Implantable devices and methods for treating gastroesophageal reflux disease (GERD) and the digestive system.

Abstract

This subject discloses a method and apparatus for treating gastrointestinal disorders, the method comprising implanting a pulse generator and a plurality of electrodes subcutaneously in the abdomen of a patient, wherein the electrodes are in electrical contact with a target region in the abdomen of the patient, and activating the target region by applying electrical stimulation.

Description

Technical Field

[0001] The present disclosure generally relates to medical devices, and more particularly to medical devices related to the digestive system and GERD.

Background Art

[0002] Among other digestive system diseases, gastroesophageal reflux disease (GERD) is the most common outpatient gastroenterological diagnosis in the United States, with a prevalence of 10% - 30% and an annual incidence of 0.38% - 0.45% in Western European countries. In the United States, 20% of the adult population experiences GERD-related symptoms weekly, and 7% daily. GERD is known to significantly reduce the health-related quality of life and impose a significant economic burden on the healthcare system.

[0003] GERD is caused by the unwanted movement of acidic gastric contents into the esophagus. Such movement is typically caused by changes in the sphincter between the stomach and esophagus, including abnormal relaxation of the lower esophageal sphincter (LES), incomplete clearance of gastric reflux from the esophagus, or a hiatal hernia. Among them, GERD symptoms can include abdominal pain, heartburn, regurgitation, chest pain, acid swallowing, and asthma. GERD complications can include mucosal injury, erosive esophagitis (EE), Barrett's disease, and esophageal cancer.

[0004] Typical GERD treatments include lifestyle modifications, drug therapies such as proton pump inhibitors (PPIs), H2 receptor antagonists or antacids, and surgery.

[0005] While the effectiveness of current GERD treatments is generally acknowledged, unaddressed needs and significant challenges remain. Approximately 10%–15% of adult patients with EE do not achieve complete remission after 8 weeks of treatment. Furthermore, even when continuing the initial curative dose, 15%–23% of adult EE patients with Los Angeles classification grades A and B, and 24%–41% with grades C and D, experience relapse within 6 months of treatment. In addition, up to 40% of adult patients with non-erosive reflux disease (NERD) still experience symptoms even with standard dose (once daily) PPI therapy.

[0006] Concerns have been raised regarding the long-term safety of PPI drugs. These concerns are linked to a variety of potential adverse effects, including osteoporosis, kidney disease, neuropathy, dementia, liver disease, and anemia.

[0007] Surgical treatment for GERD typically involves fundoplication, which can be performed via open or endoscopic intervention. Fundoplication offers an alternative for patients who do not respond to drug therapy or who are unwilling to use such drugs for extended periods. In recent years, various endoscopic interventions have been developed and used for minimally invasive GERD treatment. However, their use in clinical practice has been limited due to potential complications and controversial efficacy.

[0008] U.S. Patent No. 10,426,955 discloses a method for treating patients with gastroesophageal reflux disease by implanting electrodes. The aforementioned patent discloses an apparatus and methodology for the treatment of transient lower esophageal sphincter relaxation (tLESRs).

[0009] U.S. Patent No. 7,660,636 discloses an electrical stimulation device and method for the treatment of dysphagia. In some embodiments, the electrical stimulation device comprises one or more electrode channels, each comprising a first electrode positioned in electrical contact with tissue in a target area of ​​the patient, and a second electrode positioned in electrical contact with tissue in the posterior neck or posterior chest area of ​​the patient. A series of electrical pulses are then applied to the patient through one or more electrode channels according to a treatment procedure for dysphagia.

[0010] U.S. Patent No. 5,716,385 discloses an electronic pacemaker used to prevent and / or treat gastroesophageal reflux by counteracting relaxation of the diaphragmatic crus. The pacemaker may be implantable or connected to the skeletal muscle of the diaphragmatic crus through the skin. A sensor is used to identify spontaneous intermittent relaxation of the diaphragm. During these spontaneous intermittent relaxations, one or more electrodes are used to stimulate the skeletal muscle of the diaphragmatic crus, thereby causing contraction of the lower esophageal sphincter. [Overview of the Initiative]

[0011] According to some embodiments of the present invention, a method is provided for treating a patient suffering from a digestive disorder, comprising implanting a pulse generator and a plurality of electrodes subcutaneously in the patient's abdomen, wherein the electrodes are in electrical contact with a target region in the patient's abdomen, and activating the target region by applying electrical stimulation.

[0012] According to some embodiments of the present invention, the target region includes muscle, nerve, muscle-nerve junction, or any combination thereof.

[0013] According to some embodiments of the present invention, the electrical stimulation described above is optimized to treat the patient's digestive system in such a way that it leads to a change in the flow rate of ingested material in a desired direction.

[0014] According to some embodiments of the present invention, the electrical stimulation comprises a series of current-controlled asymmetric bursts intended to generate asymmetric contractions of selected abdominal muscles, wherein the direction of the rapid phase of the burst is upward and the direction of the slow phase of the burst is downward.

[0015] According to some embodiments of the present invention, the above modification is to reduce the reflux of ingested material from the patient's stomach into the esophagus, thereby alleviating GERD symptoms.

[0016] According to some embodiments of the present invention, the above modification is an increase in the intake flow from the patient's stomach to the duodenum, thereby alleviating symptoms of gastroparesis.

[0017] According to some embodiments of the present invention, the above modification is an increase in the intake flow from the patient's colon to the rectum, thereby alleviating constipation symptoms.

[0018] According to some embodiments of the present invention, the electrical stimulation comprises a series of current-controlled asymmetric bursts intended to generate asymmetric contractions of selected abdominal muscles, wherein the direction of the rapid phase of the burst is upward and the direction of the slow phase of the burst is downward.

[0019] According to some embodiments of the present invention, the method further comprises embedding at least one sensor, wherein the stimulus is synchronized with at least one bodily signal acquired by the at least one sensor.

[0020] According to some embodiments of the present invention, the sensor includes at least one member from among an accelerometer, gyroscope, magnetic compass, inclinometer, piezoelectric sensor, electrocardiogram (ECG), electroencephalogram (EEG), electromyograph (EMG), microphone, electrical impedance sensor, oximeter, optical interferometer, pH meter, and optosensor.

[0021] According to some embodiments of the present invention, the body signal includes at least one member of respiration, heartbeat, blood pressure, muscle or ligament tension, body position, arousal condition, or muscle activity level.

[0022] According to some embodiments of the present invention, activating the target area is adapted to cause a body reflex.

[0023] According to some embodiments of the present invention, the reflex includes at least one member of the esophageal reflex due to swallowing or the diaphragmatic crus reflex due to swallowing.

[0024] According to an aspect of some embodiments of the present invention, there is provided a subcutaneous implantable device for treating a gastrointestinal disorder, including a control unit, a power source, a pulse generator, and a plurality of electrodes adapted to be disposed in electrical contact with a target area of the abdomen, wherein the pulse generator is designed to activate the target area by transmitting a stimulation signal through the electrodes.

[0025] According to some embodiments of the present invention, the electrical stimulation is characterized by a maximum voltage of +20V, a maximum current of 20mA, a pulse frequency range of 20Hz to 50Hz, a burst frequency range of 0.2Hz to 4Hz, and a pulse width of 25μs to 300μs.

[0026] According to some embodiments of the present invention, the gastrointestinal disorder is at least one member of the group consisting of gastroesophageal reflux disease (GERD), gastric paresis, obesity, incontinence, and constipation.

[0027] According to some embodiments of the present invention, the electrical stimulation includes repetitive pulse bursts, and the shape of the burst is set according to the desired physiological effect.

[0028] According to some embodiments of the present invention, the implantable device further includes at least one sensor.

[0029] According to some embodiments of the present invention, the electrical stimulation is synchronized with at least one body signal acquired by the sensor.

[0030] According to some embodiments of the present invention, the sensor includes at least one member selected from an accelerometer, a gyroscope, a magnetic compass, an inclinometer, a piezoelectric sensor, an electrocardiogram (ECG), an electroencephalogram (EEG), an electromyogram (EMG), a microphone, an electrical impedance sensor, an oximeter, an optical interferometer, a pH meter, and an optosensor.

[0031] According to some embodiments of the present invention, the body signal includes at least one member selected from respiration, heartbeat, blood pressure, muscle or ligament tension, body position, arousal condition, or muscle activity level.

[0032] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field to which this invention belongs. Methods and materials similar or equivalent to those described herein can be used in the implementation or testing of embodiments of the present invention, but exemplary methods and / or materials are described below. In case of conflict, the present patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

Brief Description of Drawings

[0033] The subject matter of the present disclosure will be more fully understood and recognized from the following detailed description, which is to be interpreted in association with the drawings in which corresponding or similar numerals or characters indicate corresponding or similar components. Unless otherwise indicated, the drawings provide exemplary embodiments or aspects of the present disclosure and do not limit the scope of the present disclosure.

[0034] [Figure 1A] It is a diagram schematically showing an apparatus for treating a patient suffering from a digestive system disorder according to some exemplary embodiments of the subject matter of the present disclosure. [Figure 1B] This figure schematically shows a partial cross-sectional view of the shell of Figure 1A according to some exemplary embodiments of the subject matter of this disclosure. [Figure 2] This figure shows an exemplary device implanted in the abdomen of a patient for treating digestive system disorders, according to some exemplary embodiments of the subject matter of this disclosure. [Figure 3A] This figure shows an exemplary waveform of an electrical stimulation, including an asymmetric burst, according to some exemplary embodiments of the subject matter of this disclosure. [Figure 3B] This figure shows an exemplary waveform of an electrical stimulation, including an asymmetric burst, according to some exemplary embodiments of the subject matter of this disclosure. [Figure 3C] This figure shows an exemplary waveform of an electrical stimulation including a symmetrical burst, according to some exemplary embodiments of the subject matter of this disclosure. [Figure 3D] This figure shows a detailed view of one of the bursts from Figures 3A to 3C, according to some exemplary embodiments of the subject matter of this disclosure. [Figure 4] This figure schematically illustrates a portion of exemplary data acquired by a sensor according to some embodiments of the subject matter of this disclosure. [Modes for carrying out the invention]

[0035] Embodiments of the present invention disclose a method for treating patients suffering from digestive disorders, particularly gastroesophageal reflux disease (GERD), gastroparesis, constipation, incontinence, and obesity. The method includes implanting a pulse generator and a plurality of electrodes subcutaneously, and activating selected target muscles by applying electrical stimulation through the electrodes.

[0036] In addition, or otherwise, the electrical stimulation in the method of the present disclosure may be applied to a nerve or a muscle-nerve junction.

[0037] In some embodiments, the methods of the present disclosure further include implanting at least one sensor in a patient's body. Optionally, the methods include synchronizing an electrical stimulus with at least one bodily signal acquired by the at least one sensor.

[0038] In one exemplary embodiment, the method of the present disclosure is used to treat GERD by increasing esophageal motility, thereby increasing the movement of ingested material from the esophagus into the stomach.

[0039] In one exemplary embodiment, the method of the present disclosure is used to treat GERD or gastroparesis by increasing gastric motility, thereby increasing the movement of ingested material from the stomach into the duodenum.

[0040] In one exemplary embodiment, the method of the present disclosure is used to treat GERD by improving the contractility of the lower esophageal sphincter (LES), thereby reducing reflux of ingested food from the stomach into the esophagus.

[0041] In one exemplary embodiment, the method of the present disclosure is used to treat GERD by improving the contractility of the upper esophageal sphincter (UES), thereby reducing reflux of ingested material from the esophagus into the pharynx.

[0042] In one exemplary embodiment, the method of the present disclosure is used to treat fecal incontinence by improving the contractile force of the anal sphincter.

[0043] In one exemplary embodiment, the method of the present disclosure is used to treat urinary incontinence by improving the contractile force of the urethral sphincter.

[0044] In one exemplary embodiment, the method of the present disclosure is used to treat obesity or obesity by directing the reflux of ingested food from the stomach to the esophagus, thereby causing an unpleasant sensation and leading to loss of appetite.

[0045] In one exemplary embodiment, the method of the present disclosure is used to treat obesity or obesity by increasing the internal pressure of the stomach, thereby increasing satiety.

[0046] In embodiments in which the method of this disclosure is used to treat obesity or obesity, the electrical stimulation is applied before, during, or after meals, or the stimulation is applied between meals.

[0047] In one exemplary embodiment, the method of the present disclosure is used to treat constipation by increasing intestinal motility, thereby increasing the flow of ingested material along the digestive tract toward the rectum.

[0048] In some embodiments, the methods of the present disclosure include applying electrical stimulation in synchronization with a motility or sensory event associated with the gastrointestinal tract, such as eating, the sensation of a gas mass, the urge to defecate, or the urge to urinate. In addition, or the stimulation may be applied at a specific time or continuously. In addition, or the stimulation may be applied at the discretion of the user, physician, machine, or any combination thereof.

[0049] An exemplary embodiment of the subject matter of this disclosure is a subcutaneously implantable device for treating patients with gastrointestinal disorders, comprising a signal generator and a plurality of electrodes. Upon activation, the implantable device may generate electrical stimulation to treat various gastrointestinal symptoms or diseases.

[0050] In some embodiments, the apparatus of the present disclosure further comprises at least one sensor. In some embodiments, the sensor is an implantable sensor adapted to be embedded in the patient's esophageal wall and senses the acidity of the esophagus. The sensor is configured to output the acidity level to a processor via a wired or wireless connection. In some embodiments, the device controller receives acidity monitoring data to control therapeutic parameters such as stimulation timing, stimulation intensity, stimulation waveform, and stimulation frequency in order to maximize the therapeutic effect. In some embodiments, the sensor is temporarily implanted.

[0051] In some embodiments, the apparatus of the present disclosure comprises a biocompatible, hermetically sealed shell enclosing components such as mechanical elements, electrical circuit configurations, a processor or arithmetic unit, a power supply, sensing elements, and electrodes.

[0052] In other embodiments, the apparatus of the present disclosure comprises one main shell and at least one additional shell, the main shell encapsulating a processor or arithmetic unit, and the components encapsulated in the at least one additional shell are controlled by the main shell. Communication between the main shell and the at least one additional shell may be established by a wired connection, a wireless connection, or a combination thereof.

[0053] In some embodiments, the shell is sized to be suitable for subcutaneous implantation.

[0054] In some embodiments, the maximum length, width, or depth dimension of the shell is less than 10 mm, 7 mm, 5 mm, 3 mm, or 2 mm.

[0055] In some embodiments, the device of the Disclosure comprises a rechargeable battery. In some embodiments, the rechargeable battery is wirelessly rechargeable by a charger located outside the patient's body. In other embodiments, a charging port wired to an implantable device is installed percutaneously so as to be accessible from outside the patient's body. In other embodiments, mechanical energy utilized from body movement is used to charge the rechargeable battery without requiring an external charger. In other embodiments, the device of the Disclosure comprises a non-rechargeable battery.

[0056] In some embodiments, the apparatus of the present disclosure comprises at least two electrodes. During installation of the apparatus, the electrodes are embedded so as to be in electrical contact with at least one target region. The target region may include muscle, nerve, muscle-nerve junction, or a combination thereof.

[0057] In some embodiments, the electrodes are designed as intramuscular, epimyseal, or nerve cuff electrodes. In addition, or otherwise, the electrodes may be designed in any other way known in the art to deliver electrical stimulation to muscles, nerves, or muscle-nerve junctions.

[0058] In some embodiments, electrodes are further designed to acquire and transmit electrical signals from a target region to the device.

[0059] In some embodiments, electrodes deliver electrical stimuli generated by the device's signal generator to a target area such that the current flows through a portion of the patient's body from one electrode to at least one other electrode.

[0060] In some embodiments, the electrical stimulation includes current-controlled pulses or voltage-controlled pulses. The pulses may be monophase, biphase, or a combination thereof. Biphase pulses may be asymmetrical or symmetrical with respect to a reference voltage or reference current. The pulses may have any shape known in the art that is utilized in electrical stimulators, such as rectangular pulses, triangular pulses, or sinusoidal pulses.

[0061] In some embodiments, the stimulation pulse is characterized by a maximum voltage of 10V, 20V, 30V, or 40V (base to peak), and a maximum current of 0.1mA, 1mA, 5mA, 10mA, or 20mA.

[0062] In some embodiments, the stimulation pulse is repeated periodically over a predetermined period of time.

[0063] In some embodiments, the electrical stimulation includes bursts of repetitive pulses. The stimulation bursts may be modulated to include substantially identical pulses, gradually increasing pulses, gradually decreasing pulses, or any other desired modulation method.

[0064] In some embodiments, the pulse repetition frequency may be in the range of 10 Hz to 200 Hz.

[0065] In some embodiments, the pulse width may be in the range of 20 μs to 1000 μs.

[0066] In some embodiments, the stimulus burst is characterized by a burst repetition frequency in the range of 0.1 Hz to 10 Hz.

[0067] In some embodiments, the stimulus burst may be symmetric, asymmetric, or a combination thereof, where a symmetric burst is a current or voltage waveform that differs during the rise and fall of the current or voltage.

[0068] In some embodiments, any of the parameters of the apparatus of this disclosure may be fine-tuned to elicit optimal treatment. Optimized parameters may include, among many, implantation location, electrode placement location, number of device activations, and characteristics of electrical stimulation. In some embodiments, an initial setup session may be required, which may determine the optimization parameters.

[0069] In some embodiments, the parameters characterizing the apparatus configuration and electrical stimulation of the present disclosure are set according to a desired physiological effect. Settable parameters include the number and position of electrodes, electrode activation sequence, pulse control method (current control or voltage control), stimulation intensity, pulse shape, pulse frequency, burst shape, burst frequency, and stimulation timing.

[0070] In some embodiments, multiple electrodes are positioned at different locations in the abdominal muscle tissue, and stimulation is applied sequentially through the electrodes, resulting in abdominal muscle contractions in a desired order. In one exemplary embodiment, stimulation is applied through electrodes positioned at different heights on the rectus abdominis and external oblique muscles, resulting in the abdominal muscle tissue contracting sequentially from the upper abdomen to the lower abdomen, thereby enhancing the propagation of gastrointestinal contents in a desired direction toward the rectum.

[0071] In some embodiments, the shape of the stimulation burst is set according to the desired physiological effect. In one exemplary embodiment, the electrical stimulation comprises a series of controlled current pulse bursts set in an asymmetric shape, such that the rise time of the burst is substantially shorter than the fall time of the burst. Such stimulation can potentially enhance esophageal motility and alleviate GERD symptoms. Potentially, the enhancement is mediated through a vibrating conveyor mechanism in which a structure carrying movable material is periodically linearly displaced such that its movement is faster in one direction and slower in the other. Using this mechanism, the material can have a net displacement in the rough direction in which the slower movement occurs. Potentially, by applying the shape of the stimulation burst, the flow of ingested material from the esophagus to the stomach can be induced by the above mechanism.

[0072] In another exemplary embodiment, a similar stimulus is applied, but the duration of the burst is substantially longer than the duration of the burst's descent. Such a stimulus may potentially increase reflux of ingested material from the stomach into the esophagus or induce nausea or vomiting.

[0073] In another exemplary embodiment, the electrical stimulation comprises a series of controlled current pulse bursts applied to the lower part of the abdominal muscle tissue and set in an asymmetrical shape, such that the rising time of the bursts is substantially shorter than the falling time of the bursts. Such stimulation may potentially enhance the motility of the lower part of the gastrointestinal tract and propel the gastrointestinal contents toward the rectum and anus.

[0074] In some embodiments, the configuration and stimulation parameters of the apparatus of this disclosure are optimized to improve the functionality of one or more gastrointestinal sphincters.

[0075] In one exemplary embodiment, electrical stimulation is applied to the rectus abdominis and external oblique muscles, inducing repeated rapid increases in intra-abdominal pressure. Rapid increases in intra-abdominal pressure may potentially trigger innate bodily reflexes such as the straining-induced esophageal reflex or the straining-induced diaphragmatic crus reflex, which in turn may increase the tone of the LES or UES. Alternatively, repetitive contractions of the LES can be induced by means other than innate reflexes. Optionally, repeated activation of the LES and / or UES, mediated either by reflexes or other means, may lead to long-term improvements in sphincter capacity. Optionally, the contraction repetition frequency and intensity are set to optimize LES strengthening by inducing desired levels of LES muscle load and rest. In another exemplary embodiment, the anal and / or urethral sphincter is strengthened by inducing repetitive contractions of the pelvic floor muscles by applying similar stimulation to the lower abdominal muscle tissue.

[0076] In some embodiments, the apparatus of the present disclosure comprises at least one sensor adapted for acquiring body signals.

[0077] In some embodiments, the above at least one sensor is based on any of the following: an accelerometer, a gyroscope, a magnetic compass, an inclinometer, a piezoelectric sensor, an electrocardiogram (ECG), an electroencephalogram (EEG), an electromyograph (EMG), a microphone, an electrical impedance sensor, an oximeter, an optical interferometer, a pH meter, and an optosensor.

[0078] In some embodiments, at least one signal obtained is the result of a physiological phenomenon that may affect the effectiveness of electrical stimulation therapy. Such phenomena may include, among many others, respiration, heart rate, blood pressure, muscle or ligament tension, body position, arousal condition, or muscle activity level.

[0079] In some embodiments, the electrical stimulation is synchronized with one or more of the acquired signals.

[0080] A potential benefit of synchronizing electrical stimulation with physiological phenomena is to enhance the effectiveness of electrical stimulation therapy. For example, electrically stimulating abdominal muscle tissue during the exhalation phase of breathing may lead to increased reflux of food from the stomach into the esophagus due to increased abdominal pressure when the contractile force of the lower abdominal sphincter (LES) is reduced due to diaphragmatic relaxation. On the other hand, electrically stimulating abdominal muscle tissue during the inhalation phase may enhance the effectiveness of transmitting the mechanical effect of abdominal muscle contraction to the LES muscle tissue as a result of increased abdominal tension and / or stiffness. Consequently, synchronizing the respiratory cycle and stimulation so that the stimulation is effective only during inhalation can enhance the effectiveness of the therapy when the stimulation is intended to reduce GERD symptoms. Conversely, synchronizing the respiratory cycle and stimulation so that the stimulation is effective during exhalation can enhance the effectiveness of the therapy when the stimulation is intended to reduce appetite.

[0081] In some embodiments, the electrical stimulation is synchronized with the respiratory cycle so that the stimulation is effective during the inhalation phase, or the electrical stimulation is synchronized with the respiratory cycle so that the stimulation is effective during the exhalation phase.

[0082] In some embodiments, the electrical stimulation is synchronized with intraperitoneal pressure so that the stimulation is effective when intraperitoneal pressure is maximized, or the electrical stimulation is synchronized with intraperitoneal pressure so that the stimulation is effective when intraperitoneal pressure is minimized.

[0083] In some embodiments, the devices of this disclosure are controllable by a user via wireless communication. Such communication may be implemented using any available wireless communication technology, such as Wi-Fi, Bluetooth, Bluetooth Low Energy (BLE), or Near Field Communication (NFC). Alternatively, a custom communication protocol may be used.

[0084] In some embodiments, a smartphone may be used as the communication device used to control the embeddable device. Alternatively, different standalone remote control devices may be used.

[0085] An exemplary embodiment of the subject matter of this disclosure is a method for treating gastroesophageal reflux disease (GERD) in a patient, comprising: implanting at least two intramuscular electrodes in the rectus abdominis and external oblique muscles; implanting a control unit in a subcutaneous position with the at least two electrodes wired to the control unit by subcutaneous lead wires; and applying a series of electrical bursts to the electrodes, wherein the electrical bursts are adapted to electrically stimulate target muscles and / or nerves of the patient, thereby reducing reflux of ingested material from the stomach into the esophagus and alleviating GERD symptoms.

[0086] According to some embodiments, the above method further includes inducing asymmetric contraction of a target muscle by applying a series of asymmetric electrical bursts.

[0087] In some embodiments, the direction of the rapid phase of the burst is upward, and the direction of the slow phase of the burst is downward. Potentially, such bursts can induce movement in the patient's digestive system.

[0088] In some embodiments, the above movement is intended to return the contents of the esophagus to the stomach and alleviate GERD symptoms.

[0089] According to some embodiments, the order of the rapid and slow phases of the burst can be reversed, thereby changing the direction of the induced movement of the contents of the gastrointestinal tract.

[0090] According to some embodiments, the stimulus burst is symmetrical.

[0091] According to some embodiments, the above method further includes providing a pulse generator in the control unit for generating electrical stimulation.

[0092] According to some embodiments, the electrical stimulation is characterized by a maximum voltage range of 10V, 20V, 30V, 40V (base to peak), a maximum current range of 0.1mA, 1mA, 5mA, 10mA, 20mA, a pulse frequency range of 10Hz to 200Hz, a burst frequency range of 0.1Hz to 10Hz, and a pulse duration range of 20μS to 1000μS.

[0093] According to some embodiments, the above method further includes comprising at least one sensor designed to acquire body signals.

[0094] According to some embodiments, the above-mentioned bodily signals include at least one member from the group consisting of respiration, heart rate, ECG, blood pressure, gastric and esophageal compression and position, monotonous movement, and body position.

[0095] According to some embodiments, the sensor is at least one member of the group consisting of piezoelectric sensors, accelerometers, ECG sensors, EEG sensors, EMG sensors, gyroscopes, and optosensors.

[0096] According to some embodiments, the above method further includes synchronizing bodily signals with stimuli.

[0097] According to some embodiments, the synchronization includes activating electrical stimulation when the diaphragm is tense. In other embodiments, the electrical stimulation is activated when the diaphragm is relaxed. In addition, or the synchronization includes activating electrical stimulation when abdominal pressure is increasing. In other embodiments, the electrical stimulation is activated when abdominal pressure is decreasing. In addition, or the synchronization includes activating electrical stimulation during the inhalation phase of breathing. In other embodiments, the electrical stimulation is activated during the exhalation phase of breathing.

[0098] According to some embodiments, the implanted device is wirelessly controllable by the user of the device. In some embodiments, such control includes activating and deactivating electrical stimulation, as well as setting the stimulation intensity. In some embodiments, such wireless control is utilized by a smartphone.

[0099] Another exemplary embodiment of the subject matter of this disclosure is a device for treating obesity, comprising a subcutaneously implanted electrode and a control unit, the control unit further comprising a pulse generator for supplying electrical stimulation signals to the electrode, wherein the electrical stimulation bursts are adapted to induce reflux of ingested material from the stomach into the esophagus. In some other embodiments, the electrical stimulation bursts are adapted to increase intraperitoneal pressure, thereby enhancing satiety.

[0100] Another exemplary embodiment of the subject matter of this disclosure is a device for treating constipation or gastric paralysis, the device comprising a subcutaneously implanted electrode and a control unit, the control unit further comprising a pulse generator for supplying electrical stimulation signals to the electrode, the electrical stimulation bursts being adapted to increase gastric motility and enhance the propagation of gastrointestinal contents from the stomach into the duodenum. In some other embodiments, the electrical stimulation bursts are adapted to propagate gastrointestinal contents from the transverse colon into the sigmoid colon. One technical challenge disclosed in this disclosure is how to mitigate the risks or complexities associated with deep electrode implantation for electrically stimulating the LES or other intrinsic muscles such as the leg.

[0101] One technical solution involves implanting subcutaneous electrodes in the area of ​​external muscles such as the external oblique and rectus abdominis muscles, thereby electrically stimulating these external muscles and triggering a physical reflex that acts on the target internal muscles.

[0102] Before detailing at least one embodiment of the present invention, it should be understood that the present invention is not necessarily limited to the configuration details and arrangement and / or application of components described below and / or linked to the drawings. Other embodiments of the present invention are possible, or can be implemented or performed in various ways.

[0103] Referring here to Figure 1A, an apparatus 100 for treating gastrointestinal disorders is shown according to some embodiments of the subject matter of this disclosure. The apparatus 100 comprises a control unit 103 enclosed in a shell 106, a plurality of electrodes 101, 102, and a sensor 104. Optionally, the electrodes 101, 102 and the sensor 104 are connected to the control unit 103 via lead wires 110. In some embodiments, the sensor 114 is located inside the shell 106 or on the outer surface of the shell 106. Optionally, the electrodes 101, 102 are fabricated from a biocompatible, non-irritating material.

[0104] In some embodiments, the device 100 can be controlled by a remote control device 130 using wireless communication.

[0105] Referring here to Figure 1B, the configuration of the shell 106 is shown in more detail. In some embodiments, the shell 106 is designed to house the electrical circuit configuration and electrical components necessary to generate and control electrical stimulation. Optionally, the shell 106 is hermetically sealed to prevent the entry of bodily fluids or particles when implanted in the patient's body. Optionally, the shell 106 is made of a flexible or semi-flexible material to conform well to the patient's body. Optionally, the shell 106 is made of a biocompatible material. Optionally, the shell 106 is made of an electrically insulating material.

[0106] In some embodiments, the control unit 103 is housed within a shell 106. Optionally, the shell 106 comprises an electrical circuit board 108 and a power source such as a battery 105. Optionally, the electrical circuit board 108 comprises a pulse generator 107, as well as additional electrical components such as a microcontroller, digital circuits, memory, communications, high-voltage circuits, analog circuits, high-voltage switches and bridges, and protection circuits. In some embodiments, the control unit 103, the circuit board 108, the battery 105, and the pulse generator 107, or any combination thereof, are housed in a separate shell.

[0107] Referring here to Figure 2, an exemplary embodiment of a device 200 for treating gastrointestinal disorders after being implanted in a patient's body is shown. The device 200 comprises a shell 206 and two electrodes 201 and 202. During the implantation procedure, electrodes 201 and 202 are positioned in electrical contact with the target area, which is the rectus abdominis muscle 221 and the external oblique muscle 222, respectively. Optionally, lead wires 211 and 212 connect the electrodes to the shell 206.

[0108] Optionally, the lead wire 211 is designed to have at least one electrical property dependent on mechanical tension or stretching, for example, tension-dependent electrical resistance or tension-dependent capacitance. In such embodiments, the lead wire 211 functions as a mechanical tension or stretching sensor. Optionally, the lead wire 211 is designed to provide an electrical signal in response to body movements associated with breathing. Optionally, or a breathing sensor is included in the device 200 as a separate component (not shown).

[0109] When activated, the device 200 generates electrical stimulation that is delivered to a target area via lead wires 211, 212 and electrodes 201, 202, thereby causing selected abdominal muscles to contract and relax in a predetermined pattern. Optionally, the electrical stimulation generated by the device 200 can be controlled via wireless communication by a remote control device 230. Optionally, the remote control device 230 is a smartphone.

[0110] Referring to Figures 3A and 3B, exemplary waveforms of electrical stimulation including an asymmetrical burst are shown, with the direction of the rapid phase of the burst being upward and the direction of the slow phase of the burst being downward. Referring to Figure 3C, exemplary waveforms of electrical stimulation including an asymmetrical burst are shown, with the direction of the rapid phase of the burst being downward and the direction of the slow phase of the burst being upward.

[0111] In Figure 3A, two exemplary asymmetric bursts 300 are graphically represented, each burst containing a series of biphasic pulses in descending order. The horizontal axis of the graphical representation may represent time, while the vertical axis may represent voltage or current. Optionally, the voltage or current of the first pulse 301 of the burst corresponds to a desired intensity level 302. Optionally, the intensity level 302 is adjustable by the user of the device. Optionally, the pulse voltage or current decreases linearly from the first pulse to the last pulse of the burst. Alternatively, a differential burst format is applied. Optionally, the inter-burst period 303 is maintained between two consecutive bursts. Optionally, the inter-burst period 303 is adjustable by the user of the device. Alternatively, the inter-burst period 303 is adjustable by machine.

[0112] In Figure 3B, two exemplary asymmetric bursts 310 are graphically represented. Burst 310 is similar to burst 300, but the pulse voltage or current increases linearly from the first pulse to the last pulse of the burst.

[0113] In Figure 3C, one exemplary symmetrical burst 320 is graphically represented. Burst 320 is similar to bursts 300 and 310, but the pulse voltage or current increases linearly from the first pulse to the last pulse of the burst, and then decreases. Optionally, burst 320 is constructed by applying burst 300 after burst 310.

[0114] Figure 3D shows a detailed diagram of two consecutive biphasic pulses, one of bursts 300, 310, or 320. Optionally, the pulses exhibit a rectangular shape and represent a constant current or constant voltage. Optionally, each pulse includes a positive phase 330 followed by a negative phase 331. Alternatively, the order of the positive and negative phases is reversed. Optionally, the pulse phases are formed such that no net charge transfer occurs during the pulse. Optionally, the positive phase period 332 is identical to the negative phase period 333. Optionally, the inter-pulse period 334 is maintained between two consecutive pulses. Optionally, the inter-pulse period 334 is adjustable by the user of the device. Alternatively, the inter-pulse period 334 is adjustable by the machine.

[0115] Referring here to Figure 4, a portion of exemplary signals 400 obtained by a respiratory sensor included in an implantable device for treating gastrointestinal disorders, according to some embodiments of the subject matter of this disclosure. Optionally, the signal 400 is a voltage signal output from a tension-dependent respiratory sensor implanted in the patient's abdomen or chest. Optionally, the signal 400 can be analyzed by a control unit included in the device, for example, by identifying maximum and minimum values ​​401 and 402 of the signal, thereby synchronizing electrical stimulation with the patient's respiratory cycle.

Claims

1. A subcutaneously implantable device for treating gastrointestinal disorders, comprising a control unit, a power supply, a pulse generator, and a plurality of subcutaneously implanted electrodes adapted to be implanted in electrical contact with a target region of a patient's abdomen, wherein the pulse generator is adapted to be implanted in the target region and to activate the target region by transmitting a stimulating signal through the electrodes, the power supply is adapted to power the pulse generator, and the control unit is adapted to control the power supply.

2. The apparatus according to claim 1, wherein the electrical stimulation is characterized by a maximum voltage of +20V, a maximum current of 20mA, a pulse frequency range of 20Hz to 50Hz, a burst frequency range of 0.2Hz to 4Hz, and a pulse width of 25μs to 300μs.

3. The apparatus according to claim 1, wherein the digestive disorder is at least one of the group consisting of gastroesophageal reflux disease (GERD), gastroparesis, obesity, incontinence, and constipation.

4. The apparatus according to claim 1, wherein the electrical stimulation includes repetitive pulse bursts, the shape of the bursts is set according to a desired physiological effect.

5. The apparatus according to claim 1, further comprising at least one sensor, wherein a stimulus is synchronized with at least one bodily signal acquired by the at least one sensor, the bodily signal comprising at least one of respiration, heart rate, blood pressure, muscle or ligament tension, body position, arousal condition, or muscle activity level, and the sensor comprising at least one selected from the group consisting of an accelerometer, gyroscope, magnetic compass, inclinometer, piezoelectric sensor, electrocardiogram (ECG), electroencephalogram (EEG), electromyograph (EMG), microphone, electrical impedance sensor, oximeter, optical interferometer, pH meter, and optosensor.

6. The apparatus according to claim 1, wherein the apparatus comprises an implantable sensor adapted to be embedded in the esophageal wall and further adapted to sense the acidity level of the esophagus, the sensor further configured to output the acidity level, and a controller further configured to control at least one parameter associated with the fault according to the acidity level.

7. The apparatus according to claim 1, wherein the electrodes are adapted to be embedded on the target region, which is the rectus abdominis muscle and the external oblique muscle.

8. A method for treating digestive system disorders, The implantation of a pulse generator and multiple electrodes subcutaneously in the patient's abdomen, wherein the electrodes are in electrical contact with a target area in the patient's abdomen, and By applying electrical stimulation, the target region is activated. A method that includes this.

9. The method according to claim 8, wherein the target region includes muscle, nerve, muscle-nerve junction, or any combination thereof.

10. The method according to claim 8, wherein the electrical stimulation is optimized to treat the patient's digestive system for altering the flow rate of ingested material in a desired direction.

11. The method according to claim 8, wherein the electrical stimulation comprises a series of current-controlled asymmetric bursts intended to generate asymmetric contractions of selected abdominal muscles, wherein the direction of the rapid phase of the bursts is upward and the direction of the slow phase of the bursts is downward.

12. The method according to claim 10, wherein the modification is a reduction in reflux of ingested material from the patient's stomach into the esophagus, thereby alleviating GERD symptoms.

13. The method according to claim 11, wherein the modification is an increase in the amount of food transported from the patient's stomach to the duodenum, thereby alleviating symptoms of gastroparesis.

14. The method according to claim 11, wherein the modification is an increase in the amount of food ingested from the patient's colon to the rectum, thereby alleviating constipation symptoms.

15. The method according to claim 10, wherein the electrical stimulation comprises a series of current-controlled asymmetric bursts intended to generate asymmetric contractions of selected abdominal muscles, wherein the direction of the rapid phase of the bursts is upward and the direction of the slow phase of the bursts is downward.

16. The method according to claim 10, further comprising implanting at least one sensor, wherein the stimulus is synchronized with at least one bodily signal acquired by the at least one sensor, the sensor including at least one member of an accelerometer, gyroscope, magnetic compass, inclinometer, piezoelectric sensor, electrocardiogram (ECG), electroencephalogram (EEG), electromyograph (EMG), microphone, electrical impedance sensor, oximeter, optical interferometer, pH meter, and optosensor, and the bodily signal including at least one member of respiration, heart rate, blood pressure, muscle or ligament tension, body position, arousal condition, or muscle activity level.

17. The method according to claim 10, wherein activating the target region is adapted to elicit a physical reflex.

18. The method according to claim 10, wherein the reflex includes at least one member of the straining esophageal reflex or the straining peduncle reflex.

19. The method according to claim 10, further comprising measuring the acidity level to control at least one parameter associated with the defect.

20. A method for treating digestive system disorders, The method involves using a pulse generator to apply electrical stimulation to a target area in the patient's abdomen, wherein the stimulation is applied via electrodes, and the electrodes are in electrical contact with the target area in the patient's abdomen. The acidity level of the esophagus is detected by a sensor, and the acidity level is output to a controller, and The controller controls at least one parameter associated with the electrical stimulation according to the acidity level. A method that includes this.

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