Therapeutic electrical muscle stimulation device and treatment method

Abstract

Described herein are therapeutic electrical muscle stimulation (EMS) devices for detecting, diagnosing, treating, or preventing neurological diseases. These devices (including EMS kits, user interfaces and control systems, etc.) and methods may be used as part of a therapeutic or non-therapeutic procedure. For example, these methods and devices may be part of an exercise or fitness and / or may be used as part of a treatment, such as, in particular, for physiotherapy and / or for treating a condition or disease.

Description

[0001] Priority declaration

[0002] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 355,070, filed on June 23, 2022, entitled “THERAPEUTIC ELECTRICAL MUSCLE STIMULATION APPARATUS AND METHOD OF TREATMENT,” which is incorporated herein by reference in its entirety.

[0003] Incorporated by Reference

[0004] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0005] background

[0006] Neurological disorders involve dysfunction of the nervous system and associated anatomical structures. Structural, biochemical, or electrical abnormalities in the brain, spinal cord, or other nerves present with a wide variety of signs and symptoms, providing targets for therapeutic intervention and diagnosis. Such diseases and conditions are often difficult to detect, diagnose, and treat, requiring extensive evaluation and multidisciplinary considerations.

[0007] There are limited options for comprehensive analysis outside of the hospital setting, and patients are often left to manage symptoms with little chance of relief other than risky surgical intervention or medication. For example, disorders that manifest as involuntary muscle spasms or seizures often result in prolonged symptoms and limited or significantly delayed management.

[0008] Electrical muscle stimulation (EMS) may be a treatment option for some patients, but the associated hardware is restrictive, with limited adaptability and functionality to the user's specific needs. Adhesive electrodes prohibit physical activity during use and often lack preventive elements that could reduce the incidence of disease-related symptoms.

[0009] Even if EMS can adapt based on uploaded treatment plans, it still does not realize the individualized, personalized, and rapid response required to improve the quality of life of these patients. In addition, EMS is often only available to patients who are currently diagnosed with a disease or condition.

[0010] Being able to continuously monitor patients for signs or indications of disease-related events may provide improved treatment.In addition to treatment, the methods and devices described herein may address the preventive, diagnostic, and prognostic shortcomings associated with neurological diseases.

[0011] Public Overview

[0012] Described herein is an apparatus (including an EMS suit, a user interface, and a control system, etc.) for an electrical muscle stimulation (EMS) system, which may include hardware, software, and / or firmware, that can provide diagnosis, prevention, treatment, and detection of diseases and conditions (including symptoms associated with diseases and conditions). In general, the apparatus and methods described herein can be used as part of a therapeutic process or a non-therapeutic process. For example, these methods and apparatus can be part of an exercise or fitness (including weight loss) regimen. However, the methods and apparatus described herein can also or alternatively be used as part of a treatment, such as, in particular, for physical therapy and / or for treating a condition or disease.

[0013] In general, a therapeutic electrical muscle stimulation (EMS) device for treating a user suffering from a neurological disease may include a wearable upper torso region having a detection system having one or more sensors configured to detect user-specific biometric data. In addition, a processor is operably coupled to one or more sensors. The processor (e.g., a processing unit) may be configured to interpret the user-specific data. An interface may be operably coupled to the processor, which may be configured to receive one or more predetermined user-specific attributes associated with a neurological disease. A plurality of electrode assemblies on an inner surface of the upper torso region may be operably connected to the processor, wherein each electrode assembly may be configured to provide a therapeutically effective amount of electrical stimulation based on the user-specific data.

[0014] For example, a method of treating a user for a neuromuscular disease may include: receiving user movement data from one or more sensors of an electrical muscle stimulation (EMS) suit worn by the user; detecting neural indicators and / or neuromuscular indicators from the user movement data; and applying therapeutic treatment to the user from one or more electrodes of the EMS suit.

[0015] Receiving can include receiving accelerometer data. In some examples, receiving includes receiving movement data having a frequency consistent with a tremor in one or more body parts, for example, the frequency can be greater than 2 Hz. In some examples, the neural indicator and / or the neuromuscular indicator is consistent with a stroke. The neural indicator and / or the neuromuscular indicator can be consistent with Alzheimer's disease. In some examples, a potential pathology associated with the neural indicator and / or the neuromuscular indicator is identified and output.

[0016] Devices are also described herein. For example, a therapeutic electrical muscle stimulation (EMS) device for treating a user with a neurological disease may include: a wearable upper torso region including a detection system having one or more sensors configured to detect user-specific biometric movement data; a processor operably coupled to the one or more sensors, the processor configured to interpret the user-specific data to identify neural indicators and / or neuromuscular indicators from the biometric movement data; and a plurality of electrode assemblies on an inner surface of the upper torso region, each of the electrode assemblies operably connected to the processor, wherein each of the electrode assemblies is configured to provide electrical stimulation, wherein the processor is further configured to apply therapeutic treatment to the user from one or more electrodes in the plurality of electrode assemblies based on the identified neural indicators and / or neuromuscular indicators.

[0017] Also described herein is a device for diagnosis. For example, an electrical muscle stimulation (EMS) device for diagnosing a disease may include: a wearable upper torso region including a detection system having one or more sensors configured to detect user-specific biometric movement data; a processor operably coupled to the one or more sensors, the processor configured to interpret the user-specific biometric movement data to determine a disease profile; a plurality of electrode assemblies on an inner surface of the upper torso region, each of the electrode assemblies operably connected to the processor, wherein each of the electrode assemblies is configured to provide electrical stimulation; and an interface operably coupled to the processor, the interface configured to output a diagnostic comparison of the user-specific biometric data and one or more disease profiles.

[0018] In some examples, the device may also include a controller that may be electrically connected to the plurality of electrode assemblies, the controller may be configured to initiate EMS via the plurality of electrode assemblies according to an automatically adjustable stimulation regimen based on the data. The one or more sensors may include at least one accelerometer that may be configured to detect changes in acceleration associated with a neurological disease. The interface may be configured to communicate with one or more remote databases to obtain predetermined user-specific biometric data, wherein the therapeutically effective amount of electrical stimulation may be adjusted by the predetermined user-specific biometric data.

[0019] In some examples, the processor can be configured to establish one or more thresholds based on initial user-specific biometric data, wherein the initial user-specific biometric data can be acquired by one or more sensors within a predetermined duration starting from the first use of the EMS. Each of the one or more sensors can be associated with a plurality of electrode assemblies. The stimulation scheme can define a duration, intensity, location, pulse pattern, or stimulation sequence, and wherein the stimulation scheme can be configured to automatically adjust based on subsequent user-specific biometric data. The device can also include a lower region of the legs and buttocks of a user that can be configured to confirm, the lower region can include one or more sensors configured to detect user-specific biometric data associated with a neurological disease, wherein one or more sensors are operably coupled to the processor; and the plurality of electrode assemblies can be configured to provide a therapeutically effective amount of electrical stimulation to the legs and buttocks of the user based on the data. The user-specific biometric data can be associated with the incidence of tremors.

[0020] In some examples, user-specific data can be shared with one or more remote databases, and wherein a therapeutically effective amount of electrical stimulation can be associated with a threshold value that is configured to be adjusted based on one or more changes in the one or more remote databases. The therapeutically effective electrical stimulation can be automatically adjusted based on subsequent user-specific biometric data. The one or more sensors can include a plurality of sensors configured to acquire data associated with muscle tissue. At least one of the one or more sensors can be an electromyography sensor configured to predict tremors, wherein bioelectric signals can be detected prior to involuntary muscle contractions. The neurological disease can be Alzheimer's disease, Parkinson's disease, Huntington's disease, brain injury, spinal cord injury, autoimmune disease, restless legs syndrome, essential tremor, and a genetic neurological disease.

[0021] In some examples, a therapeutically effective amount of electrical stimulation may be sufficient to prevent or reduce involuntary muscle activity associated with a neurological disease. The one or more sensors may include a plurality of sensors configured to detect user-specific data associated with respiration. The one or more sensors may include a plurality of sensors configured to detect user-specific data associated with body temperature. The one or more sensors may include a plurality of sensors configured to detect user-specific data associated with sweating. Each of the one or more sensors may be integrated with a plurality of electrode assemblies. The user-specific biometric data may include a plurality of biometric characteristics obtained from more than one sensor. The processor may be configured to compare the interpreted data with one or more neurological disease profiles.

[0022] Typically, an electrical muscle stimulation (EMS) device for diagnosing a disease may include a wearable upper torso region, the wearable upper torso region including a detection system, the detection system may have one or more sensors configured to detect user-specific biometric data. A processor may be operably coupled to one or more sensors. The processor may be configured to interpret the user-specific biometric data and compare the interpreted user-specific biometric data with one or more disease profiles. A plurality of electrode assemblies on the inner surface of the upper torso region, each of the electrode assemblies may be operably connected to the processor, wherein each of the electrode assemblies is configured to provide electrical stimulation, wherein the electrical stimulation may at least effectively challenge a biological tissue response. An interface may be operably coupled to the processor, the interface may be configured at least to present a diagnostic comparison of the user-specific biometric data with one or more disease profiles.

[0023] In some examples, the device may further include a controller electrically connected to the plurality of electrode assemblies. The controller may be configured to initiate diagnostic EMS excitation via the plurality of electrode assemblies. One or more sensors may include at least one accelerometer configured to detect acceleration changes associated with a disease. The interface may be configured to communicate with one or more remote databases to obtain one or more predetermined biometric factor ranges, wherein the processor is configured to compare user-specific biometric data with one or more predetermined biometric factor ranges.

[0024] In some examples, the processor can be configured to establish one or more thresholds based on initial user-specific biometric data, wherein a deviation of the detected user-specific biometric data from the initial user-specific biometric data is associated with a disease. Each of the one or more sensors can be associated with a plurality of electrode assemblies. The user-specific data can be shared with one or more remote databases, and wherein the therapeutically effective amount of electrical stimulation is associated with a threshold value that is configured to be adjusted based on one or more changes in the one or more remote databases. The diagnosis of the disease can be based on the user-specific biometric data. The one or more sensors can include a plurality of sensors configured to acquire data associated with muscle tissue. One of the one or more sensors can be an electromyography sensor configured to detect tremors. The diagnosed disease can be a neurological disease.

[0025] In some examples, the one or more sensors may include a plurality of sensors configured to detect user-specific data associated with respiration. The one or more sensors may include a plurality of sensors configured to detect user-specific data associated with body temperature. Each of the one or more sensors may be integrated with a plurality of electrode assemblies. The user-specific biometric data may include a plurality of biometric characteristics obtained from more than one sensor. The processor may be configured to compare the interpreted data with one or more neurological disease profiles to determine a diagnosis of the disease.

[0026] For example, the present invention describes a therapeutic electrical muscle stimulation (EMS) device for treating a user with a neurological disease, the EMS device comprising: a wearable garment comprising a detection system having one or more sensors configured to detect user-specific biometric movement data, and a processing system comprising a plurality of electrode assemblies; a processor operably coupled to the one or more sensors, the processor configured to interpret the user-specific biometric movement data to identify neural indicators and / or neuromuscular indicators from the user-specific biometric movement data; and wherein the plurality of electrode assemblies are on an inner surface of the wearable garment, further wherein each of the plurality of electrode assemblies is operably connected to the processor and configured to provide electrical stimulation to the user, wherein the processor is further configured to apply therapeutic treatment to the user from one or more electrodes in the plurality of electrode assemblies based on the identified neural indicators and / or neuromuscular indicators.

[0027] The processor may include a controller configured to initiate EMS via the plurality of electrode assemblies according to an automatically adjustable stimulation protocol based on the data. Any of the one or more sensors may include at least one accelerometer configured to detect acceleration changes associated with a neurological disease.

[0028] Any of these devices may include an interface configured to communicate with one or more remote databases to obtain predetermined user-specific biometric data, wherein the therapeutically effective amount of electrical stimulation is adjusted by the predetermined user-specific biometric data.

[0029] In any of these devices, the processor may be configured to establish one or more thresholds based on initial user-specific biometric data acquired by one or more sensors within a predetermined duration starting from a first use of the EMS.

[0030] Each of the one or more sensors can be associated with a plurality of electrode assemblies. In any of these examples, the stimulation scheme defines a duration, intensity, location, pulse pattern, or stimulation sequence, and wherein the stimulation scheme is configured to automatically adjust based on subsequent user-specific biometric data. The wearable garment can include an upper torso region. In some examples, the wearable garment can also or alternatively include a lower region configured to confirm the user's legs and buttocks.

[0031] The user-specific biometric data may be associated with the incidence of tremor. The therapeutically effective amount of electrical stimulation may be associated with an adjustable threshold. The therapeutically effective amount of electrical stimulation may be automatically adjusted based on subsequent user-specific biometric data.

[0032] One or more sensors may be configured to acquire data associated with muscle tissue. At least one of the one or more sensors may include an electromyographic sensor, and the processor is configured to predict tremor based on data from one or more sensors including the electromyographic sensor. The processor may be configured to apply EMS before an involuntary muscle contraction associated with tremor. In some examples, the processor may be configured to apply EMS within about 1 second (about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 30 seconds, about 40 seconds, about 45 seconds, about 60 seconds, about 1.5 minutes, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, etc.) of detecting an involuntary muscle contraction associated with tremor.

[0033] Neurological diseases associated with these devices and methods of using these devices can be selected from the group consisting of: Alzheimer's disease, Parkinson's disease, Huntington's disease, brain injury, spinal cord injury, autoimmune disease, restless legs syndrome, essential tremor and inherited neurological diseases. The therapeutically effective amount of electrical stimulation can be sufficient to prevent or reduce involuntary muscle activity associated with a neurological disease.

[0034] The one or more sensors may include a plurality of sensors configured to detect user-specific data associated with respiration. The one or more sensors may include a plurality of sensors configured to detect user-specific data associated with body temperature. The one or more sensors may include a plurality of sensors configured to detect user-specific data associated with sweating. Each of the one or more sensors may be integrated with a plurality of electrode assemblies. The user-specific biometric data may include a plurality of biometric characteristics obtained from more than one sensor. The processor may be configured to compare the interpreted data with one or more neurological disease profiles.

[0035] In any of these methods and apparatus, the processor may include a trained machine learning agent that is trained to identify neural indicators and / or neuromuscular indicators from user-specific biometric movement data. The trained machine learning agent may be trained based on a curated dataset that includes biometric data from individuals wearing the same or different suits (e.g., suits with similar sensors and / or similarly positioned sensors) that record biometric movement data and have identified individuals with one or more neurological diseases / neuromuscular diseases. In some cases, the training set may include information about severity and / or specific diagnostic information.

[0036] The present invention also describes an electrical muscle stimulation (EMS) device for diagnosing a disease, the device comprising: a wearable area, the wearable area including a detection system having one or more sensors configured to detect user-specific biometric movement data; a processor, the processor being operably coupled to the one or more sensors, the processor being configured to interpret the user-specific biometric movement data to determine a disease profile; a plurality of electrode assemblies on an inner surface of the upper torso area, each of the electrode assemblies being operably connected to the processor, wherein each of the electrode assemblies is configured to provide electrical stimulation; and an interface, the interface being operably coupled to the processor, the interface being configured to output a diagnostic comparison of the user-specific biometric data with one or more disease profiles.

[0037] As mentioned, the processor may include a trained machine learning agent. In some examples, the trained machine learning agent may be configured to determine a disease profile based on user-specific biometric movement data. The machine learning agent may be trained on a curated dataset that includes biometric data from individuals wearing the same or different suits (e.g., suits with similar sensors and / or similarly positioned sensors) that record biometric movement data and have identified individuals with one or more known neurological / neuromuscular diseases. In addition to specific diagnostic information, the training set may include information about severity and / or patient age, gender, weight, body shape, overall health (e.g., muscle tone, etc.), etc.

[0038] Any of these devices may include a controller electrically connected to the plurality of electrode assemblies, the controller configured to initiate diagnostic EMS stimulation via the plurality of electrode assemblies.The one or more sensors may include at least one accelerometer configured to detect acceleration changes associated with a disease.

[0039] The interface may be configured to communicate with one or more remote databases to obtain one or more predetermined biometric factor ranges, wherein the processor is configured to compare the user-specific biometric data with the one or more predetermined biometric factor ranges. The processor may be configured to establish one or more thresholds based on the initial user-specific biometric data, wherein the deviation of the detected user-specific biometric data from the initial user-specific biometric data is associated with the disease. Each of the one or more sensors may be associated with a plurality of electrode assemblies. The one or more sensors may include a plurality of sensors configured to acquire data associated with muscle tissue. At least one of the one or more sensors may be an electromyography sensor configured to detect tremors. The one or more sensors may include a plurality of sensors configured to detect user-specific data associated with respiration. The one or more sensors may include a plurality of sensors configured to detect user-specific data associated with body temperature.

[0040] Each of the one or more sensors may be integrated with a plurality of electrode assemblies.

[0041] The processor may be configured to compare the interpreted data to one or more neurological disease profiles to determine a diagnosis of the disease.

[0042] As mentioned, methods of using any of these devices are also described herein. For example, a method of treating a user for a neuromuscular disease may include: receiving user movement data from one or more sensors of an electrical muscle stimulation (EMS) suit worn by the user; detecting neural indicators and / or neuromuscular indicators from the user movement data; within about 5 minutes (e.g., about 2 seconds, about 3 seconds, about 4 seconds, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 30 seconds, about 40 seconds, about 45 seconds, about 60 seconds, about 1.5 minutes, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, etc.) of detecting the neural indicators and / or neuromuscular indicators, such as within about 1 minute, applying therapeutic treatment to the user from one or more electrodes of the EMS.

[0043] Any of these methods may include receiving accelerometer data. Receiving may include receiving movement data having a frequency consistent with a tremor in one or more body parts. For example, the frequency may be 2 Hz or higher.

[0044] In some examples, the neural indicators and / or neuromuscular indicators are consistent with stroke. The neural indicators and / or neuromuscular indicators may be consistent with Alzheimer's disease. Any of these methods may include identifying and outputting a potential pathology associated with the neural indicators and / or neuromuscular indicators.

[0045] Alternatively or additionally, EMS devices (e.g., suits) that can be used with users diagnosed with a neurological disease are also described herein; generally, these EMS suits can be configured to provide therapy configured to reduce or improve functional impairments associated with a specific neurological disease (e.g., tremors, loss of coordination, etc.). For example, the device can include a processor and / or controller that is programmed to deliver EMS therapy configured to be specific to the disease.

[0046] All methods and apparatus described herein (in any combination) are contemplated herein and may be used to achieve the benefits described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] A better understanding of the features and advantages of the methods and apparatus described herein will be obtained by referring to the following detailed description setting forth illustrative embodiments and the accompanying drawings, in which:

[0049] Figure 1A-1F An example of an EMS device as described herein is shown.

[0050] Figure 2A-2C Examples of parts of an EMS device are shown.

[0051] Figure 3A-3B An example of an EMS device (eg, an EMS suit) worn on a user is shown.

[0052] Figure 4A-4B Another example of an EMS device as described herein is shown.

[0053] Figure 5 Example hydration of electrodes for an EMS device is shown.

[0054] Figure 6 One example of a power supply for an EMS device is shown.

[0055] Figure 7A-7D An example of a combined power supply and controller for an EMS device as described herein is shown.

[0056] Figure 8A-8E An example of a combined power supply and controller for an EMS device is shown.

[0057] Figure 9A-9F An example of a combined power supply and controller for an EMS device is shown.

[0058] Fig.10 One example of a portion of a combined power supply / controller for an EMS device is shown.

[0059] Fig.11An example of an EMS device as described herein is schematically shown.

[0060] Fig.12 An example of a control system (eg, application software) for an EMS device is schematically shown.

[0061] Detailed Description

[0062] Described herein are electrical muscle stimulation (EMS) devices (e.g., devices and systems, including suits, controls, operating protocols, etc.) that include therapeutic systems for detecting, preventing, diagnosing, and / or treating a disease or condition. The EMS device may include a plurality of structural elements adapted to acquire user-specific data associated with the disease or condition. The structural element may include a sensor associated with the EMS device and configured to acquire user-specific data before, during, and / or after use, and the user-specific data may relate to signs or symptoms of the disease, condition, or risk factors thereof.

[0063] Each sensor can be configured to receive or acquire data that can be interpreted by the treatment system and used to detect, prevent, diagnose and / or treat a disease or condition.For example, the sensor can detect or acquire biometric data associated with the user.

[0064] In some examples, the treatment system may include an interface that is operably connected to the treatment system and is configured to receive one or more inputs associated with a user. For example, a user interface may receive user input to generate a user profile that may adjust parameters of a treatment system (e.g., a sensor). In some examples, the interface may communicate with one or more databases or electronic systems that have data generated or established outside the EMS device that may be incorporated into the treatment system operation. For example, the interface may communicate with one or more electronic medical record systems that have user-specific information, such as medical history, laboratory test results, examination notes, or other relevant information associated with a disease or condition or its risk factors. The treatment system may interpret the remote user-specific information and adjust one or more of the sensors or one or more parameters for sensor operation based on the remote user-specific information to achieve target sensor operation.

[0065] In some examples, a stimulation (EMS) device may include one or more sensors configured to acquire and / or generate data and information within the device to detect, diagnose, prevent, and / or treat a condition (e.g., a neurological disease) based on user-specific characteristics. The sensors may utilize various techniques to acquire biological and physiological information (e.g., muscle characteristics) from a user. For example, a sensor may be configured to detect a tremor or other symptom of a disease or condition, which may be interpreted by the EMS device (e.g., via a therapeutic system) and used to determine, establish, and / or execute a therapeutic stimulation regimen based on the detected tremor. The stimulation treatment regimen may be tailored to the symptoms or detected information associated with the disease or condition.

[0066] In some examples, an EMS device as described herein may include one or more sensors to obtain user-specific biometric data related to the incidence of tremor. For example, one or more sensors may include an accelerometer to determine movement (e.g., acceleration) on a macroscopic or microscopic scale. An EMS device (e.g., an EMS suit) may include one or more accelerometer sensors located or located within, on, and / or associated with an EMS suit to fully operate and detect user-specific data. An accelerometer sensor (e.g., an accelerometer) may be configured to sense changes in the acceleration of a user at an area or region of the user's anatomical structure and / or the user's entire body. The detected changes may include changes or ratios of acceleration from a stable state of motion to a deviation from motion (e.g., tremor). A stable state of motion may include no motion (e.g., sedentary) or motion associated with a natural or natural biomechanical operation of a user's anatomical structure (e.g., a biological tissue such as muscle tissue). An accelerometer sensor may include one or more inertial measurement units (IMUs) configured to detect or acquire user-specific data associated with the inertia of the user's anatomical structure.

[0067] In some examples, the accelerometer sensor can be configured to detect symptoms of a disease or condition (e.g., tremor). Detection by the sensor can include acquiring data by the sensor that is interpreted by an EMS device (e.g., a therapy system). Based on the interpreted and acquired data, the EMS device can provide an alert or notification of the detected event.

[0068] In some examples, the EMS device can provide electrical stimulation via one or more electrodes as described herein. For example, a stimulation scheme can be established based on sensor data or the interpretation of sensor data, and the sensor data includes stimulation parameters such as stimulation intensity, duration, anatomical position, sequence, etc. In some examples, the stimulation scheme can be adjusted based on subsequent data acquired by one or more of the sensors associated with the EMS device (e.g., EMS suit). In some examples, the adjustment is dynamic, and one or more of the stimulation parameters can be increased or decreased based on the data subsequently acquired or one or more of the stimulation parameters can be adjusted in a combination of increase and decrease. For example, an initial stimulation scheme can be established based on the detection of tremor, and after a period of time, additional data associated with the continuation of tremor can be acquired, which can make the stimulation scheme change one or more of the stimulation parameters. In some examples, the stimulation scheme can terminate after providing therapeutically effective stimulation.

[0069] One or more of the sensors may include a thermal sensor configured to detect biometric data related to the user's internal and / or external temperature. Body temperature may be a factor in one or more disease states or used to detect, predict, treat, prevent, or diagnose a disease or condition. A thermal sensor (e.g., a temperature sensor) may be located or capable of being located on the EMS device to obtain or detect the temperature of a user's vain contact, infrared sensing, etc. The data may then be sent to a processor (e.g., a processing unit) for interpretation and analysis according to any of the processes described herein.

[0070] One or more of the sensors may be adapted to detect user-specific biometric data associated with breathing. For example, respiratory volume, rhythm, pulse oxygen level, etc. may be detected by one or more respiratory sensors. In some examples, the respiratory sensor may include a sensor associated with the EMS suit that detects changes in volume when the user inhales. For example, a resistance sensor positioned throughout the suit may detect strain on the EMS suit when the user inhales. The detected strain may be interpreted in one or more algorithms adapted to quantify respiratory volume and respiratory rate. The respiratory sensor may also include an optical element configured to detect pulse oxygen by optically sensing blood flow through one or more blood vessels associated with the sensor.

[0071] One or more of the sensors may include an electromyographic sensor configured to detect electrical events associated with muscle function. The electromyographic sensor may detect or acquire user-specific data associated with muscle function and may be configured to predict voluntary muscle function, involuntary muscle function, or a combination of involuntary and voluntary muscle function.

[0072] Detection of user-generated electrical signals can provide data related to the incidence or prediction of biological activity associated with an impending disease. For example, an electromyographic sensor can detect pulses associated with biological activity associated with a disease from the nervous system to one or more biological tissues simultaneously or before occurrence. The data can be interpreted by a processor and can be a factor in detecting, diagnosing, preventing and / or treating the disease. For example, processing in conjunction with electromyographic sensor data can provide support for stimulation parameters and providing EMS by one or more electrodes.

[0073] Muscle properties may relate to the form and / or function of one or more muscle groups, muscles, or muscle regions. An example of a muscle property may be muscle density. Muscle properties may be acquired entirely by sensors. In some examples, elements of muscle properties may be acquired by sensors and input into one or more algorithms suitable for calculating or quantifying muscle properties including the acquired data. In some examples, quantification of muscle density may relate to the ratio of muscle to non-muscle tissue across or throughout an area of ​​the user's body. In some examples, quantification of muscle density may relate to the ratio of lean muscle to other tissue across or throughout an area of ​​the user's body. In some examples, quantification of muscle density may relate to the ratio of muscle tissue (e.g., muscle fibers) concentration within, across, or throughout the user's body.

[0074] Typically, an EMS device may include an EMS suit, which has one or more sensors that are coupled to the suit or can be coupled to the suit. The sensor may be associated with the EMS suit in the configuration that allows the relevant operation of the sensor to obtain data and information. The sensor may be operably connected to the EMS suit and / or associated with one or more elements (e.g., circuit, electrode, controller, processor, power supply, etc.) associated with the EMS suit. Each sensor may be independently or in combination with one or more other sensors or EMS suit elements to obtain and / or determine user-related attributes (e.g., muscle properties), and the user-related attributes may be transferred to the EMS system associated with the system to stimulate and / or manage stimulation regimens.

[0075] As described herein, an EMS device may include an optical sensor configured to measure user-specific muscle properties. The optical sensor may be located or capable of being located on an EMS suit. The location or arrangement of the optical sensor may be based on the target area of ​​the user being analyzed. The optical sensor may be located on the EMS suit at a position outside the user and proximal to a muscle group. For example, the pectoralis major is typically located on both sides of the sagittal plane and below the clavicle. Therefore, an optical sensor configured to obtain the muscle density of the pectoralis major may be positioned at or near the anatomical position of the pectoralis major on the EMS suit accordingly.

[0076] The optical sensor may operate based on the transmission of light modified by one or more body tissues (e.g., muscle tissue). Muscle properties may be determined or determinable based on changes in light emitted from the optical sensor. The change in light may involve a change or modification in one or more properties of the light emitted by the optical sensor. The emitted light is received by the optical sensor after transmission. The change in received light may be related to or understood as the effect of the light contacting the user's anatomical structure (e.g., muscle tissue). The change in emitted light may be related to one or more optical properties of biological tissue. Some examples of optical properties may include absorption, refraction, reflection, and scattering of light. Optical properties may be related to determinable properties of tissue contacted by the emitted light.

[0077] In some examples, the change in emitted light can include the refraction of light passing through the user's anatomical structure. For example, the change in emitted light can be a function of the refractive index (RI). RI is a characteristic optical variable that controls the propagation of light in a medium (e.g., biological tissue). The measurement of the RI of biological tissue (e.g., muscle tissue) can be associated with the density of the tissue as a factor of the change in the speed of light passing through the tissue. For example, one or more of the optical sensors of the EMS device described herein can emit light passing through one or more tissue layers of the user's body at an initial speed. When the light passes through the tissue layer, the initial speed can be observed by the optical sensor, and the modified speed can be observed based on the change in speed when the light passes through each tissue layer. Considering muscle tissue, the optical sensor can emit light that can penetrate the user's skin and continue to pass through the skin to the muscle tissue, wherein the light has a speed at the point of initial contact with the muscle tissue. When the light passes through the muscle tissue, the speed of the light can change (e.g., decrease), and the change in speed can be acquired by the optical sensor. In some examples, the change in emitted light can be observed or acquired by the optical sensor at different distances (e.g., penetration depth) and / or time intervals.

[0078] In some examples, the optical sensor described herein is suitable for acquiring scattered light caused by contact of emitted light with one or more biological tissues (e.g., muscle tissue). The scattered light analysis performed by the EMS device described herein can involve the influence of biological tissue on the emitted light, so that light particles scatter when contacting with various tissue structures (e.g., cells, fibers, extracellular matrix, etc.). For example, the light emitted by the optical sensor emitting element can have initial light properties (e.g., wavelength, frequency, intensity, etc.). When the emitted light contacts or engages with biological tissue (e.g., muscle tissue or muscle fiber), particles from the emitted light can be scattered by the tissue, and the optical sensor can acquire or sense the scattered light particles. The properties of the scattered light acquired (e.g., vector, reflection angle, speed, amount, concentration, etc.) can provide data input for quantifying one or more characteristics of biological tissue (e.g., the density of muscle tissue).

[0079] In some examples, the optical sensors described herein are suitable for acquiring information or data related to the reflection of light emitted into or through biological tissue (e.g., muscle tissue). For example, the optical sensor can emit light reflected by one or more layers of biological tissue. The reflected light can be acquired or sensed by the optical sensor, and data or information such as reflection angle, speed, duration, and other optical properties can be interpreted by the EMS device described herein. The reflection of the emitted light can provide different modifications to the light based on the biological tissue that affects the reflection. For example, muscle tissue can reflect light differently or identically with dermal tissue or interstitial tissue. The EMS system can interpret the sensor data to determine specific tissue characteristics (e.g., muscle density).

[0080] In some examples, an EMS suit (e.g., an EMS device) may include more than one optical sensor having a transmitting element, and each transmitting element may be configured to emit light having a property unique to the associated transmitting element. Unique light property values ​​may be interpreted by one or more receiver elements of the optical sensor and incorporated into the data received by each receiver element to distinguish the position of the associated transmitting element from which the light is emitted. For example, a first light may be emitted by an optical sensor transmitting element having an initial light property X and penetrate the user's body. After the light contacts one or more biological tissues (e.g., muscle tissue), particles having the initial light property X may be scattered and changed to a property Y that may be sensed by the optical sensor. The difference between property X and property Y may be processed in the EMS device (e.g., by a processor) to calculate muscle properties. The calculated muscle properties may then be incorporated into the EMS device, and a stimulation scheme may be established to provide stimulation based on muscle property data.

[0081] In some examples, the optical sensor includes an emitting element and a receiver element. The emitting element and the receiver element can be combined into a single sensor unit. The emitting element can emit light into one or more tissues of the user's body or through one or more tissues of the user's body. The receiver element can receive the light after the light has contacted one or more biological tissues (e.g., muscle tissue of the user) or is otherwise modified by one or more biological tissues (e.g., muscle tissue of the user).

[0082] In some examples, the light emitted by the optical sensor is laser or other forms of light suitable for penetrating biological tissue (eg, muscle tissue) sufficiently for analysis sensed by the optical sensor and EMS device (eg, EMS suit).

[0083] As described herein, an EMS device may include one or more bioelectric sensors to assess the bioelectric properties of biological tissue (e.g., muscle tissue). For example, the impedance of electrical pulses or energy emitted into the biological tissue of a user may be related to the biological properties of the tissue (e.g., muscle tissue). Some examples of bioelectric sensors may include a transmitting element and a receiver element. The bioelectric sensor transmitting element may emit electrical pulses into, through, across, or throughout the user's body tissue. The emitted electrical pulses may penetrate one or more biological tissues and be modified by the composition, orientation, position, type, arrangement, etc. of the biological tissue. For example, muscle tissue density may provide different modifications based on an increase in density or a decrease in density.

[0084] In some examples, the bioelectric sensor may include a transmitting element and a receiver element. The transmitting element may be configured to transmit an electric pulse into one or more biological tissues, through the biological tissue and / or across the one or more biological tissues. The receiver element may be configured to receive the transmitted electric pulse after the transmitted electric pulse has contacted one or more biological tissues (e.g., muscle tissue) or otherwise modified by one or more biological tissues (e.g., muscle tissue). In some examples, the electric pulse from the sensor may be modified from the initial properties when the sensor transmits or transmits the pulse. The difference in the received pulse may be combined or understood by the EMS device to determine or calculate the muscle properties that can be used to determine and establish a stimulation scheme. For example, in the case where the muscle is denser, the impedance may be greater. The receiver element may accordingly obtain or sense the change of the electric pulse associated with the increased muscle density, and adjust or establish stimulation parameters based on sensor data.

[0085] In some examples, the sensor is an ultrasonic sensor with a transmitting element and a receiver element. The ultrasonic sensor can be suitable for transmitting the sound of the initial frequency and wavelength into one or more biological tissues, across or through one or more biological tissues. The receiver element can be configured to receive the transmitted ultrasonic wave after the transmitted ultrasonic wave has contacted one or more biological tissues (e.g., muscle tissue) or is otherwise modified by one or more biological tissues (e.g., muscle tissue). In some examples, the ultrasonic wave from the sensor can be modified from the initial properties when the sensor transmits or transmits the ultrasonic wave. The difference of the received ultrasonic wave can be combined or understood by the EMS device to determine or calculate the muscle characteristics that can be used to determine and establish a stimulation scheme. For example, in the case of denser muscles, the ultrasonic wave can be reduced or reduced after contacting or passing through muscle tissue. The receiver element can obtain or sense the change of the ultrasonic wave related to the increased muscle density accordingly, and adjust or establish the stimulation parameters based on the sensor data.

[0086] In some examples, sensors coordinate with each other to combine or compile the data thus obtained.Sensors can transmit sensor data and sensor attributes (such as sensor position and sensor parameters) to compile and / or combine data to be interpreted by the EMS device in the establishment, determination and / or adjustment of the stimulation scheme.For example, the sensor on the chest of the EMS suit can transmit information on a predetermined position, targetable muscle groups and biological tissue properties.In some examples, energy (e.g., light, sound, electricity, etc.) can be emitted by a first sensor and received by a second sensor.The second sensor can be the same sensor or a different sensor.The second sensor can be a sensor of the same type as the first sensor, or can be a sensor of a different type from the first sensor.For example, the first sensor can emit a certain type of energy on the front side or part of the user, and the energy passes through the biological tissue to receive on the back side or part of the user.

[0087] In some examples, the EMS device described herein may include a processor operably coupled to a sensor. The processor may be suitable for interpreting data or information acquired or sensed by the sensor. For example, the processor may be suitable for incorporating sensor data into one or more algorithms for quantifying tissue properties (e.g., muscle tissue density). In some examples, the processor may be suitable for including one or more coefficients for interpreting sensor data. In some examples, the coefficient is predetermined based on known quantitative analysis of the optical properties of biological tissues (e.g., muscle tissue). In some examples, as described herein, the coefficient can be established based on the training of the algorithm within a period of time starting from the user engaging the EMS suit. For example, the user can engage the EMS suit, and the sensor can begin to acquire data from one or more sensors. The data can be interpreted into an initial algorithm, which is modified within a period of time until enough calculations provide user-specific coefficients that can be applied to subsequent user engagements.

[0088] A stimulation scheme or treatment scheme can be developed or established based on the interpretation of sensor data. Stimulation intensity, duration, arrangement, frequency, etc. can be modified based on the interpretation of sensor data or EMS device (e.g., processor) to sensor data. For example, an optical sensor can obtain data related to the optical properties of muscle tissue contacted by the light emitted by the optical sensor. The optical properties can provide data for determining the muscle density of the user, and the muscle density value can provide user-specific modifications to the stimulation scheme. The stimulation scheme can provide increased intensity, higher frequency, shorter pulse duration for denser muscle tissue. Each factor or aspect of the stimulation scheme can be suitable for user-specific muscle characteristics to provide optimal stimulation to one or more muscles. In some examples, based on optimized electrical stimulation for sensed muscle characteristics, the stimulation scheme can be more intense or less intense. Another example can include a bioelectric sensor that obtains data related to the bioelectric properties of muscle tissue contacted by the electrical pulse emitted by the bioelectric sensor. The bioelectric properties can provide data for determining the muscle density of the user, and the muscle density value can provide user-specific modifications to the stimulation scheme.

[0089] In some examples, stimulation parameters of a stimulation regimen can be adjusted by sensor data when a user engages the EMS device. The sensor can continuously acquire data over a period of time, and the data can cause adjustments to the stimulation regimen, or parameters of the stimulation regimen, or both. For example, a sensed increase in muscle density can increase a stimulation parameter to increase the stimulation provided by the electrodes.

[0090] The EMS device may include an integrated controller and power supply, including an integrated controller and power supply with user input / output (e.g., touch screen), which is compact and can be coupled to an EMS suit for controlling the suit and / or for communicating with one or more remote servers. An EMS device with wettable electrical contacts is also described herein, which is suitable for reliable and easy use (e.g., use at home or in a studio environment) by the wearer of the suit. An EMS suit device is also described herein, which is easier to wear, adjust and manipulate than traditional EMS suits, and can allow movement and flexibility while maintaining reliable and sufficient contact between a user and a plurality of EMS electrodes. Any device described herein may include a user interface configured to enhance the ease of operation and effectiveness of the EMS suit. For example, a device (e.g., system) for the safe and effective operation of the EMS suit is described herein, which includes limiting or preventing the operation in a manner that may be less effective and / or dangerous to the user.

[0091] In some examples, one or more sensors acquire data to be incorporated into an algorithm for calculating one or more user-specific muscle properties. For example, one or more of the sensors can acquire the size of the muscle based on the change of energy (e.g., light, sound, ultrasonic vibration, etc.) from the transmitting element to the receiver element after the energy is modified based on contact with muscle tissue. The initial value or attribute of the energy signal transmitted to the user's tissue and / or transmitted through the user's tissue can be different from the terminal value or attribute of the energy received by the receiver element. The difference in energy attribute values ​​can be input into an algorithm suitable for generating one or more function values ​​(e.g., duration, intensity, sequence, stimulation arrangement, etc.) for developing and / or executing a stimulation scheme. For example, muscle thickness and / or muscle density can be muscle properties related to the stimulation scheme. The transmitting element of the sensor can transmit a signal through the dermis of the user until the first incident of the signal contacts the muscle tissue. At the first incident contact, the signal may change due to the distance from the sensor to the muscle tissue, and is (the time x speed of sound from the sensor to send and then receive the sound / energy pulse) / 2.

[0092] Typically, an EMS device may include an EMS suit having a plurality of electrodes coupled thereto or capable of being coupled thereto, wherein the electrodes are positioned / positionable on the EMS suit in such an arrangement that provides muscle stimulation during the operation of the EMS suit while preventing the current from being dangerously (e.g., transthoracic flow) through the body of the user wearing the EMS suit. The individual electrodes of the EMS suit may be controlled by a processor to transmit electrical pulses to the muscles of the user wearing the EMS suit. In some examples, the processor controls the electrodes based on data and information received from the sensor. When an electrical pulse is transmitted via a pair of electrodes, an electric current (i.e., a charged particle flow) flows from one electrode (of the pair of electrodes) through a portion of the user's body (e.g., through the muscle tissue below the pair of electrodes) and flows to another electrode (of the pair of electrodes). The user's body completes the circuit including the pair of electrodes, thereby allowing the current to flow between the pair of electrodes during the operation of the EMS suit, because the electrical pulse is transmitted via the electrodes. A pair of electrodes may include two electrodes corresponding to a common channel in a plurality of channels, and the plurality of channels are used to transmit electrical pulses channel by channel during the operation of the EMS suit. A pair of electrodes may also include two electrodes that allow current to flow between them during operation of the EMS suit, one electrode in the pair of electrodes serving as a positive electrode (anode) and the other electrode in the pair of electrodes serving as a negative electrode (cathode). Using alternating current (AC), each electrode in a given pair may reverse the current flow in each cycle (or frame). That is, each electrode may change from a positive electrode (anode) to a negative electrode (cathode) with each cycle (or frame).

[0093] For example, Figure 1A-1F An example of an EMS system as described herein is shown. This example shows a wireless whole-body electrical muscle stimulation (EMS) system comprising a suit / vest, a lower body (pants / shorts) portion, a combined power supply / controller / user interface, and an electrode wetting source (e.g., a spray bottle). Figure 1A Examples of upper 101 and lower 103 underwear sets are shown. The underwear set can be configured to allow electrical connection between the electrodes and the underlying skin in appropriate areas of the body (e.g., above a target muscle group). For example, the underwear set can include openings and / or conductive areas (or can be completely conductive). The underwear set can be configured to fit the patient's body, for example as a stretch and / or compression garment. The underwear set can be washable.

[0094] Figure 1BAn example of an upper torso (e.g., vest) portion 105 of an EMS suit and a lower body portion 107 of an EMS suit is shown. The upper torso portion and the lower body portion can support a plurality of electrodes 109 that can be integrated into the device. As described in more detail below, these electrodes can be wettable electrodes that are adapted to be easily wetted by the user. The upper torso portion and the lower body portion can include one or more adjustable straps that allow the user to attach and adjust the fit. Figure 1B The upper torso portion 105 is shown configured as a vest, and the lower body region is configured as a chaps-like configuration to be worn over an underwear set. Figure 4A-4B As shown, the underwear set as well as the upper torso region and the lower body region can be integrated together into a single garment.

[0095] In any of these examples, the EMS suit can have electrodes strategically positioned to apply EMS to target muscle groups, such as the quadriceps (quadriceps), hamstrings, glutes, abdominals, chest, lower back, mid-back, upper back (trapezius), biceps and triceps, and / or calves.

[0096] In any of these examples, the electrical connector (e.g., "cable") can be integrated into the package. For example, coupling the power supply / controller into the package can automatically couple the electrodes to the power supply / controller via a single (e.g., multiplexed) connection, thereby significantly simplifying contact. For example, the integrated electrical connector can couple via an internal cable arranged to not restrict freedom of movement.

[0097] The electrodes of the EMS suit can be arranged in the EMS suit to cover portions of the user's body in order to stimulate specific muscle groups (e.g., arms, legs, chest, abdomen, back, etc.) by delivering electrical pulses that stimulate the muscle tissue under the user's skin. In particular, as will be described in more detail below, the electrodes described herein can be arranged in a manner that increases the ability of the electrodes to maintain reliable communication with the patient's skin during treatment and thereby provide energy to the underlying muscles.

[0098] For example, an upper body portion (e.g., torso, including chest, vest, etc.) can be worn on the upper torso of the user's body. The upper body portion can be coupled to the lower body portion, for example, via one or more mechanical connectors and / or electrical connectors. Thus, any buckle / strap shown can include a mechanical connector and an electrical connector.

[0099] In any of these devices, the connector 111 (e.g., buckle) can be configured to make and / or confirm electrical connection. For example, the power supply / controller can sense and / or confirm that each connector is coupled and / or secured. For example, the controller can provide a test current / pulse to confirm electrical connection (via the electrical properties of the connection, indicating an open circuit if not properly attached). Electrical contact with the user's skin can be similarly or additionally confirmed by the system and can be used as part of a safety interlock and / or power saving protocol.

[0100] In some examples, the upper body part may include a left front part, a right front part and a rear part. In some embodiments, the left front part has a first pair of electrodes positioned on the inner surface of the left front part and in the upper half of the left front part, and the right front part has a second pair of electrodes positioned on the inner surface of the right front part and in the upper half of the right front part. In this way, when the user's body wears an EMS suit, the first pair of electrodes can be arranged on one or more left pectoral muscles of the body (or top), and the first pair of electrodes can therefore be positioned on the first side (e.g., left side) of the median sagittal plane of the body and the first side (e.g., front side) of the frontal plane (frontal plane) of the body. The second pair of electrodes can be arranged on one or more right pectoral muscles of the body (or top), and the second pair of electrodes can be positioned on the second side (e.g., right side) of the median sagittal plane of the body and the first side (e.g., front side) of the frontal plane of the body.

[0101] Electrical pulses may be delivered by the respective electrode pairs so that the flow of current is primarily between each pair of electrodes through the target muscle area, so that current does not flow between an electrode in a first pair of electrodes and an electrode in a second pair of electrodes or any other pair of electrodes to avoid applying electrical energy to areas not intended to be stimulated. For example, the devices described herein may prevent current from flowing through the midsagittal plane of a user's body in the region of the thorax during operation of an EMS suit.

[0102] Figure 1C An example of an integrated controller / power supply 113 is also shown. In this example, the integrated power supply / controller includes separate mechanical and electrical connectors; however, in some examples, the same connector may be mechanically and electrically connected to the EMS suit. For example, in Figure 1C In the embodiment, the device includes a pair of electrical connectors 115 which can be attached to the electrical coupling contacts on the set. Figure 1A-1FIn, only a single pair (e.g., anode / cathode) connector is shown. In some examples, multiple connectors / contacts can be used. In this example, the suit can include an integrated multiplexed electrical manifold that can guide and / or switch the applied energy to a pair or more pairs of electrodes to which power is to be applied to apply EMS. Typically, power can be applied to each electrode pair once (sequentially), or in a manner that nearby electrodes communicated with the body are not activated simultaneously by applying electrical energy. The power supply / controller 113 can be held to the EMS suit by a pocket and / or a mechanical connector such as Velcro, a belt, etc. Multiple mechanical connectors can be included.

[0103] Figure 1D and Figure 1E An example of an arm electrode support 119 including electrodes 109 that can be used to apply electrical energy to the biceps and / or triceps is shown. In this example, where the arm electrode support is not integral to the upper / torso portion 105, an additional external cable 121 can be used to connect the arm electrodes to contacts 117 on the upper / torso portion (vest) 105. Alternatively, in some examples, the electrodes and / or electrode support can be integrated into the upper / torso EMS garment.

[0104] In any one of these devices, the rear of the upper body part of the EMS suit can include multiple electrodes 109, which include, for example, a third pair of electrodes positioned on the inner surface of the rear part and in the left half of the rear part, and a fourth pair of electrodes positioned on the inner surface of the rear part and in the right half of the rear part. When the user's body wears the EMS suit, the third pair of electrodes can be arranged on one or more left back muscles of the body (or top), and the third pair of electrodes can therefore be positioned on the first side (e.g., left side) of the median sagittal plane of the body and the second side (e.g., rear side) of the frontal plane of the body. Meanwhile, the fourth pair of electrodes can be arranged on one or more right back muscles of the body (or top), and the fourth pair of electrodes can therefore be positioned on the second side (e.g., right side) of the median sagittal plane of the body and the second side (e.g., rear side) of the frontal plane of the body. Other configurations and arrangements can be used.

[0105] Any of the electrodes described herein may be a wettable electrode that includes an absorbent substrate in electrical communication with the electrode (forming a fluid / wetting reservoir) and is configured to contact the user's skin (either directly or through an underwear suit). These wettable electrodes are configured to retain a conductive fluid (e.g., water, including saline), which can help make reliable electrical contact with the user's skin and maintain electrical properties even when the user sweats during physical exercise while wearing the EMS suit. This may be particularly helpful because these wettable electrodes can be configured (in terms of size and position) to allow continuous electrical contact with the skin without significant changes in electrical properties due to sweating. The electrode assembly may also include one or more ports or openings that are configured to connect to a fluid source 125 (e.g., such as Figure 1F The electrode assembly may be provided with a spray bottle (e.g., a spray bottle shown as an example in Figure 1) to allow a conductive fluid (e.g., saline) to be transferred to the fluid reservoir. For example, each electrode assembly may include a port on the outwardly facing side to which a fluid source may be coupled to apply the fluid (e.g., by spraying). The fluid port may also be configured to prevent leakage of the fluid (e.g., saline) from the port and / or from the electrode assembly. The electrode assembly may include a fluid reservoir, which may be a porous material (e.g., a sponge and / or a wettable hydrogel, etc.).

[0106] Figure 1A-1F The device shown does not show other parts of the associated application or device that can be used to control the applied power to drive the EMS of target muscle.Controller 113 may include a user interface (e.g., touch screen) for direct communication with the user and / or controller 113 may be configured to communicate wirelessly with one or more external processors (such as smart phones, tablet computers, computers, etc.).In some examples, the user can communicate via a smart phone or tablet computer (not shown).In some examples, the user can communicate with a remote processor.Any one of controller / power supply, smart phone and / or remote processor may include software, firmware and / or hardware for engaging with the user and / or for the operation of the control device, including software, firmware and / or hardware for enabling one or more safety protocols based on the user's condition and the previous operation of one or more EMS devices to prevent the user from exceeding the predetermined amount or calculated amount of the EMS to a separate body area (muscle) and / or whole body.

[0107] Figure 2AAn example of an upper torso portion 105 is shown. In this example, the upper torso portion includes a connector port 201 that can be coupled to an integrated controller / power supply (not shown). The device also includes a plurality of mechanical connectors (e.g., buckles, clasps, etc.) 202 and a plurality of adjustable straps (e.g., Velcro straps) 203, including side straps 204. The upper torso portion in this example also includes a zipper 205. A plurality of electrode pads 206 can also be integrated into the upper torso portion. The device can also include a connector (e.g., a buckle) 207 for coupling to a lower portion. Any of these connectors and / or straps can be adjustable and can include a retainer 208.

[0108] Figure 2B An example of a lower portion 107 is shown. The lower portion may also include one or more mechanical connectors and / or electrical connectors 216 for coupling to an upper portion (to which a power supply / controller may be attached). Alternatively or additionally, the lower portion may hold a controller / power supply (and may provide power and control the operation of the upper portion). For example, the lower portion may include a pocket and / or attachment site 213 for a controller / power supply and / or may include a connector port 211. The lower portion may include a hip belt 212 for securing the device to the waist (e.g., to or above an underwear set). In some examples, the device may include an adjustable strap and / or buckle and / or other components to adjust the fitting 216. The lower portion may also include one or more electrode assemblies (including electrical pads 215) for applying EMS to muscles / muscle groups on the lower body.

[0109] Figure 2C An example of an arm electrode support 119 is shown from the top 229 and the bottom 228 (user contact side). The arm electrode support can include one or more attachments (e.g., a band 221) including a loop 223 and / or a Velcro attachment portion 224. The arm electrode support can also include one or more electrode assemblies 222.

[0110] Figure 3A and Figure 3B An example of an EMS suit as described herein worn on a user is shown. Figure 3A In FIG. 1 , the EMS suit includes all the above components, including an upper portion 305 and a lower portion 307. The upper portion and the lower portion are coupled together, and a power supply / controller 350 is shown coupled to the lower portion. The user also wears an upper 301 and lower 303 underwear suit.

[0111] The EMS suit shown may include electrodes on the legs (e.g., quadriceps), buttocks, lumbar region, back, trapezius, and one or more electrodes on the abdomen, pectoralis and arms. The position may be adjustable within a predetermined or arbitrary range. For example, on the legs, the lower portion may be configured to allow adjustment of the position of the electrodes in one or two positions, such as adjusting the electrode positions on the inner thigh muscles or the inner and outer muscles. The electrodes may be positioned at a distance of between 5cm and 10cm. In another example, the device may be configured to allow adjustment of the position of the abdominal muscles, including adjusting the paired electrodes to be further or closer apart. The central abdomen may be adjusted and / or a more laterally separated position may be used.

[0112] Figure 4A-4B Another example of an EMS suit device similar to the above device is shown, where an underwear suit may not be required. In this example, the device includes an appearance similar to a diving suit and can be at least partially formed of an elastic material (such as a polymer material (e.g., neoprene, etc.)) that is breathable and configured to maintain electrodes (e.g., electrode assemblies) in contact with the skin. For example, in Figure 4A and Figure 4B In, the EMS suit can include an upper portion 405 and a lower portion 407, or can be an integral suit (e.g., an integrated upper portion and lower portion). The suit can be formed from an elastic fabric and include a closure system 447 (e.g., a zipper). The electrode assembly can be integrated into the suit, but can be configured to allow selection of one or more alternative positions, for example to allow a user to adjust the spacing of the anode electrode and the cathode electrode. Thus, the electrode can include an input (e.g., a strap, a selector, etc.) for allowing or locking the position of the electrode assembly. As described above, any of these electrode assemblies can be configured to allow a fluid (e.g., saline) to be applied as part of the electrode assembly. In Figure 4A and Figure 4B In the example arrangement shown, the electrodes may be coupled to a power source / controller 450 via internal wires (not visible).

[0113] In some examples, an electrode assembly or electrode described herein may include one or more sensors as described herein. For example, Figure 4BAn enlarged arrangement of sensors positioned throughout an EMS device is shown. Sensors 412 are shown, and examples of sensor elements (e.g., transmitting elements or receiver elements) 413 can be positioned at locations on the EMS device to be operably connected to the user's biological tissue. In some examples, sensors 412 are integrated with or otherwise associated with electrodes or electrode assemblies. In some examples, sensors 412 are located or can be located on the interior of the EMS suit so that they contact the user's skin or are substantially near the user's skin.

[0114] As described above, any of these devices may include an electrode assembly configured to wet the electrode or wettable electrode. For example, these devices may be configured so that fluid (e.g., water, saline, etc.) can be added to wet the skin contact surface of the electrode assembly. Electrical contact is essential for the normal function and control of the EMS device. The electrode assembly can be wetted before and / or after the application device, and in particular when the electrode assembly includes a fluid reservoir area, such as a porous material (e.g., a sponge and / or a wettable hydrogel, etc.). Figure 5 An example of applying a fluid (e.g., water) 567 via a spray bottle to wet the electrodes 565 on the inside of the suit 563 (and specifically, to wet the porous skin contacting surface of the electrodes) is shown. In some examples, the suit can include one or more ports into which a fluid (e.g., water, saline, etc.) can be added. The fluid can be a conductive fluid.

[0115] Any device described herein may include sensors that can confirm the position and / or activity of the user, such as motion sensors, position sensors, etc. The sensor may be included with one or more electrodes and / or may be included with a controller (or a power supply and / or controller, including an integrated power supply / controller). Sensors such as accelerometers may be used to confirm that the user is performing a predetermined action / exercise (as described below), and therefore the application of EMS may be coordinated with the prescribed movement. The sensor may also be used as a safety trigger, such as stopping or pausing (or reducing in some cases) the application of EMS based on the sensed motion and / or position.

[0116] Typically, the suits described herein can be cleaned and maintained by the user. For example, the suit can be treated with an antibacterial solution and rinsed with water. Anti-odor products can be applied after each use and / or after applying the antibacterial solution. The suit can be dried, for example, by processing in a dry area. An air drying system can be used to accelerate drying. Heated air or room temperature air can be used to dry the suit. Typically, the suit can be washed, for example, by soaking in a low concentration of soap solution. The suit can be washed and / or rinsed in cold water to clean (including removing excess salt from increased fluid and / or sweat).

[0117] Also described herein are power sources and / or combined power sources (eg, batteries) and controllers. Figure 6 An example of a power source (e.g., a battery) 600 is shown. This example can be used with a device as shown herein and can include a simple user interface showing power level 661, wireless connectivity 662 (e.g., Bluetooth connection), etc. In some examples described in more detail below, additional user interface information (e.g., a touch screen) can be included. Any of these devices may include an audio output terminal 663 (e.g., a speaker) that can be used as an output terminal. The power source / controller can be, for example, 500g or less (e.g., 450g or less, 400g or less, 350g or less, 300g or less, 250g or less, etc.). The device can be relatively small (e.g., 20cm×10cm×5cm or less, 18cm×8cm×3cm or less, 16.5cm×8cm×3cm or less, etc.). The device can also include an on / off button that can be controlled manually or automatically. Any of these power sources can be configured as a battery, such as a lithium ion (Li-Ion) battery. The power source can include a charging port (e.g., a mini USB port). In some examples, the power supply may also or additionally include a port for connecting to the EMS suit and / or a cable connected to the EMS suit. As described above, in some examples, the power supply (or power supply / controller) may be configured to be fixed in a bag in the suit and may be electrically coupled to the suit when in the bag.

[0118] Any of these power supplies and power supplies / controllers may include one or more emergency shutoff controls or override shutoff controls. The shutoff control may be configured to immediately stop applying power to the electrodes. In some configurations, the shutoff control may be configured to completely shut down the device; in other examples, the shutoff control may continue sensing / monitoring and processor functions until a resting condition is met, but may disable the application of power to any electrode (e.g., for delivering EMS). For example, in some examples, an emergency shutoff control (or override shutoff control) may be included on an outer surface of a battery or battery / controller. In some examples, the suit may have an integrated shutoff control on the front outer surface of the suit that may be easily actuated by a user.

[0119] Any of these packages may include one or more sensors (e.g., physiological sensors) including a heart rate sensor, a pulse oxygenation sensor, a respiration sensor, etc. In some examples, the device may be configured to trigger a safety shutdown of the EMS if the sensor detects a user's physiological signal that exceeds a predetermined safety threshold, for example, if the heart rate exceeds, for example, 180 bpm (e.g., 155 bpm, 160 bpm, 165 bpm, 170 bpm, 175 bpm, 180 bpm, 190 bpm, 195 bpm, 200 bpm, 205 bpm, etc.), and / or if the blood pressure exceeds a predetermined range, etc.

[0120] Figure 7A-7D An example of a combined power supply / controller 700 is shown. In this example, the combined power supply / controller includes a touch screen input 771 and may include one or more additional inputs 772, including an emergency shutoff control. The combined power supply / controller may also include an attachment (input) 775 for coupling to a charging source and / or for coupling to an input / output (including a cable input / output) on an EMS suit. Figure 8A-8E Shows something like Figure 7A-7D Another example of a combined power supply / controller 800 is shown, which also includes a display screen (which can optionally be a touch screen) 871 and one or more input terminals 872, including, for example, an emergency shutoff control. Figure 9A-9F Another example of a combined power supply / controller is shown including a display 971 and an input 972. This example also shows an interface or adapter 976 for coupling to an EMS suit and / or a charger for charging the power supply integrated with the controller.

[0121] Fig.10 An image of a prototype combined power supply / controller 1000 is shown with the housing removed, showing visible display screen 1071 and input 1072. The controller may include one or more processors, memory, timers, and control circuitry, including wireless circuitry and / or power control circuitry.

[0122] Fig.11 An example of an EMS device is shown that includes an EMS suit 1103 that includes a controller / power supply that can operate with software on one or more of a user device (e.g., a smartphone 1107), a remote server 1105, and / or a coach (or course) processor 1111. Fig.11In the embodiment of the present invention, the EMS suit 1103 can be controlled by the controller 1105 worn. As described above, the local wear (EMS suit) controller can include a safety override control, and can generally control the application of the EMS to the electrode / electrode assembly in the suit. The controller (e.g., integrated power supply / controller 1105) worn locally can be, for example, wirelessly communicated with any one of the user device 1107, the coach / course processor 1111 and / or the remote server via Bluetooth (or other wireless technologies). For example, the suit that can be identified by the unique identifier (e.g., name, number, address, etc.) associated with the user can receive instructions for transmitting a predetermined EMS solution corresponding to the desired training solution. The solution can be transmitted by the local controller, but can be combined with a remote server, a coach course / server (e.g., for collective exercise) or run from a user device (e.g., smart phone 1111).

[0123] In particular, the device can be configured so that during a training session, a selected or prescribed training regimen can be provided to the user, instructing the user to perform one or more actions. As described above, a sensor (e.g., a motion sensor (e.g., an accelerometer)) can be included as part of the combined power supply / controller, and the controller can confirm whether the user has started a prescribed movement, is continuing to perform a prescribed movement, or has completed a prescribed movement before applying or continuing to apply EMS.

[0124] Typically, the application of EMS can be directed to a specific set of muscles or muscle groups corresponding to a specific activity. For example, the device can be configured to apply exercises for specific user goals, such as increasing endurance, mobility and / or strength. These exercises can include a set of defined movements or actions (e.g., exercises, yoga / stretching postures or movements, etc.), and can be presented to the user simultaneously with the application of EMS to one or more muscles (or muscle groups) associated with the movement or action.

[0125] For example, a strength training routine may include resistance exercises (weights, bands, body weight, etc.), core strength, high-intensity interval training, etc., and may target specific muscles. The device may automatically apply EMS in a manner coordinated with the presentation (and assumed performance) of movement and / or may detect the user's movement and apply EMS when the user is performing the appropriate corresponding movement or shortly thereafter. In some examples, the device may therefore provide the user with immediate feedback that the movement is performed within the desired activity level, thereby further enhancing the effect of the EMS.

[0126] In any of these devices, the intensity of the device can be automatically adjusted to adjust the EMS applied or a range of EMS intensity can be set in which the user can select the intensity (e.g., high, medium, low, off, or X% of 100%, where a range of 100% is automatically set by the system).

[0127] Specifically, the device described herein can control and / or set the maximum EMS power / intensity that can be applied to a particular user based at least in part on one or more of the following: (1) the user's initial baseline (e.g., starting baseline); (2) input provided by the user; and (3) the history of EMS applied to the same user (including the last z hours or z days). The device can control the applied EMS power / intensity specific to each muscle or muscle group (e.g., the maximum intensity / power applied to the quadriceps femoris can be different from the maximum power / intensity applied to the biceps, for example). Alternatively, the maximum power / intensity of the applied EMS can be the same in all muscles / muscle groups. The device described herein can adjust the EMS power / intensity by adjusting one or more of the following: the applied pulse frequency (e.g., between 0Hz / off and 120Hz, such as between 0Hz-100Hz, between 50Hz-120 Hz, between 60Hz-120 Hz, between 70Hz-120 Hz, between 80Hz-100Hz, between 70Hz-100Hz, between 8 ... Hz, etc.), applied current (e.g., between about 0.2 milliamperes (mA)-120mA, between about 1mA-90mA, between about 1mA-100mA, between about 5mA-110mA, between about 1mA-120mA, etc., or any range within these values), pulse width (e.g., between about 100 microseconds (μs) to about 500μs, between about 200μs to about 450μs, between about 150μs to about 400μs, or any range between these values). In some examples, the EMS power / intensity can be adjusted by adjusting the ramp-up time (the time to ramp up to the maximum applied current) and / or by adjusting the frequency within the application session (increasing or decreasing the frequency).

[0128] In some examples, the intensity or stimulation parameters or automatic adjustment of the stimulation scheme can be adjusted based on information acquired by the sensor (e.g., optical ultrasound, electrical sensor). In some examples, the adjustment can be triggered based on a predetermined stimulation interval or duration. In other examples, the user can selectively engage the controller to initiate an update or adjustment process, including the operation of the sensor to acquire data and provide updated sensor data for processing by the EMS device, which can be used for adjustment.

[0129] Generally, the devices described herein can be configured to apply power to only a subset of electrodes (e.g., a muscle or muscle group), and can apply power to separate sets of electrodes corresponding to different muscles in an alternating manner to avoid stimulating multiple sets of electrodes simultaneously.

[0130] The devices described herein can be configured to safely apply EMS by controlling the applied energy (e.g., frequency and / or current and / or pulse width and / or ramp-up / ramp-down time) based on a combination of one or more of the following: (1) the user's initial baseline (e.g., starting baseline); (2) input provided by the user; and (3) the history of EMS application to the same user (including the last z hours or z days). In particular, the devices described herein can automatically set the maximum applied EMS power and / or intensity by estimating a maximum value specific to a particular user based on the user's specific baseline and the user's recent (e.g., within the last z hours, where z is between about 8 hours or less, about 24 hours or less, about 36 hours or less, about 48 hours or less, about 60 hours or less, about 72 hours or less, etc.).

[0131] An initial baseline may be set based on the user's initial responses to questions such as the user's age, fitness level, general or specific health issues, etc. In some examples, the device may perform an automated Q&A / testing session to set a baseline / initial user level. For example, a user may respond to questions about their ability to feel certain EMS inputs from one or more (or all) of the electrodes. The user may also be asked to perform various actions (e.g., exercise) while wearing the device and / or without the device, and feedback may be provided by self-report or via one or more sensors (e.g., heart rate sensor, pulse oxygenation sensor, accelerometer / position sensor, etc.).

[0132] Baseline data can be estimated, and an initial maximum level of EMS intensity / power can be determined. The initial baseline can be determined from group data of similarly situated users (e.g., users grouped by age group, gender, health, weight, height, etc.). The initial baseline data can be set based in part on user-reported responses to various different EMS stimulation levels for each muscle / muscle group (or subset of muscles / muscle groups).

[0133] The data set for each user can be maintained locally (e.g., on a user-specific EMS suit / controller) and / or can be stored in a remote database and accessed by the user-specific EMS. The user information (data) can include a specific response to the initial baseline data collection and / or the initial baseline values ​​estimated by the system (including initial baseline values ​​specific to each muscle or muscle subset). In some cases, the initial baseline values ​​for different muscles can be determined based on patient-specific estimates for one or more muscles (e.g., quadriceps, biceps, pectoralis, etc.).

[0134] The user-specific baseline data may be adjusted periodically. The user-specific data may be protected. For example, if the user-specific data is recorded in a remote database, it may be anonymous and indexed by a separate security key corresponding to a specific user. In some cases, the baseline information may be specific to an EMS system (e.g., an EMS suit) and / or specific to a user. A user may be uniquely associated with a specific EMS suit.

[0135] The maximum EMS intensity / power that can be applied to the user can be adjusted as the system is operated. Typically, the initial (e.g., baseline) EMS intensity / power can be set low to avoid harming the user. In the case of continued use, the maximum intensity can be adjusted. For example, the device can be configured to increase the maximum intensity with regular use and / or at the user's request.

[0136] For safety, any device described herein may reduce and / or reset the maximum value if EMS has not been applied within a certain timeframe (e.g., if more than x hours or x days have passed since the last EMS use). For example, for every x number of hours that the user has not operated the EMS device (e.g., if the user has not performed EMS in 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 14 days, etc.), the maximum intensity / power may be scaled toward the initial baseline.

[0137] In addition, the system can lock out or prevent EMS from being applied more frequently than a predetermined time period. For example, the device can be configured to prevent the user from applying EMS more than one session (or more than a maximum number of minutes or maximum aggregate energy) every x hours or x days (e.g., no more than once every 20 hours, every 24 hours, every 30 hours, every 36 hours, every 40 hours, every 44 hours, every 48 hours, every 52 hours, every 56 hours, every 60 hours, etc.).

[0138] Any device described herein can gradually increase the intensity of EMS (e.g., the power of EMS), such as by increasing one or more of the frequency, pulse width, amplitude, etc. in the process of treating the session until the limit of the maximum intensity. For example, the device can automatically increase the applied EMS power from the initial starting level to 100% of the maximum EMS power / intensity available to the patient, which is calculated for a specific session (based on the input selected by the baseline, history, and / or user). In one example, a new user can have a maximum baseline power of 60Hz for its first session, a pulse width of about 200μs, and an amplitude of, for example, 100mA (which can depend on the electrode parameters). The applied intensity / power can be a function of one or more of these parameters. The device can increase the applied EMS power / intensity from 50% of the value to a maximum value of 100% (e.g., starting from 30Hz and increasing to 60Hz, etc.), which can be specific to a specific muscle or a group of muscles.

[0139] Typically, these devices may include software that can perform any of these methods. For example, the software can be an application software (app) configured to run on a user's device (e.g., a smart phone) and / or on a power supply / controller. The software can be configured to control the EMS for a specific purpose or to coordinate control of a group of users who may be exercising together (e.g., as part of a class). For example, Fig.12 Schematically shown is user software 1207 which may be used to assist a user in performing a personal training exercise or a portion of a training course.

[0140] The application software 1207 can allow the user to select a specific training session and / or course, and can coordinate the application of the training session and the application of EMS. In some examples, as described above, the application software can record progress and can adjust the maximum possible EMS intensity / power for each session. Therefore, the application software can automatically adjust the settings for each exercise (EMS settings).

[0141] A session ("exercise") may start the EMS using settings based on the various base settings (baselines) as described above, and the device may optimize the maximum possible EMS intensity and / or power for each setting, and the onset of that maximum during the course of the session. As described above, this may therefore be customized for each user and specific to their body and fitness level, and configured to prevent injury or discomfort to the user. The device may recalibrate the base settings.

[0142] Any of these devices may include a user interface, which may be, for example, displayed on a power supply / controller and / or a user device (e.g., a smart phone, a television / display, etc.). The user interface may include input / output for each EMS electrode and / or corresponding muscle group, including showing intensity levels (e.g., as frequency, amplitude, pulse width and / or some combination or derived value of these, e.g., generally "intensity"). The user may be allowed to select the value of each or some of these items, which may be limited to the maximum level selected or set by the system. The user interface may also show corresponding positions / movements / exercises and / or may show a coach or model that performs or instructs a user to perform them. Typically, a device (e.g., software, firmware, etc.) may coordinate the application of the EMS via the EMS suit for the session being performed, including coordinating the activation of appropriate electrodes.

[0143] As described herein, the techniques and systems described herein may also allow one or more devices to save resources regarding communication bandwidth resources, processing resources, memory resources, power resources, and / or other resources. Additional technical effects may also be achieved by implementing the techniques disclosed herein. Example processes and systems and devices including one or more processors and one or more memories and a non-transitory computer-readable medium storing computer-executable instructions are described herein, which when executed by one or more processors perform various actions and / or processes disclosed herein.

[0144] application

[0145] In some examples, an EMS device as described herein is used as a therapeutic device for diagnosing, treating, preventing, and / or detecting a disease and / or condition. The therapeutic application may relate to any disease or condition, including a disease or condition detectable with a minimally invasive or non-invasive sensor associated with an EMS device. In some examples, a disease profile may be stored, developed, established, acquired, or otherwise known to an EMS device and may be used to compare or cross-reference user-specific biometric data obtained by the EMS device via one or more sensors.

[0146] The disease profile may include known characteristics of the disease or condition, such as symptoms, risk factors, genetic factors, biological factors, physiological factors, and / or any other relevant information related to the disease state. The disease profile may provide a similarity score based on a comparison of the disease profile with the user-specific biometric data acquired by the EMS device. For example, the similarity score may indicate the similarity between the observed or acquired user-specific biometric data and the known characteristics of the disease or condition.

[0147] In some examples, an EMS device as described herein can detect a disease or condition. Detection of a disease or condition can include an EMS suit sensing or analyzing user-specific factors associated with the disease or condition. One or more sensors within the suit can be adapted to receive biological data and / or physiological data associated with the user and associated with signs, symptoms or other manifestations of the disease or condition. For example, detection can include an accelerometer sensor detecting changes in user-related acceleration, and can signal the simultaneous or impending occurrence of biological activity (e.g., tremor) associated with the disease. In some examples, more than one type of sensor detects different user-specific biometric information, which is interpreted and compiled by a processor to take into account the incidence of detection of biological activity associated with the disease.

[0148] Detection may include identifying a triggering event associated with a symptom of a condition or disease. Detection may be sufficient to identify factors that support prediction of an upcoming disease-related biological activity. For example, an electromyography sensor may sense electrical pulses prior to involuntary muscle activity associated with a disease. Another example may include more than one sensor acquiring different biometric data that may be combined and interpreted by a processor to establish a prediction of an upcoming disease-related biological activity.

[0149] For any application of the EMS device described herein, a threshold value associated with the user-specific biometric data detected by the sensor can be established. The threshold value can be a user-specific threshold value based on the user engaging the EMS device (e.g., the user wearing the device) for a period of time. When establishing the threshold value, when the sensor begins to acquire user-specific data, the duration can start from the first use. When data is accumulated by the EMS device, patterns, rhythms, or other natural fluctuations in the user-specific biometric data can be incorporated into establishing user-specific threshold values. For example, developing a threshold value using an EMS device can be a calibration of the EMS device for a specific user.

[0150] In some examples, the development of thresholds or standard values ​​associated with biometric data detected by a sensor can be predetermined. For example, the known values ​​include a range of values ​​with a minimum value and a maximum value that can be considered a health state. The range of health state values ​​can include an upper or lower limit associated with the specific biometric factor being evaluated. In some examples, the predetermined threshold can be adjusted or established by an individual (e.g., a healthcare provider) based on known acceptable values ​​or health state values ​​for a specific biometric factor.

[0151] In some examples, an EMS device as described herein can diagnose a disease or condition. Diagnosis of a disease or condition can include an EMS suit sensing or analyzing user-specific factors associated with a disease or condition. One or more sensors within the suit can be adapted to receive biological data and / or physiological data associated with a user and with signs, symptoms, or other manifestations of a disease or condition. In some examples, diagnosing a disease or condition can include EMS stimulation as a test or excitation of one or more biological tissues. As described herein, diagnostic EMS excitation can be provided by one or more electrode assemblies. In some examples, diagnostic EMS excitation can be provided according to a test scheme based on user-specific information, predetermined user information, one or more disease profiles, one or more evaluation procedures based on disease profiles, etc. For example, diagnosing a disease using an EMS device as described herein can include a user engaging an EMS device (e.g., wearing an EMS suit) and starting a diagnostic scheme. One or more sensors can acquire or detect user-specific information, and one or more electrode assemblies can provide electrical pulses or stimulations to excite or test associated biological tissues (e.g., muscle tissue), which can cause a physiological response. The response may be detected by one or more sensors, and the data may be sent to a processor for interpretation. The processor may interpret the data and compare the detected user-specific information with the disease profile to present a diagnosis.

[0152] The diagnosis may include input from a remote source (eg, a healthcare provider). The data acquired by the EMS device may be transmitted to a remote device or database for further evaluation and consideration.

[0153] In some examples, an EMS device as described herein can treat a disease or condition. Treatment of a disease or condition can include the EMS suit sensing or analyzing user-specific factors associated with the disease or condition. One or more sensors within the suit can be adapted to receive biological and / or physiological data associated with the user and associated with signs, symptoms, or other manifestations of the disease or condition.

[0154] As described herein, treating a disease with an EMS device can include providing EMS by one or more electrodes (e.g., an electrode assembly) based on user-specific biometric data. In some examples, the provided EMS can be dynamically adjusted based on user-specific biometric data. In some examples, the EMS can be dynamically adjusted based on a known or suspected disease of the user. In some examples, the EMS can be adjusted by the user or another person (e.g., a healthcare provider) through an interface of the engagement system to adjust the EMS maximum, minimum, or a value therebetween.

[0155] In some examples, EMS devices as described herein can prevent diseases or illnesses. Prevention of diseases or illnesses can include EMS suits sensing or analyzing user-specific factors associated with diseases or illnesses. One or more sensors in the suit can be suitable for receiving biological data and / or physiological data associated with the signs, symptoms or other manifestations of the disease or illness associated with the user. In some examples, prevention can be related to the signs or symptoms of the disease or illness. Preventing diseases or illnesses can include interpreting user-specific biometric data, which is associated with predictions or assessments related to biological activities related to the upcoming disease. For example, an EMS device can obtain user-specific biometric data related to an upcoming stroke or tremor. After acquiring the data, the EMS device can establish and execute a stimulation scheme based on the biological activities related to the predicted or observed diseases. By providing electrical stimulation before or after the biological activities related to the disease, the EMS device can prevent the occurrence of biological activities related to the disease (for example, stimulation can prevent or reduce the severity of stroke).

[0156] In some examples, a user may suffer from tremors or be at risk of developing tremors. Tremors may be associated with another disease or condition. Tremors may be independent of a disease or condition. For example, tremors may involve test tremors, action tremors, postural tremors, motor tremors, intention tremors, task-specific tremors. Some examples of tremor characteristics that can be detected by an EMS device include amplitude or frequency or a combination thereof. When an EMS device detects a tremor or detects a predictive indicator of a tremor, the device can provide an alarm or warning. In addition, with or without an alarm or warning, the EMS device can provide electrical stimulation to prevent or inhibit the effects of tremors.

[0157] An example of a disease or condition that can be detected, prevented, treated and / or diagnosed can be Parkinson's disease. Parkinson's disease is a neurological disease that can be treated with medication or conservatively managed. The methods and devices described herein can be used in place of or in addition to other techniques for treating Parkinson's disease, particularly for treating Parkinson's disease. For example, Parkinson's disease can be treated by applying EMS to one or more anatomical regions of a user.

[0158] Typically, Parkinson's disease can be treated by applying EMS during one or more treatment sessions as described herein. The treatment can be passive (e.g., without user / patient exercise), or active (including actively moving or exercising). One or more treatments can be applied, including one or more 5-40 minute sessions (e.g., 10-30 minutes, 10-20 minutes, etc.). Multiple treatment sessions can be applied. For example, the treatment session can be repeated as needed, or repeated every x days (e.g., every 2 days, every 3 days, every 4 days, every 5 days, every 6 days, every 7 days, every 8 days, every 9 days, every 10 days, etc.). In some examples, the treatment can be repeated with a reduced frequency after the treatment of the initial number.

[0159] An example of a disease or condition that can be detected, prevented, treated and / or diagnosed can be Alzheimer's disease. Alzheimer's disease is a neurological disease that can be treated with medication or conservatively managed. The methods and devices described herein can be used in place of or in addition to other techniques for treating Alzheimer's disease in particular for treating Alzheimer's disease. For example, Alzheimer's disease can be treated by applying EMS to one or more anatomical regions of a user.

[0160] Typically, Alzheimer's disease can be treated by applying EMS during one or more treatment sessions as described above. The treatment can be passive (e.g., without user / patient exercise), or active (including actively moving or exercising). One or more treatments can be applied, including one or more 5-40 minute sessions (e.g., 10-30 minutes, 10-20 minutes, etc.). Multiple treatment sessions can be applied. For example, the treatment session can be repeated as needed, or repeated every x days (e.g., every 2 days, every 3 days, every 4 days, every 5 days, every 6 days, every 7 days, every 8 days, every 9 days, every 10 days, etc.). In some examples, the treatment can be repeated at a reduced frequency after the initial number of treatments.

[0161] An example of a disease or condition that can be detected, prevented, treated and / or diagnosed can be Huntington's disease. Huntington's disease is a neurological disease that can be treated with medication or conservatively managed. The methods and devices described herein can be used in place of or in addition to other techniques for treating Huntington's disease. For example, Huntington's disease can be treated by applying EMS to one or more anatomical regions of a user.

[0162] Typically, Huntington's disease can be treated by applying EMS during one or more treatment sessions as described above. The treatment can be passive (e.g., without the user / patient exercising), or active (including actively moving or exercising). One or more treatments can be applied, including one or more 5-40 minute sessions (e.g., 10-30 minutes, 10-20 minutes, etc.). Multiple treatment sessions can be applied. For example, a treatment session can be repeated as needed, or repeated every x days (e.g., every 2 days, every 3 days, every 4 days, every 5 days, every 6 days, every 7 days, every 8 days, every 9 days, every 10 days, etc.). In some examples, the treatment can be repeated at a reduced frequency after an initial number of treatments.

[0163] An example of a disease or condition that can be detected, prevented, treated, and / or diagnosed can be sclerosis (e.g., ALS). Sclerosis is a neurological disease that can be treated with medication or managed conservatively. The methods and devices described herein can be used in addition to or instead of other techniques for treating sclerosis. For example, sclerosis can be treated by applying EMS to one or more anatomical regions of a user.

[0164] Typically, sclerosis can be treated by applying EMS during one or more treatment sessions as described above. Treatment can be passive (e.g., without user / patient exercise), or active (including actively moving or exercising). One or more treatments can be applied, including one or more 5-40 minute sessions (e.g., 10-30 minutes, 10-20 minutes, etc.). Multiple treatment sessions can be applied. For example, treatment sessions can be repeated as needed, or every x days (e.g., every 2 days, every 3 days, every 4 days, every 5 days, every 6 days, every 7 days, every 8 days, every 9 days, every 10 days, etc.). In some examples, treatments can be repeated at a reduced frequency after an initial number of treatments.

[0165] The example of a disease or condition that can be detected, processed and / or diagnosed can be brain injury. Brain injury can describe the condition associated with nervous system (e.g., brain) damage, which can be treated with medication or conservatively treated. These methods and devices described herein can replace other techniques for treating brain injury or be particularly used to treat brain injury in addition to other techniques for treating brain injury. For example, brain injury can be treated by applying EMS to one or more anatomical regions of the user.

[0166] Typically, brain injury can be treated by applying EMS during one or more treatment sessions as described above. Treatment can be passive (e.g., without user / patient exercise), or active (including active movement or exercise). One or more treatments can be applied, including one or more 5-40 minute sessions (e.g., 10-30 minutes, 10-20 minutes, etc.). Multiple treatment sessions can be applied. For example, a treatment session can be repeated as needed, or repeated every x days (e.g., every 2 days, every 3 days, every 4 days, every 5 days, every 6 days, every 7 days, every 8 days, every 9 days, every 10 days, etc.). In some examples, the treatment can be repeated at a reduced frequency after the initial number of treatments.

[0167] An example of a disease or condition that can be detected, prevented, treated and / or diagnosed can be an epileptic seizure. An epileptic seizure is a neurological disease or is associated with a neurological disease and can be treated with medication or conservatively managed. The methods and devices described herein can be used in place of or in addition to other techniques for treating epileptic seizures to treat epileptic seizures. For example, an epileptic seizure can be treated by applying EMS to one or more anatomical regions of a user.

[0168] Typically, epileptic seizures can be treated by applying EMS during one or more treatment sessions as described above. Treatment can be passive (e.g., without user / patient exercise), or active (including actively moving or exercising). One or more treatments can be applied, including one or more 5-40 minute sessions (e.g., 10-30 minutes, 10-20 minutes, etc.). Multiple treatment sessions can be applied. For example, a treatment session can be repeated as needed, or repeated every x days (e.g., every 2 days, every 3 days, every 4 days, every 5 days, every 6 days, every 7 days, every 8 days, every 9 days, every 10 days, etc.). In some examples, the treatment can be repeated at a reduced frequency after an initial number of treatments.

[0169] An example of a disease or condition that may be detected, prevented, treated and / or diagnosed may be restless legs syndrome.

[0170] Specifically, methods and devices for treating restless legs syndrome (RLS) are described herein. Restless legs syndrome or Willis-Ekbom disease is a neurosensory disorder that can be treated with medication or conservatively managed. These methods and devices described herein can be used to treat RLS in place of or in addition to other techniques for treating RLS, including whole body vibration, pneumatic compression, and near infrared light. For example, RLS can be treated by applying EMS to the lower extremities (e.g., legs, buttocks, etc.) including the calf muscles (bilateral or unilateral). In some examples, RLS treatment by EMS can also be applied to other muscles of the body, including the chest muscles, back, etc.

[0171] Typically, RLS can be treated by applying EMS during one or more treatment sessions as described above. The treatment can be passive (e.g., without user / patient exercise), or active (including actively moving or exercising the legs). One or more treatments can be applied, including one or more 5-40 minute sessions (e.g., 10-30 minutes, 10-20 minutes, etc.). Multiple treatment sessions can be applied. For example, a treatment session can be repeated as needed, or repeated every x days (e.g., every 2 days, every 3 days, every 4 days, every 5 days, every 6 days, every 7 days, every 8 days, every 9 days, every 10 days, etc.). In some examples, the treatment can be repeated at a reduced frequency after an initial number of treatments.

[0172] Any of the methods and devices described herein may be used for one or more therapeutic indications, such as physical therapy for a patient (user) recovering from injury, surgery, etc.

[0173] In some examples, the user suffers from or is at risk of developing a neurological disease. Some non-limiting examples of neurological diseases may include: abscess septum pellucidum, acid lipase disease, acid maltase deficiency, acquired epileptic aphasia, acute disseminated encephalomyelitis, ADHD, Adie's pupil, Pupil), Adie syndrome, adrenoleukodystrophy, agenesis of the corpus callosum, agnosia, Acardi syndrome, AIDS, Alexander disease, Alpers disease, alternating hemiplegia, Alzheimer's disease, amyotrophic lateral sclerosis, anencephaly, aneurysm, Angelman syndrome, angiomatosis, hypoxia, antiphospholipid syndrome, aphasia, apraxia, arachnoid cyst, arachnoiditis, Arnold-Chiari malformation, arteriovenous malformation, Asperger syndrome, ataxia, ataxia-telangiectasia, ataxia and cerebellar or spinocerebellar degeneration, atrial fibrillation and stroke, autism, dysautonomia, back pain, Barth syndrome, Batten disease, Becker's myotonia, Behcet's disease, Bell's palsy, benign essential blepharospasm, benign focal muscular atrophy Amyotrophy), Benign Intracranial Hypertension, Bernhardt-Roth Syndrome, Binswanger's Disease, Blepharospasm, Bloch-Sulzberger Syndrome, Brachial Plexus Injury, Bradbury-Eggleston Syndrome, Brain and Spinal Tumors, Brain Aneurysm, Brain Injury, Brown-Sequard Syndrome, Bulbous Muscular Atrophy, Cadasil, Canavan Disease, Carpal Tunnel Syndrome, Causalgia, Cavernous Angioma, Central Spinal Cord Syndrome, Central Pain Syndrome, Central Pontine Myelinolysis, Head Disease, Ceramidase Deficiency, Cerebellar Degeneration, Cerebellar Hypoplasia, Cerebral Aneurysm, Cerebral Arteriosclerosis, Cerebral Atrophy, Cerebral BeriberiBeriberi), cerebral gigantism, cerebral hypoxia, cerebral palsy, cerebro-oculofacial-skeletal syndrome, Charcot-Marie-Tooth disease, Chiari malformation, chorea, chronic inflammatory demyelinating polyneuropathy (CIDP), chronic pain, Coffin-Lowry syndrome, colpocephaly, coma and persistent vegetative state, congenital facial diplegia, congenital myasthenia, congenital myopathy, corticobasal degeneration, cranial arteritis, craniosynostosis, Creutzfeldt-Jakob disease, cumulative trauma disorder, Cushing syndrome, giant cell inclusion disease, Dancing Eyes-Dancing Feet Syndrome, Dandy-Walker syndrome, Dawson disease, dementia, Lewy body dementia, dentatorubral ataxia, dentatorubral atrophy Atrophy), dermatomyositis, developmental movement disorder, Devic syndrome, diabetic neuropathy, diffuse sclerosis, Dravet syndrome, autonomic dysfunction, dysgraphia, dyslexia, dysphagia, myoclonic cerebellar acoordination, dystonia, early infantile epileptic encephalopathy, empty sella syndrome, encephalitis, encephalitis lethargica, encephalocele, encephalopathy, cerebral trigeminal angiomatosis, epilepsy, Erb-Duchenne and Dejerine-Klumpke palsy, Erb's palsy, essential tremor, extrapontine myelinolysis, Fabry disease, Fahr syndrome, syncope, familial dysautonomia, familial angiomatosis, familial idiopathic basal ganglia calcification, familial periodic paralysis, familial spastic paralysis, Farber disease, febrile seizures, fibromuscular dysplasia, Fisher syndrome, floppy infant syndrome Syndrome), Foot Drop, Friedreich's Ataxia, Frontotemporal Dementia, Gangliosidosis, Gaucher's Disease, Gerstmann's Syndrome, Gerstmann-Straussler-Scheinker Disease, Giant Cell Arteritis, Giant Cell Inclusion Disease, Globoid Cell Leukodystrophy, Glossopharyngeal Neuralgia, Glycogen Storage Disease, Guillain-Barré Syndrome, Hallervorden-Spatz Disease, Head Injury, Migraine Continua, Hemifacial Spasm, Hemiplegia Alterans, Hereditary Neuropathy, Hereditary Spastic Paraplegia, Hereditary Ataxia Polyneuritiformis, Herpes Zoster, Herpes Zoster Otic, Hirayama SyndromeSyndrome), Holmes-Adie syndrome, holoprosencephaly, HTLV-1-associated myelopathy, Hughes syndrome, Huntington's disease, hydrocephalus, hydrocephalus, hydromyelia, Hypernychthemeral syndrome, lethargy, hypertonia, hypoxia, immune-mediated encephalomyelitis, inclusion body myositis, incontinence pigmenti, infantile hypotonia, infantile neuroaxonal dystrophy, infantile phytanic acid storage disease, infantile Refsum disease Disease), Infantile Spasms, Inflammatory Myopathy, Iniencephaly, Intestinal Lipodystrophy, Intracranial Cysts, Intracranial Hypertension, Isaac Syndrome, Joubert Syndrome, Kearns-Sayre Syndrome, Kennedy Disease, Kinsbourne Syndrome, Kleine-Levin Syndrome, Klippel-Feil Syndrome, Klippel-Trenaunay Syndrome (KTS), Kluver-Bucy Syndrome, Korsakoff's Amnesic Syndrome, Krabbe Disease, Kugelberg-Welander Disease, Kuru, Lambert-Eaton Myasthenic Syndrome, Landau-Kleffner Syndrome, Lateral Medullary Syndrome, Learning Disabilities, Leigh Disease, Lennox-Gastaut Syndrome, Lesch-Nyhan Syndrome, Leukodystrophy, Levine-Critchley Syndrome, Dementia with Lewy Bodies, Lipid Storage Disease, Lipoproteinosis, Lissenchephaly, Locked-In Syndrome, Lou Gehrig's Disease Gehrig's Disease), Lupus, Lyme Disease, Machado-Joseph Disease, Macroencephaly, Melkersson-Rosenthal Syndrome, Meningitis, Menkes Disease, Meralgia Paresthetica, Metachromatic Leukodystrophy, Microcephaly, Migraine, Miller Fisher Syndrome, Mini-Strokes, Mitochondrial Myopathy, Motor Neuron Disease, Moyamoya DiseaseDisease), Mucolipidoses, Mucopolysaccharidoses, Multiple Sclerosis (MS), Multiple System Atrophy, Muscular Dystrophy, Myasthenia Gravis, Myoclonus, Myopathy, Myotonia, Narcolepsy, Neuroacanthocytosis, Neurodegenerative Brain Iron Deposits, Neurofibromatosis, Neuroleptic Malignant Syndrome, Neurological Complications of AIDS, Neurological Complications of Lyme Disease, Neurological Consequences of Cytomegalovirus Infection, Neurological Manifestations of Pompe Disease, Neurological Sequelae of Lupus, Neuromyelitis Optica or Devic Disease, Neuromyotonia, Neuronal Ceroid Lipofuscinosis, Neuronal Migration Abnormality, Neuropathy, Neurosarcoidosis, Neurotoxicity, Cavernous Hemangioma (Nevus Cavernosus), Niemann-Pick Disease, Non-24-Hour Sleep-Wake Disorder, Normal Pressure Hydrocephalus, Occipital Neuralgia, Hidden Cord Incomplete Closure Sequence, Ohtahara Syndrome, Olivopontocerebellar Atrophy, Opsoclonus-Myoclonus Myoclonus, orthostatic hypotension, O'Sullivan-McLeod syndrome, overuse syndrome, pantothenate kinase-related neurodegenerative disease, paraneoplastic syndrome, paresthesia, Parkinson's disease, paroxysmal choreoathetosis, paroxysmal migraine, Parry-Romberg, Pelizaeus-Merzbacher disease Disease), Perineural Cysts, Periodic Paralysis, Peripheral Neuropathy, Periventricular Leukomalacia, Pervasive Developmental Disorder, Nerve Compression, Piriformis Syndrome, Plexopathy, Polymyositis, Pompe Disease, Porencephaly, Postherpetic Neuralgia, Postinfectious Encephalomyelitis, Postpoliomyelitis Syndrome, Postural Hypotension, Postural Tachycardia Syndrome (POTS), Primary Lateral Sclerosis, Prion Disease, Progressive Multifocal Leukoencephalopathy, Progressive Sclerosing Poliomyelitis, Progressive Supranuclear Palsy, Agnosia, Pseudotumor Cerebri, Ramsay-Hunt Syndrome I, Ramsay-Hunt Syndrome II, Rasmussen Encephalitis, Reflex Sympathetic Dystrophy Syndrome, Refsum Disease Disease), repetitive movement disorder, repetitive stress injury, restless legs syndrome, retroviral myelopathy, Rett syndrome, Reye syndrome, rheumatic encephalitis, Riley Day syndrome, Saint Vitus Dance, Sandhoff disease, schizencephaly, Septo-Optic dysplasiaDysplasia), shaken baby syndrome, herpes zoster, Shy-Drager syndrome, Sjögren's syndrome, sleep apnea, sleeping sickness, Sotos syndrome, spasticity, spinal cord infarction, spinal cord injury, spinal cord tumor, spinocerebellar atrophy, spinocerebellar degeneration, stiff-person syndrome, striatonigral degeneration, stroke, Sturge-Weber syndrome, SUNCT headache, syncope, syphilitic myelosclerosis, syringomyelia, Tabes dorsalis Dorsalis), tardive dyskinesia, Tarlov cyst, Tay-Sachs disease, temporal arteritis, tethered cord syndrome, Thomsen myotonia, thoracic outlet syndrome, thyrotoxic myopathy, tinnitus, Todd's palsy, Tourette syndrome, transient ischemic attack, transmissible spongiform encephalopathy, transverse myelitis, traumatic brain injury, tremor, trigeminal neuralgia, tropical spastic paralysis, Troyer syndrome, tuberous sclerosis, vasculitis including temporal arteritis, Von Economo disease, Von Hippel-Lindau disease (VHL), Von Recklinghausen disease, Wallenberg syndrome, Werdnig-Hoffman disease, Wernicke-Korsakoff syndrome, West syndrome, whiplash, Whipple disease, Williams syndrome, Wilson's disease, Wolman disease, X-linked spinal and bulbar muscular atrophy, and Zellweger syndrome. The term neurological disease may refer to any disease or condition related to the nervous system. In some examples, a nervous system disease may refer to a neuromuscular disease, a muscle disease, a motor dysfunction, an injury, a somatic disease, or a reproductive system-related disease. In some examples, the term nervous system disease may refer to any disease or condition that a person with reasonable skill in the art would consider to be a nervous system disease.

[0174] In some examples, a user may be diagnosed with a disease or condition (e.g., a neurological disease). In some examples, a user may be at risk of developing a disease or condition. In some examples, a user may have a disease or condition but not show any signs or symptoms of the disease or condition. In some examples, a user may show signs or symptoms of a disease or condition without being diagnosed with the disease or condition.

[0175] In some examples, a user is at risk for a disease or condition based on the user's family history, age, gender, lifestyle, habits, comorbidities, genetic variations, acquired molecular aberrations.

[0176] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are considered to be part of the inventive subject matter disclosed herein and can be used to achieve the benefits described herein.

[0177] Generally, any method and device described herein can be used for physical therapy. For example, EMS can be used as a rehabilitation tool for a series of neuromuscular disorders in adults and children, including, but not limited to, stroke, spinal cord injury, ABI, and cerebral palsy. EMS can be used alone or with other conventional physical therapy adjuncts. For example, EMS can be used to reverse muscle atrophy and improve muscle strength; for supporting function (i.e., the stepping of the foot during gait), for improving local circulation and reducing skin damage; for increasing and / or maintaining the range of joint motion, for reducing spasticity or muscle spasm; for improving cardiovascular function (e.g., via the simultaneous activity of large muscle groups); for rehabilitation (e.g., learning new activities via mobile learning that is usually not available); for maintaining bone density; and / or for rehabilitation therapy (e.g., CNS cell birth and CNS myelination).

[0178] The process parameters and step sequences described and / or illustrated herein are provided as examples only and may be changed as desired. For example, although the steps shown and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order shown or discussed. The various example methods described and / or illustrated herein may also omit one or more steps described or illustrated herein, or include additional steps in addition to the disclosed steps.

[0179] Any of the methods described herein (including user interfaces) may be implemented as software, hardware, or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions executable by a processor (e.g., a computer, tablet, smart phone, etc.), which, when executed by the processor, causes the processor to control the execution of any steps, including but not limited to: display, communication with a user, analysis, modification of parameters (including timing, frequency, intensity, etc.), determination, reminders, etc. For example, any of the methods described herein may be performed at least in part by a device including one or more processors having a memory storing a non-transitory computer-readable storage medium storing a set of instructions for the process of the method.

[0180] Although various embodiments have been described and / or illustrated herein in the context of a fully functional computing system, one or more of these exemplary embodiments may be distributed in various forms as a program product, regardless of the specific type of computer-readable medium used to actually perform the distribution. The embodiments disclosed herein may also be implemented using software modules that perform certain tasks. These software modules may include scripts, batch processing, or other executable files that may be stored in a computer-readable storage medium or a computing system. In some embodiments, these software modules may configure a computing system to perform one or more example embodiments disclosed herein.

[0181] As described herein, the computing devices and systems described and / or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions, such as those contained in the modules described herein. In their most basic configuration, these computing devices can each include at least one memory device and at least one physical processor.

[0182] The term "memory" or "memory device" as used herein generally refers to any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device can store, load, and / or maintain one or more modules described herein. Examples of memory devices include, but are not limited to, random access memory (RAM), read-only memory (ROM), flash memory, hard disk drive (HDD), solid-state drive (SSD), optical drive, cache, variations or combinations of one or more thereof, or any other suitable memory for storage.

[0183] In addition, the term "processor" or "physical processor" as used herein generally refers to a processor of any type or form of hardware implementation that can interpret and / or execute computer-readable instructions. In one example, the physical processor can access and / or modify one or more modules stored in the above-mentioned memory device. Examples of physical processors include, but are not limited to, a microprocessor, a microcontroller, a central processing unit (CPU), a field programmable gate array (FPGA) implementing a soft-core processor, an application-specific integrated circuit (ASIC), one or more parts thereof, one or more variations or combinations thereof, or any other suitable physical processor.

[0184] Although shown as separate elements, the method steps described and / or illustrated herein may represent portions of a single application. Additionally, in some embodiments, one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as the method steps.

[0185] Furthermore, one or more devices described herein may convert data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more modules described herein may convert a processor, volatile memory, non-volatile memory, and / or any other portion of a physical computing device from one form of computing device to another form of computing device by executing on the computing device, storing data on the computing device, and / or otherwise interacting with the computing device.

[0186] The term "computer-readable medium" as used herein generally refers to any form of device, carrier or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media include, but are not limited to, transmission-type media such as carrier waves and non-transient media such as magnetic storage media (e.g., hard drives, tape drives, and floppy disks), optical storage media (e.g., compact disks (CDs), digital video disks (DVDs), and BLU-RAY disks), electronic storage media (e.g., solid-state drives and flash memory media), and other distribution systems.

[0187] Those of ordinary skill in the art will recognize that any process or method disclosed herein may be modified in a variety of ways. The process parameters and order of steps described and / or illustrated herein are given as examples only and may be changed as needed. For example, although the steps shown and / or described herein may be shown or discussed in a particular order, the steps do not necessarily need to be performed in the order shown or discussed.

[0188] The various exemplary methods described and / or shown herein may also omit one or more of the steps described or shown herein, or include additional steps in addition to those steps disclosed. In addition, the steps of any method disclosed herein may be combined with any one or more steps of any other method disclosed herein.

[0189] A processor as described herein may be configured to perform one or more steps of any method disclosed herein.Alternatively or in combination, a processor may be configured to combine one or more steps of one or more methods as disclosed herein.

[0190] When a feature or element is referred to herein as "on another feature or element", it can be directly on another feature or element, or there can also be intermediate features and / or elements. In contrast, when a feature or element is referred to as "directly on another feature or element", there are no intermediate features or elements. It will also be understood that when a feature or element is referred to as "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element, or there can be intermediate features or elements. In contrast, when a feature or element is referred to as "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although described or shown with respect to one embodiment, the features and elements described or shown in this way can be applied to other embodiments. Those skilled in the art will also recognize that the reference to a structure or feature that is set to be "adjacent" to another feature can have a portion that covers adjacent features or is located below adjacent features.

[0191] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, as used herein, the singular forms "a", "an", and "the" are also intended to include the plural forms, unless the context clearly indicates otherwise. It will be further understood that when used in this specification, the terms "comprises" and / or "comprising" specify the presence of stated features, steps, operations, elements, and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items, and may be abbreviated as " / ".

[0192] Spatially relative terms such as "under", "below", "lower", "over", "upper" and similar terms may be used herein to easily describe the relationship between one element or feature and another element or feature as shown in the accompanying drawings. It will be understood that spatially relative terms are intended to include different orientations of the device in use or operation other than the orientation depicted in the accompanying drawings. For example, if the device in the accompanying drawings is inverted, the elements described as "below" or "below" other elements or features will be oriented to be "above" other elements or features. Therefore, the exemplary term "below" can cover both upper and lower orientations. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially relative descriptors used herein are interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and similar terms are used herein only for the purpose of interpretation unless otherwise specifically indicated.

[0193] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Therefore, without departing from the teachings of the present invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0194] Throughout this specification and the appended claims, unless the context requires otherwise, the word "comprise" and variations such as "comprises" and "comprising" mean that various components can be used together in methods and articles (e.g., compositions and devices including apparatuses and methods). For example, the term "comprising" will be understood to mean the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0195] Generally, any apparatus and method described herein should be understood to be inclusive, but all or a subset of components and / or steps may optionally be exclusive and may be expressed as "consisting of various components, steps, sub-components or sub-steps" or optionally "consisting essentially of various components, steps, sub-components or sub-steps."

[0196] As used herein in the specification and claims, including in the examples, and unless otherwise expressly specified, all numbers may be considered as if preceded by the words "about" or "approximately", even if the term does not appear explicitly. The phrase "about" or "approximately" may be used when describing amplitude and / or position to indicate that the value and / or position described is within the reasonable expected range of the value and / or position. For example, a numerical value may have a value of + / -0.1% of a stated value (or range of values), + / -1% of a stated value (or range of values), + / -2% of a stated value (or range of values), + / -5% of a stated value (or range of values), + / -10% of a stated value (or range of values), etc. Unless otherwise indicated by the context, any numerical value given herein should also be understood to include about or approximately that value. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range listed herein is intended to include all subranges contained therein. It should also be understood that when a value is disclosed, "less than or equal to" the value, "greater than or equal to the value," and possible ranges between the values ​​are also disclosed, as appropriately understood by those skilled in the art. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and starting points and ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, and 10 to 15 are disclosed. It should also be understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0197] Although various illustrative embodiments are described above, any of several changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be changed, and in other alternative embodiments, one or more method steps may be skipped together. Optional features of various device and system embodiments may be included in some embodiments and not included in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted as limiting the scope of the invention as set forth in the claims.

[0198] The examples and descriptions included herein show specific embodiments in which the subject matter can be practiced by way of illustration and not limitation. As mentioned, other embodiments can be utilized and derived therefrom so that structural and logical substitutions and changes can be made without departing from the scope of the present disclosure. If in fact more than one is disclosed, for convenience only, such embodiments of the subject matter of the invention may be referred to herein individually or collectively by the term "invention", and it is not intended that the scope of the present application be voluntarily limited to any single invention or inventive concept. Therefore, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or variations of various embodiments. After reading the above description, the combination of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art.

Claims

1. A therapeutic electrical muscle stimulation (EMS) device for treating a user suffering from a neurological disorder, the device comprising: a wearable garment comprising a detection system having one or more sensors configured to detect user-specific biometric movement data and a processing system comprising a plurality of electrode assemblies; a processor operably coupled to the one or more sensors, the processor configured to interpret the user-specific biometric movement data to identify neural indicators and / or neuromuscular indicators from the user-specific biometric movement data; and wherein the plurality of electrode assemblies are on an inner surface of the wearable garment, and further wherein each of the plurality of electrode assemblies is operably connected to the processor and configured to provide electrical stimulation to a user, Wherein, the processor is further configured to apply therapeutic treatment to the user from one or more electrodes in the plurality of electrode assemblies based on the identified neural indicators and / or neuromuscular indicators.

2. The device according to claim 1, wherein: The processor includes a controller configured to initiate EMS via the plurality of electrode assemblies according to a stimulation protocol that is automatically adjustable based on the data.

3. The device according to any one of claims 1 or 2, wherein: The one or more sensors include at least one accelerometer configured to detect changes in acceleration associated with a neurological disease.

4. The apparatus according to any one of claims 1 to 3, further comprising an interface configured to communicate with one or more remote databases to obtain predetermined user-specific biometric data, wherein: The therapeutically effective amount of electrical stimulation is adjusted based on the predetermined user-specific biometric data.

5. The device according to any one of claims 1 to 4, wherein: The processor is configured to establish one or more thresholds based on initial user-specific biometric data acquired by the one or more sensors within a predetermined duration starting from a first use of the EMS.

6. The device according to any one of claims 1 to 5, wherein: Each of the one or more sensors is associated with the plurality of electrode assemblies.

7. The device according to any one of claims 8 to 13, wherein: The stimulation protocol defines a duration, intensity, location, pulse pattern or sequence of stimulations, and wherein the stimulation protocol is configured to automatically adjust based on subsequent user-specific biometric data.

8. The device according to any one of claims 1 to 7, wherein: The wearable garment includes an upper torso region.

9. The device according to any one of claims 1 to 8, wherein: The wearable garment includes a lower region configured to identify legs and buttocks of a user.

10. The device according to any one of claims 1 to 9, wherein: The user-specific biometric data is associated with an incidence of tremor.

11. The device according to any one of claims 1 to 10, wherein: A therapeutically effective amount of electrical stimulation is associated with an adjustable threshold.

12. The device according to claim 11, wherein The therapeutically effective amount of electrical stimulation is automatically adjusted based on subsequent user-specific biometric data.

13. The device according to any one of claims 1 to 12, wherein: The one or more sensors are configured to acquire data associated with muscle tissue.

14. The device according to any one of claims 1 to 12, wherein: At least one of the one or more sensors includes an electromyographic sensor, and the processor is configured to predict a tremor based on data from the one or more sensors including the electromyographic sensor.

15. The device according to any one of claims 1 to 14, wherein: The processor is configured to apply the EMS prior to an involuntary muscle contraction associated with a tremor.

16. The device according to any one of claims 1 to 15, wherein: The neurological disease is selected from the group consisting of Alzheimer's disease, Parkinson's disease, Huntington's disease, brain injury, spinal cord injury, autoimmune disease, restless legs syndrome, essential tremor and inherited neurological diseases.

17. The device according to any one of claims 1 to 16, wherein: The therapeutically effective amount of electrical stimulation is sufficient to prevent or reduce involuntary muscle activity associated with the neurological disorder.

18. The device according to any one of claims 1 to 17, wherein: The one or more sensors include a plurality of sensors configured to detect user-specific data associated with respiration.

19. The device according to any one of claims 1 to 18, wherein: The one or more sensors include a plurality of sensors configured to detect user-specific data associated with body temperature.

20. The device according to any one of claims 1 to 19, wherein: The one or more sensors include a plurality of sensors configured to detect user-specific data associated with perspiration.

21. The device according to any one of claims 1 to 20, wherein: Each of the one or more sensors is integrated with the plurality of electrode assemblies.

22. The device according to any one of claims 1 to 21, wherein: The user-specific biometric data includes multiple biometric characteristics obtained from more than one sensor.

23. The device according to any one of claims 1 to 22, wherein: The processor is configured to compare the interpreted data to one or more neurological disease profiles.

24. The device according to any one of claims 1 to 23, wherein: The processor includes a trained machine learning agent that is trained to identify neural indicators and / or neuromuscular indicators from the user-specific biometric movement data.

25. An electrical muscle stimulation (EMS) device for diagnosing a disease, the device comprising: a wearable region including a detection system having one or more sensors configured to detect user-specific biometric movement data; a processor operably coupled to the one or more sensors, the processor configured to interpret the user-specific biometric movement data to determine a disease profile; a plurality of electrode assemblies on an inner surface of the upper torso region, each of the electrode assemblies being operably connected to the processor, wherein each of the electrode assemblies is configured to provide electrical stimulation; and An interface operably coupled to the processor, the interface configured to output a diagnostic comparison of the user-specific biometric data with one or more of the disease profiles.

26. The device according to claim 25, wherein The processor includes a trained machine learning agent, wherein the trained machine learning agent is configured to determine the disease profile based on the user-specific biometric movement data.

27. The apparatus of claim 25, further comprising a controller electrically connected to the plurality of electrode assemblies, the controller configured to initiate diagnostic EMS stimulation via the plurality of electrode assemblies.

28. The device according to any one of claims 25 to 27, wherein: The one or more sensors include at least one accelerometer configured to detect changes in acceleration associated with a disease.

29. The device according to any one of claims 25 to 28, wherein: The interface is configured to communicate with one or more remote databases to obtain one or more predetermined ranges of biometric factors, wherein the processor is configured to compare the user-specific biometric data with the one or more predetermined ranges of biometric factors.

30. The device according to any one of claims 25 to 29, wherein: The processor is configured to establish one or more thresholds based on initial user-specific biometric data, wherein a deviation of the detected user-specific biometric data from the initial user-specific biometric data is associated with a disease.

31. The device according to any one of claims 25 to 30, wherein: Each of the one or more sensors is associated with the plurality of electrode assemblies.

32. The device according to any one of claims 25 to 31, wherein: The one or more sensors include a plurality of sensors configured to acquire data associated with muscle tissue.

33. The device according to any one of claims 25 to 32, wherein: At least one of the one or more sensors is an electromyography sensor configured to detect tremor.

34. The device according to any one of claims 25 to 33, wherein: The one or more sensors include a plurality of sensors configured to detect user-specific data associated with respiration.

35. The device according to any one of claims 25 to 34, wherein: The one or more sensors include a plurality of sensors configured to detect user-specific data associated with body temperature.

36. The device according to any one of claims 25 to 35, wherein: Each of the one or more sensors is integrated with the plurality of electrode assemblies.

37. The device according to any one of claims 25 to 36, wherein: The processor is configured to compare the interpreted data to one or more neurological disease profiles to determine a diagnosis of the disease.

38. A method for treating a user for a neuromuscular disease, the method comprising: receiving user movement data from one or more sensors of an electrical muscle stimulation (EMS) suit worn by the user; detecting neural indices and / or neuromuscular indices from the user movement data; Within 1 minute of detecting the neural index and / or neuromuscular index, therapeutic treatment is applied to the user from one or more electrodes of the EMS suit.

39. The method of claim 38, wherein: Receiving includes receiving accelerometer data.

40. The method of claim 38, wherein: Receiving includes receiving movement data having a frequency consistent with a tremor in one or more body parts.

41. The method of claim 40, wherein: The frequency is greater than 2 Hz.

42. The method of claim 38, wherein: The neurological and / or neuromuscular indicators are consistent with a stroke.

43. The method of claim 38, wherein: The neurological and / or neuromuscular markers are consistent with Alzheimer's disease.

44. The method of claim 38, further comprising identifying and outputting a potential pathology associated with the neural and / or neuromuscular indicators.

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