KR20220148156A - Systems and methods for using transdermal electrical stimulation devices to provide titration therapy - Google Patents

Abstract

The disclosed electrical stimulation system creates an intervention to help a patient adhere to a diet. The wearable device includes a microprocessor, an electrical stimulator, and at least one electrode, wherein the electrode comprises a T2 to T12 dermatome or meridian of a patient, a C5 to T1 dermatome across the hand and/or arm, and/or upper configured to deliver electrical stimulation to the epidermis through a range of 0.1 mm to 10 mm or a range of 0.1 mm to 20 mm of the dermis of the chest region. The device is configured to provide electrical stimulation according to a stimulation protocol, and to communicate wirelessly with an accompanying control device configured to monitor and record the patient's appetite pattern and deliver an appropriate therapy. The control device is also configured to monitor, record and modify the stimulation parameters of the stimulation protocol.

Description

Systems and methods for using transdermal electrical stimulation devices to provide titration therapy

cross reference

This application is the following U.S. Provisional Patent Application, namely,

U.S. Provisional Patent Application No. 62/532,317 entitled "Systems and Methods for Engaging In Eating Interventions and Appetite Modulation Based on Closed Loop Glucose Monitoring," filed July 13, 2017; and

U.S. Provisional Patent Application No. 62/413,213 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on October 26, 2016.

U.S. Patent Application Serial No. 15/728,413 entitled "Systems and Methods for Using A Transcutaneous Electrical Stimulation Device to Deliver Titrated Therapy," filed on October 9, 2017, and registered with U.S. Patent No. 10,765,863, claiming priority to U.S. Patent Application No. 16/694,990, titled "Systems and Methods for Using A Transcutaneous Electrical Stimulation Device to Deliver Titrated Therapy," filed on November 25, 2019, as a continuation-in-part of U.S. Patent Application Serial No. 16/694,990, filed September 8, 2020 ) is a continuation application.

U.S. Patent Application No. 15/728,413 also refers to the following U.S. Provisional Patent Application, namely:

U.S. Provisional Patent Application No. 62/532,317 entitled "Systems and Methods for Engaging In Eating Interventions and Appetite Modulation Based on Closed Loop Glucose Monitoring," filed July 13, 2017; and

U.S. Provisional Patent Application No. 62/413,213 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on October 26, 2016.

is a continuation-in-part of U.S. Patent Application No. 15/716,866 entitled "Systems and Methods for Using Transcutaneous Electrical Stimulation to Enable Dietary Interventions," filed September 27, 2017, claiming priority to

U.S. Patent Application No. 15/716,866 is also directed to the following U.S. Provisional Patent Application, i.e.,

U.S. Provisional Patent Application No. 62/532,317 entitled "Systems and Methods for Engaging In Eating Interventions and Appetite Modulation Based on Closed Loop Glucose Monitoring," filed July 13, 2017;

U.S. Provisional Patent Application No. 62/413,213 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on October 26, 2016; and

U.S. Provisional Patent Application No. 62/393,486, titled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed September 12, 2016

U.S. Patent Application Serial No. 15/702,676, entitled "Systems and Methods for Using Transcutaneous Electrical Stimulation to Enable Dietary Interventions," filed September 12, 2017, registration number: U.S. Patent No. 10,335,302, issued: July 2, 2019) is a continuation-in-part application.

U.S. Patent Application No. 15/702,676 is also directed to the following U.S. Provisional Patent Application, namely:

U.S. Provisional Patent Application No. 62/413,213 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on October 26, 2016;

U.S. Provisional Patent Application No. 62/393,486 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed September 12, 2016;

U.S. Provisional Patent Application No. 62/378,393 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on August 23, 2016; and

U.S. Provisional Patent Application No. 62/341,917 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on May 26, 2016.

U.S. Patent Application No. 15/590,750, entitled "Systems and Methods for Enabling A Patient To Achieve A Weight Loss Objective Using An Electrical Dermal Patch," filed on May 9, 2017, with priority to U.S. Patent Application No. 15/590,750, which claims priority to Patent No. 10,376,145, registration date: August 13, 2019) is a continuation-in-part application.

U.S. Patent Application No. 15/590,750 also refers to the following U.S. Provisional Patent Application, i.e.,

U.S. Provisional Patent Application No. 62/413,213 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on October 26, 2016;

U.S. Provisional Patent Application No. 62/393,486 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed September 12, 2016;

U.S. Provisional Patent Application No. 62/378,393 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on August 23, 2016;

US Provisional Patent Application No. 62/341,917 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed May 26, 2016; and

U.S. Provisional Patent Application No. 62/326,541 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on April 22, 2016.

U.S. Patent Application No. 15/370,944 entitled "Systems and Methods for Increasing A Delay in the Gastric Emptying Time for a Patient Using a Transcutaneous Electro-Dermal Patch," filed December 6, 2016, which claims priority to Registration No.: U.S. Patent No. 9,956,393, filed May 1, 2018) is a continuation-in-part application.

U.S. Patent Application No. 15/370,944 is also referred to as U.S. Patent Application No. 15/052,791 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on February 24, 2016. date, registration number: U.S. Patent No. 10,118,035, registration date: November 6, 2018) is a continuation-in-part application.

U.S. Patent Application No. 15/370,944 is also referred to as U.S. Patent Application No. 15/052,784 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on February 24, 2016. date, registration number: U.S. Patent No. 10,143,840, registration date: December 4, 2018) is a continuation-in-part application.

U.S. Patent Application No. 15/370,944 is also referred to as U.S. Patent Application No. 15/052,791 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on February 24, 2016. No.: U.S. Patent No. 10,118,035, issued November 6, 2018) and U.S. Patent Application No. 15/052,784 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro- Dermal Patch", filed February 24, 2016, registration number: U.S. Patent No. 10,143,840, filed December 4, 2018) U.S. Patent Application Serial No. 15/204,752, entitled "Systems and Method for Enabling Appetite Modulation and/or Improving Dietary Compliance Using Percutaneous Electrical Neurostimulation", filed July 7, 2016, accession number: U.S. Patent No. 10,154,922, filed December 18, 2018).

US Patent Application No. 15/052,791; U.S. Patent Application No. 15/052,784 and hence U.S. Patent Application No. 15/204,752 (which are CIPs of the '791 and '784 applications) are

U.S. Provisional Patent Application No. 62/248,059 entitled "Systems and Methods for Enabling Pain Management Using an Electro-Dermal Patch," filed on October 29, 2015;

US Provisional Patent Application No. 62/247,113 entitled "Systems and Methods for Enabling Appetite Modulation Using an Electro-Dermal Patch," filed on October 27, 2015;

U.S. Provisional Patent Application No. 62/246,526 entitled "Systems and Methods for Enabling Appetite Modulation Using an Electro-Dermal Patch," filed on October 26, 2015;

US Provisional Patent Application No. 62/242,957 entitled "Systems and Methods for Enabling Appetite Modulation Using an Electro-Dermal Patch," filed on October 16, 2015;

U.S. Provisional Patent Application No. 62/242,944 entitled "Systems and Methods for Enabling Appetite Modulation Using an Electro-Dermal Patch," filed on October 16, 2015;

U.S. Provisional Patent Application No. 62/240,808 entitled "Systems and Methods for Enabling Appetite Modulation Using an Electro-Dermal Patch," filed on October 13, 2015;

U.S. Provisional Patent Application No. 62/237,356 entitled "Systems and Methods for Enabling Appetite Modulation Using Transcutaneous Electrical Neurostimulation," filed on October 5, 2015;

U.S. Provisional Patent Application No. 62/189,805 entitled "Dermatome Stimulation System," filed July 8, 2015;

U.S. Provisional Patent Application No. 62/189,800 entitled "Dermatome Stimulation Method," filed July 8, 2015;

US Provisional Patent Application No. 62/161,362 entitled "Dermatome Stimulation Method," filed on May 14, 2015;

US Provisional Patent Application No. 62/161,353 entitled "Dermatome Stimulation System," filed on May 14, 2015;

U.S. Provisional Patent Application No. 62/141,333 entitled "Dermatome Stimulation Method," filed April 1, 2015;

U.S. Provisional Patent Application No. 62/141,328 entitled "Dermatome Stimulation System," filed April 1, 2015;

U.S. Provisional Patent Application No. 62/133,530 entitled "Dermatome Stimulation Method," filed March 16, 2015;

US Provisional Patent Application No. 62/133,526 entitled "Dermatome Stimulation System," filed March 16, 2015;

U.S. Provisional Patent Application No. 62/120,082 entitled "Dermatome Stimulation Methods," filed on February 24, 2015; and

U.S. Provisional Patent Application No. 62/120,067 entitled "Dermatome Stimulation System," filed on February 24, 2015, claims priority.

This application also relates to International Application No. PCT/US16/19416 entitled "Systems and Methods for Enabling Appetite Modulation and/or Improving Dietary Compliance Using an Electro-Dermal Patch," filed on February 24, 2016. will be.

All applications mentioned above are incorporated herein by reference in their entirety.

technical field

DETAILED DESCRIPTION The present disclosure relates generally to systems and methods for generating an appropriate dietary intervention by providing transdermal electrical stimulation using an electrical skin patch optimized for long-term wear. The disclosed system delivers electrical stimulation to a predetermined anatomical region of a user in a manner that is convenient, easy to use and may increase patient compliance. More specifically, the present disclosure is easy to self-administer, can be programmed and monitored using a mobile handheld device, can be used to reduce appetite and hunger, avoid nausea, minimize habituation and increase adherence to dietary regimes. An electrical stimulation device comprising a low profile, wearable, disposable skin patch programmed to stimulate nerves in a patient from an epidermal layer or an outer surface of the epidermis in a consumable manner. The disclosure may also integrate with a plurality of other hardware devices or software applications depending on the type, degree, nature and range of personality and the desired degree of dietary compliance and the desired amount of weight loss and/or the need for long-term weight maintenance. A low profile, wearable, disposable skin patch that can be controlled by

Obesity or overweight is a condition often caused by an imbalance between food intake and calorie expenditure. Excess body weight is associated with several additional risks, including cardiovascular complications (such as high blood pressure and hyperlipidemia), gallbladder disease, metabolic syndrome, cancer, polycystic ovary disease, pregnancy-related complications, arthritis-related complications, and other orthopedic complications due to stress on the joints of the body. increase the possibility of Obesity is also thought to be a major cause of type 2 diabetes (T2DM) in many ethnic groups.

Certain methods and systems for using electrical stimulation to control food intake are disclosed in the art. In US Pat. Nos. 8,538,532 and 8,185,206, serous electrodes are surgically implanted in the gastrointestinal tract to cause impaired gastric myoelectric activity, retrograde propagation of slow waves in the stomach, inhibition of gastric vestibular contractions and delayed gastric emptying. Gastric arrhythmias were associated with gastrointestinal symptoms and delayed gastric emptying was associated with weight loss. Electrical stimulation therapy is configured to induce at least partial gastric distension, thereby inducing a feeling of fullness and suppressing the patient's excessive food intake. Electrical stimulation therapy is delivered to the patient's gastrointestinal tract by electrodes deployed by one or more implantable leads connected to the electrical stimulator. Stimulation protocols require significant amounts of energy and are explicitly designed not to cause muscle contraction or otherwise electrically modulate the slow pulses of the stomach.

Although potentially effective, these therapies require a medical professional to surgically place the device and/or administer the therapy, and require significant amounts of energy to cause actual damage to muscle contractions or slow pulses in the stomach. do. Patients must visit a healthcare professional at the start of treatment to place the device, then periodically administer therapy and/or modify device programming. This need for frequent doctor visits is inconvenient for most patients and can have a detrimental effect on patient compliance.

With respect to prior art approaches to suppress appetite using external electrical stimulation, this approach has the following characteristics that are effective in enabling patients to independently administer the device and concomitant therapy: small floor area; implementation by the patient; Real-time or near real-time feedback from a patient (eg, food intake, exercise, hunger) to monitor, acquire, record, and/or transmit physiological data, or a wearable configured to be worn around a human body, eg, a wrist. real-time or near real-time feedback from a device, eg, a device with a physiological sensor; ability to stimulate multiple times a day or a week; Daily or on-demand feedback from the device to the patient regarding diet compliance, exercise, and calories burned; storage of stimulation parameters and other real-time inputs; It does not provide an effective dietary intervention, and the combination of electrical stimulation profile and floor area conducive to long-term wear. In addition, prior art therapies with some degree of flexibility include electrodes that must be connected via cables to a control or power box. Prior art therapies that are cordless are generally bulky, inflexible and cannot be worn for long periods of time.

Because successful weight loss is ultimately a matter of achieving high adherence to a dietary regime, successful devices go beyond simple stimulation by combining wearability, physical comfort, ease of use, accurate intervention, and integration of numerous data sources to determine an individual's gastric volume, In addition to effectively controlling gastric emptying rate, appetite, hunger, satiety levels, satiety levels and/or fullness, it is absolutely critical to provide a holistic, real-time view of an individual's diet compliance. do.

Accordingly, there is a need for a low profile, long lasting electrical nerve stimulation device that is programmable and designed to be worn for longer periods of time. There is also a need for a device that can effectively integrate appetite management data with existing weight management information, such as calorie consumption and intake.

There is a need for an electrical nerve stimulation device that is wearable and can be controlled, programmed and self-administered by the patient to increase patient independence. It also includes real-time or near-real-time feedback from patient parameters including but not limited to exercise, diet, hunger, appetite, well-being, and monitoring, acquiring, recording and/or transmitting physiological data to suppress appetite and thus obesity , in real time from other wearable devices configured to be worn around the human body, e.g., the wrist, e.g., devices with physiological sensors, to frequently adjust and tailor therapy to treat diseases of overweight, eating disorders, metabolic syndrome Or we need an electrical nerve stimulation device that can get near real-time feedback. There is a need for an electrical stimulation device configured to intelligently trigger and initiate stimulation automatically and without continuous management of the user. There is a need for an electrical nerve stimulation device capable of accelerating therapeutic effect and efficacy by stimulating multiple times a day or a week. There is a need for an electrical nerve stimulation device that provides daily feedback from the device to the patient on parameters such as diet compliance and calories burned.

There is also a need for an electrical nerve stimulation device capable of storing other real-time inputs and stimulation parameters, such as diaries and movement monitoring, to provide real-time recordings and treatment profiles to physicians and patients. Inputs from electrical nerve stimulation devices and other information sources configured to be worn around the human body, such as a wrist, for example, devices with physiological sensors, to monitor, acquire, record, and/or transmit physiological data can be saved.

There is also a need for a physician to be able to flexibly program the electrical nerve stimulation device and still instruct the patient so that the patient can adjust the device parameters within a limited range or within predetermined parameters (to increase the patient's independence).

There is also a need for electrical nerve stimulation devices that target appetite or hunger suppression rates, do not require implantation, and do not require wires or remote electrodes to provide stimulation. There is a need for an electrical nerve stimulation device that is remotely programmable but still wireless, can be bent at any point along the body, is waterproof, and is configured to be extended or worn permanently. There is also a need for a patient implementable and wearable electrical nerve stimulation device for suppressing postprandial blood glucose levels and effectively regulating multiple hormones and microbiota related to gastrointestinal function. There is a need for an electrical nerve stimulation device that has a size, shape, and weight and is made of a material that can effectively wear the device. Such a device may eliminate the need for stimulation parameters that require high power requirements (which may make wearability impractical or impossible). There is also a need for an electrical nerve stimulation device that is controllable by a companion device (eg, a smartphone) and that does not include a visible or tactile user interface on the stimulation device itself. There is a need for an electrical nerve stimulation device with unique electrical stimulation and floor area based on electrode design and stimulation parameters that allow a user to comfortably wear the device.

A holistic approach to managing a patient's calorie intake and consumption profile is also needed. Existing approaches focus on caloric intake, but do not analyze, monitor, or collect data on important precursors of caloric intake, i.e. appetite or hunger levels. There are yet to be exploited advantages to integrating data related to appetite, hunger and/or craving levels, active suppression or control of appetite, caloric intake, weight gain and caloric expenditure. These and other advantages are set forth in conjunction with the detailed description and drawings.

The following embodiments and aspects thereof are described and illustrated in connection with systems, tools, and methods that are illustrative, illustrative, and non-limiting in scope. This application discloses numerous embodiments.

Disclosed herein is a computer program product configured to generate a real-time intervention in response to a user's degree of appetite or hunger, comprising: a first plurality of program instructions stored in a non-transitory memory of a client device, wherein, when executed, the first plurality of program instructions: the client device is adapted to cause the user to generate at least one visual or audible prompt, the at least one visual or audible prompting the user to input data indicative of the user's appetite or hunger degree via a microphone or display of the client device the first plurality of programming instructions adapted to: a second plurality of program instructions stored in a non-transitory memory of the client device or other computing device, when executed, the second plurality of program instructions obtain input data indicative of a degree of appetite or hunger of the user, based on the input data to determine the user's appetite pattern or hunger pattern, the second plurality of program instructions; a third plurality of program instructions stored in a non-transitory memory of the client device or other computing device, when executed, the third plurality of program instructions to determine the timing of future appetite or hunger events on a per-user basis based on the appetite pattern or hunger pattern to, the third plurality of program instructions; and a fourth plurality of program instructions stored in a non-transitory memory of the client device or other computing device, wherein when executed, the fourth plurality of program instructions determines and generates the intervention based on the determined timing of a future appetite or hunger event. , a computer program product comprising the fourth plurality of program instructions.

Optionally, the second plurality of program instructions are further configured to visually display at least one of the appetite pattern as a graphical representation of the inputted appetite degree over time or the appetite pattern as a graphical representation of the inputted hunger degree over time. The graphical representation may include at least one of a topographic map, a scatter plot, or a bar chart indicating at least one of appetite peaks, i.e., highs and valleys, i.e., troughs, or hunger peaks and valleys. The color of the graphic representation may indicate the degree of appetite or the degree of hunger.

Optionally, the second plurality of program instructions are configured to visually indicate the appetite pattern or hunger pattern as a composite hunger score.

Optionally, the third plurality of program instructions are further configured to determine the timing of a future appetite event or hunger event by evaluating a frequency at which the user's degree of appetite or degree of hunger exceeds a threshold value.

Optionally, the third plurality of program instructions are further configured to determine the timing of a future appetite event or hunger event by determining a plurality of dates and times when the user's appetite or hunger degree exceeds one or more thresholds.

Optionally, the determination of the timing of a future appetite event or hunger event is based on one or more thresholds that establish a baseline amount of appetite or hunger, wherein the one or more thresholds are manually modified by a user or automatically by a computer program product. can be

Optionally, the fourth plurality of program instructions generates the intervention by generating data indicative of a visual indication or audible feedback, wherein the visual indication or audible feedback conveys a recommendation to drink or eat the prescribed beverage or food.

Optionally, the fourth plurality of program instructions generates the intervention by generating data indicative of a visual indication or audible feedback, wherein the visual indication or audible feedback conveys a recommendation to engage in a predetermined physical exercise or physical activity. Optionally, the computer program product generates at least one of a physical exercise or physical activity timer or visual instruction for a particular physical exercise or specific physical activity based on a recommendation to engage in a predetermined physical exercise or physical activity, and generates a visual instruction via the client device. and a fifth plurality of program instructions configured to present visually or audibly.

Optionally, the fourth plurality of program instructions generates the intervention by generating data indicative of a visual indication or auditory feedback, wherein the visual indication or auditory feedback conveys a recommendation to engage in a mindfulness activity. Optionally, the computer program product further comprises a fifth plurality of program instructions configured to generate and visually or audibly present at least one of a meditation image or meditation music based on the recommendation to engage in a mindfulness activity. do.

Optionally, the fourth plurality of program instructions generates the intervention by generating data indicative of a visual indication or audible feedback, wherein the visual indication or audible feedback conveys a recommendation to engage in a cognitive exercise. Optionally, the computer program product further comprises a fifth plurality of program instructions configured to generate and visually or audibly present at least one of a mental challenge or a mental puzzle based on the recommendation to engage in a cognitive exercise. .

Optionally, the fourth plurality of program instructions generates the intervention by generating data indicative of a visual indication or audible feedback, wherein the visual indication or audible feedback conveys a recommendation to engage with the food-related image. Optionally, the computer program product further comprises a fifth plurality of program instructions configured to generate and visually present the food-related image based on the recommendation to engage in the food-related image through the client device.

Optionally, the fourth plurality of program instructions generates the intervention by generating data indicative of a visual indication or audible feedback, wherein the visual indication or audible feedback is during a text message, email, voice call, social media platform, or video conference. Communicate recommendations to engage with virtual or real world coaches through at least one. Optionally, the computer program product is a fifth plurality of programs configured to generate and visually or audibly present an interface for participating in at least one of a text message, email, voice call, social media platform, or video conference, via the client device. It contains more commands.

Optionally, the fourth plurality of program instructions generates the intervention by generating data indicative of a visual indication or audible feedback, wherein the visual indication or audible feedback conveys a recommendation to titrate a dose of the drug. The drug may be at least one of a diabetes drug or a weight loss drug.

Optionally, the fourth plurality of program instructions are automatically with a separate medical device that adjusts or assists a human function to optimize at least one of timing or dosing of therapy delivered to the user via the separate medical device. Interface directly to create interventions. The separate medical device may be at least one of an intravenous delivery device or controller thereof, a smart intravenous pump or smart infusion system, an enteric nutrient pump, a continuous blood glucose monitoring device, a wearable drug pump, and an artificial pancreas.

Optionally, the fourth plurality of program instructions generate the intervention by automatically interfacing with an electrical skin patch separate from the client device, configured to apply electrical stimulation to the skin of the user. The electrical skin patch includes a housing, a controller positioned within the housing, at least one electrode positioned in physical communication with the housing and configured to be in electrical contact with the skin of a user, and at least one electrode positioned within the housing and in electrical communication with the controller and the at least one electrode. It may include a pulse generator. The pulse generator may be configured to generate an electrical stimulation comprising a plurality of electrical pulses defined by a stimulation parameter, wherein the stimulation parameter is a first pulse width in a range of 10 μsec to 10 msec, a first pulse width in a range of 100 μA to 100 mA. a pulse amplitude, and a first pulse frequency ranging from 1 Hz to 100 Hz.

Optionally, the second plurality of program instructions determine a time window associated with each of the inputted data and, for each time window, a range of values of all inputted data associated with the time window around the value to form a pattern. Determines the user's appetite pattern or hunger pattern based on the input data by determining whether it is within a predetermined range.

The at least one visual or audible prompt may be in the form of at least one of an audio message, a video message, a text message, or a graphic message.

Optionally, the first plurality of program instructions are configured to cause the client device to generate at least one visual or audible prompt at a first rate during a first time window and at a second rate after the first time window, wherein The 2 ratio is less than the first ratio. The first rate may range from 1 time per day to 24 times per day, and the first time window may range from 1 day to 1 month. The first plurality of program instructions may be configured to provide the user with an option to modify the first ratio via a display of the client device.

Optionally, if the degree of appetite or degree of hunger of the user is expected to be less than the first threshold in the future time window, the third plurality of programming instructions do not generate an intervention during the future time window.

Optionally, if the degree of appetite or degree of hunger of the user is expected to be greater than or equal to a first threshold in a future time window, the third plurality of programming instructions generates an intervention during the future time window.

Optionally, when executed, the first plurality of program instructions generates at least one visual or audible prompt in the form of a visual analog scale and displays the visual analog scale to the client device, wherein the visual analog scale Each value within represents a different degree of appetite or hunger. The visual analog scale may be a light bar with a sliding scale, wherein a first end of the sliding scale indicates a low degree of appetite and a second end of the sliding scale indicates a high degree of appetite.

Optionally, when executed, the first plurality of program instructions generates at least one visual or audible prompt in the form of a plurality of icons, each of the plurality of icons representing a different degree of appetite or hunger.

Optionally, when executed, the first plurality of program instructions generates at least one visual or audible prompt in the form of auditory data and plays the auditory data through a speaker of the client device.

Optionally, when executed, the second plurality of program instructions receives the appetite pattern or hunger pattern of the user and displays the appetite pattern or hunger pattern on the client device, wherein the appetite pattern or hunger pattern is a time of day on the first axis , in the form of a graph having a calendar day on the second axis, and in the form of an icon representing the degree of appetite or hunger of the user drawn on the graph in relation to the time zone of the day and the calendar day. At least one of the size, shape, color, and pattern of the icon may indicate the user's appetite or hunger level.

The device can be used to treat diseases including any of obesity, overweight, eating disorders, metabolic syndrome and diabetes. According to various aspects of the present specification, the electric skin patch device can treat a person having a body mass index (BMI) of 25 or more (25-30 for overweight, 30 or more for obesity, and 35 or more for morbid obesity).

The present disclosure also provides an electrical skin patch secured to a patient's skin comprising a housing, an electrical pulse generator positioned within the housing, and at least one electrode attached to the housing and in electrical communication with the electrical pulse generator to aid in weight loss by a patient. A method for enabling a weight loss goal to be achieved, wherein the electrical pulse generator is configured to deliver electrical pulses having a pulse amplitude in the range of 1 mA to 65 mA, the method comprising: a plurality of electrical pulses configured for execution in a device external to an electrical skin patch receiving data indicative of at least one of weight, well-being, hunger, appetite, calories consumed by the patient, and calories burned by the patient using the program instructions of ; applying a plurality of stimulation sessions to the skin of a patient using the electrical skin patch for a duration of one week, each of the plurality of stimulation sessions comprising the electrical pulses, wherein at least some of the plurality of stimulation sessions are longer than 15 minutes applying a plurality of stimulation sessions having a duration, the plurality of stimulation sessions including at least twice in the week; repeatedly applying the plurality of stimulation sessions for a predetermined period of time; and after a predetermined period of time, based on at least one of data indicative of weight, data indicative of well-being, data indicative of hunger, data indicative of appetite, data indicative of calories consumed by the patient, and data indicative of calories burned by the patient. modifying the plurality of stimulation sessions using a plurality of program instructions configured to execute on a device external to the electrical skin patch.

Optionally, the predetermined period of time is at least 14 days, wherein the plurality of stimulation sessions are modified by reducing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 10%.

Optionally, the predetermined period of time is at least 14 days, wherein the plurality of stimulation sessions are modified by increasing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 10%.

Optionally, the predetermined period of time is at least 30 days, wherein the plurality of stimulation sessions are modified by reducing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 20%.

Optionally, the predetermined period of time is at least 30 days, wherein the plurality of stimulation sessions are modified by increasing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 20%.

Optionally, the method uses a plurality of program instructions configured to execute on a device external to the electrical skin patch, wherein data indicative of weight, data indicative of well-being, data indicative of hunger, data indicative of appetite, data indicative of calories consumed by the patient The method further includes prompting the patient to enter at least one of data, and data indicative of calories burned by the patient.

Optionally, the method uses a plurality of program instructions configured to execute on a device external to the electrical skin patch to interface with a second device, comprising: data indicative of weight, data indicative of well-being, data indicative of hunger, data indicative of appetite; The method further includes automatically receiving at least one of data representing calories consumed by the patient and data representing calories consumed by the patient. The second device may be at least one of a scale and a wristband configured to measure calories burned by the patient.

Optionally, the method further comprises receiving data indicative of a weight loss goal using a plurality of program instructions configured to execute on a device external to the electrical skin patch. The method may further include prompting the patient to input data representing a weight loss goal using the plurality of program instructions configured to execute on the device external to the electrical skin patch. The method may further include modifying the plurality of stimulation sessions using a plurality of program instructions configured to execute on a device external to the electrical skin patch based on data indicative of a weight loss goal after a predetermined period of time. Optionally, the plurality of stimulation sessions is modified by increasing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 10%. Optionally, the plurality of stimulation sessions is modified by reducing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 10%.

Optionally, the method uses a second plurality of program instructions configured to execute on a second device external to the electrical skin patch and in data communication with a plurality of program instructions configured to execute on a device external to the electrical skin patch, wherein the health care provider weights The method further includes prompting to enter data indicative of a weight loss goal. The method may further include modifying the plurality of stimulation sessions using a plurality of program instructions configured to execute on a device external to the electrical skin patch based on data indicative of a weight loss goal after a predetermined period of time. Optionally, the plurality of stimulation sessions is modified by increasing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 10%. Optionally, the plurality of stimulation sessions is modified by reducing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 10%.

Optionally, each of said electrical pulses is defined by a plurality of stimulation parameters, said plurality of stimulation parameters comprising a pulse width in a range of 10 microseconds to 10 msec and a pulse frequency in a range of 1 Hz to 100 Hz.

Optionally, the total energy delivered by the plurality of stimulation sessions applied over said one week is at least 0.25 joules and the total energy delivered by one of the plurality of stimulation sessions does not exceed 6 joules.

Optionally, each of said at least two stimulation sessions occurs on a different day of said week.

Optionally, the plurality of stimulation sessions comprises at least seven stimulation sessions in said week, each of said seven stimulation sessions occurring on a different day of said week.

Optionally, none of said plurality of stimulation sessions applied to the patient's skin over said week have a duration greater than 12 hours, and no pulse amplitude greater than 45 mAmp.

Optionally, the method further comprises generating at least one of a visual, audible and vibratory signal to the patient within 30 minutes prior to initiating one of said plurality of stimulation sessions via the electrical skin patch.

Optionally, the method comprises instructing the patient to secure the electrical skin patch to the patient's skin by generating at least one of a visual, audible and vibratory signal using the electrical skin patch 60 minutes prior to initiating one of the plurality of stimulation sessions. further comprising steps.

Optionally, the method comprises instructing the patient to secure the electrical skin patch to the patient's skin by generating at least one of a visual, audible and vibratory signal using the electrical skin patch within 60 minutes of starting a wake up alarm. further comprising steps.

Optionally, the electrical skin patch is programmed to apply at least a portion of the plurality of stimulation sessions between 6 am and 9 am, 11 am and 2 pm or 5 pm and 9 pm.

Optionally, each of said plurality of stimulation sessions is separated from a subsequent stimulation session of said plurality of stimulation sessions by an amount of time at least 25% of a duration of a subsequent stimulation session of said plurality of stimulation sessions.

The present disclosure also provides an electrical skin patch secured to a patient's skin comprising a housing, an electrical pulse generator positioned within the housing, and at least one electrode attached to the housing and in electrical communication with the electrical pulse generator to aid in weight loss by a patient. A method for enabling a weight loss goal to be achieved, wherein the electrical pulse generator is configured to deliver electrical pulses having a pulse amplitude in the range of 1 mA to 65 mA, the method comprising: a plurality of electrical pulses configured for execution in a device external to an electrical skin patch receiving data indicative of at least one of weight, well-being, hunger, appetite, calories consumed by the patient, and calories burned by the patient using the program instructions of ; applying a plurality of stimulation sessions to the skin of a patient using the electrical skin patch for a duration of one week, each of the plurality of stimulation sessions comprising the electrical pulses, wherein at least some of the plurality of stimulation sessions are longer than 15 minutes applying a plurality of stimulation sessions having a duration, the plurality of stimulation sessions including at least twice in the week; repeatedly applying the plurality of stimulation sessions; and after the trigger, based on at least one of data indicative of weight, data indicative of well-being, data indicative of hunger, data indicative of appetite, data indicative of calories consumed by the patient, and data indicative of calories burned by the patient. modifying the plurality of stimulation sessions using a plurality of program instructions configured to execute on a device external to the patch.

Optionally, the trigger is a signal from a health care provider and is received by a plurality of program instructions, wherein the plurality of program instructions determines at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions. by reducing multiple stimulation sessions.

Optionally, the trigger is a signal from a health care provider and is received by a plurality of program instructions, wherein the plurality of program instructions determines at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions. by increasing the number of stimulation sessions to be modified.

Optionally, the trigger is an elapsed period of at least 14 days, wherein the plurality of stimulation sessions are modified by reducing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 10%.

Optionally, the trigger is an elapsed period of at least 14 days, wherein the plurality of stimulation sessions are modified by increasing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 10%.

Optionally, the trigger is an elapsed period of at least 30 days, wherein the plurality of stimulation sessions are modified by reducing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 20%.

Optionally, the trigger is an elapsed period of at least 30 days, wherein the plurality of stimulation sessions are modified by increasing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 20%.

Optionally, the method uses a second plurality of program instructions configured to execute on a second device external to the electrical skin patch and in data communication with a plurality of program instructions configured to execute on a device external to the electrical skin patch, wherein the health care provider weights The method further includes prompting to enter data indicative of a weight loss goal. The method may further include modifying the plurality of stimulation sessions based on data indicative of a weight loss goal using a plurality of program instructions configured to execute on a device external to the electrical skin patch. Optionally, the plurality of stimulation sessions is modified by increasing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 10%. Optionally, the plurality of stimulation sessions is modified by reducing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the plurality of stimulation sessions by at least 10%.

Optionally, each of said electrical pulses is defined by a plurality of stimulation parameters, said plurality of stimulation parameters comprising a pulse width in a range of 10 microseconds to 10 msec and a pulse frequency in a range of 1 Hz to 100 Hz.

Optionally, the total energy delivered by the plurality of stimulation sessions applied over said one week is at least 0.25 joules, and the total energy delivered by one of the plurality of stimulation sessions does not exceed 6 joules.

Optionally, each of said at least two stimulation sessions occurs on a different day of said week.

Optionally, none of said plurality of stimulation sessions applied to the patient's skin over said week have a duration of greater than 12 hours, and no pulse amplitude greater than 45 mAmp.

Optionally, the method further comprises generating at least one of a visual, audible and vibratory signal to the patient within 30 minutes prior to initiating one of said plurality of stimulation sessions via the electrical skin patch.

Optionally, the method comprises instructing the patient to secure the electrical skin patch to the patient's skin by generating at least one of a visual, audible and vibratory signal using the electrical skin patch 60 minutes prior to initiating one of the plurality of stimulation sessions. further comprising steps.

Optionally, the method further comprises instructing the patient to secure the electrical skin patch to the patient's skin by generating at least one of a visual, audible and vibratory signal using the electrical skin patch within 60 minutes of initiating the wake-up alarm. .

Optionally, the electrical skin patch is programmed to apply at least a portion of the plurality of stimulation sessions between 6 am and 9 am, 11 am and 2 pm or 5 pm and 9 pm.

Optionally, each of said plurality of stimulation sessions is separated from a subsequent one of said plurality of stimulation sessions by an amount of time at least 25% of a duration of a subsequent one of said plurality of stimulation sessions.

Also disclosed herein is an electrical skin patch configured to be worn continuously by a patient for at least 24 hours, comprising: a housing comprising a controller in electrical communication with a pulse generator; and at least two electrodes attached to the patient's skin and configured to be in electrical communication with the pulse generator, wherein the controller, when executed and transmitted to the pulse generator, causes the pulse generator to cause a first electrical stimulation pulse and a second electrical stimulation program instructions for generating and transmitting a pulse to the at least two electrodes, wherein the first electrical pulse is defined by a first phase having a first polarity and a second phase having a second polarity opposite the first polarity and the second electrical pulse follows the first electrical pulse and is defined by a third phase having a third polarity, and a fourth phase having a fourth polarity opposite the third polarity, the second polarity being the third polarity The same, an electric skin patch is disclosed.

Optionally, the second electrical pulse follows the first electrical pulse after a predetermined waiting period.

Optionally, the first polarity is positive, the second polarity is negative, the third polarity is negative, and the fourth polarity is positive.

Optionally, the first polarity is negative, the second polarity is positive, the third polarity is positive, and the fourth polarity is negative.

Optionally, each of the two or more electrodes comprises a hypoallergenic conductive gel having one or more adhesive surfaces.

Optionally, the electrode does not comprise imidazolidinyl urea or diazolidinyl urea.

Optionally, the electrode comprises a carboxymethylcellulose polymer and propylene glycol.

Optionally, the at least one adhesive surface is configured to adhere to the patient's skin and has a peel strength in the range of 1.0 Newtons to 2.1 Newtons.

Optionally, the at least one adhesive surface is configured to adhere to the skin of the patient and has a total skin contacting surface area in the range of 2 cm 2 to 4 cm 2 .

Optionally, the at least two electrodes are positioned in the same plane parallel to the patient's skin and separated by a distance of 0.05 cm 2 to 0.4 cm 2 .

Optionally, the amplitudes of the first phase, the second phase, the third phase and the fourth phase are the same, and the pulse widths of the first phase, the second phase, the third phase and the fourth phase are the same.

Optionally, the predetermined time interval is from 1 minute to 10 minutes.

Optionally, the amplitudes of the first and fourth phases are equal, wherein the pulse widths of the first and fourth phases are equal, the amplitudes of the second and third phases are equal, and the second and third phases are equal in amplitude. The pulse widths of the phases are the same, and at least one of the amplitude and the pulse width of the first phase is different from the amplitude and the pulse width of the second phase.

Optionally, a first phase is defined as a waveform characterized by a first period and a second period, wherein the first period comprises the first 10 μs of the waveform and the second period comprises the remainder of the waveform, wherein the The waveform is defined by a maximum amplitude for a first period and an amplitude less than the maximum amplitude for a second period.

Optionally, the maximum amplitude ranges from 20 mA to 40 mA.

Optionally, the maximum amplitude is in the range of 20 mA to 40 mA and the average amplitude over the first and second periods is in the range of 10 mA to 20 mA.

Optionally, the pulse generator has a maximum compliance voltage in the range of 40 volts to 60 volts.

Optionally, at least one of the first phase, the second phase, the third phase and the fourth phase is defined by a waveform characterized by a first period, a second period and a third period, wherein the first period of time is of the waveform. at least a portion of 0 to 10 μs, the second period includes at least a portion of 10 μs to 100 μs of the waveform, and the third period includes at least a portion of 100 μs to 200 μs of the waveform, wherein the first The period is determined by the maximum amplitude, and the second and third periods are determined by the remaining amplitudes less than the maximum amplitude.

Optionally, the maximum amplitude ranges from 20 mA to 40 mA.

Optionally, the attenuation of the residual amplitude in the second period is defined as a first negative slope having a first magnitude, and the attenuation of the remaining amplitude in the third period is defined as a second negative slope having a second magnitude, Here, the first size is smaller than the second size.

Optionally, the average of the maximum amplitude and the remaining amplitudes is in the range of 10 mA to 20 mA.

In some embodiments, disclosed herein is an electrical skin patch configured to be worn continuously by a patient for at least one day, comprising: a housing comprising a controller in electrical communication with a pulse generator; and two electrodes configured to adhere to the patient's skin, positioned in the same plane parallel to the patient's skin, and in electrical communication with the pulse generator at a distance of 0.05 cm to 0.4 cm; and program instructions that, when transmitted to a pulse generator, cause the pulse generator to generate and transmit a first set of electrical stimulation pulses and a second set of electrical stimulation pulses to at least two electrodes, each of the two or more electrodes comprising: A hypoallergenic conductive gel comprising at least one adhesive surface, wherein the hypoallergenic conductive gel does not comprise imidazolidinyl urea or diazolidinyl urea, wherein at least one adhesive surface is configured to adhere to the skin of a patient. and 2 cm2 and a total skin contact surface area ranging from 4 cm 2

Optionally, the electrode comprises a carboxymethylcellulose polymer and propylene glycol.

Optionally, each of the electrical stimulation pulses is defined by a charge balanced biphasic waveform, wherein the first set of electrical stimulation pulses and the second set of electrical stimulation pulses are separated by a predetermined time interval.

Optionally, the predetermined time interval is randomly assigned and is at least 1 minute in length.

Optionally, the pulse generator has a maximum compliance voltage in the range of 40 volts to 60 volts.

Optionally, each electrical stimulation pulse is defined by a waveform characterized by a first period, a second period and a third period, wherein the first period comprises at least a portion of 0 to 10 μs of the waveform, and a second period The period includes at least a portion of 10 μs to 100 μs of the waveform, and the third period includes at least a portion of 100 μs to 200 μs of the waveform, wherein the first period is defined by a maximum amplitude, and The 3 period is defined by the remaining amplitude less than the maximum amplitude.

Optionally, the maximum amplitude of the electrical skin patch is between 20 mA and 40 mA.

Optionally, in a second period, the attenuation of the residual amplitude is determined by a slope of a first negative amplitude having a first magnitude, and in a third period, the attenuation of the remainder amplitude is determined by a slope of a second negative amplitude having a second magnitude. , where the first size is smaller than the second size.

Optionally, the average of the maximum amplitude and the remaining amplitudes is in the range of 10 mA to 20 mA.

In some embodiments, the present disclosure provides a method of using an electrical skin patch, wherein each electrical stimulation pulse has a pulse width ranging from 10 μsec to 10 msec, a pulse amplitude ranging from 100 μA to 100 mA, and a pulse ranging from 1 Hz to 100 Hz. programming the controller to include the frequency; and determining whether the patient experiences a change in appetite as a result of applying the first set of electrical stimulation pulses or the second set of electrical stimulation pulses to the patient's skin, wherein the patient determines that the two electrodes using an electric skin patch that does not experience erythema, scaling, itching, folliculitis, or intertrigo at the point of attachment to the skin of the skin.

Optionally, the method comprises: programming the controller such that each electrical stimulation pulse comprises a pulse width in the range of 10 μsec to 10 msec, a pulse amplitude in the range of 100 μA to 100 mA, and a pulse frequency in the range of 1 Hz to 100 Hz; and determining whether the patient experiences a change in appetite as a result of applying the first set of electrical stimulation pulses or the second set of electrical stimulation pulses to the skin of the patient, wherein the patient determines that the two electrodes The patient does not experience erythema, scaling, itching, folliculitis, or hepatitis at the point of attachment to the patient's skin.

Disclosed herein is a system for generating a real-time intervention in response to a patient's degree of appetite, comprising: a housing; a controller located within the housing; at least one electrode positioned in physical communication with the housing and configured to be in electrical contact with the patient's skin; and a pulse generator positioned within the housing and in electrical communication with a controller and the at least one electrode, wherein the pulse generator is configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by a stimulation parameter. wherein the stimulation parameter comprises a first pulse width in the range of 10 μsec to 10 msec, a first pulse amplitude in the range of 100 μA to 100 mA, and a first pulse frequency in the range of 1 Hz to 100 Hz; a first plurality of program instructions stored in a non-transitory memory of the client device separate from the electrical skin patch, wherein when executed, the first plurality of program instructions cause the client device to: via a microphone or display of the client device, the patient's degree of appetite the first plurality of program instructions configured to generate a prompt to the patient to input data representing a second plurality of program instructions stored in a non-transitory memory of a client device or other device separate from the electrical skin patch, wherein, when executed, the second plurality of program instructions determine a patient's appetite pattern based on the input data , the second plurality of program instructions; and a third plurality of program instructions stored in a non-transitory memory of a client device or other device separate from the electrical skin patch, wherein when executed, the third plurality of program instructions determine an intervention based on an appetite pattern and generate the intervention. and the third plurality of program instructions.

Optionally, the intervention is to send at least one of a text-based message, a video message, an audio message, or a graphic message to the patient via the client device.

Optionally, the intervention is to modify the stimulation parameter such that at least one pulse width is different from the first pulse width, the pulse amplitude is different from the first pulse amplitude, and the pulse frequency is different from the first pulse frequency.

Optionally, the second plurality of program instructions determine a time window associated with each input data, and for each time window, a range of values of all input data associated with the time window is predetermined around the values to constitute a pattern. Determine the patient's appetite pattern based on the data entered by determining whether it is within the range. The time window may range from 1 hour to 3 hours.

Optionally, the second plurality of program instructions determine a time window associated with each input data, and for each time window, a range of values of all input data associated with the time window is predetermined around the values to constitute a pattern. Determine the patient's appetite pattern based on the data entered by determining whether it is within the range.

Optionally, the second plurality of program instructions determine a time window associated with each input data, and determine for each time window whether a number of individual input data values associated with the time window is large enough to constitute a pattern. determine the patient's appetite pattern based on the data input by

Optionally, the second plurality of program instructions determine a time window associated with each input data, and determine for each time window whether the number of individual input data values associated with the time window is too small to constitute a pattern. determine the patient's appetite pattern based on the data input by The time window may range from 1 hour to 3 hours.

Optionally, the prompt is in the form of at least one of an audio message, a video message, a text message, and a graphic message.

Optionally, the first plurality of program instructions are configured to cause the client device to generate the prompt at a first rate during the first time window and at a second rate after the first time window, wherein the second rate is greater than the first rate. small. Optionally, the first rate ranges from 1 time per day to 24 times per day, and the first time window ranges from 1 day to 1 month. Optionally, the first plurality of program instructions are configured to provide the patient with an option to modify the first ratio via a display of the client device.

Optionally, the third plurality of program instructions are configured to: process an appetite pattern indicative of the patient's appetite to determine whether the patient's appetite is expected to be greater than or less than the first threshold in a future time window; decide to intervene. Optionally, if the patient's degree of appetite is expected to be less than the first threshold in a future time window, the third plurality of program instructions do not generate an intervention during the future time window. Optionally, if the patient's degree of appetite is expected to be greater than the first threshold in a future time window, the third plurality of program instructions generates an intervention during the future time window. The intervention may cause at least one of a text-based message, a video message, an audio message, or a graphic message to be transmitted to the patient via the client device. The intervention may modify the stimulation parameter such that at least one pulse width is different from the first pulse width, the pulse amplitude is different from the first pulse amplitude, and the pulse frequency is different from the first pulse frequency.

Optionally, when executed, the first plurality of program instructions generates a prompt in the form of a visual analog scale, and displays the prompt on the client device, wherein each value according to the visual analog scale represents a different degree of appetite. The visual analog scale may be a light bar with a sliding scale, wherein a first end of the sliding scale indicates a low degree of appetite and a second end of the sliding scale indicates a high degree of appetite.

Optionally, when executed, the first plurality of program instructions generates a prompt in the form of a plurality of icons, each of the plurality of icons indicating a different degree of appetite.

Optionally, when executed, the first plurality of program instructions generate a prompt in the form of an audible query and play the audible query through a speaker of the client device.

Optionally, when executed, a third plurality of program instructions receive the patient's appetite pattern, display the appetite pattern on the client device, the appetite pattern comprising: a time of day on a first axis, a calendar day on a second axis; and an icon indicating the degree of appetite of the patient displayed on the graph in relation to the time of day and the calendar day. Optionally, at least one of the size, shape, color or pattern of the icon indicates the degree of appetite of the patient.

Optionally, when executed, the third plurality of program instructions receive the weight trend and appetite pattern of the patient, determine a composite score of the patient, wherein the composite score is a function of the patient's past appetite degree and weight trend; The composite score is displayed on the client device. Optionally, when executed, the third plurality of program instructions are configured to cause the client device to transmit the composite score to an online fellowship group, wherein the patient is a member of the online fellowship group.

Also disclosed herein is a system for generating a real-time intervention in response to a patient's degree of appetite, comprising: a housing; a controller located within the housing; at least one electrode in physical communication with the housing and configured to be in electrical contact with the patient's skin; and a pulse generator positioned within the housing and in electrical communication with a controller and the at least one electrode, wherein the pulse generator is configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by a stimulation parameter. configured, the electric skin patch; a first plurality of program instructions stored in a non-transitory memory of a client device separate from the electrical skin patch, wherein, when executed, the first plurality of program instructions communicate with the electrical skin patch and communicate with the patient via a microphone or display of the client device. the first plurality of program instructions for prompting a patient to input data indicative of a degree of appetite; and a second plurality of program instructions stored in a non-transitory memory of the client device or other device separate from the electrical skin patch, wherein, when executed, the second plurality of program instructions receive data indicative of a patient's degree of appetite, wherein the patient's appetite is By processing the data indicative of severity, we develop predictions about whether a patient's appetite will be above or below a threshold in a future time window, and if the patient's appetite is expected to be below a threshold in a future time window, we recommend that you intervene in a future time window. and generating a first intervention in a future time window if the patient's degree of appetite is expected to exceed a threshold value without generating the second plurality of program instructions.

Optionally, the first intervention is a signal generated by the second plurality of program instructions and transmitted to the electrical skin patch at or before a future time window.

Optionally, the first intervention comprises at least one of graphics, text, audio and video, wherein at least one of the graphics, text, audio and video comprises a prerecorded message from an individual connected with the patient within the social network.

Optionally, the first intervention comprises at least one of graphics, text, audio and video, wherein at least one of the graphics, text, audio and video comprises a real-time message from an individual connected with the patient within the social network.

Also disclosed herein is an electrical skin patch adapted to be worn continuously by a patient for at least three days, comprising: a housing comprising a controller in electrical communication with a pulse generator; and at least two electrodes in electrical communication with the pulse generator and configured to adhere to the skin of a patient, wherein the controller, when executed and transmitted to the pulse generator, causes the pulse generator to include a first set of electrical stimulation pulses and a second set of pulses. program instructions for generating and transmitting electrical stimulation pulses of at least two electrodes, each of the two or more electrodes comprising a hypoallergenic conductive gel having at least one adhesive surface.

Optionally, the electrode does not comprise imidazolidinyl urea or diazolidinyl urea.

Optionally, the electrode comprises a carboxymethylcellulose polymer and propylene glycol.

Optionally, the at least one adhesive surface is configured to adhere to the patient's skin and has a peel strength in the range of 1.0 Newtons to 2.1 Newtons.

Optionally, the at least one adhesive surface adheres to the patient's skin and is configured to have a total skin contacting surface area in the range of 2 cm 2 to 4 cm 2 .

Optionally, the at least two electrodes are disposed in the same plane parallel to the patient's skin and separated by a distance of 0.05 cm 2 to 0.4 cm 2 .

Optionally, each electrical stimulation pulse is defined by a charge balanced biphasic waveform, wherein the first set of electrical stimulation pulses and the second set of electrical stimulation pulses are separated by a predetermined time interval. The predetermined time interval may range from 1 minute to 10 minutes.

Optionally, each electrical stimulation pulse is defined by a waveform characterized by a first period and a second period, wherein the first period comprises the first 10 μs of the waveform and the second period comprises the remainder of the waveform and, the waveform is determined to have an amplitude smaller than the maximum amplitude during the first period and the maximum amplitude during the second period. The maximum amplitude may range from 20 mA to 50 mA. The maximum amplitude may be in the range of 20 mA to 50 mA, and the average amplitude over the first and second periods may be in the range of 10 mA to 30 mA.

Optionally, the pulse generator has a maximum compliance voltage in the range of 40 volts to 60 volts. Optionally, each electrical stimulation pulse is defined by a waveform characterized by a first period, a second period and a third period, wherein the first period comprises at least a portion of 0 to 10 μs of the waveform, and a second period The period includes at least a portion of 10 μs to 100 μs of the waveform, and the third period includes at least a portion of 100 μs to 200 μs of the waveform, wherein the first period is defined by a maximum amplitude, and The 3 period is defined by the remaining amplitude less than the maximum amplitude. Optionally, the maximum amplitude ranges from 20 mA to 50 mA. Optionally, in a second period, the attenuation of the residual amplitude is determined by a slope of a first negative amplitude having a first magnitude, and in a third period, the attenuation of the remainder amplitude is determined by a slope of a second negative amplitude having a second magnitude. , where the first size is smaller than the second size. Optionally, the average of the maximum amplitude and the remaining amplitudes is in the range of 10 mA to 30 mA.

Also disclosed herein is an electrical skin patch configured to be worn continuously by a patient for at least three days, comprising: a housing comprising a controller in electrical communication with a pulse generator; and two electrodes attached to the patient's skin, located in the same plane parallel to the patient's skin, and configured to be in electrical communication with the pulse generator at a distance of 0.05 cm to 0.4 cm; program instructions that, when transmitted to the generator, cause the pulse generator to generate and transmit a first set of electrical stimulation pulses and a second set of electrical stimulation pulses to at least two electrodes, each of the at least two electrodes comprising at least one A hypoallergenic conductive gel having an adhesive surface, wherein the hypoallergenic conductive gel does not comprise imidazolidinyl urea or diazolidinyl urea, wherein at least one adhesive surface adheres to the patient's skin, and Disclosed is an electrical skin patch configured to have a total skin contacting surface area in the range of to 4 cm 2 .

Optionally, the electrode comprises a carboxymethylcellulose polymer and propylene glycol.

Optionally, each electrical stimulation pulse is defined by a charge balanced biphasic waveform, wherein the first set of electrical stimulation pulses and the second set of electrical stimulation pulses are separated by a predetermined time interval. The predetermined time interval can be randomly assigned and is at least 1 minute.

Optionally, the pulse generator has a maximum compliance voltage in the range of 40 volts to 60 volts. Optionally, each electrical stimulation pulse is defined by a waveform characterized by a first period, a second period and a third period, wherein the first period comprises at least a portion of 0 to 10 μs of the waveform, and a second period The period includes at least a portion of 10 μs to 100 μs of the waveform, and the third period includes at least a portion of 100 μs to 200 μs of the waveform, wherein the first period is defined by a maximum amplitude, and The 3 period is defined by the remaining amplitude less than the maximum amplitude. Optionally, the maximum amplitude ranges from 20 mA to 50 mA. Optionally, in a second period, the attenuation of the residual amplitude is determined by a slope of a first negative amplitude having a first magnitude, and in a third period, the attenuation of the remainder amplitude is determined by a slope of a second negative amplitude having a second magnitude. , where the first size is smaller than the second size. Optionally, the average of the maximum amplitude and the remaining amplitudes is in the range of 10 mA to 30 mA.

The present specification also provides a method of using the aforementioned electric skin patch, wherein each electrical stimulation pulse has a pulse width in the range of 10 μsec to 10 msec, a pulse amplitude in the range of 100 μA to 100 mA, and a pulse frequency in the range of 1 Hz to 100 Hz. programming the controller to include; and assessing whether the patient experiences a change in appetite as a result of applying the first set of electrical stimulation pulses or the second set of electrical stimulation pulses to the patient's skin, wherein the patient determines that the two electrodes A method is disclosed that does not experience erythema, scaling, itching, folliculitis, or hepatitis at the point of attachment to the skin of a patient.

In some embodiments, disclosed herein is an electrical stimulation system comprising: a housing, a controller positioned within the housing, at least one electrode positioned within the housing and configured to electrically contact a patient's skin, a controller positioned within the housing and the at least one electrode; an electrical skin patch comprising a pulse generator in electrical communication, the pulse generator configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by a stimulation parameter; and a first plurality of program instructions stored in a non-transitory memory of a client device separate from the electrical skin patch, wherein when executed by the client device, the first plurality of program instructions are in communication with the electrical skin patch, the patient's Disclosed is an electrical stimulation system comprising a first plurality of program instructions for obtaining blood glucose state data, generating a modulated signal based on the blood glucose state data, and transmitting the modulated signal to an electric skin patch.

Optionally, the stimulation parameters include a pulse width in the range of 10 μsec to 10 msec, a pulse amplitude in the range of 100 μA to 100 mA, and a pulse frequency in the range of 1 Hz to 100 Hz.

Optionally, the modulated signal defines a second plurality of stimulation parameters, wherein the second plurality of stimulation parameters include a second pulse width in the range of 10 μsec to 10 msec, a second pulse amplitude in the range of 100 μA to 100 mA, and 1 Hz. to 100 Hz, wherein the at least one pulse width is different from the second pulse width, the pulse amplitude is different from the second pulse amplitude, and the pulse frequency is different from the second pulse frequency.

Optionally, the second plurality of stimulation parameters are selected such that after applying the stimulation session defined by the second plurality of stimulation parameters, the patient's blood glucose index improves as compared to the patient's blood glucose index before applying the stimulation session.

Optionally, the first plurality of program instructions prompt the patient to enter blood glucose status data by displaying a visual analog scale on the client device.

Optionally, when executed, the first plurality of program instructions generate a modulated signal based on a time of day.

Optionally, when executed, a first plurality of program instructions periodically and automatically obtain the blood sugar status data from a second device comprising a blood sugar sensor configured to wirelessly communicate the blood sugar status data to the client device. Get status data.

Optionally, the electrical skin patch includes a blood glucose sensor that periodically and automatically monitors and records the patient's blood glucose status data.

Optionally, when executed, the first plurality of program instructions prompt the patient to input data indicative of the patient's appetite level via a microphone or display of the client device.

Optionally, when executed, the first plurality of program instructions generates a modulated signal based on the blood glucose state data and data indicative of a patient's degree of appetite.

In some embodiments, disclosed herein is an electrical stimulation system comprising: a housing, a controller positioned within the housing, at least one electrode positioned within the housing and configured to electrically contact a patient's skin, a controller positioned within the housing and electrically with the at least one electrode an electrical skin patch comprising a pulse generator in communication, the pulse generator configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by a stimulation parameter; and a first plurality of program instructions stored in a non-transitory memory of a client device separate from the electric skin patch, wherein when executed by the client device, the first plurality of program instructions are in communication with the electric skin patch; Prompt the patient to input data representing the patient's appetite level through a microphone or display of the client device, obtain blood glucose status data of the patient, generate a modulation signal based on the blood glucose status data and time of day, and An electrical stimulation system is disclosed that transmits a modulated signal to an electrical skin patch.

Optionally, when executed, the first plurality of program instructions prompt the patient to input data indicative of the patient's degree of appetite by displaying a visual analog scale on the client device.

Optionally, when executed, the first plurality of program instructions further generate a modulated signal based on the data indicative of the patient's degree of appetite.

Optionally, the stimulation parameters include a session frequency, a session duration, a pulse width in the range of 10 μsec to 10 msec, a pulse amplitude in the range of 100 μA to 100 mA, and a pulse frequency in the range of 1 Hz to 100 Hz, wherein the modulated signal is define a second plurality of stimulation parameters, wherein the second plurality of stimulation parameters include a second session frequency, a second session duration, a second pulse width in the range of 10 µsec to 10 msec, a second pulse width in the range of 100 µA to 100 mA two pulse amplitudes, and a second pulse frequency ranging from 1 Hz to 100 Hz.

Optionally, when executed, the first plurality of programming instructions receive the blood glucose status data before 11 am, examine the blood glucose status data to determine whether the patient's blood glucose level is greater than 100 mg/dL, the determining an electrical skin patch after 5 p.m. based on

Optionally, when executed, the first plurality of programming instructions receive the blood glucose status data before 11 am, examine the blood glucose status data to determine whether the patient's blood glucose level is greater than 100 mg/dL, the determining an electrical skin patch after 5 pm generates the modulated signal configured to generate an electrical stimulation based on at least one of a session duration, an increased second pulse amplitude relative to the pulse amplitude, and an increased second pulse frequency compared to the pulse frequency.

Optionally, when executed, the first plurality of program instructions receive the blood glucose status data periodically throughout the day, examine the blood glucose status data to determine whether the patient's blood glucose level is greater than 140 mg/dL, the determining Based on , within 2 hours after determining that the blood sugar level is greater than 140 mg/dL, the electrical skin patch generates the modulated signal configured to generate the electrical stimulation.

Optionally, when executed, the first plurality of program instructions receive the blood glucose status data periodically throughout the day, examine the blood glucose status data to determine whether the patient's blood glucose level is greater than 140 mg/dL, and examining data indicative of a degree of appetite, and generating, based on the determination, the modulated signal configured to generate an electrical stimulus within 2 hours of determining that the blood glucose level is greater than 140 mg/dL and the patient's appetite level is greater than a predetermined value do.

Optionally, when executed, a first plurality of program instructions receive the blood glucose status data, examine the blood glucose status data to determine whether the patient's blood glucose level is less than 80 mg/dL, and based on the determination, Generate a modulated signal.

Optionally, when executed, a first plurality of program instructions receive the blood glucose status data, examine the blood glucose status data to determine whether the patient's blood glucose level is less than 80 mg/dL, and based on the determination, generate a modulated signal, wherein the modulated signal is at a second session frequency reduced relative to the session frequency, a second session duration reduced relative to the session duration, a second pulse amplitude reduced relative to the pulse amplitude, and a pulse frequency and at least one of a reduced second pulse frequency compared to the present invention.

Optionally, when executed, a first plurality of program instructions receive the blood glucose status data, examine the blood glucose status data to determine whether an increase rate of the patient's blood glucose level exceeds 2 mg/dL per minute, the determining The modulated signal is generated based on

Optionally, when executed, a first plurality of program instructions receive the blood glucose status data, examine the blood glucose status data to determine whether an increase rate of the patient's blood glucose level exceeds 2 mg/dL per minute, the determining generate the modulated signal based on: a second session frequency increased relative to a session frequency, a second session duration increased relative to a session duration, a second pulse amplitude increased relative to a pulse amplitude; and a second pulse frequency increased relative to the pulse frequency.

Optionally, the second plurality of stimulation parameters are selected such that the patient's blood glucose level decreases by 20 mg/dL after applying a stimulation session defined by the second plurality of stimulation parameters.

Optionally, the second plurality of stimulation parameters, wherein after applying the stimulation session defined by the second plurality of stimulation parameters, the patient's hemoglobin A1C level decreases by at least 1% relative to the patient's hemoglobin A1C level prior to applying the stimulation session chosen to do

Optionally, the second plurality of stimulation parameters is determined such that, after applying the stimulation session defined by the second plurality of stimulation parameters, the patient's hepatic gluconeogenesis is compared to hepatic gluconeogenesis prior to applying the stimulation session. chosen to be as low as at least 1%.

Optionally, the second plurality of stimulation parameters, after applying the stimulation session defined by the second plurality of stimulation parameters, improve the patient's degree of insulin resistance by at least 1% compared to the patient's degree of insulin resistance before applying the stimulation session chosen to be

Optionally, the second plurality of stimulation parameters, after applying the stimulation session defined by the second plurality of stimulation parameters, the patient's level of glycemic homeostasis improves by at least 1% compared to the patient's glycemic homeostasis prior to applying the stimulation session chosen to be

Optionally, the second plurality of stimulation parameters, after applying the stimulation session defined by the second plurality of stimulation parameters, the patient's HOMA-IR level is reduced by at least 4% relative to the HOMA-IR level prior to applying the stimulation session chosen to do

In some embodiments, disclosed herein is a system for generating a real-time intervention in response to a patient's degree of appetite, comprising: a housing, a controller positioned within the housing, at least one electrode positioned within the housing and configured to electrically contact the patient's skin; An electrical skin patch comprising a pulse generator positioned and in electrical communication with a controller and the at least one electrode, the pulse generator configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by a stimulation parameter, the the electrical skin patch, wherein the stimulation parameters include a pulse width in the range of 10 μsec to 10 msec, a pulse amplitude in the range of 100 μA to 100 mA, and a pulse frequency in the range of 1 Hz to 100 Hz; a first plurality of program instructions stored in a non-transitory memory of a client device separate from the electric skin patch, wherein when executed, the first plurality of program instructions communicate with the electric skin patch and via a microphone or display of the client device the first plurality of program instructions for prompting the patient to input data representing the degree of appetite of the patient, and transmitting the data representing the degree of appetite of the patient to at least one server; and a second plurality of program instructions stored in a non-transitory memory of the at least one server, wherein, when executed, the second plurality of program instructions receive data indicative of a patient's appetite degree, wherein the patient's appetite degree is determined by the patient's appetite. processing the data indicative of the degree to determine whether it is between a first threshold value and a second threshold value or between a second threshold value and a third threshold value, each of the first threshold value, the second threshold value, and the third threshold value is different, and sends a first intervention to the client device if the patient's appetite degree is between the first and second thresholds, and transmits a second intervention to the client device if the patient's appetite degree is between the second and third thresholds. send an intervention to a client device, wherein the first intervention is different from a second intervention, each of the first and second interventions being transmitted from at least one server to a client device and presented to a patient via the client device A system comprising a second plurality of program instructions is disclosed.

Optionally, when executed, the first plurality of program instructions generates a visual prompt in the form of a visual analog scale, and displays the visual prompt on the client device, wherein each value according to the visual analog scale indicates a different degree of appetite. indicates.

Optionally, when executed, the first plurality of program instructions transmits a signal to the electrical skin patch in response to data indicative of a patient's degree of appetite.

Optionally, when executed, the first plurality of program instructions generates a visual prompt in the form of a plurality of icons and displays the visual prompt on the client device, wherein each of the plurality of icons indicates a different degree of appetite.

Optionally, when executed, the first plurality of program instructions generates a plurality of auditory queries and plays the plurality of auditory queries through a speaker of the client device.

Optionally, the first intervention comprises at least one of graphics, text, audio and video, wherein at least one of the graphics, text, audio and video comprises coaching instructions to assist the patient in achieving dietary compliance. .

Optionally, the second intervention comprises at least one of graphics, text, audio and video, wherein at least one of the graphics, text, audio and video comprises a message from an individual connected with the patient within the social network.

Optionally, when executed, the second plurality of program instructions process the data indicative of the patient's appetite degree to determine whether the patient's appetite degree falls between a third threshold value and a fourth threshold value (a fourth threshold value) is different from the first threshold, the second threshold, and the third threshold, and if the patient's degree of appetite is between the third and fourth thresholds, send a third intervention to the client device (the third intervention is different from the first intervention and the second intervention), the third intervention is transmitted from the at least one server to the client device and presented to the patient via the display.

Optionally, the first intervention comprises at least one of graphics, text, audio and video, wherein at least one of the graphics, text, audio and video comprises data indicative of an appetite profile of the patient.

Optionally, the second intervention comprises at least one of graphics, text, audio and video, wherein at least one of the graphics, text, audio and video comprises a prerecorded message from an individual connected with the patient within the social network.

Optionally, the third intervention comprises at least one of graphics, text, audio and video, wherein at least one of the graphics, text, audio and video comprises a real-time message from an individual connected with the patient within the social network.

Optionally, when executed, at least one of the first plurality of program instructions and the second plurality of program instructions receives a plurality of values indicative of a weight trend of the patient and a past degree of appetite of the patient, and determines a composite score of the patient, wherein The composite score is a function of the patient's past appetite and weight trends), and the composite score is displayed on the client device.

Optionally, when executed, at least one of the first plurality of program instructions and the second plurality of program instructions transmits the composite score to an online social group, wherein the patient is a member of the online social group.

Optionally, when executed, at least one of the first plurality of program instructions and the second plurality of programming instructions receives a composite score of a member of an online social group, wherein the composite score of the member includes the member's past appetite score and weight trend is a function of ), and displays the composite score of the member on the client device.

Optionally, when executed, at least one of the first plurality of program instructions and the second plurality of program instructions comprises: a weight trend of the patient, a plurality of values indicative of a past degree of appetite of the patient, a plurality of values indicative of a past amount of exercise of the patient, and receiving a plurality of values indicative of a patient's past well-being, determining a composite score of the patient, wherein the composite score is a function of the patient's past appetite, weight trends, past well-being, and past exercise; displayed on the client device.

In some embodiments, disclosed herein is a system for generating a real-time intervention in response to a patient's degree of appetite, comprising: a housing, a controller positioned within the housing, at least one electrode positioned within the housing and configured to electrically contact the patient's skin; An electrical skin patch comprising a pulse generator positioned and in electrical communication with a controller and the at least one electrode, the pulse generator configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by a stimulation parameter, the Stimulation parameters include: an electrical skin patch comprising a pulse width in the range of 10 μsec to 10 msec, a pulse amplitude in the range of 100 μA to 100 mA, and a pulse frequency in the range of 1 Hz to 100 Hz; a first plurality of program instructions stored in a non-transitory memory of a client device separate from the electric skin patch, wherein when executed, the first plurality of program instructions communicate with the electric skin patch and via a microphone or display of the client device a first plurality of program instructions for prompting the patient to input data representing the degree of appetite of the patient, and transmitting the data representing the degree of appetite of the patient to the at least one server; and a second plurality of program instructions stored in a non-transitory memory of the at least one server, wherein, when executed, the second plurality of program instructions receive data indicative of a patient's appetite degree, and receive data indicative of the patient's appetite degree. processing to determine whether the patient's appetite level is above or below a threshold, and if the patient's appetite level falls below the threshold, no intervention is sent to the client device, if the patient's appetite level exceeds the threshold A system comprising a second plurality of program instructions to send a first intervention to a client device.

Optionally, when executed, at least one of the first plurality of program instructions and the second plurality of program instructions processes data indicative of a degree of appetite of the patient to determine when the patient is hungry at a future time.

Optionally, when executed, the first plurality of program instructions send a signal to an electrical skin patch positioned on the patient's skin based on the future time.

Optionally, when executed, the first plurality of program instructions generates a visual prompt in the form of a visual analog scale, wherein each value along the visual analog scale represents a different degree of appetite.

Optionally, the visual prompt is a light bar with a sliding scale, wherein one end of the sliding scale indicates a low degree of appetite and a second end of the sliding scale indicates a high degree of appetite.

Optionally, when executed, the first plurality of program instructions sends a signal to the electrical skin patch in response to the data indicative of the high degree of appetite.

Optionally, when executed, the first plurality of program instructions generates a visual prompt in the form of a plurality of icons, each of the plurality of icons indicating a different degree of appetite.

Optionally, when executed, the first plurality of program instructions generate a plurality of audible queries via a speaker of the client device to prompt the user to verbally respond to the data indicative of a patient's appetite level.

Optionally, the first intervention comprises at least one of graphics, text, audio and video, wherein at least one of the graphics, text, audio and video comprises coaching instructions for helping the patient achieve dietary compliance.

Optionally, the first intervention comprises at least one of graphics, text, audio and video, wherein at least one of the graphics, text, audio and video comprises a prerecorded message from an individual connected with the patient within the social network.

Optionally, the first intervention comprises at least one of graphics, text, audio and video, wherein at least one of the graphics, text, audio and video comprises a real-time message from an individual connected with the patient within the social network.

Optionally, when executed, at least one of the first plurality of program instructions and the second plurality of program instructions receive a plurality of values indicative of a weight trend of the patient and a past degree of appetite of the patient, determine a composite score of the patient; Here, the composite score is a function of the patient's past appetite and weight trend), and the composite score is displayed on the client device.

Optionally, when executed, at least one of the first plurality of program instructions and the second plurality of program instructions transmits the composite score to an online social group, wherein the patient is a member of the online social group.

Optionally, when executed, at least one of the first plurality of program instructions and the second plurality of programming instructions receives a composite score of a member of an online social group, wherein the composite score of the member includes the member's past appetite score and weight trend is a function of ), and displays the composite score of the member on the client device.

Optionally, when executed, at least one of the first plurality of program instructions and the second plurality of program instructions comprises: a weight trend of the patient, a plurality of values indicative of a past degree of appetite of the patient, a plurality of values indicative of a past amount of exercise of the patient, and receiving a plurality of values indicative of a patient's past well-being, determining a composite score of the patient, wherein the composite score is a function of the patient's past appetite, weight trends, past well-being, and past exercise; displayed on the client device.

In some embodiments, disclosed herein is a method of enabling a patient to achieve a weight loss goal comprising a housing, an electrical pulse generator positioned within the housing, and at least one electrode attached to the housing and in electrical communication with the electrical pulse generator providing an electrical skin patch to the patient comprising: providing an electrical skin patch to the patient, wherein the electrical pulse generator is configured to deliver electrical pulses having a pulse amplitude in the range of 5 mA to 45 mA; instructing the patient to secure the electrical skin patch to the patient's skin; applying a plurality of stimulation sessions to the skin of a patient using the electrical skin patch for a duration of one week, each of the plurality of stimulation sessions comprising the electrical pulses, wherein at least some of the plurality of stimulation sessions are longer than 15 minutes applying a plurality of stimulation sessions to the patient's skin having a duration, the plurality of stimulation sessions including at least one in the week; and instructing the patient to repeatedly apply the plurality of stimulation sessions until the weight loss goal is achieved.

Optionally, each of said electrical pulses is defined by a plurality of stimulation parameters, said plurality of stimulation parameters comprising a pulse width in a range of 10 microseconds to 10 msec and a pulse frequency in a range of 1 Hz to 100 Hz.

Optionally, the total energy delivered by the plurality of stimulation sessions applied over the week is at least 0.25 joules.

Optionally, the plurality of stimulation sessions comprises at least two times in the week, each of the two stimulation sessions occurring on a different day of the week.

Optionally, the total energy delivered by one of said plurality of stimulation sessions does not exceed 6 joules.

Optionally, the plurality of stimulation sessions comprises at least seven stimulation sessions in said week, each of said seven stimulation sessions occurring on a different day of said week.

Optionally, a first stimulation session of the plurality of stimulation sessions is separated from a second stimulation session of the plurality of stimulation sessions by an amount of time equal to or greater than one quarter of a duration of a second stimulation session of the plurality of stimulation sessions.

Optionally, the method further comprises instructing the patient to repeatedly apply said plurality of stimulation sessions over at least 4 weeks.

Optionally, the method further comprises causing the patient to lose at least 2 pounds over said at least 4 weeks.

Optionally, the method comprises instructing the patient to repeatedly apply said plurality of stimulation sessions over at least 4 weeks; and allowing the patient to lose weight for said at least 4 weeks such that the patient maintains a loss of at least 90% of said weight loss for at least 30 days after the patient has applied the end of said plurality of stimulation sessions.

Optionally, the method further comprises applying at least three of the plurality of stimulation sessions to the skin of the patient daily using the electrical skin patch, wherein each of the three stimulation sessions of the plurality of stimulation sessions comprises: The plurality of stimulation parameters, occurring on different days, including the pulse width, the pulse frequency, and the pulse amplitude, are determined after application of at least one of the three stimulation sessions of the plurality of stimulation sessions. Government activity is set to slow from a first level to a second level, wherein the second level of gastric vestibular activity is maintained for at least one hour after applying the end of the plurality of stimulation sessions.

Optionally, the method further comprises generating, via the electrical skin patch, at least one of a visual, audible and vibratory signal to the patient within 30 minutes prior to initiating a stimulation session of one of said plurality of stimulation sessions.

Optionally, the method comprises: causing the patient to manually trigger at least one of the plurality of stimulation sessions by generating at least one of a visual, auditory, and vibration signal using the electrical skin patch within 30 minutes prior to initiating the one of the plurality of stimulation sessions It further includes the step of instructing.

Optionally, the method instructs the patient to secure the electrical skin patch to the patient's skin by generating at least one of a visual, audible and vibratory signal using the electrical skin patch within 60 minutes prior to initiating one of said plurality of stimulation sessions. further comprising the step of

Optionally, the method further comprises instructing the patient to secure the electrical skin patch to the patient's skin by generating at least one of a visual, audible and vibratory signal using the electrical skin patch within 60 minutes of initiating the wake-up alarm. .

In some embodiments, disclosed herein is a method of enabling a patient to achieve a weight loss goal comprising a housing, an electrical pulse generator positioned within the housing, and at least one electrode attached to the housing and in electrical communication with the electrical pulse generator providing an electrical skin patch to the patient, the electrical pulse generator comprising: an electrical pulse generator having a pulse amplitude ranging from 5 mA to 45 mA, a pulse width ranging from 10 μsec to 10 msec, and a pulse frequency ranging from 1 Hz to 100 Hz providing the patient with an electrical skin patch configured to deliver a pulse; instructing the patient to secure the electrical skin patch to the patient's skin; applying a plurality of stimulation sessions to the skin of a patient using the electrical skin patch for a duration of one week, each stimulation session comprising the electrical pulse and having a duration of at least 15 minutes, wherein the plurality of stimulation sessions comprises the electrical pulses and has a duration of at least 15 minutes; applying a plurality of stimulation sessions to the patient's skin, the sessions comprising at least two days of the week occurring on different days of the week; and instructing the patient to repeatedly apply said plurality of stimulation sessions for at least 4 weeks.

Optionally, the electrical skin patch is programmed to apply at least a portion of the plurality of stimulation sessions between 6 am and 9 am, 11 am and 2 pm or 5 pm and 9 pm.

Optionally, the total energy delivered by the plurality of stimulation sessions applied over the week is at least 0.5 joules.

Optionally, the total energy delivered by one stimulation session of said plurality of stimulation sessions does not exceed 6 joules.

Optionally, each of said plurality of stimulation sessions is separated from a subsequent one of said plurality of stimulation sessions by an amount of time greater than 25% of a duration of a subsequent one of said plurality of stimulation sessions.

Optionally, the method further comprises causing the patient to lose at least 2 pounds during said at least 4 weeks.

Optionally, the method comprises instructing the patient to repeatedly apply said plurality of stimulation sessions over at least 4 weeks; and allowing the patient to lose an amount of body weight during said at least 4 weeks such that the patient maintains a loss of at least 90% of said weight loss for at least 30 days after the patient has applied the end of said plurality of stimulation sessions. .

Optionally, the method further comprises applying at least two of the plurality of stimulation sessions to the skin of the patient daily using the electrical skin patch.

Optionally, the method further comprises generating at least one of a visual, audible and vibratory signal to the patient within 30 minutes prior to initiating one of said plurality of stimulation sessions via the electrical skin patch.

Optionally, the method comprises: causing the patient to manually trigger at least one of the plurality of stimulation sessions by generating at least one of a visual, auditory, and vibration signal using the electrical skin patch within 30 minutes prior to initiating the one of the plurality of stimulation sessions It further includes the step of instructing.

Optionally, the method instructs the patient to secure the electrical skin patch to the patient's skin by generating at least one of a visual, audible and vibratory signal using the electrical skin patch within 60 minutes prior to initiating one of said plurality of stimulation sessions. further comprising the step of

In some embodiments, disclosed herein is a method of enabling a patient to achieve a weight loss goal comprising a housing, an electrical pulse generator positioned within the housing, and at least one electrode attached to the housing and in electrical communication with the electrical pulse generator providing an electrical skin patch to the patient, the electrical pulse generator comprising: an electrical pulse generator having a pulse amplitude ranging from 5 mA to 45 mA, a pulse width ranging from 10 μsec to 10 msec, and a pulse frequency ranging from 1 Hz to 100 Hz providing the patient with an electrical skin patch configured to deliver a pulse; at least one of the patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 frontal and lateral dermatomes of the patient instructing the patient to secure the electrical skin patch to the skin; applying a plurality of stimulation sessions to the skin of a patient using the electrical skin patch for a duration of one week, each of the plurality of stimulation sessions comprising the electrical pulses, wherein at least some of the plurality of stimulation sessions are at least 15 minutes wherein the plurality of stimulation sessions comprises at least one in said week, the total energy delivered by any of the plurality of stimulation sessions does not exceed 6 joules, and wherein the plurality of stimulation sessions applied over the week applying a plurality of stimulation sessions to the patient's skin, wherein the total energy delivered by all of the sessions is at least 0.5 joules; and instructing the patient to repeatedly apply said plurality of stimulation sessions for at least 4 weeks.

Optionally, the electrical skin patch is programmed to apply at least a portion of the plurality of stimulation sessions between 6 am and 9 am, 11 am and 2 pm or 5 pm and 9 pm.

Optionally, the method further comprises applying to the patient's skin at least two of the plurality of stimulation sessions on different days of the week using the electrical skin patch, wherein at least two of the plurality of stimulation sessions Each stimulation session has a duration of at least 15 minutes.

Optionally, the method further comprises generating at least one of a visual, audible and vibratory signal to the patient within 30 minutes prior to initiating one of said plurality of stimulation sessions via the electrical skin patch.

Optionally, the method comprises instructing the patient to manually trigger at least one of the plurality of stimulation sessions by generating at least one of a visual, audible and vibrational signal to the patient within 30 minutes prior to initiating the one of the plurality of stimulation sessions further includes

Optionally, the method further comprises instructing the patient to secure the electrical skin patch to the skin of the patient by generating at least one of a visual, audible and vibratory signal to the patient within 60 minutes prior to initiating one of the plurality of stimulation sessions. include

Optionally, none of said plurality of stimulation sessions applied to the patient's skin during said week have a duration greater than 12 hours, and said pulse amplitude does not exceed 45 mAmp.

In some embodiments, disclosed herein is an electrical skin patch configured to delay excretion of gastric contents in a patient, comprising: a housing having a base surface defined by an entire base surface area epidermis; a controller located within the housing; at least one electrode having a base surface and attached to the base surface of the housing, the base surface of the at least one electrode being configured to electrically contact the epidermis of the patient, the base surface of the at least one electrode and the base surface of the housing at least one of at least one electrode configured to be attached to the epidermis of a patient; and a pulse generator positioned within the housing and in electrical communication with a controller and the at least one electrode, the pulse generator configured to generate a plurality of stimulation sessions, each of the plurality of stimulation sessions comprising a plurality of electrical pulses; , each of the plurality of electrical pulses is defined by a plurality of stimulation parameters, wherein the plurality of stimulation parameters are determined after application of at least one of the plurality of stimulation sessions to the epidermis of the patient within 90 minutes of the patient ingesting a meal. wherein the postprandial time of emptying 50% of the patient's gastric contents is set to increase by at least 5% relative to the postprandial time of emptying 50% of the patient's gastric contents without applying at least one of the plurality of stimulation sessions. to start

Optionally, the electrical skin patch comprises: an electric field generated by the plurality of stimulation sessions in a patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 direct contact with at least one of the frontal and lateral dermatomes, no direct contact with the patient's gastrointestinal tract, no direct contact with the patient's vagus nerve, and no direct contact with the patient's vagus nerve; It is configured to adhere to the epidermis.

Optionally, the base surface of the housing is not configured to adhere to the epidermis of the patient and is located less than 4 mm above the epidermis of the patient, wherein the base surface of the at least one electrode is configured to adhere to the epidermis of the patient and comprises 10 in ² of It has the largest surface area in contact with the epidermis.

Optionally, the electrical skin patch further comprises a second electrode, wherein the at least one electrode and the second electrode are separated by a distance of less than 20 mm, wherein the housing, the at least one electrode, and the second electrode are combined to have a height not exceeding 1 inch.

Optionally, the plurality of stimulation parameters are further defined such that each of the plurality of electrical pulses has a pulse width of less than 1 ms and at least one electrode is a foam electrode or a hydrocolloid electrode.

Optionally, the plurality of stimulation parameters comprises: a postprandial time at which 95% of the patient's gastric contents are empty after applying at least one of the plurality of stimulation sessions to the epidermis of the patient within 90 minutes of the patient ingesting a meal, wherein the It is further determined to increase by at least 5% relative to the postprandial time of emptying 95% of the patient's gastric contents without applying at least one of the plurality of stimulation sessions.

Optionally, the electrical skin patch further comprises a transceiver in communication with at least one of the controller and the pulse generator, and a plurality of program instructions stored in a non-transitory computer readable memory of a device physically separate from the electrical skin patch, to be executed when the program instructions obtain patient condition data, generate a modulated signal based on the patient condition data, and wirelessly transmit the modulated signal from the device to the transceiver, wherein the modulated signal is configured to include the plurality of stimuli. and data for modulating at least one of the parameters.

Optionally, the patient status data comprises at least one of hunger of the patient, hunger appetite of the patient, level of satiety of the patient, level of satiety of the patient and degree of well-being experienced by the patient.

Optionally, the plurality of stimulation parameters is configured such that after applying at least one of the plurality of stimulation sessions to the epidermis of the patient, and before applying the at least one of the plurality of stimulation sessions, the appetite or hunger of the patient is determined by the appetite or hunger of the patient. It is further determined to decrease compared to

Optionally, the plurality of stimulation parameters is configured such that after applying at least one of the plurality of stimulation sessions to the epidermis of the patient, gastric retention of the patient is compared to gastric retention of the patient prior to applying the at least one of the plurality of stimulation sessions. It is additionally set to increase by 5%.

Optionally, the plurality of stimulation parameters are configured such that after applying at least one of the plurality of stimulation sessions to the epidermis of the patient, the patient's postprandial plasma blood glucose concentration is determined in the patient's postprandial plasma without applying the at least one of the plurality of stimulation sessions. It is further determined to decrease by at least 5% relative to the blood glucose concentration.

In some embodiments, disclosed herein is an electrical skin patch configured to delay gastric emptying in a patient having a body mass index of 25 or greater, comprising: a housing having a base surface defined by a total base surface area; a controller located within the housing; at least one electrode having a base surface and attached to the base surface of the housing, the base surface of the at least one electrode being configured to electrically contact the epidermis of the patient, wherein the base surface of the at least one electrode and the base of the housing at least one electrode, wherein at least one of the surfaces is configured to adhere to an epidermis of a patient; and a pulse generator positioned within the housing and in electrical communication with a controller and the at least one electrode, the pulse generator configured to generate a plurality of stimulation sessions, each of the plurality of stimulation sessions comprising a plurality of electrical pulses; , wherein each of the plurality of electrical pulses is defined by a plurality of stimulation parameters, wherein the plurality of stimulation parameters are applied to the epidermis of the patient within 90 minutes of the patient ingesting a meal and for at least 5 minutes during at least one of the plurality of stimulation sessions. after applying one, the postprandial time to empty 50% of the patient's gastric contents is set to increase by at least 5 minutes compared to the postprandial time to empty 50% of the patient's gastric contents without applying at least one of the plurality of stimulation sessions; Disclosed is an electric skin patch.

Optionally, the electrical skin patch comprises: an electric field generated by the plurality of stimulation sessions in a patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 attached to the epidermis of the patient so as to be in direct contact with at least one of the frontal and lateral dermatomes, not in direct contact with the gastrointestinal tract of the patient, not in direct contact with the vagus nerve of the patient, and penetrate to a depth of 25 mm or less through the epidermis of the patient. configured to be

Optionally, the base surface of the housing is not configured to adhere to the epidermis of the patient and is positioned less than 4 mm above the epidermis of the patient, wherein the base surface of the at least one electrode is configured to adhere to the epidermis ^of the patient, and wherein the It has the largest surface area in contact with the epidermis.

Optionally, the electrical skin patch further comprises a second electrode, wherein the at least one electrode and the second electrode are separated by a distance of less than 10 mm, wherein the housing, the at least one electrode, and the second electrode in combination have a height not exceeding 1 inch.

Optionally, the electrical skin patch has a volume ranging from 0.10 in ³ to 0.5 in ³ , a weight ranging from 10 g to 80 g, and a base surface of at least one electrode ranging from 0.1 in ² to 0.8 in ² per gram weight of the electrical skin patch. It has a ratio of surface area to weight.

Optionally, the plurality of stimulation parameters comprises: emptying 95% of the patient's gastric contents after applying at least one of the plurality of stimulation sessions to the epidermis of the patient for at least 5 minutes within 90 minutes after the patient consumes a meal The postprandial time is further defined to increase by at least 5 minutes relative to the postprandial time in which 95% of the patient's stomach contents are empty without applying at least one of the plurality of stimulation sessions.

Optionally, the electrical skin patch further comprises a transceiver in communication with at least one of the controller and the pulse generator, and a plurality of program instructions stored in a non-transitory computer readable memory of a device physically separate from the electrical skin patch, wherein , when executed, the program instructions obtain patient condition data, generate a modulated signal based on the patient condition data, and wirelessly transmit the modulated signal from a device to a transceiver, wherein the modulated signal is configured to include the plurality of stimuli. and data for modulating at least one of the parameters.

Optionally, the patient status data comprises at least one of hunger of the patient, hunger appetite of the patient, level of satiety of the patient, level of satiety of the patient and degree of well-being experienced by the patient.

Optionally, the plurality of stimulation parameters are determined such that the patient's appetite or hunger after applying at least one of the plurality of stimulation sessions to the epidermis of the patient is a response to the appetite or hunger of the patient prior to applying the at least one of the plurality of stimulation sessions. decrease relative to and further determine that the patient's level of nausea does not increase relative to the patient's level of nausea prior to application of said at least one of said plurality of stimulation sessions.

Optionally, the plurality of stimulation parameters is such that, after applying at least one of the plurality of stimulation sessions to the epidermis of the patient, gastric retention of the patient is 5 compared to gastric retention of the patient prior to applying the at least one of the plurality of stimulation sessions. It is additionally set to increase by %.

Optionally, the electrical skin patch further comprises an adhesive layer positioned on the base surface of the at least one electrode, wherein, when the adhesive layer of the electrical skin patch is configured to adhere to the epidermis of the patient, the electrical skin patch is 1.0 Newton to 2.1 Newtons.

Optionally, the plurality of stimulation parameters is such that the weight of the patient after applying at least one of the plurality of stimulation sessions to the epidermis of the patient is at least 1% compared to the body weight of the patient prior to applying the at least one of the plurality of stimulation sessions It is further determined to decrease by

Optionally, when executed, the program instructions obtain a first stimulation protocol and generate a modulated signal using the first stimulation protocol. Still optionally, when executed, the program instructions obtain a second stimulation protocol, wherein the second stimulation protocol is different from the first stimulation protocol, and uses the second stimulation protocol to generate a second modulated signal; Here, the second modulated signal includes data for modulating at least one of a plurality of stimulation parameters.

Optionally, the plurality of stimulation parameters comprises a first pulse width, a first pulse amplitude, a first pulse frequency, a first pulse shape, a first duty cycle, a first session duration, and a first session frequency, The patch is configured to modify at least one of a first pulse width, a first pulse amplitude, a first pulse frequency, a first pulse shape, a first duty cycle, a first session duration, and a first session frequency using the second modulated signal. , a second pulse width, a second pulse amplitude, a second pulse frequency, a second pulse shape, a second duty cycle, a second session duration, or a second session frequency, wherein the at least one second pulse width is the first different from the pulse width, the second pulse amplitude is different from the first pulse amplitude, the second pulse frequency is different from the first pulse frequency, the second pulse shape is different from the first pulse shape, and the second duty cycle is different from the first duty cycle, the second session duration is different from the first session duration, and the second session frequency is different from the first session frequency.

In some embodiments, disclosed herein is an electrical skin patch configured to delay gastric emptying in a patient, comprising: a housing; a controller located within the housing; at least one electrode attached to the housing and configured to be in electrical contact with the epidermis of the patient, the at least one electrode having a base surface defined by a total base surface area, wherein at least a portion of the total base surface area is in the epidermis of the patient wherein said portion of the total base surface area configured to adhere to the epidermis of the patient is less than or equal to 10 in ² , and wherein said portion of the total base surface area comprises an electric field generated by the plurality of stimulation sessions at C5, C6, C7, C8 of the patient. , T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 at least one electrode configured to attach to the epidermis of a patient in direct contact with at least one of the frontal and lateral dermatomes; and a pulse generator positioned within the housing and in electrical communication with a controller and the at least one electrode, the pulse generator configured to generate the plurality of stimulation sessions, each of the plurality of stimulation sessions comprising a plurality of electrical pulses. wherein each of the plurality of electrical pulses is defined by a plurality of stimulation parameters, wherein the plurality of stimulation parameters include: at least one of the plurality of stimulation sessions for at least 5 minutes within 90 minutes of the patient eating a meal. wherein the postprandial time of emptying 50% of the patient's gastric contents after application to the epidermis is determined to increase by at least 5% relative to the postprandial time of emptying 50% of the patient's gastric contents without applying at least one of the plurality of stimulation sessions Initiate a skin patch.

Optionally, the electrical skin patch further comprises a transceiver in communication with at least one of the controller and the pulse generator, and a plurality of program instructions stored in a non-transitory computer readable memory of a device physically separate from the electrical skin patch, wherein , when executed, the program instructions obtain patient condition data, generate a modulated signal based on the patient condition data, and wirelessly transmit the modulated signal from a device to a transceiver, wherein the modulated signal is configured to include the plurality of stimuli. and data for modulating at least one of the parameters.

Optionally, the patient status data comprises at least one of hunger of the patient, hunger appetite of the patient, level of satiety of the patient, level of satiety of the patient and degree of well-being experienced by the patient.

Optionally, the plurality of stimulation parameters is such that, after applying at least one of the plurality of stimulation sessions to the epidermis of the patient, gastric retention of the patient is 5 compared to gastric retention of the patient prior to applying the at least one of the plurality of stimulation sessions. It is additionally set to increase by %.

In some embodiments, the present disclosure provides a method of modulating at least one of appetite, hunger, satiety level, or satiety level in a patient, the method comprising: providing an electrical skin patch configured to adhere to an epidermal layer of a patient, the electrical skin patch comprising: providing an electrical skin patch comprising a controller, at least one electrode configured to be in electrical contact with an epidermal layer of the patient, and a pulse generator in electrical communication with the controller and the at least one electrode; defining a plurality of stimulation parameters; and programming the pulse generator to generate a plurality of electrical pulses using the plurality of stimulation parameters, wherein the plurality of stimulation parameters are determined after application of at least one stimulation to the epidermal layer of the patient, the patient's level of appetite, hunger, satiety, and A method is disclosed, comprising programming a pulse generator configured to modify at least one of the bite levels.

Optionally, after application of the at least one stimulus to the epidermal layer of the patient, the patient's appetite decreases compared to the appetite of the patient prior to applying the at least one stimulus.

Optionally, after applying the at least one stimulus to the epidermal layer of the patient, the patient's hunger is reduced relative to the hunger of the patient prior to applying the at least one stimulus.

Optionally, the patient's level of satiety after applying the at least one stimulation to the epidermal layer of the patient is increased relative to the level of satiety of the patient prior to applying the at least one stimulation.

Optionally, after applying the at least one stimulation to the epidermal layer of the patient, the patient's level of bite is increased relative to the level of bite of the patient prior to applying the at least one stimulation.

Optionally, after applying the at least one stimulation to the epidermal layer of the patient, the patient's level of satiety increases compared to the patient's level of satiety prior to applying the at least one stimulation.

Optionally, the plurality of stimulation parameters are defined such that after applying at least one stimulation to the epidermal layer of the patient, the patient's appetite is modulated from the first state to the second state, wherein the first state determines the first plurality of quantitative appetite measurements. wherein each of said first plurality of quantitative appetite measures is determined using a visual analog scale prior to stimulation and taken at a different predetermined time of day, wherein the second state is determined by a pre-stimulation appetite profile comprising: an appetite profile after stimulation comprising a quantitative appetite measure, each of said second plurality of quantitative appetite measure determined using said visual analog scale after stimulation and taken at a different predetermined time of day, wherein: During a given predetermined time period of time, at least one of the second plurality of quantitative appetite measures differs from at least one of the first plurality of quantitative appetite measures by at least 5% to indicate a decrease in appetite in the patient.

Optionally, the plurality of stimulation parameters are defined such that after applying at least one stimulation to the epidermal layer of the patient, the patient's hunger is modulated from the first state to the second state, wherein the first state determines the first plurality of quantitative hunger measurements. wherein each of said first plurality of quantitative hunger measures is determined using a visual analog scale prior to stimulation, taken at a different predetermined time of day, wherein the second state is defined by a pre-stimulation hunger profile comprising: a hunger profile after stimulation comprising a quantitative hunger measure, each of said second plurality of quantitative hunger measures determined using said visual analog scale after stimulation and taken at a different predetermined time of day, wherein: for a given predetermined time period of time, at least one of the second plurality of quantitative hunger measures differs from at least one of the first plurality of quantitative hunger measures by at least 5% indicative of a decrease in hunger in the patient.

Optionally, the plurality of stimulation parameters are defined such that after applying at least one stimulation to the epidermal layer of the patient, the patient's level of satiety is modulated from the first state to the second state, wherein the first state is a first plurality of quantitative measures of satiety. wherein each of said first plurality of quantitative satiety measures is determined using a visual analog scale prior to stimulation and taken at a different predetermined time of day, wherein the second state is a second a post-stimulation satiety profile comprising a plurality of quantitative satiety measures, each of said second plurality of quantitative satiety measures determined using said visual analog scale after stimulation and taken at a different predetermined time of day, wherein , during a given predetermined time of day, at least one of the second plurality of quantitative satiety measures differs from at least one of the first plurality of quantitative satiety measures by at least 5% to indicate an increase in the patient's level of satiety.

Optionally, the plurality of stimulation parameters are set such that after applying at least one stimulation to the epidermal layer of the patient, the patient's level of bite is adjusted from the first condition to the second condition, wherein the first condition is the first plurality of quantitative bites. and wherein each of said first plurality of quantitative satiety measures is determined using a visual analog scale prior to stimulation and taken at a different predetermined time of day, wherein said second state is defined by a post-stimulation bite profile comprising a second plurality of quantitative bite measurements, each of the second plurality of quantitative bite measurements determined using the visual analog scale after stimulation, wherein taken over a time period, wherein, during a given predetermined time of day, at least one of the second plurality of quantitative bite measurements differs from at least one of the first plurality of quantitative bite measurements by at least 5% such that the patient's level of bite indicates an increase in

Optionally, the plurality of stimulation parameters are defined such that after applying at least one stimulation to the epidermal layer of the patient, the level of satiety of the patient is adjusted from the first state to the second state, wherein the first state is a first plurality of quantitative measures of satiety. wherein each of said first plurality of quantitative satiety measures is determined using a visual analog scale prior to stimulation and taken at a different predetermined time of day, wherein the second state is a second a post-stimulation satiety profile comprising a plurality of quantitative measurements of satiety, wherein each of said second plurality of quantitative measurements of satiety is determined using said visual analog scale after stimulation and taken at a different predetermined time of day, wherein , for a given predetermined time of day, at least one of the second plurality of quantitative satiety measures differs from at least one of the first plurality of quantitative satiety measures by at least 5% to indicate an increase in the patient's level of satiety.

Optionally, the plurality of stimulation parameters are defined such that after applying at least one stimulation to the epidermal layer of the patient, the patient's appetite is modulated from the first state to the second state, wherein the first state determines the first plurality of quantitative appetite measurements. wherein each of said first plurality of quantitative appetite measures is determined using a visual analog scale prior to stimulation, and is taken at a different predetermined time of day, said first plurality of quantitative appetite measures comprising: defines a first region representative of the first condition, wherein the second condition is defined by a post-stimulation appetite profile comprising a second plurality of quantitative appetite measures, wherein each of the second plurality of quantitative appetite measures comprises: Post-stimulation determined using the visual analog scale, taken at different predetermined times of the day, and wherein the second plurality of quantitative appetite measures collectively define a second region indicative of the second condition, wherein the second Zone 1 differs from said second zone by at least 5% indicative of a decrease in the patient's appetite.

Optionally, the plurality of stimulation parameters are defined such that after applying at least one stimulation to the epidermal layer of the patient, the patient's hunger is modulated from the first state to the second state, wherein the first state determines the first plurality of quantitative hunger measurements. wherein each of said first plurality of quantitative hunger measures is determined using a visual analog scale prior to stimulation, and is taken at a different predetermined time of day, said first plurality of quantitative hunger measures comprising: defines a first region representative of the first state, wherein the second state is defined by a post-stimulation hunger profile comprising a second plurality of quantitative hunger measures, each of the second plurality of quantitative hunger measures comprises: After stimulation, determined using the visual analog scale, taken at different predetermined times of the day, and wherein the second plurality of quantitative hunger measures collectively define a second region representing the second state, wherein the second Region 1 differs from the second region by at least 5% to indicate a decrease in the patient's hunger.

Optionally, the plurality of stimulation parameters are defined such that after applying at least one stimulation to the epidermal layer of the patient, the patient's level of satiety is modulated from the first state to the second state, wherein the first state is a first plurality of quantitative measures of satiety. wherein each of said first plurality of quantitative satiety measures is determined using a visual analog scale prior to stimulation and taken at a different predetermined time of day, wherein said first plurality of quantitative satiety measures comprises: The satiety measures collectively define a first region indicative of the first state, wherein the second state is defined by a post-stimulation satiety profile comprising a second plurality of quantitative satiety measures, wherein the second plurality of quantitative satiety measures are defined. each of the measurements determined using the visual analog scale after stimulation and taken at a different predetermined time of day, wherein the second plurality of quantitative satiety measures collectively define a second region representing the second state; wherein the first region differs from the second region by at least 5% to indicate an increase in the patient's level of satiety.

Optionally, the plurality of stimulation parameters are set such that after applying at least one stimulation to the epidermal layer of the patient, the patient's level of bite is adjusted from the first condition to the second condition, wherein the first condition is the first plurality of quantitative bites. wherein each of said first plurality of quantitative satiety measures is determined using a visual analog scale prior to stimulation and taken at a different predetermined time of day, wherein said first a plurality of quantitative satiety measures collectively define a first region indicative of the first state, wherein the second state is defined by a post-stimulation satiety profile comprising a second plurality of quantitative satiety measures; 2 each of a plurality of quantitative bite measurements is determined using the visual analog scale after stimulation, and taken at a different predetermined time of day, wherein the second plurality of quantitative bite measurements is indicative of the second condition. , wherein the first region differs from the second region by at least 5% to indicate an increase in the patient's level of bite.

Optionally, the plurality of stimulation parameters are defined such that after applying at least one stimulation to the epidermal layer of the patient, the level of satiety of the patient is adjusted from the first state to the second state, wherein the first state is a first plurality of quantitative measures of satiety. wherein each of said first plurality of quantitative satiety measures is determined using a visual analog scale prior to stimulation, taken at a different predetermined time of day, said first plurality of quantitative satiety measurements comprising: Measures collectively define a first region indicative of the first condition, wherein the second condition is defined by a post-stimulation satiety profile comprising a second plurality of quantitative measures of satiety, wherein the second plurality of quantitative measures of satiety each determined using the visual analog scale after stimulation and taken at a different predetermined time of day, wherein the second plurality of quantitative satiety measures collectively define a second region representing the second state, wherein The first region differs from the second region by at least 5% to indicate an increase in the patient's level of satiety.

Optionally, the plurality of stimulation parameters are set such that after applying at least one stimulation to the epidermal layer of the patient, the patient's appetite is modulated from the first state to the second state, wherein the appetite of the patient in the second state is that of the first state. decreased relative to the patient's appetite, wherein the first state appetite is measured using a scale at a predetermined time of day for a first predetermined time period, and wherein the second state appetite is a first predetermined time period after stimulation is initiated. and duration is measured using the scale at the predetermined time of day over a second predetermined time period equal to, wherein the second state appetite decreases to be less than or equal to 95% of the first state appetite.

Optionally, the plurality of stimulation parameters are such that after applying at least one stimulation to the epidermal layer of the patient, the patient's hunger is modulated from the first state to the second state, wherein the hunger of the patient in the second state is the hunger of the first state. decreases relative to the patient's hunger, wherein the first state hunger is measured using a scale at a predetermined time of day for a first predetermined time period, and wherein the second state hunger is a first predetermined time period after stimulation is initiated. is measured using the scale at the predetermined time period of the day over a second predetermined time period equal in duration to, and wherein the second state hunger decreases to be less than or equal to 95% of the first state hunger.

Optionally, the plurality of stimulation parameters are set such that after applying at least one stimulation to the epidermal layer of the patient, the level of satiety of the patient is adjusted from the first condition to the second condition, wherein the level of satiety of the patient in the second condition is selected from the first condition wherein the first state satiety level is measured using a scale at a predetermined time of day during a first predetermined time period, and wherein the second state satiety level is increased relative to the patient's level of satiety in the second state after stimulation begins. 1 measured using the scale at the predetermined time of day for a second predetermined time period equal in duration to a predetermined time period, wherein the second state satiety level is at least 105% of the first state satiety level; increases

Optionally, the plurality of stimulation parameters are set such that after applying at least one stimulation to an epidermal layer of the patient, the patient's level of bite is adjusted from the first state to the second state, wherein the first state of the bite level is a first is measured using a scale at a predetermined time of day for a predetermined time period, wherein the second state bite level is during a second predetermined time period of the day that is the same in duration as the first predetermined time period after stimulation begins. measured using the scale at the predetermined time period, wherein the second state bite level increases to at least 105% of the first state bite level.

Optionally, the plurality of stimulation parameters are set such that the level of satiety of the patient is adjusted from the first state to the second state after applying at least one stimulation to the epidermal layer of the patient, wherein the level of satiety in the first state is a first predetermined time. is measured using a scale at a predetermined time of day during a period, wherein the second level of state satisfaction is the predetermined level of satisfaction of the day over a second predetermined time period equal in duration to the first predetermined time period after stimulation begins. Measured using the scale over time, the level of satisfaction in the second state increases to at least 105% of the level of satisfaction in the first state.

Optionally, the plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's gastric vestibular momentum decreases relative to the patient's gastric vestibular momentum prior to stimulation.

Optionally, the plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's gastric motility decreases relative to the patient's gastric motility prior to stimulation.

Optionally, the plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's gastric emptying rate decreases relative to the patient's gastric emptying rate prior to stimulation.

Optionally, the plurality of stimulation parameters is configured such that after at least one stimulation, the patient's appetite decreases relative to the patient's appetite before stimulation for a predetermined time period and the patient's level of nausea is at a level of the patient's prior to stimulation for the predetermined time period. It is additionally selected so as not to increase compared to

Optionally, the plurality of stimulation parameters is such that after at least one stimulation, the patient's hunger decreases relative to the patient's hunger before stimulation for a predetermined time period, and the patient's level of nausea is at a level of the patient's prior to stimulation for the predetermined time period. It is additionally selected so as not to increase compared to

Optionally, the plurality of stimulation parameters is configured such that after at least one stimulation, a level of satiety of the patient increases relative to a level of satiety of the patient prior to stimulation for a predetermined time period, and wherein the level of nausea of the patient increases with respect to a level of satiety of the patient prior to stimulation during the predetermined time period. It is additionally chosen not to increase relative to the level of nausea.

Optionally, the plurality of stimulation parameters is configured such that after at least one stimulation, the patient's level of bite is increased relative to the patient's level of bite for a predetermined period of time and the patient's level of nausea is increased in the patient prior to stimulation during the predetermined period of time. It is chosen additionally so as not to increase compared to the level of nausea.

Optionally, the plurality of stimulation parameters is configured such that after at least one stimulation, the patient's level of satiety increases relative to the patient's level of satiety for a predetermined time period relative to the patient's level of satiety, and the patient's level of nausea increases the patient's level of satiety prior to stimulation during the predetermined time period. It is additionally selected so as not to increase relative to the level.

Optionally, the plurality of stimulation parameters are further selected such that after the at least one stimulation, the patient's appetite decreases relative to the patient's appetite before the stimulation for a predetermined period of time, wherein at least one of the patient's level of dyspepsia or the patient's level of nausea does not increase relative to at least one of the patient's level of dyspepsia or nausea level prior to stimulation during said predetermined period of time, wherein said at least one stimulation does not cause said patient to experience no pain sensation.

Optionally, the plurality of stimulation parameters are further selected such that after the at least one stimulation, the patient's hunger decreases relative to the patient's hunger before the stimulation for a predetermined period of time, wherein the patient's level of dyspepsia or the patient's level of nausea is at least one does not increase relative to at least one of the patient's level of dyspepsia or nausea level prior to stimulation during said predetermined period of time, wherein said at least one stimulation does not cause said patient to experience no pain sensation.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's level of satiety increases relative to the patient's level of satiety prior to stimulation for a predetermined period of time, wherein the patient's level of dyspepsia or the patient's level of nausea at least one does not increase relative to at least one of the patient's level of dyspepsia or nausea level prior to stimulation during said predetermined period of time, wherein said at least one stimulation does not cause said patient to experience no pain sensation.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's level of bite is increased relative to the patient's level of bite prior to stimulation for a predetermined period of time, wherein the patient's dyspepsia level or the patient's At least one of the levels of nausea does not increase relative to at least one of the level of dyspepsia or the level of nausea of the patient prior to stimulation for said predetermined period of time, wherein said at least one stimulation does not cause the patient to experience no pain sensation.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's level of satiety increases relative to the patient's level of satiety prior to stimulation over a predetermined time period, wherein the patient's level of dyspepsia or the patient's nausea at least one of the levels does not increase relative to at least one of the patient's dyspepsia level or the nausea level prior to stimulation for said predetermined period of time, wherein said at least one stimulation does not cause the patient to experience no pain sensation.

Optionally, the plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's total body weight decreases by at least 1% relative to the patient's total body weight before stimulation.

Optionally, the plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's excess weight is reduced by at least 3% relative to the patient's excess weight before stimulation.

Optionally, the plurality of stimulation parameters is configured such that after at least one stimulation, the patient's total body weight decreases by at least 1% relative to the patient's total body weight before stimulation, and the patient's level of well-being is greater than 5% relative to the patient's level of well-being before stimulation. to be additionally selected not to decrease.

Optionally, the plurality of stimulation parameters is characterized in that after at least one stimulation, the patient's excess body weight is reduced by at least 3% relative to the patient's excess weight prior to the stimulation, and the patient's level of well-being is greater than 5% compared to the patient's level of well-being before the stimulation. to be additionally selected not to decrease.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's preprandial ghrelin level decreases by at least 3% relative to the patient's preprandial ghrelin level prior to stimulation.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's postprandial ghrelin level decreases by at least 3% relative to the patient's postprandial ghrelin level before stimulation.

Optionally, the plurality of stimulation parameters are further selected such that after at least one stimulation session the patient's motor output increases by at least 3% relative to the patient's motor output before stimulation.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's glucagon-like peptide-1 level increases by at least 3% relative to the patient's glucagon-like peptide-1 level prior to stimulation.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's leptin level increases by at least 3% relative to the patient's leptin level prior to stimulation.

Optionally, the plurality of stimulation parameters are configured such that after at least one stimulation, the patient's appetite decreases relative to the patient's appetite before stimulation for a predetermined time period, and the patient's level of nausea is at a level of the patient's prior to stimulation for the predetermined time period. It is additionally chosen not to increase by more than 10% compared to

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the level of Peptide YY in the patient increases by at least 3% relative to the level of Peptide YY in the patient prior to stimulation.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's lipopolysaccharide level decreases by at least 3% relative to the patient's lipopolysaccharide level prior to stimulation.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's motilin-related peptide level decreases by at least 3% relative to the patient's motilin-related peptide level prior to stimulation.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's cholecystokinin level increases by at least 3% relative to the patient's cholecystokinin level prior to stimulation.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's resting metabolic rate increases by at least 3% relative to the patient's resting metabolic rate before stimulation.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's plasma-beta endorphin level increases by at least 3% relative to the patient's plasma-beta endorphin level prior to stimulation.

Optionally, the plurality of stimulation parameters is such that after at least one stimulation, the patient's hunger decreases relative to the patient's hunger before stimulation for a predetermined period of time, and the patient's level of nausea is compared to the patient's level of nausea before stimulation for the predetermined time period. It is additionally chosen not to increase by more than 10%.

Optionally, the plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's glycemic homeostasis or balance of insulin and glucagon is improved by at least 3% relative to the patient's glycemic homeostasis prior to stimulation.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's hemoglobin A1c level decreases by an amount equal to at least 0.3%.

Optionally, said plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's triglyceride level decreases by at least 3% relative to the patient's triglyceride level prior to stimulation.

Optionally, the plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's total blood cholesterol level decreases by at least 3% relative to the patient's total blood cholesterol level prior to stimulation.

Optionally, the plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's blood glucose level decreases by at least 3% relative to the patient's blood glucose level prior to stimulation.

Optionally, the plurality of stimulation parameters are further selected such that after at least one stimulation, the patient's degree of insulin resistance improves by at least 3% compared to the patient's degree of insulin resistance before stimulation.

Optionally, the plurality of stimulation parameters are further selected such that, after at least one stimulation, the composition of the patient's intestinal microbiota is modulated from the first state to the second state, wherein the first state is that of Bacteroidetes. having a first level and a first level of firmicutes, wherein the second state has a second level of Bacteroidetes and a second level of Firmicutes, and wherein the second level of Bacteroidetes is bacillus greater than the first level of Theroidetes by at least 3%, wherein the second level of Firmicutes is at least 3% less than the first level of Firmicutes.

Optionally, the plurality of electrical pulses comprises a pulse width in the range of 10 μsec to 100 msec, a pulse amplitude in the range of 100 μA to 500 mA, and a pulse frequency in the range of 1 Hz to 10,000 Hz.

Optionally, said plurality of electrical pulses comprises a pulse width in a range of 10 microseconds to 10 msec and a pulse amplitude in a range of 15 mA to 30 mA.

Optionally, said plurality of electrical pulses comprises a pulse amplitude in the range of 100 mA to 100 mA.

Optionally, the plurality of electrical pulses comprises a pulse width in the range of 10 microseconds to 100 msec and a pulse amplitude in the range of 5 mA to 45 mA.

Optionally, the pulse generator generates an electric field, wherein the electric field is configured to penetrate a range of 0.1 mm to 25 mm through the epidermal layer of the patient through the at least one electrode.

Optionally, the method further comprises: determining a central electrical stimulation response threshold for the patient; determining a spinal electrical stimulation response threshold for the patient; defining at least a portion of the plurality of stimulation parameters such that at least one of pulse width, pulse amplitude, and pulse frequency is set above a spinal electrical stimulation response threshold but below a central electrical stimulation response threshold; and generating the plurality of electrical pulses, wherein the plurality of electrical pulses are defined by the pulse width, the pulse amplitude and the pulse frequency.

Optionally, the method further comprises: determining a maximum allowable electrical stimulation response threshold for the patient; determining a spinal electrical stimulation response threshold for the patient; defining at least a portion of the plurality of stimulation parameters such that at least one of a pulse width, a pulse amplitude, and a pulse frequency is set above a spinal electrical stimulation response threshold but below a maximum allowable electrical stimulation response threshold; and generating the plurality of electrical pulses, wherein the plurality of electrical pulses are defined by the pulse width, the pulse amplitude and the pulse frequency.

Optionally, the method includes determining a central electrical stimulation response threshold for the patient; defining at least a portion of the plurality of stimulation parameters such that at least one of a pulse width, a pulse amplitude, and a pulse frequency is set below a central electrical stimulation response threshold; and generating the plurality of electrical pulses, wherein the plurality of electrical pulses are defined by the pulse width, the pulse amplitude and the pulse frequency.

Optionally, the method comprises determining a maximum tolerated electrical stimulation response threshold for the patient; defining at least a portion of the plurality of stimulation parameters such that at least one of a pulse width, a pulse amplitude, and a pulse frequency is set below a maximum allowable electrical stimulation response threshold; and generating the plurality of electrical pulses, wherein the plurality of electrical pulses are defined by the pulse width, the pulse amplitude and the pulse frequency.

Optionally, the method finds the patient's midclavicular line, proceeds down from the patient's midclavicular line to the lower ribs of the rib cage, and moves further down from the bottom ribs to identify a deployment point, the upper central portion of the electrical skin patch determining placement of the electrical skin patch on the patient by placing the

Optionally, moving further down from the bottom rib to identify the placement point is in the range of 1 cm to 6 cm.

Optionally, the method comprises said plurality of dermatomes such that at least one of C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 dermatomes of the patient is electrically stimulated. and generating an electrical pulse of

Optionally, the method comprises at least one of C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 frontal and lateral dermatomes of the patient electrically said ascites so that none of the C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 posterior dermatomes of the patient are electrically stimulated while being stimulated. and generating an electrical pulse of

Optionally, the method comprises at least one of C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 frontal and lateral dermatomes of the patient electrically said ascites such that while stimulated, none of the patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, or T12 posterior dermatome is electrically stimulated. and generating an electrical pulse of

Optionally, the method comprises a C8 anterior or posterior dermatome of the patient located on the patient's hand, wrist, elbow and fingers, a C8 anterior or posterior dermatome located on the patient's arm, a C8 dermatome located on the upper torso of the patient, the patient's arm wherein at least one of a T1 anterior or posterior dermatome located at The method further comprises generating a pulse.

Optionally, the method comprises the patient's T2 anterior and lateral thoracic dermatomes, T3 anterior and lateral thoracic dermatomes, T4 anterior and lateral thoracic dermatomes, T5 anterior and lateral thoracic dermatomes, T6 anterior and lateral thoracic dermatomes, T7 anterior and lateral thoracic dermatomes, and At least one of the lateral thoracic dermatome, T8 anterior and lateral thoracic dermatome, T9 anterior and lateral thoracic dermatome, and T10 anterior and lateral thoracic dermatome is electrically stimulated, and the patient's T2 posterior thoracic dermatome, T3 posterior thoracic derma Electrical stimulation of one of: T4 posterior thoracic dermatome, T5 posterior thoracic dermatome, T6 posterior thoracic dermatome, T7 posterior thoracic dermatome, T8 posterior thoracic dermatome, T9 posterior thoracic dermatome, and T10 posterior thoracic dermatome. and generating the plurality of electrical pulses so as not to

Optionally, the method comprises the patient's T2 anterior and lateral thoracic dermatomes, T3 anterior and lateral thoracic dermatomes, T4 anterior and lateral thoracic dermatomes, T5 anterior and lateral thoracic dermatomes, T6 anterior and lateral thoracic dermatomes, T7 anterior and lateral thoracic dermatomes, and generating the plurality of electrical pulses such that at least one of a lateral thoracic dermatome, a T8 anterior and lateral thoracic dermatome, a T9 anterior and lateral thoracic dermatome, or a T10 anterior and lateral thoracic dermatome is electrically stimulated. .

Optionally, the method includes installing an application on an external device, wherein the application obtains patient state data, and installing the application on the external device, configured to prompt the patient to enter the patient state data through the application ; generating a modulated signal based on the patient condition data using the application, the modulated signal comprising instructions for modulating at least one of a plurality of stimulation parameters, the plurality of stimulation parameters comprising: a pulse width, a pulse generating a modulated signal using an application comprising at least one of amplitude, pulse frequency, pulse shape, duty cycle, session duration, and session frequency; wirelessly transmitting the modulated signal from an external device to an electrical skin patch using the application; receiving the modulated signal at an electrical skin patch; a first pulse width, a first pulse amplitude, a first pulse width, a first pulse amplitude, a second pulse width, a first pulse amplitude, a second pulse width, a first pulse amplitude, and a second modulating signal in the electrical skin patch to modify at least one of the pulse width, pulse amplitude, pulse frequency, pulse shape, duty cycle, session duration, and session frequency calculating a first pulse frequency, a first pulse shape, a first duty cycle, a first session duration, or a first session frequency; and a first pulse width, a first pulse amplitude, a first pulse frequency, a first pulse shape, a first duty cycle, a first session duration, or a first session frequency in the electrical skin patch. It further comprises the step of generating

Optionally, the patient condition data includes: a degree of hunger experienced by the patient, a degree of appetite experienced by the patient, a level of satiety experienced by the patient, a level of satiety experienced by the patient, a level of satiety experienced by the patient, a degree of indigestion experienced by the patient, a degree of indigestion experienced by the patient and at least one of the degree of nausea experienced and the degree of well-being experienced by the patient.

Optionally, the method further comprises: obtaining a first stimulation protocol via the application; and generating a modulated signal using the first stimulation protocol within the application.

Optionally, the method includes: acquiring a second stimulation protocol via the application, the second stimulation protocol being different from the first stimulation protocol; generating a second modulated signal using the second stimulation protocol within the application, the second modulated signal having a pulse width, pulse amplitude, pulse frequency, pulse shape, duty cycle, session duration, and session frequency generating a second modulated signal comprising instructions for modulating at least one of; wirelessly transmitting, via the application, the second modulated signal from an external device to an electric skin patch; and receiving the second modulated signal at an electrical skin patch; Using a second modulating signal in the electrical skin patch to modify at least one of the pulse width, pulse amplitude, pulse frequency, pulse shape, duty cycle, session duration and session frequency to obtain at least one second pulse width, a second The method further includes calculating a pulse amplitude, a second pulse frequency, a second pulse shape, a second duty cycle, a second session duration, and a second session frequency.

Optionally, the second pulse width is different from the first pulse width, wherein the electrical skin patch generates a second plurality of electrical pulses using the second pulse width, and the electrical skin patch generates the second plurality of electrical pulses. It is used to stimulate the epidermal layer of the patient.

Optionally, the second pulse amplitude is different from the first pulse amplitude, wherein the electrical skin patch generates a second plurality of electrical pulses using the second pulse amplitude, and the electrical skin patch generates the second plurality of electrical pulses. It is used to stimulate the epidermal layer of the patient.

Optionally, the second pulse frequency is different from the first pulse frequency, wherein the electrical skin patch generates a second plurality of electrical pulses using the second pulse frequency, and the electrical skin patch generates the second plurality of electrical pulses. It is used to stimulate the epidermal layer of the patient.

Optionally, the second pulse shape is different from the first pulse shape, wherein the electrical skin patch uses the second pulse shape to generate a second plurality of electrical pulses, and the electrical skin patch generates the second plurality of electrical pulses. It is used to stimulate the epidermal layer of the patient.

Optionally, the second duty cycle is different from the first duty cycle, wherein the electrical skin patch generates a second plurality of electrical pulses using the second duty cycle, and wherein the electrical skin patch generates the second plurality of electrical pulses. It is used to stimulate the epidermal layer of the patient.

Optionally, the second session duration is different from the first session duration, wherein the electrical skin patch generates a second plurality of electrical pulses using the second session duration, and wherein the electrical skin patch uses the second plurality of electrical pulses. Electrical pulses are used to stimulate the patient's epidermal layer.

Optionally, the second session frequency is different from the first session frequency, wherein the electrical skin patch uses the second session frequency to generate a second plurality of electrical pulses, and the electrical skin patch uses the second plurality of electrical pulses. to stimulate the patient's epidermal layer.

Optionally, the method includes: prompting the user to input data through an application installed on the external device; generating a signal based on the data; wirelessly transmitting the signal from an external device to an electrical skin patch; receiving the signal at an electrical skin patch; and modifying at least one of the plurality of stimulation parameters using the signal, wherein the plurality of stimulation parameters include: a pulse width, a pulse amplitude, a pulse frequency, a pulse shape, a duty cycle, a session duration, and at least one of session frequencies.

Optionally, the signal is generated based on data input by the user and a plurality of values, each of the plurality of values comprising: a pulse width, a pulse amplitude, a pulse frequency, a pulse shape, a duty cycle, a session duration, and a session frequency indicates the maximum numerical limit or the minimum numerical limit for at least one of

Optionally, the method includes obtaining patient condition data over a period of time using an application installed on the external device, wherein the patient condition data includes: the patient's appetite, the patient's hunger, the patient's well-being level, the patient's nausea level, the patient's acquiring the patient status data, which includes at least one of a body weight, an amount of calories consumed by the patient, and an amount of calories consumed by the patient; after the period of time, generating a signal based on the patient condition data; wirelessly transmitting a signal to the electrical skin patch; and generating a plurality of electrical pulses using a plurality of second stimulation parameters, wherein the second plurality of stimulation parameters are determined based on the signal, wherein the second plurality of stimulation parameters are a plurality of stimulation parameters. at least one stimulation parameter different from at least one of the stimulation parameters.

Optionally, if the appetite level exceeds the threshold level, the second plurality of stimuli is at least one of a pulse width, a pulse amplitude, a pulse frequency, a pulse duty cycle, a pulse shape, a session duration, or a session frequency of the plurality of stimulation parameters. has at least one of increased pulse width, pulse amplitude, pulse frequency, pulse duty cycle, pulse shape, session duration, or session frequency compared to one.

Optionally, if the level of appetite is below the threshold level, the second plurality of stimuli is at least one of a pulse width, pulse amplitude, pulse frequency, pulse duty cycle, pulse shape, session duration, or session frequency of the plurality of stimulation parameters. has at least one of a reduced pulse width, pulse amplitude, pulse frequency, pulse duty cycle, pulse shape, session duration, or session frequency compared to

Optionally, if the level of nausea exceeds the threshold level, the second plurality of stimulations comprises at least one of a plurality of stimulation parameters: pulse width, pulse amplitude, pulse frequency, pulse duty cycle, pulse shape, session duration, session frequency. at least one of a reduced pulse width, pulse amplitude, pulse frequency, pulse duty cycle, pulse shape, session duration or session frequency compared to one.

Optionally, if the level of hunger exceeds the threshold level, the second plurality of stimuli is at least one of a pulse width, a pulse amplitude, a pulse frequency, a pulse duty cycle, a pulse shape, a session duration, or a session frequency of the plurality of stimulation parameters. has at least one of increased pulse width, pulse amplitude, pulse frequency, pulse duty cycle, pulse shape, session duration, or session frequency compared to one.

Optionally, if the level of hunger is less than the threshold level, the second plurality of stimuli is at least one of a pulse width, a pulse amplitude, a pulse frequency, a pulse duty cycle, a pulse shape, a session duration, or a session frequency of the plurality of stimulation parameters. has at least one of a reduced pulse width, pulse amplitude, pulse frequency, pulse duty cycle, pulse shape, session duration, or session frequency compared to

In some embodiments, provided herein is a method for allowing a person to follow a diet plan, the method comprising the steps of providing an electrical skin patch configured to adhere to an epidermal layer of a person, wherein the electrical skin patch is in electrical contact with a controller, the epidermal layer of the patient providing an electrical skin patch comprising at least one electrode configured to: and a pulse generator in electrical communication with the controller and the at least one electrode; generating a plurality of electrical pulses having a therapy session duration and a therapy session frequency, each of the plurality of electrical pulses being defined by a pulse width, a pulse amplitude, a pulse shape, a pulse frequency, the pulse shape, the pulse width, generating a plurality of electrical pulses, wherein the pulse amplitude and the pulse frequency are selected to enable a person to follow a diet plan; acquiring data for a period of time by using an application installed on an external device, wherein the data includes at least one of a calorie intake timing, a calorie intake amount, and a calorie intake content; after the period of time, generating a signal using the application based on the data; transmitting the signal to the electrical skin patch; and generating a second plurality of electrical pulses using the plurality of stimulation parameters, wherein the plurality of stimulation parameters are determined based on the signal, a second pulse width, a second pulse amplitude, a second pulse frequency, a second generating a second plurality of electrical pulses comprising at least one of a two pulse duty cycle, a second pulse shape, a second therapy session duration, and a second therapy session frequency.

Optionally, the epidermal layer ranges from 0.1 mm to 25 mm from at least one of the human C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 dermatomes. located within

Optionally, when the caloric intake is different from the predetermined amount, the second pulse width is greater than the pulse width.

Optionally, when the caloric intake is different from the predetermined amount, the second pulse amplitude is greater than the pulse amplitude.

Optionally, when the caloric intake is different from the predetermined amount, the second pulse frequency is greater than the pulse frequency.

Optionally, if the caloric intake differs from the predetermined amount, the second therapy session duration is greater than the therapy session duration.

Optionally, if the caloric intake differs from the predetermined amount, the second therapy session frequency is greater than the therapy session frequency.

Optionally, the caloric intake content comprises at least one of an amount of carbohydrate, an amount of protein, an amount of fat, an amount of sugar, an amount of a vitamin, an amount of a mineral and an amount of a glycemic index.

Optionally, when at least one of the amount of carbohydrate, the amount of fat, the amount of sugar and the amount of the glycemic index is different from the predetermined amount, the second pulse width is greater than the pulse width.

Optionally, when at least one of the amount of carbohydrate, the amount of fat, the amount of sugar and the amount of the glycemic index is different from the predetermined amount, the second pulse amplitude is greater than the pulse amplitude.

Optionally, when at least one of the amount of carbohydrate, the amount of fat, the amount of sugar, and the amount of the glycemic index is different from the predetermined amount, the second pulse frequency is greater than the pulse frequency.

Optionally, the second therapy session duration is longer than the therapy session duration if at least one of the amount of carbohydrate, amount of fat, amount of sugar and amount of glycemic index is different from the predetermined amount.

Optionally, the second therapy session frequency is greater than the therapy session frequency if at least one of the amount of carbohydrate, amount of fat, amount of sugar, and amount of glycemic index is different from the predetermined amount.

In some embodiments, provided herein is a method for allowing a person to follow a diet plan, the method comprising the steps of providing an electrical skin patch configured to adhere to an epidermal layer of a person, wherein the electrical skin patch is in electrical contact with a controller, the epidermal layer of the patient providing an electrical skin patch comprising at least one electrode configured to: and a pulse generator in electrical communication with the controller and the at least one electrode; generating a plurality of electrical pulses at a first predetermined time of day using the electrical skin patch; acquiring data over a period of time using an application installed on a device separate from the electrical skin patch, wherein the data includes at least one of calorie intake timing and calorie intake; after the period of time, generating a signal using the application based on the data; transmitting the signal to the electrical skin patch; and generating a second plurality of electrical pulses using the plurality of stimulation parameters, wherein the plurality of stimulation parameters are determined based on the signal and comprising a second predetermined time of day. Disclosed is a method comprising the step of generating

Optionally, the epidermal layer ranges from 0.1 mm to 25 mm from at least one of the human C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 dermatomes. located within

Optionally, if the caloric intake differs from the predetermined amount, the second plurality of electrical pulses are generated at a second predetermined time of day, wherein the second predetermined time of day is different from the first predetermined time of day; Calorie intake is based on timing.

Optionally, the data further comprises at least one of an amount of carbohydrate consumed by the person, an amount of fat consumed by the person, and an amount of sugar consumed by the person.

Optionally, if the amount of carbohydrate is different from the predetermined amount, the second plurality of electrical pulses are generated at a second predetermined time of day, wherein the second predetermined time of day is different from the first predetermined time of day, and , based on the timing of calorie intake.

Optionally, if the amount of fat is different from the predetermined amount, the second plurality of electrical pulses are generated at a second predetermined time of day, wherein the second predetermined time of day is different from the first predetermined time of day and , based on the timing of calorie intake.

optionally, when the amount of sugar is different from the predetermined amount, the second plurality of electrical pulses are generated at a second predetermined time of day, wherein the second predetermined time of day is different from the first predetermined time of day, Calorie intake is based on timing.

Optionally, the electrical skin patch further comprises a transceiver, wherein the signal is wirelessly transmitted to the electrical skin patch.

Optionally, the device is at least one of a mobile phone, a tablet computer and a laptop computer.

In some embodiments, the present disclosure provides a method of enabling a person to follow a diet plan, the diet plan comprising at least one of a recommended calorie intake timing, a recommended calorie intake content, and a recommended calorie intake, the method comprising: providing an electrical skin patch configured to adhere to an epidermal layer of a person, the electrical skin patch comprising a controller, at least one electrode configured to be in electrical contact with an epidermal layer of a patient, and electrically connected to the controller and the at least one electrode providing an electrical skin patch comprising a pulse generator in communication; generating a plurality of electrical pulses at a first predetermined time of day, the plurality of electrical pulses comprising at least one of a pulse width, a pulse amplitude, a pulse frequency, a duty cycle, a pulse shape, a therapy session duration, and a therapy session frequency generating a plurality of electrical pulses defined by acquiring data over a period of time using an application installed on a device separate from the electrical skin patch, wherein the data includes at least one of calorie intake timing, calorie intake content, and calorie intake; using the application to compare at least one of calorie intake timing, calorie intake content and calorie intake with at least one of recommended calorie intake timing, recommended calorie intake content and recommended calorie intake; generating a signal using the application based on the comparison; transmitting the signal to the electrical skin patch; and generating a second plurality of electrical pulses using the plurality of stimulation parameters, wherein the plurality of stimulation parameters are determined based on the signal, a second pulse width, a second pulse amplitude, a second pulse frequency, a second generating a second plurality of electrical pulses comprising at least one of a two pulse duty cycle, a second pulse shape, a second therapy session duration, a second therapy session frequency, and a second predetermined time of day; to disclose a method.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second pulse width is greater than the pulse width.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second pulse amplitude is greater than the pulse amplitude.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second pulse frequency is greater than the pulse frequency.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second therapy session duration is greater than the therapy session duration.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second therapy session frequency is greater than the therapy session frequency.

Optionally, the caloric intake content comprises at least one of an amount of carbohydrate, an amount of fat, an amount of sugar and an amount of a glycemic index.

Optionally, the second pulse width is greater than the pulse width if at least one of the amount of carbohydrate, amount of fat, amount of sugar and amount of glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second pulse amplitude is greater than the pulse amplitude if at least one of the amount of carbohydrate, the amount of fat, the amount of sugar, and the amount of the glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second pulse frequency is greater than the pulse frequency if at least one of the amount of carbohydrate, the amount of fat, the amount of sugar and the amount of the glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second therapy session duration is longer than the therapy session duration if at least one of the amount of carbohydrate, amount of fat, amount of sugar, and amount of glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second therapy session frequency is greater than the therapy session frequency if at least one of the amount of carbohydrate, amount of fat, amount of sugar and amount of glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the electrical skin patch further comprises a transceiver, wherein the signal is wirelessly transmitted to the electrical skin patch.

Optionally, the device is at least one of a mobile phone, a tablet computer and a laptop computer.

In some embodiments, the present disclosure provides a method for a person to follow a diet plan using an electric skin patch attached to the epidermal layer of the person, wherein the diet plan includes a recommended calorie intake timing, a recommended calorie intake content, and a recommended calorie intake. as defined by at least one of: generating a plurality of electrical pulses at a first predetermined time of day, wherein the plurality of electrical pulses have a pulse width, a pulse amplitude, a pulse frequency, a pulse duty cycle, and a pulse shape. , generating a plurality of electrical pulses defined by at least one of a therapy session duration and a therapy session frequency; receiving data to an application installed on a device separate from the electrical skin patch, the data comprising at least one of calorie intake timing, calorie intake content, and calorie intake; using the application to compare at least one of calorie intake timing, calorie intake content, and calorie intake with at least one of recommended calorie intake timing, recommended calorie intake content, and recommended calorie intake; generating a signal using the application based on the comparison; transmitting a signal to the electrical skin patch; and generating a second plurality of electrical pulses using the plurality of stimulation parameters, wherein the plurality of stimulation parameters are determined based on the signal, a second pulse width, a second pulse amplitude, a second pulse frequency, a second generating a second plurality of electrical pulses comprising at least one of a two pulse duty cycle, a second pulse shape, a second therapy session duration, a second therapy session frequency, and a second predetermined time of day; to disclose a method.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second pulse width is greater than the pulse width.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second pulse amplitude is greater than the pulse amplitude.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second pulse frequency is greater than the pulse frequency.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second therapy session duration is greater than the therapy session duration.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second therapy session frequency is greater than the therapy session frequency.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second pulse width is less than the pulse width.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second pulse amplitude is less than the pulse amplitude.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second pulse frequency is less than the pulse frequency.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second therapy session duration is shorter than the therapy session duration.

Optionally, if the caloric intake differs from the recommended caloric intake by a predetermined amount, the second therapy session frequency is less than the therapy session frequency.

Optionally, the caloric intake content comprises at least one of an amount of carbohydrate, an amount of fat, an amount of sugar and an amount of a glycemic index.

Optionally, the second pulse width is greater than the pulse width if at least one of the amount of carbohydrate, amount of fat, amount of sugar or amount of glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second pulse amplitude is greater than the pulse amplitude if the amount of carbohydrate, the amount of fat, the amount of sugar, or the amount of the glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second pulse frequency is greater than the pulse frequency if the amount of carbohydrate, amount of fat, amount of sugar or amount of glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second therapy session duration is greater than the therapy session duration if the amount of carbohydrate, amount of fat, amount of sugar or amount of glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second therapy session frequency is greater than the therapy session frequency if the amount of carbohydrate, amount of fat, amount of sugar or amount of glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second pulse width is less than the pulse width if at least one of the amount of carbohydrate, amount of fat, amount of sugar, or amount of glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second pulse amplitude is less than the pulse amplitude if the amount of carbohydrate, the amount of fat, the amount of sugar, or the amount of the glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second pulse frequency is less than the pulse frequency if the amount of carbohydrate, the amount of fat, the amount of sugar or the amount of the glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second therapy session duration is shorter than the therapy session duration if the amount of carbohydrate, amount of fat, amount of sugar or amount of glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the second therapy session frequency is less than the therapy session frequency if the amount of carbohydrate, amount of fat, amount of sugar or amount of glycemic index differs from the recommended caloric intake content by a predetermined amount.

Optionally, the electrical skin patch further comprises a transceiver, wherein the signal is wirelessly transmitted to the electrical skin patch.

Optionally, the device is at least one of a mobile phone, a tablet computer and a laptop computer.

In some embodiments, disclosed herein is a method of forcing a patient to follow a diet plan to achieve a target weight using an electrical skin patch attached to an epidermal layer of a patient, the method comprising: generating a plurality of electrical pulses, the plurality of electrical pulses comprising: generating a plurality of electrical pulses defined by at least one of pulse width, pulse amplitude, pulse shape, pulse frequency, therapy session duration and therapy session frequency; obtaining patient condition data using an application installed in a device external to the electrical skin patch, the data including data representing a patient's weight; comparing the patient's weight to a target weight; generating a signal using the application based on the comparison; transmitting a signal to the electrical skin patch; and generating a second plurality of electrical pulses using the plurality of stimulation parameters, wherein the plurality of stimulation parameters are determined based on the signal, a second pulse width, a second pulse shape, a second pulse amplitude, a second generating a second plurality of electrical pulses comprising at least one of a second pulse frequency, a second therapy session duration, and a second therapy session frequency.

Optionally, if the patient's body weight is less than or equal to the target body weight, at least one of the second pulse width, the second pulse amplitude, the second pulse frequency, the second therapy session duration, and the second therapy session frequency is the pulse width, the pulse amplitude, the pulse frequency, therapy session duration, and therapy session frequency.

Optionally, if the patient's body weight is greater than the target body weight, at least one of the second pulse width, the second pulse amplitude, the second pulse frequency, the second therapy session duration, and the second therapy session frequency is a pulse width, a pulse amplitude, is increased relative to at least one of pulse frequency, therapy session duration, and therapy session frequency.

Optionally, the electrical skin patch further comprises a transceiver, wherein the signal is wirelessly transmitted to the electrical skin patch.

Optionally, the device is at least one of a mobile phone, a tablet computer and a laptop computer.

In some embodiments, the present disclosure provides a method of using an electrical skin patch attached to an epidermal layer of a person to follow a diet plan to achieve a target weight, the method comprising: generating a plurality of electrical pulses through the electrical skin patch; generating a plurality of electrical pulses, wherein the plurality of electrical pulses are defined by at least one of a pulse width, a pulse amplitude, a pulse frequency, a therapy session duration, and a therapy session frequency; obtaining data using an application installed on a device separate from the electrical skin patch, wherein the data measures at least one of a person's appetite, a person's hunger, a person's satiety level, a person's satiety level, and a person's fullness level. indicating, obtaining data; generating a signal using the application based on the data; transmitting a signal to the electrical skin patch; and generating a second plurality of electrical pulses using the plurality of stimulation parameters, wherein the plurality of stimulation parameters are determined based on the signal, a second pulse width, a second pulse amplitude, a second pulse frequency, a second generating a second plurality of electrical pulses comprising at least one of a second therapy session duration, and a second therapy session frequency.

Optionally, if the person's appetite differs from the target appetite level by a predetermined amount, at least one of a second pulse width, a second pulse amplitude, a second pulse frequency, a second therapy session duration, and a second therapy session frequency is Pulse width, pulse amplitude, pulse frequency, therapy session duration and second therapy session frequency are increased.

Optionally, when the hunger of the person differs from the target hunger level by a predetermined amount, at least one of a second pulse width, a second pulse amplitude, a second pulse frequency, a second therapy session duration, and a second therapy session frequency are Pulse width, pulse amplitude, pulse frequency, therapy session duration and second therapy session frequency are increased.

Optionally, at least one of a second pulse width, a second pulse amplitude, a second pulse frequency, a second therapy session duration, and a second therapy session frequency if the individual's level of satiety differs from the target satiety level by a predetermined amount. increases as compared to pulse width, pulse amplitude, pulse frequency, therapy session duration and second therapy session frequency.

Optionally, a second pulse width, a second pulse amplitude, a second pulse frequency, a second therapy session duration, and a second therapy session frequency if the individual's bite level differs from the target bite level by a predetermined amount. At least one increases as compared to the pulse width, pulse amplitude, pulse frequency, therapy session duration and second therapy session frequency.

Optionally, at least one of a second pulse width, a second pulse amplitude, a second pulse frequency, a second therapy session duration, and a second therapy session frequency if the individual's level of satiety differs from the target level of satiety by a predetermined amount. increases as compared to pulse width, pulse amplitude, pulse frequency, therapy session duration and second therapy session frequency.

Optionally, if the person's appetite differs from the target appetite level by a predetermined amount, at least one of a second pulse width, a second pulse amplitude, a second pulse frequency, a second therapy session duration, and a second therapy session frequency is Pulse width, pulse amplitude, pulse frequency, therapy session duration and second therapy session frequency decrease.

Optionally, when the hunger of the person differs from the target hunger level by a predetermined amount, at least one of a second pulse width, a second pulse amplitude, a second pulse frequency, a second therapy session duration, and a second therapy session frequency are Pulse width, pulse amplitude, pulse frequency, therapy session duration and second therapy session frequency decrease.

Optionally, at least one of a second pulse width, a second pulse amplitude, a second pulse frequency, a second therapy session duration, and a second therapy session frequency if the individual's level of satiety differs from the target satiety level by a predetermined amount. is decreased compared to the pulse width, pulse amplitude, pulse frequency, therapy session duration and second therapy session frequency.

Optionally, a second pulse width, a second pulse amplitude, a second pulse frequency, a second therapy session duration, and a second therapy session frequency if the individual's bite level differs from the target bite level by a predetermined amount. At least one decreases compared to pulse width, pulse amplitude, pulse frequency, therapy session duration and second therapy session frequency.

Optionally, at least one of a second pulse width, a second pulse amplitude, a second pulse frequency, a second therapy session duration, and a second therapy session frequency if the individual's level of satiety differs from the target level of satiety by a predetermined amount. is decreased compared to the pulse width, pulse amplitude, pulse frequency, therapy session duration and second therapy session frequency.

Optionally, the electrical skin patch further comprises a transceiver, wherein the signal is wirelessly transmitted to the electrical skin patch.

Optionally, the device is at least one of a mobile phone, a tablet computer and a laptop computer.

In some embodiments, the present disclosure provides a method of regulating at least one of appetite, hunger, satiety level or bite in a person, the method comprising: providing an electrical skin patch configured to adhere to an epidermal layer of a person, the electrical skin patch comprising: a controller providing an electrical skin patch comprising at least one electrode configured to be in electrical contact with the human epidermal layer, and a pulse generator in electrical communication with the controller and the at least one electrode; defining a first plurality of stimulation parameters; generating a plurality of electrical pulses using the first plurality of stimulation parameters, wherein the first plurality of stimulation parameters are the patient's appetite, hunger, satiety level, and bite after applying at least one stimulation to the epidermal layer of the patient. generating a plurality of electrical pulses determined to modify at least one of the sensitivity levels; acquiring data using the electrical skin patch and an application installed on a separate device, the data comprising: a person's appetite, hunger, satiety level, fullness level, fullness level, calorie intake, body weight, calorie intake type and calorie intake obtaining data indicative of at least one of the times; generating a signal using the application based on the data; transmitting a signal to the electrical skin patch; and generating a second plurality of electrical pulses using a second plurality of stimulation parameters, wherein the second plurality of stimulation parameters are determined. start

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that a daily calorie intake of the individual after stimulation is reduced relative to a daily calorie intake of the individual prior to stimulation, wherein the daily calorie intake before stimulation is a function of the amount of calories consumed by the person during a first predetermined time period before stimulation, and wherein the daily calorie intake after stimulation is a function of the amount of calories consumed by the person during a second predetermined time period after stimulation is initiated and in duration equal to the first predetermined time period. This is a function of the amount of calories consumed.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that the individual's daily calorie intake after stimulation is less than 99% of the individual's daily calorie intake prior to stimulation, wherein Calorie intake is a function of the amount of calories consumed by a person during a first predetermined time period prior to stimulation, and wherein said daily caloric intake after stimulation is a second predetermined time period equal in duration to the first predetermined time period after stimulation begins. It is a function of the amount of calories consumed by a person during the period.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that after the at least one stimulation, the target daily calorie intake compliance of the person increases compared to the target daily calorie intake compliance of the person before the stimulation.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are such that, after at least one stimulation, the daily calorie intake of the person decreases from a daily calorie intake range of greater than 1600 calories to a range of 600 calories to 1600 calories. more is chosen

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that, after at least one stimulation, the human's daily calorie intake decreases from greater than 2000 calories per day to less than 2000 calories per day.

Optionally, the first plurality of electrical pulses and the second plurality of electrical pulses comprise a pulse width in the range of 10 μsec to 100 msec, a pulse amplitude in the range of 100 μA to 500 mA, and a pulse frequency in the range of 1 Hz to 10,000 Hz .

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that after at least one stimulation, the total body weight of the person decreases by at least 1% relative to the total body weight of the person before stimulation.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that after the at least one stimulation, the excess weight of the person is reduced by at least 1% relative to the excess weight of the person before the stimulation.

Optionally, wherein the first plurality of stimulation parameters and the second plurality of stimulation parameters decrease the total body weight of the person after at least one stimulation by at least 1% relative to the total body weight of the person before stimulation, and wherein the level of well-being of the person increases is additionally selected not to decrease by more than 5% relative to the well-being level of

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are such that after the at least one stimulation, the excess body weight of the person is reduced by at least 1% as compared to the excess weight of the person before the stimulation, and the level of well-being of the person is improved after the at least one stimulation. It is further selected such that it does not decrease by more than 5% relative to the level of human well-being.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that, after at least one stimulation, the human pre-prandial ghrelin level decreases by at least 1% relative to the human pre-prandial ghrelin level prior to stimulation.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that post-prandial ghrelin levels in the human after at least one stimulation decrease by at least 1% relative to postprandial ghrelin levels in the human prior to stimulation.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that after at least one stimulation session the patient's motor output increases by at least 1% relative to the patient's motor output before stimulation.

Optionally, said first plurality of stimulation parameters and said second plurality of stimulation parameters are such that, after at least one stimulation, the human glucagon-like peptide-1 level is at least 1% compared to the human glucagon-like peptide-1 level prior to stimulation. further selected to increase.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that after the at least one stimulation, the human leptin level increases by at least 1% relative to the human leptin level before the stimulation.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are such that after the at least one stimulation, the patient's appetite decreases relative to the patient's appetite before the stimulation for a predetermined period of time, and the patient's level of nausea is reduced by the predetermined time period. It is further selected so as not to increase by more than 10% relative to the patient's nausea level prior to stimulation during the period of time.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that after at least one stimulation, the human level of peptide YY increases by at least 1% relative to the level of human peptide YY before stimulation.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that after at least one stimulation, the human lipopolysaccharide level decreases by at least 1% relative to the human lipopolysaccharide level prior to stimulation.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are such that after at least one stimulation, the level of the human motilin-related peptide decreases by at least 1% relative to the level of the human motilin-related peptide before the stimulation. additionally selected.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that after at least one stimulation, the human cholecystokinin level increases by at least 1% relative to the human's cholecystokinin level prior to stimulation.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that the resting metabolic rate of the human after at least one stimulation increases by at least 1% relative to the resting metabolic rate of the human prior to stimulation.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further adjusted to increase plasma-beta endorphin levels of the human after at least one stimulation by at least 1% relative to plasma-beta endorphin levels of the human prior to stimulation is chosen

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are such that after the at least one stimulation, the patient's hunger decreases relative to the patient's hunger before the stimulation for a predetermined period of time, and the patient's level of nausea is reduced by the predetermined time period. It is further selected so as not to increase by more than 10% relative to the patient's nausea level prior to stimulation during the period of time.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that after at least one stimulation, the human hemoglobin A1c level decreases by an amount equal to at least 0.3%.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that after the at least one stimulation, the human triglyceride level decreases by at least 1% relative to the human triglyceride level prior to the stimulation. .

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that after at least one stimulation, the human total blood cholesterol level decreases by at least 1% relative to the human total blood cholesterol level prior to the stimulation. .

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that after the at least one stimulation, the human blood glucose level decreases by at least 1% relative to the human blood glucose level before the stimulation.

Optionally, the first plurality of stimulation parameters and the second plurality of stimulation parameters are further selected such that, after at least one stimulation, a composition of the human gut microbiota is modulated from the first state to the second state, wherein the first state has a first level of Bacteroidetes and a first level of Firmicutes, the second state has a second level of Bacteroidetes and a second level of Firmicutes, and a second level of Bacteroidetes The level is at least 3% greater than the first level of Bacteroidetes and the second level of Firmicutes is at least 3% lower than the first level of Firmicutes.

In some embodiments, disclosed herein is a method for causing a person to follow a diet plan, the method comprising: providing an electrical skin patch configured to adhere to an epidermal layer of a person, the electrical skin patch configured to be in electrical contact with a controller, the epidermal layer of the patient; providing an electrical skin patch comprising at least one electrode configured and a pulse generator in electrical communication with the controller and the at least one electrode; generating a plurality of electrical pulses having a therapy session duration and a therapy session frequency, each of the plurality of electrical pulses being defined by a pulse width, a pulse amplitude, a pulse shape, a pulse frequency, the pulse shape, the pulse width, providing a plurality of electrical pulses, wherein the pulse amplitude and the pulse frequency are selected to enable a person to follow a diet plan; Acquiring data over a period of time using an application installed on an external device, the data comprising: calorie intake timing, calorie intake, calorie intake content, appetite level, appetite timing, hunger level, satiety level, satiety level, fullness level obtaining data comprising at least one of: , an amount of calories burned, and an activity level; generating a signal using the application based on the data after the time period; transmitting the signal to the electrical skin patch; generating a second plurality of electrical pulses using a plurality of stimulation parameters, the plurality of stimulation parameters being determined based on the signal, a second pulse width, a second pulse amplitude, a second pulse frequency, a second generating a second plurality of electrical pulses comprising at least one of a pulse duty cycle, a second pulse shape, a second therapy session duration, and a second therapy session frequency; transmitting at least a portion of the data and at least one of the plurality of stimulation parameters from the external device to a server using the application; storing said data and said at least a portion of said plurality of stimulation parameters in a database using said server; associating the data and at least a portion of the plurality of stimulation parameters with an electronic profile of the patient using the server; using the server to share the patient's electronic profile with another individual's electronic profile; using the server to communicate with one or more of the above-mentioned timing of calorie intake, calorie intake, calorie intake content, degree of appetite, timing of appetite, degree of hunger, level of satiety, level of satiety, level of satiety, level of satiety, amount of calories burned, activity level, and said individual; sending at least one of a plurality of associated stimulation parameters to the application; and at least one of a plurality of stimulus parameters associated with the calorie intake timing, calorie intake, calorie intake content, degree of appetite, timing of appetite, degree of hunger, level of satiety, level of satiety, level of satiety, amount of calories burned, activity level, patient; calorie intake timing, calorie intake, calorie intake content, appetite level, timing of appetite, hunger level, satiety level, satiety level, satiety level, burnout associated with one or more of the individual in relation to or for at least one of a plurality of stimulation parameters. and visually displaying in the application at least one of an amount of calories burned, an activity level, and a plurality of stimulation parameters. It should be understood that a server may represent one or more computing devices, whether individually identifiable or collectively acting as a cloud service.

Optionally, in any of the above embodiments, the duty cycle may be between 1% and 100%, and the pulse shape may be any of single-phase, two-phase, and sine wave. Additionally, in any of the above embodiments, it is further added that each stimulation session is between 1 and 24 stimulation sessions per day and between 2 and 168 stimulation sessions per week with a stimulation session duration between 1 minute and 120 minutes. can be limited to Stimulation session duration may also range from 1 minute to substantially continuous.

Optionally, in any of the above embodiments, the stimulation session is a first pulse frequency greater than the pivot frequency after the first session having a first pulse frequency less than or equal to a pivot frequency, such as a 50 Hz frequency or a frequency in the range of 25 Hz to 75 Hz configured to provide alternating stimulation sessions followed by a second session having a two pulse frequency.

Optionally, the control device is further configured to monitor, record and modify stimulation parameters of the stimulation protocol. The control device may include any of a smartphone, tablet, personal digital assistant, and may be in data communication with a remote patient care facility or patient care personnel.

Optionally, the control device comprises a graphical user interface screen configured to receive appetite, feeding, weight and activity information data from the patient and display the data on the screen. Still optionally, the control device is configured to generate and display a plurality of charts and graphs representing the informational data, and to manage and generate prompts related to patient compliance on the graphical user interface screen based on the data.

Optionally, the control device is configured to receive and integrate exercise and weight loss information from a third party device.

Optionally, the control device is configured to provide a rescue stimulation session, wherein the rescue stimulation session is an on-demand stimulation session applied when occurrence of an unplanned hunger event or potential hunger event determined by analyzing the data begins. is determined as

Optionally, the stimulation device comprises at least one sensor and the control device is configured to modify the stimulation parameter based on data received from the at least one sensor. The sensor may include any or a combination of a blood glucose sensor, a nerve sensor, an accelerometer, an impedance sensor, and a bioimpedance sensor.

Also disclosed herein is a device for providing electrical stimulation through 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, or any increment therein, of the dermis from the outer surface of the epidermal layer of a patient, comprising: a microprocessor, a wireless transceiver; a housing comprising a pulse generator, a power management module, and at least one electrode extending within the housing or from an exterior surface of the housing; at least one conductive pad in electrical communication with an electrode and configured to be disposed on a skin surface of a patient, wherein the at least one electrode is positioned such that an electric field generated by the at least one electrode is shallow and widely distributed over the skin surface wherein the shallow is defined as a depth of no more than 25 mm from the skin surface, and the broad distribution is defined as the area for attaching the at least one conductive pad to at least the skin surface, wherein the device has a maximum output voltage of 500V and a maximum output current of 500mA.

The pad may have a shape including any of irregular, rectangular, circular, square, oval, and triangular, the longest length of the pad in the range of 2 inches to 4 inches, and the widest width or diameter of the pad being 1.25 inches to 3 inches and is approximately 0.2 inches thick. In other embodiments, the electrode/pad combination may have a shape comprising any one of irregularities, rectangles, circles, squares, ellipses, and triangles, where the widest width is 0.25 inches to 5 inches, and the highest height is 0.25 inches to 5 inches, and the thickest thickness may be from 0.25 inches to 5 inches. In other embodiments, the device may include two of these electrode/pad combinations placed side by side.

Also disclosed herein is a device for treating a disease comprising at least one of obesity, overweight, eating disorders, metabolic syndrome and diabetes in a patient, wherein the device comprises an epidermis of a T2 anterior thoracic dermatome, a T3 anterior thoracic dermatome of the patient. Epidermis, T4 Epidermis of anterior thoracic dermatome, T5 Epidermis of anterior thoracic dermatome, T6 Epidermis of anterior thoracic dermatome, T7 Epidermis of anterior thoracic dermatome, T8 Epidermis of anterior thoracic dermatome, T9 Epidermis of anterior thoracic dermatome, T10 Epidermis of anterior thoracic dermatome , the epidermis of the T11 frontal thoracic dermatome, and the epidermis of the T12 frontal thoracic dermatome through electrical stimulation through the range of 0.1 mm to 25 mm of the dermis or any increments therein from the outer surface of the epidermal layer of the patient. and wherein the electrical stimulation is increased based on data from the first parameter and the electrical stimulation is decreased based on data from the second parameter. The first parameter may include any of appetite, hunger, weight, body mass index (BMI), body fat, and the second parameter may include any of nausea, indigestion, heartburn, sensation at the site of stimulation .

Also disclosed herein is a device for treating a disease comprising at least one of obesity, overweight, eating disorders, metabolic syndrome and diabetes in a patient, wherein the device comprises an epidermis of a T2 anterior thoracic dermatome, a T3 anterior thoracic dermatome of the patient. Epidermis, T4 Epidermis of anterior thoracic dermatome, T5 Epidermis of anterior thoracic dermatome, T6 Epidermis of anterior thoracic dermatome, T7 Epidermis of anterior thoracic dermatome, T8 Epidermis of anterior thoracic dermatome, T9 Epidermis of anterior thoracic dermatome, T10 Epidermis of anterior thoracic dermatome , the epidermis of the T11 front thoracic dermatome, and the epidermis of the T12 frontal thoracic dermatome through electrical stimulation through the range of 0.1 mm to 25 mm of the dermis or any increments therein from the outer surface of the epidermal layer of the patient. wherein the electrical stimulation is reduced based on data indicative of an excessive loss of appetite, an excessive loss of hunger, an actual weight below the target weight, an actual calorie intake below the target calorie intake, an actual BMI below the target BMI; Start the device.

Also disclosed herein is a device for treating a disease comprising at least one of obesity, overweight, eating disorders, metabolic syndrome and diabetes in a patient, wherein the device comprises an epidermis of a T2 frontal thoracic dermatome, a T3 epidermis of an anterior thoracic dermatome of the patient. , T4 epidermis of front thoracic dermatome, T5 epidermis of front thoracic dermatome, T6 epidermis of front thoracic dermatome, T7 epidermis of front thoracic dermatome, T8 epidermis of front thoracic dermatome, T9 epidermis of front thoracic dermatome, T10 epidermis of front thoracic dermatome, Electrical stimulation through the range of 0.1 mm to 10 mm or range of 0.1 mm to 20 mm of the dermis from the outer surface of the epidermal layer of the patient by applying electrical stimulation to any of the epidermis of the T11 frontal thoracic dermatome, and the epidermis of the T12 frontal thoracic dermatome. wherein the patient is stimulated with a first stimulation algorithm for inducing weight loss and a second stimulation algorithm for maintaining weight loss, wherein the first total stimulation energy per day of the first stimulation algorithm is greater than a second total stimulation energy per day of the second stimulation algorithm.

Also disclosed herein is a device for suppressing appetite or food cravings in a patient, said device having a length of 5 inches or less, a width of 2 inches or less, a height of 1.5 inches or less, preferably a height of 0.35 inches or less. a body, a microprocessor, a wireless transceiver, a pulse generator, a power management module, and at least one electrode extending along a lower surface of the device body; The device comprises an epidermis of the patient's T2 anterior thoracic dermatome, T3 anterior thoracic dermatome, T4 anterior thoracic dermatome, T5 anterior thoracic dermatome, T6 anterior thoracic dermatome, T7 anterior thoracic dermatome, T8 anterior Dermis from the outer surface of the epidermal layer of a patient by applying electrical stimulation to any of the following: epidermis of thoracic dermatome, T9 anterior thoracic dermatome, T10 anterior thoracic dermatome, T11 anterior thoracic dermatome, and T12 anterior thoracic dermatome. configured to deliver electrical stimulation through a range of 0.1 mm to 10 mm or a range of 0.1 mm to 20 mm of and provide stimulation for at least two stimulation sessions per week, wherein each stimulation session has an on period of from 10 minutes to 120 minutes or substantially continuous.

In some embodiments, provided herein is a method of regulating blood glucose levels in a patient, comprising the steps of providing an electrical skin patch configured to adhere to an epidermal layer of a patient, wherein the electrical skin patch is configured to be in electrical contact with a controller, the epidermal layer of the patient; providing an electrical skin patch comprising at least one electrode configured and a pulse generator in electrical communication with the controller and the at least one electrode; defining a plurality of stimulation parameters; providing a blood glucose sensor to the patient to continuously monitor the patient's blood glucose level in a closed loop configuration; and programming the pulse generator to generate a plurality of electrical pulses using the plurality of stimulation parameters, and stimulating the patient based on a threshold blood glucose level, wherein after applying at least one stimulation to the epidermal layer of the patient, the patient's and wherein the blood glucose level is modified, the modifying which may result in a modification of the stimulus, comprising stimulating the patient.

Optionally, stimulation ceases when a predetermined lower blood glucose level is reached.

Optionally, an optimal or intense stimulation protocol is initiated when the patient's blood glucose level is above a predetermined threshold level.

Optionally, the level of hemoglobin A1C decreases by at least 1% at a p value of 0.05 after at least one stimulation session.

Optionally, the level of hemoglobin A1C is fully normalized after at least one stimulation session.

Optionally, the level of hemoglobin A1C is <7.0% after at least one stimulation session.

In some embodiments, the present disclosure provides a method of modulating a patient's will power reserve, the method comprising: providing an electrical skin patch configured to adhere to an epidermal layer of a patient, the electrical skin patch comprising: a controller; providing an electrical skin patch comprising at least one electrode configured to be in electrical contact with an epidermal layer, and a pulse generator in electrical communication with the controller and the at least one electrode; defining a plurality of stimulation parameters; and programming a pulse generator to generate a plurality of electrical pulses using the plurality of stimulation parameters, wherein the plurality of stimulation parameters are determined such that the patient's willpower reserve is modified after at least one stimulation of the epidermal layer of the patient; , wherein the willpower reserve is at least a function of any one or combination of the patient's hunger score, diet compliance, exercise level, appetite control, amount of calories consumed, type of calories consumed, timing of meals, and body weight. A method comprising programming a generator is disclosed. Optionally, the willpower reserve is an inverse function of the hunger score.

Optionally, the willpower reserve is a combined function of dietary willpower and exercise willpower, wherein the dietary willpower is an inverse function of hunger score or a directly proportional function of diet adherence, and wherein the exercise willpower is a function that is directly proportional to exercise level .

Optionally, said diet willpower is a directly proportional synthetic function of diet adherence and appetite control, wherein said diet adherence is at least a function of the amount of calories consumed and the type of calories consumed.

Optionally, one or both of the diet willpower graph being displayed in the red region and the electrical skin patch flashing red using one or more LEDs occurs when the patient's appetite control and diet adherence are low.

Optionally, one or both of the diet willpower graph being displayed in the yellow region and the electrical skin patch flashing yellow using one or more LEDs occurs when the patient's appetite control and diet compliance increases.

Optionally, when the patient's appetite control and diet adherence are high, one or both of the diet willpower graph being displayed in the green area and the electrical skin patch flashing green using at least one LED occurs.

Optionally, the willpower reserve is an inverse function of a craving profile of the patient, wherein the craving profile is a function of at least one of an amount of calories consumed, a type of calories consumed, and timing of a meal.

Optionally, the willpower reserve is a composite function of at least two of: amount of calories consumed, type of calories consumed, timing of meals, level of exercise, and body weight.

Optionally, the willpower reserve is a composite function of hunger score improvement, diet adherence and exercise level.

Optionally, the patient is provided with a VAS light bar periodically to record patient inputs related to successful diet plan maintenance, non-meal snack restriction plan success, health food intake success, and hunger control success.

Optionally, the willpower reserve may also include bonus points earned for each hunger rescue bolus, bonus points earned from exercise, bonus points earned from keeping a patient's daily diary, bonus points earned from favorable daily weight changes, and at least one of the bonus points earned by positively coaching other patients within the patient's social network group.

Optionally, the patient periodically provides input to the displayed light bar VAS to assess diet willpower.

Optionally, the patient's willpower reserve is displayed in graphical form.

Optionally, the patient is a member of a fellowship group comprising a plurality of members, each member having an associated willpower reserve profile generated from each member's archived daily willpower reserve for a period of time. Optionally, the collective willpower reserve of the social group is determined based on the willpower reserve of each member of the social group. Optionally, the group willpower reserve is an average of the willpower reserves of each member of the fellowship group.

Optionally, a member having at least a predetermined minimum willpower reserve may coach another member.

Optionally, the member's willpower reserve exceeding the predetermined threshold results in the member at least one reward.

Optionally, a member may subscribe to another member's diet plan, exercise regime, and/or stimulation parameter that has reached a predetermined threshold willpower reserve.

Optionally, the willpower reserve of the member enables the member to accumulate points and bonuses corresponding to the degree of the willpower reserve, and use the points and bonuses to obtain a plurality of rewards and participate in games between members of the social group have.

In some embodiments, provided herein is a method of stimulating an internal reflex system of a patient, the method comprising the steps of providing an electrical skin patch configured to adhere to an epidermal layer of a patient, the electrical skin patch comprising: a controller; providing an electrical skin patch comprising at least one electrode configured to contact, and a pulse generator in electrical communication with the controller and the at least one electrode; defining a plurality of stimulation parameters; and programming the pulse generator to generate a plurality of electrical pulses using the plurality of stimulation parameters, wherein the plurality of stimulation parameters are the patient's gastric vestibular motility, gastric emptying, and gastric emptying after application of at least one stimulation to the epidermal layer of the patient. , programming a pulse generator configured to modify at least one of appetite, body weight, ghrelin, insulin and blood sugar.

Optionally, stimulating the patient's internal reflex system comprises delivering said plurality of electrical pulses to at least one of T2-T12 and C5-T1 dermatomes.

Optionally, stimulation of the in vivo reflex system is enhanced by matching the stimulation session with a preprandial and/or postprandial window.

Optionally, said preprandial window is associated with a first period comprising ghrelin secretion immediately prior to an expected feeding, and said postprandial window is associated with a second period comprising digestive activity after feeding.

Optionally, said first period spans about 60 minutes prior to the expected feeding time and said second period spans about 2 hours after a meal.

Optionally, said first period spans about 60 minutes prior to the expected feeding time and said second period spans about 60 minutes after a meal.

In some embodiments, the present disclosure provides a method of regulating at least one of appetite, hunger, satiety level or bite in a person, the method comprising: providing an electrical skin patch configured to adhere to an epidermal layer of a person, the electrical skin patch comprising: a controller providing an electrical skin patch comprising at least one electrode configured to be in electrical contact with the human epidermal layer, and a pulse generator in electrical communication with the controller and the at least one electrode; defining a first plurality of stimulation parameters, wherein the first plurality of stimulation parameters include a therapy session duration, a stimulation amplitude, and a frequency of a therapy session; generating a plurality of electrical pulses using the first plurality of stimulation parameters, wherein the first plurality of stimulation parameters are the patient's appetite, hunger, satiety level and bite sensation after application of at least one stimulation to the epidermal layer of the patient. generating a plurality of electrical pulses determined to modify at least one of the levels; acquiring data using the electrical skin patch and an application installed on a separate device, the data comprising: a person's appetite, hunger, satiety level, fullness level, fullness level, calorie intake, body weight, calorie intake type and calorie intake obtaining data indicative of at least one of timing; generating a signal using the application based on the data; and transmitting a signal to the electrical skin patch.

Optionally, the duration of the therapy session ranges from 20 minutes to 40 minutes.

Optionally, the stimulation amplitude ranges from 10 mA to 30 mA.

Optionally, the frequency of therapy sessions is 3 times per day.

Optionally, the frequency of the therapy session is configured to begin in the range of 20 minutes to 90 minutes prior to the person's meal time.

Optionally, the application is configured to generate a graphical user interface comprising the visual bar and configured to receive input from the person modifying the position of the visual bar based on the hunger level of the person, wherein when modifying the position of the visual bar , the application is configured to modify one or more of the first plurality of stimulation parameters.

Optionally, the device separated from the electric skin patch is at least one of a mobile phone, a tablet computer, an intelligent personal assistant, a chat robot, a chatter robot, a chatterbot, a chatbot, an artificial conversation entity, an artificial intelligence agent, a talkbot, and a chatterbox.

In some embodiments, disclosed herein is a method that enables a TPM to prescribe, configure, manage, monitor, and intervene in an EDP device based stimulation regimen for a user.

Optionally, the user visits his TPM for a health check-up or evaluation. Optionally, the TPM recommends the EDP device of the present disclosure to the user based on the user's medical condition, such as obesity or overweight.

Optionally, the TPM downloads the HMA to the user's smartphone (acting as a companion device).

Optionally, TP1M allows the user to identify an appropriate stimulation area (and thus user's placement of the EDP device on the body), and also provides the user with orientation regarding the use and function of the electrical skin patch device. The EDP device is located at an identified location on the user's body.

Optionally, the TPM associates or links itself to the user, the user's EDP device, and the HMA, for example by entering the user's unique code into the user's HMA. Still optionally, the TPM pairs or synchronizes the user's smartphone with the user's EDP device.

Optionally, the TPM configures or programs the stimulation protocol and parameters, including various relevant thresholds, ranges, associated with the planned therapy session and the unscheduled rescue on demand session. The TPM may optionally prescribe a low-calorie plan diet for the user. Optionally, the HMA confirms that the configuration (by the TPM) is successful and the EDP device also, optionally, for example a vibration, audible and/or visual indication or signal (eg, a flashing LED of a specific color). to confirm successful configuration.

Optionally, the TPM delivers a first scheduled therapy session to the user in the presence of the TPM to ensure that the HMA or therapy configuration is beneficial to the user.

Optionally, if the user feels okay after the first session, the user may leave to continue the therapy at home, or if the user reports discomfort or deterioration in well-being, for example due to nausea, the TPM will notify the stimulation protocol and parameters reprogram the

Optionally, the user continues stimulation therapy at home, and during therapy (results of recorded unplanned hunger events and delivered rescue sessions) a plurality of health-related information (eg, user's weight, appetite, hunger, exercise) , scores related to well-being (including, but not limited to, well-being profiles including recorded nausea and/or dyspepsia events), values related to calories consumed, and individualized hunger profiles.

Optionally, and when necessary, the TPM adjusts stimulation parameters and protocols for both the scheduled session and the rescue session based on the plurality of user health related information while the user continues stimulation therapy at home. Optionally, the TPM also intervenes by reconfiguring or reprogramming the EDP device and HMA and/or disabling and reactivating the EDP device when needed. Optionally, the user's stimulation is suspended, suspended and/or prompts the user to revisit the user's TPM to re-evaluate the user's medical condition or progress.

Optionally, the user may use multiple options for purchasing the EDP device along with the services of the TPM. Optionally, the TPM's fee schedule is enforced through the user's unique code, which is only valid for a predetermined period of time. Optionally, the TPM's fee is associated with the user achieving one or more therapy goals within a period of time.

The foregoing and other embodiments of the present specification will be described in more detail in the drawings and the detailed description given below.

These and other features and advantages of this specification may be better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings.
1A is a block diagram of a system for stimulating nerves and nerve endings in body tissues in accordance with various embodiments of the present disclosure.
1B is a block diagram of a system for stimulating or modulating nerves and nerve endings in a body tissue according to another embodiment of the present disclosure;
1C is a block diagram of a system for stimulating or modulating nerves and nerve endings in a body tissue according to another embodiment of the present disclosure.
1D is a block diagram of a system for stimulating or modulating nerves and nerve endings in body tissues according to another embodiment of the present disclosure.
1E is a block diagram of a system for stimulating or modulating nerves and nerve endings in a body tissue according to another embodiment of the present disclosure.
1F is a block diagram of a system for stimulating or modulating nerves and nerve endings in a body tissue according to another embodiment of the present disclosure.
2A is a side perspective view of an electric skin patch (EDP) device in accordance with some embodiments herein.
FIG. 2B is a front perspective view of the electrical skin patch device of FIG. 2A ;
FIG. 2C is a top perspective view of the electrical skin patch device of FIG. 2A ;
2D is an oblique perspective view of a replacement hydrogel with an electric skin patch and liner from which the hydrogel has been removed according to an embodiment of the present specification;
3A illustrates a first pattern of electrodes according to a particular embodiment.
3B illustrates a second pattern of electrodes according to certain embodiments.
4A is a perspective view of an electrical skin patch device configured to provide electrical stimulation therapy in accordance with some embodiments.
4B is a side perspective view of an electric skin patch device according to another embodiment of the present disclosure;
4C is a bottom perspective view of the electric skin patch device of FIG. 4B .
4D is an oblique top perspective view of an electric skin patch device according to another embodiment of the present disclosure;
4E is an oblique top perspective view of the controller assembly of the electric skin patch device of FIG. 4D ;
4F is an oblique bottom perspective view of the controller assembly of the electric skin patch device of FIG. 4D ;
4G is a side cross-sectional perspective view of an electrical skin patch device including a capacitive connection (dielectric material) between an electrode contact and a hydrogel of an electrode assembly in accordance with an embodiment of the present disclosure;
4H is an oblique top perspective view of the controller assembly of the electric skin patch device of FIG. 4D with a portion of the overmold cut to expose additional components of the controller assembly;
FIG. 4I is an oblique top perspective view of an electrode assembly of the electric skin patch device of FIG. 4D ;
FIG. 4J is an oblique bottom perspective view of the electrical skin patch device of FIG. 4D ;
FIG. 4K is a side perspective view of the electrical skin patch device of FIG. 4D .
FIG. 4L is an oblique top, short-axis cross-sectional perspective view of the electrical skin patch device of FIG. 4D ;
FIG. 4M is a front cross-sectional perspective view of the electrical skin patch device of FIG. 4D ;
FIG. 4N is an oblique top long axis cross-sectional perspective view of the electrical skin patch device of FIG. 4D ;
FIG. 4O is a side cross-sectional perspective view of the electrical skin patch device of FIG. 4D .
FIG. 4P illustrates a first pattern of electrodes of the electrical skin patch device of FIG. 4D according to one embodiment.
FIG. 4Q is a diagram illustrating a second pattern of electrodes of the electric skin patch device of FIG. 4D in accordance with one embodiment.
FIG. 4R is a diagram illustrating a third pattern of electrodes of the electric skin patch device of FIG. 4D according to one embodiment;
FIG. 4S is a diagram illustrating a fourth pattern of electrodes of the electric skin patch device of FIG. 4D according to one embodiment.
5A is an oblique top perspective view of an electrical skin patch device in accordance with some embodiments.
5B is a side perspective view of the EDP device of FIG. 5A ;
5C is a bottom view of the EDP device of FIG. 5A.
5D is an oblique top perspective view of the EDP device of FIG. 5A with a portion of the overmold removed.
FIG. 5E is a cross-sectional side view of the EDP device of FIG. 5D.
5F is a top perspective view of the EDP device of FIG. 5A with the entire overmold removed.
6A depicts an electrical skin patch device herein constructed of a skin patch, positioned in a lateral thoracic dermatome, and wirelessly controlled by a smartphone, in accordance with various embodiments.
6B is a schematic diagram of a plurality of electric skin patch users in a state in which a companion device is shared through a common network connection according to an embodiment of the present specification;
6C shows steps of one embodiment of a method for aggregating, organizing, and analyzing stimulation parameters and patient hunger, appetite, and well-being scores for a plurality of patients each having an EDP device with the linked companion device connected to an integrated patient network. A flow chart listing the
6D is a flow diagram illustrating steps involved in constructing and reconstructing stimulation provided by an electrical skin patch (EDP) device using one or more downloadable applications in accordance with an embodiment herein.
6E is a flow diagram illustrating steps associated with a method of a companion device for verifying and/or authenticating a data transmission received from a remote server in accordance with some embodiments herein.
6F is a flow diagram illustrating steps associated with a method of encrypting, authenticating, and/or verifying data transmission between an EDP, a companion device, and a remote server based on the FDA approval status of the EDP in accordance with some embodiments herein.
7 is a screenshot of a companion device showing a journal widget according to an embodiment of the present specification.
8 is a screenshot of a companion device showing a list view of diary items according to an embodiment of the present specification.
9 is a screenshot of a companion device showing a calendar view of a journal entry according to an embodiment of the present specification.
10 is a screenshot of a companion device showing a quick input button view according to an embodiment of the present specification.
11 is a screenshot of a companion device showing an appetite input screen according to an embodiment of the present specification.
12 is a screenshot of a companion device showing an exercise input screen according to an embodiment of the present specification.
13 is a screenshot of a companion device showing a hunger input screen according to an embodiment of the present specification.
14 is a screenshot of a companion device showing a stimulation session input screen according to an embodiment of the present specification.
15 is a screenshot of a companion device showing a weight input screen according to an embodiment of the present specification.
16 is a screenshot of a companion device showing a wellness input screen according to an embodiment of the present specification.
17A is an example showing the distribution of anterior and lateral T2-T12 dermatomes over the chest and abdomen of a human body.
17B is an illustration showing the distribution of anterior and posterior C5-T1 dermatomes over the hand, arm, and upper thoracic regions of the human body.
17C is an example showing the distribution of C5-T1 dermatomes over the ventral side of the hand and lower arm of the human body.
17D is a flow diagram listing the steps involved in one method of identifying the appropriate placement location of an electrical skin patch on a patient's anterior chest surface in accordance with an embodiment of the present disclosure.
17E is a diagram showing the front and rear regions of the human hand controlled by the median nerve.
18A depicts T6 stimulation using an electrical skin patch device in accordance with certain embodiments.
18B depicts T7 stimulation using an electrical skin patch device in accordance with certain embodiments.
18C depicts T6 and T7 stimulation using an electrical skin patch device in accordance with certain embodiments.
19A depicts a C8 stimulation location on the ventral or anterior (palm) side of a user's hand using an electrical skin patch, according to certain embodiments.
19B depicts the location of C8 stimulation on the dorsal or posterior side of a user's hand using an electrical skin patch, according to certain embodiments.
19C depicts C8 and T1 stimulation locations on the ventral side of the lower arm or wrist region of a user using an electrical skin patch, according to certain embodiments.
19D depicts the location of median nerve stimulation on the abdomen and dorsal side of the forearm or wrist region of a user using an electrical skin patch, in accordance with certain embodiments.
20A shows one embodiment of an electrical skin patch device herein wrapped around the edge of a user's hand to stimulate a C8 dermatome.
20B shows another embodiment of an electrical skin patch device herein wrapped around the edge of a user's hand to stimulate a C8 dermatome.
21A is a perspective view of a band comprising an electric skin patch (EDP) device of the present disclosure, in accordance with one embodiment.
21B is a perspective view of a wrist watch including an EDP device of the present specification according to an embodiment.
22A depicts a first embodiment of a hand glove comprising one or more EDP devices herein.
22B shows a second embodiment of a pair of hand gloves comprising one or more EDP devices herein.
22C illustrates a third embodiment of a pair of hand gloves comprising one or more EDP devices herein.
22D shows a fourth embodiment of a hand glove comprising at least one EDP device of the present disclosure.
23 is a perspective view of a hand gear including at least one EDP device of the present disclosure according to an embodiment.
24 is a perspective view of a finger ring including an EDP device of the present disclosure according to one embodiment.
25 illustrates a compressible ball comprising an EDP device of the present disclosure in accordance with one embodiment.
26 shows a hand gear comprising an EDP device of the present disclosure according to one embodiment.
27A is a flow diagram illustrating steps associated with a method of determining a stimulus response threshold and suppressing appetite in a patient using an electrical skin patch (EDP) device in various embodiments herein.
27B is a flow diagram illustrating steps associated with a method of determining a stimulus response threshold and suppressing appetite in a patient using an electrical skin patch (EDP) device in various embodiments herein.
27C is a flow diagram illustrating steps associated with a method of suppressing appetite in a patient using an electrical skin patch device in various embodiments herein.
28 is a flow diagram illustrating steps associated with a method of suppressing appetite in a patient using an electrical skin patch device in various embodiments herein.
29 is a flow diagram illustrating steps associated with a method of suppressing appetite in a patient using an electrical skin patch device in various embodiments herein.
30 is a flow diagram illustrating steps associated with a method of suppressing appetite in a patient using an electrical skin patch device in various embodiments herein.
31 is a flow diagram illustrating steps associated with a method of suppressing appetite in a patient using an electrical skin patch device in various embodiments herein.
32A is a flow diagram illustrating steps associated with a method of suppressing appetite in a patient using an electrical skin patch device in various embodiments herein.
32B is a flow diagram of a plurality of steps associated with another embodiment of a method for managing hunger or appetite in a patient.
32C is a graphical representation of a patient's hunger map in accordance with some embodiments herein.
32D is a flow diagram of a plurality of steps associated with another embodiment of a method of managing hunger or appetite in a patient.
33 is a flowchart illustrating steps involved in suppressing a patient's appetite using an electric skin patch device and an interlocking device paired with a separate monitoring device in accordance with one embodiment of the present specification.
34 is a flow diagram illustrating steps associated with a method of suppressing appetite in a patient using an electrical skin patch device in various embodiments herein.
35A is a Visual Analog Scale (VAS) questionnaire for assessing hunger or appetite according to one embodiment.
35B is a VAS questionnaire for evaluating a feeling of fullness according to an embodiment.
35C is a VAS questionnaire for evaluating a bite according to an embodiment.
35D is a VAS questionnaire for evaluating satiety according to an embodiment.
36A is a graph illustrating the hunger profile before and after stimulation of a first patient according to one embodiment.
36B is a graph illustrating the hunger profile before and after stimulation of a second patient according to one embodiment.
36C is a graph illustrating the hunger profile before and after stimulation of a third patient, according to one embodiment.
36D is a graph illustrating the hunger profile before and after stimulation of a fourth patient according to one embodiment.
36E is a graph illustrating a pre- and post-stimulation hunger profile of a fifth patient according to one embodiment.
36F is a graph showing the median AUC (area under the curve) hunger scores for the pre-stimulation, terminating and post-stimulation scenarios.
36G is a graph illustrating hunger profiles before and after stimulation over an extended period of time according to a first embodiment.
36H is a graph illustrating hunger profiles before and after stimulation over an extended period of time according to a second embodiment.
36I is a graph showing hunger scores for the pre-stimulation, stimulation termination, and post-stimulation scenarios.
37A is a graph illustrating a satiety profile before and after stimulation of a first patient according to one embodiment.
37B is a graph illustrating a satiety profile before and after stimulation of a second patient according to one embodiment.
37C is a graph illustrating the satiety profile before and after stimulation of a third patient, according to one embodiment.
37D is a graph illustrating the satiety profile before and after stimulation of a fourth patient according to one embodiment.
37E is a graph illustrating the pre- and post-stimulation satiety profiles of a fifth patient according to one embodiment.
37F is a graph showing the median AUC (area under the curve) satiety scores for pre-stimulation, stimulation termination, and post-stimulation scenarios.
37G is a graph illustrating a pre- and post-stimulation satiety profile over an extended period of time according to a first embodiment.
37H is a graph illustrating a pre- and post-stimulation satiety profile over an extended time period according to a second embodiment.
37I is a graph showing satiety scores for pre-stimulation, stimulation termination, and post-stimulation scenarios.
38A is a graph showing the exercise scores of a sample patient who received stimulation therapy according to an embodiment of the present specification.
38B is a graph showing the body weight of a sample patient who received stimulation therapy according to an embodiment of the present specification.
38C is a graph illustrating a body mass index (BMI) of a sample patient who received stimulation therapy according to an embodiment of the present specification.
38D is a graph showing appetite scores of sample patients who received stimulation therapy according to an embodiment of the present specification.
38E is a graph showing the dietary compliance scores of sample patients who received stimulation therapy according to an embodiment of the present specification.
38F is a graph showing the well-being score of a sample patient who received stimulation therapy according to an embodiment of the present specification.
Fig. 39 is a side view of an EDP device according to a less preferred embodiment;
Fig. 40 is a side view of another EDP device according to a less preferred embodiment;
Fig. 41 is a side view of another EDP device according to a less preferred embodiment;
42 is a side view of another EDP device according to a less preferred embodiment.
43 is an illustration of a transdermal multi-electrode array that may be used with the devices herein.
44 is a block diagram of a mobile electronic platform that may be used with the devices herein.
45 is an illustration of an EDP device receiving wireless energy for stimulation in accordance with a less preferred embodiment.
46 is an illustration of another EDP device receiving wireless energy for stimulation in accordance with a less preferred embodiment.
47A is a bar graph illustrating the mean cumulative change in gastric vestibular motility index for various stimulation sessions, according to one embodiment.
47B is a bar graph illustrating maximal plasma endorphin levels measured for various stimulation sessions in accordance with one embodiment.
48A is a block diagram of a Health Management Application (HMA) in communication with an Intelligent Personal Assistant (IPA) system in accordance with an embodiment.
48B is a block diagram of an HMA in communication with an IPA system according to another embodiment.
48C is a block diagram of an HMA herein in communication with an IPA system as well as a big data database server according to an exemplary embodiment.
49 is a flow diagram illustrating exemplary steps associated with one embodiment of a method of automatically triggering rescue therapy based on a user's individualized hunger profile or map using an electrical skin patch device.
50 is a flow diagram illustrating exemplary steps associated with one embodiment of a method of automatically titrating a therapy based on a user's dynamic well-being profile using an electrical skin patch device.
51 illustrates a graphical user interface with a visual light bar.
52 is a flow diagram illustrating a method for enabling a TPM to prescribe, configure, manage, monitor, and intervene in an EDP device based stimulation regimen for a user in accordance with some embodiments.
53A is a horizontal bar graph showing willpower levels corresponding to low or reduced hunger levels.
FIG. 53B is the bar graph of FIG. 53A showing willpower levels corresponding to high hunger levels.
54A is a vertical bar graph illustrating a user's diet willpower.
54B is a vertical bar graph illustrating a user's exercise willpower.
55A is a top perspective view of an EDP device according to an embodiment of the present specification.
55B is another top perspective view of an EDP device according to an embodiment of the present specification.
FIG. 55C is a bottom perspective view of the EDP device of FIG. 55A;
FIG. 55D is a bottom perspective view of the EDP device of FIG. 39A with the hydrogel pad removed.
FIG. 55E is a side perspective view of the EDP device of FIG. 55A;
FIG. 55F is a first side perspective view of the EDP device of FIG. 55A with a portion of the housing cut away;
FIG. 55G is a second side perspective view of the EDP device of FIG. 55A with a portion of the housing cut away;
55H is a top perspective view of an EDP device in accordance with some embodiments.
55I is a top perspective view of another EDP device in accordance with some embodiments.
55J is a top perspective view of another EDP device in accordance with some embodiments.
55K shows a bottom view of a waterproof electrode pad assembly using two types of skin contact adhesives in accordance with some embodiments.
FIG. 55L is an disassembled or exploded view of the electrode pad assembly of FIG. 55K ;
55M is an exploded or disassembled view of an electrode pad assembly using a foam pad with an acrylic adhesive or hydrocolloid adhesive.
56 illustrates an example use of a swallow detection device in accordance with some embodiments.
57 is a flow diagram illustrating steps associated with one embodiment of a method of eliciting feedback related to a patient's medical condition from at least one of a social networking group (or social group) and an online coaching or concierge service using an electrical skin patch device; to be.
58 is a flow diagram of a plurality of exemplary steps of a method for recognizing a moment of feeding in accordance with some embodiments.
59A illustrates a first pulse waveform according to an embodiment.
59B illustrates a second pulse waveform according to one embodiment.
60 shows a graph comparing the % total weight loss (% TBWL) achieved using the EDP device herein for 3 months with the % TBWL achieved using a gastric balloon for 6 months.
61 shows a third pulse waveform according to an embodiment of the present specification.
62 is a flow diagram illustrating steps in an example use case of titrating a stimulation therapy based at least on a user's blood glucose state data in accordance with embodiments herein.
63 is a flow diagram illustrating steps in an additional example use case of titrating a stimulation therapy based at least on the user's blood glucose state data in accordance with embodiments herein.
64 is a flow diagram illustrating steps in an example use case of titrating a stimulation therapy based at least on a user's blood glucose state data in accordance with an embodiment herein.
65 is a flow diagram illustrating steps in another example use case of titrating a stimulation therapy based at least on a user's blood glucose state data in accordance with an embodiment herein.
66 is a flow diagram illustrating steps in another example use case of titrating a stimulation therapy based at least on a user's blood glucose state data in accordance with an embodiment herein.
67 is a flow diagram illustrating steps in another example use case of titrating a stimulation therapy based at least on a user's blood glucose state data in accordance with an embodiment herein.
68 is a flow diagram illustrating steps in another example use case of titrating a stimulation therapy based at least on a user's blood glucose state data in accordance with an embodiment herein.
69 is a flow diagram illustrating steps in another example use case of titrating a stimulation therapy based at least on a user's blood glucose state data in accordance with an embodiment herein.
70 is a flow diagram illustrating a plurality of steps involved in an embodiment of a method for automatically generating one or more interventions based on an identified health trend of a user using an EDP device.
71 is a linear gradient weight trend with respect to a target weight loss goal of a user according to an embodiment of the present specification.
72A illustrates a first heat map plotted as an icon or dot representing appetite data for a first time period in accordance with an embodiment herein.
72B illustrates a second heat map plotted with icons or dots representing appetite data for a second time period in accordance with an embodiment herein.
73 illustrates a plurality of waveforms or pulses, including symmetric and asymmetric, two-phase, charge balanced waveforms, generated by an EDP device in accordance with embodiments herein.
74A illustrates a train of symmetric two-phase charge balancing pulses in accordance with an embodiment herein.
74B illustrates a train of asymmetric two-phase charge balanced pulses in accordance with an embodiment herein.
74C illustrates another column of symmetric two-phase charge balanced pulses in accordance with embodiments herein.
74D depicts another column of asymmetric two-phase charge balanced pulses in accordance with embodiments herein.
75A is a flow diagram illustrating a plurality of steps for generating a train of two-phase pulses in accordance with an embodiment herein.
75B is a flow diagram illustrating a plurality of steps for generating a train of two-phase pulses in accordance with an alternative embodiment herein.
76 shows a VAS composed of a color spectrum for evaluating the intensity of hunger or appetite according to an embodiment of the present specification.
77A is a flow diagram illustrating a plurality of steps for allowing a user to record their appetite or hunger in accordance with some embodiments herein.
77B is another flow diagram illustrating a plurality of steps for enabling a user to record their appetite or hunger in accordance with some embodiments herein.
78 is a flow diagram illustrating a plurality of steps for enabling a patient to apply structural stimulation therapy in accordance with some embodiments herein.
79A is a flow diagram illustrating a plurality of steps for predicting a future appetite or hunger event in accordance with some embodiments herein.
79B is another flow diagram illustrating a plurality of steps for predicting a future appetite or hunger event in accordance with some embodiments herein.
80 is a flow diagram of multiple steps of a method of using an EDP device during intermittent fasting by a user in accordance with some embodiments herein.
81 is a flow diagram of a plurality of steps of a method of recommending an optimal eating and eating profile, nutritional profile, activity/training profile, and/or stimulation regimen using a patient's genetic profile in accordance with some embodiments herein.
82 is a graph illustrating a first plot of stimulus intensity and a second plot of intensity of appetite or hunger versus time in accordance with some embodiments herein.
83 is a flow diagram illustrating multiple steps of a method of personalizing a diet plan by a user in accordance with some embodiments herein.
84 is a flow diagram of a plurality of steps enabling a stimulation protocol as a result of ingestion of an appetite or hunger-inducing drug by a patient in accordance with some embodiments herein.
85 is a flow diagram of a plurality of steps in a method of recommending a personalized nutritional or diet plan and/or stimulation regimen for a patient using a machine learning model in accordance with some embodiments herein.
86 is a block diagram of a system for applying or modulating magnetic stimulation to nerves and nerve endings of body tissues according to another embodiment of the present disclosure.

The present specification is convenient, easy to use, and controls the patient's appetite, hunger, satiety level, satiety level or satiety level by delivering electrical stimulation to a predetermined part of the user's anatomical part in a manner that can increase patient compliance. It relates to a system and method for More specifically, the present disclosure relates to self-administration using a mobile handheld device running a health care application (HMA) configured for placement in the anterior, lateral and/or posterior T2 to T12 and/or C5-T1 dermatomes of a patient. Easy to implement, programmable and monitorable, anterior, lateral and/or posterior T2 to T12 and from the outer surface of the patient epidermal layer through the range of 0.1 mm to 10 mm of the dermis or through the range of 0.1 mm to 20 mm of the dermis and /or programmed to stimulate nerves located proximal to the C5-T1 dermatomes in a manner that can modulate the patient's appetite, hunger, satiety level, bite level or fullness level, prevent nausea, indigestion, and minimize habituation An electrical stimulation device comprising a low profile wearable disposable skin patch. In various embodiments, the depth of stimulation through the epidermal layer of the patient is between 0.1 mm and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 mm or any increment range therein. The disclosure also describes a plurality of different hardware devices or software applications depending on the type, degree, nature and extent of modulation of desired appetite, hunger, satiety, satiety or satiety level, including immediate massive weight loss or long-term weight maintenance. A low profile wearable disposable skin patch that can be integrated with and controlled by this application.

In various embodiments, an electrical skin patch consisting of a discrete disposable waterproof adhesive patch or pad for placement on a user's skin, particularly an area comprising anterior, lateral and/or posterior T2-T12 dermatomes and/or C5-T1 dermatomes. An electrical nerve stimulation device in the form of (EDP) is disclosed. In various embodiments, the EDP is wireless and incorporates flexible circuitry and elastomeric overmolding, making the device waterproof and flexible enough to be molded to body contours for greater comfort and permanent wearability. In some embodiments, the EDP device also modulates ghrelin production.

According to various aspects herein, the resulting benefits of modulating appetite, hunger, satiety level, satiety level or fullness level include treatment of diseases associated with overweight or persons with metabolic syndrome, treatment of obesity and prevention or management of T2DM do. According to various aspects herein, the electrical skin patch device treats a person having a body mass index (BMI) of 25 or greater (25-30 for overweight, 30 or greater for obesity, and 35 or greater for morbid obesity). In the embodiments herein, the electrical skin patch device is wearable and can be controlled and programmed by the patient so that the patient can administer the therapy and the patient does not need frequent medical professional visits. In an embodiment, the electrical skin patch device is designed for placement in anterior, lateral and/or posterior thoracic dermatomes and/or C5-T1 dermatomes of a patient. Accordingly, the patient may place the electrical skin patch device on the patient himself/herself without the assistance of a medical professional.

In embodiments, the electrical skin patch device is wirelessly coupled to an interlocking device (eg, smartphone, watch, glove, wristband, or tablet) that can be used to program the electrical skin patch device so that the patient can receive therapy on demand. make it feasible In some embodiments, all therapies provided by the electrical skin patch device are combined with a storage or log (to keep a log of therapy) and patient compliance reminders. The benefits provided by wearable and self-acting electrical skin patch devices include, among other things, improved patient independence and improved patient compliance with stimulation protocols, resulting in improved dietary compliance and overall efficacy and improved outcomes by patients and other devices. Increases the ability to modify stimulation parameters based on real-time feedback provided to the electrical skin patch device. In some embodiments, the electrical skin patch device is driven by an algorithm derived from patient input data and monitored data (eg, movement monitored by a separate device). Adjustment of the algorithm and thus stimulation is performed manually by the patient and automatically by the device itself or the companion device. In some embodiments, the electrical skin patch device is driven by an algorithm derived from patient input data and monitored data (eg, movement monitored by a separate device). In some embodiments, the algorithm is also derived from monitored parameters such as leptin (for ghrelin inhibition), glucagon-like peptide 1 (GLP-1), hemoglobin A1C, and blood glucose levels (for the treatment of diabetes), lipids and triglycerides. These parameters are measured at baseline and over time during treatment and are used as input to titrate therapy.

In one exemplary use case scenario, the patient is identified as pre-diabetic if the patient's monitored or tested HbA1c is found to be in the range of 5.7% to 6.4%. The patient receives stimulation therapy of at least 15 minutes per week using the electrical skin patch device for a period of at least 4 weeks, preferably 8 weeks or any increments therein. In some embodiments, after stimulation therapy, the patient's HbA1c level decreases by at least 0.1% relative to the patient's HbA1c level prior to stimulation therapy. In some embodiments, the patient's stimulation regimen is repeated until the patient stabilizes (ie, no longer responds) or the patient's HbA1c level reaches less than 5.7% (ie, the normal range for a non-diabetic patient).

In some embodiments, the HMA is configured to predict or predict future HbA1c levels in a patient for a period of at least 8 weeks of stimulation therapy after a predetermined period of pregnancy. A patient's HbA1c level is determined according to a predetermined time period, such as bi-monthly, during the stimulation therapy period. In some embodiments, the patient's HbA1c level is determined using a blood glucose meter. In some embodiments, the patient's HbA1c level is determined using a continuous blood glucose monitoring device (eg, which may be a wearable device). Patients are also prompted by the HMA to enter their appetite/hunger and weight data for at least an 8-week stimulation therapy period. HbA1c levels determined during the first 4 weeks of pregnancy are used in HMA and correlated with appetite/hunger and/or weight data to predict or predict future HbA1c levels without waiting 8 weeks. Predicting future HbA1c levels may be achieved by the controller executing a plurality of programming instructions, which, when executed, 1) obtain past HbA1c level changes, 2) historical electrical stimulation parameters and Acquire timing, 3) generate a relationship between past electrical stimulation parameters and measured HbA1c levels, and 4) extrapolate anterior potential HbA1c levels based on the generated relationship and potential electrical stimulation parameters.

Adjustment of the algorithm and thus stimulation is performed manually by the patient or automatically by the electric skin patch device itself or by the interlocking device or both. According to some aspects herein, the healthcare professional can flexibly program the electrical skin patch and still instruct the patient, provided that the patient sets the device parameters (to increase patient independence) within a limited range or predetermined parameters. Can be adjusted.

This specification relates to a number of embodiments. The following information is provided to enable those skilled in the art to practice the present invention. The language used herein should not be construed as a general disclaimer of any one particular embodiment, nor should it be used to limit the claims beyond the meaning of the terminology used in this embodiment. The generic principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terms and phrases used are for the purpose of describing exemplary embodiments only and should not be construed as limiting the present invention. Accordingly, the present invention is to be accorded the widest scope including numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. In the interest of clarity, details relating to technical material known in the art related to the present invention have not been described in detail so as not to unnecessarily obscure the present invention.

For the purposes of this specification, the terms “trigger” and “triggering” do not necessarily mean immediately triggering a stimulus. “Trigger” and “triggering” are defined as initiating or initiating the execution of a protocol that may result in a stimulus for a predetermined period of time.

The term "modulation" refers to any form of regulation, manipulation, or control for changing a given variable from one state to another.

In the description and claims of this application, each of the words "comprising," "comprising," and "having," and variations thereof, are not necessarily limited to the members of the list to which the word may be associated. It should be noted that any feature or component described in connection with a particular embodiment may be used and implemented with any other embodiment unless otherwise specified.

As used herein, the singular element means "at least one" or "one or more" elements unless the context clearly dictates otherwise.

The terms “patient,” “individual,” “person,” and “user” are used interchangeably throughout this specification and refer to a person receiving treatment or stimulation from the devices and methods herein.

The term "hunger" is defined as a bodily sensation that indicates a person's physical need for food, and may relate to low blood glucose levels and/or ghrelin concentrations in a person's blood and/or intestinal hormones that cause hunger.

The term "appetite" is defined as a desire for food that may be triggered by an emotional, psychological and/or sensory response to the appearance, taste or smell of food.

A "bite" is defined as the sensation of fullness that results in cessation of intake.

The term "satisfaction" is defined as the feeling of the presence of an adequate amount of food in the stomach. The term "satisfaction" is understood to refer to a psychological or cognitive sensation by a patient that can be objectively measured using the scales described herein. The term "physiological satiety" refers to a physical measurement of the actual contents of a person's stomach.

The term "satisfaction" is defined as a feeling of fullness that prolongs the time between meals (the higher the satiety, the longer the separation time between two meals). It is intended to refer to the patient's perception of a sense of fullness that prolongs the time between meals.

The phrase "change in satiety" is defined as a change in a patient's perception of a feeling of fullness or hunger in the stomach.

The term "dietary adherence" refers to whether or not limited in terms of total allowable calories, type or amount of nutritional intake, or some combination thereof, to achieve a target daily, weekly or monthly caloric intake and/or target type or amount of nutritional intake. limited to the patient's ability to adhere to the prescribed calorie intake regime, whether or not

The phrase "maintaining weight" means maintaining a certain amount of weight loss already achieved and now adjusting your appetite or hunger suppression/reduction goal to avoid weight gain. In some embodiments, weight loss maintenance involves participating in a surgical procedure (such as various bariatric surgeries) to maintain weight loss achieved by surgery, applying the EDP herein and using appetite or hunger suppression/reduction. accompanying

The term "microbiota" is defined as a collection of microorganisms that reside in a previously established environment, such as the stomach or gastrointestinal system. The term "gut microbiome" or "gut microflora" is the name given to the microbiome that lives in the human gut.

The term "glycemic index (GI)" is defined as the number associated with a particular type of food that food affects a person's blood sugar (also known as blood sugar) level. A value of 100 represents the standard, i.e., the equivalent of pure blood sugar. The glycemic index is calculated by determining the incremental area under the glycemic response curve of a particular portion of a test food expressed as a percentage of the response to the same amount of carbohydrate in a standard food eaten by the same subject.

The term "glycemic load (GL)" is defined as the glycemic index multiplied by the grams of carbohydrates per serving. The GL is based on the specific amount and carbohydrate content of the test food and is calculated as the weighted average of the dietary glycemic index multiplied by the percentage of the total energy of the test food. If the test food contains quantifiable carbohydrates, then GL = GI (%) × grams of carbohydrates per serving.

The terms "epidermal layer" and "epidermal" are used interchangeably throughout this specification, and refer to the outermost, protective, nonvascular layer of human skin covering the dermis and all variations of the word "epidermal". should be construed as including

The term "power source" is used to refer to any energy-providing device, including a lithium ion battery, a beta voltaic battery, a solar cell, a nickel cadmium battery, a fuel cell, a mobile phone, or a remote charging station.

The term "controller" is used to denote a processing unit configured to control stimulation initiation, stimulation termination, type and/or extent of stimulation, "control unit", "processing unit", "microcontroller", "microprocessor" or includes the term "processor".

The term “pulse generator” means a device configured to generate electrical pulses according to instructions of a controller. It is understood that the pulse generator and controller may be integrated into a single device or multiple devices.

The term "electrode" is used to refer to a conductive material capable of receiving electrical pulses and transmitting electrical pulses to another surface.

The term "modulating" or "modulating" means any form of regulation, manipulation, or control for changing a given variable from one state to another.

An increase or decrease in a level or rate is determined by the formula [(new level or rate) - (old level or rate)]/(old level or rate).

The phrase “at least one of x, y, and z” means that only one of x or y or z must be true or present in order to satisfy this constraint.

The term "dermatome" refers to an area of skin that is primarily dominated and/or supplied by certain spinal nerves.

The term "meridian" refers to a low-resistance fluid channel through which various chemical and physical transport takes place, an individual pathway that exists between the subcutaneous tissue and serves as a channel for the flow of interstitial microfluids throughout the body.

The term “big data” refers to vast amounts of structured, semi-structured and unstructured data that have the potential to be mined and analyzed for patterns and information.

The term "bolus" refers to a discrete single dose of stimulation provided in one instance as opposed to a "constant stimulus," which refers to a stimulus of a certain intensity delivered at a constant rate and over a certain period of time.

The term "gastric emptying time" is defined as the time it takes to empty a predetermined percentage (eg, 25%, 50%, 75% or 95%) of a patient's stomach contents. The measurement of gastric emptying time is established assuming the same composition of a known bolus of food. Thus, if we compare the postprandial time of emptying 50% of the gastric contents of a patient with stimulation with the postprandial time of emptying 50% of the patient's gastric contents without applying a stimulation session, the comparison shows that the patient consumed food and liquids of the exact same composition. Assume the intake situation.

The term “direct electrical stimulation” of a given anatomical structure is meant to encompass the anatomical structure in the electric field produced by the electrical stimulation.

"Meal" refers to a case in which a certain amount of solid or liquid food, such as breakfast, lunch, or dinner, is consumed during the day, including various snacks in between.

The term "gastric retention" refers to a measure of the amount of contents remaining in the stomach after a predetermined period of gastric activity.

The terms "server", "server(s)" and "at least one server" refer to one or more servers, including cloud configurations, in which no particular individual server can be identified.

The term "interneuron" is defined as the broad class of neurons found in the human body. Interneurons create neural circuits that enable communication between sensory or motor neurons and the central nervous system (CNS).

The term "metabolic or health status" of a patient refers to the following therapeutic parameters that define the physiology of the patient: amount or rate of abdominal motility, gastric motility, gastric emptying time, gastric retention, gastric acceptance or distension, appetite or hunger level; level of satiety, satiety, or fullness; target daily calorie intake adherence or dietary adherence; sleep quality; glucagon-like peptide 1 (GLP-1), leptin, serotonin, peptide YY, beta endorphin levels, resting metabolic rate, cholecystokinin; total body weight; total weight loss, excess weight loss; well-being level; preprandial and postprandial ghrelin levels; acyl-ghrelin; total ghrelin; peak values of triglycerides, cholesterol, lipopolysaccharides, motilin related peptides or plasma motilin levels; degree of blood sugar, blood sugar peak; blood glucose levels in non-diabetic or non-diabetic patients, pre-diabetic and postprandial plasma glucose concentrations in diabetic patients, glycemic control, fasting blood or plasma glucose; hemoglobin A1C; glycemic homeostasis, HOMA-IR (homeostasis model assessment—estimated insulin resistance); fasting plasma insulin levels; degree of insulin resistance; gut microbiome; metabolic rate (eg, RMR or BMR); perception of stomach fullness or hunger; exercise output, which is defined as the amount of calories burned during a given time period or the number of steps taken during a given time period; hepatic gluconeogenesis; prolactin levels; dopamine levels; and/or at least one or any subset or combination of plasma cytokeratin 18 (CK-18).

The term "real time" refers to the temporal coincidence between two events. For example, if a dietary intervention is described as being provided "in real time" with respect to the collection of appetite data, it may be 24 hours, preferably 12 hours, preferably 6 hours, after the dietary intervention obtains appetite data; preferably within 1 hour or any increment therein. This is contrasted with a patient diary in which data is acquired over several weeks and then the treatment regimen is modified based on long-term data collection.

The term "metabolic adaptation" relates to metabolic adaptation to weight loss, including hormonal changes that promote adaptive thermogenesis, increased mitochondrial efficiency and decreased energy expenditure, decreased satiety and increased hunger. As the diet phase progresses, these adaptations threaten dietary adherence, make additional weight loss increasingly difficult, and make it easier for individuals to experience rapid weight recovery after dieting is stopped.

The term "FTO gene" refers to a protein associated with fat mass and obesity, also called alpha-ketoglutarate dependent dioxygenase FTO, an enzyme encoded by the FTO gene located on chromosome 16 in humans.

electric skin patch system

1A is a block diagram of a system 100 for stimulating or modulating nerves and nerve endings in body tissue in accordance with one embodiment herein. The system 100 includes an electrical skin patch (EDP) device 110 in data communication with an interlocking device 105 . In various embodiments, the companion device 105 may also be in data communication with a remote patient care facility, data server, and/or patient care personnel. Interlocking device 105 comprising a computer readable medium and processor may be a computer, server, mobile phone, gateway, laptop, desktop computer, netbook, personal data assistant, remote control device or cellular, Internet, TCP/IP, Ethernet, It may be any type of computing and communication device, including Bluetooth, other devices capable of accessing a wired or wireless network.

In various embodiments, the electrical skin patch device 110 is applied via a microprocessor or microcontroller 112 , one or more electrodes 118 electronically coupled to the transceiver 114 to communicate wirelessly with the interlock device 105 . a housing 111 comprising a pulse generator 116 for generating a plurality of electrical pulses for have In some embodiments, the power management module 120 includes a battery having a voltage in the range of 1.5V to 4.5V (for a single battery). The voltage depends on the chemistry of the battery you are using. In another embodiment, the power management module 120 includes a plurality of batteries stacked in series to increase the voltage supply, and the voltage per battery ranges from 1.5V to 4.5V. The power management module 120 has one or more additional receptacle slots 130 for snap-on or clip-on attachment of a disposable electronic assembly including a battery to provide additional backup charge to the electrical skin patch device 110 .

Optionally, housing 111 also provides a push button for turning device 110 on/off, allowing user control or setting of multiple stimulation therapy protocols, eg, toggling stimulation up or down. or one or more actuators 122 , such as switches, and one or more visual indicators 124 , such as light emitting diodes (LEDs), and, for example, the on/off status of the electrical skin patch device 110 , among other information, among other information, ect. one or more tactile and audio indicators 126, such as vibrators, buzzers, or beeps, to provide feedback to the user regarding the start or end of . In one embodiment, the one or more actuators 122 include a touch-sensitive screen that allows a user to tap a finger to control and adjust a stimulation therapy protocol while the user is still wearing the electrical skin patch device 110 . do. Another embodiment is (additionally or alternatively) a control interface on the EDP, for example a slider on the EDP surface, an infrared interface in which communication between the EDP 110 and the companion device 105 is achieved by transmission of infrared radiation; An external magnet or electromagnet may include a reed switch located on the EDP 110 or a magnetic interface to activate a GMR (Giant Magnetoresistance) device or sensor, or an audible (speaker) command input interface.

In various embodiments, the EDP 110 allows, for example, user control or setting of a plurality of stimulation therapy protocols and parameters (eg, a predetermined number of button presses may correspond to a predetermined function setting of the EDP). by actuating one or more buttons (actuator 122) to By issuing predetermined voice-based commands to the EDP's audible (speaker) command input interface, or via an Intelligent Personal Assistant (IPA) system (described with reference to FIGS. 48A-C) that can communicate directly with the EDP 110 ). ; or a wrist watch or wristband (e.g., band 2105 of FIG. 21A or wristwatch 2106 of FIG. 21B), which also includes an accelerometer or inclinometer for detecting, capturing, and obtaining the user's haptic motion ) programmable and directly by issuing commands through predetermined physical body movements, such as haptic motions of the wrist or hand (for example) when wearing the EDP 110 configured as do.

It is also understood that, in one embodiment, the EDP does not include such on/off actuators or stimuli toggle actuators, and is fully controlled by an external device as described below.

In various embodiments, the housing 111 is sealed to be waterproof or waterproof. In some embodiments, the housing 111 is hermetically sealed. In various embodiments, the housing 111 is a polyolefin, PET (polyethylene terephthalate), polyurethane, polynorbornene, polyether, polyacrylate, polyamide (polyether block amide, also known as Pebax®), polysiloxane , polyether amide, polyether ester, trans-polyisoprene, polymethyl methacrylate (PMMA), cross-linked trans-polyoctylene, cross-linked polyethylene, cross-linked polyisoprene, cross-linked polycyclooctene, inorganic-organic hybrid polymer , copolymer blends of polyethylene and Kraton®, styrene-butadiene copolymers, urethane-butadiene copolymers, polycaprolactone or oligocaprolactone copolymers, polylactic acid (PLLA) or polylactide (PL/DLA) copolymers, PLLA -molded with polymeric materials including, but not limited to, polyglycolic acid (PGA) copolymers and photocrosslinkable polymers. In some embodiments, the housing 111 is made of a transparent polymeric material that allows visibility of the electronic components and circuitry contained therein.

In various embodiments, microprocessor 112 may be configured to control various physiological parameters of the individual, such as the individual's heart rate, pulse rate, heart variability per beat, EKG or ECG, respiration rate, skin temperature, core body temperature, body heat flow, galvanic skin reaction or GSR, EMG, EEG, EOG, blood pressure, body fat, water level, activity level, oxygen intake, blood glucose or blood glucose level, body position, pressure on muscles or bones, and/or UV radiation exposure and absorption in electronic communication with one or more sensors 135 to generate data indicative of In certain instances, the data indicative of various physiological parameters is a signal or signals themselves generated by one or more sensors 135 , and in certain other instances the data is based on a signal or signals generated by one or more sensors 135 . to be calculated by the microprocessor 112 . Methods for generating data representative of various physiological parameters and the sensors used therein are well known to those skilled in the art.

Table 1 provides some examples of well-known parameters, and the sensors used to measure the parameters. The data types listed in Table 1 are intended to be examples of data types that may be generated by one or more sensors 135 . It should be understood that other types of data related to other parameters may also be generated by the electrical skin patch device 110 without departing from the scope of this disclosure. It is further understood that the sensor may be located in the housing 111 as shown in FIG. 1A , or located remotely from the housing 111 , and configured to be in electronic communication with the microcontroller 112 via a wireless transceiver 114 . .

Microprocessor 112 is programmed to summarize and analyze data representative of physiological parameters of an individual. For example, microprocessor 112 may be programmed to calculate an average, minimum, or maximum heart rate or respiration rate over a defined period of time, such as 10 minutes. The electrical skin patch device 110 may also derive information regarding a physiological state of an individual based on data indicative of one or more physiological parameters. Microprocessor 112 is programmed to derive such information using known methods based on data indicative of one or more physiological parameters. Table 2 gives examples of the types of information that can be derived and shows some of the data types that can be used for them.

Additionally, the electrical skin patch device 110 may also generate data indicative of various contextual parameters related to the environment surrounding the individual. For example, the electrical skin patch device 110 may generate data indicative of air quality, voice level/quality, lighting quality or ambient temperature near the individual, or global location of the individual. The electrical skin patch device 110 may include one or more sensors for generating a signal in response to a contextual characteristic related to the environment surrounding the individual, the signal being ultimately used to generate data of the type described above. . These sensors are as well known as how they generate contextual parameter data such as air quality, voice level/quality, ambient temperature and global positioning.

In one embodiment, the electrical skin patch device 110 uses the following three sensors 135: 1) to determine electrode integrity, i.e., whether the electrodes have functioned properly or have been compromised, the tissue to be stimulated and one or more electrodes ( 118), or for estimating body fat or body mass index (BMI) and modifying or managing stimulation therapy accordingly (in another embodiment, the first impedance or bioimpedance sensor comprises: used to detect and verify the contact integrity of the one or more electrodes 118 with the tissue to be stimulated, and a second impedance or bioimpedance sensor is used to estimate body fat or body mass index (BMI), 2) walking, running , an accelerometer or inclinometer for monitoring user activity, such as detection and monitoring, detection and monitoring of quality of sleep, including movement, distance traveled, sleep time, and detection of user input to the electrical skin patch device 110 , and 3) the presence of neural activity. and a neural activity monitor for detecting an amount (firing rate) of neural activity.

In one embodiment, the electrical skin patch device 110 uses the following three sensors 135: 1) to determine electrode integrity, i.e., whether the electrodes have functioned properly or have been compromised, the tissue to be stimulated and one or more electrodes ( 118), or for estimating body fat or body mass index (BMI) and modifying or managing stimulation therapy accordingly (in another embodiment, the first impedance or bioimpedance sensor comprises: used to detect and verify the contact integrity of the one or more electrodes 118 with the tissue to be stimulated, and a second impedance or bioimpedance sensor is used to estimate body fat or body mass index (BMI), 2) walking, running , an accelerometer or inclinometer for monitoring user activity, such as movement, distance traveled, sleep quality, including sleep duration, detection and monitoring, detection of user input to the electrical skin patch device 110 , and 3) the presence of neural activity; It includes only one or a combination of neural activity monitors for detecting the amount of neural activity (firing rate) and no other sensors. With respect to verifying contact integrity, in one embodiment, sufficient contact integrity of one or more electrodes 118 is achieved with a predetermined amount of electrode with the epidermal layer of the patient, such as in the range of 200 ohms to 1000 ohms as measured by an impedance sensor. It should be understood that it is determined in terms of achieving impedance.

The nerve sensor is an indication that the electrical skin patch device 110 has been placed in the correct location or area, an indication that the electrical skin patch device 110 is increasing neuronal activity in accordance with and in accordance with the stimulation protocol, or a neurological response rate. Used to generate multiple feedbacks, including but not limited to indications that the stimulation protocol should be modified because it is too slow or insufficient. This plurality of feedback generated by the neural sensor is provided to the user via a health care software application running on the user's portable computing device, such as a smartphone, PDA, tablet, which in various embodiments functions as the companion device 105 . In some embodiments, the neural sensor is coupled to at least one of the one or more stimulation electrodes 118 , while in some alternative embodiments the neuronal sensor is coupled to at least one additional sensing electrode in addition to the one or more stimulation electrodes 118 . . In some embodiments, the electrical skin patch device 110 also integrally includes a blood glucose sensor for monitoring the user's blood glucose level. In some embodiments, the blood glucose sensor is configured as a standalone third party device in wireless communication with the healthcare application herein.

In some embodiments, electrode 118 is in housing 111 , while in other embodiments electrode 118 may be removably connected to housing 111 . In one embodiment, the electrode 118 is positioned partially or wholly within the housing 111 and extends outwardly in electrical communication with the hydrogel pad (eg, as described with reference to FIGS. 4D-4S ). configured to be In another embodiment, the electrode 118 is configured such that the electrode 118 is a snap-coupled electrode that can be removably connected to the outer surface of the housing 111 . This involves removing the electrodes 118 and/or hydrogel pads and replacing them with new electrodes 118 and hydrogel pads, thereby reusing the electric skin patch device 110 with new electrodes and hydrogel pads and after only a few days of use. This allows the cost of failing electrodes to be minimized. In another embodiment, the electrode 118 is configured to be removably connectable to the outer surface of the housing 111 using at least one magnet. The use of the magnet(s) allows the user to use minimal force or effort to reattach the electrode 118 to the housing 111 as compared to a snap fit configuration.

1B is a block diagram of a system 141 for stimulating or modulating nerves and nerve endings in body tissue in accordance with another embodiment herein. In some embodiments, with reference to FIG. 1B , an electric skin patch device (EDP) 140 includes a microcontroller 142 , a wireless transceiver 144 , a lithium ion battery, a beta volta battery, a solar cell, a nickel-cadmium battery, or It includes a power management module 150 such as a fuel cell, a pulse generator 146 , and at least one electrode 148 , and does not include other physical inputs or sensors in the EDP 140 itself. The remaining inputs are at the companion device 105 and are actuated via the wireless coupling of the companion device 105 and the EDP 140 .

In some embodiments, rather than including a physical on/off switch, the EDP 140 shown in FIG. 1B is always using the least amount of power so that the 'off' state represents a low power state. While no stimulus is provided, there is at least a periodic 'wake-up' of the EDP 140 to check for communication from the companion device 105 . 'Wake up' puts the device in an 'on' state, and in some embodiments does not include stimulation, where EDP 140 executes a diagnosis to report to companion device 105 . Therefore, while in the 'off' state, the EDP 140 is continuously using a very small amount of power, providing no stimulation, waiting for a signal from the companion device, diagnostics, or requiring very little power. Other non-stimulatory activities are being performed. In some embodiments, the energy usage is less than 5 μA average current while in the 'off' state, or ranges from 0.1 μA to 5 μA average current, and greater than 10 μA average current while in the 'on' state. In some embodiments, the energy usage is greater than or equal to 1 μA while in the 'on' state than during the 'off' state. When the EDP 140 receives a signal from the companion device 105 to initiate stimulation, the EDP enters an 'on' state and uses the amount of energy associated with the stimulation level. In another embodiment, EDP 140 does not use energy while in an 'off' state and must be woken up or switched to an 'on' state by a signal from a companion device.

1C is a block diagram of a system 161 for stimulating or modulating nerves and nerve endings in body tissue in accordance with another embodiment herein. In some embodiments, referring to FIG. 1C , an electric skin patch device (EDP) 160 includes a microcontroller 162 , a wireless transceiver 164 , and a power management module 170 (eg, a lithium ion battery, beta voltaic battery, solar cell, nickel cadmium battery or fuel cell), pulse generator 166, one electrode 168, optional single actuator 172 to turn on or off EDP 160, physiological parameters of the patient It includes one sensor 175 for detecting , and no other physical input to the EDP 160 itself. In one embodiment, sensor 175 is a neural sensor. The remaining inputs are at the companion device 105 , which is actuated via the wireless coupling of the companion device 105 and the EDP 160 .

According to various aspects herein, each component of the electrical skin patch (power management module, microprocessor or microcontroller, pulse generator, transceiver and one or more electrodes) is in a separate housing, separate device, or otherwise from each other. They may be physically located apart. For example, as described with reference to FIG. 1A , the electrical skin patch device 110 includes a power management module 120 , a microprocessor or microcontroller 112 , a pulse generator 116 , and a transceiver within a housing 111 . 114 , and one or more electrodes 118 , wherein the one or more electrodes 118 are in physical communication with the hydrogel pad.

However, in a first alternative embodiment as shown in FIG. 1D , the electrical skin patch device 180 is in physical contact or not in contact with the hydrogel pad and the antenna 184 for receiving the electrical pulse signal 186 . and a transceiver 182 having an electrode 183 that may or may not be present. The housing 181 may be positioned around the transceiver 182 and the electrode 183 , or the substrate carrier may be used to support the low profile transceiver and/or electrode circuitry without any additional housing structure. In this embodiment, the external device 185 includes a power source, a controller, and a pulse generator configured to generate a plurality of electrical pulses as described above with reference to FIGS. 1A-1C . External device 185 may be a watch, mobile phone, sensor pod configured to be attached to a patient using a strap or band, or other wearable device. The external device 185 wirelessly transmits an electrical pulse 186 to the transceiver 182 , which in turn transmits the electrical pulse to the electrode 183 and then through the hydrogel pad to the epidermal layer of the patient.

In a second alternative embodiment, as shown in FIG. 1E , the EDP device 190 includes a transceiver 182 having an antenna 184 for receiving a signal 196 , a pulse generator 187 , and a hydrogel. and an electrode 183 in physical communication with the pad. A housing 191 may be positioned around the transceiver 182 , the pulse generator 187 , and the electrode 183 . In this embodiment, the external device 192 includes a power source and a controller configured to generate an electrical signal, a power signal or a data signal 196 , which is transmitted wirelessly to the transceiver 182 , which in turn is a pulse generator. 187 and used by pulse generator 187 to generate a plurality of electrical pulses. External device 192 may be a watch, mobile phone, sensor pod configured to be attached to a patient using a strap or band, or other wearable device. Electrical pulses are delivered to electrodes 183 , which are then delivered through an optional hydrogel pad to the epidermal layer of the patient.

In a third alternative embodiment, as shown in FIG. , a pulse generator 187 , and an electrode 183 in physical communication with the hydrogel pad. Housing 194 may be positioned around transceiver 182 , microcontroller 193 , pulse generator 187 , and electrode 183 . In this embodiment, the external device 198 includes a power source and a transceiver configured to generate a power signal 197 , which is transmitted wirelessly to the transceiver 182 of the EDP device 195 , which in turn is a microcontroller 193 and a pulse generator 187, which generates a plurality of electrical pulses. External device 198 may be a watch, mobile phone, sensor pod configured to be attached to a patient using a strap or band, or other wearable device. Electrical pulses are delivered to electrodes 183 , which are then delivered through an optional hydrogel pad to the epidermal layer of the patient.

In a fourth alternative embodiment, the power source, controller, pulse generator, transceiver, electrode and hydrogel pad are each coupled together in a single housing. In a fifth alternative embodiment, the controller, pulse generator and/or transceiver are coupled together in a first housing, while the electrodes, power source and/or hydrogel pad are in a disposable second housing such that the electrodes, power source and hydrogel are in a second housing. When the gel is exhausted, it can be discarded. Accordingly, the controller, pulse generator, and/or transceiver may be reused and connected to a second electrode, power source, and/or hydrogel pad to create a refreshed device.

It is understood that each of the above embodiments may be implemented without a transceiver, and may replace wireless communication with a wired connection between an external device and an electric skin patch. Also in each embodiment, signal processing to determine data indicative of a physiological state is performed at the sensor level, ie at the impedance or other sensor, at the controller level of the EDP device, or at the external device level using mobile application software or other programs. It should be understood that this can be done in

Electrical Skin Patch (EDP) Device Configuration

Prior art TENS (transcutaneous electrical nerve stimulation) or externally worn electrical stimulation devices are not suitable for prolonged wear (eg, more than several hours). Stimulation therapy herein requires a wearable device that is attached to a user's skin during wake up time to automatically enable the user to multiple specific treatment protocols over time. For this to be possible, the EDP device of the present disclosure must have a high level of extended wearability that is not damaged by dropping the device or causing skin irritation or itching.

Thus, in accordance with one aspect of the present specification, the electrical skin patch device 110 is comprised of a wearable disposable skin patch that is adhesively attached to the user's skin. Optionally, the EDP comprises at least one or a pair of removable and replaceable conductive hydrogel, hydrocolloid or foam pads, wherein the tab (Fig. It has an adhesive base surface covered with (as described with reference to 2d). Alternatively, conductive hydrogels, hydrocolloids (containing gel-like components in an adhesive compound laminated to a flexible waterproof outer layer) or foam pads (described with respect to FIG. part, and the entire assembly is discarded when the battery is depleted. The hydrogel pad provides electrical conductivity from the EDP device to the user's skin surface. A hydrogel is composed of an aqueous absorbent polymer and an aqueous electrolyte. Electric current is transmitted to the skin through the hydrogel's electrolyte. In various embodiments, both the hydrogel and the internal electrolyte meet the biocompatibility requirements set forth by ISO 10993-5, 10, which is incorporated herein in its entirety. In some embodiments, the EDP device uses a 'foam electrode' (or foam pad comprising a polyethylene acrylic foam adhesive) with a dry or wet conductive gel applied to the center of the electrode assembly. The foam is disposed along the perimeter of the electrode assembly and provides adhesion to the skin. The gel is a conductive medium between the electrode metal and the skin. The 'foam electrode' is impermeable to water because the foam is a closed cell and acts as a barrier preventing water penetration into the conductive gel.

According to one aspect of the present specification, the electrical skin patch device 110 is long-term, eg, at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 It is configured to be worn for use continuously for days or for any increments therein or continuously for up to 3 months, and to be removed only for the purpose of refilling and/or optionally changing the replaceable conductive hydrogel pad. According to another aspect of the present specification, the electrical skin patch device 110 is used to treat erythema (redness), scaling, itching (pruritus), stratum corneum exfoliation, adhesive irritation, bacterial infection associated with occlusion (follicleitis), irritant contact dermatitis, and hepatitis. It provides stimulation therapy while minimizing the same skin irritation and related side effects. It should be noted that obese people with abdominal bloating are particularly vulnerable to intertidal dermatitis ( Candida Albicans ), which causes abdominal rash and irritation. Therefore, the EDP device of the present specification uses an electrode suitable for long-term stimulation without promoting the aforementioned skin problems.

In some embodiments, the electrical skin patch is configured to be worn continuously by the patient for at least 3 days and is attached to the patient's skin and configured to be in electrical communication with the pulse generator and a housing comprising a controller in electrical communication with the pulse generator. It includes two electrodes. The controller includes program instructions that, when executed and transmitted to the pulse generator, cause the pulse generator to generate and transmit a first set of electrical stimulation pulses and a second set of electrical stimulation pulses to the at least two electrodes. Each of the at least two electrodes comprises a hypoallergenic conductive gel having at least one adhesive surface.

In another embodiment, the electrical skin patch is affixed to the patient's skin and a housing configured to be worn continuously by the patient for at least 3 days, the housing including a controller in electrical communication with the pulse generator, and coplanar parallel to the patient's skin at least two electrodes positioned at and configured to be in electrical communication with the pulse generator at a distance of 0.05 cm to 0.4 cm, wherein the controller, when executed and transmitted to the pulse generator, causes the pulse generator to generate a first set of electricity program instructions for generating and transmitting a stimulation pulse and a second set of electrical stimulation pulses to at least two electrodes, each of the at least two electrodes comprising a hypoallergenic conductive gel having at least one adhesive surface, wherein the author The polar conductive gel does not comprise imidazolidinyl urea or diazolidinyl urea, wherein at least one adhesive surface is configured to adhere to the skin of a patient, and and a total skin contact surface area ranging from 4 cm 2

In one embodiment, the method of using the electrical skin patch described above includes each electrical stimulation pulse having a pulse width ranging from 10 µsec to 10 msec, a pulse amplitude ranging from 100 µA to 100 mA, and a pulse frequency ranging from 1 Hz to 100 Hz. and programming the controller to evaluate whether the patient experiences a change in appetite as a result of applying the first set of electrical stimulation pulses or the second set of electrical stimulation pulses to the skin of the patient, wherein The patient does not experience erythema, scaling, itching, folliculitis, or hepatitis at the point where the two electrodes are attached to the patient's skin.

Thus, in some embodiments, the EDP device is made of a hypoallergenic conductive gel with at least one adhesive surface and a contact surface (on the user's skin) having sufficient adhesive properties to remain attached to the user's skin for at least 12 hours. using self-adhesive electrodes or electrode pads with a surface to contact). In an embodiment, the hypoallergenic conductive gel is made of a hydrogel that does not contain known allergens such as imidazolidinyl urea or diazolidinyl urea. In an example, the gel has been tested and approved as non-allergenic using the IgE skin test, specifically the conductive gel is registered below a negative IgE skin test or threshold that is considered not to cause an allergic reaction. In some embodiments, the hydrogel is prepared from a modified carboxymethylcellulose polymer with propylene glycol.

The adhesive of the pad is preferably biocompatible to prevent skin irritation due to prolonged use of the patch. Loctite®, manufactured by Henkel, is a non-limiting example of a medical or biocompatible adhesive. The adhesive on the pad provides sufficient adhesion integrity of the EDP to the user's skin. In various embodiments, the EDP has an average minimum 'peel strength' (for living skin) of between 1.0 and 2.1 Newtons, preferably 1.5 Newtons, such that the EDP adheres to the skin for at least 8 hours of intense activity, such as exercise. . In one embodiment, the EDP device uses KM30B hydrogel manufactured by Katecho Inc. with a 'peel strength' in the range of 1 Newton to 2.5 Newton. Those skilled in the art will understand that 'peel strength' is the force required to remove or peel an EDP with an adhesive pad from the user's skin and is a measure of the adhesion integrity of the EDP. 'Peel strength' is quantified by pulling the device from a flexible end or edge at a 90 degree angle from the skin surface, typically with peel rates ranging from 100 to 500 mm/min. In an alternative embodiment, placement of the electrical skin patch device 110 is accomplished using a band, strap, or belt without any adhesive (eg, in the region of the user's abdomen, torso, arm, or wrist). In embodiments, the band, strap, or belt is made of a flexible or elastic material such as, but not limited to Lycra or Spandex, and due to its elasticity, a target location/area (eg, abdomen, torso) , arm or wrist) to hold the electrical skin patch device 110 . In some embodiments, the band, strap, or belt is additionally or alternatively secured in place using conventional fastening means, such as, but not limited to, Velcro, clasp, or buckle fastening. In another embodiment, the electrical skin patch device 110 is a tight undershirt (eg, body glove, lycra or spandex underwear) that, when worn by a user, positions the integrated electrical skin patch device 110 on a desired dermatome. ) are incorporated into shape-fitting garments such as In an embodiment, the electrical skin patch device 110 is directly attached to a shape-fitting garment or integrated into the garment as a woven circuit. It should be understood that the term “adhered” is intended to encompass any form that achieves skin contact with the device, including adhesives, bands, straps or belts.

According to some embodiments, the one or more electrodes 118 may be configured such that the electrical skin patch device 110 provides electrical stimulation therapy to the user through a range of 0.1 mm to 10 mm or a range of 0.1 mm to 20 mm of the dermis from the outer surface of the epidermal layer of the patient. to be able to provide In various embodiments, the depth of stimulation through the epidermal layer of the patient ranges from 0.1 mm to 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 , 17, 18, 19, 20, 21, 22, 23, 24 or 25 mm or any increments therein. One embodiment herein uses two electrodes disposed within a hydrogel, foam or hydrocolloid pad (commonly referred to as an electrode pad). Electrode pads are placed on the user's skin surface to deliver electrical pulses through the skin and stimulate nerves and nerve endings in body tissue under the skin in the electrode area.

2A , 2B and 2C are side, front and top perspective views of an electric skin patch device 210 according to one embodiment having a pair of conductive hydrogel pads 220 and a device housing 213 . Housing 213 contains the microcontroller, pulse generator, wireless transceiver and power management module of the system described with reference to FIG. 1A . Electrodes extend from the housing 213 to the pad 220 for placement proximate to the patient's skin surface. In one embodiment, the pad 220 has at least one, preferably two electrodes (not shown) disposed or printed on the lower surface 222 of the pad 220 . In some embodiments, pad 220 has two electrodes, each electrode disposed on or printed on opposite halves of lower surface 222 . In an embodiment, the distance between the two electrodes is less than 20 mm, preferably less than 15 mm, preferably less than 10 mm, preferably less than 5 mm. In one embodiment, the distance between the two electrodes is about 4 mm. The pad 220 allows the electrode to directly contact the outer surface of the skin when attached to the user's skin. It should be understood that the housing 213 remains over the skin surface while the electrodes are in contact with the skin surface. In some embodiments, the housing 213 is held within a range of 2 mm to 4 mm, preferably 2 mm above the skin surface. In various embodiments, the electrode may be in the form of a typical gel-based skin electrode, a gel-free skin electrode, or a skin puncture or skin abrasive electrode to reduce skin-electrode impedance. In various embodiments, the electrode surface area ranges from 0.1 in ² to 10 in ^{2 ,} 0.001 in ² to 0.1 in ^{2 ,} or 0.001 in ² to 10 in ² . In some embodiments, the total surface area occupied by the bases of the two electrodes is less than 10 in ² , preferably less than 5 in ² . In some embodiments, the total surface area occupied by the two electrodes is less than 10 in ² , preferably less than 8 in ² , more preferably less than 7 in ² .

In some embodiments, the hydrogel pad 220 of the electrical skin patch device herein is replaceable, allowing the possibility of reattachment of a new conductive pad and thus a new adhesive surface to the EDP device. 2D is an oblique perspective view of a replacement hydrogel 240 with liners 242 and 243 and an electric skin patch 230 from which the hydrogel has been removed according to an embodiment of the present specification. According to one aspect of the present specification, the used hydrogel pad may be peeled off the EDP device by pulling the removal tab 241 . In one embodiment, the removal tab 241 is made of a white polyester film. One side of this film has an acrylic adhesive. When building the hydrogel and removal tab assembly, the acrylic side is placed facing the hydrogel on both the top and bottom. Replacement pad 240 is a custom shaped hydrogel sandwiched between two transparent release liners 242 , 243 according to one embodiment. The EDP-facing release liner 242 is peeled off. The second portion of the release liner 243 facing the skin surface is used to process the hydrogel 240 and position it accurately under the EDP 230 . Light finger pressure is applied through the second release liner 243 to ensure good contact to the EDP 230 . The second liner 243 is then peeled off to expose the working surface of the hydrogel.

In an alternative embodiment, referring back to FIGS. 2A-2C , the housing 213 may be detachable from and snap connected to the hydrogel pad 220 . In another embodiment, the hydrogel pad 220 may be removably connected to the housing 213 using at least one magnet. The use of the magnet(s) requires the user to use minimal force or effort to separate and reconnect the hydrogel pad 220 and the housing 213 as compared to a snap fit configuration.

The skin patch or pad 220 may have different shapes and sizes for different body types and areas of stimulation. In some embodiments, the patch or pad has an irregular shape. In various embodiments, the patch or pad 220 is a rectangle having a length of about 2 inches, a width of about 1 inch and a thickness of about 0.2 inches. In another embodiment, the patch or pad 220 is a rectangle having a length of about 3 inches to 5 inches, a width of about 0.5 inches to 2.5 inches, and a thickness of about 0.10 inches to 0.30 inches. In various other embodiments, the patch or pad 220 is circular or circular having a diameter of about 2 inches to 4 inches and a thickness of about 0.10 inches to 0.30 inches. In another embodiment, the patch or pad 220 is a square having a side of about 2 inches to 4 inches and a thickness of about 0.10 inches to 0.30 inches. The patch or pad 220 may have other sizes and shapes including, but not limited to, oval or triangular. In other embodiments, the electrode/pad combination may have a shape comprising any one of irregular, rectangular, circular, square, oval, and triangular, wherein the widest is 0.25 inches to 5 inches and the highest is 0.25 inches. to 5 inches and the thickest is 0.25 to 5 inches. In other embodiments, the device will include two of these electrode/pad combinations placed side by side.

According to various embodiments, electrodes are disposed or printed on the lower surface 222 of the pad 220 in the form of a plurality of patterns or geometries. 3A and 3B show a first pattern 305 and a second pattern 310 of the first electrodes 318 and 318' and the second electrodes 328 and 328', respectively. Referring to Figure 3A, in one embodiment, each of the electrodes 318, 318' includes an elongate 'backbone' 319, 319' and a plurality of 'tooths' 317 extending vertically from the backbone. 317') has a 'comb'-like pattern. The two electrodes 318 and 318' are opposite to each other so that the 'tooth' 317 of the first electrode 318 is alternately configured between the 'tooth' 317' of the second electrode 318'. is located Referring to FIG. 3B , in one embodiment, each of the electrodes 328 and 328' has a 'square wave' pattern including a plurality of peaks 329 and 329' and valleys 327 and 327'. In one embodiment, the peak 329 of the first electrode 328 is such that the peak 329 ′ of the second electrode 328 ′ fits within the peak 329 of the first electrode 328 . ') is wider than the peak 329'. Referring simultaneously to FIGS. 3A and 3B , patterns 305 , 310 are printed on the lower adhesive surfaces 322 , 332 of skin patches or pads 320 , 330 . Those skilled in the art will appreciate that the first and second patterns 305 and 310 are exemplary only. In some embodiments, the skin patches or pads 320 , 330 are transparent such that the pattern of electrodes 318 , 318 ′, 328 , 328 ′ is visible to the user through the patches or pads 320 , 330 .

According to various embodiments, the electric field generated by electrodes, such as electrodes 318, 318', 328, 328', is shallow and widely distributed to spread and apply stimulation therapy over a sufficiently large area. The properties of the generated electric field depend at least on the distance between the electrode and the electrode pattern or geometry on the patch or pad. According to one embodiment, the distance between the two electrodes 318, 318' and 328, 328' is fixed along the entire length of the electrodes 318, 318', 328, 328'. In one embodiment, the electric field generated by the electrode is distributed along the attachment area of the electric skin patch device and penetrates a depth of up to 20 mm from the skin surface. In other words, in various embodiments, the electric field generated by the EDP device has a width and length equal to the width and length of the device footprint, and a depth sufficient to target neural tissue within 20 mm of the skin surface.

4A shows an electrical skin patch device 410 configured to provide electrical stimulation therapy through 10 mm or 20 mm of the dermis from the outer surface of the epidermal layer of a patient, in accordance with some embodiments. In various embodiments, the depth of stimulation through the epidermal layer of the patient is between 0.1 mm and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 mm or any increment range therein. The electrical skin patch device 410 has a housing 413 , an electrode pad or skin patch for placement on the skin surface of a user (removed to improve visibility of the electrode 411 ), and an exposed distal tip 416 into the housing. It includes an electrode 411 in the form of an insulated fine wire 415 in a state extending from the lower surface of the 413 . When the electrical skin patch device 410 is placed on a patient, the electrodes 411 are completely disposed within the pad or skin patch and do not penetrate or directly contact the patient's skin. The housing 413 contains the microcontroller, pulse generator, wireless transceiver, and power management module of the system described with reference to FIGS. 1A-1C .

4B and 4C are side and bottom perspective views, respectively, of another embodiment of an electrical skin patch device 420 herein. The electrical skin patch device 420 shown in FIGS. 4B and 4C is an electrical skin patch device 420 in contrast to the electrical skin patch devices 210 , 410 having a profile with raised housings 213 , 413 . It differs from the electrical skin patch devices 210 and 410 shown in FIGS. 2A-2C and 4A, respectively, in that all components of the electrical skin patch device 420 are located in a single patch such that α has a flat profile. The sub-profile of the electrical skin patch device 420 facilitates use and placement by a patient. In various embodiments, the electrical skin patch device 420 has a width (w) of no more than 2 inches, a length (L) of no more than 5 inches, and a height (h) of no more than 1.5 inches, preferably 0.35 inches or less. In some embodiments, the electrical skin patch devices herein have a height h of less than 1 inch, preferably less than 3/4 inch, more preferably less than 1/2 inch.

In various embodiments, the electrical skin patch device 420 has a weight of 5 ounces or less.

In various embodiments, the electrical skin patch device 420 has an ingress protection rating (IPX) of at least IPX7, such that the electrical skin patch device 420 is placed on the body without water damage to the patient while the electrical skin patch device 420 is placed on the body. Allow yourself to shower and swim for at least 30 minutes. In some embodiments, the hydrogel (of the electrical skin patch) is surrounded by closed cell foam along its perimeter to prevent water penetration into the hydrogel and reduced adhesion in long showers and/or 30 minute swims. In various alternative embodiments, the EDP device 420 has an ingress protection rating (IP) ranging from IP3 to IP5, preferably a waterproof rating of IP4 according to IEC standard 60529 (i.e., from splashing water from any direction for 5 minutes). protection). The electrical skin patch device 420 is constructed of a flexible rubber or silicone material that has sufficient structural strength to remain on the body once placed but still flexible enough to be peeled off by the edge. The electric skin patch device 420 can be stored when not in use. In another embodiment, the electrical skin patch device 420 has an Ingress Protection Rating (IPX) of at least IPX1, IPX2, IPX3, IPX4, IPX5, or IPX6 as known to those skilled in the art.

Referring to FIG. 4C , in various embodiments, the lower surface of the electrical skin patch device 420 has at least one electrode 428 having a specific configuration and capable of providing sufficient current to stimulate the dermatome at various ratings and pulses. ) is included. In one embodiment, the electric skin patch device 420 includes two electrodes 428 , 428 ′ having a pattern similar to that described with reference to FIG. 3B . In various embodiments, the electrical skin patch device 420 has a profile that is as ergonomically low as possible and is configured to be uniform in shape, yet still provide strong adhesive properties that last for at least 4 weeks during normal use. 4B-4C , the electrical skin patch device 420 does not include a visible or tactile user interface and all communications with the electrical skin patch device 420 use an interlocking device as further described below. This is achieved wirelessly using

In some embodiments, the electrical skin patch device 420 includes a disposable battery that provides operating power for at least 90 days of use. In one embodiment, electrical skin patch device electronic circuitry in combination with electrodes is used to sense skin placement and automatically turn therapy on and off, as further described below. As described with reference to FIGS. 4B and 4 , the electrical skin patch device electronic core and the adhesive pad with electrodes are all bonded to one flat component configured to provide therapy for a minimum of 3 months. Alternatively, as described with reference to FIGS. 2A-2D and 4A , the electrical skin patch device electronic core is located in a housing separate from the pad, and in some embodiments can be easily replaced by a patient or healthcare professional. .

4D is an oblique top perspective view of an electrical skin patch device 430 according to another embodiment of the present disclosure. The electrical skin patch 430 includes a controller assembly 431 and an electrode assembly 432 . In one embodiment, the controller assembly 431 is reusable and detachable from the disposable electrode assembly 432 . It should be understood that while the electrode assembly 432 is in contact with the skin surface, the controller assembly 431 remains over the skin surface. In some embodiments, the controller assembly 431 is held within a range of 2 mm to 4 mm above the skin surface, preferably within 2 mm above the skin surface. In some embodiments, EDP 430 has an oval or surfboard-like shape as shown in FIG. 4D . The surfboard shape allows better adhesion to the patient's skin surface and better mobility. In one embodiment, the elliptical or surfboard-like shape of the EDP 430 has a minor axis or dimension in the range of 0.1 inches to 0.6 inches, preferably about 0.33 inches, and in the range 2 inches to 8 inches, preferably about 5.365 inches. It has a major axis or dimension in inches or any increments therein. In various embodiments, the elliptical shape of the EDP 430 may require the user to orient the device in such a way that the short dimension of the EDP traverses the minimum radius of the skin topography at the desired body location.

4E is an oblique top perspective view of the controller assembly 431 of the electrical skin patch device of FIG. 4D . The controller assembly 431 is flexible and includes a flexible circuit with carrier and electrode contacts, discrete electrical components, a rechargeable battery, and a flexible overmold 435 . In a less preferred embodiment, the controller assembly includes a rigid housing instead of an overmold. In some embodiments, overmold 435 includes a low hardness material having a defined geometry through a single shot injection mold process with one hardness over the entire overmold 435 .

In various embodiments, the material for the overmold 435 includes, for example, a thermoplastic elastomer (TPE) such as Monprene manufactured by Teknor Apex as a super soft TPE gel. TPE is processed like any other thermoplastic material, but generally has a low modulus of elasticity, making the assembly flexible. In various embodiments, the TPE used as the material of the overmold 435 has a hardness ranging from 30 to 70, preferably 45 to 65, more preferably 50 to 60, and 15 psi to 55 psi on a sub zero shore (00) scale. , preferably having a tensile modulus (indicating flexural properties) in the range of 30 to 45 psi. For example, Monpren Ultra Soft Gel grade CP-32053G (manufactured by Techner Apex) has a hardness measurement of 53 on the sub-zero shore (00) scale and a tensile modulus of about 37 psi. The viscosity range of Monpren Ultra Soft Gels ranges from 30 to 65 on the Sub Zero Shore (00) scale. The EDP device herein has measurements on the Flexural Modulus Scale according to ASTM D-747 in the overall range of 10 psi to 35 psi, preferably 15 psi to 25 psi. This overmolding material applies to all other embodiments disclosed herein, whether single shot embodiments or double shot molding embodiments.

In another embodiment, the thermosetting material creates the overmold 435 and facilitates the manufacture of the controller assembly 431 because the low hardness thermoset material, such as liquid silicone rubber (LSR), has a low viscosity at room temperature prior to curing. used for This allows filling the injection mold cavity to place less stress on the flexible circuit during processing.

In some embodiments, overmold 435 includes a plurality of slots 433 . Slot 433 imparts increased flexibility to controller assembly 431 and provides tooling access so that the flexible circuitry therein can be accurately held in place during the overmolding process. Slot 433 also acts as a window to the flex circuitry therein. In some embodiments, the controller assembly 431 further includes a light emitting diode (LED) that visually communicates a user product function and/or product status through a window-like slot 433 .

4F is an oblique bottom perspective view of the controller assembly 431 of the electrical skin patch device of FIG. 4D . Visible on the underside of the controller assembly 431 is a flex circuit 441 with the edges of the overmold 435 around its perimeter. In various embodiments, flex circuit 441 provides three functions. First, flex circuit 441 contains and carries individual electrical components and batteries. Second, the flexible circuit provides electrical contacts 439 that are used to connect to the hydrogel of the electrical skin patch. Third, the flexible circuit provides a recharge path for the rechargeable battery if desired. In some embodiments, the flexible circuit carrier 437 for the circuit is comprised of a single or multi-layer polyimide/copper laminate that has been processed by masking and etching a copper substrate to create the circuit. In some embodiments, the individual components of controller assembly 431 are mounted surfaces or “through holes” similar to processes used to manufacture rigid printed circuit boards.

In various embodiments, electrode contacts 439 are gold plated copper pads created as part of the etching and plating process of flex circuit 441 . The flex circuit 441 is comprised of a single or multilayer polyimide/copper laminate, where each layer of copper has circuit traces masked in such a way that when acid is applied, the exposed copper is etched away, leaving masked areas in place. The masking material is then removed with a solvent to expose the remaining copper that creates the circuit. Electrode contacts 439 are then gold plated to ensure connection of the EDP to the hydrogel. Creating electrical contacts in this way has three advantages. First, this occurs in the processing step and is built into the cost of the flex circuit 441 so that no additional processing is required to attach and process individual connectors to both the controller assembly 431 and the electrodes. Second, it eliminates the tight tolerances required for typical electrical connections. Third, since the electrical contact of the controller assembly 431 is in direct contact with the hydrogel of the electrode assembly, no connector is required for the electrode, thereby reducing the electrode cost.

In another embodiment, as shown in cross-section FIG. 4G , an electric skin patch device (EDP) 490 includes a housing 491 and a capacitive connection between the electrode contacts 439 and the hydrogel 436 of the electrode assembly. and a very thin dielectric material 485 laminated over hydrogel 436 or electrode contacts 439 . In various embodiments, the thickness of the dielectric laminate ranges from 0.001 inches for a single layer of dielectric material, 0.003 inches for two layers of dielectric material to 0.005 inches or less for three layers of dielectric material. Dielectric material 485 creates a DC blocking capacitor used in the output stage circuit. This alternative connection has three advantages. First, the exposed metal electrode contacts 439 on the underside of the controller assembly need not be of a non-oxidizing type, such as gold, as they do not rely on intimate conductor/conductor contacts to maintain electrical connections. Second, the circuit impedance of the drive circuit is much more predictable as the connection to the hydrogel may not be a variable resistor in subsequent use. Third, there is no need to maintain a physical contact (and an electrical short) between the two metal contacts, which improves the reliability/robustness of the connection.

4H is an oblique top perspective view of the controller assembly 431 of the electric skin patch device of FIG. 4D with a portion of the overmold 435 cut away to expose additional components of the controller assembly 431 . In some embodiments, the flexible circuit 441 includes a flexible circuit carrier 437 having a plurality of discrete components 445 and at least one battery 447 surface mount soldered to exposed conductor pads. In some embodiments, the flexible circuit anchors 443 are laminated around the flexible circuit carrier 437 . In various embodiments, anchor 443 comprises a layer of polyimide or other semi-rigid material. Drilling holes 449 along the length of the perimeter of the anchor 443 are included to allow the overmold 435 material to be actively attached to the flex circuit 441 , creating a robust/reusable controller assembly 431 . In various embodiments, battery 447 is a flat-panel technology battery followed by most battery chemistries. In some embodiments, battery 447 is rechargeable. In various embodiments, the controller assembly 431 has a typical floor area of 1.5 in ² for a physical aspect ratio of the width to length of the flexible circuit carrier 437 of about 1:1.

4I is an oblique top perspective view of an electrode assembly 432 of the electrical skin patch device of FIG. 4D . In various embodiments, the electrode assembly 432 is flexible and includes a hydrogel 436 , a hydrogel carrier 438 , a release liner 442 , and an electrode bezel 434 . The electrode contact surface is not shown as it is below the surface of the hydrogel 436 . The electrode surface is in physical contact and in electrical communication with the hydrogel 436 contained in the polymer coating (carrier). Electrode bezel 434 is designed to hold carrier 438 and hydrogel 436 in place. A release liner 442 is on the base of the surface of the carrier 438 and serves to protect the adhesive coating on the surface of the carrier 438 until the user is ready to use the EDP. At this point, the release liner 442 is removed and the carrier 438 and adhesive are exposed.

Once the EDP is fully assembled, the electrode contacts 439 shown in FIG. 4F are in physical contact with the hydrogel 436 shown in FIG. 4I to deliver electrical stimulation from the EDP to the patient's skin surface. The hydrogel carrier 438 and release liner 442 simply detach the controller assembly from the electrode assembly 432 so that the reusable controller assembly can be combined with a new electrode assembly.

4J is an oblique bottom perspective view of the electrical skin patch device 430 of FIG. 4D . Shown are the overmold 433 and flexible circuit carrier 437 of the controller assembly, and the hydrogel 436, hydrogel carrier 438 and electrode bezel 434 of the electrode assembly.

4K is a side perspective view of the electrical skin patch device 430 of FIG. 4D . In various embodiments, EDP 430 has a thickness or height h ranging from 0.075 inches to 0.25 inches from the patient's skin surface. In one embodiment, EDP 430 has a thickness or height h of 0.156 inches from the patient's skin surface.

4L and 4M are oblique, top perspective, short-axis and anterior perspective, cross-sectional views of the electrical skin patch device 430 of FIG. 4D , respectively. Overmold 435 of controller assembly 431 , discrete components 445 , battery 447 , flexible circuit carrier 437 , and circuit carrier anchor 443 , and hydrogel of electrode assembly 432 ( 436 , the hydrogel carrier 438 and the electrode bezel 434 are visible. The controller assembly 431 is separated from the electrode assembly 432 such that the overmold 435 lies within the area defined by the electrode bezel 434 and the electrode contacts (439 in FIG. 4F ) are in physical contact with the hydrogel 436 . configured to be connected. Using the patient's skin surface as a reference point, the overmold 435 of the controller assembly 431 and the electrode bezel 434 of the electrode assembly 432 include the distal or outer surface 430d of the EDP 430 . Hydrogel 436 includes a proximal or inner skin-facing surface 430p of the EDP. Discrete components 445 , battery 447 , flexible circuit carrier 437 , and circuit carrier anchor 443 are located within controller assembly 431 at a central portion of EDP 430 . The hydrogel carrier 438 is positioned between the hydrogel 436 and the electrode bezel 434 of the electrode assembly 432 at the periphery of the EDP 430 .

4N and 4O are an oblique top perspective view, a long axis perspective view, and a side view, respectively, of the electrical skin patch device 430 of FIG. 4D . Overmold 435 , discrete component 445 , battery 447 , flexible circuit carrier 437 , circuit carrier anchor 443 , and slot 433 of controller assembly 431 , electrode assembly 432 ) of the hydrogel 436 (see FIG. 4o ), the hydrogel carrier 438 , and the electrode bezel 434 are shown.

According to various embodiments, an electrode, such as electrode contact 439 of FIG. 4F , is disposed or printed on the pad subsurface of EDP device 430 of FIG. 4D in a plurality of patterns or geometries. 4P to 4S show a first pattern 450 of corresponding first electrodes 451 and 452, second electrodes 456 and 457, third electrodes 461 and 462, and fourth electrodes 466 and 467, respectively. ), the second pattern 455 , the third pattern 460 , and the fourth pattern 465 are illustrated. In an embodiment, the distance between electrodes such as electrode 439 of FIG. 4F or electrodes of the first, second, third and fourth electrode patterns of FIGS. 4P-4S is less than 20 mm, preferably less than 15 mm, Preferably less than 10 mm, preferably less than 5 mm. In one embodiment, the distance between the electrodes is about 4 mm.

Referring to FIG. 4P , in one embodiment, each of the electrodes 451 , 452 has a generally 'sinusoidal' pattern 450 and extends along the long axis 480 of the pad 475, which is, for example, substantially elliptical. . Pattern 450 includes a plurality of peaks 453 and 453' and valleys 454 and 454'. In one embodiment, the peak 453 of the first electrode 451 is such that the peak 453 ′ of the second electrode 452 fits within the peak 453 of the first electrode 451 . is wider than the peak 453' of Referring to FIG. 4Q , in another embodiment, the electrodes 456 and 457 each also have a generally 'sinusoidal' pattern 455 that extends along the long axis 480 of the pad 476 . The 'sine wave' pattern 455 has a 'period' (where 'period' is the distance between successive peaks and valleys measured along the long axis 480 ) where the pattern 455 is longer than the pattern 450 . is different from the pattern 450 of FIG. 4P in that . As a result, pattern 455 has a plurality of peaks 458 , 458 ′ and valleys 459 having a smaller number compared to the number of peaks 453 , 453 ′ and valleys 454 , 454 ′ in pattern 450 . , 459').

Referring now to FIG. 4R , in one embodiment, the electrodes 461 , 462 each have a linear pattern 460 and extend along the long axis 480 of the pad 477 . According to one embodiment, the gap 464 between the electrodes 461 , 462 is maintained along the long axis 480 or held constant. Referring to FIG. 4S , in one embodiment, electrodes 466 , 467 each have a linear pattern 465 and extend along a minor axis 481 of pad 478 , axes 480 and 481 being relative to each other. It is practically vertical. According to one embodiment, the gap 468 between the electrodes 466 , 467 is maintained along the minor axis 481 or remains constant.

5A is an oblique top perspective view of an electric skin patch device 500 according to another embodiment of the present disclosure. The EDP device 500 is overmolded and configured in a shape such as a round, round, or “sand dollar”. The overmold 515 includes a first overmold portion 505 forming a perimeter of the EDP device 500 and a second overmold portion 510 forming a central portion of the EDP device 500 . While described with reference to the "sand dollar" configuration shown in FIG. 5A, the "two-shot" overmold process (including the first and second overmold portions) is not limited to sand dollar shapes and is not limited to any of the EDP's It can be applied to create shapes. 5B is a side perspective view of EDP device 500 showing hydrogel pad 520 . A hydrogel pad 520 in the shape of a concentric ring in some embodiments is also shown in FIG. 5C , which is a bottom view of the EDP device 500 . As shown in FIG. 5B , an overmold 515 comprising first and second overmold portions 505 , 510 encloses the total surface area or floor area of the hydrogel pad 520 in accordance with aspects herein. All.

FIG. 5D is an oblique top perspective view of EDP device 500 with a portion of overmold 515 (of FIG. 5A ) removed to reveal internal components of the EDP device. 5E is a cross-sectional side view, while FIG. 5F is a top perspective view of the EDP device 500 with the entire overmold 515 (of FIG. 5A) removed.

Referring now to FIGS. 5D-5F , first and second overmold portions 505 , 510 are flexible circuits having a plurality of discrete electronic components (such as those described with reference to FIG. 1A ) including rechargeable batteries. and a flexible circuit carrier 525 supporting a housing 530 comprising: The housing 530 is in electrical communication with an electrode contact 535 that is in physical contact with the hydrogel pad 520 . It should be understood that the housing 530 remains over the skin surface while the electrode contact 535 in physical contact with the hydrogel pad 520 contacts the skin surface. In some embodiments, the housing 530 is held within a range of 2 mm to 4 mm above the skin surface, preferably within 2 mm above the skin surface. In some embodiments, flexible circuit anchors 540 are laminated around electrode contacts 535 . In various embodiments, anchor 540 comprises a layer of polyimide or other semi-rigid material. A perforated hole 542 is included along the length of the perimeter of the anchor 540 so that the material of the overmold parts 505 and 510 is absorbed and attached therein to completely surround the electrode contact 535 and the hydrogel pad 520 . can Because the overmold portions 505 and 510 surround the hydrogel pad 520 together, this allows the flexible circuit to provide electrical contacts for connection to the hydrogel, thereby eliminating the need for tight tolerance individual electrical connectors. Keep the cost of gel-based electrodes low.

Referring back to FIG. 5A , in some embodiments, overmold portions 505 , 510 include a low hardness material having a defined geometry via a two shot injection mold process. In various embodiments, the material for the overmolds 505 and 510 comprises a thermoplastic elastomer (TPE) such as, for example, Monprene (manufactured by Techner Apex) as a super soft TPE gel. TPE is processed like any other thermoplastic material, but generally has a low modulus of elasticity, making the assembly flexible. The first shot injection mold forms the overmold portion 505 as the narrow cross-sectional hoop or perimeter of the EDP device 500 , while the second shot injection mold forms the overmold portion 510 .

In various embodiments, the TPE used as the material for the overmold portions 505, 510 has a hardness ranging from 30 to 70, preferably 45 to 65, more preferably 50 to 60 on a sub zero shore (00) scale. and a tensile modulus (indicating flexural properties) ranging from 15 psi to 55 psi, preferably from 30 psi to 45 psi. For example, Monpren Ultra Soft Gel Grade CP-32053G (manufactured by Techner Apex) has a hardness measurement of 53 on the sub-zero shore (00) scale and a tensile modulus of about 37 psi. The viscosity of Monpren Ultra Soft Gel ranges from 30 to 65 on the Shore (00) scale of sub-zero. The use of a low hardness material, such as monprene gel, in conjunction with the built-in flex joint of the flexible circuit, makes the EDP device assembly quite flexible and on a flex modulus scale according to ASTM D-747 ranging from 10 psi to 35 psi, preferably from 15 psi to 25 psi. It is understood that measurements for

In accordance with aspects herein, a flex joint exists between a rigid or inflexible non-separable assembly within an EDP device. In one embodiment, the battery and flex circuit are non-separable assemblies. Thus, there is a flexible joint between these two assemblies. In various embodiments, flex joints between rigid non-separable assemblies are designed for both first and second shot tooling (for a two-shot injection mold process) such that soft overmold material is present between the rigid assemblies in a fully fabricated EDP device. obtained by doing Further, the joint is oriented within the body of the EDP device so that when the EDP device is placed on the patient's body in such a way as to adequately stimulate the intended dermatome, the flexural joint is perpendicular to the curvilinear contour of the patient's body in this position so that the EDP device flex to conform to the curvature of the patient's body.

In one embodiment, the overmolded portion 505 uses a higher hardness TPE compared to the overmolded portion 510 . The overmold 505 is made of a slightly higher hardness material (than the overmold portion 510) because the perimeter of the device should be flexible, but the handling of the EDP is rough and will damage the electronic circuitry involved when stretching is induced. This is because tensile integrity must be provided so as not to cause The higher hardness material used to create the narrow cross-section hoop 505 along the perimeter is a modified TPE grade G-7970 manufactured by Kraton Corporation according to one embodiment. This TPE grade is a block polymer in which the elastomeric portion of the molecule is a saturated olefin polymer. The higher hardness material, in various embodiments, ranges from 35 to 45 Shore A, and the lower hardness material is less than 35 Shore A.

In various embodiments, the electrical skin patch device 500 has a penetration protection rating (IPX) of at least IPX7, and while the electrical skin patch device 500 is placed on the body without water damage to the electrical skin patch device 500, a patient Allow the person to shower and swim for at least 30 minutes. In various alternative embodiments, EDP device 500 has an ingress protection rating (IP) ranging from IP3 to IP5 according to IEC standard 60529 and preferably a waterproof rating of IP4 (i.e. protection from splashing water from any direction for 5 minutes). ) has

In various embodiments, flexible overmolds, such as overmold 435 of FIG. 4E and overmold 515 of FIG. 5A are also non-toxic to protect against accidental contact with skin.

In various embodiments, housing 530 has a typical floor area of 1.5 inches ² for a physical aspect ratio of width to length of flexible circuit carrier 525 of about 1:1.

In one embodiment, an electrical skin patch device (EDP) comprises an over-skin printed circuit designed to be printed directly onto a patient's epidermis. The printable EDP includes film electrodes of sufficient thickness to withstand the current required for the electrical stimulation protocol of current specifications without sacrificing quality. The printable EDP includes a wireless transceiver (for communication with an interlocking device), a microcontroller, a power management module or battery, a pulse generator and at least one electrode. In some embodiments, the printable EDP further comprises at least one sensor.

In another embodiment, an electrical skin patch device (EDP) comprises a highly flexible membrane or 'flex circuit' configured to be attached to the epidermis of a patient. The 'flex circuit' is configured to be applied and adhered to the patient's skin like a conventional tattoo. A 'flex circuit' consists of a curved or 'S' shaped circuit. The curved shape allows the 'flex circuit' to move with the patient's skin without being damaged. A 'flex circuit' EDP includes a wireless transceiver (for communication with an interlocking device), a microcontroller, a power management module or battery, a pulse generator and at least one electrode. In some embodiments, the 'flex circuit' EDP further comprises at least one sensor.

In another embodiment, an electrical skin patch device (EDP) comprises a combination of a printed circuit board with connectors, eg, grade FR-4, and a flex circuit, eg, Kapton®.

In various embodiments, the dimensions and/or form factor of the electrical skin patch devices herein may include at least one dimension of length or width exhibiting the following attributes: less than 1.26 inches; a volume ranging from 0.1 inch ³ to 0.5 inch ³ ; weight ranging from 10 g to 80 g; a physical aspect ratio of width to thickness in the range of 1:1 to 6:1; a maximum height or thickness of the EDP of less than 1 inch, preferably less than 3/4 inch, more preferably no more than 1/2 inch; floor area of EDP devices ranging from 3.5 inch ² (1:1 aspect ratio) to 6 inch ² (6:1 aspect ratio); any one or combination of electrical aspect ratios ranging from 1:1 to 1.5:1. In various embodiments, the ratio of EDP electrode surface area to EDP weight is selected to keep the size of the electrode equal to or less than the skin-contacting floor area of the EDP device. In some embodiments, the ratio of EDP electrode surface area to EDP weight ranges from 0.1 to 0.8 square inches per gram weight of the EDP device, preferably from 0.2 in ² /gram to 0.5 in ² /gram.

In some embodiments, an EDP of substantially rectangular shape (eg, that of FIGS. 4B, 4C ) has a width of 1.25 inches, a length of 4.0 inches, and a height of 0.15 inches. In some embodiments, the circular shape EDP (eg, that of FIGS. 5A-5F ) has a radius of 1.125 inches and a height of 0.15 inches.

Although different physical configurations may exist for an electrical skin patch, it is understood that it is important for the device to deliver sufficient electrical stimulation in a patch structure of an appropriate size, i.e., a patch structure that is not large enough to be uncomfortable to wear. To this end, in one embodiment, a preferred electrical skin patch comprises electrodes removably attached to the surface of the housing. The contact surface area of these electrodes is preferably less than 10 in ² , more preferably less than 8 in ² , still more preferably less than 7 in ² , and is in the range of 0.1 in ² to 10 in ² or more preferably 0.5 in ² to 4 in ² ; , the programmable current range is 100 mA to 500 mA, or more preferably 2 mA to 50 mA. In this embodiment, the current density of the electric skin patch is 10 μA/in ² to 5000 mA/in ² , more preferably 25 μA/in ² to 1000 mA/in ² , even more preferably 0.5 mA/in ² . to 100 mA/in ² . In this configuration, the total contact surface area of the electrical skin patch is equal to the contact surface area of the electrode(s).

In another embodiment, a preferred electrical skin patch comprises an electrode that is at least partially attached within the housing and is not removably attached to a surface of the housing. The contact surface area of these electrodes is preferably less than 10 in ² , more preferably less than 8 in ² , still more preferably less than 7 in ² , and is in the range of 0.1 in ² to 10 in ² or more preferably 0.5 in ² to 4 in ² ; , the programmable current range is 100 mA to 500 mA, more preferably 2 mA to 50 mA. In this embodiment, the current density of the electric skin patch is 10 μA/in ² to 5000 mA/in ² , more preferably 25 μA/in ² to 1000 mA/in ² , even more preferably 0.5 mA/in ² . to 100 mA/in ² range. The total contact surface area of the electrical skin patch in this configuration is equal to the contact surface area of the electrode(s) plus some additional amount for the peripheral portion of the housing, which is typically an additional 5% to 10% over the electrode(s) surface area. It will not reach more contact surface area.

In either configuration, one, two, three or more electrodes may be attached to or incorporated into the housing without departing from the scope of the present invention, each of which is understood to have the characteristics described above.

55A and 55B are, according to one embodiment, having a pair of removable, replaceable conductive hydrogel, hydrocolloid or foam pads 5520 ( FIG. 55C ) and a substantially rectangular shaped patch housing 5535 , according to one embodiment. It is a top perspective view of an electrical skin patch device 5510 , and FIG. 55C is a bottom view thereof. In one embodiment, the housing approximates an oval or curved rectangle. The patch housing 5535 includes a microcontroller, a pulse generator, a wireless transceiver, and a power management module as described with reference to FIG. 1A . Electrodes extend from housing 5535 to pad 5520 for placement proximate to the patient's skin surface. It is understood that the housing 5535 remains over the skin surface while the electrode pad 5520 contacts the skin surface. In some embodiments, the housing 5535 remains within the range of 2 mm to 4 mm above the skin surface, preferably within 2 mm. In one embodiment, the pad 5520 has two electrodes 5518 disposed or printed on the lower surface 5522 of the pad 5520 . The lower surface 5522 is adhesive (covered by the tab) so that the base surface 5522 can adhere to the skin when the tab is removed. The peel strength of the adhesively bonded pad 5520 ranges from 1.0 Newtons to 2.1 Newtons, allowing the device to adhere to the skin for at least 8 hours in strenuous activity, such as exercise. The pad 5520 allows the electrode to make direct contact with the outer surface of the skin when attached to the user's skin. 55C , in an embodiment, the pad 5520 has each of two electrodes 5518 disposed or printed on opposite halves of the lower surface 5522 . In an embodiment, the distance 'D' between the two electrodes 5518 is less than 20 mm, preferably less than 15 mm, preferably less than 10 mm, preferably less than 5 mm. In one embodiment, the distance 'D' between the two electrodes is about 4 mm. In one embodiment, each of the printed electrodes 5518 is 0.01 in ² to 10 in ² divided by depressions or spines 5503 having a width 'W' in the range of 1 mm to 12 mm, preferably 6 mm, Preferably it has a surface area in the range of 1.7 in ² . In some embodiments, the total surface area occupied by the bases of the two electrodes 5518 is preferably less than 10 in ² , more preferably less than 8 in ² , more preferably 7 in ² or less, or within the range of 0.1 in ² to 10 in ² . . According to some embodiments, the skin contact surface area of each of the two electrodes 5518 is 3 cm±0.5 cm, the distance ‘D’ is about 0.2 cm±0.1 cm and the area between the two electrodes is 0.2 cm±0.1 cm, preferably is in the range of 0.05 cm 2 to 0.4 cm 2 . According to some embodiments, the total skin-contacting surface area of the two electrodes 5518 ranges from 2 cm 2 to 4 cm 2 .

According to one embodiment, the housing 5535 includes a first portion 5525 forming a perimeter or outer boundary of the EDP device 5510 , and a second portion 5530 forming a central portion of the EDP device 5510 . include In various embodiments, the system electronics described with reference to FIG. 1A is substantially enclosed within the second portion 5530 . In some embodiments, the upper surface 5512 of the second portion 5530 allows the EDP device 5510 to toggle between an activated state or an inactive state and/or to be depressed while the EDP device 5510 is in an activated state. and a button 5513 that can be actuated such as to press or toggle to provide feedback to the patient when In some embodiments, button 5513 may provide different functions depending on the number of times the button is pressed or the position of a switch. For example, pressing or toggling button 5513 while EDP device 5510 is active and attached to the patient's skin provides tactile feedback such as vibration or audio feedback indicating tissue and electrode contact integrity and electrode integrity. can do.

In one embodiment, the overall length of the EDP device 5510 along the longitudinal axis 5501 is less than 200 mm, preferably less than 100 mm, preferably about 76 mm, while the overall width along the axis 5502 . (where axis 5502 is substantially perpendicular to longitudinal axis 5501 ) is less than 200 mm, preferably less than 100 mm, preferably less than 50 mm, preferably approximately 46 mm. In one embodiment, the width of the second portion 5530 along the axis 5502 is 32 mm to allow a 7 mm thickness of the first portion 5525 that forms the perimeter or outer boundary of the EDP device 5510 . In one embodiment, button 5513 has a first dimension of 11 mm along longitudinal axis 5501 and a second dimension of 16 mm along axis 5502 .

In some embodiments, visual feedback may additionally or alternatively be generated via LEDs according to various configurations. Also, in some embodiments, instead of a separate button 5513 , the entire top surface 5512 is configured to function as an actuable button. In one embodiment, FIG. 55H shows an EDP device 5510h having a visual indicator 5540 comprising at least one LED and a button 5513 positioned on the top surface 5512 of the second portion 5530 . do. In another embodiment, FIG. 55I shows an EDP device 5510i having a first portion 5525 surrounding a perimeter of a central second portion 5530 . In this embodiment, button 5513 is located on top surface 5512 of second portion 5530 , while visual indicator 5540 is visually displayed using at least one LED enclosed within second portion 5530 . a perimeter or rim of an illuminated button 5513 . In another embodiment, FIG. 55J shows an EDP device 5510j having a first portion 5525 surrounding a perimeter of a central second portion 5530 . In this embodiment, the entire upper surface 5512 of the second portion is configured to function as an actuable button 5513 . A visual indicator 5540 comprising one or more LEDs is also located on the top surface 5512 . The visual indicator 5540 of the embodiment of FIGS. 55H, 55I and 55J includes a red light indicating that the patient's health parameters, such as willpower level, score, reserve or reserve, are very low (below a predetermined minimum willpower threshold); to be understood to produce visual feedback including, but not limited to, a yellow light indicating that the patient's willpower reserve is in the intermediate zone, and a green light indicating that the patient's willpower reserve is strong or high (exceeding a predetermined willpower threshold) do. Instead of willpower, visual indicator 5540 may be used to generate feedback corresponding to any health parameter, such as, but not limited to, target weight, diet adherence, hunger level, exercise or activity level. Additionally, visual indicator 5540 may be used to indicate an active or inactive state of the EDP device in lieu of or in addition to feedback generated via button 5513 . Furthermore, a visual indicator may be used to indicate the EDP's battery level.

Referring again to FIGS. 55A-C , in various embodiments the hydrogel pad 5520 is replaceable to allow attachment of a new conductive pad and thus a new adhesive surface to the EDP device 5510 . 55D is a bottom perspective view of the EDP device 5510 with the hydrogel pad removed. Two electrode contacts 5519 in electrical communication with the housing 5535 ( FIGS. 55A , 55B ) are visible on the lower surface 5542 of the second portion 5530 . According to one aspect, around the circumference, perimeter, or outer boundary 5543 of the lower surface 5542 of the first portion 5525 ( FIGS. 55A , 55B ), a ridge or rim portion 5545 may nest, Forming a recess or hollow, the hydrogel electrode pad 5520 ( FIG. 55C ) may snap into a nest, recess, or hollow interior such that it is flush with the ridge or rim portion 5545 . This allows the patient to easily match the electrode or hydrogel pad to the EDP device via a snap or pin configuration corresponding to the electrode contacts 5519 while making the electrode less visible. In one embodiment, the ridge or rim portion 5545 has a thickness of 2 mm. FIG. 55E is a side perspective view of an EDP device 5510 with a hydrogel pad 5520 fitted in place or snapped into a nest formed by a first portion 5525 at the bottom of the EDP device 5510 .

According to one aspect, in some embodiments, electrode pad 5520 (FIG. 55C) provides two types of skin contact adhesive that renders the electrode substantially waterproof (as opposed to electrode pad 520 , which uses only hydrogel as an adhesive). includes FIG. 55K shows a bottom view of the waterproof electrode pad assembly 5565 , while FIG. 55L shows an exploded view of the electrode pad 5565 . As shown in FIG. 55K , the lower surface 5566 of the electrode pad 5565 includes a first skin contact adhesive 5567 , and along the perimeter of the lower surface 5566 of the pad and a first skin contact adhesive region 5567a . , 5567b) with a second skin contact adhesive 5568 along the middle rib 5569 (ie, between the two electrodes 5518 shown in FIG. 55C). In various embodiments, the first skin contact adhesive 5567 is a hydrogel used as the primary adhesive to the skin as well as a conductive medium that allows current to flow from the EDP device to the patient's skin. The second skin contact (secondary) adhesive 5568 may be an adhesive coated polyester nonwoven fabric (e.g., Hypafix manufactured by Smith and Nephew) or an adhesive coated polyethylene acrylic foam (e.g., It is an acrylic pressure sensitive adhesive using MDFT4532 manufactured by Coating and Converting Technologies. The electrode pad 5565 may be peeled off the EDP device by pulling the removal tab 5570 .

Referring now to FIG. 55L , the electrode pad assembly 5565 includes a pair of snap portions 5571 on top followed by a thermoplastic polymer or PET (polyethylene terephthalate) layer 5572, a double-sided tape layer 5573, a carbon-containing a vinyl layer 5574 , a snap eyelet 5575 , a first skin contact adhesive or hydrogel 5567 and a second skin contact acrylic adhesive 5568 .

The acrylic adhesive 5568 is not soluble in water and thus water does not permeate. The hydrogel 5567 is impermeable to water. When the hydrogel 5567 comes into contact with water (such as a person's sweat or shower), it absorbs water and becomes less sticky to the skin while maintaining electrical conductivity. Due to the use of the secondary acrylic adhesive 5568, the adhesion to the skin does not change even in the presence of water. The use of the secondary adhesive 5568 allows the user to perspire or shower to retain the electrode pad assembly 5565 and EDP device to the skin during vigorous activity where the adhesion of the primary adhesive or hydrogel 5567 may decrease. can

55M is an exploded or disassembled view of an electrode pad assembly using a foam pad with an acrylic adhesive or hydrocolloid adhesive. Referring now to FIG. 55M , the electrode pad assembly 5585 includes a pair of snap or romefast studs 5586 on top followed by a thermoplastic polymer or PET (polyethylene terephthalate) layer 5587, a double-sided tape layer. 5588 , a first adhesive layer 5589 , a carbon-containing vinyl layer 5590 , an eyelet 5591 for snap or romfast, and a second skin contact adhesive or hydrogel layer 5592 .

In some embodiments, PET layer 5587 has a thickness of 0.005 inches.

In some embodiments, the first adhesive layer 5589 is comprised of a foam with an acrylic adhesive. In some embodiments, the first adhesive layer 5589 is 0.032 inches thick. In embodiments where the first adhesive layer 5589 is a foam, acrylic layer, the second adhesive or hydrogel layer 5592 is 0.032 inches thick.

In some embodiments, the first adhesive layer 5589 is comprised of a hydrocolloid adhesive. In embodiments where the first adhesive layer 5589 is a hydrocolloid adhesive layer, the second adhesive or hydrogel layer is 0.020 inches thick. In one embodiment, the surface area of the hydrocolloid layer is at most 8 in ² . In embodiments, the hydrocolloid adhesive is designed to be waterproof and sweat resistant, and to be retained during intensive exercise. In an embodiment, the hydrocolloid adhesive is designed to adhere to the skin for a period of time ranging from at least 8 hours to several days.

55F and 55G are side perspective views with a portion of the housing 5535 cut away to expose an assembly of the EDP device 5510 according to one embodiment also showing how the respective portions of the housing are connected. Referring now to FIGS. 55F , 55G , according to one aspect, the central second portion 5530 is a clamshell comprising a first upper or upper portion 5531 and a second lower or lower portion 5532 . manufactured as a mold, and a space 5555 is formed between the upper and lower portions to receive or receive the system electronics described with respect to FIG. 1A . The first portion 5525 is made of a flange, collar, or rib 5550 that runs along the inner circumference of the first portion 5525 . Similarly, first portion 5531 also has a flange, collar or rib 5560 that extends vertically downward and runs along the inner circumference of first portion 5531 . During assembly, flange 5550 is fitted between first and second portions 5531 , 5532 of clamshell-shaped central second portion 5530 and is used to connect them. In various embodiments, the flange 5550 includes a vertically extending flange 5560 to retain the first portion 5525 by the second portion 5530 and form an assembly of the EDP device 5510 . L-shaped to be locked. Also visible is a ridge or rim portion 5545 defining a nest therebetween to receive hydrogel pad 5520 (or waterproof electrode pad 5565 in FIGS. 55K , 55L in some embodiments).

The EDP device assembly formed by connecting the first portion 5525 by the clamshell-like second portion 5530 is characterized by the simplicity of EDP device assembly; secure fit of the first and second portions 5525 and 5530; In some embodiments, one or more within space 5555 to generate light around the rim of button 5513 (as shown in FIG. 55I ) that is the entire upper surface 5512 (as shown in FIG. 55J ). ease of accommodating LEDs; allowing a plurality of different colored first portions or skirts 5525 to be easily altered and reassembled with a second portion 5530; allowing internal components within space 5555 (eg, including the system electronics of FIG. 1A ) to be recycled or replaced; and effectively protecting internal components from damage.

Referring again to FIGS. 55A, 55B, and 55F, in some embodiments the central second portion 5530 is made of rigid plastic, while the first skirted portion 5525 is made of silicone, rubber, LSR (liquid silicone rubber). ) or any other flexible polymer known to those skilled in the art. In other embodiments, the material for both the first and second portions 5525 and 5530 includes silicone, rubber or LSR of similar or different hardness grades. In one embodiment, the material for the first portion 5525 is low hardness silicon, while the material for the second portion 5530 is relatively high hardness silicon. In some embodiments, the material for housing 5535 comprises a thermoplastic elastomer (TPE), such as, for example, Monprene manufactured by Techner Apex as a super soft TPE gel. TPE is processed like any other thermoplastic material, but generally has a low modulus of elasticity, making the assembly flexible. In various embodiments, the TPE used as the material for the housing 5535 has a hardness ranging from 30 to 70, preferably 45 to 65, more preferably 50 to 60, and 15 psi to 55 psi on a sub zero shore (00) scale. , preferably having a tensile modulus (indicating flexural properties) in the range of 30 psi to 45 psi. For example, Monpren Ultra Soft Gel Grade CP-32053G (manufactured by Techner Apex) has a hardness measurement of 53 on the sub-zero shore (00) scale and a tensile modulus of about 37 psi. The viscosity of Monpren Ultra Soft Gel ranges from 30 to 65 on the Shore (00) scale of sub-zero. The EDP device herein has measurements on the Flexural Modulus Scale according to ASTM D-747 in the overall range of 10 psi to 35 psi, preferably 15 psi to 25 psi.

In various embodiments, the dimensions and/or form factor of the electrical skin patch device 5510 may include at least one dimension of length or width representing less than 1.26 inches; a volume ranging from 0.1 inch ³ to 0.5 inch ³ ; weight ranging from 10 g to 80 g; a physical aspect ratio of width to thickness in the range of 1:1 to 6:1; a height (h) of less than 1 inch, preferably less than 3/4 inch, more preferably less than or equal to 1/2 inch; floor area of EDP devices ranging from 3.5 inch ² (1:1 aspect ratio) to 6 inch ² (6:1 aspect ratio); any one or combination of electrical aspect ratios ranging from 1:1 to 1.5:1. In various embodiments, the ratio of EDP electrode surface area to EDP weight is selected to keep the size of the electrode equal to or less than the skin-contacting floor area of the EDP device. In some embodiments, the ratio of EDP electrode surface area to EDP weight ranges from 0.1 to 0.8 square inches per gram weight of the EDP device, preferably from 0.2 in ² /gram to 0.5 in ² /gram.

Interlocking device/control

Referring again to FIG. 1A , the electrical skin patch device 110 is in data communication with and controlled by the interlocking device 105 in accordance with an aspect herein. The companion device 105 may also be in data communication with a remote patient care facility and/or patient care personnel. The interlocking device 105 is in data communication with the electrical skin patch device 110 via a direct link to actuate the therapy. According to a preferred embodiment, the companion device 105 includes a watch, wristband, and wristband that controls the electric skin patch device 110 via a wireless connection such as Bluetooth, WiFi or other private/public cellular or TCP/IP network such as the Internet; A portable computing device such as a smartphone, tablet, or PDA. In some embodiments, the companion device is referred to as a separate or external device because it is physically separate from the EDP and is external to the EDP. In some embodiments, the companion device may be a wearable activity monitor that tracks heart rate, movement and other physiological data. In some embodiments, the EDP may be integrated into a wearable activity monitor and may communicate with an external device, such as a smartphone, running a software application in data communication with the wearable activity monitor.

In an embodiment, the companion device 105 may perform data communication not only with the EDP device but also with other devices or equipment at the same time. For example, the companion device 105 configured as a smartphone may communicate data with a car or a car audio system while communicating with at least one EDP device. Therefore, when the user is in the car, the car acts as a master, and the smartphone (interlocking device) acts as a slave, while between the smart phone and the EDP device, the smart phone acts as the master and the EDP acts as a slave.

The interlocking device 105 is configured to monitor and record ('learn') the patient's appetite pattern and to monitor and record, learn and modify the stimulation parameters of the stimulation protocol delivered by the electrical skin patch device 110 . In some embodiments, all therapies provided by the electrical skin patch device 110 are combined with a record (keep log of therapy) and patient compliance reminders provided by the interlocking device 105 . FIG. 6A shows an electrical skin patch device 610 herein configured as a skin patch and disposed in the lateral thoracic dermatome, eg, wirelessly controlled by a smartphone 605 , according to one embodiment.

Referring to FIG. 1A , in accordance with one aspect, the companion device 105 , which in various embodiments is a handheld computing device (eg, smartphone, tablet, PDA), executes or implements a health care software application. The health care application activates, deactivates, and controls the electrical skin patch device 110 to provide a plurality of stimulation regimens or protocols in accordance with various embodiments. In some embodiments, this is enabled by pairing or synchronizing the portable computing device with the electrical skin patch device 110 (either wirelessly or via a wired connection). In some embodiments, the health care application pairs or synchronizes and controls more than one electrical skin patch device 110 worn by a user to treat a combination of conditions.

In another embodiment, the health care application also monitors, acquires, records, and/or transmits physiological data to receive and incorporate exercise and weight loss information with one or more electrical skin patch devices 110 herein. Physiological sensors configured to be worn on the human body, such as around the wrist, may be used to communicate (via pairing or synchronization) with third-party devices (including third-party application software on external devices). In various embodiments, the third-party device includes a blood glucose sensor.

In an embodiment in which the health care application is paired or synchronized with the plurality of electric skin patch devices 110 , it is desirable for the user to be able to confirm that the health care application has been successfully paired or synchronized with each of the plurality of electric skin patch devices. In some embodiments, the electric skin patch device and the companion device (running the health care application) flash similar colors (using LEDs) to indicate successful pairing or synchronization. Thus, each of the plurality of electrical skin patch devices, for example, blinks a color sequentially or simultaneously with the interlocking device, indicating successful pairing or synchronization with each of the electrical skin patch devices. In some embodiments, the companion device (running the health care application) displays a unique identifier (ID) of the electric skin patch device, indicating successful pairing or synchronization with the electric skin patch device. Accordingly, the unique ID of each of the plurality of electrical skin patch devices is displayed on the companion device, indicating successful pairing or synchronization with each of the electrical skin patch devices.

According to one aspect of the present disclosure, a cervical auscultation is used to detect pharyngeal swallowing and thus determine whether a user is indulging in an eating activity. 56 illustrates a swallow detection device 5605 configured to be worn around the neck by a user in accordance with some embodiments. The healthcare application may communicate (via pairing or synchronization) with the swallow detection device 5605 to monitor, acquire, record, and analyze sounds the user swallows while participating in feeding. In one embodiment, swallow detection device 5605 includes an accelerometer for detecting signals related to swallowing sounds and noises related to laryngeal elevation and carotid pulse. The detected signal is transmitted to a health care application (of a companion device such as a smartphone) for sound processing and analysis. Depending on the analysis, for example, dry swallowing (not related to eating) and wet swallowing, taking into account at least the repeatability of the plurality of swallowing events, the time elapsed between the plurality of swallowing events, and the overall duration including the plurality of swallowing events. Distinguish between swallowing (related to eating). Thus, in some embodiments the prolonged occurrence of multiple swallowing events may be considered ingestion of a meal. In various embodiments, the swallow detection sensor 4005 is configured to be worn or attached to a user's skin to cover an optimal site for swallow detection. In an embodiment, the optimal site is any of a) the lateral border of the organ just below the cricoid cartilage, b) the midpoint between the center of the cricoid cartilage and the site above the center of the cricoid cartilage, and c) the site just above the jugular notch. include that

In various alternative embodiments, the impedance and/or acoustic detection of gastrointestinal sounds at the gastrointestinal level of the user is used to determine an eating event.

According to another embodiment of the present specification, an inertial sensor such as an accelerometer or inclinometer is used for automatic diet monitoring to automatically determine a user's feeding activity or feeding moment. In various embodiments, the accelerometer or inclinometer detects a plurality of dietary data related to physical body movements, such as haptic motions of the user's (e.g.) wrist or hand, related to a food intake gesture (also referred to as a hand and mouth gesture); For capture and acquisition, it is included in a wristband or wristwatch, such as band 2105 of FIG. 21A or wristwatch 2106 of FIG. 21B . The plurality of diet data is passed to a health care application that processes and analyzes the plurality of diet data and implements an eating moment recognition method to identify when a user is eating. According to one embodiment, a method for recognizing a moment of eating comprises: a) performing eating gesture detection on a plurality of dietary data captured by an accelerometer integrated within the user's wristband or wristwatch/smart watch, b) a moment of eating or We cluster these eating gestures along the temporal dimension to identify activities.

As described herein below, in embodiments in which the health care application communicates with an intelligent personal assistant (IPA), the identification or determination of an eating moment or activity (by a feeding moment recognition method) by the HMA is communicated to the IPA, The IPA may ask if the user is actually eating, and if so, can then deliver an audible prompt to the user that warns the user if an eating event is unscheduled or does not match the eating regime the user is following. In some embodiments, the feeding moment recognition method is implemented directly by the IPA device so that the dietary data of the wrist watch or band is passed directly to the IPA device (in communication with the wrist watch or band) to detect an eating event or activity.

58 is a flow diagram of a plurality of exemplary steps of a method of recognizing a moment of feeding implemented by an HMA in accordance with some embodiments. At step 5805, the user wears a wrist worn device, such as a wristband or wristwatch/smart watch, comprising at least an accelerometer that continuously captures and communicates a plurality of dietary data indicative of the user's food intake gesture to the HMA. . The HMA receives and stores a plurality of diet data from the accelerometer. At step 5810 , the plurality of diet data is filtered using a filter such as, for example, an exponentially weighted moving average, and the resulting filtered data is scaled to a unit norm (eg, normalized to 12). do. In step 5815, a data frame is extracted from the filtered and normalized result data of step 5810 using a sliding window approach with a predetermined overlap, for example 50% overlap. It is understood that the frame size is chosen such that the extracted frame contains the entire food intake gesture. Gesture duration is based on factors such as the user's eating style and whether or not multitasking (eg, reading a book, socializing with friends) while eating or drinking. In various embodiments, the frame size ranges in duration from 2 seconds to 10 seconds. In one embodiment, the frame size is selected to be 6 seconds in duration.

In step 5820, a plurality of statistical functions are computed for each extracted frame. In one embodiment, five statistical functions are calculated including mean, variance, skewness, kurtosis and root mean square of the frame. These frame-level features create a five-dimensional feature vector for each axis of the accelerometer, according to one embodiment.

At step 5825, the user's food intake gesture (eg, defined as an arm and hand gesture involving bringing food into the mouth from a resting position on a table and then lowering the arm and hand to the original resting position) is yes For example, they are identified using a classifier such as a Random Forest learning algorithm or the Scikit-learn Python package.

Then, at step 5830, an eating moment or activity of the user is estimated based on the temporal density of the identified food intake gesture. Such an event is interpreted as an eating moment or activity if a predetermined minimum number of identified food intake gestures are within a predetermined temporal distance of each other. In an embodiment, a density-based clustering algorithm such as Density-based spatial clustering of applications with noise (DBSCAN) is used to identify high food intake gesture densities as clusters in the time domain. In one embodiment, centroids of these clusters are identified as feeding instantaneous occurrences.

According to another aspect herein, an accelerometer or inclinometer included in a wristband or wristwatch, such as band 2105 of FIG. 21A or wristwatch 2106 of FIG. is used to detect, capture, and obtain a plurality of gesture data corresponding to . In an embodiment, the plurality of predetermined haptic motions of the wrist indicate a plurality of user initiated commands and/or inputs to the HMA.

Accordingly, the feeding moment recognition method of FIG. 58 is configured to detect and interpret a plurality of predetermined haptic motions of the user's wrist. For example, the number of repetitive circular motions of the hand (e.g., 3 or more) using the wrist as the pivot axis can cause the user to trigger a standard or pre-programmed stimulation session (before or after a meal) or to experience unplanned hunger. Triggering a hunger or appetite scale to record an event can be detected and interpreted by an eating moment recognition method indicating a desire to trigger a rescue stimulation session. In some embodiments, the direction of this repetitive circular motion of the hand may be further differentiated to indicate different commands and/or inputs by the user. For example, in one embodiment, a clockwise rotational movement of the hand using the wrist as the pivot axis may be detected and interpreted as indicating that the user desires to trigger a standard or pre-programmed stimulation session (pre-meal or post-prandial). and the counterclockwise rotation motion may indicate that the user wishes to trigger a hunger or appetite scale to record an unscheduled hunger event and consequently trigger a rescue stimulation session.

Suppose a user uses their wrist as a pivot and rotates their hand counterclockwise to trigger a hunger VAS bar scale on a wristband or wristwatch. Next, in some embodiments, the user may move their hand up and down in a vertical plane with the wrist pivoted to input and record the intensity of hunger they are experiencing. For example, the number of times the user moves his/her hand up and down may indicate the level of hunger that the user wants to input. Thus, on a hunger scale of 1 to 5, one up and down movement of the hand may represent a level 1 hunger intensity, and five consecutive up and down movements of the hand may correspondingly represent a level 5 hunger intensity. In an alternative embodiment, the user may move the hand from side to side in a horizontal plane with the wrist pivoted to input and record the intensity of hunger experienced by the user. Accordingly, the number of times the user moves his/her hand left and right may indicate the level of hunger that the user wants to input.

According to another aspect herein, a wristband or wristwatch includes a touch sensitive display screen configured to receive and subsequently interpret a user's taps and/or swipes. In a non-limiting example, the user may trigger the hunger VAS bar scale by rotating his or her hand counterclockwise with the wrist as the pivot. Next, the user can use a certain number of taps or swipes on the display screen of his wristband or watch to enter and record the intensity of hunger he is experiencing. Thus, on a hunger scale from 1 to 5, a single tap or swipe represents level 1 of hunger intensity, whereas a tap or swipe of 5 represents level 5 of hunger intensity. In embodiments, multiple haptic motions of the hand (using the wrist as pivot) and a tap or swipe on the display screen (of a wristband or wristwatch) to enable the user to issue commands and/or inputs to the HMA It should be understood that any one or combination of wipes may be used.

In another embodiment, the health care application may also detect and communicate a plurality of wireless proximity sensor tags. A plurality of proximity tags are located in potential meal supply and/or intake areas, such as, but not limited to, refrigerators, pantries, kitchens and restaurants, to detect a user's proximity in these areas. Upon detection of the user's presence in these areas, the HMA may prompt and warn the user regarding unplanned meal intake, for example.

In accordance with aspects herein, a plurality of electrical skin patch (EDP) devices together with a plurality of additional devices when paired or synchronized with at least one companion device of the user constitute a health or treatment network or ecosystem for the user. Similarly, a health or treatment network or ecosystem of multiple users is networked together to form a large-scale or wide-area health or treatment ecosystem (stylized as the Internet of Things). In embodiments, the additional device is a third party device (including physiological sensors) configured to be worn on the human body, such as around the wrist, a blood glucose sensor, an Intelligent Personal Assistant (IPA) system (described in detail herein below), proximity devices including but not limited to sensor tags, swallow detection devices (eg, device 5605 of FIG. 56 ), Bluetooth activation locks, and kitchen appliances (eg, refrigerators). In embodiments, a health or treatment network or ecosystem may connect additional devices capable of synchronizing wired or wirelessly. In some embodiments, a health or treatment network or ecosystem may preferentially synchronize a subset of additional devices, such as, for example, third party devices (including physiological sensors).

In some embodiments, multiple electrical skin patch (EDP) devices 110 are networked with a single companion device 105 to aggregate data feedback from EDP devices 110 . The aggregated data is then used to modify stimulation parameters and develop more accurate stimulation algorithms. In various embodiments, companion device 105 enables social networking with friends and family, provides voice recognition and voice feedback, and includes anti-hacking data protection for HIPAA compliance. In some embodiments, wireless connections (for pairing or synchronization) optionally comply with HIPAA and other regulatory agency requirements and laws pertaining to OUS (non-US) countries for patient data privacy. In various embodiments, the wireless connection is encrypted to prevent hacking of the device to retrieve patient data, inappropriately arouse the patient, and/or destroy the device.

In various embodiments, as shown in FIG. 6B , multiple EDP users 620 , 630 , 640 , 650 , 660 using companion devices 625 , 635 , 645 , 655 , 665 may be connected to each other, such as through a cloud-based connection. A shared network connection 621 allows them to network with each other and communicate about their therapy, which can improve patient compliance with stimulation protocols, thereby increasing dietary compliance. For example, networked EDP users can share and exchange experiences, progress, diet ideas and success stories. In some embodiments, exchanges over the network are automatically entered into the companion device resulting in changes to the therapy provided by the EDP device. For example, in one embodiment, aggregated dosing data is used to reset baseline default dosing settings to provide different dietary regimen recommendations. Traditionally, small group clinical studies are conducted to obtain data used to formulate dosing strategies. Networking EDP users via a companion device can automatically obtain a larger amount of aggregated user settings, for example via a cloud-based connection, which can be used to automatically fine-tune dosing settings. In some embodiments, EDP users have the ability to share data with friends and family who are also users via a network connection. In some embodiments, EDP users may be divided into diet clubs based on connected friends and/or based on a diet type selected by the user. Thus, in various embodiments, a user may connect with friends and also a defined "group" with respect to the type of diet plan the user follows: the Atkins, Mediterranean, and intermittent fasting types that the user follows. Also, in some embodiments, users connected to a group, eg, Weight Watchers, may receive “group therapy” support from a coordinator or therapist as needed or in the form of input at periodic intervals. In embodiments, “groups” also enable communication between EDP devices, between users, and between users and coordinators or therapists. This interconnection between friends, groups, and moderators/therapists provides a larger support network for EDP users and promotes user compliance.

In some embodiments, the EDP user network functions as a dosing setting and dietary information exchange. For example, in an aggregate patient data network, a number of different patients have EDPs that communicate with personal companion devices. 6C lists steps in one embodiment of a method in which a linked companion device aggregates, organizes, and analyzes a patient's hunger, appetite, and well-being scores and stimulation parameters for a plurality of patients, each having an EDP device connected to an aggregate patient network. It is a flow chart. At step 672 , each patient connects to the aggregate patient network using their companion device. At step 674, periodically, for example, several times a day, once a day, from 2 to 6 times a week or in any such increments, the patient's corresponding hunger, appetite and well-being score (hunger, Appetite, well-being scores (collectively referred to as patient status data), along with stimulation parameters of the patient, including but not limited to stimulation pulse width, pulse amplitude, pulse frequency, pulse shape, duty cycle, session duration, and session frequency The anonymized data about it is sent to a central server or set of servers.

At the central server, at step 676, the anonymized data from multiple users is organized into an aggregate database, including: 1) stimulation pulse width, pulse amplitude, stimulation parameters including, but not limited to, pulse frequency, pulse shape, duty cycle, session duration and session frequency, and 2) stimulation that generally leads to sufficient appetite suppression without an unacceptable decrease in well-being for a particular demographic segment. Analyzed to determine stimulation parameters including, but not limited to, pulse width, pulse amplitude, pulse frequency, pulse shape, duty cycle, session duration, and session frequency. In some embodiments, patient status data, such as hunger and appetite scores, are aggregated into a composite score, also referred to as a satiety score. In some embodiments, an exercise score that reflects calories burned is also factored into a composite or satiety score. Users can share their composite scores with friends and family (along with treatment or stimulation settings that lead to composite scores) via social networking (and/or online coaching or concierge services) to provide advice, encouragement and progress with dieting colleagues. can lead to

It should be understood that while in some embodiments data relating to a patient's stimulation parameters is anonymized, in some embodiments the data may not be anonymized if the patient signs their respective privacy rights.

In various embodiments, hunger and appetite scores across demographic profiles are optimal appetite and hunger levels or scores for a given age, gender, race, body fat, BMI, ethnicity, weight loss goal, or bacterial microbiome profile. are analyzed to determine which stimulus settings to achieve. Thus, once the optimal stimulus setting has been identified for a given user, it is then determined how the stimulus setting should be modified, titrated or personalized for the given user in order to match the optimal stimulus setting, and a new (optimal) stimulus setting is established. to transmit a modulated signal. In various embodiments, electrical stimulation dosing settings are titrated and personalized from one user and/or group of users to another user and/or group of users based on optimal stimulation settings tracked, analyzed, and determined across various group demographic profiles. do.

In various embodiments, the EDP device and the electrical stimulation it delivers are configurable and reconfigurable for different therapies and different aspects within a particular therapy. For example, with respect to weight loss and management, the patient and/or the linkage device may configure the EDP to deliver electrical stimulation to promote active weight loss in the patient, and deliver the electrical stimulation upon reaching a target body weight. The EDP can be reconstructed to maintain the patient at the target weight. This may be done via one or more applications downloaded to the companion device. 6D is a flow diagram illustrating steps involved in using one or more downloadable applications to construct and reconstruct stimulation provided by an electrical skin patch (EDP) device in accordance with an embodiment herein. In step 680, the patient obtains an EDP from the medical professional. At step 681 , the patient wears the interlocking device to the EDP and a separate physiological monitoring with physiological sensors configured to wear it on the body, such as around the wrist, to monitor, acquire, record, and/or transmit physiological data to the interlocking device. Pair with a device, wherein the companion device is configured to generate and modify stimulation parameters based on the monitored physiological data. In step 682 , the patient downloads from an online marketplace a first application designed to configure the EDP to achieve a first goal related to weight loss for a particular therapy, eg, weight management. The patient places the EDP on his or her body in step 683 . In step 684 , the first application sets specific baseline stimulation parameters designed to achieve the first goal, and based on patient diaries input to the companion device and/or physiological data sent to the companion device by a separate monitoring device. Construct an EDP for the first target by titrating or fine-tuning the stimulation parameters based on After the first goal is achieved, in step 685, the patient downloads from the online marketplace a second application designed to reconfigure the EDP to achieve a second goal related to a particular therapy, eg, weight maintenance for weight management. Download.

In various embodiments, one or both of the first and second applications are available from an online marketplace for a fee. Additionally, both the first and second applications may be separate individual applications residing on the companion device, separately obtained by accessing the online application marketplace associated with the companion device, and clicking on separate individual icons from the home screen of the companion device to be activated and executed. In another embodiment, the first application is downloaded from an online application marketplace associated with the companion device so that the second application and all subsequent applications responsible for modulating the stimulation parameters of the EDP are made available via the first application to the marketplace of this application. While being accessed and downloaded, it can be activated and executed by clicking a separate unique icon from the home screen of the companion device. Specifically, the first application provides a gateway to a database or library of additional applications that may provide different stimulation parameters based on input, weight, and other criteria that are different or different from the first application.

The second application then establishes, in step 686 , specific baseline stimulation parameters designed to achieve said second goal, and patient diaries input to the companion device and/or physiological data transmitted to the companion device by a separate monitoring device. Construct the EDP for the second target by titrating or fine-tuning the stimulation parameters based on In one embodiment, for weight management, stimulation parameters for a first goal (weight loss) focus more on patient diary records of well-being and hunger as input to titration therapy, while a second goal (weight maintenance) Stimulation parameters for α are more focused on daily body weight as input to titration therapy. Although weight management has been used to describe the above methods for modifying the therapy provided by the EDP, in various embodiments, the method using one or more online applications to configure and reconfigure the stimulation parameters of the EDP may include electrical stimulation therapy. It can be used under any conditions that accept it.

In various embodiments, the EDP and companion device are open source allowing the creation of applications for devices designed to practice treatment regimen methods similar to those described above. In another embodiment, a single master application downloadable to the companion device is responsible for controlling the EDP and setting the initial stimulation parameters. This master application comes with the EDP with initial purchase, can be purchased separately from the online marketplace, or downloaded free of charge. In various embodiments, additional software upgrades, such as in-application or “in-app” purchases, may be obtained for a fee within the master application and used to fine-tune the regimen. In various embodiments, such software upgrades include, for example, new diet plans, new workout plans, and improved fitness tracking, among others. In various embodiments, such software upgrades are created by a third party or by the creator of the master application. In some embodiments, a new application or software upgrade to the master application reconfigures the EDP to provide electrical stimulation targeted to different conditions. For example, in various embodiments, the application or upgrade reconfigures baseline EDP stimulation parameters to treat dysmenorrhea, back pain, incontinence, and other conditions including but not limited to peripheral neuropathy including diabetic peripheral neuropathy. In some embodiments, the electrical components of the device are the same, and the patient uses a different disposable electrode patch portion and repositions the device on his or her body. These applications and upgrades modify the algorithms used in the companion device to alter the stimulation parameters so that EDP treats various diseases. For example, in one embodiment, the patient initially uses EDP for weight management in a manner similar to that described above. She then downloads a paid online application to her companion device that reconstructs EDP stimuli to treat dysmenorrhea. Then she can use the initial application to revert her EDP back to her weight management settings. She can continue to download new applications and upgrades and reconfigure EDP to treat multiple different ailments and move back and forth between different ailments. For non-weight loss applications such as urinary incontinence, back pain, dysmenorrhea, peripheral neuropathy, including diabetic peripheral neuropathy, you can download a completely different application, whereas for new or different weight loss plans, you can download It is desirable to be able to download additional applications through the weight loss application itself, so as to avoid having multiple different and unique weight loss applications on the home screen of the companion device.

As the presently disclosed embodiments relate to medical treatment, it is essential to store, transmit and verify patient-specific data, such as data representing specific stimulus settings and patient condition data, in a secure and authenticated manner. In one embodiment, data transfers between the EDP, the companion device, and any remote server(s) are verified and authenticated by using, for example, checksums, private and public keys, and other forms of verification known in the art. receive At any time, if one or more data transmissions have not been properly verified or authenticated, any new or tampered stimuli settings associated with such data transmissions will be discarded or otherwise set aside and previously associated with a fully validated and/or authenticated complete data transmission set. Only stimulus settings are used. Alternatively, the system may lock the use of any stimulation setting until such data transmission can be fully verified with any new or modulated stimulation setting associated therewith.

6E is a flow diagram illustrating steps associated with a method of a companion device for verifying and/or authenticating a data transmission received from a remote server in accordance with some embodiments herein. At step 690 , the patient obtains an electrical skin patch (EDP) device from a medical professional. In step 691 the patient pairs the companion device with the EDP and remote server in a secure manner where it is verified and authenticated. At step 692, the companion device receives a data transmission comprising the new or modulated stimulus settings from the remote server. The companion device then checks in step 693 whether the data transmission has been properly verified and/or authenticated. In one embodiment, once the data transmission has been properly verified and/or authenticated, the companion device controls the EDP to deliver electrical stimulation based on the new or modulated stimulation settings in step 694 . In one embodiment, if the data transmission is not properly verified and/or authenticated, the new or tampered stimulus setup is discarded or set aside and the previous stimulus setup associated with the fully verified and/or authenticated complete data transmission set is replaced in step 695 ) is used in In other embodiments, if the data transmission has not been properly verified and/or authenticated, the companion device, along with any new or modulated stimulus settings associated therewith at step 696, may proceed with any of the data transmissions until the data transmission can be fully verified. Locks the use of the stimulus settings of

In another embodiment, the communication between the EDP, the companion device, and any remote server(s) is dependent on whether the particular EDP associated with data transfer is a device marketed under FDA regulatory approval or a device not marketed under FDA regulatory approval. may include an indication such as a packet header, identifier, tag or other representation of the Different data processing may occur depending on these identifiers (indicating government regulatory governance or some scope). For example, if the companion device or remote server(s) determines that the EDP in question is to be FDA approved (based on an identifier stored in memory within the EDP), it may determine that the data stored or the encryption, authentication and/or data transfer applied to it are transmitted. or may trigger a different or higher level of verification. In one case, all data transfers to and from the EDP, all data transfers between the EDP and the companion device, and/or all data transfers between the companion device and the remote server are encrypted, authenticated and anonymized according to the verification. In other cases, only data transmissions containing patient-specific stimulus settings or patient status data are encrypted, authenticated and/or verified, and all other data transmissions are unencrypted.

On the other hand, if the companion device or remote server(s) determines that the EDP in question is not subject to FDA approval (based on an identifier stored in memory within the EDP), then this is the lower level applicable to the stored data or data transfer in connection with the FDA case. encryption, authentication and/or verification of In one embodiment, none of the data transfers to and from the EDP, data transfers between the EDP and the companion device, and/or data transfers between the companion device and the remote server(s) are encrypted, authenticated, or verified. In other cases, only data transmissions including patient-specific stimulus settings or patient status data are authenticated and/or verified, and data transmissions are not encrypted.

6F is a flow diagram illustrating steps associated with a method of encrypting, authenticating, and/or verifying data transmission between an EDP, a companion device, and a remote server based on the FDA approval status of the EDP in accordance with some embodiments herein. At step 661 , the patient obtains an electrical skin patch (EDP) device from a medical professional. The patient pairs the companion device with the EDP and remote server in a secure manner that is verified and authenticated at step 662 . At step 663 the companion device and/or remote server determines whether the EDP should be FDA approved based on the indications on the EDP (packet header, identifier, tag). In one embodiment, if it is determined that the EDP needs FDA approval, then all data transfers to and from the EDP, all data transfers between the EDP and the companion device, and/or all data transfers between the companion device and the remote server are performed in step 664 ) is encrypted, authenticated, and verified. In another embodiment, in step 666, if it is determined that the EDP should be FDA approved, including patient-specific stimulus settings or patient conditions to and from the EDP and/or between the EDP and the companion device and/or between the companion device and the remote server. Only data transmissions that are sent are encrypted, authenticated and/or verified, and all other data transmissions are unencrypted. In another embodiment, if it is determined that the EDP is not subject to FDA approval, then none of the data transfers to and from the EDP, between the EDP and the companion device, and/or between the companion device and the remote server are encrypted at step 667; Not certified and verified. In another embodiment, if it is determined in step 669 that the EDP is not subject to FDA approval, including patient-specific stimulus settings or patient conditions to and from the EDP and/or between the EDP and the companion device and/or between the companion device and the remote server. Only data transfers that require authentication are authenticated and/or verified, and data transfers are not encrypted.

In accordance with one aspect of the present disclosure, patient condition data and, if necessary, stimulus settings, parameters and protocols are transmitted to an insurance company to support medical treatment such as bariatric surgery or other insurance claims or other general insurance data needs. In some embodiments, this data transmission may be encrypted, authenticated, and verified as described in step 666 .

The health care application of the present specification (hereinafter referred to as 'HMA') includes a plurality of program commands and algorithms, and implements a plurality of graphical user interfaces (GUIs) enabling a plurality of functions, non-limiting examples thereof is explained later.

Referring again to FIG. 1A , in various embodiments, the HMA may verify a link with the electric skin patch device 110 and indicate a battery life of the electric skin patch device 110 . In an embodiment, the EDP device 110 periodically enters a sleep mode or state when not stimulated, for example to conserve power. In a sleep mode or 'off' state, the EDP device 110 uses minimal power. As a result of being in a low power state, the Bluetooth connection between the EDP device and the companion device (portable computing device 105 ) may be lost, or pairing or synchronization between the EDP device and the companion device may be lost. Also, if the distance between the EDP device and the companion device exceeds a certain limit, the Bluetooth connection may be disconnected. To ensure proper connectivity between the EDP device and the companion device, the HMA issues an audible, visual and/or tactile (e.g. vibration) alarm when the Bluetooth connection between the EDP device and the companion device deteriorates and the EDP device cannot be detected. can create

The HMA is determined that a) the electrical skin patch device 110 has been properly placed on the user's body, e.g., by ensuring sufficient electrode and tissue contact or integrity, and b) one or more electrodes 118 have aged or damaged (e.g., It makes it possible to create an audio and/or visual indicator that indicates to the portable computing device 105 that it needs to be replaced (as confirmed by an impedance measurement, for example). In some embodiments, electrode and tissue contact integrity and electrode integrity, ie, whether the electrode is functioning properly or has been compromised, is checked via at least one sensor, such as an impedance or bioimpedance sensor of the electric skin patch device 110 . In another embodiment, an acoustic sensor capable of detecting a specific acoustic signal unique to a specific region of the human body may be used to determine whether the electric skin patch device 110 is properly positioned on the user's body. In various embodiments, sufficient electrode and tissue contact or integrity is determined to achieve electrode impedance in the range of 200 ohms to 1000 ohms. In one embodiment, the pulse amplitude is adjusted automatically because there is a constant current source (from one or more batteries). The constant current source circuit automatically adjusts the pulses to maintain the programmed amplitude when the electrode-tissue interface impedance changes. This automatic adjustment can be programmed to occur for voltages ranging from 0.1V to 500V. Thus, the pulse amplitude is automatically modulated to maintain a constant current source. In other words, the stimulation pulse amplitude or intensity is automatically adjusted as a function of the electrode-tissue interface impedance change. In some embodiments, the pulse intensity varies as a directly proportional function of the electrode-tissue interface impedance change. In some embodiments, the pulse intensity varies as a direct inverse function of the electrode-tissue interface impedance change.

The HMA also evaluates and indicates to the user that the electrical skin patch device 110 has been placed in an appropriate location, such as a T2-T12 and/or C5-T1 dermatome for an eating disorder, the sensed nerves prior to initiating stimulation therapy. activity can be analyzed. In various embodiments, the accuracy or adequacy of the electrical skin patch device location is assessed via a neural activity monitor of the electrical skin patch device 110 . In various embodiments, sensing or monitoring neural activity is accomplished by using sense amplifier circuitry to measure neural activity and output a representative signal to a microcontroller or microprocessor of the electrical skin patch device 110 . The microcontroller algorithmically processes the data to determine whether or not there is neural activity. In some embodiments, the sense amplifier circuit measures the neural activity signal directly using the same electrodes used for stimulation. In another embodiment, the sense amplifier circuit measures the neural activity signal separately using different electrodes than those used for stimulation. In another embodiment, the sense amplifier circuit measures the neural activity signal using the same electrodes used for stimulation and both electrodes used for stimulation and other electrodes. In various embodiments, the sense amplifier circuit includes a gain in the range of 1 to 100,000,000 and all values therebetween, and a bandpass filter in the range of 0.1 Hz to 10,000 Hz and all combinations therebetween. These functions are accomplished using conventional analog circuitry known in the art, such as operational amplifier circuits and transistor circuits. In one embodiment, the process used by the microprocessor to process the sensed neural activity includes counting the number of events within a predetermined period of time. In another embodiment, the process is modified to add a moving average in the form of a finite impulse response (FIR) or infinite impulse response (IIR) digital filter.

HMA accelerates therapeutic effectiveness and efficacy by allowing users to self-administer therapies, including the ability to stimulate multiple times a day or a week. In various embodiments, self-actuation is actuated via a button on the interlocking device 105 that is used to trigger the electrical skin patch device 110 upon demand. Triggering the electrical skin patch device 110 is defined as triggering a protocol that can result in stimulation over a predetermined time period and does not necessarily indicate that electrical stimulation begins immediately. The linkage device 105 and/or the electrical skin patch device 110 include pre-programmed limits that prevent the patient from being overstimulated. Additionally, the interlocking device 105 and/or the electrical skin patch device 110 includes a trigger to prompt the patient for stimulation based on time of day, past trends in appetite, calorie intake, and exercise data.

HMA can also evaluate the effects of stimulation by analyzing the nerve activity sensed during stimulation therapy. Depending on the effectiveness, the health care application may automatically recommend and/or implement adjustments or modifications to the plurality of stimulation parameters. In some embodiments, the recommended adjustments to the plurality of stimulation parameters must be permitted or approved for implementation by at least one of a user (ie, a patient) and/or a remote patient care facility or personnel. In various embodiments, neural activity is sensed using a sense amplifier circuit as described above.

The HMA allows the user to enter their current weight per day through a GUI screen, and provides real-time feedback from the patient, recorded in the patient's diary, from exercise and patient parameters such as, but not limited to, fitness, diet, hunger, appetite and well-being. or other wearable devices, e.g., the human body (e.g., the human body (e.g., It allows for real-time or near real-time integration of feedback such as steps taken as an indicator of calories burned from devices with physiological sensors configured to be worn around the wrist, for example. Incorporating feedback from patients and other devices can modify therapy as needed to suppress appetite and treat conditions such as obesity, overweight and/or metabolic syndrome. According to various aspects of the present specification, the electric skin patch device is capable of treating a person having a body mass index (BMI) of 25 or greater (25-30 for overweight, 30 or greater for obesity, and 35 or greater for morbid obesity).

The HMA provides recording, storage and display of all stimulation parameters, as well as other real-time inputs such as diaries and exercise monitoring, to provide real-time recordings and treatment profiles to physicians and patients. Stored information includes combinations of inputs from stimulation devices and other sources of information, for example, devices with physiological sensors configured to be worn on the human body, such as around the wrist, to monitor, acquire, record, and/or transmit physiological data. do. According to one aspect, the HMA allows the patient to record her daily diary parameters (eg, hunger, appetite, well-being, exercise) using, for example, emoticons displayed to the patient on the touch screen display of the companion device. have. In one example, to record the intensity of hunger, the patient may be presented or prompted visually with a plurality of bear emoticons representing various levels of gastrointestinal fasting. In other words, a bear emoji with an empty stomach may indicate a high level of hunger or appetite, while a bear emoji with a full stomach may indicate a low level of hunger or appetite. On a scale of 0 to 5 or 0 to 10, the lowest level of hunger or appetite (corresponding to 0) can be represented by a bear emoji with a full stomach, and the highest level of hunger or appetite (corresponding to 5 or 10). may be indicated by a completely empty stomach emoji, while intermediate levels of hunger or appetite may be indicated by correspondingly varying degrees of full or empty stomach emoji. Accordingly, the patient is visually presented or prompted with a plurality of icons or emoticons, each of which represents a different degree of hunger or appetite.

The HMA may communicate with one or more third party service providers for user activation or automated ordering of electrode patches, eg, standard meals such as Jenny Craig, or accessories such as fitness coaching services. HMA's communication support with one or more third party service providers also allows for sourcing and payment for online services and/or advertisements.

The HMA makes it possible to display a GUI screen so that the user can provide inputs such as, for example, feeding information and activity information. In various embodiments, the eating information generally includes standard regular meals and the user's meal profile or routine, such as the number of meals per day consumed and the type and amount of food eaten at each meal per day. For example, in some embodiments, the user's standard regular eating and eating profile includes at least the number and timing of meals per day (eg, 3 meals a day, 8 a.m., noon lunch, 6 p.m.). . Users can manually adjust meal timing. The standard regular eating and eating profiles represent the user's general eating habits and are likely to be modified by the user over a long period of time, so they are typically entered only once by the user. In some embodiments, the standard regular eating and eating profile includes a standard diet plan including, but not limited to, Mediterranean diet, intermittent fasting, Jenny Craig, Weight Watchers, SlimFast, and Custom Plan. indicates.

In various embodiments, the eating information additionally or alternatively includes the user's real-time actual eating and eating profile, such as the time of intake of a meal during the day and the type and amount of food eaten at the meal. In other words, whenever the user eats, the user records the occurrence of a meal event, time stamped automatically by the application (in real time), the type and amount of food eaten. If the type and amount of meals and food consumed coincides with the user's standard regular meal profile, the user can simply select the type and amount of meals and food from the pre-stored eating profile of the user.

In various embodiments, an HMA in communication with a swallow detection device, such as device 5605 of FIG. 56 , detects whether the user is participating in an eating event. In an alternative embodiment, the user's eating event, activity or moment is automatically determined using an inertial sensor, such as an accelerometer, for automatic diet monitoring. In an embodiment, the accelerometer may be used on a wrist, such as band 2105 of FIG. 21A or wrist watch 2106 of FIG. Included in a band or wrist watch. The plurality of diet data is passed to a health care application implementing the eating moment recognition method (FIG. 58) to process and analyze the plurality of diet data and automatically identify when the user is eating.

Upon detecting an eating event, the HMA prompts the user to enter the type and amount of meal consumed, and provides the user with healthier food options (eg, via the intelligent personal assistant system described below with reference to FIGS. 48A-C). ), automatically timestamping meal intake events, automatically determining whether meal intake matches the user's standard regular eating profile, and if the meal intake does not match the user's standard regular eating profile (i.e., advising the user to avoid eating (other than a scheduled or planned feeding event) and performing any one or combination of actions that automatically trigger a stimulation session during and/or after a meal, i.e., after the user has finished eating a meal; .

According to one aspect of the present specification, real-time eating and eating profiles are utilized to calculate the actual amount of calories consumed by the user per day. On the other hand, the user's standard regular eating and eating routine is utilized to calculate the amount of calories that the user is expected or likely to consume per day. The difference between the daily, weekly, or monthly expected calorie intake value and the actual calorie intake value may prompt the user from the health care application for multiple recommendations.

According to some aspects herein, it is advantageous to evaluate the quality of the meal or diet consumed along with the amount of calories consumed as a result of the meal or diet per day. In some embodiments, the quality of a meal or diet is determined based on a mixture of macronutrients such as carbohydrates (also referred to as “carbohydrates”), proteins, and fats present in the meal or diet. Thus, the user's standard diet plan can suggest acceptable ratios for each macronutrient. For example, the local diet (by Berry Sears, PhD) suggests a meal of 40% carbs, 30% protein and 30% fat, and the Atkins diet suggests a meal of 5% carbs, 25% protein and 75% fat. On the other hand, the ketogenic diet suggests a meal that is 10% carbohydrates, 45% protein, and 45% fat. Thus, for users trying to follow a standard diet plan or custom diet plan designed around a specific percentage of macronutrients, the expected percentage of macronutrients and estimated calories to be consumed per day are known by the health care application and saved in advance

In various embodiments, the user's actual or real-time eating and eating profile represents the type and amount of food eaten at the meal, as well as the amount of time a meal was consumed per day. The type and amount of food eaten allows you to calculate the ratio of calories consumed to macronutrients (carbohydrates, protein, and fat) consumed. While in some embodiments the health care application calculates the proportions of all three macronutrients (carbohydrates, protein and fat) consumed in a meal, in various alternative embodiments the amounts and effects of any one or two macronutrients are calculated. It is understood that monitoring and accounting are necessary. For example, in some embodiments, a health care application focuses on monitoring and determining the effectiveness of ingested carbohydrates compared to an acceptable amount of carbohydrates allowed based on a standard diet plan that the user is following.

Thus, in one aspect, carbohydrate-containing foods are evaluated on a scale called a glycemic index (GI), which is used to calculate a glycemic load (GL) associated with the ingested food. The GI ranks carbohydrate-containing foods based on their effect on blood sugar levels over a period of time. Carbohydrate-containing foods are compared to glucose or white bread as a reference food for a GI score of 100. GI compares foods containing the same amount of carbohydrates in grams. Carbohydrates that break down quickly during digestion have a higher glycemic index (eg, a GI greater than 70). High GI carbohydrates, such as baked potatoes, release glucose into the blood quickly. Slowly breaking down carbohydrates, such as oats, gradually release glucose into the bloodstream. These carbohydrates have a low glycemic index (eg, a GI less than about 55). The glycemic response is slower and more gentle. Because low-GI foods break down slowly, they can prolong digestion and help you feel full.

The glycemic index compares the likelihood that foods containing the same amount of carbohydrates raise blood sugar. However, the amount of carbohydrates consumed also affects blood sugar levels and insulin response. The glycemic load (GL) takes into account both the GI of the food and the amount of carbohydrates in the portion or portion eaten. GL is based on the idea that small amounts of high GI foods have the same effect on blood sugar levels as large amounts of low GI foods. GL is calculated by multiplying GI by the amount of carbohydrates in a serving of food (in grams).

Thus, according to another aspect of the present disclosure, real-time eating and meal profiles are utilized to calculate the proportion of macronutrients, i.e. carbohydrates, proteins and fats, or at least the glycemic load (GL) associated with the meal profile per day. On the other hand, the user's standard regular eating and eating routine is utilized to calculate a predicted, acceptable or expected proportion of macronutrients consumed by the user per day, or at least an acceptable glycemic load. The difference between the daily, weekly, or monthly expected and actual macronutrient ratios or the difference between the daily, weekly, or monthly expected and actual blood glucose load may prompt the user from the health care application for a plurality of recommendations.

Activity information relates to how much and when a person moves and/or exercises during the day, and utilizes both data input by the user and data sensed by one or more sensors 135 . The data entered by the user is detailed about the user's daily activities, for example, the fact that the user worked at a desk from 9:00 am to 5:00 pm and took aerobics classes from 6:30 pm to 7:30 pm. may contain information. Relevant data sensed by sensor 135 may include heart rate, movement sensed by an accelerometer, heat flow, respiration rate, calories burned, and galvanic skin response (GSR). Therefore, the burned or used calories (calorie consumption) is determined by multiplying the exercise type input by the user by the exercise time input by the user; multiplying the sensed motion by the motion time and multiplying the filter constant; It can be calculated in a variety of ways, including multiplying the sensed heat flux by the exercise time and multiplying it by a filter constant or by a constant based on metabolic equivalence (MET). In some embodiments, the user's resting metabolic rate (RMR) or basal metabolic rate (BMR) is also calculated to estimate the amount of calories consumed by the user and then used to calculate the daily calorie balance. As is known to those skilled in the art, RMR or BMR is the rate at which a user burns energy or calories at rest, and is at least a function of the user's age, sex, height and weight. This helps the body meet its basic requirements to function optimally.

The amount of calories actually consumed by an individual is compared with the amount of calories burned or consumed by the individual during a daily, weekly or monthly period, hereinafter referred to as the user's energy balance. A positive or surplus energy balance indicates that there are more actual calories consumed compared to calories burned, and is considered to represent a potential weight gain scenario for the user over a period of time. A negative energy balance indicates fewer actual calories consumed compared to calories burned, and is considered to represent a potential weight loss scenario for the user over a period of time.

Continuing the various non-limiting examples of the plurality of functions of the HMA, in various embodiments the HMA also enables presenting a GUI screen that allows a user to record their hunger or appetite profile. The hunger or appetite profile includes data such as the time of day at which the user is hungry and the intensity at which the user feels hunger. In some embodiments, the intensity of hunger is recorded by the user, for example, by selecting from a scale of 1 to 5, where 1 represents mild hunger and 5 represents very high hunger intensity. In various embodiments, the hunger profile includes only the times during which the user is hungry but ideally should not eat a meal. This may include, for example, times that do not match the user's standard regular eating and eating profile or routine.

The HMA can also provide daily feedback to the patient from the electrical skin patch device on diet compliance, calories burned, and diet plan indications.

The HMA also enables receiving, processing and analyzing blood glucose data generated by a blood glucose sensor included as one of the sensors 135 in some embodiments or configured as a third party device in wireless communication with the HMA. In various embodiments, the blood glucose data may be used to detect diseases such as, for example, a hyperglycemic rush due to a large carbohydrate meal, and to treat or manage diseases in which excess insulin secretion can cause hunger in non-diabetic users. analyzed for titration.

HMA represents a weight trend, including a user's standard regular eating and eating profile, actual eating and eating profile, energy balance information, weight loss or gain rate over time period such as daily, weekly or monthly, blood glucose data trend and hunger profile. Multiple charts or graphs can be created and displayed.

The HMA prompts the user if the user forgets to apply or wear the electrical skin patch device and/or deactivate the recommended duration or frequency of stimulation therapy; Prompt the user with respect to the stimulation protocol that the scheduled stimulation will start within the next T minutes, e.g., 10 or 15 minutes, and if not deactivated, select the option to disable the scheduled stimulation allowing the scheduled stimulation to start after T minutes adherence to stimulation therapy presented to the user; The user selects a standard predefined diet plan (e.g., from a drop-down list of several predefined diet plans such as the Mediterranean Diet, the Atkins Diet or Jenny Craig) or enters a custom plan as part of a standard regular eating and eating routine. manage and generate prompts (actual phone calls with audio, visual and/or tactile) relating to a plurality of dietary compliance aspects including, but not limited to, dietary compliance or instructions. The user also records details about the actual meals performed and meal times. For example, audio, visual and/or tactile alert(s) may be generated if the user is not adhering to a selected dietary regimen. The compliance prompt is to encourage patient compliance and, in some embodiments, includes a composite score and display of overall patient progress.

The HMA may recommend and/or implement modifications to the stimulation pattern or protocol upon receipt of input from the user during and/or after stimulation that the user experiences nausea, indigestion, heartburn, or sensations at the site of stimulation.

The HMA further allows the user to evaluate stimulation habituation, nausea and/or dyspepsia scenarios and modify stimulation patterns or protocols accordingly. In various embodiments, such events are input by the patient into the electrical skin patch device or linkage device. For example, in one embodiment, the patient may enter a nausea event, dyspepsia event, or hunger event via a GUI on one or both devices. The microprocessor then processes these events algorithmically and modifies the stimulus accordingly.

HMA allows remote care facilities and/or care staff to monitor the user's hunger profile, standard eating and eating profiles, actual eating and eating profiles, energy balance, weight trends, blood glucose data, and irritant-induced nausea, dyspepsia, and habituation events. provide access to health-related information of a plurality of users (via cellular and/or private or public wired or wireless networks, eg, the Internet). In some embodiments, the health care application periodically transmits the user's health-related information apart from allowing remote care facilities and/or care personnel to access such information in real time or on demand when needed. In various embodiments, the user's authorization is required to allow such access to the user's health-related information.

The HMA also allows for detection of ablation of an electrical skin patch device, and impedance or bioimpedance electrodes allow health care applications to regularly or continuously monitor electrode and skin contact impedance. This allows the health care application to detect whether the user has removed or worn the electric skin patch device. In some embodiments, when the electrical skin patch device is configured for use as a 24/7 wearable device, detecting removal of the electrical skin patch device corresponds to omission of the user's health-related information. However, in other embodiments in which the electrical skin patch device is configured for use on an as-needed or on-demand basis, the missing user health related information is treated as if any stimulation event did not occur.

HMA also provides unique electrical stimulation properties and 'footprints' based on electrode design and stimulation parameters, allowing patients to use a variety of stimulation methods.

In another non-limiting example, HMA makes it possible to provide a weight loss graph with pictures of patients corresponding to various milestones in the weight loss graph.

In another non-limiting example, HMA allows an obese surgeon, physician, dietitian or medical staff to tell a new patient about their medical practice.

In another non-limiting example, HMA allows the patient to maintain a time interval between meals and fluids. For example, the HMA can notify the user when sufficient time has elapsed for a meal after drinking a beverage, and vice versa.

In another non-limiting example, an HMA allows a patient to see a physician and request medical care; be able to set daily reminders for prescribed vitamins and supplements; allowing the patient to query the dietitian; communicate weight loss seminars and support group schedules to patients; enable healthcare providers to deliver healthy recipes to patients to support patients' continued weight loss success; enable bariatric surgery patients to stay tracked through reminders and pre-populated checklist-psychological assessments, insurance pre-approval, physician-guided diets; to enable clinicians and patients to record their thoughts and progress throughout the day; enable exchange of information with third-party applications; enable the patient to track water intake along with food eaten; enable automatic tracking of calories, protein, fat and carbohydrates consumed by the patient; scan barcodes on packaged foods to allow patients to view nutritional information, and to automatically record daily supplies in a journal; enable the physician or medical staff to enter specific goals for the patient; With the patient's approval, the physician can share patient status data with fellow care/department physicians to request better recommendations from the patient; monitoring food/caloric intake improves dietary adherence, thus allowing the patient to instill weight management habits; Physicians, nutritionists, and other health care providers can send push notifications to patients to keep them engaged and motivating them to their health goals.

In various embodiments, the plurality of health-related information of the user may be used to suggest and/or implement a plurality of recommendations including stimulation patterns or protocols, medications (eg, insulin intake), diet and/or action plans. It is understood to be utilized by the management application. For example, if the user's actual caloric intake is found to be consistently higher than the expected caloric intake over a period of time, the health care application may include a specific standard diet plan for the user; One or a combination of changes from the first standard diet plan to the second standard diet plan may be recommended or recommend or change an existing stimulation protocol to suppress the user's appetite and/or increase activity levels such as walking, exercise It may prescribe a customization of an existing standard diet plan that the user may follow, which may be a suggestion to the user to follow the guidelines.

In some embodiments, the plurality of recommendations are automatically generated by the health care application and presented to the user for user approval for implementation. In some embodiments, the plurality of recommendations automatically generated by the health care application are presented to the remote patient care facility and/or personnel for authorization or approval, and then implemented or presented back to the user for final authorization for implementation. . In some embodiments, the health care application receives a plurality of recommendations prescribed by the remote patient care facility and/or personnel based on the plurality of health-related information of the user.

In various embodiments, the user may include a plurality of recommendations automatically generated by the health care application and recommendations received as prescriptions or recommendations from the remote care facility or personnel, a reason for each of the plurality of recommendations, and received from the remote care facility or personnel. one or more annotations or memos from the remote patient care facility or personnel explaining the authorization/approval or disapproval of each of the multiple recommendations issued by the presented in the GUI. The user then reviews the implementation of each of the multiple recommendations and either approves/approves or disapproves. However, in some embodiments, permission to implement multiple recommendations may not be required from the user and/or remote patient care facility or personnel. For example, in one embodiment where the electrical skin patch device is worn 24 hours a day, the number of stimulation sessions per specified time period is automatically titrated up or down based on the recommendations. In another embodiment, the stimulation duration is automatically titrated up or down based on recommendations. In other embodiments, other stimulation parameters are automatically changed based on recommendations.

In various embodiments, the companion device includes a 'diary' for the patient to enter, track, record and display patient parameters. 7 is a screenshot of a companion device showing a journal widget 705 according to an embodiment of the present specification. Journal widget 705 includes an icon that allows the patient to enter and view entries in the journal. The journal widget 705 includes a quick entry button icon 706 that, when pressed, causes the companion device to display a button for creating a journal entry. The journal widget 705 also includes a list view of the journal entry icon 707 , which when pressed causes the companion device to display the journal in list format. Journal widget 705 also includes a calendar view of journal entry icon 708 , which when pressed causes the companion device to display the journal in calendar format.

8 is a screenshot of a companion device showing a list view of a journal item 805 according to an embodiment of the present specification. The list view of journal entry 805 is accessed by pressing the list view of journal entry icon 707 shown in FIG. 7 . In various embodiments, the list view of diary entries 805 displays items entered by the patient for stimulation sessions 806 and patient parameters, eg, instances such as hunger 807 and appetite 808 . Stimulation session item 806 indicates the time 816 of the item and details 826 of the stimulation session. Each patient parameter item 807 , 808 displays a score along with the time of the item 817 , 818 , the type of parameter 837 , 838 , and a description 827 , 828 associated with the item. The list view of journal entry 805 also displays the date 803 and the name of the journal 802 being viewed.

9 is a screenshot of a companion device showing a calendar view of a journal entry 905 according to an embodiment of the present specification. The calendar view of journal entry 905 is accessed by pressing the calendar view of journal entry icon 708 as shown in FIG. 7 . The calendar view of the journal entry 905 displays the day 906 of the month being viewed. When an individual date is clicked, the journal entries for that day are displayed as a list 907 . The patient can scroll through the list 907 to view the items. The calendar view of journal entry 905 also displays the name of journal 902 viewing the year and month 903 .

10 is a screenshot of a companion device showing a quick input button view 1005 in accordance with an embodiment of the present specification. The quick input button view 1005 is accessed by pressing the quick input button icon 706 as shown in FIG. 7 . In one embodiment, quick entry button view 1005 displays six quick entry buttons: Appetite 1006 , Exercise 1007 , Hunger 1008 , Stimulate (i.e. Stimulate) Session 1009 , and Weight 1010 . , and well-being 1011 . The quick input button shown in FIG. 10 is only an example, and is not intended to limit the present invention. In other embodiments, fewer or more quick entry buttons are included in the quick entry button view. When one of the quick input buttons 1006, 1007, 1008, 1009, 1010, 1011 is pressed, the companion device displays an input screen for the selected button. The quick entry button view 1005 also displays the name of the journal 1002 being viewed.

11 is a screenshot of a companion device showing an appetite input screen 1105 according to an embodiment of the present specification. Appetite input screen 1105 allows a user to enter a type 1106 and item 1107 of a patient parameter, in this case appetite, and a score 1108 associated with the parameter. Score 1108 has a numeric value 1109 and an associated description 1110 to assist the patient in determining the best score for the current parameter. In some embodiments, the description of the case of appetite relates to the amount the patient ate compared to the amount recommended by the patient's diet. In some embodiments, the score ranges from 1 to 5. Appetite entry screen 1105 also displays the time and date 1103 and the name of diary 1102 at which the entry was entered. The patient may press the disk icon 1101 to save the item or the X icon 1104 to cancel the item.

12 is a screenshot of a companion device showing an exercise input screen 1205 according to an embodiment of the present specification. The exercise input screen 1205 allows the user to enter a type 1206 and item 1207 of a patient parameter (in this case, an exercise), and a score 1208 associated with the parameter. Score 1208 has a numeric value 1209 and an associated description 1210 to assist the patient in determining the best score for the current parameter. In some embodiments, for exercise, the description relates to how many steps the patient took per day. In some embodiments, the score ranges from 1 to 5. The exercise entry screen 1205 also displays the time and date 1203 and the name of the journal 1202 at which the entry was entered. The patient can press the disk icon 1201 to save the entry or the X icon 1204 to cancel the entry.

13 is a screenshot of a companion device showing a hunger input screen 1305 according to an embodiment of the present specification. The hunger input screen 1305 allows the user to enter a type 1306 and item 1307 of a patient parameter, in this case hunger, and a score 1308 associated with the parameter. Score 1308 has a numeric value 1309 and an associated description 1310 to assist the patient in determining the best score for the current parameter. In some embodiments, the description of hunger relates to the level of hunger experienced by the patient. In some embodiments, the score ranges from 1 to 5. The hunger input screen 1305 also displays the time and date 1303 and the name of the journal 1302 at which the entry was entered. The patient can press the disk icon 1301 to save the entry or the X icon 1304 to cancel the entry.

14 is a screenshot of a companion device showing a stimulation session input screen 1405 in accordance with an embodiment of the present disclosure. The stimulation session input screen 1405 allows the user to enter the type 1406 and item 1407 of the session, in this case the stimulation session, and the level 1408 associated with the session. Level 1408 has a numeric value 1409 and associated description 1410 to help the patient determine the level that best represents what has been applied during the current session. In some embodiments, for stimulation sessions, the description relates to the number of times the stimulation is delivered per day and the amount of time the stimulation is applied during each session. In some embodiments, the level ranges from 1 to 4. Stimulation session entry screen 1405 also displays the time and date 1403 and the name of diary 1402 at which the entry was entered. The patient may press the disk icon 1401 to save the item or the X icon 1404 to cancel the item.

15 is a screenshot of a companion device showing a weight input screen 1505 according to an embodiment of the present specification. The weight input screen 1505 allows the user to enter the type 1506 and item 1507 of the patient parameter, in this case the weight, and the weight in pounds 1508 associated with the parameter. Weight entry screen 1505 includes a numeric keypad 1509 that the patient uses to enter body weight. The weight entry screen 1505 also displays the time and date 1503 and the name of the journal 1502 at which the entry was entered. The patient can press the disk icon 1501 to save the item or the X icon 1504 to cancel the item.

16 is a screenshot of a companion device showing a wellness input screen 1605 in accordance with an embodiment of the present specification. The wellness input screen 1605 allows the user to enter a type 1606 and item 1607 of a patient parameter, in this case well-being, and a score 1608 associated with the parameter. Score 1608 has a numeric value 1609 and an associated description 1610 to assist the patient in determining the best score for the current parameter. In some embodiments, the well-being description relates to the level of nausea, indigestion, and/or abdominal discomfort experienced by the patient. In some embodiments, the score ranges from 1 to 3. The wellness entry screen 1605 also displays the time and date 1603 and the name of the journal 1602 at which the entry was entered. The patient may press the disk icon 1601 to save the entry or the 'X' icon 1604 to cancel the entry.

HMA, in some embodiments, quantitatively measures one or more of a person's appetite, hunger, level of satiety, level of satiety, level of satiety, level of well-being, level of nausea, feeling of pain, level of indigestion, perception of food, and changes thereof. It should be understood that it incorporates a GUI that presents scales, surveys or questionnaires designed to evaluate.

For example, the Simple Nutritional Appetite Questionnaire (SNAQ) is an appetite assessment tool that predicts weight loss. The SNAQ includes questions that rank intensity of appetite, postprandial fullness, taste of food, and number of meals eaten each day on a scale of 1 to 5. If your SNAQ score is 14 or less, you are more likely to lose 5% or more of your weight within 6 months. The ghrelin hunger scale (G scale) is a two-dimensional scale where a first scale from 1 to 7 on the y-axis is used to assess hunger/fullness, and a second scale from 1 to 7 on the x-axis is for the last meal (breakfast, It is used to evaluate the time elapsed after lunch, snack, or dinner).

Generally, each of these scales is a form of visual analog scale (VAS). VAS is a question-based assessment mechanism, where a visual scale is associated with each question and answering the question requires choosing a quantifiable position within the visual scale that represents a particular level or degree. Scales usually consist of lines (of varying lengths) with a fixed word at each end (i.e., from 'never hungry' on the left to 'never hungry more than this' on the right) to indicate extremes. The patient is asked to mark along a line that corresponds to his or her feelings. Quantification of measurements is performed by measuring the distance from the left end of the line to the mark. In some embodiments, the VAS is associated with a sensation of pain (eg, due to stimulation), hunger, appetite, biting, fullness, satiety, overall quality of life, degree of nausea, degree of well-being, degree of indigestion, food It can be used to assess perceptions of food aversion, food aversion, and dietary adherence. According to some aspects herein, a user is provided with a GUI for activating VAS-based lights or progress bars, allowing the user to record parameters such as levels of hunger, appetite and well-being.

35A illustrates a VAS questionnaire 3505 for assessing hunger sensation or appetite. Questionnaire 3505 presents the patient with an antecedent question, such as "How hungry are you?", while the two extremes of scale line 3508 (3506, 3507) describe a feeling of minimum and maximum hunger. fixed by the word In one embodiment, the two extremes 3506 and 3507 are described as "never hungry" and "never more hungry than this," respectively.

35B illustrates a VAS questionnaire 3510 for assessing satiety. Questionnaire 3510 presents the patient with an antecedent question, such as "How full do you feel?", while the two extremes of scale line 3513 (3511, 3512) describe minimum and maximum satiety. fixed by the word In one embodiment the two extremes 3511 and 3512 are described as "not at all full" and "completely full", respectively.

35C illustrates a VAS questionnaire 3515 for assessing bite. Questionnaire 3515 presents the patient with an antecedent question, such as "How satisfied are you?", while the two extremes of scale line 3518 (3516, 3517) describe minimum and maximum bites. fixed by the word In one embodiment, the two extremes 3516 and 3517 are described as "I am completely empty" and "I can't eat more", respectively.

35D illustrates a VAS questionnaire 3520 for assessing satiety. Questionnaire 3520 presents the patient with an antecedent question, such as "How much do you think you can eat?", while the two extremes of scale line 3523 (3521, 3522) describe minimum and maximum satiety. fixed by the word In one embodiment, the two extremes 3521 and 3522 are described as "many" and "not at all" respectively.

One of ordinary skill in the art will recognize that for each questionnaire in FIGS. 35A-D, the preceding question and fixed words at the two extremes of the scale may be linguistically modified in alternative embodiments without departing from the purpose of evaluation or the feeling to be evaluated. will be able For example, in an alternative embodiment, the main question of questionnaire 3520 is "How much more do you want to eat now?", while the two extremes 3521 and 3522 are described as "very" and "not at all." Additionally, other intermediate languages may be used between the two extremes.

In various alternative embodiments, the GUI showing the VAS questionnaire is designed to assess aspects such as, but not limited to, health-related overall quality of life, degree of nausea, feeling of pain, degree of well-being, and degree of indigestion. can be For example, in one embodiment, to assess the level of nausea, the VAS questionnaire may present an antecedent question such as "Do you feel nauseated?", the two extremes of the scale being described as "a lot" and "not at all." . In another embodiment, a VAS questionnaire may present a preceding question, such as "How satisfied are you overall with your health?", to assess your overall health-related quality of life or degree of well-being, and a scale The two extremes of are described as "completely dissatisfied" and "completely satisfied". In another embodiment, to assess the severity of dyspepsia, the VAS questionnaire presents the preceding question, "In the past 2 weeks, your ability to eat or drink (including when, what, and how much) has been disrupted by gastrointestinal problems?" can and the two extremes of the scale are described as "very" and "not at all". In yet another embodiment, to assess bowel movement, the VAS questionnaire may present a plurality of antecedent questions to assess defecation time, whether a bowel movement is an emergency, bowel frequency and/or amount of defecation.

In some embodiments, as described above, the VAS is a quantifiable position within a visual scale representing a particular level, intensity or degree (or 1, 2, 3, 4, or 5 on a VAS scale ranging from 1 to 5, for example). It consists of a questionnaire with each question representing the same number). In some alternative embodiments, the VAS is configured as a spectrum of colors, wherein each color of the spectrum may be quantified (optionally in the form of a number) to indicate a particular level, intensity, or degree. 76 illustrates a hunger or appetite VAS scale 7600 consisting of a color spectrum, where each color is quantified as a number representing the intensity of hunger or appetite when selected by the user. As an example, scale 7600 ranges from light green, dark green, yellow, orange to red, corresponding to intensities of 1 to 5, where light green (quantifiable as 1) represents the lowest intensity of hunger/appetite. On the other hand, red (quantifiable as 5) represents the highest hunger/appetite intensity. The scale may vary in different embodiments, for example, instead of a color spectrum representing a scale of 1 to 5, the color spectrum may represent a scale of 1 to 10. Accordingly, the VAS may be displayed as a questionnaire, number and/or color spectrum in various embodiments.

In various embodiments, the HMA determines the timing, duration and amplitude of a stimulation session planned or scheduled by the user; the timing, duration and amplitude of the on-demand or rescue bolus (discussed below herein); the amount and type of calories consumed per day; For example, hunger based on aggregation of rescue bolus and/or VAS hunger scale items whenever a user is hungry; user's weight; For example, calories burned based on the number of steps taken; A GUI is provided to record a daily diary record of daily quality of life and/or nausea/indigestion items for VAS.

In embodiments, the patient is prompted to input at least one of data indicative of weight, data indicative of well-being, data indicative of hunger, data indicative of appetite, data indicative of calories consumed by the patient, and data indicative of calories consumed by the patient. are prompted In embodiments, the electrical skin patch uses data indicative of weight, data indicative of well-being, data indicative of hunger, data indicative of appetite, calories consumed by the patient using a plurality of program instructions configured to execute on a device external to the electrical skin patch. interface with a second device (a third-party device) to automatically receive at least one of data indicative of the calories consumed by the patient. In an embodiment, the data represents a weight loss goal.

Accordingly, a health care application may be used with one or more electrical skin patch devices herein to receive and integrate exercise or calories burned and weight loss information, to monitor, acquire, record and/or transmit physiological data ( For tracking and recording physiological data related to running, such as wrist or foot (e.g., cadence, steps taken, calories burned, run time, gait, heart rate) on the wrist or foot (e.g., as a smart watch) Physiological sensors configured to be worn on the human body, such as smart shoes that utilize multiple sensors, may be used to communicate (via pairing or synchronization) with third-party devices (including third-party application software on external devices).

In some embodiments, the third party device enables diet monitoring (in terms of quantity and type or quality of calories consumed) and communicates diet information to the HMA for display to the user, for example, on the user's associated device. do. In various embodiments, the user's dietary regimen information (received from third-party devices and/or applications) is used alone or in conjunction with the user's daily diary information to titrate stimulation regimens. In embodiments, the third party device captures daily weight with a WIFI or Bluetooth enabled bathroom scale and automatically enters this data into the user's daily diary. In embodiments, a third-party device may monitor an exercise, such as a smart watch, that communicates exercise or fitness information (eg, but not limited to steps taken, heart rate, etc.) to the HMA for display on the user's companion device. It is a wearable device. Exercise or fitness information is also used in the HMA to titrate stimulation therapy. In some embodiments, a third party device such as a bathroom scale or wristband/watch may be configured to measure and/or measure calories burned by the patient.

Regardless of whether the third-party device is third-party application software of an external device or entirely a second external device (eg, a watch, wristband, bathroom scale, smart shoe, diabetic wearable pump, or other medical device, etc.) , directly from the EDP device, directly from a health care application, or directly from a server in data communication with the EDP device or health care application herein. In some embodiments, the user's daily diary information, including but not limited to appetite scores, may be displayed on the user's third-party device, such as a smart watch. As a result, the third-party application or the second external device can retrieve the patient log entries, the patient's hunger level, the patient's well-being level, the patient's appetite level, stimulus settings, or any data tracked by the third-party device to the EDP device and and/or display any information collected by the EDP device and/or the health care application, including any data tracked by the health care application and an aggregate/composite weight management performance score that aggregates to yield a single composite score.

In some embodiments, the HMA prompts the user to click on a selfie or photo of her that represents the user's input on her health status, including the current body outline, outline, shape and size. In some embodiments, the selfie is of a specific body part, such as the face, torso, and/or buttocks. In embodiments, the user's selfie is processed and stored by the HMA as an avatar or graphical representation of the user. In an embodiment, the HMA prompts the user to click and enter his selfie at predetermined time intervals, such as, for example, daily, every other day, twice or three times a week during the course of stimulation treatment. If the user's health goal is to lose weight, the evolving avatar, selfie or photographic record that the HMA periodically collects and stores (during the course of stimulation therapy) may indicate that the user's body outline is an ideal or target body outline, shape (e.g. eg, in the user's target body weight) and/or at the start of therapy or compared to the body outline for an initial period. The user's evolved body outline, shape, and size are displayed in comparison to the user's body outline and/or ideal or target body outline and shape prior to initiation of stimulation therapy. These comparative displays serve to provide the user with a record of evolving long-term health performance. In various embodiments, the user may have her evolved avatar printed on her clothing and displayed as a picture on her communication networks or channels, including but not limited to social media networks, social groups, Facebook, and WhatsApp. can be displayed.

In various embodiments, the health care application herein may provide information on the user's daily well-being at the end of each day, at a convenient and user-selected time (e.g., using the GUI of a VAS questionnaire or an intelligent personal assistant described herein below). using voice-based input) to query the user. In some embodiments, the VAS questionnaire relates to, but is not limited to, at least the user's satisfaction with hunger/appetite management throughout the day, adherence to a diet regimen throughout the day, and overall well-being level throughout the day. The HMA also automatically downloads health or fitness-related information from a third-party device each day, preferably at the end of the day. In some embodiments, the HMA prompts the user to record their weight at least once a week (or more often, such as daily in alternative embodiments). In embodiments, the HMA may include daily inputs recorded on VAS questionnaires, daily fitness-related information from third-party devices (eg, steps performed), and general information such as wearing an EDP device to stimulate according to a predetermined protocol. Generate automated feedback or advice based on aggregated health-related information from multiple users, including, but not limited to, compliance, daily rescue bolus, and daily or weekly weight measurements. In some embodiments, the automated feedback is delivered to the user via an intelligent personal assistant (IPA) as described below herein.

In some embodiments, the health care application herein may be installed or implemented directly on a third party device, such as a wrist watch, via download from a remote server. In such embodiments, the health care application is configured for compatibility and use with such third party devices. Accordingly, in addition to displaying information collected from the EDP device and/or health care application, a third party device may be used to manage the titration or setting of stimulation parameters, including patient diary entries. Such an embodiment would eliminate the need for a separate companion device.

In various embodiments, the third party device may provide the following patient related data: heart rate, pulse rate, heart variability per beat, EKG or ECG, respiration rate, skin temperature, core temperature, body heat flow, galvanic skin response or GSR, EMG, EEG, EOG, blood pressure, body fat, water level, activity level, oxygen intake, blood sugar or blood sugar level, body location, pressure on muscles or bones, and/or UV radiation exposure and absorption, or Table 1 and Table above 2, air quality, noise level/quality, lighting quality or ambient temperature around the patient, or overall location of the patient, weight of the patient, food eaten, activity or exercise (e.g., performed One or any combination of data indicating the type and amount of steps (steps, swimming, running) may be tracked.

According to an aspect of the present specification, the HMA may communicate or interface with an intelligent personal assistant (hereinafter also referred to as IPA) system and operate or drive. In embodiments, the IPA system accepts and processes the user's voice-based input, including providing the user with a voice-based output such as, but not limited to, an alert, reminder, information or prompt to the user, or A plurality of tasks or services may be performed based on the command. In accordance with various aspects herein, an IPA system is designed to simulate a conversation with one or more human users via an auditory method. IPA systems are also called chat robots, chatter robots, chatterbots, chatbots or chatbots, artificial conversation entities (ACEs), artificial intelligence agents (AIAs), talkbots and/or chatterboxes. In some embodiments, the IPA system includes an IPA device running an IPA software application. In some embodiments, the IPA system is implemented as a client-server architecture in which an IPA device (client) communicates with an IPA server. In this embodiment, the IPA software application is implemented as a client component resident on the IPA device, and a server component resident on the IPA server. Alternatively, the IPA software application may be implemented only on the IPA server side.

In various embodiments, the IPA device is capable of accepting voice-based input (using one or more microphones) and generating voice-based output (using one or more speakers), cellular, Internet, TCP/IP, Ethernet , a portable or portable computing device capable of accessing a Bluetooth, wired or wireless network. Examples of such portable computing devices include, but are not limited to, smartphones, tablets, speakers, or PDAs.

48A is a block diagram of an HMA herein, integrated and in communication with an IPA system, according to an exemplary embodiment. In this embodiment, the HMA is implemented as a client-side software component in the companion device 4805 (similar to the companion device 105 of FIG. 1A ) in data communication with the at least one EDP device 4810 herein. The companion device 4805 also communicates via the network 4825 with a healthcare server 4815 implementing the server-side software component of the HMA, and optionally a remote patient care facility and/or patient care personnel. Network 4825 may be a cellular, Internet, TCP/IP, Ethernet, Bluetooth, wired or wireless network. According to one embodiment, the companion device 4805, and thus the HMA client component, is further in data communication with the IPA device 4830 implementing the client-side software component of the IPA software application. IPA device 4830 also communicates via network 4825 with an IPA server 4835 that implements the server-side software component of the IPA software application. The companion device 4805 communicates with at least one EDP device 4810 and an IPA device 4830 via a direct wired or wireless link such as WiFi or Bluetooth, for example via pairing or synchronization, or via a network 4825 . It should be understood that data can be communicated. Similarly, health care server 4815 and IPA server 4835 may also be in data communication with each other via network 4825 . Thus, in this embodiment, the IPA system includes a standalone IPA device 4830 separate from the companion device 4805 . In other words, the IPA and HMA software applications are installed or implemented on separate devices.

48B is a block diagram of an HMA herein integrated and in communication with an IPA system, according to another exemplary embodiment. In this embodiment, the HMA and IPA software applications are installed or implemented as client-side software components on the companion device 4805 in data communication with at least one EDP device 4810 herein. The client-side HMA and IPA software components of the companion device 4805 are in data communication with each other. The IPA software component on the companion device 4805 may or may not communicate directly with the at least one EDP device 4810 . The companion device 4805 also includes a health care server 4815 implementing the server-side software component of the HMA, an IPA server 4835 implementing the server-side software component of the IPA software application, and optionally a remote patient care facility and and/or communicate via network 4825 with patient care personnel. Network 4825 may be a cellular, Internet, TCP/IP, Ethernet, Bluetooth, wired or wireless network. In addition, the health management server 4815 and the IPA server 4835 are capable of data communication with each other through the network 4825 . Thus, in this embodiment, the IPA system does not include a standalone IPA device 4830 separate from the companion device 4805 . In other words, the IPA and HMA software applications are installed or implemented on the same client-side device, ie, companion device 4805 .

During operation, the HMA communicates with the IPA system and enables a voice-based interface with the user. Accordingly, the voice support interface of the IPA system augments or replaces the plurality of GUIs and related functions implemented by the HMA herein. Referring now to FIGS. 48A and 48B , in various embodiments, the user's voice-based inputs, commands, commands, and/or queries (collectively referred to as 'inputs') interact (with client-side HMA software components) received by a client-side IPA software component residing on device 4805 or separately residing on IPA device 4830 . The client-side IPA software component, in some embodiments, streams the user's voice-based input over the network 4825 to the IPA server 4835 for further processing and then to the HMA server 4815 and/or companion device 4805. It may communicate with a resident client-side HMA software component. In another embodiment, the client-side IPA software component may itself communicate with the client-side HMA software component residing on the HMA server 4815 and/or companion device 4805 after processing the user's voice-based input. .

According to various aspects, the IPA system processes the user's voice-based input to derive input programming instructions, which are communicated to the HMA for a plurality of health care related operations associated with the EDP device 4810 herein. Similarly, output program instructions associated with a plurality of prompts, alerts, reminders, commands, or status reports (collectively referred to as 'outputs') generated by the HMA may be output by the companion device 4805 and/or the HMA server 4815 forwarded to the IPA device 4830 and/or the IPA server 4835 . According to various aspects, the IPA system processes these output program instructions to convert the output program instructions to speech-based output, which are communicated to the user as information and/or for further user action.

According to some embodiments, the HMA is a user's hunger profile, standard eating and eating profile, actual eating and eating profile, energy balance, weight trend, blood glucose data, and multiple user's ( and/or social network aggregated) health-related information with the IPA system. In some embodiments, the HMA periodically transmits the user's health-related information in addition to allowing the IPA system to access such information in real time or on demand when needed. In various embodiments, the user's authorization is required to allow such access to the user's health-related information.

An HMA in communication with the IPA system enables receiving from and providing to the user voice based inputs and outputs associated with a plurality of functions enabled by the HMA, non-limiting examples of which are described below.

The HMA communicating with the IPA system includes instructions regarding the battery life of the EDP device 4810 so that the HMA (the companion device 4805) successfully links (eg, via pairing or synchronization) with the EDP device 4810 . It enables voice-based communication to the user to indicate what has been done.

The HMA, in communication with the IPA system, provides voice-based communication to the user indicating that a) the EDP device 4810 is properly positioned on the user's body, and b) one or more electrodes of the EDP device 4810 are obsolete and need to be replaced. make it possible in

The HMA in communication with the IPA system enables voice-based communication to the user indicating whether the EDP device 4810 has been placed in a suitable location, such as a T2-T12 and/or a C5-T1 dermatome for an eating disorder.

The HMA in communication with the IPA system enables voice-based communication by the user to the HMA that the user needs to administer stimulation therapy on demand. Additionally, the HMA in communication with the IPA system allows voice-based instructions or commands by the user to select, set and/or modify a plurality of stimulation parameters, settings or protocol regimens.

The HMA in communication with the IPA system enables voice-based communication that prompts the user for stimulation based on time of day, past trends in appetite, calorie intake, and exercise data.

The HMA in communication with the IPA system enables voice-based communication to the user regarding the effects of stimulation during stimulation therapy. This includes guiding the user through recommended adjustments or modifications to a plurality of stimulation parameters. In some embodiments, recommended adjustments to a plurality of stimulation parameters for implementation by the user through voice-based acceptance are allowed or should be authorized.

The HMA in communication with the IPA system enables voice-based notifications to the user when sufficient time has elapsed since ingestion of a beverage or vice versa.

The HMA in communication with the IPA system enables voice-based user input regarding the current weight per day. Voice-based communications to the user include current stimulation parameters and other real-time inputs such as log and exercise monitoring.

The HMA in communication with the IPA system enables voice-based user input including, but not limited to, eating information and activity information. The eating information includes the user's standard regular eating and eating profile (representing the user's general eating habits), as well as the user's real-time actual eating and eating profile, such as the actual meal time per day, and the type and amount of food consumed from the actual meal. .

The HMA in communication with the IPA system enables voice-based communication to the user regarding the difference between the user's daily, weekly or monthly expected and actual calorie intake values, including multiple recommendations (by the HMA) due to the calculated differences. . Speech-enabled user communications may also include carbohydrates, proteins and fats compared to acceptable amounts of macronutrients allowed according to a standard diet plan followed by the user, including, for example, the effect of such additional intake on the user's weight loss goals. such as guiding the amount of additional macronutrients and/or ingested glycemic load.

The HMA in communication with the IPA system enables voice-based user input regarding activity information, such as how much and when the user moves and/or exercises during the day.

The HMA communicating with the IPA system enables voice-based communication to the user when the user is in a positive or negative energy balance. Such communication may be triggered by a voice-based query of the user asking for energy balance status during the day or average weekly or monthly energy balance. The HMA in communication with the IPA system may also include the user's standard regular eating and eating profiles, actual eating and eating profiles, weight trends, including rates of weight loss or gain, blood glucose data trends and hunger profiles over time periods such as daily, weekly or monthly. enable voice-based (eg, based on the user's voice-based query) reporting to the user about

The HMA in communication with the IPA system enables voice-based user input regarding hunger or appetite profiles.

The HMA in communication with the IPA system can, for example, enable user activation or automatic ordering of accessories such as electrode patches; Enable voice-based communication with one or more third-party service providers for standard meal or fitness coaching services such as Jenny Craig. The HMA may communicate with one or more third-party service providers via the IPA system, thus allowing sourcing and payment for online services and/or advertisements as well.

The HMA in communication with the IPA system enables voice-based feedback to the user on detected conditions such as diet adherence, calories burned, diet plan, and hyperglycemic rush. The HMA in communication with the IPA system also generates a voice-based prompt if the user forgets to apply the electrical skin patch device and/or deactivates the recommended duration or frequency of stimulation therapy; Option to generate a voice-based prompt to the user regarding the stimulation protocol that the scheduled stimulus will start within the next T minutes, e.g., 10 minutes, and disable the scheduled stimulus allowing the scheduled stimulus to start after T minutes if not deactivated Stimulation therapy compliance that asks the user to A plurality of compliance modalities including, but not limited to, various dietary regimen adaptations or instructions in which the user selects a standard pre-determined dietary regimen using interactive voice-based input or enters a customized plan as part of a standard regular eating and eating routine enable voice-based prompts to the user in relation to Users also use interactive voice-based input to record details about actual meals and meal times. For example, voice-based alert(s) may be generated if the user does not comply with a selected dietary plan. Voice-enabled compliance prompts are intended to encourage user compliance and, in some embodiments, include guiding the overall score and overall patient progress.

Referring to FIG. 48A , for example, the IPA device 4830 may include a sensor that detects the proximity of the EDP device 4810 . The IPA device 4830 may be placed, for example, in the user's kitchen. When a user wearing the EDP device 4810 enters the kitchen, the IPA device 4830 detects the user's presence and communicates the user's presence in the kitchen to the companion device 4805 in real or near real time. The HMA of the companion device 4805 processes the user's kitchen visit (assuming that the user's kitchen visit is likely to lead to an eating event based on the user's past eating history) at least in light of the user's current energy balance and standard diet plan. to determine whether the user should eat or not. The HMA generates an alert if the user's energy balance is positive and/or the user's meal intake is not scheduled as a result of a kitchen visit and does not match a standard diet plan. In some embodiments, an alert is communicated to the IPA system, resulting in the IPA device 4830 in the kitchen providing a voice-based alert to the user to convince the user not to consume the unscheduled meal. In an alternative embodiment, the HMA alert results in triggering the EDP device 4810 to initiate a therapeutic stimulus or a short, low amplitude alert stimulus pulse.

However, if the user visits the kitchen near mealtime, the IPA device 4830 in the kitchen may ask the user what the user is eating or planning to eat. Based on the user's response, the IPA system, for example, in addition to providing advice on how much food the user can consume, can also analyze potential amounts and types of calories for the food the user is eating or about to eat and provide the user with a healthier option. Food options can be recommended. In various other embodiments, the IPA system integrates the user's hunger level, profile, and timing with the IPA system's knowledge of the user's kitchen inventory to proactively advise the user what to eat and if the user is hungry or likely to be hungry at a particular time. Knowing that there is, it makes recommendations (what foods to eat and how much to eat, what to avoid, etc.). These IPA system-based preemptive food intake recommendations, initiation of therapeutic stimuli, or short, low-amplitude warning stimulation pulses are based on various combinations of events, for example, the user leaves home, or the user's distress feeling for an after-hours snack. It can be triggered based on a specific time to feel.

According to another aspect, the IPA system responds differently depending on at least time of day when the user verbally communicates to the IPA system that he is hungry. For example, if the user indicates hunger at mealtime, the HMA communicating with the IPA system may recommend a healthy recipe or offer to order food from various restaurants. However, if the user indicates hunger past a standard or scheduled meal time, the HMA communicating with the IPA system (using wireless communication) will send a signal to a Bluetooth activated lock that locks the pantry or terminates the function of the kitchen appliance. can

The HMA in communication with the IPA system enables voice-based user input related to nausea, indigestion, heartburn or sensations at the site of stimulation during and/or after stimulation.

The HMA in communication with the IPA system enables voice-based alerts to the user when the EDP device 4810 is removed from the user's body.

In embodiments in which the health care application implements the eating moment recognition method (FIG. 58) and also communicates with the IPA system, the identification or determination of a meal moment or activity by the HMA is communicated to the IPA system, which results in the IPA system allowing the user to An audible prompt may be delivered to the user asking if they are actually eating, and if so, alert the user if, for example, a meal event is unscheduled or inconsistent with the meal regime the user is following. In some embodiments, the meal instant recognition method is implemented directly by an IPA device that can communicate directly with the EDP device 4810 . In some embodiments, EDP device 4810 is configured as a band or wrist watch (eg, band 2105 of FIG. 21A or wrist watch 2106 of FIG. for example) an accelerometer for detecting, capturing, and acquiring a plurality of dietary data related to physical body movements, such as haptic motions of the wrist or hand. In this embodiment, the diet data from the EDP device (wrist watch or band) is sent to the IPA device (in communication with the watch or band) to detect an eating event or activity to issue an appropriate audible prompt or dialog to the user. delivered directly

In another non-limiting example, an HMA in communication with the IPA system enables voice-based setting by the user of daily reminders for prescribed vitamins and supplements; enable users to make voice-based queries to nutritionists; enable voice-based guidance to the user of schedules of weight loss seminars and support groups; enable healthcare providers to deliver healthy recipes to users to support continued weight loss success; enable bariatric surgery patients to be tracked via voice-assisted reminders and pre-populated checklist reviews (psychological examinations, insurance pre-approval, physician-guided diets); enable clinicians and users to record their daily thoughts and progress; enable the user to provide voice-assisted commands to enable or disable exchange of information with third-party applications; enable the user to receive voice-based status reports related to the tracked calories, protein, fat and carbohydrate consumed by the user; scan barcodes on packaged foods to allow users to listen to nutritional information, issue voice-based commands to automatically record feed intake daily diaries; to instill weight management habits in the patient as voice-capable prompts related to food/calorie intake lead to better dietary compliance; Physicians, nutritionists and other health care providers can send voice-based push notifications to users to keep them engaged and motivated to their health goals.

As described herein above, the plurality of health-related information of the user suggests and/or recommends a plurality of recommendations including stimulation patterns or protocols, medications (eg, insulin intake, etc.), diet and/or action plans. It is utilized by the HMA to implement. In some embodiments, the plurality of recommendations is guided to the user for voice-enabled approval for implementation.

In another non-limiting example, an HMA in communication with an IPA system can deliver voice-based prompts to the user and receive voice-based user input related to the user's daily 'diary' for tracking and recording the user's parameters. do. For example, instead of presenting the user with the GUI screens of FIGS. 8-13 to track and record user parameters related to appetite, exercise, hunger, stimulation sessions, weight, and well-being, the HMA communicating with the IPA system is Allows based prompts to be communicated to the user for each user parameter and allows the user to track and record these parameters via voice based input, commands or instructions. For example, in some embodiments, the HMA in communication with the IPA system may use speech recognition language/auditory scales or intensity scales (eg, may be larger scales) to help users determine their hunger levels (eg, appetite). , exercise or other daily 'journal' based parameters) and hunger events/episodes (including hunger event date and time) and use these as triggers to initiate or titrate treatment. In embodiments, the verbal/auditory hunger scale may be an analog numeric hunger scale from 1 to 10 or an analog intensity hunger scale, wherein a descriptor such as "not hungry", "somewhat hungry" and "very hungry" is spoken to the user. to select to display/enter the user's current hunger status. In an embodiment, the verbal/auditory scale is activated by a verbal input or command (to the IPA system) such as, but not limited to, "I'm hungry".

The following are exemplary, non-limiting, simulated interactions that may occur using an IPA system:

Patient: I'm hungry

IPA system: how hungry are you on a scale of 1 to 10

Patient: Not really... I'd say 5/10

IPA System: Thanks, we only have 45 minutes left for our scheduled meal, so let's see if we can hold out until then [record hunger event]

But if the patient responds very, I am 6/10,

IPA System: Wait, I'll give you a light rescue session [a 15-minute stimulation therapy at 10 mA starts automatically], which goes like this:

IPA system: I think it will help. The next meal is in 60 minutes. Let me know if you need more help. I'm next to you.

Instead, if the patient says: I am very hungry ...8/10

IPA system: Please wait. I'll give you a full rescue session [15 minute stimulation therapy starts automatically at 20 mA]

The aforementioned voice-based interaction is how an HMA communicating with an IPA system enables voice-based input of daily 'diary' parameters by a user, and at least the level of input (on a verbal/auditory scale) and input of the parameters. It illustrates how a stimulus of a user, including a rescue session, can be triggered and/or titrated based on time.

The following is another exemplary, non-limiting simulated interaction that may occur using an IPA system:

Patient: Today's hunger was quite severe around mid-morning.

IPA System: Sorry. I see you didn't use the stimulus rescue button during that time. Why not activate the rescue button tomorrow at 10am? By the way, you are doing really well with your weight loss and so far have lost more than 8 pounds above the average of other users. Well done!!

In various embodiments, the HMA in communication with the IPA system also enables voice-based diet coaching according to the user's verbal input of the user's daily 'diary' parameter.

48C is a block diagram of an HMA herein in communication with an IPA system as well as a big data database server according to an exemplary embodiment. In this embodiment, the HMA and IPA software applications are installed or implemented as client-side software components of the companion device 4805 in data communication with at least one EDP device 4810 herein. The client-side HMA and IPA software components of the companion device 4805 are in data communication with each other. The IPA software component of the companion device 4805 may or may not communicate directly with the at least one EDP device 4810 . The companion device 4805 also includes a state management server 4815 implementing the server-side software component of the HMA, an IPA server 4835 implementing the server-side software component of the IPA software application, and optionally a remote patient care facility and and/or communicate via network 4825 with patient care personnel. Network 4825 may be a cellular, Internet, TCP/IP, Ethernet, Bluetooth, wired or wireless network. In addition, the health management server 4815 and the IPA server 4835 are capable of data communication with each other through the network 4825 . According to one aspect of the present disclosure, the server-side software component of the HMA communicates with the big data database server 4840 via network 4825 in addition to communicating with the IPA system. The big data database server 4840 communicates with the EDP device 4810 and the companion device 4805 via the network 4825 and stores a plurality of health-related data of the user. In various embodiments, the big data database server 4840 uses an EDP device (e.g., device 4810) and a corresponding companion device (e.g., device 4805) over a network 4825, respectively. It communicates with multiple networks or multiple user groups. Accordingly, in various embodiments, the big data database server 4840 may access and store a plurality of aggregated health-related data (hereinafter referred to as 'health-related data' of users) of a plurality of networks or user groups. In various embodiments, health-related data may also include attribute data including, but not limited to, date of birth, work address, home address, social security number, gender, height, occupation, income, current and past diseases and medications, and family history of illness. includes Big data database server 4840 via network 4825 provides information on seller or shopping transaction records such as news, weather and climate forecasts, demographics, genomes, geographic maps, electronic health records, GPS, supermarket or store checkout data, public holidays, Communicate with a plurality of general data sources or databases, including, but not limited to, those relating to holidays and other data. Accordingly, in various embodiments, the big data database server 4840 may store a plurality of data (hereinafter referred to as "general data") by accessing a plurality of general data sources.

In one embodiment, the server-side software component of the HMA also analyzes the general data as well as a plurality of user health-related data (including attribute data), and generates a plurality of patterns and correlations from the user's health-related data and the general data; , big data mining big data database server 4840 to predict the impact of these patterns and correlations on a particular user, and ultimately generate and implement a plurality of predictive stimulation regimens or outcomes corresponding to the predicted effects. Implement the analysis engine. In various embodiments, the big data analytics engine uses case-based reasoning (constructing a process of solving a new problem based on the solution of a similar problem in the past), fuzzy logic (based on a degree of truth rather than the usual true or false boolean logic). An artificial intelligence program that implements one or more of (constructing a process of solving a problem) and/or rule-based reasoning (constructing a process of solving a problem according to a plurality of predetermined rules or criteria).

In some embodiments, the big data analytics engine may provide a plurality of user past and present (specific date) health related data (eg, past and present daily 'diary') (in a predetermined past time period such as week, month or year). items, caloric intake, exercise trends, etc.) to predict the onset of a hunger event and to pre-trigger or recommend a stimulation session (eg, a rescue session) prior to a predicted or anticipated hunger event.

In some embodiments, the big data analytics engine mines the general data and identifies a plurality of adverse factors that are likely to contribute to EDP users' failure to achieve their goals, such as weight loss goals. For example, historical shopping data may suggest an increase in purchases from unhealthy or high-calorie restaurants, such as gourmet food, gourmet food, and carbonated soft drinks, before and after holidays such as Christmas or Thanksgiving. When an EDP user has a high positive energy balance and a holiday is approaching, the HMA will automatically generate an alert via the IPA system to prompt the user to pay attention and eat unhealthy food during certain high-risk periods, for example a few days before and after Christmas. make sure not to It automatically generates a similar alert when a user's birthday approaches.

In some embodiments, the big data analytics engine may associate general data with the user's health and attribute data. For example, if the user's GPS coordinates are known, additional general data may be associated with the user, such as weather, time of day, place and place category (eg, home, work, bar, restaurant, concert hall). If the user's GPS coordinates indicate that the bar or restaurant is with the user, the HMA can automatically alert the user to the possibility of an addiction. In another embodiment, if historical trends suggest a correlation of a user's spikes in positive energy balance after visiting a bar or restaurant, the HMA is a preventative stimulus the next time the user visits the bar or restaurant to curb appetite. Sessions can be scheduled automatically. In another example, the big data analytics engine may access the user's OpenTable (online restaurant reservation service) reservations or the user's calendar reservations for bar or restaurant visits. Thus, the HMA can automatically alert the user of potential addiction before the user visits the bar or restaurant, trigger an event or recommend a rescue session before the user visits the bar or restaurant.

As another example, a user may be more likely to be vitamin D deficient given that the user has the same genetics and is likely to have the same level of sunlight exposure as the user's location. This correlation can be further emphasized if the user's exercise regime is primarily limited to indoor training. Thus, the HMA can automatically recommend regular checks for vitamin D to users and encourage users to include sufficient outdoor exercise or training.

In another embodiment, the big data analytics engine may identify statistically significant trends, where users feel more tired during the day after strenuous exercise. In the same example, the system may find that the user's sleep is more fragmented at night after strenuous exercise. In one embodiment, strenuous exercise or training is a potential contributing factor to negative well-being if the correlation between strenuous exercise, segmental sleep, and energy depleted the next day is strong enough and there are no other significant correlations despite appropriate data sources and types. flagged as In another embodiment, per-user trends may be compared to aggregated data to enhance the validity of per-user correlations. For example, big data analytics engines may also continue to discover that a significant proportion of the general population experiences segmental sleep at night after strenuous training. Therefore, the HMA can alert the user when the user's exercise intensity is high on a specific day through the IPA system and suggest an appropriate exercise regime.

Electrical skin patch device placement

In various embodiments, the electrical skin patch device of the present disclosure (eg, the electrical skin patch device 110 of FIGS. 1A-1C ) is 'on the user's body' to provide stimulation therapy for a plurality of diseases or treatments. located in or near the 'region of interest'.

In various embodiments, the 'region of interest' includes a dermatome. As will be appreciated by those skilled in the art, a dermatome is an area of skin supplied by sensory neurons originating from a spinal ganglion. There are 8 cervical nerves (except for C1 without dermatome), 12 thoracic nerves, 5 lumbar nerves and 5 sacral nerves. Each of these nerves transmits a relaying sensation from a specific area of the skin to the brain.

In some embodiments, the 'region of interest' includes a thoracic dermatome, eg, an anterior or lateral (T2-T12) dermatome of the user. In another embodiment, the 'region of interest' is an anterior (anterior) C5-T1 dermatome of the upper chest region (hereinafter collectively referred to as a 'hand dermatome'), along with the anterior (anterior) and/or of the user's hand and arm. Posterior (posterior) C5 - Contains the same dermatome as the T1 dermatome. In various embodiments, the 'region of interest' explicitly refers to the posterior (posterior) C5-T1 dermatome of the upper thoracic region since the dorsal region is not accessible to the user and thus a physician will be required to apply the device herein. Exclude. In another embodiment, the 'region of interest' includes an epidermal region for stimulating the median nerve in the hand, more specifically the wrist region.

However, in some embodiments the 'region of interest' includes the posterior (posterior) T2-T12 and/or C5-T1 dermatomes. In this embodiment, the EDP device of the present disclosure is configured to be easily placed in the dorsal dermatome by a user with minimal or no assistance from a third party such as a medical practitioner. Thus, in some embodiments, the EDP device is incorporated into a tight undershirt that, when worn by the user, simply places the integrated EDP device on the desired back dermatome. In some embodiments, a user may place the EDP device in a desired dorsal dermatome using an elastic band, strap, or belt that wraps around their torso, wherein the elastic band, strap, or belt comprises an EDP device herein. do.

In some embodiments, the 'region of interest' is the patient's T2 anterior, lateral and/or posterior thoracic dermatome, T3 anterior, lateral and/or posterior thoracic dermatome, T4 anterior, lateral and/or posterior thoracic dermatome, T5 anterior , lateral and/or posterior thoracic dermatome, T6 anterior, lateral and/or posterior thoracic dermatome, T7 anterior, lateral and/or posterior thoracic dermatome, T8 anterior, lateral and/or posterior thoracic dermatome, T9 anterior, lateral and/or at least one of a posterior thoracic dermatome, or a T10 anterior, lateral and/or posterior thoracic dermatome. In some embodiments, the 'region of interest' is the patient's T2 anterior and lateral thoracic dermatomes, T3 anterior and lateral thoracic dermatomes, T4 anterior and lateral thoracic dermatomes, T5 anterior and lateral thoracic dermatomes, and T6 anterior and lateral thoracic dermatomes of the patient. a patient's T2 posterior thoracic dermatome, T3, comprising at least one of: T7 anterior and lateral thoracic dermatome, T8 anterior and lateral thoracic dermatome, T9 anterior and lateral thoracic dermatome, and T10 anterior and lateral thoracic dermatome; any of posterior thoracic dermatome, T4 posterior thoracic dermatome, T5 posterior thoracic dermatome, T6 posterior thoracic dermatome, T7 posterior thoracic dermatome, T8 posterior thoracic dermatome, T9 posterior thoracic dermatome, and T10 posterior thoracic dermatome. does not include

In some embodiments, the 'region of interest' is a patient's C8 anterior or posterior dermatome located on the patient's hand, wrist, elbow and fingers, a C8 anterior or posterior dermatome located on the patient's arm, and a C8 skin located on the upper torso of the patient. node, a T1 anterior or posterior dermatome located on the patient's arm, a T1 anterior or posterior dermatome located on the patient's wrist, elbow and hand, and a T1 anterior or posterior dermatome located on the upper torso of the patient.

In some embodiments, the 'region of interest' is the patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 frontal, lateral and/or at least one of the posterior dermatomes.

In some embodiments, the 'region of interest' is at least one of C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 frontal and lateral dermatomes of the patient. one, and not any portion of the patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 posterior dermatomes.

In an alternative but less preferred embodiment, the 'region of interest' comprises one or more meridians.

17A is an illustration showing the distribution 1700 of anterior and lateral, or anterior T2-T12 dermatomes across the thorax and abdomen, ie, torso, of a human body. Anterior dermatomes are defined as anterior and lateral thoracic dermatomes that do not explicitly include the patient's dorsal or spinal roots. In various embodiments, the electrical skin patch devices of the present disclosure are positioned on the epidermal surface on the anterior portion 1702 or the lateral portion 1704 of the T2 - T12 dermatome. The electrode(s) positioned on the skin patch or pad of the electrical skin patch device provide electrical stimulation to the epidermis of the target dermatome(s). The T2 to T12 dermatomes can be identified anatomically as follows:

T2 - the apex of the armpit.

T3 - the intersection of the midclavicular line and the third intercostal space.

T4 - the intersection of the midclavicular line and the 4th intercostal space, located at the level of the nipple.

T5 - The intersection of the midclavicular line and the 5th intercostal space, located horizontally midway between the level of the papilla and the level of the xiphoid process.

T6 - the intersection of the midclavicular line and the horizontal height of the xiphoid process.

T7 - the intersection of the horizontal height and the midclavicular line at 1/4 of the distance between the xiphoid process and the level of the umbilicus.

T8 - the intersection of the midline of the clavicle with the horizontal height of one-half the distance between the level of the xiphoid process and the level of the umbilicus.

T9 - the intersection of the midline of the clavicle with the horizontal height of 3/4 of the distance between the level of the xiphoid process and the level of the umbilicus.

T10 - the intersection of the midclavicular line at the horizontal level of the navel.

T11 - the intersection of the midclavicular line at the horizontal level between the level of the umbilicus and the inguinal ligament.

T12 - the intersection of the midclavicular line and the midpoint of the inguinal ligament.

17B is an illustration showing the distribution 1701 of the anterior and posterior, C5-T1 dermatomes across the hand 1705, arm 1710, and upper chest 1715 regions of the human body. In various implementations, the electrical skin patch devices of the present disclosure include the anterior portion 1720 of the C5-T1 dermatome in the hand 1705 and arm 1710 with the anterior (anterior) C5-T1 dermatome of the upper chest 1715 . ) and/or on the epidermal surface of the posterior portion 1725 . 17C is an example depicting the distribution of C5-T1 dermatomes over the hand 1705 and lower arm 1711 regions. In various embodiments, the electrical skin patch devices of the present disclosure may be applied to the epidermal surface of the anterior (palm) and/or posterior surface of the hand 1705 targeting C6 - C8 dermatomes or the lower portion targeting C5 and T1 dermatomes. located on the epidermal surface of the anterior and/or posterior of the arm 1711 (eg, the wrist region). Electrode(s) located on a pad or skin patch of the device provide electrical stimulation to the epidermis of the targeted dermatome(s).

C5-T1 dermatomes can be identified anatomically as follows:

C5 - Lateral (radial) side of the antecubital fossa just next to the elbow.

C6 - the dorsal surface of the proximal phalanx of the thumb.

C7 - the dorsal surface of the proximal phalanx of the middle finger.

C8 - the dorsal surface of the proximal phalanx of the little finger.

T1 - Medial (ulnar) side of the medial epicondyle of the humerus and immediately proximal to the antecubital fossa.

As shown in FIG. 17E , in some embodiments, the electrical skin patch device of the present disclosure is positioned on an epidermal surface on an anterior 1740 and/or posterior 1745 of a wrist region 1750 that targets the median nerve. . Electrode(s) located on a pad or skin patch of the device provide electrical stimulation to the epidermis of the target median nerve. In the hand, the median nerve supplies motor innervation to the first and second lumbar muscles. The median nerve also supplies the muscle of the tibial ridge by repeated basilar branches. The median nerve innervates the skin of the palm of the index finger, thumb and middle finger, half of the ring finger, and the base of the nail. The lateral part of the palm is supplied by the palmar skin branch of the median nerve, which leaves the proximal nerve in the wrist fold. Thus, in some embodiments, epidermal region 1752 on anterior surface 1740 of wrist region 1750 and/or epidermal region 1754 on posterior surface 1745 of wrist region 1750 may be used to induce satiety, weight loss, and/or improved metabolism. Electrically stimulated to target the median nerve.

In some embodiments, hand dermatomes, such as C5-T1 dermatomes, as well as epidermal regions associated with median nerve stimulation of the wrist region use conductive metal electrodes (eg, but not limited to, gold) without an adhesive skin patch. You have to understand that you are stimulated by it. In these embodiments, conductive metal electrodes are placed on the appropriate epidermis (in some embodiments, the user applies a conductive gel) to deliver electrical stimulation pulses without a skin patch. In one embodiment, the conductive metal electrode stimulates the dermatomes C8 and T1 at the location of the median nerve below the wrist (ventral side). In one embodiment, the electrodes are on either side of the nerve.

17D is a flow diagram listing steps involved in a method of identifying a location to properly place an electrical skin patch on a patient's anterior chest surface in accordance with an embodiment of the present disclosure. At step 1732, the patient, physician, or person placing the EDP device on the patient locates the patient's midclavicular line. The person applying the device proceeds downward from the midclavicular line to the bottom rib of the patient's rib cage in step 1734 . At the bottom rib, in step 1736, the person applying the device moves down 2 cm to identify the placement point. At step 1738, the person applying the device places the top central portion of the electrical skin patch at the placement point.

Referring again to FIG. 1A , in various embodiments, at least one thoracic dermatome from T2 to T12 and/or an 'arm dermatome' or 'hand dermatome' (C5-T1) is, in various embodiments, the electrical skin patch device 110 . ) to provide electrical stimulation therapy through 10 mm or 20 mm of the dermis at the outer surface of the epidermal layer of the patient, wherein the one or more electrodes 118 are disposed in FIGS. 2A-2C, 3A, 3B and 4A and configured to be placed on a skin patch or pad as described with reference to Figures 4C.

Prior art has focused on one of three approaches: 1) stimulation of the back near the root of the spine, 2) providing percutaneous electrical stimulation requiring electrode implantation, or 3) stimulation using conventional acupuncture meridians. However, the electrical skin patch device 110 of the present disclosure provides electrical stimulation through 10 mm or 20 mm of the dermis at the outer surface of a patient's epidermal layer, and, according to various embodiments, an anterior surface with nerves closer to the skin surface; Target the lateral or posterior thoracic dermatomes and/or anterior or posterior 'hand dermatomes' (excluding the posterior (C5-T1) dermatomes of the upper dorsal region). The electric skin patch device 110 of the present specification generates an electric field determined by a voltage over distance, and this electric field penetrates to a shallower depth than conventional stimulation. This allows the electric skin patch device 110 to have a relatively smaller electrode 118 and lower current density so that the device requires less power than prior art devices to affect the target tissue. The electric field generated by the EDP device 110 is at least a function of electrode geometry, electrode-tissue interface impedance, and stimulation current amplitude. By providing an integrated device design and targeting the anterior, lateral or posterior thoracic dermatome and/or C5-T1 dermatome, the patient can independently apply the electrical skin patch device and stimulation. Devices of the prior art, especially those that stimulate the back (posterior side), require a medical professional for application.

In some embodiments, the electrical skin patch device 110 stimulates regions of the T6 and/or T7 dermatomes. In some embodiments, the electrical skin patch device 110 stimulates an area of at least one of T6 to T10 dermatomes. In some embodiments, the electrical skin patch device 110 stimulates regions of the C8 and/or T1 dermatomes in the patient's hand. In another embodiment, the electrical skin patch device 110 stimulates regions of the T6, T7, C8 and/or T1 dermatomes.

In one embodiment, as shown in FIG. 18A , the electrical skin patch device 1800 stimulates a T6 dermatome comprising meridians. In another embodiment, as shown in FIG. 18B , the electrical skin patch device 1810 stimulates the T7 dermatome. In another embodiment, as shown in FIG. 18C , the electrical skin patch device 1820 stimulates both T6 and T7 dermatomes. In some embodiments, referring to FIG. 18A , an electrical skin patch device 1800 is placed over the rib T6 to stimulate the intercostal nerve 1805 and the T6 dermatome via one or more electrodes disposed on the pad or skin patch. Delivers electrical stimulation 1802 and electrical stimulation 1804 below rib T6. In one embodiment, the EDP device 1800 is positioned 2 cm below the edge or edge of the rib cage (at least on either side of the abdomen) to stimulate the T6 dermatome. In another embodiment, referring to FIG. 18B , an electrical skin patch device 1810 is placed over the ribs T7 to stimulate the intercostal nerves 1815 and T7 dermatomes via one or more electrodes disposed on a pad or skin patch. Deliver electrical stimulation 1812 and electrical stimulation 1814 below rib T7. In one embodiment, the EDP device 1810 is positioned 2 cm to 6 cm (preferably 3.5 cm to 4.5 cm) below the edge or edge of the rib cage (at least on either side of the abdomen) to stimulate the T7 dermatome. In another embodiment, referring to FIG. 18C , an electrical skin patch device 1820 is configured to stimulate intercostal nerves 1825 , 1835 and T6 and T7 dermatomes via one or more electrodes disposed on a pad or skin patch. Delivers electrical stimulation 1822 below rib T6 and above rib T7 and electrical stimulation 1824 below rib T7. In one embodiment, the EDP device 1820 is positioned 2.5 cm to 3.5 cm below the edge or edge of the rib cage (on at least one of both sides of the abdomen) to stimulate both T6 and T7 dermatomes.

In one embodiment, the electrical skin patch device 1800 is positioned at a very specific portion of the patient's T6 dermatome. Specifically, the EDP device 1800 is positioned in the upper left quadrant along the midclavicular line 2 cm below the rib cage at a 90 degree angle towards the abdominal wall at a depth of approximately 0.5 cm to 1 cm. In other words, the EDP device 1800 is located at the intersection of two lines drawn on a patient standing, namely, a first line vertically down from the middle of the clavicle and a second line horizontally across the xiphoid process. The first line and the second line form a 90 degree angle at the right and left sides of the anterior torso of the patient.

According to one aspect of the present specification, the T6 dermatome is stimulated to suppress appetite and/or treat diseases such as obesity, overweight, eating disorders, metabolic syndrome. According to another aspect of the present disclosure, the T7 dermatome is stimulated to treat type 2 diabetes mellitus (T2DM). According to another aspect herein, any of the T6 to T10 dermatomes are stimulated to treat T2DM. According to another aspect herein, up to two dermatomes, such as T6 and T7, are stimulated simultaneously or alternately to treat multiple diseases (eg, appetite suppression and T2DM). According to another aspect of the present specification, any two of the dermatomes T6 to T10 are stimulated simultaneously or alternately. According to another aspect of the present specification, the C8 or T1 dermatome is stimulated to suppress appetite and/or treat diseases such as obesity, overweight, eating disorders, metabolic syndrome. According to another aspect of the present specification, up to two dermatomes, such as C8 and T1, are stimulated simultaneously or alternately. In another embodiment, the T6, C8 and/or T1 dermatomes are stimulated to suppress appetite and/or to treat diseases such as obesity, overweight, eating disorders, metabolic syndrome and/or T7 dermatomes are type 2 diabetes mellitus (T2DM) is stimulated to treat. In yet a further embodiment, multiple dermatomes are stimulated simultaneously, eg, any one or any combination of T6, T7, C8 and/or T1 dermatomes are stimulated simultaneously.

In some embodiments, the electrical skin patch device 110 stimulates regions of the C8 and/or T1 dermatomes in the patient's hand. In another embodiment, the electrical skin device 110 stimulates the median nerve in the wrist region. In one embodiment, as shown in FIG. 19A , the electrical skin patch device 1900 is applied via one or more electrodes disposed on a pad or skin patch C8 on the anterior (palm) or ventral side 1905 of the hand 1910 . irritate the skin. In another embodiment, as shown in FIG. 19B , an electrical skin patch device 1900 stimulates a C8 dermatome on the back or dorsal side 1906 of a hand 1910 via one or more electrodes disposed on a pad or skin patch. do. In yet another embodiment, as shown in FIG. 19C , the electrical skin patch device 1900 may be disposed on the anterior or ventral side of the lower arm or wrist region 1915 via one or more electrodes disposed on a pad or skin patch. Both C8 and T1 dermatomes are stimulated. In some embodiments, as shown in FIG. 19D , the electrical skin patch device 1900 is a front side 1930 of the wrist region 1940 to target the median nerve, via one or more electrodes disposed on a pad or skin patch. ) on the epidermal region 1920 and/or on the posterior surface 1935 , the epidermal region 1925 .

It should be understood that, in various embodiments, the electrical skin patch device 1900 is disposed in line with the patient's finger so that the longitudinal axis 1901 of the electrical skin patch device 1900 is approximately in the direction of the finger. However, in various alternative embodiments the electrical skin patch device may not be placed in line with the patient's fingers. In various embodiments, the electrical skin patch device 1900 is placed in the patient's non-dominant hand. In some embodiments, the electrical skin patch device 1900 is located on the back of the hand or the dorsal side of the hand (Fig. as shown in 19b).

According to one aspect, the electrical skin patch device 1900 is sufficiently flexible to conform to the contour of the user's hand 1910 and not interfere with the free movement of the hand 1910 . Referring back to FIG. 1A , a microcontroller ( Basic electronic devices, such as power management module 120 including 112 , transceiver 114 , pulse generator 116 , and acceptor slot 130 are polyimide, polyether ether ketone (PEEK) or transparent conductive poly It is mounted on a flexible plastic substrate such as an ester film to form a flex circuit. Alternatively, the underlying electronic device is substantially compact such that the rigid substrate does not need to be bent over a small area in some embodiments. In some embodiments, the power management module 120 including the receiver slot 130 , the actuator 122 and the indicators 124 , 126 may include a microcontroller 112 , a transceiver 114 to enable increased flexibility. and physically separated or separated from electronic circuitry such as pulse generator 116 . In various embodiments, the housing 111 of the electrical skin patch device 110 is made of a flexible material such as silicone, rubber, or any other flexible polymer known to those skilled in the art.

In some embodiments, the electrical skin patch device is configured to stimulate the C8 dermatome on the anterior (palm side) or ventral side as well as the back or dorsal side of the user's hand via one or more electrodes disposed on the pad or skin patch. In one embodiment, as shown in FIG. 20A , the electric skin patch device 2000 includes a first patch portion 2015, a second patch portion 2020, and first and second patch portions 2015 and 2020. and a third patch part or bridge 2025 connecting them. In some embodiments, the first and second patch portions 2015, 2020 have a substantially semicircular shape connected by a substantially rectangular bridge 2025 such that the electric skin patch device 2000 forms an approximate 'hourglass' shape. to be. In another embodiment, as shown in FIG. 20B , the first and second patch portions 2015 ′, 2020 ′ are substantially rectangular bridges such that the electric skin patch device 2000 ′ forms an approximate 'H' shape. are substantially rectangular connected by (2025'). In various embodiments, the bridges 2025, 2025' are narrow (ie, the width is substantially less than the length of the bridge) to increase the flexibility of this portion of the electrical skin patch device 2000, 2000'. It should be understood that the 'hourglass' and 'H' shape configurations of FIGS. 20A and 20B are non-limiting examples of the various shapes that the electric skin patch device may have in various embodiments.

In some embodiments, all three patch portions 2015, 2020 and 2025 are adhesive. However, in an alternative embodiment, only the first and second patch portions 2015, 2020 are adhesive, while the bridge portion 2025 is non-adhesive to improve the comfort, abrasion resistance and overall flexibility of the patches 2000, 2000'. it's a castle The non-adhesive bridge portion 2025 may be configured as a thinner portion compared to the adhesive first and second adhesive patch portions 2015 and 2020.

During use, the electrical skin patch device 2000 , 2000 ′ has the first patch portion 2015 positioned on the anterior (palm) or ventral side 2005 while the bridge 2025 wraps around the edge 2011 of the hand 2010 . ) and wraps the edge 2011 of the hand 2010 , respectively, such that the second patch portion 2020 is glued or placed on the back or dorsal side 2006 . According to one aspect of the present specification, a first electrode is disposed on the first patch portion 2015 to stimulate the C8 dermatome on the ventral side 2005 , and the second electrode is disposed on the dorsal side 2006 of the hand 2010 . It is placed on the second patch portion 2020 to stimulate the C8 dermatome.

In some embodiments, the electric skin patch device 2000 , 2000 ′ is configured such that an underlying electronic circuit including a power management module is disposed in one of the first or second patch portions 2015 , 2020 . Accordingly, referring to FIGS. 1A , 20A and 20B , the electric skin patch device 110 is a power management module including a microcontroller 112 , a transceiver 114 , a pulse generator 116 , and a receptor slot 130 ( 120), actuators 122 and indicators 124, 126 are constructed or arranged with patches 2000, 2000' of FIGS. In one embodiment, the microcontroller 112 , the transceiver 114 , the pulse generator 116 , the power management module 120 including the receiver slot 130 , the actuator 122 and the indicators 124 , 126 are 2 It is located on the patch portion 2020, that is, on the patch portion attached to the back or dorsal side 2006 of the hand 2010 to prevent damage to electronic components due to daily use.

In another embodiment, the electric skin patch device 2000 , 2000 ′ is configured such that the underlying circuit and power management module are distributed between the first patch portion 2015 and the second patch portion 2020 . Accordingly, referring to FIGS. 1A , 20A and 20B , the electric skin patch device 110 is a power management module including a microcontroller 112 , a transceiver 114 , a pulse generator 116 , and a receptor slot 130 . 120, an actuator 122 and an indicator 124, 126 are physically distributed between the first and second patch portions 2015, 2020 to improve the flexibility of the electric skin patch device 2000, 2000'. It is constructed or arranged with the patches 2000 and 2000' of FIGS. 20A and 20B to be separated. In one embodiment, microcontroller 112 , transceiver 114 , pulse generator 116 , actuator 122 and indicators 124 , 126 are, for example, first patch portion 2015 (hand 2010). While located on the ventral or palmar side 2005 ), the power management module 120 , including the receptor slot 130 , is positioned on the second patch portion 2020 (the dorsal or back side 2006 of the hand 2010 ). ) is attached to). In another embodiment, microcontroller 112 , transceiver 114 , pulse generator 116 , actuator 122 , and indicators 124 , 126 are, for example, second patch portion 2020 (hand 2010). While located on the dorsal or back side 2006 ), the power management module 120 , including the receptor slot 130 , is located on the first patch portion 2015 (ventral or palmar side 2005 of the hand 2010 ). ) is attached to).

With continued reference to FIGS. 1A , 20A and 20B , in one embodiment, first and second electrodes 118 and sensor 135 are disposed on first patch portion 2015 , ie, hand 2010 . ) is placed on the front side (palm) or the ventral side (2005) attached to the patch portion. In another embodiment, the first and second electrodes 118 are disposed on the first patch portion 2015 , while the sensor 135 is located on the second patch portion 2020 . In another embodiment, the first and second electrodes 118 are disposed on the second patch portion 2020 , while the sensor 135 is located on the first patch portion 2020 . In another embodiment, the first and second electrodes 118 are disposed in the first and second patch portions 2015, 2020, respectively, while the sensor 135 is disposed in the first or second patch portions 2015, 2020. ) is located in

In various embodiments, the electrical skin patch device of FIGS. 19A, 19B, 19C, 19D, 20A, and 20B is illustrated as being placed in a location on the user's hand, but in various alternative embodiments, such electrical It should be noted that the skin patch device may be placed at other points to stimulate the C5-C8 and/or T1 dermatomes of the user's arm or upper chest region. In some embodiments, hand dermatomes, such as C5-T1 dermatomes, as well as epidermal regions associated with median nerve stimulation in the wrist region use conductive metal electrodes (eg, but not limited to, gold) without an adhesive skin patch. It should be further understood that it is stimulated by In other words, the electrode is not placed on the adhesive skin patch. In such embodiments, conductive metal electrodes are placed on the appropriate epidermis (in some embodiments, the user applies a conductive gel) to deliver electrical stimulation pulses without a skin patch. In one embodiment, the conductive metal electrode stimulates the dermatomes C8 and T1 at the location of the median nerve below the wrist (ventral side). In one embodiment, the electrodes are located on either side of the median nerve.

According to another aspect, the EDP device 110 , 140 or 160 of FIGS. 1A-1C is configured with a wearable gear for stimulating the region of the C8 and/or T1 dermatomes in the patient's hand. Accordingly, in some embodiments, the EDP device herein is configured as a wristband or wristwatch, as shown in FIGS. 21A and 21B , respectively. It should be noted that EDP devices may not contain adhesives, such as wristbands or wristwatches, and the integrity of contact with the user's skin may be lower compared to the adhesive patch construction of EDP devices. Referring now to FIG. 21A , wristband 2105 includes a flexible band or strap 2110 that is worn to wrap around a patient's wrist. The flexible band 2110 has an inner surface (not shown) that, when worn, interfaces with the patient's skin and an outer surface 2115 . Band 2110 is secured around the wrist and secured in place using conventional fastening means, such as, but not limited to, Velcro, clasp, or buckle fastening. According to one embodiment, the EDP device 2100 , which may be similar to the EDP device 110 , 140 or 160 of FIGS. 1A-1C , provides a flexible band 2110 when the wristband 2105 is worn around the wrist. is incorporated within the flexible band 2110 to expose one or more electrodes 2118 such that an inner surface of the epidermal layer touches the outer surface of the patient's epidermal layer. To facilitate visibility and for illustrative purposes, EDP device 2100 and one or more electrodes 2118 are shown exposed in FIG. 21A through outer surface 2115 . However, the EDP device 2100, in various embodiments, is embedded within and between the inner and outer surfaces of the flexible band 2110, while only one or more electrodes 2118 cover the inner surface of the band. It should be understood that exposure through the skin allows it to come into contact with the patient's skin. In various embodiments, EDP device 2100 is positioned within band 2110 such that, when worn, one or more electrodes 2118 stimulate both C8 and T1 dermatomes by touching or contacting the front or ventral side of wrist region 2120 . do. In a preferred embodiment, the EDP device 2100 includes a band such that, when worn, one or more electrodes 2118 contact or contact the ulnar region (where dermatomes C8 and T1 meet) on the anterior or ventral side of wrist region 2120. 2110).

In various alternative embodiments, EDP device 2100 is configured in the form of an armband (instead of wristband 2105 ). This embodiment is similar to wristband 2105 in terms of overall structure and design, but flexible band 2110 is worn anywhere on the patient's arm such that one or more electrodes 2118 stimulate the patient's C8 dermatome. have a size that can be

In another alternative embodiment, the EDP device is configured in the form of a wrist watch 2106 as shown in FIG. 21B . Referring to FIG. 21B , wrist watch 2106 includes a flexible band 2110 that is worn to wrap around a patient's wrist. The flexible band 2110 has an inner surface 2114 and an outer surface 2115 that interface with the patient's skin when worn. Band 2110 is secured around the wrist and secured in place using conventional fastening means, such as, but not limited to, Velcro, clasp, or buckle fastening. According to one embodiment, the EDP device 2100 , which may be similar to the EDP device 110 , 140 or 160 of FIGS. 1A-1C , provides a flexible band 2110 when the wrist watch 2106 is worn around the wrist. ) is incorporated within the flexible band 2110 to expose one or more electrodes 2118 in contact with the outer surface of the patient's epidermal layer. In various embodiments, EDP device 2100 is positioned within band 2110 such that, when worn, one or more electrodes 2118 stimulate both C8 and T1 dermatomes by touching or contacting the anterior or ventral side of the wrist region. Dial 2125 comprising a graphical user interface (GUI) attached to band 2110 in some embodiments is located on the dorsal side of the wrist when wrist watch 2106 is worn by a patient. In a preferred embodiment, EDP device 2100 is placed within band 2110 such that, when worn, one or more electrodes 2118 contact or contact the ulnar region (where dermatomes C8 and T1 meet) on the anterior or ventral side of the wrist region. is located

In some embodiments, flexible band 2110 may be removed from dial 2125 and replaced with another similar flexible band. In another embodiment, flexible band 2110 is detachable from dial 2125 and is worn on a wrist, arm, or hand separate from dial 2125 . In this embodiment, the EDP device 2100 located within the flexible band 2110 is in wireless data communication with the user's smartphone (which functions as a companion device). In another embodiment, an EDP device 2100 configured to be worn on a wrist, arm, or band as in FIG. 21A is combined with the wrist watch 2106 of FIG. 21B, which may alternatively not include an EDP device therein. data communication. In some embodiments, wrist mounted EDP device configurations such as those described with reference to FIGS. 21A , 21B operate at pulse amplitudes ranging from 5 mA to 10 mA.

In various embodiments, hand dermatomes, such as C5-T1 dermatomes, and epidermal regions associated with median nerve stimulation of the wrist region may be treated with conductive metal electrodes 2118 (eg, cracked conductive) without the use of an adhesive skin patch. The same as, but not limited to, the embodiment used as a metal) is stimulated. In other words, electrode 2118 is not disposed on the adhesive skin patch. As discussed with reference to FIGS. 21A-21B , a conductive metal electrode 2118 is positioned on the appropriate epidermis (in some embodiments, the user applies a conductive gel) to deliver electrical stimulation pulses without a skin patch. In one embodiment, conductive metal electrode 2118 stimulates dermatomes C8 and T1 at the location of the median nerve below the wrist (ventral side).

In another embodiment, the EDP device of the present specification is configured in the form of hand gloves, and may be one (wearing only on one hand) or a pair of gloves (wearing on both hands). 22A , 22B , 22C and 22D show first and second hand gloves 2201 , 2202 , 2203 , 2204 including at least one EDP device 2200a - 2200j , collectively referred to as EDP device 2200 . Examples 2, 3 and 4 are shown respectively. Gloves 2201 , 2202 , 2203 , 2204 have an inner surface (not shown) and an outer surface 2215 that, when worn, contact the skin of the patient's hand on both the abdomen and dorsal side. According to one embodiment, at least one EDP device 2200 ( 2200a - 2200j ), which may be similar to the EDP device 110 , 140 or 160 of FIGS. The surface is integrated into the gloves 2201 , 2202 , 2203 , 2204 to expose one or more electrodes 2218 that are in contact with an outer surface of the patient's epidermal layer. To facilitate visibility and for purposes of illustration, the EDP device 2200 and one or more corresponding electrodes 2218 are shown exposed in FIGS. 22A-D, through the outer surface 2215 . However, it should be understood that in various embodiments, only one or more electrodes 2218 may be exposed through the inner surface such that the EDP device 2200 may contact the patient's skin while resting on the inner surface of the glove.

22A-22D illustrate multiple positions of one or more EDP devices 2200a - 2200j for stimulating C5-C8 and/or T1 dermatomes of a patient's hand. 22A-22D illustrate a plurality of locations of one or more EDP devices 2200 ( 2200a - 2200j ) on the dorsal side of a patient's hand, however, the one or more EDP devices 2200 may alternatively or additionally be located on the abdomen of the patient's hand. It should be understood that it may be located on the lateral side and irritate the C8 and/or T1 dermatomes. Accordingly, in various embodiments one or more EDP devices 2200 are positioned such that corresponding electrodes stimulate the dorsal and/or ventral C5-C8 and/or T1 dermatomes of one or both hands of the patient. In one embodiment, to stimulate both C8 and T1 dermatomes, at least one EDP device 2200 has a corresponding electrode 2218 as shown in FIG. 22C , with a glove 2203 extending over the wrist region 2220 . is positioned to contact the ulnar region of the patient's wrist as shown.

23 shows another embodiment in which the EDP device is configured in the form of hand gear 2305 . The hand gear 2305 is similar to a partial glove including a portion 2310 that wraps around the index finger, a portion 2320 that wraps around the thumb, and a portion 2325 that wraps around the wrist. The hand gear 2305 has an outer surface 2315 and an inner surface (not shown) that, when worn, contacts the patient's skin. In various embodiments, at least one EDP device 2300 (which may be similar to EDP device 110 , 140 or 160 of FIGS. It is positioned on the inner surface of the hand gear 2305 to be exposed to contact. To facilitate visibility and to illustrate, EDP device 2300 and one or more electrodes 2318 are shown exposed in FIG. 23 , through outer surface 2315 . However, it should be understood that in various embodiments only one or more electrodes 2318 may be exposed so that the EDP device 2300 may rest on the inner surface of the hand gear 2305 and contact the patient's skin. According to various embodiments, the at least one EDP device 2300 is located on the wrist wrapping portion 2325 to stimulate the C8 dermatome on the dorsal side of the wrist and/or stimulate both the C8 and T1 dermatomes on the ventral side of the wrist. is located To stimulate both the C8 and T1 dermatomes, the EDP device is positioned such that the corresponding electrode stimulates the ventral ulnar region of the patient's wrist.

24 shows another embodiment in which the EDP device is configured in the form of a ring 2405 sized to be worn on a patient's little finger or little and/or ring finger. Ring 2405 has an inner surface 2414 and an outer surface 2415 that interface with the patient's skin when worn. In various embodiments, the at least one EDP device 2400 (which may be similar to the EDP device 110 , 140 or 160 of FIGS. 1A-1C ) is connected to one or more electrodes 2418 when the ring 2405 is worn ) is positioned on the inner surface 2414 (or alternatively embedded within the ring 2405 and placed between the inner and outer surfaces 2414, 2415) such that it is exposed in contact with the surface of the patient's epidermal layer. One or more electrodes 2418 stimulate the C8 dermatome when the ring 2405 is worn by the patient on the little or ring finger. It should be understood that one or more electrodes 2418 may contact the patient's skin (little or ring finger) anywhere along the circumference of the pinky or ring finger to stimulate the C8 dermatome.

25 shows another embodiment in which the EDP device is configured in the form of a compressible toy or unit 2505 sized to be held in the hand of a patient. The compressible toy 2505 may be, such as, but not limited to, a ball (as shown in FIG. 25), a cylinder, an egg-shaped toy, or any other compressible toy that can be squeezed or compressed while held in the patient's hand. not) may take any form. As shown in FIG. 25 , the compressible toy 2505 has an outer surface 2515 that contacts the patient's skin when the toy 2505 is held in the hand by the patient. In various embodiments, the at least one EDP device 2500 is positioned on the outer surface 2515 such that one or more electrodes 2518 of the EDP device contact the patient's skin when the toy 2505 is held in the hand by the patient. . Alternatively, the at least one EDP device 2500 may include an outer surface 2515 of the toy 2505 such that one or more electrodes 2518 of the EDP device contact the patient's skin when the patient holds the toy 2505 in the hand. ) can be placed within the toy 2505 . According to one aspect of the present disclosure, toy 2505 is held in the hand by the patient. One or more electrodes 2518 contact the C8 dermatome on the ventral side of the patient's palm or hand. In one embodiment, the area exposing the electrode 2518 on the toy 2505 is marked or tattooed indicating that the patient should hold the toy 2505 so that the mark/tattoo is in contact with the area corresponding to the C8 dermatome.

In some embodiments, one or more electrodes 2518 deliver stimulation when toy 2505 is squeezed or compressed by the patient, but switch off stimulation when toy 2505 is relaxed or decompressed by the patient. Therefore, when the compressible toy 2505 is repeatedly compressed and relaxed, stimulation and non-stimulation cycle repeatedly in the C8 dermatome. In another embodiment, the one or more electrodes 2518 initiate stimulation when the toy 2505 is first held and then continue to stimulate according to a pre-programmed stimulation protocol while the patient holds the toy 2505 in the hand. . In another embodiment, one or more electrodes 2518 initiate a pre-programmed stimulation protocol when toy 2505 is held (with or without compression) in the patient's hand. Thereafter, the patient may continue to squeeze the toy 2505 periodically without affecting application of the stimulation protocol.

26 shows another embodiment in which the EDP device is configured in the form of a hand or palm gear 2605 . The hand gear 2605 includes, for example, a housing 2611 having an upper or outer surface 2615 containing a GUI display, and a lower or inner surface that, when worn, contacts the patient's skin on the dorsal side of the patient's hand 2606 not visible). A plurality of arms 2620 extend from housing 2611 to allow hand gear 2605 to be worn and held on a patient's hand 2606 as shown in FIG. 26 . In various embodiments, the EDP device (not shown) is such that one or more electrodes of the EDP device are exposed through the lower or inner surface of the housing 2611 so that when worn, the EDP device will contact the patient's skin (the dorsal side of the patient's hand 2606 ). It is located within the housing 2611 to allow According to one embodiment, one or more electrodes stimulate the patient's dorsal C8 dermatome of hand 2606 .

Thus, in accordance with some aspects herein, electrical stimulation (using the electrical skin patch device 110 of FIG. 1A ) through 10 mm or 20 mm of the dermis from the outer surface of the epidermal layer of a patient is an appetite suppressant, ghrelin production Non-invasive treatment of control, eating disorders, overweight or overweight, obesity, metabolic syndrome and diabetes. In various embodiments, the depth of stimulation through the epidermal layer of the patient ranges from 0.1 mm to 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 , 17, 18, 19, 20 mm or any increments therein.

mechanism of action

The therapy goals of the presently disclosed embodiments may be achieved by one or more of the following mechanisms of action. In the first mechanism of action the hunger pain is negated and operates on one or more predetermined stimulation parameters. Small diameter nerve fibers transmit pain impulses through a theoretical "gate mechanism", whereas larger diameter nerve fibers inhibit the transmission of pain impulses by smaller nerves, effectively blocking or closing this theoretical gate. It is believed that stimulating large nerve fibers can close the gate, blocking pain and blocking the feeling of hunger. In a second mechanism of action, production of endorphins, a natural pain-relieving hormone produced by the body, may be up-regulated or increased to act on one or more predetermined stimulation parameters to again block the sensation of hunger.

In a third mechanism of action, this embodiment, operating under one or more stimulation parameters, induces somatic-somatic, somatic-autonomous and/or somatic-visceral reflexes resulting in afferent central and efferent visceral effects. In various embodiments, electrical stimulation from the outer surface of the epidermal layer of a patient through the dermis of a dermatome disclosed herein produces an internal reflex with sensory nerves that connect specifically to the stomach as an efferent pathway. As a result of this stimulation, the stomach slows down the emptying process and decreases appetite by increasing a feeling of fullness, fullness, or satiety. Similarly, in various embodiments, electrical stimulation from the outer surface of a patient's epidermal layer through the dermis of a particular dermatome, such as a T7 dermatome, also causes sensory nerve endings to dermatome T7 as an afferent pathway and the pancreas as an efferent pathway. Produces visceral reflexes with branches of the stimulating sensory nerves.

In a fourth mechanism of action, the present application provides a method for modifying an individual's perception of food or otherwise attenuating a positive emotional association with food, thus increasing aversion or negative association with food intake, comprising: a patient providing an electrical skin patch configured to adhere to an epidermal layer of providing an electrical skin patch comprising: a pulse generator comprising: defining a plurality of stimulation parameters; and programming the pulse generator to generate a plurality of electrical pulses using the plurality of stimulation parameters wherein the stimulation parameters of are determined to increase the patient's aversion to food intake after application of at least one stimulation to the epidermal layer of the patient. In this regard, the stimulation parameter may be: a) the stimulus is painful, or b) the stimulus is adjusted to the actual food intake time of the person and is automatically triggered during the person's actual food intake time, this time being determined directly or by a controller from an external device. or programmed with a pulse generator and automatically triggers the stimulus at the appropriate time, c) the stimulus is adjusted to a time other than the actual human food intake time and automatically triggered for a different time, which time is directly or from an external device. programmed with a controller or pulse generator and automatically trigger the stimulus at these times, d) the stimulus can be scheduled to be triggered manually at a given time by the patient either directly through the interface of the EDP or via an external device as the patient requires have. The advantage of this method is that, in addition to the physiological effects of appetite regulation, it achieves a psychological effect of associating negative sensations (electrical stimulation) with food intake, thereby weakening the positive association an individual has with food, and thus a major psychological effect on compulsive eating. It weakens one of the stimuli. In this regard, the present invention achieves an aversion to food intake in addition to a decrease in appetite.

According to one aspect, the fourth mechanism of action is agnostic of the dermatome deploying the EDP device. In some embodiments, the user's negative association with food or dissociation of the user's positive emotions towards the food is substantially influenced and enhanced by the timing of the stimulus near meal intake, such as before, during, and/or after a meal. In various embodiments, EDP device stimulation affects non-specific dermatomes, cranial nerves, cervical and lumbar sacral dermatomes to act through this mechanism.

In a fifth mechanism of action, the presently disclosed embodiment selectively induces electrical central nerve stimulation over electrical spinal stimulation. Electrical stimulation in the perceptual range is central (sensory), and electrical stimulation in the non-perceptual range is the spinal cord (autonomy). Electrical stimulation above the sensory response threshold results in selective central stimulation, and electrical stimulation below the sensory response threshold results in selective spinal stimulation. Thus, determining a patient's sensory response threshold can adjust electrical stimulation parameters for selective central or spinal stimulation to modulate the patient's appetite level.

27A is a flow diagram illustrating steps associated with one embodiment of a method of using an electrical skin patch (EDP) device to determine a stimulus response threshold and suppress appetite in a patient. In step 2722, the EDP device is placed on the patient's body. At step 2724, a central electrical stimulation response threshold for the patient is determined. Then, at step 2726, a spinal electrical stimulation response threshold for the patient is determined. The microcontroller of the EDP device is then programmed such that in step 2728 at least one of the pulse width, pulse amplitude and pulse frequency of the delivered electrical stimulation is set above the spinal electrical stimulation response threshold but below the central electrical stimulation response threshold. . In step 2730, the EDP device generates a plurality of electrical pulses defined by the pulse width, pulse amplitude and pulse frequency set in step 2728.

27B is a flow diagram illustrating steps associated with another embodiment of a method of using an electrical skin patch (EDP) device to determine a stimulus response threshold and suppress appetite in a patient. In step 2742, the EDP device is placed on the patient's body. At step 2744, a maximum allowable electrical stimulation response threshold that can be measured as a pain sensation for the patient is determined. Then, at step 2746, a spinal electrical stimulation response threshold for the patient is determined. The microcontroller of the EDP device then sets, in step 2748, at least one of a pulse width, a pulse amplitude, and a pulse frequency of the delivered electrical stimulation to be above the spinal electrical stimulation response threshold but below the maximum allowable electrical stimulation response threshold. programmed to be In step 2750 , the EDP generates a plurality of electrical pulses defined by the pulse width, pulse amplitude and pulse frequency set in step 2748 .

In a sixth mechanism of action, the electrical skin patch (EDP) device of the present disclosure stimulates specific dermatomes as described above to modulate ghrelin and suppress appetite. The gastric mucosa plays a role in ghrelin-induced gastric contractions. Endogenous primary afferent neurons (IPANs), including multiple axonal interneurons, may be involved in the transmission of signals from the mucosa to the muscle plexus. Ghrelin may stimulate and modulate gastric contraction through cholinergic, adrenergic, serotonergic and/or opioid action and/or nitric oxide synthase in the myofascial plexus. The stimulating effect of ghrelin on gastric motility is mediated by the intrinsic enteric nerve pathway and direct stimulation of capsaicin-sensitive afferent neurons. There is a close interaction between ghrelin and enteric neurotransmission involving stimulation of the excitatory nervous system and/or inhibition of the inhibitory nervous system via ghrelin receptors under stimulation of intrinsic neural pathways. During fasting, ghrelin secretion is induced by adrenergic agonists (topically released norepinephrine) released by neurons that act directly on the B1 receptors of ghrelin-secreting cells of the stomach, resulting in elevated plasma ghrelin levels due to fasting.

Stimulation to certain dermatomes, such as dermatome T6, induces a somato-visceral arc reflex, which results in inhibition of ghrelin-producing B1 adrenergic neurons. As a result, ghrelin levels decrease. This decrease in ghrelin triggers the activity of the enteric nervous system and intrinsic primary afferent neurons contained in the gastric mucosa (necessary as a final step in the action of ghrelin on gastric and gastric vestibular motility).

Accordingly, in various embodiments herein, it is believed that the EDP device suppresses appetite through the following mechanism. To begin, the EDP device delivers an electrical stimulus to the cutaneous nerve of dermatome T6 (or any other dermatome described herein) to activate the somatic-visceral reflex described above. In some embodiments, the EDP device delivers electrical stimulation to the cutaneous nerves of the dermatomes T5-T10. Stimulation of the intrinsically inhibitory B1 adrenergic plexus (neuron) reduces ghrelin production during fasting. This reduces the activity of the enteric nervous system and intrinsic primary afferent neurons (responsible for the final step required for ghrelin action on gastrointestinal motility). Decreased plasma ghrelin levels result in suppression of appetite as well as decreased gastric motility and decreased gastric emptying time.

In a seventh mechanism of action, an electrical skin patch (EDP) device embodiment herein uses electrical stimulation to effect a decrease in gastric vestibular or gastric activity that induces a feeling of satiety during an increased time period between meals. In one embodiment, through application of the correct stimulation parameters, gastric vestibular motility can be modulated faster than gastric emptying time. Specifically, more than 10% change in gastric vestibular motility can be achieved after applying one electrical stimulation session, but gastric emptying time increases by more than 10% only after at least 2 sessions and after only 1 session. is no change In one embodiment, greater than 10% change in gastric vestibular motility can be achieved after applying one electrical stimulation session, whereas gastric emptying time increases by greater than 10% only after at least two sessions, Each session takes place on a different day and all sessions occur within a week. In one embodiment, while greater than 10% change in gastric vestibular motility is attainable after applying one electrical stimulation session, gastric emptying time increases by greater than 10% only after at least 3 sessions, each Sessions are held on different days and all sessions occur within one week.

In another mechanism of action, the electrical skin patch (EDP) device embodiments herein use electrical stimulation to reduce gastric vestibular activity, resulting in decreased gastric motility and slower gastric emptying. Somatic stimulation of T2-T12 and/or C5-T1 dermatomes using the electrical skin patch device of the present disclosure affects the modulation of gastrointestinal phase pressure activity and consequently decreases gastric vestibular motility and increases plasma beta-endorphin levels. make it Therefore, somatic stimulation reduces gastric pressure activity before and after meals to slow gastric emptying, resulting in a feeling of satiety for a long time between meals.

FIG. 47A shows a sham stimulation session 4705, a stimulation session 4710 that targets the hand dermatomes (C8 and/or T1), and a stimulation session 4715 that targets the thoracic dermatomes (T2-T12). Chart 4700 illustrating the mean cumulative change (20 minute increments) in the gastric vestibular motility index. Note the effect of hand and abdominal stimulation sessions on gastric vestibular motility. 47B shows a sham stimulation session 4706, a stimulation session 4711 targeting the hand dermatomes (C5-C8 and/or T1), and a stimulation session 4716 targeting the thoracic dermatomes (T2-T12) and Chart 4701 illustrating the relevant maximum plasma endorphin levels (pg/ml). It should be noted that endorphin levels increase as a result of hand and abdominal stimulation sessions. In a further mechanism of action, the electrical skin patch (EDP) device of the present disclosure uses electrical stimulation to modulate the gut microbiota to improve the ratio of beneficial and harmful gut microbiota, serotonin, glucagon-like peptide 1 (GLP1) and Regulates secretion of multiple hormones such as leptin, reduces serum levels of lipopolysaccharide (LPS), improves metabolic inflammation and insulin resistance, regulates resting metabolic rate (RMR) and improves glycemic homeostasis. The specific therapy goals associated with each of the hormones and other physiological markers listed above are discussed further below.

It should be understood that delayed gastric emptying improves postprandial blood sugar and improves insulin sensitivity. Delayed gastric emptying causes food to stay in the stomach longer, which reduces ghrelin production and reduces hunger. Thus, delayed gastric emptying delays the ghrelin cycle, reducing daily ghrelin levels, overcoming the ghrelin-induced 'craving' effect.

In an eighth mechanism of action, the electrical skin patch (EDP) device of the present disclosure uses electrical stimulation to affect gastric distension/disregulation resulting in improved satiety, fullness and weight loss. The plurality of stimulation parameters is at least one of a therapeutically sufficient amount of delay in gastric emptying time in the patient, a therapeutically sufficient amount of increased gastric retention in the patient, and/or a therapeutically sufficient amount of gastric distension/accommodation disorders in the patient. is chosen to cause

In a ninth mechanism of action, the electrical skin patch (EDP) device of the present disclosure uses electrical stimulation to effect a decrease in plasma motilin, resulting in a decrease in gastric motility and improved satiety, satiety and weight loss.

In a tenth mechanism of action, the electrical skin patch (EDP) device of the present disclosure uses electrical stimulation to inhibit nitric oxide synthase in the vicinity of feeding events (pre/pre-prandial, during feeding and post/post feeding) to increase gastric muscle tone. maintains or increases gastric emptying, impairs gastric receptivity/distension, and increases gastric retention.

In some embodiments, affects gastric vestibular pressure, gastric vestibular motility, gastric emptying, satiety, satiety, ghrelin production, ghrelin circulation, GLP1, blood sugar (hemoglobin A1c), insulin, appetite, and changes in body weight (weight loss). It is possible to measure the effect of eliciting internal reflexes through selective skin stimulation.

According to some aspects herein, the mechanism of action associated with ventral skin stimulation (targeting T2-T1 and preferably T5-T10 dermatomes) includes activating intrinsic reflexes relayed at the spinal cord level. Abdominal skin stimulation causes somatic and visceral afferents to converge on the same neurons in layer 5 of the olfactory bulb of the spinal cord, depolarize each other and exert reciprocal presynaptic inhibition. This inhibition reduces gastric vestibular motility in both amplitude and frequency, leading to delayed gastric emptying, a feeling of fullness and satiety. This inhibition also reduces gastric ghrelin production and circulation. The sum of these effects results in appetite suppression and weight loss. In some embodiments, the dermatomes (T2-T12 and preferably T5-T10) are selected for somatic electrical stimulation, since this is at the level of the spine at which outflow from the upper digestive tract occurs.

According to some embodiments, electrical stimulation of dermatomes (C5-T1) and preferably dermatomes (C8-T1) is used to stimulate dermatomes (T2-T12) and preferably dermatomes (T5-T10). cause the same effect as Electrical stimulation of the dermatome (C5-T1) and preferably the dermatome (C8-T1) elicits a centrally relayed visceral reflex. Somatic afferent stimulation effects are viscerally efferent (in an inhibitory manner) when the entrances and exits of the afferent and efferent limbs are separated by up to two vertebral levels. Dermatomes (C5-T1) and preferably dermatomes (C8-T1) are separated by only one vertebral level. The stimulation therapy of the present specification uses this phenomenon to stimulate the internal reflex system, resulting in suppression, specifically, suppression of upper gastrointestinal motility. Stimulation of dermatomes (T2-T12 and preferably T5-T10) (eg torso) and dermatomes (C5-T1) and preferably dermatomes (C8-T1) (eg wrist) The similarity of responses between the livers shows the predominance of the spinal relay centers. This is further evidenced by a similar increase in beta-endorphin levels, whether electrical stimulation was performed at the abdominal or hand level. A further indication that the electrical stimulation of the skin of the dermatomes (T2-T12 and C5-T1, preferably T5-T10 and C8-T1) is essentially inhibited is that plasma levels of norepinephrine, epinephrine and dopamine are not altered. In addition, heart rate, systolic and diastolic blood pressure are not altered when these dermatomes are electrically stimulated.

Existing approaches to nerve stimulation of the gastrointestinal system to induce satiety or weight loss have generally focused on the parasympathetic nervous system (vagus nerve). However, the present specification relates to electrical stimulation of internal organs system to achieve satiety, appetite suppression, weight loss and improvement of blood sugar. In other words, a mechanism of action according to various aspects herein uses external skin stimulation to activate inhibitory pathways through the nervous system, such as a) slowing gastric vestibular motility (both amplitude and frequency), and b) delaying gastric emptying. c) induce decreased appetite and weight loss, d) decrease ghrelin, e) increase insulin, f) improve blood sugar (hemoglobin A1c), g) increase gastric retention/bloat, h ) decreases plasma motilin.

Stimulation of the visceral system via percutaneous electrical nerve stimulation of targeted dermatomes is further enhanced by targeting stimulation sessions to coincide with specific pre- and postprandial “metabolic windows”. The preprandial window is associated with the body's secretion of ghrelin just prior to the expected feeding. In some embodiments, the approximately 60 minute preprandial period is referred to as the "ghrelin window." After a meal, there is a period of postprandial digestive activity lasting about two hours, called the "gastric vestibular exercise window." In various embodiments, the EDP system of the present disclosure is administered within or around the ghrelin window (reducing ghrelin to reduce appetite) and/or vestibular motility window (reducing gastric vestibular motility to delay gastric emptying and cause satiety) enable timing stimulation in This stimulation session may be triggered directly (manually) by the patient, by a preset schedule (eg, entered by the user), or by an eating event by a swallowing detection device, such as device 5605 of FIG. 56 . triggered automatically in connection with the detection of, or triggered by, for example, an eating moment recognition method (FIG. where the accelerometer is included in a wristband or wristwatch, such as band 2105 of FIG. 21A or wristwatch 2106 of FIG. 21B. In yet a further embodiment, the stimulation session is automatically triggered by a sensor configured to sense a hunger or eating event/signal, such as, but not limited to, a visceral sound, dilation of a renal receptor.

A mechanism of inhibition of action via the in vivo system can be activated by the wearable EDP device herein to time nerve stimulation sessions to coincide with specific metabolic windows that occur around meal times throughout the day and throughout the week.

In another mechanism of action, the electrical skin patch (EDP) device(s) of the present disclosure use myelinated A-delta fibers to transmit signals to the spinal cord (afferent pathway) of an epidermal (skin) nociceptor free terminal nerve. Surface electrical stimulation may be used. The EDP devices and HMA systems herein a) do not cause pain, i.e., in some embodiments do not violate a pain threshold as measured by a score on the VAS pain scale, and b) involuntary skeletal muscle contractions or spasms (involuntary muscle spasms). Optimize electrical stimulation of these superficial nerves in the skin to increase tactile sensitivity (eg, tingling) without causing rapid blinking).

According to another mechanism of action, abdominal skin stimulation of T6-T7 dermatomes using the electric skin patch (EDP) device of the present disclosure induces improved beta cell function of the pancreas.

Methods of treating neurodegenerative diseases using the EDPs herein

As discussed throughout this specification, transcutaneous electrical nerve stimulation of specific dermatomes reduces gastric emptying time and prolongs gastric retention. Because Alzheimer's disease (AD), diabetes, and obesity are linked with a common dependence on the central nervous system's insulin signaling pathway, reducing gastric emptying time using nerve stimulation with direct neuromodulation selectively on sensory afferents can lead to Alzheimer's disease. It can reduce insulin resistance and improve neurological function in patients suffering from neurodegenerative diseases such as (AD). Insulin resistance is a key factor in the development of Alzheimer's disease pathology because insulin regulates not only energy homeostasis, but also synaptic plasticity and memory function.

Obesity is a major risk factor for the development of insulin resistance. High levels of fasting insulin resistance, as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), are associated with decreased cognitive ability. Delaying gastric emptying through percutaneous electrical stimulation of major dermatomes can reduce fasting insulin resistance by at least 0.1% after multiple stimulation sessions. Transcutaneous electrical stimulation of dermatomes (T6 and T7), among other dermatomes and according to the disclosed embodiment, can increase delayed gastric emptying time by 25% in overweight patients (BMI>25), with HOMA-IR by 0.5-1 may decrease, improving fasting insulin levels (part of the calculation used to determine HOMA-IR) by at least 15%, and decreasing hemoglobin A1c (HbA1c) by 0.5, which is 50% effective at GLP-1 receptors appear in the agonist. Thus, in one embodiment, the plurality of transdermal electrical stimulation sessions results in a therapeutic endpoint that is within 30% to 70% of a therapeutically effective amount of a glucagon-like peptide (GLP-1) receptor agonist.

A positive therapeutic outcome may also be achieved by applying transdermal electrical stimulation in accordance with the disclosed embodiments to treat Parkinson's disease (PD). Lowering HOMA-IR through stimulation of major dermatomes such as the dermatome (T6) reduces the extracellular accumulation of Aβ in plaques, and this deposition is a major pathological driver of AD. In addition, the patient can see an increase in cerebral blood flow. The patient can see a 15% increase in local blood glucose metabolism. PD patients treated with percutaneous electrical stimulation will show improvement on "motor" and "non-motor" disease scales, including cognition. Motor symptoms include bradykinesia, tremor, spasticity, gait and postural disturbances, usually by the Unified Parkinson's Disease Assessment Scale (UPDRS Part III) or the Movement Disorders Society-sponsored revised Unified Parkinson's Disease Assessment Scale (MDS-UPDRS-III). It is measured.

Positive therapeutic results may also be achieved by applying transdermal electrical stimulation to treat Alzheimer's disease (AD) in accordance with the disclosed embodiments. Improvements in cognitive abilities in patients with Alzheimer's disease (in addition to formal neuropsychological tests) can be assessed in several ways. The Mini Mental Status Exam (MMSE) is one of the most widely used and validated bedside tools for the assessment of mental status. The Mattis Dementia Rating Scale (DRS), which yields a total DRS score, is a reliable and clinically useful scale for the mental status of patients with Alzheimer's disease. A score cutoff of less than 120 can be used to identify dementia. DRS-2 is the latest version of DRS and is frequently used to assess the cognitive status of the elderly in both clinical and research settings. According to the examples disclosed herein, transcutaneous electrical stimulation will result in a mean improvement of at least 2.5 points in the treatment group in DRS-2 over 1 year compared to exacerbation in control patients.

Alternative scales that are appropriate tools to monitor dementia progression include the Severe Impairment Battery (SIB), a revised 19-item AD Collaborative Study - Daily Living Inventory Activities (ADCS-ADL19), and Clinician Interview-Based Impression Changes Plus Caregiver Input (CIBIC-) Plus), the Neuropsychiatric List, and the Behavioral Assessment Scale for Geriatric Patients (BGP Care Dependence Subscale). An additional test that may show benefit comes from the Montreal Cognitive Assessment (MoCA), a simple cognitive assessment that can identify specific memory deficits. Finally, the Wechsler Memory Scale (WMS-IV) is an effective tool to assess cognition through orientation, time estimation, mental control, clock drawing, accidental recall, inhibition, and speech reproduction tests. Transcutaneous electrical stimulation according to embodiments disclosed herein will exhibit improvement in treatment groups measured using any of the scales described above.

By using electrical nerve stimulation of specific major dermatomes, patients can see a combination of improvements in insulin resistance, as measured by HOMA-IR, modification of amyloid load, local cerebral blood glucose metabolism, and direct action by sensory afferent stimulation, resulting in improvement in cognitive function. may lead to improvement.

Stimulation pattern/therapy induction protocol

As previously discussed, a plurality of health-related information of a user, such as a user's hunger profile, standard eating and eating profile, actual eating and eating profile, energy balance, weight trend, blood glucose data, irritant-induced nausea, dyspepsia, and habituation events , used by a health care application to propose and/or implement a plurality of recommendations, including stimulation patterns or protocols, medications (eg, insulin intake, etc.), diet and/or action plans. It should be understood that this integrated system provides some degree of independence to the user and encourages patient compliance. However, notwithstanding the foregoing, the present application provides that the doctor program the EDP directly, program the EDP through the companion device, or remotely access the desired protocol from a remote server or third party computing device to the EDP directly or through the companion device. It is applied to establish or modify the stimuli protocol to communicate.

In various embodiments, recommendations related to stimulation patterns or protocols may include: number of stimulation sessions per day; duration of each stimulus; the time or moment of application of the stimulation session; stimulus intensity, stimulus pulse shape, frequency, width and amplitude; stimulus duty cycle; stimulus continuity profile; driving, setting, customizing or adjusting a plurality of stimulation parameters including, but not limited to, minimum and maximum overall duration or course of stimulation treatment of days, weeks or months. Below are exemplary standard setting ranges for some stimulation parameters:

펄스 폭: 10㎲ec 내지 10msec

Pulse Width: 10 µsec to 10 msec

펄스 진폭: 100㎂ 내지 500㎃, 60㎃ 미만, 100㎂ 내지 100㎃, 100㎂ 내지 500㎃, 1㎃ 내지 30㎃, 1㎃ 내지 65㎃, 15㎃ 내지 30㎃, 5㎃ 내지 45㎃ 및 전술된 범위 내 그 안의 임의의 증분

Pulse amplitudes: 100 mA to 500 mA, less than 60 mA, 100 mA to 100 mA, 100 mA to 500 mA, 1 mA to 30 mA, 1 mA to 65 mA, 15 mA to 30 mA, 5 mA to 45 mA and the above any increment within

펄스 주파수: 1Hz 내지 10,000Hz, 바람직하게는 1Hz 내지 100Hz, 바람직하게는 1Hz 내지 100Hz이고, 자극 신호에 포함된 100Hz보다 큰 다른 주파수는 없다.

Pulse frequency: 1 Hz to 10,000 Hz, preferably 1 Hz to 100 Hz, preferably 1 Hz to 100 Hz, no other frequency greater than 100 Hz included in the stimulus signal.

펄스 형상: 단상, 2상, 사인파

Pulse shape: single-phase, two-phase, sine wave

듀티 사이클: 매주 계산되는 1% 내지 100%

Duty cycle: 1% to 100% calculated weekly

자극 세션 지속시간: 1분 내지 120분 또는 50ms 내지 120분 또는 거의 연속적으로

Stimulation session duration: 1 minute to 120 minutes or 50 ms to 120 minutes or nearly continuous

자극 세션 수/일: 1 내지 24

Number of stimulation sessions/day: 1 to 24

세션 수/주: 1 내지 168 또는 1 내지 실질적으로 연속적으로

Number of sessions/week: 1 to 168 or 1 to substantially continuously

매일 식전 자극: 대부분의 환자가 일반적으로 식사 직전에 배고픔이 최고조에 달한다고 보고하므로 매일 매 식사 30분 내지 1시간 전에

Daily pre-meal stimulation: 30 minutes to an hour before each meal each day, as most patients report that hunger peaks usually just before meals.

버스트 모드(비율로 프로그래밍 가능한 펄스 버스트): 0.1Hz 내지 100Hz

Burst mode (rate-programmable pulse burst): 0.1 Hz to 100 Hz

램프 업/다운 모드(무자극으로부터 피크 또는 정상 상태로 이동(램프 업)하는 데 걸리는 시간, 및 피크 또는 정상 상태 자극으로부터 무자극으로 이동(램프 다운)하는 데 걸리는 시간): 0.1초 내지 60초

Ramp up/down mode (time taken to go from no stimulus to a peak or steady state (ramp up), and time taken to go from a peak or steady state stimulus to no stimulus (ramp down)): 0.1 to 60 seconds

변조 모드: 0.1초 내지 60초의 기간 동안 위/아래로 변조하는 1% 내지 100% 진폭 범위; 변조는 선형 또는 사인파일 수 있다; 즉, "변조 모드"에서 진폭은 목표 진폭(예를 들어, 10㎃)의 1% 내지 100%에서 변하고 이 진폭 변화는 0.1초 내지 60초의 기간 동안 발생한다.

Modulation mode: 1% to 100% amplitude range modulating up/down for a period of 0.1 seconds to 60 seconds; Modulation can be linear or sinusoidal; That is, in the "modulation mode", the amplitude varies from 1% to 100% of the target amplitude (eg, 10 mA) and this amplitude change occurs for a period of 0.1 seconds to 60 seconds.

전극 임피던스(전극-조직 인터페이스 임피던스): 100옴 내지 5킬로옴, 10옴 내지 5킬로옴, 200옴 내지 1000옴, 500옴 내지 1000옴 또는 1킬로옴 내지 100킬로옴

Electrode Impedance (Electrode-Tissue Interface Impedance): 100 ohms to 5 kiloohms, 10 ohms to 5 kiloohms, 200 ohms to 1000 ohms, 500 ohms to 1000 ohms or 1 kiloohm to 100 kiloohms

In an embodiment, the duty cycle of stimulation is optimized or adjusted such that the EDP device remains in a sleep mode between successive stimulation sessions corresponding to an active mode of the EDP device. In various embodiments, the sleep mode corresponds to an average current of less than 10 μA, while the active mode corresponds to an average current in the range of 2 mA to 30 mA.

In some embodiments, the electrical skin patch device provides electrical stimulation with the following parameters adjustable by the patient using the interlocking device:

활성 전하 균형 위상이 있는 단상 펄스 형상

Single-phase pulse shape with active charge balance phase

펄스 폭: 25㎲ec에서 400㎲ec까지 25㎲ec 간격으로

Pulse Width: 25 µsec to 400 µsec in 25 µsec increments

펄스 진폭: 1㎃에서 50㎃까지 1㎃ 간격으로

Pulse amplitude: from 1 mA to 50 mA in 1 mA increments

펄스 주파수: 1Hz, 5Hz, 10Hz, 15Hz, 20Hz, 25Hz, 30Hz, 40Hz, 50Hz, 60Hz, 70Hz, 80Hz, 90Hz, 100Hz, 150Hz, 200Hz

Pulse frequency: 1Hz, 5Hz, 10Hz, 15Hz, 20Hz, 25Hz, 30Hz, 40Hz, 50Hz, 60Hz, 70Hz, 80Hz, 90Hz, 100Hz, 150Hz, 200Hz

자극 세션 시간: 5분에서 60분까지 5분 간격으로

Stimulation Session Duration: 5 to 60 minutes in 5-minute intervals

In some embodiments, the electrical skin patch device provides electrical stimulation with the following parameters adjustable by the patient using the interlocking device:

펄스 폭: 100㎲ec 내지 500msec, 바람직하게는 10㎲ec 내지 100msec

Pulse width: 100 μsec to 500 msec, preferably 10 μsec to 100 msec

펄스 진폭: 1㎂ 내지 1㎃

Pulse amplitude: 1 mA to 1 mA

펄스 주파수: 0.1Hz 내지 1kHz

Pulse frequency: 0.1 Hz to 1 kHz

자극 세션 시간: 1분 내지 24시간

Stimulation Session Duration: 1 minute to 24 hours

자극 세션 수/일: 1 내지 24

Number of stimulation sessions/day: 1 to 24

세션 수/주: 1에서 실질적으로 연속적으로

Sessions/week: from 1 to substantially continuous

In various embodiments, the plurality of stimulation parameters is a therapeutically sufficient amount of delay in gastric emptying time in the patient, a therapeutically sufficient amount of increased gastric retention in the patient, a therapeutically sufficient amount of gastric distension/accommodation disorders in the patient, is selected or configured to cause at least one of a decrease in a therapeutically sufficient amount of plasma motilin in the patient.

In one embodiment, the electrical pulses, whether single waveform or multiple waveforms, only have a frequency of up to 200 Hz or less. In other words, the system does not deliver electrical pulses whose frequency exceeds 200 Hz. In other embodiments, the electrical pulses are delivered in a single waveform and do not take the form of multiple waveforms integrated or combined together.

In various embodiments, the electrical skin patch device is wearable and capable of providing electrical stimulation more often than one day a week. In addition, stimulation parameters and protocols are programmed to be therapeutically effective without causing habituation, nausea and/or indigestion. Thus, in some embodiments, the amount of electrical stimulation delivered corresponds to 30 minutes per day at an amplitude of 20 mA (or equivalent energy of 10 mA hours = 10 mA x 60 minutes), but less than 240 mA hours per day (i.e., 20 mA hours per day). less than 12 hours at mA, less than 6 hours at 40 mA, or less than 24 hours at 10 mA), and the amount delivered includes all energy increments between the minimum and maximum amounts. In another embodiment, the minimum amount of electrical stimulation delivered is energy equivalent to 5 minutes per day at 10 mA, while the maximum amount of electrical stimulation delivered is energy equivalent to 12 hours per day at 30 mA, and the amount delivered is between the minimum and maximum Includes all energy increments between quantities. According to some embodiments, the minimum weekly amount of electrical stimulation delivered is equivalent to 30 minutes per day at 10 mA delivered 3 days per week (a patient's minimum estimated skin resistance of 400 ohms equals about 5 Joules per session or 15 Joules per week) ) energy, whereas the maximum amount of electrical stimulation delivered per week is the energy equivalent to 24 hours a day at 30 mA delivered 7 days per week (1000 ohms, the patient's maximum expected skin resistance, equals about 44,000 joules per week), The quantity includes all energy increments between the minimum and maximum amounts. In an alternative embodiment, the maximum weekly amount of electrical stimulation delivered is energy equivalent to 12 hours per day at 45 mA delivered 7 days per week. In another embodiment, the minimum weekly amount of electrical stimulation delivered is 60 Joules with two stimulation sessions of 30 Joules per stimulation at 20 mA, while the maximum weekly amount of electrical stimulation delivered is 13,000 Joules, at 20 mA for 7 days. A 12 hour stimulus is provided, and the amount delivered includes all energy increments between the minimum and maximum amounts. Any of the foregoing maximums may be combined with any of the foregoing minimums, and it should be understood that the amount delivered includes all energy increments between the minimum and maximum.

Table Z shows the energy delivered to a patient for stimulation therapy ranging from 30 minutes of the day to 12 hours of the day at programmed parameters of a pulse amplitude of 20 mA, a pulse width of 200 μsec, and a frequency of 20 Hz, wherein the patient The skin resistance of is estimated to be 650 ohms (skin resistance ranges from 400 ohms to 1000 ohms) according to an embodiment.

Table Z

Stimulus energy for various time intervals

In some embodiments, the electrical skin patch device provides a constant basal electrical stimulation rate with the following parameters adjustable by the patient using the interlocking device. In some embodiments, the electrical skin patch device provides electrical stimulation at mealtime and has the following parameters that the patient can adjust using the interlocking device:

매일 식전 자극: 대부분의 환자는 일반적으로 식사 직전에 배고픔이 최고조에 달한다고 보고하므로 매일 각 식사 시간(아침, 점심 및 저녁 식사)보다 적어도 1분 내지 2시간 전에 자극.

Daily pre-meal stimulation: Stimulation at least 1 minute to 2 hours before each meal time (breakfast, lunch, and dinner) each day, as most patients typically report their hunger peak just before meals.

매일 식사 동안 또는 식후 자극: 매 식사 섭취 동안 또는 각 식사 섭취 직후 또는 적어도 1분 내지 120분 후 자극.

Daily During or Postprandial Stimulation: Stimulation during each meal intake or immediately after or at least 1 minute to 120 minutes after each meal intake.

In accordance with aspects herein, stimulation sessions are timed to coincide with pre- and post-prandial “metabolic windows”. The preprandial window is associated with the body's release of ghrelin just before an expected or scheduled meal. It should be understood that an individual has a ghrelin profile comprising a plurality of peak or maximum levels of ghrelin plasma concentrations and a plurality of valleys or minimum levels of ghrelin plasma concentrations distributed over a time span of 24 hours. Multiple peaks or maximal levels of ghrelin plasma concentrations generally correspond to expected or scheduled meal times (eg, breakfast, lunch, and dinner). According to various aspects herein, the preprandial window begins with an increase or spike in ghrelin plasma concentration and peaks near the expected or scheduled timing of a meal. In some embodiments, the approximately 60 minute preprandial window is referred to as the "ghrelin window." In various embodiments, the stimulation session is timed to occur within the ghrelin window, and the stimulation session begins when the ghrelin plasma concentration is within a range of maximum tolerated levels of the ghrelin plasma concentration. Stimulation during the ghrelin window reduces ghrelin plasma concentrations, leading to decreased appetite or meal preparation.

The postprandial window is associated with a progressively decreasing secretion of ghrelin in the body during and/or after a meal. According to various aspects herein, the postprandial window begins during and/or after the peak of meal intake and reaches a trough corresponding to a minimal level of ghrelin plasma concentration. Thus, in some embodiments, there is a period of postprandial digestive activity lasting about 1 to 2 hours after a meal, referred to as the "gastric vestibular exercise window." In various embodiments, the stimulation session is timed to occur within the gastric vestibular movement window, wherein the stimulation session ends when the ghrelin plasma concentration is within a minimum acceptable level range of the ghrelin plasma concentration. Stimulation during the gastric vestibular motility window reduces gastric vestibular motility, delaying gastric emptying and causing satiety.

In one embodiment, the baseline stimulation schedule or protocol is a pulse amplitude of 20 mA at 15 minutes and postprandial time with a pulse amplitude of 20 mA at the preprandial time, respectively, immediately prior to and upon completion of each meal, such as breakfast, lunch, and dinner. 3 stimulation sessions per day of 60 minutes each. In other words, the baseline stimulation regimen or protocol includes 3 x 1.25 hours = a total of 3.75 hours (15 minutes before and 60 minutes after each meal). In some embodiments, the baseline pulse amplitude ranges from 5 mA to 10 mA to allow for a total stimulation duration greater than 3.75 hours. In various embodiments, these preprandial and postprandial stimulation sessions are manually triggered by the user (eg, in response to a predetermined prompt). In some alternative embodiments, pre- and post-prandial stimulation sessions may include pre-stored meal time schedules or calendars, daily diary entries (eg, but not limited to weight), hunger events, and/or other eating-related events (eg, automatically triggered based on past records of unscheduled feeding events). In some alternative embodiments, the postprandial stimulation session detects an eating event by a swallow detection device, such as device 5605 of FIG. 56, or uses a plurality of data (representing the user's eating gesture) captured by an accelerometer. automatically triggered in conjunction with the detection of an eating event by the meal moment recognition method (FIG. 58) implemented by the HMA, where the accelerometer, such as the band 2105 of FIG. Included in a wristband or wristwatch. In another alternative embodiment, the baseline stimulation scheme or protocol is pre-programmed by a factory setting or by a physician, while the user may schedule only the timing of meal times.

In some embodiments, the device is programmed to apply at least a portion of the stimulation session between 6 AM and 9 AM, 11 AM and 2 PM, or 5 PM and 9 PM.

Any initial, baseline, or default stimulation parameters implemented upon device startup and without the benefit of user input regarding appetite, hunger, satiety level, satiety level, fullness level, well-being status, nausea status or other information are for everyone. It is understood that it may be universally fixed or based on any one or combination of parameters of a person such as age, sex, ethnicity, weight, body mass index, body fat percentage and/or race. Thus, stimulus dosing may be based on initially classifying an individual into one or more template groups and selecting a corresponding protocol. For example, you can classify individuals into different groups (BMI 40 and above, BMI 35-39, BMI 30-34, BMI 25-29) and apply a standard or baseline stimulation plan for all individuals within that classification. This is, for example, a combination of age and gender (women 65 years and older, women 55-64, women 45-54, women 35-44, women 25-34, women 24 and younger, men 65 years and older, men 55-64, men The same can be applied to 45-54, male 35-44, male 25-34, male 24 years old or younger). Additionally, the initial stimulus setting may be based on any parameter indicative of the patient's degree of appetite, hunger, level of satiety, level of satiety, or level of satiety.

It should be further understood that any selected stimulation parameter may be titrated for a given patient. Specifically, the parameter may be adjusted up or down based on the amount of stimulation the patient feels and/or immediately reported pain, nausea or other discomfort.

In some embodiments, the stimulation continuity profile is continuous, for the duration of each stimulation session to which the stimulation profile is applied; intermittent, including short intervals of Y seconds without stimulation; a step-up stimulus in which the stimulus amplitude and/or frequency increases at a predetermined rate from the start to the completion of the stimulus session duration; or a step-down stimulus in which the stimulus amplitude and/or frequency decreases at a predetermined rate from the start to the completion of the stimulus session duration. In some embodiments, the stimulus continuity profile may vary from day to day. For example, a stimulation profile applied over a treatment duration of 4 weeks may include: continuous stimulation in which the number and/or intensity of stimulation does not change throughout treatment; a step-up stimulus in which the intensity and number of daily sessions increases at a predetermined rate each day or weekly; It may be at least one of a step-down stimulus in which the intensity and number of daily sessions decreases at a predetermined rate daily or weekly.

According to one aspect, the stimulation energy delivered to the patient in each stimulation session may be increased or decreased by modifying either the stimulation pulse amplitude or the stimulation pulse width. In one embodiment, both the pulse width and the pulse amplitude may be modified.

In one embodiment, the stimulation pulse width is varied while the pulse amplitude remains constant. For example, the pulse width may be modified in increments of 25 microseconds, for example within the range of 50 microseconds to 400 microseconds, whereas the pulse amplitude can be modified in any increments within or within the range of 10 milliseconds to 200 milliseconds. is the range In one embodiment, the pulse amplitude is fixed at, for example, 50 mA (assuming a 500 ohm load). The waveform shape is chosen to be single-phase with charge balance. In embodiments where the pulse width may be increased while the pulse amplitude is fixed, the number of episodes of nausea may increase.

In another embodiment, the stimulation pulse amplitude is varied while the pulse width remains constant. For example, in a state where the pulse width is fixed to, for example, 100 μsec, the pulse amplitude may be modified within a range of, for example, 100 μA to 500 mA. The waveform shape can be maintained in single phase while maintaining charge balance.

It should be noted herein that the pulse amplitude range may be electrode dependent. In one embodiment, the electrode-skin interface impedance (a function of electrode design and skin type) determines the target nerve for stimulation (or inhibition) as well as this range.

According to one aspect herein, the target or total pulse amplitude during a stimulation session is not delivered or reached immediately or immediately at the beginning of the stimulation session, but rather, in various embodiments, the pulse amplitude is such that the target pulse amplitude is reached over a predetermined period of time. It is gradually increased or ramped up. For example, a baseline pulse amplitude of 20 mA in a stimulation session starts at a very low pulse amplitude such as 0 or 5 mA and is gradually reached over a predetermined period of time (eg, 1 minute). This means that the instantaneous or immediate delivery of a 20 mA pulse amplitude can surprise and cause discomfort to the user, whereas the gradual pulse amplitude ramp-up profile herein allows the user to familiarize the user with the electrical energy to be delivered and exposes the pulse amplitude. It has the advantage of preventing shocks or alarms due to the initial spike of

In some embodiments, the time or moment of application of the stimulation session is 't' minutes prior to a meal, eg, breakfast, lunch, snack, dinner, where 't' ranges from 1 minute to 150 minutes; just before going to bed; It may be when hunger begins and/or just prior to an expected hunger event based on the user's recorded hunger profile.

According to one embodiment, the stimulation regimen or protocol is timed with 3 stimulation sessions per day (3 x 30 minutes per day), 30 minutes each after a meal (ie, after breakfast, lunch, dinner).

According to aspects herein, an EDP device can deliver stimulation therapy over an extended period of time while minimizing skin irritation or rash.

When a user's skin is exposed to electrical stimulation, each electrical pulse not only induces a nerve conduction response, but also triggers a chemical reduction-oxidation (redox) reaction. The redox reaction produces ions, and when ions accumulate, they negatively affect the pH of the local tissue, resulting in acidity and skin irritation.

73 shows a first waveform 7305 that is a single-phase waveform, a second waveform 7310 that represents a symmetric, two-phase, charge balanced waveform, a third waveform 7315 that represents an asymmetric, two-phase, charge balanced waveform, and a spiked waveform A fourth waveform 7320 is shown illustrating a two-phase waveform or pulse. Consider a single-phase pulse 7305, such as a square wave, with a positive wave going up and down the baseline. When these waves are applied, this waveform triggers a neural response, but also a one-way redox reaction, producing an increased number of ions over time. Now consider changing this single-phase pulse 7305 to a two-phase pulse (eg, waveform 7310 or 7315), eg, a square wave-like pulse that goes positive, then negative, and then back to baseline. In this case, one induces a neural response with each wave, but the redox reaction is reversed by changing the wave phase. Thus, a positive wave can drive a redox reaction forward, whereas a negative wave can drive a redox reaction backwards, reducing ion production.

A symmetric, two-phase, charge balanced waveform starts at baseline, increases rapidly to a peak current with a first current ramp slope greater than 1, approaches an indeterminate vertical value, and remains stable at this peak current for a period of time (T1). and rapidly decreasing to the baseline with a second current ramp slope less than -1 and approaching an indeterminate vertical value, and rapidly decreasing to a negative current value with the same second current ramp slope or negative first current ramp slope, with time It plateaus at this current for period T2 and rapidly increases to baseline with a negative second current ramp slope or first current ramp slope. The asymmetric, two-phase, charge balanced waveform starts at baseline, increases rapidly to peak current with a first current ramp slope greater than 1, remains stable at peak current, then decreases for a period of time T1, and then decreases to -1 rapidly decreasing to baseline with a smaller second current ramp slope, rapidly decreasing to a negative current value with a third current ramp slope less than -1, maintaining a plateau at this current, and from baseline with a positive fourth current ramp slope , wherein the first, second, third, and fourth current ramp slopes are all different, or at least one of the first and third and second and fourth current ramp slopes is different.

In various embodiments, stimulation sessions herein include charge balancing, two-phase symmetric or asymmetric waveforms or current pulses 7310 , 7315 . In other words, in various embodiments, the EDP device generates pulse-to-pulse inverted symmetric or asymmetric, two-phase, charge balanced waveforms or pulses 7310 , 7315 . The waveform is driven by an algorithm that stops at predetermined time intervals (eg every 5 minutes, allowing the skin to rest for 1-2 minutes), then continues until the prescribed time of therapy. The predetermined time interval may also be a random value in various embodiments so as not to create skin fatigue. In an embodiment, the waveform is further characterized by a rapid attainment of peak amplitude followed by an almost instantaneous drop in amplitude.

Negative waves in waveforms 7310 and 7315 reverse the redox reaction, but the reduction or elimination of ions is not 100%. This would be over the 90% range. In some embodiments, ion generation includes 1) generation of a biphasic pulse, such as a symmetric or asymmetric waveform 7310, 7315; and optionally 2) the first pulse is followed by a second pulse, wherein the second pulse is the same as the first pulse except that the phase of the second pulse is reversed with respect to the first pulse. is further reduced by

74A shows first and second pulses 7410 in which the phase or polarity is reversed with respect to first pulses 7405 and there is a predetermined time interval or waiting time 7407 between pulses 7405 and 7410; A second successive symmetric two-phase pulse 7405, 7410 is illustrated.

74B shows a second pulse in which the phase or polarity of the second pulse 7420 is reversed with respect to the first pulse 7415, optionally with a predetermined time interval or waiting time 7417 between the pulses 7415 and 7420. 1 and 2 successive asymmetric biphasic pulses 7415 and 7420 are illustrated. 74A, 74B, negative pulses 7405n, 7415n of each of the first two-phase pulses 7405, 7415 reverse most of the redox reaction, and each second two-phase pulse Negative pulses 7410 and 7420 of 7410 n and 7420 n continue to reverse, extending the reaction further, reversing more redox reactions before producing more ions.

In some embodiments, the amplitudes of the first phase, the second phase, the third phase, and the fourth phase are the same, and the pulse widths of the first phase, the second phase, the third phase, and the fourth phase are the same.

In some embodiments, the predetermined time interval ranges from 1 minute to 10 minutes.

Thus, by applying the train of pulses of FIG. 74A or 74B to the left and right two electrodes of the EDP device of the present specification, a) a positive pulse is applied to the left electrode and a negative pulse is applied to the right electrode; b) a negative pulse is applied immediately to the left electrode and a positive pulse is applied to the right electrode; c) it is preferred that there is a waiting time between pulses during which no stimulation occurs; d) a negative pulse is applied to the left electrode and a positive pulse is applied to the right electrode; e) A positive pulse is applied to the left electrode and a negative pulse is applied to the right electrode. It should be understood that the term phase refers to a portion of a waveform that has a consistent positive or negative polarity, and the term polar refers to the negative or positive stimulus state of a pulse.

74C shows that the phase or polarity of the second pulse 7430 is reversed with respect to the first pulse 7425 and a predetermined time interval or waiting time 7427 between pulses 7425 and 7430, according to an alternative embodiment. first and second successive symmetric two-phase pulses 7425 and 7430 are illustrated. As shown in FIG. 74C , a positive pulse 7425p of a first two-phase pulse 7425 is followed by a positive pulse 7430p of a second two-phase pulse 7430 .

74D illustrates that the phase or polarity of the second pulse 7440 is reversed with respect to the first pulse 7435 and optionally a predetermined time interval or waiting time 7437 between pulses 7435 and 7440, according to an alternative embodiment. ), illustrate first and second successive asymmetric two-phase pulses 7435 and 7440 . 74D , a positive pulse 7435p of a first two-phase pulse 7435 is followed by a positive pulse 7440p of a second two-phase pulse 7440 . 74C, 74D, positive pulses 7425p, 7435p of each of the first two-phase pulses 7425, 7435 reverse most of the redox reaction, and each second two-phase pulse ( Positive pulses 7430, 7440, 7430p, 7440p, continue to reverse, extending the reaction further, reversing more redox reactions before producing more ions.

In some embodiments, the amplitudes of the first phase and the fourth phase are the same, the pulse widths of the first phase and the fourth phase are the same, and the amplitudes of the second phase and the third phase are the same, wherein the second phase and the The pulse width of the third phase is the same, wherein at least one of the amplitude and the pulse width of the first phase is different from the amplitude and the pulse width of the second phase.

In some embodiments, the first phase is defined by a waveform characterized by a first period and a second period, wherein the first period includes the first 10 μs of the waveform and the second period includes the remainder of the waveform , wherein the waveform is defined by a maximum amplitude during a first period and an amplitude less than the maximum amplitude during a second period.

In some embodiments, at least one of the first phase, the second phase, the third phase and the fourth phase is defined by a waveform characterized by a first period, a second period, and a third period, wherein the first period includes at least a portion of 0 to 10 μs of the waveform, the second period includes at least a portion of 10 μs to 100 μs of the waveform, and the third period includes at least a portion of 100 μs to 200 μs of the waveform, Here, the first period is determined by the maximum amplitude, and the second period and the third period are determined by the remaining amplitudes smaller than the maximum amplitude.

By applying the pulse train of Figure 74c or 74d to the left and right two electrodes of the EDP device herein a) a positive pulse is applied to the right electrode while a negative pulse is applied to the left electrode; b) a positive pulse is applied immediately to the left electrode and a negative pulse is applied to the right electrode; c) it is desirable to have a waiting time between pulses for which no stimulation occurs; d) then a positive pulse is applied to the left electrode and a negative pulse is applied to the right electrode; e) A negative pulse is applied to the left electrode and a positive pulse is applied to the right electrode. It should be understood that the term phase refers to a portion of a waveform that has a consistent positive or negative polarity, and the term polar refers to the negative or positive stimulus state of a pulse.

75A is a flow diagram illustrating a plurality of steps for generating a train of two-phase pulses in accordance with an embodiment herein. In step 7505, the left and right two electrode EDP device generates a two-phase charge balanced train of pulses (eg, the pulse train of FIGS. 74A, 74B). The pulses are symmetrical or asymmetrical in various embodiments. Further, the pulse train is characterized in that any two consecutive first and second pulses (of the pulse train) are reversed in phase with respect to each other.

In step 7510, a first pulse is applied to the left and right electrodes of the EDP device. In step 7515, the left electrode receives a positive pulse while the right electrode receives a negative pulse. In step 7520, the left electrode immediately receives a negative pulse, while the right electrode receives a positive pulse. In step 7525, there is a predetermined waiting time before a second pulse successively following the first pulse is received at the electrode. At the end of the waiting time, in step 7530, a second pulse is applied to the left and right electrodes of the EDP device. In step 7535, the left electrode now receives a negative pulse, while the right electrode receives a positive pulse. Finally, in step 7540, the left electrode immediately receives a positive pulse, while the right electrode receives a negative pulse.

Thus, in some embodiments, the first electrical pulse is defined by a first phase having a first polarity, and a second phase having a second polarity opposite the first polarity, wherein the second electrical pulse comprises the first electrical pulse and is defined by a third phase having a third polarity and a fourth phase having a fourth polarity opposite the third polarity, the second polarity being equal to the third polarity. In some embodiments, the first polarity is positive, the second polarity is negative, the third polarity is negative, and the fourth polarity is positive.

75B is a flow diagram illustrating a plurality of steps of generating a train of two-phase pulses in accordance with an embodiment herein. In step 7545, the left and right two-electrode EDP device generates a two-phase charge balancing train of pulses (eg, the pulse train of FIGS. 74C, 74D). The pulses are symmetrical or asymmetrical in various embodiments. Further, the pulse train is characterized in that any two consecutive first and second pulses (of the pulse train) are reversed in phase with respect to each other.

In step 7550, a first pulse is applied to the left and right electrodes of the EDP device. In step 7555, the left electrode receives a negative pulse while the right electrode receives a positive pulse. In step 7560, the left electrode immediately receives a positive pulse, while the right electrode receives a negative pulse. In step 7565, there is a predetermined waiting time before a second pulse successively following the first pulse is received at the electrode. At the end of the waiting time, in step 7570, a second pulse is applied to the left and right electrodes of the EDP device. In step 7575, the left electrode now receives a positive pulse, while the right electrode receives a negative pulse. Finally, in step 7580 the left electrode immediately receives a negative pulse, while the right electrode receives a positive pulse.

Thus, in some embodiments, the first electrical pulse is defined by a first phase having a first polarity, and a second phase having a second polarity opposite the first polarity, wherein the second electrical pulse comprises the first electrical pulse is defined by a third phase having a third polarity, and a fourth phase having a fourth polarity opposite the third polarity, the second polarity being equal to the third polarity. In some embodiments, the first polarity is negative, the second polarity is positive, the third polarity is positive, and the fourth polarity is negative.

As shown in FIG. 61 , in one embodiment, each of the three stimulation sessions delivered per day each has a pulse waveform 6100 having the following characteristics or parameters:

최대 준수 전압: 45볼트(다양한 실시예에서 40V 내지 60V 범위일 수 있음)

Maximum Compliance Voltage: 45 volts (may range from 40V to 60V in various embodiments)

펄스 진폭: 30㎃(다양한 실시예에서 20㎃, 30㎃ 또는 40㎃ 중 하나일 수 있음)

Pulse amplitude: 30 mA (which may be one of 20 mA, 30 mA, or 40 mA in various embodiments)

펄스 폭: 200㎲ec

Pulse width: 200㎲ec

펄스 주파수: 30Hz(다양한 실시예에서 20Hz, 30Hz 또는 40Hz 중 하나일 수 있음)

Pulse frequency: 30 Hz (may be one of 20 Hz, 30 Hz, or 40 Hz in various embodiments)

파형: 2상(전하 균형)

Waveform: two-phase (charge balanced)

Due to the EDP electrode impedance ranging from 300 ohms to 1000 ohms and the patient's skin resistance, the waveform 6100 initially immediately reaches the maximum amplitude value 6105 . The peak amplitude value 6105 is in the range of 25 mA to 30 mA in some embodiments, and in the range of 20 mA to 50 mA in other embodiments. The peak amplitude value 6105 degrades almost instantaneously to the first amplitude value 6110 in the first time period 6115 . In an embodiment, the first amplitude value 6110 is in the range of 20 mA to 22 mA and the first time period 6115 is 80 microseconds. Thereafter, waveform 6100 is further deteriorated during a second time period 6120 to achieve a second amplitude value 6125 . In an embodiment, the second time period 6120 is 120 microseconds and the second amplitude value 6125 ranges from 4 mA to 8 mA. Basically, waveform 6100 behaves as a waveform identical to a waveform having an average amplitude of 18 mA over the first and second time periods. In an embodiment, the sum of the first and second time periods 6115 and 6120 is 200 microseconds. Also, in this embodiment, the first time period 6115 is about 40% (ie, 80 μsec) of the total pulse width (ie, 200 μsec), whereas in other embodiments the first time period 6115 is between 5% and 5% of the total pulse width (ie, 200 μsec). 95% range, where the max and min can be any increments therein of the pulse width.

A sharp drop in the peak amplitude value 6105 from the first time period 6115 to the first amplitude value 6110 and from the remaining second time period 6120 to the second amplitude value 6125 causes a sharp drop in the waveform at the beginning. It is understood that a tingling perception or feeling is imparted and then diminished. In some embodiments, the waveform may immediately reach a peak amplitude value of 6105 and then rapidly deteriorate to a lower amplitude value of 6125 (without deteriorating to a first amplitude value 6110 first). In one embodiment, the pulse waveform of FIG. 61 has a pulse amplitude of 30 mA and a frequency of 30 Hz, and in an alternative embodiment the pulse amplitude may be 20 mA or 40 mA and the frequency may be 20 Hz or 40 Hz. In one preferred embodiment, waveform 6100 is characterized by a peak amplitude of 40 mA, a pulse frequency of 30 Hz, and a pulse width of 200 microseconds.

A sharp tingling is characteristic of the stimulation therapy herein compared to prior art TENS devices, waveform 6100, which is an upper compliance voltage limit of 45 volts combined with a low skin impedance of less than 1000 ohms to the electrodes of the EDP device of the present disclosure. ) due to the same waveform parameters as those of Prior art TENS devices tend to use high voltages, such as 80 volts or more. Prior art and prior art TENS units operating at similar amplitudes, capping or limiting the voltage at 45 volts for the EDP device herein combined with waveform 6100 enables a unique stimulus footprint and unique patient sensation. It is understood that the vibrations and muscle spasms normally produced in the body are prevented.

In another embodiment, waveform 6100 includes a maximum compliance voltage ranging from 40 volts to 60 volts, a peak amplitude value 6105 ranging from 20 mA to 50 mA, a first time period 6115 of 10 μs, and the remainder of the waveform is characterized by an average amplitude over a second time period 6120 , first and second time periods ranging from 10 mA to 30 mA.

In yet another embodiment, the waveform is characterized by a first period of time, a second period of time, and a third period of time, wherein the first period comprises at least a portion of 0 μs to 10 μs of the waveform, and wherein the second period of time includes at least a portion of 10 μs to 100 μs of the waveform, and the third period includes at least a portion of 100 μs to 200 μs of the waveform, wherein the first period is defined by a peak or maximum amplitude, and the second and The third period is defined by the remaining amplitude less than the maximum amplitude. In this embodiment, the peak or maximum amplitude is in the range of 20 mA to 50 mA. In this embodiment, in the second period, the attenuation of the residual amplitude is determined by the slope of the first negative amplitude having a first magnitude, and in the third period the attenuation of the remaining amplitude is determined by the slope of the second negative amplitude having the second magnitude. , wherein the first size is smaller than the second size. In this embodiment, the average of the peak or maximum amplitude and the remaining amplitude is in the range of 10 mA to 30 mA.

In various embodiments, any two consecutive stimulation pulses having the waveforms described with reference to the embodiment above and FIG. 61 are separated by a predetermined time interval. In some embodiments, the predetermined time interval ranges from 1 minute to 10 minutes. In another embodiment, the predetermined time interval is randomly assigned and is at least 1 minute.

It should be further understood that, contrary to certain prior art approaches, the waveform is preferably a single waveform and not a set of multiple waveforms that are multiplexed, aggregated or combined of waveforms in different frequency ranges, particularly greater than 500 Hz.

In one embodiment, the EDP has a predetermined voltage limit, for example in the range of 40 volts to 60 volts or any increments therein. This voltage limit has the effect of rapidly dropping the initial 30 mA pulse to a lower amperage (eg, 18 mA).

In accordance with an aspect herein, a remote patient care facility or personnel, as well as a user, controls a plurality of stimulation parameters by the user via a health care application and/or via an actuator 122 such as a button or switch in FIG. 1A and Can be adjusted. In some embodiments, the remote care facility or personnel is authorized to control and adjust all stimulation parameters, while the user may control and adjust a subset of the stimulation parameters with or without authorization/approval of the remote care facility or personnel. have. For example, the user may change the number of stimulation sessions per day, eg, from 2 sessions per day to 1 session per day; change the stimulation session duration, eg, from 30 minutes to 15 minutes; and/or change the stimulation pulse amplitude from 20 mA to 150 mA, for example. In one embodiment, the maximum change is limited to a predetermined amount or multiple of the previous setting.

It should be noted that changing the pulse width is a less energy efficient approach, as it usually requires a larger fixed voltage than necessary. Energy efficiency considerations include varying both pulse width and pulse amplitude to find the smallest combination that will result in neural activation. In some embodiments, the patient may use sensory feedback as a mechanism to modify or select a stimulus. For example, when using larger amplitudes, patients may experience more inflammation or tingling and thus may use discomfort as a means of modifying therapy. In some embodiments, battery life may also dictate the choice of whether to increase pulse width, pulse amplitude, or both.

In a preferred embodiment, the user may increase the stimulation pulse amplitude from the minimum default amplitude setting (eg, 100 μA) to a 'sensory threshold' corresponding to the amplitude at which the user can feel the stimulation. The user can then save the 'sensory threshold' setting and continue stimulation at this setting. Sensory perception differs from person to person, and thus, in various embodiments, the 'sensory threshold' ranges from about 5 mA to 10 mA at the bottom and about 20 mA to 30 mA at the top.

In some embodiments, the stimulation protocol comprises alternating stimulation sessions between a first session having a low pulse frequency, eg, less than 50 Hz, and a second session, eg, having a high pulse frequency greater than 50 Hz.

In yet another embodiment, the user may control and adjust a subset of the stimulation parameters within a standard set range as described above or within a narrower band range or limit within a standard set range. For example, the user can modify the stimulation pulse width, amplitude and frequency by up to +/- 50% from the original, default or standard settings. In another example, the user may modify all stimulation parameters by +/−10% (from the original, default or standard settings) except allowing the amplitude to decrease indefinitely for safety and/or convenience reasons. Authorization of remote patient care facilities or personnel may be required for users to modify stimulation parameters beyond the restricted range. In some embodiments, the extent to which a user can control and adjust a subset of stimulation parameters is established by a remote patient care facility or personnel. Further, in some embodiments, the user may control and adjust stimulation parameters within a first range at the start of therapy, but as the therapy progresses (eg, after 2 to 3 weeks), the user may control and adjust stimulation parameters within a second range. The parameter may be controlled and adjusted, wherein the second range is narrower, limited or constrained as compared to the first range.

Also disclosed herein is an electrical skin patch configured to be worn continuously by a patient, comprising: a housing including a controller in electrical communication with a pulse generator; and at least two electrodes attached to the patient's skin and configured to be in electrical communication with the pulse generator, wherein the controller, when executed and transmitted to the pulse generator, causes the pulse generator to cause a first electrical stimulation pulse and a second electrical stimulation program instructions for generating and transmitting a pulse to the at least two electrodes, wherein the first electrical pulse is defined by a first phase having a first polarity and a second phase having a second polarity opposite the first polarity and the second electrical pulse follows the first electrical pulse and is defined by a third phase having a third polarity, and a fourth phase having a fourth polarity opposite the third polarity, the second polarity being the third polarity The same, an electric skin patch is disclosed.

Optionally, the electrical skin patch is configured to be worn continuously by the patient for at least 24 hours.

Optionally, the second electrical pulse follows the first electrical pulse after a predetermined waiting period. Optionally, the first polarity is positive, the second polarity is negative, the third polarity is negative, and the fourth polarity is positive. Optionally, the first polarity is negative, the second polarity is positive, the third polarity is positive, and the fourth polarity is negative.

Optionally, each of the at least two electrodes comprises a hypoallergenic conductive gel having at least one adhesive surface. Optionally, the electrode does not comprise imidazolidinyl urea or diazolidinyl urea. Optionally, the electrode comprises a carboxymethylcellulose polymer and propylene glycol. Optionally, the at least one adhesive surface is configured to adhere to the patient's skin and has a peel strength in the range of 1.0 Newton to 2.1 Newton. Optionally, the at least one adhesive surface is configured to adhere to the skin of the patient and has a total skin contacting surface area in the range of 2 cm 2 to 4 cm 2 . Optionally, the at least two electrodes are disposed in the same plane parallel to the patient's skin and spaced apart by a distance of 0.05 cm 2 to 0.4 cm 2 .

Optionally, the amplitudes of the first phase, the second phase, the third phase and the fourth phase are the same and the pulse widths of the first phase, the second phase, the third phase and the fourth phase are the same.

Optionally, the predetermined time interval is from 1 minute to 10 minutes.

Optionally, the amplitudes of the first and fourth phases are equal, wherein the pulse widths of the first and fourth phases are equal, the amplitudes of the second and third phases are equal, and the second and third phases are equal in amplitude. The pulse widths of the phases are the same, and at least one of the amplitude and the pulse width of the first phase is different from the amplitude and the pulse width of the second phase.

Optionally, the first phase is defined as a waveform characterized by a first period and a second period, wherein the first period includes the first 10 μs of the waveform and the second period includes the remainder of the waveform, wherein the The waveform is defined by a maximum amplitude for a first period and an amplitude less than the maximum amplitude for a second period. Optionally, the maximum amplitude is in the range of 20 mA to 40 mA, optionally, the maximum amplitude is in the range of 20 mA to 40 mA, and the average amplitude over the first and second periods is in the range of 10 mA to 20 mA is in Optionally, the pulse generator has a maximum compliance voltage in the range of 40 volts to 60 volts.

Optionally, at least one of the first phase, the second phase, the third phase and the fourth phase is defined by a waveform characterized by a first period, a second period and a third period, wherein the first period of time is of the waveform. at least a portion of 0 μs to 10 μs, the second period includes at least a portion of 10 μs to 100 μs of the waveform, and the third period includes at least a portion of 100 μs to 200 μs of the waveform, wherein the The first period is determined by the maximum amplitude, and the second period and the third period are determined by the remaining amplitude less than the maximum amplitude. Optionally, the maximum amplitude is between 20 mA and 40 mA.

Optionally, in a second period, the attenuation of the residual amplitude is determined by a slope of the first negative amplitude having a first magnitude, and in a third period, the attenuation of the remaining amplitude is determined by a slope of the second negative amplitude having a second magnitude. , wherein the first size is smaller than the second size.

Optionally, the average of the maximum amplitude and the remaining amplitudes is in the range of 10 mA to 20 mA.

In some embodiments, disclosed herein is an electrical skin patch configured to be worn continuously by a patient, comprising: a housing comprising a controller in electrical communication with a pulse generator; and two electrodes positioned in the same plane parallel to the patient's skin at a distance of 0.05 cm 2 to 0.4 cm 2 and configured to attach to the patient's skin in electrical communication with the pulse generator, wherein the controller is configured to: program instructions that, when transmitted to the generator, cause the pulse generator to generate and transmit a first set of electrical stimulation pulses and a second set of electrical stimulation pulses to at least two electrodes, wherein each of the two or more electrodes comprises at least one A hypoallergenic conductive gel having one adhesive surface, wherein the hypoallergenic conductive gel does not comprise imidazolidinyl urea or diazolidinyl urea, wherein the at least one adhesive surface is configured to adhere to the skin of a patient and , 2cm2 Disclosed is an electrical skin patch having a total skin contacting surface area in the range of to 4 cm 2 .

Optionally, the electrical skin patch is configured to be worn continuously by the patient for at least one day.

Optionally, the electrode comprises a carboxymethylcellulose polymer and propylene glycol.

Optionally, each of the electrical stimulation pulses is defined by a charge balanced biphasic waveform, wherein the first set of electrical stimulation pulses and the second set of electrical stimulation pulses are separated by a predetermined time interval.

Optionally, the predetermined time interval is randomly assigned and is at least 1 minute in length.

Optionally, the pulse generator has a maximum compliance voltage in the range of 40 volts to 60 volts.

Optionally, each electrical stimulation pulse is defined by a waveform characterized by a first period, a second period and a third period, wherein the first period comprises at least a portion of 0 to 10 μs of the waveform, and a second period the period includes at least a portion of 10 μs to 100 μs of the waveform, and the third period includes at least a portion of 100 μs to 200 μs of the waveform, wherein the first period is defined by a maximum amplitude, and The 3 period is defined by the remaining amplitude less than the maximum amplitude. Optionally, the maximum amplitude of the electrical skin patch is between 20 mA and 40 mA.

Optionally, in a second period, the attenuation of the residual amplitude is determined by a slope of a first negative amplitude having a first magnitude, and in a third period, the attenuation of the remainder amplitude is determined by a slope of a second negative amplitude having a second magnitude. , where the first size is smaller than the second size. Optionally, the average of the maximum amplitude and the remaining amplitudes is in the range of 10 mA to 20 mA.

In some embodiments, the present disclosure provides a method of using an electrical skin patch, wherein each electrical stimulation pulse has a pulse width ranging from 10 μsec to 10 msec, a pulse amplitude ranging from 100 μA to 100 mA, and a pulse frequency ranging from 1 Hz to 100 Hz. programming the controller to include; and determining whether the patient experiences a change in appetite as a result of applying the first set of electrical stimulation pulses or the second set of electrical stimulation pulses to the skin of the patient, wherein the patient experiences the Disclosed is a method of using an electric skin patch that does not experience erythema, scaling, itching, folliculitis, or intertidal itchiness at the point of attachment to the skin of this patient.

Optionally, the method further comprises programming the controller such that each electrical stimulation pulse comprises a pulse width in the range of 10 μsec to 10 msec, a pulse amplitude in the range of 100 μA to 100 mA, and a pulse frequency in the range of 1 Hz and 100 Hz; and determining whether the patient experiences a change in appetite as a result of applying the first set of electrical stimulation pulses or the second set of electrical stimulation pulses to the skin of the patient, wherein the patient experiences the This patient does not experience erythema, scaling, itching, folliculitis, or hepatic flaking at the point of attachment to the skin.

It should be understood that the type and number of stimulation parameters a user may control and adjust may vary in various embodiments.

According to one aspect of the present specification, a health management software application may include a plurality of default or standard stimuli preconfigured to drive therapy for a plurality of diseases, such as, for example, obesity, overweight, eating disorders, metabolic syndrome or appetite suppression and T2DM. protocol is provided.

Exemplary Stimulation Protocols for Treating Diseases of Obesity, Overweight, Eating Disorders, Metabolic Syndrome or Appetite Suppression and/or T2DM

In various embodiments, a standard stimulation protocol for stimulating T6, C8 and/or T1 dermatomes for the treatment of obesity, overweight, eating disorders, metabolic syndrome or for appetite suppression or T7 dermatomes for treating T2DM is: For example, it may include a plurality of pre-configured standard settings, such as at least three setting options such as weak, optimal, and strong. For example, one embodiment of a standard optimal stimulation protocol is self-contained 30-45 minutes before lunch and at an intensity that the patient can still feel without bothering the patient, for example at a frequency of 20 Hz and a 'sensory threshold' amplitude of 10 mA. Include 2 sessions per day of 30 minutes immediately before or after a specific time (eg, after 8 or 9 pm). The standard mild stimulation protocol is 30 to 45 minutes before lunch or just before bed or after a specific time (e.g., after 8 or 9 pm) a day at a frequency of 20 Hz and a 'sensory threshold' amplitude of 5 mA to 35 mA. Includes one 20-minute session. The standard intensity stimulation protocol is 3 30 minutes per day, 30-45 minutes before lunch, just before bedtime, and after specific times (e.g., after 8 or 9 PM) at a frequency of 40 Hz and a ‘sensory threshold’ amplitude of 10 mA. includes one session. In some embodiments, the latent effect is in the presence of a stimulus, wherein the stimulus is provided for a specific time period and the effect is not observed until the specific time period has elapsed and/or the effect is maintained for a specific time period after stimulation. For example, in one embodiment, ghrelin remains inhibited for at least several weeks after stimulation.

In various embodiments, the stimulation parameters and protocols do not elicit painful, uncomfortable or uncontrollable sensations in the user (i.e., do not reach a threshold of painful sensations) and include obesity, overweight, eating disorders, metabolic syndrome, or appetite. It should be noted that inhibiting and/or making it possible to treat T2DM disease.

In one preferred embodiment, a standard or baseline stimulation regimen or protocol (also referred to as the 'default mode of operation') is set up with, for example, three stimulation sessions per day of 30 minutes each with a pulse amplitude of 20 mA. Each of the three stimulation sessions per day is started 30 to 60 minutes before, preferably 45 minutes before meal times, for example breakfast, lunch and dinner. In various embodiments, the remote patient care facility or personnel establish meal times that, in some embodiments, may conform to a diet plan. Thus, the HMA application is preset in a standard or baseline stimulation protocol to initiate stimulation in the absence of the user's initial health-related data. As therapy progresses, the health care application recommends and periodically adjusts baseline stimulation protocols or patterns based on the user's health-related information. In another preferred embodiment, the baseline stimulation schedule or protocol is administered at 15 minutes and postprandial time each having a pulse amplitude of 20 mA, respectively, immediately before the start of each meal and at the completion of each meal, such as breakfast, lunch, and dinner, respectively. Three stimulation sessions per day of 60 minutes each with a pulse amplitude of 20 mA are set up. In other words, the baseline stimulation modality or protocol includes 3 x 1.25 hours = a total of 3.75 hours (15 minutes before and 60 minutes after each meal). In some embodiments, the baseline pulse amplitude ranges from 5 mA to 10 mA allowing for a total stimulation duration of greater than 3.75 hours. In various embodiments, this postprandial stimulation session is manually triggered by the user. In some alternative embodiments, the pre- and post-prandial stimulation sessions are automatically triggered based on a pre-stored meal time schedule. In some alternative embodiments, the postprandial stimulation session detects an eating event by a swallow detection device, such as device 5605 of FIG. is automatically triggered in connection with detecting an eating event by the feeding moment recognition method (FIG. 58) implemented by the HMA using Included in the same wristband or wristwatch.

It should be understood that, in some embodiments, the standard optimal stimulation protocol (of the three options of weak, optimal, and strong) is established from the baseline stimulation protocol, which is the default protocol set for most users. In another embodiment, the standard baseline stimulation protocol is the only preconfigured setting available to the user in lieu of multiple stimulation options, such as three options: weak, optimal, and strong. However, the baseline stimulation protocol is programmable, tunable, or modifiable. That is, in various embodiments the remote care facility or personnel may modify the baseline stimulation parameters to a higher level of stimulation, a longer duration, and/or a greater number of times per day.

It should be understood that a default or default stimulation protocol may be established through a number of different mechanisms. First, biomarkers can be used to define thresholds that, if met, represent appropriate default or baseline stimulus settings. In an embodiment, the biomarker may be a pain level, a heart rate value, a skin impedance value, a degree of pupil dilation, a blood pressure value, a salivary cortisol value, or an EKG value. The pain level may be determined by a visual analog scale, and the patient may verbally state or input into the computing device a level of the visual analog scale equal to the amount of pain the patient experiences. Heart rate and blood pressure may be determined from an existing heart rate monitor or blood pressure monitor that may be integrated into the watch or patch. Pupil dilation can be measured visually or using a camera. The EKG value may be determined from an existing EKG device. The skin impedance value may be determined from an impedance sensor integrated into the EDP.

Biomarkers can be used to determine when a patient receives a sufficient amount of stimulation. For example, in one embodiment, the stimulation provided is sufficient if the measured heart rate increases by at least 5%, but no more than 20%, over a period of 5 minutes after stimulation begins. If the measured heart rate does not increase by at least 5%, the stimulus provided is not sufficient. If the measured heart rate increases by more than 20%, preferably by more than 15%, more preferably by more than 10%, the stimulus provided is too excessive.

For example, in one embodiment, a given stimulus is sufficient if the pain level measured using the VAS scale is greater than 5 but less than 8 over a period of five minutes after the stimulus begins. If the measured pain level does not exceed 5, the stimulus provided is not sufficient. If the measured pain level exceeds 8, the stimulus provided is too excessive.

For example, in one embodiment, the stimulation provided is sufficient if the measured blood pressure increases by at least 5%, but no more than 20%, over a period of 5 minutes after stimulation begins. If the measured blood pressure does not increase by more than 5%, the stimulus provided is not sufficient. If the measured blood pressure increases by more than 20%, preferably by more than 15%, more preferably by more than 10%, the stimulus provided is too excessive.

For example, in one embodiment, provided stimulation is sufficient if the measured skin impedance increases by at least 5%, but no more than 20%, over a period of 5 minutes after stimulation begins. If the measured skin impedance does not increase by more than 5%, the stimulus provided is not sufficient. If the measured skin impedance increases by more than 20%, preferably by more than 15%, more preferably by more than 10%, the stimulus provided is too excessive.

For example, in one embodiment, the stimulation provided is sufficient if the measured degree of pupil dilation increases by at least 5% and no more than 20% over a period of 5 minutes after stimulation begins. If the degree of pupillary dilatation does not increase by more than 5%, the stimulus provided is not sufficient. If the degree of pupillary dilation increases by more than 20%, preferably by more than 15%, more preferably by more than 10%, the stimulus provided is too excessive.

For example, in one embodiment, the stimulation provided is sufficient if the measured EKG value increases by at least 5%, but no more than 20%, over a period of 5 minutes after stimulation begins. If the EKG value does not increase by more than 5%, the stimulus provided is not sufficient. If the EKG value increases by more than 20%, preferably by more than 15%, more preferably by more than 10%, the stimulus provided is too excessive.

For example, in one embodiment, the stimulation provided is sufficient if the measured salivary cortisol value increases by at least 5%, but no more than 20%, over a period of 5 minutes after stimulation begins. If the salivary cortisol level does not increase by more than 5%, the stimulus provided is not sufficient. If the salivary cortisol value increases by more than 20%, preferably by more than 15%, more preferably by more than 10%, the stimulus provided is too excessive.

In operation, the patient is first subjected to stimulation with a low range of stimulation values, such as a pulse amplitude of 20 mA, a pulse width of 120 microseconds, and a pulse frequency of 30 Hz. If one or more of the aforementioned biomarkers fails to achieve the required threshold, the patient will receive stimulation with a stimulation value in the mid-range, such as a pulse amplitude of 30 mA, a pulse width of 120 μsec, and a pulse frequency of 30 Hz. . If one or more of the aforementioned biomarkers do not achieve the required threshold, the patient will be stimulated with a high range of stimulation values, such as a pulse amplitude of 40 mA, a pulse width of 120 µsec, and a pulse frequency of 30 Hz. .

In other embodiments, the process may be reversed. In operation, the patient is first subjected to stimulation with a high range of stimulation values, such as a pulse amplitude of 40 mA, a pulse width of 120 μsec, and a pulse frequency of 30 Hz. If one or more of the aforementioned biomarkers exceeds the essential threshold, the patient will receive stimulation with a stimulation value in the mid-range, such as a pulse amplitude of 30 mA, a pulse width of 120 μsec, and a pulse frequency of 30 Hz. If one or more of the aforementioned biomarkers still exceeds the essential threshold, the patient will receive stimulation with a lower range of stimulation values, such as a pulse amplitude of 20 mA, a pulse width of 120 μsec, and a pulse frequency of 30 Hz. .

Some embodiments further include customization options that allow the user to adjust or set a subset of stimulation parameters that the user is permitted to control within a limited range. It should be understood that the number of preconfigured settings (eg, weak, optimal, strong) may vary across various embodiments. In addition, stimulation protocols with weak, optimal, and strong configurations are exemplary only and may vary across various embodiments and to target specific disorders such as appetite suppression or T2DM. For example, stimulation protocols related to ghrelin regulation, and hence appetite regulation, are a stimulation pulse width of 200 µsec, a pulse amplitude corresponding to the user's 'sensory threshold' equal to 20 mA, a pulse frequency of 20 Hz, stimulation of 30 min. Session duration and may include one session per day for 4 weeks. Another exemplary stimulation protocol related to appetite suppression is a current of 6 Hz of duration 0.1 milliseconds (ms) starting with an intensity of 1 to 20 milliamps (mA) until the intensity reaches the user's 'sensory threshold'. Frequency can be used to include 15-minute stimulation sessions.

According to one aspect of the present specification, a health care application may include a user's hunger profile, standard eating and eating profile, actual eating and eating profile, energy balance, weight trend, blood sugar data and stimuli-induced nausea, indigestion, habituation events, such as, Recommend and periodically adjust stimulation protocols or patterns based on user health-related information. For example, the user's energy balance is an amount in excess of a predetermined amount of energy balance threshold in a particular calorie intake schedule per day by about 5% as specified in the user's standard regular eating and eating profile, and the user is also overweight or If determined to be obese, the health care application may initiate an optimal stimulation protocol for two weeks with an activity regime that includes, for example, daily or weekly goals of walking, exercise, running, swimming related to increasing the user's calorie expenditure. can suggest that The health care application monitors the user's adherence to the recommended optimal stimulation protocol and activity regime for two weeks. The resulting energy balance and compliance profile of the user is recorded and displayed to the user in the form of a chart, graph, table, or any other visual format that is advantageously apparent to one of ordinary skill in the art. At the start of therapy or throughout the duration of therapy, the healthcare application may recommend a standard or customized diet plan to the user as part of a holistic approach to improving the effectiveness of stimulation therapy. For example, Table 3 shows a 1200 Kcal/day customized diet plan recommended by a health care application (among a plurality of such diet plans pre-stored in the health care application).

If the user's energy balance and/or weight trend shows improvement, for example, if the energy balance decreases below a positive energy balance threshold and/or the weight loss rate is within a predetermined tolerance limit, the health care application may may be advised to switch to a mild stimulation protocol over the next two weeks. For example, if the weight loss or weight loss rate exceeds or exceeds a predetermined threshold (e.g., X% greater than Y%), the health care application may recommend or automatically recommend therapy from the current optimal stimulation protocol to a mild stimulation protocol. can be titrated with On the other hand, if the user's energy balance and/or weight trend remains the same as at the start of stimulation therapy or worsens, on the other hand, because the user does not adhere to the activity regime (and consequently the user does not burn the required amount of calories), for example, If the user's energy balance is found to be positive by M%, where M%>L% and/or the weight loss rate is below a predetermined tolerance limit or there is no significant weight loss, the health care application provides the user with a strong stimulus over the next two weeks. It may be recommended to switch to a protocol.

According to aspects herein, a health care application continuously monitors and analyzes a plurality of health-related information or data of a user to identify new health trends and consequently based on the identified health trends or patterns, within a predetermined time period. , automatically (as opposed to manually by the user and/or TPM) one or more interventions in real time within a time frame or time window that identifies a health trend and/or within a future time window in which the identified health trend or pattern is expected to occur. to determine and create

In embodiments, the HMA may include a plurality of health-related information of the user, such as the user's hunger profile, standard eating and eating profile, actual eating and eating profile (including calorie intake), energy balance, weight data and trends, blood sugar data , any or any of daily or periodic scores related to , willpower levels, hunger, appetite, and well-being (enter 'diary'), exercise or calorie burn, daily or periodic composite scores, irritation-induced nausea, indigestion, and habituation events. It is programmed to refer to combinations of two or more to identify health trends. The plurality of health-related information or data of the user also includes physiological data from a separate device having a physiological sensor configured to be worn on a human body, such as around a wrist.

Appetite data representing the degree of appetite experienced by the patient is stored in a database in relation to the time of day and the calendar day. The system accesses a database to obtain appetite data, and processes it to generate appetite graphs, tables, charts, or other visual representations. The system further accesses the database to obtain appetite data, and processes it to develop appetite patterns that determine the patient's possible appetite levels over future time windows. The system stores an appetite pattern comprising a plurality of appetite levels for a particular time window of a given calendar day, and further uses the appetite patterns to trigger an intervention based on these predicted appetite levels. Accordingly, the exemplary database includes actual historical logs of appetite levels stored in relation to time of day, time window, and/or calendar day, and predicted future patterns of appetite level in relation to time of day, time window, and/or calendar day.

70 is a flow diagram illustrating a plurality of steps associated with one embodiment of a method for automatically generating one or more interventions using an EDP device based on an identified health trend of a user. In step 7002, the user acquires an electric skin patch (EDP) device, and uses the EDP device to monitor, acquire, monitor, obtain, e.g., physiological data, and an associated device such as a smartphone (implementing the HMA herein); Pair with a separate device, which is a device with physiological sensors, configured to be worn on the human body, such as around the wrist, for recording and/or transmission. In some embodiments, pairing with a separate device may be performed at any time within a treatment cycle. In step 7004, the device is set to a default operating mode. In some embodiments, the default mode of operation includes the following stimulation parameters, a pulse width in the range of 10 μsec to 10 msec, a pulse amplitude in the range of 100 μA to 100 mA, and a pulse frequency in the range of 1 Hz and 100 Hz. In some embodiments, the default mode of operation for most patients is 30 to 60 minutes, preferably 45 minutes, before or after the end of meal times, such as breakfast, lunch and dinner, for example. Three stimulation sessions per day of 30 minutes each are set to begin. In some embodiments, the default mode of operation includes the stimulation parameters and parameter ranges listed with respect to FIG. 27C and includes daily stimulation. The EDP device is placed on the user's body in step 7006 for use.

At step 7008 , the companion device executing the HMA is configured to perform a plurality of health measures as needed for a first predetermined time period immediately after wearing or using the EDP for the first time, and a second time period subsequent to the first predetermined time period. Prompts to obtain and store relevant information or data. In embodiments, the first predetermined period of time is referred to as a 'learning period' during which the HMA attempts to obtain sufficient data points related to one or more health-related information or data deemed sufficient to identify one or more health-related trends or patterns. . The 'learning period' is the time frame immediately after the user first uses the EDP. In various embodiments, the 'learning period' ranges from 1 day to 1 month. A second period of time after the 'learning period' (as opposed to predetermined and time-limited as a 'learning period') generally continues until the end of the therapy and/or until one or more goals of the therapy are achieved.

As previously discussed herein, the HMA may be a user's explicit or It is programmed to periodically prompt the user to provide 'daily diary' input or other health-related information that may require manual entry. In accordance with aspects herein, the HMA implements a notification protocol during a 'learning period' that triggers the HMA to generate a notification or prompt for the user to input or provide relevant health-related information, such as appetite or hunger data, at predetermined time intervals. implement In embodiments, the HMA prioritizes evaluation of the user's hunger or appetite profile during the 'learning period' to subsequently identify relevant trends or patterns.

In embodiments, the HMA prompts the user to enter data indicative of the user's degree of appetite or hunger (and/or other 'daily diary' parameters such as exercise and well-being) via a microphone or display of the client or companion device. In various embodiments, the user is prompted at a predetermined relevant time, the user's input is subsequently received, and time stamped using one of the following: a light bar VAS, a VAS consisting of a questionnaire, a number, a color spectrum ( 76) or a plurality of icons, emojis or emoticons are created on the touch-enabled display of the companion device, and the user provides a finger-based input of the degree or intensity of appetite/hunger (identifying a value in the VAS or the user's appetite level) A visual prompt that allows you to provide an emoji that visually represents the ), for example, a tactile input, such as a certain number of finger taps on the display screen by the user, a shaking motion of the interlocking device, where the degree of motion represents the patient's degree of appetite (e.g., interlocking) Shaking the device 7 times means an appetite or hunger score of 7 out of 10) or when the user wears a wrist watch or wristband (which includes an accelerometer or inclinometer to detect, capture, and acquire the user's haptic motion) and when present (eg) through a predetermined physical body movement, such as a haptic action of the wrist or hand; a vibrating prompt (via the companion device and/or EDP device) where the user may subsequently provide input via any haptic motion as discussed above or by actuating a button on the EDP device; an audible prompt, wherein the HMA in communication with the IPA system, companion device, or EDP device communicates a voice-based prompt to the user and enables receiving voice-based user input via the IPA system, companion device, or EDP device; by actuating a button on the EDP device itself or a button on a remote toggle switch configured to be worn on the user's neck or placed on the user's wrist in the form of a wristwatch or wristband; or time stamped by activating a light source (eg, one or more LEDs) in the EDP device. Accordingly, the prompt triggered by the HMA is in the form of at least one of an audio message, a video message, a text message, and a graphic message.

In some embodiments, the user aurally prompts for an appetite scale, and the user's time-stamped input is received via at least one of a finger-based input, a haptic input, or a voice input.

In an embodiment, the notification protocol triggers a prompt at a first rate or frequency during a 'learning period' (a first time period) and prompts at a second rate or frequency during a second time period (ie after a 'learning period') , wherein the second ratio is less than the first ratio. The goal is to intensively attack the user with input requests for appetite/hunger to establish patterns during the learning period, i.e. to have enough data to create customized or personalized interventions and therapies. In one embodiment, the interval between notifications is at least 1 hour and the first rate of notifications is greater than once per day and less than 24 times per day. In some embodiments, the frequency of alerts may decrease at the end of the 'learning period' or when the HMA establishes a trend or pattern. In an alternative embodiment, the frequency of notifications may remain unchanged.

Optionally, in an embodiment, the notification option and notification protocol may or may not be activated by the user in the user's companion device. In an embodiment, the notification option and notification protocol for 'learning period' are activated by default and may be deactivated by the user. In some embodiments, the user may control/modify the first rate or frequency of notifications, with the constraint that the frequency of notifications cannot be reduced to less than once per day.

In step 7010, the companion device executing the HMA continuously or periodically analyzes a plurality of health-related information or data of the user for a predetermined time period to identify one or more health patterns or trends. In some embodiments, health trends may be derived by forming or generating a topographic map describing one or more health-related information or data of a user and determining trends from the map. In some embodiments, one or more health patterns or trends may be derived from a user's daily aggregate appetite or hunger score accumulated over a predetermined period of time. In some embodiments, a first plurality of combined daily appetite or hunger scores (also referred to as a 'general global appetite or hunger score') may correspond to a typical day when the user eats, and a second plurality of combined daily aggregate appetite or hunger scores. A score (also referred to as a 'fasting aggregate appetite or hunger score') may correspond to the day the user is fasting. In some embodiments, the HMA compares the first and second plurality of daily aggregate appetite or hunger scores to determine one or more patterns or trends.

In step 7012, the HMA determines whether a health trend or pattern exists or has been identified. If a health trend exists or is identified, then at step 7014 the HMA can prospectively and automatically initiate at least one of a plurality of types of interventions, for example, based on a prediction of the level of appetite that the patient is likely to have in a given future time window. Create and provide to users. In some embodiments, once the pattern is determined, the HMA has confidence that the patient's appetite will be less than, equal to, or greater than a predetermined appetite threshold in a future time window. Based on this determination, an intervention may be triggered, the level and type of intervention based on the extent to which the patient's appetite is less than, equal to, or greater than a predetermined threshold. These interventions include:

코칭 기반 개입 - 이는 (예를 들어) 식욕 관리 방법에 대한 온라인 코칭 또는 조언(그래픽, 오디오, 비디오 및/또는 문자 메시지를 포함함)을 제공한다. 일부 실시예에서, 코칭 기반 개입은 환자의 식욕 정도와 관련된 조언을 나타내는 시각적 표시 또는 청각적 전달 중 적어도 하나를 생성하고, 여기서 조언은 사용자의 약 투여, 음식 선택, 식사 시간, 음식 섭취, 음식 금주, 운동 참여, 다이어트 계획 선택 또는 다이어트 순응 정도에 관한 지침을 제공한다. 이러한 코칭 기반 개입은 환자의 식욕이 주어진 시간 창에서 미리 정해진 임계값보다 클 것으로 예측되는 경우 트리거된다. 대안적으로, 이러한 식욕 데이터가 미리 정해진 임계값을 초과하는 경우, 이러한 코칭 기반 개입은 환자의 식욕 데이터 획득과 관련하여 실시간으로 트리거될 것이다. 예를 들어, 감소하는 자극 강도 및/또는 식욕 또는 배고픔의 정도 또는 강도 증가는 코칭 기반 개입을 정당화할 수 있다. 도 82는 본 명세서의 일부 실시예에 따라 시간에 따라 자극 강도(8205)의 제1 플롯 및 식욕 또는 배고픔 강도(8210)의 제2 플롯을 예시하는 그래프(8200)이다. 자극과 식욕 또는 배고픔의 강도는 y축에서 포인트 기반 VAS 스케일(예를 들어, 10포인트 VAS)을 사용하여 측정되는 반면, 시간은 x축에서 주(또는 일) 단위로 측정된다. 도시된 바와 같이, 식욕 또는 배고픔의 강도가 증가할 수 있고/있거나 자극의 강도가 감소할 수 있기 때문에 식욕 또는 배고픔의 강도의 제2 플롯(8210)은 지점(8215)에서 자극의 강도의 제1 플롯(8205)과 교차한다. 일부 실시예에서, 포인트(8215)는 코칭 기반 개입의 필요한 포인트를 나타낸다.

Coaching-based interventions - These provide (eg) online coaching or advice (including graphics, audio, video and/or text messages) on how to manage appetite. In some embodiments, the coaching-based intervention generates at least one of a visual indication or an audible delivery indicative of advice related to a patient's degree of appetite, wherein the advice is the user's medication administration, food selection, meal times, food intake, food abstinence , providing guidance on exercise participation, choosing a diet plan, or adherence to a diet. Such coaching-based interventions are triggered when a patient's appetite is predicted to be greater than a predetermined threshold in a given time window. Alternatively, if such appetite data exceeds a predetermined threshold, such coaching-based intervention will be triggered in real time with respect to obtaining the patient's appetite data. For example, decreasing stimulus intensity and/or increasing degree or intensity of appetite or hunger may justify a coaching-based intervention. 82 is a graph 8200 illustrating a first plot of stimulus intensity 8205 and a second plot of appetite or hunger intensity 8210 over time in accordance with some embodiments herein. Stimulus and intensity of appetite or hunger are measured using a point-based VAS scale (eg, 10-point VAS) on the y-axis, while time is measured in weeks (or days) on the x-axis. As shown, a second plot 8210 of the intensity of appetite or hunger may be the first of the intensity of the stimulus at point 8215 because the intensity of the stimulus or hunger may increase and/or the intensity of the stimulus may decrease. Intersect with plot 8205 . In some embodiments, point 8215 represents a required point of a coaching-based intervention.

소셜 네트워크 기반 개입 - 이는 미리 녹음된 또는 실시간 그래픽, 오디오, 비디오 및/또는 문자 메시지가 사용자의 친목 그룹 또는 소셜 네트워크 구성원으로부터 사용자에게 전달되도록 한다. 실시예에서, 소셜 네트워크 기반 개입을 통해 HMA는 소셜 네트워크(사용자가 구성원임)에 연결하고, 소셜 네트워크로부터 사용자의 식욕 정도와 관련된 조언의 시각적 표시, 사용자의 식욕 정도와 관련된 조언의 청각적 통신, 자동화된 메시지, 소셜 네트워크에서 연결된 개인이 미리 녹음된 메시지, 및 소셜 네트워크에서 연결된 개인의 실시간 메시지 중 적어도 하나를 수신할 수 있다. 실시예에서, 조언은 사용자의 약 투여, 음식 선택, 식사 시간, 음식 섭취, 음식 자제, 운동 참여, 다이어트 계획 선택, 또는 식이 요법 순응 정도에 관한 지침을 제공한다. 이러한 소셜 네트워킹 기반 개입은 환자의 식욕이 주어진 시간 창에서 미리 정해진 임계값보다 클 것으로 예측되는 경우 트리거된다. 대안적으로, 이러한 식욕 데이터가 미리 정해진 임계값을 초과하는 경우, 이러한 소셜 네트워킹 기반 개입은 환자의 식욕 데이터 획득과 관련하여 실시간으로 트리거될 것이다.

Social Network Based Intervention - This allows pre-recorded or real-time graphics, audio, video and/or text messages to be delivered to the user from the user's social group or social network member. In an embodiment, through a social network based intervention, the HMA connects to a social network (of which the user is a member), a visual indication of an advice related to the user's appetite level from the social network, an audible communication of the advice related to the user's appetite level, from the social network; At least one of an automated message, a pre-recorded message of a person connected in the social network, and a real-time message of the person connected in the social network may be received. In embodiments, the advice provides guidance regarding the user's medication administration, food choices, meal times, food intake, food abstinence, exercise participation, diet plan selection, or degree of dietary adherence. Such social networking based interventions are triggered when the patient's appetite is predicted to be greater than a predetermined threshold in a given time window. Alternatively, if such appetite data exceeds a predetermined threshold, such social networking based intervention will be triggered in real time with respect to obtaining the patient's appetite data.

구조 세션 기반 개입 - 이는 하루 중 시간대에 사용자에게 적어도 하나의 구조 세션을 제공한다. 이러한 구조 세션 기반 개입은 환자의 식욕이 주어진 시간 창에서 미리 정해진 임계값보다 클 것으로 예측되는 경우 트리거된다. 대안적으로, 이러한 식욕 데이터가 미리 정해진 임계값을 초과하는 경우, 이러한 구조 세션 기반 개입은 환자의 식욕 데이터 획득과 관련하여 실시간으로 트리거될 것이다.

Rescue Session Based Intervention - This provides the user with at least one rescue session at any time of day. This rescue session-based intervention is triggered when the patient's appetite is predicted to be greater than a predetermined threshold in a given time window. Alternatively, if such appetite data exceeds a predetermined threshold, this rescue session based intervention will be triggered in real time with respect to obtaining the patient's appetite data.

디폴트 자극 파라미터 및 프로토콜을 수정, 조정 또는 적정하는 것을 포함할 수 있는 자극 적정 기반 개입. 구체적으로, 시스템은 전기 자극의 수, 타이밍, 강도, 펄스 폭, 펄스 진폭 및 펄스 주파수 중 적어도 하나를 수정한다. 선택적으로, 상기 수정은 트리거 후에 발생한다. 선택적으로 트리거는 건강 돌봄 제공자로부터의 신호; 적어도 14일의 경과된 시간 기간; 최소 30일의 경과된 시간 기간을 포함할 수 있다. 실시예에서, 펄스 폭은 10㎲ec 내지 10msec 범위이고, 펄스 진폭은 1mAmp 내지 65mAmp 범위이고, 펄스 주파수는 1Hz 및 100Hz 범위이다. 실시예에서, 1주일에 걸쳐 적용된 복수의 자극 세션에 의해 전달된 총 에너지는 0.25주울 이상이고, 개별 자극 세션에 의해 전달된 총 에너지는 6주울을 초과하지 않는다. 실시예에서, 수정은 체중, 웰빙, 배고픔, 식욕, 환자에 의해 섭취된 칼로리, 환자에 의해 소모된 칼로리, 및 체중 감량 목표(여기서, 데이터는 디바이스에 의해, 예를 들어, 스케일 및 손목 밴드와 같은 제2 디바이스로부터 전송/수신되거나, 환자에 의해 입력되거나, 건강 돌봄 제공자에 의해 입력될 수 있음) 중 적어도 하나를 나타내는 데이터에 기초한다. 일부 실시예에서, 시스템은 데이터를 수신하기 위해 전기 피부 패치 외부의 디바이스에서 실행하도록 구성된 복수의 프로그램 명령어를 사용한다. 일부 실시예에서, 시스템은 전기 피부 패치 외부의 제2 디바이스에서 실행하고 제1 복수의 프로그램 명령어와 데이터 통신하며 건강 돌봄 제공자가 데이터를 입력하도록 프롬프트하도록 구성된 제2 복수의 프로그램 명령어를 사용한다. 실시예에서, 자극 적정 기반 개입은 또한 전기 자극이 필요한 하루 중 복수의 시간대, 전기 자극이 필요하지 않은 하루 중 복수의 시간대, 및 하나 이상의 예정된 전기 자극으로의 변경 중 적어도 하나를 결정하는 것을 포함한다. 일부 실시예에서, 자극 세션의 적어도 일부는 적어도 15분의 지속시간을 갖는다. 실시예에서, 자극은 1주의 지속시간에 걸쳐 인가되고, 이 주에 적어도 2번의 자극 세션이 있다. 일 실시예에서, 적어도 2개의 자극 세션은 다른 날에 발생한다. 실시예에서, 1주일에 7번의 자극 세션이 있고, 각각의 짝수 자극 세션은 주의 다른 날에 발생한다. 실시예에서, 각각의 자극 세션은 상기 복수의 자극 세션 중 후속 세션의 지속시간의 25% 이상의 시간 기간만큼 상기 복수의 자극 세션 중 후속 세션과 분리된다. 일부 실시예에서, 시스템은 전기 피부 패치를 통해 자극 세션을 시작하기 30분 이내에 환자에게 시각, 청각 및 진동 신호 중 적어도 하나를 생성한다. 일부 실시예에서, 시각, 청각 및 진동 신호 중 적어도 하나는 자극 세션을 시작하기 60분 전에 또는 기상 알람을 시작하기 60분 후에 피부에 전기 피부 패치를 고정하도록 환자에게 지시한다. 일부 실시예에서, 전기 피부 패치는 오전 6시와 오전 9시, 오전 11시와 오후 2시 또는 오후 5시와 9시 사이에 자극 세션의 적어도 일부를 적용하도록 프로그래밍된다. 실시예에서, 자극 세션의 최대 지속시간은 12시간이고 최대 펄스 진폭은 45mAmp이다. 일부 실시예에서, 건강 추세는 자극 파라미터, 프로토콜 또는 패턴의 자동 조정 또는 하향 조정으로 이어지는 양일 수 있다. 일부 실시예에서, 건강 추세는 자극 파라미터, 프로토콜 또는 패턴의 자동 조정 또는 상향 조정으로 이어지는 음일 수 있다.

Stimulus titration based interventions, which may include modifying, adjusting or titrating default stimulation parameters and protocols. Specifically, the system modifies at least one of the number, timing, intensity, pulse width, pulse amplitude, and pulse frequency of the electrical stimuli. Optionally, said modification occurs after a trigger. Optionally, the trigger may be a signal from a health care provider; an elapsed time period of at least 14 days; It may include an elapsed time period of at least 30 days. In an embodiment, the pulse width is in the range of 10 microseconds to 10 msec, the pulse amplitude is in the range of 1 mAmp to 65 mAmp, and the pulse frequency is in the range of 1 Hz and 100 Hz. In an embodiment, the total energy delivered by a plurality of stimulation sessions applied over a week is at least 0.25 joules, and the total energy delivered by individual stimulation sessions does not exceed 6 joules. In an embodiment, the modification is weight, well-being, hunger, appetite, calories consumed by the patient, calories burned by the patient, and a weight loss goal (where the data is communicated by the device, e.g., with a scale and wristband). may be transmitted/received from the same second device, inputted by a patient, or inputted by a health care provider). In some embodiments, the system uses a plurality of program instructions configured to execute in a device external to the electrical skin patch to receive the data. In some embodiments, the system uses a second plurality of program instructions configured to execute in a second device external to the electrical skin patch and in data communication with the first plurality of program instructions and to prompt the health care provider to enter data. In an embodiment, the stimulation titration-based intervention further comprises determining at least one of a plurality of times of day in which electrical stimulation is not required, a plurality of times of day in which electrical stimulation is not required, and a change to one or more scheduled electrical stimulations. . In some embodiments, at least a portion of the stimulation session has a duration of at least 15 minutes. In an embodiment, stimulation is applied over a duration of one week, with at least two stimulation sessions in this week. In one embodiment, the at least two stimulation sessions occur on different days. In an embodiment, there are seven stimulation sessions per week, each even-numbered stimulation session occurring on a different day of the week. In an embodiment, each stimulation session is separated from a subsequent one of the plurality of stimulation sessions by a period of time at least 25% of the duration of the subsequent one of the plurality of stimulation sessions. In some embodiments, the system generates at least one of a visual, audible, and vibratory signal to the patient within 30 minutes of initiating a stimulation session via the electrical skin patch. In some embodiments, at least one of the visual, audible and vibratory signals instructs the patient to secure the electrical skin patch to the skin 60 minutes prior to starting the stimulation session or 60 minutes after starting the wake up alarm. In some embodiments, the electrical skin patch is programmed to apply at least a portion of a stimulation session between 6 am and 9 am, 11 am and 2 pm, or 5 pm and 9 pm. In an embodiment, the maximum duration of the stimulation session is 12 hours and the maximum pulse amplitude is 45 mAmp. In some embodiments, a health trend may be a quantity that leads to an automatic adjustment or downward adjustment of a stimulation parameter, protocol or pattern. In some embodiments, health trends may be negative leading to automatic adjustments or upward adjustments of stimulation parameters, protocols or patterns.

ο More specifically, the plurality of stimulation sessions may be repeatedly applied over a predetermined time period. After a period of time, in order to deliver an appropriate regimen, the plurality of stimulation sessions may include data indicative of weight, data indicative of well-being, data indicative of hunger, data indicative of appetite, data indicative of calories consumed by the patient, and calories burned by the patient. may be modified based on at least one of data indicating a weight loss goal and data indicating a weight loss goal. In some embodiments, the plurality of stimulation sessions are modified by reducing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the stimulation session. In some embodiments, the plurality of stimulation sessions are modified by increasing at least one of a number, amplitude, frequency or pulse width of electrical pulses of the stimulation session. In some embodiments, the predetermined period of time is at least 14 days. In one embodiment, the plurality of stimulation sessions are modified by reducing at least one of the number, amplitude, frequency or pulse width of the electrical pulses of the stimulation session by at least 10%. In one embodiment, the plurality of stimulation sessions is modified by increasing at least one of the number, amplitude, frequency or pulse width of the electrical pulses of the stimulation session by at least 10%. In some embodiments, the predetermined period of time is at least 30 days. In one embodiment, the plurality of stimulation sessions is modified by reducing at least one of the number, amplitude, frequency or pulse width of the electrical pulses of the stimulation session by at least 20%. In one embodiment, the plurality of stimulation sessions is modified by increasing at least one of the number, amplitude, frequency or pulse width of the electrical pulses of the stimulation session by at least 20%.

ο Stimuli-increasing titration-based intervention is triggered, for example, if the patient's appetite is predicted to be greater than a predetermined threshold in a given time window. A stimulus reduction titration-based intervention is triggered when the patient's appetite is predicted to be less than a predetermined threshold in a given time window. Alternatively, if such appetite data exceeds a predetermined threshold, this stimulus increased titration based intervention is triggered in real time with respect to the collection of the patient's appetite data. Alternatively, if such appetite data is below a predetermined threshold, this stimulus reduced titration based intervention is triggered in real time with respect to the patient's appetite data collection.

데이터 표시 기반 개입 - 일부 실시예에서, 이는 식욕 패턴 또는 사용자의 과거 식욕 정도가 연동 디바이스 또는 클라이언트 디바이스에 표시되게 하고, 여기서 식욕 패턴은 제1 축에 하루 중 시간대, 제2 축에 달력 일, 및 하루 중 시간대와 달력 일과 관련하여 그래프에 표시된 사용자의 식욕 정도를 나타내는 아이콘을 갖는 히트 맵 또는 그래프의 형태이다. 아이콘의 크기, 형상, 색상 또는 패턴 중 적어도 하나는 환자의 식욕 정도 또는 사용자의 식욕 정도가 복수의 날에 걸쳐 변화한 정도를 나타낸다. 사용자의 식욕 패턴 또는 과거의 식욕 정도는 히트 맵, 지형도, 차트, 표, 및 그래프 중 적어도 하나의 형태로 표시될 수 있음을 이해해야 한다. 이러한 데이터 표시 기반 개입은 환자의 식욕이 주어진 시간 창에서 미리 정해진 임계값보다 클 것으로 예측되는 경우 트리거된다. 대안적으로, 이러한 식욕 데이터가 미리 정해진 임계값을 초과하는 경우, 이러한 데이터 디스플레이 기반 개입은 환자의 식욕 데이터 획득과 관련하여 실시간으로 트리거된다.

Data Representation Based Intervention—In some embodiments, this causes an appetite pattern or past appetite level of the user to be displayed on the companion device or client device, wherein the appetite pattern comprises a time of day on a first axis, a calendar day on a second axis, and It is in the form of a heat map or graph with icons representing the user's appetite level displayed on the graph in relation to the time of day and calendar day. At least one of the size, shape, color or pattern of the icon indicates the degree to which the patient's appetite level or the user's appetite level has changed over a plurality of days. It should be understood that the user's appetite pattern or past appetite level may be displayed in the form of at least one of a heat map, a topographic map, a chart, a table, and a graph. These data indication-based interventions are triggered when the patient's appetite is predicted to be greater than a predetermined threshold in a given time window. Alternatively, if such appetite data exceeds a predetermined threshold, such data display based intervention is triggered in real time with respect to obtaining the patient's appetite data.

In some embodiments, the intervention includes a plurality of electrical stimuli automatically applied to the user, a plurality of electrical stimuli applied to the user upon request by the user, an exercise performed by the user, calories consumed by the user, calories consumed by the user, and the user. and displaying data representing the degree of appetite of the user superimposed on data representing at least one of a meal eaten and a drug taken by the user.

In some embodiments, the overlaid data is represented by a first icon and a second icon plotted on a chart having calendar days on one axis and time of day on the second axis, and at least of a color and size of the first icon. One indicates the degree of appetite of the user, and at least one of the color and size of the second icon indicates the intensity of the plurality of electrical stimulations automatically applied to the user, the strength of the plurality of electrical stimulations requested by the user and applied to the user, and performed by the user. It represents at least one of the amount of exercise, the amount of calories consumed by the user, meal time, and the amount of medication the user took.

In another embodiment, the overlapped data is displayed as a first icon and a second icon displayed on a chart having a calendar day on one axis and a time zone of the day on a second axis, and at least one of a color and a size of the first icon is represents a change in the user's appetite, and at least one of the color and size of the second icon indicates the intensity of the plurality of electrical stimulations automatically applied to the user, the strength of the plurality of electrical stimulations requested by the user and applied to the user, and the user It represents a change in at least one of the amount of exercise performed, the calories consumed by the user, the meal time, and the amount of the drug the user took.

According to some embodiments, the intervention relates to displaying data on the user's past appetite levels on the companion device, wherein the data is displayed in a first heat map having calendar days on one axis and time of day on a second axis. represented by an icon, wherein the color of the icon represents the patient's degree of appetite, the data is represented by the icon displayed on a second heat map with calendar days on one axis and time of day on the second axis, wherein the color of the icons represents a degree of appetite of the user, wherein the first heat map represents data taken during a first time period, and the second heat map represents data taken during a second time period, and wherein the first heat map and the second heat map The difference in appetite between patients is expressed as a value.

72A shows a first heat map 7205 plotted with a first set of icons or dots 7215 representing the user's appetite data over a first time period, such as a first week. The first heat map 7205 has a calendar day 7210 on the x-axis and a time of day 7212 on the y-axis. 72B is a second heat map 7220 plotted with a second set of icons or dots 7225 representing the user's appetite data over a second time period, eg, over the second week immediately following the first week. shows The second heat map 7220 also has a calendar day 7210 on the x-axis and a time of day 7212 on the y-axis. The colors of the first and second sets of icons or dots 7215 and 7225 represent the user's appetite. For example, in some embodiments, the color of the icon or dot may range from white, gray, black, green, yellow, orange to red, where white represents the lowest intensity or degree of appetite and red represents the highest. Indicating levels of appetite, different colors between white and red indicate progressive degrees of appetite. When the first and second heat maps 7205 and 7220 are presented to the user they represent a change (increase or decrease) in the user's appetite between the first and second time periods. Thus, based on one or more interventions, the user's heat map may evolve from a first map 7205 to a second map 7220 (red dot reduction and green dot expansion) to represent the efficacy of the overall treatment provided by the EDP. have.

Appetite or hunger data displayed in a heat map, such as map 7205 or 7220, is important because interventions, such as titration of stimulation therapy, can be determined, timed, and prescribed depending on appetite/hunger intensity and time of day and day of the month. It must be understood that action is possible. In some embodiments, the stimulation regimen may be adjusted in proportion to a numerical appetite or hunger input. For example, if the user enters an appetite or hunger score of 8 (on a hunger scale from 0 to 10), for example, automatic coaching advice and/or peer support (messages from individuals who are members of a social group of which the user is also a member). form) and immediate intervention in the form of a rescue stimulation session can occur. In another example, if a user's weekly or monthly heatmaps can reveal concentrated hotspots (high-intensity appetite or hunger data) at specific times of the day, stimulation regimens can be adjusted accordingly and target vulnerable times of the day. can In an embodiment, the intervention aims to focus the user's orange and red hotspots at specific times of the day of the week moving to the green dots in the time zones of the same days of the following week.

In some embodiments, the color of the icons or dots 7215, 7225 is a color spectrum-based VAS (e.g., VAS 7600 in FIG. 76) used to receive a user's input regarding the intensity of appetite or hunger. It is understood to be a direct representation of color.

In other embodiments, heat maps may also be used for research purposes. Compare the efficacy of various weight loss treatments, including, for example, sleeve gastrectomy versus knee bands, a low-fat diet versus a high-protein diet, and monitor patients post-surgery (or post-weight loss) to anticipate weight recovery to reduce hunger-related conditions. Can be used to observe and look for increases in hunger scores. In another example, diabetic patients may have an advantage in titrating drugs ahead of anticipated hotspots. HMA can use heat maps to establish correlations between hunger hotspots and glucometer scores. Hunger/appetite is a precursor to eating, so being able to quantify and time hunger can help the patient or therapist to anticipate and act in advance.

According to another embodiment, the intervention relates to receiving the user's weight trend and appetite pattern and determining the user's overall score, wherein the composite score is a function of the user's past appetite degree and weight trend. In one embodiment, the intervention displays a composite score to the client device. In another embodiment, the intervention causes the client device to send the overall score to an online social or social network group, where the user is a member of the online social or social network group. In one embodiment, the intervention displays the daily or weekly composite score as icons or dots on the heat map.

According to another embodiment, the intervention relates to plotting and displaying the composite score as an icon or point on a heat map, such as map 7205 or 7220 . In this embodiment, the composite score is the daily or weekly appetite/hunger average or total score.

Disclosed herein is a system for generating a real-time intervention in response to a patient's degree of appetite, comprising: an electrical skin patch comprising: a housing; a controller located within the housing; at least one electrode positioned in physical communication with the housing and configured to be in electrical contact with the patient's skin; and a pulse generator located within the housing and in electrical communication with a controller and the at least one electrode, wherein the pulse generator is configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by a stimulation parameter, wherein The stimulation parameters include: an electrical skin patch comprising a first pulse width in the range of 10 μsec to 10 msec, a first pulse amplitude in the range of 100 μA to 100 mA, and a first pulse frequency in the range of 1 Hz and 100 Hz; a first plurality of program instructions stored in a non-transitory memory of a client device separate from the electrical skin patch, when executed, prompting the patient to input data indicative of the patient's appetite by the client device via a microphone or display of the client device a first plurality of program instructions adapted to generate a second plurality of program instructions stored in a non-transitory memory of a client device or other device separate from the electrical skin patch, the second plurality of program instructions, when executed, determining an appetite pattern of a patient based on the input data; and a third plurality of program instructions stored in a non-transitory memory of a client device or other device separate from the electrical skin patch, wherein the third plurality of program instructions, when executed, determine an intervention based on an appetite pattern and generate the intervention. Disclosed is a system comprising:

Optionally, the intervention is to send at least one of a text-based message, a video message, an audio message, or a graphic message to the patient via the client device.

Optionally, the intervention is to modify the stimulation parameter such that at least one pulse width is different from the first pulse width, the pulse amplitude is different from the first pulse amplitude, and the pulse frequency is different from the first pulse frequency.

Optionally, the second plurality of program instructions determine a time window associated with each of the inputted data, and for each time window, a predetermined range of values around the values such that a range of values of all the inputted data associated with the time window constitutes a pattern. Determines the patient's appetite pattern based on the input data by determining whether it is within range. The time window may range from 1 hour to 3 hours.

Optionally, the second plurality of program instructions determine a time window associated with each of the inputted data, and for each time window, a predetermined range of values around the values such that a range of values of all the inputted data associated with the time window constitutes a pattern. Determines the patient's appetite pattern based on the input data by determining whether it is not within the range.

Optionally, the second plurality of program instructions determine a time window associated with each of the inputted data, and determine for each time window whether a number of individual inputted data values associated with the time window is large enough to constitute a pattern. By doing so, the patient's appetite pattern is determined based on the input data.

Optionally, the second plurality of program instructions determine a time window associated with each of the inputted data, and determine for each time window whether a number of individual inputted data values associated with the time window is too low to constitute the pattern. By determining, the patient's appetite pattern is determined based on the input data. The time window may range from 1 hour to 3 hours.

Optionally, the prompt is in the form of at least one of an audio message, a video message, a text message, and a graphic message.

Optionally, the first plurality of program instructions are configured to cause the client device to generate the prompt at a first rate during a first time window and at a second rate after the first time window, wherein the second rate is less than the first rate. Optionally, the first rate ranges from 1 time per day to 24 times per day, and the first time window ranges from 1 day to 1 month. Optionally, the first plurality of program instructions are configured to provide the patient with an option to modify the first ratio via a display of the client device.

Optionally, the third plurality of program instructions determine an intervention by processing an appetite pattern indicative of the patient's appetite to determine whether the patient's appetite is expected to be greater than or less than a first threshold in a future time window. do. Optionally, if the patient's degree of appetite is expected to be less than a first threshold in a future time window, the third plurality of program instructions do not generate an intervention in a future time window. Optionally, if the patient's degree of appetite is expected to be greater than the first threshold in the future time window, the third plurality of program instructions generates an intervention during the future time window. The intervention may cause at least one of a text-based message, a video message, an audio message, or a graphical message to be transmitted to the patient via the client device. The intervention may modify the stimulation parameter such that at least one pulse width is different from the first pulse width, the pulse amplitude is different from the first pulse amplitude, and the pulse frequency is different from the first pulse frequency.

Optionally, when executed, the first plurality of programming instructions generates a prompt in the form of a visual analog scale, causing the prompt to be displayed on the client device, wherein each value according to the visual analog scale indicates a different degree of appetite . The visual analog scale may be a light bar having a sliding scale, wherein a first end of the sliding scale indicates a low degree of appetite and a second end of the sliding scale indicates a high degree of appetite.

Optionally, when executed, the first plurality of program instructions generates a prompt in the form of a plurality of icons, each of the plurality of icons indicating a different degree of appetite.

Optionally, when executed, the first plurality of program instructions generate a prompt in the form of an audible query and cause the audible query to be played through a speaker of the client device.

Optionally, when executed, a third plurality of program instructions receive the patient's appetite pattern and cause the appetite pattern to be displayed on the client device, wherein the appetite pattern is a time of day on a first axis and a calendar on a second axis. in the form of a graph with icons representing the day, and the patient's degree of appetite plotted on the graph in relation to the time zone and calendar day. Optionally, at least one of the size, shape, color or pattern of the icon indicates the degree of appetite of the patient.

Optionally, when executed, a third plurality of program instructions receive the weight trend and appetite pattern of the patient, and determine a composite score of the patient, wherein the composite score is a function of a past appetite degree and weight trend of the patient, wherein Have the overall score displayed on the client device. Optionally, when executed, the third plurality of program instructions are configured to cause the client device to transmit the composite score to an online fellowship group, wherein the patient is a member of the online fellowship group.

Also disclosed herein is a system for generating a real-time intervention in response to a patient's degree of appetite, comprising: an electrical skin patch comprising: a housing; a controller located within the housing; at least one electrode in physical communication with the housing and configured to be in electrical contact with the patient's skin; and a pulse generator located within the housing and in electrical communication with a controller and the at least one electrode, wherein the pulse generator is configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by a stimulation parameter. patch; a first plurality of program instructions stored in a non-transitory memory of a client device separate from the electrical skin patch, when executed, communicating with the electrical skin patch and inputting data indicative of a patient's degree of appetite through a microphone or display of the client device a first plurality of program instructions to prompt the patient to do so; and a second plurality of program instructions stored in a non-transitory memory of the client device or other device separate from the electrical skin patch, wherein the second plurality of program instructions, when executed, receive data indicative of a patient's degree of appetite, the patient's Process data representing appetite levels to develop predictions about whether a patient's appetite level will be above or below a threshold in a future time window, and generate an intervention in a future time window if the patient's appetite level is expected to be below a threshold , and generating a first intervention in a future time window if the patient's degree of appetite is expected to be above a threshold, the system comprising a second plurality of program instructions.

Optionally, the first intervention is a signal generated by the second plurality of program instructions and transmitted to the electrical skin patch at or before a future time window.

Optionally, the first intervention comprises at least one of graphics, text, audio and video, wherein at least one of the graphics, text, audio and video comprises a prerecorded message from an individual connected with the patient within the social network.

Optionally, the first intervention comprises at least one of graphics, text, audio and video, wherein at least one of the graphics, text, audio and video comprises a real-time message from an individual connected with the patient within the social network.

It should be understood that the HMA automatically creates and provides one or more of a plurality of types of interventions based at least on identified health trends or patterns without manual intervention of the user and/or the TPM. Further, at least one of a plurality of types of interventions may be generated, in real time with respect to the identification of health trends or patterns; determine the health trend and within a predetermined time window, for example within 72 hours, preferably within 24 hours, preferably within 12 hours, preferably within 2 hours; or that the health trend is presented to the user in any of a future time window during which it is expected to occur or recur. Determination of health trends, and more specifically appetite patterns, is based on obtaining a sufficient amount of data within a predetermined range for a given time window. In particular, the system analyzes the acquired appetite data (each data element has a time stamp associated with it) so that a) how many data points are within a given time window, and b) the data are clustered around a particular value. Determines whether or not it is too spread out over a range of values to form a pattern. In one embodiment, data is considered sufficiently clustered if a majority of the data elements are within a predetermined deviation from the average appetite value in a given time window. In one embodiment, data is considered sufficiently clustered if a majority of the data points fall outside a predetermined deviation from the average appetite value in a given time window. A time window represents a time range for a given day, such as 11 AM to 1 PM or 5 PM to 8 PM. In one embodiment, preferably the time window is greater than or equal to 1 hour and less than or equal to 6 hours.

In a first non-limiting example of steps 7012 and 7014, the HMA monitoring or tracking a plurality of health-related information or data of the user determines that the user's hunger level occurs consecutively ('N', eg, 3). , can be determined to be higher than a predetermined threshold level during an event, time or day, eg, for 'N' consecutive eating events or for one or more eating events distributed over consecutive 'N' days. Thus, the HMA can flag these recurrent successive occurrences of high hunger levels as indicative of a health trend. As a result, the HMA automatically creates and provides at least one of a plurality of types of interventions for a corresponding future time window in which the pattern occurs.

In a second non-limiting example of steps 7012 and 7014 , the HMA monitoring or tracking a plurality of health-related information or data of the user may be configured such that the user's appetite level is at least 'W' days (eg, 2 days). It may be determined that a predetermined threshold is exceeded at certain times of the day (eg, lunch time) in succession. Additionally, the user's well-being level may be found to be above a predetermined threshold level (indicating a sub-optimal stagnant or deteriorating well-being) during certain times of the day and for at least 'W' consecutive days. Based on recurrent successive occurrences of high appetite levels and suboptimal stagnant or worsening well-being, HMA can conclude that a health trend exists, and based on this, a multiple for a corresponding future time window in which the pattern occurs. It is possible to automatically create and provide at least one of the tangible interventions.

In a third non-limiting example of steps 7012 and 7014 , the HMA monitoring or tracking a plurality of health-related information or data of the user indicates that the user's weight loss is below the target range for days 'Z', i.e., 5 consecutive days. can be decided At the same time, for 'Z' days consecutively, the user's appetite level was found to be slightly above the predetermined threshold level and the user's well-being level was also above the predetermined threshold level (indicating a sub-optimal stagnant or deteriorating well-being). was found to be As a result, the HMA may conclude that a health trend exists and based thereon may automatically generate and provide at least one of a plurality of types of interventions during a corresponding future time window in which the pattern occurs.

In a fourth non-limiting example of steps 7012 and 7014, an HMA that monitors or tracks a plurality of health-related information or data of a user may indicate that the user has 'V' different days (where 'V' different days are at least 3). 'T', e.g., 3 or more hunger levels, that exceed a predetermined threshold level within the same or similar predetermined time frame or time window on the same or similar predetermined time frame or time window (each day being separated by 1 to 2 days) You may decide to report an item. Assume that a user reports hunger above a threshold level within a time range ranging from ±15 minutes to ±3 hours, for example at 6:45 AM (or any other time such as breakfast, lunch, or dinner). . In other words, the user reports hunger above the threshold at 'V' times, eg at 6:45 am, 7:00 am and 6:30 am on three different days each. Repeated occurrences of high hunger levels within the same period window are determined as potential health trends. As a result, the HMA may automatically generate and provide at least one of a plurality of types of interventions for a corresponding future time window in which the pattern occurs. High hunger level events occur sporadically (e.g., a user reports hunger exceeding a threshold level at 6:45 AM, 2:00 PM, and 9:00 PM), resulting in the same or similar predetermined time frame or time If not within the window, it is understood that this is not recognized as a pattern or health trend by the HMA.

In a fifth non-limiting example of steps 7012 and 7014, the HMA monitoring or tracking a plurality of health-related information or data of the user may determine that the user's weight loss goal is not met during the target time period. If the HMA determines that the user did not lose X pounds by week Y (required to achieve or be on track to meeting the weight loss goal over a set period of time), this may indicate that the user did not lose the weight loss goal. It is assumed that it can be concluded that there is a health trend in Based on this determination, the HMA may automatically generate and provide at least one of a plurality of types of interventions for a corresponding future time window in which the pattern occurs.

In a sixth non-limiting example of steps 7012 and 7014 , the HMA monitoring or tracking a plurality of health-related information or data of the user may be configured to reduce the user's weight relative to the target linear gradient weight trend or graph 7105 of FIG. 71 . can be verified. 71 , the user's goal or goal is to reduce a first body weight 7110 to a second body weight 7115 within a period of 'q' weeks 7120 , where the second body weight 7115 is It is smaller than the first weight 7110 . Accordingly, it is assumed that the user's weight trend or graph 7105 slopes linearly downward over 'q' weeks 7120 . Now, at any point in time, for example, at the end of 'r' weeks 7125 ('r' weeks less than 'q' weeks), the user's weight may be w ₁ 7130 , which is At the end of the 'r' weeks 7125 may be overlaid on a graph 7105 or a weight trend required. In other words, the user is not achieving the target weight loss. In this situation, it is assumed that the HMA determines health trends associated with hunger levels that exceed a predetermined threshold for consecutive 'N' days. At the same time, the HMA also determines that the health trend associated with the level of well-being is above a predetermined threshold (indicating a sub-optimal stagnant or deteriorating well-being) for consecutive 'N' days. Because the user's weight (w ₁ ) 7130 is above the desired weight trend or graph 7105, the HMA places less emphasis on well-being-related health trends, higher weights or considerations, or attaches to hunger-related health trends. can Based on this determination, the HMA may automatically generate and provide at least one of a plurality of types of interventions for a corresponding future time window in which the pattern occurs.

However, at any point in time, for example, at the end of 's' weeks 7135 ('s' weeks less than 'q' weeks), the user's weight may be w ₂ 7140 , which is The weight trend or graph 7105 required relative to the end of the 's' weeks 7135 may be below. In other words, the user is over-achieving the target weight loss. In this situation, it is assumed that the HMA determines health trends associated with hunger levels that exceed a predetermined threshold for consecutive 'N' days. At the same time, the HMA also determines that the health trend associated with the well-being level is above a pre-determined threshold (either stagnating below optimal or indicating deterioration in well-being) for consecutive 'N' days. Because the user's weight (w ₂ ) 7140 is below the desired weight trend or graph 7105 , the HMA emphasizes well-being-related health trends, less emphasis on lower weight or considerations, or attaches to hunger-related health trends. can Based on this determination, the HMA may automatically generate and provide at least one of a plurality of types of interventions. In embodiments, the HMA may evaluate the user's weight to fall within a specific predetermined range or band of the desired weight trend or graph 7105 . The stimulus is then titrated by weighing the hunger trend against the well-being trend using the deviation of the user's weight above or below a predetermined band associated with the weight graph 7105 .

In a seventh non-limiting example of steps 7012 and 7014, the HMA is a historical representation of the user's previous appetite level to determine the degree to which the user's appetite level has changed (increased or decreased) over a predetermined time period at the same time of day. Compare the user's most recent data set (the first set of appetite data) indicative of his or her appetite with respect to the data (the second set of appetite data). In an embodiment, the HMA also generates a value indicative of the determined degree of change in appetite. The HMA then determines and automatically generates at least one of the plurality of types of interventions based on comparing the first and second sets of appetite data.

In various embodiments, the type of intervention automatically generated for the user and/or the timing of providing the type of intervention to the user is the amount of change in the user's most recent appetite data relative to the past appetite data for a predetermined period of time at the same time of day. (increase or decrease) depends. In some embodiments, an intervention of a first type is automatically generated or triggered and communicated to the user if the amount of change is less than a predetermined threshold, whereas a second type of intervention is automatically generated or if the amount of change is greater than a predetermined threshold. Triggered and delivered to the user.

In an eighth non-limiting example of steps 7012 and 7014, the HMA determines a time window associated with each of the input appetite data, and for each time window the value range of all input appetite data associated with this time window is a pattern. within a predetermined range around the value to constitute or not within a predetermined range; and determining the user's appetite pattern based on the input appetite data by determining at least one of when the number of individually inputted appetite data values associated with the time window is large enough or, alternatively, too low to constitute the pattern. In an embodiment, the time window ranges from 1 hour to 3 hours. Thereafter, the HMA determines and automatically generates at least one of the plurality of types of interventions when the value range of the input appetite data associated with the input time window constitutes a pattern.

In a ninth non-limiting example of steps 7012 and 7014, the HMA prospectively predicts the user's appetite level based on analysis of historical appetite data associated with a particular time of day; prospectively identifying a period of time during which the patient's degree of appetite exceeds a threshold, based on the analysis of the past appetite data with respect to the particular time of day, wherein the period corresponds to the particular time of day; and determine at least one of determining whether a degree of appetite of the user is expected to be greater than or less than a threshold value in a future time period.

Subsequently, the HMA determines and automatically creates at least one of the plurality of types of interventions in or before the future time window. For example, if the user's appetite degree is expected to be less than a threshold in a future time window, the HMA will not generate an intervention during the future time window. However, if the user's appetite degree is expected to be greater than a threshold in a future time window, the HMA generates at least one of a plurality of types of interventions during the future time window. In various embodiments, the HMA performs the following tasks based on the prospective prediction of the patient's appetite level: 1) modify parameters for a plurality of predetermined electrical stimuli, 2) add additional electrical stimuli, 3) electrical remove the stimulus, 4) generate a notification, and 5) deliver a text-based message, video message, audio message, or graphic message to the user.

Referring again to FIG. 70, if no health trend has been determined or confirmed at step 7012, then at step 7016, the HMA determines whether additional information or data from the user is required to identify an impending or subsequent health trend. evaluate If so, at step 7018, the HMA may automatically prompt the user to enter data from a specific point in the day to obtain additional information or data needed to ascertain or determine whether a health trend exists. Optionally, the HMA may modify the notification rate or frequency and timing to obtain additional or missing health-related data or data necessary to identify patterns. Optionally, the HMA may prompt or warn after a predetermined period of time (eg, a day) that the user does not provide sufficient data to establish an appetite pattern and that the user is stimulated based on a predetermined default stimulus or mode of operation. can In other words, in accordance with aspects herein, the notification rate or frequency is modified based on past user input of health related information, such as appetite or hunger. Thus, for example, the HMA may increase the rate or frequency of future prompts if user input is below a predetermined threshold in response to past prompts regarding appetite, for example. Conversely, the HMA may increase the rate or frequency of future prompts, for example if user input exceeds a predetermined threshold in response to past prompts regarding appetite. Those skilled in the art will appreciate that the change in prompt frequency may be applied to hunger, satiety, satiety, satiety, calorie input, exercise input, among other variables.

In particular, as data is collected, the HMA evaluates the data to determine whether there is a trend. You may decide that more data is needed if the appetite data for a particular window differs by more than 20% as determined by a visual analog scale, for example, within an hour of a typical lunchtime (noon). In this case, it is unclear what the user's appetite is for the key time of day. In various embodiments, the HMA may also assume that appetite was below a threshold if the user did not provide appetite/hunger data, for example. Based on the user input of the prompt, additional information or data, the HMA may or may not confirm the existence of a health trend, and thus may or may not generate one or more interventions in step 7020 .

As a non-limiting example of steps 6016 , 7020 , an HMA monitoring or tracking a plurality of health-related information or data of a user may be configured such that the user's appetite level is continuously reduced for at least 'W' days (eg, 2 days). It may be determined that a predetermined threshold is crossed at certain times of the day (eg, lunch time). However, the user cannot provide input related to well-being level for one or all of the 'W' days. In the absence of well-being-related information or data, HMA cannot identify health trends related to increased appetite. Thus, the HMA (associated device) automatically prompts the user for the well-being level, and if the subsequently entered well-being level also shows a worsening trend, the HMA may conclude that there is a health trend related to increased appetite. Based on this conclusion, the HMA may automatically generate and provide at least one of a plurality of types of interventions for a corresponding future time window in which the pattern occurs.

However, if, at step 7016, the HMA determines that no additional information or data from the user is needed to identify a health trend, then at step 7022, the HMA does not generate any intervention, and the user's multiple health Relevant information is continuously or periodically analyzed to identify one or more health trends.

According to one aspect, after creating and providing the intervention to the user, the HMA may query the user whether the user is satisfied with the intervention. If the user is not satisfied with the intervention, the user may be immediately prompted for his or her appetite or hunger data at this time and/or another intervention may be provided. For example, if the first intervention included coaching advice, the second intervention may include modification of electrical stimulation parameters triggered by patient input indicating that the patient is not satisfied with the intervention.

Various embodiments may also be in addition to or in lieu of automatic stimulation conditioning or titration and/or in addition to or in addition to pre-configured settings (eg, weak, optimal, strong) of a standard stimulation protocol based on the identification or identification of one or more health trends. Instead, it involves triggering a real-time stimulus based on the user's expressed request or need. An on-demand stimulus (hereinafter also referred to as a “rescue” or “rescue session”) is applied when an unscheduled or unscheduled hunger event is initiated and/or a known hunger event in the user's hunger profile is potentially triggered.

In various embodiments, a rescue session is initiated by a shaking motion of a user's smartphone operating as the companion device 105 of FIG. 1A in some embodiments; by issuing a voice-based command to a health care application (HMA) via the intelligent personal assistant (IPA) system described with reference to FIGS. 48A-48C ; by actuating a button on the EDP device itself or a remote toggle switch that is configured to be worn on the user's neck or placed on the user's wrist in the form of a wristwatch or wristband; Predetermined physical body movements, such as haptic motions of the wrist or hand (for example) when the user is wearing a wristwatch or wristband (which contains an accelerometer or inclinometer for sensing, capturing, and acquiring the user's haptic motion) Manually initiated by the user in a number of ways, including but not limited to issuing a command via In another embodiment, as described above with reference to FIGS. 48A-C, for example, using an IPA system (eg, consisting of a Bluetooth speaker) in a food intake area - eg, a kitchen - (user A rescue session is automatically triggered by detecting the presence of an EDP device (worn by In some embodiments, the HMA installed on the user's smartphone utilizes the smartphone's GPS sensor to determine whether the user is, for example, in a restaurant. If a user is found to be visiting a restaurant and it is not mealtime, the user is prompted and provided with a rescue session. In yet another embodiment, a rescue session may have physiological sensors configured to be worn on the human body, such as around a wrist, to monitor, acquire, record, and/or transmit physiological data to receive and incorporate exercise and weight loss information. Triggered by a user action on a third-party device (including third-party application software on external devices).

In a preferred embodiment, the request for a rescue session is initiated by actuating a button on the user's smartphone that functions as the companion device 105 of FIG. 1A . In some embodiments, the button is physical, such as a designated key on a smartphone, while in other embodiments, the button is virtual, such as a software-based icon on a smartphone. The user can actuate the button multiple times, such as repeatedly pressing or clicking the button. In order to avoid such a case, if repeated or multiple operations occur within a predetermined time range (in seconds or minutes) of each other, the repeated or multiple operations are registered or counted as a single operation. Activating the button (eg, by pressing a physical button or software icon) activates a light bar, in some embodiments, configured on a visual analog scale (VAS) from 0 to 10, where 0 indicates no hunger. and 10 represents the most severe hunger level. 51 is a depiction of a graphical user interface with a visual light bar. It should be noted herein that FIG. 51 is described in relation to a light bar having a scale of 0 to 10 in accordance with this specification, any range may be used, and any incremental iteration may correspond to any length of treatment time. . For example, you could choose a range from 0 to 100 for the light bar to represent the patient's hunger level.

As shown in FIG. 51 , the light bar VAS 5100 expands or advances from 0 on the far left 5102 of the scale to 10 on the far right 5104 of the scale depending on the period of time the user presses the button. In other words, the longer the user presses the button, the longer the light bar extends. In one embodiment, the closer the light bar is to 10 going from 5102 to 5104, the darker the light bar is. In one embodiment, the user may repeatedly press the light bar 5100 on the touchscreen device until an appropriate hunger level is selected. In another embodiment, the user may slide the light bar 5100 from right to left or left to right on the touchscreen device to indicate the level of hunger.

According to one aspect, the length or extent of the light bar VAS not only indicates the hunger level of a hunger event, but also indicates the duration of a potential rescue session that may be triggered. In some embodiments, the length or extent of the light bar VAS is equal to the duration of the rescue session. Thus, a light bar VAS length representing 7 (eg, out of 0-10 VAS) triggers a rescue session therapy of 7 minutes, a light bar VAS length representing 8 triggers a rescue session therapy of 8 minutes, which A maximum of 10 minutes of rescue sessions corresponding to the maximum light bar VAS length representing 10 continues. According to one embodiment, the threshold or minimum actionable hunger level required to trigger any rescue session is set to 5 (ie the midpoint of the light bar VAS). Thus, a light bar VAS length representing 5 triggers a rescue session regimen of 5 min. However, a light bar VAS length indicating a hunger level of less than 5, i.e. 0, 1, 2, 3 or 4, is registered as a low-intensity hunger event but does not trigger a rescue session. In some embodiments, a high (eg, greater than 6) hunger level for the light bar VAS may trigger a proportionally higher amplitude of the rescue stimulus in conjunction with or instead of a longer rescue stimulus time.

It should be understood that in an alternative embodiment, the threshold or minimum actionable hunger level required to trigger any rescue session is set to six. In this alternative embodiment, a light bar VAS length indicating a hunger level of less than 6, i.e. a level of 0, 1, 2, 3, 4 or 5 would register as a low-intensity hunger event but would not trigger a rescue session.

In some embodiments, depending on the user's hunger intensity: a) no stimulation as the intensity level is below the threshold, b) the hunger intensity level exceeds the threshold but less than 8 which can trigger a 15-minute rescue session at 10 mA Yes, c) a hunger intensity level greater than 8 can trigger a 15-minute rescue session at 20 mA.

In some embodiments, the duration of the rescue session is proportional to the length or extent of the light bar VAS. For example, a VAS hunger intensity level of 7 (on a scale of 0 to 10) could trigger a proportional structural stimulus of 10 minutes at, for example, 20 mA, whereas a VAS hunger intensity level of 6 could trigger a proportional structure stimulus, for example, at 20 mA, for example, 15 5 min of proportional structural stimulation can be triggered at mA. A VAS hunger intensity level of less than 6 (or less than 5 in an alternative embodiment) may not trigger any rescue session.

In another embodiment, the duration of the rescue session is proportional to the actual caloric intake (or caloric intensity) by the patient. Consider a scenario in which a patient records calorie intake or intake in excess of the planned intake, for example, the patient's actual calorie intake at lunch is 800 calories instead of the planned 600 calories. Thus, in this scenario the patient is provided with postprandial rescue sessions proportional to the patient's caloric intake.

Although users are allowed on-demand stimulation and customized stimulation protocols, in various embodiments the health care application ensures that the user does not engage in excessive or insufficient stimulation (e.g., continuous monitoring, It is programmed to ensure limited or limited controlled access to a subset, and/or limited user controlled access only to a limited range within a standard set range). For example, a user may add the number of daily sessions beyond what is scheduled based on standard protocol settings such as weak, optimal, strong, or baseline stimulation protocols, but with some limitations or limitations. For example, a user may have 5 additional “structures” in the first month of stimulation therapy, decrease to 4 daily in the second month, and 3 daily in the third month of therapy. It is important to understand that limits are important to avoid habituation over time. Additionally, the number of stimulation sessions may be limited and then decreased, allowing stimulation intensity, such as amplitude and frequency, to be adjusted up or down (e.g., +/- 10%) by a set amount. . In some embodiments, users are allowed up to 12 rescue sessions per day of short duration, eg, 5 minutes.

In one embodiment, the user is allowed a daily total rescue budget of, for example, up to 60 minutes of rescue therapy, which can be delivered in a bolus or rescue session of a minimum of 5 minutes and a maximum of 10 minutes at an amplitude similar to the baseline stimulation protocol. Accordingly, a user is allowed a maximum of 12 rescue sessions (12 x 5 minutes) of 5 minutes each and a minimum of 6 rescue sessions (6 x 10 minutes) of 10 minutes each each day. Thus, in the context of using the light bar VAS, the user can record an unlimited number of low-level hunger events, but the maximum budget for actual rescue therapy is 60 minutes, with no bolus of less than 5 minutes. In an alternative embodiment, 60 minutes of rescue therapy may be delivered in a 15 minute bolus or rescue session, allowing for 4 rescue sessions (4×15 minutes) of 15 minutes each. It should be understood that, in alternative embodiments, the total daily rescue budget may be set in terms of minimum and maximum stimulation amplitude, frequency, or number of rescue sessions within a defined time period.

In another embodiment, the user is allowed a daily total rescue budget of, for example, up to 90 minutes of rescue therapy, which can be delivered in a bolus or rescue session of a minimum of 15 minutes with an amplitude similar to the baseline stimulation protocol. Thus, the user is allowed a maximum of 6 rescue sessions (6 x 15 minutes) each day of 15 minutes each. In some embodiments, a daily total rescue budget of up to 60 minutes or 90 minutes may be used only between meals, such as 30 minutes or more before meals or 90 minutes or more after meals.

In one embodiment, the user is allowed a default pre-programmed stimuli and/or a daily number of stimuli, eg, 10 times, that may be delivered in a real-time rescue session delivered in response to the patient's request. Prior to generating the rescue session, the system preferably analyzes the total number of stimuli delivered in a previous time period, such as 24 hours or less, and determines that the stimulus session is determined based on a combination of the pre-programmed number of stimuli and the requested real-time rescue session Determine whether and how often it can be served.

In an embodiment, the daily total structured budget is comprised of at least two components, the first component is the daily discretionary structured budget, and the second component is the daily automatic structured budget. A daily discretionary rescue budget limits the rescue sessions a user can have at their own discretion or at their discretion, whereas a daily automatic rescue budget allows users to automatically Restricts the rescue session being delivered. In some embodiments, the daily total rescue budget is set to, for example, 60 minutes, while the daily discretion and automatic rescue budget is set to, for example, 30 minutes each. In alternative embodiments, the daily total rescue budget may be set to a smaller or higher value, and the daily discretion and automatic rescue budget may also include different percentages of the total rescue budget. In embodiments where the total daily rescue budget is up to 90 minutes of rescue therapy, the daily discretionary and automatic rescue budgets are set to 45 minutes each, for example.

According to one aspect herein, hunger events, levels, and triggered "rescue sessions" are tracked to generate a user's individualized hunger profile or hunger map over a predetermined time period and/or a predetermined number of rescue sessions ( Date and time stamped including the duration of each rescue session) and recorded (eg, via light bar VAS). In various embodiments, the predetermined period of time ranges from several days (eg, 5 to 7 days) to several weeks (eg, 3 to 6 weeks). In various embodiments, the predetermined number of rescue sessions ranges from 1 to 10 sessions. One or more thresholds or filter conditions, such as, but not limited to, a predetermined period of time and/or number of rescue sessions, can be set to obtain a sufficient level of confidence that the rescue session exhibits a pattern of hunger rather than a one-time random event. It must be understood that the

A user's personalized hunger profile or map is dynamic, indicating the occurrence of an event when the user actually feels hungry or thinking about food, and in some embodiments a hunger spike for the user. Thus, in various embodiments, a user's individualized hunger profile is utilized to automatically customize, modify, drive, and deliver stimulation regimens or protocols to target the user's hunger spikes. In other words, a variable number of daily rescue sessions is interpreted as a user's hunger or bite level on a given day, used, for example, to create an individualized hunger map of a user for a given day showing the timing and/or intensity of hunger clusters. do. This hunger map is then used to automatically titrate and time stimulation therapy. For example, in some embodiments, a threshold or filter condition (to identify patterns of hunger) is recorded, for example, on three separate days in the same week, and recorded, for example, within 60 minutes of the same time of day, for example. A minimum of 3 hunger events (each triggering a rescue session or bolus - ie each of the 3 hunger events is an intensity level of 5 or greater out of a 0 to 10 light bar VAS) can be configured or set to. Thus, fulfillment of a threshold or filter condition may trigger an automatic 10-minute rescue session or bolus, for example, in that time period of the subsequent week(s).

A user's individualized hunger profile or map represents a dynamic record of daily and weekly appetite trends and is tracked and generated throughout the user's treatment cycle. A dynamic hunger profile or map may be presented to the user on a daily and/or weekly basis, and may be used as a measure or record of daily hunger intensity and distribution, and thus, stimulation treatment progress over time. In some embodiments, the user's daily weight graph is overlaid or juxtaposed with the user's individualized hunger map as it progresses during stimulation therapy to communicate treatment progress. A user's daily weight trend and hunger profile are utilized to titrate or trigger therapy, as well as enable automatic coaching to provide advice and encouragement to the user based on performance and compliance. A user's personalized hunger profile or map is communicated to the user, social group, physician, automated diet coach or concierge service.

In some embodiments, the health care application continuously monitors a user's blood glucose indicators, such as, but not limited to, blood glucose levels or blood glucose status data, in order to properly titrate therapy in a closed loop configuration, the blood glucose level, status data or data using a continuous blood glucose sensor integrated with the EDP as one of the sensors 135 in FIG. allow the user to enter blood glucose levels orally at predetermined intervals (and/or as may be prompted by the IPA) via an IPA system in communication with the health care application; or third party application software on an external device, or entirely a second external device (including but not limited to, for example, watches, smart shoes, diabetic wearable pumps or other medical devices, etc.); obtained or received by the healthcare application by at least one of using a third party device comprising a continuous blood glucose sensor in communication (via pairing or synchronization) with the HMA, alone or in combination with a plurality of physiological sensors . It should be understood that, in some embodiments, the HMA is installed or embedded in the third-party device itself, thus eliminating the need for a separate companion device. It should be further understood that continuous blood glucose sensors may be used by patients who do not have diabetes or have not been diagnosed with diabetes.

Depending on the blood glucose data received, time of day and/or such historical blood glucose data and other current and/or historical health-related information, such as current and/or past meal profiles or current and/or past appetite or hunger levels Based on information including, but not limited to, the HMA recommends (for user approval) or (user approval) a modified stimulation regimen (eg, modified timing, duration, number and/or intensity of stimulation sessions). can be started automatically (if approved in advance by the For example, referring to the flowchart of FIG. 62 , the user's blood glucose level or blood glucose state data is obtained by the HMA in step 6205 . In step 6210, when it is determined that the user's blood glucose status data is higher than normal by a predetermined blood glucose threshold, for example, when the blood glucose status data is 200 mg/dL or more, the HMA in step 6215, yes For example, the EDP can be programmed to deliver a stimulation session of 15 minutes duration at a 20 mA intensity (ie, the HMA can generate and deliver a modulating signal to the EDP). If the blood glucose status data is not greater than 200 mg/dL, the stimulation session is not delivered and the HMA continues to periodically and automatically monitor the user's blood glucose status data. In one exemplary scenario, in step 6220a, after a predetermined interval, eg, after an hour, if it is determined that the user's blood glucose level is still high (eg, 200 mg/dL or greater), the step At 6225 , the HMA may reprogram the EDP to (eg) deliver one or more subsequent stimulation sessions with increased therapy duration and intensity. After a stimulation session and a predetermined interval, when the blood glucose status data is no longer greater than 200 mg/dL, the HMA periodically automatically updates the user's blood glucose status data without reprogramming the EDP to deliver one or more subsequent stimulation sessions. Continue monitoring.

In another example scenario, if at step 6220b it is determined that the user's blood glucose level has decreased by at least 1% (relative to the blood glucose level prior to stimulation) after a predetermined interval, then at step 6230 the HMA determines that the EDP is fixed at a predetermined Allow stimulation to continue with a predetermined minimum amplitude and/or intensity for a duration or until the user's blood glucose level returns to a normal level. If the user's blood glucose level has not dropped by at least 1% (relative to the pre-stimulation blood glucose level) even after the stimulation session and a predetermined interval, the HMA will periodically and automatically continue the user's blood glucose status data without allowing the EDP to continue stimulation. monitor In some embodiments, titration of the stimulation session(s) and therapy protocol and/or pattern may be a warning alarm or feedback advising the user to stop eating, for example, when blood glucose levels are observed to remain high for a period of time. (audio, visual and/or tactile) to the user.

63 is a flow diagram illustrating a plurality of example stimulation protocols followed after the user's blood glucose level or blood glucose state data is obtained by the HMA in step 6305 . In one exemplary protocol, in step 6310a, if the user's blood glucose level is greater than 100 mg/dL when waking up in the morning, the HMA is administered for an extended period of time (to achieve a fasting state) with a feeling of fullness (e.g., , equal to a hunger level of less than 6 on a hunger scale from 0 to 10), the EDP can be programmed to deliver at least one stimulation session, wherein the extended time period is at least 5 minutes. In another exemplary protocol, in step 6310b, if the user's blood glucose level is greater than 140 mg/dL at any time of day, the HMA is administered to prevent the user from overeating (on a hunger scale from 0 to 10). ) the EDP can be programmed to deliver at least one stimulation session to reduce or suppress hunger to a level less than 6; In another exemplary protocol, in step 6310c, the HMA administers the EDP to deliver at least one stimulation session such that the user's blood glucose level reaches a predetermined minimum, such as 80 mg/dL, before the user feels hungry enough to eat. can be programmed. In another exemplary protocol, in step 6310d, the HMA programs the EDP to deliver at least one stimulation session at night, eg, beyond 7 pm, such that the user's blood glucose level is less than 100 mg/dL in the morning. can do. In another example protocol, at step 6310e, the HMA may program the EDP to deliver at least one stimulation session such that the user's blood glucose rate is maintained below 2 mg/dL per minute.

64 is a flowchart illustrating steps of a method of titrating a stimulation therapy based at least on the user's blood glucose state data according to an embodiment of the present specification. In step 6405 , the user wears the EDP device of the present disclosure in communication with a separate companion device or client device implementing the health management application (HMA) of the present disclosure. The EDP device can be adapted to stimulation parameters including, but not limited to, session frequency, session duration, pulse width in the range of 10 μsec to 10 msec, pulse amplitude in the range of 100 μA to 100 mA, and pulse frequency in the range of 1 Hz to 100 Hz. and generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by At step 6410, the HMA a) uses a continuous blood glucose sensor integrated with the EDP as one of the sensors 135 of FIG. 1A to periodically and automatically monitor and record the user's blood glucose status data, b) a predetermined At intervals (and/or as may be prompted by the HMA) a VAS (Visual Analog Scale) light bar is displayed on the client device to prompt the user to enter blood glucose status data, c) allowing the user to communicate with the health care application. to enable oral entry of blood glucose status data at predetermined intervals (and/or as may be prompted by the IPA) through the IPA system, or d) periodically and automatically using a third party device; Obtaining or receiving the user's blood glucose status data or level using at least one of obtaining the status data and wirelessly communicating the blood glucose status data to the client device. The third party device, alone or in conjunction with a plurality of physiological sensors, may include an external device or a second external device (eg, a watch, a smart shoe, 3rd party application software (including, but not limited to, diabetic wearable pumps or other medical devices).

It should be understood that the user's blood glucose status data obtained or received by the HMA is time stamped to associate a time of day with the monitored blood glucose status data. In some embodiments, the HMA obtains or receives blood glucose state data at a particular predetermined time of day, which is then stored in association with the obtained blood glucose state data.

At step 6415 , the HMA prompts the user to input the user's degree of appetite or hunger. In various embodiments, the user is prompted via the IPA system in communication with the HMA, the microphone/speaker system of the client device, and/or the display of the client device. The user may select a scheduled or planned meal (e.g., according to a need determined by the HMA based on the obtained or received blood glucose status data and/or in relation to the time of day for which the user's blood glucose status data is obtained or received by the HMA). , breakfast, lunch, dinner) before and/or after) may be prompted to enter their appetite level into a predetermined schedule.

At step 6420 , the HMA is based on any or combination of obtained or received blood glucose state data, time of day and data indicative of the user's degree of appetite or hunger (to titrate stimulation protocol and/or parameters). Generate a modulated signal. In step 6425, the modulated signal is sent to the EDP. It should be understood that the modulated signal includes a plurality of stimulation parameters and/or protocols that enhance the user's blood glucose index compared to the user's blood glucose index prior to applying the modulated signal. In various embodiments, the glycemic index may include indicators including, but not limited to, blood glucose level, hemoglobin A1C level, hepatic gluconeogenesis, degree of insulin resistance, level of blood glucose homeostasis, and HOMA-IR level (various blood glucose indices and See the 'Therapy Goals' section herein for related improvement goals).

65 is a flowchart illustrating steps in a use case of titrating a stimulus based on at least a user's blood glucose state data according to an embodiment of the present specification. In step 6505, the HMA obtains or receives the user's blood glucose status data before 11 am and in the morning. The HMA checks whether the blood glucose status data obtained or received in step 6510 is greater than 100 mg/dL. If the blood glucose data is greater than 100 mg/dL, then at step 6515, the HMA generates and passes a modulating signal to the EDP, where the modulating signal is configured to cause the electrical skin patch to generate an electrical stimulation after 5 PM. The modulated signal comprises an increased second session frequency compared to the previous session frequency, an increased second session duration compared to the previous duration, an increased second pulse amplitude compared to the previous pulse amplitude, and a second increased compared to the previous pulse frequency. It should be understood that it includes at least one of the pulse frequencies. If the blood glucose state data is not greater than 100 mg/dL, a modulation signal is not generated and the HMA continues to periodically and automatically monitor the user's blood glucose state data.

66 is a flowchart illustrating steps in another use case of titrating a stimulus based at least on the user's blood glucose state data according to an embodiment of the present specification. In step 6605, the HMA obtains or receives the user's blood glucose state data periodically during the day. The HMA, in step 6610, checks whether the obtained or received blood glucose status data is greater than 140 mg/dL. If the blood glucose data is greater than 140 mg/dL, then at step 6615, the HMA generates a modulating signal and forwards it to the EDP, where the modulated signal determines that the blood glucose level is greater than 140 mg/dL, and within 2 hours after determining that the electrical skin patch is configured to generate an electrical stimulus. If the blood glucose state data is not greater than 140 mg/dL, a modulation signal is not generated and the HMA continues to monitor the user's blood glucose state data throughout the day.

67 is a flowchart illustrating steps in another use case of titrating a stimulus based at least on the user's blood glucose state data according to an embodiment of the present specification. In step 6705, the HMA obtains or receives blood glucose state data of the user periodically during the day. The HMA, in step 6710, checks whether the obtained or received blood glucose status data is greater than 140 mg/dL. If the blood glucose data is greater than 140 mg/dL, then at step 6715 the HMA also examines data indicative of the user's degree of appetite or hunger. The HMA examines the last stored degree of appetite (in the user's daily diary entry) and/or determines the current level of appetite or hunger (immediately upon obtaining or receiving blood glucose status data or at a predetermined later time or after a time interval). It should be understood that the user may be prompted to obtain. If the blood glucose data is greater than 140 mg/dL and the degree of appetite is also greater than a predetermined threshold or value, in step 6720, the HMA generates and transmits a modulated signal to the EDP, where the modulated signal indicates that the blood glucose level is 140 mg The electrical skin patch is configured to generate the electrical stimulation within a predetermined time, such as 2 hours, after determining that it is greater than /dL and that the user's appetite level is greater than the predetermined number. When the blood glucose state data is not greater than 140 mg/dL or the user's appetite level is not greater than a predetermined number, a modulation signal is not generated and the HMA continues to monitor the user's blood glucose state data throughout the day.

68 is a flowchart illustrating steps in another use case of titrating a stimulus based at least on the user's blood glucose state data according to an embodiment of the present specification. In step 6805, the HMA obtains or receives the user's blood glucose state data. The HMA, in step 6810, checks whether the obtained or received blood glucose status data is less than 80 mg/dL. If the blood glucose data is less than 80 mg/dL, then at step 6815, the HMA generates a modulated signal and passes it to the EDP. The modulated signal includes a reduced second session frequency compared to the previous session frequency, a reduced second session duration compared to the previous duration, a reduced second pulse amplitude compared to the previous pulse amplitude, and a reduced second session frequency compared to the previous pulse frequency It should be understood that it includes at least one of the pulse frequencies. When the blood glucose state data is 80 mg/dL or more, a modulation signal is not generated and the HMA continues to monitor the user's blood glucose state data.

69 is a flowchart illustrating steps in another use case of titrating a stimulus based on at least a user's blood glucose state data according to an embodiment of the present specification. In step 6905, the HMA obtains or receives the user's blood glucose state data. The HMA, at step 6910, checks whether the patient's rate of increase in blood glucose is greater than 2 mg/dL per minute. If the rate of increase is greater than 2 mg/dL per minute, at step 6915, the HMA generates a modulated signal and passes it to the EDP. The modulated signal comprises an increased second session frequency compared to the previous session frequency, an increased second session duration compared to the previous duration, an increased second pulse amplitude compared to the previous pulse amplitude, and a second increased compared to the previous pulse frequency. It should be understood to include at least one of the pulse frequencies. When the rate of increase is 2 mg/dL or less per minute, a modulated signal is not generated and the HMA continues to monitor the user's blood glucose status data.

In some embodiments, the health care application is configured to communicate with an insulin pump that the user can use to inject insulin, while the electrical skin patch device herein is configured to continuously monitor the user's blood glucose level in a closed loop configuration. , use the continuous blood glucose sensor as one of the sensors 135 in FIG. 1A or as a standalone third party device in wireless communication with the HMA. Thus, for example, if the user's blood sugar level is above normal by a predetermined blood sugar threshold, the health care application recommends starting an optimal or strong stimulation protocol with a diet plan, such as that described in Table 3, over a two-week period. can do. In some embodiments, the HMA may be preconfigured or preauthorized by the user to automatically trigger an optimal or strong stimulation protocol if the user's blood glucose level is found to be higher than normal. In various embodiments, the predetermined blood glucose threshold comprises a fasting blood glucose level greater than 80 mg%. The health care application continuously monitors the user's blood sugar level during therapy and allows the user to suppress the postprandial blood sugar level. When the stimulation therapy confirms that the user's blood sugar level is moving to normal levels, the health care application communicates this information to the user's insulin pump to slow insulin delivery/infusion. As previously discussed, the stimulation protocol can be automatically adjusted to weak, optimal, strong, or the stimulation regimen can be stopped entirely, depending on the effect on the user's blood glucose level. In some embodiments, the HMA is preconfigured or pre-authorized by the user to automatically titrate (ie, start, stop, or adjust a stimulation protocol) a stimulation regimen according to monitored blood glucose levels, while in alternative embodiments the HMA may not use the relevant stimulation It should be understood that a therapy or protocol (eg, mild, optimal, strong, or complete cessation stimulation) is recommended to the user, and the accepted stimulation therapy or protocol is initiated when the user accepts the recommendation.

In some embodiments, the electrical skin patch device of the present disclosure is sized in the form of a skin patch covering both T6 and T7 dermatomes. In an alternative embodiment, the user may use a first electrical skin patch on T6 dermatomes and a second electrical skin patch on T7 dermatomes. In this case, the health care application treats obesity, overweight, eating disorders, metabolic syndrome and diseases of T2DM by stimulating the T6 and T7 dermatomes alternately. In some embodiments, the electrical skin patch devices herein are sized to cover both C8 and T1 dermatomes (as shown in FIG. 19C ). In an alternative embodiment, the user may use a first electrical skin patch device on a C8 dermatome and a second electrical skin patch device on a T1 dermatome. In this case, health care applications treat obesity, overweight, eating disorders, and metabolic syndrome by stimulating C8 and T1 dermatomes alternately. In various embodiments, a plurality of electrical skin patch devices of the present disclosure treat T6, T7, C8 and/or T1 dermatomes that are simultaneously or alternately stimulated for diseases of obesity, overweight, eating disorders, metabolic syndrome, and/or T2DM. used to cover

Various suggestions and recommendations automatically generated by the healthcare application for initial new stimulation protocols, pattern and parameter settings, as well as those associated with adjusting such stimulation protocols and settings, may, in various embodiments, be approved and advised by remote patient care facilities and/or personnel. It should be noted that the user can implement it only after However, in some embodiments, prior authorization of the remote patient care facility or personnel may not be required. The health care application allows users to set pre-approval options or disable them.

In some embodiments, the electric skin patch device is a stimulation algorithm with different stimulation parameters by first allowing the patient to lose excess weight and then maintain the weight loss to treat obesity, overweight, eating disorders, diseases of metabolic syndrome. is driven For example, in one embodiment, the patient is stimulated with a first stimulation algorithm to induce weight loss. When the patient reaches the target weight, the stimulation algorithm is changed to a second stimulation algorithm to maintain weight loss. In some embodiments, the total daily stimulation energy provided by the first algorithm to induce weight loss is greater than the daily total stimulation energy provided by the second algorithm to maintain weight loss.

Exemplary Stimulation Protocols for Managing Habituation, Nausea, Indigestion, and Skin Inflammation

Habituation refers to a decrease in sensory perception of a stimulus after providing it for a long period of time. In various embodiments herein, in order to overcome habituation, the stimulus intensity is increased or decreased gradually over the entire therapy session, contrary to prior art practice that requires the patient to manually increase or decrease the intensity periodically during the therapy session. designed to do This disclosure also learns how and how often to manually adjust the desired stimulus intensity to customize stimulus parameters that modify the stimulus to prevent habituation.

According to an exemplary embodiment, stimulus intensity (including pulse amplitude and/or frequency) increases or decreases arithmetic (ie, linearly) or geometrically (ie, exponentially) over time. It is noted that an increase in stimulation intensity always exceeds the user's 'sensory threshold' (already determined prior to a stimulation session) and a decrease in stimulation therapy is constrained so that the stimulation intensity does not fall below the 'sensory threshold'. For example, in the case of a geometric increase or decrease, the stimulus intensity is multiplied or divided by a fixed factor per unit time. For example, the stimulation intensity may be geometrically increased or decreased by a factor Z for every minute of the therapy session, where Z is, for example, 1.004. This is equivalent to about a 27% increase or decrease in stimulation intensity during a 60-minute therapy session. In various embodiments, 'Z' includes a 10% to 50% increase or decrease in any given parameter. In another embodiment, the stimulation intensity increases or decreases linearly by a fixed amount, such as 0.5 mA, every minute of the therapy session. In other embodiments, the rate of increase or decrease is adjusted to account for passive changes in stimulus intensity. For example, if a user reduces stimulation intensity during a therapy session, the auto-increase rate may be too high for this user and should be reduced in subsequent therapy sessions. Similarly, if a user increases stimulation intensity during a therapy session, the auto-increase rate may be too low for this user and should be increased in subsequent therapy sessions. In this way, the automatic habituation reward is adaptive and responsive to the user's physiology.

In a further embodiment, the stimulation continuity profile may be a step-up or step-down profile, the stimulation amplitude and/or frequency may increase or decrease on a per-session basis and/or the number of stimulation sessions per day may be a stimulation regimen to prevent habituation. or it may increase or decrease over the duration of the process.

In various embodiments, if the user feels nausea or indigestion before, during, and/or after the stimulation session, the user may provide input to the health care application that a nausea and/or indigestion event has occurred, which may indicate that the user's dynamic It is automatically time stamped and stored by the application to create and display wellness profiles or maps.

In a preferred embodiment, nausea and/or indigestion events that constitute a well-being parameter are recorded by actuating a button on the user's smartphone that functions as the companion device 105 of FIG. 1A . In some embodiments, the button is physical, such as a designated key on a smartphone, while in other embodiments, the button is virtual, such as a software-based icon on a smartphone. Activating a button (eg, by pressing a physical button or software icon) activates, in some embodiments, a light bar consisting of a 0 to 10 VAS (Visual Analog Scale), where 0 is nausea and/or or no dyspepsia (ie, highest level of well-being), and 10 indicates the most severe level of nausea and/or indigestion (ie, worst level of well-being).

The light bar VAS expands or progresses depending on the duration of time the user presses the button. In other words, the longer the user presses the button, the longer the light bar extends. In one aspect, the length or extent of the light bar VAS is indicative of the level or intensity of nausea and/or indigestion experienced. According to one embodiment, the threshold or minimum actionable nausea and/or indigestion level is set to 4 in the VAS. Thus, a light bar VAS length that exhibits a nausea and/or indigestion level of 3 or less (ie, 1, 2 or 3) does not trigger any action. However, a light bar VAS length that exhibits a nausea and/or dyspepsia level of 4 or greater is registered as a high intensity and therefore an actionable nausea and/or dyspepsia or negative wellness event.

As a result of an actionable nausea and/or dyspepsia event, a health care application may modify an existing stimulation protocol, e.g., if the nausea and/or dyspepsia intensity is between 7 and 9, the current strong stimulation protocol may be replaced by a weak stimulation protocol. It may be recommended to switch to Additionally or alternatively, the stimulus continuity profile may be converted to a step-down profile. Moreover, the health care application may recommend pausing the stimulation session for one or more days before resuming with a step-down stimulation protocol. In another embodiment, the health care application may recommend pausing the stimulation session as well as not allowing any rescue sessions for more than one day before resuming with a step-down stimulation protocol. For example, in one embodiment, any single nausea and/or dyspepsia event of intensity 10 on the VAS scale causes all subsequent therapy sessions to cease immediately and prompt the user to contact a physician. In another example, if a user records K numbers of nausea and/or dyspepsia events of between 4 and 6 intensities, within an L time period, the HMA may convert the stimulus continuity profile to a step-down profile. In another embodiment, for example, a cumulative actionable VAS score of 15 in the same week, ie a score of 4, 5, and 6 in combination, causes the health care application to terminate treatment. In another embodiment, any actionable cumulative score greater than 10 in the same week indicates that the health care application converts a baseline therapy session from 30 minutes to 15 minutes each (i.e., a total of 30 minutes x 3 day sessions = 90 minutes per day instead of 30 minutes per day). 15 minutes x 3 day sessions = 45 minutes per day). In this embodiment, if the frequency of these actionable nausea and/or dyspepsia events persists, therapy is terminated.

In various embodiments, the modification of an existing stimulation protocol is performed at night when the user is in bed. According to one aspect, the HMA not only allows the user to enter and record nausea and/or indigestion events, but also allows the user to enter additional information such as event duration and GUI screen display to the user, nausea and/or indigestion. After a predetermined period of time has elapsed since the recording of the event, it is possible to check and record whether the user is still feeling the same. If the user reports that they still feel nausea and/or indigestion after a predetermined period of time, the HMA prompts the user to see or contact the doctor and also to send a notification to the user's doctor or remote care facility.

According to an exemplary embodiment, the electrical skin patch device of the present disclosure generates a two-phase, symmetrical, rectangular pulse with a modulated current. This pulse waveform is charge balanced to prevent iontophoretic build-up under the electrode, which can cause skin irritation and potential skin damage. According to another exemplary embodiment, the EDP device generates a two-phase asymmetric charge balance pulse with a regulated current. Thus, in various embodiments, the EDP device generates pulse-to-pulse inverted symmetric or asymmetric, two-phase, charge balanced pulses. Modulated current pulses provide more stable stimulation than modulated voltage pulses because the stimulation current is generally independent of the electrode-skin impedance changing over the course of a therapy session. To address different skin types and electrode qualities (due to repeated use and air exposure), the maximum output voltage is 100V and the maximum output current is 50mA. Finally, the pulse pattern is a continuous stimulus with randomly varying interpulse spacing such that the stimulation frequency has a uniform probability distribution between 50 Hz and 150 Hz. Alternatively, the frequency of the stimulus may have a Gaussian probability distribution between 50 Hz and 150 Hz or some other probability distribution. An advantage of providing frequency stimulation at randomly varying interpulse intervals (as opposed to frequency stimulation at constant interpulse intervals) is that the latter type of stimulation may induce less neural habituation.

Another embodiment comprises repositioning the electrical skin patch device from a first point of stimulation to a second point of stimulation and alternating between the first and second points of stimulation to avoid habituation, skin irritation, nausea and/or indigestion. may include

According to some embodiments, the stimulus sensation experienced by the user is modulated by modifying the waveform of the transmitted pulse without modifying the pulse amplitude by more than 10%. Thus, in an embodiment, the EDP device delivers an electrical stimulation of, for example, a two-phase current and an amplitude of 20 mA having a first waveform, wherein the first waveform is a ramp waveform 5905 as shown in FIG. 59A . . It should be understood that while the first waveform may provide a user with a comfortable and therapeutically effective sensory stimulus, it may not be therapeutically effective or may be below the “sensory threshold” for other users. In accordance with aspects herein, rather than substantially increasing the amplitude of the stimulus that may increase the risk of nausea, indigestion and/or habituation, the waveform of the electrical stimulation is modified to a second waveform, wherein the second waveform is It is a square wave 5910 as shown in 59b.

Accordingly, in one embodiment, the first pulse shape is modified to the second pulse shape in response to determining that the stimulation comprising the first pulse shape is not sufficiently therapeutically effective. By modifying the slope function of the first pulse shape without modifying the total pulse amplitude by more than 30%, preferably by 20% or less, more preferably by 10% or less, the first pulse shape is changed to the second pulse shape. is modified to In another embodiment, the first pulse shape increases the rate of increase from the minimum pulse amplitude to the maximum pulse amplitude, increases the rate of decrease from the maximum pulse amplitude to the minimum pulse amplitude, and/or the pulse is maintained at the maximum pulse amplitude. By extending the time, it is modified to the second pulse shape.

For an exemplary test environment, Table W shows that two electrodes (one embodiment of an EDP device herein) were placed in series with the patient's skin/abdominal impedance using a MetroOhm AutoLab PGSTAT128N electrochemical workstation. A plurality of skin impedance magnitudes obtained by connecting are shown. Next, an electrode attached to the patient's abdomen was connected to the stimulator of one embodiment of the EDP device herein programmed with an asymmetric two-phase charge balance waveform. As shown in Table X, the regulated current output was set to various values using a frequency of 20 Hz and a pulse width of 200 μs, and a compliance voltage waveform was obtained on an oscilloscope.

table W

table X

As shown in Table X, a maximum peak compliance voltage of about 40 volts was obtained at a current of about 16 mA. The waveform for the 20 mA setting is illustrated as a first waveform 5905 in FIG. 59A. Further increasing the nominal current setting did not increase the peak voltage beyond 40 volts (since this was the maximum compliance voltage of the stimulator used). However, as the nominal current setting was increased, the leading voltage edge became steeper, producing a more 'spherical waveform' illustrated by the second waveform 5910 in FIG. 59B . This increased the sensation of stimulation for the user by applying more charge to the user (ie, the area under the curve) and/or by making the initial rise of the current waveform steeper, which minimizes the accommodative effect.

In some embodiments herein, the inverted waveform is alternated every pulse to ensure balanced charge while changing the leading edge time constant (ie, slope). The 'slope waveform' 5905 is characterized by a rate of increase from a minimum amplitude to a maximum amplitude less than that of the 'square waveform' 5910 and/or a rate of decrease from the maximum amplitude to a minimum amplitude less than that of the 'square waveform' 5910 It should be noted that The two waveforms 5905 and 5910 have the same peak compliance voltage, but different time constants for the rising phase, resulting in different stimulus levels perceived by the user. Accordingly, if the waveform is modified from the first waveform to the second waveform, the stimulus sensation for the user is increased. In embodiments, modulation or titration of the waveform may be performed in response to a user's input to the VAS hunger scale. In other words, if the user's VAS hunger scale shows no increased or altered hunger levels after at least one stimulation session using the stimulus with the first waveform, but still shows a high hunger level, the stimulation waveform is automatically (after user approval) or the user is manually modified to the second waveform. In various embodiments, the slope of the stimulation pulse waveform gradually decreases from a substantially 'slope' waveform to a less sloped or substantially 'spherical' waveform. In some embodiments, this waveform is modified from a 'slope' waveform to a less sloped or 'square' waveform without modifying the pulse amplitude by more than 10%.

Placebo Stimulation Protocol for Psychotherapy

In accordance with some aspects herein, the HMA programs the EDP device to deliver placebo stimulation to the user in lieu of or in addition to an actual stimulation session. Placebo stimulation refers to creating the perception of a stimulus to control the user's psychology without actual electrical stimulation treatment. In embodiments, placebo stimulation creates a psychological 'feel' in the user of receiving stimulation treatment, leading to a positive therapeutic effect (also referred to as the "placebo effect" or "placebo response").

In various embodiments, to create a placebo effect, the EDP device vibrates with an amplitude and/or frequency perceptible to the user, blinking an LED during the therapy session to give the user a feeling that a therapy session is in progress. , generating an auditory intonation or sound, generating a verbal message to give the impression that therapy is being delivered.

It should be understood that, in various embodiments, placebo stimulation sessions may be interleaved with actual electrical stimulation sessions.

increment or residual therapy benefits (latent effects), therapy vacation and maintenance therapy

In accordance with aspects herein, a user's stimulation therapy program or cycle delivered using an EDP device embodiment herein comprises a plurality of steps or stages:

The first therapy phase is a period of time during which a pre-programmed and customized and/or on-demand stimulation session is delivered to the user. The first therapy phase is characterized by the fact that the user has a first (baseline) metabolic or health state at the beginning of the first therapy phase and a second metabolic or health state at the end of the first therapy phase. The first metabolic or health state is a quantitative value of only one parameter of a patient's metabolic or health state, a quantitative value of a subset of all parameters defining a metabolic or health state, or a quantitative value of all parameters defining a metabolic or health state. It can be determined in relation to a value.

The first therapy phase may last for a period of time ranging from days, weeks to months to achieve a second metabolic or health state that is an improved or fully cured metabolic or health state compared to the user's first metabolic or health state. is the active treatment period. In embodiments, achieving the second metabolic or health state comprises achieving one or more underlying therapeutic goals that define the metabolic or health state, such as, but not limited to, target weight loss and/or target blood glucose levels. In an embodiment, the end of the first therapy phase a) achieves at least one or a subset or combination of therapy goals underlying the user's metabolic or health condition (see the definition of "metabolic or health condition" earlier herein). and/or b) by the user completing a predetermined number of stimulation sessions (eg, 3 sessions over 3 separate days) during a predetermined therapy time period (eg, 3 months or 6 months). is displayed

The second therapy phase (which begins at the end of the first therapy phase) does not deliver any stimuli to the user, but the user still continues to receive incremental treatment or residual benefits (also referred to as 'delayed effects') from treatment in the first therapy phase. It is a period of time to possess or enjoy. In other words, as long as the stimulation session is interrupted and the user continues to maintain the second metabolism or health state even if the user is on therapy leave, or the user's second metabolism or health state does not deteriorate by more than 15% during the second therapy phase. No change. That is, the at least one therapy goal achieved (at the end of the first therapy phase) that defines the metabolic state is not lowered by more than 15%. In embodiments, the second phase of therapy may extend over days, weeks, or months.

In some embodiments, the second therapy phase may be extended for a period of time less than, equal to, or greater than the first therapy phase or treatment period without degrading by more than 15%. For example, if during the first therapy phase the user is stimulated for a minimum period of time, for example at 5 mA per session for at least 15 minutes each time (or preferably at 20 mA per session for 30 minutes each time) over 3 days. After three stimulations, improvement of the therapy goal, such as delayed gastric emptying (e.g., 10% delay in gastric emptying after stimulation therapy compared to delayed gastric emptying before stimulation therapy), continues for at least one day after terminating stimulation .

60 shows a graph comparing a therapy goal, such as % TBWL, achieved using the EDP device herein for 3 months, to % total body weight loss (% TBWL) achieved using gastric balloons for 6 months. Referring to FIG. 60 , a first %TBWL value 6005 is achieved over 6 months using a gastric balloon as a first diet regime and a first lifestyle (ie, a specific exercise intensity), and a second % A TBWL value (6010) was achieved using a gastric balloon for 6 months with the second diet regime and second lifestyle, whereas a third %TBWL value (6015) was achieved using the first diet regime and lifestyle (and gastric balloon). is achieved using ).

A first histogram 6020 illustrates the %TBWL values achieved using a first stimulation protocol lasting over 3 months and combined with a first diet regime and a first lifestyle, and a second histogram 6025 shows that While illustrating %TBWL values achieved using a second stimulation protocol that lasted over 3 months and combined with a first diet regime and a first lifestyle, a third histogram 6030 lasted more than 3 months and The %TBWL values achieved using a second stimulation protocol combined with two diet regimes and a second lifestyle are illustrated. In other words, the %TBWL values represented by the first, second and third bar graphs 6020, 6025, 6030 are achieved at the end of the 3-month period (first therapy phase).

A fourth histogram 6035 shows a comparison of the first histogram 6020 and associated %TBWL values achieved using a first stimulation protocol lasting over 3 months and combined with a first diet regime and first lifestyle. Illustrating the %TBWL values maintained at the end of 3 months after termination of stimulation (i.e., at the end of the second therapy phase), the fifth histogram 6040 lasts at least 3 months, and the first diet regime and the first Maintained at the end of 3 months after terminating stimulation (i.e., at the end of the second therapy phase) compared to a second histogram (6025) and associated %TBWL values achieved using a second stimulation protocol coupled with lifestyle While illustrating %TBWL values obtained, a sixth histogram 6045 is a third histogram 6030 achieved using a second stimulation protocol lasting over 3 months and combined with a second diet regime and a second lifestyle. ) and associated %TBWL values exemplified at the end of 3 months after termination of stimulation (ie, at the end of the second therapy phase).

As can be observed from Figure 60, a) 70% to 90% of the %TBWL values achieved during the first therapy phase were prolonged or maintained during the second therapy phase, and b) the % achieved using stimulation therapy. The TBWL values were comparable to the corresponding %TBWL values achieved using the gastric balloon.

In various embodiments, the end of the second therapy phase is indicated by the user's metabolism or health state returning to a third metabolism or health state, wherein the third metabolism or health state is 15% greater than the second metabolism or health state. lower than the excess. However, in some embodiments, the third metabolic or health state may be equivalent to the user's first or baseline metabolic or health state.

Thus, in one embodiment, after a first phase of treatment with one of the aforementioned stimulation protocols, wherein the first phase lasts for any of 1 to 6 months, preferably 3 months, the patient % to 15%, preferably 6% to 10% of the total body weight is lost. After the stimulation has ceased and the time of the second phase (eg 1 to 6 months, preferably 3 months) has elapsed, the percentage of total body weight lost is between 2% and 14%, preferably between 5% and 9%. % range.

The third therapy phase (which begins when the second therapy phase ends) is a period of time during which stimulation treatment is resumed in the user as part of a maintenance regimen. The goal of maintenance therapy is that either the user continues to stay or maintain the second metabolic or health state (if the user is in the second metabolic or health state at the end of the second therapy phase) or (when the user ends the second therapy phase) To ensure that the second metabolism or health state is re-achieved and then maintained). Maintenance therapy may include a lower level of stimulation energy or intensity (eg, fewer stimulation sessions per week and/or or lower amplitude stimulation sessions). In embodiments, the third phase of therapy may be extended over several weeks or months.

The EDP-based methods and systems herein are capable of delivering stimulation therapy to a patient over an extended period of time (weeks to months) with exceptionally high patient compliance with a regimen, while simultaneously reducing the risk of habituation, nausea and/or indigestion. It should be understood that undesirable effects can be effectively avoided and managed. Due to the high adherence to treatment during prolonged treatment periods, the patient's metabolic or health status is continually reset to a better condition throughout the first phase of therapy, eventually leading to a second metabolic or health status. As a result, even if stimulation is discontinued at the end of the first phase of therapy, the patient remains in the second phase of therapy from a second metabolic or health state achieved due to the cumulative or latent effect (or 'neurostimulation lasting effect') of the stimulation therapy. continue to benefit therapeutically. Thus, the patient can take a vacation from treatment during the second-line therapy phase, further eliminating the tendency to habituate to stimuli while the patient rests from the normal routine of treatment.

After treatment leave, ie during the third therapy phase, stimulation at lower levels of delivered energy is recommended to maintain metabolic resetting without risk of habituation. In various embodiments, maintenance therapy over an extended period will proceed through a combination of therapy leave and maintenance stimulation (low level stimulation intensity or energy). Inputs to long-term maintenance therapy can be obtained from ongoing patient diaries (eg, daily weight, hunger, well-being).

In accordance with aspects herein, a stimulation therapy program or cycle comprising first, second and third therapy phases is administered, controlled and executed by the HMA via reminders, prompts and stimulation sessions with subscription billing options. For example, in some embodiments, if at least one therapy goal, such as weight loss, has been achieved, or a certain predetermined number of stimulation sessions have been completed during a predetermined therapy time period (eg, 3-6 months), the HMA a) automatically cease stimulation (in the second therapy phase) so that the patient's body can eliminate the habituation effect, and b) the renewal cost (possibly in the third therapy phase) for the user to initiate maintenance therapy (in the third therapy phase). less than the fee required during phase 1 of therapy).

How to use

According to various aspects herein, a user may apply or use the electrical skin patch device of the present disclosure with active, regular, periodic, no intervention, and/or minimal intervention, and is responsible for prescribing the EDP device and monitoring the therapy. may be monitored and managed by a physician, dietitian, weight loss clinician, or remote patient care facility (hereinafter referred to as a third-party manager (TPM)).

In some embodiments, the user visits the doctor for only one session, where, depending on the user's medical condition, the doctor removes 10 pieces of the dermis from the outer surface of the epidermal layer of the patient, as described with reference to FIGS. 1A-1C . It is possible to prescribe the electric skin patch device of the present disclosure to the user along with the stimulation configuration of the electric skin patch device through mm or 20 mm. In some embodiments, the user visits the TPM for a health check-up or evaluation, wherein, depending on the user's medical condition, the TPM is directed to the dermis from the outer surface of the epidermal layer of the patient, as described with reference to FIGS. 1A-1C . The electric skin patch device of the present specification can be prescribed to the user along with the stimulation configuration of the electric skin patch device through 10 mm or 20 mm.

In various embodiments, the depth of stimulation through the epidermal layer of the patient is between 0.1 mm and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 mm or any increments therein.

In some embodiments, the user's need for EDP device therapy is determined based at least on his or her current BMI for appetite control. For example, EDP device therapy is recommended if the user's current BMI exceeds a BMI threshold in the range of 20 to 25, preferably greater than or equal to 25. Alternatively or additionally, the TPM may utilize, for example, the user's SNAQ score to assess whether the user is anorexia or anorexia. If so, the TPM may not recommend EDP device therapy to the user. Similarly, if a user's BMI is less than 20, EDP device therapy may be considered not ideal for the user. In other words, the TPM evaluates the user's medical condition to ensure that the user is benefiting from and not harmed by stimulation therapy.

During the session, the physician or TPM then allows the user to identify the appropriate stimulation area, e.g., T6, C8 and/or T1 dermatomes for obesity, overweight, eating disorders, diseases of the metabolic syndrome, and T7 for T2DM management Helps or directs the identification of dermatomes, and also provides orientation to the user regarding the use and function of the electrical skin patch device. In various embodiments, an appropriate area of stimulation may be identified, for example, by one or more temporary tattoos (eg, small dots) or an image of the user may be taken with a mark or icon representing an appropriate area on the user's body. 17D is a flow diagram listing steps involved in a method of identifying an appropriate placement location for an electrical skin patch on a user's anterior chest surface in accordance with an embodiment herein. At step 1732, with the user preferably standing, the TPM looks for the user's midclavicular line. The TPM then proceeds downward from the midclavicular line to the bottom rib of the user's rib cage at step 1734. From the bottom rib, in step 1736, the TPM moves down 2 cm to identify a placement point. At step 1738, the TPM places the top central portion of the electrical skin patch at the placement point.

During the session, the doctor or TPM may further assist the user to download a health care application to the user's computing device, such as a smartphone, tablet, PDA, laptop, computer, and demonstrate pairing or synchronization of the application with the user's computing device. . A user may now or in the future allow a health care application to communicate with a physician or remote patient care facility.

In alternative embodiments, no intervention of a physician or TPM may be required for initial setup and orientation of use of the electric skin patch device. In this embodiment, the user simply purchases the electrical skin patch device that comes with a compact disc containing detailed audiovisual instructions showing usage, application download instructions, functions, and identification of the appropriate stimulation area. Additionally or alternatively, the audiovisual instructions may also be made accessible to users through a dedicated website hosting a web version of the health care application.

In some embodiments, the HMA also includes a device placement function that enables identification of an appropriate location on the user for placement of the EDP device. In one embodiment, when the HMA is installed in the user's smartphone (consisting of an interlocking device), the device placement function provides an identification mark or icon on the user's body while photographing the user's torso with the user's smartphone. It works by overlaying the image. Thus, when the TPM activates the device placement function (eg, by activating an icon on the user's smartphone), the TPM stands at a predetermined distance (eg, 20 inches) from the user's torso and holds the smartphone's camera. Activate to instruct the user to view an image of the user's torso. Overlay marks, icons, or dots on the image while visible on the body. The device placement function captures and stores the image to be overlaid, and the TPM uses it to place a temporary tattoo on the user. When the device placement function or feature is activated again, the position of the tattoo can be compared to the overlay. Whenever it is necessary to review the placement of the EDP device, the device placement function is activated, which displays the stored image with an overlay, preferably with an overlay for the contours of the nipple and umbilicus.

The HMA also enables the TPM to be associated with the user's EDP. To enable this association, in some embodiments, the TPM is presented with a GUI, and the TPM, for example, enters a unique code that associates the user, and thus the user's EDP device, with the TPM. The TPM then pairs or synchronizes the user's computing device with the user's EDP device. By associating or linking the user with the TPM, the TPM can receive and access progress reports related to the user's health-related information and various therapy goals on a regular basis, in real-time or near-real time, to make appropriate adjustments to stimulation protocols and parameters when needed. or may be titrated; A number of functions may be possible, including, but not limited to, the TPM's ability to remotely disable and re-enable EDP devices when needed.

The TPM now configures, sets or programs the stimulation protocol and parameters for the therapy. According to various embodiments, the TPM configures the stimulation regimen to be established as a standard or baseline stimulation protocol in the absence of the user's initial health-related data. As previously discussed, in one embodiment the standard or baseline stimulation protocol (also referred to as the 'default mode of operation') is set up with three stimulation sessions per day of 30 minutes each with a pulse amplitude of 20 mA. Each of the three stimulation sessions per day is started 30 to 60 minutes before, preferably 45 minutes before meal times, for example breakfast, lunch and dinner. As therapy progresses, the TPM periodically adjusts the baseline stimulation protocol or pattern based on the user's health-related information and the HMA's recommendations.

In another preferred embodiment, the baseline stimulation regimen or protocol is a pulse of 20 mA at 15 minutes and postprandial time, respectively, with a pulse amplitude of 20 mA at the preprandial time just before the start and at the completion of each meal, such as breakfast, lunch, and dinner. Three stimulation sessions per day of 60 minutes each with an amplitude are set up. In other words, the baseline stimulation modality or protocol consists of 3 x 1.25 hours = a total of 3.75 hours (15 minutes before and 60 minutes after each meal). In some embodiments, the baseline pulse amplitude ranges from 5 mA to 10 mA allowing for a total stimulation duration of greater than 3.75 hours. In various embodiments, these preprandial and postprandial stimulation sessions are manually triggered by the user. In various embodiments, the HMA generates reminders or prompts for the user to manually trigger preprandial and postprandial stimulation sessions. In some alternative embodiments, the pre- and post-prandial stimulation sessions are automatically triggered based on a pre-stored meal time schedule. In some alternative embodiments, the postprandial stimulation session detects an eating event by a swallow detection device, such as device 5605 of FIG. 56, or uses a plurality of data (representing the user's eating gesture) captured by an accelerometer. is automatically triggered by detecting a feeding event by the feeding moment recognition method (FIG. 58) implemented by the HMA, where the accelerometer is either on a wristband such as band 2105 of FIG. 21A or wristwatch 2106 of FIG. Wrist watch included.

The TPM also configures rescue protocols and parameters for allowable rescue sessions. Configurable rescue protocols and parameters include the minimum number of rescue sessions allowed per day, duration, and stimulus intensity. The TPM may also program the rescue session based on triggers such as, but not limited to, the user's energy balance. For example, if the user's energy balance is positive and exceeds a predetermined threshold, one or more rescue sessions are triggered to occur in addition to a standard stimulation regimen or schedule.

According to various embodiments, the TPM allocates a total energy budget to alternatively or additionally planned or scheduled therapy sessions (eg, some part of a standard or baseline stimulation protocol) and rescue sessions (ie, unscheduled on-demand sessions). to program the stimulation protocol and parameters. In various embodiments, the total energy budget may be distributed between the planned therapy session and the rescue session according to the daily total rescue budget (described previously herein). In various embodiments, the total energy budget is measured in Joules. The TPM may distribute the total energy budget allocated over the time period. In other words, the TPM programs the stimulation therapy by applying to the user the total amount of energy (in the form of stimulation) that is distributed over the duration of the therapy time. The TPM has the flexibility to program or distribute the allocated energy budget in any manner suitable for the user, for example, 40 mA stimulation for 23 hours or 10 mA stimulation per day for 30 minutes a day. According to various aspects, the following constraints apply to the flexibility of the TPM in distributing the total energy budget allocated over a period of time:

사용자는 반드시 주당 할당된 총 에너지 예산의 특정량('에너지 입력'이라고도 함)을 받아야 한다. 다양한 실시예에서, 주당 최소 에너지 입력은 주당 한번 1분의 5㎃ 자극이고, 주당 최대 에너지 입력은 24시간 기간 동안 50㎃의 일정 자극을 구성한다. 따라서, 6개월 또는 180일의 전체 요법 사이클에 대해 최대 에너지 입력은 50㎃ x 하루 24시간 x 180일이다.

Users must receive a certain amount (also called 'energy input') of their total energy budget allocated per week. In various embodiments, the minimum energy input per week is a 5 mA stimulus once per week, and the maximum energy input per week constitutes a constant stimulus of 50 mA over a 24-hour period. Thus, for a full therapy cycle of 6 months or 180 days, the maximum energy input is 50 mA x 24 hours per day x 180 days.

허용된 구조 세션에서 사용자에게 전달되는 에너지의 양은 계획된 요법 세션(예를 들어, 표준 또는 기준선 자극 프로토콜의 세션)의 에너지 양의 2배보다 커서는 안 된다. 일부 실시예에서, 허용된 구조 세션의 에너지 양은 계획된 요법 세션의 에너지 양의 5% 내지 200% 범위이어야 한다.

The amount of energy delivered to the user in an allowed rescue session should not be greater than twice the amount of energy in a planned therapy session (eg, a session of a standard or baseline stimulation protocol). In some embodiments, the amount of energy allowed in the rescue session should be in the range of 5% to 200% of the energy amount of the planned therapy session.

바람직하게는, 구조 세션과 계획된 요법 세션은 미리 정해진 오프 시간 기간으로 분리된다. 일부 실시예에서, 미리 정해진 오프 시간 기간은 세션(구조 또는 계획된 치료)에서 Z분의 자극마다 적어도 10% x Z분의 오프 시간(즉, 자극 없음)이 필요하도록 정해진다.

Preferably, the rescue session and the scheduled therapy session are separated by a predetermined off time period. In some embodiments, the predetermined period of off time is such that for every Z minute of stimulation in a session (rescue or planned treatment), at least 10% x Z minute of off time (ie, no stimulation) is required.

구조 세션과 계획된 요법 세션이, 연속적으로 발생하는 경우, 전체 치료 사이클에 대해 할당된 총 에너지 예산의 위반을 야기하는 과도한 양의 총 에너지 입력이 사용자에게 발생해서는 안 된다. 따라서, 예를 들어, 사용자가 계획된 요법 세션 직전에 구조 세션을 요구하는 경우 HMA는 a) 요구된 구조 세션을 예정된 또는 계획된 요법 세션으로 대체하는 것, 즉 계획된 요법 세션을 예정대로 계속하는 동안 요구된 구조 세션이 허용되지 않는 것, b) 요구된 구조 세션을 시작한 다음 계획된 요법 세션으로 이동하지만 필요한 경우 계획된 세션을 자르고, 전체 요법 사이클에 할당된 총 에너지 예산이 위반되거나 초과되지 않도록 하는 것 중에서 선택하도록 프로그래밍되거나 구성된다. 구조 세션이 계획된 요법 세션과 오버랩하면 계획된 요법 세션이 앞으로 이동되어 두 세션이 미리 정해진 오프 시간 기간 이상으로 분리된다. 마찬가지로, 구조 세션이 계획된 요법 세션과 오버랩하지 않는 경우 구조 세션(구조 및 계획)이 미리 정해진 오프 시간 기간 이상으로 분리되어 있으면 구조 세션이 허용될 수 있다. 그러나, 모든 경우에, 사용자에게 입력되는 총 에너지는 할당된 총 에너지 예산을 초과할 수 없다.

When the rescue session and the planned therapy session occur consecutively, the user must not experience an excessive amount of total energy input that would result in a violation of the total energy budget allocated for the entire treatment cycle. Thus, for example, if a user requests a rescue session immediately prior to a scheduled therapy session, the HMA may a) replace the requested rescue session with the scheduled or scheduled therapy session, i.e., while continuing the scheduled therapy session as scheduled. Rescue sessions not allowed, b) start the requested rescue session, then move on to the planned therapy session, but cut the planned session if necessary, and ensure that the total energy budget allocated for the entire therapy cycle is not violated or exceeded. programmed or configured. If the rescue session overlaps the planned therapy session, the planned therapy session is moved forward, separating the two sessions by more than a predetermined off time period. Likewise, a rescue session may be allowed if the rescue session (rescue and planning) is separated by more than a predetermined off time period, provided that the rescue session does not overlap with the planned therapy session. However, in all cases, the total energy input to the user cannot exceed the allocated total energy budget.

Once the TPM completes programming or configuration of the stimulation protocol and parameters, the HMA confirms that the configuration is successful, and the EDP device also provides, for example, vibration, audible and/or visual indications (e.g., flashing a specific color LED). to confirm successful configuration. In some embodiments, the TPM may also prescribe a low calorie plan diet for the user. In various embodiments, a first scheduled therapy session is delivered to the user at the TPM's office or clinic to ensure that the stimulation parameters are helpful to the user. For example, in a baseline stimulation protocol, a 30-minute or 60-minute session is delivered to the user. If the user feels okay after the first session, the user can continue the therapy at home. However, if the user complains of discomfort such as nausea or reports deterioration in well-being, the TPM reprograms the stimulation protocol and parameters, for example by lowering the intensity, duration, number of stimulation sessions per day and/or total energy budget. .

The user continues the TPM construct stimulation therapy at home. At home, the user may take off the EDP device for a period of time and then forget to put on the EDP device for the next scheduled therapy session. The impedance or bioimpedance sensor of the EDP device is used to detect and verify the contact integrity of the EDP device electrode and the tissue to be stimulated to detect whether the user is wearing the EDP device. In some embodiments, when the impedance or bioimpedance measurement detects that the user is not wearing the EDP device, the EDP device and/or the companion device implementing the HMA, such as a smartphone, smart watch, or smart band, , generates a vibratory, audible and/or visual (eg blinking LED) alert that repeats at periodic intervals until the user puts on the EDP device. If the user wears the EDP device as indicated by the impedance measurement, it is also determined whether the user has been exposed to water while the user is moving, for example in the shower, swimming or in the rain. At least one of an impedance, humidity and temperature sensor included in the EDP device is utilized to determine whether a person and/or the EDP device has been exposed to water. When the user and/or the EDP device is exposed to water, the EDP device automatically turns off and all stimulation ceases.

According to one embodiment, the HMA uses an EDP device and/or a companion device (e.g., smartphone, smart watch, smart band) at least 30 minutes prior to the scheduled stimulation session to provide vibration, auditory and/or visual (e.g., For example, the LED blinks) to generate an alarm or reminder. According to one embodiment, the HMA generates a vibratory, audible and/or visual (eg blinking LED) alert or reminder at least 60 minutes prior to the scheduled stimulation session. This advance reminder allows the time required to pick up and put on the EDP device if the user takes it off. Thus, in some embodiments, an alert or reminder is linked to the user's stimulation session schedule and prompts the user to a required time (eg, 60 minutes) prior to the scheduled session to ensure that the user wears the EDP device on time. It is programmed to remind you. Accordingly, in one embodiment, the smartphone includes a plurality of programmatic instructions to automatically set an alarm for a predetermined period of time, such as 120 minutes to 5 minutes and any increments therein prior to the scheduled stimulation session. An alarm, which may be visual, auditory and/or vibratory, and may be delivered via a smartphone or the EDP itself, communicates to the patient the need to wear the EDP to conduct a stimulation session.

However, the user's first stimulation session on this day may be scheduled later than breakfast time, in which case the reminder may alert the patient after the patient leaves for work that day (probably left the EDP device at home). To address this scenario, in some embodiments, the first alert or reminder of the day is linked with the user's breakfast programmed according to the user's wake-up schedule. For example, in one embodiment, the first alert or reminder of the day is a smartphone (associated device) to trigger a reminder (to wear an EDP device) within 0 to 60 minutes after the user's wake-up alarm sounds. Links to the user's alarm clock in . Thus, in some embodiments, the first alert or reminder for this day is linked to the user's wake-up schedule, while the remaining alerts or reminders for the day are linked to the user's schedule of the stimulation session.

According to another aspect, the EDP device is programmed to alert the user prior to initiating a stimulation session. In some embodiments, for example, the EDP device generates a low intensity stimulus or vibration as a ready signal to alert the user prior to applying the full therapy stimulus. This prevents the user from being startled by the sudden stimulus occurring. According to another aspect, the EDP device is switched off or deactivated upon detecting that the user's skin temperature rises above the threshold temperature within a predetermined time period to protect the user from skin burns.

As the user continues to use the EDP device at home, stimulation parameters and protocols for both the planned session and the rescue session are adjusted based on the user's plurality of health-related information generated as a result of the EDP device use. According to one aspect, the TPM may intervene periodically by monitoring the user's health related information and resetting or reprogramming the EDP device and HMA. Thus, while the HMA is configured to automatically adjust or titrate stimuli based on the user's health-related information, wellness score, and/or rescue session, in various embodiments the TPM may remotely (with or without user's consent) remotely at any time. HMA can be replaced and reprogrammed. Additionally, in accordance with some aspects, the unique code of the TPM allows the user to apply stimulation therapy only for a predetermined period of time, such as in the range of several days to four weeks. At the end of a predetermined period of time, the HMA may turn off the EDP device and thus interrupt therapy and return to the TPM to the user (if necessary) for evaluation, adjustment, feedback and/or consultation of stimulation protocols and parameters, before stopping therapy and resuming therapy. You may be prompted to contact us.

According to various embodiments, as previously discussed herein, all time-stamped hunger items or events (whether planned or unplanned), intensity levels, and triggered rescue sessions are the user's individualized hunger. Tracked (date and time stamped including the duration of each rescue session) and recorded (eg, via light bar VAS) to create a profile or hunger map. In some embodiments, the user's personalized hunger map is in the form of a scattergram or heat map. The scattergram maps and displays a plurality of icons or dots of different colors, where each dot corresponds to a hunger event, and the color of the dot corresponds to a hunger event and represents the recorded hunger intensity level. Where rescue sessions or dots exhibit a pattern of hunger or hunger spikes, for example, a large number of high-intensity hunger dots over a certain period of time (eg, 5-7 days) to several weeks (eg, 3 When meeting at specific times of the day (ranging from weeks to 6 weeks)), the HMA and/or TPM can customize, modify, drive and deliver stimulation regimens or protocols to target the user's hunger spikes.

According to various embodiments, the TPM programs the HMA for surveys that are provided to the user and filled out to the user each day during the therapy period. The TPM programs the HMA to present the survey to the user according to the user's preferred or desired time of day or time window. For example, a user may want the survey to be displayed within a time window between 5:00 PM and midnight each day. Thus, the HMA informs and presents the survey to the user within the desired window of time. The user can participate in the survey or defer the survey to a later time. Users can also request a survey at any time (outside of their preferred time). In various embodiments, the survey allows the user to summarize, enter, and record health-related information, including at least the day's hunger, appetite, exercise and well-being level. Scores representing degrees of appetite, exercise, hunger and well-being are recorded via the respective light bar VAS or via the GUI screens of FIGS. 11 , 12 , 13 and 16 respectively. Users can also enter and record the total calories consumed on this day. It should be understood that surveys persuade users to at least regularly provide data related to hunger, appetite, exercise, well-being and calorie levels consumed.

Thus, surveys serve to guard against scenarios in which users may not themselves motivate themselves to record their health-related information on a regular basis. In practice, the user may not feel the need for a rescue session and may not exhaust the total daily rescue budget. In this case, it is also not possible to generate an individualized hunger map of the user and determine the stimulus modulation as the therapy progresses. The need to record hunger levels within a survey protects the scenario where the user does not require a rescue session.

According to various aspects, the HMA ensures that a user responds to a survey. Thus, in some embodiments, if the user does not respond to the survey, the user is continuously, repeatedly, or periodically alerted to fill out the survey. The alert may be vibration, audible and/or visual (eg blinking an LED) generated by the EDP device and/or the user's smartphone (acting as a companion device). In some embodiments, a user may only resolve an alert by responding to a survey. In some embodiments, if the user does not respond to the survey for a predetermined period of time, such as 1, 2, 3, 4, 5, 6, or 7, or any number of days or increments therein, the EDP device is turned off or Either disabled or the TPM can remotely disable the EDP device and is only re-enabled by the TPM. The TPM may remotely reset or reactivate the EDP device by entering or providing a reactivation code to the user based on the conversation with the user.

The TPM's ability to remotely disable and re-enable an EDP device is dependent on whether the user's recorded health-related information (via surveys) may indicate that the user has lost too much weight, such as, but not limited to, frequent recurring high levels of nausea. It is understood to be advantageous even in scenarios where there is a possibility of some harm (if therapy is continued in the current state).

The TPM is scheduled during therapy when needed, for example, during initial setup of the EDP device and/or based on information provided by the user via a survey or based on the user's individualized hunger and/or wellness map or profile. Allowed by the HMA to establish or reconfigure various thresholds, ranges, protocols and parameters associated with therapy sessions and rescue sessions. For example, the TPM may configure and reconfigure thresholds to determine when an unplanned hunger event is considered actionable and when a nausea and/or indigestion event is considered actionable. The TPM can also construct and reconstruct what happens when actionable unplanned hunger and nausea (and/or indigestion) events occur. Thus, the TPM ramps down the stimulus if the user records a single nausea and/or dyspepsia event of intensity 9 followed by fewer nausea events of intensity 6 or 7 (e.g., 2-3 times). The HMA can be programmed to do this. The TPM can also program the HMA to ramp down the stimulus to counter habituation or fatigue. Thus, after a predetermined period of time (e.g., 3 to 12 weeks - configurable in the TPM), the HMA initiates an anti-habituation temporary rampdown (e.g., through a decrease in amplitude, frequency, and/or session duration). can be configured to start. Alternatively, the TPM may configure the HMA to stop stimulation therapy for a period of time and then restart it.

Since the TPM is associated with the user's EDP device, via a unique code entered by the TPM during the initial setup or configuration of the EDP device for the user, the TPM will periodically or periodically, daily, weekly, or TPM to retrieve the user's health-related information. Receive at any other period that can be customized from In various embodiments, the user's health-related information may be transmitted and stored in a cloud-based data center, and the TPM may be notified or the information may be sent directly to the TPM. A user's health-related information includes, at a minimum, the user's weight, appetite, hunger, exercise, score related to well-being (wellness profile including recorded nausea and/or indigestion events), values related to calories consumed, and individualized hunger profile (recorded). unplanned hunger events and delivered results of rescue sessions). In some embodiments, the TPM additionally or alternatively receives a composite score associated with and derived from any one or any combination of the user's health-related information. In various embodiments, the TPM may have the HMA installed on the user's smartphone and/or access a web version of the HMA to monitor the user and receive health related information. In various embodiments, the HMA version installed on the smartphone of the TPM enables association with multiple users and thus data communication.

According to various aspects herein, the TPM may intervene at various stages or stages of therapy depending on the user's health-related information, trends, and/or the user's progress in relation to the therapy goals or endpoints set to be achieved through the therapy. have. For example, if a user achieves a therapy goal, the TPM may extend the therapy (for example, if the user loses 10 pounds according to the weight loss goal, the TPM may recommend continuing the therapy to lose an additional 10 pounds). ), the therapy can be completely terminated and a new therapy, for example, for weight maintenance, can be extended. The new regimen may use a different stimulation protocol or may be the same as before, but may use a higher calorie diet, for example.

52 is a flow diagram illustrating multiple steps of a method for enabling a TPM to prescribe, configure, manage, monitor, and intervene in an EDP device based stimulation regimen for a user in accordance with some embodiments. In step 5202, the user visits his TPM for a health check-up or evaluation. The TPM recommends the EDP device of the present disclosure to the user based on the user's medical condition, for example obesity or overweight. In step 5204, the TPM downloads the HMA to the user's smartphone (acting as a companion device). Thereafter, in step 5206, the TPM may provide the user with an appropriate stimulation region (and thus, placement of the EDP device on the user's body), and also provides the user with directions regarding the use and functionality of the electrical skin patch device. The EDP device is located at an identified location on the user's body. Next, at step 5208, the TPM associates or links itself to the user, the user's EDP device, and the HMA, for example by entering the user's unique code into the user's HMA. associating or linking the user with the TPM enables the TPM to periodically receive and access, in real-time or near real-time, health-related information of the user and progress reports related to various therapy goals; A plurality of functions may be possible, including, but not limited to, the ability to properly adjust or titrate stimulation protocols and parameters when needed, and to have the TPM remotely deactivate and re-activate the EDP device when needed.

The TPM pairs or synchronizes the user's smartphone with the user's EDP device in step 5210 . Thereafter, at step 5212, the TPM configures or programs the stimulation protocol and parameters, including various relevant thresholds, ranges, associated with the planned therapy session and the unscheduled rescue session. In one embodiment, the TPM configures a stimulation regimen designed to be established as a standard or baseline stimulation protocol in the absence of the user's initial health-related information. At step 5214 , the TPM also programs the user's HMA to generate and provide to the user a survey to elicit health-related information for the user. The survey is programmed to be presented to the user on a daily basis within the user's preferred time window. The TPM may optionally prescribe a low calorie diet designed for the user. The HMA, at step 5216, confirms that the configuration (by the TPM) is successful, and the EDP device may also, for example, by vibration, audible and/or visual indications or signals (eg, blinking an LED of a certain color). Confirm successful configuration.

At step 5218 , the TPM delivers the first scheduled therapy session to the user in the presence of the TPM to ensure that the HMA or therapy configuration is helpful to the user. If the user feels good after the first session, the user may leave at step 5220 to continue therapy at home. However, if the user reports discomfort or deterioration in well-being, for example, due to nausea, then the TPM reprograms the stimulation protocol and parameters at step 5222 . At home, the user continues the stimulation therapy, at step 5224 , and during the therapy a plurality of health-related information (eg, the user's weight, appetite, hunger, exercise, well-being (recorded nausea and/or dyspepsia cases) well-being profile (including but not limited to), values related to calories consumed, and individualized hunger profiles (including, but not limited to, recorded unscheduled hunger events and outcomes of rescue session delivery). If and when needed, at step 5226, the TPM adjusts stimulation parameters and protocols for both the scheduled session and the rescue session based on the plurality of user health related information while the user continues stimulation therapy at home. The TPM also intervenes by resetting or reprogramming the EDP device and HMA, and disabling and reactivating the EDP device when needed.

At step 5228, the user's stimulation is stopped, suspended and/or prompted for the user to revisit his or her TPM to re-evaluate his or her medical condition or progression.

In accordance with some aspects herein, a user has multiple options for purchasing an EDP device with the services of a TPM. In one embodiment, the user uses the service of the TPM at a first fee and purchases the EDP device at the first price. In some embodiments, the first fee and the first price are fixed, one-time values valid for the user's entire treatment cycle. In another embodiment, the user may pay a single, one-time, fixed price for a bundled transaction that includes the TPM's service and the EDP device price. In another embodiment, the user purchases a bundled transaction consisting of the TPM's service and the EDP device price at a price valid for a predetermined period of time (eg, 1 week to 3 months) and repeats after a predetermined period of time. In yet another embodiment, the first price is a one-time payable value, while the first fee is valid for a predetermined period of time, for example, one week to three months, and recurs after a predetermined period of time. According to one aspect, the TPM's fee schedule is enforced through a unique code that is valid only for a predetermined period of time. For example, if the TPM's first fee is valid for one month of therapy, the TPM's unique code (entered into the user's HMA) prompts the user to deactivate the EDP device at the end of the month and satisfy the TPM. Based on the user's medical condition, the TPM may extend the therapy for an additional month (using a different unique code) for an additional fee. Prolonged therapy may be started immediately or restarted after discontinuing the user. In another embodiment, the EDP device may be purchased at a one-time price but the TPM's fee is linked to the achievement of a specified goal. For example, the TPM's first fee includes setting up an initial EDP therapy, and subsequent costs must be paid after the user achieves a weight loss goal of eg 10 pounds. In other words, the TPM's fee is linked to the user achieving one or more therapy goals within a period of time.

In various embodiments, the therapy provided by an electric skin patch (EDP) device herein is driven or triggered by a plurality of variables. These variables are entered into the interlocking device by the patient or healthcare professional and sensed by the sensors of the EDP to be worn on a separate device, e.g., around the wrist, to monitor, acquire, record and/or transmit physiological data. may be transmitted to the companion device or EDP via a device having a physiological sensor configured to do so, or may be obtained by a combination of any of the above means. In various embodiments, the variable is stored, preset and/or measured or entered on a regular basis, as determined in advance or over a period of time. In some embodiments, the variable comprises a primary variable comprising a primary driver for any regimen, and a secondary variable comprising a secondary indicator that may or may not affect the regimen. Some variables, such as body weight (in pounds), are entered into the patient log based on actual values, while others, such as hunger, appetite, and satiety, are based on a predetermined range of score values or a scale such as the Visual Analog Scale (VAS). points are awarded The companion device's treatment algorithm analyzes these scores against predetermined limits and automatically modifies the therapy accordingly. In some embodiments, the algorithm analyzes these scores daily. In other embodiments, the algorithm analyzes the score every other day, every 3 days, every 4 days, every 5 days, every 6 days, or once a week. In various embodiments, the score value ranges from 0 to 100. In a preferred embodiment, the score value ranges from 1 to 10, more preferably from 1 to 5 or from 1 to 3 depending on the variable. In some embodiments, a high numerical score indicates that the electrical stimulation therapy provided by the EDP is inadequate and additional stimulation is required. A low numerical score value indicates that the electrical stimulation therapy provided by the EDP is excessive and the stimulation should be reduced. Conversely, in other embodiments, a high numerical score value indicates that the stimulus is excessive and needs to be decreased, and a low numerical score value indicates that the stimulus is inadequate and needs to be increased. In some embodiments, a numerical score value close to the middle of the score range indicates that the therapy is adequate and can remain unchanged.

In one embodiment, the system uses one or more of a trigger, such as a patient's blood glucose level, metabolic level, hemoglobin A1c and/or blood glucose, to initiate stimulation or adjust stimulation settings. Using built-in physiological sensors or third-party external devices that already measure metabolism, blood glucose, blood glucose levels or hemoglobin A1c, the companion device collects this data and integrates it with existing patient condition data, based on the integrated patient condition data profile. to create a modulated stimulus setting that may include a signal to start therapy, change therapy, or stop therapy. In one embodiment, when the patient's blood glucose level increases, the stimulation setting is adjusted upward to increase the rate, frequency, or total amount of stimulation. In one embodiment, if the patient's blood glucose level is reduced or normalized (eg, as a result of the delivered stimulation therapy), the stimulation setting is adjusted downward to decrease the rate, frequency, or total amount of stimulation. In one embodiment, stimulation therapy is discontinued when the patient's blood glucose level decreases or normalizes (eg, as a result of the delivered stimulation therapy). In another embodiment, when patient condition data changes, including an increase or decrease in metabolism, blood glucose, blood glucose level, or hemoglobin A1c, the interlocking device directs the EDP to another location on the patient's body (e.g., to stimulate another dermatome) For example, it may be recommended to move from C8 to T1 in the hand or, for example, from T7 to T6 in the abdominal region).

In some embodiments, therapy is driven by three major sets of drivers. Primary drivers were hunger, defined as the patient's desire to eat; Appetite, defined as the amount of food a patient eats (also considered calorie intake) in relation to a diet plan; and simply defined well-being to the extent that the patient feels good. In some embodiments, well-being is further subdivided into feelings of particularly nausea, indigestion, discomfort, energy levels, and weakness/strength. Each of these primary drivers may be attributed to a score input to the companion device, as shown in FIGS. 11, 13 and 16 .

For example, in the case of hunger, with reference to Figure 13, a patient can enter a hunger score from 1 to 5, where 1 indicates that the patient is not hungry at all, 2 indicates that the patient is rarely hungry, 3 indicates that the patient is not particularly hungry, 4 indicates that the patient is often hungry, and 5 indicates that the patient is extremely hungry most of the time. In some embodiments, a hunger score with a higher numerical value indicates that appetite suppression is inadequate and the patient requires greater stimulation. The treatment algorithm of the interlocking device recognizes the need for greater stimulation with higher scores and titrates the therapy accordingly. For example, in one embodiment, if a patient enters a hunger score greater than 3 in the patient diary over a period of 4 to 7 consecutive days within the first week, the algorithm uses the score to progressively increase the duration of each stimulation session. increase to After 3 weeks, if the patient enters a hunger score greater than 3 in the patient log for 3 consecutive days, the algorithm uses the score to increase the number of stimulation sessions per day. Conversely, a low hunger score indicates that stimulation should be reduced. For example, if a patient enters a hunger score of 1 for 3 consecutive days within the first week, the duration and frequency of the stimulation sessions decrease. In another embodiment, the hunger score scale scales from 1 to 10.

In another embodiment, rather than a scale for determining the presence or absence of hunger, the system presents the patient with a scale configured to record changes in their hunger after stimulation. For example, in one embodiment, the hunger change score scale is scaled from 1 to 3, where 1 indicates no change, 2 indicates slight change, and 3 indicates significant change in hunger after stimulation. If the patient reports 1 with no change in hunger after stimulation, the stimulation parameter is increased.

Referring to FIG. 11 for appetite, the patient can enter an appetite score from 1 to 5, where 1 indicates that the patient ate significantly less than their diet and 2 indicates that the patient ate slightly less than their diet. ate, 3 indicates that the patient followed their diet, 4 indicates that the patient slightly exceeded their diet, and 5 indicates that the patient significantly exceeded their diet. As with the hunger score discussed above, in some embodiments, an appetite score with a higher numerical value indicates that appetite suppression is inadequate and the patient requires greater stimulation. The treatment algorithm of the interlocking device recognizes the need for greater stimulation with higher scores and titrates the therapy accordingly. For example, in one embodiment, if the patient enters an appetite score greater than 3 in the patient log for 4 to 7 consecutive days within the first week, the algorithm uses the score to progressively increase the duration of each stimulation session make it If after 3 weeks the patient enters an appetite score greater than 3 in the patient log for 3 consecutive days, the algorithm uses the score to increase the number of stimulation sessions per day. Conversely, a low appetite score indicates that stimulation should be reduced. For example, if a patient enters an appetite score of 1 for 3 consecutive days within the first week, the duration and frequency of the stimulation session decrease. In another embodiment, the appetite scale is scaled from 1 to 10.

As discussed above, in some embodiments a plurality of variables that drive or induce therapy, such as hunger, appetite, satiety, fullness, and feelings of pain, nausea or indigestion, are are assessed alternately on at least one of a plurality of scientific VAS scales. Graphs 36A-38F represent exemplary data that the inventor believes to be indicative of the benefits of the therapies of the present invention. Data can be collected and compared for each patient before and after stimulation, for sample patient groups before and after stimulation, or using two separate patient groups, one group of patients receiving stimulation and another group of patients not receiving stimulation (control group). have to understand Thus, post-stimulation benefits will be achieved whether compared to the same user population before stimulation or to another user population serving as a control.

36A-36I are a set of graphs illustrating the effect of a stimulus on a feeling of hunger assessed on a Visual Analog Scale (VAS) in accordance with some embodiments, whereas FIGS. is a set of graphs illustrating the effect of stimulation on satiety assessed for 36A-36E , according to one embodiment, a sample of 5 patients for the purpose or goal of weight loss includes a first case corresponding to a pre-stimulation scenario in which 5 patients did not receive stimulation therapy, and 5 Patients were assessed for feeling of hunger (using VAS) in the second case (using VAS), which corresponds to the post-stimulation scenario receiving stimulation therapy using the EDP herein.

According to one embodiment, 5 patients were assessed both before and after stimulation using a VAS hunger questionnaire, such as the questionnaire in FIG. 35A, with a 100 mm VAS line. In the first case (prior to stimulation), each patient's response or score to the VAS hunger questionnaire is recorded immediately prior to a meal (eg, breakfast) in one embodiment, but the first response to which no patient is given stimulation therapy or scores were recorded every 60 minutes, starting with scores 3606a to 3606e. In the second case (post-stimulation), each patient's response or score to the VAS hunger questionnaire was recorded immediately before a meal (eg, breakfast) but with stimulation therapy prior to a meal, eg, 30 minutes before a meal, respectively. was re-recorded every 60 min, starting with the first response or score (3607a to 3607e) recorded after treatment of patients. According to one embodiment, the response or score associated with the first instance is recorded on the first day, while the response or score associated with the second instance is the same as on the first day on the second day, preferably at the same time of day. Recorded under eating or fasting conditions.

As shown in FIG. 36A , the hunger response or score of the first patient in the first case (ie, pre-stimulation) is recorded for the first day and plotted on a graph, where the x-axis represents time in minutes, and y- The axis represents the VAS hunger response or score in millimeters to create a pre-stimulation hunger profile 3605a. Thereafter, in accordance with an embodiment herein, the first patient receives the stimulation therapy, and the hunger response or score for the second instance (ie, after stimulation) is also displayed on the graph to generate the post-stimulation hunger profile 3608a . Similarly, the responses or scores of the second, third, fourth and fifth patients were evaluated for each pre-stimulation hunger profile (3605b, 3605c, 3605d, 3605e) and each stimulus, as shown in FIGS. 36B-36E . Post-hungry profiles 3608b, 3608c, 3608d, and 3608e are recorded to generate. As can be observed from FIGS. 36A-36E , the hunger profiles after stimulation (3608a, 3608b, 3608c, 3608d, 3608e) have reduced hunger size compared to the hunger profiles before stimulation (3605a, 3605b, 3605c, 3605d, 3605e). reflects the In some embodiments, the patient's post-stimulation hunger profile reflects at least a 5% reduction in hunger size compared to the patient's pre-stimulation hunger profile. In some embodiments, delivery of stimulation of at least 15 minutes within a time window of 60 minutes to 180 minutes from the last stimulation at least once per week, at least 2 to 6 times per week (or any increments therein), at least once per day , or at least 2 to 8 times per day (or any increments therein), reduces the patient's post-stimulation regime composite appetite or hunger score by at least 10% as compared to the patient's pre-stimulation regime composite appetite or hunger score.

36F depicts a first bar 3610 representing the area under the median curve (AUC) hunger score prior to stimulation. The AUC value is determined by calculating the area under the line defining a given plot profile. The second bar 3611 represents the median AUC end-of-stimulation hunger score derived from the AUC values for the sample patient's end-of-stimulation hunger profile (ie, the hunger profile recorded starting immediately after the end of stimulation regimen), and the third bar 3612 ) represents the median AUC post-stimulation hunger score derived from the AUC values for the post-stimulation hunger profile of sample patients. In various embodiments, stimulation termination is defined as the termination of a stimulation period lasting ranging from one session to multiple sessions over six months. In various embodiments, post-stimulation is defined as the time after cessation of therapy and ranges from 1 day after cessation to 6 months after cessation. As shown in this figure, the median AUC hunger scores 3611 and 3612 corresponding to the stimulus termination and post-stimulation scenarios are decreased compared to the median AUC hunger scores 3610 corresponding to the pre-stimulation scenarios. In other words, the stimulation therapy herein suppresses hunger. In some embodiments, the area under the curve (AUC) of the patient's hunger profile after stimulation reflects at least a 5% decrease compared to the patient's AUC of the patient's hunger profile before stimulation.

36G and 36H also illustrate a decrease in the magnitude of the hunger score assessed after stimulation compared to that assessed before stimulation for at least one patient. 36G and 36H are charts with an x-axis representing time in weeks and a y-axis representing hunger scores. FIG. 36G shows the pre-stimulation hunger profile (3615g) versus the post-stimulation hunger profile (3616g) over a long period of time, such as several weeks and up to 32 weeks. Similarly, FIG. 36H also shows the pre-stimulation hunger profile 3615h versus the post-stimulation hunger profile 3616h for the same extended time period. As can be observed from FIGS. 36G and 36H , the post-stimulation hunger profiles (3616 g, 3616 h) show reduced hunger AUC and magnitude compared to the respective pre-stimulation hunger profiles (3615 g, 3615 h) even over an extended period of time.

FIG. 36I shows a first median or mean hunger score 3620 (assessed using a VAS hunger questionnaire such as that of FIG. 35A), recorded on the first day prior to stimulation therapy (pre-stimulation scenario) in one or more patients; a second median or mean hunger score 3622 recorded at the end of application of stimulation therapy (stimulation termination scenario) to one or more patients; and a third median or mean hunger score (3624) recorded on the second day after application of stimulation therapy (post-stimulation scenario) to one or more patients.

Referring now to FIGS. 37A-E , according to one embodiment, a sample of 5 patients for the purpose or goal of weight loss includes a first case corresponding to a pre-stimulation scenario in which 5 patients did not receive stimulation therapy, and Five patients were assessed for satiety (using VAS) in the second case, corresponding to the post-stimulation scenario, where 5 patients received stimulation therapy using the EDP herein.

According to one embodiment, 5 patients were assessed both before and after stimulation using a VAS satiety questionnaire, such as the questionnaire in FIG. 35D , with a 100 mm VAS line. In the first case (prior to stimulation), each patient's response or score on the VAS Satiety Questionnaire was recorded immediately prior to a meal (eg, breakfast) in one embodiment, but the first response to which the patient was not subjected to stimulation therapy. Or starting at scores 3706a to 3706e, recorded every 60 minutes. In the second case (post stimulation), each patient's response or score on the VAS satiety questionnaire was measured immediately before a meal (eg, breakfast) and after treating each patient with stimulation therapy, eg, a meal. Starting with the first response or score (3707a-3707e) recorded 30 minutes earlier, re-recorded every 60 minutes. According to one embodiment, the response or score associated with the first instance is recorded on the first day, while the response or score associated with the second instance is recorded on the second day, preferably at the same time of day, with the same meal or fasting as on the first day. conditions are recorded.

37A , the satiety response or score of the first patient in the first case (ie, pre-stimulation) was recorded and graphed on day 1, where the x-axis represents time in minutes and the y- The axis represents the VAS satiety response or score in millimeters to create a pre-stimulation satiety profile 3705a. The first patient then receives stimulation therapy according to embodiments herein, and the satiety response or score for the second instance (ie, post stimulation) is also graphed to generate a post-stimulation satiety profile 3708a. Similarly, the responses or scores of the second, third, fourth and fifth patients were measured for each pre-stimulation satiety profile (3705b, 3705c, 3705d, 3705e) and after each stimulation as shown in FIGS. 37B-E. are recorded to generate satiety profiles 3708b, 3708c, 3708d, 3708e. As can be observed from FIGS. 37A-E , post-stimulation satiety profiles 3708a, 3708b, 3708c, 3708d, 3708e have reduced satiety magnitudes compared to pre-stimulation satiety profiles 3705a, 3705b, 3705c, 3705d, 3705e. reflects the In some embodiments, the patient's post-stimulation satiety profile reflects at least a 5% increase in satiety magnitude compared to the patient's pre-stimulation satiety profile.

37F shows a first bar 3710 representing the median AUC pre-stimulation satiety score derived from the AUC values for the pre-stimulation satiety profile of at least one patient, the at least one patient's end-of-stimulation satiety profile (i.e., immediately after the end of stimulation therapy). A second bar (3711) representing the median AUC stimulation end satiety score, derived from the AUC values for the satiety profile recorded starting from the A third bar 3712 representing the post-satisfaction score is shown. In various embodiments, stimulation termination is defined as the termination of a stimulation period lasting ranging from one session to multiple sessions over six months. In various embodiments, post-stimulation is defined as the time after cessation of therapy and ranges from 1 day after cessation to 6 months after cessation. As shown in this figure, the median AUC satiety scores 3711 and 3712 corresponding to the stimulus termination and post-stimulation scenarios are higher or improved compared to the median AUC satiety scores 3710 corresponding to the pre-stimulation scenarios. In other words, the stimulation therapy herein suppresses hunger or improves satiety. In some embodiments, the area under the curve (AUC) of the satiety profile after stimulation of the patient reflects an increase of at least 5% relative to the AUC of the patient's satiety profile before stimulation.

37G and 37H also illustrate the reduced magnitude of satiety scores for at least one patient assessed after stimulation compared to those assessed before stimulation. 37G and 37H are charts with an x-axis representing time in weeks and a y-axis representing satiety scores. 37G depicts the pre-stimulation satiety profile (3715g) versus the post-stimulation satiety profile (3716g) over long periods of time, such as several weeks and up to 32 weeks. Similarly, FIG. 37H also depicts a pre-stimulation satiety profile 3715h versus a post-stimulation satiety profile 3716h for the same extended time period. As can be observed from FIGS. 37G and 37H , the post-stimulation satiety profiles (3716 g, 3716 h) show improved or increased satiety AUC and magnitude compared to the respective pre-stimulation satiety profiles (3715 g, 3715 h) even over an extended period of time. .

FIG. 37I shows a first median or mean satiety score 3720 (assessed using a VAS hunger questionnaire such as that of FIG. 35D) recorded on the first day prior to application of stimulation therapy (pre-stimulation scenario) to at least one patient, at least A second median or mean satiety score (3722), recorded at the end of application of stimulation therapy (end-of-stimulation scenario) to one patient, and a second time after application of stimulation therapy (post-stimulation scenario) to at least one patient Another graph showing the third median or mean satiety score (3724).

36A-36I depict hunger levels before and after and FIGS. 37A-37I depict satiety levels before and after VAS in various patient sensory pre- and post-stimulation scenarios, such as satiety and fullness, in various embodiments, in various embodiments. It should be understood that similarly evaluated and recorded using In addition, pre-stimulation levels of patient sensations, such as hunger, appetite, satiety, satiety, and fullness, are measured using a scale (e.g., VAS) at predetermined times of the day for a predetermined time period, followed by stimulation of the patient sensations. It should be understood that the level is measured after the stimulation is initiated using a scale at a predetermined time of day over a second predetermined time period equal in duration to the first predetermined time period. Further, in various embodiments, a patient's change in satiety, defined as a change in the patient's perception of stomach fullness or hunger, is measured using a scale (eg, VAS) to determine efficacy of therapy provided by the EDP device. do. Further, in various embodiments, the results obtained by the VAS for all patient sensations as well as changes in satiety are used to modify the stimuli provided by the EDP device.

Referring to FIG. 16 for well-being in one embodiment, the patient may enter a score from 1 to 3, where 1 indicates no nausea/abdominal discomfort, and 2 indicates intermittent nausea/abdominal discomfort. and 3 indicates that the patient experiences frequent nausea/abdominal discomfort. In some embodiments, a higher score for Well-being indicates that the stimulus is so intense that the patient experiences nausea and requires reduction of the stimulus. The treatment algorithm of the interlocking device recognizes the need for stimulation reduction as the score increases and titrates the therapy accordingly. For example, in one embodiment, if the patient enters a wellness score of 3 in the patient diary for 3 consecutive days, the algorithm uses the score to progressively decrease the number of stimulation sessions per day or week and/or the length of each stimulation session. In one embodiment, parameter modifications based on well-being scores override those based on hunger and/or appetite scores. Tracking these key drivers ensures that patients are provided with the appropriate amount of stimulation so that they do not experience nausea, indigestion, lack of energy or weakness, and that they do not have too much appetite or eat too much food. to determine the best way to continuously modify the stimulus for Tracking these variables enables the provision of therapy stimulation protocols to patients by automatically modifying stimulation parameters based on pre-determined variable ranges and limits without the need for ongoing patient administration.

In some embodiments, the therapy is further driven by two sets of secondary indicators. Secondary indicators include patient weight and calories burned/exercise. The weight may be input in pounds, and the calories/exercise consumed may be due to a score input to the companion device as shown in FIGS. 15 and 12 . For example, in the case of body weight, referring to FIG. 15 , the patient may input his or her body weight in pounds by using the keypad of the companion device. In one embodiment, the patient enters his or her weight in a weekly patient diary. In another embodiment, the companion device is configured to communicate wirelessly with a wireless scale (ie, a bathroom scale) such that the patient's weight is automatically entered into the companion device when the patient weighs himself or herself on the scale. This improves system accuracy by eliminating the possibility of the patient entering the wrong weight. In addition, the system can track how often and when the patient weighs his or her weight, send reminders, and titrate therapy based on the delivered weight. In another embodiment, the companion device is configured to wirelessly communicate with a separate body fat measurement device. As with the patient's weight, the calculated body fat is automatically transmitted to the interlocking device to improve the therapy titration based on the system accuracy, body fat measurement tracking and reminder, and the transmitted body fat data. In various embodiments, the companion device is configured to communicate wirelessly with a separate device capable of measuring a plurality of physiological parameters including, but not limited to, patient weight, body fat, lean mass, and body mass index (BMI). The data of these parameters are automatically entered into the treatment algorithm of the interlocking device and used to drive therapy by modifying the electrical stimulation parameters.

12 , for calories burned/exercise, the patient can enter an exercise score from 1 to 5, where 1 indicates that the patient walked more than 10,000 steps per day, and 2 indicates that the patient walked more than 10,000 steps per day. represents 7,500 to 10,000 steps, 3 represents the patient walked 5,000 to 7,500 steps per day, 4 represents the patient walked 2,500 to 5,000 steps per day, and 5 represents the patient walked 2,500 to 2,500 steps per day Indicates that you walked less than a step. In some embodiments, the secondary indicator is a separate, separate device, such as a device with a physiological sensor configured to be worn on the human body, such as around the wrist, to monitor, obtain, record, and/or transmit physiological data (eg, for fitness input). on the device) and physiological inputs (eg, ghrelin levels).

Similar to primary drivers, tracking these secondary indicators can help determine the best way to continuously modify stimuli to provide the patient with the appropriate amount of stimuli. In some embodiments, secondary indicators have less value than primary drivers in determining the best way to modify EDP stimulation parameters. Although embodiments with three primary drivers and two secondary indicators have been discussed, further embodiments with more or fewer primary drivers and/or secondary indicators are possible and the variables presented are not intended to limit the invention. not.

The EDP device herein can be used to enable a patient to follow a dietary regimen. In some embodiments, the system provides information about timing of food intake by the patient, for example, via application or software on the microprocessor of the EDP, total calories consumed, and type of food consumed (i.e., glycemic index, carbohydrate profile, and protein profile). ) is calculated. The system then titrates the electrical stimulation therapy using the information calculated through an algorithm through the application or software. For example, if a patient eats outside of normal meal times, consumes too many calories based on their diet, and/or consumes foods with a high glycemic index or carbohydrate profile, the system will recognize this and determine the stimulus amplitude, frequency, Increase any one or combination of session number, session length, or session timing.

Specifically, in various embodiments, the system calculates time of intake, total calories consumed, and type of food consumed, as described above, along with other parameters such as exercise and sustained weight loss, and based on these calculations, the following regimen adjustments do:

환자가 미리 결정된 기간(예를 들어, 3일) 동안 식이 요법 계획에 기초하여 너무 많은 칼로리를 섭취하면, 자극 지속시간, 강도 및/또는 세션 수가 증가한다.

If the patient consumes too many calories based on the dietary regimen for a predetermined period of time (eg, 3 days), the stimulation duration, intensity, and/or number of sessions increases.

환자가 미리 정해진 기간(예를 들어, 3일) 동안 매일 하루 중 특정 시간대에 너무 많은 음식을 섭취하는 경우, 자극 타이밍이 과식 시간 전(예를 들어, 30분 또는 1시간 전)으로 변경되고/되거나 추가 자극 세션이 과식 시간 전에 추가된다.

If the patient consumes too much food at certain times of the day each day for a predetermined period of time (e.g., 3 days), the timing of stimulation is changed to before the time of overeating (e.g., 30 minutes or 1 hour before) and/ or an additional stimulation session is added prior to the overeating time.

환자가 미리 정해진 기간(예를 들어, 3일) 동안 식이 요법 계획 이외의 음식(예를 들어, 너무 많은 탄수화물)을 섭취하면, 자극 지속시간, 강도, 세션 시간 및/또는 세션 수가 증가한다.

If the patient consumes food (eg, too many carbohydrates) outside of the dietary regimen for a predetermined period of time (eg, 3 days), stimulation duration, intensity, session time, and/or number of sessions increases.

환자가 일정 기간(예를 들어, 3일) 동안 운동을 중단하면 자극 파라미터가 증가한다.

Stimulation parameters increase when the patient stops exercising for a period of time (eg, 3 days).

치료 과정 후에 환자가 미리 결정된 양의 목표 체중을 감량한 경우, 시스템 알고리즘은 일부 실시예에서 의사에 의해 또는 다운로드 가능한 애플리케이션을 통해 자극 파라미터를 감소시킨다.

If the patient has lost a predetermined amount of the target weight after the course of treatment, the system algorithm, in some embodiments, reduces the stimulation parameter by the physician or via a downloadable application.

For some patients, it is not necessary for the patient to keep track of the amount of calories in each food consumed, but rather it is easier to adapt when a diet plan is presented along with a list of foods in which the calorie profile of each food item is already known. Accordingly, in some embodiments, the system provides the patient with a number of breakfast, lunch, dinner and optionally snack plans from which to choose. The calorie profile of each of these meal plans is pre-calculated. This calorie profile is pre-programmed into the software or application of the EDP device. Patients no longer need to track the calorie content of each food item consumed and can simply report their adherence to their chosen meal plan. Further, in some embodiments, the EDP may be configured to monitor, acquire, record, and/or transmit physiological data, such as athletic data, to the EDP in a separate device, such as a device with a physiological sensor configured to be worn on the body, such as around the wrist. It can be linked to a wearable device, so that calories burned tracked by a separate device can be subtracted from calories consumed according to a specific meal plan to provide calorie balance information to the patient and the system.

In some embodiments, the patient is instructed to follow a 1200 calorie/day diet plan. Based on the above, consuming too many calories and/or consuming the wrong calories (eg, bad glycemic index, eating too much sugar and/or eating too many carbohydrates) in excess of baseline 1200 will increase the stimulus. If bad eating habits (eg, too many wrong calories) are concentrated at certain times of the day, the system adjusts to add sessions just before certain times to reduce hunger and improve eating behavior.

In some embodiments, the stimulus is programmed to begin before the patient begins his or her diet regimen (eg, one week before). Initiating stimulation before the patient changes to a new dietary plan improves compliance because the patient's appetite decreases before the meal change is made and they are less likely to be discouraged if they deviate from the diet due to high hunger. In another embodiment, the patient receives only stimulation therapy and does not proceed with a dietary regimen.

27C is a flow diagram illustrating steps associated with one embodiment of a method of using an electrical skin patch device to suppress appetite in a patient. At step 2702 , the patient obtains an electrical skin patch (EDP) device from a medical professional in accordance with the devices disclosed herein.

The EDP device is set to a default mode of operation by the patient or medical practitioner in step 2704 . In some embodiments, the default mode of operation is a pulse width in the range of 10 microseconds to 10 msec; pulse amplitude in the range of 100 μA to 500 mA; pulse frequency ranging from 1 Hz to 10,000 Hz; pulse duty cycle ranging from 1% to 100%; a session duration in the range of 1 minute to 120 minutes or substantially continuous; and stimulation parameters and parameter ranges including from 1 to 24 sessions per day. In a preferred embodiment, the default mode of operation is a pulse width equal to 200 microseconds; pulse amplitude equal to 5 mA; pulse frequency equal to 20 Hz; pulse duty cycle equal to 100%; session duration, such as 30 minutes; and stimulation parameters including one session per day. In another preferred embodiment, the default operating mode is set to 3 stimulation sessions per day of 30 minutes each with a pulse amplitude of 20 mA for most patients. Each of the three stimulation sessions per day is started 30 to 60 minutes before, preferably 45 minutes before meal times, for example breakfast, lunch and dinner. In another preferred embodiment, the baseline stimulation modality or protocol comprises pulses of 20 mA at 15 minutes and postprandial time each having a pulse amplitude of 20 mA at the preprandial time just before the start and at the completion of each meal, such as breakfast, lunch, and dinner. Three stimulation sessions per day of 60 minutes each with amplitude are set up. In other words, the baseline stimulation modality or protocol includes 3 x 1.25 hours = a total of 3.75 hours (15 minutes before and 60 minutes after each meal). In some embodiments, the baseline pulse amplitude ranges from 5 mA to 10 mA allowing for a total stimulation duration of greater than 3.75 hours. In various embodiments, these preprandial and postprandial stimulation sessions are manually triggered by the user. In various embodiments, the HMA generates reminders or prompts for the user to manually trigger preprandial and postprandial stimulation sessions. In some alternative embodiments, the pre- and post-prandial stimulation sessions are automatically triggered based on a pre-stored meal time schedule. In some alternative embodiments, the postprandial stimulation session detects an eating event by a swallow detection device, such as device 5605 of FIG. Triggered automatically in connection with detecting an eating event by the meal moment recognition method (FIG. 58) implemented by the HMA using the accelerometer with the band 2105 of FIG. Included in the same wristband or wristwatch.

Then, in step 2706, the EDP device is placed on the patient's body by the patient or medical professional. The patient may modify the default mode of operation within a predetermined set of ranges in step 2708 . The patient responds to patient feedback or feedback provided by a separate wearable device, e.g., a device with physiological sensors configured to be worn on the human body, such as around the wrist, to monitor, acquire, record and/or transmit physiological data. Based on the default operation mode can be modified. At step 2710, the EDP device displays appetite, stimulation session, calorie intake, and patient weight in various graphical user interfaces (GUIs). Other parameters may also be listed, and the listing of step 2710 is not intended to limit the invention. The EDP device forces or allows a change of operating mode in case of nausea, indigestion or habituation via patient input or saves battery in step 2712 . The EDP device enforces a change when the feedback data provided by the device or other wearable device is outside a preset range indicating that habituation is occurring. In some embodiments, habituation occurs when hunger returns over time despite electrical stimulation via the stimulation protocols disclosed herein.

Return of hunger indicates loss of appetite suppression due to the patient's habituation to electrical stimulation. The patient may change the mode of operation if they experience nausea and/or indigestion.

28 is a flow diagram illustrating steps associated with another embodiment of a method of using an electrical skin patch device to suppress appetite in a patient. In step 2802 , the patient obtains an electrical skin patch (EDP) device from a medical professional in accordance with the devices disclosed herein. The EDP device is set to a default mode of operation by the patient or healthcare professional in step 2804 . In various embodiments, the default mode of operation includes the stimulation parameters and parameter ranges listed above with respect to FIG. 27C . Then, in step 2806, the EDP device is placed on the patient's body by the patient or medical professional. The EDP device automatically modifies the default operating mode based on a predetermined trigger in step 2808 . In various embodiments, the trigger is data obtained from a separate device having a physiological sensor configured to be worn on the body, such as around the wrist, to monitor, acquire, record, and/or transmit physiological data, which is data transmitted to the companion device. and, but not limited to, patient diary records of appetite, hunger, and well-being. For example, in one embodiment, the patient records an appetite diary entry having a score of 5, wherein the patient is most likely to indicate non-conformity to a diet (ie, not following a diet plan) or poor adherence to the diet. During a recent meal, their diet was substantially exceeded. In some embodiments, one or more score of 5 for appetite triggers the interlocking device to automatically increase a therapy parameter, such as, for example, an increase in stimulation intensity, duration, or session.

In another embodiment, for example, a patient records a hunger diary entry with a score of 1, wherein the patient did not experience any hunger at the time of the most recent meal. In some embodiments, a score of one or more for hunger triggers the interlocking device to automatically decrease a therapy parameter, such as, for example, a decrease in stimulation intensity, duration, or session. At 2810 , the EDP device displays appetite, stimulation session, calorie intake, and patient weight in various graphical user interfaces (GUIs). Other parameters may also be listed, and the listing of step 2810 is not intended to limit the invention. The EDP device then follows a ramp-down procedure in which the stimulation parameters are sequentially decreased in step 2812 to conserve battery and avoid potential habituation.

29 is a flow diagram illustrating steps associated with another embodiment of a method of using an electrical skin patch device to suppress appetite in a patient. In step 2902 , the patient obtains an electrical skin patch (EDP) device from a medical professional in accordance with the devices disclosed herein. The EDP device is set to a default mode of operation by the patient or healthcare professional in step 2904 . In various embodiments, the default mode of operation includes the stimulation parameters and parameter ranges listed above with respect to FIG. 27C . Then, in step 2906, the EDP device is placed on the patient's body by the patient or medical professional. The EFP device automatically modifies the default mode of operation after a predetermined number of days in the patient diary record for appetite or hunger in step 2908 . In various embodiments, the predetermined number of days ranges from 1 to 7 days. In one embodiment, the predetermined number of days is three days. In one embodiment, in combination with step 2908, the EDP device enables the patient to manually adjust stimulation parameters to address nausea, indigestion, or provide emergency stimulation to address hunger, in step 2910. At step 2912 , the EDP device displays appetite, stimulation session, calorie intake, and patient weight in various graphical user interfaces (GUIs). Other parameters may also be listed and the listing of step 2912 is not intended to limit the invention. The EDP device then follows a ramp-down procedure in which the stimulation parameters are sequentially decreased in step 2914 to conserve battery and avoid potential habituation.

30 is a flow diagram illustrating steps associated with another embodiment of a method of using an electrical skin patch device to suppress appetite in a patient. At step 3002 , the patient obtains an electrical skin patch (EDP) device from a medical professional in accordance with the devices disclosed herein. The EDP device is set to a default mode of operation by the patient or healthcare professional in step 3004 . In various embodiments, the default mode of operation includes the stimulation parameters and parameter ranges listed above with respect to FIG. 27C . Then, in step 3006, the EDP device is placed on the patient's body by the patient or medical professional. The EFP device automatically modifies the default operation mode in step 3008 after a predetermined amount of calorie intake or calorie burning determined by information collected from a separate device or a journal entry, or after a predetermined number of days of weight data has been recorded. do. In various embodiments, the predetermined number of days ranges from 1 to 7 days. In one embodiment, the predetermined number of days is three days. In one embodiment, in combination with step 3008 , the EDP device allows the patient to manually adjust stimulation parameters to address nausea, dyspepsia, or provide emergency stimulation to address hunger, at step 3010 . At step 3012, the EDP device displays appetite, stimulation session, calorie intake, and patient weight in various graphical user interfaces (GUIs). Other parameters may also be listed, and the listing of step 3012 is not intended to limit the invention. The EDP device then follows a ramp-down procedure in which the stimulation parameters are sequentially decreased in step 3014 to conserve battery and avoid potential habituation.

31 is a flow diagram illustrating steps associated with another embodiment of a method of using an electrical skin patch device to suppress appetite in a patient. At step 3102 , the patient acquires an electrical skin patch (EDP) device, and uses the EPD device to monitor, acquire, record and/or transmit physiological data to a companion device such as a smartphone and a separate device, eg, physiological data. To do this, pair it with a device that has a physiological sensor configured to be worn on the body, such as around the wrist. In some embodiments, pairing with a separate device may be performed at any time within a treatment cycle. In some embodiments, the treatment cycle lasts 3 months. In step 3104, the device is set to a default operating mode. In some embodiments, the default mode of operation includes the stimulation parameters and parameter ranges listed above with respect to FIG. 27C and includes daily stimulation.

The EDP device is placed on the patient's body in step 3106 . At step 3108 , the companion device accumulates patient variable data including, but not limited to, appetite, hunger, well-being, weight, calories burned/weight loss, in the patient journal over a predetermined period of time. In some embodiments, the companion device accumulates data over a range of 1 to 7 days. In one embodiment, the companion device accumulates data for three days. Then, at step 3110, the companion device wirelessly drives the stimulation therapy via the EDP device based on the patient diary data accumulated during the treatment cycle. During the treatment cycle, if the patient experiences nausea and/or indigestion, the interlocking device rapidly ramps down the stimulation parameters in step 3112 . During the treatment cycle, if the patient feels a defined satiety with no hunger along with good dietary adherence, the interlock device will stimulate stimulation at a minimum threshold equal to one 15-minute stimulation session every other day to conserve battery and prevent habituation. Slowly lower or leave the stimulus unchanged in step 3114 . During the treatment cycle, if the patient experiences hunger and is non-conforming to the diet, the interlocking device ramps up the stimulus accordingly in step 3116 . At step 3118 , the interlocking device modifies the stimulus based on actual weight loss, measured ghrelin levels, or estimated calories burned during the treatment cycle. In one embodiment, the companion device uses a weight loss predictor algorithm based on calorie input versus calorie intake. In step 3120, the companion device displays a composite score measuring the overall success derived from the variable input. If the patient is not compliant, the interlocking device will provide an audible and/or visual reminder to the patient at step 3122 . Optionally, at step 3124 , the companion device provides the patient with the option to share their results via social media with designated friends and family.

In an alternative embodiment, the companion device first accumulates the patient diary data before the EDP device is set to the default mode of operation. Referring to FIG. 31 , in this alternative embodiment, step 3108 is performed prior to step 3104 . The remaining steps proceed in the same order.

In another embodiment, the patient is provided with a manual option to operate the EDP device. The patient may operate the device at low, medium and high settings based on patient variable data. For example, in one embodiment, the patient starts the EDP device at a high setting but begins to experience nausea and/or indigestion. The patient then resets the EDP device to a medium setting and then to a low setting. Eventually, the patient feels hungry and resets the EDP device to an intermediate setting. In some embodiments, the protocol is driven by a therapy intensity scale, such as 1 to 5 or 1 to 10, or driven by a graphic on the display of the companion device. In some embodiments, manual manipulation using low, medium, and high settings is combined with the protocol described with reference to FIGS. 27C-31 to establish baseline EDP device settings.

32A is a flow diagram illustrating steps associated with another embodiment of a method of using an electrical skin patch device to suppress appetite in a patient. In step 3202, the patient receives instructions from the medical professional, receives an electric skin patch (EDP) device, and downloads the patient diary application to an associated device such as a smartphone. Optionally, at step 3204, the patient immediately puts on the EDP, turns it on, and pairs it with the companion device so that the companion device begins recording appetite, hunger and wellness parameters in the Patient Diary application. In one embodiment, the EDP then initiates a default parameterized regimen (ie, every other day, 1X/day for 30 minutes) at step 3212 with no patient input required. The patient diary application then accumulates key data such as appetite, hunger and well-being (ie, nausea, indigestion, energy levels, weakness/fatigue) over a predetermined period of time at step 3216 . After a minimum period of time (i.e., 3 days) has elapsed at step 3218, the Patient Journal application initiates modifications to default parameter settings that may or may not result in an immediate stimulus, where the modifications may be made to any stimulus or It can include increments or decrements for timing variables.

Alternatively, in another embodiment, immediately after step 3204 the patient puts on the EDP, the patient diary application provides the patient with various options (ie, high, medium, low appetite control) in step 3214 and , start setting partially customized parameters based on the selected option. The patient log application then continues accumulating key data and begins modifying parameter settings, as detailed in steps 3216 and 3218, respectively.

Optionally, in another embodiment, after the patient receives the EDP and downloads the patient diary application ( 3202 ), the patient does not immediately put on the EDP in step 3206 , but first turns on the EDP and pair it with the companion device and Start recording key data parameters such as appetite, hunger and well-being in the Patient Journal application. In step 3222, if the patient diary application accumulates key data for a predetermined period of time, the patient is instructed by the application to wear the EDP. Then, in step 3224, once the companion device receives confirmation that the EDP is being worn, the patient log application may or may not result in an immediate stimulus, the patient log application may or may not result in an immediate stimulus based on the accumulated data developed by the patient log application. Initiate the stimulation protocol. Based on continued key data entry, at step 3226, the patient journal application may initiate further modifications to parameter settings that may or may not result in an immediate stimulus, where the modifications may be made to any stimulus or timing variable. It can include increments or decrements.

Still optionally, in another embodiment, after step 3202 in which the patient receives the EDP and downloads the patient diary application, the patient does not immediately put on the EDP in step 3208, but first turns on the EDP, pair with other wearable devices, such as devices with physiological sensors configured to be worn on the human body, such as around the wrist, to monitor, acquire, record, and/or transmit physiological data; and key data parameters such as well-being and data from other wearable devices such as fitness/exercise to the Patient Journal application. At step 3232 , if the patient diary application accumulates key data and data from other wearable devices for a predetermined period of time, the patient is instructed by the application to wear the EDP. Then, in step 3234, upon receipt of confirmation that the EDP is worn by the companion device, the patient log application is developed by the patient log application based on all accumulated data that may or may not result in immediate stimulation. Initiate a customized stimulation protocol. Based on ongoing key data input and ongoing input from other wearable devices, at step 3236, the patient log application may initiate further modifications to parameter settings that may or may not result in immediate stimulation; Modifications herein may include increments or decrements for any stimulus or timing variable.

32B is a flow diagram of a plurality of steps associated with another embodiment of a method for managing hunger or appetite in a patient. In step 3240, the patient downloads a health management application (HMA) to a companion device such as a smartphone. At step 3242, the patient is prompted by the health care application to enter data indicative of the patient's appetite or hunger level (ie, degree of desire or intention to eat). In embodiments, the prompt generated by the health care application is either visual (via one or more graphical user interfaces displayed on the companion device) or audible (via an intelligent personal assistant (IPA) system in communication with the speaker or HMA of the companion device). can be hostile Similarly, the input provided by the patient may be audible through at least one graphical user interface displayed on the companion device or through a microphone of the companion device or IPA system.

In embodiments, the visual or audible prompt may be in the form of at least one of an audio message, a video message, a text message, or a graphic message. In some embodiments, the visual or audible prompt is in the form of a visual analog scale (VAS), where each value in the VAS represents a different degree of appetite or hunger. In some embodiments, the VAS is a light bar with a sliding scale, wherein a first end of the sliding scale indicates a low degree of appetite or hunger, and a second end of the sliding scale indicates a high degree of appetite or hunger. In some embodiments, the visual or audible prompt is in the form of a plurality of icons, each of the plurality of icons indicating a different degree of appetite or hunger.

In some embodiments, the HMA causes the companion device to generate a visual or audible prompt at a first rate during a first time window and at a second rate after the first time window, wherein the second rate is greater than the first rate. small. In some embodiments, the first rate ranges from 1 time per day to 24 times per day, and the first time window ranges from 1 day to 1 month. In some embodiments, the HMA provides the patient with an option to modify the first ratio via a display of the companion device.

In step 3244, the degree of input of hunger or appetite data is obtained or recorded by the health care application and used to determine the patient's appetite pattern or hunger pattern. In some embodiments, the HMA determines a time window associated with each input degree of appetite or hunger data, and values such that for each time window a range of values for all input degrees of appetite or hunger data associated with this time window constitutes a pattern. Determines an appetite pattern or a hunger pattern by determining whether it is within a predetermined range around it.

In an embodiment, the HMA is further configured to generate and visually display at least one of an appetite pattern as a graphical representation of the input hunger degree over time or a hunger pattern as a graphical representation of the input hunger degree over time. In various embodiments, the graphical representation includes at least one of a topographic map, a scatter plot, or a bar chart indicating at least one of appetite peaks and valleys or hunger peaks and valleys. In various embodiments, the color and/or intensity or hue of a color in the graphical representation indicates a degree of appetite or a degree of hunger.

It should be understood that the accuracy of the graphical representation of at least one appetite or hunger pattern improves over time as more and more hunger or appetite data are acquired or recorded by the HMA over a period of time. In an embodiment, the at least one appetite or hunger pattern comprises one or more hunger or appetite peaks (eg, hunger frequency peak 3256 in FIG. 32C ). In some embodiments, hunger peaks are presented to the patient as a color bar (e.g., red or orange bar) for the time of day and the intensity of the color increases as historical hunger event data becomes more accurate (e.g., from pale orange to (in bright orange), that is, there are more hunger event items at certain times of the day during the time period. In addition, various preemptive interventions and stimulation treatments begin to affect the patient's appetite, and over time, hunger decreases, resulting in a decrease in color intensity (e.g., from bright orange to pale orange) to record hunger or appetite. This can be reduced. Color may further be used to specify the timing of an intervention or intervention based on the type of intervention or timing of the intervention, for example using a specially colored, shaped or sized icon.

In some embodiments, the appetite pattern or hunger pattern is a graph having a time of day on a first axis, calendar days on a second axis, and an icon displaying the user's degree of appetite or hunger on the graph in relation to the time of day and calendar day. is the form of In some embodiments, at least one of the size, shape, color, or pattern of the icon indicates the degree of appetite or hunger of the user.

In some embodiments, the HMA is configured to visually indicate an appetite pattern or hunger pattern as a composite appetite or hunger score. In some embodiments, the aggregate appetite or hunger score for a day reflects an aggregation of appetite or hunger data that occurs beyond a predetermined but yet modifiable threshold. In some embodiments, the aggregation may be determined in terms of appetite or hunger data input by the patient, while in other embodiments the aggregation may be determined in terms of frequency of appetite or hunger data input by the patient. In some embodiments, the overall appetite or hunger score is determined as the average of VAS appetite or hunger scores measured multiple times during the day over a period of time. In some embodiments, the overall appetite or hunger score is determined as the average of at least 2 VAS appetite or hunger scores measured during the day. In one embodiment, the overall appetite or hunger score is determined as the average 8 VAS appetite or hunger score measured over the day. In embodiments, a daily composite appetite or hunger score may be archived and used to compare a current composite score to a historical composite score to measure the effectiveness of a treatment or therapy over time. In some embodiments, there may be a first composite appetite or hunger score during a regular day when the patient is eating, and a second composite appetite or hunger score during a fasting day. In some embodiments, first and second overall appetite or hunger scores may be compared. In various embodiments, trends in the daily aggregate appetite or hunger scores may be used to titrate therapy and/or guide patients.

In step 3246, the HMA determines the timing of a future appetite or hunger event on a per-patient basis based on the appetite or hunger pattern. In some embodiments, the timing of a future appetite or hunger event is determined by determining a plurality of dates and times when the user's appetite or hunger degree exceeds one or more predetermined but modifiable thresholds that define a baseline appetite or hunger degree. it is decided A baseline appetite or hunger degree, when run, is calculated by: 1) obtaining historical appetite or hunger data, and 2) calculating an average, arithmetic mean, or other function of the appetite or hunger data for a given time of day or week to produce an output value. It may be determined by the controller executing the plurality of program instructions to determine. This output value can be specified as a baseline appetite or hunger degree. In some embodiments, the HMA determines the degree or intensity of appetite or hunger for a future appetite event or hunger event (eg, based on past use of a VAS hunger or appetite rating scale to input a hunger or appetite event). . In embodiments, the threshold may be manually modified by the patient or automatically modified by the HMA.

In some embodiments, the timing of a future appetite or hunger event is determined by evaluating the frequency with which the user's appetite or hunger level exceeds a predetermined but yet modifiable threshold. Thresholds allow health care applications to determine the likelihood or probability that a future appetite or hunger event will occur, allowing the most likely future appetite or hunger event to be selectively targeted for preemptive intervention. In other words, the HMA predicts the likelihood that a hunger or appetite event will occur based on the number of past hunger or appetite events that occurred during a particular time of day(s). In embodiments, the threshold may be manually modified by the patient or automatically modified by the HMA.

At 3248 , the HMA determines one or more preemptive interventions and generates the one or more preemptive interventions based on the determined timing of future appetite or hunger events. In some embodiments, the HMA does not cause an intervention to be generated during a future time window if the user's degree of appetite or degree of hunger is expected to be less than a first threshold in a future time window. In some embodiments, the HMA generates at least one intervention during a future time window if the user's degree of appetite or degree of hunger is expected to be greater than or equal to the first threshold in the future time window.

In embodiments, the one or more preemptive interventions are generated at the beginning of a predetermined intervention time window before future appetite or hunger events occur to dampen or prevent the cravings before they become overwhelming or overwhelming. The predetermined intervention time window is automatically adjustable by the patient, the TPM or by the HMA. In some embodiments, the predetermined intervention time window ranges from 15 to 40 minutes prior to the time of occurrence of a future appetite or hunger event. In some embodiments, the predetermined intervention time window is 30 minutes prior to the occurrence time of a future appetite or hunger event.

32C is a graphical representation of a patient's hunger map 3200 in accordance with some embodiments herein. Hunger map 3200 illustrates the frequency of recurrent hunger events 3254 recorded at the same time of day 3255 over multiple days in the form of a topographical map of hunger frequency peaks 3256 . In some embodiments, this hunger frequency peak 3256 represents the likelihood of a hunger event occurring at a specific time of day.

Line 3257 represents the threshold for creating a proactive intervention. For example, the threshold line 3257 is set to the frequency of 4 hunger peaks. This means that all hunger frequency peaks 3256 above 4 will be tagged by the health care application as having a high enough probability of occurrence to warrant proactive intervention. Thus, the modification of the probability threshold line 3257 (manually by the patient, automatically by the TPM, or automatically by the HMA) is the hunger map ( 3200) to adjust the sensitivity. In an embodiment, threshold line 3257 also determines the generation of alerts, reminders, and prompts by the HMA. Accordingly, at every hunger frequency peak 3256 above the threshold line 3257 , the HMA generates audio, visual and/or tactile alerts, reminders and prompts for the patient for proactive intervention.

Map 3200 also illustrates a predetermined intervention time window 3258 (as the width of color bar 3259 ) for hunger frequency peak 3256 above threshold line 3257 . According to one embodiment, each of the intervention time windows 3258 is set 30 minutes before the hunger frequency peak 3256 occurs above the threshold line 3257 . In addition, hunger frequency peak 3256 is presented to the patient as a time of day color bar 3259 . In various embodiments, the color intensity of the bar 3259 varies (eg, from pale yellow to light yellow) as the number of hunger or appetite inputs/events increases (indicative of increased accuracy of hunger or appetite data) during certain times of the day. ) or the color intensity of the bar 3259 decreases as the number of hunger or appetite inputs/events decreases during certain times of the day (e.g., various preemptive interventions and/or stimulation treatments may affect the patient's appetite). It begins to have an effect and may decrease (eg, from light yellow to pale yellow) when hunger or appetite events decrease by reducing hunger over time.

In various embodiments, the health care application generates any one or combination of the following proactive interventions:

a) Stimulation-based intervention, in this case the HMA is configured to interface automatically with an EDP device, separate from the interlocking device, configured to apply electrical stimulation to the patient's skin. In some embodiments, the applied electrical stimulation corresponds to a rescue stimulation session. The rescue stimulation session may be started automatically by the healthcare application, or the healthcare application may prompt the patient for an expected upcoming appetite or hunger event and recommend the patient to manually trigger the rescue stimulation session. In some embodiments, the stimulation parameters of the rescue stimulation session include a first pulse width in the range of 10 μsec to 10 msec, a first pulse amplitude in the range of 100 μA to 100 mA, and a first pulse frequency in the range of 1 Hz to 100 Hz.

b) non-stimulus-based interventions, which aim to preemptively disperse, motivate and/or sedate a patient's hunger or appetite using interventions or recommendations driven by a health care application, for example, by a delivery modality such as: do with:

시각적 표시 또는 청각적 피드백을 통해 환자에게 처방된 구조용 간식(음료 및/또는 음식)을 마시거나 먹으라는 권고를 전달한다. 일부 실시예에서, 건강 관리 애플리케이션은 환자가 건강 관리 애플리케이션과 통합된 전자상거래 인터페이스를 통해 구조 음료 또는 음식을 주문할 수 있게 한다.

Advise the patient to drink or eat the prescribed rescue snack (drink and/or food) via visual indication or audible feedback. In some embodiments, the health care application allows the patient to order rescue drinks or food through an e-commerce interface integrated with the health care application.

시각적 표시 또는 청각적 피드백을 통해 환자에게 미리 정해진 신체 운동 또는 신체 활동에 참여하라는 권고를 전달한다. 일부 실시예에서, HMA는 미리 정해진 신체 운동이나 신체 활동에 참여하라는 권고에 기초하여 신체 운동 또는 신체 활동 타이머 또는 특정 신체 운동 또는 특정 신체 활동에 대한 시각적 지시 중 적어도 하나를 생성하고 연동 디바이스를 통해 시각적으로 또는 청각적으로 제시하도록 구성된다.

A recommendation to engage in a predetermined physical exercise or physical activity is communicated to the patient through visual indications or audible feedback. In some embodiments, the HMA generates at least one of a physical exercise or physical activity timer or a visual indication for a specific physical exercise or specific physical activity based on a recommendation to engage in a predetermined physical exercise or physical activity and provides a visual indication via the companion device. presented visually or audibly.

시각적 표시 또는 청각적 피드백을 통해 환자에게 명상과 같은 마음챙김 활동에 참여하라는 권고를 전달한다. 일부 실시예에서, HMA는 마음챙김 활동에 참여하라는 권고에 기초하여 명상 이미지 또는 명상 음악 중 적어도 하나를 생성하고 연동 디바이스를 통해 시각적으로 또는 청각적으로 제시하도록 구성된다.

Communicate the recommendation to the patient to engage in mindfulness activities, such as meditation, through visual cues or audible feedback. In some embodiments, the HMA is configured to generate and visually or audibly present at least one of a meditation image or meditation music based on the recommendation to engage in mindfulness activity.

시각적 표시 또는 청각적 피드백을 통해 환자의 마음을 점유/분산시키기 위해 환자에게 인지 활동 또는 운동에 참여하라는 권고를 전달한다. 일부 실시예에서, HMA는 인지 운동에 참여하라는 권고에 기초하여 정신적 도전 또는 정신적 퍼즐 중 적어도 하나를 생성하고 연동 디바이스를 통해 시각적으로 또는 청각적으로 제시하도록 구성된다. 예를 들어, 환자는 십자말 퍼즐 또는 미니 비디오 게임을 포함하지만 이로 국한되지 않는 정신적 도전을 받을 수 있다. 먹는 것에 대해 생각하는 과정은 뇌에 인지적 부담을 부과하고 뇌를 다른 인지 활동에 참여시키는 것은 그렇지 않은 경우 이러한 정신적 자원을 점유하거나 음식에 대한 갈망에서 멀어지게 할 수 있는 것으로 이해된다.

Communicate recommendations to the patient to engage in a cognitive activity or exercise to occupy/dissipate the patient's mind through visual indications or audible feedback. In some embodiments, the HMA is configured to generate and visually or audibly present at least one of a mental challenge or a mental puzzle based on a recommendation to engage in a cognitive exercise. For example, a patient may be faced with a mental challenge including but not limited to a crossword puzzle or mini video game. It is understood that the process of thinking about eating places a cognitive burden on the brain and engaging the brain in other cognitive activities can otherwise seize these mental resources or drive away from food cravings.

시각적 표시 또는 청각적 피드백을 통해 사용자가 배고픔이나 식욕에 시각적으로 참여할 수 있도록 설계된 게임에 참여하라는 권고를 환자에게 전달한다. 예를 들어, 일 실시예에서, 사용자가 (본 명세서 전반에 걸쳐 설명된 바와 같이) 임계값 수준보다 높은 식욕 또는 배고픔 수준을 보고할 때, HMA는 보고되거나 결정된 식욕 또는 배고픔 수준을 나타내는 시각적 이미지 또는 청각 신호를 사용자에게 제공하도록 구성된다. 사용자의 식욕 또는 배고픔 수준은 이모지, 개인 아바타 또는 디자인, 크기, 형상 또는 색상이 VAS를 통해 사용자가 보고한 대로 식욕 또는 배고픔 수준을 나타내는 기타 그래픽 기호로 표시될 수 있다. 사용자는 그런 다음 이모지, 개인 아바타 또는 기타 그래픽 기호를 잡거나, 산호, 패배, 제어, 제압, 공격, 싸우거나 다른 방식으로 참여해야 하는 게임이 제공된다. 사용자가 이모지, 개인 아바타 또는 기타 그래픽 기호를 성공적으로 참여하면 식욕 또는 배고픔 수준의 디자인, 크기, 형상 또는 색상이 수정된다. 일부 방식으로 시각을 수정하여 자신의 배고픔이나 식욕 수준을 시각적 또는 청각적으로 참여하는 사용자의 행위는 인지 운동이나 개입을 구성하며, 배고픔이나 식욕의 수준을 직접 감소시킬 수 있는 것으로 이해된다.

The patient is advised to engage in a game designed to visually engage the user in hunger or appetite, either through a visual indication or audible feedback. For example, in one embodiment, when a user reports an appetite or hunger level above a threshold level (as described throughout this specification), the HMA may display a visual image or and provide an audible signal to the user. A user's appetite or hunger level may be indicated by an emoji, personal avatar or other graphic symbol whose design, size, shape or color indicates the appetite or hunger level as reported by the user via VAS. The user is then presented with a game in which he must grab an emoji, personal avatar or other graphic symbol, coral, defeat, control, subdue, attack, fight or otherwise engage. When a user successfully engages an emoji, personal avatar, or other graphic symbol, the design, size, shape or color of the appetite or hunger level is modified. It is understood that the user's act of visually or aurally engaging his or her hunger or appetite level visually or aurally by modifying the vision in some way, constitutes a cognitive exercise or intervention, and may directly reduce the level of hunger or appetite.

시각적 표시 또는 청각적 피드백을 통해 환자에게 긍정적인 음식 관련 이미지와 부정적인 음식 관련 이미지에 참여하라는 권고를 전달한다. 긍정적인 음식 이미지에는 브로콜리, 당근, 새싹, 잎이 많은 채소 또는 샐러드와 같은 건강한 야채가 포함될 수 있다. 부정적인 음식 관련 이미지에는 억센 덩어리, 지방 덩어리, 음식물 쓰레기, 담배 꽁초 또는 기타 쓰레기와 같은 식욕을 돋우지 않는 이미지가 포함될 수 있다. 일부 실시예에서, HMA는 음식 관련 이미지에 참여하라는 권고에 기초하여 연동 디바이스를 통해 음식 관련 이미지를 시각적으로 표시하고 생성하도록 구성된다.

Advise patients to engage with positive food-related images and negative food-related images through visual cues or audible feedback. A positive food image could include healthy vegetables such as broccoli, carrots, sprouts, leafy greens, or salads. Negative food-related images may include non-appetizing images, such as chunky chunks, fat chunks, food waste, cigarette butts, or other garbage. In some embodiments, the HMA is configured to visually display and generate a food-related image via the companion device based on a recommendation to engage with the food-related image.

시각적 표시 또는 청각적 피드백을 통해 문자 메시지, 이메일, 음성 통화, 소셜 미디어 플랫폼 또는 화상 회의 중 적어도 하나를 통해 가상 또는 실제 코치에 참여하라는 권고를 환자에게 전달한다. 이러한 참여의 목적은 환자에게 동기를 부여하고 격려하며 경고하는 것이다. 일부 실시예에서, HMA는 문자 메시지, 이메일, 음성 통화, 소셜 미디어 플랫폼 또는 화상 회의 중 적어도 하나에 참여하기 위한 인터페이스를 생성하고 연동 디바이스를 통해 시각적으로 또는 청각적으로 제시하도록 구성된다.

Communicate the recommendation to the patient to engage with the virtual or physical coach via at least one of text message, email, voice call, social media platform, or video conferencing via visual indication or audible feedback. The purpose of this participation is to motivate, encourage and warn the patient. In some embodiments, the HMA is configured to generate and visually or audibly present an interface for participating in at least one of a text message, email, voice call, social media platform, or video conference.

c) drug-based interventions, for example:

시각적 표시 또는 청각 피드백을 통해 환자에게 약물의 시간 및/또는 용량을 적정하라는 권고를 전달한다. 일부 실시예에서, 약물은 당뇨병 약물 또는 체중 감량 약물 중 적어도 하나이다. 예를 들어, 펜터민은 경구 복용하고 약 4시간 내에 최고 농도에 도달하는 다이어트 약물이다. 예상되는 향후 배고픔 이벤트에 기초하여, 건강 관리 애플리케이션은 예상되는 향후 배고픔 이벤트에 대한 효과를 최대화하기 위해 약물을 복용해야 정확한 시기에 대한 최적의 스케줄을 프로그래밍할 수 있다. 따라서, 예상되는 향후 배고픔 이벤트는 치료가 (예를 들어, 비만, 당뇨병 또는 기타 대사 상태의 치료에서) 배고픔/섭식 이벤트와 직접 또는 간접적으로 관련되어 있는 환자의 약물 투여 시간을 정하거나 약물 투여를 적정하는 데 사용된다.

Recommendations are communicated to the patient to titrate the time and/or dose of the drug via visual indication or auditory feedback. In some embodiments, the drug is at least one of a diabetes drug or a weight loss drug. Phentermine, for example, is a diet drug that reaches peak concentrations within about 4 hours of being taken orally. Based on the expected future hunger event, the health care application can program the optimal schedule for the exact time when the drug should be taken to maximize the effect on the anticipated future hunger event. Thus, anticipated future hunger events can be determined by timing or titration of drug administration in patients whose treatment is directly or indirectly related to a hunger/eating event (eg, in the treatment of obesity, diabetes, or other metabolic conditions). used to do

and automatically directly interface with a separate medical device that modulates or assists human functions to optimize at least one of timing or dosing of therapy delivered to the user via the separate medical device. In some embodiments, the separate medical device is at least one of an intravenous delivery device or controller thereof, a smart intravenous pump or smart infusion system, an enteric nutrient pump, a continuous blood glucose monitoring device, a wearable drug pump, or an artificial pancreas.

32D is a flow diagram of a plurality of steps associated with another embodiment of a method of managing hunger or appetite in a patient. At step 3260 , the patient receives instructions from the healthcare professional, receives an electric skin patch (EDP) device, and downloads a health care application (HMA) to an associated device such as a smartphone. In step 3262 the patient turns on the EDP, pairs it with the companion device and is instructed to wear the EDP by the application.

Then, in step 3264, upon receiving confirmation that the EDP is being worn, the patient may be placed on a predetermined total daily rescue budget (eg, 3 to 5 rescue sessions per day not exceeding 100 minutes in total per day) ) can trigger an on-demand structured stimulation session (consists of an unscheduled stimulus). In some embodiments, the rescue sessions each comprise short duration sessions, such as, for example, durations ranging from 5 minutes to 20 minutes. The patient's triggering of these rescue sessions is improvised whenever the patient feels hungry, and the HMA does not generate a prompt for the patient to trigger the rescue session. Additionally or alternatively, whenever a patient feels hungry, a light bar VAS can be used to record spontaneous hunger and its degree or intensity without eliciting a structural stimulus. Again, the HMA does not prompt the patient to record these hunger events.

It should be understood that the rescue session is a patient-led, real-time stimulation intervention as a result of the patient experiencing an unplanned hunger craving. However, the patient may continue to receive daily scheduled/scheduled stimulation treatments/sessions based on the daily meal cycle.

At step 3266, patient triggered rescue sessions and/or non-stimulation based spontaneous hunger or appetite events are tracked (including date and time stamping) and recorded by the HMA. In accordance with some aspects herein, it is recognized that despite prompts, reminders, and encouragement generated by health care applications and/or online concierge services, a patient may not be able to record the extent of appetite or hunger data. However, it is recognized that it is likely that patients use rescue stimulation sessions to attenuate hunger/appetite and/or record spontaneous hunger or appetite events that are not necessarily followed by stimulation sessions.

Accordingly, at step 3268, the healthcare application associates each patient-triggered rescue session and/or non-stimulus-based voluntary hunger with a hunger or appetite event. In some embodiments, such hunger or appetite events do not necessarily have an associated hunger or appetite intensity level, but in some embodiments may simply indicate the occurrence of a hunger or appetite event (of unrecorded intensity) on a specific date and time. It should be understood that there is In some embodiments, a predetermined number of rescue sessions or spontaneous hunger cases ( One or more filter conditions, including but not limited to (ranging from 1 to 10), are set to achieve a sufficient level of confidence that rescue sessions and/or spontaneous hunger events are indicative of a pattern of hunger rather than a one-time random event. One or more filter conditions may be manually adjustable by the patient, TPM, or automatically adjustable by the HMA.

In step 3270 , hunger or appetite events are achieved or recorded by the health care application and used to determine the patient's appetite pattern or hunger pattern. In some embodiments, the HMA determines a time window associated with each hunger or appetite event, and for each time window a range of values of all hunger or appetite events associated with this time window fall within a predetermined range around the values to constitute a pattern. By determining whether there is an appetite pattern or a hunger pattern.

In an embodiment, the HMA is further configured to generate and visually display at least one of a hunger or appetite pattern as a graphical representation of a hunger event recorded over time. In various embodiments, the graphical representation includes at least one of a topographic map, a scatter plot, or a bar chart indicating at least one of appetite peaks and valleys or hunger peaks and valleys. In some embodiments, a color and/or intensity or hue of a color in the graphical representation indicates a frequency of hunger or appetite events or a degree/intensity of hunger or appetite events.

In some embodiments, the appetite pattern or hunger pattern includes an icon representing the frequency or degree of hunger or appetite events displayed on the graph in relation to the time of day on the first axis, the calendar days on the second axis, and the time of day and calendar days. It is in the form of a graph with In some embodiments, at least one of the size, shape, color or pattern of the icon indicates the frequency or degree of hunger or appetite events of the user.

It should be understood that the accuracy of the graphical representation of at least one appetite or hunger pattern improves over time as more and more hunger or appetite data are acquired or recorded by the HMA over a period of time. In an embodiment, the at least one appetite or hunger pattern comprises one or more hunger or appetite peaks and valleys. In some embodiments, hunger peaks are indicated to the patient as a color bar (e.g., red or orange bar) for the time of day and the intensity of the color (e.g., from pale orange to pale orange) as historical hunger event data becomes more accurate. (in bright orange), that is, during a period of time, there are more hunger event items during certain times of the day. In addition, various preemptive interventions and stimulation treatments begin to affect the patient's appetite, and over time the hunger decreases, resulting in a decrease in the intensity of the color, resulting in a hunger or appetite record (e.g., from bright orange to pale orange). ) can be reduced.

In some embodiments, the HMA is configured to visually indicate an appetite pattern or hunger pattern as a composite appetite or hunger score. In some embodiments, the overall appetite or hunger score during the day reflects an aggregation of the frequency of hunger or hunger events occurring beyond a predetermined but modifiable threshold. In some embodiments, the aggregation may be determined in terms of the degree of hunger or appetite events occurring beyond a predetermined but modifiable threshold. In some embodiments, the overall appetite or hunger score is determined as an average of VAS hunger or appetite event scores. In embodiments, a composite appetite or hunger score may be used to measure the effectiveness of a treatment or therapy over time. In some embodiments, there may be a first composite appetite or hunger score for a regular day on which the patient is eating, and a second composite appetite or hunger score for a fasting day. In some embodiments, first and second overall appetite or hunger scores may be compared. In various embodiments, trends in daily aggregate appetite or hunger scores may be used to titrate therapy and/or coach patients.

At step 3272 , the HMA determines the timing of a future appetite or hunger event per patient based on the appetite pattern or hunger pattern. In some embodiments, the timing of a future appetite or hunger event is determined by determining a plurality of dates and times when the patient's degree of appetite or hunger event exceeds one or more predetermined but modifiable thresholds. In embodiments, the threshold may be manually modified by the patient or automatically modified by the HMA.

In some embodiments, the timing of a future appetite or hunger event is determined by evaluating the frequency at which the patient's appetite or hunger event exceeds a predetermined but modifiable threshold. Thresholds allow health care applications to determine the likelihood or probability that a future appetite or hunger event will occur, allowing the most likely future appetite or hunger event to be selectively targeted for preemptive intervention. In embodiments, the threshold may be manually modified by the patient or automatically modified by the HMA.

At step 3274 , the HMA determines one or more preemptive interventions and generates the one or more preemptive interventions based on the determined timing of future appetite or hunger events. In various embodiments, the one or more proactive interventions include at least one of a stimulus-based intervention, a non-stimulus-based intervention, and a drug-based intervention described with reference to step 3248 of FIG. 32B .

In embodiments, the one or more preemptive interventions are generated at the beginning of a predetermined intervention time window before future appetite or hunger events occur to dampen or prevent the cravings before they become overwhelming or overwhelming. The predetermined intervention time window is adjustable by the patient, the TPM, or automatically adjustable by the HMA. In some embodiments, the predetermined intervention time window ranges from 15 minutes to 40 minutes prior to the time of occurrence of a future appetite or hunger event. In some embodiments, the predetermined intervention time window is 30 minutes prior to the occurrence time of a future appetite or hunger event.

In some embodiments, a typical daily stimulus is: a) a scheduled or scheduled pre-meal stimulation session of 45 minutes each (total scheduled pre-meal stimulation sessions) that occurs 45 minutes prior to a scheduled meal time (eg, before breakfast, lunch, dinner) = 45 min x 3 = 135 min); b) 15 minutes of scheduled preemptive stimulation sessions (to anticipate and attenuate future/expected hunger events) x 2 sessions to preempt expected hunger events = 30 minutes of stimulation in total; and c) one session of 15 minutes subject to a total daily stimulation of 180 minutes on a budget not exceeding 200 minutes.

77A is a flow diagram illustrating a plurality of steps for enabling a user to record their appetite or hunger in accordance with some embodiments herein. In step 7702 , the user downloads a health management application (HMA) to a companion device such as a smartphone. At step 7704, the HMA generates one or more prompts that prompt the patient to enter data indicative of an appetite or hunger event (ie, desire or intent to eat). In some embodiments, the one or more prompts are randomly generated or generated at a predetermined fixed time per day or weekly. It should be understood that one or more prompts advise the patient to record a hunger event even when the patient is not hungry.

In some embodiments, at step 7706a, the patient uses a light bar VAS intensity scale to display appetite or hunger events in the form of degrees (eg, "I am hungry 6/10 at this time of day"), intensity, or scores using a light bar VAS intensity scale. Enter Alternatively, in some embodiments, in step 7706b, the patient simply enters his or her appetite or hunger event as an instance or occurrence without using the VAS scale to record the degree, intensity, or score corresponding to the hunger event. do.

At step 7708, the HMA acquires and records the patient's entered appetite or hunger event along with the patient's entered date and time.

77B is a flow diagram illustrating a plurality of steps for enabling a user to record appetite or hunger in accordance with some embodiments herein. In step 7710 , the user downloads a health management application (HMA) to a companion device such as a smartphone. At step 7712, the patient voluntarily enters data indicative of an appetite or hunger event (ie, desire or intent to eat) without being prompted or prompted by the HMA.

In some embodiments, at step 7714a, the patient uses a light bar VAS intensity scale to indicate appetite or hunger in the form of degree (eg, "I am hungry 6/10 at this time of day"), intensity, or score using a light bar VAS intensity scale. Enter the event. Alternatively, in some embodiments, in step 7714b, the patient simply enters an appetite or hunger event as an instance or occurrence to record the degree, intensity, or score corresponding to the hunger event without using the VAS scale.

At step 7716, the HMA acquires and records the patient-entered appetite or hunger event along with the patient-entered date and time.

78 is a flow diagram illustrating a plurality of steps for enabling a patient to apply structural stimulation therapy in accordance with some embodiments herein. In step 7802, the patient receives instructions from the healthcare professional, receives an electric skin patch (EDP) device, and downloads a health care application (HMA) to an associated device such as a smartphone. In step 7804, the patient turns on the EDP, pair it with the companion device, and is instructed to wear the EDP by the application.

Then, at step 7806, upon receiving confirmation that the EDP is being worn, the patient may have a predetermined total daily rescue budget (eg, 3 to 5 rescue sessions per day not exceeding 100 minutes in total per day) not) can trigger a rescue stimulation session of a predetermined duration. In some embodiments, rescue sessions include short duration sessions, such as, for example, durations ranging from 5 minutes to 20 minutes each. Triggering these rescue sessions by the patient is improvised whenever they are hungry or want to eat, and the HMA does not generate a prompt for the patient to trigger a rescue session.

In some embodiments, the patient triggers the rescue stimulus by actuating a button on the EDP or clicking an icon or button (eg, shortcut) on the companion device. In some embodiments, rescue stimulation may be automatically triggered by the HMA as a result of the patient recording a spontaneous hunger event using the VAS intensity scale and predetermined threshold intensity settings. For example, if a patient records a hunger event at an intensity of 7/10, the HMA may automatically trigger a rescue stimulation session, but if a patient records a hunger event at an intensity of 6/10, the HMA may not trigger a rescue stimulation session.

At step 7808, the patient triggered rescue session is tracked (including date and time stamping) and recorded by the HMA.

79A is a flow diagram illustrating a plurality of steps for predicting a future appetite or hunger event in accordance with some embodiments herein. At step 7902 , the patient receives instructions from the healthcare professional, receives an electric skin patch (EDP) device, and downloads a health care application (HMA) to a companion device such as a smartphone. At step 7904 , the patient may or may not be instructed by the application to turn on the EDP and pair it with the companion device, and immediately put on the EDP.

In some embodiments, at step 7906a, the patient enters data indicative of an appetite or hunger event in response to one or more prompts generated by the HMA. Data indicative of an appetite or hunger event may include a corresponding degree, intensity or score (entered using the VAS intensity scale) or may not include a corresponding degree, intensity or score and instead simply an appetite or hunger event can constitute the occurrence of Alternatively, in some embodiments, at step 7906b, the patient enters data indicative of a spontaneous or improvised appetite or hunger event without being prompted by the HMA to do so. Data indicative of a voluntary appetite or hunger event may include a corresponding degree, intensity or score (entered using the VAS intensity scale) or may not include a corresponding degree, intensity or score and instead simply include a voluntary appetite or hunger score. You can configure the occurrence of hunger events.

At step 7908, the HMA acquires, records, and aggregates the patient-entered appetite or hunger events along with the patient-entered date and time. In step 7910, the HMA predicts the timing of future appetite or hunger events personalized to or per patient based on the aggregated appetite or hunger events.

At step 7910 , the HMA sends a personalized and predicted future appetite or hunger event to the companion device, a) an appetite or hunger event at a specific time of day (eg, a high hunger peak in the hunger map indicates a high probability of occurrence of hunger) a peak, bar, icon, or Marked by a colored hunger map.

At step 7912 , the HMA determines one or more preemptive interventions and generates the one or more preemptive interventions based on the determined timing of future appetite or hunger events. In various embodiments, the one or more proactive interventions include at least one of a stimulus-based intervention, a non-stimulus-based intervention, and a drug-based intervention described with reference to step 3248 of FIG. 32B .

In embodiments, the one or more preemptive interventions are generated at the beginning of a predetermined intervention time window before future appetite or hunger events occur to dampen or prevent the cravings before they become overwhelming or overwhelming. The predetermined intervention time window is adjustable by the patient, the TPM, or automatically adjustable by the HMA. In some embodiments, the predetermined intervention time window ranges from 15 to 40 minutes prior to the time of occurrence of a future appetite or hunger event. In some embodiments, the predetermined intervention time window is 30 minutes prior to the occurrence time of a future appetite or hunger event.

79B is a flow diagram illustrating a plurality of steps for predicting a future appetite or hunger event in accordance with some embodiments herein. At step 7914, the patient receives instructions from the healthcare professional, receives an electric skin patch (EDP) device, and downloads a health care application (HMA) to an associated device such as a smartphone. In some embodiments, the patient may not receive an EDP device at step 7914 but may instead receive an EDP device later at step 7918 .

At step 7916, the HMA generates prompts at a predetermined but modifiable rate for a predetermined period of time to allow the patient to enter preliminary or baseline appetite or hunger data. In various embodiments, the predetermined prompt rate ranges from once every 120 minutes to once every 60 minutes at the same time of day. In some embodiments, the predetermined prompt rate is once every 90 minutes at the same time of day. In various embodiments, the predetermined period of time may range from one day to several weeks. In some embodiments, the predetermined period of time is between 1 week and 2 weeks. In an embodiment, the prompt by the HMA is set to start at the wake up time and end at the patient's bed time.

At step 7918, once the HMA has accumulated the patient's preliminary or baseline appetite or hunger data, the patient is instructed to turn on the EDP, pair it with the companion device, and wear the EDP by the application. Then, in step 7920, upon receipt of confirmation that the EDP is being worn by the interlocking device, the HMA may or may not result in an immediate stimulus, which may or may not result in the HMA developed by the HMA based on at least accumulated preliminary or baseline appetite or hunger data. Initiate a custom stimulation protocol.

In some embodiments, the tailored stimulation protocol is a function of accumulated preliminary or baseline appetite or hunger data and/or the patient's diet or health goal(s). In some embodiments, the patient's dietary or health goal(s) may include one or both of a qualitative goal and a quantitative goal. Qualitative goals may consist of adhering to a specific standard diet regime including, but not limited to, a keto, Atkins, or Mediterranean diet plan. In some embodiments, a quantitative goal may correspond to a patient's desire to reach a target weight over a target time period, eg, 3 months. With the help of a dietitian, health care provider, or third-party manager (TPM), the patient estimates how few daily calories they need to consume to achieve their target weight goal and determine a daily eating plan over the target period. For example, to maintain the patient's current weight with moderate exercise, a patient can typically consume 2300 calories per day. Thus, to lose 12 pounds over a target period of 12 weeks (ie 3 months), the patient would have to reduce their daily caloric intake by 500 calories, up to 1800 calories per day. Thus, in one embodiment, the patient's daily meal plan may set calories for three daily meals and a “rescue” snack between two and three daily meals. This quantitative daily meal plan may be combined or integrated with a standard qualitative diet plan chosen by the patient.

In some alternative embodiments, the patient may put on the EDP and begin the customized stimulation therapy while generating a prompt in the HMA at step 7916 . That is, in some embodiments, prompting by the HMA to accumulate the patient's preliminary or baseline appetite or hunger data may be continued with the stimulation treatment protocol. However, this stimulation treatment protocol may only be based on the patient's diet or health goal(s) until a sufficient amount of preliminary or baseline appetite or hunger data has been aggregated by the HMA (i.e., at the end of a predetermined period). have.

In step 7922, the HMA predicts the timing of future appetite or hunger events personalized to or per patient based on the accumulated preliminary or baseline appetite or hunger data. At step 7924 , the HMA generates a personalized and predicted future appetite or hunger event and displays it on the companion device as a graphical representation of the predicted future appetite or hunger event over time. In various embodiments, the graphical representation includes at least one of a topographic map, a scatter plot, or a bar chart indicating at least one of appetite peaks and valleys or hunger peaks and valleys. In various embodiments, the color and/or intensity or hue of a color in the graphical representation is indicative of the degree or frequency of an appetite or hunger event.

At step 7926 , the HMA determines one or more preemptive interventions and generates the one or more preemptive interventions based on the determined timing of future appetite or hunger events. In various embodiments, the one or more proactive interventions include at least one of a stimulus-based intervention, a non-stimulus-based intervention, and a drug-based intervention described with reference to step 3248 of FIG. 32B .

In embodiments, the one or more preemptive interventions are generated at the beginning of a predetermined intervention time window before future appetite or hunger events occur to dampen or prevent the cravings before they become overwhelming or overwhelming. The predetermined intervention time window is automatically adjustable by the patient, the TPM or by the HMA. In some embodiments, the predetermined intervention time window ranges from 15 minutes to 40 minutes prior to the time of occurrence of a future appetite or hunger event. In some embodiments, the predetermined intervention time window is 30 minutes prior to the occurrence time of a future appetite or hunger event.

80 is a flow diagram of multiple steps of a method of using an EDP device during intermittent fasting by a user in accordance with some embodiments herein. In step 8002, the user receives instructions from the healthcare professional, receives an electric skin patch (EDP) device, and downloads a health care application (HMA) to an associated device, such as a smartphone.

At 8004 , the HMA provides at least one GUI screen to allow the user to provide input regarding the eating and eating profile to be followed over a period of time. In one embodiment, the user enters his or her eating and eating profile as intermittent fasting along with fasting date(s) and duration (ie, the user chooses not to eat for a specific duration when the patient is awake). In one use case scenario, a user may choose to follow intermittent fasting 2-3 days a week (eg, every other day) with a fasting duration of 12 hours per day. In various embodiments, the fasting duration may range from 4 to 22 hours per day, or any increments therein. In some embodiments, the user may select the option of intermittent fasting from a drop-down list of a plurality of standard eating and eating profiles including, but not limited to, Mediterranean, Jenny Craig, Weight Watchers, and Slimfast.

In step 8006, the HMA obtains the user's input regarding its eating and eating profile and creates a fasting-based stimulation schedule for implementation during the user's fasting period of the day. In some embodiments, the HMA divides the fasting period into a plurality of time segments, and stimulation sessions are scheduled for automatic delivery at the beginning or end of each time segment. In some embodiments, the plurality of time segments are selected based on the amount of time that hunger or appetite suppression peaks as a result of the stimulation session. For example, for a stimulation session of 15 minutes, hunger or appetite suppression peaks at the end of 2 hours (also called 'hunger suppression peak duration'). In some embodiments, the HMA is pre-programmed to use a hunger suppression peak duration of 2 hours, which can be customized or personalized to the user as the HMA accumulates the user's various health-related parameters and trends over a sufficient period of stimulation treatment.

Thus, we divide the fasting time into four time segments, with a fasting time of 8 hours and a peak duration of hunger suppression of 2 hours. Thus, the HMA creates a stimulation schedule in which stimulation is applied at the beginning or end of each time segment. In some embodiments, the stimulation schedule is dynamic and adapts according to the user's health-related parameters and trends accumulated by the HMA over a period of time. For example, as the user adapts to fasting and his or her appetite or hunger trends indicate a decrease in the degree and/or frequency of appetite or hunger during the fasting period, the HMA may perform fasting-based stimulation with a lower frequency or number of stimulation sessions during the fasting period. Schedules can be recommended or implemented automatically.

In step 8008, the user is instructed to turn on the EDP, pair it with the companion device and wear the EDP by the HMA. Then, in step 8010, upon receiving confirmation that the EDP is being worn by the companion device, the HMA implements a fasting-based stimulation schedule using the EDP to apply the scheduled stimulation session to the user's intermittent fasting day(s). . It should be understood that step 8008 may be implemented prior to step 8006 in alternative embodiments.

81 is a flow diagram of a plurality of steps of a method of utilizing a patient's genetic profile to recommend an optimal eating and eating profile, nutritional profile, activity/training profile, and/or stimulation regimen in accordance with some embodiments herein. In step 8102, the patient downloads a health care application (HMA) to an associated device, such as a smartphone. At step 8104 , the patient acquires an EDP device and uses the EDP device as a companion device and a separate device, eg, around the wrist to monitor, acquire, record, and/or transmit a plurality of physiological data. pair with a device that has a physiological sensor configured to be worn on the

In step 8106, the HMA generates a prompt requesting the patient to enter data representing his/her genetic profile. In some embodiments, patients are specifically asked to enter information related to their FTO genes separately from data related to other genes related to fitness, health and nutrition. If the patient has their own DNA test report, the patient can enter or upload the report through one or more GUIs displayed on the interlocking device. Alternatively, if the patient has not undergone a DNA test, the HMA recommends a DNA test, and the test results are entered by the patient if available.

In step 8108 , the HMA allows the patient to receive their 'daily diary' inputs (eg, appetite, hunger, exercise, well-being and weight) or the patient's explicit or manual input, such as, for example, blood glucose data from a scenario. Generates periodic prompts leading to providing other health-related information that may be needed, wherein blood glucose data is determined by the patient using a third party blood glucose meter that may not be in data communication with the companion device. However, in the case of a continuous blood glucose monitoring device that wirelessly communicates with the companion device, the patient's blood glucose (HbA1c) data is directly obtained by the HMA.

At step 8110 , the HMA creates at least one GUI screen that allows the patient to enter their dietary regimen or health goal(s). In some embodiments, the patient's dietary or health goal(s) may include quantitative goals. For example, in some embodiments, a quantitative goal may correspond to a patient's desire to reach a target weight over a target period of time, eg, 3 months.

In step 8112, the HMA uses the acquired genetic profile, 'daily diary' or health-related inputs, allergy data, blood glucose data, physiological data and diet or health goal(s) to individualize feeding and eating to the patient. generate at least one recommendation related to the profile, the nutritional profile, the activity/training profile, and/or the stimulation treatment. For example, at least one recommendation is the best food for the patient (eg, animal and/or plant foods), a standard diet plan that is best for the patient (eg, Mediterranean diet, intermittent fasting, Jenny Crake, Slim fast, etc.) or whether the patient should consume little or no carbohydrates, and information about the duration of time. In another example, a patient can typically consume 2300 calories per day to maintain the patient's current weight with moderate exercise. Thus, to lose 12 pounds over a target period of 12 weeks (ie 3 months), the patient would have to reduce their daily calorie intake by 500 calories, up to 1800 calories per day. Thus, in one embodiment, the HMA recommends that a patient's daily meal plan can set calories for three daily meals and a “rescue” snack between two to three meals a day. This quantitative daily meal plan can be combined or integrated with the standard diet plan recommended by the HMA. In another embodiment, dairy or nutritional recommendations are associated with the genetic or nutritional data obtained above by 1) eliminating foods that tend to react badly or 2) eliminating certain known allergens, such as gluten or dairy.

At step 8114, if the HMA recommends stimulation treatment, the patient is instructed by the HMA to wear the EDP to begin stimulation treatment.

83 is a flow diagram illustrating multiple steps of a method of personalizing a diet plan by a user in accordance with some embodiments herein. In step 8302 , the patient receives instructions from the medical professional, receives an electric skin patch (EDP) device, and downloads a health care application (HMA) to an associated device such as a smartphone.

At step 8304 , the HMA provides at least one GUI screen to allow the user to provide input regarding a diet plan that may be followed and desired for a period of time. It should be understood that the user may want to follow a diet plan for, for example, weight loss as well as a healthy lifestyle. In some embodiments, a user may select a diet plan from a drop-down list of a plurality of standard eating and meal profiles including, but not limited to, Mediterranean, Intermittent Fasting, Jenny Craig, Weight Watchers, and SlimFast. In some embodiments, as described with reference to FIG. 80 , the diet plan may include one's genetic profile, a 'daily diary' or health-related input (eg, appetite, hunger, exercise, well-being and weight), blood glucose data and As a result of analyzing multiple pieces of information, such as those related to physiological data, it may be a customized diet plan recommended by HMA.

At step 8306, the user experiences an unfamiliar appetite or hunger event that may create a challenge for the user in terms of adhering to the diet plan. For example, a user may experience extreme appetite or hunger at meal times planned or scheduled according to a diet plan. Alternatively or additionally, a user may wish to eat outside of a planned or scheduled meal time, resulting in an unplanned meal.

In step 8308, the user uses the HMA to record an unfamiliar appetite or hunger event. In various embodiments, unfamiliar appetite or hunger events are recorded with or without intensity or degree of appetite/hunger. At step 8310, the user uses his/her hunger map (generated by the HMA and displayed to the user) to personalize, adjust or adjust the diet as needed and anticipate cravings by applying appropriate healthy snacks and/or structural stimuli. and stop For example, a user may choose to have a snack at a predetermined time of the day before an expected hunger or appetite occurs to reduce the degree of hunger or appetite a person may experience, or the user may choose to have a snack at a predetermined time of day, or the user may interact with a coach, exercise, You may choose to engage in certain interventions prior to the onset of an anticipated hunger or appetite event, such as a food-related image experience or meditation. In some embodiments, the hunger map generated by the HMA analyzes the user's past planned and unplanned appetite or hunger events to indicate expected future appetite or hunger events. To apply the rescue stimulus, the patient turns on the EDP, pairs it with an interlocking device, and wears the EDP to initiate stimulation.

In step 8312, to assess dietary compliance, the user includes (via at least one GUI screen generated by the HMA) ketones, HbA1c, gut microbiota profile, adiponectin, insulin, GLP-1 and leptin, but Periodically measure and input at least one data representative of, but not limited to, metabolic processes.

In step 8314, the HMA uses the at least one data representative of the user's metabolic process and diet plan to automatically titrate the stimulation protocol and/or parameters. For example, absence of ketones or evidence of an imbalance in the gut microbiota may require increasing/modulating stimulation duration, frequency and/or timing.

84 is a flow diagram of a plurality of steps enabling a stimulation protocol as a result of a patient ingesting an appetite or hunger-inducing drug in accordance with some embodiments herein. At step 8402 , the patient receives instructions from the medical professional, receives an electric skin patch (EDP) device, and downloads a health care application (HMA) to a companion device such as a smartphone.

At step 8404, the HMA allows the patient to enter details of the drug(s) such as, for example, drug chemistry/salt, timing of administration of the drug during the day, and mode of administration of the drug (oral, intravenous, inhalation). Create one or more GUI screens to enable In some embodiments, the input provided by the patient may be audible through the microphone of the companion device or the IPA system.

At step 8406 , the HMA uses the details of the drug(s) to determine if the drug(s) may cause an increase in the patient's appetite or hunger. For example, medicinal cannabis or marijuana (including cannabidiol (CBD) and tetrahydrocannabinol (THC)) is known to increase appetite or hunger while reducing nausea and discomfort. At least two major causes of increased appetite or hunger are: a) cannabis enters the olfactory bulb, which enhances the smell and taste of food, and b) increased ghrelin production, which affects the area of the hypothalamus that causes patients to seek food that there is The appetite- or hunger-stimulating effects of cannabis peak after a delay time that depends on the rate of absorption of medicinal cannabis, which in turn depends at least on the mode of consumption. In general, appetite or hunger peaks after a delay of about 30 minutes when inhaling cannabis, whereas appetite or hunger peaks after a delay of about 90 minutes when ingested orally. However, the delay time is also controlled by the amount of cannabis ingested, potency, tolerance and substances that may be ingested with it. Similarly, there are other medicines such as antipsychotics (eg Seroquel and Olanzapine) that lower estrogen and thus undesirably increase a patient's appetite or hunger.

At step 8408, based on the determination (that the drug(s) is likely to cause an unwanted increase in the patient's appetite or hunger), the HMA reduces ghrelin production to ameliorate the unwanted increase in the patient's appetite or hunger Automatically generate stimulation protocols and schedules for In some embodiments, the stimulation session is scheduled to occur 30 to 45 minutes before the time when the appetite or hunger peak effect of cannabis is expected to occur. For example, if a patient takes THC orally at 10 am, given that the latency to peak appetite is about 90 minutes, HMA schedules a stimulation session of 15 minutes 60 minutes after the dosing time, i.e. , the stimulation is scheduled to occur at 11 am to reduce the ghrelin rush associated with THC intake.

At step 8410, the patient turns on the EDP, pairs it with the companion device, and is instructed to wear the EDP by the application. It should be understood that in alternative embodiments, step 8410 may be implemented prior to step 8404, 8406, or 8408. Then, at step 8412 , when the companion device receives confirmation that the EDP is being worn, the HMA implements and delivers the stimulation session(s) to the patient based on the generated stimulation protocol and schedule.

In some embodiments, a plurality of algorithms based on template matching, trained neural networks, and/or other techniques including, but not limited to, deep learning may be used to recommend and personalize a nutritional or diet plan and/or stimulation regimen for a patient. can be used for

85 is a flow diagram of multiple steps of a method of utilizing a machine learning model to recommend a personalized nutritional or diet plan and/or stimulation regimen for a patient in accordance with some embodiments herein. In step 8502, the patient downloads a health care application (HMA) to an associated device, such as a smartphone. In step 8504 , the patient acquires the EDP device and uses the EDP device around the wrist to monitor, acquire, record and/or transmit a plurality of physiological data to the companion device and at least one individual device. pair with a first device having a physiological sensor, configured to be worn on the human body, and optionally a second device, such as a continuous blood glucose monitor, configured to be worn on the human body to monitor, acquire, record and/or transmit patient blood glucose data. .

At step 8506, the HMA determines whether the patient is currently following an eating and eating profile or diet plan (including but not limited to Mediterranean Diet, Jenny Crake, Weight Watchers, Slimfast, etc.), a 'daily diary' ' or multiple patient data indicative of health-related inputs, e.g., appetite, hunger, exercise, well-being and weight, blood glucose data, physiological data, gut microbiome profile, drug (including dosage, timing and composition), genetic profile Enter data representing metabolic processes including, but not limited to, demographics (including but not limited to age, sex, race, ethnicity, nationality, etc.), ketones, adiponectin, insulin, GLP-1, and leptin Create at least one GUI screen that lets you do that.

Some data may be entered by the patient periodically, eg daily (eg 'daily diary' data), and some of the data entered by the patient may be valid for a long period of time, eg, from 3 months to Current eating and eating profiles you can try to follow over a 6-month period, while some data, for example, show that a patient only has one ) to be entered. In addition, some of the data may be acquired automatically by the HMA without manual intervention of the patient, such as, for example, blood glucose data that may be obtained directly from a continuous blood glucose monitoring device at predetermined time intervals.

In step 8508, the HMA acquires and stores the plurality of patient data and implements a machine learning model for further processing and analysis of the plurality of patient data. In various embodiments, machine learning models may include one or more support vector machines, linear regression models, clustering analysis models, boost decision trees, neural networks, deep learning models, or combinations thereof. In some embodiments, the machine learning model is a deep learning feedforward network, such as a multilayer recurrent neural network (RNN).

In some embodiments, the multi-layer RNN is trained to generate and recommend a personalized nutrition or diet plan based on one or more predicted patient parameters, such as, for example, the patient's blood glucose data and/or body weight. In some embodiments, the predicted patient parameter may be derived from or associated with the patient's dietary regimen or health goal(s). Dietary intake is a major determinant of blood glucose levels, and thus, in some embodiments, RNNs trained to achieve normal blood glucose levels recommend food choices that elicit a normal postprandial (post-meal) glycemic response.

Postprandial hyperglycemia is a risk factor for type 2 diabetes, cardiovascular disease, and cirrhosis and is associated with obesity. Prior art methods use meal carbohydrate content despite the fact that meal carbohydrate content is a poor predictor of PPGR (postprandial glycemic response). Another method aimed at estimating PPGR is the glycemic index and derived glycemic load, which quantify the PPGR for the intake of a single test food type. These prior art methods consist of multidimensional patient data or parameters such as physical activity or exercise, genetic profile, gut microbiome profile, and complex effects of drugs and any combination of foods and varying amounts consumed at different times of the day. It has limited applicability to assessing PPGR for actual meals.

In some embodiments, the RNN is trained using supervised training, wherein a plurality of patient data is trained using a learning algorithm for a predetermined training period (eg, between 1 day and 8 weeks or any increment therein). is provided as input to the model for processing, and the output of the model is continuously monitored for correction when necessary. For example, the blood glucose data and/or body weight predicted by the RNN may be automatically compared by the HMA with the actual monitored blood glucose data and the patient's body weight to apply corrective feedback to the RNN when needed. In various embodiments, the learning algorithm is one of a stochastic gradient descent, batch gradient descent, or mini-batch gradient descent algorithm.

At step 8510, as a result of processing the plurality of patient data, the HMA generates and recommends a personalized nutrition or diet plan for the patient, along with stimulus-based interventions if necessary. As an illustrative example, as a result of processing multiple patient data or parameters over a period of time, the RNN is associated with the patient's gut microbiota (e.g., populated by bacteroides stercoris) and postprandial Associations between blood sugar spikes can be found, and as a result, HMA can generate a set of specific food recommendations to avoid blood sugar spikes. In embodiments, specific food or diet recommendations may be selected from a database of foods with complete nutritional value. In another example, the RNN may discover that a patient experiences blood sugar spikes as a result of eating grapes or raisins as part of their breakfast, so the HMA may recommend figs with a lower glycemic index instead. In another example, the RNN could rate the patient as experiencing an unfamiliar hunger craving 1.5 hours after taking one of the medications. Consequently, HMA can automatically schedule rescue stimulation sessions for patients 1 hour after taking the drug to ameliorate drug-induced hunger cravings.

At step 8512, if the HMA recommends stimulation treatment, the patient is instructed by the HMA to wear the EDP to begin stimulation treatment.

33 is a flow diagram illustrating the steps involved in using an electric skin patch device and an interlocking device paired with a separate monitoring device for appetite suppression in a patient in accordance with one embodiment of the present disclosure. In step 3302, the patient obtains an EDP from a medical professional. The patient pairs the companion device with the EDP and separate monitoring device in step 3304 . The separate monitoring device is configured to measure a plurality of physiological parameters including, but not limited to, body weight, body fat, lean mass and BMI of the patient, and wirelessly transmit the monitored data to the companion device. The patient then places the EDP on his or her body in step 3306 . In step 3308, the companion device sets the EDP to the default stimulation mode based on the initial physiological data collected from the separate monitoring device. Based on the ongoing data gathering input, the companion device continuously modifies the electrical stimulation provided by the EDP in an effort to suppress the patient's appetite in step 3310 . Optionally, in step 3312, the patient manually adjusts the stimulation parameters based on the patient's well-being, eg, lowers the stimulation parameters if the patient experiences nausea, indigestion, or discomfort at the stimulation site.

34 is a flow diagram illustrating steps associated with another embodiment of a method of using an electrical skin patch device to suppress appetite in a patient. In step 3402, the patient acquires an electrical skin patch (EDP) device and uses the EPD device to monitor, acquire, record, and/or transmit physiological data to a companion device such as a smartphone and a separate device, eg, physiological data. To pair devices with physiological sensors configured to be worn on the body, such as around the wrist. In some embodiments, pairing with a separate device may be performed at any time within a treatment cycle. In some embodiments, the treatment cycle lasts 3 months. In step 3404, the device is set to a default operating mode. In some embodiments, the default mode of operation includes the stimulation parameters and parameter ranges listed above with respect to FIG. 27C and includes daily stimulation.

The EDP device is placed on the patient's body in step 3406 . In step 3408, the companion device determines the user's actual eating and meal profile, such as the number of hours eaten per day, the type and amount of food eaten at the meal, a standard diet plan (eg, Mediterranean diet, regional diet, Atkins diet, the user's standard regular eating and eating routines, such as, but not limited to, the ketogenic diet, intermittent fasting, Jenny Craig, custom plans, etc., in the patient's diary for a predetermined period of time, including appetite, hunger, well-being, weight and Accumulate patient variable data including, but not limited to, calories burned/weight loss. In some embodiments, the companion device accumulates data over a range of 1 to 7 days. In one embodiment, the companion device accumulates data for three days. Then, at step 3410, the companion device wirelessly drives stimulation therapy via the EDP device based on the patient diary data accumulated during the treatment cycle.

During the treatment cycle, if the patient has a positive or surplus energy balance (indicating more actual calories burned compared to calories consumed) for a predetermined period of time, eg, 3 days, the interlocking device sends step 3412 ) ramp up stimulation parameters (eg, by increasing stimulation duration, intensity, and/or number of sessions). During the treatment cycle, the patient compares the patient's actual eating and If the glycemic load (calculated based on the meal profile) is exceeded, the companion device ramps up the stimulation parameter in step 3414 . Alternatively or additionally, in steps 3412 and 3414, the interlocking device may provide a score of 5, eg, for 3 to 5 days, indicating that the patient has poor or no dietary compliance with reference to the patient's standard diet plan. Ramp up the stimulation parameters when recording an appetite diary entry with Accordingly, in some embodiments, a health care application uses appetite parameters indicative of a patient's dietary compliance to evaluate whether the patient is likely to be in surplus energy balance and thus likely to exceed an acceptable glycemic load.

If, during the treatment cycle, the patient exceeds the total number of meals per day for a predetermined period of time as compared to the number of meals allowed according to the patient's standard diet plan, the interlocking device may at step 3416 immediately prior to an additional meal event (e.g., , 30 minutes or 1 hour before) may include additional stimulation sessions. At step 3418 , if the patient overeats at a particular time and continues to exhibit such overeating behavior for a predetermined period of time, e.g., 3 to 5 days, then the companion device is triggered immediately prior to the overeating event or time (e.g., 30 minutes or 1 hour before) the timing of stimulation may be altered or may include an additional stimulation session immediately prior to the overeating event. In some embodiments, energy balance and glycemic load are calculated for every meal of the day, which in turn enables calculation of the meal contributing to the highest percentage of daily calorie (or surplus energy) and glycemic load. A meal that contributes to the highest percentage of calorie and glycemic load per day during a predetermined time period is identified as an overeating event.

During a treatment cycle, if the patient stops exercising for a predetermined period of time (e.g., 3 to 5 days), or if the patient's exercise score is 5 (Figure 12), the minimum level of expected exercise and calories burned If indicated and is in surplus energy balance for a predetermined period of time (eg, 3 to 5 days), the interlocking device ramps up the stimulation parameter at step 3420 . In step 3422, after a course of treatment or cycle, if the patient has lost sufficient weight or has reached a target weight, the interlocking device sets the stimulation parameters into a maintenance mode in which stimulation parameters such as stimulation intensity, duration, and number of sessions are all lowered. make corrections

Optionally, at step 3424, the companion device provides the patient with the option to share the results with designated friends and family via social media. In an alternative embodiment, the companion device first accumulates the patient diary data before the EDP device is set to the default mode of operation. Referring to FIG. 34 , in this alternative embodiment, step 3408 is performed prior to step 3404 . The remaining steps proceed in the same order.

49 is a flow diagram illustrating steps associated with one embodiment of a method of using an electrical skin patch device to automatically trigger rescue therapy based on a user's individualized hunger profile or map. At step 4902 , the patient obtains an electrical skin patch (EDP) device from a medical professional in accordance with the devices disclosed herein.

The EDP device is set to a default mode of operation by the patient or medical practitioner in step 4904 . In some embodiments, the default mode of operation or baseline stimulation protocol is set to 3 stimulation sessions per day of 30 minutes each with a pulse amplitude of 20 mA. Each of the three stimulation sessions per day is 30 to 60 minutes, preferably 45 minutes before a scheduled or scheduled meal time, for example breakfast, lunch and dinner, or any other scheduled meal time according to the user's diet plan. It begins. In a preferred embodiment, the baseline stimulation schedule or protocol provides a pulse amplitude of 20 mA at 15 minutes and postprandial time, respectively, with a pulse amplitude of 20 mA at the preprandial time immediately before the start and at the completion of each meal, such as breakfast, lunch, and dinner. Set up as three stimulation sessions per day of 60 minutes each. In other words, the baseline stimulation modality or protocol includes 3 x 1.25 hours = a total of 3.75 hours (15 minutes before each meal and 60 minutes after each meal). In some embodiments, the baseline pulse amplitude ranges from 5 mA to 10 mA allowing for a total stimulation duration of greater than 3.75 hours. In various embodiments, this postprandial stimulation session is manually triggered by the user. In some alternative embodiments, the pre- and post-prandial stimulation sessions are automatically triggered based on a pre-stored meal time schedule. In some alternative embodiments, the postprandial stimulation session detects an eating event by a swallow detection device, such as device 5605 of FIG. Triggered automatically by detecting an eating event by the meal moment recognition method (FIG. 58) implemented by the HMA using an accelerometer, such as wristband 2105 in FIG. 21A or wrist watch 2106 in FIG. Or included in a wrist watch.

At step 4906 , the EDP device is placed on the patient's body by the patient or healthcare professional to begin delivering stimulation therapy according to a baseline stimulation protocol.

At step 4908 , in a particular week (eg, the first week of treatment), the user is prompted for the date and time of an unplanned or unscheduled hunger event, which is a hunger event that does not comply with the timing of the user's planned or scheduled meal time. In addition, record the intensity or level of hunger. In various embodiments, the user uses a light bar visual analog scale (VAS) on his smartphone (functioning as a companion device) to record the level of hunger along with the date and time of the hunger event. In some embodiments, the light bar VAS is configured on a scale of 0 to 10, where 0 represents no hunger and 10 represents the maximum level of hunger. Then, at step 4910, if the recorded level of hunger intensity is less than 5, the hunger event in the VAS is recorded as a low intensity hunger event with the date and time of the hunger event, but a corresponding rescue session is not triggered. The recorded date, time and level of hunger events are used to create and display the user's personalized hunger profile or map.

However, in step 4912, if the level of the recorded hunger intensity is 5 or greater, the hunger event is recorded as an actionable hunger event. As a result, the following actions are taken: a) In step 4914, a rescue session duration is determined. In various embodiments, the rescue session duration is equal to the level of hunger recorded in the light bar VAS. For example, if the recorded hunger level is 6, the duration of the corresponding rescue session is determined to be 6 minutes. In some embodiments, the level of hunger recorded in the light bar VAS may alternatively or additionally affect rescue session intensity. For example, if the recorded hunger level is 6, the duration of the corresponding rescue session is 6 minutes and/or the intensity of the rescue session is maintained at the first intensity level. Similarly, if the recorded hunger level is 8, the duration of the corresponding rescue session is 8 minutes and/or the intensity of the rescue session is maintained at the second intensity level. The first intensity level is different from the second intensity level. In an embodiment, the first intensity level is lower than the second intensity level. In an embodiment, the first intensity level is greater than the second intensity level. b) In step 4916, the determined rescue session duration is compared with the user's daily discretionary rescue budget. In some embodiments, the user's daily discretionary structure budget is predetermined at 30 minutes. If the determined rescue session duration is within this day's discretionary rescue budget, then rescue session therapy is triggered and delivered to the user for the determined rescue duration. On the other hand, if the determined rescue session duration is outside the discretionary rescue budget for this day, an alert is displayed to the user and the remote patient care facility or personnel and the rescue session therapy is rejected or delivered to the user only after approval by the remote patient care facility or personnel. . c) in step 4918, the date, time and level of hunger are recorded to determine if the filter or threshold condition(s) are met to determine if the hunger event forms a pattern of recurrent hunger analgesia or spikes . As previously discussed herein, the filter or threshold condition may be a predetermined time period (several days (5 to 7 days) to several weeks (3 to 6 weeks)) and/or a predetermined number of rescue sessions (1 to 6 weeks). 10 session range). Alternatively or additionally, a filter or threshold condition may include, for example, 3 minimum hunger events (each event is recorded within eg 60 minutes of the same time of day and eg recorded on 3 different days in the same week) triggering a rescue session or bolus, ie each of the three hunger events is an intensity level greater than or equal to 5 on a light bar VAS of 0 to 10). The recorded date, time and level of hunger events are also used to create and display the user's personalized hunger profile or map.

At step 4920, if the actionable hunger event meets or meets the filter or threshold condition(s) then a rescue session of, for example, 5 minutes or 10 minutes, is followed by a subsequent week of therapy at the recorded time of the actionable hunger event. (e.g., the second week of treatment) is scheduled automatically. In various embodiments, automatic scheduling of rescue sessions in subsequent weeks is subject to a daily automatic rescue budget for subsequent weeks. That is, a rescue session is automatically scheduled for a subsequent week only if the duration of the rescue session is within the automatic rescue budget of the subsequent week. In some embodiments, the user's daily auto-rescue budget is predetermined at 30 minutes.

Steps 4908 - 4920 are repeated weekly for each occurrence of an unscheduled hunger event for the duration of the stimulation regimen for the user. Thus, by repeating steps 4908 - 4920 for all hunger events not scheduled for one week, an automatic rescue delivery plan or schedule is created this week for subsequent weeks. An automatic rescue delivery plan or schedule is followed along with the baseline stimulation protocol throughout the user's treatment cycle. Because unplanned hunger events are still recorded throughout the treatment cycle, therefore, if the user records fewer actionable hunger events in one week, the number and/or level of automatic rescue deliveries decreases in subsequent weeks and vice versa. It should be understood that

As discussed above, the user is allowed a predetermined amount of daily total rescue budget, which in various embodiments is the sum of the daily discretionary rescue budget and the daily automatic rescue budget. In some embodiments, the daily total rescue budget is set to, for example, 60 minutes, while the daily discretion and automatic rescue budget is set to, for example, 30 minutes each. In alternative embodiments, the daily total rescue budget may be set to a smaller or higher value, and the daily discretion and automatic rescue budget may also include different percentages of the total rescue budget.

50 is a flow diagram illustrating steps associated with one embodiment of a method of using an electrical skin patch device to automatically titrate or adjust therapy based on a user's dynamic well-being profile indicative of the occurrence of a nausea and/or dyspepsia event. to be. In step 5002 , the patient obtains an electrical skin patch (EDP) device from a medical professional in accordance with the devices disclosed herein.

The EDP device is set to a default mode of operation by the patient or healthcare professional in step 5004 . In some embodiments, the default mode of operation or baseline stimulation protocol is set to 3 stimulation sessions per day of 30 minutes each with a pulse amplitude of 20 mA. Each of the three stimulation sessions per day is 30 to 60 minutes, preferably 45 minutes before a scheduled or scheduled meal time, for example breakfast, lunch and dinner, or any other scheduled meal time according to the user's diet plan. It begins. In a preferred embodiment, the baseline stimulation schedule or protocol provides a pulse amplitude of 20 mA at 15 minutes and postprandial time, respectively, with a pulse amplitude of 20 mA at the preprandial time immediately before the start and at the completion of each meal, such as breakfast, lunch, and dinner. Set up as three stimulation sessions per day of 60 minutes each. In other words, the baseline stimulation regimen or protocol includes 3 x 1.25 hours = a total of 3.75 hours (15 minutes before each meal and 60 minutes after each meal). In some embodiments, the baseline pulse amplitude ranges from 5 mA to 10 mA allowing for a total stimulation duration greater than 3.75 hours. In various embodiments, this postprandial stimulation session is manually triggered by the user. In some alternative embodiments, the pre- and post-prandial stimulation sessions are automatically triggered based on a pre-stored meal time schedule. In some alternative embodiments, the postprandial stimulation session detects an eating event by a swallow detection device, such as device 5605 of FIG. is automatically triggered with reference to detecting an eating event by the meal moment recognition method (FIG. 58) implemented by the HMA, where the accelerometer, such as the band 2105 of FIG. 21A or the wrist watch 2106 of FIG. Included in a wristband or wristwatch.

In step 5006, the EDP device is placed on the patient's body by the patient or healthcare professional to begin delivering stimulation therapy according to a baseline stimulation protocol.

In step 5008, the user records the date and time of occurrence of the nausea and/or indigestion event, as well as the intensity or level of nausea and/or indigestion. In various embodiments, the user uses a light bar visual analog scale (VAS) on his smartphone (functioning as a companion device) to record the level of nausea and/or indigestion along with the date and time of the event. In some embodiments, the light bar VAS is configured on a scale of 0 to 10, where 0 represents no nausea and/or indigestion (ie, the highest level of well-being) and 10 represents the most intense of nausea and/or indigestion. It represents the level (ie the worst level of well-being).

Then, at step 5010, if the recorded level of nausea and/or dyspepsia intensity is less than or equal to a threshold level in the VAS, eg, 3, the nausea and/or dyspepsia event is flagged with the date and time of the event. Together they are logged as low-intensity events, but no action is triggered. The recorded date, time and level of nausea and/or indigestion events are used to create and display the user's personalized wellness profile or map. However, in step 5012, if the recorded level of nausea and/or dyspepsia intensity is greater than 3, then the nausea and/or dyspepsia event is recorded as high intensity action, thus resulting in titration or adjustment of the continuing stimulation therapy protocol. possible event. The date, time and level of the nausea and/or indigestion event is re-recorded and provided to create a user's wellness profile or map.

In an alternative embodiment, therapy titration or adjustment is based on the user's quality of life VAS level (instead of nausea and/or dyspepsia events), wherein a lower quality of life level may reduce stimulation intensity and/or duration. you have to understand what is

57 is a method of using an electrical skin patch device to elicit feedback, coaching, or advice related to a patient's medical condition from at least one of a social network group (or social group) and an online coaching or concierge service, a care provider, or a physician. It is a flow chart illustrating the steps associated with one embodiment. In embodiments, the online coaching or concierge service is an algorithm-based automated virtual coach and/or real coach person, care provider, nutritionist or physician communicating with the patient's social group and/or EDP (or companion device). In various embodiments, the patient's medical condition includes, but is not limited to conditions such as obesity, high levels of hunger, appetite, weight and/or low levels of well-being. At 5702 , the patient obtains an electrical skin patch (EDP) device from a medical professional in accordance with the devices disclosed herein.

The EDP device is set to a default mode of operation by the patient or medical practitioner in step 5704 and is synchronized or paired with a corresponding client or companion device implementing the health management application (HMA) herein. In some embodiments, the default mode of operation or baseline stimulation protocol is set to 3 stimulation sessions per day of 30 minutes each with a pulse amplitude of 20 mA. Each of the three stimulation sessions per day is 30 to 60 minutes, preferably 45 minutes before a scheduled or scheduled meal time, for example breakfast, lunch and dinner, or any other scheduled meal time according to the user's diet plan. It begins. In a preferred embodiment, the baseline stimulation schedule or protocol provides a pulse amplitude of 20 mA at 15 minutes and postprandial time, respectively, with a pulse amplitude of 20 mA at the preprandial time immediately before the start and at the completion of each meal, such as breakfast, lunch, and dinner. 3 stimulation sessions per day of 60 minutes each. In other words, the baseline stimulation regimen or protocol includes 3 x 1.25 hours = a total of 3.75 hours (15 minutes before and 60 minutes after each meal). In some embodiments, the baseline pulse amplitude ranges from 5 mA to 10 mA allowing for a total stimulation duration of greater than 3.75 hours. In various embodiments, this postprandial stimulation session is manually triggered by the user. In some alternative embodiments, the pre- and post-prandial stimulation sessions are automatically triggered based on a pre-stored meal time schedule. In some alternative embodiments, the postprandial stimulation session detects an eating event by a swallow detection device, such as device 5605 of FIG. Triggered automatically in connection with detecting a feeding event by the meal moment recognition method (FIG. 58) implemented by the HMA using Included in the same wristband or wristwatch. In some embodiments, the baseline stimulation protocol includes parameters having a pulse width in the range of 10 μsec to 10 msec, a pulse amplitude in the range of 100 μA to 100 mA, and a pulse frequency in the range of 1 Hz to 100 Hz.

At step 5706 , the EDP device is placed on the patient's body by the patient or healthcare professional to begin delivering stimulation therapy according to a baseline stimulation protocol. In various embodiments, the patient communicates with one or more remote servers via EDP and may allow the patient to communicate with at least one of a social network group (or social group) and an online coaching or concierge service, care provider, or physician.

In step 5708 the patient enters or records (as a result of a prompt by the HMA) parameters such as appetite, hunger, degree or level of exercise and well-being or the intensity, degree or level of a plurality of health status data. In some embodiments, the HMA prompts the patient to enter data indicative of the patient's appetite, hunger, exercise, and well-being through a microphone or display of the client device. In various embodiments, the user uses a light bar visual analog scale (VAS) on his smartphone (functioning as a client or companion device) to record the level of health status data or parameters. In some embodiments, the light bar VAS is configured as a 0 to 10 or 0 to 5 scale, where 0 represents the lowest intensity or degree of a health status parameter, and 10 or 5 represents the highest intensity of the health status parameter. In some embodiments, the patient is visually indicated or prompted with a plurality of icons or emoticons, wherein each of the plurality of icons represents a different degree of a health condition parameter, such as hunger or appetite. In some embodiments, the HMA prompts for input regarding a health condition, such as degree of appetite or hunger, by generating a plurality of audible queries that are played through a speaker of the client device. It should be appreciated that, in an alternative embodiment, the IPA system (in communication with the HMA) may prompt the patient to receive voice-based input from the patient regarding his or her health condition, such as degree of appetite or hunger.

In step 5710 , the patient shares one or more of a plurality of data (shareable dates) with at least one of an online social network group or social group (group of which the patient is a member) and an online coaching or concierge service. The plurality of data includes a level, degree, score or value associated with past and/or present hunger, appetite, exercise, weight, well-being, willpower, urge to eat profile, hunger profile, standard eating and eating profile, actual eating and eating profile. , diet plan, exercise regime, energy balance, weight change, blood glucose data, rescue bolus events, default/baseline or current stimulation parameters, protocol and stimulation-induced nausea, dyspepsia and habituation events. In various embodiments, a patient is understood to share any combination, aggregate function/score (derived from any one or any combination of sharable data) or subset of the plurality of data described above. In some embodiments, the patient has at least one or a combination of ( (manually or automatically) when triggered by the HMA. Additionally, the HMA determines the patient's composite score, wherein the composite score is a function of any two or more of the patient's past appetite, weight trends, past well-being, and past exercise, and wherein the composite score is displayed on the client or the linked device. make it The composite score may additionally or alternatively be shared manually or automatically by the patient when triggered by an HMA, a member of a social network group or social group and/or an online coaching service.

In some embodiments, the plurality of data is automatically shared with an online social network group or social group when it is determined that at least a subset of the plurality of data is indicative of a patient's worsening or an underlying medical condition. Note that, in some embodiments, the online coaching or concierge service may communicate with a social network group and/or the patient's EDP (or companion device) and access or automatically receive a plurality of data related to the patient. Should be.

In one embodiment, the plurality of data (sharable data) is provided to an online social network group or social group and/or an online coaching service (actually the patient records an appetite or hunger score/level above a predetermined threshold score/level). automatically shared with coaches, nutritionists or caregivers). In some embodiments, the threshold score/level for appetite or hunger is 5.5 (on a scale of 0-10). For example, an appetite or hunger score/level of 5.5 to 8.5 triggers the patient's shareable data to be automatically shared with online social network groups or social groups and/or online coaching services (including real coaches, nutritionists or caregivers) do. An appetite or hunger score/level above 8.5 not only triggers automatic sharing of the patient's sharable data, but also indicates the severity of the condition, for example by repeatedly flashing the patient's sharable data in a light shade such as red, to an online social network group. Or pass it on to a member of a social group.

According to one aspect herein, at least one health condition data or sharable data, e.g., a hunger event or rescue therapy event entered or recorded by the patient and/or derived from the patient's health status data or sharable data The aggregated scores or functions obtained are automatically shared in real time with the social group and/or online coaching service to trigger real-time coaching, advice or feedback of the online coaching service and/or the social group. Coaching or advice is, in some embodiments, with an automated virtual coach or sponsor, while in other embodiments, such coaching or advice may additionally or alternatively communicate with the patient's fellowship group and/or EDP (or companion device). It is understood to be provided by a real coach person, care provider, nutritionist or physician.

Members of social network groups or social groups and/or online coaching services may provide multiple interventions as advice or responses to a patient's shared multiple data. In various embodiments, the plurality of interventions or responses may include coaching instructions, encouraging messages (pre-recorded and/or real-time), morale-boosting emojis, stimulation parameters and protocols associated with members identified as having improved medical conditions, and modified exercises. elements such as, but not limited to, regimes and modified diet plans.

According to aspects herein, the plurality of interventions, advice or responses of the social network group or social group and/or online coaching service depend on the level of the patient's worsening condition indicated by the shared plurality of data. In embodiments, members of social network groups or social groups and/or online coaching services may be encouraged or upset by the severity of the patient's condition as revealed through a plurality of shared data, including video, GIF (graphical interchange format), text Encouragement to enter messages and/or emojis. These videos, GIFs, text messages and/or emojis may be pre-stored for automatic delivery to the patient when needed, depending on the severity of the patient's condition.

In step 5712a, the HMA determines whether the patient's level or degree of appetite or hunger is greater than a first threshold but less than or equal to a second threshold. In some embodiments, the first threshold and the second threshold are 0 and 5.5 on a scale of 0 to 10, respectively. If the patient's degree of appetite or hunger is between the first and second thresholds, then a member of the social network group or social group and/or the online coaching service may respond with a first intervention at step 5714a. In some embodiments, the first intervention is a pre-recorded encouraging and grateful emoji, such as a video, GIF (Graphic Interchange Format), text-based message, and/or member of a social network group or social group and/or online coaching service. It can contain messages. In some embodiments, the first intervention includes pre-recorded coaching instructions from members of social network groups or social groups and/or online coaching services to assist the patient in maintaining dietary compliance. In some embodiments, the first intervention may include displaying the patient's own appetite profile to the patient's client or control device.

In step 5716a, the HMA determines whether the patient's level or degree of appetite or hunger is greater than a second threshold but less than or equal to a third threshold. In some embodiments, the second and third thresholds are 5.5 and 8.5 on a scale of 0 to 10, respectively. If the patient's degree of appetite or hunger is between the second and third thresholds, then a member of the social network group or social group and/or the online coaching service may respond with a second intervention at step 5718a. In some embodiments, the second intervention includes pre-recorded messages such as videos, GIFs, text-based messages and/or emojis biased towards irritating and possibly depicting the resulting risk of not controlling appetite or hunger. Members of social network groups or social groups and/or online coaching services may also recommend other actions, such as rescue sessions, modified stimulation parameters for the patient, and/or coaching guidelines to help the patient achieve dietary compliance. can

In step 5720a, the HMA determines whether the patient's level or degree of hunger or appetite is greater than a third threshold and less than or equal to a fourth threshold. In some embodiments, the third and fourth thresholds are 8.5 and 10 on a scale of 0 to 10, respectively. If the patient's appetite or hunger level is between the third and fourth thresholds, then, in step 5722a, a member of the social network group or social group and/or the online coaching service may respond with a third intervention. A patient's appetite level between the third and fourth thresholds is interpreted as a level at which the patient requires immediate assistance and intervention. In some embodiments, in a tertiary intervention, a member of a social network group or social group and/or a coaching person, dietitian or caregiver (eg, instead of an automated online coaching service) can make and/or message the patient in real time. can send

Feedback, coaching and advisory responses may additionally or alternatively, in some embodiments, allow patients to social network groups or social groups via communication channels including, but not limited to, Facebook Messenger, WhatsApp, or other communication applications known to those skilled in the art. It can be elicited by enabling manually sharing a plurality of data (shareable data) or a subset thereof with one or more users who are not members of

It should be understood that the first, second, third and fourth thresholds may vary on a scale for defining at least the degree of appetite or hunger. Also, in some embodiments, intervention may be based on a single threshold. Thus, in a series of alternative steps, at step 5712b, the HMA determines whether the patient's level or degree of appetite or hunger is above a threshold. In some embodiments, the threshold is 5.5 on a scale of 0 to 10. If the degree of appetite or hunger falls below the threshold, then at step 5714b the HMA does not deliver any intervention to the patient. However, if the degree of appetite or hunger exceeds the threshold, then at step 5716b the HMA allows members of the social network group or social group and/or the online coaching service to respond with an intervention. In various embodiments, the intervention may include coaching instructions to help the patient achieve dietary compliance, pre-recorded messages (videos, GIFs, text-based messages and/or emojis) by one or more individuals connected with the patient within a social network. ) and/or one or more members of social network groups or social groups and/or live messages (real-time calls and/or live videos, GIFs, text-based messages and/or emojis) of online coaching services.

In another alternative set of steps and in accordance with aspects herein, the type and nature of the online coaching service and/or the feedback, coaching and advice provided by the coaching person, dietitian or caregiver may be determined by the level or extent of hunger or appetite; based on at least one of time of day, number of steps taken (ie, exercise score/level), calories consumed, and patient location. For example, at step 5712c, the patient's reported high level or degree of hunger or appetite (eg, exceeding a predetermined threshold, such as 5.5) may be determined by the patient at a particular time of day (eg, If you frequently report high levels (after training at the gym), they may be flagged as 'chronic'. Thus, the automated online coaching service detects these 'chronic' correlations and, in step 5714c, advises the patient to preemptively stimulate at or near specific times of the day. As another example, in step 5712d , the patient-reported high level of hunger or appetite (eg, exceeding a predetermined threshold, such as 5.5) is determined if the patient-reported high level is more random and less frequent. May be flagged as 'acute'. Thus, in step 5714d, the automated online coaching service responses vary, either distracting the patient (freeing them from the psychological pain of hunger), or providing the patient with their goals and health concerns that prey on hunger pain. including, but not limited to, reminders of risk and/or triggering media presentations to the patient. The media presentation may be, for example, a pre-stored GIF, audio and/or an encouraging video. The media may allow the patient himself, a friend, or a loved one to request, encourage, and remind the patient to overcome obesity and/or achieve a target weight.

[In some embodiments, the HMA processes data indicative of a patient's appetite (as discussed earlier herein with respect to big data analytics) to determine when the patient is hungry at a future time and at that future time. Based on it, it transmits a signal to an electrical skin patch placed on the patient's skin.

In step 5724, the patient expresses gratitude for the feedback or updates it with an improved plurality of data related to the patient's medical condition and, for example, the patient's medical condition, or involvement of a member of a social network group and/or an online coaching service. Alternatively, you can respond to advice responses or feedback.

In various embodiments, titration or adjustment of therapy relates to adjusting or completely terminating stimulation therapy to reduce and/or prevent further occurrence of nausea and/or dyspepsia events. As discussed earlier herein, upon the occurrence of an actionable nausea and/or dyspepsia event, a health care application may modify an existing stimulation protocol, e.g., to convert the current baseline stimulation protocol to a mild stimulation protocol. can recommend Additionally or alternatively, the stimulus continuity profile may be converted to a step-down profile. Further, the health care application may recommend pausing the stimulation session for one or more days before resuming with a step-down stimulation protocol. For example, in one embodiment, any single nausea and/or dyspepsia event of intensity 10 on the VAS scale causes all subsequent therapy sessions to cease immediately and prompt the user to contact a physician. In another embodiment, for example, the health care application terminates the therapy if the cumulative actionable VAS score in the same week is a combined 15 (ie, 4, 5, and 6 points). In another embodiment, if the cumulative actionable score in the same week is greater than 10, the healthcare application reduces the decreasing baseline therapy sessions from 30 minutes to 15 minutes each. In this embodiment, therapy is terminated if the frequency of these actionable nausea and/or dyspepsia events continues.

Although the therapeutic efficacy of the device has been described above with respect to the level of control of appetite, hunger, satiety, satiety, caloric intake and/or weight loss, it may also be described in terms of delaying gastric emptying time or increasing gastric residence time. may be Applying the treatment protocol described above, a patient with a BMI of 25 or greater was subjected to multiple stimulation sessions where the electric field generated by the electrical skin patch was applied to the epidermal layer of the patient, and the patient's C5, C6, C7, C5, C6, C7, C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11 and T12 Penetrates 0.1 mm to 25 mm through the epidermal layer of the patient in direct contact with at least one of the frontal and lateral dermatomes let it do The electrical skin patch has a housing having a base surface, wherein the base surface is defined by a total base surface area, wherein at least a portion of the total base surface area is configured to adhere to an epidermal layer of a patient, wherein the total base surface area is less than 10 in ² ; wherein the skin patch has a controller within the housing, at least one electrode positioned within the housing and configured to be in electrical contact with an epidermal layer of the patient, wherein the electrical skin patch is positioned within the housing and in electrical communication with the controller and the at least one electrode. It has a pulse generator.

Advantageously, the electrical skin patch comprises a transceiver in communication with at least one of the controller and the pulse generator, and a plurality of programming instructions stored in a non-transitory computer readable memory of a device physically separate from the electrical skin patch, wherein , when executed, the program instructions obtain patient status data from an external device (eg, a mobile phone running a health care application), generate a modulated signal based on the patient status data, and wirelessly from the device to a transceiver. It is further understood that transmitting the modulated signal, wherein the modulated signal comprises data for modulating at least one of the plurality of stimulation parameters. As discussed throughout this specification, patient status data includes at least one of a patient's hunger, a patient's hunger appetite, a patient's level of satiety, a patient's level of satiety, and a degree of well-being experienced by the patient. The program instructions obtain a first stimulation protocol and generate a modulated signal using the first stimulation protocol. The program instructions obtain a second stimulation protocol, wherein the second stimulation protocol is different from a first stimulation protocol, and uses the second stimulation protocol to generate a second modulated signal, wherein the second modulated signal includes a plurality of data for modulating at least one of the stimulation parameters of The electrical skin patch uses the second modulated signal to generate at least one of a first pulse width, a first pulse amplitude, a first pulse frequency, a first pulse shape, a first duty cycle, a first session duration, and a first session frequency. and modifying to calculate a second pulse width, a second pulse amplitude, a second pulse frequency, a second pulse shape, a second duty cycle, a second session duration, or a second session frequency. the at least one second pulse width is different from the first pulse width, the second pulse amplitude is different from the first pulse amplitude, the second pulse frequency is different from the first pulse frequency, and the second pulse shape is different from the first pulse frequency. different in shape, the second duty cycle is different from the first duty cycle, the second session duration is different from the first session duration, and the second session frequency is different from the first session frequency.

operably, the pulse generator is configured to generate a plurality of stimulation sessions, wherein each of the plurality of stimulation sessions comprises a plurality of electrical pulses, each of the plurality of electrical pulses being defined by a plurality of stimulation parameters; The plurality of stimulation parameters is determined such that a postprandial time at which 50% of the patient's gastric contents are empty after at least one of the plurality of stimulation sessions is applied to the epidermal layer of the patient within 90 minutes of the patient ingesting the meal is determined by the plurality of stimulation sessions. an increase of at least 5% relative to postprandial time in which 50% of the patient's gastric contents are empty without applying at least one of It should be understood that in other embodiments, at least one of the plurality of stimulation sessions may be applied to the epidermal layer of a patient within 3 hours, 2.5 hours, 2 hours, 1.5 hours, 1 hour, 0.5 hours or any increment therein of a meal. do. In the examples provided herein, a time period of 90 minutes is used, although any of the time increments listed above may be used.

In some embodiments, the systems herein are used to generate a real-time intervention in response to a patient's appetite level, wherein the electrical skin patch and at least one plurality stored in a non-transitory memory of the client device separate from the electrical skin patch. It should be understood that it contains the programming instructions of In some embodiments, the electrical skin patch comprises a housing, a controller positioned within the housing, at least one electrode in physical communication with the housing and configured to electrically contact the patient's skin, and a controller and at least one electrode positioned within the housing and electrically connected to the housing. It contains a pulse generator that communicates with The pulse generator is configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by a stimulation parameter as discussed herein. In some embodiments, the system includes a first plurality of program instructions, a second plurality of program instructions, and a third plurality of program instructions. The first plurality of program instructions are stored in a non-transitory memory of the client device separate from the electrical skin patch and, when executed, cause the client device to input data indicative of the patient's degree of appetite through a microphone or display of the client device such that the patient is configured to generate a prompt to The second plurality of program instructions are stored in a non-transitory memory of the client device or other device separate from the electrical skin patch, and when executed, determine the patient's appetite pattern based on the input data. A third plurality of program instructions are stored in a non-transitory memory of the client device or other device separate from the electrical skin patch, and when executed determine the intervention based on the appetite pattern and generate the intervention.

In some embodiments, the system herein is used to generate a real-time intervention in response to a patient's degree of appetite, wherein the electrical skin patch and at least one It should be understood that this includes programming instructions. In some embodiments, the electrical skin patch comprises a housing, a controller positioned within the housing, at least one electrode in physical communication with the housing and configured to electrically contact the patient's skin, and a controller and at least one electrode positioned within the housing and electrically connected to the housing. It contains a pulse generator that communicates with The pulse generator is configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by a stimulation parameter as discussed herein. In some embodiments, the system includes a first plurality of program instructions and a second plurality of program instructions. The first plurality of program instructions are stored in a non-transitory memory of the client device separate from the electrical skin patch and, when executed, communicate with the electrical skin patch and transmit data indicative of a patient's degree of appetite through a microphone or display of the client device. Prompt the patient to enter. The second plurality of program instructions are stored in a non-transitory memory of the client device or other device separate from the electrical skin patch, and when executed, receive data indicative of a patient's appetite degree, and process the data indicative of the patient's appetite degree to process the patient develop a prediction as to whether the patient's appetite will be above or below a threshold in a future time window A first intervention is generated in a future time window if the threshold is expected to be exceeded.

The present invention may be defined by a plurality of different therapy endpoints with respect to a delay in gastric emptying time or an increase in gastric residence time, including:

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 위 내용물의 95%를 비우는 식후 시간이 상기 복수의 자극 세션 중 적어도 하나를 적용하지 않고 환자의 위 내용물의 95%를 비우는 식후 시간에 비해 적어도 5%분만큼 증가하도록 복수의 자극 파라미터를 한정한다.

After application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient has consumed the meal), the postprandial time during which 95% of the patient's stomach contents are empty is at least one of the plurality of stimulation sessions. Define the plurality of stimulation parameters to increase by at least 5% min relative to the postprandial time in which 95% of the patient's gastric contents are empty without applying

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 위 배출 시간이 자극 전 환자의 위 배출 시간에 비해 적어도 1%만큼 지연되도록 복수의 자극 파라미터를 한정한다.

After application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient has consumed the meal), the patient's gastric emptying time is delayed by at least 1% compared to the patient's gastric emptying time prior to stimulation A plurality of stimulation parameters are defined as much as possible.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 하나 이상을 환자의 표피층에 10분 이상 연속 자극으로 적용한 후, 환자의 위 배출 시간이 자극 전 환자의 위 배출 시간에 비해 적어도 5분만큼 지연되도록 복수의 자극 파라미터를 한정한다.

After applying one or more of the plurality of stimulation sessions (preferably within 90 minutes after the patient ingests a meal) to the epidermal layer of the patient as continuous stimulation for at least 10 minutes, the patient's gastric emptying time is equal to the patient's gastric emptying time before stimulation. Define a plurality of stimulation parameters to be delayed by at least 5 min.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 위 배출 시간이 자극 전 환자의 위 배출 시간에 비해 적어도 10분만큼 지연되도록 복수의 자극 파라미터를 한정한다.

After application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient has consumed the meal), the patient's gastric emptying time is delayed by at least 10 minutes compared to the patient's gastric emptying time prior to stimulation A plurality of stimulation parameters are defined as much as possible.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 하나 이상을 환자의 표피층에 적어도 40분 연속 자극으로 적용한 후, 환자의 위 배출 시간이 자극 전 환자의 위 배출 시간에 비해 적어도 20분만큼 지연되도록 복수의 자극 파라미터를 한정한다.

After at least 40 minutes of continuous stimulation of at least 40 minutes of continuous stimulation of one or more of the plurality of stimulation sessions (preferably within 90 minutes after the patient has consumed a meal), the patient's gastric emptying time is equal to the patient's gastric emptying time prior to stimulation. Define a plurality of stimulation parameters to be delayed by at least 20 min.

(바람직하게는 환자가 식사를 섭취한 후 60분 이내에) 복수의 자극 세션 중 하나 이상을 환자의 표피층에 적어도 90분 연속 자극으로 적용한 후, 환자의 위 배출 시간이 자극 전 환자의 위 배출 시간에 비해 적어도 24분만큼 지연되도록 복수의 자극 파라미터를 한정한다.

After applying one or more of the plurality of stimulation sessions (preferably within 60 minutes after the patient has consumed a meal) to the epidermal layers of the patient for at least 90 minutes of continuous stimulation, the patient's gastric emptying time is equal to the patient's gastric emptying time prior to stimulation. Define a plurality of stimulation parameters to be delayed by at least 24 min.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 (위 고형물 함량의 50%의) 위 배출 시간이 자극 전 환자의 위 배출 시간에 비해 적어도 15분만큼 지연되도록 복수의 자극 파라미터를 한정한다.

After application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient has consumed a meal), the patient's gastric emptying time (of 50% of the gastric solids content) is reduced to the patient's gastric emptying time prior to stimulation. A plurality of stimulation parameters are defined to be delayed by at least 15 minutes relative to the ejection time.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 (위 고형물 함량의 50%의) 위 배출 시간이 자극 전 환자의 위 배출 시간에 비해 적어도 25분만큼 지연되도록 복수의 자극 파라미터를 한정한다.

After application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient has consumed a meal), the patient's gastric emptying time (of 50% of the gastric solids content) is reduced to the patient's gastric emptying time prior to stimulation. A plurality of stimulation parameters are defined to be delayed by at least 25 minutes relative to the ejection time.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 (위 고형물 함량의 50%의) 위 배출 시간이 자극 전 환자의 위 배출 시간에 비해 적어도 10%만큼 지연되도록 복수의 자극 파라미터를 한정한다.

After application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient has consumed a meal), the patient's gastric emptying time (of 50% of the gastric solids content) is reduced to the patient's gastric emptying time prior to stimulation. A plurality of stimulation parameters are defined to be delayed by at least 10% relative to the ejection time.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 하나 이상을 환자의 표피층에 5분 이상 연속 자극으로 적용한 후, 환자의 (위 고형물 함량의 50%의) 식후 위 배출 시간이 적어도 5분만큼 지연되도록 복수의 자극 파라미터를 한정한다.

Postprandial gastric emptying of the patient (of 50% of gastric solids content) after one or more of a plurality of stimulation sessions (preferably within 90 minutes after the patient has consumed a meal) are applied as continuous stimulation to the epidermal layer of the patient for at least 5 minutes Define a plurality of stimulation parameters such that the time is delayed by at least 5 minutes.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 적어도 1%의 주간 듀티 사이클로 복수의 자극 세션을 환자의 표피층에 적용한 후, (위 고형물 함량의 50%의) 환자의 식후 위 배출 시간이 적어도 5분만큼 지연되도록 복수의 자극 파라미터를 한정한다.

After applying multiple stimulation sessions to the epidermal layer of the patient with a weekly duty cycle of at least 1% (preferably within 90 minutes after the patient has consumed a meal), the patient's postprandial gastric emptying time (of 50% of gastric solids content) is reduced. Define a plurality of stimulation parameters to be delayed by at least 5 minutes.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 위 체류(즉, 고형 위 내용물의 체류)가 음식 섭취 후 120분에 50%만큼 증가하도록 복수의 자극 파라미터를 한정한다.

After application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient consumes a meal), the patient's gastric retention (i.e., retention of solid gastric contents) occurs at 120 minutes after ingestion of the food. Define a plurality of stimulation parameters to increase by 50%.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 위 운동량 또는 비율이 자극 전 환자의 위 운동량 또는 비율에 비해 5% 내지 10%의 범위로 감소되도록 복수의 자극 파라미터를 한정한다.

After application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient has consumed the meal), the patient's gastric momentum or rate is between 5% and Define a plurality of stimulation parameters to be reduced in the range of 10%.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 위 조절 또는 팽창이 자극 전 환자의 위 조절 또는 팽창에 비해 적어도 15%만큼 손상되도록 복수의 자극 파라미터를 한정한다.

After application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient has consumed the meal), the patient's gastric control or distension is at least 15% greater than the patient's gastric control or distension prior to stimulation. Define multiple stimulation parameters to be impaired as much as possible.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 위 정체가 복수의 자극 세션 중 적어도 하나를 적용하기 전의 환자의 위 정체에 비해 5%만큼 증가하도록 복수의 자극 파라미터를 한정한다.

After application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient consumes the meal), the patient's gastric retention before applying at least one of the plurality of stimulation sessions Define a plurality of stimulation parameters to increase by 5% compared to .

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 위 정체가 복수의 자극 세션 중 적어도 하나를 적용하기 전의 환자의 위 정체에 비해 증가하도록 복수의 자극 파라미터를 한정한다.

After application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient consumes the meal), the patient's gastric retention before applying at least one of the plurality of stimulation sessions Define a plurality of stimulation parameters to increase relative to .

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 하나 이상을 환자의 표피층에 5분 이상 적용한 후, 환자의 위 내용물의 50%를 비우는 식후 시간이 복수의 자극 세션 중 적어도 하나를 적용하지 않고 환자의 위 내용물의 50%를 비우는 식후 시간에 비해 적어도 5분만큼 증가하도록 복수의 자극 파라미터를 한정한다.

After at least 5 minutes of application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient has consumed the meal), the postprandial time during which 50% of the patient's gastric contents are emptied occurs during the plurality of stimulation sessions. Define a plurality of stimulation parameters to increase by at least 5 minutes relative to a postprandial time in which 50% of the patient's gastric contents are empty without applying at least one.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 하나 이상을 환자의 표피층에 5분 이상 적용한 후, 환자의 위 내용물의 95%를 비우는 식후 시간이 상기 복수의 자극 세션 중 적어도 하나를 적용하지 않고 환자의 위 내용물의 95%를 비우는 식후 시간에 비해 적어도 5분만큼 증가하도록 복수의 자극 파라미터를 한정한다.

After application of one or more of the plurality of stimulation sessions to the epidermal layer of the patient for at least 5 minutes (preferably within 90 minutes after the patient has consumed the meal), the postprandial time at which 95% of the patient's gastric contents are empty is defined as the plurality of stimulation sessions. define a plurality of stimulation parameters to increase by at least 5 minutes relative to a postprandial time in which 95% of the patient's gastric contents are empty without applying at least one of

복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 식욕 또는 배고픔이 복수의 자극 세션 중 적어도 하나를 적용하기 전의 환자의 식욕 또는 배고픔에 비해 감소하고 그리고 환자의 메스꺼움 수준이 복수의 자극 세션 중 적어도 하나를 적용하기 전의 환자의 메스꺼움 수준에 비해 증가하지 않도록 복수의 자극 파라미터를 한정한다.

After applying at least one of the plurality of stimulation sessions to the epidermal layer of the patient, the patient's appetite or hunger decreases as compared to the patient's appetite or hunger prior to applying the at least one of the plurality of stimulation sessions, and the patient's level of nausea decreases with the plurality of stimulation sessions. A plurality of stimulation parameters are defined such that they do not increase relative to the patient's level of nausea prior to application of at least one of the sessions.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 하나 이상을 환자의 표피층에 5분 이상 적용한 후, 환자의 위 내용물의 50%를 비우는 식후 시간이 복수의 자극 세션 중 적어도 하나를 적용하지 않고 환자의 위 내용물의 50%를 비우는 식후 시간에 비해 적어도 5%만큼 증가하도록 복수의 자극 파라미터를 한정한다.

After at least 5 minutes of application of at least one of the plurality of stimulation sessions to the epidermal layer of the patient (preferably within 90 minutes after the patient has consumed the meal), the postprandial time during which 50% of the patient's gastric contents are emptied occurs during the plurality of stimulation sessions. A plurality of stimulation parameters are defined to increase by at least 5% relative to a postprandial time of emptying 50% of the patient's gastric contents without applying at least one.

(바람직하게는 환자가 식사를 섭취한 후 90분 이내에) 복수의 자극 세션 중 적어도 하나를 환자의 표피층에 적용한 후, 환자의 위 내용물의 25%, 50%, 75% 또는 95%를 비우는 식후 시간이 복수의 자극 세션 중 적어도 하나를 적용하지 않고 환자의 위 내용물의 등가량을 비우는 식후 시간에 비해 적어도 5%, 10%, 15%, 20%, 25% 또는 50% 또는 그 안의 임의의 증분만큼 증가하도록 복수의 자극 파라미터를 한정한다.

Postprandial time in which 25%, 50%, 75% or 95% of the patient's gastric contents are empty after at least one of a plurality of stimulation sessions is applied to the epidermal layer of the patient (preferably within 90 minutes after the patient has consumed the meal) at least 5%, 10%, 15%, 20%, 25%, or 50% or any increment therein relative to the postprandial time of emptying the patient's equivalent amount of gastric contents without applying at least one of the plurality of stimulation sessions Define a plurality of stimulation parameters to increase.

주어진 날의 총 누적 자극이 5분 초과 60분 미만이 되도록 전술한 요법 목표 중 임의의 것을 달성하도록 복수의 자극 세션을 한정한다.

The plurality of stimulation sessions are defined to achieve any of the aforementioned therapy goals such that the total cumulative stimulation for a given day is greater than 5 minutes and less than 60 minutes.

주어진 날의 자극의 적어도 일부, 바람직하게는 주어진 날의 누적 자극의 대부분이 오후 2시 이후에 적용되도록 전술한 요법 목표 중 임의의 것을 달성하도록 복수의 자극 세션을 한정한다.

The plurality of stimulation sessions is defined to achieve any of the aforementioned therapy goals such that at least a portion of the stimulation on a given day, preferably a majority of the cumulative stimulation on a given day, is applied after 2pm.

Unlike the prior art that directly stimulates the muscle tissue of the gastrointestinal tract to affect gastric emptying time, Applicants' electric pulses are: 1) the generated electric field does not directly contact the patient's gastrointestinal tract and 2) the patient's vagus nerve; each electrical pulse is defined with a maximum pulse width of 1 ms, preferably less than 1 ms, preferably less than 0.5 ms, preferably less than 0.2 ms, 3) the generated electric field activates the patient's internal reflexes and activates the parasympathetic nervous system , the autonomic nerves, the muscles of the gastrointestinal tract, including the stomach, esophagus, duodenum, small or large intestine, or generally smooth muscles, and 4) are so arranged that the electric field does not penetrate more than 20 mm through the skin of the patient. .

In addition, electrical pulses are delivered through a special electrical skin patch device with limited space (less than 10 in ² ) that does not require two differently positioned electrodes. Preferably, the device has two electrodes with a first electrode and a second electrode spaced apart by a distance of less than 20 mm and has an adhesive layer located at a portion of the total base surface area, wherein the adhesive layer of the electrical skin patch The average minimum peel strength of the electrical skin patch when attached to the epidermal layer of this patient ranges from 1.0 Newton to 2.1 Newton.

Gastric emptying time can be measured in a variety of ways, and the therapy endpoints described above are equally applicable regardless of the measurement technique employed. For example, the therapy endpoints described above can be assessed using gastric emptying scintigraphy (GES), which uses radionuclides to measure gastric emptying time. The number of stomachs measured by scintigraphy after radiolabeling the solid or liquid component of a meal has a direct correlation with the volume of the remaining meal without geometric assumptions about the shape of the stomach. Alternative tests include respiratory tests and acetaminophen absorption. Respiratory tests, assuming normal small bowel absorption and lung function, measure gastric emptying indirectly because gastric emptying is the rate-limiting step in the processing and excretion of 13C-octanoic acid. An exemplary protocol for measuring gastric emptying rate is described in "Consensus Recomendations for Gastric Emptying Scintigraphy: A Joint Report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine", Abell et al., American Journal of Gastroenterology. , 2007, pages 753-763, the entire contents of which are incorporated herein by reference.

preserving willpower

According to one aspect of the present specification, 'the urge to eat' is recognized as a function of hunger (physical desire) and appetite (psychological desire). Therefore, it should be understood that the EDP system of the present specification weakens the user's 'craving to eat' so that the user does not have to exert, waste, or consume too much 'willpower' to follow a diet, exercise or other therapy-related regime. In other words, the EDP system of the present disclosure allows the user to preserve willpower and improve the amount of reserve and thus reserve willpower as stimulation therapy progresses.

According to some embodiments, willpower is determined or calculated as an inverse function of hunger level or score. In other words, as the user's hunger score decreases, the conserved willpower increases, whereas as the hunger score increases, the user's willpower is consumed or wasted. Thus, the HMA may be used to illustrate the user's hunger score trend over a predetermined time period and the user's willpower conservation status or trend over the same predetermined time period, such as in the form of a light bar VAS, or other graphical form apparent to those skilled in the art. Provides a GUI that displays vertical or horizontal bar graphs. In some embodiments, the user's hunger score over a predetermined time period is expressed together as a total hunger score over the time period. Similarly, a user's willpower retention level or score is determined or calculated as the inverse function of the total hunger score over a period of time. FIG. 53A depicts willpower VAS 5305 where color bar portion 5306 represents an amount or level of willpower that is preserved as a result of a lower or reduced hunger level experienced by the user. On the other hand, FIG. 53B illustrates the willpower VAS 5310 in which the color bar portion 5312 represents a reduced level or amount of willpower preserved as a result of a high or increased hunger level experienced by the user. In other words, VAS 5310 communicates that the level or amount of willpower wasted is higher than VAS 5305 . Accordingly, the user's willpower conservation status is determined and displayed based on the user's hunger profile or map for a predetermined period of time.

According to some embodiments, willpower is determined or calculated as a combined function of two subparameters, such as diet willpower and exercise willpower. According to various embodiments, dietary willpower is calculated as an inverse function of hunger level or a directly proportional function of diet adherence, whereas exercise willpower is calculated as a directly proportional function of the amount or level of exercise or activity of the user. 54A, 54B illustrate dietary willpower and exercise willpower levels, represented as vertical piston bar graphs 5405 and 5410, respectively, in accordance with one embodiment. The piston 5412 for exercise willpower level 5410 rises as the user exercises more. The piston 5407 for the diet willpower level 5405 rises (or the hunger level is lower) the better the user follows his diet plan. Thus, the diet and exercise willpower are affected by the diet and exercise level, and the two piston bars 5405 and 5410 move up or down accordingly.

In accordance with some embodiments, diet willpower is determined or calculated as a direct proportional composite function of diet compliance and hunger control or appetite control. Dietary willpower status or level is displayed, for example, as a vertical or horizontal bar graph. In various embodiments, the user's score includes at least an amount of calories and a type of calories consumed and is displayed as a vertical bar graph. Similarly, hunger control or appetite control scores are displayed as another vertical bar graph. According to one aspect, when the user's hunger is high and the diet compliance is low, the diet willpower graph is displayed as a red area and/or the EDP blinks red via an LED. As hunger goes down and diet adherence increases, the diet willpower graph is displayed in the yellow area and/or the EDP blinks yellow. If hunger goes all the way down and diet adherence is high, the diet willpower graph is displayed in the green area and/or the EDP blinks green.

According to one aspect herein, a user is encouraged and rewarded for achieving and maintaining a high willpower level, reserve, or reserve, for example by achieving a yellow or green zone. In various embodiments, the reward is in the form of points, badges, and/or emojis. Users can share rewards such as badges or points within social networks. In some embodiments, users may use rewards for discounts, partially or fully waive therapy subscription fees, and/or obtain coupons for other services.

According to some embodiments, the willpower level, reserve, or reserve is calculated or determined as an inverse function of the user's 'cravings' profile or map. According to some embodiments, the 'cravings' profile is itself a measure of total caloric intake (less than 1200 calories in one example of a daily diet plan), type of calories consumed (e.g., the diet composition of carbohydrates versus protein is 20 :80) and mealtime (eg, ideally consumed at mealtime). Thus, the greater the 'craving to eat', the greater the willpower wasted or used, and the lower the willpower that is conserved or reserved.

According to another embodiment, the willpower level, reserve, or reserve is the total intake of calories (less than 1200 calories in one example of a daily diet plan), the type of calories consumed (eg, the diet composition of carbohydrates and proteins is 20: 80), mealtime (e.g., ideally eaten at mealtime), exercise or activity level (ideal goal is for example 10,000 steps), and body weight (e.g., ideally 5 of your target weight) %) is calculated or determined as an aggregate function of at least two of a plurality of parameters, including but not limited to.

In another embodiment, the willpower level, reserve, or reserve is calculated or determined as a combined function of hunger score improvement, diet adherence, and exercise level. In various embodiments, the overall willpower level or score is assessed periodically, such as daily or weekly. In one aspect, to determine a composite willpower level or score, the user includes assessing the user's success in maintaining a particular diet plan, such as consuming 1200 calories per day, evaluating success in limiting non-meal snacks, and VAS light bars are provided periodically to help you assess your success in eating healthy food, and success in controlling your hunger. Additionally, determining the overall willpower level or score may include bonus points earned from each hunger rescue bolus, bonus points earned from exercise or activity, bonus points earned from daily journaling, bonus points earned from favorable daily weight changes, and/or Examples include automatic input such as bonus points earned for positive coaching of other patients within the user's social network group.

It should be understood that a user's willpower level, reserve, or reserve may be calculated or determined as a function of one or more of the basic parameters described above. In an alternative embodiment, the user is provided with a light bar VAS to assess the user's diet willpower on a daily, weekly, or any other suitable cycle. The user's willpower level, score, reserve or reserve includes, but is not limited to, a vertical or horizontal bar graph, a piston bar graph, a graph such as a VAS light bar, a gas tank, an hourglass illustration, or any other suitable display that is advantageously apparent to one of ordinary skill in the art. It is displayed to the user as a plurality of graphs that are not limited to .

In various embodiments, a user's willpower level, score, reserve, or reserve is archived throughout a stimulation therapy cycle or period to generate a willpower profile or map of the user. The willpower profile or map of multiple EDP users may determine an average willpower level or score for a population or group of EDP users. According to one aspect, the HMA compares the willpower level or score of a particular user with an average willpower level or score of a representative population or group of EDP users over a predetermined period of time to determine their willpower level with respect to a representative population or group of users. It communicates to the user the extent to which it is faced. In various embodiments, a representative population of a group of users may be a population of characteristic age, gender, ethnicity, weight, weight loss goal, body mass index, percentage body fat, and/or race.

According to another aspect herein, a user's willpower level or score also affects the aggregate, aggregated, or collective willpower level or score of a social network group, also referred to as a 'social group', of which the user may be a member. Social groups that share similar health goals (e.g. weight loss) can share success stories, can share non-HIPAA information, share progress and compare performance, and rewards for achieving high levels of willpower (points, emo information, media) can be displayed and shared by users, including but not limited to sharing of stimulation parameters and/or protocols leading to better weight loss, improved diet compliance, higher levels of well-being and increased levels of preservation of willpower. Benefit user members in a variety of ways, including but not limited to these.

In other words, an individual user may have a personal willpower level or score, as well as be associated with a collective willpower level or score of a social group of which the user is a member. In various embodiments, the fellowship group may work toward a group goal related to willpower level, hunger control, weight loss, and/or dietary adherence. Thus, in some embodiments, as the user's level of willpower increases, the social group's collective willpower score increases and vice versa. In some embodiments, a user with at least a predetermined minimum score for a level of willpower may coach other social group members. In some embodiments, a high level or score above a predetermined threshold for the user's willpower is a reduction in the user's monthly stimulation treatment fee, a free coupon for another service (eg, a discount coupon for gym admission or membership), a free or may result in one or more rewards including, but not limited to, discounted customized concierge services, coaching or support related to the EDP devices and health care applications herein. As another example, if a social group has a collective goal of achieving a total weight loss of 5%, member users who have achieved or are close to achieving the goal may receive an encouraging emoji from group members for group support. To support and encourage group members, successful members or high achievers may also share therapy credentials with the group, including but not limited to diet plans, exercise regimes, stimulation parameters, protocols, and willpower levels. Again, whenever a user triggers a rescue session or bolus and/or fills out a daily journal, for example, the user is rewarded with bonus willpower points and this event socializes so that other members can send emoji encouragement to the user. It is automatically forwarded to other members of the group.

The online concierge service associated with the EDP device and health care application herein provides a daily diary entry, hunger map, daily rescue session map, diet adherence, weight trend, exercise data, stimulation protocol, diet plan, willpower level or score. may access, process and analyze health-related information about you, including but not limited to. According to one aspect, the online concierge service functions as an automated online coaching service that educates the patient on various functions or usage of the EDP device through a step-by-step audio video demonstration showing the patient how to use the EDP device. According to another aspect, the online concierge service may include adjusted or modified stimulation parameters, settings and protocols; modifications to the exercise routine, format, frequency and duration; and/or provide intervention in the form of adjustments to the user's diet plan. In another aspect, the online concierge service said, "You're doing amazingly well compared to your social group - your overall score is X for the whole group Y, and our calculations show your weight loss goal by date D." You will achieve Z-pounds", "We recommend adding 2000 steps to your routine", "I'm doing well, my hunger score will be lower and the weight loss will be a total weight loss for all users or your social group. "You are showing recurrent signs of hunger after dinner around 8pm - we suggest you eat more protein at dinner and apply a rescue stimulation session at 7:30pm Enables the patient to receive automated or personalized encouragement and advice (e.g., during dietary progress based on diary entries), including but not limited to "or other advice that is apparent to those of skill in the art.

Thus, in various embodiments, the online concierge or diet coach service checks the user's correct use of the EDP device and compliance with operating guidelines and daily diaries, and allows the user to check the timing of stimulation sessions (eg, meal times). suggest that users should adopt a calorie counting regime (from the Approved App List), and users to join social groups (from the Approved List) for moral support. suggest (e.g., from an approved list such as Jenny Craig) to the user to move to a prepackaged meal replacement plan, encourage the user to do more exercise and have a recommendation or approved third party with physiological sensors Suggest to use the device and algorithmically respond to user input with encouragement and recommendations including, but not limited to, suggesting that the user participate in an intensive coaching plan from an approved list. In one aspect, the use of online coaching and recommendation functionality through a concierge service enables targeted advertising in addition to various recommendations including, but not limited to, calorie counting apps, prepackaged meal plans, and third party physiological monitoring devices. support, provide and sell

In various embodiments, status, scores, and trends related to the social group's collective goals are aggregated and shared periodically (eg, daily, weekly, bi-weekly, monthly) among social group members, eg, in the form of a graph. and can also be compared against individual member status, scores and trends. Group goals may include willpower level, hunger score, weight loss, calorie intake, exercise score, and/or dietary adherence.

In various embodiments, a user may subscribe to a dietary plan, exercise regime, or stimulation parameter of a social group member who has achieved a certain threshold score (eg, whether such threshold score is a health or willpower score). can It encourages social group members with high willpower scores to gain followers by allowing social group members to post success credentials including but not limited to diet plans, exercise regimes, stimulation parameters, protocols, and willpower levels.

According to various aspects, a user's willpower score or level may be utilized, for example, to participate in a game or tournament between members of a social group. In various embodiments, a user may earn points and bonuses corresponding to achieving multiple degrees or levels of willpower. In various embodiments, as the user accumulates points to progressively higher points, the user achieves a high level of willpower as well as achieves a percentage of their weight loss goal, a diet to stay below 1200 Kcal/day. It may be necessary to successfully pass multiple filters related to various health parameters including, but not limited to, fitness, exercise or activity equivalent to 10,000 steps per day. Accumulated points allow the user to obtain emojis, electronic badges, reductions in the user's stimulation treatment fees, free discount coupons for other services (e.g., coupons for discounted rates on gym admission or membership or admission to related health or fitness camps); You may earn or receive multiple rewards at various levels including, but not limited to, free or discounted custom concierge services, coaching or support related to the EDP devices and health care applications herein.

Comprehensive Dietary Outcome, Health or Treatment Compliance Score

According to various aspects herein, a function of a category or group of metrics comprising at least a) adherence to a stimulation treatment regime, b) actual diet and wellness outcomes, and c) effective communication with the TPM within a social or social networking group. A combined or composite score is determined. In various embodiments, the composite score represents the degree to which the patient is well compliant with the treatment regime, and thus the patient is doing well in terms of the patient's overall health and well-being goals. In various embodiments, the combined, composite, or compliance score may include whether the patient wears the EDP device on a daily basis; whether the patient provides or enters daily diary data as needed; whether the patient regularly receives stimulation session therapy as scheduled (ie, does not miss scheduled sessions); whether the patient reports calories consumed by recording actual calories consumed; the extent to which the patient adheres to a restricted calorie diet (ie, a planned diet); the type or quality of calories consumed (ie, whether the patient is on a healthy diet); whether the patient records their actual weight each day; actual daily weight loss of the patient; whether the patient uses a wearable device, such as a device with physiological sensors configured to be worn on the human body, such as around the wrist, to monitor, acquire, record, and/or transmit physiological data; the patient's actual exercise score or metric, such as, for example, the number of steps taken to determine calories burned; the patient's appetite score; the patient's sleep quality determined based at least on the patient's sleep time sensed or recorded by an accelerometer or inclinometer included in the EDP device; whether the patient is proactive enough to request a rescue session when needed (ie, hungry at an unscheduled mealtime); How engaged the patient is within the social group and how well they communicate with the TPM, e.g., whether the patient encourages other social group members with emojis and/or whether the patient communicates with the TPM and the TPM in response to a planned or scheduled feedback request is a function of a plurality of factors, including but not limited to

In embodiments, a patient is incentivized, rewarded, and encouraged for achieving a high compliance score as an individual as well as compared to the overall compliance score of a fellowship group associated with the patient. In various embodiments, the patient may receive an encouraging or congratulatory text message (eg, from a celebrity or person), bonus points, emoticons/emojis, gift certificates or coupons, health related accessories, health care programs (eg, Jenny Craig). ) and gyms, free or discounted registration, through any means, including but not limited to; In embodiments, the patient is also incentivized, rewarded, and encouraged if the patient is able to spread awareness and adoption of the EDP device to other individuals (eg, users not currently using the EDP device). For example, patients are rewarded and encouraged to use and/or share the benefits of EDP devices by inviting people, for example, on Facebook or WhatsApp.

In embodiments, the HMA is the patient's daily diary entry data (appetite, hunger, exercise, well-being, etc.) or the patient's health status data (hunger, appetite, exercise, weight, well-being, willpower, eating urge profile, hunger profile, standardized eating, etc.) and a rolling summary of meal profiles, actual eating and eating profiles, diet plan, exercise regime, energy balance, weight changes, blood glucose data, rescue bolus events and stimulus-induced nausea, dyspepsia, and habituation events); Any one or any combination of data is used to generate a composite score representing the patient's overall health status or performance.

It should be understood that, in various embodiments, the composite score may be a function of a subset of a plurality of factors described above. In addition, a composite score is not only determined for an individual patient, but also aggregated for the Fellowship Group and/or all EDP Users to allow comparison of the individual score with the score of the Fellowship Group and/or the entire EDP User Community. In one aspect, the composite score for the patient's composite receptionist or fellowship group alone and/or the composite score aggregated for all EDP users is used to titrate or adjust the stimulation regimen. According to another aspect, the aggregate score associated with an individual patient and/or associated with a fellowship group is shared with an online automated coaching or concierge service and/or designated care provider, physician, coach or support group. Such sharing may include, but is not limited to, online diet coaching inputs including, but not limited to, words of congratulations and encouragement if the overall score improved or an emoji if the overall score is improved, warnings including health food options and/or diet compliance tips if the overall score is lagging. can be automatically triggered (eg, via phone calls and/or video conferencing).

therapy goals

In various embodiments, the systems and methods herein use electrical skin patches that provide pre-programmed and/or customized stimulation protocols to induce gastric vestibular and gastric motility changes to slow the passage of food. In various embodiments, as described above, the health care application software may be used to regulate gut hormones, modulate the gut microbiome, assess gastric vestibular and gastric motility, suppress appetite, achieve dietary compliance, suppress hunger or increase satiety, satiety or satiety. Provides and/or enables programming that is pre-programmed or set 'on demand' by the patient or clinician (in real time) for a plurality of therapy goals that are customizable or adjustable. It should be noted that any or multiple of the methods of use or treatment examples provided above may be used to achieve a therapy goal.

It is also noted that the percentage change in the values listed below is expressed by the formula [(new value) - (old value)]/(old value)]. Therefore, when a specific parameter is measured as a percentage, the percentage change is reflected by the above formula, not by the delta value.

The following are a plurality of non-limiting and exemplary goals:

In some embodiments, after at least one stimulation session or a determinable period of time after stimulation has ended, the ratio, level, or amount of any patient parameter as discussed throughout this specification is the ratio, level or amount of the patient parameter prior to stimulation, or corrected for the quantity. In one case, after at least one stimulation session or a determinable period of time after stimulation has ended, the proportion, level or amount of this patient parameter is reduced compared to the proportion, level or amount of the patient parameter prior to stimulation. In other instances, after at least one stimulation session or a determinable period of time after stimulation has ended, the proportion, level, or amount of the patient parameter is increased compared to the proportion, level, or amount of the patient parameter prior to stimulation.

In some embodiments, the patient experiences a decrease in appetite or hunger by at least 5% after stimulation has ended or at least 1 minute after stimulation has ended.

In some embodiments, after at least one minute or at least one stimulation session from when stimulation is terminated, the patient experiences a decrease in appetite or hunger to be 95% or less of the pre-stimulation or hunger level.

In some embodiments, at least 1 minute after stimulation begins, the patient experiences a perceptible decrease in appetite or hunger.

In some embodiments, at least 1 minute after stimulation begins, the patient experiences an increase in the level of satiety, satiety, or satiety by at least 5%.

In some embodiments, at least 1 minute after the end of stimulation or after at least one stimulation session, the patient experiences an increase in the level of satiety, satiety, or satiety that is greater than or equal to 105% of the level of satiety, satiety, or satiety prior to stimulation. .

In some embodiments, after at least one stimulation session, the patient's compliance with the target daily calorie intake increases relative to the patient's compliance with the target daily calorie intake prior to stimulation.

In some embodiments, the systems and methods herein reduce the patient's daily calorie intake after stimulation compared to the patient's daily calorie intake prior to stimulation, wherein the daily calorie intake prior to stimulation is administered to the patient for a first predetermined time period prior to stimulation. is a function of the amount of calories consumed by the patient, wherein the daily caloric intake after stimulation is a function of the amount of calories consumed by the patient during a second predetermined time period equal in duration to the first predetermined time period after stimulation begins. For example, reduction can be quantified as less than or equal to 99% of pre-stimulation caloric intake, wherein caloric intake is reduced to a range of 600 to 1600 calories, reduced from more than 2000 calories per day to less than 2000 calories per day, or 1600 calories per day. Reduce to less than 1600 calories per day.

In some embodiments, the amount or rate of gastric vestibular motility, gastric motility, gastric emptying, hunger, or appetite level of the patient after at least one stimulation session is modified relative to a corresponding amount prior to stimulation.

In some embodiments, the patient's gastric vestibular motility, gastric motility or gastric emptying rate after at least one stimulation session is modified relative to the patient's gastric vestibular motility, gastric motility or gastric emptying rate prior to stimulation, preferably the patient's Gastric vestibular motility, gastric motility, or gastric emptying rate decreases relative to the patient's gastric vestibular motility, gastric motility, or gastric emptying rate prior to stimulation.

In some embodiments, the patient's gastric emptying time after at least one stimulation session is delayed by at least 1% relative to the patient's gastric emptying time prior to stimulation.

In some embodiments, the patient's gastric emptying time after at least 10 minutes of continuous stimulation is delayed relative to the patient's gastric emptying time prior to stimulation by at least 5 minutes.

In some embodiments, the patient's gastric emptying time after at least 20 minutes of continuous stimulation is delayed by at least 10 minutes relative to the patient's gastric emptying time prior to stimulation.

In some embodiments, the patient's gastric emptying time after at least 40 minutes of continuous stimulation is delayed relative to the patient's gastric emptying time prior to stimulation by at least 20 minutes.

In some embodiments, the patient's gastric emptying time after at least 60 minutes of continuous stimulation is delayed relative to the patient's gastric emptying time prior to stimulation by at least 24 minutes.

In some embodiments, the patient's gastric emptying time after at least one stimulation session is delayed relative to the patient's gastric emptying time prior to stimulation by at least 25 minutes.

In some embodiments, the patient's postprandial gastric emptying time (of 50% of gastric solids content) after at least one stimulation session is delayed by at least 5 minutes, wherein the patient has a BMI of 25 or greater.

In some embodiments, the patient's postprandial gastric emptying time (of 50% of gastric solids content) after at least one stimulation session is delayed by at least 10 minutes, wherein the patient has a BMI of 25 or greater.

In some embodiments, the patient's postprandial gastric emptying time (of 50% of gastric solids content) after stimulation of at least 5 minutes is delayed by at least 5 minutes.

In some embodiments, at a weekly duty cycle of at least 1%, the patient's postprandial gastric emptying time (of 50% of gastric solids content) is delayed by at least 5 minutes.

In some embodiments, at a weekly duty cycle ranging from 1% to 99%, the patient's postprandial gastric emptying time (of 50% of gastric solids content) is delayed by at least 5 minutes.

In some embodiments, the patient's gastric retention (ie, retention of solid gastric contents) after at least one stimulation session is increased by 50% at 120 minutes after ingestion of food, wherein the patient has a BMI of 25 or greater.

In some embodiments, the amount or rate of gastric or gastric vestibular motility in the patient after at least one stimulation session ranges from 8% to 10% on a logarithmic scale compared to the amount or rate of gastric or gastric vestibular motility in the patient prior to stimulation decreases to

In some embodiments, the patient's stomach acceptance or distension after at least one stimulation session is impaired by at least 15% compared to the patient's stomach acceptance or distension prior to stimulation.

In some embodiments, after at least one stimulation session, the patient's glucagon-like peptide 1 (GLP-1) is reduced by at least 20% relative to the patient's glucagon-like peptide 1 (GLP-1) prior to stimulation.

In some embodiments, the patient's glucagon-like peptide 1 (GLP-1) in the first state is greater than the glucagon-like peptide 1 (GLP-1) in the second state, wherein the first state is glucagon-like prior to stimulation. The first state is defined by the area under the curve (AUC) corresponding to peptide 1 (GLP-1), the second state is defined by the second AUC corresponding to glucagon-like peptide 1 (GLP-1) after stimulation, and 1 AUC differs from the second AUC by at least 10% to indicate a decrease in the patient's glucagon-like peptide 1 (GLP-1).

In some embodiments, the patient's level of appetite or hunger in the first state is greater than the appetite or hunger in the second state, wherein the first state is an area under the first curve (AUC) corresponding to the pre-stimulation level of appetite or hunger. wherein the second state is defined by a second AUC corresponding to an appetite or hunger level after stimulation, wherein the first AUC differs from the second AUC by at least 5%, such that a decrease in the patient's appetite or hunger level indicates

In some embodiments, the patient's level of satiety, satiety, or satiety in the first state is lower than the level of satiety, satiety, or satiety in the second state, wherein the first state corresponds to a level of satiety, satiety, or satiety prior to stimulation. and wherein the second state is defined by a second AUC corresponding to a level of satiety, satiety, or satiety after stimulation, wherein the first AUC differs from the second AUC by at least 5%, the patient indicates an increase in the level of satiety, satiety, or satiety.

In some embodiments, after at least one stimulation session, the patient's amount of satiety, satiety, or satiety level increases relative to a corresponding amount prior to stimulation.

In some embodiments, after at least one stimulation session, the patient's level of appetite or hunger decreases relative to the patient's level of appetite or hunger before stimulation for a predetermined period of time, and the patient's level of nausea and/or indigestion is reduced for a predetermined period of time There is no increase compared to the previous patient's level of nausea, wherein the stimulus does not cause the patient to experience pain sensations.

In some embodiments, the patient's level of satiety, satiety, or satiety after at least one stimulation session increases relative to the patient's level of satiety, satiety, or satiety prior to stimulation for a predetermined period of time, and the patient's nausea and/or dyspepsia The level does not increase relative to the patient's level of nausea prior to stimulation for a predetermined period of time, wherein the stimulation causes the patient to experience no pain sensation.

In some embodiments, the patient's total body weight after at least one stimulation session is reduced by at least 1% relative to the patient's total body weight prior to stimulation. In some embodiments, the patient's total body weight after at least one stimulation session is reduced by at least 3% relative to the patient's total body weight prior to stimulation. In some embodiments, after at least one stimulation session, the patient's total body weight decreases by at least 1% relative to the patient's total body weight prior to stimulation, and the patient's level of well-being does not decrease by at least 5% compared to the patient's well-being level before stimulation does not In some embodiments, after at least one stimulation session, the patient's total body weight decreases by at least 3% relative to the patient's total body weight before stimulation, and the patient's level of well-being does not decrease by at least 5% compared to the patient's well-being level before stimulation does not

In some embodiments, the patient's preprandial ghrelin level after at least one stimulation session decreases by at least 1%, preferably at least 3% compared to the patient's preprandial ghrelin level prior to stimulation. In some embodiments, the patient's postprandial ghrelin level after at least one stimulation session decreases by at least 1%, preferably at least 3%, compared to the patient's postprandial ghrelin level before stimulation.

In some embodiments, after at least one stimulation session, the patient's post-stimulation ghrelin level decreases by at least 1%, preferably at least 3%, relative to the patient's pre-stimulation ghrelin level, wherein the pre-stimulation ghrelin level is measured prior to stimulation, Post-stimulation ghrelin levels are measured more than 10 weeks after at least one stimulation session.

In some embodiments, the acyl-ghrelin and total ghrelin of the patient in the first state are greater than the acyl-ghrelin and total ghrelin in the second state, wherein the first state is a first corresponding to acyl-ghrelin and total ghrelin prior to stimulation. is defined by the area under the curve (AUC), wherein the second state is defined by a second AUC corresponding to acyl-ghrelin and total ghrelin after stimulation, wherein the first AUC differs from the second AUC by at least 10%, A decrease in the patient's acyl-ghrelin and total ghrelin is shown.

In some embodiments, the patient's glucagon-like peptide-1, leptin, serotonin, peptide YY, beta endorphin levels, resting metabolic rate, and/or cholecystokinin levels of the patient after at least one stimulation session prior to stimulation include: Serotonin, peptide YY, beta-endorphin levels, resting metabolic rates and/or corresponding levels of cholecystokinin are increased.

In some embodiments, the patient's level of triglyceride, cholesterol, lipopolysaccharide and/or motilin-related peptide after at least one stimulation session is determined by the patient's level of triglyceride, cholesterol, lipopolysaccharide, and/or motilin-related peptide corresponding to a corresponding level of the patient's triglyceride, cholesterol, lipopolysaccharide and/or motilin-related peptide. decreases compared to

In some embodiments, the patient's peak plasma motilin level value after at least one stimulation session is reduced by at least 20% relative to the patient's plasma motilin level peak value prior to stimulation.

In some embodiments, the patient's plasma motilin level peak value in the first state is greater than the plasma motilin level peak value in the second state, wherein the first state is below the curve corresponding to the pre-stimulation plasma motilin level peak value is defined by area (AUC), and the second state is defined by a second AUC corresponding to the plasma motilin level peak value after stimulation, wherein the first AUC differs from the second AUC by at least 10%, such that the patient's Denotes a decrease in plasma motilin level peak values.

In some embodiments, the patient's glucagon-like peptide-1 level increases after at least one stimulation session by at least 1%, preferably at least 3%, compared to the patient's glucagon-like peptide-1 level before stimulation.

In some embodiments, the patient's C-peptide level after at least one stimulation session decreases proportionally to insulin by at least 2% after at least 15 minutes of stimulation compared to the patient's C-peptide level prior to stimulation.

In some embodiments, the patient's leptin level after at least one stimulation session increases by at least 1%, preferably at least 3%, relative to the patient's leptin level before stimulation.

In some embodiments, the patient's serotonin level after at least one stimulation session increases by at least 1%, preferably at least 3%, compared to the patient's serotonin level before stimulation.

In some embodiments, the level of Peptide YY in the patient after at least one stimulation session is increased by at least 1%, preferably at least 3% compared to the level of Peptide YY in the patient prior to stimulation.

In some embodiments, after at least one stimulation session, the patient's level of Peptide YY decreases by at least 20% relative to the patient's level of Peptide YY prior to stimulation.

In some embodiments, the patient's peptide YY level in the first pre-stimulation state is greater than the peptide YY level in the second post-stimulation state, wherein the first pre-stimulation state is below the first curve corresponding to the pre-stimulation peptide YY level is defined by area (AUC), wherein the second post-stimulation state is defined by a second AUC corresponding to the post-stimulation peptide YY level, wherein the first AUC differs from the second AUC by at least 10%, such that the patient's peptide Represents a decrease in the YY level.

In some embodiments, the patient's beta-endorphin level after at least one stimulation session increases by at least 1%, preferably at least 3%, relative to the patient's beta-endorphin level before stimulation.

In some embodiments, the patient's resting metabolic rate after at least one stimulation session increases by at least 1%, preferably at least 3%, compared to the patient's resting metabolic rate before stimulation.

In some embodiments, the patient's cholecystokinin (CCK) level increases after at least one stimulation session by at least 1%, preferably at least 3% relative to the patient's cholecystokinin level prior to stimulation.

In some embodiments, after at least one stimulation session, the patient's cholecystokinin level decreases by at least 20% relative to the patient's cholecystokinin level prior to stimulation.

In some embodiments, the patient's cholecystokinin level in the first pre-stimulation state is greater than the cholecystokinin level in the second post-stimulation state, wherein the first pre-stimulation state is the area under the first curve corresponding to the pre-stimulation cholecystokinin level (AUC). ), and the second post-stimulation state is defined by a second AUC corresponding to the post-stimulation cholecystokinin level, wherein the first AUC differs from the second AUC by at least 10%, thereby indicating a decrease in the patient's cholecystokinin level. indicates.

In some embodiments, the patient's lipopolysaccharide level after at least one stimulation session is reduced by at least 1%, preferably at least 3% compared to the patient's lipopolysaccharide level before stimulation. In some embodiments, reducing lipopolysaccharide levels also reduces metabolic inflammation and insulin resistance.

In some embodiments, the patient's motilin-related peptide level after at least one stimulation session is reduced by at least 1%, preferably at least 3%, compared to the patient's motilin-related peptide level before stimulation.

In some embodiments, the patient's triglyceride level after at least one stimulation session decreases by at least 1%, preferably at least 3%, compared to the patient's triglyceride level before stimulation.

In some embodiments, the patient's glycemia level after at least one stimulation session is improved by at least 1%, preferably at least 3%, compared to the patient's glycemic level before stimulation.

In some embodiments, the patient's blood glucose (GLU) peak after at least one stimulation session is lowered by at least 10% relative to the patient's blood glucose (GLU) peak prior to stimulation.

In some embodiments, the blood glucose of the non-diabetic or non-diabetic patient is reduced to a fasting level of less than 100 mg/dL after at least one stimulation session, thereby overall reducing the likelihood of the patient developing pre-diabetes in the future.

In some embodiments, postprandial plasma glucose concentrations in prediabetic and diabetic patients after at least one stimulation session decreased by at least 5% as measured up to 2 hours after the blood glucose tolerance test.

In some embodiments, the patient's glycemic control is improved after at least one stimulation session. In some embodiments, the patient's glycemic control after at least one stimulation session is modified relative to the patient's glycemic control prior to stimulation, preferably the patient's glycemic control is increased compared to the patient's glycemic control prior to stimulation. In some embodiments, the level of hemoglobin A1C after at least one stimulation session decreases by at least 1%, preferably at least 3%, compared to the patient's hemoglobin A1C level before stimulation. In some embodiments, after at least one stimulation session, the A1C hemoglobin level decreases by at least 5% relative to the patient's hemoglobin A1C level prior to stimulation. In some embodiments, the hemoglobin A1C level after at least one stimulation session decreases by 0.5% relative to the patient's hemoglobin A1C level prior to stimulation. It should be noted that since hemoglobin A1C is measured as a percentage, what is described herein is a percentage change relative to the level before stimulation. For example, if the baseline hemoglobin A1C level is measured to be 7%, then a 5% decrease counts as a 0.35% decrease, thus a 6.75% decrease in the hemoglobin A1C level.

In some embodiments, the level of hemoglobin A1C decreases by at least 1% with a p value of 0.05 after at least one stimulation session. In some embodiments, the level of hemoglobin A1C is fully normalized after at least one stimulation session. In some embodiments, the level of hemoglobin A1C after at least one stimulation session is <7.0% (such as 154 mg per dL of expected average blood glucose in a diabetic patient).

In some embodiments, the patient's blood glucose homeostasis after at least one stimulation session is improved by at least 1%, preferably at least 3%, compared to the patient's blood glucose homeostasis before stimulation. Optionally, glycemic homeostasis is quantified by reducing HOMA-IR (homeostasis model assessment—estimated insulin resistance) by >5% compared to baseline HOMA-IR, calculated as described above with respect to hemoglobin A1C. In some embodiments, the patient's HOMA-IR level after at least one stimulation session decreases by at least 4% compared to the HOMA-IR level prior to applying the stimulation session. Fasting blood sugar decreases by 20 mg/dL after at least one stimulation session in some type 2 diabetic patients.

In some embodiments, after at least one stimulation session, the patient experiences a decrease in fasting plasma insulin levels of >5% as compared to baseline fasting plasma insulin levels.

In some embodiments, after at least one stimulation session, the patient experiences a decrease in fasting plasma blood glucose levels of >5% as compared to baseline fasting plasma blood glucose levels.

In some embodiments, the patient's degree of insulin resistance after at least one stimulation session is modified in proportion to the patient's degree of insulin resistance before stimulation, preferably the patient's degree of insulin resistance is increased compared to the patient's degree of insulin resistance before stimulation . In some embodiments, the patient's degree of insulin resistance after at least one stimulation session is improved by at least 1%, preferably at least 3%, compared to the patient's degree of insulin resistance before stimulation.

In some embodiments, the patient's beta cell function of the pancreas is improved after at least one stimulation session compared to the patient's beta cell function prior to stimulation.

In some embodiments, the patient's total blood cholesterol level after at least one stimulation session is reduced by at least 1%, preferably at least 3%, compared to the patient's total blood cholesterol level before stimulation.

In some embodiments, the composition of the patient's gut microbiota after at least one stimulation session is modified relative to the composition of the patient's gut microbiota prior to stimulation. In some embodiments, after at least one stimulation session, the composition of the patient's intestinal microbiota is modulated from a first state to a second state, wherein the first state is a first level of Bacteroidetes and a first level of Firmicutes. wherein the second state has a second level of Bacteroidetes and a second level of Firmicutes, wherein the second level of Bacteroidetes is at least 1% greater than the first level of Bacteroidetes; preferably by at least 3% greater and the second level of Firmicutes is lower than the first level of Firmicutes by at least 1%, preferably by at least 3%.

In some embodiments, after at least one session of the stimulation session the patient experiences a change, preferably a perceptible decrease in appetite or hunger lasting for at least one day.

In some embodiments, the patient's appetite is reduced by 5% over at least one day of stimulation therapy.

In some embodiments, after at least one session of stimulation, the patient reports "improved" dietary adherence, wherein the dietary adherence is achieving a daily calorie intake goal. In some embodiments, an “improved” dietary regimen adherence is at least 5% closer to a daily calorie intake goal established or established using the EDP device herein.

In some embodiments, the patient has a TWL (total weight loss) of greater than 1%, more preferably 2%, 5%, 10% and any increments therein, or EWL (overweight loss) within 6 months of stimulation therapy. A therapy goal is reached when at least 1%, more preferably 2%, 5%, 10% and any increments therein are achieved.

In some embodiments, a patient has reached a therapy goal if they can change their metabolic rate (eg, RMR or BMR) by 10%. In some embodiments, the stimulation regimen is intended to effect at least a 5% improvement in RMR.

In some embodiments, application of electrical stimulation through the EDP embodiments disclosed herein alters a person's perception of a feeling of fullness or hunger. Specifically, when EDP therapy is applied, the stimulation parameters are selected such that, after at least one stimulation session, the patient's perception of a feeling of fullness or emptiness increases by at least 1% relative to the patient's perception of a feeling of fullness or emptiness before stimulation. do. It can be measured over a day, week, month or other period of time.

In some embodiments, application of electrical stimulation via the EDP embodiments disclosed herein causes a person to have increased athletic output that is defined as the amount of calories burned in a given period of time or the number of steps taken in a given period of time. Specifically, when EDP therapy is applied, the stimulation parameters are selected such that after at least one stimulation session the patient's motor output increases by at least 1% relative to the patient's motor output before stimulation. These workout results can be measured over a day, week, month or other time period.

In some embodiments, the athletic output is a wrist or foot to monitor, acquire, record, and/or transmit physiological data for receiving and integrating exercise and weight loss information with one or more electrical skin patch devices herein. It should be understood that measurements may be made with third party devices (including third party application software on external devices) that have physiological sensors configured to be worn on the human body, such as around (eg, smart shoes).

In some embodiments, the patient's hepatic gluconeogenesis (glucose production in the liver) is lowered by at least 1% relative to the patient's hepatic gluconeogenesis prior to stimulation after at least one stimulation session for the patient's T7 dermatome, thereby improving blood sugar. . The patient may be pre-diabetic or diabetic.

In some embodiments, the patient's prolactin level after at least one stimulation session increases by at least 5% relative to the patient's prolactin level prior to stimulation within a predetermined amount of time.

In some embodiments, after at least one stimulation session, the patient's dopamine levels decrease by at least 5% relative to the patient's dopamine levels prior to stimulation.

In some embodiments, after at least one stimulation session, the patient's plasma cytokeratin 18 (CK-18) level decreases by at least 5% relative to the patient's plasma cytokeratin 18 (CK-18) level prior to stimulation. It should be understood that CK-18 levels correlate with the extent of NAFLD (nonalcoholic fatty liver disease), hepatocellular apoptosis and the presence of NASH (nonalcoholic steatohepatitis) in the patient.

In some embodiments, at the end of the first phase of therapy, the patient is in a second metabolic or health state relative to the first metabolic or health state at the beginning of the first therapy phase, wherein the second metabolic or health state is the first does not worsen by more than 5% to 50% and any increments therein during a vacation period extending beyond the end of the therapy phase, wherein the patient is not receiving any treatment, wherein the vacation period is the period associated with the first therapy phase at least equal to

Achieving dietary compliance

In one embodiment, using an EDP device in accordance with the methods described herein allows a patient to better limit their daily caloric intake to a predetermined amount and is designed to maximize specific nutritional components such as vitamins, minerals and proteins. Pre-determined dietary regimes, including better adherence to diets, reduced undesirable nutritional components such as carbohydrates, fats and sugars, and better adherence to diets designed to have a glycemic index below a pre-determined amount can be better complied with. The present disclosure facilitates adherence to dietary goals for individuals who are overweight (Body Mass Index 25-29.9) or obese (Body Mass Index 30 or greater), in particular, willpower alone or in combination with exercise improves diet compliance and weight loss. Or, especially given that it is an inefficient approach to weight management.

Therapeutically, the EDP device may be used in conjunction with a predetermined diet plan that includes a nutritional profile, a set of foods, and/or a maximum number of calories to ensure that the patient adheres to the predetermined plan.

Thus, in one embodiment, the present disclosure allows for increased diet regimen compliance. The patient is provided with an EDP device, it is attached to the epidermal layer of the patient, and a stimulation regime is initiated. The patient also receives the diet plan electronically or manually as an application running on an external device that defines the diet plan. The diet plan may establish a maximum daily calorie intake, such as 600 calories to 1600 calories, may require a specific nutritional profile, such as a specific number or type of vegetables, protein and/or supplements, and/or carbohydrates, sugars and/or You may need to avoid certain types of foods, such as foods with a high glycemic index. The parameters of the diet plan are, electronically or manually, by an application running on an external device, the patient's activity level (seating, moderate activity, active), the patient's gender, the patient's age, the patient's weight, the patient's height, receiving an indication of the patient's body fat percentage and/or the patient's body mass index. As the patient uses the device and records food intake to a program on the external device that communicates with the EDP device, or in a separate third-party program that transmits information to the program that communicates with the EDP device, the program communicating with the EDP device may determines whether the diet system is adhered to. If the patient does not avoid certain types of food, consumes a certain nutritional profile, and/or exceeds the maximum daily caloric intake, the program adjusts the stimulus parameters to reduce appetite and/or hunger levels and uses these adjusted stimulus parameters to the EDP device, which then increases stimulation intensity, duration and/or frequency to reduce appetite and/or hunger levels and to allow the patient to better adhere to the diet regime. Conversely, if the patient does not consume enough calories, the program adjusts the stimulation parameters to increase appetite and/or hunger levels, sends the adjusted stimulation parameters to the EDP device, and then the device determines the stimulation intensity, duration and and/or decrease the frequency to increase appetite and/or hunger levels, which again allows the patient to better adhere to the diet regime.

In another embodiment, the present disclosure allows for improved diet regimen management. One real problem with doctors and diet programs is that patients stay on the prescribed diet. The present disclosure allows for improved diet management. A third party administrator, such as a physician or health care provider, provides the EDP device to the patient and programs the EDP device with an initial stimulation regime based on the prescribed diet plan. A diet plan may establish a maximum daily caloric intake, such as in the range of 600 calories to 1600 calories, may require a specific nutritional profile, such as a specific number or type of vegetables, protein and/or supplements, and/or carbohydrates, sugars and/or Or you may need to avoid certain types of foods, such as foods with a high glycemic index. The parameters of the diet plan are the application running on the external device, electronically or manually, the patient's activity level (seated state, moderate activity, active), the patient's gender, the patient's age, the patient's weight, the patient's height, the patient may be based on receiving an indication of the body fat percentage of the patient and/or the patient's body mass index. As the patient uses the device and records food intake to a program on the external device that communicates with the EDP device, or in a separate third-party program that transmits information to the program that communicates with the EDP device, the program communicating with the EDP device may determines whether the diet system is adhered to. If a patient does not avoid certain types of food or consume a particular nutritional profile and/or exceeds their maximum daily caloric intake, the third-party administrator may modulate the stimulus parameters to reduce appetite and/or hunger levels and The stimulated parameters may be transmitted to the EDP device, which then increases the stimulation intensity, duration and/or frequency to reduce appetite and/or hunger levels and allow the patient to better adhere to the diet regime. Conversely, if the patient does not consume enough calories, the third-party administrator may modulate the stimulation parameters to increase appetite and/or hunger levels and send these modulated stimulation parameters to the EDP device, which may then be stimulated By reducing the intensity, duration and/or frequency, appetite and/or hunger levels are increased, which in turn allows the patient to better adhere to the diet regime.

In another embodiment, the present disclosure allows for improved dietary maintenance and prevents weight recovery. After reaching the target weight, through one of the aforementioned treatment methods, the patient's diet plan is adjusted to a new diet plan that reflects the weight maintenance goal, not the weight loss goal. These diet plans, which may be manually received electronically or with an application running on an external device, may contain between 1600 calories and 2800 calories, different nutritional profiles, and/or specific types of foods, such as carbohydrates, sugars, and/or foods with high glycemic index. You can establish a higher maximum daily caloric intake than previous diet plans, such as with less emphasis on avoidance. The parameters of the new diet plan are the application running on an external device, electronically or manually, the patient's activity level (seated, moderate activity, active), the patient's gender, the patient's age, the patient's weight, the patient's height, may be based on receiving an indication of the patient's body fat percentage and/or the patient's body mass index. As the patient uses the device and records food intake to a program on the external device that communicates with the EDP device, or in a separate third-party program that transmits information to the program that communicates with the EDP device, the program communicating with the EDP device may decides whether or not to comply with the new diet regime. If a patient does not avoid certain types of food or consume a particular nutritional profile and/or exceeds a new maximum daily caloric intake, the program will adjust the stimulus parameters to reduce appetite and/or hunger levels and The parameters are sent to the EDP device, which then increases the stimulus intensity, duration and/or frequency to reduce appetite and/or hunger levels and allow the patient to better adhere to the diet regime. Conversely, if the patient does not consume enough calories, the program adjusts the stimulation parameters to increase appetite and/or hunger levels and sends the adjusted stimulation parameters to the EDP device, which then sends the stimulation intensity, duration and/or or by reducing the frequency to increase appetite and/or hunger levels, again allowing the patient to better adhere to the diet regime.

Alternatively, instead of adjusting the stimulation parameters if the patient does not avoid certain types of foods or consume certain nutritional profiles and/or exceed new maximum daily calorie intakes, Programs in direct communication with the third party application may alter the diet plan itself by increasing or decreasing the maximum daily calorie intake, changing the nutritional profile, and/or changing the types of foods to be avoided.

38A-38F show how a stimulation regimen herein affects or modulates a plurality of patient variables or parameters, such as body weight, BMI (body mass index), appetite, diet compliance, and well-being for 10 sample patients. An illustrative chart is shown. According to one embodiment, 10 sample patients for the purpose or goal of weight loss were treated with a stimulation therapy herein over a period of 4 weeks and the patients used an interlocking device to use a plurality of variables or parameters over a period of 4 weeks. status was recorded. As shown in FIG. 38A , 10 patients also exercised over a 4-week period and recorded an exercise score 3805 using their interlocking device (described above with reference to FIG. 12 ). The bar graph 3810 shows the median exercise scores per week calculated from the exercise scores of 10 sample patients, while the line graph 3815 shows the exercise scores per week for each of the 10 patients. As can be observed in the bar graph 3810, the median motor scores 3811, 3812, 3813 improved over weeks 2, 3, and 4, respectively.

38B is a chart showing the extent to which weight parameters for 10 sample patients change over the course of 4 weeks as the patient exercised (as previously described with reference to FIG. 15 ), received stimulation therapy, and recorded body weight using an interlocking device. shows The bar graph 3820 represents the median body weight per week calculated from the weights of 10 sample patients, while the line graph 3825 represents the weight per week of each of the 10 patients. As can be observed in bar graph 3820 , the median body weights 3822 , 3823 , 3824 , 3826 are the first, second, It continued to decrease during the 3rd and 4th weeks.

38C shows a chart illustrating the changes in BMI parameters for 10 sample patients over the course of 4 weeks as the patients exercise and receive stimulation therapy. The bar graph 3830 shows the median BMI per week calculated from the BMI of 10 sample patients, while the line graph 3835 shows the BMI per week for each of the 10 patients. As can be observed in the histogram 3830 , the median BMI 3832 , 3833 , 3834 , 3836 was compared to the median BMI 3831 at baseline (ie, before receiving stimulation therapy) in the first, second, second It continued to decrease during the 3rd and 4th weeks.

38D shows appetite parameters for 10 sample patients over the course of a 4 week period as the patient exercised (as previously described with reference to FIG. 11 ), received stimulation therapy, and recorded an appetite score 3847 using an interlocking device. A chart showing the degree of change is displayed. The bar graph 3840 shows the median appetite score per week calculated from the appetite scores of 10 sample patients, while the line graph 3845 shows the appetite scores per week for each of the 10 patients. As can be observed in the histogram 3840 , the median appetite scores 3842 , 3843 , 3844 , 3846 were first and second compared to the median appetite score 3841 at baseline (ie, prior to receiving stimulation therapy). , continued to decrease during the 3rd and 4th weeks.

38E shows a chart illustrating the extent to which diet adherence parameters for 10 sample patients change over the course of 4 weeks as the patient exercises, receives stimulation therapy, and records a diet adherence score 3857 using an interlocking device. . Bar graph 3850 shows the median diet adherence score per week calculated from the diet adherence scores of 10 sample patients, while line graph 3855 shows the diet adherence score per week for each of 10 patients. As can be observed in the histogram 3850, the median diet adherence score (3852, 3853, 3854, 3856) was compared to the median diet adherence score (3851) at baseline (ie, before receiving stimulation therapy). Improvements were made during the 1st, 2nd, 3rd and 4th weeks. Graph 3850 reveals a major advantage of the wearable and self-acting electrical skin patch device herein, particularly in terms of increasing patient independence and improving patient compliance with stimulation protocols, which in turn improves diet compliance. .

38F shows wellness parameters for 10 sample patients over the course of a 4 week period as the patient exercised (as previously described with reference to FIG. 16 ), received stimulation therapy, and recorded a wellness score 3867 using an interlocking device. Show a chart illustrating the degree of change. Bar graph 3860 shows the weekly median well-being score calculated from the well-being scores of 10 sample patients, while bar graph 3865 shows the well-being score (y-axis) for a number of patients reporting symptoms of nausea/abdominal pain each week. ) shows the change in As can be observed in the bar graph 3860 , the median wellness scores 3862 , 3863 , 3864 , 3866 can be observed in the bar graph 3865 , for some patients the weekly wellness scores (e.g., , there was intermittent deterioration in well-being scores (3868, 3869, 3870) for 4, 2, and 3 patients, respectively, but first compared to the median well-being score (3861) at baseline (i.e., before receiving stimulation therapy). , remained stable during the second, third and fourth weeks.

The pre-stimulation level of a plurality of patient variables or parameters (e.g., including but not limited to body weight, body mass index (BMI), appetite, diet compliance, and well-being) is determined in a first predetermined time period (e.g., , 4 weeks), measured using a scale (e.g., VAS) at a predetermined time of day, and the post-stimulation level of the patient variable or parameter is equal in duration to the first predetermined time period after stimulation is initiated. 2 It should be understood that measurements are made using a scale at a predetermined time of day during a predetermined period of time.

Each pre- and post-stimulation level, profile or measure can be determined by comparing data from a single individual or by first aggregating pre-stimulation data from multiple individuals and post-stimulation data from multiple individuals and comparing the two aggregated data sets. It should be understood that it can be evaluated. Additionally, it should be understood that the effect of stimulation can be assessed by comparing parameters measured from an individual or group (in the form of aggregated data) to a non-stimulated control individual or group as described above. In this case, the comparison is made between the no-stimulation and post-stimulation effects of different individuals or groups of individuals (control), as opposed to comparing the pre-stimulation measurements and the post-stimulation effect of the same individual or group of individuals.

Fig. 39 is a side view of an EDP device according to a non-preferred embodiment; EDP device 3900 has all electronics 3902 , power 3901 , power delivery mechanism 3903 such as a coil, and electrodes 3904 captured within a single unit structure. The EDP device 3900 includes one electrode 3904 in the form of a very thin wire that passes through the skin tissue (skin) and reaches the dermatome. The wire is completely coated with electrical insulation except for the distal end, which is open to form an electrode. This part is designed to be inserted within or near the dermatome of interest.

The EDP device 3900 is intended to be placed and attached to the skin over the dermatome of interest. Device 3900 may have different shapes and sizes for different body types. Placement may be accomplished via a biocompatible adhesive, band, belt, or other method of securing to surface 3905 . The proper location of electrode 3904 may be determined by a sensing mechanism. This sensing mechanism may be patient feedback, an electronic sensing mechanism (eg, a biopotential amplifier with analog filtering), or both. Once an appropriate location has been found, the patient can get a tattoo to mark a spot for future device placement.

Figure 40 is another non-preferred embodiment of an EDP device fully implanted with electrodes. The target dermatome(s) is stimulated via a small structure 4005 having a plurality of anodes and a plurality of cathodes and disposed in a subcutaneous region 4006 of the patient's body 4007 proximate to the target dermatome(s). The structure 4005 also has a receiving mechanism to receive power from outside the patient's body 4007 . Power is transferred to the structure 4005 from the EDP device 4000 including a battery 4001 , an electronic device 4002 , and a power delivery mechanism 4003 such as a coil. The EDP device 4000 is disposed with its lower surface 4004 in close proximity to the subcutaneous region 4006 to facilitate the transfer of power from the power delivery mechanism 4003 to the structure 4005 .

Figure 41 is another non-preferred embodiment of an EDP device with electrodes 4105 not being part of the main device housing. The target dermatome(s) are stimulated via these electrodes 4105 operatively connected to the EDP device 4100 via a cable 4104 . Cable 4104 may be permanently connected to or disconnected from device 4100 . The electrodes may be dermal, transdermal, or a combination of the two. It should be understood that other portions of device 4100 are also removable. For example, the unit may be configured such that both the power source 4101 and the electrode 4105 are separable. This makes electronic device 4102 a reusable element of device 4100 , while power source 4101 and electrode 4105 may be disposable. Other such configurations are conceivable. Optionally, device 4100 also includes a power delivery mechanism, such as a coil. The lower surface 4103 of the device includes an adhesive for securing the device 4100 to the skin surface of the patient.

FIG. 42 is another non-preferred embodiment of the EDP device 4200, showing that no electrodes are disposed on the surface of the device and that there is only one transdermal element 4203 extending outwardly from the surface of the device. Device 4200 includes a battery 4201 , an electronic device 4202 , and optionally a power delivery mechanism. This embodiment allows multiple electrodes to be on the transdermal element 4203 . The lower surface 4204 of the device includes an adhesive for securing the device 4200 to the skin surface of the patient.

FIG. 43 is one embodiment of the transdermal element 4203 of FIG. 42 . Element 4203 has four electrodes 4301 connected to four pads 4305 via conductors 4302 . The element substrate 4303 may be made of a flexible material such as Kapton® (polyimide film) or other such material, and the electrodes 4301 and the traces may be made of gold, platinum, or the like. An insulating material such as polyimide or parylene can be used to prevent shorting of the tissue's electrode conductors.

Referring now to FIG. 44 , a block diagram of a system 4400 in accordance with a non-preferred embodiment is shown. System 4400 may be included in mobile computing nodes such as, for example, cellular phones, smartphones, tablets, ultrabooks(®), notebooks, laptops, personal digital assistants, and mobile processor-based platforms. However, in another embodiment, a portion thereof may be included in the electronic device of the device of FIGS. 39 to 42 (eg, excluding one of the two cores, a keyboard, etc.).

A multiprocessor system 4400 is shown that includes a first processing element 4470 and a second processing element 4480 . Although two processing elements 4470 and 4480 are shown, it should be understood that embodiments of system 4400 may include only one such processing element. System 4400 is illustrated as a point-to-point interconnection system, wherein first processing element 4470 and second processing element 4480 are coupled via point-to-point interconnection 4450 . It should be understood that any or all of the illustrated interconnects may be implemented as a multidrop bus rather than a point-to-point interconnect. As shown, each of processing elements 4470 and 4480 may be a multicore processor including first and second processor cores (ie, processor cores 4474a and 4474b and processor cores 4484a and 4484b). These cores 4474a, 4474b, 4484a, 4484b may be configured to execute instruction code in a manner similar to the methods discussed herein.

Each processing element 4470 , 4480 may include at least one shared cache. The shared cache may store data (eg, instructions) utilized by one or more components of a processor, such as cores 4474a, 4474b and 4484a, 4484b, respectively. For example, the shared cache may locally cache data stored in memories 4432 and 4434 for faster access by components of the processor. In one or more embodiments, the shared cache is one or more intermediate levels, such as level 2 (L2), level 3 (L3), level 4 (L4) or other level caches, last level caches (LLCs), and/or combinations thereof. May contain cache.

Although only two processing elements 4470 and 4480 are shown, it should be understood that the scope of the present disclosure is not limited thereto. In other embodiments, one or more additional processing elements may be present in a given processor. Alternatively, one or more of the processing elements 4470 and 4480 may be elements other than a processor, such as an accelerator or electric field programmable gate array. For example, the additional processing element(s) may include an additional processor(s) identical to the first processor 4470 , an additional processor(s) heterogeneous or asymmetric with respect to the first processor 4470 , an accelerator (eg, graphics accelerator or DSP (digital signal processing) unit), electric field programmable gate array, or any other processing element. There may be various differences between the processing elements 4470 and 4480 in terms of a spectrum of performance metrics including architecture, micro-architecture, thermal, power consumption characteristics, and the like. This difference can effectively manifest as asymmetry and heterogeneity between processing elements 4470 and 4480 . For at least one embodiment, the various processing elements 4470 and 4480 may reside in the same die package.

The first processing element 4470 may further include a memory controller logic circuit (MC) 4472 and a point-to-point (P-P) interface 4476 and 4478 . Similarly, second processing element 4480 may include MC 4482 and P-P interfaces 4486 and 4488 . MCs 4472 and 4482 couple the processor to respective memories, namely, memory 4432 and memory 4434, which may be portions of main memory attached locally to each processor. Although MC logic circuits 4472 and 4482 are shown integrated into processing elements 4470 and 4480, in alternative embodiments the MC logic circuitry is discrete logic external to rather than integrated within processing elements 4470, 4480. It may be a circuit.

First processing element 4470 and second processing element 4480 may be coupled to I/O subsystem 4490 via P-P interfaces 4476 and 4486 respectively via P-P interconnects 4462 and 4404 . As shown, I/O subsystem 4490 includes P-P interfaces 4494 and 4498. I/O subsystem 4490 also includes an interface 4492 for coupling I/O subsystem 4490 with high performance graphics engine 4438 . In one embodiment, a bus may be used to couple graphics engine 4438 to I/O subsystem 4490 . Alternatively, a point-to-point interconnect 4439 may couple these components.

The I/O subsystem 4490 may then be coupled to the first bus 4410 via an interface 4496 . In one embodiment, first bus 4410 may be a peripheral component interconnect (PCI) bus, or a bus such as a PCI Express bus or other third generation I/O interconnect bus, although the scope of the present invention is limited thereto. doesn't happen

As shown, various I/O devices 4414 , 4424 may be coupled to a first bus 4410 with a bus bridge 4418 that may couple a first bus 4410 to a second bus 4420 . can In one embodiment, the second bus 4420 may be a low pin count (LPC) bus. A disk drive or other mass storage that may contain, for example, a keyboard/mouse 4422 , communication device(s) 4426 , which in turn may communicate with a computer network, and, in one embodiment, code 4430 . Various devices including a data storage unit 4428 such as devices may be coupled to the second bus 4420 . Code 4430 may include instructions for performing one or more embodiments of the methods described above. Also, an audio I/O 4424 may be coupled to a second bus 4420 .

Note that other embodiments are contemplated. For example, instead of the point-to-point architecture shown, the system may implement a multidrop bus or other communication topology such as this. Further, the elements of FIG. 44 may alternatively be partitioned using more or fewer integrated chips than those shown in FIG. 44 .

45 is another non-preferred embodiment of an EDP device 4500 without integrated active electronics. Instead, the antenna 4505 is coupled to a simple passive rectifier circuit 4502 to convert the RF signal 4511 into energy delivered to the electrodes 4503 and 4504 . The antenna 4505 may be of various designs, such as a dipole antenna, an inverted-F antenna, a fractal antenna, or other antenna capable of efficiently receiving transmitted RF power. The external wireless device 4510 sends an RF signal 4511 to the EDP device 4500 . It should be understood that wireless energy in the form of electromagnetic energy, RF energy, ultrasonic energy, or any combination thereof is transmitted from the external wireless device 4510 (eg, a smartphone) to the EDP device 4500 . Embodiments may use a half-wave rectifier, a full-wave rectifier, or any other passive rectifier circuit known in the art for the passive rectifier circuit. Embodiments may have one antenna 4505 or an additional second antenna 4506 to account for RF signal polarization. Electrodes 4503 and 4504 may be transdermal and/or skin surface electrodes. Embodiments will include sufficient electronic intelligence to avoid unintentional stimulation from other external wireless devices, whether other patient controllers or some other wireless device (eg, airport security scanner, etc.). This intelligence may be in the form of reading specific data packets encoded in an RF transmission via modulation such as amplitude modulation, frequency shift keying modulation, or other conventional techniques.

An embodiment for external wireless device 4510 is a battery powered portable device. An embodiment for an external wireless device may be a smartphone or other commercially available mobile electronic platform (such as shown in FIG. 44 ). Embodiments may include an attachment 4512 to a smartphone or commercially available mobile electronic platform that includes one or more of an antenna, RF signal generator circuitry, RF communication circuitry, and an additional portable power source (eg, a battery). can Embodiments for external wireless devices may be portable, thereby incorporating a portable power source. Embodiments for external wireless devices are not portable and therefore do not require a portable power source and may rely on using an AC mains power source (connected to an electrical wall socket). Embodiments include the ability to encode data in an RF transmission so that it can only pair with a desired EDP device.

Figure 46 is another non-preferred embodiment similar to that of Figures 40 and 45 combined. More specifically, the EDP device 4605 is fully implanted with electrode, antenna, and rectifier circuitry. The target dermatome(s) is stimulated through this small structure having a plurality of anodes and a plurality of cathodes and disposed in the subcutaneous region 4606 of the patient's body 4607 proximate to the target dermatome(s). Wireless energy 4601 in the form of electromagnetic energy, RF energy, ultrasonic energy, or any combination thereof is transmitted from the external wireless device 4600 in conjunction with the embodiment described in FIG. 45 .

magnetic stimulation

In various embodiments, the stimulation delivered by the systems and methods herein is provided by a magnetic stimulation.

86 is a block diagram of a system 8600 for the application of magnetic stimulation or modulation of nerves and nerve endings in body tissues in accordance with another embodiment herein. In some embodiments, referring to FIG. 86 , system 8600 is configured with a hybrid skin patch (HDP) device 8605 that can be toggled to deliver electrical or magnetic stimulation and is in data communication with an interlocking device 8610 . . In various embodiments, companion device 8610 executes a health management application (HMA) herein.

In various embodiments, the HDP device 8605 is via a microprocessor or microcontroller 8615 , one or more electrodes 8622 , or at least one electronically coupled to the transceiver 8617 to communicate wirelessly with the companion device 8610 . Pulse generator 8620 for generating a plurality of electrical pulses for application to magnetic coil 8625 of or a fuel cell).

In various embodiments, the HDP device 8605 is configured to operate in a first mode of electrical stimulation or a second mode of magnetic stimulation. In an embodiment, the HMA creates a GUI that provides the user with options to operate the HDP device 8605 in either a first mode or a second mode. In some embodiments, the user may modify the operating mode of the HDP device 8605 only after authorization of the TPM. In some embodiments, the HDP device 8605 has at least one physical configured to toggle from a first position for operating the device 8605 in a first mode to a second position for operating the device 8605 in a second mode. actuators (eg, push buttons or switches).

In various embodiments, the HDP device 8605 is placed at or near a 'region of interest' on the user's body to provide electrical or magnetic stimulation therapy for a plurality of conditions or treatments. When the HDP device 8605 operates in the second mode of magnetic stimulation, the plurality of electrical pulses generated by the pulse generator 8620 are time-varying induced in the user's 'region of interest' in the at least one magnetic coil 8625 . create a magnetic field In various embodiments, a 'region of interest' includes a dermatome (as previously described herein in the section entitled "Electric Skin Patch Device Deployment").

Magnetic stimulation has an advantage in that it is painless compared to electrical stimulation that may cause pain or discomfort that may cause tingling to the user. A time-varying magnetic field is used to induce an electric current in the user's 'region of interest' tissue. In various embodiments, the induced electric field and thus the induced current have sufficient amplitude and duration, thereby stimulating the user's neuromuscular tissue in the same manner as the first electrical stimulation mode. Therefore, magnetic stimulation can be used to activate tissues, peripheral nerves, and nerve endings without the pain caused by electrical stimulation. Also, there is no need to dispose the electrodes.

Additionally, magnetic stimulation is independent of the user's clothing and bone/tissue structure. Therefore, stimulating excitatory tissue with a time-varying magnetic field is desirable because this technique can be applied non-invasively and is virtually painless. This electrodeless technique is ideally suited for stimulating superficial tissues such as motor neurons.

telemedicine prescription

As previously discussed, the electrical skin patch device is in data communication with and is controlled by the interlocking device. The companion device may be in data communication with one or more remote care facilities and/or care personnel that may enable telemedicine or electronic health care so that a health care professional can evaluate, diagnose, and treat a patient from a remote location using telecommunication technology. can

According to one aspect herein, the user's hunger profile, standard eating and eating profile, actual eating and eating profile, energy balance, weight trend, blood glucose data, willpower level, including, for example, stimulation protocol, settings and parameters, for example. A plurality of health-related information of the user, such as daily or cyclical scores related to , hunger, appetite, exercise and well-being, daily or cyclical composite scores, irritant-induced nausea, indigestion and habituation events (for example) in the cloud It is recorded, archived and stored by the management application software. In various embodiments, the user's stimulation protocols, settings, and parameters, as well as recorded and archived health-related information, are provided in real time, on demand and/or periodically to one or more remote care facilities, health care industry participants, such as insurance companies, and and/or passed on to patient care personnel.

This allows users to communicate their health status, trends, treatment or therapy details and therapy results to remote care facilities and/or patient care personnel for evaluation, advice, support and further treatment and/or medication options. For example, weight loss programs that focus on diet often fail due to weight gain after the program ends. However, health care application software that is HIPAA compliant can remotely monitor a user's weight, blood sugar, blood pressure and overall activity level, for example; continuous by supporting multiple modes of communication, including but not limited to video conferencing, teleconferencing, email and chat, to enable interactive, real-time and/or asynchronous weight-maintenance advice or stimulation regimes for users. Allows for weight maintenance. For example, the user's nutrition specialist, fitness trainer and/or concierge service associated with the EDP device and health care application herein may access, process and analyze, adjust or modify the user's health-related information. stimulation parameters, settings, and protocols; modifications to the exercise routine, format, frequency and duration; and/or provide intervention in the form of adjustments to the user's dietary regimen.

hydrolysis of adipose tissue

According to one aspect, stimulation of internal reflexes using the EDP device of the present disclosure permits innervation of white adipose tissue to hydrolyze it. Even after losing weight, there are spots or areas where a large amount of adipose tissue remains (eg, fat in the hips or upper arms or flanks of the torso). In some embodiments, such points or sites are stimulated over an extended period of time, eg, daily, to hydrolyze the adipose tissue accumulated at these points or sites.

The above examples are merely illustrative of many applications of the methods and systems herein. Although only a few embodiments of the invention have been described herein, it should be understood that the invention may be embodied in many other specific forms without departing from the spirit or scope of the invention. Accordingly, the present examples and examples are to be regarded as illustrative and not restrictive, and the invention may be modified within the scope of the appended claims.

Claims (39)

A computer program product configured to generate a real-time intervention in response to a user's degree of appetite or hunger, comprising:
a first plurality of program instructions stored in a non-transitory memory of a client device, wherein when executed, the first plurality of program instructions are configured to cause the client device to generate at least one visual or audible prompt to the user; wherein the at least one sight or sound is configured to prompt the user to input data indicative of an appetite or hunger degree of the user through a microphone or display of the client device;
a second plurality of program instructions stored in a non-transitory memory of the client device or other computing device, wherein, when executed, the second plurality of program instructions obtain input data indicative of a degree of appetite or hunger of the user, the input The second plurality of program instructions for determining the user's appetite pattern or hunger pattern based on the data;
a third plurality of program instructions stored in a non-transitory memory of the client device or other computing device, wherein, when executed, the third plurality of program instructions are configured to cause future appetite events or hunger events for each user based on the appetite pattern or hunger pattern. determining the timing of the third plurality of program instructions; and
a fourth plurality of program instructions stored in a non-transitory memory of the client device or other computing device, wherein when executed, the fourth plurality of program instructions determines an intervention based on the determined timing of the future appetite or hunger event and determines the intervention generating the fourth plurality of program instructions
A computer program product comprising The method of claim 1 , wherein the second plurality of program instructions visually display at least one of the appetite pattern as a graphical representation of the degree of hunger input over time, or the hunger pattern as a graphical representation of the degree of hunger input over time. A computer program product, further configured to appear as 3. The computer program product of claim 2, wherein the graphical representation comprises at least one of a topographic map, a scatter plot, or a bar chart representing at least one of appetite peaks and valleys or hunger peaks and valleys. 3. The computer program product of claim 2, wherein the color of the graphical representation indicates a degree of appetite or a degree of hunger. The computer program product of claim 1 , wherein the plurality of second program instructions are configured to visually display the appetite pattern or the hunger pattern as a composite hunger score. The computer of claim 1 , wherein the third plurality of program instructions are further configured to determine the timing of the future appetite event or hunger event by evaluating a frequency at which the degree of appetite or degree of hunger of the user exceeds a threshold value. program product. The method of claim 1 , wherein the third plurality of program instructions determine the timing of the future appetite or hunger event by determining a plurality of dates and times when the degree of appetite or hunger of the user exceeds one or more threshold values. A computer program product, further configured to determine. 2. The computer of claim 1, wherein the determination of the timing of a future appetite or hunger event is based on one or more thresholds defining a baseline amount of appetite or hunger, the one or more thresholds being manually or by the user. A computer program product, which may be automatically modified by the program product. The method of claim 1 , wherein the fourth plurality of program instructions generate the intervention by generating data indicative of a visual indication or audible feedback, wherein the visual indication or audible feedback is an instruction to drink or eat a prescribed beverage or food. A computer program product that delivers recommendations. The method of claim 1 , wherein the fourth plurality of program instructions generate the intervention by generating data indicative of a visual indication or audible feedback, the visual indication or audible feedback prompting participation in a predetermined physical exercise or physical activity. A computer program product that delivers recommendations. The method of claim 10 , further comprising generating at least one of a physical exercise or physical activity timer or visual indication for a specific physical exercise or specific physical activity based on the recommendation to participate in the predetermined physical exercise or physical activity, and via the client device. and a fifth plurality of program instructions configured to visually or aurally present. The method of claim 1 , wherein the fourth plurality of program instructions generate the intervention by generating data indicative of a visual indication or auditory feedback, the visual indication or auditory feedback prompting participation in a mindfulness activity. A computer program product that delivers recommendations. 13. The method of claim 12, further comprising: a fifth plurality of program instructions configured to generate at least one of a meditation image or meditation music based on the recommendation to engage in the mindfulness activity and present visually or audibly via the client device. containing, a computer program product. The method of claim 1 , wherein the fourth plurality of program instructions generate the intervention by generating data indicative of a visual indication or audible feedback, wherein the visual indication or audible feedback conveys a recommendation to engage in a cognitive exercise. computer program products. 15. The method of claim 14, further comprising a fifth plurality of program instructions configured to generate at least one of a mental challenge or a mental puzzle based on the recommendation to engage in the cognitive exercise and present visually or audibly via the client device. which is a computer program product. The method of claim 1 , wherein the fourth plurality of program instructions generate the intervention by generating data indicative of a visual indication or audible feedback, the visual indication or audible feedback conveying a recommendation to combine with a food-related image. , computer program products. 17. The computer program product of claim 16, further comprising a fifth plurality of program instructions configured to generate and visually display via the client device a food-related image based on a recommendation to combine with the food-related image. The method of claim 1 , wherein the fourth plurality of program instructions generates the intervention by generating data indicative of a visual indication or audible feedback, wherein the visual indication or audible feedback is a text message, email, voice call, social media A computer program product that conveys a recommendation to participate in a virtual or physical coach via at least one of a platform or video conferencing. 19. The programming of claim 18, wherein the fifth plurality of programming is configured to create and visually or audibly present an interface to participate in at least one of the text message, email, voice call, social media platform, or video conference. A computer program product, further comprising manner instructions. The method of claim 1 , wherein the fourth plurality of program instructions generates the intervention by generating data indicative of a visual indication or audible feedback, wherein the visual indication or audible feedback conveys a recommendation to titrate a dose of a drug. , computer program products. The computer program product of claim 20 , wherein the drug is at least one of a diabetes drug or a weight loss drug. The method of claim 1 , wherein the fourth plurality of program instructions comprises: a separate medical device for adjusting or assisting human functions to optimize at least one of timing or dosing of therapy delivered to the user via a separate medical device; and automatically generating the intervention by directly interfacing. 23. The method of claim 22, wherein the separate medical device is at least one of an intravenous delivery device or controller thereof, a smart intravenous pump or smart infusion system, an enteric nutrient pump, a continuous blood glucose monitoring device, a wearable drug pump, or an artificial pancreas. , computer program products. The computer program product of claim 1 , wherein the fourth plurality of program instructions generate the intervention by automatically interfacing with an electrical skin patch separate from the client device configured to apply electrical stimulation to the skin of the user. 25. The skin patch of claim 24, wherein the electrical skin patch is positioned within the housing, a controller positioned within the housing, at least one electrode positioned in physical communication with the housing and configured to electrically contact the skin of the user, and and a pulse generator in electrical communication with the controller and the at least one electrode. 26. The method of claim 25, wherein the pulse generator is configured to generate an electrical stimulation comprising a plurality of electrical pulses defined by a stimulation parameter, the stimulation parameter having a first pulse width in the range of 10 μsec to 10 msec, 100 μA to 100 A computer program product comprising a first pulse amplitude in the range of mA and a first pulse frequency in the range of 1 Hz to 100 Hz. The value perimeter of claim 1 , wherein the second plurality of program instructions determine a time window associated with each of the inputted data, and for each time window, a range of values of all inputted data associated with the time window constitutes a pattern. A computer program product for determining a user's appetite pattern or hunger pattern based on the inputted data by determining whether it is within a predetermined range of The computer program product of claim 1 , wherein the at least one visual or audible prompt is in the form of at least one of an audio message, a video message, a text message, or a graphic message. The method of claim 1 , wherein the first plurality of program instructions cause the client device to generate at least one visual or audible prompt during a first time window at a first rate and after the first time window at a second rate. and the second ratio is less than the first ratio. 30. The computer program product of claim 29, wherein the first rate ranges from 1 time per day to 24 times per day, and the first window of time ranges from 1 day to 1 month. 31. The computer program product of claim 30, wherein the first plurality of program instructions are configured to provide a user with an option to modify the first ratio via a display of the client device. The method of claim 1 , wherein if the degree of appetite or the degree of hunger of the user is expected to be less than a first threshold for a future time window, the third plurality of program instructions do not generate the intervention during the future time window. Not a computer program product. 2. The method of claim 1, wherein if the degree of appetite or hunger of the user is expected to be greater than or equal to a first threshold value for a future time window, the third plurality of program instructions is configured to cause the intervention during the future time window. A computer program product that generates The method of claim 1 , wherein, when executed, the first plurality of program instructions generates at least one visual or audible prompt in the form of a visual analog scale and displays the visual analog scale on the client device. and each value within the visual analog scale represents a different degree of appetite or hunger. 35. The method of claim 34, wherein the visual analog scale is a light bar having a sliding scale, wherein a first end of the sliding scale indicates a low degree of appetite and a second end of the sliding scale indicates a high degree of appetite. , computer program products. The computer of claim 1 , wherein, when executed, the first plurality of program instructions generates at least one visual or audible prompt in the form of a plurality of icons, each of the plurality of icons representing a different degree of appetite or hunger. program product. The computer program of claim 1 , wherein, when executed, the first plurality of program instructions generate at least one visual or audible prompt in the form of audible data and play the auditory data through a speaker of the client device. product. The method of claim 1 , wherein, when executed, the second plurality of program instructions receives an appetite pattern or hunger pattern of a user, and displays the appetite pattern or hunger pattern on the client device, wherein the appetite pattern or hunger pattern is A computer program product in the form of a graph having a time of day on an axis 1, calendar days on an axis, and icons indicating on the graph a user's degree of appetite or hunger in relation to the time of day and calendar days. 39. The computer program product of claim 38, wherein at least one of a size, shape, color or pattern of the icon indicates an appetite or hunger degree of a user.

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