Non-invasive devices and methods for treating the digestive system and synchronizing stimulation with respiration.

Abstract

To provide a non-invasive device and method for treating digestive system diseases, such as gastroesophageal reflux disease (GERD).SOLUTION: A noninvasive ergonomic self-use device 100 includes a plurality of electrodes 102, 104, and a processor in electrical communication with the electrodes. The processor is configured to switch two or more of the electrodes between at least an ECG mode of operation, in which the electrodes receive user body signals, and an EPG mode, in which the electrodes generate electrical pulses for stimulating the abdominal muscles of the user.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] In some embodiments, the present invention relates to medical devices, and specifically, but not limited to, devices and methods related to the digestive system.

Background Art

[0002] Gastroesophageal reflux disease (GERD) is caused by gastric acid rising from the stomach into the esophagus. GERD is typically caused by abnormal relaxation of the lower esophageal sphincter (LES), which normally keeps the upper part of the stomach closed, a decrease in the discharge of gastric reflux from the esophagus, or a change in the barrier between the stomach and the esophagus, including a hiatal hernia.

[0003] Digestive system diseases such as gastroesophageal reflux disease (GERD) are typically treated through lifestyle changes and medications. Drug therapy is associated with various side effects, raising concerns about the safety of its long-term use. Surgical therapies and endoscopic interventions provide alternative methods for users who do not respond to drug therapy or who resist using such drugs for a long period, but they are also associated with side effects.

[0004] The foregoing examples of the related art and their related limitations are intended to be illustrative and non-limiting. Other limitations of the related art will become apparent to those skilled in the art after reading this specification and the drawings.

[0005] The background art includes U.S. Patent No. 9,925,375, "Non-invasive device and method for treating gastro esophageal reflux disease (GERD) and the digestive system," granted on March 27, 2018.

[0006] The background technology includes the master's thesis "Evaluation of Algorithms for ECG Derived Respiration in the Context of Heart Rate Variability Studies" by Lasse Sohrt-Petersen of Biomedical Engineering and Informatics at Alborg University. [Overview of the Initiative]

[0007] The following embodiments and aspects are described and illustrated, without limiting the scope, along with systems, apparatus and methods intended to be typical and exemplary. One exemplary embodiment of the disclosed invention is a non-invasive treatment apparatus comprising a plurality of electrodes and a processor electrically connected to the electrodes, wherein the processor is configured to switch at least two of the electrodes between an ECG mode in which the electrodes receive bodily signals from a subject and an EPG mode in which the electrodes generate electrical pulses to stimulate the abdominal muscles. In some embodiments, the processor is further configured to detect an inspiratory phase from the ECG signals received from the electrodes and to switch from the ECG mode to the EPG mode as a result of detecting the inspiratory phase. In some embodiments, the detection includes utilizing an electrocardiogram-derived respiration algorithm to detect the inspiratory phase. In some embodiments, the apparatus is further configured to treat digestive symptoms by stimulation, wherein the digestive symptoms are selected members from the group consisting of gastroesophageal reflux disease, obesity, and constipation. In some embodiments, the electrodes are configured to be positioned on the abdominal muscles at waist height of the subject. In some embodiments, the processor is further configured to synchronize electrical pulses for stimulating the abdominal muscles with the subject's inspiratory phase and between heartbeats to avoid loss of ECG data. In some embodiments, the electrodes are dual-function for operating EPG and ECG modes. In some embodiments, the device further includes an ECG circuit connectable to the electrodes, wherein switching the operation to EPG mode includes disconnecting the ECG circuit from the electrodes, and switching to ECG mode includes reconnecting the ECG circuit to the electrodes. In some embodiments, the processor is configured to switch from EPG mode to ECG mode during pulse bursts. In some embodiments, the device includes one or more accelerometers or gyro units electrically connected to the processor, wherein the accelerometers or gyro units are configured to adjust the stimulation intensity in response to body position and physical activity.In some other embodiments, the processor is configured to measure the muscle response to a stimulus and to adjust the stimulus parameters that produce a stable muscle movement.

[0008] Another exemplary embodiment of the disclosed invention is a non-invasive treatment device, the device being an ECG sensor, the ECG sensor comprising a plurality of electrodes configured to be located in the abdominal region of a subject, wherein the electrodes are configured to monitor the ECG signal of the subject and to apply stimulation to the muscles of the abdominal region; a piezoelectric sensor configured to generate a second signal in response to a variation in waist circumference and the location of the abdominal region; and a processor electrically connected to the electrodes, wherein the processor is configured to select a sensor associated with the lowest variation from the first and second variations to measure a first variation in the respiratory period of the subject detected from the ECG sensor and a second variation in the respiratory period of the subject detected from the piezoelectric sensor, and to apply stimulation in response to the inspiratory phase detected by the selected sensor. In some embodiments, the device further comprises a band, wherein the band is configured to interconnect the piezoelectric sensor and at least one electrode base of the plurality of electrodes and to transmit abdominal movement during inspiration or expiration between the piezoelectric sensor and at least one electrode base to detect a second inspiratory phase. In some embodiments, the electrodes include magnetic studs, the male portion of which is attracted to a female snap fixed to a plastic base in order to maintain a proper mechanical and conductive connection.

[0009] One exemplary embodiment of the disclosed invention is an apparatus comprising a plurality of electrodes configured to be located in the abdominal region of a user, a piezoelectric sensor configured to generate a second signal in response to changes in waist circumference and the location of the abdominal region, and a band, wherein the band is configured to interconnect the piezoelectric sensor and at least one electrode base of the plurality of electrodes and to transmit abdominal movement during inspiration or expiration between the piezoelectric sensor and at least one electrode base in order to monitor the user's inspiration.

[0010] In some embodiments, the electrodes include magnetic studs, the male portion of which is attracted to a female snap fixed to a plastic base in order to maintain a proper mechanical and conductive connection.

[0011] One exemplary embodiment of the disclosed invention is an apparatus comprising two TENS electrodes, wherein the electrodes are configured to be located in the abdominal region of a user; an ungrounded ECG amplifier connected to the electrodes and configured to amplify ECG signals; and a processor electrically connected to the electrodes, wherein the processor is configured to receive user body signals from the electrodes, to calculate ECG results obtained from the signals, and to send the ECG results to an application.

[0012] In some embodiments of the present invention, non-invasive devices (hereinafter referred to as "the Devices") and methods for treating gastroesophageal reflux disease (GERD) and the digestive system are provided. In some embodiments, the Devices are configured to affect the abdominal muscles. In some embodiments, the abdominal muscles then promote the activity of the digestive system (e.g., contraction and / or motility). In some embodiments, the abdominal muscles are affected by electrical pulses applied by electrodes. In some embodiments, the generation of electrical pulses is synchronized with a specific phase of the respiratory cycle (e.g., the inspiratory phase). In some embodiments, the Devices include piezoelectric elements configured to generate signals in response to variations in the spatial position and orientation of the electrodes around the waist in the abdominal region during the respiratory cycle. In some embodiments, the piezoelectric elements are mounted on the tip of a semi-rigid or rigid system mount. In some embodiments, the mount is connected to at least one electrode base. In some embodiments, the mount is connected between two electrode bases. In some embodiments, the mount is connected to a device control box. In some embodiments, the mount is connected to a belt.

[0013] In some embodiments, pulse generation is synchronized with a specific phase of the respiratory cycle. In some embodiments, pulse generation is synchronized with the inspiratory phase of the respiratory cycle. In some embodiments, information regarding the phase of the respiratory cycle is derived from ECG analysis.

[0014] In some embodiments, the device generates electrical pulses. In some embodiments, the pulses are synchronized with bodily signals. In some embodiments, bodily signals include respiratory-related chest movement, respiratory-related abdominal movement, ECG, chest impedance, oximeter recording, body motion (accelerometer), and body position. In some embodiments, the electrical pulses are applied during the inspiratory phase of the respiratory cycle.

[0015] In some embodiments of the present invention, an apparatus is provided which includes two or more electrodes and a processor electrically connected to the electrodes. The processor is configured to switch the electrodes between an ECG mode in which the electrodes measure an ECG signal and a stimulation mode in which the electrodes generate electrical pulses to stimulate the abdominal muscles.

[0016] In some embodiments, the device includes a processor equipped with an EDR (electrocardiogram-led respiration) algorithm configured to derive the phases of the respiratory cycle from the ECG signal.

[0017] In some embodiments, the processor is configured to switch between operating modes, such as electrical pulse generation and ECG monitoring, in synchronization with the phases of the respiratory cycle. In some embodiments, electrodes are configured to receive ECG signals and / or transmit stimulation pulses in synchronization with the increase in pressure applied to the digestive system during inspiration.

[0018] In some embodiments, the device includes at least a first pair of electrodes configured to monitor an ECG signal, and a second pair of electrodes configured to apply electrical pulses affecting the abdominal muscles.

[0019] In some embodiments, the electrode includes an adhesive surface (e.g., a conductive hydrogel) configured to adhere the electrode to the skin.

[0020] In some embodiments of the present invention, an apparatus is provided which includes two or more electrodes for stimulating abdominal muscles by transmitting electrical pulses synchronized with the phases of the respiratory cycle, the electrodes monitoring an ECG signal during the transmission of stimulating electrical pulses.

[0021] In some embodiments, the electrical device includes a processor that controls the starting and / or stopping of electrical pulses. In some embodiments, the processor is configured to execute an algorithm for identifying a respiratory phase based on an ECG signal, e.g., ECG-induced respiration (EDR).

[0022] In some embodiments of the present invention, an apparatus is provided which includes a piezoelectric (PE) element for generating a signal in response to changes in the waist circumference of the user's abdominal region during a breathing cycle, and two or more stimulating electrodes for stimulating the user's abdominal muscles by transmitting electrical pulses in synchronization with the signal from the piezoelectric element. In some embodiments, the piezoelectric (PE) element is configured to generate a signal in response to changes in the positions of the two or more electrodes relative to each other and / or relative to the PE element.

[0023] In some embodiments, the waist-waist change in the abdominal region detected by the piezoelectric element corresponds to one or more transitional stages between phases of the respiratory cycle. In some embodiments, the electrode base is connected to a piezoelectric sensor, and as a result, the signal from the piezoelectric element corresponds to the relative motion of the electrode base with respect to the piezoelectric sensor. In some embodiments, the relative motion corresponds to the phases of the respiratory cycle.

[0024] In some embodiments, the device includes a band that interconnects a piezoelectric (PE) element and at least one electrode base. In some embodiments, the band is axially immobile and immobile, and is configured to transmit relative motion between the PE sensor and one or more electrode bases during inhalation and / or exhalation. In some embodiments, the band is rigid.

[0025] In addition to the exemplary embodiments and models described above, further embodiments and models will become apparent from the drawings and from reading the detailed description below. One technical issue disclosed in this disclosure is how to optimize the synchronization between the stimulation pulse and the patient's respiration. Synchronization is required to generate pulses only when abdominal pressure is positive (or rigid) throughout the inspiratory cycle. One technical solution is to simultaneously detect the respiratory phase using a piezoelectric sensor via an LP (low-pass) filter (defined as the piezo mode) and the EDR (ECG-inducing respiration) method (defined as the ECG mode), and to select the optimal mode of execution to determine the timing of the next series of stimulation pulses. In some embodiments, the device determines the inspiratory phase per stimulation by either the ECG mode or the piezo mode. In some embodiments, each sensor (ECG sensor and piezo sensor) outputs the respiratory time in each respiratory cycle. The device calculates the deviation of continuous measurements per sensor for a specific period. In one embodiment, the specific period is 10 seconds. The device selects a more stable sensor to determine the inspiratory period in order to synchronize the stimulation with the inspiratory period. The stable mode is the mode in which the mean deviation between respiratory times measured continuously in a specific time interval cycle is minimized. Typically, the piezo mode is more stable in a resting state, but combined physical movement during exercise makes the piezo mode noisier; therefore, during exercise, the ECG mode is typically more stable, and the device changes mode accordingly. Another technical issue is how to utilize stimulating electrodes to measure the ECG signal. Such utilization allows for ECG measurement from a belt placed on the patient's buttocks, without the need to place electrodes as typically used by conventional ECG devices.

[0026] Another technical solution is to implement a single-channel ECG that utilizes only two large electrodes used for stimulation, thereby simplifying the use of the device. Typically, an ECG requires a third ground electrode. However, the system floats (e.g., isolated from any conductive elements). Accelerometer functions: 1. Detection of body position enables adjustment of stimulation intensity according to the body position. 2. Detection of body activities (such as walking, running) enables adjustment of stimulation intensity according to the body activities. 3. Enables piezo synchronization with the respiratory cycle. 4. Measures the muscle response to stimulation so that the device can generate stable muscle movements.

[0027] In some embodiments, the device uses ECG data for the EDR algorithm. The device is wirelessly connected to the application via BLE communication and needs to minimize interference from the noisy environment, so it is small in size, thereby enabling monitoring of a good ECG signal without a ground electrode.

[0028] There is a large difference between the input of the ECG amplifier (on the order of several mV) and the output of the stimulation (about 120V - 300V), and both use the same electrodes, so it is necessary to protect the ECG amplifier from the high voltage of the stimulation and the charge remaining on the electrodes after the end of the stimulation burst. The protection is achieved by disconnecting the ECG with a set of optocouplers (controlled by the main processor) and discharging the electrodes by short - circuiting them for a short time (0.5 - 5 mS) following the end of the burst.

Brief Description of the Drawings

[0029] Exemplary embodiments are shown in the referenced figures. The elements and dimensions of the specifications shown in the figures are generally selected for convenience and clarity of explanation and are not necessarily shown in a fixed proportion. The figures are noted below. [Figure 1A] It is a simplified perspective view of an electrical device (hereinafter referred to as this device) according to some embodiments of the present invention. [Figure 1B] It is a simplified perspective view of an electrical device (hereinafter referred to as this device) according to some embodiments of the present invention. [Figure 1C]This is a simplified perspective view of an electrical device (hereinafter referred to as "the device") according to several embodiments of the present invention. [Figure 2] This is a simplified plan view of the position of a device on the human body according to some embodiments of the present invention. [Figure 3A] This is a simplified graph, according to some embodiments of the present invention, which superimposes the electrocardiogram output and the respiratory waveform monitored by this device. [Figure 3B] This is a simplified graph, according to some embodiments of the present invention, which superimposes the electrocardiogram output and the respiratory waveform monitored by this device. [Figure 3C] This is a simplified graph, according to some embodiments of the present invention, which superimposes the electrocardiogram output and the respiratory waveform monitored by this device. [Figure 4] This is a simplified electrical flowchart of the operation of the device according to some embodiments of the present invention. [Figure 5A] These are simplified plan and cross-sectional views of a PE sensor of the device, mounted on a band that interconnects electrode bases, according to some embodiments of the present invention. [Figure 5B] This is a simplified drawing of the PE sensor of the device according to some embodiments of the present invention. [Figure 5C] This is a simplified drawing of the PE sensor of the device according to some embodiments of the present invention. [Figure 5D] This is a simplified drawing of the PE sensor of the device according to some embodiments of the present invention. [Figure 5E] This is a simplified drawing of the PE sensor of the device according to some embodiments of the present invention. [Figure 6A] This is a simplified exploded assembly diagram of the skin contact surface of the apparatus and electrodes according to some embodiments of the present invention. [Figure 6B] This is a simplified plan view of the skin contact surface of the apparatus and electrodes according to some embodiments of the present invention. [Figure 6C]This is a simplified plan view of the skin contact surface of the apparatus and electrodes according to some embodiments of the present invention. [Figure 7A] This is a simplified plan view of a positioner for a positioner of the apparatus according to some embodiments of the present invention. [Figure 7B] This is a simplified plan view of a positioner for a positioner of the apparatus according to some embodiments of the present invention. [Figure 7C] This is a simplified plan view of a positioner for a positioner of the apparatus according to some embodiments of the present invention. [Figure 8A] This graph, according to some embodiments of the present invention, shows the changes in heart rate and R peak amplitude obtained by EDR in correlation with a reference respiratory cycle signal. [Figure 8B] This graph, according to some embodiments of the present invention, shows the change in pulse rate and R peak amplitude obtained by EDR in correlation with the signal of a reference respiratory cycle. [Figure 9] This graph, according to some embodiments of the present invention, depicts the trigger points of processor pulse generation obtained by an EDR based on changes in pulse rate (Figure 9A), R peak amplitude (Figure 9B), and a combination of these two algorithms (Figure 9C), with respect to a reference respiratory system signal measured by a nasal flow sensor thermistor. [Figure 10] This is a graph of exemplary EDR triggers generated during subject movement, obtained with background interference in the data. [Figure 11A] This graph shows the respiratory cycle over the signal obtained from the PE element sensor during exercise and the signal obtained from the PE element sensor after passing through a 2Hz low-pass filter. [Figure 11B] This graph shows the respiratory cycle over the signal obtained from the PE element sensor during exercise and the signal obtained from the PE element sensor after passing through a 2Hz low-pass filter. [Figure 12A] This is a graph of the trigger position obtained from the input of a piezoelectric element sensor in a stationary state. [Figure 12B] This is a graph of the trigger position obtained from the input of a piezoelectric sensor during movement. [Figure 13] This is a simplified drawing of a control unit according to some embodiments of the disclosed invention. [Figure 14A] The following are illustrative screenshots of the application for operating the disclosed device and controlling physiological parameter reports. [Figure 14B] The following are illustrative screenshots of the application for operating the disclosed device and controlling physiological parameter reports. [Figure 14C] The following are illustrative screenshots of the application for operating the disclosed device and controlling physiological parameter reports. [Figure 14D] The following are illustrative screenshots of the application for operating the disclosed device and controlling physiological parameter reports. [Figure 14E] The following are illustrative screenshots of the application for operating the disclosed device and controlling physiological parameter reports. [Modes for carrying out the invention]

[0030] Embodiments of the present invention disclose an ergonomic, self-administered, non-invasive device for facilitating the treatment of gastrointestinal disorders or symptoms, such as gastroesophageal reflux disease (GERD), obesity, and constipation. The device is positioned on the skin of the user's abdomen and adapted to generate electrical pulses that affect the abdominal muscles, which then apply intra-abdominal pressure that affects the expulsion of esophageal contents and / or inhibits gastric reflux and alleviates the symptoms of gastroesophageal reflux.

[0031] In some embodiments, electrical pulses are synchronized with user bodily signals. For example, pulses may be synchronized with respiratory cycles, heart rate-ECG measurements, monotonous movements, and body position. Synchronization may be performed by sensors included in the device. In some cases, respiration and body position change gastric and esophageal pressure and position. In some embodiments, electrical pulses are synchronized with respiratory cycles and generate pulses only when abdominal pressure associated with the respiratory cycle is positive, i.e., during inspiration. In some embodiments, for example, in the treatment of GERD, electrical pulses are generated when abdominal pressure increases and stopped when abdominal pressure decreases.

[0032] In some embodiments of the present invention, an apparatus is provided. In some embodiments, the apparatus includes a plurality of electrodes configured to generate electrical pulses. In some embodiments, the electrodes are configured to receive ECG signals. In some embodiments, the electrodes are dual-function (e.g., TENS / ECG monitoring) electrodes.

[0033] In some embodiments, the device includes a processor configured to switch the electrode mode of the function between a mode for receiving an ECG signal (ECG mode) and a mode for generating electrical pulses (EPG mode). In some embodiments, the device processor is configured to switch the electrode mode of the function between bursts of electrical pulses from a pulse-generating mode to a mode for receiving an ECG signal. In some embodiments, the device processor is configured to switch the electrode mode of the function between individual electrical pulses within one or more bursts of pulses between a mode for generating electrical pulses (EPG) and a mode for receiving an ECG signal (ECG mode). In some embodiments, the processor is configured to switch between EPG (electrical pulse generation mode) and ECG (electrocardiogram) mode in synchronization with the respiratory cycle phase. In some embodiments, the processor is configured to analyze ECG signals from electrodes over a period of time and derive a respiratory cycle waveform from the ECG analysis. In some embodiments, the processor is configured to identify the respiratory phase of a respiratory cycle over a period of time from the derived waveform. In some embodiments, the processor is configured to synchronize the generation of stimulation pulses with an increase or decrease in pressure applied by the abdominal muscles to the digestive system (e.g., stomach, esophagus) during the respiratory cycle. In some embodiments, the processor is configured to control parameters of the stimulation electrical pulse, such as frequency, amplitude, waveform, and current. In some embodiments, the electrodes include an adhesive surface (e.g., an adhesive hydrogel) and are attached to the body by adhesion. In some embodiments, the device is applied to the user's body by adhesion alone, without other support (e.g., a belt or harness). In some embodiments, the device includes at least one belt for securing the device across the abdominal region. In some embodiments of the present invention, the synchronization of stimulation and respiration may be used in a manner that promotes gastrointestinal activity (e.g., contraction and / or motility). In some embodiments, the method includes stimulating the abdominal muscles. In some embodiments, the method includes attaching a plurality of electrodes to the user's body at the level of the navel. In some embodiments, the method includes acquiring waveforms of one or more respiratory cycles and identifying at least the inspiratory phase of the respiratory cycles. In some embodiments, the method includes generating one or more electrical pulses from two or more electrodes during the inspiratory phase of a respiratory cycle. In some embodiments, the method includes acquiring an ECG signal. In some embodiments, the method includes acquiring waveforms of one or more respiratory cycles and identifying at least the inspiratory phase of the respiratory cycles using EDR (electrocardiogram-led respiration) techniques. In some embodiments, the method includes acquiring ECG data between the generated stimulating electrical pulses. In some embodiments of the present invention, a piezoelectric element configured to generate a signal in response to lumbar fluctuations in the abdominal region during a respiratory cycle and changes in the spatial position and orientation of the electrodes relative to each other. In some embodiments, the piezoelectric element detects transitions between respiratory cycle phases, such as the start of inspiration and / or expiration. In some embodiments, the piezoelectric element is mounted on the tip of a semi-rigid or rigid mount. In some embodiments, the mount is connected between at least two electrode bases. In some embodiments, the mount is connected to a device control box. In some embodiments, the mount is connected to a belt.

[0034] In some embodiments, the device includes a band that interconnects a piezoelectric element with at least one electrode base. In some embodiments, the band is configured to transmit relative motion between the electrode base and the piezoelectric element over a complete breathing cycle (during inhalation and exhalation). In some embodiments, the band is non-expandable and non-compressible in the axial direction. In some embodiments, the band is rigid. In some embodiments, the band includes a portion of a belt.

[0035] Hereinafter, we refer to Figures 1A, 1B, 1C, and 2, which are simplified perspective and plan views of apparatus and implementations of apparatus according to several embodiments of the present invention. As shown in Figure 1A, the electrical apparatus (100) includes two or more electrodes (102) and (104) mounted on electrode bases (110 / 112) respectively connected to opposing ends of a connecting band (106). In some embodiments, at least one surface of the electrodes (102 / 104) is coated with a biocompatible adhesive (e.g., conductive hydrogel) hydrogel (628) configured to allow multiple use of one or more electrodes (102 / 104) on the skin without the use of additional support such as a belt. In some embodiments, one or more bases (110 / 112) include part of the band (106). In some embodiments, the electrodes (102 / 104) are dual-function electrodes (e.g., EPG / ECG monitoring). The EPG function includes generating pulses that stimulate the abdominal muscles, and the ECG function includes monitoring the body's ECG signals. The EPG / ECG monitoring functions of electrodes (102 / 104) alternate at regular intervals, as described in more detail elsewhere in this specification.

[0036] In some embodiments, the apparatus (100) includes, for example, an electrical component such as a processor circuit board, switches, and a voltage booster, and a control box (108) housing at least a processor (202) (Figure 4A). In some embodiments, the processor (202) is in electrical and / or data communication with electrodes (102 / 104). As will be described in more detail elsewhere in this specification, in some embodiments, the processor (202) is configured to switch the electrodes (102 / 104) between at least an ECG mode and an EPG mode of operation. When set to ECG mode, the electrodes monitor bodily ECG signals, and when set to EPG mode, the electrodes generate electrical pulses to stimulate the abdominal muscles, which then promotes gastrointestinal activity. In some embodiments, the apparatus includes separate electrodes for the ECG mode of operation and electrodes for the EPG mode of operation. In some embodiments, the electrodes (102 / 104) are disposable.

[0037] In some embodiments, the device (100) includes a band (106) that interconnects electrode bases (110 / 112) at their ends (606) and (604), respectively (Figure 6A). In some embodiments, the band (106) transmits the relative motion between the electrode bases (110 / 112) generated by the contraction and relaxation of the chest and / or abdominal muscles during the respiratory cycle (inhalation and exhalation). In some embodiments, the electrodes (102 / 104) and the control box (108) are in electrical and data communication state via at least one electrical and data conduit located within the band (106).

[0038] According to some embodiments, the electrical device (100) includes a number of control buttons (204). In some embodiments, the control buttons (204) allow for manual activation or deactivation of the stimulation pulse. In some embodiments, activation is performed automatically by tension applied to a piezoelectric (PE) element connected to one end of a band (106) by a band (106). In some embodiments, the device (100) is activated by an application on a mobile device (e.g., a smartphone, smart tablet, or laptop computer).

[0039] As shown in the exemplary embodiment depicted in Figure 2, generating stimulating electrical pulses on the rectus abdominis and external oblique muscles in the lateral abdominal region of the body brings about the most effective response in the digestive tract, and primarily the esophagus and stomach, to the device (100).

[0040] As shown in Figure 2, a simplified perspective view of the implementation of the apparatus in Figure 1A, the authors of this disclosure have found that positioning the pulse-emitting electrodes (e.g., (102 / 104) on the abdominal muscles at the height of the subject's waistline, e.g., on the rectus abdominis and external oblique muscles, results in the most effective treatment of the gastrointestinal tract. As depicted in the exemplary embodiment shown in Figure 2, electrode (102) is placed on the lower rectus abdominis in a horizontal configuration, and electrode (104) is placed on the lower oblique muscle in a vertical configuration. As will be described in more detail elsewhere in this specification, the difference in movement between the rectus abdominis and external oblique muscles during the respiratory cycle is represented by the fluctuation of tension / compression force on the PE sensor (508).

[0041] According to some embodiments, one or more phases of the respiratory cycle are determined by signals detected by electrodes (102 / 104). According to some embodiments, electrodes (102 / 104) transmit stimulation pulses in synchronization with increases or decreases in pressure exerted by the abdominal muscles on the digestive system (e.g., stomach, esophagus) during the respiratory cycle.

[0042] Hereinafter, we refer to Figures 3A, 3B, and 3C, collectively called Figure 3. Figures 3A and 3B are simplified graphs overlaying diagrams of electrical stimulation pulses generated by the processor of the device and ECG measurements, according to several embodiments of the present invention. Figure 3C is a simplified graph overlaying diagrams of electrical stimulation pulses, ECG measurements, and a respiration reference monitored by a nasal pressure sensor or nasal thermistor, according to several embodiments of the present invention. In some embodiments, and as shown in Figures 3A and 3B, the processor (202) of the device (100) is configured to sample the ECG signal approximately 1000 times per second on average during the interval (385) between individual heartbeats (e.g., 60 BPM). In some embodiments, as depicted in Figure 3A, the electrical pulse (330) is biphasic, having a time pattern and an arbitrary regulated pattern. The generated pulses (330) are synchronized with the patient's respiratory phase and are generated between heartbeats during the inspiratory phase, and in a predetermined pattern (e.g., velocity and / or duration).

[0043] As will be described in more detail elsewhere in this specification, the electrodes (102 / 104) of the device (100) are dual-function (e.g., EPG / ECG monitoring) electrodes and are time-shared for generating pulses or reading ECG signals. In this configuration, during pulse generation, electrodes (102 / 104) do not read ECG signals, and vice versa. As described elsewhere in this specification, the ECG is sampled between 200 and 1500 times per second. For example, in some embodiments, the ECG samples 1000 samples during a heartbeat of 60 BPM. The duration of a single generated pulse is very short (approximately 0.45 mS) compared to the duration of an ECG cycle (385) (approximately 1 second), and therefore, the ECG input missed by the unmeasured portion (325) of the ECG measurement during pulse burst generation is negligible.

[0044] As described elsewhere in this specification, in some embodiments, the electrode (102 / 104) is a dual-function (e.g., EPG / ECG monitoring) electrode. The EPG function includes generating electrical stimulation pulses that stimulate the digestive system, and the ECG function includes monitoring the body's ECG signal. As described in more detail elsewhere in this specification, the EPG / ECG monitoring function of the electrode (102 / 104) alternates at set intervals.

[0045] In some embodiments, the electrical pulse (330) is generated as a controlled burst of short pulses. In some embodiments, a single burst contains pulses between 5 and 25, 10 and 20, or 13 and 16. In some embodiments, the pulse duration is between 0.10 and 0.60 mS, 0.20 and 0.55 mS, or 0.30 and 0.50 mS. In some embodiments, 1 to 3 bursts are applied during the inspiratory phase of the respiratory cycle.

[0046] In some embodiments, and as shown in Figure 3C, information regarding the respiratory cycle is derived from a respiratory monitor, such as a nasal pressure sensor or nasal thermistor placed adjacent to the subject's nostrils.

[0047] In some embodiments, rib cage expansion temporarily increases the circumference of the body's torso compared to other parts, applying tension to the band (106) at waist height. Such tension applies force to a PE sensor (508) that emits an electrical signal indicating rib cage expansion or inspiration. The inspirational phase (375) is the period when the pressure on the abdominal organs (e.g., stomach) is greatest as a result of diaphragmatic and rib cage expansion.

[0048] During exhalation, the process is reversed, and because the band (106) is axially inexpandable and incompressible or rigid, the contraction of the rib cage reduces the circumference of the body's torso at waist height, applying a compressive force to the band (106), which is represented by the generation of a negative (inverted) electrical signal from the PE sensor (508). The processor (202) is configured to identify the signal emitted by the PE sensor (508) and transmitted to the processor (202), and to identify the signal associated with the inspiratory phase (375) of the respiratory cycle (322) (Figure 3C). As soon as the processor (202) identifies the signal, it switches the electrodes (102 / 104) to the EPG mode of operation, and in turn generates bursts of pulses that act on the abdominal muscles.

[0049] As shown in the exemplary embodiment depicted in Figure 3A, the processor (202) switches (activates) the electrodes (102 / 104) to operational EPG mode to generate a burst (332) of pulses (330) at or immediately after the start of the intake phase (375), and switches (deactivates) the electrodes (102 / 104) to operational ECG mode at or immediately after the end of the intake phase (375).

[0050] Additionally or alternatively, the electrical device (100) includes an ECG monitor (406) configured to transmit an ECG signal (320) to a processor (202), which not only provides information about the phases of the respiratory cycle (i.e., inspiration / expiration) but also predicts when the inspirational phase begins (350), when gastrointestinal treatment is most effective. In some embodiments, and as will be described in detail elsewhere in this specification, electrodes (102 / 104) are configured to receive the ECG signal.

[0051] As described elsewhere in this specification, the processor (202) is configured to execute algorithms for identifying the waveform and phase of respiration from an ECG signal, such as ECG-derived respiration (EDR). In some embodiments, the processor executes algorithms for identifying respiration waveforms estimated from the RR interval of the ECG.

[0052] EDR (ECG-Induced Respiratory Respiration - a technique for obtaining respiratory signals from ECG) is based on the ECG QRS pattern: variability in heart rate, R peak amplitude, and QRS region. As shown in Figure 3B, in some embodiments, the pulse duration is 0.2 mS, and the gap duration between pulses (395) is approximately 28 mS (the burst duration is approximately 450 mS, and the gap between bursts can vary between 0 mS and 1000 mS). In some embodiments, ECG samples can be taken between pulses (e.g., at a rate of 1 kHz). During switching, the system isolates the ECG circuit immediately before the pulse and reconnects it immediately after the pulse (switching to EPG mode before the pulse and back to ECG mode after the pulse). In this configuration, only about 0.1–0.2% of the sample is missed (Figure 3B, 325). Nevertheless, heart rate detection remains unaffected.

[0053] In some embodiments, and as depicted in Figure 3C, the processor (202) synchronizes the generated bursts so that bursts are generated between predicted continuous heartbeats and during the inspiratory phase (375) of the respiratory cycle. In this configuration, the processor (202) switches to the ECG mode of the operation about 10–100 mS after the burst and returns to the EPG mode of the operation immediately before the next heartbeat. In the transition from EPG to ECG, the electrodes are short-circuited for a duration of 0.5 mS to 2 mS to discharge the electrodes.

[0054] Isolating the ECG circuit of the electrode and discharging the electrode are performed for the purpose of protecting the ECG circuit from high-voltage stimulation signals. As described elsewhere in this specification, in some embodiments, the electrode (102 / 104) is a dual-function (e.g., EPG / ECG monitoring) electrode that prevents the electrode from performing ECG sampling during the EPG mode of operation.

[0055] The potential benefit of obtaining complete ECG measurements (320 / 320-1) throughout a complete respiratory cycle (322) lies in providing the processor (202) with an accurate ECG database for EDR analysis and to accurately identify phases and phase divisions at all points along the respiratory cycle.

[0056] The potential advantage of precisely identifying the exact point in the respiratory cycle phase is that the processor (202) can accurately identify the start of the inspiratory phase (375), and accordingly synchronize the application of the electrical pulse burst (332) to the point in the respiratory cycle where the gastrointestinal stimulation treatment is most effective.

[0057] In some embodiments, the processor (202) is in communication with one or more electrical switching devices that switch the electrodes (102 / 104) from an operational ECG mode to an operational EPG mode and vice versa. For example, when the switch is in the closed position, the electrodes (102 / 104) are switched to an operational ECG mode to receive an ECG signal (320). Alternatively, when the switch is in the open position, the electrodes (102 / 104) are switched to an operational EPG mode and are in communication with a two-phase pulse generator and a DC / DC converter booster (e.g., a 120VDC410 booster) and generate a stimulation pulse (330).

[0058] A potential advantage of this configuration is that, in some embodiments, the processor (202) switches the mode of operation of the electrodes (102 / 104) between an ECG mode for acquiring an ECG signal and an EPG mode for generating bursts (332) of electrical pulses (330). A potential advantage of this configuration is that the processor (202) is configured to switch the electrodes (102 / 104) to the ECG mode of operation between bursts (332) of pulses (330) and / or between individual pulses (330).

[0059] In some embodiments, the processor (202) is configured to control and adjust parameters of the pulses (330) generated by the electrodes (102 / 104), such as frequency and / or burst form (pulse amplitude, voltage, current, etc.). In some embodiments, the electrodes (102 / 104) are discharged between the ECG mode and the EPG mode of the operation.

[0060] In some embodiments, and as shown in Figure 3C, the processor (202) of the device (100) switches the electrodes (102 / 104) from an ECG mode for operations to acquire an ECG signal (320) to an EPG mode for operations to generate bursts (332) of electrical pulses (330) during a period in which at least the following conditions are simultaneously present: the respiratory cycle (322) is in the inspiratory phase (375), and the ECG is between beatings (i.e., QRS complex).

[0061] According to some embodiments of the present invention, the electrical pulse (330) of the device (100) is determined by the following parameter: frequency between 25 and 40 Hz. In some embodiments, the frequency is 35 Hz. In some embodiments, the pulse is two-phase. In some embodiments, the duration of the pulse is between 0.35 mS and 0.50 mS. In some embodiments, the duration of the two-phase pulse is 0.45 mS. In some embodiments, there is a 28 mS difference between pulses (330). In some embodiments, the electrodes (102 / 104) are configured to discharge during a 28 mS difference (395) before switching to the ECG mode of operation. In some embodiments, the potential of the electrical pulse (330) is between 100 V and 140 V, or between 110 V and 130 V. In some embodiments, the potential of the electrical pulse (330) is 120 V.

[0062] Herein, we refer to Figure 4, a simplified flowchart of the operation of the electrical device (100) according to some embodiments of the present invention. In the exemplary embodiment depicted in Figure 4, in block (402), electrodes (102 / 104) are in the ECG mode of operation and are configured to receive ECG signals. The ECG signals from electrodes (102 / 104) are transmitted to a processor (202) located in block (404). A PE sensor (508) (block (406)) transmits signals to the processor (202) simultaneously or sequentially, associated with fluctuations in the body's waist circumference during the respiratory cycle. In block (408), the processor (202) analyzes the inputs from electrodes (102 / 104) and the PE sensor (508) and identifies the phase of the respiratory cycle based on the received inputs. In block (410), the processor (202) determines the start of the inspiratory phase (375) of the respiratory cycle (322), and in block (412), switches the electrodes (102 / 104) from the operational ECG mode (block (402)) to the operational EPG mode, at which point in block (414), the electrodes (102 / 104) generate stimulation pulses. After the generation of stimulation pulses (330) and / or in the middle of individual pulses (block (416)), the processor (202) switches the electrodes (102 / 104) back from the operational EPG mode (block (412)) to the operational ECG mode in block (402), in block (418), thereby stopping the generation of electrical pulses (330) (block (420)).

[0063] In block (422), in order to identify the expiratory phase (380) of the respiratory cycle (322), the PE sensor (508) processor (202) switches the electrodes (102 / 104) back from the EPG mode of operation (block (412)) to the ECG mode of operation in block (402) in block (418), thereby stopping the generation of electrical pulses (330) (block (420)).

[0064] Hereinafter, we refer to Figure 5A, a cross-sectional and plan view showing the PE sensor of the apparatus mounted on an interconnecting band according to some embodiments of the present invention, and Figures 5B, 5C, 5D, and 5E, which show a simplified cross-sectional view illustrating the PE sensor of the apparatus. In the exemplary embodiments depicted in Figures 5A, 5B, and 5C, the apparatus (500) includes a piezoelectric (PE) sensor (508) mounted on a mount (550). In some embodiments, the mount (550) includes an elastic PE base (509) connected to one or more cantilever beams (512). In some embodiments, the elastic PE base (509) is made of metal and / or polymer.

[0065] In some embodiments, the PE mount (550) is connected to a band (106) that is axially non-expandable and non-compressible. The band (106) interconnects the PE sensor (508), the mount (550), and the electrode base (112), so that the movement of the electrode base (112) relative to the mount (550) exerts a bending force on the PE base (509) of the mount (550) via the band (106), deforming the piezoelectric sensor (508). In some embodiments, the band (106) connects the PE sensor (508) to other parts of the device (500), such as a strap (206).

[0066] The tension and compression forces acting on the mount (550) cause the abdominal cavity and primarily the diaphragm to move in accordance with the respiratory cycle (322) as a result of the expansion and contraction of the rib cage, resulting in forces acting on the mount (550) that deform the PE element. The deformation of the PE sensor (508) generates an electrical signal to the processor (202).

[0067] According to some embodiments, and as shown in Figure 5A, a portion of the band (106) can move back and forth within the housing (502) in conjunction with the phases of the respiratory cycle.

[0068] In some embodiments, and as shown in Figures 5B and 5C, the base (509) of the piezoelectric sensor (508) is connected to a mount (550) which is connected to a band (106). For illustrative purposes only, in the exemplary embodiments depicted in Figures 5B and 5C, the mount (550) is connected to a stationary point (555).

[0069] As shown in Figure 5B, when the band (106) moves toward the housing (502) in the direction indicated by arrow (575), the band (106) exerts a moment of force in the direction indicated by arrow (577), exerting a bending force on the base (509) and bending the base (509) (for example, away from the body wall (580) of the subject), and deforming the PE sensor (508). The deformation of the PE sensor (508) generates an electrical signal of the first polarity. As shown in Figure 5C, when the band (106) exerts tension in the direction away from the housing (502) as indicated by arrow (595), it exerts a bending force on the mount (550) and bends the base (509) in the opposite direction (for example, towards the body wall (580) of the subject). Bending the base (509) deforms the PE sensor (508) in the opposite direction (for example, toward the body wall (580) of the subject) and generates a second electrical signal of the opposite polarity.

[0070] Since the movement of the band (106) is associated with the respiratory phase of the subject, the polarity of the electrical signal generated by the PE sensor (508) is associated with the respiratory phase of the subject (the direction in which the PE sensor (508) is deformed by the base (509)).

[0071] In some embodiments, the processor (202) is configured to combine information transmitted from the piezoelectric sensor (508) to the processor (202) with ECG information transmitted from the electrodes (102 / 104) to the processor (202), and to generate accurate identification at all points along the respiratory cycle, such as the start of the inspiratory phase (375) when the effect on the abdominal muscles and stomach is most effective. According to some embodiments, the processor (202) is configured to synchronize with the identification of electrical pulses and phases of the respiratory cycle.

[0072] In addition to fluctuations in the body's torso circumference during the respiratory cycle, in some embodiments, the expansion and contraction of the sternocostal cavity, abdominal cavity, and primarily the diaphragm alters the spatial position of the electrodes (102 / 104) relative to each other. Figures 5D and 5E illustrate the change in the spatial position of electrode base (110) relative to electrode base (112) during the subject's inspiratory phase. In the exemplary embodiments depicted in Figures 5D and 5E, electrode base (110) is positioned forward on the subject's body compared to electrode base (112) shown in Figure 2.

[0073] Figure 5D illustrates the device (500) placed on a subject during exhalation, where the bases (110 / 112) of the electrodes (102 / 104) are typically on the same plane of the subject's body wall (580). During inspiration, and as shown in Figure 5E, the radial movement of electrode base (110) in the direction indicated by the arrow (525) in Figure 5E is greater at electrode base (110) than at electrode base (112). As a result, at the end of the inspirational phase (375), the electrode bases (110 / 112) are on different planes.

[0074] As will be described in more detail elsewhere in this specification, the spatial positional difference of the electrode base (110) relative to the electrode base (112) exerts a deformable force (e.g., bending and / or shearing force) on the mount (550) and deforms the PE sensor (508).

[0075] Hereinafter, we refer to Figures 6A, 6B, and 6C, which are simplified illustrated exploded views and plan views of the skin contact surfaces of the apparatus and electrodes according to some embodiments of the present invention. In some embodiments, the relative distance between electrodes (102 / 104) and / or the relative angle is adjustable. As shown in Figure 6A, in some embodiments, the electrodes (102 / 104) include a back surface (616) and skin contact sides (620) coated with a biocompatible conductive hydrogel (628) configured to adhere to the skin. In some embodiments, the back surface (616) includes one or more couplers (622 / 624) configured to connect electrodes (102 / 104) to electrode bases (110 / 112), respectively.

[0076] In some embodiments, at least one of the couplers (622 / 624) is configured to conduct electrical pulse energy from a device (100) pulse generator (not shown) to the electrode skin contact surface (620) and / or an ECG signal from the skin contact surface (620) to the processor (202). Additionally or alternatively, in some embodiments, one of the couplers (622 / 624) is configured to conduct pulse energy from a pulse generator (not shown) to the electrode skin contact surface and / or an ECG signal from the skin contact surface (620) to the processor (202), while the other is electrically isolated and serves as an anti-rotation coupler.

[0077] In some embodiments, the standard metal spring male couplers (622 and 624) of the TENSE / ECG electrodes are replaceable with a pair of conductive magnetic studs. The magnetic male studs are attracted to female snaps mounted on a plastic base (112), maintaining proper mechanical and conductive coupling. This feature allows for comfortable and easy coupling, as there is no need to press the couplers to connect the electrodes to the device. It also allows for easy removal of the device from the body without peeling the electrodes from the skin, and for putting the device back while ensuring good contact with the electrodes, overcoming the technical problem of pressing the device against the electrodes when the electrodes are placed on soft skin.

[0078] To avoid "hot spots," the studs are secured to electrodes by means of conductive carbon-coated eyelets (626).

[0079] In some embodiments, the device includes an electrode rotation mechanism (608) which includes a polygonal rotatable nut (610) into which one or more couplers (622 / 624) on the back (606) are fitted. In some embodiments, the polygonal rotatable nut (610) is configured to allow the electrodes (102 / 104) to rotate and be positioned in multiple orientations relative to the band (106). A potential advantage of the electrodes (102 / 104) being rotatable is that the electrodes are adjustable to the activity of the device (100) to produce the most effective response in the digestive tract and primarily the esophagus and stomach. In some embodiments, the couplers (622 / 624) are conductive and configured to conduct pulse energy from the device (100) to the skin contact surface (620) of the electrodes and / or ECG signals from the skin contact surface (620) to the processor (202).

[0080] In some embodiments, the electrodes (102 / 104) are structurally similar to electrodes used for transcutaneous electrical stimulation (TENS). For example, having a layered structure (from the back surface (616) to the skin contact surface (620)) may include a durable topcoat woven fabric, a conductive layer, such as a silver-filled polymer, a conductive carbon film, a hydrogel layer, or a siliconeized release liner.

[0081] In some embodiments, the mechanism (608) of the band (106) includes a matching washer (612) that fits into a collar (614) for securing the strap (206) to the band (106) and the electrode (102) base (110). The collar (614) is pivotally connected to the band (106) so that the strap (206) is kept aligned with the band (106).

[0082] In some embodiments, the device (600) including a fixing cap (616) has counterclockwise threads for securing the cap (616) to the second end (606) of the band (106).

[0083] Turning to Figures 7A, 7B, and 7C, collectively referred to as Figure 7, they are simplified illustrations of the device and positioner in plan view according to several embodiments of the present invention. As shown in Figure 7, in some embodiments, the positioner (700) is dimensioned and fitted to position the electrical device (e.g., 100 / 400 / 600) on the user's body. In some embodiments, the positioner (700) is used to position the device (100 / 400 / 600) at a predetermined location relative to the user's navel. As shown in the exemplary embodiment depicted in Figure 7, the positioner (700) includes a positioner body (702), a umbilical locator hole (704) located at one end of the body (702), one or more band (106) supports (706) protruding from the body, notches (708) that fit one or more electrodes, and one or more handles (714) extending from the body (702) in the direction opposite to the band (106) supports (702). For example, as shown by the dashed line for electrode (102) in Figure 7A, the notches (708) are formed to support the rotation of one or both electrodes (102 / 104) via a polygonal rotatable projection (608). In some embodiments, the positioner (700) is flat. In some embodiments, the positioner (700) is expandable to fit the bodies of various users. In some embodiments, the positioner (700) has an irregular contour to conform to the body of various users. In some embodiments, the positioner (700) is flexible to conform to the body of various users.

[0084] The positioner (700) is configured to serve as a baseline positioning device, that is, to position electrodes (102 / 104) at locations empirically found to be the most effective locations for both ECG signal acquisition and electrical pulse generation (EPG). In some exemplary embodiments, and as depicted in Figures 7B and 7C, the positioner (720) includes a pivot-connected baseline positioning arm (722) and a device (100 / 400 / 600) carrier arm (724). In some embodiments, the positioner (720) includes a protractor (750) positioned around a pivot hinge (726) connecting the baseline positioning arm (722) and the device (100 / 400 / 600) carrier arm (724).

[0085] For the most effective treatment of the gastrointestinal tract, the device (100 / 400 / 600) is placed in a baseline position on the user's body by positioning the positioner (720) so that the opening (704) is positioned around the user's umbilicus (navel). Following this, the device (100 / 400 / 600) carrier arm (724) is pivoted relative to the baseline positioning arm (722) until an optimal response is achieved (e.g., generation of the strongest ECG signal and / or the most effective electrical pulse), and the angle (α) determined by the protractor (750) is recorded for the particular user. The final positioning step includes pivoting one or more electrodes (102 / 104) until the acquisition of an optimal response is achieved, thereby determining the positioning of the device (100 / 400 / 600). At this stage, the electrodes (102 / 104) are attached to the skin (for example, by removing the peel-off film to expose the adhesive surface), and the positioner (720) is removed.

[0086] Experimental results As described elsewhere in this specification, ECG-induced respiration (EDR) algorithms are used to obtain information about the respiratory cycle and its phases (i.e., inspiration and expiration). Figures 8A, 8B, 9A, 9B, 10, 11A, 11B, 12A, and 12B are graphs representing the results of EDR and piezoelectric sensors obtained during experiments performed by the authors of this disclosure, demonstrating the correlation between the various ECG inputs obtained, the respiratory cycle, and the generation of trigger points (i.e., points of electrical pulse electrode activation) that correlate with the onset of the inspirational phase of the respiratory cycle.

[0087] Figure 8A shows a heart rate input (802) plotted against a reference signal (804) generated by a respiratory monitor placed adjacent to the subject's nostril, such as a nasal pressure sensor or thermistor, indicating the duration between consecutive heartbeats (e.g., RR interval). The graph in Figure 8A shows the correlation between the heart rate input (802) and the reference signal (804).

[0088] For example, Figure 8B shows the R-peak amplitude (806) plotted against a reference signal (804) generated by a respiratory monitor such as a nasal pressure sensor or thermistor placed adjacent to the subject's nostril. The graph in Figure 8B shows the correlation between the R-peak amplitude (806) and the reference signal (804).

[0089] The graph shown in Figure 9A illustrates trigger points (902) generated by the processor based on a heart rate input (802), and the graph is plotted against a reference signal (804) generated by a respiratory monitor placed adjacent to the subject's nostril, such as a nasal pressure sensor or thermistor. In some embodiments, as described in detail elsewhere in this specification, the processor (202) of the electrical device (100) is configured to activate electrodes (102 / 104) to generate electrical pulses at the trigger points (902) generated as shown in Figure 9A.

[0090] Similar to the graph shown in Figure 9A, the graph shown in Figure 9B demonstrates a trigger point (904) generated by the processor based on the R peak amplitude (806), and the graph is plotted against a reference signal (804) generated by a respiratory monitor placed adjacent to the subject's nostril, such as a nasal pressure sensor or thermistor. In some embodiments, as described in detail elsewhere in this specification, the processor (202) of the electrical device (100) is configured to activate electrodes (102 / 104) to generate an electrical pulse at the trigger point (904) generated as shown in Figure 9B.

[0091] The graph shown in Figure 9C demonstrates a trigger point (906) generated by the processor based on a combined input from the heart rate input (802) and the R peak amplitude (806). In some embodiments, as will be described in detail elsewhere in this specification, the processor (202) of the electrical device (100) is configured to activate electrodes (102 / 104) at the generated trigger point (906) as shown in Figure 9C in order to generate an electrical pulse.

[0092] The graphs shown in Figures 9A, 9B, and 9C represent the trigger points (902 / 904 / 906) generated by the processor (202), which are located in correlation with the start of the inspiratory phase (375) of the respiratory cycle (322).

[0093] Herein, we refer to Figure 10, an exemplary EDR trigger graph obtained with background interference to the data generated by the subject's movement. As shown in Figure 10, the ECG-inducible respiration (EDR) algorithm used to obtain information about the respiratory cycle and its phases (i.e., inspiration and expiration) is configured to overcome "noise" interference and subject movement during the treatment period and generate trigger points (1002). In some embodiments, as will be described in detail elsewhere in this specification, the processor (202) of the electrical device (100) is configured to activate electrodes (102 / 104) at trigger points (1002) generated in correlation with the start of the inspirational phase of the respiratory cycle, as shown in Figure 10, in order to generate electrical pulses. The generated respiratory cycle (1022) and trigger points (1002) are shown in Figure 10, corresponding to the ECG measurement (1020) from which the EDR data was obtained.

[0094] Figure 11A is a graph of the respiratory cycle (1122) generated by the processor (202) based on the signal obtained from the PE sensor (508), as described in detail elsewhere in this specification. Figure 11B shows a graph of the respiratory cycle (1124) generated by the processor (202) based on the signal obtained from the PE sensor (508) and passed through a low-pass 2 Hz filter, as described in detail elsewhere in this specification.

[0095] Figures 12A and 12B represent trigger positions obtained from input from the piezoelectric sensor (508) as described elsewhere in this specification, while stationary (12A) and during user movement (12B). Figure 12A shows a graph of triggers (1202) correlated with the respiratory cycle (1222) while stationary. Figure 12B shows a graph of triggers (1204) correlated with the respiratory cycle (1224), generated by the processor (202) based on the signal obtained from the PE sensor (508) and data with background interference generated by the subject's movement. As shown in Figure 12B, the processor (202) of the device (100) is configured to activate electrodes (102 / 104) at the generated trigger point (1204), as shown in Figure 12B, correlated with the start of the inspiratory phase (rising segment of the graph) of the respiratory cycle obtained from the PE element for generating electrical pulses as described elsewhere in this specification.

[0096] Figure 13 is a simplified illustration of a control box according to several embodiments of the disclosed inventive features. The control box (108) includes a CPU (processor) (202), a BLE (Bluetooth Low Energy) (1082), a high-voltage generator (1083), a full-bridge unit (1084), a piezoelectric amplifier (1085), an ECG amplifier (1086), and electrodes (102 / 104). The CPU(202) is configured for controlling the device. According to some embodiments, the CPU(202) sends and receives data and commands via BLE(1082) to communicate with an application. This application is described in more detail in Figures 14A, 14B, 14C, and 14D. The CPU(202) also controls the high-voltage generator(1083). The high-voltage generator (1083) is configured to apply current to the electrodes (102 / 104). The high-voltage generator (1083) can generate up to approximately 120 volts and is connected to the full-bridge unit (1084). The full-bridge unit (1084) is configured to sequentially switch the current between electrodes (102 / 104). The full-bridge unit (1084) is controlled by the CPU (1081). The electrodes (1087) are also connected to the ECG amplifier (1086) and are configured to be placed on the human body for monitoring and stimulating ECG and respiration. The ECG amplifier (1086) is configured to amplify and filter the ECG signal and transmit the output of the electrodes (102 / 104) to the CPU (1081). The piezoelectric amplifier (1085) is configured to filter out piezoelectric noise and amplify the piezoelectric signal. According to some embodiments, the device includes one or more accelerometers electrically connected to a CPU and providing information on body position and movement (not shown).

[0097] Figures 14A, 14B, 14C, 14D, and 14E show exemplary screenshots of the application for operation, control, and reporting of physiological parameters of the disclosed device. According to some embodiments, the device may be controlled by an application. According to some embodiments, the application collects data from the user and / or related to the device.

[0098] Figure 14A illustrates a screenshot of the application (1401) for controlling the device. The user can turn the stimulation on and off via touchscreen keys on the screen (1401). The user can also change the stimulation intensity via the "+" and "-" touchscreen keys on the screen (1401). The application may also display error messages in the lower area of ​​the screen (not shown). For example, messages if a replaceable electrode is disconnected, too dry, or completely depleted. The application may send the following data about the screen (1401) to the cloud: the time of on / off operation, information on intensity changes, and all warning messages displayed on the screen.

[0099] Figures 14B and 14C illustrate screens (1402) and (1403) related to the collection of user data. Screen (1402) displays the user's symptoms. The user can edit symptoms using screens (1402) and (1403). In some embodiments, each identified symptom includes severity and time of event (real-time or retrospective, such as a night event reported in the morning). Identified symptoms may be sent to the cloud. Figure 14D illustrates that screen (1404) is for collecting daily activity and sending activity to the cloud. Figure 14E illustrates screen (1405) representing two counts: the number of triggers to activate stimulation according to the ECG and the number of triggers to activate stimulation according to the piezoelectric sensor. Screen (1405) also provides information about the time the device was operating in each mode. A software application may also enable monitoring of heart rate and respiratory rate and sending this information to the cloud.

[0100] Throughout this application, various embodiments of the invention may be presented in range format. It should be understood that descriptions in range format are merely for convenience and brevity and should not be interpreted as a firm limitation on the scope of the invention. Therefore, range descriptions should be considered as specifically disclosing all possible subranges, as well as the individual numerical values ​​within those ranges. For example, a range description such as 1 to 6 should be considered as having specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, and similarly, individual digits within ranges such as 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range. A numerical range, whenever indicated herein, means to include any cited digit (fraction or integer) within the indicated range. The phrases “extending the range between the first and second digits” and “extending the range between the first and second digits” are used interchangeably herein and mean to include the first and second digits, and all fractions and integers between them.

[0101] In the description and claims of this application, each of the words “comprise,” “include,” and “have,” and their forms, is not necessarily limited to the elements in the list to which the word may be associated. In addition, in the event of any inconsistency between this application and any document incorporated by reference, this application is intended to prevail. The descriptions of various embodiments of the invention have been made for illustrative purposes only and are not intended to be exhaustive or limiting to the embodiments disclosed. Many modifications and variations will be obvious to those skilled in the art without departing from the scope and spirit of the embodiments described. The terminology used herein has been selected to best describe the principles of the embodiments, the practical applications or technical improvements across the technologies found in the market, or to enable those skilled in the art to understand the embodiments disclosed herein.

Claims

1. A non-invasive device, said non-invasive device is Two electrodes are positioned on the abdominal muscles at waist height of the subject, A processor electrically connected to the aforementioned electrodes, Includes an ECG amplifier connected to the electrode, configured to receive an ECG signal, The two electrodes are dual-function electrodes, and the processor alternately performs an ECG mode in which the electrodes receive ECG signals from the subject's body and an EPG mode in which the electrodes generate electrical pulses to stimulate the subject's abdominal muscles. In the ECG mode, the processor derives the phase of the subject's respiratory cycle based on the QRS pattern data extracted from the ECG signal. A non-invasive device in which, upon detecting the inspiratory phase of the respiratory cycle, the processor switches the two electrodes to the EPG mode and synchronizes the electrical pulses with the inspiratory phase.

2. The non-invasive device according to claim 1, further configured to treat a digestive symptom by the stimulation, wherein the digestive symptom is one symptom selected from the group consisting of gastroesophageal reflux disease, obesity, and constipation.

3. The non-invasive apparatus according to claim 1, further comprising an ECG circuit connectable to the electrode, wherein switching to EPG mode includes disconnecting the ECG circuit from the electrode, and switching to ECG mode includes reconnecting the ECG circuit to the electrode.

4. A piezoelectric sensor configured to generate a second signal in response to changes in waist circumference and the position of the abdominal region, further comprising a piezoelectric sensor from which the processor detects the intake phase, The non-invasive device according to claim 1, characterized in that the processor is configured to select either the ECG mode or the piezoelectric sensor based on measuring a first variation in the respiratory cycle time of the subject's respiration detected from the ECG sensor, measure a second variation in the respiratory cycle time of the subject's respiration detected from the piezoelectric sensor, and apply the stimulus according to the inspiratory phase detected based on the selection.

5. The non-invasive device according to claim 1, wherein the QRS pattern data includes at least one of (i) variability in heart rate and (ii) variability in R peak amplitude.

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