclosure, the system and device disclosed herein can be used in combination with a large number of external devices (not shown). For example, the system and device can be connected to a phone, a watch, a remote controller and / or a tablet computer. The external device can store data of various patients. For example, in addition to additional information, the data can also be used to find the relationship between the application of electrical stimulation to the patient and the patient's respiratory response to such electrical stimulation. The relationship data of a large number of patients can be gathered, and then used to find the trend or common part of OSA in various demographics. The storage device can be a local storage device or a remote storage device (for example, it can be accessed via more than one device and / or network (including but not limited to wide area network (WAN), wireless local area network (WLAN), virtual private network (VPN) and the Internet)). Data can be obtained and operated locally or remotely, and can be used immediately and / or saved for later use and / or for equipment. In an embodiment, a vibration motor or a speaker can be used with any one of the systems and devices disclosed herein to provide feedback and warnings to the user, or used as an alarm or notification.

[0154] In an embodiment, 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 collects and analyzes data and controls stimulation parameters based on the analyzed data. The computer can communicate with one or more central systems (e.g., cloud systems). These central systems can be connected to company computers or doctor computers. Doctors can provide inputs through these computers to control stimulation parameters, check sensor data, and generate compliance reports. In an embodiment, the mobile device or computer receives patient feedback through an application (e.g., tapping to trigger an accelerometer) or through a button pressed by the patient. For example, feedback can include data illustrating appropriate movement of the tongue. In an embodiment, sensors can also be used to confirm that the tongue or other tissues have moved.

[0155] In embodiments, the systems and devices disclosed herein may include user-worn components (e.g., Fig.13 1310) and desktop components (such as Fig.101010). The desktop component can be battery powered or connected to a main wall-based power source. The desktop component can provide power wirelessly or through a hardwired connection to a rechargeable battery associated with the user-worn component. In an embodiment, the desktop component can include processing hardware.

[0156] It is contemplated that the systems, devices, and operations disclosed herein can be used to stimulate or otherwise treat various tissues and / or conditions. For example, lymphatic return can be regulated by neural stimulation of the lymph nodes. This limitation leads to various effects, including isolating infectious bacteria, limiting the colonization of malignant cells, increasing antibody production in response to vaccines, and increasing class conversion to IgG antibodies (e.g., during allergic desensitization). In one embodiment, electrical stimulation can be targeted to lymph nodes and nerves that innervate lymph nodes, including axillary lymph nodes in the armpit and neck, inguinal lymph nodes and popliteal lymph nodes in the leg, and nerves (such as sciatic nerves).

[0157] In an embodiment, the system and device disclosed herein can be used to target branches of the vagus nerve. It is known that the vagus nerve is stimulated to treat a variety of diseases and indications. For example, in relation to traumatic bleeding events or their risks, stimulation of the vagus nerve or splenic nerve can be used as a treatment to reduce bleeding time, total blood loss, and postoperative bleeding risk. In an embodiment, stimulation can be applied prophylactically (e.g., before surgery or before experiencing activities with traumatic risks (such as sports or armed forces combat), or during or after a traumatic event) to resolve bleeding. When used in conjunction with surgery, stimulation can be applied a few days after surgery to further reduce the risk of postoperative bleeding. In addition, it is known that stimulating the vagus nerve can treat inflammatory diseases, such as rheumatoid arthritis and inflammatory bowel disease. In an embodiment, regular stimulation of the vagus nerve can be used to treat these diseases. Stimulation of the vagus nerve can further be used to enhance sensory perception and treat migraines, epilepsy, or depression.

[0158] The systems and devices disclosed herein can stimulate various other nerves. For example, stimulating peripheral sensory nerves and spinal sensory nerves can relieve pain. Stimulating the sacral nerves that control the bladder can control incontinence and overactive bladder. Brain regions can be stimulated, similar to deep brain stimulators, to target source areas or prevent the spread of epileptic seizures. The phrenic nerves can be stimulated to control the contraction of the diaphragm, allowing the replacement of a mechanical ventilator that improves muscle tone while using a mechanical ventilator. The motor nerves that drive muscle movement can be stimulated to control muscle contraction. For example, in an embodiment, various tissues of the appendages can be mapped and stimulated by a grid of various electric fields to control the gross and fine movements of the arms, wrists, and hands.

[0159] According to various aspects of the present disclosure, the systems and devices disclosed herein can be used to provide operating power to an in-vivo battery or in-vivo device (such as an implanted device). Fig.24 As shown, the electrode pairs are controlled to provide electrical outputs to a battery or device 2430 in a person or human body. Certain electrical outputs 2410 can be targeted to one terminal 2420 of the battery or device 2430, and other electrical outputs 2415 can be targeted to another terminal 2425 of the battery or device 2430, thereby generating a differential current between points 2420, 2425. The periodic signals f1 and f2 2410 from electrodes E1 and E2 can generate a potential below the surface S at the battery terminal T 2120. Similarly, the periodic signals f1' and f2' 2415 from electrodes E1' and E2' can generate a potential below the surface S' at the battery terminal T' 2425. The potential at T 2420 and T' 2425 can be controlled to allow the battery or device 2430 to enter a charging state. Such charging can be used to power an implantable stimulator 2430, or to charge the battery of a stimulator or other implanted device 2430.

[0160] Certain schemes of the present disclosure may include some, all, or none of the above advantages and / or include one or more other advantages, which are obvious to those skilled in the art from the drawings, descriptions, and claims included herein. In addition, although specific advantages have been listed above, various schemes of the present disclosure may include all, some, or none of the listed advantages and / or include other advantages not specifically listed above.

[0161] Each scheme disclosed herein is an example of the present disclosure and can be implemented in various forms. For example, although some schemes herein are described as separate schemes, each scheme in the scheme herein can be combined with one or more schemes in other schemes herein. The specific structures and functional details disclosed herein should not be understood as restrictive, but only as the basis of the claims, and as a representative basis for teaching those skilled in the art to adopt the present disclosure differently with almost any suitable specific structure. In the entire description of the drawings, the same reference numerals may refer to similar or identical elements.

[0162] The phrases "in one embodiment," "in each embodiment," "in various embodiments," "in some embodiments," or "in other embodiments" may each refer to more than one embodiment of the same or different embodiments according to the present disclosure. A phrase in the form "A or B" means "(A), (B), or (A and B)." A phrase in the form "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)."

[0163] Any of the methods, programs, algorithms or codes described herein may be converted into a programming language or a computer program, or expressed in a programming language or a computer program. The terms "programming language" and "computer program" used herein include any language used to specify instructions to a computer, and include (but are not limited to) the following languages ​​and their derivatives: Assembler, Basic, batch files, BCPL, C, C+, C++, Delphi, Fortran, Java, JavaScript, machine code, operating system command language, Pascal, Perl, PL1, scripting language, Visual Basic, metalanguages ​​that specify programs themselves, and all first, second, third, fourth, fifth or later computer languages. Databases and other data models, as well as any other metalanguages, are also included. There is no difference between an interpreted language, a compiled language, or a language that is compiled and interpreted. There is no difference between the compiled version and the source code version of the program. Therefore, a reference to a program is a reference to any and all of these states, where a programming language can exist in more than one state (e.g., source code, compiled, object or link). A reference to a program may include actual instructions and / or the intent of these instructions.

[0164] It should be understood that the foregoing description is merely an illustration of the present disclosure. Without departing from the present disclosure, those skilled in the art may design various substitutions and modifications. Therefore, the present disclosure is intended to include all such substitutions, modifications and variations. The schemes described with reference to the accompanying drawings are only presented to show certain examples of the present disclosure. Other schemes, elements, steps, methods and techniques that are not substantially different from the schemes, elements, steps, methods and techniques described above and / or in the appended claims are also intended to fall within the scope of the present disclosure.

Claims

1. A device for electrically stimulating tissue, comprising: a first pair of electrodes configured to contact a person and conduct a first AC current between the first pair of electrodes through tissue of the person; as well as a second pair of electrodes configured to contact the person and conduct a second AC current between the second pair of electrodes through tissue of the person, Wherein the first pair of electrodes and the second pair of electrodes are configured to be positioned on the person such that the first AC current and the second AC current are simultaneously conducted through a target tissue of the person, the first AC current and the second AC current being configured to stimulate the target tissue.

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

3. The device according to claim 2, wherein: The current conducted through the target tissue has a frequency different from the first frequency and different from the second frequency.

4. The device according to claim 3, wherein: The current conducted through the target tissue has a frequency equal to the frequency difference between the first frequency and the second frequency.

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

6. The device according to claim 1, wherein: The first pair of electrodes and the second pair of electrodes are in one of a staggered configuration, a nested configuration, or a nearest neighbor configuration.

7. The apparatus according to claim 1, further comprising: a first battery configured to supply power to the first pair of electrodes; as well as a second battery configured to supply power to the second pair of electrodes, wherein 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.

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

9. The device according to claim 8, wherein: The controller is configured to set the parameters of the first AC current and the second AC current by: Setting the first frequency and the second frequency to fundamental frequency values; In response to determining that an event has occurred, setting the first frequency to a different frequency value than the base frequency value for a first time period after the event; During a second time period after the first time period, maintaining the first frequency at the different frequency value and maintaining the second frequency at the base frequency value; as well as In a third time period after the second time period, the first frequency is restored to the base frequency value.

10. The device according to claim 8, further comprising a first electrode array and a second electrode array, wherein the first electrode array comprises the first pair of electrodes, and The second electrode array includes the second pair of electrodes.

11. The device according to claim 10, wherein: The controller is also configured to: determining a subset of the first electrode array and a subset of the second electrode array that, when activated, cause stimulation of the target tissue; activating the subset of the first electrode array without activating all electrodes of the first electrode array, wherein the subset of the first electrode array includes the first pair of electrodes; as well as The subset of the second electrode array is activated without activating all electrodes of the second electrode array, wherein the subset of the second electrode array includes the second pair of electrodes.

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

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

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

15. The device according to claim 8, further comprising a housing, wherein the controller is located inside the housing, and The first pair of electrodes and the second pair of electrodes are located on the surface of the shell.

16. The apparatus of claim 1, further comprising: at least one patch configured to adhere to the skin of the person, the at least one patch comprising the first pair of electrodes and the second pair of electrodes; at least one battery; as well as At least one electrical connection is configured to electrically couple the at least one battery with the at least one patch.

17. The apparatus according to claim 1, wherein: tissue in at least a portion of the path of the first AC current is not stimulated by the first AC current, and Wherein tissue in at least a portion of a path of the second AC current is not stimulated by the first AC current.

18. The apparatus of claim 1, further comprising: a third pair of electrodes configured to contact the person and conduct a third AC current between the third pair of electrodes and through tissue of the person; as well as a fourth pair of electrodes configured to contact the person and conduct a fourth AC current between the fourth pair of electrodes and through tissue of the person, Wherein the first pair of electrodes, the second pair of electrodes, the third pair of electrodes and the fourth pair of electrodes are configured to be positioned on the person so that the first AC current, the second AC current, the third AC current and the fourth AC current are simultaneously conducted through the target tissue of the person and stimulate the target tissue.

19. The apparatus according to claim 18, wherein: tissue in at least a portion of the path of the third AC current is not stimulated by the third AC current, and Wherein tissue in at least a portion of a path of the fourth AC current is not stimulated by the fourth AC current.

20. The apparatus of claim 1, wherein: The target tissue includes the human's hypoglossal nerve.

21. A method of electrically stimulating tissue by means of a first pair of electrodes in contact with a person and a second pair of electrodes in contact with the person, comprising: at the same time: conducting a first AC current between the first pair of electrodes and through tissue of the person, and conducting a second AC current between the second pair of electrodes and through tissue of the person, Wherein based on the positioning of the first pair of electrodes and the second pair of electrodes on the person, the first AC current and the second AC current are simultaneously conducted through a target tissue of the person, and the first AC current and the second AC current are configured to stimulate the target tissue.

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

23. The method according to claim 22, wherein: The current conducted through the target tissue has a frequency different from the first frequency and different from the second frequency.

24. The method according to claim 23, wherein: The current conducted through the target tissue has a frequency equal to the frequency difference between the first frequency and the second frequency.

25. The method according to claim 24, wherein: The frequency difference is less than 200 Hz.

26. The method of claim 21, further comprising: Parameters of the first AC current and the second AC current are set, the parameters including the first frequency of the first AC current and the second frequency of the second AC current.

27. The method according to claim 26, wherein: Setting the parameters of the first AC current and the second AC current includes: Setting the first frequency and the second frequency to fundamental frequency values; In response to determining that an event has occurred, setting the first frequency to a different frequency value than the base frequency value for a first time period after the event; During a second time period after the first time period, maintaining the first frequency at the different frequency value and maintaining the second frequency at the base frequency value; and In a third time period after the second time period, the first frequency is restored to the base frequency value.

28. The method according to claim 26, wherein: The first pair of electrodes is in a first electrode array, and The second pair of electrodes is in a second electrode array.

29. The method according to claim 28, further comprising: determining a subset of the first electrode array and a subset of the second electrode array that, when activated, cause stimulation of the target tissue; activating the subset of the first electrode array without activating all electrodes of the first electrode array, wherein the subset of the first electrode array includes the first pair of electrodes; as well as The subset of the second electrode array is activated without activating all electrodes of the second electrode array, wherein the subset of the second electrode array includes the second pair of electrodes.

30. The method of claim 26, wherein: Setting the parameters of the first AC current and the second AC current includes: determining at least one of confirmation of muscle tension or tissue stimulation based on sensor data from an electromyography (EMG) sensor; and The parameters of the first AC current and the second AC current are set based on at least one of the confirmation of the muscle tone or the tissue stimulation.

31. The method of claim 26, wherein: Setting the parameters of the first AC current and the second AC current includes: determining a sleep state of the person based on sensor data from an electroencephalogram (EEG) sensor; and The parameters of the first AC current and the second AC current are set based on the sleeping state of the person.

32. The method of claim 26, wherein: Setting the parameters of the first AC current and the second AC current includes: determining a breathing rate of the person based on sensor data from a photoplethysmography (PPG) sensor; and The parameters of the first AC current and the second AC current are set based on the breathing rate.

33. The method of claim 21, wherein: tissue in at least a portion of the path of the first AC current is not stimulated by the first AC current, and Wherein tissue in at least a portion of a path of the second AC current is not stimulated by the first AC current.

34. The method according to claim 21 further comprises: at the same time: conducting a third AC current between a third pair of electrodes and through tissue of the person, and conducting a fourth AC current between a fourth pair of electrodes and through tissue of the person, and Wherein, based on the positioning of the third pair of electrodes and the fourth pair of electrodes on the person, the first AC current, the second AC current, the third AC current and the fourth AC current are simultaneously conducted through the target tissue.

35. The method of claim 34, wherein: tissue in at least a portion of the path of the third AC current is not stimulated by the third AC current, and Wherein tissue in at least a portion of a path of the fourth AC current is not stimulated by the fourth AC current.

36. The method of claim 21, wherein: The target tissue includes the human's hypoglossal nerve.

37. A device for electrically stimulating tissue, comprising: a housing configured to be attached to human tissue; a first battery and a second battery, which are located in the housing; a first pair of electrodes electrically coupled to the first cell; a second pair of electrodes electrically coupled to the second cell; as well as an attachment mechanism configured to attach the housing or at least one of the first pair of electrodes and the second pair of electrodes to tissue of the person such that the first pair of electrodes and the second pair of electrodes contact the tissue of the person, wherein 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.

38. The apparatus of claim 37, wherein: The first pair of electrodes and the second pair of electrodes are located at a surface of the housing.

39. The apparatus of claim 37, further comprising: at least one patch configured to adhere to the skin of the person, the at least one patch comprising the first pair of electrodes and the second pair of electrodes; as well as At least one electrical connection is configured to couple the first battery and the second battery to the at least one patch.

40. The apparatus of claim 39, wherein: The at least one patch includes a first patch and a second patch, wherein the first patch includes the first pair of electrodes, and The second patch includes the second pair of electrodes.

41. The apparatus of claim 39, wherein: The at least one patch comprises: a first patch comprising a first electrode of said 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 said second pair of electrodes; and A fourth patch includes the second electrode of the second pair of electrodes.

42. The apparatus of claim 37, wherein: The housing is configured to be placed within the oral cavity of the person and to be removable from the oral cavity.

43. The apparatus of claim 42, wherein: The housing has a shape that traces the gum line of the oral cavity of the person.

44. The apparatus of claim 37, wherein: The housing is configured to be attached to the skin of the person beneath the person's chin.

45. The apparatus of claim 44, wherein: The housing has a shape that traces the jawline of the person.

46. ​​The device of claim 37, further comprising charging pins located at a surface of the housing, the charging pins being electrically coupled to the first battery and the second battery, Wherein the charging pins are configured to conduct power to recharge the first battery and the second battery.

47. The apparatus of claim 37, further comprising a wireless communication device within the housing, the wireless communication device configured to provide wireless communication capabilities to communicate with a central system.

48. The apparatus of claim 47, further comprising a controller located within the housing, wherein the wireless communication device is configured to transmit firmware updates to the controller, the firmware updates being provided by the central system.

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

50. A method for electrically stimulating a hypoglossal nerve, comprising: conducting a first AC current between the first pair of electrodes and through tissue of the person; conducting a second AC current between a second pair of electrodes and through tissue of the person; as well as The person's hypoglossal nerve is stimulated by the first AC current and the second AC current, wherein stimulation of the hypoglossal nerve causes movement of the person's tongue.

51. The method of claim 50, wherein: The first AC current has a first frequency and the second AC current has a second frequency, wherein the first frequency and the second frequency are both greater than 1000 Hz.

52. The method of claim 51, wherein: The current conducted through the hypoglossal nerve has a frequency that is different from the first frequency and different from the second frequency.

53. The method of claim 52, wherein: The current conducted through the hypoglossal nerve has a frequency equal to a frequency difference between the first frequency and the second frequency.

54. The method of claim 53, wherein: The frequency difference is less than 200 Hz.

55. A method for electrically stimulating neurons to treat a disease, comprising: conducting a first AC current between the first pair of electrodes and through tissue of the person; conducting a second AC current between a second pair of electrodes and through tissue of the person; as well as Neurons of the person are stimulated by the first AC current and the second AC current, wherein stimulation of the neurons provides treatment for a disease.

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

57. The method of claim 56, wherein: The current conducted through the neuron has a frequency that is different from the first frequency and different from the second frequency.

58. The method of claim 57, wherein: The current conducted through the neuron has a frequency equal to the frequency difference between the first frequency and the second frequency.

59. The method of claim 55, wherein: The disease comprises at least one of an inflammatory disease, restricted lymphatic flow, and incontinence.

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